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History > 2009 > USA > Health (VII)



Jon Han

How Biology Influences Our Behavior



















A Modest Public Plan


November 29, 2009
The New York Times


It is astonishing, but the question of whether a small slice of Americans should be able to choose between a government-run health insurance plan and private health insurance plans is threatening passage of much-needed health care reform.

Senate Democrats barely mustered enough votes to start debating their reform bill, and some senators who voted to allow debate have said flatly that they will not support the final bill if it retains its public option clauses. If they mean what they say, their defection could make it extremely hard to overcome a Republican-led filibuster.

We got to this juncture because, in an already overheated political debate, no issue has drawn more demagoguery and less rational analysis than the public option. And while both political parties exaggerate what a public plan could do, Republican critics are particularly divorced from reality.

They say the public option would start a government takeover of all health care; interpose government bureaucrats between patients and their doctors; sound the death knell for private insurance; and lead many companies to dump insurance benefits. They also say it could cost taxpayers a lot.

Democrats, meanwhile, claim that competition from a public plan would help drive down insurance premiums and the overall cost of medical care.

We wish the proposed public plan could be powerful enough to demand low rates from health care providers, charge much lower premiums than private plans and attract large numbers of enrollees. But neither the House nor Senate versions would have that kind of power.

Here is what a public option — as structured in the House and Senate bills — would do and would not do:

HOW IT WOULD WORK Both bills would create new insurance exchanges, with an array of plans to choose from, for a limited number of Americans — those who lack group coverage and must buy policies directly from insurers and those who work for small employers, about 30 million people within a few years. With millions of potential new clients, all major insurers are expected to participate. And Congress willing, a new public plan would also be available.

The government would run the public plan, but both the Senate and House versions would require it to compete on a “level playing field.” It would have to follow the same rules as the private plans, meet the same benefit standards, maintain the same reserves, and support itself entirely with premium income, with no federal help beyond start-up money that would have to be repaid.

The secretary of health and human services, as the head of the plan, would have to negotiate rates with health care providers just as the private plans do.

WHAT IT COULDN’T DO Because of intense opposition from conservatives, both bills shunned a more robust public plan that would have had the power to virtually force doctors to serve its beneficiaries — at Medicare rates that are typically less than private plans pay them.

As a result, the current weaker versions could find it difficult to compete with well-entrenched private insurers. The Congressional Budget Office believes public plan premiums would actually end up higher than the average private plan premium. This is partly because the public plan would probably attract the sickest patients, whose bills are highest, and who might fear that private plans would find some way to jettison them.

All told, the C.B.O. estimates that the House bill’s public plan would attract only six million enrollees. The Senate version, which would allow states to opt out, might attract only three million to four million.

This is not going to destroy the private insurance market or start a government takeover of the health care system, or put bureaucrats in control, any more than private plans do. Nevertheless, in a recent Senate debate, Republicans insisted that more than 100 million Americans might enroll in a public plan, the vast majority of them dumped by employers from coverage that they were satisfied with.

That overblown claim is based on a study showing that a much more robust plan could offer far lower premiums than private plans, and if available to virtually everyone, it could attract huge numbers of enrollees.

In that no-longer-relevant scenario, private plans would indeed lose a lot of their subscribers. But workers would still not lose their employer-sponsored benefits. Their employer’s subsidy would follow them to the exchanges, where they would have a much wider choice of plans than they now do. Even in a nightmare scenario that lives only in Republicans’ fevered rhetoric, workers would be better off than they now are.

Although the public plan is supposed to be self-sustaining, critics worry that if it starts to fail, future Congresses will bail it out with taxpayer money. We hope they are wrong. If the public plan gets into financial trouble, it should simply raise its premiums or close.

SO IS IT STILL WORTH DOING? Even with the constraints, a public plan could be a useful part of health care reform. Most important, it would compete in markets dominated by one or two private insurers that can charge more and not worry about losing customers.

The presence of a public plan could serve as a brake on unwarranted premium increases by the private companies. The C.B.O. said a public plan with negotiated rates would place “downward pressure on the premiums of private plans.” A public plan would also provide a safe harbor for people who do not trust the insurance industry and would prefer a government plan even if its premiums were higher. And it would be a place to test innovative ideas for controlling costs and improving quality.

The C.B.O., a notably cautious evaluator, could be wrong in its assessments. The plan might turn out to be better at negotiating lower rates. And with no need to turn a profit, it might be able to charge less than private plans and attract millions more people than expected. That could force private plans to lower their own rates.

We are not holding our breath. The public plan could face enormous practical problems entering markets where private insurers already have well-established networks of providers or where hospital groups already have the upper hand in negotiating with insurers.

Even a weak public plan would be better than no public plan. It would expand the choices available to millions of Americans and could help slow the relentless increases in the cost of health insurance. Congress certainly owes Americans a more rational and informed debate.

This editorial is a part of a continuing series by The New York Times that is providing a comprehensive examination of the policy changes and politics behind the debate over health care reform.

A Modest Public Plan, NYT, 29.11.2009, http://www.nytimes.com/2009/11/29/opinion/29sun1.html






The Cancer Lounge


November 29, 2009
The New York Times


The cancer patient racked them up and broke. Clackety-clack. Seven ball in the corner pocket. Five ball in the side.

Light was seeping out of day. The long, brick-walled room was getting busy. People hooked to IVs in whispered conversation. Others working a jigsaw puzzle. Playing gin rummy. All of them caught in an unwelcome dance with mortality.

This is what passes for pleasure in a cancer hospital.

Paul Gugliotta always sought out the pool table. His game had sharpened beyond expectations. Since a diagnosis of lymphoma in June, Mr. Gugliotta, a chemical engineer from Long Island, had had two lengthy stays at Memorial Sloan-Kettering Cancer Center on the Upper East Side. He chafed at being cooped up in his antiseptic room. He even fled the grounds several times, in violation of the rules, wandering down to the 59th Street Bridge and ordering a hot open-faced turkey sandwich at a nearby diner. Then one day he stumbled upon the recreation center, which can be reached from the hospital’s 15th floor, and it became his nesting ground.

It is something of a cancer patient’s corner bar, minus the booze. Mr. Gugliotta hung around and talked cancer, talked life. He sampled just about everything the center offered. Pottery, copper enameling, blackjack. He made a toolbox, a stained-glass thermometer. His wife, Francine, said, “I never thought I’d see him doing decoupage, but sure enough.”

Now, Mr. Gugliotta, 46, is a commuter, reporting every three weeks for chemotherapy. While the chemicals are mixed, a process that can make patients wait up to two hours, he repairs to the recreation center and begins methodically rocketing balls into pockets. He knows the good cue is stashed in the back. “It’s enjoyable here,” he said. “And it’s where you can talk about what’s inside you, because it’s inside everyone here.”

Nothing about this big room will cure what brings its visitors to Sloan-Kettering. Distraction from the truths and riddles of the vile disease they have, though, is sometimes good enough, a counterpoint to the scientific experiments that fill the rest of the hospital, and to the claustrophobia of their thoughts. It’s a place to have some fun within a building where it’s hard for many who enter to imagine fun.


Putting Fear in Its Place

Recreation centers are staples of nursing homes and pediatric wards, but are unusual in general hospitals for adults. But since Sloan-Kettering is a cancer hospital, patients typically stay a while — the average is six days, and many are there for weeks or even months at a stretch — then return repeatedly as outpatients.

“There is a lot of down time with nothing to do,” said Yolanda Toth, the adult recreation center’s director. “After you’ve counted all the holes in the ceiling of your room and all the blocks and watched enough television, you’re pretty bored. And then you start thinking — what’s going to happen to me?”

Patients can avoid those crushing fears, or confront them, at the center, open daily from 9 a.m. to 8 p.m. The sprawling room, its walls adorned with patient art, contains a pool table, a foosball table, a movie screen, a sitting area and tables for scheduled craft workshops; adjoining it is a terrace with commanding views. Visiting performers appear — comedians, Juilliard students. The library is braced with 12,000 volumes, including plenty of paperbacks; hardcover editions are too heavy for some of the patients.

Doctors or nurses are not allowed in the recreation center. It’s the No White Coats Rule. If they need to see a patient, they call and the person is sent back to their room. “Sometimes doctors will wander in and we will very politely tell them to wander out,” Ms. Toth said.

In a 434-bed hospital, the recreation center got roughly 35,000 visits last year, including from outpatients and family members. At the start of a week, when new patients tend to be admitted, only a few dribble in. Other times, several dozen people populate the place.

Many patients are too weak or straitened by grief to come by, or don’t see the point. Others glide into the center in wheelchairs, even on stretchers. Many pad in rolling IV poles, the dangling drip bags working on their cancer even as they make rag dolls or play cards.


All in the Cards

Texas Hold ’em was Monday evening. Just three patients showed, so the dealer, another volunteer and a visitor joined in. No money changed hands. But there would be prizes.

Douglas Meyers dealt the requisite two cards, accepted bets, turned over the flop. He is 26, a technology project manager at Citibank, who volunteers to deal poker hands. Cancer runs in his family — his mother died of melanoma — and that connection got him engaged.

The weekly poker game commenced in June (before that Mr. Meyers presided over the roulette wheel). Beginners are welcome. Not long ago, though, a former participant in the World Series of Poker landed in the hospital. He sat down and did quite well indeed.

On this Monday, Lee Piepho, 67, was fumbling his way through the hands. An English professor at Sweet Briar College in Virginia, he was in the hospital to address an infection after having had surgery for a soft-tissue sarcoma. And he was rusty. Back in 1958, when he was 16, Mr. Piepho lost $25 in a Chicago poker game, had to nervously explain the sour outcome to his father and abandoned cards. But now this.

Unsure of his instincts, he folded successive hands, then raked in one big pot with a straight, snatched another with two pairs. A young woman shuffled by with her IV trolley, a scarf masking her baldness, and she smiled on his good fortune. Besides cards, Mr. Piepho had been using the center’s library, caught part of the Alfred Hitchcock film “Notorious” the other day, played Speed Scrabble.

He felt comfortable in the center. Among other things, it allowed his cancer to be out front, because it was everywhere in the room. It is those without cancer who felt strange here.

Outside of the hospital, Mr. Piepho rarely speaks of his condition, even to close friends. “I think there’s a certain ethical responsibility about handling cancer,” he said. “There’s a burden you place on people when you tell them you have it. Here there’s no burden. This particular place is common ground.”

Nursing a decent stack of chips, Mr. Piepho played the remaining hands warily, folding miserable cards early. He wound up the winner with a chip count of 19, eclipsing a 68-year-old woman who had had surgery for uterine cancer and now seemed to have a growth in her lungs.

Mr. Piepho collected his prize: a green Brooks Brothers tie.


Oil Painting Is Out

The recreation idea at Sloan-Kettering goes back to 1947, and in the early years the department functioned out of two small second-floor rooms, ferrying activities throughout the hospital. There were some art classes, sewing circles and a little music. A spinet piano was wheeled clumsily from floor to floor.

Two years after Sloan-Kettering opened its new building in 1973, the recreation department earned an entire floor of the old adjoining structure, where it remains. The scope of activities broadened enormously. The place was renovated with a gift from the estate of Abby Rockefeller Mauzé, and is paid for out of the hospital’s operating budget.

Strong odors are avoided, since patients in chemotherapy can develop severe headaches or nausea from potent smells. Therefore, no oil paints. Only stems with mild scents are chosen for the flower-arranging sessions. Busy patterns can make patients dizzy, so solid-colored carpeting and simple tile adorn the floor.

Ms. Toth has years of quirky episodes to recount. A man from Florida was admitted for throat cancer surgery. His parents came up from Maryland to sit at his bedside. Eventually, they began to gnaw at his nerves. He told Ms. Toth that they were jigsaw puzzle nuts. Could she dig up the toughest puzzle she had and get them going on it? She fished out a monster with 1,500 pieces and a fiendish pattern. They spent days attacking it, affording their son the peace he craved.

Six years ago, the mother of a soon-to-be bride was a patient, not doing very well, and the family feared she might not make the wedding. They moved up the date and held the ceremony at the recreation center. A justice of the peace presided. Ms. Toth made the wedding cake.

On New Year’s Eve, the center stays open until 1 a.m. Last year, there was nonalcoholic Champagne and belly dancers. They’re coming again this year.


A Tough Crowd

Maury Fogel said, “Hi, did I wake you?”

He said, “Ever go to the eye doctor and get these magazines with small print? I can’t see, Doc! You get new glasses — it costs you 500 bucks.”


The comedians come twice a month. The rules are: no vulgarity, no death jokes, no cancer jokes, no edgy medical jokes. Mr. Fogel, a messenger who moonlights as a stand-up comedian, puts the bill together. On this night, there was an audience of 14.

Billy Bingo came on. He promotes himself as New York’s Bravest Comic, because he used to be a firefighter. Mr. Bingo said: “People say I look like Sonny Bono. What do you think? I usually get, ‘After the tree.’ ”

He said: “We had a fire in a massage parlor. You want to talk about a fast response! I was already there.”

Some chuckles, an occasional deep-throated laugh. Tough crowd.

Earlier, the “Look Good ... Feel Better” program for women had 10 patients clustered around a square table gazing into makeup mirrors. “We don’t talk about doctors or appointments,” Penny Worth, a former Broadway performer and the program’s coordinator, told them. “We get away from that. Be girls.”

The concept: Teach cancer patients to use makeup and wigs to improve their looks and their spirits. Hence, sharpen eyebrow pencils every day when going through treatment. Wash wigs after six to eight wearings in spring and summer, 12 to 15 in fall and winter.

Afterward, Ms. Worth and the volunteers broke into the old ragtime song “Oh, You Beautiful Doll.”

Josephine Walsh was circling the room. She’s a veteran. She is 84, and has been coming to the recreation center for 22 years from her home in Queens. First she had cancer in a kidney, then breast cancer, and now she is an outpatient. She watched a daughter die of lung cancer at 40.

“My whole life is seeing doctors, trust me,” Ms. Walsh said. She shows up at least once a week, likes to make jewelry, talk to whoever is around. “I ask them where their boo-boo is,” she said. “It’s easy to talk with someone who lives in the same shoes.”

She looked on as a woman from Florida with rectal and lung cancer pasted leaves into a collage, something achieved. The woman inhaled deeply, feeling a little woozy.

Ms. Walsh told her: “You forget all your troubles when you’re in here.”

She told her: “You’ll be well. God bless you.”


The Would-Be Olympian

Stories take hold in the recreation center for moments in time, then relocate, overtaken by new ones. Happy stories, sad stories.

For weeks, one of the odder sights had been the genial young man, usually connected to the IV pole he had nicknamed Bertha, on the terrace doing the regimen he devised: 1,000 jumping jacks, 250 push-ups, 500 situps, 400 lunges. He was training to represent Nigeria in the Olympics in the skeleton, a sledding event.

He was aiming for the 2014 Olympic Winter Games in Sochi, Russia. Nigeria has never sent anyone to the Winter Games in the skeleton. Nigeria has never sent anyone to the Winter Games in anything. And he had never tried the skeleton.

The man’s name is Seun Adebiyi. He is 26. Born in Nigeria, he moved to Alabama with his mother, a math professor, when he was 6. In May, he graduated from Yale Law School. He is on leave from his job as an operations analyst with Goldman Sachs in Salt Lake City. Salt Lake City happens to be one of two places in the country with a facility to practice skeleton. You lie on your stomach and ride the sled at absurd speeds down a twisting course.

Early next year, Mr. Adebiyi intends to take the New York bar exam. Eventually, he hopes to return to Nigeria and try to make the country better. In addition to his workouts, he has been studying for the bar in the center, in jeans and a T-shirt. “I continue to think of me as I was before I came here,” he said. “Wearing the hospital gown is like a form of surrender I’m not willing to do yet.”

Mr. Adebiyi said that he had felt since he was little that he ought to be in the Olympics. For years, he swam competitively. He missed qualifying for the 2004 Summer Games by a tenth of a second in the 50-meter freestyle. The slim miss sent him into a funk.

Last March, he researched alternate events that would be less competitive in Nigeria. Well, winter sports aren’t big in a country without any actual winter. Skeleton seemed the ticket. He had never been on a sled, but so what.

Then in June a swelling he had noticed in his groin led him to find out he had lymphoblastic lymphoma and stem-cell leukemia, two rare and aggressive cancers. As Mr. Adebiyi put it, “It completely reshuffled the deck.”

This was his seventh week at Sloan-Kettering. Chemotherapy had contained things for now. Yet he urgently needed a bone marrow transplant. He has no full siblings. Available donors are sparse for people of African descent. A good donor has not yet been found.

Mr. Adebiyi dealt with the unknown through daily meditation. He began a blog, nigeria2014.wordpress.com, in part to advocate for minority donors, to help others if he can’t help himself.

He liked it at the recreation center. “When you talk about your cancer, you don’t get the intake of breath, the sharp gasp,” he said. “No one is rushing to get anywhere.”

The place provided him needed space from his hospital roommates, of which he’s had 10. He had overheard one on the phone orchestrating his funeral, what sort of urn for his ashes.

Mr. Adebiyi was discharged this month. The search for a donor continues. Those who knew him at the center hope that he will return soon and that the hospital will have something to put in him, give his story a good ending. Meanwhile, he went looking for a used skeleton sled. He needed to practice.

    The Cancer Lounge, NYT, 29.11.2009, http://www.nytimes.com/2009/11/29/nyregion/29cancer.html






Op-Ed Contributor

Fighting the Wrong Health Care Battle


November 29, 2009
The New York Times


Princeton, N.J.

AS the health care debate enters its decisive stage, liberals in Congress should be ready to trade the public option for provisions that will actually make the reforms succeed.

Discussion of the public option — a government insurance plan that would be offered to individuals and small businesses buying coverage through new insurance exchanges — has been dominated by ideological politics. Conservatives claim it would amount to a government takeover, while liberals imagine that it would radically alter the insurance market by providing better protection at lower cost.

As it now stands in Congress, however, the public option would do neither. According to the Congressional Budget Office, it would enroll less than 2 percent of the population and probably have higher premiums than private plans. For progressives to say they will block reform without a public option is not just foolish, but potentially tragic if it results in legislative deadlock.

An earlier version of the public option, available to the entire public, might have realized progressive hopes and conservative fears. By paying doctors and hospitals at Medicare rates (which are 20 percent to 30 percent below those paid by private insurers), the public option would have had a distinct price advantage. But by severely cutting revenue to health-care providers, it would also have set off such a political crisis that Congress would never have passed it.

Instead, the bills in Congress now call for the government plan to negotiate rates with providers, as private insurers do. That limitation exposes a defect in the idea. The government plan may well have to charge higher premiums because it is likely to attract more than its share of the chronically ill and other high-cost subscribers. It could go into a death spiral of mounting costs.

But giving the exchanges the necessary authority to regulate private insurers could solve many of the problems that motivated the public option in the first place. Strengthening that authority and accelerating the timetable for reform are what liberals in Congress should be looking for in a deal.

The basic aim of reform is to create a more efficient and equitable system for health insurance and health care and to provide subsidies so everyone can afford coverage. Those who obtain insurance individually or through small businesses now get a rotten deal in the market. Out of every dollar in premiums they pay, nearly 30 cents goes for administrative overhead (as opposed to about 7 cents in large-employer plans). And those in poor health may be denied coverage for pre-existing conditions or be charged astronomical rates for insurance.

By creating a single, large “risk pool” for individuals and employees of small businesses, the exchanges should give those vulnerable groups the advantages of large-employer plans. The bill would also ban pre-existing condition exclusions and require insurers to offer coverage to everyone in the exchange at the same rate regardless of health (albeit with some adjustment according to age).

For these reforms to succeed, there needs to be effective regulatory authority to prevent insurers from engaging in abusive practices and subverting the new rules. The bill passed by the House would provide for that authority and lodges it in the federal government, though states could take over the exchanges if they met federal requirements. The Senate bill would leave most of the enforcement as well as the running of the exchanges to the states.

Yet many states have a poor record of regulating health insurance, and some would resist passing legislation to conform with the new federal law. Under the Senate bill, the federal government can step in if a state failed to set up an exchange. But it’s hard enough to get reform through Congress; to try to repeat that process in 50 state legislatures would be asking for trouble and guaranteeing delay.

Accelerating the timetable of reform ought to be a priority. Although the legislation calls for some important interim measures, the Senate bill defers opening the exchanges and extending coverage until 2014. By comparison, when Medicare was enacted in 1965, it went into effect the next year.

For Congress to put off expanding coverage to 2014 would be asking for a lot of patience from voters. It would also give the opponents of reform two elections to undo it. President Obama would have to run for re-election in 2012 defending a program from which people would have seen little benefit.

To speed the process, the legislation ought to give states financial incentives to adopt the reforms on their own as early as mid-2011. A state like Massachusetts, which already has a working exchange, could move expeditiously to qualify for federal money. The final deadline for the federal government’s expansion of coverage should be no later than Jan. 1, 2012.

Let the moderate Democrats who oppose the public option say they stopped a government takeover. Liberals should be prepared to give up what is now a mere symbol for changes in the bill that would deliver affordable insurance more effectively and quickly to the millions of Americans who desperately need it.


Paul Starr, a professor of sociology and public affairs at Princeton, was a senior health policy adviser in the Clinton administration.

    Fighting the Wrong Health Care Battle, NYT, 29.11.2009, http://www.nytimes.com/2009/11/29/opinion/29starr.html






Brain Power

Surgery for Mental Ills

Offers Hope and Risk


November 27, 2009
The New York Times


One was a middle-aged man who refused to get into the shower. The other was a teenager who was afraid to get out.

The man, Leonard, a writer living outside Chicago, found himself completely unable to wash himself or brush his teeth. The teenager, Ross, growing up in a suburb of New York, had become so terrified of germs that he would regularly shower for seven hours. Each received a diagnosis of severe obsessive-compulsive disorder, or O.C.D., and for years neither felt comfortable enough to leave the house.

But leave they eventually did, traveling in desperation to a hospital in Rhode Island for an experimental brain operation in which four raisin-sized holes were burned deep in their brains.

Today, two years after surgery, Ross is 21 and in college. “It saved my life,” he said. “I really believe that.”

The same cannot be said for Leonard, 67, who had surgery in 1995. “There was no change at all,” he said. “I still don’t leave the house.”

Both men asked that their last names not be used to protect their privacy.

The great promise of neuroscience at the end of the last century was that it would revolutionize the treatment of psychiatric problems. But the first real application of advanced brain science is not novel at all. It is a precise, sophisticated version of an old and controversial approach: psychosurgery, in which doctors operate directly on the brain.

In the last decade or so, more than 500 people have undergone brain surgery for problems like depression, anxiety, Tourette’s syndrome, even obesity, most as a part of medical studies. The results have been encouraging, and this year, for the first time since frontal lobotomy fell into disrepute in the 1950s, the Food and Drug Administration approved one of the surgical techniques for some cases of O.C.D.

While no more than a few thousand people are impaired enough to meet the strict criteria for the surgery right now, millions more suffering from an array of severe conditions, from depression to obesity, could seek such operations as the techniques become less experimental.

But with that hope comes risk. For all the progress that has been made, some psychiatrists and medical ethicists say, doctors still do not know much about the circuits they are tampering with, and the results are unpredictable: some people improve, others feel little or nothing, and an unlucky few actually get worse. In this country, at least one patient was left unable to feed or care for herself after botched surgery.

Moreover, demand for the operations is so high that it could tempt less experienced surgeons to offer them, without the oversight or support of research institutions.

And if the operations are oversold as a kind of all-purpose cure for emotional problems — which they are not, doctors say — then the great promise could quickly feel like a betrayal.

“We have this idea — it’s almost a fetish — that progress is its own justification, that if something is promising, then how can we not rush to relieve suffering?” said Paul Root Wolpe, a medical ethicist at Emory University.

It was not so long ago, he noted, that doctors considered the frontal lobotomy a major advance — only to learn that the operation left thousands of patients with irreversible brain damage. Many promising medical ideas have run aground, Dr. Wolpe added, “and that’s why we have to move very cautiously.”

Dr. Darin D. Dougherty, director of the division of neurotherapeutics at Massachusetts General Hospital and an associate professor of psychiatry at Harvard, put it more bluntly. Given the history of failed techniques, like frontal lobotomy, he said, “If this effort somehow goes wrong, it’ll shut down this approach for another hundred years.”


A Last Resort

Five percent to 15 percent of people given diagnoses of obsessive-compulsive disorder are beyond the reach of any standard treatment. Ross said he was 12 when he noticed that he took longer to wash his hands than most people. Soon he was changing into clean clothes several times a day. Eventually he would barely come out of his room, and when he did, he was careful about what he touched.

“It got so bad, I didn’t want any contact with people,” he said. “I couldn’t hug my own parents.”

Before turning to writing, Leonard was a healthy, successful businessman. Then he was struck, out of nowhere, with a fear of insects and spiders. He overcame the phobias, only to find himself with a strong aversion to bathing. He stopped washing and could not brush his teeth or shave.

“I just looked horrible,” he said. “I had a big, ugly beard. My skin turned black. I was afraid to be seen out in public. I looked like a street person. If you were a policeman, you would have arrested me.”

Both tried antidepressants like Prozac, as well as a variety of other medications. They spent many hours in standard psychotherapy for obsessive-compulsive disorder, gradually becoming exposed to dreaded situations — a moldy shower stall, for instance — and practicing cognitive and relaxation techniques to defuse their anxiety.

To no avail.

“It worked for a while for me, but never lasted,” Ross said. “I mean, I just thought my life was over.”

But there was one more option, their doctors told them, a last resort. At a handful of medical centers here and abroad, including Harvard, the University of Toronto and the Cleveland Clinic, doctors for years have performed a variety of experimental procedures, most for O.C.D. or depression, each guided by high-resolution imaging technology. The companies that make some of the devices have supported the research, and paid some of the doctors to consult on operations.

In one procedure, called a cingulotomy, doctors drill into the skull and thread wires into an area called the anterior cingulate. There they pinpoint and destroy pinches of tissue that lie along a circuit in each hemisphere that connects deeper, emotional centers of the brain to areas of the frontal cortex, where conscious planning is centered.

This circuit appears to be hyperactive in people with severe O.C.D., and imaging studies suggest that the surgery quiets that activity. In another operation, called a capsulotomy, surgeons go deeper, into an area called the internal capsule, and burn out spots in a circuit also thought to be overactive.

An altogether different approach is called deep brain stimulation, or D.B.S., in which surgeons sink wires into the brain but leave them in place. A pacemaker-like device sends a current to the electrodes, apparently interfering with circuits thought to be hyperactive in people with obsessive-compulsive disorder (and also those with severe depression). The current can be turned up, down or off, so deep brain stimulation is adjustable and, to some extent, reversible.

In yet another technique, doctors place the patient in an M.R.I.-like machine that sends beams of radiation into the skull. The beams pass through the brain without causing damage, except at the point where they converge. There they burn out spots of tissue from O.C.D.-related circuits, with similar effects as the other operations. This option, called gamma knife surgery, was the one Leonard and Ross settled on.

The institutions all have strict ethical screening to select candidates. The disorder must be severe and disabling, and all standard treatments exhausted. The informed-consent documents make clear that the operation is experimental and not guaranteed to succeed.

Nor is desperation by itself sufficient to qualify, said Richard Marsland, who oversees the screening process at Butler Hospital in Providence, R.I., which works with surgeons at Rhode Island Hospital, where Leonard and Ross had the operation.

“We get hundreds of requests a year and do only one or two,” Mr. Marsland said. “And some of the people we turn down are in bad shape. Still, we stick to the criteria.”

For those who have successfully recovered from surgery, this intensive screening seems excessive. “I know why it’s done, but this is an operation that could make the difference between life and death for so many people,” said Gerry Radano, whose book “Contaminated: My Journey Out of Obsessive-Compulsive Disorder” (Bar-le-Duc Books, 2007), recounts her own suffering and long recovery from surgery. She also has a Web site, freeofocd.com, where people from around the world consult with her.

But for the doctors running the programs, this screening is crucial. “If patients are poorly selected or not followed well, there’ll be an increasing number of bad outcomes, and the promise of this field will wither away,” said Dr. Ben Greenberg, the psychiatrist in charge of the program at Butler.

Dr. Greenberg said about 60 percent of patients who underwent either gamma knife surgery or deep brain stimulation showed significant improvement, and the rest showed little or no improvement. For this article, he agreed to put a reporter in touch with one — Leonard — who did not have a good experience.


The Danger of Optimism

The true measure of an operation, medical ethicists say, is its overall effect on a person’s life, not only on specific symptoms.

In the early days of psychosurgery, after World War II, doctors published scores of papers detailing how lobotomy relieved symptoms of mental distress. In 1949, the Portuguese neurologist Egas Moniz won the Nobel Prize in medicine for inventing the procedure.

But careful follow-up painted a darker picture: of people who lost motivation, who developed the helpless indifference dramatized by the post-op rebel McMurphy in Ken Kesey’s novel “One Flew Over the Cuckoo’s Nest,” played by Jack Nicholson in the 1975 movie.

The newer operations pinpoint targets on specific, precisely mapped circuits, whereas the frontal lobotomy amounted to a crude slash into the brain behind the eyes, blindly mangling whatever connections and circuits were in the way. Still, there remain large gaps in doctors’ understanding of the circuits they are operating on.

In a paper published last year, researchers at the Karolinska Institute in Sweden reported that half the people who had the most commonly offered operations for obsessive-compulsive disorder showed symptoms of apathy and poor self-control for years afterward, despite scoring lower on a measure of O.C.D. severity.

“An inherent problem in most research is that innovation is driven by groups that believe in their method, thus introducing bias that is almost impossible to avoid,” Dr. Christian Ruck, the lead author of the paper, wrote in an e-mail message. The institute’s doctors, who burned out significantly more tissue than other centers did, no longer perform the operations, partly, Dr. Ruck said, as a result of his findings.

In the United States, at least one patient has suffered disabling brain damage from an operation for O.C.D. The case led to a $7.5 million judgment in 2002 against the Ohio hospital that performed the procedure. (It is no longer offered there.)

Most outcomes, whether favorable or not, have had less remarkable immediate results. The brain can take months or even years to fully adjust after the operations. The revelations about the people treated at Karolinska “underscore the importance of face-to-face assessments of adverse symptoms,” Dr. Ruck and his co-authors concluded.


The Long Way Back

Ross said he felt no difference for months after surgery, until the day his brother asked him to play a video game in the basement, and down the stairs he went.

“I just felt like doing it,” he said. “I would never have gone down there before.”

He said the procedure seemed to give the psychotherapy sessions a chance to work, and last summer he felt comfortable enough to stop them. He now spends his days studying, going to class, playing the odd video game to relax. He has told friends about the operation, he said, “and they’re O.K. with it — they know the story.”

Leonard is still struggling, for reasons no one understands. He keeps odd hours, working through most nights and sleeping much of the day. He is not unhappy, he said, but he has the same aversion to washing and still lives like a hermit.

“I still don’t know why I’m like this, and I would still try anything that could help,” he said. “But at this point, obviously, I’m skeptical of the efficacy of surgery, at least for me.”

Ms. Radano, who wrote the book about her recovery, said the most important thing about the surgery was that it gave people a chance. “That’s all people in this situation want, and I know because I was there,” she said while getting into her car on a recent afternoon.

On the passenger seat was a container of decontaminating hand wipes. She pointed and laughed. “See? You’re never completely out.”

    Surgery for Mental Ills Offers Hope and Risk, NYT, 27.11.2009, http://www.nytimes.com/2009/11/27/health/research/27brain.html






Trying to Explain a Drop

in Infant Mortality


November 27, 2009
The New York Times


MADISON, Wis. — Seven and a half months into Ta-Shai Pendleton’s first pregnancy, her child was stillborn. Then in early 2008, she bore a daughter prematurely.

Soon after, Ms. Pendleton moved from a community in Racine that was thick with poverty to a better neighborhood in Madison. Here, for the first time, she had a full-term pregnancy.

As she cradled her 2-month-old daughter recently, she described the fear and isolation she had experienced during her first two pregnancies, and the more embracing help she found 100 miles away with her third. In Madison, county nurses made frequent home visits, and she got more help from her new church.

The lives and pregnancies of black mothers like Ms. Pendleton, 21, are now the subject of intense study as researchers confront one of the country’s most intractable health problems: the large racial gap in infant deaths, primarily due to a higher incidence among blacks of very premature births.

Here in Dane County, Wis., which includes Madison, the implausible has happened: the rate of infant deaths among blacks plummeted between the 1990s and the current decade, from an average of 19 deaths per thousand births to, in recent years, fewer than 5.

The steep decline, reaching parity with whites, is particularly intriguing, experts say, because obstetrical services for low-income women in the county have not changed that much.

Finding out what went right in Dane County has become an urgent quest — one that might guide similar progress in other cities. In other parts of the state, including Milwaukee, Racine and two other counties, black infant death rates remain among the nation’s highest, surpassing 20 deaths per thousand in some areas.

Nationwide for 2007, according to the latest federal data, infant mortality was 6 per 1,000 for whites and 13 for blacks.

“This kind of dramatic elimination of the black-white gap in a short period has never been seen,” Dr. Philip M. Farrell, professor of pediatrics and former dean of the University of Wisconsin School of Medicine and Public Health, said of the progress in Dane County.

“We don’t have a medical model to explain it,” Dr. Farrell added, explaining that no significant changes had occurred in the extent of prenatal care or in medical technology.

Without a simple medical explanation, health officials say, the decline appears to support the theory that links infant mortality to the well-being of mothers from the time they were in the womb themselves, including physical and mental health; personal behaviors; exposure to stresses, like racism; and their social ties.

Those factors could in turn affect how well young women take care of themselves and their pregnancies.

Karen Timberlake, the Wisconsin secretary of health services, said that in Dane County, the likely explanation lay in “the interaction among a variety of interrelated factors.”

“Our challenge is,” Ms. Timberlake said, “how can we distill this and take it to other counties?”

Only about 5 percent of Dane County’s population is black, and the sharp drop in the mortality rate also tracked larger declines in the numbers of very premature and underweight births for blacks, said Dr. Thomas L. Schlenker, the county director of public health.

A three-year study, led by Dr. Gloria E. Sarto of the University of Wisconsin, is using tools including focus groups and research on pollution to compare the experiences of black mothers here with those in Racine County, which has the highest black infant mortality in the state.

It is not hard to imagine why death rates would be lower in Dane County than in Racine, which is more segregated and violent, or in Milwaukee, a larger city. Dane County has a greater array of public and private services, but pinpointing how they may have changed over the decade in ways that made a difference is the challenge.

Dr. Schlenker, the county health director, credits heightened outreach to young women by health workers and private groups. “I think it’s a community effect,” he said. “Pregnant women need to feel safe, cared for and valued. I believe that when they don’t, that contributes to premature birth and fetal loss in the sixth or seventh month.”

He pointed to services that started in the mid-90s and have gathered steam. For instance, a law center, ABC for Health, has increasingly connected poor women with insurance and medical services. He said local health maintenance organizations were now acting far more assertively to promote the health of prospective mothers.

And a federally supported clinic, Access Community Health Center, which serves the uninsured and others, has cared for a growing number of women using nurse-midwives, who tend to bond with pregnant women, spending more time on appointments and staying with them through childbirth.

County nurses visit low-income women at high risk of premature birth, providing transportation to appointments and referrals to antismoking programs or antidepression therapies. Another program sends social workers into some homes. The programs exist statewide, but in Milwaukee, Racine and other areas they do not appear to have achieved the same broad coverage, said Ms. Timberlake, the state health leader.

And community leaders in Dane County, shocked by high mortality rates, started keeping closer watch on young pregnant women.

“The African-American community in Madison is close-knit,” said Carola Gaines, a black leader and coordinator of Medicaid services for a private insurance plan.

Similar community efforts are now being promoted in other struggling cities.

Brandice Hatcher, 26, who recently moved into a new, subsidized apartment in Madison, spent her first 18 years in foster care in Chicago before moving two years ago.

When she learned last June that she was pregnant, Ms. Hatcher said, “I didn’t know how to be a parent and I didn’t know what services could help me.”

Over the summer she started receiving monthly visits from Laura Berger, a county nurse, who put her in touch with a dentist. That was not just a matter of comfort; periodontal disease elevates the risk of premature birth, increasing the levels of a labor-inducing chemical.

Ms. Hatcher had been living in a rooming house, but she was able to get help from a program that provided a security deposit for her apartment. She attained certification as a nursing assistant while awaiting childbirth.

Under a state program, a social worker visits weekly and helps her look for jobs. And she receives her prenatal care from the community center’s nurse-midwives. A church gave her baby clothes and a changing table.

Ms. Hatcher said she would not do anything to jeopardize her unborn baby’s prospects. She has named her Zaria and is collecting coins and bills in a glass jar, the start, she said, of Zaria’s personal savings account.

    Trying to Explain a Drop in Infant Mortality, NYT, 27.11.2009, http://www.nytimes.com/2009/11/27/us/27infant.html






From the Hospital Room

to Bankruptcy Court


November 25, 2009
The New York Times


NASHVILLE — Some of the debtors sitting forlornly in this city’s old stone bankruptcy court have lost a job or gotten divorced. Others have been summoned to face their creditors because they spent mindlessly beyond their means. But all too often these days, they are there merely because they, or their children, got sick.

Wes and Katie Covington, from Smyrna, Tenn., were already in debt from a round of fertility treatments when complications with her pregnancy and surgery on his knee left them with unmanageable bills. For Christine L. Phillips of Nashville, it was a $10,000 trip to the emergency room after a car wreck, on the heels of costly operations to remove a cyst and repair a damaged nerve.

Jodie and Charlie Mullins of Dickson, Tenn., were making ends meet on his patrolman’s salary until she developed debilitating back pain that required spinal surgery and forced her to quit nursing school. As with many medical bankruptcies, they had health insurance but their policy had a $3,000 deductible and, to their surprise, covered only 80 percent of their costs.

“I always promised myself that if I ever got in trouble, I’d work two jobs to get out of it,” said Mr. Mullins, a 16-year veteran of the Dickson police force. “But it gets to the point where two or three or four jobs wouldn’t take care of it. The bills just were out of sight.”

Although statistics are elusive, there is a general sense among bankruptcy lawyers and court officials, in Nashville as elsewhere, that the share of personal bankruptcies caused by illness is growing.

In the campaign to broaden support for the overhaul of American health care, few arguments have packed as much rhetorical punch as the there-but-for-the-grace-of-God notion that average families, through no fault of their own, are going bankrupt because of medical debt.

President Obama, in addressing a joint session of Congress in September, called on lawmakers to protect those “who live every day just one accident or illness away from bankruptcy.” He added: “These are not primarily people on welfare. These are middle-class Americans.”

The Senate majority leader, Harry Reid of Nevada, made a similar case on Saturday in a floor speech calling for passage of a measure to open debate on his chamber’s health care bill.

The legislation moving through Congress would attack the problem in numerous ways.

Bills in both houses would expand eligibility for Medicaid and provide health insurance subsidies for those making up to four times the federal poverty level. Insurers would be prohibited from denying coverage to those with pre-existing health conditions. Out-of-pocket medical costs would be capped annually.

How many personal bankruptcies might be avoided is unpredictable, as it is not clear how often medical debt plays a back-breaking role. There were 1.1 million personal bankruptcy filings in 2008, including 12,500 in Nashville, and more are expected this year.

Last summer, Harvard researchers published a headline-grabbing paper that concluded that illness or medical bills contributed to 62 percent of bankruptcies in 2007, up from about half in 2001. More than three-fourths of those with medical debt had health insurance.

But the researchers’ methodology has been criticized as defining medical bankruptcy too broadly and for the ideological leanings of its authors, some of whom are outspoken advocates for nationalized health care.

At the bankruptcy court in Nashville, lawyers provided a spectrum of estimates for the share of cases in Middle Tennessee where medical debt was decisive, from 15 percent to 50 percent. But many said they felt the number had been growing, and might be higher than was obvious because medical bills are often disguised as credit card debt.

“This has really become the insurance system for the country,” said Susan R. Limor, a bankruptcy trustee who calculated that 13 of the 48 Chapter 7 liquidation cases on her docket one recent afternoon included medical debts of more than $1,000.

Under Chapter 7, a debtor’s assets are liquidated and the proceeds are used to pay creditors; any remaining debts are discharged, and filers are left with a 10-year stain on their credit ratings.

“You can’t believe how many people discharge medical debts,” Ms. Limor said. “It’s a kind of trailing indicator of who’s suffering in this economy.”

Kyle D. Craddock, a bankruptcy lawyer here, said his medical cases were heartbreaking because the financial devastation was so rapid and ill-timed. “They’re sick, they’re bankrupt, and if they stay sick for too long, they end up losing their jobs as well,” he said.

That was the case for Ms. Phillips, 45, who said she was fired in October from her job in a shipping department because she had missed so much work while recuperating from her car accident and operations. Her firing came only 11 days after she filed for bankruptcy, listing about $7,000 in unpaid medical bills among her $187,000 in liabilities.

“The medical bills put me over the edge,” said Ms. Phillips, who lost her health insurance along with her job. “I had no money for food at this point. How was I going to do it?”

It was the same for the Mullinses, who have two children. They had a mortgage and owed money on credit cards and student loans. “But the medical problem is what took us down,” said Ms. Mullins, who is packing to move from the two-bedroom house they will soon surrender to Wells Fargo. “Everything was due, they wanted their money now, now, now, and it just became overwhelming.”

For some, like Nathan W. Hale, 34, who had an attack of pancreatitis two months after losing his job with a Nashville cable company, it is the absence of insurance that pulls them under. Others, like Robin P. Herron, 35, of Eagleville, Tenn., have insurance, but it is not enough. Her Blue Cross Blue Shield policy covered only 80 percent of the cost when her daughter needed surgery to remove a cyst from a fallopian tube, leaving her $6,000 in debt.

After cortisone injections failed to cure his gimpy knee, Mr. Covington, 31, had surgery because the pain was forcing him to miss days of work as an emergency medical technician. His recovery kept him off the job for five months.

Simultaneously, his wife, a 911 dispatcher, developed sciatica while pregnant and had to take months off on reduced disability pay. Their insurance policy, with an $850 monthly premium, has a $4,000 annual deductible per family.

As the bills rolled in, the Covingtons compounded their troubles by placing medical charges on credit cards, simply to make the collection agencies stop calling. They fell months behind on their mortgage, and by August had lost their house and both cars.

Mr. Covington, who has taken a second job, said he found it ironic that it had not been the recession that forced them into bankruptcy. “I tell my wife that we beat the economy,” he said, “but health care beat us.”

    From the Hospital Room to Bankruptcy Court, NYT, 25.11.2009, http://www.nytimes.com/2009/11/25/health/policy/25bankruptcy.html






Scared and Silent, Runaway, 13,

Spent 11 Days in the Subways


November 24, 2009
The New York Times


Day after day, night after night, Francisco Hernandez Jr. rode the subway. He had a MetroCard, $10 in his pocket and a book bag on his lap. As the human tide flowed and ebbed around him, he sat impassively, a gangly 13-year-old boy in glasses and a red hoodie, speaking to no one.

After getting in trouble in class in Bensonhurst, Brooklyn, and fearing another scolding at home, he had sought refuge in the subway system. He removed the battery from his cellphone. “I didn’t want anyone to scream at me,” he said.

All told, Francisco disappeared for 11 days last month — a stretch he spent entirely in subway stations and on trains, he says, hurtling through four boroughs. And somehow he went undetected, despite a round-the-clock search by his panicked parents, relatives and family friends, the police and the Mexican Consulate.

Since Oct. 26, when a transit police officer found him in a Coney Island subway station, no one has been able to fully explain how a boy could vanish for so long in a busy train system dotted with surveillance cameras and fliers bearing his photograph.

But this was not a typical missing-person search. Francisco has Asperger’s syndrome, a form of autism that often causes difficulty with social interaction, and can lead to seemingly eccentric behavior and isolation. His parents are Mexican immigrants, who say they felt the police were slow to make the case a priority.

“Maybe because you might not understand how to manage the situation, because you don’t speak English very well, because of your legal status, they don’t pay you a lot of attention,” said Francisco’s mother, Marisela García, 38, a housecleaner who immigrated in 1994 and has struggled to find ways to help her son.

The police, however, say they took the case seriously from the start, interviewing school officials and classmates, canvassing neighborhoods and leafleting all over the city.

Francisco says his odyssey wound through three subway lines: the D, F and No. 1. He would ride a train until its last stop, then wait for the next one, wherever it was headed. He says he subsisted on the little he could afford at subway newsstands: potato chips, croissants, jelly rolls, neatly folding the wrappers and saving them in the backpack. He drank bottled water. He used the bathroom in the Stillwell Avenue station in Coney Island.

Otherwise, he says, he slipped into a kind of stupor, sleeping much of the time, his head on his book bag. “At some point I just stopped feeling anything,” he recalled.

Though the boy’s recollections are incomplete, and neither the police nor his family can retrace his movements in detail, the authorities say that he was clearly missing for 11 days and that they have no evidence he was anywhere but the subway.

For his parents, the memories of those 11 frantic days — the dubious sightings, the dashed hopes and no sleep — remain vivid. “It’s the most terrible thing,” his mother said in Spanish.

Just what propelled Francisco to take flight on Oct. 15 is unclear. Administrators at his school, Intermediate School 281, would not comment. But Francisco said he had failed to complete an assignment for an eighth-grade class, and was scolded for not concentrating.

After school, he phoned his mother to say he was heading home. She told him the school had called and she wanted a serious talk with him.

His first impulse was to flee. He walked eight blocks to the Bay Parkway station and boarded a D train. It seemed a safe place to hide, he said.

When he did not arrive home, his mother started to panic. In January, after another problem at school, Francisco had left home and ridden the subway, but returned after five hours. “We thought this time it would be the same,” Ms. García said. “But unfortunately it wasn’t.”

Her husband, also named Francisco Hernandez, went to the nearest subway station and waited for several hours while she stayed at home on Bay 25th Street with their 9-year-old daughter, Jessica. After midnight, the couple called the police, and two officers from the 62nd Precinct visited their apartment.

The next morning, Mr. Hernandez, 32, a construction laborer, borrowed a bicycle and scoured Bensonhurst. He and his wife separately explored the subway from Coney Island to Midtown Manhattan.

They had been trying to help their son for years. Born in Brooklyn, Francisco grew up a normal child in many ways, his mother said, earning mostly passing grades and enjoying drawing and video games. But he had no friends outside school, and found it difficult to express emotions. A gentle, polite boy, he spoke — when he did speak — in a soft monotone.

In 2006, his parents had him evaluated at a developmental disabilities research clinic on Staten Island, where his Asperger’s was diagnosed. The clinic’s chief neuropsychologist concluded that Francisco struggled in situations that demanded a “verbal or social response.”

“His anxiety level can elevate, and he freezes in confusion because he does not know what to do or say,” the doctor wrote.

After he disappeared, his parents printed more than 2,000 color leaflets with a photo of Francisco wearing the same red hoodie; friends and relatives helped post them in shops, on the street and throughout the subway in Brooklyn. The family hand-lettered fluorescent-colored signs.

“Franky come home,” one pleaded in Spanish. “I’m your mother I beg you I love you my little boy.”

Francisco said he never saw the signs. He lost sense of time. He was prepared, he said, to remain in the subway system forever.

No one spoke to him. Asked if he saw any larger meaning in that, he said, “Nobody really cares about the world and about people.”

Sightings were reported. An image of a boy resembling Francisco had been captured by a video game store’s security camera, but he turned out to be someone else, the police said. A stranger called Mr. Hernandez to say he had spotted Francisco with some boys at a movie theater in Sheepshead Bay, Brooklyn. A search turned up nothing.

Ms. García said one detective told her the boy was probably hiding out with a friend. She replied that her son had no friends to hide out with. Frustrated, the parents sought help from the Mexican Consulate. Officials there contacted the Spanish-language news media, which ran brief newspaper and television reports about Francisco, and called the police — “to use the weight that we have to encourage them, to tell them that we have an emergency,” a consular spokesman said.

Six days after Francisco’s disappearance, on Oct. 21, the case shifted from the police precinct to the Missing Persons Squad, and the search intensified. A police spokeswoman explained that a precinct must complete its preliminary investigation before the squad takes over.

The squad’s lead investigator on the case, Detective Michael Bonanno, said he turned the focus to the subway. He and his colleagues blanketed the system with their own signs, rode trains and briefed station attendants.

About 6 a.m. on Oct. 26, the police said, a transit officer stood on the D train platform at the Stillwell Avenue station studying a sign with Francisco’s photo. He turned and spotted a dirty, emaciated boy sitting in a stopped train. “He asked me if I was Francisco,” the boy recalled. “I said yes.”

Asked later how it felt to hear about the work that had gone into finding him, Francisco said he was not sure. “Sometimes I don’t know how I feel,” he said. “I don’t know how I express myself sometimes.”

Apart from leg cramps, he was all right physically, and returned to school a week later. But Ms. García said she was still trying to learn how to manage her son’s condition. Though doctors had recommended that Francisco be placed in a small school for children with learning disorders, she said, officials at his school told her he was testing fine and did not need to be transferred.

“I tell him: ‘Talk to me. Tell me what you need. If I ever make a mistake, tell me,’ ” she said. “I don’t know, as a mother, how to get to his heart, to find out what hurts.”

One of the fluorescent signs hangs on the living room wall. The others are stacked discreetly in a corner, and Ms. García said she was not ready to discard them.

“It’s not easy to say it’s over and it won’t happen again,” she said.

    Scared and Silent, Runaway, 13, Spent 11 Days in the Subways, NYT, 24.11.2009, http://www.nytimes.com/2009/11/24/nyregion/24runaway.html






Shifting Vaccine for Flu to Elderly


November 24, 2009
The New York Times


Federal health officials are trying to shift supplies of the seasonal flu vaccine away from chain pharmacies and supermarkets to nursing homes, hoping to counter a shortage that threatens to cause a wave of deaths this winter among the nation’s most vulnerable population.

The extent of the shortage is still unclear, but Janice Zalen, director of special programs for the American Health Care Association, which represents 11,000 nursing homes and assisted-living facilities, called it “a very big problem.”

Ms. Zalen said that of 1,000 nursing home managers who responded to a survey of the association’s 11,000 members, 800 reported they could not get enough vaccine.

Dr. Carol Friedman, head of adult immunization at the Centers for Disease Control and Prevention, said she did not have a figure for the size of the shortage, but added, “It’s a problem, and it’s all over the country.”

Mary Hahn, who manages six Ohio nursing homes with 800 beds, said she could not get vaccine for any of her patients.

“It’s just so disheartening, because we’re having to leave people unprotected,” she said. “You see people get flus and get sent to the hospital because they really can’t fight it off.”

A nationwide shortage of the seasonal flu vaccine has been reported for several weeks, but nursing homes and their suppliers have grown more alarmed in recent days. Of the 36,000 Americans who die of seasonal flu in the average year, more than 90 percent are 65 or older, and nursing home outbreaks are particularly deadly. By contrast, the swine flu epidemic has been most deadly among younger people.

The nursing homes’ predicament has been caused by a confluence of factors. Because of the swine flu pandemic, far more people than usual are seeking vaccination, Dr. Friedman said — even though the seasonal vaccine does not protect against swine flu.

The five companies licensed to make flu shots for the United States originally planned to make only slightly more than the 118 million they made in 2008. Then, production problems caused GlaxoSmithKline to cut its run by half; Novartis’s shrank by 10 percent. Then all five companies had to switch over early to making swine flu vaccine.

So the total supply of vaccine is about 114 million doses, of which about 95 million have been shipped.

At the same time, reports of price gouging have grown more frequent. That also happened in 2004, when sterility problems at a British plant cut the American flu vaccine supply in half; prices shot up as high as $90 a dose, from the normal level of $8 to $9.

Gouging is illegal in about half the states, but each state varies in how big a price increase constitutes gouging and as to whether an emergency must have been declared for the law to kick in.

“To pursue a case, we need to show it’s not just a couple of dollars but is very significant,” said Attorney General Richard Blumenthal of Connecticut, who has opened an investigation.

Criminal charges are less likely than a civil suit, Mr. Blumenthal said. But he added that if distributors were “masquerading or fraudulently claiming to have vaccine,” that could end in a criminal charge. While he had suspicions, he said, “we don’t have hard evidence yet.”

Dr. Friedman said that once the agency became aware of the shortage at nursing homes, “we began working with the manufacturers to see if they could redirect some of their vaccine.”

“Several big-box retailers and pharmacies volunteered to go into the long-term-care facilities and set up flu clinics,” she said.

Dr. Friedman said she knew of one major supplier to nursing homes that received 100,000 fewer doses from the vaccine makers than it had ordered. Her agency began acting as a broker among the homes, vaccine distributors and other customers. Since then, she said, that supplier has found about 50,000 more doses.

“That’s definitely not going to close the gap,” she said, “but it will help.”

Also, both she and Ms. Zalen said, pharmacy and supermarket chains like Walgreen’s and Safeway that bought millions of doses to sell for $25 to $30 have offered to give shots in nursing homes. They do not charge but get Medicare reimbursements, which vary by state but run up to $25.

By contrast, Bob McKay, chief of sales for PharMerica, one of the two largest wholesale pharmacies supplying nursing homes, said he had received 95 percent of the 300,000 doses he ordered and “the voids are getting filled in” at the nursing homes he supplies.

“We’re not hearing rage and craziness out there,” Mr. McKay said. “If a lot of homes were still short, they’d be beating our doors down.”

But he said he had asked some not to buy shots for their staffs. Flu experts say that in nursing homes, vaccination of staff members is just as important as patient vaccination.

Prices offered to PharMerica for the extra doses they needed were “in the $15-$16 range,” Mr. McKay said. “That’s more than we’d normally pay, but not price-gouging.”

Jim Mathews, an executive at Hometown Pharmacy, a smaller wholesale pharmaceutical company supplying Michigan nursing homes, said that late last month he found himself 3,000 doses short; his usual supplier, which charges $6.75 per dose, was out of stock. He called the C.D.C. for advice, was directed to a Web page listing other suppliers and contacted all 10. Only one had vaccine, and it sent him a fax in broken English asking for $57 to $59 per dose.

Mr. Mathews said he reported that to local law enforcement officials, but he is more worried about the patients who will not get shots.

“When I first recognized the potential death toll from this shortage, there was time to prioritize the remaining supply for the most vulnerable elderly,” he said. “Now I’m afraid it’s too late. From what I see, the seasonal flu vaccine shortage is going to cost more lives than the H1N1 shortage is.”

Dr. Friedman, of the C.D.C., said she had heard of “about 15” price-gouging complaints.

Dr. Lillian Overman, an internist in East Hartford, Conn., was one of the first to alert Mr. Blumenthal, the state’s attorney general, about gouging accusations. On Oct. 26, her office manager began looking for vaccine, for which she normally pays $8.50 a dose. A saleswoman at ABO Pharmaceuticals in San Diego wanted $60 per dose, she said.

“That’s just prohibitive,” a frustrated Dr. Overman said. “If I’d known there would be a shortage, I would have called in my most vulnerable patients first.”

Mark Nemeth, an ABO sales manager, denied that anyone there had asked for $60.

“I can guarantee you without a shadow of a doubt, we would never have offered it at that price,” he said; the company is asking “in the ballpark of $12 to $14” for its remaining supplies.

    Shifting Vaccine for Flu to Elderly, NYT, 24.11.2009, http://www.nytimes.com/2009/11/24/health/24flu.html






Health Care Debate

Revives Abortion Campaigners


November 24, 2009
The New York Times


WASHINGTON — Lobbying over abortion was turning into a sleepy business. But the health care debate has brought a new boom, and both sides are exploiting it with fund-raising appeals.

“The reaction has been phenomenal, like a match dropped on dry kindling,” said Cecile Richards, president of the Planned Parenthood Federation of America.

Abortion opponents have been blanketing their supporters with solicitations and alarms since House Democrats laid out their health care proposals three months ago. “The largest expansion of abortion since Roe vs. Wade,” warns the Web site Stop the Abortion Mandate, which directs visitors to sign up with the anti-abortion fund-raising group Susan B. Anthony List.

“It is far and away, in the history of our group, the biggest fulcrum of activism we have ever had,” said Marjorie Dannenfelser, the group’s president, adding that the 12-year-old organization has seen its contributions spike more than 50 percent from 2007, the last year without a national election. Among other things, her group is using the money for automated phone campaigns in pivotal states and spending more than $130,000 on an advertising campaign aimed at Senator Harry Reid, the Democratic leader, in his home state of Nevada. (The National Right to Life Committee is soliciting donations at stoptheabortionagenda.com.)

Abortion-rights groups got into the act two weeks ago, when the House of Representatives adopted an amendment sponsored by Representative Bart Stupak, Democrat of Michigan, to block the use of federal subsidies for policies that cover abortion. “Stop Abortion Coverage Ban!,” declares an online solicitation from NARAL Pro-Choice America, warning that “Women could lose the right to use their own personal, private funds to purchase an insurance plan with abortion coverage in the new health system.”

“Stop Stupak!,” is the headline of a new online petition that doubles as a fund-raiser for Emily’s List, which raises money for female candidates who support abortion rights. The group’s president, Ellen Malcolm, said in an interview that she had not seen such an outpouring of support since Webster vs. Reproductive Health Services, the 1989 Supreme Court decision that appeared to re-open the question of a right to the procedure.

“Women are up in arms,” Ms. Malcolm said, adding that her group had made an exception to its no-lobbying policy to pressure the women it helped elect.

This week the Web site of Cosmopolitan Magazine carried a “Secrets and Advice” column entitled “Are Your Rights in Jeopardy?” that directed readers to a similar “Stop Stupak” Web site from the Planned Parenthood Federation of America. A third “Stop Stupak” campaign, by a group called the Progressive Change Campaign Committee, has raised more than $23,000 from more than 700 donors since it started Nov. 11, according to its host, the online fund-raising venture ActBlue.

“We have seen money coming in at every level,” said Ms. Richards of Planned Parenthood, which is also patching calls into lawmakers’ offices in several states. “Congressman Stupak managed to crystallize this movement in a way that is hard to replicate.”

Veteran observers of the fight say that each side feels an honest threat from the legislation. “It is not like burning your house down to collect the insurance,” said Rachel Laser, of the moderate Democratic group Third Way.

But the practical stakes for abortion are in some ways quite narrow. No one in the debate proposes adding or removing restrictions on the procedure itself. And leaders of both parties say their goal is to avoid using federal tax money to pay for abortion while subsidizing insurance coverage.

Democratic leaders favor requiring insurance companies to segregate any federal subsidies they receive from private premiums that they could use to cover abortion. Abortion opponents in Congress call that an accounting gimmick and want to prevent women from using the subsidies to buy plans that cover abortion no matter which dollars the insurer uses to pay for it. Women could still use their own money to pay for the procedure. In any case the provisions would directly affect roughly 15 percent of the population not currently receiving health coverage from either employers or the government.

What’s more, polls shows that abortion ranks low among priorities in the health care overhaul. In a poll conducted Nov. 12-15 by the nonpartisan Pew Research Center, only 3 percent of respondents who opposed the health care proposal volunteered abortion as their reason, and when offered a list of alternatives just 8 percent chose abortion as a top concern.

Almost none of those who favor the overall proposals volunteered abortion as a reason, and a plurality of them — 46 percent — agreed with abortion opponents that coverage of the procedure should not be included in government benefits. Thirty-five percent thought the plan should cover abortion. The poll was conducted with 1,003 adults nationwide and has a margin of sampling error of plus or minus four percentage points.

Just a few months ago, some pollsters were predicting an end to the culture wars as younger generations grew more accustomed to same-sex unions and less passionate about opposing abortion. The long-running abortion fight played little role in the 2008 presidential race or even in last summer’s relatively uneventful Supreme Court confirmation. But now the issue threatens to sidetrack the broader debate over a health care overhaul. A group of Democratic abortion opponents in the House said they will block the final legislation if it allows subsidies for abortion coverage, and a group of abortion-rights supporters said they will block the bill if it restricts the subsidies.

The interest groups that organized to do battle over the issue never decamped from the sides of the Potomac, said Andrew Kohut, the president of the Pew Research Center who oversaw its recent poll. And their determination to reinvigorate their ground troops may be one reason abortion has become a flash point in the health care debate.

“The advocates on both sides are very loud,” Mr. Kohut said, “and they are making their case.”

    Health Care Debate Revives Abortion Campaigners, NYT, 24.11.2009, http://www.nytimes.com/2009/11/24/health/policy/24abortion.html






Signs That Swine Flu Has Peaked


November 21, 2009
The New York Times


Although federal health officials decline to use the word “peaked,” the current wave of swine flu appears to have done so in the United States.

Flu activity is coming down in all regions of the country, the Centers for Disease Control and Prevention said Friday, though it is still rising in Hawaii, Maine and some isolated areas.

The World Health Organization said Friday that there were “early signs of a peak” in much of the United States.

On Wednesday, the American College Health Association, which surveys over 250 colleges with more than three million students, said new cases of flu had dropped in the week ending Nov. 13. It was the first drop since school resumed in the fall, and it was significant — new cases were down 27 percent from the week before.

And on Friday, Quest Diagnostics, the country’s largest laboratory, said its tests of 142,000 suspected flu specimens since May showed that the flu peaked in late October.

Nonetheless, Dr. Anne Schuchat, the director of immunization and respiratory diseases at the C.D.C., chose her words carefully, saying: “I wish I knew if we had hit the peak. Even if a peak has occurred, half the people who are going to get sick haven’t gotten sick yet.”

Dr. Schuchat also noted that even when new infections topped out, hospitalizations and deaths were still on the way up, because most took place days or weeks later.

Privately, federal health officials say they fear that if they concede the flu has peaked, Americans will become complacent and lose interest in being vaccinated, increasing the chances of another wave.

In New York, where cases peaked last May, vaccine clinics have gone begging for takers as long lines form in the rest of the country.

Epidemiologists expected a peak about now, because flu waves typically last six to eight weeks.

The current fall wave of new infections began in late August in the Southeast, where schools start earlier than on the East or West Coasts; it took several weeks to spread across the country and began falling in the Southeast two weeks ago.

The drop was clearly not caused by the swine flu vaccine drive, which has not gone as fast as the authorities had hoped because the vaccine seed strain grew so slowly.

Only about 54 million doses are available now, and Dr. Schuchat said she wanted to “apologize for the frustration the public has been experiencing.”

Lone Simonsen, an epidemiologist at George Washington University, said she expected a third wave in December or January, possibly beginning in the South again.

“If people think it’s going away, they can think again,” Dr. Simonsen said.

Based on death rates in New York City and in Scandinavia, she has argued that both 1918 and 1957 had mild summer waves followed by two stronger waves, one in fall and one in midwinter.

Only 43 states are now reporting “widespread” flu activity, down from 48 two weeks ago.

As Dr. Schuchat noted, that is still above peak activity in a typical flu season.

The winter flu season usually starts in December; it is expected to return this year.

Since last week, 21 children and teenagers died of confirmed or suspected cases of the flu, Dr. Schuchat said. Based on her agency’s belief that three pediatric deaths take place for each confirmed one, about 600 children and teenagers have died since this epidemic began.

The World Health Organization said the flu appeared to be peaking in the United States and some Western European countries, like Belgium, Britain and Ireland. But it was moving rapidly east and north.

Canada’s outbreak is still intensifying, as is the one in Norway, and Eastern Europe and Central Asia, including Afghanistan, are seeing a surge in cases.

Norway reported finding a mutated virus in three people who died or were severely ill. The mutation, known as D222G on the receptor binding domain, allow the virus to grow deeper in the lungs.

The mutation does not appear to be circulating and may have spontaneously arisen in the three patients, said Geir Stene-Larsen, director of the Norwegian Institute of Public Health. Only 3 of Norway’s 70 tested samples had it.

Asked about that, Dr. Schuchat said the same mutation had also been found in mild cases in several countries and it did not make the virus resistant to vaccine or to treatment with drugs like Tamiflu. She said that she did not want to “underplay” it, but that “it’s too soon to say what this will mean long term.”

The D222G mutation allows the virus to bind to receptors on cells lining the lungs, which are slightly different from those in the nose and throat.

Henry L. Niman, a flu tracker in Pittsburgh, has been warning for a week that the same mutation has repeatedly been found in Ukraine, which is in the grips of a severe outbreak and where surprising numbers of people have died with lung hemorrhages.

Separate reports of Tamiflu-resistant virus also surfaced Friday. Duke University Medical Center said it had found four cases among its patients in six weeks, and British health authorities reported five in one Welsh hospital.

Although Tamiflu resistance would be a serious worry for health officials, it was not clear that the strains were circulating outside the hospitals. Many isolated cases of resistant virus have been found.

    Signs That Swine Flu Has Peaked, NYT, 21.11.2009, http://www.nytimes.com/2009/11/21/health/21flu.html






News Analysis

Culture Clash in Medicine


November 20, 2009
The New York Times


This week, the science of medicine bumped up against the foundations of American medical consumerism: that more is better, that saving a life is worth any sacrifice, that health care is a birthright.

Two new recommendations, calling for delaying the start and reducing the frequency of screening for breast and cervical cancer, have been met with anger and confusion from some corners, not to mention a measure of political posturing.

The backers of science-driven medicine, with its dual focus on risks and benefits, have cheered the elevation of data in the setting of standards. But many patients — and organizations of doctors and disease specialists — find themselves unready to accept the counterintuitive notion that more testing can be bad for your health.

“People are being asked to think differently about risk,” said Sheila M. Rothman, a professor of public health at Columbia University. “The public state of mind right now is that they’re frightened that evidence-based medicine is going to be equated with rationing. They don’t see it in a scientific perspective.”

For decades, the medical establishment, the government and the news media have preached the mantra of early detection, spending untold millions of dollars to spread the word. Now, the hypothesis that screening is vital to health and longevity is being turned on its head, with researchers asserting that mammograms and Pap smears can cause more harm than good for women of certain ages.

On Monday, the United States Preventive Services Task Force, a federally appointed advisory panel, recommended that most women delay the start of routine mammograms until they are 50, rather than 40, as the group suggested in 2002. It also recommended that women receive the test every two years rather than annually, and that physicians not train women to perform breast self-examination.

The task force, whose recommendations are not binding on insurers or physicians, concluded after surveying the latest research that the risks caused by over-diagnosis, anxiety, false-positive test results and excess biopsies outweighed the benefits of screening for women in their 40s. It found that one cancer death is prevented for every 1,904 women ages 40 to 49 who are screened for 10 years, compared with one death for every 1,339 women from 50 to 74, and one death for every 377 women from 60 to 69.

On Friday, the American College of Obstetricians and Gynecologists plans to announce a similar revision to its screening guidelines for cervical cancer. It will advise that women receive their first Pap test at age 21; the previous standard had been three years after a woman’s first sexual intercourse or age 21, whichever came first. The group also is recommending that the test be performed every two years instead of annually for women ages 21 to 30.

“A review of the evidence to date shows that screening at less frequent intervals prevents cervical cancer just as well, has decreased costs and avoids unnecessary interventions that could be harmful,” said Dr. Alan G. Waxman, a professor at the University of New Mexico who directed the process.

The challenge of persuading patients and doctors to accept such standards requires a transformational shift in thinking, particularly when the disease involved is as prevalent, as deadly, and as potentially curable as cancer. How do you convince them that it is in their best interest to play the odds when they have been conditioned for so long to not gamble on health? After all, for the one in 1,904 women in their 40s whose life would be saved by early detection of breast cancer, taking the risk would in retrospect seem a bad choice.

“This represents a broader understanding that the efforts to detect cancer early can be a two-edged sword,” said Dr. H. Gilbert Welch, a professor of medicine at Dartmouth who is among the pioneers of research into the negative effects of early detection. “Yes, it helps some people, but it harms others.”

Dr. Welch said this week’s recommendations could mark a turning point in public acceptance of that notion. “Now we’re trying to negotiate that balance,” he said. “There’s no right answer, but I can tell you that the right answer is not always to start earlier, look harder and look more frequently.”

That concept is proving easier to swallow in the halls of Dartmouth Medical School than in the halls of Congress. Coming as they did at the height of debate over a sweeping health care overhaul, the recommendations have provided fresh ammunition for those who warn that greater government involvement in medical decision-making would lead to rationing of health care. It has not mattered that the breast cancer screening recommendation is only advisory, and that the federal government, the American Cancer Society, and numerous private insurers have said they will not adopt it.

Senator Kay Bailey Hutchison, a Republican who is running for governor of Texas, cited the task force’s screening statistics in a floor speech on Thursday. “One life out of 1,904 to be saved,” Ms. Hutchison said, “but the choice is not going to be yours. It’s going to be someone else that has never met you, that does not know family history.” She added, “This is not the American way of looking at our health care coverage.”

The health care bills in both the House and the Senate would establish commissions to encourage research into the effectiveness of medical tests and procedures, but would not require that the findings be translated into practice or reimbursement policies.

As throughout history, it may take decades for medical culture to catch up to medical science. Dr. Rothman pointed out that it took 20 years for the public to accept the discovery in 1882 that tuberculosis was caused by a bacterium and not by heredity or behavior. More than 160 years after the Hungarian-born physician Ignaz Semmelweis posited that hand-washing could prevent the spread of infectious disease, studies still show that half of all hospital workers do not follow basic hygiene protocols.

“It’s going to take time, there’s no doubt about it,” said Louise B. Russell, a research professor at the Rutgers University Institute of Health who has studied whether prevention necessarily saves money (and found it does not always do so). “It’s going to take time in part because too many people in this country have had a health insurer say no, and it’s not for a good reason. So they’re not used to having a group come out and say we ought to do less, and it’s because it’s best for you.”

    Culture Clash in Medicine, NYT, 20.11.2009, http://www.nytimes.com/2009/11/20/health/20assess.html






Guidelines Push Back Age

for Cervical Cancer Tests


November 20, 2009
The New York Times


New guidelines for cervical cancer screening say women should delay their first Pap test until age 21, and be screened less often than recommended in the past.

The advice, from the American College of Obstetricians and Gynecologists, is meant to decrease unnecessary testing and potentially harmful treatment, particularly in teenagers and young women. The group’s previous guidelines had recommended yearly testing for young women, starting within three years of their first sexual intercourse, but no later than age 21.

Arriving on the heels of hotly disputed guidelines calling for less use of mammography, the new recommendations might seem like part of a larger plan to slash cancer screening for women. But the timing was coincidental, said Dr. Cheryl B. Iglesia, the chairwoman of a panel in the obstetricians’ group that developed the Pap smear guidelines. The group updates its advice regularly based on new medical information, and Dr. Iglesia said the latest recommendations had been in the works for several years, “long before the Obama health plan came into existence.”

She called the timing crazy, uncanny and “an unfortunate perfect storm,” adding, “There’s no political agenda with regard to these recommendations.”

Dr. Iglesia said the argument for changing Pap screening was more compelling than that for cutting back on mammography — which the obstetricians’ group has staunchly opposed — because there is more potential for harm from the overuse of Pap tests. The reason is that young women are especially prone to develop abnormalities in the cervix that appear to be precancerous, but that will go away if left alone. But when Pap tests find the growths, doctors often remove them, with procedures that can injure the cervix and lead to problems later when a woman becomes pregnant, including premature birth and an increased risk of needing a Caesarean.

Still, the new recommendations for Pap tests are likely to feed a political debate in Washington over health care overhaul proposals. The mammogram advice led some Republicans to predict that such recommendations would lead to rationing.

Senator Tom Coburn, a Republican from Oklahoma who is also a physician, said in an interview that he would continue to offer Pap smears to sexually active young women. Democratic proposals to involve the government more deeply in the nation’s health care system, he said, would lead the new mammography, Pap smear and other guidelines to be adopted without regard to patient differences, hurting many people.

“These are going to be set in stone,” Mr. Coburn said.

Senator Arlen Specter, a Pennsylvania Democrat and longtime advocate for cancer screening, said in an interview: “And this Pap smear guideline is yet another cut back in screening? That is curious.” Mr. Specter, who was treated for Hodgkin’s lymphoma in 2005 and 2008, said Congress was committed to increasing cancer screenings, not limiting them.

Representative Rosa DeLauro, Democrat of Connecticut, said that the new guidelines would have no effect on federal policy and that “Republicans are using these new recommendations as a distraction.”

“Making such arguments, especially at this critical point in the debate, merely clouds the very simple issue that our health reform bill would increase access to care for millions of women across the country,” she said.

There are 11,270 new cases of cervical cancer and 4,070 deaths per year in the United States. One to 2 cases occur per 1,000,000 girls ages 15 to 19 — a low incidence that convinces many doctors that it is safe to wait until 21 to screen.

The doctors’ group also felt it was safe to test women less often because cervical cancer grows slowly, so there is time to catch precancerous growths. Cervical cancer is caused by a sexually transmitted virus, human papillomavirus, or HPV, that is practically ubiquitous. Only some people who are exposed to it develop cancer; in most, the immune system fights off the virus. If cancer does develop, it can take 10 to 20 years after exposure to the virus.

The new guidelines say women 30 and older who have three consecutive Pap tests that were normal, and who have no history of seriously abnormal findings, can stretch the interval between screenings to three years.

In addition, women who have a total hysterectomy (which removes the uterus and cervix) for a noncancerous condition, and who had no severe abnormalities on previous Pap tests, can quit having the tests entirely.

The guidelines also say that women can stop having Pap tests between 65 and 70 if they have three or more negative tests in a row and no abnormal test results in the last 10 years.

The changes do not apply to women with certain health problems that could make them more prone to aggressive cervical cancer, including H.I.V. infection or having an organ transplant or other condition that would lead to a suppressed immune system.

It is by no means clear that doctors or patients will follow the new guidelines. Medical groups, including the American Cancer Society, have been suggesting for years that women with repeated normal Pap tests could begin to have the test less frequently, but many have gone on to have them year after year anyway.

Debbie Saslow, director of breast and gynecologic cancer for the American Cancer Society, said professional groups were particularly concerned because many teenagers and young women were being tested and then needlessly subjected to invasive procedures.

In addition, Dr. Saslow said, doctors in this country have been performing 15 million Pap tests a year to look for cervical cancer in women who have no cervix, because they have had hysterectomies.

Dr. Carol L. Brown, a gynecologic oncologist and surgeon at Memorial Sloan-Kettering Cancer Center, said the new guidelines should probably not be applied to all women, because there are some girls who begin having sex at 12 or 13 and may be prone to develop cervical cancer at an early age.

“I’m concerned that whenever you send a message out to the public to do less, the most vulnerable people at highest risk might take the message and not get screened at all,” Dr. Brown said.

Dr. Kevin M. Holcomb, an associate professor of clinical obstetrics and gynecology at NewYork-Presbyterian/Weill Cornell hospital, said that when he heard the advice to delay Pap testing until 21, “My emotional response is ‘Wow, that seems dangerous,’ and yet I know the chances of an adolescent getting cervical cancer are really low.”

As with the new mammogram recommendations, women may not readily give up a yearly cancer test.

“For people who’ve been having the testing regularly every year, it’s a big emotional change to test less frequently and there’s this fear of ‘Oh my gosh, I might be missing something,’ ” said Ivy Guetta, 49, of Westport, Conn., who plans to continue with annual Pap tests. Ms. Guetta has three daughters, ages 17, 14 and 8, and at the moment, she would not encourage them to wait until they turn 21.

Jen Jemison, 24, a legal assistant from Babylon, N.Y., said she thought she began getting Pap smears when she was about 18, but said that if she had been aware that the procedure for treating precancerous lesions could lead to premature births, she would have waited until she turned 21.

On the other hand, Ms. Jemison said that now that she is over 21, “I would still go every year” for the Pap test.

“One of my cousins had cervical cancer, so that’s in my head too,” she said. “I’d rather get it checked out regularly than have to worry about that.”

Gardiner Harris contributed reporting from Washington, and Pam Belluck from Connecticut.

    Guidelines Push Back Age for Cervical Cancer Tests, NYT, 20.11.2009, http://www.nytimes.com/2009/11/20/health/20pap.html






Rising Prices of Drugs

Lead to Call for Inquiry


November 19, 2009
The New York Times


Democrats in Congress asked for two separate investigations of drug industry pricing Wednesday as they continue working on legislation to overhaul the nation’s health care system.

Responding to news reports of unusually high wholesale price increases in brand-name prescription drugs, four House leaders and one senator asked for government reviews of the pricing practices.

Although drug makers challenge the theory, some experts say the run-up in wholesale prices may be partly related to the industry’s concerns about future cost containment under any health care legislation.

“Recent studies have indicated that the industry may be artificially raising prices for certain pharmaceutical products in expectation of new reforms,” the House Democrats wrote in a letter to the Government Accountability Office, a nonpartisan investigative arm of Congress. “Any price gouging is unacceptable, but anticipatory price gouging is especially offensive,” the letter added, asking the G.A.O. to conduct an expedited review of the price increases.

The House letter was signed by four representatives who have been active in the health care legislation: Charles B. Rangel of New York, chairman of the Ways and Means Committee; Henry A. Waxman of California, chairman of the Energy and Commerce Committee; and Pete Stark of California, and John Lewis of Georgia, chairmen of two Ways and Means subcommittees.

Separately, Senator Bill Nelson of Florida, a Democrat who has led efforts in the Senate to seek more concessions from drug makers, wrote to the inspector general of the Department of Health and Human Services asking for “an immediate and thorough investigation into drug industry pricing and recent increases, and the extent to which these increases may affect the Medicare and Medicaid programs.”

Both letters cited a New York Times article on Monday reporting that wholesale prices of brand-name drugs rose about 9 percent in the 12 months that ended Sept. 30, the highest increase in years — even as the Consumer Price Index was declining during the same 12-month period.

The Times article cited a Wall Street analyst’s calculations; a study sponsored by the AARP, the advocacy group for older Americans; and a report by IMS Health, a consulting firm to the drug industry.

The price increases could add more than $10 billion to the nation’s drug bill, which is on track to exceed $300 billion this year.

At that rate, the increases would more than offset at least the first year of savings that the drug industry has agreed to make under a provision of the health care bill that was approved by the Senate Finance Committee and has been incorporated into the full Senate bill introduced on Wednesday. That measure calls for the industry to come up with discounts and rebates that would save Medicare recipients and the government $8 billion a year for 10 years.

“I want to know if there’s a back-door move under way by the drug makers to recover some of the concessions they’ve promised for health care reform,” Senator Nelson said in a statement Wednesday.

Drug companies do not deny having raised wholesale prices at the highest rate in years. But they say it has nothing to do with the impending health care legislation. They say the price increases are necessary to maintain profits for research and employment in the face of a difficult business environment, which includes a slowdown in sales of many brand-name products, expiring patents and increasing competition from generic drugs.

The wholesale prices of brand-name drugs most commonly used by Medicare recipients rose in the latest 12-month period at the fastest rate since at least 1992, according to Stephen W. Schondelmeyer, a pricing expert working with AARP.

Separately, a study by the investment bank Credit Suisse found that prices for all drugs from the eight largest United States pharmaceutical companies had risen, on average, at the highest rate in at least five years.

And IMS Health said there were higher-than-expected price increases this year.

Mr. Schondelmeyer, professor of pharmaceutical economics at the University of Minnesota, and Catherine J. Arnold, a senior drug industry analyst for Credit Suisse, have said they believe that part of the reason for the price increases was to get ahead of possible cost containment measures in health care reform.

Professor Schondelmeyer and Joseph P. Newhouse, a Harvard health economist, said there were precedents for drug price increases before government actions affecting the industry.

The House Democrats also said the G.A.O. had previously found unusual price increases in some prescription drugs in the year before Congress added drug benefits to Medicare.

The House letter on Wednesday said that the G.A.O. could build on that work.

The House members are also asking the G.A.O. to submit a proposal to continuously monitor prescription drug prices. The House health care bill already includes a provision authorizing Medicare to negotiate directly with manufacturers — a proposal hotly opposed by the industry.

Ken Johnson, an official with the drug industry’s trade association, said in a statement that calls for an investigation were “based on misleading use of statistics and sensationalized media reports.”

Mr. Johnson, senior vice president for the Pharmaceutical Manufacturers and Research Association, did not deny any of the specific findings of AARP, Credit Suisse and IMS Health reports, which were based on data supplied by manufacturers and wholesalers. But he said other measurements of drug price increases show they have risen substantially less than 9 percent.

Mr. Johnson accused AARP of “trying to muddy the waters for its own political gain as we enter the homestretch of the health care reform debate.”

An AARP executive vice president, John Rother, said in a statement: “This isn’t about politics. It’s about affordable health care.”

    Rising Prices of Drugs Lead to Call for Inquiry, NYT, 19.11.2009, http://www.nytimes.com/2009/11/19/health/policy/19drugs.html







Altering How We Use and Pay Doctors


November 19, 2009
The New York Times


To the Editor:

Re “Reform and Medical Costs” (editorial, Nov. 15):

I was disappointed that in your otherwise thoughtful analysis of health care reform I couldn’t find the words “primary care” or “family physician” mentioned even once.

Central to the problems of high cost, overtesting, overtreatment and poor coordination endemic in our current system is the lack of value placed on primary care medicine.

Which of the following do you think is more efficient and would lead to better health outcomes: a patient who sees a cardiologist for his high blood pressure, an endocrinologist for his uncomplicated diabetes and an orthopedic surgeon for his osteoarthritis, or a patient who sees a single well-trained family physician or general internist for all three — a doctor who can also assure that needed screening and preventive care take place?

The answer is clear from a range of studies comparing counties, states and countries: places where primary care and generalist physicians are valued have the best health outcomes and lowest costs. We need to reform our system in such a way that the best and brightest students are attracted to careers in primary care.

Mark Ebell
Athens, Ga., Nov. 16, 2009

The writer, a doctor, is deputy editor of American Family Physician and associate professor in the department of epidemiology and biostatistics at the University of Georgia.

To the Editor:

In your editorial you state, “Doctors mostly perform high-cost tests because they want to help their patients and get paid handsomely for doing so.” In most cases a physician’s income is unaffected by the costs of the outside diagnostic studies that he orders.

As for handsome compensation, a physician’s income is not what it used to be. Over the last two decades, physicians’ earnings have grown more slowly than other workers’ earnings. Over the same period the portion of a typical doctor’s day during which he works to cover his practice expenses has increased dramatically.

High-achieving seniors in college must consider the duration and rigor of a medical education, and the debt that they will probably owe at its conclusion. They must also think about the income that they could earn over those seven or eight years if they pursued a less demanding profession.

I believe that becoming a primary care physician or more recently even a general surgeon is actually now a poor economic decision; if present trends persist it will simply become an untenable one.

Richard Williams
Wenatchee, Wash., Nov. 16, 2009

The writer is a doctor.

To the Editor:

Clinic-model hospitals where attending physicians are paid a straight salary have the illusion of providing good care at a cheap cost because they are bolstered by federal subsidies like research grants and large payments for training resident physicians. But the truth is that without cheap resident-physician labor (often at below-minimum wages if you do the math) and those federal subsidies, these hospitals could not survive.

Now combine this illusion with the cynical view that most physicians are more interested in a fast buck than taking good care of their patients and you arrive at the misguided “expert” view that changing how physicians outside the clinic system are paid will save money while improving patient care.

Some suggest that we change the fee-for-service method of physician payment to one that pays a single fee per episode of illness regardless of the varying amount of work necessary for each person.

The private insurance companies already tried this and called it “episodic care.” It failed. And if the government were to force this method on the entire health care system it would remove the pay incentive that drives every other sector of our capitalist economy.

Physicians have families, too, and if they work harder and longer they simply want to be paid for their time — which is very different from delivering unnecessary care. But if you remove the incentive to work harder by forcing episodic-care payments, what you’ll get is less effort and less talent.

Brian Broker
Phoenixville, Pa., Nov. 15, 2009

The writer is an otolaryngologist.

To the Editor:

Discussing proposals to address the problem of rising medical costs, you write: “Most agree that the solution is to push doctors to accept fixed payments to care for a particular illness or for a patient’s needs over a year. No one knows how to make that happen quickly.”

HealthAccessRI has known for several years how to make this happen immediately. Our model of subscription or membership-based primary care (not concierge medicine) gives people their own doctor with whom to develop a trusting relationship at a cost nearly everyone can afford — just $25 to $30 per month.

Primary care provides the majority of people’s health care needs. Call up auto insurance agents and ask for a policy that covers tune-ups and oil changes and they’ll laugh at you. Diverting dollars that go to primary care through insurance money handlers is equally absurd. Worse, it is the underlying reason that there is a shortage of primary care physicians that will continue indefinitely.

While others tinker with insurance, we know that fixed payments to care for a patient’s primary care needs over a year will make the majority of Americans’ health care needs affordable and accessible.

James Schwartz
Barrington, R.I., Nov. 15, 2009

The writer is a doctor.

    Altering How We Use and Pay Doctors, NYT, 19.11.2009, http://www.nytimes.com/2009/11/19/opinion/l19health.html






Breaching a Barrier to Fight Brain Cancer


November 17, 2009
The New York Times


Dr. Howard Riina threaded a slender tube through a maze of arteries in Dennis Sugrue’s brain, watching X-ray images on a monitor to track his progress. At the site where a previous operation had removed a malignant tumor, he infused a drug called mannitol and unleashed a flood of the cancer drug Avastin.

Doctors and nurses watched intently, worried that the Avastin could cause brain swelling, a hemorrhage or a seizure. But Mr. Sugrue emerged unscathed. A half hour after the procedure, he woke up from anesthesia mumbling, “More is better,” and wishing aloud that he could have had a bigger dose.

It was an experiment. Mr. Sugrue, 50, who works for a hedge fund and has two teenage children, was in a study for people with glioblastoma — the same type of brain tumor that killed Senator Edward M. Kennedy of Massachusetts in August — and was only the second person ever to have Avastin sprayed directly into his brain.

Getting drugs into the brain has always been a major challenge in treating tumors and other neurological diseases, because the blood-brain barrier, a natural defense system, keeps many drugs out. The study that Mr. Sugrue is in, at NewYork-Presbyterian/Weill Cornell, combines old technologies in a new way to open the barrier and deliver extraordinarily high doses of Avastin straight to these deadly tumors — without soaking the rest of the brain in the drug and exposing it to side effects.

The goal is to find better ways to treat glioblastomas. But the technique might also be useful for brain metastases, meaning cancer that has spread from other parts of the body, like the breasts or lungs — something that occurs in about 100,000 people a year in the United States. The same procedure could also deliver other drugs and might eventually be used to treat neurological disorders like multiple sclerosis or Parkinson’s disease, if suitable therapies are developed.

The defense system that doctors are trying to breach evolved to keep out toxins and microbes. It consists mainly of cells that line the walls of capillaries in the brain and are so tightly packed that many molecules in the bloodstream cannot slip out between cells to reach the brain tissue itself. But certain drugs, like mannitol, will temporarily open the barrier and were first used more than 20 years ago to help other medicines reach the brain.

The new technique refines the art of opening the barrier: it uses microcatheters — fine, highly flexible tubes that are inserted into an artery in the groin and then threaded up into tiny blood vessels nearly anywhere in the brain — to spray chemotherapy directly onto tumors or areas from which they have been removed. The catheters are normally used to deliver clot-dissolving drugs to the brain to treat strokes.

“This will substantially alter the way that chemotherapy is given in the future,” said Dr. John Boockvar, the brain surgeon who devised the trial. “But we have to prove that at certain doses, nobody gets hurt.”

Referring to glioblastoma patients, Dr. Riina said, “Everyone is looking for something to do for these people.”

“Even if you buy someone just a year, that could be a wedding or a graduation,” he continued. “You never know what might happen in the year they hold onto.”

The study, which began in August, is still in its earliest phase, meaning its main goal is to measure safety, not efficacy — to find out if it is safe to spray Avastin directly into brain arteries and at what dose. Nonetheless, the doctors were pleased when M.R.I. scans of the first few patients showed that the treatment seemed to erase any sign of recurring glioblastomas. But how long the effect will last remains to be seen.

“A beautiful M.R.I. scan doesn’t mean it’s cured,” Dr. Boockvar said.

Despite a beautiful scan, the first patient who was treated died in October, from pneumonia and the spread of glioblastoma to his brainstem.

Innovations are desperately needed to make headway against glioblastoma, which is “one of the most deadly tumors that exist in humans,” said Dr. Russell Lonser, chairman of surgical neurology at the National Institutes of Health.

“This is a very good start,” Dr. Lonser said. “The early data is very interesting and exciting.”

The complexity of a study like this goes beyond the science. Clinical trials are also a complicated pact, emotionally and ethically, between desperate patients and doctors who must balance their ambition as researchers against their duty as clinicians, and must walk a fine line between offering too much hope and not enough.

“I tell patients, ‘I’m going to try to cure your disease, but so far glioblastoma is an incurable disease,’ ” Dr. Boockvar said.


Extending Life

“I’m optimistic,” Mr. Sugrue said one morning in September, after scheduling a second brain operation. But he had tears in his eyes.

There are about 10,000 new cases of glioblastoma a year in the United States, mostly in people over 45. The tumors are notorious for growing back like weeds even after being cut out and blasted with chemotherapy and radiation, and they are nearly always fatal. With the best treatment, the median survival time is about 15 months.

But in the last five years, the number of patients who survive 2 years has increased to 25 percent, from 8 percent, largely because doctors began using a chemotherapy pill called temozolomide, or Temodar, along with radiation (Temodar is believed to seep through the blood-brain barrier).

Dr. Boockvar said he thought that if he could just keep patients alive for two years, more advances might come along and give them time.

“The glioblastoma population is very studyable, unfortunately, because the prognosis is so grim,” he said.

Patients often wind up on the frontlines of research, figuring they have little to lose and hoping they will be lucky enough to test the big breakthrough. More than 500 studies for people with glioblastoma are listed on the government Web site www.clinicaltrials.gov.

Mr. Sugrue, who lives in Stamford, Conn., with his wife, Donna, and their children Molly and Tim, began having headaches in April. He thought he had a sinus problem. But a scan found a brain tumor nearly the size of a golf ball. A local doctor referred him to Dr. Boockvar. He had the standard treatment: surgery, temozolomide pills and six weeks of radiation, which ended on June 25.

By July, an ominous bright spot on his M.R.I. scan suggested that the tumor might already be growing back. He continued chemotherapy, but the spot kept enlarging.

By mid-September, the Sugrues were back in Dr. Boockvar’s office to plan their next step. Stubbly hair was growing in on Mr. Sugrue’s scalp, except for a bare patch, around an arcing scar above his right ear. His eyes, bright blue with thick, dark lashes that gave him a boyish look, searched the doctor’s face.

The headaches had returned. New scans, displayed on a computer screen, showed signs of brain swelling and bright spots that should not have been there. Dr. Boockvar recommended more surgery and then chemotherapy with Avastin, which had recently been approved for recurring glioblastoma.

It was approved for intravenous use — to be dripped into a vein, usually in the arm — but he said Mr. Sugrue would be an ideal candidate for his study, in which the drug would be infused directly into an artery in the brain, producing levels at least 50 times what the intravenous route could achieve. One other patient had been treated that way, and M.R.I. scans showed that recurring tumors seemed to have melted away.

Mr. Sugrue said he was all for it, even though Dr. Boockvar warned him that the drug was no magic bullet. Then Dr. Boockvar ticked off the risks from a second brain operation.

“I have to quote you a 5 percent risk you’ll be visibly weak,” he said. “A 1 percent chance of paralysis on the left side.”

Mr. Sugrue wiped his eyes and began to apologize for losing his composure, but the surgeon cut him off and said, “In neurosurgery they say that if you don’t make your patient cry, you haven’t gotten informed consent.”

The trial grew out of a conversation about a year ago between Dr. Boockvar and Dr. Riina, an expert in using microcatheters to treat strokes.

“I said, ‘Why can’t you infuse chemotherapy for my brain tumor patients?’ ” Dr. Boockvar recalled. “And he said: ‘I can. Just show me what you want to do.’ ”

Dr. Riina said, “Technically, I can go anywhere in your brain.”

He said microcatheter technology had advanced “light-years” in the last decade and was just waiting for a new drug to come along for glioblastoma.

They wrote up a plan to test what they called “superselective intra-arterial cerebral infusion” of Avastin in 30 patients with glioblastomas that had recurred after standard treatment. Each patient would receive just one treatment directed into the brain, followed weeks later by a series of intravenous treatments with Avastin.

Their study involves a technique first developed about 30 years ago, which uses mannitol to open the blood-brain barrier temporarily to get chemotherapy into the brain. Mannitol pulls water out of the tightly packed cells lining the capillaries so that they shrink and pull away from one another, opening up gaps through which drug molecules can pass into the brain.

The technique was developed by Dr. Edward A. Neuwelt, a neurosurgeon at Oregon Health Sciences University and the Veterans Affairs Hospital in Portland. Its best results have been in people with a rare type of brain tumor called a primary central nervous system lymphoma. But it has not been helpful with glioblastoma, because until recently there was no chemotherapy to infuse that would have much effect on those tumors.

Dr. Neuwelt said that Avastin had helped to renew interest in opening the blood-brain barrier but that researchers disagreed about whether the drug would lend itself to that use.

Avastin starves tumors by blocking the growth of new blood vessels, which they need to survive. Dr. Boockvar said microcatheters should increase the odds of success by delivering a high dose of the drug directly to where it was needed most. Earlier research with other drugs used larger catheters inserted into the carotid arteries, which feed the entire brain — meaning that the tumor did not receive the most concentrated dose and that healthy brain tissue was exposed to the toxic drugs.

By mid-November, the researchers had treated five patients, including Mr. Sugrue; they first infused mannitol, waited five minutes and then sprayed in the Avastin. In all the patients’ M.R.I. scans, the telltale bright spots that marked tumor growth faded away after the treatment.

“I can’t tell you what it means,” Dr. Boockvar said. “Nobody knows.”

Indeed, the death of the first patient was a reminder that glioblastoma can invade other parts of the brain and the spinal fluid and that the highly localized spray of Avastin might miss deadly seeds of cancer.

But Dr. Boockvar remained hopeful for the remaining patients, describing the scans as “astronomically far better than I had anticipated.”


Hope and Anxiety

Mr. Sugrue was still in the hospital in late September when Dr. Boockvar burst into his room and got him out of bed to look at his own before-and-after scans.

“He took me to this room with all these computers and said, ‘I’ve got to show you this,’ ” Mr. Sugrue recalled. “This M.R.I. was a thing of beauty. I’m excited that he’s excited. That means a lot to me.”

Dr. Boockvar said: “Avastin may not be the best drug for this delivery technique. What’s exciting about our results is that we’ve proven there is a local effect.

“Suppose someone said, ‘I have much better drug.’ Now I can say I at least have a delivery system.”

With patients, Dr. Boockvar tries to walk a fine line, trying to level with them and yet not rob them of all hope. He knows the emotional toll that a cancer diagnosis can take: his own father had leukemia for about eight years and died in September. Mrs. Sugrue said the doctor urged her and her husband to resist doing an Internet search for glioblastoma because they would just read that it was a death sentence.

They said they tried to follow his advice, but when the subject of prognosis came up in an interview, both had tears in their eyes.

“You don’t ask the question if you don’t want the answer,” Mrs. Sugrue said. “What will be, will be. You do what you can.”

    Breaching a Barrier to Fight Brain Cancer, NYT, 17.11.2009, http://www.nytimes.com/2009/11/17/health/17tumor.html






In Reversal,

Panel Urges Mammograms

at 50, Not 40


November 17, 2009
The New York Times


Most women should start regular breast cancer screening at age 50, not 40, according to new guidelines released Monday by an influential group that provides guidance to doctors, insurance companies and policy makers.

The new recommendations, which do not apply to a small group of women with unusual risk factors for breast cancer, reverse longstanding guidelines and are aimed at reducing harm from overtreatment, the group says. It also says women age 50 to 74 should have mammograms less frequently — every two years, rather than every year. And it said doctors should stop teaching women to examine their breasts on a regular basis.

Just seven years ago, the same group, the United States Preventive Services Task Force, with different members, recommended that women have mammograms every one to two years starting at age 40. It found too little evidence to take a stand on breast self-examinations.

The task force is an independent panel of experts in prevention and primary care appointed by the federal Department of Health and Human Services.

Its new guidelines, which are different from those of some professional and advocacy organizations, are published online in The Annals of Internal Medicine They are likely to touch off yet another round of controversy over the benefits of screening for breast cancer.

Dr. Diana Petitti, vice chairwoman of the task force and a professor of biomedical informatics at Arizona State University, said the guidelines were based on new data and analyses and were aimed at reducing the potential harm from overscreening.

While many women do not think a screening test can be harmful, medical experts say the risks are real. A test can trigger unnecessary further tests, like biopsies, that can create extreme anxiety. And mammograms can find cancers that grow so slowly that they never would be noticed in a woman’s lifetime, resulting in unnecessary treatment.

Over all, the report says, the modest benefit of mammograms — reducing the breast cancer death rate by 15 percent — must be weighed against the harms. And those harms loom larger for women in their 40s, who are 60 percent more likely to experience them than women 50 and older but are less likely to have breast cancer, skewing the risk-benefit equation. The task force concluded that one cancer death is prevented for every 1,904 women age 40 to 49 who are screened for 10 years, compared with one death for every 1,339 women age 50 to 74, and one death for every 377 women age 60 to 69.

The guidelines are not meant for women at increased risk for breast cancer because they have a gene mutation that makes the cancer more likely or because they had extensive chest radiation. The task force said there was not enough information to know whether those women would be helped by more frequent mammograms or by having the test in their 40s. Other experts said women with close relatives with breast cancer were also at high risk.

Dr. Petitti said she knew the new guidelines would be a shock for many women, but, she said, “we have to say what we see based on the science and the data.”

The National Cancer Institute said Monday that it was re-evaluating its guidelines in light of the task force’s report.

But the American Cancer Society and the American College of Radiology both said they were staying with their guidelines advising annual mammograms starting at age 40.

The cancer society, in a statement by Dr. Otis W. Brawley, its chief medical officer, agreed that mammography had risks as well as benefits but, he said, the society’s experts had looked at “virtually all” the task force and additional data and concluded that the benefits of annual mammograms starting at age 40 outweighed the risks.

Other advocacy groups, like the National Breast Cancer Coalition, Breast Cancer Action, and the National Women’s Health Network, welcomed the new guidelines.

“This is our opportunity to look beyond emotions,” said Fran Visco, president of the National Breast Cancer Coalition. The task force “is an independent body of experts that took an objective look at the data,” Ms. Visco said. “These are the people we should be listening to when it comes to public health messages.”

Some women, though, were not pleased. “I know so many people who had breast cancer and survived, and what saved their lives was early detection,” Janet Doughty, 44, of San Clemente, Calif., said in a telephone interview. She said she had had an annual mammogram since her late 30s and would not stop now.

The guidelines are not expected to have an immediate effect on insurance coverage but should make health plans less likely to aggressively prompt women in their 40s to have mammograms and older women to have the test annually.

Congress requires Medicare to pay for annual mammograms. Medicare can change its rules to pay for less frequent tests if federal officials direct it to.

Private insurers are required by law in every state except Utah to pay for mammograms for women in their 40s.

But the new guidelines are expected to alter the grading system for health plans, which are used as a marketing tool. Grades are issued by the National Committee for Quality Assurance, a private nonprofit organization, and one measure is the percentage of patients getting mammograms every one to two years starting at age 40.

That will change, said Margaret E. O’Kane, the group’s president, who said it would start grading plans on the number of women over 50 getting mammograms every two years.

The message for most women, said Dr. Karla Kerlikowske, a professor in the department of medicine, epidemiology and biostatistics at the University of California, San Francisco, is to forgo routine mammograms if they are in their 40s.

Starting at age 50, Dr. Kerlikowske said, “the message is to get 10 mammograms in a lifetime, one every two years.” That way they get the most benefit and the least harm from the test. If women are healthy, she added, they might consider having mammograms every two years until age 74.

Nearly two-thirds of all women in their 40s had mammograms within the last two years, as did 72 percent of women age 50 to 65, according to an editorial by Dr. Kerlikowske that accompanies the report.

In order to formulate its guidelines, the task force used new data from mammography studies in England and Sweden and also commissioned six groups to make statistical models to analyze the aggregate data. The models were the only way to answer questions like how much extra benefit do women get if they are screened every year, said Donald A. Berry, a statistician at the University of Texas M. D. Anderson Cancer Center and head of one of the modeling groups.

“We said, essentially with one voice, very little,” Dr. Berry said. “So little as to make the harms of additional screening come screaming to the top.”

The harms are nearly cut in half when women have mammograms every other year instead of every year. But the benefits are almost unchanged.

The last time the task force issued guidelines for mammograms, in 2002, the reportwas announced by Tommy G. Thompson, the secretary of health and human services. When the group recommended mammograms for women in their 40s, some charged the report was politically motivated. But Dr. Alfred Berg of the University of Washington, who was the task force chairman at the time, said “there was absolutely zero political influence on what the task force did.”

It was still a tough call to make, Dr. Berg said, adding that “we pointed out that the benefit will be quite small.” In fact, he added, even though mammograms are of greater benefit to older women, they still prevent only a small fraction of breast cancer deaths.

Different women will weigh the harms and benefits differently, Dr. Berg noted, but added that even for women 50 and older, “it would be perfectly rational for a woman to decide she didn’t want to do it.”

Researchers worry the new report will be interpreted as a political effort by the Obama administration to save money on health care costs.

Of course, Dr. Berry noted, if the new guidelines are followed, billions of dollars will be saved.

“But the money was buying something of net negative value,” he said. “This decision is a no-brainer. The economy benefits, but women are the major beneficiaries.”


Roni Caryn Rabin contributed reporting.

    In Reversal, Panel Urges Mammograms at 50, Not 40, NYT, 17.11.2009, http://www.nytimes.com/2009/11/17/health/17cancer.html







Reform and Medical Costs


November 15, 2009
The New York Times


Americans are deeply concerned about the relentless rise in health care costs and health insurance premiums. They need to know if reform will help solve the problem. The answer is that no one has an easy fix for rising medical costs. The fundamental fix — reshaping how care is delivered and how doctors are paid in a wasteful, dysfunctional system — is likely to be achieved only through trial and error and incremental gains.

The good news is that the bill just approved by the House and a bill approved by the Senate Finance Committee would implement or test many reforms that should help slow the rise in medical costs over the long term. As a report in The New England Journal of Medicine concluded, “Pretty much every proposed innovation found in the health policy literature these days is encapsulated in these measures.”

Medical spending, which typically rises faster than wages and the overall economy, is propelled by two things: the high prices charged for medical services in this country and the volume of unnecessary care delivered by doctors and hospitals, which often perform a lot more tests and treatments than a patient really needs.

Here are some of the important proposals in the House and Senate bills to try to address those problems, and why it is hard to know how well they will work:

FORCED PRODUCTIVITY GAINS Both bills would reduce the rate of growth in annual Medicare payments to hospitals, nursing homes and other providers by amounts comparable to the productivity savings routinely made in other industries with the help of new technologies and new ways to organize work. This proposal could save Medicare more than $100 billion over the next decade. If private plans demanded similar productivity savings from providers, and refused to let providers shift additional costs to them, the savings could be much larger.

Critics say Congress will give in to lobbyists and let inefficient providers off the hook. That is far less likely to happen if Congress also adopts strong “pay-go” rules requiring that any increase in payments to providers be offset by new taxes or budget cuts.

CADILLAC COVERAGE The Senate Finance bill would impose an excise tax on health insurance plans that cost more than $8,000 for an individual or $21,000 for a family. It would most likely cause insurers to redesign plans to fall beneath the threshold. Enrollees would have to pay more money for many services out of their own pockets, and that would encourage them to think twice about whether an expensive or redundant test was worth it. Economists project that most employers would shift money from expensive health benefits into wages. The House bill has no similar tax. The final legislation should.

SIMPLIFIED FORMS Any doctor who has wrestled with multiple forms from different insurers, or patients who have tried to understand their own parade of statements, know that simplification ought to save money. When the health insurance industry was still cooperating in reform efforts, its trade group offered to provide standardized forms for automated processing. It estimated that step would save hundreds of billions of dollars over the next decade. The bills would lock that pledge into law.

ELECTRONIC MEDICAL RECORDS The stimulus package provided money to convert the inefficient, paper-driven medical system to electronic records that can be easily viewed and transmitted. This requires upfront investments to help doctors convert. In time it should help restrain costs by eliminating redundant tests, preventing drug interactions, and helping doctors find the best treatments.

REFORM OF THE DELIVERY SYSTEM Virtually all experts agree that the fee-for-service system — doctors are rewarded for the quantity of care rather than its quality or effectiveness — is a primary reason that the cost of care is so high. Most agree that the solution is to push doctors to accept fixed payments to care for a particular illness or for a patient’s needs over a year. No one knows how to make that happen quickly.

The bills in both houses would start pilot projects within Medicare. They include such measures as accountable care organizations to take charge of a patient’s needs with an eye on both cost and quality, and chronic disease management to make sure the seriously ill, who are responsible for the bulk of all health care costs, are treated properly. For the most part, these experiments rely on incentive payments to get doctors to try them.

INDEPENDENT COMMISSION Testing innovations do no good unless the good experiments are identified and expanded and the bad ones are dropped. The Senate bill would create an independent commission to monitor the pilot programs and recommend changes in Medicare’s payment policies to prod providers to adopt reforms that work. The changes would have to be approved or rejected as a whole by Congress, making it hard for narrow- interest lobbies to bend lawmakers to their will.

MANAGED COMPETITION The bills in both chambers would create health insurance exchanges on which small businesses and individuals could choose from an array of private plans and possibly a public option. All the plans would have to provide standard benefit packages that would be easy to compare. To get access to millions of new customers, insurers would have a strong incentive to sell on the exchange. And the head-to-head competition might give them a strong incentive to lower their prices, perhaps by accepting slimmer profit margins or demanding better deals from providers.

A PUBLIC PLAN The final legislation might throw a public plan into the competition, but thanks to the fierce opposition of the insurance industry and Republican critics, it might not save much money. The one in the House bill would have to negotiate rates with providers, rather than using Medicare rates, as many reformers wanted.

COMPARING TREATMENTS The president’s stimulus package is pumping money into research to compare how well various treatments work. Is surgery, radiation or careful monitoring best for prostate cancer? Is the latest and most expensive cholesterol-lowering drug any better than its generic competitors? The pending bills would spend additional money to accelerate this effort.

Critics have charged that this sensible idea would lead to rationing of care. (That would be true only if you believed that patients should have an unbridled right to treatments proven to be inferior.) As a result, the bills do not require, as they should, that the results of these studies be used to set payment rates in Medicare.

Congress needs to find the courage to allow Medicare to pay preferentially for treatments proven to be superior. Sometimes the best treatment might be the most expensive. But over all, we suspect that spending would come down through elimination of a lot of unnecessary or even dangerous tests and treatments.

NEGOTIATING DRUG PRICES The House bill would authorize the secretary of health and human services to negotiate drug prices in Medicare and Medicaid. Some authoritative analysts doubt that the secretary would get better deals than private insurers already get. We believe negotiation could work. It does in other countries.

MALPRACTICE REFORM Missing from these bills is any serious attempt to rein in malpractice costs. (Trial lawyers, major supporters of the Democratic Party, have seen to that.) Malpractice awards do drive up insurance premiums for doctors in high-risk specialties, and there is some evidence that doctors engage in “defensive medicine” by performing tests and treatments primarily to prove they are not negligent should they get sued.

Patients who are injured because of a doctor’s or a hospital’s negligence must have recourse. We favor reforms that would try to compensate injured people fairly and promptly — perhaps through mediation or expert tribunals — but would not prevent them from filing suit as a last resort or cap the awards they could receive. Even then, the savings might be modest. Doctors mostly perform high-cost tests because they want to help their patients and get paid handsomely for doing so.

Republican critics say, correctly, that the health care bills would saddle the government with large new costs to cover the uninsured by expanding Medicaid and providing subsidies to help low- and middle-income people buy insurance. And they say, incorrectly, that the effort should not move ahead until a sure-fire way is found to rein in rising health care costs.

Their arguments overlook the fact that the government is already paying many of these costs, through special payments to hospitals, each time a person without insurance, and with no means to pay, goes to an expensive emergency room for treatment. It also overlooks the fact that both bills are designed to keep deficits from increasing over the next decade or two.

It would be unfair, and unnecessary, to leave tens of millions of people uninsured while we wait to figure out ways to hold down the rise in health care costs.

This editorial is a part of a continuing series by The Times that is providing a comprehensive examination of the policy challenges and politics behind the debate over health care reform.

    Reform and Medical Costs, NYT, 15.11.2009, http://www.nytimes.com/2009/11/15/opinion/15sun1.html






US adult smoking rate rises slightly


Friday November 13 2009
AP foreign
AP Medical Writer= ATLANTA (AP)


Cigarette smoking rose slightly for the first time in almost 15 years, dashing health officials' hopes that the U.S. smoking rate had moved permanently below 20 percent.

A little under 21 percent of U.S. adults said they smoked, according to a 2008 national survey by the U.S. Centers for Disease Control and Prevention. That's up slightly from the year before, when just 19.8 percent said they were smokers. It also is the first increase in adult smoking since 1994, experts noted.

The increase was so small, it could be just a blip, so health officials and experts say smoking prevalence is flat, not rising. But they are unhappy.

"Clearly, we've hit a wall in reducing adult smoking," said Vince Willmore, spokesman for the Campaign for Tobacco-Free Kids, a Washington, D.C.- based research and advocacy organization.

There's a general perception that smoking is a fading public health danger. Feeding that perception are indoor smoking laws, cigarette taxes and Congress' recent decision to allow the Food and Drug Administration to regulate tobacco.

But health officials believe gains have been undermined by cuts in state tobacco control campaigns. Some advocates believe tobacco companies are overcoming increasing obstacles.

Cigarette marketing has persisted and is effectively reaching kids and minorities with messages about flavored or menthol products, said Dr. Clyde Yancy, president of the American Heart Association.

The tobacco industry also has been discounting cigarettes to offset tax increases and keep smokes affordable, Willmore said.

Between 1997 and 2004, the average retail price of a pack of cigarettes â? adjusted for inflation â? jumped 63 percent, and adult smoking declined about 15 percent. Between 2004 and 2008, the price rose just 2 percent, while adult smoking declined by just about 1 percent, he said, citing industry sales data.

"There's a clear correlation," Willmore said.

Cigarette smoking is the leading preventable cause of death and illness in the United States, and is a cause of cancers, heart disease and other fatal conditions.

The adult smoking rate has been dropping, in starts and stops, since the mid-1960s when roughly 2 out of 5 U.S. adults smoked. Now it's 1 in 5. However, federal health goals for the year 2010 had hoped to bring the rate down to close to 1 in 10.

Adult smoking hovered at about 21 percent from 2004 to 2006, then dropped a full percentage point in 2007, said Dr. Matthew McKenna, director of the CDC's Office on Smoking and Health.

The 2007 drop gave CDC officials hope that U.S. smoking was plummeting again. "Now that appears to be a statistical aberration," McKenna said.

The new survey's results come from in-person interviews of nearly 22,000 U.S. adults.

The study was released Thursday, published in the CDC publication, Morbidity and Mortality Weekly Report.

Also on Thursday, the CDC released state-by-state results on smoking from a different survey, conducted by telephone, of more than 400,000 adults. West Virginia and Indiana had the highest smoking rates, at about 26 percent, but four other states â? Kentucky, Missouri, Oklahoma and Tennessee â? had rates about as high.

Utah had, by far, the lowest smoking rate, with only about 9 percent of Utah residents describing themselves as current smokers.

Many of the states that have the lowest smoking rates are those that have been the most aggressive about indoor smoking laws and about state taxes that drive up the cost of cigarettes, said Dr. Thomas Frieden, the CDC's director.

Health officials are optimistic that more and more smokers will be discouraged from lighting up by escalating cigarette taxes, including a 62-cent federal tax that took effect in April. That may cause smoking to go down when the 2009 smoking data comes in, some advocates said.

Perhaps the recession will have an impact, too.

"In general, when people have less money, they smoke less," Frieden said. "Time will tell."


On the Net:

CDC report: http://www.cdc.gov/mmwr

    US adult smoking rate rises slightly, NYT, 13.11.2009, http://www.guardian.co.uk/world/feedarticle/8806367






Forty Years' War

Medicines to Deter Some Cancers

Are Not Taken


November 13, 2009
The New York Times


Many Americans do not think twice about taking medicines to prevent heart disease and stroke. But cancer is different. Much of what Americans do in the name of warding off cancer has not been shown to matter, and some things are actually harmful. Yet the few medicines proved to deter cancer are widely ignored.

Take prostate cancer, the second-most commonly diagnosed cancer in the United States, surpassed only by easily treated skin cancers. More than 192,000 cases of it will be diagnosed this year, and more than 27,000 men will die from it.

And, it turns out, there is a way to prevent many cases of prostate cancer. A large and rigorous study found that a generic drug, finasteride, costing about $2 a day, could prevent as many as 50,000 cases each year. Another study found that finasteride’s close cousin, dutasteride, about $3.50 a day, has the same effect.

Nevertheless, researchers say, the drugs that work are largely ignored. And supplements that have been shown to be not just ineffective but possibly harmful are taken by men hoping to protect themselves from prostate cancer.

As the nation’s war on cancer continues, with little change in the overall cancer mortality rate, many experts on cancer and public health say more attention should be paid to prevention.

But prevention has proved more difficult than many imagined. It has been devilishly difficult to show conclusively that something simple like eating more fruits and vegetables or exercising regularly helps. And, as the response to the prostate drugs shows, people are not enthusiastic about taking anticancer pills, or are worried about side effects or not really convinced the drugs work. Others are just unaware of them.

And prostate cancer is not unique. Scientists have what they consider definitive evidence that two drugs can cut the risk of breast cancer in half. Women and doctors have pretty much ignored the findings.

Companies have taken note, saying that it makes little economic sense to spend decades developing drugs to prevent cancer. The better business plan seems to be looking for drugs to treat cancer. That is a sobering lesson, said Dr. Ian M. Thompson Jr., chairman of the urology department at the University of Texas Health Science Center in San Antonio.

“A scientific discovery that is very clear cut and that is not implemented by the public is a tragedy,” he said.


Few Sure Things

A few ways are known for sure to prevent cancer; the biggest is to avoid cigarette smoking. That alone would drop the cancer death rate by a third. No other measure comes close.

Another huge success, for breast cancer, is to avoid taking estrogen and progestin at menopause. Sales of those drugs plummeted in 2002 after a federal study, the Women’s Health Initiative, concluded that they did not prevent heart disease and might increase breast cancer. The next year, the breast cancer rate dropped by 15 percent after having steadily increased since 1945.

The vaccine for human papilloma virus, protects against most strains of the virus, which causes cervical cancer.

But other measures that are often assumed — and marketed — as ways to prevent cancer may not make much difference, researchers say.

For example, public health experts for years recommended eating five servings of fruits and vegetables a day to prevent cancer, but the evidence is conflicting, at best suggestive, and far from definitive.

Low-fat diets were long thought to prevent breast cancer. But a large federal study randomizing women to a low-fat or normal diet and looking for an effect in breast cancer found nothing, said its director, Ross L. Prentice of the Fred Hutchinson Cancer Research Center in Seattle.

Fiber, found in fruits, vegetables and grains, is often thought to prevent colon cancer, even though two large studies found no effect.

“We thought we would show relationships that were strong and true,” said Dr. Tim Byers, professor of epidemiology at the Colorado School of Public Health, “particularly for dietary choices and food and vegetable intake. Now we have settled into thinking they are important but it’s not like saying you can cut your risk in half or three-quarters.” Others wonder whether even such qualified support is misplaced.

There has to be a reason the research disappointed, said Colin B. Begg, chairman of the department of epidemiology and biostatistics at Memorial Sloan-Kettering Cancer Center. Perhaps the crucial time to intervene is early in life.

“That’s one possibility,” Dr. Begg said. “The other is that it’s all sort of nonsense to begin with.”

Many hold out hope for exercise or weight loss. Studies have associated strenuous exercise with less cancer. But that is the same sort of evidence that misled scientists about aspects of diet.

“I think it’s wishful thinking,” said Dr. Susan Love, a breast surgeon and president of the Dr. Susan Love Research Foundation. “We would like things to be more in our control. I think that’s part of it. And in the absence of anything else, what do we tell women about how to prevent breast cancer? We tell them to exercise and eat a good diet.”

As for obesity, researchers differ. Studies that observed large numbers of people often found that fatter people have more cancer. But many of the correlations are weak, and different studies have pointed to different cancers, raising questions about whether some of the effects are real.

Dr. Otis W. Brawley, chief medical officer of the American Cancer Society, said he was convinced. The strongest link, he and others say, is with obesity and breast cancer. But there, Dr. Brawley says, the crucial period may occur early in life — girls who gain weight when they are young, he said, tend to start menstruating earlier, which increases their breast cancer risk because it adds years of exposure to the body’s estrogen. It may be that weight loss in adulthood does not help.

“We have very little evidence that losing weight or changing diet reduces risk of cancer,” he said. “It is likely that it takes years to effect a change in risk. We do have data that the change in diet decreases cardiovascular disease risk, so it’s easier to advocate diet change.”

Others, like Donald A. Berry, head of the division of quantitative sciences at the University of Texas M. D. Anderson Cancer Center, are dubious about blaming obesity for cancer rates. If there is a risk, Dr. Berry said, he suspects it is small. The studies are relying on correlations — they cannot assess cause and effect. And studies that come up with such associations are likely to be published, even though often the associations turn out to be spurious. That means, Dr. Berry said, that “the false-positive rate skyrockets.”

Still, Dr. Prentice said, disheartening as the findings have been, it would be a mistake to give up on lifestyle changes. Instead, he said, perhaps it is time to rethink the way studies are done.

“This should be a stimulus to our research community to say, How can we conduct observational studies in a way to reveal more reliable information?” Dr. Prentice said.

Diet and exercise, he added, “are likely quite important, but we just aren’t getting the answers.”


Great Hopes Dashed

Dr. Peter Greenwald knows the dashed hopes of cancer prevention research firsthand. As far back as 1981, when he arrived at the National Cancer Institute to direct “cancer prevention and control,” Dr. Greenwald began thinking about testing whether simple measures, like vitamin supplements, could prevent common cancers.

He focused on what looked like it could be a sure thing — beta carotene, found in orange fruits and vegetables as well as in green leafy vegetables.

The body converts beta carotene to vitamin A, which can prevent cancer in rats. People eating the most fruits and vegetables had less cancer. And the more beta carotene in a person’s blood, the lower the cancer risk. Lung cancer seemed particularly vulnerable to beta carotene’s effects, particularly in smokers and former smokers.

What was needed was cause-and-effect evidence, studies showing that if people bolstered their beta carotene and vitamin A levels, they would be protected from cancer. The cancer institute decided to take it on with two large studies.

But not only did the supplements not work, but there was evidence that beta carotene might actually increase cancer risk in smokers.

Dr. Greenwald and his colleagues still held out hope for vitamins and minerals as cancer preventatives. So his group proposed the largest cancer prevention clinical trial ever tried, involving 35,000 men 50 and older. This time, the idea was that vitamin E and selenium might prevent prostate cancer.

Once again, there was presumptive evidence. But this time it was harder to persuade scientists to go ahead. After the beta carotene and vitamin A studies, several other studies had also failed to find evidence that food components or special diets could prevent cancer.

“By this time, a lot of people were very concerned,” said Dr. Scott M. Lippman, an oncologist at M. D. Anderson. He argued that the huge study had to be done. The supplements were being promoted for “prostate health,” and the evidence that they might actually work was tantalizing.

The selenium and vitamin E study ended early. Once again, there was no protection from cancer, and there were hints the supplements might be causing cancer. Once again, the great hope turned into a stunning disappointment.

Prevention researchers say they are left sadder but wiser.

“Over the years, I’ve grown more skeptical and more cautious,” said Dr. Meir J. Stampfer, a professor of nutrition and epidemiology at the Harvard School of Public Health. “Findings get reported in the literature, and the more extreme findings tend to excite the imagination. Then, as evidence accumulates, those findings are not confirmed.”

Dr. Stampfer remains optimistic, though, pointing to the story of heart disease, where softer evidence eventually led to discoveries that measures like lowering blood pressure and cholesterol could prevent disease. An amazing decline in illness and death resulted. “Cancer is harder,” Dr. Stampfer said, but he added that it is too soon to give up. Dr. Greenwald, too, has not given up. He still hopes a diet with fruits and vegetables, along with exercise and weight control, might help prevent cancer. But he knows the evidence is not definitive and scientists have been fooled before. As for Dr. Lippman, he said the field had suffered from an excess of premature enthusiasm, especially before the beta carotene studies.

“We were pulled into this,” he said. “People said, We’ve got it! There were incredibly high expectations that were, in retrospect, unrealistic.”


Claims That Go Too Far

David G. Schardt, a senior nutritionist with the Center for Science in the Public Interest, an advocacy group, likes to relax in front of his television set at night. But what he was seeing last winter made his blood boil.

“I would sit there watching network news and the ads would come on,” Mr. Schardt said. Bayer, advertising its One A Day vitamins, was saying the selenium in the pills might improve “prostate health.” And as he drove to his office in Washington, Mr. Schardt heard Bayer advertisements on the radio that actually mentioned prostate cancer.

“I couldn’t believe it,” he said. After all, the federal study had already shown that selenium was useless and might be harmful. Finally, on Oct. 1, Mr. Schardt and the Center for Science in the Public Interest filed a lawsuit.

Tricia McKernan, a Bayer spokeswoman, says the advertisements relied on the Food and Drug Administration’s “permitted qualified health claim that ‘selenium may reduce the risk of certain cancers,’ ” especially prostate cancer. The F.D.A. no longer permits that claim, Ms. McKernan noted. She said Bayer was revising its packaging and promotional materials for its One A Day Men’s and One A Day Men’s 50+ vitamins, removing references to selenium reducing prostate cancer risk.

But a subtle promotion of selenium and vitamin E by supplement makers goes on, with claims that the pills improve “prostate health” by increasing the body’s “antioxidant defenses.”

Dr. Thompson said he sees the lure of supplements when he counsels patients. “I can’t tell you how many times I talked to somebody about prostate cancer prevention,” he said. He gives the high-risk men a prescription for one of the drugs that work. But the men do not fill it.

Instead, he said, they are taking “prostate health” vitamins.

In 1990, Dr. Victor G. Vogel was at M. D. Anderson and had high hopes of changing the world. It just may be possible, he thought, to prevent many cases of breast cancer in women at high risk, a group that includes every woman over age 60, the time when the risk takes a sharp turn upward.

Dr. Vogel was to be an investigator in a huge study of 13,000 women that seemed to have everything going for it. It would test a drug, tamoxifen, an estrogen-blocker widely used to treat women with breast cancer. The studies showing the drug’s effects in breast cancer patients, though, had an unexpected bonus. It looked as if tamoxifen was also preventing new cancers in the opposite breast.

“By the time we got to 1990, there was just a huge amount of data,” Dr. Vogel said. The drug’s risks were well established and seemed well worth taking if the benefit was cutting cancer in half among women at high risk. Most side effects, like hot flashes, were temporary. But there also was a risk of blood clots similar to that conferred by birth control pills or estrogen used to relieve symptoms of menopause. And there were about two additional cases of uterine cancer per 1,000 women per year.

By 1998, the results were in. Tamoxifen cut the breast cancer rate in half. Similar studies in Britain and Italy, also involving high-risk women who had not had breast cancer, came to similar conclusions. And women did not have to take the drug for a lifetime — they needed just five years of therapy.

Dr. Vogel was ecstatic.

“If I had told you in 1990 that in 10 years I would have a pill that would cut the risk of breast cancer in half, you wouldn’t have believed me,” he said.

But, he said, to his shock, “The world said, So what?”

“We were met with shoulder shrugs and harrumphs,” Dr. Vogel said. Sales of tamoxifen, worldwide, “didn’t budge.”

Maybe, Dr. Vogel thought, the problem was that internists and gynecologists were not comfortable prescribing a drug used to treat cancer patients. Then, in 1999, he had a chance to do another breast cancer prevention trial, this time of an osteoporosis drug, raloxifene, or Evista, which did not have the cancer drug taint. It was to be compared with tamoxifen.

The $110 million study, involving 19,000 women, ended in 2006. The two drugs were found to be equally effective in preventing breast cancer, but with raloxifene there was no excess uterine cancer and the clotting risk was 30 percent less.

“It was a spectacular clinical trial,” Dr. Vogel said. But, he added, “Once again, the world met the result with a shrug and a harrumph.”

“Those were your tax dollars and mine,” he added. “You can’t do too many $110 million studies.”

He cannot understand why no one cares, but some doctors say they see a number of problems. It is usually not the cost; tamoxifen is about 30 cents a day and raloxifene $3.30 a day. It is doctors’ practices and women’s concerns.

Most doctors, said Dr. Therese B. Bevers, medical director of the Cancer Prevention Center at M. D. Anderson, do not take the first step — calculating a woman’s lifetime risk of getting breast cancer — in part because that can lead to the next step, spending an hour or so discussing cancer risk and drug risks and benefits.

Dr. Bevers suggests the drugs for women whose lifetime odds exceeds 20 percent. That could include, for example, a 55-year-old woman who began menstruating early (increasing the risk), had her first child late (again increasing the risk), and whose mother and sister got breast cancer. About half the time, though, women with that kind of risk turn down the drugs, Dr. Bevers said. “The No. 1 reason I hear is, ‘Oh, I just don’t like to take medications,’ ” she added.

Others, like Cecilia Anderson, who is 57 and lives in Houston, worry about side effects. “I felt like my quality of life was in question,” she said. “I am busy, I am out there. I totally love my life and don’t want it to be compromised.” Her lifetime risk of breast cancer is 20.5 percent, compared with an average risk of 9.8 percent for a woman her age. Ms. Anderson declined the drugs. “I live a different lifestyle,” she said. “I eat organic foods, I exercise. Through all of that comes a spiritual element as well. Mind, body, and spirit are all connected.”


Studies’ Complications

Then came the studies of finasteride and dutasteride for prostate cancer. The drugs block the conversion of testosterone to dihydrotestosterone, a hormone that prostate cancers need to grow. They are on the market to shrink the prostate in older men, whose prostates often enlarge. (Finasteride is also sold to grow hair — but the dose is one-fifth the dose that shrinks prostates and that dose has not been tested for cancer prevention.) Doctors can prescribe the drugs for cancer prevention but, at this point, that is not on their label.

The prostate cancer studies were complicated by other another factor; at first, researchers thought, erroneously, that finasteride was actually spurring the growth of aggressive prostate cancers. The drug’s side effects can include impotence or decreased ejaculate. But the Food and Drug Administration concluded that these effects, if they occur at all, are gone after a year.

Now, even though the F.D.A. deemed the drug’s adverse reactions to be “usually mild and transient.” The American Urological Association and the American Society for Clinical Oncology recommend that men 50 and older consider taking it. But there appears to be little interest even among high-risk men.

Dr. Vogel wonders what message the indifference to the breast cancer and prostate cancer drugs is sending. Why would a company want to develop drugs for cancer prevention?

That is a lesson that hits home, said Dr. Gregory Curt, an oncologist who directs emerging products at AstraZeneca, a drug company.

He hopes companies will take more interest when researchers find biomarkers — cancer risk indicators that are the equivalent of blood pressure or cholesterol. That way people taking the drugs can see that they are reducing their risk. And studies can be smaller and quicker because companies can follow these markers rather than waiting for people to develop cancer.

But risk assessment is not easy, and biomarkers are still more of a dream than a reality. There are other problems, too. If each cancer requires a different drug for prevention, how many drugs can a person take? For now, Dr. Curt said, the very idea of cancer prevention is daunting. And since cancer can take decades to develop, by the time a study concludes, a drug’s patent life may be over.

It is not a pretty picture, Dr. Vogel said.

“You have to think that in boardrooms they are saying, Man, did we learn a lesson,” he said. “We will stay as far away as possible from cancer prevention.”

    Medicines to Deter Some Cancers Are Not Taken, NYT, 13.11.2009, http://www.nytimes.com/2009/11/13/health/research/13prevent.html






Op-Ed Contributor

The Short Life of a Diagnosis


November 10, 2009
The New York Times


Cambridge, England

THE Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association, is the bible of diagnosis in psychiatry, and is used not just by doctors around the world but also by health insurers.

Changing any such central document is complicated. It should therefore come as no surprise that a committee of experts charged with revising the manual has caused consternation by considering removing Asperger syndrome from the next edition, scheduled to appear in 2012. The committee argues that the syndrome should be deleted because there is no clear separation between it and its close neighbor, autism.

The experts propose that both conditions should be subsumed under the term “autism spectrum disorder,” with individuals differentiated by levels of severity. It may be true that there is no hard and fast separation between Asperger syndrome and classic autism, since they are currently differentiated only by intelligence and onset of language. Both classic autism and Asperger syndrome involve difficulties with social interaction and communication, alongside unusually narrow interests and a strong desire for repetition, but in Asperger syndrome, the person has good intelligence and language acquisition.

The question of whether Asperger syndrome should be included or excluded is the latest example of dramatic changes in history of the diagnostic manual. The first manual, published in 1952, listed 106 “mental disorders.” The second (1968), listed 182, and famously removed homosexuality as a disorder in a later printing. The third (1980) listed 265 disorders, taking out “neurosis.” The revised third version (1987) listed 292 disorders, while the current fourth version cut the list of disorders back to 283.

This history reminds us that psychiatric diagnoses are not set in stone. They are “manmade,” and different generations of doctors sit around the committee table and change how we think about “mental disorders.”

This in turn reminds us to set aside any assumption that the diagnostic manual is a taxonomic system. Maybe one day it will achieve this scientific value, but a classification system that can be changed so freely and so frequently can’t be close to following Plato’s recommendation of “carving nature at its joints.”

Part of the reason the diagnostic manual can move the boundaries and add or remove “mental disorders” so easily is that it focuses on surface appearances or behavior (symptoms) and is silent about causes. Symptoms can be arranged into groups in many ways, and there is no single right way to cluster them. Psychiatry is not at the stage of other branches of medicine, where a diagnostic category depends on a known biological mechanism. An example of where this does occur is Down syndrome, where surface appearances are irrelevant. Instead the cause — an extra copy of Chromosome 21 — is the sole determinant to obtain a diagnosis. Psychiatry, in contrast, does not yet have any diagnostic blood tests with which to reveal a biological mechanism.

So what should we do about Asperger syndrome? Although originally described in German in 1944, the first article about it in English was published in 1981, and Asperger syndrome made it only into the fourth version of the manual, in 1994. That is, the international medical community took 50 years to acknowledge it. In the last decade thousands of people have been given the diagnosis. Seen through this historical lens, it seems a very short time frame to be considering removing Asperger syndrome from the manual.

We also need to be aware of the consequences of removing it. First, what happens to those people and their families who waited so long for a diagnostic label that does a good job of describing their profile? Will they have to go back to the clinics to get their diagnoses changed? The likelihood of causing them confusion and upset seems high.

Second, science hasn’t had a proper chance to test if there is a biological difference between Asperger syndrome and classic autism. My colleagues and I recently published the first candidate gene study of Asperger syndrome, which identified 14 genes associated with the condition.

We don’t yet know if Asperger syndrome is genetically identical or distinct from classic autism, but surely it makes scientific sense to wait until these two subgroups have been thoroughly tested before lumping them together in the diagnostic manual. I am the first to agree with the concept of an autistic spectrum, but there may be important differences between subgroups that the psychiatric association should not blur too hastily.


Simon Baron-Cohen, the director of the Autism Research Center at Cambridge University, is the author of “The Essential Difference.”

    The Short Life of a Diagnosis, NYT, 10.11.2009, http://www.nytimes.com/2009/11/10/opinion/10baron-cohen.html






Obama Seeks Revision

of Plan’s Abortion Limits


November 10, 2009
The New York Times


WASHINGTON — President Obama suggested Monday that he was not comfortable with abortion restrictions inserted into the House version of major health care legislation, and he prodded Congress to revise them.

“There needs to be some more work before we get to the point where we’re not changing the status quo” on abortion, Mr. Obama said in an interview with ABC News. “And that’s the goal.”

On the one hand, Mr. Obama said, “we’re not looking to change what is the principle that has been in place for a very long time, which is federal dollars are not used to subsidize abortions.”

On the other hand, he said, he wanted to make sure “we’re not restricting women’s insurance choices,” because he had promised that “if you’re happy and satisfied with the insurance that you have, it’s not going to change.”

Before passing its health bill on Saturday, the House adopted an amendment that would block the use of federal money for “any health plan that includes coverage of abortion,” except in the case of rape or incest or if the life of a pregnant woman is in danger.

Some private insurance now covers abortion. Under the bill, most private insurers would receive federal subsidies on behalf of low- and middle-income people.

The Senate is working on its own version of health legislation.

Senator Susan Collins, a Maine Republican and pivotal centrist courted by the White House, delivered a blistering critique of the Senate bill on Monday, saying she could not support it because it would increase insurance costs for many middle-income families and small businesses.

“We should rewrite the whole bill,” Ms. Collins said. “There is considerable unease on both sides of the aisle about the impact of this bill, and as more analysis is done, I believe those concerns will only grow.”

Ms. Collins and the other Maine senator, Olympia J. Snowe, are among the few Republicans who had been considered potential supporters of the bill, drafted mainly by Senate Democrats with help from the White House.

Ms. Collins appeared to dash those hopes on Monday, even as she affirmed her belief that Democrats and Republicans could still find significant areas of agreement.

Summarizing her study of the bill over the past 10 weeks, Ms. Collins said it was “too timid” in revamping the health care system to reward high-quality care. She said the bill included “billions of dollars in new taxes and fees that will drive up the cost of health insurance premiums.”

And she noted that many of the taxes would take effect before the government started providing subsidies to low- and middle-income people to help them buy insurance.

Thus, Ms. Collins said, “there will be a gap for even low-income people where the effect of these fees will be passed on to consumers and increase premiums before any subsidies are available to offset those costs.”

The bill sets standards for the value of insurance policies, stipulating that they must cover at least 65 percent of medical costs, on average.

Most policies sold in the individual insurance market in Maine do not meet those standards, Ms. Collins said, so many insurers would have to raise premiums to comply with the requirements. As a result, she said, the premium for a 40-year-old buying the most popular individual insurance policy in Maine would more than double, to $455 a month.

The chairman of the Senate Finance Committee, Max Baucus, Democrat of Montana, has tried to answer such criticism, saying that many of the current policies provided meager bare-bones coverage.

The Senate Democratic leader, Harry Reid of Nevada, has drafted a health bill that he hopes to take to the Senate floor within weeks. He is waiting for a cost analysis by the Congressional Budget Office.

Supporters of the Senate bill said they believed that their efforts would gain momentum from the approval of a broadly similar bill in the House on Saturday by a vote of 220 to 215. But Representative Robert E. Andrews, Democrat of New Jersey and an architect of the House bill, said, “The hardest part is still ahead of us.”

The House and Senate bills differ in at least five ways: how to configure a new government insurance plan; whether to require employers to provide coverage to employees; whether to finance the legislation with a tax on high-income people or a tax on high-cost insurance plans; how strictly to limit coverage of abortion; and whether illegal immigrants should have access to new insurance marts, or exchanges.

The House bill imposes more stringent restrictions on the coverage of abortion.

Ms. Collins said the Senate Finance Committee “did a good job of putting up a firewall that would prevent federal funds from being used to finance abortions.” But she added, “If Congress makes the mistake of establishing a new government-owned insurance company, it would need to extend the prohibition to that company because it is using federal funds.”

    Obama Seeks Revision of Plan’s Abortion Limits, NYT, 10.11.2009, http://www.nytimes.com/2009/11/10/health/policy/10health.html







The Ban on Abortion Coverage


November 10, 2009
The New York Times


When the House narrowly passed the health care reform bill on Saturday night, it came with a steep price for women’s reproductive rights. Under pressure from anti-abortion Democrats and the United States Conference of Catholic Bishops, lawmakers added language that would prevent millions of Americans from buying insurance that covers abortions — even if they use their own money.

The restrictions would fall on women eligible to buy coverage on new health insurance exchanges. They are a sharp departure from current practice, an infringement of a woman’s right to get a legal medical procedure and an unjustified intrusion by Congress into decisions best made by patients and doctors.

The anti-abortion Democrats behind this coup insisted that they were simply adhering to the so-called Hyde Amendment, which bans the use of federal dollars to pay for almost all abortions in a number of government programs. In fact, they reached far beyond Hyde and made it largely impossible to use a policyholder’s own dollars to pay for abortion coverage.

The bill brought to the floor already included a careful compromise that should have satisfied reasonable legislators on both sides of the abortion issue. The vast majority of people expected to buy policies on the new exchanges would pay part of the premium and receive government tax credits to pay for the rest. The compromise would have prohibited the use of the tax subsidies to pay for almost all abortions, but it would have allowed the segregation and use of premium contributions and co-payments to pay for such coverage. A similar approach allows 17 state Medicaid programs to cover abortions using only state funds, not federal matching funds.

Yet neither the Roman Catholic bishops nor anti-abortion Democrats were willing to accept this compromise. They insisted on language that would ban the use of federal subsidies to pay for “any part” of a policy that includes abortion coverage.

If insurers want to attract subsidized customers, who will be the great majority on the exchange, they will have to offer them plans that don’t cover abortions. It is theoretically possible that insurers could offer plans aimed only at nonsubsidized customers, but it is highly uncertain that they will find it worthwhile to do so.

In that case, some women who have coverage for abortion services through policies bought by small employers could actually lose that coverage if their employer decides to transfer its workers to the exchange. Ultimately, if larger employers are permitted to make use of the exchange, ever larger numbers of women might lose abortion coverage that they now have.

The restrictive language allows people to buy “riders” that would cover abortions. But nobody plans to have an unplanned pregnancy, so this concession is meaningless. It is not clear that insurers would even offer the riders since few people would buy them.

The highly restrictive language was easily approved by a 240-to-194 vote and incorporated into the overall bill, which squeaked through by a tally of 220 to 215. It was depressing evidence of the power of anti-abortion forces to override a reasonable compromise. They were willing to scuttle the bill if they didn’t get their way. Outraged legislators who support abortion rights could also have killed the bill but sensibly chose to keep the reform process moving ahead.

The fight will resume in the Senate, where the Finance Committee has approved a bill that incorporates the compromise just rejected by the House. We urge the Senate to stand strong behind a compromise that would preserve a woman’s right to abortion services.

    The Ban on Abortion Coverage, NYT, 10.11.2009, http://www.nytimes.com/2009/11/10/opinion/10tue1.html






News Analysis

The Medical Industry Grumbles,

but It Stands to Gain


November 9, 2009
The New York Times


For any industry, there has to be at least some good news any time Congress votes to expand the market by tens of millions of customers.

But the business world found plenty to complain about Sunday, as it assessed the House bill that would make sweeping changes in the health care system and extend insurance coverage to millions more Americans.

Insurers do not like the provision to create a new government-run insurance program. Drug makers oppose billions of dollars in rebates they would have to give to the government over 10 years. Makers of artificial hips, heart defibrillators and other medical devices are not particularly happy about the proposed 2.5 percent tax on their products.

And employers large and small oppose rules that, for many of them, would make health care coverage — long a job benefit — become a federally mandated obligation.

That is why, as attention now shifts to the Senate, where Democratic leaders are trying to merge two bills into one, virtually every business group with a stake in the outcome will be hoping to strike at least a slightly better deal than they found in the House version.

And they may indeed get a break from the Senate, where the need for Democrats to compromise to win 60 votes may ensure a more business-moderate outcome.

And yet, many analysts said on Sunday that even the House bill was not as bad for business as many in the health care industry might have feared when the overhaul effort began many months ago.

“All industries stand to gain from this legislation,” Steven D. Findlay, senior health policy analyst with Consumers Union in Washington, said in an interview. “They’re going to continue to fight their narrow issues and get the best that they can get. But all of them are aware they stand to gain significant new business and new revenue streams as more Americans get health coverage and money flows into the system for them.”

Of course, new revenue streams apply only to companies in the business of selling medical goods and services. To employers required to provide worker health benefits or else, in many cases, pay some sort of financial penalty, the House legislation offers little to cheer about.

Employer groups complained on Sunday that the House bill would impose insurance obligations while doing little to rein in the medical costs that help drive premiums higher year after year. In fact, those groups argue, the bill’s creation of a government-run insurance program, which may pay doctors and hospitals less than private insurers do, could end up shifting even more medical costs to the private insurance system that employers use.

“This won’t just hurt business, it will hurt millions of workers who have coverage through their employers,” said John J. Castellani, president the Business Roundtable, a group of chief executives of some of the nation’s biggest companies.

And the National Federation of Independent Business, representing many small businesses, said it was furious with the legislation. Susan Eckerly, senior vice president of the federation, attacked mandates, which she called punitive, and “atrocious new taxes.” The legislation, she said, was “a failed opportunity to help small-business owners with their No. 1 problem — skyrocketing health care costs.”

Another group, the Small Business Majority, praised the legislation but said the Senate needed to take more steps to lower costs.

Employers hope the final Senate legislation ends up looking more like the bill the Finance Committee passed, which does not require companies to insure their workers.

Meanwhile, the health insurance industry has been increasingly vocal about the emerging shape of the legislation, and it was sharply critical of the bill that passed on Saturday night.

“The current House legislation fails to bend the health cost curve and breaks the promise that those who like their current coverage can keep it,” Karen M. Ignagni, the chief executive of America’s Health Insurance Plans, the industry trade association, said.

The reference to a broken promise refers, in part, to people enrolled in privately offered Medicare Advantage insurance plans, which would lose federal subsidies under the House bill. Ms. Ignagni warned of cuts that would “force millions of seniors out of the program entirely.”

But the promise reference also refers to the bill’s provision of a new government-run insurance plan that would compete directly with the health plans offered by private insurers. The insurance industry has long opposed such a move and warns that it will eventually force many people with private insurance into the government-run program.

That “public option,” as it is known, was also in the Senate health committee bill approved in July. And the Senate majority leader, Harry Reid, Democrat of Nevada, has also signaled that he intends to include some kind of public plan in whatever Senate legislation is reached.

But some observers say the House legislation is much less of a threat than the industry had feared. While insurers were worried that the government plan would be able to piggyback on the Medicare program in being able to demand lower prices than the private insurers get from doctors and hospitals, the House legislation does not give the government plan the same bargaining power as Medicare.

“The ability of that program to gain incredible market share and have the clout to severely undermine the market is minimized,” Robert Laszewski, president of Health Policy and Strategy Associates, a consulting firm in Alexandria, Va., said in an interview.

Erik Gordon, a business professor and industry analyst at the University of Michigan, said insurers would find it difficult to price their new risks but might not be hurt too much by the competition — considering how many new customers they would have.

The drug industry expected harsh treatment from the House and got it. The bill would require drug makers to pay much more in rebates and discounts than in the $80 billion, 10-year deal that the industry struck in June with the White House and the chairman of the Senate Finance Committee, Max Baucus. The House bill tacked on $60 billion or so in rebates over 10 years, raising the total to around $140 billion.

But the White House and Mr. Baucus have said they will stay with their deal. It remains to be seen whether it survives the melding of Senate bills being directed by Mr. Reid.

“A good critic doesn’t write his review at the end of the first act of a play,” Ken Johnson, senior vice president of the pharmaceutical trade group the Pharmaceutical Research and Manufacturers of America, said in an interview. “We’re hoping the second act is a lot better.”

And while the House legislation allows direct government negotiation of Medicare drug prices — something specifically precluded in the Senate Finance bill — it does not allow Medicare to create a formulary, or list of limited drugs. Mr. Findlay, of Consumers Union, said that largely neutered Medicare’s price-negotiating power, although it would represent a first step down the price-setting path that the industry is certain to fear.

In a victory for the biotechnology drug industry, the House bill would give biotech drugs, which can cost tens of thousands of dollars a year, protection from generic competition for 12 years.

Doctors were left holding a mixed bag. The American Medical Association supported the House legislation. But the doctors’ group did not get its quid pro quo — the restoration of $210 billion in cuts to physicians’ Medicare fees over the next 10 years, which were already scheduled before the current effort. Attempts in the House and Senate to restore those cuts have been set aside at least temporarily because the issue has been seen as a political distraction from the main health care overhaul effort.


Barry Meier and Andrew Pollack contributed reporting.

    The Medical Industry Grumbles, but It Stands to Gain, NYT, 9.11.2009, http://www.nytimes.com/2009/11/09/health/policy/09industry.html






For Opponents of Abortion,

a Victory in Health Care Vote


November 9, 2009
The New York Times


WASHINGTON — A restriction on abortion coverage, added late Saturday to the health care bill passed by the House, has energized abortion opponents with their biggest victory in years — emboldening them for a pitched battle in the Senate.

The provision would block the use of federal subsidies for insurance that covers elective abortions. Advocates on both sides are calling Saturday’s vote the biggest turning point in the battle over the procedure since the ban on so-called partial birth abortions six years ago.

Both sides credited a forceful lobbying effort by Roman Catholic bishops with the success of the provision, inserted in the bill under pressure from conservative Democrats.

The provision would apply only to insurance policies purchased with the federal subsidies that the health legislation would create to help low- and middle-income people, and to policies sold by a government-run insurance plan that would be created by the legislation.

Abortion rights advocates charged Sunday that the provision threatened to deprive women of abortion coverage because insurers would drop the procedure from their plans in order to sell them in the newly expanded market of people receiving subsidies. The subsidized market would be large because anyone earning less than $88,000 for a family of four — four times the poverty level — would be eligible for a subsidy under the House bill. Women who received subsidies or public insurance could still pay out of pocket for the procedure. Or they could buy separate insurance riders to cover abortion, though some evidence suggests few would, in part because few plan for unintended pregnancies.

Not many women who undergo abortions file private insurance claims, perhaps to avoid leaving a record. A 2003 study by the Alan Guttmacher Institute found that 13 percent of abortions were billed directly to insurance companies. Only about half of those who receive insurance coverage from their employers have coverage of abortion in any event, according to a study by the Kaiser Family Foundation.

Abortion rights advocates, however, are grappling with a series of incremental defeats in the courts and in Congress, and are now bracing for another struggle as the health care legislation goes to the Senate.

“This is going to make it that much more challenging on the Senate side,” said Nancy Keenan, president of Naral Pro-Choice America.

The president and Democratic leaders alike have long promised that their proposed health care overhaul would not direct taxpayer money to pay for elective abortions. But the president has never spelled out his answer to the contentious question of how to apply that standard to the novel program of offering insurance subsidies or a government-run plan to millions of poor and middle-class Americans.

House Democratic leaders had sought to resolve the issue by requiring insurers to segregate their federal subsidies into separate accounts.

Insurance plans would have been permitted to use only consumer premiums or co-payments to pay for abortions, even if individuals who received federal subsidies used them to buy health plans that covered abortion. But the House speaker, Nancy Pelosi, was unable to hold on to enough moderate and conservative Democratic votes to pass the health bill using that approach, forcing her to allow a vote Saturday night on the amendment containing the broader ban.

Five states go further than the amendment to the health care overhaul. The five — Idaho, Kentucky, Missouri, North Dakota and Oklahoma — already bar private insurance plans from covering elective abortions.

The federal employees’ health insurance plan and most state Medicaid programs also ban coverage of abortion, complying with a three-decade old ban on federal abortion financing. Seventeen state Medicaid programs, however, do cover the procedure, by using only state money.

The bishops objected to the segregated funds proposal previously embraced by the House and Senate Democratic leaders in part because they argued that it amounted to nothing more than an accounting gimmick.

Advocates on both sides of the question weighed in, but the bishops’ role was especially pivotal in part because many Democrats had expected them to be an ally. They had pushed for decades for universal health insurance.

“We think that providing health care is itself a pro-life thing, and we think that, by and large, providing better health coverage to women could reduce abortions,” said Richard M. Doerflinger, a spokesman for the anti-abortion division of the United States Conference of Catholic Bishops.

“But we don’t make these decisions statistically, and to get to that good we cannot do something seriously evil.”

Beginning in late July, the bishops began issuing a series of increasingly stern letters to lawmakers making clear that they saw the abortion-financing issue as pre-eminent, a deal-breaker.

At the funeral of Senator Edward M. Kennedy in August, Cardinal Seán O’Malley, the archbishop of Boston, stole a private moment with Mr. Obama to deliver the same warning: The bishops very much wanted to support his health care overhaul but not if it provided for abortions. The president “listened intently,” the cardinal reported on his blog.

Bishops implored their priests and parishioners to call lawmakers. Conservative Democrats negotiating over the issue with party leaders often expressed their desire to meet the bishops’ criteria, according to many people involved in the talks. On Oct. 8 three members of the bishops conference wrote on its behalf to lawmakers, “If the final legislation does not meet our principles, we will have no choice but to oppose the bill.”

On Sunday, some abortion rights advocates lashed out at the bishops. “It was an unconscionable power play,” said Cecile Richards, president of Planned Parenthood Federation of America, accusing the bishops of “interceding to put their own ideology in the national health care plan.”

Now some Senate Democrats, including Bob Casey of Pennsylvania and Ben Nelson of Nebraska, are pushing to incorporate the same restrictions in their own bill. Senior Senate Democratic aides said the outcome was too close to call.

    For Opponents of Abortion, a Victory in Health Care Vote, NYT, 9.11.2009, http://www.nytimes.com/2009/11/09/us/politics/09abortion.html







Obama-backed health care bill

passes House


7 November 2009
USA Today


WASHINGTON (AP) — The Democratic-controlled House narrowly passed far-reaching health care legislation, handing President Obama a hard-won victory on his chief domestic priority though the road ahead in the Senate promises to be rocky.

The 220-215 vote late Saturday cleared the way for the Senate to begin a long-delayed debate on the issue that has come to overshadow all others in Congress.

"The House bill is dead on arrival in the Senate," Sen. Lindsey Graham, R-S.C., said Sunday. "It was a bill written by liberals for liberals." A Democratic colleague, Sen. Jack Reed of Rhode Island, predicted an overhaul would pass the Senate because "it's essential" to the country's economic success and people's quality of life. "It will take time," he added.

House Republicans were nearly unanimous in opposing the plan that would expand coverage to tens of millions of Americans and place tough new restrictions on the insurance industry.

A triumphant Speaker Nancy Pelosi compared the legislation to the passage of Social Security in 1935 and Medicare 30 years later.

Obama, who went to Capitol Hill on Saturday to lobby wavering Democrats, said in a statement after the vote that he looked forward to signing a bill by year's end.

Republicans detailed their objections across hours of debate on the 1,990-page, $1.2 trillion legislation.

"We are going to have a complete government takeover of our health care system faster than you can say, 'this is making me sick,"' said Rep. Candice Miller, R-Mich.

In the run-up to a final vote, conservatives from the two political parties joined forces to impose tough new restrictions on abortion coverage in insurance policies to be sold to many individuals and small groups.

The legislation would require most Americans to carry insurance and provide federal subsidies to those who otherwise could not afford it. Large companies would have to offer coverage to their employees. Both consumers and companies would be slapped with penalties if they defied the government's mandates.

Insurance industry practices such as denying coverage because of medical conditions would be banned, and insurers would no longer be able to charge higher premiums on the basis of gender or medical history. The industry would also lose its exemption from federal antitrust restrictions on price fixing and market allocation.

At its core, the measure would create a federally regulated marketplace where consumers could shop for coverage. In the bill's most controversial provision, the government would sell insurance, although the Congressional Budget Office forecasts that premiums for it would be more expensive than for policies sold by private companies.

Graham said he thinks the government option "will destroy private health care. Nobody in this country in the insurance business can compete with a government-sponsored plan, where the government writes the benefits and politicians will never raise the premiums."

Sen. Joe Lieberman, an independent from Connecticut, said that "if the public option plan is in there, as a matter of conscience, I will not allow this bill to come to a final vote because I believe the debt can break America and send us into a recession that's worse than the one we're fighting our way out of today."

The House bill drew the votes of 219 Democrats and Rep. Joseph Cao, a first-term Republican who holds an overwhelmingly Democratic seat in New Orleans. Opposed were 176 Republicans and 39 Democrats.

From the Senate, Majority Leader Harry Reid of Nevada issued a statement saying, "We realize the strong will for reform that exists, and we are energized that we stand closer than ever to reforming our broken health insurance system."

To pay for the expansion of coverage, the bill cuts Medicare's projected spending by more than $400 billion over a decade. It also imposes a tax surcharge of 5.4% on income over $500,000 in the case of individuals and $1 million for families.

Graham and Reed were on CBS' "Face the Nation." Lieberman appeared on "Fox News Sunday."

    Historic, Obama-backed health care bill passes House, UT, 7.11.2009, http://www.usatoday.com/news/washington/2009-11-07-house-health-care-vote_N.htm






Premature Births

Behind Higher Infant Death Rates in U.S.,

Report Says.


November 4, 2009
The New York Times


High rates of premature birth are the main reason the United States has higher infant mortality than do many other rich countries, government researchers reported Tuesday in their first detailed analysis of a longstanding problem.

In Sweden, for instance, only 6.3 percent of births were premature, compared with 12.4 percent in the United States in 2005 — the latest year for which international rankings are available.

Infant mortality also differed markedly: for every 1,000 births in the United States, 6.9 infants died before they turned 1, compared with only 2.4 in Sweden. Twenty-nine other countries also had lower rates.

If America could match Sweden’s prematurity rate, the new report said, “nearly 8,000 infant deaths would be averted each year, and the U.S. infant mortality rate would be one-third lower.”

Dr. Alan R. Fleischman, medical director of the March of Dimes, said the new report was “an indictment of the U.S. health care system” and the poor job it had done in taking care of women and children.

Infant mortality is widely used as a way to gauge the health of a nation, and the relatively high rates in the United States have long dismayed health officials.

The high rates of prematurity in the United States have various causes. The smallest, earliest and most fragile babies are often born to poor and minority women who lack health care and social support. The highest rates of infant mortality occur in non-Hispanic black, American Indian, Alaska Native and Puerto Rican women.

When it comes to prematurity, fertility treatments — drugs that stimulate ovulation, and procedures that implant more than one embryo in the uterus — also play a role, by raising the odds of twins or higher multiples, which have an increased risk of being born too soon.

Another factor is the increasing use of Caesarean sections and labor-inducing drugs to deliver babies early, said Marian F. MacDorman, a statistician at the National Center for Health Statistics and an author of the report.

“I don’t think there are doctors doing preterm Caesarean sections or inductions without some indications, but there sort of has been this shift in the culture,” Dr. MacDorman said. “Fifteen or 20 years ago, if a woman had high blood pressure or diabetes, she would be put in the hospital and they would try to wait it out. It was called expectant management. Now I think there’s more of a tendency to take the baby out early if there’s any question at all.”

    Premature Births Behind Higher Infant Death Rates in U.S., Report Says., NYT, 4.11.2009, http://www.nytimes.com/2009/11/04/health/04infant.html






H1N1 Widespread

in 46 States as Vaccines Lag


October 25, 2009
The New York Times


WASHINGTON — President Obama has declared the swine flu outbreak a national emergency, allowing hospitals and local governments to speedily set up alternate sites for treatment and triage procedures if needed to handle any surge of patients, the White House said on Saturday.

The declaration came as thousands of people lined up in cities across the country to receive vaccinations, and as federal officials acknowledged that their ambitious vaccination program has gotten off to a slow start. Only 16 million doses of the vaccine were available now, and about 30 million were expected by the end of the month. Some states have requested 10 times the amount they have been allotted.

Flu activity — virtually all of it the swine flu — is now widespread in 46 states, a level that federal officials say equals the peak of a typical winter flu season. Millions of people in the United States have had swine flu, known as H1N1, either in the first wave in the spring or the current wave.

Although there has been no exact count, officials said the H1N1 virus has killed more than 1,000 Americans and hospitalized over 20,000. The emergency declaration, which Mr. Obama signed Friday night, has to do only with hospital treatment, not with the vaccine. Government officials emphasized that Mr. Obama’s declaration was largely an administrative move that did not signify any unanticipated worsening of the outbreak of the H1N1 flu nationwide. Nor, they said, did it have anything to do with the reports of vaccine shortages.

“This is not a response to any new developments,” said Reid Cherlin, a White House spokesman. “It’s an important tool in our kit going forward.”

Mr. Obama’s declaration was necessary to empower Kathleen Sebelius, the secretary of Health and Human Services, to issue waivers that allow hospitals in danger of being overwhelmed with swine flu patients to execute disaster operation plans that include transferring patients off-site to satellite facilities or other hospitals.

The department first declared a public health emergency in April; Ms. Sebelius renewed it on Tuesday. But the separate presidential declaration was required to waive federal laws put in place to protect patients’ privacy and to ensure that they are not discriminated against based on their source of payment for care, including Medicare, Medicaid and the states’ Children’s Health Insurance Program.

As a practical matter, officials said, the waiver could allow a hospital to set up a make-shift satellite facility for swine flu patients in a local armory or other suitably spacious location, or at another hospital, to segregate such cases for treatment. Under federal law, if the patients are sent off site without a waiver, the hospital could be refused reimbursement for care as a sanction.

A few hospitals, including some in Texas and Tennessee, have set up triage tents in their parking lots to screen patients with fever or other flu symptoms. A Health and Human Services official said no hospitals had requested a waiver. David Daigle of the Centers for Disease Control and Prevention said he had not heard of any hospital that has faced a surge of patients so large that it had to set up a triage area or a treatment unit off site.

In Chicago on Saturday, health officials began giving free vaccinations at six City College locations, and within hours hundreds of people were turned away because supplies had been exhausted. The city distributed 1,200 vaccines to each site, immunizing more than 7,000 people, said Tim Hadac, spokesman for the Chicago Department of Public Health. All but two of the sites ran out of the vaccine.

At Truman College on Chicago’s North Side, lines formed at 7 a.m., two hours before the doors opened. Mary Kate Merna, 28, a teacher who is nine months pregnant, arrived too late to get a vaccination. “I thought I’d be a priority being nine months pregnant,” she said. “You hear it’s a national emergency and it scares you.”

In Fairfax County, Va., officials had planned to have swine flu clinics at 10 different locations on Saturday. But the county did not receive the number of doses it requested, and was forced to offer the vaccinations only at the government building. People began lining up with camping gear the night before to get vaccinations.

Merni Fitzgerald, Fairfax’s public affairs director, said officials were aiming to administer 12,000 doses of the vaccine to those most at risk for serious complications from the H1N1 virus, mainly pregnant women and children 6 to 36 months.

But that did not stop some other high-risk patients. “I lied and told the doctors I was pregnant,” said Theresa Caffey of Centreville, who has multiple sclerosis and nurses her 11-week-old son, Joshua. “I’m religious. I don’t lie. But it’s not about me. It’s for my son. It’s safer for him if I have the antibodies.”

In a briefing on Friday, Dr. Thomas Frieden, the C.D.C. director, acknowledged problems with the vaccine production. “We share the frustration of people who have waited on line or called a number or checked a Web site and haven’t been able to find a place to get vaccinated,” he said.

Federal officials predicted last spring that as many as 120 million doses could be available by now, with nearly 200 million by year’s end. But production problems plagued some of the five companies contracted to make the vaccine. All use a technology involving growing the vaccine in fertilized chicken eggs; at most of them, the seed strain grew more slowly than expected.

The manufacturers are “working hard to get vaccine out as safely and rapidly as possible,” Dr. Frieden said. But since it is grown in eggs, “even if you yell at them, they don’t grow faster.”

Since last winter’s more isolated cases of swine flu, the expectation that the virus would return with a vengeance in this flu season had posed a test of the Obama administration’s preparedness. Officials are mindful that the previous administration’s failure to better prepare for and respond to Hurricane Katrina in 2005 left doubts that dogged President George W. Bush to the end of his term.

There is no overall shortage of seasonal flu vaccine — 85 million doses have shipped, and the season has not started. But there are temporary local shortages. The seasonal flu typically hospitalizes 200,000 and kills 36,000 nationwide each year. But over 90 percent of the deaths are among the elderly, while the swine flu mostly affects the young.


Jackie Calmes reported from Washington, and Donald G. McNeil Jr. from New York. Crystal Yednak in Chicago and Holli Chmela in Fairfax, Va. contributed reporting.

    H1N1 Widespread in 46 States as Vaccines Lag, NYT, 25.10.2009, http://www.nytimes.com/2009/10/25/us/politics/25flu.html






In Shift, Cancer Society

Has Concerns on Screenings


October 21, 2009
The New York Times


The American Cancer Society, which has long been a staunch defender of most cancer screening, is now saying that the benefits of detecting many cancers, especially breast and prostate, have been overstated.

It is quietly working on a message, to put on its Web site early next year, to emphasize that screening for breast and prostate cancer and certain other cancers can come with a real risk of overtreating many small cancers while missing cancers that are deadly.

“We don’t want people to panic,” said Dr. Otis Brawley, chief medical officer of the cancer society. “But I’m admitting that American medicine has overpromised when it comes to screening. The advantages to screening have been exaggerated.”

Prostate cancer screening has long been problematic. The cancer society, which with more than two million volunteers is one of the nation’s largest voluntary health agencies, does not advocate testing for all men. And many researchers point out that the PSA prostate cancer screening test has not been shown to prevent prostate cancer deaths.

There has been much less public debate about mammograms. Studies from the 1960s to the 1980s found that they reduced the death rate from breast cancer by up to 20 percent.

The cancer society’s decision to reconsider its message about the risks as well as potential benefits of screening was spurred in part by an analysis published Wednesday in The Journal of the American Medical Association, Dr. Brawley said.

In it, researchers report a 40 percent increase in breast cancer diagnoses and a near doubling of early stage cancers, but just a 10 percent decline in cancers that have spread beyond the breast to the lymph nodes or elsewhere in the body. With prostate cancer, the situation is similar, the researchers report.

If breast and prostate cancer screening really fulfilled their promise, the researchers note, cancers that once were found late, when they were often incurable, would now be found early, when they could be cured. A large increase in early cancers would be balanced by a commensurate decline in late-stage cancers. That is what happened with screening for colon and cervical cancers. But not with breast and prostate cancer.

Still, the researchers and others say, they do not think all screening will — or should — go away. Instead, they say that when people make a decision about being screened, they should understand what is known about the risks and benefits.

For now, those risks are not emphasized in the cancer society’s mammogram message which states that a mammogram is “one of the best things a woman can do to protect her health.”

Dr. Brawley says mammograms can prevent some cancer deaths. However, he says, “If a woman says, ‘I don’t want it,’ I would not think badly of her but I would like her to get it.”

But some, like Colin Begg, a biostatistician at Memorial Sloan-Kettering Cancer Center in New York, worry that the increased discussion of screening’s risks is going to confuse the public and make people turn away from screening, mammography in particular.

“I am concerned that the complex view of a changing landscape will be distilled by the public into yet another ‘screening does not work’ headline,” Dr. Begg said. “The fact that population screening is no panacea does not mean that it is useless,” he added.

The new analysis — by Dr. Laura Esserman, a professor of surgery and radiology at the University of California, San Francisco, and director of the Carol Frank Buck Breast Care Center there, and Dr. Ian Thompson, professor and chairman of the department of urology at The University of Texas Health Science Center, San Antonio — finds that prostate cancer screening and breast cancer screening are not so different.

Both have a problem that runs counter to everything people have been told about cancer: They are finding cancers that do not need to be found because they would never spread and kill or even be noticed if left alone. That has led to a huge increase in cancer diagnoses because, without screening, those innocuous cancers would go undetected.

At the same time, both screening tests are not making much of a dent in the number of cancers that are deadly. That may be because many lethal breast cancers grow so fast they spring up between mammograms. And the deadly prostate ones have already spread at the time of cancer screening. The dilemma for breast and prostate screening is that it is not usually clear which tumors need aggressive treatment and which can be left alone. And one reason that is not clear, some say, is that studying it has not been much of a priority.

“The issue here is, as we look at cancer medicine over the last 35 or 40 years, we have always worked to treat cancer or to find cancer early,” Dr. Brawley said. “And we never sat back and actually thought, ‘Are we treating the cancers that need to be treated?’ ”

The very idea that some cancers are not dangerous and some might actually go away on their own can be hard to swallow, researchers say.

“It is so counterintuitive that it raises debate every time it comes up and every time it has been observed,” said Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health.

It was first raised as a theoretical possibility in the 1970s, Dr. Kramer said. Then it was documented in a rare pediatric cancer, but was dismissed as something peculiar to that cancer. Then it was discovered in common cancers as well, but it is still not always accepted or appreciated, he said.

But finding those insignificant cancers is the reason the breast and prostate cancer rates soared when screening was introduced, Dr. Kramer said. And those cancers, he said, are the reason screening has the problem called overdiagnosis — labeling innocuous tumors cancer and treating them as though they could be lethal when in fact they are not dangerous.

“Overdiagnosis is pure, unadulterated harm,” he said.

Dr. Peter Albertsen, chief and program director of the urology division at the University of Connecticut Health Center, said that had not been an easy message to get across. “Politically, it’s almost unacceptable,” Dr. Albertsen said. “If you question overdiagnosis in breast cancer, you are against women. If you question overdiagnosis in prostate cancer, you are against men.”

Dr. Esserman hopes that as research continues on how to advance beyond screening, distinguishing innocuous tumors from dangerous ones, people will be more realistic about what screening can do.

“Someone may say, ‘I don’t want to be screened’ ” she said. “Another person may say, ‘Of course I want to be screened.’ Just like everything in medicine, there is no free lunch. For every intervention, there are complications and problems.”

    In Shift, Cancer Society Has Concerns on Screenings, NYT, 21.10.2009, http://www.nytimes.com/2009/10/21/health/21cancer.html






Op-Ed Contributor

Have Faith in an AIDS Vaccine


October 19, 2009
The New York Times


VACCINE researchers don’t often find themselves at the center of public controversies. But a storm has erupted over the announcement last month that an experimental AIDS vaccine tested in Thailand proved modestly effective. It was billed as a major scientific advance — the long-awaited hard evidence that it is possible to inoculate people against AIDS. But now the trial has been called into question in a way that is overblown and possibly destructive.

At a biotech conference last week, I asked a major industry scientist what he thought of the Thai trial announcement, and, although no additional data had been presented, he replied simply, “I don’t believe it.” Unfortunately, such pessimism may be hard to dispel and may ultimately thwart other efforts to develop an AIDS vaccine.

Even before this controversy erupted, it had been an effort to maintain sufficient support for AIDS vaccine research and development. In 2008, private and public spending on this vital mission declined by 10 percent from the year before. A few fanatical AIDS activists have even called for ending the American government’s considerable support for AIDS vaccine research, and spending the money instead on AIDS treatment. Patient care is vital, of course, but it alone can only mitigate, not end, the pandemic.

This is why it is essential to clear things up.

The Thai study was the largest AIDS vaccine trial yet, following 16,402 volunteers for six years. It was a collaborative effort by, among others, the United States military, the National Institutes of Health and the Thai Health Ministry. (The organization I head, a nonprofit that conducts vaccine research and development but was not involved and has no commercial interest in the candidates tested.) The trial partners initially announced that the vaccine combination reduced the risk of infection by 31.2 percent in a statistically significant analysis.

A few days later, the trial collaborators began to brief researchers privately about additional data, including a second type of analysis that indicated the vaccine regimen had been slightly less effective than the first analysis suggested. This second analysis was not statistically significant, meaning that chance, rather than the protective effect of the vaccine candidate, might explain why fewer volunteers in the vaccinated group than in the placebo group were infected with H.I.V.

Some researchers questioned why both analyses weren’t announced at the same time — which certainly would have been preferable — and suggested to reporters that the second analysis called the first one into doubt. The trial sponsors say they thought the complexities of the second analysis and all additional data were best explored in a peer-reviewed paper in a scientific journal and at a presentation at the AIDS Vaccine Conference in Paris this week. But with news outlets reporting that the trial results may be a fluke, there is a risk that they will be forever tainted, whatever the final analyses show. What’s more, the stain of dubiousness may remain on all AIDS vaccine research and development.

That would be a shame. Although the candidate duo tested in the Thai trial did not prove to be a vaccine ready for the market, it may provide an unprecedented opportunity to learn how an AIDS vaccine can work. A comparison of blood samples from volunteers could indicate what specific immune responses the combination may have activated to provide protection. If so, this knowledge could help scientists improve upon the more promising candidates that have emerged since the trial candidates were designed a decade ago, and determine which ones are most likely to work.

This illustrates why the controversy over statistical significance is exaggerated. Whether you consider the first or second analysis, the observed effect of the Thai candidates was either just above or below the level of statistical significance. Statisticians will tell you it is possible to observe an effect and have reason to think it’s real even if it’s not statistically significant. And if you think it’s real, you ought to examine it carefully.

Even if the Thai vaccine regimen turns out, on examination, to have had no real benefit, researchers will still learn from the trial, as they do from every study. Moreover, other noteworthy advances featured at the Paris conference this week will offer fresh hope for an AIDS vaccine. Years of investment and dogged science are providing leads for solving one of today’s most pressing research challenges. Some 7,400 new H.I.V. infections occur daily throughout the world. Clearly we need better methods of preventing the spread of H.I.V., and no public health intervention is more powerful or cost-effective against infectious disease than a vaccine.


Seth Berkley is the president and chief executive of the International AIDS Vaccine Initiative.

    Have Faith in an AIDS Vaccine, NYT, 19.10.2009, http://www.nytimes.com/2009/10/19/opinion/19berkley.html







Who Should Treat Breast Cancer?


October 18, 2009
The New York Times


To the Editor:

In “Wanted: Mammologists” (Op-Ed, Oct. 10), Ann V. Bell, Mark Pearlman and Raymond De Vries argue that women with breast cancer need doctors “devoted to shepherding them through surgery, therapy and healing.” But introducing a “mammologist” would create yet another specialist to whom generalists would refer patients.

Mammologists would not necessarily reduce communication errors, which are often institutional issues. Besides, many women use a family doctor, internist, physician’s assistant or nurse practitioner as an initial care provider.

Coordination of care is a high priority, but why not turn to multidisciplinary breast care centers that can, in a single visit, marshal the expertise of subspecialists and ancillary services?

Edwin Wang
Wilsonville, Ore., Oct. 10, 2009

The writer is a radiologist.

To the Editor:

It is true that breast cancer treatment has become too complex for the current models of care. The multiple specialties required make it impossible for a single individual, no matter how well trained, to deliver that care.

The only solution is to put the patient at the center of the process. At many leading institutions, a multidisciplinary approach allows all relevant specialists to come together to see patients on the same day. Such an approach leads to improved communication and better care for breast cancer, and should be applied throughout medicine as care becomes more complex.

James P. Evans
Chapel Hill, N.C., Oct. 10, 2009

The writer, a doctor, is director of clinical cancer genetics at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.

To the Editor:

I am a nurse practitioner in internal medicine and have been practicing for 11 years, so I feel I have experience with breast-lump palpation and cancer detection.

If a woman has not had a clinical breast exam in the past year or mentions a lump, I do a breast exam. If we agree that there is a lump, she is immediately sent to our breast imaging clinic, where a mammogram and an ultrasound are done that day.

If the radiologist tells me the results are worrisome, the patient can immediately see one of our breast surgeons.

A woman does not have to go to a gynecologist for this care. In fact, men or women in our internal medicine clinic who mention a worrisome lump can be seen that day, whether it is in the breast, neck or testicle. We have been doing it this way for as long as I can remember.

Chris Keeney
Sayre, Pa., Oct. 10, 2009

To the Editor:

Your article describes the challenges for breast cancer patients who are shuttled between specialists. As long as our system fixes us one piece at a time, we will suffer the costs of miscommunication, and miss out on the benefits of holistic care.

This à la carte health care surely helps explain why we spend more yet have a shorter life expectancy than our European counterparts. As we consider health care access for all, let’s make sure we treat all of each person.

Necia Hobbes
Pittsburgh, Oct. 10, 2009

The writer is a student in the health law program at the University of Pittsburgh School of Law.

To the Editor:

While the tone of “Wanted: Mammologists” seems conciliatory, the text is a subtle rally to turf warfare, advocating that obstetrician-gynecologists learn to do breast biopsies.

Collaborative efforts to help patients through breast cancer treatment are well under way. In my hospital, these include a program that helps navigate patients from radiology to surgery to radiation, as well as interdepartmental teaching conferences and courses stressing comprehensive approaches.

Breast Cancer Awareness Month is as good a time as any to encourage better communication.

Miriam David
Bronx, Oct. 10, 2009

The writer is a radiologist at Jacobi Hospital specializing in breast imaging.

To the Editor:

The decreasing mortality from breast cancer is due to earlier diagnosis because of mammography and to multidisciplinary, innovative treatments.

Women should still have breast examinations by their primary-care doctors, and be taught self-examination. But breast cancers are more frequently detected by mammograms.

The diagnosis should then be established not by surgical biopsy, but by a less invasive technique, like a needle biopsy by a radiologist or surgeon.

There is no reason to go back a century to when breast biopsies were performed by gynecologists. The diagnosis and treatment of breast disease are taught within the specialty of general surgery, and there are fellowships that train specialists in all aspects of treating breast cancer.

We have too often seen the bad results of what the writers call “minimal” surgery to diagnose breast disease. Surgery should be performed only by those specifically trained to complete whatever additional procedures are deemed necessary at the time — for example, the removal of lymph nodes. This is state-of-the-art, optimal care.

Peter I. Pressman
Gordon F. Schwartz
New York, Oct. 10, 2009

The writers are, respectively, clinical professor of surgery at Weill Cornell Medical College and a professor of surgery at Jefferson Medical College. Dr. Pressman is co-author of “Breast Cancer: The Complete Guide.”

To the Editor:

It fell to general surgeons to treat breast cancer in the late 19th century when William Stewart Halsted devised the first effective treatment for it.

As medicine has advanced, the skills of radiation oncologists and radiologists have become far greater than those of practitioners who don’t do this work full time.

A team approach to most cancers, in which surgeons, oncologists, radiation therapists and radiologists diagnose and treat cancer, should be universal. My wife and I have both been cancer patients and, like others, we know that treatment is often cumbersome and unpleasant, and need not be. But construction of a new specialty won’t solve these problems.

Michael P. Kempster
Andover, Mass., Oct. 10, 2009

The writer is a retired general surgeon.

    Who Should Treat Breast Cancer?, NYT, 18.10.2009, http://www.nytimes.com/2009/10/18/opinion/l18mammo.html







How Biology Influences Our Behavior


October 15, 2009
The New York Times


To the Editor:

David Brooks’s terrific Oct. 13 column, “The Young and the Neuro,” addresses the interdisciplinary nature of the research being done today in cognitive neuroscience. Far from being merely the domain of medicine or sociology, it is a new discipline being forged through the fusion of biotechnology, psychology, physiology, and political and social science.

In the future, no single scholarly field will flourish without interrelationships with others. That this truth is being recognized is apparent in the Nobel committee’s decision to award the prize in economics to Elinor Ostrom, a political scientist at Indiana University.

University administrators should be aware that other areas that are usually relegated to “the arts” are also involved in cognitive science, including theater and performance studies, which has been examining how mirror neurons are engaged when audiences watch plays or view films.

Mr. Brooks is to be commended for recognizing the value of interdisciplinarity. Let us not forget, especially at a time when university budgets are being drastically cut, that those of us working in the humanities are contributing to “neurohumanism” as well.

Linda Charnes

Bloomington, Ind., Oct. 13, 2009

The writer is a professor of English and West European studies at Indiana University.

To the Editor:

David Brooks heralds the new way that we will be analyzing our behavior, so that we will more fully understand how we react to events and to others. But there is one flaw in Mr. Brooks’s conclusion. He declares that the categories “emotion” and “reason” will no longer be relevant.

On the contrary, this new “social cognitive neuroscience” will highlight the way our reactions are determined by our emotions rather than our reason. We will finally begin to understand scientifically what psychologists have understood for decades: how most of our actions stem from our emotions rather than our rational thought.

Mark Ettinger

New York, Oct. 13, 2009

To the Editor:

For decades, the psychoanalytic community has been helping patients to lead more productive, satisfying lives by searching for the conscious and unconscious motivations behind their actions, attitudes and behaviors. Our work has lately come under attack as being unscientific, but David Brooks describes just how our clinical theories intersect with empirical research and wider social concerns.

With the benefit of new technology, young scientists can scan brain processes and demonstrate how the unconscious brain affects behaviors and how human attachments are developed or altered. As psychoanalysts, we struggle to retain credibility in the health care debate, to get reimbursements from insurance companies and to get a seat at the table of political and cultural discourse.

We need to rethink the way we define what we do and challenge the perception of the analyst as insular and out of touch. An article like Mr. Brooks’s confirms that we are relevant. I hope that the young scientists can help us find a better way to engage. Mindy Utay

New York, Oct. 14, 2009

The writer is a social worker and psychoanalyst in private practice.

To the Editor:

David Brooks writes: “The anterior cingulate cortices in American and Chinese brains activate when people see members of their own group endure pain, but they do so at much lower levels when they see members of another group enduring it. These effects may form the basis of prejudice.”

Aren’t these effects simply a result of prejudice? Is the biochemical process the basis of prejudice or is prejudice the basis for a biochemical process taking place? To simply assume that a biochemical correlate of a social activity is its explanation is bad science, even if chemical reactions look less “fuzzy” than the materials of social and cultural life. James Slotta

Portland, Ore., Oct. 13, 2009

To the Editor:

David Brooks seems to consider it delightful that the social cognitive neuroscientists he saw at a recent academic conference were “young, hip and attractive.” But as an un-hip 62-year-old professor in a different field, I wonder whether the “geeks” and “graying professors” whose absence Mr. Brooks seems to celebrate were not there because they would be unwelcome.

Such discrimination would be not only immoral but also foolish, since even the old and un-hip just might have something to offer intellectually.

Felicia Nimue Ackerman

Providence, R.I., Oct. 13, 2009

The writer is a professor of philosophy at Brown University.

    How Biology Influences Our Behavior, NYT, 15.10.2009, http://www.nytimes.com/2009/10/15/opinion/l15brooks.html






Op-Ed Columnist

The Young and the Neuro


October 13, 2009
The New York Times


When you go to an academic conference you expect to see some geeks, gravitas and graying professors giving lectures. But the people who showed up at the Social and Affective Neuroscience Society’s conference in Lower Manhattan last weekend were so damned young, hip and attractive. The leading figures at this conference were in their 30s, and most of the work was done by people in their 20s. When you spoke with them, you felt yourself near the beginning of something long and important.

In 2001, an Internet search of the phrase “social cognitive neuroscience” yielded 53 hits. Now you get more than a million on Google. Young scholars have been drawn to this field from psychology, economics, political science and beyond in the hopes that by looking into the brain they can help settle some old arguments about how people interact.

These people study the way biology, in the form of genes, influences behavior. But they’re also trying to understand the complementary process of how social behavior changes biology. Matthew Lieberman of U.C.L.A. is doing research into what happens in the brain when people are persuaded by an argument.

Keely Muscatell, one of his doctoral students, and others presented a study in which they showed people from various social strata some images of menacing faces. People whose parents had low social status exhibited more activation in the amygdala (the busy little part of the brain involved in fear and emotion) than people from high-status families.

Reem Yahya and a team from the University of Haifa studied Arabs and Jews while showing them images of hands and feet in painful situations. The two cultures perceived pain differently. The Arabs perceived higher levels of pain over all while the Jews were more sensitive to pain suffered by members of a group other than their own.

Mina Cikara of Princeton and others scanned the brains of Yankee and Red Sox fans as they watched baseball highlights. Neither reacted much to an Orioles-Blue Jays game, but when they saw their own team doing well, brain regions called the ventral striatum and nucleus accumbens were activated. This is a look at how tribal dominance struggles get processed inside.

Jonathan B. Freeman of Tufts and others peered into the reward centers of the brain such as the caudate nucleus. They found that among Americans, that region was likely to be activated by dominant behavior, whereas among Japanese, it was more likely to be activated by subordinate behavior — the same region rewarding different patterns of behavior depending on culture.

All of these studies are baby steps in a long conversation, and young academics are properly circumspect about drawing broad conclusions. But eventually their work could give us a clearer picture of what we mean by fuzzy words like ‘culture.’ It could also fill a hole in our understanding of ourselves. Economists, political scientists and policy makers treat humans as ultrarational creatures because they can’t define and systematize the emotions. This work is getting us closer to that.

The work demonstrates that we are awash in social signals, and any social science that treats individuals as discrete decision-making creatures is nonsense. But it also suggests that even though most of our reactions are fast and automatic, we still have free will and control.

Many of the studies presented here concerned the way we divide people by in-group and out-group categories in as little as 170 milliseconds. The anterior cingulate cortices in American and Chinese brains activate when people see members of their own group endure pain, but they do so at much lower levels when they see members of another group enduring it. These effects may form the basis of prejudice.

But a study by Saaid A. Mendoza and David M. Amodio of New York University showed that if you give people a strategy, such as reminding them to be racially fair, it is possible to counteract those perceptions. People feel disgust toward dehumanized groups, but a study by Claire Hoogendoorn, Elizabeth Phelps and others at N.Y.U. suggests it is possible to lower disgust and the accompanying insula activity through cognitive behavioral therapy.

In other words, consciousness is too slow to see what happens inside, but it is possible to change the lenses through which we unconsciously construe the world.

Since I’m not an academic, I’m free to speculate that this work will someday give us new categories, which will replace misleading categories like ‘emotion’ and ‘reason.’ I suspect that the work will take us beyond the obsession with I.Q. and other conscious capacities and give us a firmer understanding of motivation, equilibrium, sensitivity and other unconscious capacities.

The hard sciences are interpenetrating the social sciences. This isn’t dehumanizing. It shines attention on the things poets have traditionally cared about: the power of human attachments. It may even help policy wonks someday see people as they really are.

    The Young and the Neuro, NYT, 15.10.2009, http://www.nytimes.com/2009/10/13/opinion/13brooks.html






Congress Is Split

on Effort to Tax Costly Health Plans


October 13, 2009
The New York Times


WASHINGTON — A proposed tax on high-cost, or “Cadillac,” health insurance plans has touched off a fierce clash between the Senate and the House as they wrestle over how to pay for legislation that would provide health benefits to millions of uninsured Americans.

Supporters, including many senators, say that the tax is essential to tamping down medical spending and that over 10 years it would generate more than $200 billion, nearly a fourth of what is needed to pay for the legislation.

Critics, including House members and labor unions, say the tax would quickly spiral out of control and hit middle-class workers, people more closely associated with minivans than Cadillacs.

The tax, a provision of the bill to be voted on Tuesday by the Senate Finance Committee, is one of the few remaining proposals under consideration by Congress that budget experts say could lead directly to a reduction in health care spending over the long term, by prompting employers and employees to buy cheaper insurance. Whether it remains in the bill is emerging as a test of the commitment by President Obama and his party to slowing the steep rise of medical expenses.

It is also a prime example of the major differences still to be bridged by Democrats as health care legislation advances to floor debate in both houses.

Under the Finance Committee bill, the tax would be imposed beginning in 2013 on employer- sponsored health plans with total premiums exceeding $8,000 for individuals and $21,000 for families, regardless of whether the coverage was paid for by the employer, the individual or both. The tax would be paid by insurers, who would be expected to pass along the cost to customers.

Critics say that would mean an increase in premiums or in out-of-pocket expenses for employees, raising medical costs for individuals and families.

Supporters say the more likely prospect is that employers would bargain-hunt or take other steps to avoid the tax, putting pressure on insurers to offer cheaper coverage and slowing the rise in medical costs for everyone.

In a preliminary estimate, the Congressional Joint Committee on Taxation calculated that absent any such employer efforts, 14 percent of family health policies and 19 percent of individual policies would be hit by the tax in 2013. By 2019, according to the estimate, 37 percent of family policies and 41 percent of individual policies would be affected. Those numbers rise over time in these calculations because although the initial tax threshold would increase with the economy’s overall inflation, premiums would be expected to rise even faster.

Many Democratic senators, led by the Finance Committee chairman, Max Baucus of Montana, like the idea of the tax, and Mr. Obama embraced it in his speech to Congress on Sept. 9.

“This reform will charge insurance companies a fee for their most expensive policies, which will encourage them to provide greater value for the money,” the president said then. “This modest change could help hold down the cost of health care for all of us in the long run.”

Congress has also heard from many economists, Republicans and Democrats alike, who support the tax.

But House Democrats, led by Speaker Nancy Pelosi and Representative Charles B. Rangel of New York, the chamber’s chief tax-writer, oppose the idea, as do labor unions and businesses. Ms. Pelosi last week floated the idea of taxing insurers’ “windfall profits” as a possible alternative, to supplement the House’s main revenue raiser, an income tax surcharge on the nation’s highest earners.

At least 173 House Democrats, two-thirds of the party caucus, have signed a letter to Ms. Pelosi voicing opposition to the insurance tax .

“The tax, supposedly aimed at Cadillac health plans, would affect millions of middle-class people,” said Representative Joe Courtney, Democrat of Connecticut. “The American people soundly rejected the idea when it was proposed by Republicans in elections last year.”

Under current law, employer-paid premiums for health insurance are not taxable. Experts say this provides a big government subsidy for such coverage, and an incentive for businesses to provide better benefits in lieu of higher wages.

In an unusual alliance reflecting the shared interest of some unions and businesses on the issue, the A.F.L.-C.I.O. and the United States Chamber of Commerce are mobilizing opposition to the tax.

James P. Gelfand, senior manager of health policy at the Chamber of Commerce, said that if the tax is imposed, “employers will have to reduce wages or benefits or increase cost-sharing.” And, he said, “employees will blame employers, not the government.”

Leaders of organized labor, which in recent years has often negotiated for benefits in place of raises, descended on Capitol Hill last week to lobby against the tax, which could hit many health plans covering unionized workers. Larry Cohen, president of the Communications Workers of America, said at least half his members would be in health plans subject to the tax in 2013.

John P. Yrchik, executive director of the Connecticut Education Association, has lobbied Mr. Courtney and other members of the state’s Congressional delegation, noting that the tax would affect teachers in 30 percent of Connecticut towns. In some towns, Mr. Yrchik said, health insurance premiums for teachers’ family policies already exceed $25,000.

Aides to Mr. Baucus, the Finance Committee chairman, said the tax had numerous benefits, and predicted that employers and employees would shop for health plans to avoid it, forcing insurers to rein in costs.

They also cited projections by the Joint Committee on Taxation that about $142 billion of the 10-year total of $201 billion to be raised by the proposal would come from increased income and payroll taxes — evidence, they said, that workers would receive increased wages if employers spent less on health benefits.

But the same expectation that employers would adjust their health plans to avoid the tax was cited by some critics as a potential harm for workers.

“Employers and insurers will reduce their benefits to avoid paying the proposed tax,” said Representative Pete Stark, the California Democrat who heads the Ways and Means Subcommittee on Health. “As a result, middle-class families will be forced to pay more for health care.”

Some experts said that the tax was a complicated, backdoor way to tax employer-provided health benefits, and a number of them maintained that simply ending the tax exemption for such benefits would be a better approach.

Others said the tax would have an uneven impact, falling harder on businesses that, for instance, have older employees or are situated in high-cost regions.

Robert H. Dobson, an actuary at Milliman, an employee benefits consulting firm, said, “The high cost of so-called Cadillac plans has as much to do with the characteristics of the covered population as it does with the richness of the benefits.”

    Congress Is Split on Effort to Tax Costly Health Plans, NYT, 13.10.2009, http://www.nytimes.com/2009/10/13/health/policy/13plans.html






Insurance Industry

Assails Health Care Legislation


October 12, 2009
The New York Times


WASHINGTON — In a blistering new attack, the health insurance industry said Sunday that health care legislation drafted by Senate Democrats would drive up premiums, rather than making coverage more affordable, as the White House contends.

A lobby for the industry, America’s Health Insurance Plans, focused its criticism on a bill likely to be approved Tuesday by the Senate Finance Committee.

“The overall impact will be to increase the cost of private insurance coverage for individuals, families and businesses above what these costs would be in the absence of reform,” said Karen M. Ignagni, president of the trade association.

Democratic aides on the Finance Committee disputed the conclusion. They said the bill would provide tax credits to millions of people to help them afford coverage. Moreover, they said, people could keep the coverage they now have if they wanted. In addition, they said, some provisions of the bill would reduce the administrative costs of insurance.

Ms. Ignagni cited a report done last week for her organization by PricewaterhouseCoopers, the accounting firm.

The report says that the cost of the average family coverage, now $12,300, will rise to $18,400 in 2016 under current law and to $21,300 if the Senate bill is adopted. Likewise, it said, the cost of individual coverage, now $4,600, will average $6,900 in 2016 under current law and $7,900 under the bill.

The study provides ammunition to Republicans attacking the legislation and might intensify the concerns of some Democrats who worry that the bill does not provide enough help to low- and middle-income people to enable them to buy insurance.

Scott Mulhauser, a spokesman for Democrats on the Finance Committee, said: “This report is untrue, disingenuous and bought and paid for by the same health insurance companies that have been gouging consumers for too long. Now that health care reform grows ever closer, these health insurers are breaking out the same tired playbook of deception. It’s a health insurance company hatchet job.”

Ms. Ignagni and PricewaterhouseCoopers said several provisions of the Senate bill would drive up insurance premiums.

First, they said, the bill would require insurance companies to sell coverage to all applicants and would prohibit them from considering health status in setting rates. But, they said, the penalties for going without coverage are modest, so the “individual mandate” is weak.

This creates “a powerful incentive for people to wait until they are sick to purchase coverage,” Ms. Ignagni said. Sick people with high medical expenses are likely to join the insurance pool, while healthier people may defer buying insurance, secure in the knowledge they can get it when they need it, the study says.

In addition, the study says, the bill would impose a new excise tax on high-cost insurance policies and new fees on insurance companies. The study, like the Congressional Budget Office, predicts that insurers will pass these costs on to their customers, in the form of higher premiums.

Finally, the study says, the bill would cut hundreds of billions of dollars from the projected growth of Medicare. To make up for these cutbacks, it says, hospitals and other health care providers are likely to increase charges to private insurers, which in turn would increase premiums charged to businesses, families and individuals.

    Insurance Industry Assails Health Care Legislation, NYT, 12.10.2009, http://www.nytimes.com/2009/10/12/health/policy/12insure.html






Op-Ed Contributors

Wanted: Mammologists


October 10, 2009
The New York Times


Ann Arbor, Mich.

OCTOBER is Breast Cancer Awareness Month, but what is it we need to be aware of? We know that for women, breast cancer is the most common cancer and, after lung cancer, the leading cause of cancer death. This month, pink ribbons and yogurt containers will remind us of the need to find a cure. But equally important is improving access to life-saving therapy for women already living with breast cancer — many of whom don’t even know it.

Delayed diagnosis of breast cancer — measured from the first health care consultation for a breast complaint to a diagnosis of cancer — is the most common and the second most costly medical claim against American doctors. Moreover, the length of delays in breast cancer diagnosis in cases that lead to malpractice litigation has been increasing in recent years. According to a study by the Physician Insurers Association of America, in 1990 the average delay was 12.7 months; in 1995 it was 14 months. The most recent data, from 2002, showed the average delay had risen to 16.3 months.

Why are there such long delays, even for women who get regular examinations? The insurers association identifies five causes: a misreading of the mammogram, a false negative mammogram, findings that fail to impress the doctor, the doctor’s failure to refer the patient to a specialist and poor communication between providers. Four of these five are preventable human errors (a false negative mammogram is a machine failure) and two — failure to make a referral and poor communication — are products of the way we organize health care.

The breast is something of an orphan in our health care system. We have cardiologists, nephrologists, hepatologists, proctologists and neurologists — but we have no “mammologists.” How did the breast get lost?

To answer this question we need to look at the division of labor in medicine and the history of specialization. In 1940, 24 percent of doctors were specialists; by the late 1960s, nearly 90 percent of medical graduates were entering specialty residencies. In the 1930s, obstetrician-gynecologists attempted to define themselves as surgeons specializing in women’s reproductive organs. But general surgeons had long considered all things surgical their exclusive turf, so obstetrician-gynecologists instead created a niche for themselves as “women’s doctors,” a kind of primary care specialty. They became the point of entry to health care for most women. Some were able to diagnose breast problems, but treatment of the breast remained for the most part with general surgeons.

When radiologists — specialists who can also diagnose breast cancer — appeared on the scene, another caregiver became involved in treatment. And radiologists were followed by radiation oncologists, medical oncologists, reconstructive surgeons and medical geneticists.

Women with breast cancer get lost in the mix, forced to make several different appointments, sit in various waiting rooms and see multiple doctors. In most cases, a woman with a breast problem will start with her obstetrician-gynecologist, who will then refer her to a surgeon (for a biopsy) or a radiologist (for a mammogram). The referring obstetrician-gynecologist may never see or hear from the patient again, and may not know if she kept her appointment or got adequate care.

Contrast this with the care given to women with gynecologic cancer. Because there is a subspecialty of gynecologic oncology, women see the same doctor from diagnosis to post-surgery follow-up. Breast malignancies outnumber gynecologic cancers 10 to one, and yet we have no subspecialty for breast care.

Why don’t more obstetrician-gynecologists perform the initial, minimal surgery required to diagnose breast cancer? The answer lies in the training of medical residents. Three organizations oversee the education of future obstetrician-gynecologists: the Accreditation Council for Graduate Medical Education, the American College of Obstetricians and Gynecologists and the American Board of Obstetrics and Gynecology. All three have different requirements regarding training in breast care. At the end of their years as residents, some obstetrician-gynecologists have a great deal of experience with the minimally invasive diagnostic procedures needed to respond to breast complaints and others do not.

Women with breast cancer need obstetrician-gynecologists who have learned how to diagnose breast cancers and breast care specialists devoted to shepherding them through surgery, therapy and healing. Given the haphazard growth in medical specialties and varied training programs for obstetrician-gynecologists, it is no surprise that there is a mismatch between patient needs and caregiver skills. Campaigns to raise awareness of breast cancer must do more than push for a cure. They must also seek to improve the way we organize care for those who suffer from this illness.


Ann V. Bell is a graduate student in sociology at the University of Michigan. Mark Pearlman is a professor of obstetrics and gynecology and the director of the Breast Fellowship Program at the University of Michigan Medical School. Raymond De Vries is a professor of obstetrics and gynecology and bioethics there.

    Wanted: Mammologists, NYT, 10.10.2009, http://www.nytimes.com/2009/10/10/opinion/10DeVries.html






Abortion Foes

Tell of Their Journey to the Streets


October 10, 2009
The New York Times


OWOSSO, Mich. — Action means many things to abortion opponents. Lobbyists and fund-raisers fight for the cause in marble hallways; volunteers at crisis pregnancy centers try to dissuade the pregnant on cozy sofas.

Then there are the protesters like James Pouillon, who was shot dead here last month while holding an anti-abortion sign outside a high school. A martyr to some, an irritant to others, Mr. Pouillon in death has become a blessing of sorts for the loosely acquainted activists who knew him as a friend: proof that abortion doctors are not the only ones under duress, proof that protests matter, and a spark for more action.

“Jim suffered the persecution for us,” said Dan Brewer, who recalls swearing at Mr. Pouillon during one of his one-man protests in the ’90s, only to join him later after becoming a born-again Christian. “Now we just have to go out and do it.”

A national tribute is already planned. Anti-abortion groups are calling on protesters to stand outside schools with signs that depict abortion on Nov. 24 in 40 to 50 cities nationwide.

Some who plan to take part, like Chet Gallagher, a former Las Vegas police officer, have been answering such calls for decades; he first got involved in the ’80s, when every month seemed to bring a new “rescue,” another chance to lock arms with fellow Christians and block access to an abortion clinic.

Others have arrived at the cause after experiencing personal traumas — in the case of Deborah Anderson, an abusive childhood and then an unwanted pregnancy — while still more fell into it through personal connections.

Together, these street activists make up an assertive minority of a few thousand people within the larger anti-abortion movement. Neither the best financed nor largest element in the mix, they are nonetheless the only face of anti-abortion that many Americans see. Indeed, persistent provocation is their defining attribute: day after day on street corners from California to Massachusetts, they stand like town criers, calling to women walking into abortion clinics, or waving graphic signs as disturbing as they are impossible to ignore.

Their ranks are more infused with emotion — they would say commitment — than top-down discipline.

Ziad Munson, a sociologist at Lehigh University who has interviewed hundreds of abortion opponents, said street protesters rarely moved into other areas of the movement and tended to work alone or in smaller groups. Even in cases when they form large and influential organizations, it is sometimes difficult to get beyond the culture of passionate dispute.

To critics, like Nancy Keenan, president of Naral Pro-Choice America, these protesters look like bullies bent on harassment. Among those who share their views but not their tactics, street activists have been marginalized as attention hogs who prefer to attract outrage rather than inspiring compassion.

In the case of Mr. Pouillon, that outrage may have led to death. The police said the man charged in the killing, Harlan J. Drake, a local truck driver, was bothered by the signs Mr. Pouillon showed children as they came to school. The day he was shot, Mr. Pouillon was showing a mangled fetus, part of an almost daily effort to put abortion into the minds of his neighbors. “It’s all about the eyes,” he used to say to fellow demonstrators. “It’s all about the eyes.”

But as the personal stories of Mr. Gallagher, Mr. Brewer and Ms. Anderson suggest, the motivations of many protesters are more complicated. They see themselves as righteous curbside critics, prophets warning the world with what they describe as the horrific truth no one wants to see. They have endured insults, threats and even estrangement from their families because they have found what nearly every activist craves: conviction, camaraderie and conflict.


The Police Officer: From Civil Law to Biblical

Chet Gallagher did not plan to join the blockade at the abortion clinic in Atlanta when he traveled there 21 years ago. But when he saw the passion of so many Christians outside the clinic, he said, he could not resist: he ended up in jail for 11 days, with James Pouillon and 700 others.

Three months later, Operation Rescue, the umbrella anti-abortion group, arrived in Las Vegas, where Mr. Gallagher was a police officer. He refused to arrest protesters, and when his sergeant suspended him, he joined the “rescuers.”

“I learned something that changed my life,” Mr. Gallagher said. “It wasn’t civil disobedience; it was biblical obedience.”

Christian fervor nourishes anti-abortion activism like little else. Church groups nationwide regularly ask Mr. Gallagher to speak because he chose his spiritual beliefs over the law. Bible quotations appear on posters and on motor homes that have become traveling billboards, and in conversation they serve as evidentiary support, like statistics.

This is a particularly American brand of faith: confrontational and action oriented. The most cited verses come not from the Gospels detailing the life of Jesus Christ but from the Old Testament prophets. Mr. Gallagher said he was inspired by Jeremiah 7, where the Lord says Israel’s “people, animals, trees, and crops will be consumed by the unquenchable fire of my anger.”

Nancy Keenan, president of Naral Pro-Choice America, said she worried that the emphasis on judgment provides tacit approval for violence, like the recent killing of Dr. George R. Tiller, an abortion provider in Kansas.

But Mr. Gallagher, 60, a white-bearded father of six, disagreed. He said Christianity must be emphasized because churches are the only institutions with the power to put abortion clinics out of business. Like Mr. Pouillon, who often protested outside congregations on Sunday mornings, Mr. Gallagher said far too many Christians nodded, but did not act.

“It really can end,” he said of abortion, “if all the Christians just went out there for seven days in a row to tell the truth peacefully.”

As for the more aggressive tactics he employs, like bringing protests to the neighborhoods where abortion doctors live, he said they were a product of faith, economics and politics.

Faith, because he said he believed abortion doctors deserve to be shamed; economics because that shame might motivate them to do other work; and politics because the era of rescues ended in 1994, after President Bill Clinton signed the Freedom of Access to Clinic Entrances Act.

The law made it a felony to use “force, threat of force or physical obstruction” to prevent someone from providing or receiving reproductive health services. “That required us to use some other strategies,” said Mr. Gallagher, who left the police force shortly after and is now director of operations for Operation Save America in Las Vegas.

Among other things, the clinic law led to the proliferation of large anti-abortion signs with graphic pictures of mutilated fetuses. Mr. Gallagher said he believed that everyone, including children, should see them. “I know I offend a lot of people,” he said. “But I’ve talked to mothers who said, ‘Because you were there with those signs I decided to have that baby.’ “

Even in protesters’ families, not everyone agrees with the approach. Mr. Gallagher said his wife divorced him in 1989 after revealing she had three abortions before they met. They remarried in 1991, but Mr. Gallagher said some of their six children had gone years without speaking to him.

“We know this is a real war and we have to fight it,” he said. “Some of our families suffered as a result. I wish I could say it was different but it’s not.”


The Survivor: An Early Gusto for a Fight

Deborah Anderson, 62, a professional test-driver for Ford with the style of a no-nonsense grandmother, introduced herself as “someone who should have been dead.”

“I’m an unwanted child,” she said, standing at a vigil for James Pouillon with an anti-abortion poster peeling from overuse. “My mother couldn’t find a back-alley abortionist, so she gave me up for adoption.”

She was 18 months old. Her sister was 4, and their adoptive mother, Ms. Anderson and her sister said in interviews, turned out to be abusive.

Childhood in their suburb of Detroit was defined by broken bones beneath frilly dresses, she said. The girls ran away when they could, but when friends or the local priest visited, Ms. Anderson said, their mother chained them to poles in the basement.

“I learned to bite and kick and scream,” she said.

That gusto for the fight is a highly valued trait in protester circles. Mr. Pouillon earned kudos for standing with anti-abortion signs even while attached to an oxygen tank. Ms. Anderson also told stories of long, cold protests, insults and jail (after being arrested at Notre Dame in May when President Obama spoke).

Her son, Jason Anderson, 35, an automobile engineer, said that as a teenager, he learned to take pride in his mother’s passion when he saw her enduring abuse for holding a graphic sign. “She’s really trying to open up people’s minds to the horrific nature of this,” he said.

The most repeated anecdotes involve abortions averted. Ms. Anderson recalled what she said was her first triumph. It was the early ’80s. After becoming pregnant with a boyfriend while separated from her husband — and deciding to have the baby despite friends’ advice to abort, she said — she was a single mother with a bumper sticker on her Chrysler Fifth Avenue that said “the heart beats at 24 days for an unborn child.”

One day in a parking lot near her home, Ms. Anderson said, a woman came up to her and said she had been on her way to get an abortion when she saw that simple statement and changed her mind. “There was a 2-year-old in the back seat,” Ms. Anderson said.

At her home in Memphis, Mich., other examples followed: of two girls from Ohio who left an abortion clinic and, she said, told Ms. Anderson that her presence had persuaded them had not gone through with it; of a young man who knocked on her door in the dead of night, after seeing anti-abortion signs in her window.

Then Ms. Anderson pulled out a black cassette recorder. Sitting on a red couch a few feet from two abortion posters, she replayed what she said was a voicemail message from several years ago. An older woman, sounding unsure and emotional, said she wanted to thank her because “you was at the clinic, and really helped my daughter.”

Ms. Anderson smiled. “I can’t tell you how many babies have been saved because of abortion protesters outside the abortion mills,” she said. “That’s what it’s all about.”


The Friend: Drawn to the Cause

Within months of becoming a born-again Christian, Dan Brewer says, he knew he had to make things right. When he saw James Pouillon on a corner in Owosso one day, he stopped his car, walked over and asked forgiveness for having accosted him.

“I put my head on his shoulder and cried,” he said.

It was the beginning of what would become an alliance. Ziad Munson interviewed abortion opponents for a book, “The Making of Pro-Life Activists,” and said most people entered the movement through social connections and only later developed an ideological commitment.

Mr. Brewer exemplifies the process. He did not have much passion for the cause early on, he said, but the resistance and support he experienced alongside Mr. Pouillon led him to more research and activism.

He said there was something rebellious, something American, about standing up against abortion. In the past, he had occasionally held signs with bible verses emphasizing love, but they did not lead to as many conversations.

Or conflicts — like the time a man drove up on the sidewalk, running over Mr. Brewer’s sign and forcing him to jump out of the way, he said.

“I don’t want to say the conflict is fun, because it isn’t,” said Mr. Brewer, 40, an easygoing state pool champion with an earring high in his left ear. “But the interaction is fun, to be able to talk to people who take the time to listen to what you have to say.”

A layoff last year from his job at a boat factory pushed him further. He joined Mr. Pouillon about three times a week, he said, partly for the camaraderie and partly — like other anti-abortion protesters — because he had come to see attention and opposition as proof of impact.

He just never thought it could turn deadly. Nor did his son Cameron.

Now 16, the second oldest of Mr. Brewer’s five children, including a foster child, Cameron was at school when the shooting happened at a nearby corner. He ran there, fearing for his father, instead finding a bloodied friend. “I got down next to him,” Cameron said. “I counted four bullet holes.”

The Brewers said they did not expect more violence. And like hundreds of others, they said they planned to keep Mr. Pouillon’s efforts alive. Mr. Brewer may not be there as often, because he is taking nursing classes, but Cameron said he was eager to fill the void.

“I thought it was cool that he did what he did,” he said. “Now that he’s dead, it makes you want to do it more.”

    Abortion Foes Tell of Their Journey to the Streets, NYT, 10.10.2009, http://www.nytimes.com/2009/10/10/us/10abortion.html






John Wild, 95,

a Developer of Ultrasound

in Cancer Diagnoses, Dies


October 7, 2009
The New York Times


Dr. John J. Wild, who collaborated on some of the first equipment to use high-frequency sound waves, or ultrasound, to obtain images of human tissue, especially for cancer diagnosis, died Sept. 18 in Edina, Minn. He was 95.

His death, at the N. C. Little Hospice, was confirmed by his daughter, Ellen Wild.

The ultrasound scans commonly used in medicine today for cancer diagnosis and for monitoring fetal development derived from the discoveries of Dr. Wild and his contemporaries, who demonstrated that ultrasonic echoes could produce images of soft tissues inside the body.

While working as a surgeon in London during World War II, Dr. Wild treated patients suffering bowel failure due to impact trauma from bomb blasts during the Blitz. He sought a noninvasive method of evaluating the bowel and drew on his familiarity with an echo-testing technique that used sound waves to detect cracks in the armor plating of tanks. The sound of the returning echoes would vary with the thickness of the tissue and its ability to contract and relax, providing information about the condition of the bowel wall.

Dr. Wild did not yet use the technique on people, but developed the idea after immigrating to the United States in 1946 and going to work in the surgery department at the University of Minnesota.

At a nearby air base, the Navy was studying the use of ultrasonic echo signals to simulate enemy terrain for pilot radar training. Dr. Wild applied this concept to tissues, first in animals, demonstrating that sound energy would echo off soft tissue. He collaborated with William Reid, an electrical engineer, and together they built an instrument that could translate the ultrasonic signals into visual images, providing a window into the human body.

Using the device to obtain images of breast tissue, Dr. Wild showed that ultrasonic pictures made it possible to distinguish between cancerous and noncancerous tissue, providing a noninvasive method for detecting and evaluating breast tumors. Drs. Wild and Reid expanded the technology to other tissues and later developed a hand-held rectal scanner for studying the large bowel and a vaginal scanner.

“Wild and Reid were the first to develop equipment specifically designed for breast scanning and attempted to differentiate benign from malignant disease,” Dr. Richard Gold, professor of radiological sciences emeritus at U.C.L.A. Medical Center, wrote in “Diagnosis of Diseases of the Breast” (W.B. Saunders, 2nd ed., 2005). “Furthermore, they were the first to differentiate between cystic and solid masses in the breast by means of ultrasonography.” (Other early work on ultrasound breast tissue imaging had been done independently by the Japanese researcher Toshio Wagai and his colleagues.)

Drs. Wild and Reid first published their work in the journal Science in 1952. “Theoretically it was thought possible to record soft tissue structure by tracing the information obtained from a sound beam sweeping through the tissues onto a fluorescent television screen,” they wrote. They concluded, “The immediate application of echography to the detection of tumors in accessible sites in the living intact human organism is envisaged.”

The cover of the March 1955 issue of Electronics magazine depicts the two researchers using their “cancer detector,” with the caption “Ultrasonic ranging speeds cancer diagnosis.”

Dr. Wild was awarded a Japan Prize from the Science and Technology Foundation of Japan, valued at $370,000, in 1991 for his work in ultrasonic imaging.

John Julian Wild was born Aug. 11, 1914, in Kent, England. He attended Cambridge University and received a B.A. in natural science in 1936, an M.A. in 1940, and a medical degree in 1942. In 1950, Dr. Wild moved his laboratory from the surgical department to the electrical engineering department at the university. He left Cambridge in 1953 and continued his research with support from local sponsors and grants from the Public Health Service.

In 1953, Dr. Wild founded a research unit at St. Barnabas Hospital in Minneapolis, where he worked until becoming director of research at the Minnesota Foundation in St. Paul in 1960. Disagreements between Dr. Wild and the foundation, which administered his grant from the National Cancer Institute, led the foundation to discontinue support for his work in 1963. Dr. Wild sued the Minnesota Foundation and in 1972 was awarded more than $16 million in defamation damages. An appeals court later overturned the award, and the suit was settled out of court in 1981. Dr. Wild was director of the Medico-Technological Institute of Minneapolis from 1966 to 1999 and also maintained a private medical practice.

In addition to his daughter, Ellen, of Bethesda, Md., his survivors include Valerie Wild, his wife of 41 years; two sons from a previous marriage, John and Douglas, both of Minneapolis; and three granddaughters.

“Universal recognition of his achievements and vision was slow to materialize,” Ms. Wild said. He was often at odds with those overseeing the direction of his work.

Dr. Wild wrote, “I think I must have come into this world with a propensity for making chaos out of order, since I always seem to be upsetting those concerned with maintaining conventional levels of orderliness and humbleness.” He continued, “in my ultrasonic work I have met many people who did not believe the evidence of their own eyes.”

He patented his first invention at the age of 14, a valve to control the flow of cold and hot water into the bathtub.

    John Wild, 95, a Developer of Ultrasound in Cancer Diagnoses, Dies, NYT, 7.10.2009, http://www.nytimes.com/2009/10/07/health/07wild.html






Three Americans

Share Nobel Prize for Medicine


October 6, 2009
The New York Times


The Nobel Prize in Physiology or Medicine was awarded this year to three American scientists who solved a problem of cell biology with deep relevance to cancer and aging. The three will receive equal shares of a prize worth around $1.4 million.

The recipients solved a longstanding puzzle involving the ends of chromosomes, the giant molecules of DNA that embody the genetic information. These ends, called telomeres, get shorter each time a cell divides and so serve as a kind of clock that counts off the cell’s allotted span of life.

The three winners are Elizabeth H. Blackburn of the University of California, San Francisco, Carol W. Greider of Johns Hopkins University School of Medicine and Jack W. Szostak of Massachusetts General Hospital. Only eight women have previously won the Nobel prize in Medicine or Physiology, and it is the first time any science Nobel has been awarded to more than one woman.

The discoveries were made some 20 years ago in pursuit of a purely scientific problem that seemingly had no practical relevance. But telomeres have turned out to play a role in two medical areas of vast importance, those of aging and cancer, because of their role in limiting the number of times a cell can divide.

Dr. Greider said in an interview Monday that she saw the prize as a celebration of the value of basic research.

Though Americans have once again made a clean sweep of the Nobel medicine prize, two of the three winners are immigrants. Dr. Blackburn was born in Tasmania, Australia, and has dual citizenship; Dr. Szostak was born in London. Dr. Blackburn came to the United States in the 1970s because it was “notably attractive” as a place to do science.

Despite ups and downs in recent years, America is still a magnet for foreign scientists, she said, “but one shouldn’t take that for granted.”

Dr. Szostak said the world was now more competitive in terms of scientific research. “So maybe we have to work a little harder to attract people from around the world and make sure they stay here,” he said.

All three of the prize-winners seem to have had science in their genes, and certainly in their home environment. Dr. Greider is the daughter of two scientists with doctorates from the University of California, Berkeley, and she, too, has a Ph.D. from that school. Dr. Szostak’s father was an engineer, which had some influence on his choice of career, he said. Both of Dr. Blackburn’s parents were family physicians, and her grandfather and great-grandfather were geologists in Australia.

The study of telomeres is notable as a field of research in which female scientists are particularly prominent. Dr. Greider said she ascribed this to a “founder effect,” the founder being Dr. Joseph Gall of Yale University. Dr. Gall was very supportive of women in science, Dr. Greider said. He trained Dr. Blackburn and other women, and they recruited others to the field “because there is a slight tendency for women to work with other women,” Dr. Greider said. She herself trained with Dr. Blackburn.

The field of telomere research grew out of a puzzle in the mechanics of copying DNA. The copying enzyme works in such a way that one of the two strands of the double helix is left a little shorter after each division. Work by the three winners and others led to the discovery of telomerase, a special enzyme that can prevent the shortening by adding extra pieces of DNA.

Dr. Blackburn addressed this problem by working with a single-celled organism found in pond water known as Tetrahymena. It was particularly suitable because its genome is divided into many small chromosomes so each cell has a large number of telomeres.

While she and Dr. Greider were working with Tetrahymena, Dr. Szostak was studying the same problem in yeast. The two groups in collaboration worked out the basic mechanism of how telomerase works and the special piece of RNA it carries to help elongate the chromosomes. RNA is a close chemical cousin of DNA.

This piece of basic biology soon turned out to have important implications for aging and cancer. Telomerase is usually active only at the beginning of life; thereafter the telomeres get shorter each time a cell divides. When they get too short, a cell is thrown into senescence, meaning that it is prevented from dividing again.

Short telomeres are known to play a role in certain diseases of aging, and may be of more general importance. Telomeres are also important in cancer, a disease in which control of cell proliferation is lost. Cancer cells need to reactivate the telomerase gene, or their telomeres will get steadily shorter, forcing them into senescence. In some 80 to 90 percent of human cancer cells, the telomerase gene has been switched back on, Dr. Blackburn said. Clinical trials are under way to see if cancers can be treated by inhibiting telomerase.

    Three Americans Share Nobel Prize for Medicine, NYT, 6.10.2009, http://www.nytimes.com/2009/10/06/science/06nobel.html






Trail of E. Coli

Shows Flaws

in Inspection of Ground Beef


October 4, 2009
The New York Times

Stephanie Smith, a children’s dance instructor, thought she had a stomach virus. The aches and cramping were tolerable that first day, and she finished her classes.

Then her diarrhea turned bloody. Her kidneys shut down. Seizures knocked her unconscious. The convulsions grew so relentless that doctors had to put her in a coma for nine weeks. When she emerged, she could no longer walk. The affliction had ravaged her nervous system and left her paralyzed.

Ms. Smith, 22, was found to have a severe form of food-borne illness caused by E. coli, which Minnesota officials traced to the hamburger that her mother had grilled for their Sunday dinner in early fall 2007.

“I ask myself every day, ‘Why me?’ and ‘Why from a hamburger?’ ”Ms. Smith said. In the simplest terms, she ran out of luck in a food-safety game of chance whose rules and risks are not widely known.

Meat companies and grocers have been barred from selling ground beef tainted by the virulent strain of E. coli known as O157:H7 since 1994, after an outbreak at Jack in the Box restaurants left four children dead. Yet tens of thousands of people are still sickened annually by this pathogen, federal health officials estimate, with hamburger being the biggest culprit. Ground beef has been blamed for 16 outbreaks in the last three years alone, including the one that left Ms. Smith paralyzed from the waist down. This summer, contamination led to the recall of beef from nearly 3,000 grocers in 41 states.

Ms. Smith’s reaction to the virulent strain of E. coli was extreme, but tracing the story of her burger, through interviews and government and corporate records obtained by The New York Times, shows why eating ground beef is still a gamble. Neither the system meant to make the meat safe, nor the meat itself, is what consumers have been led to believe.

Ground beef is usually not simply a chunk of meat run through a grinder. Instead, records and interviews show, a single portion of hamburger meat is often an amalgam of various grades of meat from different parts of cows and even from different slaughterhouses. These cuts of meat are particularly vulnerable to E. coli contamination, food experts and officials say. Despite this, there is no federal requirement for grinders to test their ingredients for the pathogen.

The frozen hamburgers that the Smiths ate, which were made by the food giant Cargill, were labeled “American Chef’s Selection Angus Beef Patties.” Yet confidential grinding logs and other Cargill records show that the hamburgers were made from a mix of slaughterhouse trimmings and a mash-like product derived from scraps that were ground together at a plant in Wisconsin. The ingredients came from slaughterhouses in Nebraska, Texas and Uruguay, and from a South Dakota company that processes fatty trimmings and treats them with ammonia to kill bacteria.

Using a combination of sources — a practice followed by most large producers of fresh and packaged hamburger — allowed Cargill to spend about 25 percent less than it would have for cuts of whole meat.

Those low-grade ingredients are cut from areas of the cow that are more likely to have had contact with feces, which carries E. coli, industry research shows. Yet Cargill, like most meat companies, relies on its suppliers to check for the bacteria and does its own testing only after the ingredients are ground together. The United States Department of Agriculture, which allows grinders to devise their own safety plans, has encouraged them to test ingredients first as a way of increasing the chance of finding contamination.

Unwritten agreements between some companies appear to stand in the way of ingredient testing. Many big slaughterhouses will sell only to grinders who agree not to test their shipments for E. coli, according to officials at two large grinding companies. Slaughterhouses fear that one grinder’s discovery of E. coli will set off a recall of ingredients they sold to others.

“Ground beef is not a completely safe product,” said Dr. Jeffrey Bender, a food safety expert at the University of Minnesota who helped develop systems for tracing E. coli contamination. He said that while outbreaks had been on the decline, “unfortunately it looks like we are going a bit in the opposite direction.”

Food scientists have registered increasing concern about the virulence of this pathogen since only a few stray cells can make someone sick, and they warn that federal guidance to cook meat thoroughly and to wash up afterward is not sufficient. A test by The Times found that the safe handling instructions are not enough to prevent the bacteria from spreading in the kitchen.

Cargill, whose $116.6 billion in revenues last year made it the country’s largest private company, declined requests to interview company officials or visit its facilities. “Cargill is not in a position to answer your specific questions, other than to state that we are committed to continuous improvement in the area of food safety,” the company said, citing continuing litigation.

The meat industry treats much of its practices and the ingredients in ground beef as trade secrets. While the Department of Agriculture has inspectors posted in plants and has access to production records, it also guards those secrets. Federal records released by the department through the Freedom of Information Act blacked out details of Cargill’s grinding operation that could be learned only through copies of the documents obtained from other sources. Those documents illustrate the restrained approach to enforcement by a department whose missions include ensuring meat safety and promoting agriculture markets.

Within weeks of the Cargill outbreak in 2007, U.S.D.A. officials swept across the country, conducting spot checks at 224 meat plants to assess their efforts to combat E. coli. Although inspectors had been monitoring these plants all along, officials found serious problems at 55 that were failing to follow their own safety plans.

“Every time we look, we find out that things are not what we hoped they would be,” said Loren D. Lange, an executive associate in the Agriculture Department’s food safety division.

In the weeks before Ms. Smith’s patty was made, federal inspectors had repeatedly found that Cargill was violating its own safety procedures in handling ground beef, but they imposed no fines or sanctions, records show. After the outbreak, the department threatened to withhold the seal of approval that declares “U.S. Inspected and Passed by the Department of Agriculture.”

In the end, though, the agency accepted Cargill’s proposal to increase its scrutiny of suppliers. That agreement came early last year after contentious negotiations, records show. When Cargill defended its safety system and initially resisted making some changes, an agency official wrote back: “How is food safety not the ultimate issue?”


The Risk

On Aug. 16, 2007, the day Ms. Smith’s hamburger was made, the No.3 grinder at the Cargill plant in Butler, Wis., started up at 6:50 a.m. The largest ingredient was beef trimmings known as “50/50” — half fat, half meat — that cost about 60 cents a pound, making them the cheapest component.

Cargill bought these trimmings — fatty edges sliced from better cuts of meat — from Greater Omaha Packing, where some 2,600 cattle are slaughtered daily and processed in a plant the size of four football fields.

As with other slaughterhouses, the potential for contamination is present every step of the way, according to workers and federal inspectors. The cattle often arrive with smears of feedlot feces that harbor the E. coli pathogen, and the hide must be removed carefully to keep it off the meat. This is especially critical for trimmings sliced from the outer surface of the carcass.

Federal inspectors based at the plant are supposed to monitor the hide removal, but much can go wrong. Workers slicing away the hide can inadvertently spread feces to the meat, and large clamps that hold the hide during processing sometimes slip and smear the meat with feces, the workers and inspectors say.

Greater Omaha vacuums and washes carcasses with hot water and lactic acid before sending them to the cutting floor. But these safeguards are not foolproof.

“As the trimmings are going down the processing line into combos or boxes, no one is inspecting every single piece,” said one federal inspector who monitored Greater Omaha and requested anonymity because he was not authorized to speak publicly.

The E. coli risk is also present at the gutting station, where intestines are removed, the inspector said

Every five seconds or so, half of a carcass moves into the meat-cutting side of the slaughterhouse, where trimmers said they could keep up with the flow unless they spot any remaining feces.

“We would step in and stop the line, and do whatever you do to take it off,” said Esley Adams, a former supervisor who said he was fired this summer after 16 years following a dispute over sick leave. “But that doesn’t mean everything was caught.”

Two current employees said the flow of carcasses keeps up its torrid pace even when trimmers get reassigned, which increases pressure on workers. To protest one such episode, the employees said, dozens of workers walked off the job for a few hours earlier this year. Last year, workers sued Greater Omaha, alleging that they were not paid for the time they need to clean contaminants off their knives and other gear before and after their shifts. The company is contesting the lawsuit.

Greater Omaha did not respond to repeated requests to interview company officials. In a statement, a company official said Greater Omaha had a “reputation for embracing new food safety technology and utilizing science to make the safest product possible.”


The Trimmings

In making hamburger meat, grinders aim for a specific fat content — 26.6 percent in the lot that Ms. Smith’s patty came from, company records show. To offset Greater Omaha’s 50/50 trimmings, Cargill added leaner material from three other suppliers.

Records show that some came from a Texas slaughterhouse, Lone Star Beef Processors, which specializes in dairy cows and bulls too old to be fattened in feedlots. In a form letter dated two days before Ms. Smith’s patty was made, Lone Star recounted for Cargill its various safety measures but warned “to this date there is no guarantee for pathogen-free raw material and we would like to stress the importance of proper handling of all raw products.”

Ms. Smith’s burger also contained trimmings from a slaughterhouse in Uruguay, where government officials insist that they have never found E. coli O157:H7 in meat. Yet audits of Uruguay’s meat operations conducted by the U.S.D.A. have found sanitation problems, including improper testing for the pathogen. Dr. Hector J. Lazaneo, a meat safety official in Uruguay, said the problems were corrected immediately. “Everything is fine, finally,” he said. “That is the reason we are exporting.”

Cargill’s final source was a supplier that turns fatty trimmings into what it calls “fine lean textured beef.” The company, Beef Products Inc., said it bought meat that averages between 50 percent and 70 percent fat, including “any small pieces of fat derived from the normal breakdown of the beef carcass.” It warms the trimmings, removes the fat in a centrifuge and treats the remaining product with ammonia to kill E. coli.

With seven million pounds produced each week, the company’s product is widely used in hamburger meat sold by grocers and fast-food restaurants and served in the federal school lunch program. Ten percent of Ms. Smith’s burger came from Beef Products, which charged Cargill about $1.20 per pound, or 20 cents less than the lean trimmings in the burger, billing records show.

An Iowa State University study financed by Beef Products found that ammonia reduces E. coli to levels that cannot be detected. The Department of Agriculture accepted the research as proof that the treatment was effective and safe. And Cargill told the agency after the outbreak that it had ruled out Beef Products as the possible source of contamination.

But federal school lunch officials found E. coli in Beef Products material in 2006 and 2008 and again in August, and stopped it from going to schools, according to Agriculture Department records and interviews. A Beef Products official, Richard Jochum, said that last year’s contamination stemmed from a “minor change in our process,” which the company adjusted. The company did not respond to questions about the latest finding.

In combining the ingredients, Cargill was following a common industry practice of mixing trim from various suppliers to hit the desired fat content for the least money, industry officials said.

In all, the ingredients for Ms. Smith’s burger cost Cargill about $1 a pound, company records show, or about 30 cents less than industry experts say it would cost for ground beef made from whole cuts of meat.

Ground beef sold by most grocers is made from a blend of ingredients, industry officials said. Agriculture Department regulations also allow hamburger meat labeled ground chuck or sirloin to contain trimmings from those parts of the cow. At a chain like Publix Super Markets, customers who want hamburger made from whole cuts of meat have to buy a steak and have it specially ground, said a Publix spokeswoman, Maria Brous, or buy a product like Bubba Burgers, which boasts on its labeling, “100% whole muscle means no trimmings.”

To finish off the Smiths’ ground beef, Cargill added bread crumbs and spices, fashioned it into patties, froze them and packed them 18 to a carton.

The listed ingredients revealed little of how the meat was made. There was just one meat product listed: “Beef.”


Tension Over Testing

As it fed ingredients into its grinders, Cargill watched for some unwanted elements. Using metal detectors, workers snagged stray nails and metal hooks that could damage the grinders, then warned suppliers to make sure it did not happen again.

But when it came to E. coli O157:H7, Cargill did not screen the ingredients and only tested once the grinding was done. The potential pitfall of this practice surfaced just weeks before Ms. Smith’s patty was made. A company spot check in May 2007 found E. coli in finished hamburger, which Cargill disclosed to investigators in the wake of the October outbreak. But Cargill told them it could not determine which supplier had shipped the tainted meat since the ingredients had already been mixed together.

“Our finished ground products typically contain raw materials from numerous suppliers,” Dr. Angela Siemens, the technical services vice president for Cargill’s meat division, wrote to the U.S.D.A. “Consequently, it is not possible to implicate a specific supplier without first observing a pattern of potential contamination.”

Testing has been a point of contention since the 1994 ban on selling ground beef contaminated with E. coli O157:H7 was imposed. The department moved to require some bacterial testing of ground beef, but the industry argued that the cost would unfairly burden small producers, industry officials said. The Agriculture Department opted to carry out its own tests for E. coli, but it acknowledges that its 15,000 spot checks a year at thousands of meat plants and groceries nationwide is not meant to be comprehensive. Many slaughterhouses and processors have voluntarily adopted testing regimes, yet they vary greatly in scope from plant to plant.

The retail giant Costco is one of the few big producers that tests trimmings for E. coli before grinding, a practice it adopted after a New York woman was sickened in 1998 by its hamburger meat, prompting a recall.

Craig Wilson, Costco’s food safety director, said the company decided it could not rely on its suppliers alone. “It’s incumbent upon us,” he said. “If you say, ‘Craig, this is what we’ve done,’ I should be able to go, ‘Cool, I believe you.’ But I’m going to check.”

Costco said it had found E. coli in foreign and domestic beef trimmings and pressured suppliers to fix the problem. But even Costco, with its huge buying power, said it had met resistance from some big slaughterhouses. “Tyson will not supply us,” Mr. Wilson said. “They don’t want us to test.”

A Tyson spokesman, Gary Mickelson, would not respond to Costco’s accusation, but said, “We do not and cannot” prohibit grinders from testing ingredients. He added that since Tyson tests samples of its trimmings, “we don’t believe secondary testing by grinders is a necessity.”

The food safety officer at American Foodservice, which grinds 365 million pounds of hamburger a year, said it stopped testing trimmings a decade ago because of resistance from slaughterhouses. “They would not sell to us,” said Timothy P. Biela, the officer. “If I test and it’s positive, I put them in a regulatory situation. One, I have to tell the government, and two, the government will trace it back to them. So we don’t do that.”

The surge in outbreaks since 2007 has led to finger-pointing within the industry.

Dennis R. Johnson, a lobbyist for the largest meat processors, has said that not all slaughterhouses are looking hard enough for contamination. He told U.S.D.A. officials last fall that those with aggressive testing programs typically find E. coli in as much as 1 percent to 2 percent of their trimmings, yet some slaughterhouses implicated in outbreaks had failed to find any.

At the same time, the meat processing industry has resisted taking the onus on itself. An Agriculture Department survey of more than 2,000 plants taken after the Cargill outbreak showed that half of the grinders did not test their finished ground beef for E. coli; only 6 percent said they tested incoming ingredients at least four times a year.

In October 2007, the agency issued a notice recommending that processors conduct at least a few tests a year to verify the testing done by slaughterhouses. But after resistance from the industry, the department allowed suppliers to run the verification checks on their own operations.

In August 2008, the U.S.D.A. issued a draft guideline again urging, but not ordering, processors to test ingredients before grinding. “Optimally, every production lot should be sampled and tested before leaving the supplier and again before use at the receiver,” the draft guideline said.

But the department received critical comments on the guideline, which has not been made official. Industry officials said that the cost of testing could unfairly burden small processors and that slaughterhouses already test. In an October 2008 letter to the department, the American Association of Meat Processors said the proposed guideline departed from U.S.D.A.’s strategy of allowing companies to devise their own safety programs, “thus returning to more of the agency’s ‘command and control’ mind-set.”

Dr. Kenneth Petersen, an assistant administrator with the department’s Food Safety and Inspection Service, said that the department could mandate testing, but that it needed to consider the impact on companies as well as consumers. “I have to look at the entire industry, not just what is best for public health,” Dr. Petersen said.


Tracing the Illness

The Smiths were slow to suspect the hamburger. Ms. Smith ate a mostly vegetarian diet, and when she grew increasingly ill, her mother, Sharon, thought the cause might be spinach, which had been tied to a recent E. coli outbreak.

Five days after the family’s Sunday dinner, Ms. Smith was admitted to St. Cloud Hospital in excruciating pain. “I’ve had women tell me that E. coli is more painful than childbirth,” said Dr. Phillip I. Tarr, a pathogen expert at Washington University in St. Louis.

The vast majority of E. coli illnesses resolve themselves without complications, according to the Centers for Disease Control and Prevention. Five percent to 10 percent develop into a condition called hemolytic uremic syndrome, which can affect kidney function. While most patients recover, in the worst cases, like Ms. Smith’s, the toxin in E. coli O157:H7 penetrates the colon wall, damaging blood vessels and causing clots that can lead to seizures.

To control Ms. Smith’s seizures, doctors put her in a coma and flew her to the Mayo Clinic, where doctors worked to save her.

“They didn’t even think her brain would work because of the seizuring,” her mother said. “Thanksgiving Day, I was sitting there holding her hand when a group of doctors came in, and one looked at me and just walked away, with nothing good to say. And I said, ‘Oh my God, maybe this is my last Thanksgiving with her,’ and I stayed and prayed.”

Ms. Smith’s illness was linked to the hamburger only by chance. Her aunt still had some of the frozen patties, and state health officials found that they were contaminated with a powerful strain of E. coli that was genetically identical to the pathogen that had sickened other Minnesotans.

Dr. Kirk Smith, who runs the state’s food-borne illness outbreak group and is not related to Ms. Smith, was quick to finger the source. A 4-year-old had fallen ill three weeks earlier, followed by her year-old brother and two more children, state records show. Like Ms. Smith, the others had eaten Cargill patties bought at Sam’s Club, a division of Wal-Mart.

Moreover, the state officials discovered that the hamburgers were made on the same day, Aug. 16, 2007, shortly before noon. The time stamp on the Smiths’ box of patties was 11:58.

On Friday, Oct. 5, 2007, a Minnesota Health Department warning led local news broadcasts. “We didn’t want people grilling these things over the weekend,” Dr. Smith said. “I’m positive we prevented illnesses. People sent us dozens of cartons with patties left. It was pretty contaminated stuff.”

Eventually, health officials tied 11 cases of illness in Minnesota to the Cargill outbreak, and altogether, federal health officials estimate that the outbreak sickened 940 people. Four of the 11 Minnesota victims developed hemolytic uremic syndrome — an usually high rate of serious complications.

In the wake of the outbreak, the U.S.D.A. reminded consumers on its Web site that hamburgers had to be cooked to 160 degrees to be sure any E. coli is killed and urged them to use a thermometer to check the temperature. This reinforced Sharon Smith’s concern that she had sickened her daughter by not cooking the hamburger thoroughly.

But the pathogen is so powerful that her illness could have started with just a few cells left on a counter. “In a warm kitchen, E. coli cells will double every 45 minutes,” said Dr. Mansour Samadpour, a microbiologist who runs IEH Laboratories in Seattle, one of the meat industry’s largest testing firms.

With help from his laboratories, The Times prepared three pounds of ground beef dosed with a strain of E. coli that is nonharmful but acts in many ways like O157:H7. Although the safety instructions on the package were followed, E. coli remained on the cutting board even after it was washed with soap. A towel picked up large amounts of bacteria from the meat.

Dr. James Marsden, a meat safety expert at Kansas State University and senior science adviser for the North American Meat Processors Association, said the Department of Agriculture needed to issue better guidance on avoiding cross-contamination, like urging people to use bleach to sterilize cutting boards. “Even if you are a scientist, much less a housewife with a child, it’s very difficult,” Dr. Marsden said.

Told of The Times’s test, Jerold R. Mande, the deputy under secretary for food safety at the U.S.D.A., said he planned to “look very carefully at the labels that we oversee.”

“They need to provide the right information to people,” Mr. Mande said, “in a way that is readable and actionable.”


Dead Ends

With Ms. Smith lying comatose in the hospital and others ill around the country, Cargill announced on Oct. 6, 2007, that it was recalling 844,812 pounds of patties. The mix of ingredients in the burgers made it almost impossible for either federal officials or Cargill to trace the contamination to a specific slaughterhouse. Yet after the outbreak, Cargill had new incentives to find out which supplier had sent the tainted meat.

Cargill got hit by multimillion-dollar claims from people who got sick.

Shawn K. Stevens, a lawyer in Milwaukee working for Cargill, began investigating. Sifting through state health department records from around the nation, Mr. Stevens found the case of a young girl in Hawaii stricken with the same E. coli found in the Cargill patties. But instead of a Cargill burger, she had eaten raw minced beef at a Japanese restaurant that Mr. Stevens said he traced through a distributor to Greater Omaha.

“Potentially, it could let Cargill shift all the responsibility,” Mr. Stevens said. In March, he sent his findings to William Marler, a lawyer in Seattle who specializes in food-borne disease cases and is handling the claims against Cargill.

“Most of the time, in these outbreaks, it’s not unusual when I point the finger at somebody, they try to point the finger at somebody else,” Mr. Marler said. But he said Mr. Stevens’s finding “doesn’t rise to the level of proof that I need” to sue Greater Omaha.

It is unclear whether Cargill presented the Hawaii findings to Greater Omaha, since neither company would comment on the matter. In December 2007, in a move that Greater Omaha said was unrelated to the outbreak, the slaughterhouse informed Cargill that it had taken 16 “corrective actions” to better protect consumers from E. coli “as we strive to live up to the performance standards required in the continuation of supplier relationship with Cargill.”

Those changes included better monitoring of the production line, more robust testing for E. coli, intensified plant sanitation and added employee training.

The U.S.D.A. efforts to find the ultimate source of the contamination went nowhere. Officials examined production records of Cargill’s three domestic suppliers, but they yielded no clues. The Agriculture Department contacted Uruguayan officials, who said they found nothing amiss in the slaughterhouse there.

In examining Cargill, investigators discovered that their own inspectors had lodged complaints about unsanitary conditions at the plant in the weeks before the outbreak, but that they had failed to set off any alarms within the department. Inspectors had found “large amounts of patties on the floor,” grinders that were gnarly with old bits of meat, and a worker who routinely dumped inedible meat on the floor close to a production line, records show.

Although none were likely to have caused the contamination, federal officials said the conditions could have exacerbated the spread of bacteria. Cargill vowed to correct the problems. Dr. Petersen, the federal food safety official, said the department was working to make sure violations are tracked so they can be used “in real time to take action.”

The U.S.D.A. found that Cargill had not followed its own safety program for controlling E. coli. For example, Cargill was supposed to obtain a certificate from each supplier showing that their tests had found no E. coli. But Cargill did not have a certificate for the Uruguayan trimmings used on the day it made the burgers that sickened Ms. Smith and others.

After four months of negotiations, Cargill agreed to increase its scrutiny of suppliers and their testing, including audits and periodic checks to determine the accuracy of their laboratories.

A recent industry test in which spiked samples of meat were sent to independent laboratories used by food companies found that some missed the E. coli in as many as 80 percent of the samples.

Cargill also said it would notify suppliers whenever it found E. coli in finished ground beef, so they could check their facilities. It also agreed to increase testing of finished ground beef, according to a U.S.D.A. official familiar with the company’s operations, but would not test incoming ingredients.


Looking to the Future

The spate of outbreaks in the last three years has increased pressure on the Agriculture Department and the industry.

James H. Hodges, executive vice president of the American Meat Institute, a trade association, said that while the outbreaks were disconcerting, they followed several years during which there were fewer incidents. “Are we perfect?” he said. “No. But what we have done is to show some continual improvement.”

Dr. Petersen, the U.S.D.A. official, said the department had adopted additional procedures, including enhanced testing at slaughterhouses implicated in outbreaks and better training for investigators.

“We are not standing still when it comes to E. coli,” Dr. Petersen said.

The department has held a series of meetings since the recent outbreaks, soliciting ideas from all quarters. Dr. Samadpour, the laboratory owner, has said that “we can make hamburger safe,” but that in addition to enhanced testing, it will take an aggressive use of measures like meat rinses and safety audits by qualified experts.

At these sessions, Felicia Nestor, a senior policy analyst with the consumer group Food and Water Watch, has urged the government to redouble its effort to track outbreaks back to slaughterhouses. “They are the source of the problem,” Ms. Nestor said.

For Ms. Smith, the road ahead is challenging. She is living at her mother’s home in Cold Spring, Minn. She spends a lot of her time in physical therapy, which is being paid for by Cargill in anticipation of a legal claim, according to Mr. Marler. Her kidneys are at high risk of failure. She is struggling to regain some basic life skills and deal with the anger that sometimes envelops her. Despite her determination, doctors say, she will most likely never walk again.


Gabe Johnson contributed reporting.

Trail of E. Coli Shows Flaws in Inspection of Ground Beef,