History > 2006 > USA > Health (I)

Like many places for alternative medicine,

the Trinity Family Health Clinic in Lynnwood, Wash.,

also has a spiritual bent.

Kevin P. Casey for The New York Times        February 3, 2006

When Trust in Doctors Erodes, Other Treatments Fill the Void

NYT

3.2.2006

http://www.nytimes.com/2006/02/03/health/03patient.html

Study:

Canadians healthier than Americans

Posted 5/30/2006
7:37 PM ET
USA Today

ATLANTA (AP) — You can add Canadians to the list of foreigners who are healthier than Americans. Americans are 42% more likely than Canadians to have diabetes, 32% more likely to have high blood pressure, and 12% more likely to have arthritis, Harvard Medical School researchers found. That is according to a survey in which American and Canadian adults were asked over the telephone about their health.

The study comes less than a month after other researchers reported that middle-aged, white Americans are much sicker than their counterparts in England.

"We're really falling behind other nations," said Dr. Steffie Woolhandler, a co-author of the Canadian study.

Canada's national health insurance program is at least part of the reason for the differences found in the study, Woolhandler said. Universal coverage makes it easier for more Canadians to get disease-preventing health services, she said.

James Smith, a RAND Corp. researcher who co-authored the American-English study, disagreed. His research found that England's national health insurance program did not explain the difference in disease rates, because even Americans with insurance were in worse health.

"To me, that's unlikely," he said of the idea that universal coverage explains international differences.

Woolhandler said her findings were different in at least one important respect: In the Canadian study, insured Americans and Canadians had about the same rates of disease. It was the uninsured Americans who made the overall U.S. figures worse, she said.

The study, released Tuesday, is being published in the American Journal of Public Health. It is based on a telephone survey of about 3,500 Canadians and 5,200 U.S. residents in 2002-03. Those surveyed were 18 or older.

The results are based on what those surveyed said about their health. In contrast, the researchers in the American-English study surveyed participants and also examined people and conducted laboratory tests on them.

The new study found that 6.7% of Americans and 4.7% of Canadians reported having diabetes; 18.3% and 13.9%, respectively, reported having high blood pressure; and 17.9% and 16.0% said they had arthritis. The Americans also reported more heart disease and major depression, but those difference were too small to be statistically significant.

About 21% of Americans said they were obese, compared with 15% of Canadians. And about 13.5% of the Americans admitted to a sedentary lifestyle, vs. 6.5% of Canadians. However, more Canadians were smokers — 19%, compared with about 17% of Americans.

About 42% of the Americans rated their quality of health care as excellent, while 39% of Canadians did.

Also, 92% of American women said they had a Pap test within the last five years, while 83% of Canadian women had. But Canadians have lower death rates from cervical cancer. "It's a little hard to interpret," Woolhandler said.

One more plus for the Americans: Fewer than 1% said they were unable to get needed care because of long waits, compared with 3.5% of Canadians.

However, about 80% of Americans had a regular doctor, while 85% of Canadians did. And nearly twice as many Americans said there were medicines they needed but couldn't afford (9.9% vs. 5.1%).

Study: Canadians healthier than Americans, UT, 30.5.2006, http://www.usatoday.com/news/health/2006-05-30-canadians-health_x.htm

Doctors Struggle to Treat

Mysterious and Unbearable Pain

May 30, 2006
The New York Times
By KATHLEEN McGRORY

It was supposed to be a typical ballet class. Cynthia Toussaint, then a senior dance major at the University of California, Irvine, engaged in her usual stretching routine: she raised her left leg to the barre and slowly bent her upper body down to her right knee.

For a moment, she delighted in the long stretch. But as she returned to an upright position, she felt a sudden pop in her hamstring. "It felt like a guitar string had been plucked and it had broken," said Ms. Toussaint, who is now 45.

An intense burning sensation followed; it felt as if her leg had been doused in gasoline and set on fire, she said. The next day, the college athletics trainer determined that she had pulled her hamstring. But even years later, the pain would not subside. It migrated to her other leg, leaving her bedridden for nearly a decade, and overtook her vocal cords, leaving her temporarily mute.

All the while, doctors puzzled over and even doubted her mysterious condition.

Ms. Toussaint now knows that she is among an estimated one million Americans living with complex regional pain syndrome, a nerve disorder formerly known as reflex sympathetic dystrophy syndrome. For patients with the disorder, a trauma as mild as a fractured wrist or a twisted ankle can cause the nerves to misfire, so much so that intense pain messages are constantly sent to the brain.

For the past 150 years, so little was known about complex regional pain syndrome that it was often diagnosed as psychosomatic. But doctors now believe that the condition complicates 1 of every 1,200 traumatic injuries. And desperate patients are turning to new, often unproven, drugs and treatments. "It is still quite a mysterious condition," said Dr. Scott M. Fishman, a pain management specialist at the University of California, Davis, and the author of "The War on Pain."

"It raises doubts in the eyes of doctors and the people that are looking for hard lab evidence or good imaging confirmation," Dr. Fishman said. "With this condition, we simply don't have that."

Baffling as it may be, the syndrome is not new to the medical literature. It was first documented by Dr. S. Weir Mitchell, a Civil War surgeon. But few physicians are familiar with it; the average patient sees 8 to 10 doctors before a diagnosis is made, according to a recent survey by American RSDHope, a support organization.

Pain is the hallmark of the condition, which outranks cancer as the most painful disease on the McGill Pain Index. For some, the sensation remains in one place, most commonly one of the extremities. For others, it spreads throughout the body, making even a light touch or minor changes in temperature agonizing.

For Ms. Toussaint, as for many other patients, the pain was life altering. When she tore her hamstring, she was on the verge of completing her bachelor's degree. She was also being considered for a part on the television series "Fame." But the injury left her in debilitating pain. She could no longer stand on her own or leave her house; riding in a car on the bumpy California roads was torture.

Ms. Toussaint dropped out of school and fell into a deep depression, she said. It took 13 1/2 years for her disorder to be diagnosed. Dozens of doctors told her it was "all in her head"; one even suggested she suffered from stage fright.

Without clear clues as to what induces the syndrome or who is particularly susceptible, doctors say that treating it is a challenge. Sympathetic nerve blocks can reduce the pain, and doctors say the relief often lasts longer than the anesthetic.

More than two dozen drugs are also being used to treat the pain. But none of the medications, which range from acetaminophen and ibuprofen to morphine and methadone, have been approved by the Food and Drug Administration for this use.

"The myth is that this condition isn't treatable, but the truth is that it responds to the same kinds of treatments that have been found effective for other neuropathic pain," said Dr. Anne Louise Oaklander, director of the nerve injury unit at Massachusetts General Hospital and an associate professor of neurology at Harvard.

Dr. Russell K. Portenoy, chairman of the department of pain medicine and palliative care at Beth Israel Medical Center in New York, added that treatment was "a trial and error" process.

Doctors tend to use the drugs that are most commonly prescribed for other conditions before the drugs that are less commonly used," he said. "But in many cases, doctors need to perform sequential trials to find out which drug or combination of drugs helps the most."

Dr. Portenoy said he is a consultant for drug companies but not on work related to the syndrome or its treatment.

Another treatment is to implant an electrical stimulator near the base of the spinal cord or the injured limb. The device sends low-level electrical signals to the spinal cord or to specific nerves and blocks pain signals from reaching the brain.

Dr. Robert J. Schwartzman of the Drexel University College of Medicine in Philadelphia is skeptical of the electrical stimulators. Although he first began implanting them in patients in 1986, he no longer does. "Long term," he said, "stimulators don't work. From what I've seen, they wear out and then they stop working."

Dr. Schwartzman treats the condition with ketamine, an anesthetic that blocks one of the body's pain receptors. In most cases, this five-day inpatient therapy reduced the pain significantly for three to six months, he said.

In addition, a 10-day outpatient procedure — more than 1,200 people are on a waiting list for it — is being tested in a controlled experiment. Although the trial has been approved by the F.D.A., it is awaiting approval by Drexel's institutional review board.

Dr. Schwartzman has also sent the most extreme cases — the 30 patients who were found to be intractable to all other treatments — to Germany for five days of prolonged ketamine anesthesia, enough to put them into a coma.

Ten patients were completely relieved of their pain, Dr. Schwartzman said, noting that the treatment has not been approved in the United States.

Some doctors have strong concerns about the ketamine treatments. Dr. Oaklander, for one, believes there is not enough research to support its effectiveness, especially in light of the risks.

Either way, said Ms. Toussaint, who has not had the therapy herself, "It says a lot about this disease that we are willing to be put in comas." New research is also helping doctors understand the pain syndrome. In early 2006, a team at Massachusetts General was the first to identify organic nerve injuries in a large group of people with the disorder. The research, published in February in the journal Pain, confirmed that the syndrome was not psychosomatic, said Dr. Oaklander, who led the study.

This progress is promising for Ms. Toussaint. Since her illness was diagnosed in 1995, medications have reduced her pain, enabling her to stand and speak again. She and her partner, John Garrett, now manage For Grace, a nonprofit organization dedicated to increasing awareness of complex regional pain syndrome. Ms. Toussaint is also running for the California State Assembly on a health-based platform.

"People see me and they recognize me as the ballerina, but they don't remember the name of my disease," she said recently, "but that's all about to change."

    Doctors Struggle to Treat Mysterious and Unbearable Pain, NYT, 30.5.2006, http://www.nytimes.com/2006/05/30/health/30pain.html

Drive for Vote on Abortion Accelerates

May 27, 2006
The New York Times
By MONICA DAVEY

Advocates of abortion rights were planning a final push this weekend for signatures to a petition that could send South Dakota's ban on abortion, which was intended as a direct legal challenge to the 1973 Supreme Court decision that established a constitutional right to abortion, to a statewide vote in November.

The advocates had intended to file the signatures — more than 16,000 are required to bring a law passed by the state legislature to the voters — several weeks from now, the deadline under their interpretation of a state law providing for such referendums.

But they said on Friday that they had heard talk from supporters of the ban about a possible legal challenge to the referendum, based on how quickly the petitions needed to be filed. As a result, the advocates said, they have decided to take the signatures to Pierre, the state capital, on Tuesday to avoid any debate over timing.

State Representative Roger Hunt, the chief sponsor of the legislation, which outlaws all abortions except when the pregnant woman's life is in jeopardy, said that he and others who supported the law had never raised a question about the filing deadline and had no intention of stirring up a legal fight over that issue.

"I don't know where this thing came from," Mr. Hunt said on Friday. "Actually, I think it's a smoke screen. The pro-abortion people have raised it, I think, in order to generate some more interest in signing their petition. The signatures have been slacking off, and they did this to beat the bushes."

Abortion rights advocates, however, said that signatures had swept in at a rapid pace. Sarah Stoesz, the president of Planned Parenthood Minnesota, North Dakota and South Dakota, said 1,100 volunteers had gathered signatures in every county in the state since the ban was signed into law in March. Ms. Stoesz predicted that opponents would gather close to 35,000 signatures, more than twice the number required, after this weekend's effort.

If enough signatures are filed, the law, which was to go into effect July 1, will be put on hold until after the November election.

"After we file, the real battle begins," Ms. Stoesz said. "We anticipate that the right wing of the country will consolidate around this election and will put enormous resources into upholding this ban."

Mr. Hunt, meanwhile, said that he certainly intended to fight for the ban in the months ahead. "Of course I'm going to be speaking out," he said. "I'm a firm believer in this."

    Drive for Vote on Abortion Accelerates, NYT, 27.5.2006, http://www.nytimes.com/2006/05/27/us/27abortion.html

Vermont signs ambitious health-insurance law

Thu May 25, 2006 8:16 PM ET
Reuters
By Darren M. Allen

MONTPELIER, Vermont (Reuters) - Vermont's governor signed a bill on Thursday that would make the state the second in the nation with near-universal health-care insurance by extending coverage to as much as 96 percent of its residents by 2010.

The law comes a month after neighboring Massachusetts passed the nation's first near-universal health-care reform plan, which aims to provide insurance to about 95 percent of the state's half-million uninsured residents by 2009.

Both plans reflect state efforts to tackle growing concerns over health care with 46 million Americans uninsured, traditional employer-based coverage shrinking and the cost of insurance premiums steadily rising.

Vermont's legislation, signed by Gov. James Douglas at a ceremony at the state's second-largest hospital, aims to reduce the ranks of uninsured -- about 10 percent of the state's 620,000 residents -- while also streamlining care given to those with coverage.

A new subsidized health-care plan called Catamount Health will be offered by insurance companies and paid for in part with a hike in the state's cigarette tax and a fee on employers who do not offer health insurance to their workers.

It will provide coverage similar to that offered to state employees, taking nearly 25,000 people off the rolls of the uninsured, backers of the legislation say.

"This is potentially a national model," said Kenneth Thorpe, an Emory University professor and health-care consultant who helped create Vermont's reforms.

Massachusetts' plan has also been touted as a possible national model by requiring all residents to obtain health insurance by July 1, 2007, or face possible tax penalties.

The Massachusetts plan will provide insurance to the lowest-earning residents by offering low- or no-cost plans, with premiums and co-payments paid entirely by the state.

In Vermont, insurers can begin offering the new plan from July 1, 2007, but some benefits will be phased-in sooner.

Douglas, a Republican, had up to a month ago threatened the Democrat-controlled Legislature with a veto if they rejected his demand that the plan be run by private insurers.

"This law preserves the private sector role in providing insurance, it preserves economic security of our state and it makes a strong commitment toward wellness and the management of chronic diseases," he said.

The reforms follow a two-year debate in the state Legislature and call for streamlined record keeping, free immunizations, and greater access to preventive care.

    Vermont signs ambitious health-insurance law, R, 25.5.2006, http://today.reuters.com/news/newsArticle.aspx?type=domesticNews&storyID=2006-05-26T001458Z_01_N25196970_RTRUKOC_0_US-VERMONT.xml

Study: Obesity rises faster in poor teens

Posted 5/23/2006 8:11 PM ET
USA Today

CHICAGO (AP) — Older American teenagers living in poverty have grown fatter at a higher rate than their peers, according to research that seems to underscore the unequal burden of obesity on the nation's poor.

"Today the percentage of adolescents age 15-17 who are overweight is about 50% higher in poor as compared to non-poor families, a difference that has emerged recently," said Johns Hopkins' sociologist Richard Miech, the study's lead author.

Obesity rates among all teens climbed substantially during the study, which covered 30 years. But the great divide according to income occurred most notably among the 15- to 17-year-old age group.

That led one outside expert to challenge the findings. Rand Corp. economist Roland Sturm said it seems implausible that younger teens would differ so much from older teens. Even if they do, he said, "It seems a rather secondary issue compared to the general trend in weight gain across all youth."

Miech argued that older teens generally have more autonomy to buy what they want and to determine their own activity levels, which he said might explain the results. And Sturm and other experts said the study's underlying message about obesity and poverty is sound.

The study appears in Wednesday's Journal of the American Medical Association. It is based on data from 10,800 youngsters ages 12 to 17 who participated in four nationally representative health surveys conducted from 1971 to 2004.

The researchers determined poverty levels using family income and the U.S. Census Bureau's poverty threshold.

In the early 1970s, about 4% of poor youngsters ages 15 to 17 were severely overweight, compared with about 5% of teens who weren't poor. By the early 2000s, those rates jumped to 23% of the poor and 14% of other kids, the researchers said.

The results contrast with recent research suggesting that while the poor are most likely to be overweight, obesity rates among U.S. adults have climbed fastest in recent decades among those with annual salaries over $60,000.

Miech said both could be right because eating and exercise habits are different for adults and adolescents.

Over the past decade, the percentage of calories from sweetened drinks has grown by more than 20% among kids in the 15-17 age group — an increase concentrated among the poor, he said.

"We also find that physical inactivity increases with age in adolescence, as well as the probability of skipping breakfast," said Miech. "Both these factors are more likely to be found among the poor and are also associated with overweight."

Economic differences have been linked to other health problems too, including AIDS, cardiovascular disease and some cancers. The disproportionate rates emerge as wealthier people seek medical care and make lifestyle changes, while the poor do not, said Barry Popkin, a nutrition scientist at the University of North Carolina at Chapel Hill.

The study shows that this trend "is emerging in late adolescence and just building into adulthood," Popkin said.

The results also show the need for healthful resources in low-income neighborhoods, said Dr. Rebecca Unger, a Chicago pediatrician who works with a group seeking to lower obesity rates among Chicago children.

Adam Drewnowski, a University of Washington researcher, said the disparity will persist unless the underlying problem, poverty, is also addressed.

"The campaign against obesity and the struggle against poverty are, in fact, one and the same," he said. "...Healthier diets cost more," he said, and access to physical activity "depends on how much money you've got."

    Study: Obesity rises faster in poor teens, UT, 23.5.2006, http://www.usatoday.com/news/health/2006-05-23-obesity-teens_x.htm

Why the Data Diverge on the Dangers of Vioxx

May 22, 2006
The New York Times
By ANDREW POLLACK and REED ABELSON

Eighteen months.

Ever since Merck pulled its arthritis painkiller Vioxx off the market in September 2004 on evidence that it could cause strokes or heart attacks, the company and its lawyers have stood by the premise that it was dangerous only to patients who took it for at least 18 months.

So it was news last week when prominent medical experts said that new data from Merck indicated that Vioxx's risks started to emerge after only four months of use. The controversy is the latest illustration of how widely open to interpretation and potential corporate pressure the results of clinical trials can be — even when reported in a leading medical journal.

Critics say it is now clear that the previous data analysis was done in a way that minimized the risks of the drug. Some also say that Merck and its academic collaborators should have known about that four-month threshold and made the earlier risks clearer in a medical journal article in March 2005.

It was the first scientific report of the clinical trial results that had prompted the company to withdraw the drug. That article, in The New England Journal of Medicine, concluded: "The increased relative risk became apparent after 18 months of treatment."

The conclusion "makes the drug look a lot safer than it was," Dr. Steven E. Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, said last week after reviewing the new data. "If you wanted to construct a legal defense that says nothing happens for 18 months, this is how you would cut the data."

Merck said the new data, seeming to show an earlier risk from Vioxx, had not yet been compiled in early 2005. But the company argues that even now that the fuller data were available, the numbers do not show a danger from Vioxx before 18 months.

The outside academic scientists who were the authors on the 2005 paper with Merck scientists said they had not seen the new information until recently and would meet this week to evaluate it. But they, too, defend the original article, saying it accurately represents the trial's findings at the time.

The new data were certain to be seized upon by lawyers representing former Vioxx users, who have filed more than 11,500 lawsuits against Merck. Doctors say the new data also suggest a somewhat greater risk for people who took Vioxx, although some said that by now, presumably more than a year and a half since anyone has taken the drug, the risks of future problems are small.

One thing that seems certain in the latest controversy is that the measurable risks posed by Vioxx depend on whose strokes and heart attacks were counted, and when.

The clinical trial at issue, called Approve, studied 2,600 people, half of whom took Vioxx and half a placebo for three years. The trial was designed to see if Vioxx could prevent precancerous colon polyps, but after concern rose about the heart risks of Vioxx, the trial was also used to study cardiac risk.

The results showed that Vioxx users had twice the risk of a heart attack, stroke, other blood clot or death from a cardiac cause than those who took a placebo. It was when Merck learned the preliminary results of that trial in September 2004 that it withdrew Vioxx from the market worldwide and the paper on the results was prepared. The New England Journal of Medicine published the results online in February 2005 and in print the next month.

The article, to illustrate its conclusion that risk did not arise before at least 18 months, used a type of graph known as a Kaplan-Meier curve to plot the cumulative number of heart attacks or other cardiac "events" that occur over time.

For 18 months the line for the Vioxx users and the one for the placebo users essentially coincide, like two runners neck and neck in a race. After 18 months, the Vioxx line rises at a much faster rate than the placebo line as the users of the drug began having heart attacks and strokes at a greater rate than the placebo group.

But as it turns out, the data used in that chart included heart attacks and other events that occurred only while a patient was taking the drug or for up to 14 days after they stopped. That point was noted in the paper, but only in passing.

The new data Merck submitted to the Food and Drug Administration earlier this month include what happened to the patients for a longer period after they stopped taking the drug. And in this presentation, the Kaplan-Meier chart — the one critics have seized upon — shows those lines starting to separate at around four months and remaining separate thereafter, although they do diverge more widely at the 18-month point.

The reason for the difference is that more patients taking Vioxx dropped out of the trial earlier than patients taking a placebo. And many of the patients who stopped taking Vioxx before the three-year study period was over did so because they had hypertension or other problems that could raise the risk of a heart attack. And so, critics say, the 14-day cutoff could miss heart attacks in these people.

"People may drop out because they had chest pain and then weeks later they had a heart attack," said Dr. Alastair J. J. Wood, a drug safety expert at Vanderbilt University. Merck says it was simply adhering to the study's original design, and that the more recent chart reflects data that were not available to analyze in early 2005. It said, and some outside experts agreed, that a 14-day cutoff is frequently used in clinical trials. Indeed, they said, measuring what happens to patients long after they have stopped using a drug could minimize the measured effects of the drug.

In any case, the company says, the difference between the two charts is not significant. In the old analysis, 22 people taking Vioxx and 20 taking a placebo had a heart attack or other event by the 18th month. The new data, which includes heart attacks after the 14-day cutoff, shows 26 events in the Vioxx group and 21 in the placebo group in the first 18 months.

"We don't feel that these data change our assessment that over the first 18 months there is not a difference in risk between Vioxx and placebo," Dr. Ned S. Braunstein, senior director of Merck Research Labs, said in an interview during the weekend.

The use of the 14-day cutoff was also criticized by some members of an advisory panel to the F.D.A., including Dr. Nissen of the Cleveland Clinic, at a meeting on Vioxx in February 2005. But the academic scientists defend the paper and say there was no undue influence.

"The product did not represent any pressure from Merck or skewed interpretation of the data," said Dr. Robert S. Bresalier of the University of Texas M. D. Anderson Cancer Center, the lead author for the paper.

Dr. Gregory D. Curfman, the executive editor of The New England Journal of Medicine, said editors there would study the new information, but said he could not comment further until then. A spokeswoman for the journal, Karen Pedersen, said that could take several weeks.

The journal has already accused Merck of deliberately omitting information about three heart attacks from a paper in 2000 reporting the results of a previous Vioxx clinical trial. Omitting the information made the drug look less dangerous, they said.

Even before publication of the article in March 2005, there was significant debate over exactly how much emphasis should be placed on the difference in risk for patients who took the drug for less than 18 months and those who had taken it longer.

One of the investigators seems to have voiced some qualms, according to an e-mail message that first surfaced as part of the Vioxx litigation, and the reviewers of the original manuscript also voiced some unease over this finding and concern about the possibility that Merck had too much influence over the conclusions. Those reviewers were anonymous.

In an e-mail message sent to his co-authors as the manuscript was being written, Dr. Marvin A. Konstam, a cardiologist at Tufts-New England Medical Center, wrote that the authors were "going out on a limb by emphasizing the 18-month issue," saying they needed to make sure they properly underscored the main finding of the study — the cardiovascular risk of the drug. Dr. Konstam, when contacted Friday, declined to comment.

Some of the outside reviewers of the article before it was published did raise concerns about the overall validity of the 18-month threshold as it was presented in the original draft.

"The 'hand' of the study sponsor seems too evident throughout the manuscript, which is written consistently in a fashion designed to support the company's public positions," said one reviewer. Another argued that the paper "aggressively promotes the safety of up to 18 months of use of rofecoxib. This goes beyond the data of the study." Rofecoxib is Vioxx's chemical name.

At the time, Merck was already the target of Vioxx-related plaintiffs' lawsuits. In the cases that have gone to trial, the company has consistently said there was no danger from Vioxx at less than 18 months' use.

So far, though, in the three of the five cases that Merck has lost in court — with juries awarding verdicts of more than $10 million each time — jurors have seemed to look more at the specifics of each patient's case than whether the drug had been take for at least 18 months.

In The New England Journal of Medicine's response to the original manuscript, the editor, Dr. Curfman, asked the authors to remove the assertion "that increased risk was observed only after 18 months." Nevertheless, the 18-month finding was published as part of the article's main results.

But Merck and the researchers continue to insist that the 18-month finding was a legitimate conclusion, based on the data that were analyzed. In commenting on this early draft, the reviewers were not aware of the statistical analysis that had been performed to reach the conclusion, said Dr. John A. Baron, a professor at the Dartmouth medical school who was one of the authors.

The researchers say they did not play down the risk of taking Vioxx, and they say they never made the claim that people taking the drug for a shorter period of time were not at any risk.

The reviewers' comments were the result of the decision to submit a preliminary draft for review as well as the typical peer-review process, said Dr. Bresalier, the paper's lead author.

While he acknowledged that Merck was involved in reviewing the manuscript, he said the paper's authors responded to all the comments raised by the editor and the reviewers and that the final draft reflected changes made to address their concerns. "The end product was a good final product," he said.

"If The New England Journal didn't think this was an appropriate and satisfactory product, they didn't have to publish it," Dr. Bresalier said.

While Dr. Bresalier and the other outside authors reached insisted that they felt comfortable with how the risks were eventually portrayed, he said the 18-month finding was not seen as critical by the researchers, even if it had been "up-played" by Merck and its lawyers.

"Of course they want to minimize their liability," he said.

    Why the Data Diverge on the Dangers of Vioxx, NYT, 22.5.2006, http://www.nytimes.com/2006/05/22/business/22drug.html

Thanks to birth control pills and other hormonal contraceptives, Stephanie Sardinha, 22,
hasn't had a mentrual period since she was 17.

By Joel Page, AP        UT        21.5.2006

   With new mindset, new contraceptives, menstruation becomes optional        UT        21.5.2006
http://www.usatoday.com/news/health/2006-05-21-stoppingperiods_x.htm

With new mindset, new contraceptives, menstruation becomes optional

Updated 5/21/2006 7:27 PM ET
USA Today

TRENTON, N.J. (AP) — For young women with a world of choices, even that monthly curse, the menstrual period, is optional.
Thanks to birth control pills and other hormonal contraceptives, a growing number of women are taking the path chosen by 22-year-old Stephanie Sardinha.

She hasn't had a period since she was 17.

"It's really one of the best things I've ever done," she says.

A college student and retail worker in Lisbon Falls, Maine, Sardinha uses Nuvaring, a vaginal contraceptive ring.

After the hormones run out in three weeks, she replaces the ring right away instead of following instructions to leave the ring out for a week to allow bleeding. She says it has been great for her marriage, preventing monthly crankiness and improving her sex life.

"I would never go back," said Sardinha, who got the idea from her aunt, a nurse practitioner.

Using the pill or other contraceptives to block periods is becoming more popular, particularly among young women and those entering menopause, doctors say.

"I have a ton of young girls in college who are doing this," says Mindy Wiser-Estin, a gynecologist in Little Silver, N.J., who did it herself for years. "There's no reason you need a period."

Such medical jury-rigging soon will be unnecessary. Already, the Seasonale birth control pill limits periods to four a year. The first continuous-use birth control pill, Lybrel, likely will soon be on the U.S. market and drug companies are lining up other ways to limit or eliminate the period.

Most doctors say they don't think suppressing menstruation is riskier than regular long-term birth control use, and one survey found a majority have prescribed contraception to prevent periods. Women have been using the pill for nearly half a century without significant problems, but some doctors want more research on long-term use.

The new methods should be popular. A non-scientific Web survey for the Association of Reproductive Health Professionals found at least two-thirds of respondents are bothered by fatigue, heavy bleeding, "really bad cramps" and even anger. Nearly half said they would like to have no period at all or decide when to have one.

For some women, periods can cause debilitating pain and more serious problems.

Two recent national surveys found about 1 in 5 women have used oral contraceptives to stop or skip their period.

"If you're choosing contraception, then there's not a lot of point to having periods," says Leslie Miller, a University of Washington-Seattle researcher and associate professor of obstetrics and gynecology whose website, noperiod.com, explains the option.

She points out women on hormonal contraception don't have real periods anyway, just withdrawal bleeding during the break from the hormone progestin.

According to Miller, modern women endure up to nine times more periods than their great-grandmothers, who began menstruating later, married young and naturally suppressed periods for years while they were pregnant or breast-feeding. Today's women may have about 450 periods.

Still, surveys also show most women consider monthly periods normal. Small wonder: Girls learn early on that menstruation is a sign of fertility and femininity, making its onset an eagerly awaited rite of passage.

The period is "way over-romanticized," says Linda Gordon, a New York University professor specializing in women's history and the history of sexuality.

"It doesn't take long for women to go from being excited about having a period to feeling it's a pain in the neck," said Gordon, author of The Moral Property of Women: A History of Birth Control Politics in America.

She says caution is needed because there's not enough data on long-term consequences of using hormones continuously. Gordon notes menopausal women for years were told that hormone drugs would keep them young — until research uncovered unexpected risks.

"People should proceed very cautiously," she says.

Today's birth control pills contain far less estrogen and progestin than those two generations ago, but still increase the risk of heart attack, stroke and blood clots. The pill should not be used by women who have had those conditions, unexplained vaginal bleeding or certain cancers, or if they are smokers over 35.

But there are benefits from taking oral contraceptives too, such as a lower risk of ovarian and endometrial cancer, osteoporosis and pelvic inflammatory disease. And forgoing periods means no premenstrual syndrome and a lower risk of anemia and migraines, says Sheldon Segal, co-author of Is Menstruation Obsolete? Segal has been involved in research for several contraceptives.

Almost since the first pill arrived in 1960, women have manipulated birth control to skip periods for events such as a wedding, vacation or sports competition.

Female doctors and nurses were among the first to block menstruation long-term to suit their schedules, said Susan Wysocki, head of the National Association of Nurse Practitioners in Women's Health.

"They were then more comfortable recommending it to their patients," said Wysocki, who uses a vaginal ring to prevent menstruation.

The idea gained momentum after Barr Pharmaceuticals launched Seasonale in November 2003. It's a standard birth control pill taken for 12 weeks, with a break for withdrawal bleeding every three months. Amid wide acceptance by doctors, sales shot up 62% last year, to $110 million.

Publicity for Seasonale made women wonder, if just four periods a year are OK, why have any at all?

Users of Pfizer Inc.'s Depo-Provera, a progestin-only contraceptive shot lasting three months, usually are period-free after a year or two. There's now a generic version, but the drug can thin bones.

And many women have been getting extra prescriptions so they could continuously stay on birth control pills, the Ortho Evra patch or the vaginal ring, rather than bleeding every fourth week. That schedule was set by the original birth control designers to mimic normal menstrual cycles. But the extra prescriptions have led to insurance company hassles.

"What Seasonale did is get rid of that nuisance," says Peter McGovern of University of Medicine and Dentistry of New Jersey.

New extended-cycle contraceptives will do the same. Wyeth is hoping by late June to get Food and Drug Administration approval to sell Lybrel, its low-dose, continuous birth control pill; approval also is pending in Canada and Europe.

Also in June, FDA should decide whether to approve Implanon, a single-rod, three-year contraceptive implanted in the upper arm that maker Organon USA has been selling it in Europe for a decade.

Berlex Inc. is developing its own birth control pill for menstrual suppression.

Barr, aiming to be a leader in extended contraception, last November bought the maker of ParaGard, an intrauterine device that blocks periods in some women. Barr's new product Seasonique, a successor to Seasonale, likely will get federal approval at week's end.

Patricia Sulak, who researches extended contraception at Texas A&M College of Medicine, applauds this new trend. The doses in standard pills are now so low, she said, that having seven days off them raises the risk of pregnancy.

"This redesign is way overdue," she says. "It's going to be the demise of 21-7."

    With new mindset, new contraceptives, menstruation becomes optional, UT, 21.5.2006, http://www.usatoday.com/news/health/2006-05-21-stoppingperiods_x.htm

Unease on Industry's Role in Hypertension Debate

May 20, 2006
The New York Times
By STEPHANIE SAUL

Three pharmaceutical companies donated $700,000 to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure.

The same three companies — Merck, Novartis and Sankyo — also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs.

The seven dinners at Ruth's Chris Steak Houses around the country are just one example of why the small medical society, the American Society of Hypertension, has been in the midst of a dispute over the influence of drug industry money.

"This is about the monetarization of medicine," Dr. Michael H. Alderman, a past president of the organization, said in a recent interview.

The dinners promoting a new definition of high blood pressure illustrate connections — among the pharmaceutical industry, academic physicians and societies that formulate opinion — that can ultimately affect patient treatment. And the dispute within the society reflects a growing unease that industry money is influencing scientific discourse in medical societies and elsewhere.

At a recent speech before another society, the American College of Cardiology, its new president, Dr. Steven E. Nissen of the Cleveland Clinic, suggested that the medical profession had become addicted to industry money just as the nation was addicted to foreign oil.

After months of controversy within the American Society of Hypertension that included accusations of industry influence, the society's president, Dr. Thomas D. Giles, said yesterday that the group's leadership would be required to disclose more details about the money they receive from industry.

Dr. Giles said the organization had always maintained a firewall between its activities and industry funding. "We don't take money that has strings attached to it," Dr. Giles said, emphasizing that its industry grants are not earmarked for any specific purpose.

The added disclosure had been sought by a board member, Jean E. Sealey, a biochemist and a longtime blood pressure researcher affiliated with Weill Medical College of Cornell University, who was among those also involved in a leadership struggle within the organization.

Dr. Alderman, a professor of medicine and epidemiology at the Albert Einstein College of Medicine in the Bronx, is one of several doctors who withdrew from a group formed by the society to write the new blood pressure definition.

He complained that the definition was derived from a hodgepodge of opinions not supported by hard science, and also questioned whether the society of 1,600 could insulate itself from the drug company donations it used to operate.

Controlling blood pressure has long been a mainstay of the pharmaceutical industry. About 65 million Americans have high blood pressure under the current definition and they help fuel a $17 billion annual market in drugs for hypertension. But another 59 million people are on the borderline, and many doctors believe the new definition of hypertension could make drugs a standard treatment for many of them, drastically expanding the potential drug market.

Dr. Giles of Louisiana State University's medical school in New Orleans was the driving force behind the new definition. The work of the group that developed it was financed by $75,000 in unrestricted drug industry grants from Merck, Novartis and Sankyo, according to Susan Rood, a spokeswoman for the Society of Hypertension. Ms. Rood also confirmed that the dinners were financed by $700,000 in grants, also unrestricted, from the same companies. The new definition that resulted was written by some of the leading experts in blood pressure medicine.

Pre-hypertension has been considered a blood pressure reading of 120/80 to 139/89, according to guidelines developed by a National Institutes of Health panel, which first identified the pre-hypertension category in 2003. Currently, pre-hypertension is generally not treated with drugs.

The new definition proposes assigning some of the people with pre-hypertension to a new category called Stage 1 hypertension. Hypertension is currently defined as blood pressure readings of 140/90 and above.

Dr. Giles estimated that the proposed definition would move half of those whose blood pressure readings are currently considered pre-hypertension to the Stage 1 hypertension category.

That determination would be based not just on their blood pressure readings, but also on other risk factors.

The proposed definition makes no specific treatment recommendations. But some specialists who have read the proposed definition say it is a short step from labeling someone with high blood pressure to prescribing pills. And they predict that if the new definition is embraced, it will expand the use of medications.

Dr. Curt D. Furberg, a professor of public health science at Wake Forest University, who was among those who withdrew from the writing group, citing concerns that its work was not evidence-based, said, "The industry wants to sell drugs and to as many people as possible."

But Dr. Giles said it was possible that the use of medication could actually contract under the new definition, with some doctors recommending lifestyle modifications rather than medication. And he said industry money or influence did not play a role in the proposed definition, which he said reflected a concern that too many people with diagnoses of pre-hypertension ended up having strokes.

"I will tell you that if you've ever sat there and watched patients in the prime of life get a stroke or a heart attack, it's heart-wrenching," Dr. Giles said last week.

The recommendations by Dr. Giles and his group are considered influential in the evolving thinking over what constitutes high blood pressure. In addition, the discussion about whose blood pressure should be treated is also being driven by a new study that concluded that a drug called Atacand by AstraZeneca could reduce the risk that people with pre-hypertension will develop hypertension.

Treating pre-hypertension was among the topics at a meeting this week of the society at the New York Hilton. The meeting ends today.

The debate is in some ways similar to questions about changing thresholds for defining high cholesterol, diabetes and obesity — areas where accusations have been leveled in the past that the pharmaceutical industry has tried to exert influence.

"All of this has got the ring of seeming to be of great benefit to the pharmaceutical industry without clear evidence that it's going to be the same benefit to the public," Dr. Alderman said recently

In statements, spokeswomen for Merck and Novartis confirmed that their companies had helped finance the society's work, but said that they had no influence over the outcome of the new definition or the content of the dinner briefings held last fall in seven cities.

Sankyo did not return calls seeking comment.

Of the seven doctors who wrote the proposed new definition, six have said that they served as consultants and speakers for pharmaceutical companies that make blood pressure medications. The seventh is a consultant and stockholder in a company that markets a diagnostic method to measure damage to blood vessels.

Such industry affiliations are not unusual among prominent doctors at academic research centers. And for years, the American Society of Hypertension, known as ASH, has operated with industry support.

But some members of ASH have become vocal critics of the influence wielded by the drug industry, including the person who was next in line to become the society's president, Dr. Sealey, who has been embroiled in a longstanding dispute with the organization's current leadership over that and other issues.

"The truth of the matter is that we have many members who are leaders in our society who are making well into the six figures from their pharmaceutical-company-supported activities," Dr. Sealey, a research biochemist and physiologist, said in an interview two weeks ago.

But many members of the society have taken umbrage at suggestions that their work for drug makers affects their scientific independence.

"There are those who accuse us of being nothing more than shills of industry; a lot of us take pretty great offense at that," said Dr. Joseph L. Izzo, a professor of medicine at the University of Buffalo who was part of the group that developed the new definition. "We've basically devoted our careers to researching this disease and how to treat it."

Dr. Sealey's assertions had fueled dissension within the society and were among the reasons that a vote to block her presidency had been expected at yesterday's business meeting of the society.

Instead, an agreement was forged under which Dr. Sealey gave up her term as president and, according to written statements circulated among those attending the meeting, the organization's leadership agreed that its board would soon submit detailed financial disclosure forms, which Dr. Giles said had been in development for more than a year.

Dr. Giles said those disclosures would go beyond the affiliations that were currently disclosed and would require leaders of the group to state how much they received, in broad categories.

    Unease on Industry's Role in Hypertension Debate, NYT, 20.5.2006, http://www.nytimes.com/2006/05/20/business/20hyper.html?hp&ex=1148184000&en=a98fc2622f7af4de&ei=5094&partner=homepage

For a Kennedy, Fighting the Stigma of Mental Illness Becomes Personal

May 15, 2006
The New York Times
By SHERYL GAY STOLBERG

WASHINGTON, May 14 — Patrick J. Kennedy was keeping an uncomfortable secret.

Representative Kennedy, scion of America's most loved and hated Democratic clan, has been a passionate advocate for ending the stigma of mental illness; he told voters years ago of his treatment for depression and cocaine abuse. But when he slipped off to the Mayo Clinic last December to get help for addiction to prescription painkillers, he had trouble overcoming that stigma himself.

When he crashed his Mustang convertible into a Capitol barricade in the middle of the night earlier this month, Mr. Kennedy, of Rhode Island, was thrust into a clash between personal privacy and political beliefs. Hours before he told the world he was checking himself back into the Mayo Clinic, he wrestled with going public.

"He consistently talked about being in the spotlight and not being able to just say, 'I'm struggling, I have issues,' " said Jack McConnell, a good friend who counseled Mr. Kennedy that morning, May 5. "One of the things he weighed was whether doing this would take the weight off his shoulders that he always felt when he was out in public."

In the mix of blessing and burden that invariably accompanies life as a Kennedy, the congressman has perhaps had more burden than most. At 38, the youngest child of Senator Edward M. Kennedy, Democrat of Massachusetts, and his first wife, Joan, is a success in his own right. But the skinny kid with the red hair and freckles is a man now, and after years of having his foibles turn up in the gossip sheets, he is at a turning point both political and personal.

"This is a test," said one of his mentors, Senator Jack Reed, Democrat of Rhode Island. "I think he has set a standard for himself of dealing forthrightly."

That forthrightness only goes so far; while in treatment, Mr. Kennedy declined an interview. He has attributed the accident to confusion caused by two medicines, Ambien, a sleep aid, and Phenergan, for gastric distress. Medical experts say his explanation for the accident is plausible, though the Capitol Police, who complained that their supervisors barred sobriety testing, said they suspected that Mr. Kennedy had been drinking. He said he had not.

Some people close to the congressman, including his father, who has lunch with his son every Thursday, said they saw nothing amiss before the accident.

"Certainly this last Christmastime we talked about it, whether he ought to try and take a reading about where his whole health stood," Senator Kennedy said. "He made a judgment to get help at that time, and he came back and was very upbeat and positive. Now he understands that this is a continuing process."

Representative Kennedy sometimes seems ill suited to the legacy of Camelot. He is reserved, and his syntax sometimes gets mangled.

There is a tentativeness about him, "a bit of awkwardness," said Representative Jim Langevin, Democrat of Rhode Island. Mr. Kennedy's biographer, Darrell M. West, a political scientist at Brown, said some people called him "the un-Kennedy."

Still, he has traded on the Kennedy mystique, using his celebrity to start his career. His celebrity did not hurt, either, when he got into various scrapes, like the time he shoved a Los Angeles airport security guard or when the Coast Guard retrieved a woman who said the two had argued while drinking on his yacht.

Mr. Kennedy's advisers say he now views these incidents, as well as his addiction and bouts of binge drinking, through the prism of his bipolar disorder, a type of depression marked by extreme highs and lows. But some wonder whether this latest incident must be his last.

"I don't think anybody realized until now how serious his problems were," said M. Charles Bakst, a longtime political columnist for The Providence Journal. "Now it all makes sense, and you realize that this kid is on the brink. And I think if it happens again, you are going to see people say, not necessarily angrily or bitterly, but sadly, maybe, that public life isn't for him."

From the moment Patrick Joseph Kennedy was born, on July 14, 1967, his was a public life. In his Capitol Hill office, Mr. Kennedy keeps a framed copy of The Cape Cod Times's coverage of his christening, with the headline "Patrick's First Bow Draws 1,200."

He was a frail child. While his cousins played touch football at the family estate in Hyannis Port, Mass., Patrick's severe asthma sidelined him. His mother struggled with alcohol dependence, and his father was often away.

"He was never the guy who hung out with the captain of the football team," said his cousin, Anthony Shriver. "He was always the guy who hung out with the guy nobody wanted to hang out with."

Those life experiences seem to have shaped him. Like many of his relatives, he is an advocate for the disenfranchised. But as Mr. Bakst said, "He seems to feel it personally."

He was interested in politics early on, and he was a frequent presence on the campaign plane during his father's 1980 run for the Democratic nomination for president.

His parents split right after that race. Later, at prep school, Patrick sought treatment for cocaine abuse. As a student at Providence College in 1988, he underwent surgery to remove a tumor from his spine. The operation left him with lingering back pain that, he has said, prompted his use of narcotics.

He was recovering in the hospital when he decided to make his first electoral bid, for the Rhode Island Legislature against an entrenched Democratic incumbent. Kennedy money poured in, and pundits knew it was over when Mr. Kennedy cleverly stationed famous relatives at polling places and had photographers offer to take Polaroid pictures of voters with them.

Mr. Kennedy entered the statehouse as a maverick and left six years later a member of the establishment. He won his first House race in 1994. Joshua Seftel, a documentary filmmaker who chronicled the race, said, "You could see a sadness in Patrick."

In the House, Mr. Kennedy caught the attention of the Democratic minority leader, Representative Richard A. Gephardt, who persuaded him to become chairman of the Democratic Congressional Campaign Committee in 2000. It was a grueling year of fund-raising and travel, marked by both the Los Angeles airport and Coast Guard episodes.

It was also the year he disclosed, in an appearance with Tipper Gore, his bipolar disorder. The announcement was unplanned, but House members were not shocked.

After the 2000 elections, Mr. Kennedy was rewarded with a coveted seat on the House Appropriations Committee. He considered running for the Senate, but decided against it. And he has made mental health his signature issue.

"He found an altitude he was comfortable flying at," said Erik Smith, who was Mr. Kennedy's spokesman at the campaign committee.

That is how it appeared, from a distance at least, until 2:45 a.m. May 4, when Mr. Kennedy crashed his car. In the lone interview he has given, to The Providence Journal, Mr. Kennedy said he was at home with a female friend when he woke up and thought he needed to go to the Capitol to vote. She tried unsuccessfully to dissuade him, he said.

Mr. Kennedy's immediate future is unclear. Senator Kennedy could not say when his son's treatment would be over, and the congressman may be greeted with as much scrutiny as sympathy on his return.

But his cousin Mr. Shriver, who said he had watched "countless members of my family" overcome addiction, was optimistic.

"Once he gets this current challenge under control, watch out," Mr. Shriver said. "He'll just knock the socks off of everybody."

    For a Kennedy, Fighting the Stigma of Mental Illness Becomes Personal, NYT, 15.5.2006, http://www.nytimes.com/2006/05/15/washington/15kennedy.html



 

Amy Carlsen of Fargo, N.D., waits in a hallway to enter surgery with her twin girls in Rochester, Minn.

By Ann Arbor Miller, AP

  5-month-old girls in ICU after separation        UT        14.5.2006
http://www.usatoday.com/news/health/2006-05-13-conjoined-twins_x.htm

 

5-month-old girls in ICU after separation

Updated 5/14/2006 12:11 AM ET
USA Today

MINNEAPOLIS (AP) — Abbigail and Isabelle Carlsen remained in intensive care under sedation Saturday, one day after doctors spent nearly seven hours in surgery separating the conjoined twins.

The 5-month-old girls were breathing with the assistance of ventilators "after an uneventful night," according to a statement released by the Mayo Clinic in Rochester, Minn.

The sisters, who spent their first months with their noses just inches apart, were recovering in separate beds.

"We've had our prayers answered up to now," the girls' parents, Amy and Jesse Carlsen, wrote in a message posted Saturday on the family's Web journal. "And we will continue to pray for a perfect recovery."

When the girls were born Nov. 29 to the Fargo, N.D., couple, they were joined at the diaphragm, pancreas and liver, and shared a common bile duct and part of an intestine.

A 70-member Mayo Clinic team has cared for the twins since Feb. 24. About 30 people took part in the operation, with specialists rotating in and out of the operating room. The separation, which took nearly seven hours, was like one major surgery after another.

After the procedure began, doctors confirmed the girls had two separate hearts. Medical imaging done in the weeks before the surgery showed Isabelle's heart was tipped into her sister's body and would have to be moved.

Mayo spokesman Lee Aase said Isabelle's blood pressure remained stable as her heart was maneuvered into her own chest cavity.

Doctors also removed both of the girls' gall bladders during the procedure, so the drainage systems in the organs could be rerouted, Aase said.

He said that after the girls' livers were separated, the medical team applauded, having completed one of the more complicated parts of the operation because of the way the organs were fused and because the circulatory structures inside the livers needed to be divided correctly.

Isabelle retained the common bile duct, and doctors constructed a biliary structure for Abbigail. The length of their intestines was a concern, too, but doctors found enough and divided it evenly between the girls.

Doctors had estimated there was a 90% to 95% chance that both girls would survive.

"The girls did great," said Randall Flick, the lead anesthesiologist. "The credit goes to them. I think they are tough little girls."

    5-month-old girls in ICU after separation, UT, 14.5.2006, http://www.usatoday.com/news/health/2006-05-13-conjoined-twins_x.htm

Attention Shoppers: Low Prices on Shots in Clinic

May 14, 2006
The New York Times
By MILT FREUDENHEIM

Everyday low prices on strep-throat exams.

That is the basic idea behind a retail approach to routine medical care now catching on among consumers and entrepreneurs. At Wal-Mart, CVS and other chain stores, walk-in health clinics are springing up as an antidote to the expense and inconvenience of full-service doctors' offices or the high-cost and impersonal last resort of emergency rooms.

For a $30 flu shot, a $45 treatment for an ear infection or other routine services from a posted price list, patients can visit nurse practitioners in independently operated clinics set up within the stores — whose own pharmacies can fill prescriptions.

"It was a lot easier to know you can just drive up the block to a clinic, rather than spend time in the pediatrician's waiting room," said Liz Lyons, who recently took her 9-year-old son to have a sore throat swabbed in a clinic at a CVS drugstore in Bethesda, Md.

She made a $10 co-payment, with her husband's insurance picking up the rest of the $59 tab.

About 100 of these clinics, which typically lease space from the host stores, are now operating around the nation. Hundreds more are in the works, bankrolled by a range of competing entrepreneurs who include Stephen M. Case, the former AOL chairman; Richard L. Scott, who once ran the nation's largest hospital chain; and Michael Howe, a former chief executive of the Arby's restaurants group.

Despite their diverse backgrounds, those executives and others share a concept of "consumer-directed health care" — a marketing and political term that usually means higher out-of-pocket medical costs — as a mass-market opportunity. Even some family physicians say the clinics may have their place in the array of American medical offerings.

And most insurers so far are welcoming retail clinics as a way to save money. The uninsured, meanwhile, typically find the clinics more affordable than most alternatives — including the for-profit storefront clinics that have long offered a full range of physician-provided medical services to a walk-in clientele.

Uwe E. Reinhardt, a professor of economics and public affairs at Princeton University, said that the store chains, with their reputations on the line, would insist that the clinics maintain high standards and low error rates. "Primary care is a neglected field in the United States, lagging other economically advanced countries," he said. "The clinics can teach the rest of our health system how primary care could be done and brought to the public."

Whether a fad or the beginning of a fundamental shift, the retail clinic trend comes in response to an erosion in employer-sponsored insurance benefits that is forcing people to pay more or all of their own health costs. It is also a reaction to the growing perception that conventional medical service for routine and preventive care has become too costly and inefficient.

" Starbucks has 10,000 locations; health care is certainly more important," said Mr. Case, who made his name and fortune on the Internet but is now betting that his chain of RediClinics at Wal-Mart, Walgreens and other retailers can be the next big thing.

Mr. Case says his epiphany came a few years ago when he took his young daughter to an emergency room on a Sunday for an ear infection. "We waited four hours and they just weren't able to see us," he recalled. "This is crazy: a society in which everything is convenient other than what people care most about, which is taking care of their health."

Mr. Case's company, Revolution Health Group, has 11 RediClinics now running, including one at a Duane Reade pharmacy on West 50th Street in Manhattan. He plans to open 90 others in various retail chains by the end of this year, and 500 within three years.

Other executives bringing their names and money to the field include Hal Rosenbluth, who sold a travel business to American Express and is now behind a clinic chain called Take Care Health Systems. It has clinics in 16 stores, and Mr. Rosenbluth has raised $77 million with an eye toward expanding to 1,400 in the next few years.

Another in the game is Dr. Glen D. Nelson, a Minneapolis surgeon and investor whose company, MinuteClinic, has branches in 73 stores.

"The clinic concept is a microcosm of what you could do to the whole system to improve it and make it more consumer friendly and economical," Dr. Nelson said.

The licensed nurse practitioners who run most of the clinics typically have advanced training and referral arrangements with local doctors for cases beyond the clinics' scope. When Ms. Lyons recently took her son, Daniel, to the MinuteClinic at the CVS in Bethesda, the nurse practitioner on duty was Trish Hughes, who performed a quick swab test to check for a streptococcal bacterial infection. In less than three minutes, that preliminary test came up negative; the swab was retained for further testing.

Ms. Lyons said she was pleased with the clinic experience. "I will be back," she said.

For Beth Brauning, 54, a self-employed house cleaner who is uninsured, the prices at a clinic in a CVS near Columbus, Ohio, were a big attraction. The nurse practitioner took her blood pressure and wrote two allergy prescriptions she needed.

The bill was $49 — "probably half what my doctor would have charged me," Ms. Brauning said. "It was such a good experience for me. You go to an emergency room, it's $300 to walk in the door."

Having someone in the store writing prescriptions could be a boon for pharmacy chains. "Pharmacy is 70 percent of our business," said Jim Maritan, a CVS vice president for strategy and business development. "It is a great experience having a nurse practitioner clinic on site."

But some doctors say the clinic-pharmacy relationship could create conflicts of interest. "We want to make sure that the patient is protected," said Dr. Joseph P. Annis, an anesthesiologist in Austin, Tex., who is the chairman of an American Medical Association council that studied the clinics for a report due out later this month.

Dr. Anne B. Francis, a pediatrician in Rochester, said it was important for children to have a physician who gets to know the family and keeps a complete health record that can help point to underlying causes of some ailments. "All earaches are not ear infections," she said.

Although some physicians are fearful of losing business to the clinics, others say that the clinics may fill a need. Larry S. Fields, a family doctor in Ashland, Ky., who is president of the American Academy of Family Physicians, said that if the clinics "stick to this limited scope, they may have a small role in providing acute health care to people who are mildly ill, when their only other alternative at the time might be an emergency room."

With no need for expensive medical equipment or office space, the clinics tend to be cheap to operate — particularly since the nurse practitioners are paid $30 to $45 an hour, compared with the $65 or much more an hour that a primary care doctor can command. A store clinic can be profitable with 25 patients over a 12-hour day, clinic executives said.

A clinic company with somewhat grander ambitions is Solantic. Its clinics are staffed by doctors and provide a wider range of services that include X-rays at $90 apiece (or two for $150).

For routine services, Solantic's prices may be slightly higher than at other clinics — $55 or more for a Solantic doctor visit compared with $45 to be seen by a nurse practitioner at a rival's clinic. But having doctors on staff "dramatically increases the number of services we can provide to a patient," said Richard L. Scott, the chairman of Solantic, which is based in Jacksonville, Fla.

Mr. Scott built Columbia- HCA Healthcare into the nation's largest hospital chain. But in the late 1990's, the company faced an array of charges that it had defrauded the government, charged private insurers for unnecessary tests and improperly paid kickbacks to referring doctors. The board forced Mr. Scott out, and the company paid billions of dollars in fines and penalties; Mr. Scott was never charged with wrongdoing. "I always wanted to create a clinic business when I was in the hospital business," Mr. Scott said.

Glenn Habern, Wal-Mart's senior vice president for business development, said that Solantic and three of its rivals would be among the clinic companies leasing space in about 60 of Wal-Mart's 1,300 "superstores" by the end of this year.

"It's still a test for us," Mr. Habern said. "If customers like it we may open more. So far, we've not seen any reason not to do so." But a big Wal-Mart competitor, Target, has evidently seen drawbacks.

At the end of this month Target plans to close the 11 MinuteClinics in stores in Maryland and Minnesota; the company would not explain why. "Target will begin remodeling to open new health clinics in these stores in fall 2006," the company said in an e-mail message.

Dr. Nelson, at MinuteClinic, said in an interview before the breakup with Target was disclosed that "the pharmacy business is a small percentage of the Target footprint."

"Target also is very disciplined," he added. "They like to have things totally designed and controlled to their own specifications. They struggled with whether they want somebody else talking to their clients."

    Attention Shoppers: Low Prices on Shots in Clinic, NYT, 14.5.2006, http://www.nytimes.com/2006/05/14/business/14clinic.html?hp&ex=1147665600&en=3bd56c45080282c1&ei=5094&partner=homepage

Bush defends prescription drug program

Tue May 9, 2006 5:44 PM ET
Reuters
By Caren Bohan

SUN CITY CENTER, Florida (Reuters) - President George W. Bush urged older Americans on Tuesday to sign up for the government's prescription drug program before a May 15 deadline and disputed complaints that the plan is too complex.

"This is a good deal for American seniors," Bush said at the Kings Point retirement community near Tampa, Florida. The visit was part of two-and-a-half day tour to promote the program in the state, a favorite retirement spot.

The program, offered to the 42 million people in the Medicare health program, began on January 1. More than 30 million are receiving drug coverage. Of those, 8.1 million have signed up voluntarily for the new program and the rest transferred from other programs or have coverage through former jobs.

Most others who are eligible must sign up within six days or face a penalty.

Democrats have called for an extension of the deadline, faulting Bush and his Republican allies for creating a plan that is too confusing for many to navigate. But Bush has rejected calls for a deadline change.

Bush has also taken heat from some Republicans over the drug plan's estimated cost of $724 billion over 10 years.

Rep. Robert Wexler, a Florida Democrat, called the program a failure and said Republicans had allowed pharmaceutical and insurance companies too much sway in its design.

"Instead of more empty rhetoric from the president and Republicans in Congress, we must fix this disastrous drug plan and extend the enrollment deadline to protect America's seniors," Wexler said.

The program relies on private insurers and health plans to deliver benefits. One difficulty for potential users has been choosing among the dozens of plans offered.

The administration has set up hotlines and enlisted the help of community groups to help sign people up.

EARLY PROBLEMS

Bush has acknowledged problems early on in the process when helplines were jammed and some poorer people had trouble shifting from other government programs. But the administration has said it has ironed out many snafus and Bush said the array of choices would benefit users in the long run.

"The reason why we felt it was necessary to provide choices is because we want the system to meet the needs of the consumer. The more choices you have, the more likely it is you'd be able to find a program that suits your specific need," Bush added.

The president is crisscrossing the state to tout the program and was joined by his brother Jeb, Florida's governor. He plans another Medicare event on Wednesday in Orlando.

In Coconut Creek on the east coast, Bush met with older adults enrolling in the program and said it would offer "significant savings." He also said the May 15 deadline did not apply for low-income people who qualified for extra help.

When he worked to push the legislation creating the drug program through Congress in 2003, Bush hoped it would gain favor for Republicans among older voters.

But Democrats believe that the problems with the plan's troubles may instead boost their bid to wrest dominance from Republicans in November's congressional election.

Bush's record-low approval rating, which fell to 31 percent in the latest Gallup poll, is a broader problem for Republicans that Democrats hope to use to their advantage.

(Additional reporting by Tabassum Zakaria)

    Bush defends prescription drug program, R, 9.5.2006, http://today.reuters.com/news/newsArticle.aspx?type=politicsNews&storyID=2006-05-09T214446Z_01_N09317367_RTRUKOC_0_US-BUSH-MEDICARE.xml

Bottlers Agree to a School Ban on Sweet Drinks

May 4, 2006
The New York Times
By MARIAN BURROS and MELANIE WARNER

The country's top three soft-drink companies announced yesterday that beginning this fall they would start removing sweetened drinks like Coke, Pepsi and iced teas from school cafeterias and vending machines in response to the growing threat of lawsuits and state legislation.

Under an agreement between beverage makers and health advocates, students in elementary school would be served only bottled water, low-fat and nonfat milk, and 100 percent fruit juice in servings no bigger than eight ounces. Serving sizes would increase to 10 ounces in middle school. In high school, low-calorie juice drinks, sports drinks and diet sodas would be permitted; serving sizes would be limited to 12 ounces.

The agreement, which includes parochial and private schools contracts, is voluntary, and the beverage industry said its school sales would not be affected because it expected to replace sugary drinks with other ones.

"This is a voluntary policy, but I think schools will want to follow it," said Susan K. Neely, president of the American Beverage Association.

Still, about 35 million public school children would be affected by the agreement, which would apply to extended school functions like band practice but would not apply to events likely to be attended by parents, like evening plays or interscholastic sports. An additional 15 million students attend schools that operate under stricter regulations, where the guidelines would not apply.

Last week, for example, Connecticut banned all sodas, including diet drinks and sports drinks like Gatorade, in its schools; New York City schools permit only low-fat milk, water and 100 percent fruit juice — which is sold under an exclusive contract with Snapple.

Contracts between schools and bottlers would be updated under the deal, and changes would not go into effect before the next school year.

The agreement was brokered by the Alliance for a Healthier Generation, a collaboration between the William J. Clinton Foundation and the American Heart Association. It is similar to an arrangement that the industry had been negotiating with a coalition of lawyers and the Center for Science in the Public Interest, an advocacy group, that had threatened to sue if an agreement could not be reached. The terms were accepted by the three biggest soft-drink companies, Coca-Cola, PepsiCo Inc. and Cadbury Schweppes (whose products include Dr Pepper and Snapple), which together control more than 90 percent of school sales.

At a news conference at his office in Harlem, Mr. Clinton called the beverage industry "courageous" for agreeing to switch to lower-calorie drinks. Mr. Clinton, who has made obesity a major issue of his postpresidency agenda, was joined by Gov. Mike Huckabee of Arkansas, a vocal proponent of fitness.

Later in the day, Mr. Clinton said it was more than the threat of lawsuits that spurred the agreement.

"We've been talking to them for months and months, and they may have liked the way we were working with them, not just singling them out," he said in a telephone interview. "I'm glad we did it without litigation and could accelerate the process."

It will take three years for the agreement to be put fully into effect. The industry has agreed at the end of each school year starting in 2007 to disclose the progress toward fulfilling the agreement. The new standards are expected to be in place in 75 percent of schools by the summer of 2008 and all by 2009. The success of the program depends on schools' willingness to amend existing contracts, industry representatives said.

The majority of school contracts with Pepsi Bottling Group, Pepsi's largest bottler, for instance, are for three to five years, said its spokeswoman, Kelly McAndrew, who said Pepsi would encourage schools to renegotiate their contracts.

"We're doing our part to communicate this new policy," she said.

Mirroring overall beverage consumption in the United States, bottled water and sports drinks have become increasingly popular in schools in recent years. But in a survey released in August, the American Beverage Association said 45 percent of all school vending sales were sweetened soda.

While the soft-drink industry was negotiating the deal, it was discussing a similar accord with the Center for Science in the Public Interest and a group of lawyers who had successfully sued tobacco companies.

Richard A. Daynard, associate dean at Northeastern University School of Law, a tobacco-lawsuit veteran, called the agreement "the first major victory for the obesity-litigation strategy."

"This would not have happened but for the threat of litigation," Professor Daynard said.

Beverage-industry officials acknowledged discussions with the lawyers but would not comment further.

Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest, applauded the agreement, but said, , "I'd like to get rid of the Gatorades and diet soft drinks completely."

Nutritionists and parent groups have pressured schools and the beverage industry for some time to restrict sales. Several states, including California, and some local school districts have banned soft-drink sales, and other states are considering similar crackdowns. In response, the beverage association last year announced a policy that would have cut back on the sale of certain soft drinks in schools. But critics said the plan was unenforceable.

Gary Ruskin, executive director of Commercial Alert, a nonprofit public-health group, said the new agreement might prove to have the same problem. Mr. Ruskin criticized it, too, because it did not address soft-drink advertising in schools and did not stop bottlers from advertising on Channel One, which is shown to seven million schoolchildren a day.

Mr. Clinton said there remained "an enormous amount to be done" about childhood obesity.

"You can't single out one cause of this problem," he said. "But if an 8-year-old child took in 45 less calories per day, by the time he reached high school, he would weight 20 pounds less than he would have weighed otherwise.."

    Bottlers Agree to a School Ban on Sweet Drinks, NYT, 4.5.2006, http://www.nytimes.com/2006/05/04/health/04soda.html?hp&ex=1146801600&en=d6a3567a85c3250b&ei=5094&partner=homepage

Doctors Object to Gathering of Drug Data

May 4, 2006
The New York Times
By STEPHANIE SAUL

Although virtually unknown to consumers, the information has long been considered the most potent weapon in pharmaceutical sales — computerized dossiers showing which physicians are prescribing what drugs. Armed with such data, a drug sales representative can pressure a doctor to write more prescriptions for a name-brand medicine or fewer orders for a competitor's drug.

But now a rebellion is under way by some doctors, who consider the data-gathering an intrusion that feeds overzealous sales practices among the nation's estimated 90,000 drug company representatives. Public officials are also weighing in. A vote on a state bill to clamp down on the practice is scheduled for today in New Hampshire, and similar bills have been introduced in other states, including Arizona and West Virginia.

To appease the doctors and try to stave off the state restrictions, the American Medical Association will soon give individual physicians the choice of declaring their prescription records off limits to drug sales representatives. The new measure is viewed as a self-policing move that the drug industry and the A.M.A., which has lucrative contracts with data-mining companies, hope will keep states from banning sales of prescription data altogether.

If the A.M.A effort succeeds, "legislators will turn their attention elsewhere, and the industry can hang on to one of its most valuable data sources," according to an article this week in the industry trade magazine Pharmaceutical Executive, which was co-written by an A.M.A. official and an executive with the leading vendor of prescription data. Even many critics concede that patients' privacy is apparently not an issue, because the tracking systems identify only the prescribing doctors, not patients. But many doctors find the use of the data by sales representatives an intrusion into the way they practice medicine.

"These doctors were outraged that people came into their office and talked to them about how many times they prescribed a particular drug," said Dr. John C. Lewin, the chief executive of the state medical association in California, one of the states where complaints about the current system arose.

The California group is beginning its own program under which doctors who do not opt out under the A.M.A. system will get comparisons of their prescribing patterns in 17 classes of drugs from the data companies, said Dr. Lewin, who added that the program was being started as a pilot effort that he hoped would be extended statewide.

Among the doctors who raised an early complaint about the system was Dr. Brad Drexler, an obstetrician in Healdsburg, Calif., who said he was surprised four years ago when pharmaceutical representatives began thanking him for writing prescriptions — the first time he realized that the drug representatives had information he assumed was private.

"I think it adds to the potential that physicians could be targeted one way or another for perks," said Dr. Drexler, alluding to the practice by drug companies of deciding which doctors to reward with the gifts, meals and other perks that sales representatives have dangled over the years, or to gauge which physicians might be worthy of signing up as paid speakers or consultants.

"It's the most powerful tool a drug rep has, for sure," said Jamie Reidy, a former drug salesman who was fired last year by Eli Lilly & Company after writing "Hard Sell," a humorous exposé of the pharmaceutical industry. Mr. Reidy said the pharmaceutical representatives received updated prescription data every two weeks. The information also sometimes characterizes each physician's prescribing patterns, Mr. Reidy said.

For example, "early prescribers" — also known among drug representatives as "cowboys," according to Mr. Reidy — are those doctors who start prescribing a drug as soon as it comes to market. If you are a drug sales representative, "you go to see that doctor in the first week," Mr. Reidy said.

Although the drug representatives are told not to share the prescribing details with doctors, some nonetheless have confronted doctors with the data. A representative might become frustrated, for example, if after providing numerous lunches to a doctor's staff, the data show that the doctor is not writing prescriptions for the company's drug.

"It just creates a weird atmosphere," Mr. Reidy said.

State Representative Cindy Rosenwald of New Hampshire, lead sponsor of her state's bill, said she was motivated partly by high Medicaid drug costs, which she said she believed had been driven up by the pharmaceutical industry's success in coaxing doctors to prescribe expensive brand-name drugs.

"To me this is a money issue," Ms. Rosenwald said. "When I look at our state's budget, the fastest-growing part of the Medicaid program here in New Hampshire is for prescription drugs. It's an enormous cost for a small state like New Hampshire."

Ms. Rosenwald's legislation has been adopted by the New Hampshire House and is tentatively set for a Senate vote this afternoon.

She said she did not believe the A.M.A.'s self-policing measure would provide enough protection, partly because even if doctors specify that their prescription records not be available to drug sales representatives, the information would still be sold to drug companies for other marketing and research purposes. The drug companies, she said, would be on their honor not to share the data with their sales staffs. A Gallup Poll commissioned by the A.M.A. in 2004 found that two-thirds of doctors surveyed were opposed to the release of such data to pharmaceutical representatives, and that 77 percent felt that an opt-out program would alleviate concerns about the release of data. Nearly a quarter of the doctors were not even aware that the pharmaceutical industry had access to such information.

That same year, the American College of Physicians requested that the A.M.A. prohibit the release or sale of doctors' prescribing information. The college represents internists and related medical subspecialties, while the A.M.A. is a broader trade group whose members include all doctors, including surgeons.

Dr. Dean Abramson, an Iowa physician, is among the doctors who plan to opt out under the new A.M.A. process, which will involve a sign-up registry that goes into use on July 1. His opposition began nearly a decade ago, he recalled, when a representative from TAP Pharmaceutical Products let slip during a sales call that Dr. Abramson wrote more prescriptions for Prevacid, a treatment for acid reflux, than any other doctor in the state.

"I was pretty surprised that they kept that data, and I was not happy at all," Dr. Abramson said. "I said, 'Why is that data even kept?' She didn't really give me an answer."

Since then, Dr. Abramson has become something of an activist against the lunches and gifts that the pharmaceutical industry dispenses to doctors. His gastroenterology group in Cedar Rapids, Iowa, accepts neither, he said.

The leading compiler and vendor of prescription data is IMS Health, a publicly traded company based in Fairfield, Conn., that had revenue last year of $1.75 billion. IMS and its competitors gather the data through contracts with retail pharmacy chains and companies that manage drug plans for insurers, then sell it to pharmaceutical companies.

IMS and its competitors — the main ones are Verispan, Dendrite International and a Dutch company, Wolters Kluwer — also pay the A.M.A. for access to its repository of information on approximately one million doctors who are graduates of American medical schools, as well as foreign medical school graduates licensed in the United States.

The A.M.A., which calls this repository Masterfile, begins collecting the information when a doctor enters medical school. Over doctors' careers, additional material includes information on their board certifications, types of practice and disciplinary records. The Masterfile information is among data that companies like IMS use in developing physician profiles.

In an interview, IMS officials said they believed that state efforts to curtail their activities were misguided. "Limiting the access to our data will not stop pharmaceutical marketing," said Robert J. Hunkler, whose job with the company includes serving as a liaison with the medical profession. Mr. Hunkler also says that the data his company collects is valuable for medical research and is sometimes shared free with researchers.

Mr. Hunkler was a co-author of the Pharmaceutical Executive article describing the new A.M.A. program. The other writer was Robert A. Musacchio, the A.M.A.'s senior vice president for publishing and business services. While Mr. Musacchio declined to disclose the exact value of its Masterfile contracts with the four main data companies, he said that the organization made $40 million a year selling information, which also includes mailing lists and a service through which hospitals can check the credentials of doctors. Mr. Musacchio said that doctors had always been able to put a "no contact" status on their Masterfile record, meaning their name would not be licensed for marketing by mail, telephone or fax.

The A.M.A.'s new registry, administered partly through a Web site, will enable doctors listed in its Masterfile to indicate that they do not want their prescribing data shared with pharmaceutical sales representatives. The decision will remain in force for three years.

And yet, even those doctors' prescription information will still be collected and transmitted to drug companies, whose other uses of the data include tallying bonuses paid to pharmaceutical representatives, which are based on sales. "What we've always stressed is that physicians have rights and they can always tell pharmaceutical representatives that they don't want to be called upon," said Mr. Musacchio. But he said the organization had always made clear to the pharmaceutical industry that its representatives should never "badger or embarrass or harass" physicians.

"They sometimes try to get their point across a little too strongly," he said.

    Doctors Object to Gathering of Drug Data, NUT, 4.5.2006, http://www.nytimes.com/2006/05/04/business/04prescribe.html?hp&ex=1146801600&en=346cd8831aba4c5d&ei=5094&partner=homepage

More working Americans go without health-care coverage

Posted 4/26/2006 9:08 AM ET
USA Today

NEW YORK (AP) — The percentage of working-age Americans with moderate to middle incomes who lacked health insurance for at least part of the year rose to 41% in 2005, a dramatic increase from the 28% in 2001 without coverage, a study released on Wednesday found.

Moreover, more than half of the uninsured adults said they were having problems paying their medical bills or had incurred debt to cover their expenses, according to a report by the Commonwealth Fund, a private health care policy foundation. The study of 4,350 adults also found that people without insurance were more likely to forgo recommended health screenings such as mammograms than those with coverage, and were less likely to have a regular doctor than their insured counterparts.

The report paints a bleak health care picture for the uninsured. "It represents an explosion of the insurance crisis into those with moderate incomes," said Sara Collins, a senior program officer at the Commonwealth Fund.

Collins said the study also illustrates how more employers are dropping coverage or are offering plans that are just too expensive for many people.

About 45.8 million Americans did not have health insurance in 2004, according to the U.S. Census Bureau.

The percentage of individuals earning less than $20,000 a year without insurance rose to 53%, up from 49% in 2001. Overall, the percentage of people without insurance rose to 28% in 2005 from 24% in 2001.

The study also found that 59% of uninsured with chronic conditions such as asthma or diabetes either skipped a dose of their medicine or went without it because it was too expensive.

One-third of those in that group visited an emergency room or stayed in a hospital overnight or did both, compared to 15% of their insured counterparts.

Collins said those statistics are significant because giving up medicines typically leads to more expensive health problems later. Treating people in expensive settings such emergency rooms places a financial burden on the health care system.

"People not being able to take care of themselves should send out a big red flag," said Collins.

HCA hoisted a red flag on Tuesday, when the the nation's largest for-profit hospital operator said its earnings fell 8.5% in the first quarter after a 13% increase in uninsured admissions cut into revenue gains. The company said its provision for "doubtful accounts" rose to $852 million from $683 million a year earlier.

The Commonwealth Fund's study was bolstered by analysis of government data funded and released by the Robert Wood Johnson Foundation, a private organization that provides health care grants.

That study found that cost prevented 41.1% of uninsured adults from seeing a doctor, compared to 9.2% of individuals with coverage.

Meanwhile, 51% of women without health insurance haven't had a mammogram in two years, compared to 22.8% of women with insurance.

And 76.3% of uninsured men between the ages of 40 to 64 haven't had the PSA test, which detects prostate cancer, in two years. That compares to 52.2% of their insured counterparts.

Researchers at the University of Minnesota School of Public Health used data from the U.S. Centers for Disease Control and Prevention to reach the study's conclusion.

    More working Americans go without health-care coverage, UT, 26.4.2006, http://www.usatoday.com/money/industries/insurance/2006-04-26-uninsured-workers_x.htm

Calif. judge backs $3 billion stem-cell effort

Fri Apr 21, 2006 10:51 PM ET
Reuters

SAN FRANCISCO (Reuters) - A California judge on Friday opened the way for the state to begin funding $3 billion of stem-cell research, ruling the controversial voter-approved California Institute for Regenerative Medicine is constitutional.

But opponents can still appeal the decision.

California has been at the center of the stem-cell debate since voters in 2004 approved using state funds for research. The debate pits groups that morally oppose using fertilized human eggs for study against others who see stem cells as key to curing many diseases such as Alzheimer's and diabetes.

Alameda County Judge Bonnie Sabraw held that the institute, approved by state voters in November 2004, is a legitimate state agency that can issue debt.

"This will enable the stem cell agency to carry out critically important research in the most exciting area of biomedical research," Dr. Phillip Pizzo, dean of the Stanford School of Medicine said in a statement.

Opponents had challenged the constitutionality of the institute, effectively freezing its efforts to issue up to $300 million in debt annually.

"We have a victory across the board on every issue presented," Robert Klein, the institute's chairman, said on a conference call.

The suit was filed in April 2005 by a group of defendants that now includes the California Family Bioethics Council, a project of the California Family Council which opposes abortion and gay marriage, and the National Tax Limitation Foundation.

President Bush in August 2001 restricted federal funding of embryonic stem cell research to existing batches of the cells, which are taken from days-old embryos and are able to be turned into all types of human tissues.

Academic researchers and biotechnology companies have complained that a lack of U.S. funding for stem cells has stymied research in the field.

Given the limitations on federal money for embryonic stem cell research, several states have moved to enact their own funding in an effort to attract fast-growing biotech businesses.

California, the most populous U.S. state, has attracted many biotechnology companies since the 2004 vote approving state funding, but companies have been frustrated while the issue was tied up in court.

"This should enable us to recruit the kind of personnel from around the world who are highly qualified yet are unable to work with stem cells in their home facilities," Dr. Irving Weissman, director of Stanford's institute for stem cell biology, said in a statement.

The stem-cell institute earlier this month issued $12.1 million to researchers, marking its first grants, backed by bond anticipation notes while its debt authority faced the court challenge.

The institute may issue up to $200 million in bond anticipation notes until the legal challenge to it is resolved, Klein said, noting that opponents will have a month to appeal Sabraw's decision after it becomes official at some point in the next ten days.

Sabraw in her ruling noted that the groups challenging the institute failed to show that the measure establishing it was "clearly, positively and unmistakably unconstitutional."

Bonds issued by the institute are valid, the judge added.

California voters approved the institute's formation by passing a November 2004 ballot measure. It allows the institute to sell up to $3 billion in state debt to fund stem-cell research that many scientists believe will lead to breakthroughs for treating various illnesses and ailments.

    Calif. judge backs $3 billion stem-cell effort, R, 21.4.2006, http://today.reuters.com/news/articlenews.aspx?type=domesticNews&storyID=2006-04-22T025146Z_01_N21302787_RTRUKOC_0_US-STEMCELLS-CALIFORNIA.xml

F.D.A. Dismisses Medical Benefit From Marijuana

April 21, 2006
The New York Times
By GARDINER HARRIS

WASHINGTON, April 20 — The Food and Drug Administration said Thursday that "no sound scientific studies" supported the medical use of marijuana, contradicting a 1999 review by a panel of highly regarded scientists.

The announcement inserts the health agency into yet another fierce political fight.

Susan Bro, an agency spokeswoman, said Thursday's statement resulted from a past combined review by federal drug enforcement, regulatory and research agencies that concluded "smoked marijuana has no currently accepted or proven medical use in the United States and is not an approved medical treatment."

Ms. Bro said the agency issued the statement in response to numerous inquiries from Capitol Hill but would probably do nothing to enforce it.

"Any enforcement based on this finding would need to be by D.E.A. since this falls outside of F.D.A.'s regulatory authority," she said.

Eleven states have legalized medicinal use of marijuana, but the Drug Enforcement Administration and the director of national drug control policy, John P. Walters, have opposed those laws.

A Supreme Court decision last year allowed the federal government to arrest anyone using marijuana, even for medical purposes and even in states that have legalized its use.

Congressional opponents and supporters of medical marijuana use have each tried to enlist the F.D.A. to support their views. Representative Mark Souder, Republican of Indiana and a fierce opponent of medical marijuana initiatives, proposed legislation two years ago that would have required the food and drug agency to issue an opinion on the medicinal properties of marijuana.

Mr. Souder believes that efforts to legalize medicinal uses of marijuana are a front for efforts to legalize all uses of it, said Martin Green, a spokesman for Mr. Souder.

Tom Riley, a spokesman for Mr. Walters, hailed the food and drug agency's statement, saying it would put to rest what he called "the bizarre public discussion" that has led to some legalization of medical marijuana.

The Food and Drug Administration statement directly contradicts a 1999 review by the Institute of Medicine, a part of the National Academy of Sciences, the nation's most prestigious scientific advisory agency. That review found marijuana to be "moderately well suited for particular conditions, such as chemotherapy-induced nausea and vomiting and AIDS wasting."

Dr. John Benson, co-chairman of the Institute of Medicine committee that examined the research into marijuana's effects, said in an interview that the statement on Thursday and the combined review by other agencies were wrong.

The federal government "loves to ignore our report," said Dr. Benson, a professor of internal medicine at the University of Nebraska Medical Center. "They would rather it never happened."

Some scientists and legislators said the agency's statement about marijuana demonstrated that politics had trumped science.

"Unfortunately, this is yet another example of the F.D.A. making pronouncements that seem to be driven more by ideology than by science," said Dr. Jerry Avorn, a medical professor at Harvard Medical School.

Representative Maurice D. Hinchey, a New York Democrat who has sponsored legislation to allow medicinal uses of marijuana, said the statement reflected the influence of the Drug Enforcement Administration, which he said had long pressured the F.D.A. to help in its fight against marijuana.

A spokeswoman for the Drug Enforcement Administration referred questions to Mr. Walters's office.

The Food and Drug Administration's statement said state initiatives that legalize marijuana use were "inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the F.D.A. approval process."

But scientists who study the medical use of marijuana said in interviews that the federal government had actively discouraged research. Lyle E. Craker, a professor in the division of plant and soil sciences at the University of Massachusetts, said he submitted an application to the D.E.A. in 2001 to grow a small patch of marijuana to be used for research because government-approved marijuana, grown in Mississippi, was of poor quality.

In 2004, the drug enforcement agency turned Dr. Craker down. He appealed and is awaiting a judge's ruling. "The reason there's no good evidence is that they don't want an honest trial," Dr. Craker said.

Dr. Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, said he had studied marijuana's medicinal effects for years but had been frustrated because the National Institutes of Health, the leading government medical research agency, had refused to finance such work.

With financing from the State of California, Dr. Abrams undertook what he said was a rigorous, placebo-controlled trial of marijuana smoking in H.I.V. patients who suffered from nerve pain. Smoking marijuana proved effective in ameliorating pain, Dr. Abrams said, but he said he was having trouble getting the study published.

"One wonders how anyone" could fulfill the Food and Drug Administration request for well-controlled trials to prove marijuana's benefits, he said.

Marinol, a synthetic version of a marijuana component, is approved to treat anorexia associated with AIDS and the nausea and vomiting associated with cancer drug therapy.

GW Pharmaceutical, a British company, has received F.D.A. approval to test a sprayed extract of marijuana in humans. Called Sativex, the drug is made from marijuana and is approved for sale in Canada. Opponents of efforts to legalize marijuana for medicinal uses suggest that marijuana is a so-called gateway drug that often leads users to try more dangerous drugs and to addiction.

But the Institute of Medicine report concluded there was no evidence that marijuana acted as a gateway to harder drugs. And it said there was no evidence that medical use of marijuana would increase its use among the general population.

Dr. Daniele Piomelli, a professor of pharmacology at the University of California, Irvine, said he had "never met a scientist who would say that marijuana is either dangerous or useless."

Studies clearly show that marijuana has some benefits for some patients, Dr. Piomelli said.

"We all agree on that," he said.

    F.D.A. Dismisses Medical Benefit From Marijuana, NYT, 21.4.2006, http://www.nytimes.com/2006/04/21/health/21marijuana.html?hp&ex=1145678400&en=73c0a8f9ab6a3c7e&ei=5094&partner=homepage


 

Nicole Figueroa and Jeffrey Resnick, at left, with other couples at a dance by the Young Adult Institute.

James Estrin/The New York Times        April 19, 2006

Learning to Savor a Full Life, Love Life Included        NYT        20.4.2006
http://www.nytimes.com/2006/04/20/us/20romance.html?hp&ex=
1145592000&en=ce905c119a7d1c78&ei=5094&partner=homepage
 

Learning to Savor a Full Life, Love Life Included

April 20, 2006
The New York Times
By JANE GROSS

Mary Kate Graham's boyfriend, Gary Ruvolo, is fond of recounting every detail of their first date 13 years ago and each candlelight anniversary dinner since. "God help me," Ms. Graham said, rolling her eyes with affectionate indulgence.

Ms. Graham and Mr. Ruvolo, both 32, accept each other's foibles with tenderness. The one time their romance was in trouble — a girl "was spending too much time at Gary's house, and I didn't like it," Ms. Graham said — they went to couples' counseling and worked it out.

Their next hurdle will be moving from their family homes, both in Brooklyn, to a group residence. There, for the first time, Ms. Graham, who is mentally retarded, and Mr. Ruvolo, who has Down syndrome, will be permitted to spend time together in private.

The pair were coached in dating, romance and physical intimacy by a social service agency at the cutting edge of a new movement to promote healthy sexuality for the seven million Americans with mental retardation and related disabilities.

In what experts say is the latest frontier in disability rights, a small but growing number of psychologists, educators and researchers are promoting social opportunities and teaching the skills to enjoy them.

A generation ago, young adults like Ms. Graham and Mr. Ruvolo were generally confined to institutions, with no expectation of a normal life. All that changed in 1975, when a court order closed the notorious Willowbrook State School on Staten Island and moved its residents, and others like them across the country, into community settings to live as fully as their limitations allowed.

That could include attending neighborhood schools and holding salaried jobs. Now many men and women in their 20's and 30's, encouraged from childhood to be independent, expect the same when it comes to expressing their romantic and sexual needs.

The prospect of their children being sexually active often alarms protective parents mindful of the high rates of molesting among the mentally retarded. And agencies, whose programs are at least partly paid for by the government, have been more likely to emphasize the prevention of abuse, disease and pregnancy than to prepare clients for intimacy.

"Plenty of people still believe that the answer to this is abstinence," said Philip H. Levy, president of the Young Adult Institute, a 50-year-old agency for the developmentally disabled that has been a trailblazer in offering sexuality workshops and social activities like the ones Ms. Graham and Mr. Ruvolo attend.

"But if you hide from this issue, it will come back to haunt you," added Mr. Levy, whose agency serves more than 20,000 people of all ages in the metropolitan area. "Plus, once you train people to think for themselves and give them a sense of promise, to not follow through is really cruel."

Virtually all agencies endorse the right of a consenting adult to have a sex life, but formal classes in dating and sexuality, like the institute offers, are rare. "Informed choice is a major theme in the field, but actual programs to support a sexual life aren't out there," said Charlie Lakin, director of research at the Institute on Community Integration at the University of Minnesota, who says that other agencies are buying the Young Adult Institute's staff training materials and inviting their professionals to speak.

Recently, for instance, Perry Samowitz, the agency's director of education, lectured in North Carolina. From the back of a hall, a disabled young man asked how old he had to be to have sex.

"How old are you?" Mr. Samowitz inquired. The answer was 35. "Sounds old enough to me," Mr. Samowitz said, expecting an argument from the young man's father, a Baptist minister.

The father surprised him. "I'm here to learn," he said.

Indeed, Maureen Graham's first reaction was fear when her daughter Mary Kate's social workers asked permission to teach her about dating and sex. "My eyes got wide when they said this could happen," Mrs. Graham said. But more quickly than most she saw the logic: "I always wanted Mary Kate to have as close to a normal life as possible. So how could I not want this for her, too?"

"This" includes the ring Ms. Graham wears, two hearts intertwined, a gift from Mr. Ruvolo. The couple talk on the telephone several times a day; and go bowling, to the movies or to a restaurant most weekends, usually with their mothers in tow.

"They are so good to each other, so supportive," Mrs. Graham said. "I don't know if they've already had sex, but they've been pretty intimate with each other, and that's O.K."

Her blessing aside, Mr. Ruvolo and Ms. Graham say they intend wait until marriage. "Before that, it'd be no good," Mr. Ruvolo said.

Marriage rarely comes up in the institute's workshops. Many are led by Bobra Fyne, a sex educator who welcomed a group of 30 first-timers one recent evening, ranging in age from 20-something to past 60.

Ms. Fyne urged them to pose one sex question they had always wanted to ask. Questions included "How can you get a girl to wear sexy lingerie?" and "How do you stop somebody from being in such a hurry?"

The second drew a quick reply. "The short answer is, 'You go first,' " Ms. Fyne said, to waves of laughter.

The six-month curriculum includes birth control and prevention of sexually transmitted diseases and abuse. But it also includes masturbation and what the syllabus calls "pleasuring your partner," topics avoided by even the few other agencies experimenting with basic social skills training, often because of parental objections.

The parents' fears are understandable, given an array of studies that found 50 percent to 85 percent of women with mental retardation were sexually assaulted before the age of 18, and 25 percent to 50 percent of men. Of those assaulted, 49 percent had been abused 10 times or more. Some experts think safe opportunities for sexual relations can prevent abuse, although there is no research on the subject.

Dr. Levy described an incident involving a client at a group home before the institute's current policies evolved. The 25-year-old resident was arrested in a public bathroom having group sex with several men he did not know. When Dr. Levy went to bail him out of jail, the young man was in tears. "Where am I supposed to go to get my needs met?" he asked.

Far safer, Dr. Levy said, is allowing such needs to be met in the group home, after a consent evaluation by a psychologist. That evaluation tests knowledge of birth control and disease prevention, the need to limit sexual activity to private locations, the difference between legal and illegal sexual acts and how to avoid exploitive situations.

At the institute, despite freewheeling talk, the goal of staff members and clients alike seems to be fostering loving and lasting relationships. "We talk about loneliness," Mr. Samowitz said. "We use soft, easy words like 'sweetheart.' "

Indeed, Ms. Fyne and others have learned that social isolation is a more pressing issue than sexuality. At an early class, Ms. Fyne asked students whether it was "O.K. to have one partner in the afternoon and another in the evening?"

The response was a wake-up call. "I don't know how to get a date, Bobra," one student called out. "So the rest of this is just garbage."

Now the dating lessons often come in a casual aside from a social worker during a recreational activity. That is how Ms. Graham and Mr. Ruvolo wound up in couples therapy, with a gentle nudge from Karuna Heisler, who supervises weekly dances as well as a theater group.

The theater group is where Nicole Figueroa, 26, and Jeffrey Resnick, 25, met. An on-again-off-again couple, they are now inseparable, under the watchful eye of Ms. Heisler. Again, their issue has been jealousy, since Mr. Resnick is very sociable and Ms. Figueroa has difficulty accepting his friendships with other women in their circle.

"We're all trying to teach her that even if Jeffrey talks to someone else, he still loves her," said Marion Resnick, his mother, who was tickled to find the pair waltzing in her son's bedroom one day.

Ms. Figueroa and Mr. Resnick are more physical with each other than Ms. Graham and Mr. Ruvolo. Ms. Heisler said that was more a matter of personal style than a predictor of sexual activity. Mrs. Resnick said, "We don't have the nerve to ask" what they are doing.

The couple themselves get giggly when asked about their sex lives.

"If she wants to sleep with me when we move to the group home, I'm O.K. with that," Mr. Resnick said. "And if not, I'm O.K. with that, too, because what I feel is happy."

    Learning to Savor a Full Life, Love Life Included, NYT, 20.4.2006, http://www.nytimes.com/2006/04/20/us/20romance.html?hp&ex=1145592000&en=ce905c119a7d1c78&ei=5094&partner=homepage

Medicare drug enrollment has holes

Posted 4/18/2006 12:16 AM ET
USA TODAY
By Richard Wolf

WASHINGTON — Two groups of Medicare beneficiaries — those with low incomes and those with few health problems — are the slowest to sign up for the program's new prescription-drug coverage.

Most beneficiaries currently eligible for the plan will face higher costs if they sign up after the May 15 deadline. Premiums will rise by 1% a month after then.

The Bush administration estimates that about 7 million eligible Medicare recipients have not signed up for drug coverage. Some outside groups, such as the Kaiser Family Foundation and Avalere Health, a health care research company, put the figure at 14 million.

Two groups are in short supply:

•Low-income seniors and disabled Americans who could qualify for extra financial help have been the hardest to enroll, often because of educational or language barriers. Up to 8.2 million were originally estimated to be eligible, but only 1.6 million have been approved.

Millions of low-income people have not applied for federal subsidies that would nearly eliminate their out-of-pocket costs. Others sought the extra help but failed the income or asset tests and declined to join the program at full cost.

"It would be optimistic to say we'd get to 2 million," says James Firman of the National Council on Aging, who heads the outreach effort to low-income groups.

•Seniors who take few expensive drugs have been slow to enroll, which actuaries assumed from the start would happen. Officials have urged them to join a plan as protection against future illnesses. Healthier people help spread the insurance risk and hold down costs.

While there are no exact numbers, "people who are healthier are going to be a bit less likely to enroll," says Mark McClellan, administrator of the Centers for Medicare and Medicaid Services.

The administration plans to release figures this week showing that nearly 30 million Medicare beneficiaries have drug coverage. That includes 7 million who signed up voluntarily. The rest had prior coverage from Medicaid, managed-care plans, private employers, or federal and military retiree plans.

"We are well on our way to achieving our goal of ... 28 (million) to 30 million enrollees in our first year," says Health and Human Services Secretary Michael Leavitt.

A year ago, the administration predicted the program would attract 39 million of Medicare's 43 million beneficiaries in 2006. The Congressional Budget Office projected 37 million.

McClellan says actuaries "lowered their estimates" to reflect difficulties in signing people up.

"The whole purpose of this drug benefit was to get drug coverage in the hands of all Medicare beneficiaries," says Dan Mendelson, president of Avalere Health. "Where are the people? That's the question."

    Medicare drug enrollment has holes, UT, 18.4.2006, http://www.usatoday.com/news/washington/2006-04-17-medicare_x.htm

Obesity Finds Niche in American Marketing

April 16, 2006
By THE ASSOCIATED PRESS
Filed at 11:03 p.m. ET
The New York Times

NEW YORK (AP) -- From the cradle to the grave and most points between, obesity has found its niche in American marketing. Make that a wide berth.

Baby seats, doorways and caskets are but a few examples from a long list of life's accouterments that are getting much bigger to accommodate much bigger people. There are also vacation resorts for those embarrassed to be seen in a bathing suit.

At Freedom Paradise on Mexico's Yucatan peninsula, the chairs are wider and without arms, to prevent getting stuck; the beds are king-sized and reinforced, to prevent collapsing; and the beach is private and secluded, to prevent gawking and staring.

''You should not be embarrassed by how big you are,'' said William Fabrey, whose online business ''Amplestuff'' offers larger versions of everyday things from umbrellas to footstools. ''You can't just yell at someone and tell them to lose weight. You're already dealing with people who think they have no worth.

''They still have to sit down on a chair that doesn't collapse,'' he said.

Like others in this small but growing group of businesses, Fabrey started his company after discussions with an overweight friend. ''She was a big woman, and she said, 'There's got to be an easier way to get through the day.' ''

To make living large a little easier, Fabrey sells lotion applicators and sponges attached to handles -- enabling the user to reach all parts of the body; handbooks on hygiene with tips on dealing with odor problems, chafing and irritations caused by skin folds. His business also provides links to physicians and medical services.

''We don't take any position on whether someone should lose weight,'' Fabrey said. ''That's up to the person.''

Seemingly every day, another study appears that shows the United States is becoming a country of fat people. According to the Centers for Disease Control and Prevention, more than 71 percent of men weigh too much, along with about 61 percent of women and 33 percent of children.

As Americans grow in weight, their life expectancy becomes shorter -- by as much as five years, according to the latest national statistics -- more than the impacts of heart disease and cancer. Obesity is fast approaching tobacco as the No. 1 cause of preventable death.

The price tag to taxpayers, according to the CDC, is a whopping $117 billion a year, a figure that some health experts dispute, claiming the government numbers are based on faulty data. Not disputed, according to obesity specialists, is the amount Americans spend trying to get thinner -- $33 billion a year.

U.S. Surgeon General Richard Carmona sounded a dire warning last month, telling university students in South Carolina ''obesity is the terror within,'' and that unless people start getting thinner, ''the magnitude of the dilemma will dwarf 9-11 or any other terrorist attempt.''

Such pronouncements help fuel criticism that catering to bigger people really means throwing wide the door to death by overeating.

But for those who are overweight, who know full well how it feels to be sneered at, laughed at, pitied and scorned, having a simple tool such as a sponge on a stick, or a sturdy footstool that can bear up to 500 pounds, makes one feel a little more human. And a little less demonized.

Joan Borgos weighed 350 pounds for 28 years, until she had gastric bypass surgery and lost 200 pounds. She began putting out LargeDirectory.com because there was nothing available ''that didn't look like a muu muu from Lane Bryant's,'' she said.

From her home in Massachusetts, she lists clothing catalogs, bridal shops (for gowns up to size 32), plus-size dating services, counseling services, seat belt extenders and lingerie. She recently added listings for teens, after desperate mothers told her they couldn't find stylish clothes for their overweight adolescents.

Even toddlers have joined the overweight ranks, with car seat manufacturers offering the ''Husky,'' which is 10 pounds heavier and four inches wider than the standard size.

''There are all kinds of theories that abound about why people are getting heavier,'' said Borgos. ''People are more sedentary, people eat more junk food and get less exercise. I don't know what it is.

''But it's a constant level of stress to live as an overweight person. You're always scoping out the environment, looking if you're going to be able to fit. ''

Kelly Bliss, a self-described ''chubby chick'' in suburban Philadelphia offers ''plus-size fitness and lifestyle coaching.''

Which means, she says, encouraging overweight clients to exercise as best they can, to eat healthily and to not focus on losing pounds.

''People cannot just stop being fat,'' she says. ''It's prejudice when you say a fat person does not need things to make them comfortable,'' she says. ''People crumble when you given them even more pressure on top of a life that's already not working.''

To make caring for the overweight ill easier, and to make patients more comfortable, there also are specialized medical products for an ever-growing clientele.

Treating the obese is called bariatric care, from Greek root meaning weight. Providing it means hospitals are paying for wider beds, wider wheelchairs, wider doorways, longer needles and bigger CT scan machines. As well as larger gowns and extra-sized slippers.

And for the end of life's road, coffin makers have introduced new lines with higher-gauge steel and widths of up to 28 inches, from the standard 24.

In Indiana, the Batesville Casket Co. calls it ''a little extra room for life's final journey.''

    Obesity Finds Niche in American Marketing, NYT, 16.4.2006, http://www.nytimes.com/aponline/business/AP-Diet-Accommodating-Obesity.html

US readies flu pandemic response plan: report

Sat Apr 15, 2006 10:48 PM ET
Reuters

WASHINGTON (Reuters) - The U.S. government would expand the Internet and possibly permit foreign countries to print U.S. currency during a flu pandemic, under a national response plan that could be approved within days by President George W. Bush, the Washington Post reported on Saturday.

An article on the newspaper's Web site said the document is the first to spell out how the government would detect and respond to a flu outbreak and continue to function through what could be an 18-month crisis capable of killing up to 1.9 million Americans.

The 240-page response plan identifies more than 300 specific tasks for federal agencies, including determining which frontline workers should be vaccinated first and expanding the Internet to accommodate a likely flood of people working from their home computers.

The newspaper said the Treasury Department is poised to sign agreements with other nations to produce currency if U.S. mints cannot operate.

The Pentagon, anticipating difficulties acquiring supplies from the Far East, is considering stockpiling millions of latex gloves.

The article, which was also to appear in the Post's Sunday editions, said the Department of Veterans Affairs has developed a drive-through medical exam to quickly assess patients who suspect they have been infected by the virus.

Bush is expected to approve the plan within a week, the article said.

The White House is eager to show it can manage the medical, security and economic fallout from a major outbreak following its widely criticized to Hurricane Katrina, the Post said. Concern about a possible pandemic has grown with the emergence of the H5N1 avian flu, the most dangerous strain in decades.

Bush is expected to adopt post-Katrina recommendations that a new interagency task force coordinate the federal response and a high-level Disaster Response Group resolve disputes among agencies or states, the newspaper said. Neither entity has been created.

When the response plan is issued, the Post said U.S. officials intend to announce several vaccine manufacturing contracts to jump-start an industry that has declined in recent decades.

To keep the 1.8 million federal workers healthy and productive through a pandemic, the Bush administration would tap into its secure stash of medications, cancel large gatherings, encourage schools to close and shift air traffic controllers to the busier hubs.

The newspaper said retired federal employees would be summoned back to work, and National Guard troops could be dispatched to cities facing possible insurrection.

    US readies flu pandemic response plan: report, R, 15.4.2006, http://today.reuters.com/news/articlenews.aspx?type=newsOne&storyid=2006-04-16T024843Z_01_N15144067_RTRUKOC_0_US-BIRDFLU-USA.xml

In End Run Around Legal Challenge, California Gives Out Stem Cell Research Grants

April 11, 2006
The New York Times
By CAROLYN MARSHALL

SAN FRANCISCO, April 10 — California's program to study embryonic stem cells awarded its first round of grants Monday, drawing on money put up by state business leaders trying to move the program forward despite legal challenges.

The program is in limbo because of lawsuits by opponents of embryonic stem cell research who challenge its constitutionality. As a result, it has been prevented from distributing any of the $3 billion in bonds approved by voters in 2004.

Instead, officials have sold $14 million in so-called bond anticipation notes. They awarded $12.1 million of that money on Monday.

The grants were given to 16 California nonprofit research institutions to train what program officials have called the next generation of stem cell researchers. The program, the California Institute for Regenerative Medicine, is raising an additional $32 million in bond anticipation notes, its chairman, Robert N. Klein, has said.

The grant recipients include stem cell research trainees at Stanford, numerous University of California campuses and the Salk Institute of Biological Studies. The grants range from $347,160 to $1.23 million.

The bonds, approved by the state last week, were bought by some of the state's wealthiest business leaders, including the venture capitalist L. John Doerr and the Qualcomm co-founder Irwin Jacobs.

In a statement, Mr. Klein called the release of money "exhilarating," but critics said the "bridge financing" could create unforeseen problems.

Jesse Reynolds of the Center for Genetics and Society, a public interest advocacy group that supports stem cell research, said the bond anticipation notes were not only high-risk loans but also had been approved without public participation.

"It raises a very real prospect that private entities could unduly influence the activity of a public agency," Mr. Reynolds said.

    In End Run Around Legal Challenge, California Gives Out Stem Cell Research Grants, NYT, 11.4.2006, http://www.nytimes.com/2006/04/11/us/11cell.html

$14 Million for Research on Stem Cells

April 5, 2006
The New York Times
By ANDREW POLLACK

LOS ANGELES, April 4 — California's stem cell research program has arranged for a stopgap infusion of $14 million from philanthropic foundations started by some of California's wealthiest businesspeople.

The money will be used to keep the program going until the resolution of lawsuits challenging its constitutionality. The litigation has prevented the state from issuing any of the $3 billion in bonds authorized by voters to finance research on medical treatments using human embryonic stem cells.

With the program nearly out of money, state officials on Tuesday authorized the sale of $14 million in so-called bond anticipation notes to six philanthropic foundations.

The notes will be paid back, with interest, once the litigation is resolved and the bonds are issued. But if the state loses in court and can never issue the bonds, the money will not be repaid.

The $14 million is likely to be only the first of a total of $50 million in such notes that will be sold in the near future, Robert N. Klein, the chairman of the stem cell program, said in a statement.

The largest purchaser of the notes, $5 million worth, will be a trust set up by Irwin Jacobs, co-founder of the wireless equipment maker Qualcomm. A foundation started by the venture capitalist L. John Doerr will buy $2 million in notes, as will a foundation started by William K. Bowes, another venture capitalist.

Other purchases of $2 million in notes will be made by a foundation started by the former homebuilder Eli Broad and one started by the owner of the San Diego Padres, John Moores. Blum Family Partners, started by the San Francisco financier Richard L. Blum, the husband of Senator Dianne K. Feinstein, will buy $1 million in notes.

So far, the California program has not been able to spend any money on research. It has been kept afloat by a $3 million loan from the state and a $5 million donation from the audio pioneer Ray Dolby. That money could run out by the end of June.

A trial was held last month in state court to consider lawsuits filed by lawyers opposed to embryonic stem cell research. A decision is expected soon but appeals could keep the matter before the courts until next year.

    $14 Million for Research on Stem Cells, NYT, 5.4.2006, http://www.nytimes.com/2006/04/05/business/05cell.html

In Connecticut, Bush Talks of Soaring Health Care Costs

April 6, 2006
The New York Times
By JIM RUTENBERG

BRIDGEPORT, Conn., April 5 — President Bush visited Connecticut on Wednesday to highlight his prescription for a stubborn national problem certain to play a prominent role in this year's federal and state election campaigns: soaring health care costs.

Mr. Bush used his appearance on a friendly discussion panel at the Playhouse on the Green here to urge Congress to support his proposal to expand Health Savings Accounts. Such accounts, established along with Mr. Bush's Medicare overhaul in 2003, are essentially tax-free depositories used to cover medical costs for those who also buy high-deductible insurance plans to cover catastrophic costs.

The administration says the accounts help push down medical expenses by making consumers more savvy about costs and can help make insurance less expensive and more accessible. The White House has been pushing the plan all week, putting the president on domestic policy ground far from the war in Iraq, though officials said tackling health care costs was a main presidential priority.

And though it is unclear whether Mr. Bush will persuade Congress to approve the main elements of his proposal, the event here allowed him to address a pressing domestic issue in a state with notoriously high insurance costs. Mr. Bush flew from Washington aboard Air Force One with Representative Christopher Shays, a Republican whose district includes Bridgeport and who is facing a stiff challenge for his seat from Diane Farrell, a Democrat who was first selectwoman of Westport.

Mr. Shays has not hesitated to disagree publicly with Mr. Bush, most recently saying the administration had made "huge mistakes" in Iraq, though he has not wavered in his support for the war.

Mr. Bush, who lost Connecticut in the 2004 election, made veiled reference to such remarks on Wednesday.

"He is an independent fellow who speaks his mind," Mr. Bush said of Mr. Shays, adding, as the crowd laughed, "But he does so in a way that gets people to listen to him."

To Mr. Shays, he said, "I'm looking forward to hearing your lecture on the way back to Washington."

Intended or not, the line allowed Mr. Shays to maintain his policy differences with the president, whom polls show to be unpopular here — even as he remains a formidable fund-raiser — while appearing with him at an event that garnered considerable attention from newspapers, radio and television.

Indeed, Democrats used the visit to paint Mr. Shays as close to the president.

Noting that Mr. Bush is unpopular in the state, Ms. Farrell said in an interview later that the joint appearance was "a reward," because "Chris has been with him on everything important, most especially on the war."

Mr. Shays said of the president, "He realizes I have opinions that are different from his." But he said traveling back and forth between Washington and Connecticut with the president gave him valuable face time and he called this visit an honor to his district.

Congressional Democrats also jumped on the visit, repeating accusations that the savings accounts favored the wealthy and could discourage people from seeing doctors when they needed to.

"It's wealth care, not health care," said Representative Rahm Emanuel of Illinois, chairman of the Democratic Congressional Campaign Committee.

Mr. Bush spent much of his time here trying to dispel those notions, speaking with panelists who lauded the savings accounts in something akin to an infomercial. A small-business owner said the accounts paid for themselves and helped her maintain health coverage for her employees. A young woman said that her account was easy to use and that "you can call up different people and get the best price for your money, without compromising quality."

    In Connecticut, Bush Talks of Soaring Health Care Costs, NYT, 6.4.2006, http://www.nytimes.com/2006/04/06/washington/06bush.html

Bill Strikes at Low-Nutrition Foods in School

April 6, 2006
The New York Times
By MARIAN BURROS

The days when children consume two orders of French fries in the school cafeteria and call it lunch may be numbered. A bipartisan group in Congress plans to introduce legislation today that would prohibit the sale in school not only of French fries but also of other fatty or sugary foods, including soft drinks.

Under the bill, an amendment to the National School Lunch Act, high nutritional standards would be required of all food sold on school premises. That means not just in cafeterias but in vending machines, school stores and snack bars as well, even at fund-raising events.

The measure, which has strong bipartisan support in both houses, would do on a national level what many school districts have been trying to do for years: require that the schools set an example by providing only healthful food and so perhaps reduce the incidence of childhood obesity.

Senator Lisa Murkowski, Republican of Alaska, has watched what goes on in the school her two teenage sons attend.

"We talk a lot about healthy nutrition, we teach the kids about the food pyramid, and then they go down the hallway and get the high fat, high sodium and high junk available in the vending machines," Ms. Murkowski said. "We need to be consistent. People are beginning to connect the dots between rising health care costs and obesity."

Senator Tom Harkin, an Iowa Democrat who has been pushing such a bill since 1994, said: "Congress is finally catching up with what parents have believed for a long time. Members of Congress are hearing from their constituents and recognizing this has become a national problem. I think finally members of Congress are asking, 'Why do we have soft drink vending machines in our schools?' "

The bill would apply to all foods other than the official school lunch, the meal for which schools receive government aid and which is already covered by other high-nutrition standards. Currently, sale of the other foods is permitted in school if they contain at least 5 percent of the recommended daily allowance of protein and certain vitamins and minerals. This standard applies regardless of the product's level of calories, fat, added sugars or sodium.

Under that approach, French fries, ice cream, candy bars, cookies, chips, snack cakes and doughnuts are allowed. Seltzer, jelly beans, chewing gum, lollipops, cotton candy and breath mints are not.

The new list of foods would take into account whether a product promoted obesity or chronic illnesses. The choices would come from recommendations of the Institute of Medicine, which expects to have a report ready this fall.

Enforcement would rest with the Department of Agriculture, which currently has authority only over the official school lunch. "The agency has done a good job with the official school lunch and could do a good job with all other food," said Margo Wootan, director of nutrition at the Center for Science in the Public Interest, which worked closely with Congress on the legislation.

Supporters of the bill have been marshaling evidence to contradict the usual criticism of proposals to serve only nutritious food in schools: that children will not eat it and that schools cannot afford to lose the revenue brought in by fatty or sugary products. A survey by the Agriculture Department and the Centers for Disease Control and Prevention found that of 17 schools that began offering healthful options, 12 actually increased revenue while only one lost, marginally; the four others reported no change.

The American Beverage Association, a trade group, said the legislation was unnecessary because since last August members of the association have limited sales of full-calorie soft drinks to 50 percent of offerings in high schools. They are not available in lower grades.

Frito-Lay, a leading manufacturer of snack foods, had no comment.

Despite the strong support for the bill among lawmakers, Kelly Brownell, director of the Yale Center for Eating and Weight Disorders, was skeptical.

"My fear," Dr. Brownell said, "is that the food industry, with the soft drink industry taking the lead, will work its hardest to weaken or kill this act."

    Bill Strikes at Low-Nutrition Foods in School, NYT, 6.4.2006, http://www.nytimes.com/2006/04/06/education/06lunch.html

Drug industry spends millions on US states: report

Thu Apr 6, 2006 12:30 AM ET
Reuters

WASHINGTON (Reuters) - The pharmaceutical industry spent $44 million lobbying U.S. state officials during a two-year period with much of the money going to fight proposals that would have reduced prescription drug costs, according to report released on Thursday.

The Center for Public Integrity said industry representatives spent the money in 2003 and 2004, a time when more than half of all states were considering proposals to reduce the cost of medicines. Prescription medicines are one of the fastest-growing expenses for state governments, which are among the pharmaceutical industry's biggest customers, the report said.

The investigative research center analyzed lobbyist disclosure documents and records from the Pharmaceutical Research and Manufacturers of America (PhRMA) as well as conducted interviews with current and former state representatives.

PhRMA, the drug industry's main trade group, spent more than $4.5 million during 2003 and 2004. Four major drugmakers -- Eli Lilly and Co., GlaxoSmithKline Plc., Pfizer Inc. and Johnson & Johnson -- each spent $3 million.

Overall, more than 40 percent of the $44 million was spent in three large states that spend the most on prescription medicines -- California, New York and Texas, according to the report funded by The Nathan Cummings Foundation, the Joyce Foundation and the Ford Foundation.

About 16 percent of all prescription drugs sold in the United States are purchased by states under the Medicaid program for the poor and other assistance initiatives, the center said. States also cover drugs for their employees and prison inmates.

As many states face a continuing budget crunch, some have turned to drug costs as an area to trim spending. Center researchers said 33 states have passed 66 pieces of legislation since 2003 aimed at cutting drug spending.

Although federal officials have said importing drugs from abroad is risky and unsafe, several states now allow residents to buy 90 days' worth of prescription medicines from other countries offering cheaper prices.

Others have begun promoting use of cheaper generic drugs, buying medicines in bulk and pushing for use of drugs they consider to be most cost-effective.

Massachusetts, New Jersey, Indiana and other states where several drugmakers are based also were heavily targeted.

    Drug industry spends millions on US states: report, R, 5.4.2006, http://today.reuters.com/News/newsArticle.aspx?type=topNews&storyID=2006-04-06T043007Z_01_N06387475_RTRUKOC_0_US-DRUGMAKERS.xml

Massachusetts Sets Health Plan for Nearly All

April 5, 2006
The New York Times
By PAM BELLUCK

BOSTON, April 4 — Massachusetts is poised to become the first state to provide nearly universal health care coverage with a bill passed overwhelmingly by the legislature Tuesday that Gov. Mitt Romney says he will sign.

The bill does what health experts say no other state has been able to do: provide a mechanism for all of its citizens to obtain health insurance. It accomplishes that in a way that experts say combines several methods and proposals from across the political spectrum, apportioning the cost among businesses, individuals and the government.

"This is probably about as close as you can get to universal," said Paul B. Ginsburg, president of the nonpartisan Center for Studying Health System Change in Washington. "It's definitely going to be inspiring to other states about how there was this compromise. They found a way to get to a major expansion of coverage that people could agree on. For a conservative Republican, this is individual responsibility. For a Democrat, this is government helping those that need help."

The bill, after the product of months of wrangling between legislators and the governor, requires all Massachusetts residents to obtain health coverage by July 1, 2007.

Individuals who can afford private insurance will be penalized on their state income taxes if they do not purchase it. Government subsidies to private insurance plans will allow more of the working poor to buy insurance and will expand the number of children who are eligible for free coverage. Businesses with more than 10 workers that do not provide insurance will be assessed up to $295 per employee per year.

All told, the plan is expected to cover 515,000 uninsured people within three years, about 95 percent of the state's uninsured population, legislators said, leaving less than 1 percent of the population unprotected.

"It is not a typical Massachusetts-Taxachusetts, oh-just-crazy-liberal plan," said Stuart H. Altman, a professor of health policy at Brandeis University. "It isn't that at all. It is a pretty moderate approach, and that's what's impressive about it. It tried to borrow and blend a lot of different pieces."

Many states, including Massachusetts, have been wrestling for years with how to cover the uninsured, and several states have come close, according to the National Conference of State Legislatures. Hawaii passed a universal access law in 1974 requiring employers to offer health care coverage for employees working 20 hours or more a week, but nearly 10 percent of people remain uncovered. Efforts to cover all citizens in Minnesota and Vermont in 1992 and in Massachusetts in 1988 fell flat in the mid-1990s when the language in the bills concerning universal coverage was repealed.

In 2003, Maine enacted a law that significantly broadened insurance coverage and combined employer payments with expanded government programs. That year, California enacted a law that required employer contributions, but it was repealed in a referendum in 2004. Massachusetts would be the first state to require its citizens to have health insurance.

The Massachusetts bill creates a sliding scale of affordability ranging from people who can afford insurance outright to those who cannot afford it at all. About 215,000 people will be covered by allowing individuals and businesses with 50 or fewer employees to buy insurance with pretax dollars, and by giving insurance companies incentives to offer stripped-down plans at lower cost. Lower-cost basic plans will be available to people ages 19 to 26.

Subsidies for other private plans will be available for people with incomes at or below 300 percent of the poverty level. Children in those families will be eligible for free coverage through Medicaid, an expansion of the current system.

The Massachusetts bill was hammered out with proposals and input from state Democratic legislators; Mr. Romney, a Republican; Senator Edward M. Kennedy, a Democrat; insurers; academics; businesses; hospitals; and advocates for the poor, including religious leaders.

They were motivated in part by a threat by the federal government to eliminate $385 million in federal Medicaid money unless the state reduced the number of uninsured people. The state was supposed to have the bill completed by January, but state officials said they were confident that the federal government would approve of Tuesday's bill.

"Whenever you can have the medical community, the business community and the advocates all applauding our efforts, I think that's indicative of a successful exercise," said State Senator Robert E. Travaglini, the majority leader.

Mr. Romney, who is considering running for president in 2008, said in an interview Tuesday that the bill, passed by a legislature that is 85 percent Democratic, was "95 percent of what I proposed."

He said, "This is really a landmark for our state because this proves at this stage that we can get health insurance for all our citizens without raising taxes and without a government takeover. The old single-payer canard is gone."

Mr. Romney pushed the idea of the "individual mandate," requiring people who can afford insurance to buy it. The bill makes it possible for employers to enable many of those people to use pretax dollars, saving them 25 percent or more. Individuals who fail to get health insurance by July 2007 will first lose their personal exemption on their state taxes. In subsequent years, they would have to pay a penalty that could be as high as half of what an affordable health care premium would cost.

Eric Fehrnstrom, the governor's communications director, said that for those people with incomes above 300 percent of poverty, "our assumption was that these would be mostly single mothers who just did not have the wherewithal to get insurance. It turned out it was mostly young males. In some cases they are making very attractive salaries. These are people who just don't imagine themselves needing care, but of course when they break a leg when they're out bungee jumping they go to the hospital and we end up paying for their care anyway."

One element that Mr. Romney and some legislators did not want was the fee for employers who do not provide health insurance.

For several months the bill seemed stalled because the House and Senate leaders could not agree on the issue of charging businesses. One proposal of an $800-per-employee charge was reduced to a maximum of $295 that would go toward paying costs for the uninsured and would be reduced as more people became insured, Mr. Travaglini said.

Because the bill is part of a budget bill, Mr. Romney has line-item veto power. He said Tuesday that he would likely change the business fee provision in some way or veto it before signing the bill.

Still, he did not seem that worried about it, saying he had been most concerned that the fee not be a payroll tax, as had been originally proposed. Mr. Travaglini said that if Mr. Romney vetoed the business fee, the legislature would override it.

Bob Baker, president of the Smaller Business Association of New England, said his members seemed to accept the idea of the fee.

"The notion of the level playing field, I think from an element of fairness and equity, people are O.K. with it, unless it impinges on their ability to pay for it," Mr. Baker said. "There hasn't been a hue and cry among our members."

Mr. Romney said that with more people insured, everyone would "get better health care" and that premiums for people who already had insurance might drop because "providers won't be pushing the cost of the uninsured onto the people who have insurance."

James Roosevelt Jr., president and chief executive of Tufts Health Plan, agreed.

"I think that will help both improve the quality of health care and lower the cost," Mr. Roosevelt said, but he added, "We would have liked more flexibility in the design of health plans to permit lower premiums that are affordable for all people."

The program, which was approved 154 to 2 in the House and 37 to 0 in the Senate, will cost $1.2 billion over three years, but only $125 million of that will be new state money. The rest will come from federal money and existing state money. After three years, lawmakers say, no new state money will be required. A new agency will administer the system.

Advocates for the uninsured held a victory rally at the Statehouse.

"We're thrilled that this truly represents a commitment to the poor and the working poor," said Rabbi Jonah Pesner, a leader of the Greater Boston Interfaith Organization.

Joseph Landais, 64, could use insurance for himself, his wife and three children. Mr. Landais, a retired hospital custodian, said his wife, a nurse's aide, makes too much for the family to be eligible for Medicaid but not enough to afford insurance. He had a hernia operation four months ago that he did not have to pay for under the free-care pool, but he had not been able to see a doctor since then, even though he is still not feeling well.

"After years that you've been working that hard," Mr. Landais said, "I think you deserve something back."

Katie Zezima contributed reporting for this article.

    Massachusetts Sets Health Plan for Nearly All, NYT, 5.4.2006, http://www.nytimes.com/2006/04/05/us/05mass.html?hp&ex=1144296000&en=1efda02422b0267b&ei=5094&partner=homepage

Tuberculosis Declines to Historic Low in the U.S.

March 24, 2006
The New York Times
By DONALD G. McNEIL Jr.

Tuberculosis cases in the United States fell to historic lows last year, public health authorities said yesterday. At the same time, doctors said, there was a small but worrisome increase in the number of cases resistant to several drugs.

The total number of cases in 2005 was 14,093, or 4.8 cases per 100,000 people, the lowest per capita rate since 1953, when national reporting began.

In New York City, which has among the nation's highest rates of tuberculosis, cases fell to 989, below 1,000 for the first time, Dr. Thomas R. Frieden, the city's health commissioner announced. The rate is still twice that of the nation, largely because New York has so many foreign-born residents, who account for 70 percent of the city's caseload.

The number of drug-resistant cases in the United States increased by 13 percent from 2003 to 2004, the last year for which data was available, said Dr. Kenneth G. Castro, head of tuberculosis elimination at the Centers for Disease Control and Prevention in Atlanta.

Of the 128 drug-resistant cases, 97 were in people born abroad. Driven by the global AIDS epidemic, tuberculosis, which thrives in weakened immune systems, is a major killer in poor countries, accounting for nearly nine million new cases and nearly two million deaths a year.

Immigrants from many countries, including China, India, Mexico, Vietnam, the Philippines, Ecuador, the Dominican Republic and Haiti, have been found with drug-resistant strains of the disease.

Health authorities are creating a new category for people resistant not only to two first-line antibiotics, but also to at least one of the expensive, toxic second-line drugs. The new classification is nicknamed XDR, for extensively drug-resistant, and supersedes MDR (multidrug-resistant).

Tuberculosis is generally curable, even the XDR type, but the treatment can take years and require surgery, Dr. Castro said.

He warned against complacency, recalling that the disease surged in the early 1990's, especially in New York.

"As we make progress against TB," Dr. Castro said, "there is a tendency to prematurely declare victory and let our guard down — and then we see a resurgence."

    Tuberculosis Declines to Historic Low in the U.S., 24.3.2006, http://www.nytimes.com/2006/03/24/health/24tb.html

Kids' prescriptions for anti-psychotic drugs skyrockets

Posted 3/16/2006 5:26 PM
USA Today

CHICAGO (AP) — Soaring numbers of American children are being prescribed anti-psychotic drugs — in many cases, for attention deficit disorder or other behavioral problems for which these medications have not been proven to work, a study found.

The annual number of children prescribed anti-psychotic drugs jumped fivefold between 1995 and 2002, to an estimated 2.5 million, the study said. That is an increase from 8.6 out of every 1,000 children in the mid-1990s to nearly 40 out of 1,000.

But more than half of the prescriptions were for attention deficit and other non-psychotic conditions, the researchers said.

The findings are worrisome "because it looks like these medications are being used for large numbers of children in a setting where we don't know if they work," said lead author Dr. William Cooper, a pediatrician at Vanderbilt Children's Hospital.

The increasing use of anti-psychotics since the mid-1990s corresponds with the introduction of costly and heavily marketed medications such as Zyprexa and Risperdal. The packaging information for both says their safety and effectiveness in children have not been established.

Anti-psychotics are intended for use against schizophrenia and other psychotic illnesses.

However, attention deficit disorder is sometimes accompanied by temper outbursts and other disruptive behavior. As a result, some doctors prescribe anti-psychotics to these children to calm them down — a strategy some doctors and parents say works.

The drugs, which typically cost several dollars per pill, are considered safer than older anti-psychotics — at least in adults — but they still can have serious side effects, including weight gain, elevated cholesterol and diabetes.

Anecdotal evidence suggests similar side effects occur in children, but large-scale studies of youngsters are needed, Cooper said.

The researchers analyzed data on youngsters age 13 on average who were involved in annual national health surveys. The surveys involved prescriptions given during 119,752 doctor visits. The researchers used that data to come up with national estimates.

Cooper said some of the increases might reflect repeat prescriptions given to the same child, but he said that is unlikely and noted that his findings echo results from smaller studies.

The study appears in the March-April edition of the journal Ambulatory Pediatrics.

Heavy marketing by drug companies probably contributed to the increase in the use of anti-psychotic drugs among children, said Dr. Daniel Safer, a psychiatrist affiliated with Johns Hopkins University, who called the potential side effects a concern.

Safer said a few of his child patients with behavior problems are on the drugs after they were prescribed by other doctors. Safer said he has let these children continue on the drugs, but at low doses, and he also does periodic tests for high cholesterol or warning signs of diabetes.

Dr. David Fassler, a University of Vermont psychiatry professor, said more research is needed before anti-psychotics should be considered standard treatment for attention deficit disorders in children.

"Given the frequency with which these medications are being used, there's no question that we need additional studies on both safety and efficacy in pediatric populations," Fassler said.

    Kids' prescriptions for anti-psychotic drugs skyrockets, UT, 16.3.2006, http://www.usatoday.com/news/health/2006-03-16-kids-drugs_x.htm

US cigarette sales drop to 55-year low

Thu Mar 9, 2006 7:30 AM ET
Reuters

WASHINGTON (Reuters) - The number of cigarettes sold in the United States in 2005 fell to the lowest level in 55 years largely due to enforcement of marketing restrictions imposed on the tobacco industry, the National Association of Attorneys General (NAAG) said on Wednesday.

According to federal tobacco tax figures, cigarettes sales slid 4.2 percent from 2004 levels in the largest one-year percentage decrease since 1999, the group said in a statement.

The attorneys general said 378 billion cigarettes were sold in the United States in 2005, the lowest number since 1951.

The drop continues an eight-year decline in cigarette smoking since the 1998 Master Settlement Agreement (MSA) between U.S. states and the tobacco industry that settled state lawsuits over the costs of treating smoking-related illnesses, the NAAG said.

Overall, cigarette sales have plunged more than 21 percent since the agreement, which raised cigarette prices and severely restricted industry marketing practices, the organization said.

"It is not a coincidence that cigarette sales are down and fewer people are smoking. The Master Settlement Agreement was designed to protect the public and reduce cigarette consumption -- and it does just that," said Vermont Attorney General Bill Sorrell.

The major companies that signed the MSA are Philip Morris, a unit of Altria Group Inc.; R.J. Reynolds Tobacco Holdings Inc.; British American Tobacco Plc's Brown & Williamson unit; and Lorillard, which trades as Carolina Group and is part of Loews Corp.

The U.S. Centers for Disease Control and Prevention considers cigarette smoking to be the leading preventable cause of death in the United States. About 440,000 people die each year from lung cancer and other diseases related to tobacco use.

    US cigarette sales drop to 55-year low, R, 9.3.2006, http://today.reuters.com/news/newsArticle.aspx?type=domesticNews&storyID=2006-03-09T123033Z_01_N085265_RTRUKOC_0_US-SMOKING.xml

Americans getting older but better - study

Thu Mar 9, 2006 12:42 PM ET
Reuters
By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - The face of America is changing and it is going to be considerably more wrinkled, according to a report issued on Thursday.

The number of people 65 and over is expected to double within the next 25 years. By 2030, 72 million people, or nearly one out of every five Americans, will be 65 or older, according to the report from U.S. Census Bureau and the National Institute on Aging.

"We are getting older," C. Louis Kincannon, director of the U.S. Census Bureau, told reporters in a telephone briefing.

"The boomers began turning 60 this year. In fact, nearly 8,000 people are now turning 60 every day. The aging of our society will have profound consequences on our future. We can expect a major wave of retirements starting in 2011."

But older people will also work longer, the report predicts.

"Companies will need to face the challenge of having to mobilize and retain older workers," said Kincannon.

Considerations will include ergonomic office equipment, "the lighting, the print size, all kinds of things that make it easier for people to continue to work," he said.

The good news is that it is not, as the Rolling Stones sang, such a drag getting old any more. "Today's older Americans are very different from their grandparents, living longer with lower rates of disability, with higher rates of education and garnering more wealth," Kincannon said.

While 14 million Americans over the age of 65 reported they were disabled in 2000, the proportion of people with a disability fell from 26.2 percent in 1982 to 19.7 percent in 1999. Most were linked to a chronic condition such as heart disease or arthritis.

But this trend may not continue. "We are seeing a very troubling increase in disability rates for younger Americans, partly driven by the epidemic of obesity," said Dr. Richard Hodes, director of the National Institute on Aging.

HOW BIG YOUR BANK BALANCE IS, GRANDMA

The proportion of people aged 65 and older classified as poor fell from 35 percent in 1959 to 10 percent in 2003, mostly due to Social Security, the report found. In 2000, the poorest 20 percent of homes headed by someone 65 or older had a net worth of $44,346 including home equity and the wealthiest were worth $449,800 including home equity.

"How people experience aging differs depending on factors such as sex, ethnicity and education," said Victoria Velkoff, chief of the Aging Studies Branch at the U.S. Census Bureau

"Roughly 40 percent of older black and Hispanic women who live alone live in poverty," Velkoff said.

The average U.S. life expectancy at birth in 2000 was 76.9 years and women live an average of 5.4 years longer than men. About 80 percent of people over 100 are women.

The United States has a lower proportion of adults aged 65 and older than most countries in Western Europe and Japan. "The U.S. is falling behind other nations in gains in life expectancy at older ages although we are not sure why," said Richard Suzman, National Institute on Aging behavioral research director .

Seniors are better educated than before. Just over 3 percent of older Americans had at least a bachelor's degree in 1950 but 17.4 percent did in 2003 and by 2030, more than a quarter of the older population was expected to have a college education.

The percentage who had completed high school quadrupled between 1950 and 2003, from 17 percent to 71.5 percent.

Older Americans may work longer, the report predicts.

By 2020, people aged 55 and over are expected to make up 20.3 percent of the labor force, up from 15.1 percent in 2003.

    Americans getting older but better - study, R, 9.3.2006, http://today.reuters.com/news/newsArticle.aspx?type=scienceNews&storyID=2006-03-09T174218Z_01_N09174837_RTRUKOC_0_US-AGING-USA.xml

New York Puts Mental Patients in Homes Illegally, Groups Say

March 8, 2006
The New York Times
By RICHARD PÉREZ-PEÑA

New York State regularly sends patients from mental hospitals to nursing homes, where it illegally houses hundreds of them without the care they need and often under conditions that approach imprisonment, according to legal groups designated by the state to represent the disabled.

Those groups said they would file a lawsuit today in Federal District Court in Brooklyn, accusing New York State of violating several federal laws and claiming that many of the mentally ill patients who have been moved from state psychiatric hospitals into the nursing homes should instead be back in their own neighborhoods, living independently but with government help.

The groups say that they have talked with the Pataki administration for years, seeking to end the practice, but that the problem has worsened. They say more than 1,000 former psychiatric patients could now be in nursing homes in New York and New Jersey. They charge that 500 to 600 are in two New Jersey homes alone, nearly twice as many as in 2002 when the practice first came to light.

The groups charge that the nursing homes do little more than medicate the mentally ill residents and do not adequately provide the services that the state is legally required to offer — treatment by psychiatrists and social workers, and training in everyday skills like shopping and cooking. The mentally ill residents, who have not been declared a threat to themselves or others, are generally not allowed to leave the nursing homes and in many cases are even restricted to their floors most of the day, the groups say.

"The state is warehousing people in nursing homes who don't need nursing home care, and not providing the services that they do need," said Cliff Zucker, executive director of Disability Advocates Inc., one of the groups filing the suit. Those who are sent out of state, he said, are isolated from family and other sources of support.

Jill Daniels, a spokeswoman for the state's Office of Mental Health, which runs the psychiatric hospitals, said the patients were being properly discharged to nursing homes, and that the state was following federal guidelines about doing so. She said they were all screened and deemed in need of nursing home care. And she said the residents were receiving proper "clinical treatment."

The suit does not accuse the nursing homes of wrongdoing, but it draws a disturbing picture of life there for the patients, arguing that the homes are simply not equipped to handle them. It says that one plaintiff, Bradley W. — the suit does not use full names to protect patients' privacy — was discharged last year from Rockland Psychiatric Center in Orangeburg, N.Y., to a nursing home in New Jersey, "and is required to wear an electronic wristband on his wrist that would signal an alarm if he tried to leave."

Edwin T. "is permitted to leave the floor and go outside only at designated times to smoke and to play basketball," it says, and Lisa H. is not allowed to go to her church. "Carlos S. sees the psychiatrist once per month, for medication purposes only."

Under Gov. George E. Pataki, the state has cut the population of its psychiatric hospitals by more than half, to about 4,000, in part to save money. Throughout that effort, people who work with the mentally ill have complained that for many of those patients, the state did not provide the right alternatives to hospitalization.

The state has placed thousands of people in large adult homes where, The New York Times reported in 2002, many were merely warehoused, neglected and even abused.

Patients and lawyers and other professionals working on their behalf contend that the ideal setting for many people released from mental hospitals is "community-based housing" — either small group residences or individual apartments — paid for by the state, with an array of support services and a high degree of independence. But for years, the Pataki administration discharged people from hospitals much faster than it added community housing.

In the last three years, the state committed itself to increasing this housing by several thousand units, but the demand still far exceeds the supply.

For the last decade, the state has also sent large numbers of people from mental hospitals to nursing homes, and it has been accused of doing so as a way to save money.

The state, for instance, pays the entire cost of community housing for the mentally ill, but when those people are instead placed in nursing homes, the costs are paid by Medicaid, and thus split among the federal government, the state and local governments.

Roger A. Bearden, a lawyer for Disability Advocates, said, "In discharge papers, the clinical reason given time and time again for sending them to the nursing homes is 'medication management,' which is and can be performed in the community."

Disability Advocates is one of several nonprofit legal groups named by the state, under a federal grant program, to represent people with disabilities. Another group with that same state designation, New York Lawyers for the Public Interest, is helping represent the plaintiffs in the suit. One of the plaintiffs in the case is Sidney Hirschfeld, director of one of four Mental Hygiene Legal Service offices that are part of the state court system, created by state law to do similar work for the mentally ill.

The suit accuses New York State of violating the Americans With Disabilities Act, a 1990 federal law, by unnecessarily segregating mental patients from the population at large and preventing them from taking advantage of other government services.

When The Times reported in 2002 that New York had placed hundreds of former psychiatric patients in nursing homes in New Jersey, Gov. James E. McGreevey, the New Jersey governor then and other New Jersey officials protested the practice and said they were unaware that the practice was so common. They dropped the matter the next year, saying that they had found nothing inappropriate about the practice, and had concluded that it did not cost New Jersey any money.

The suit focuses primarily on the two large New Jersey homes, Andover Subacute and Rehabilitation Center II, in Sussex County, and Lincoln Park Care Center, in Morris County, but it also names nine others in Queens, mostly on the Rockaway Peninsula.

    New York Puts Mental Patients in Homes Illegally, Groups Say, NYT, 8.3.2006, http://www.nytimes.com/2006/03/08/nyregion/08mental.html

Body parts snatching case reverberates

Posted 2/18/2006 1:56 PM
USA Today

CHICAGO (AP) — Every year more than 1 million Americans have medical procedures that use bone or other tissue from a cadaver — like disk replacements or dental implants.

But what if the donated tissue came from someone who died of cancer? Or AIDS? Or hepatitis?

That worry caused by a ghoulish scandal in the body parts business has led to distress for hundreds of people, and some prospective patients are now reconsidering how they want their surgeries done.

Experts familiar with the situation say patients' chances of getting a disease from the suspect tissue are small, but doctors are urging them to be tested.

"This is diabolical ... if what has been alleged has been done," said Dr. Stephen Pineda, an orthopedic surgeon in Springfield, Ill. "What it does to the whole public perception of bone and all other grafts can be catastrophic."

Investigators are trying to determine if a New Jersey company, Biomedical Tissue Services of Fort Lee, sold bone and tissue illegally obtained from corpses that were too old, sick or otherwise ineligible to be donors. BTS closed last month.

The Food and Drug Administration and federal Centers for Disease Control and Prevention say the risk of infection is low but unknown. So dozens of hospitals have contacted hundreds of patients around the country who got body parts traced to the company between early 2004 and September 2005. They are being offered testing for AIDS, hepatitis and syphilis.

Those are the three illnesses that the FDA requires donor tissue to be tested for — singled out because they cause long-lasting infections that pose a greater risk of transmission through transplanted tissue than short-lived infections.

But some patients worry about tissue or bone from bodies weakened by cancer, age or other ailments. Doctors concede that's theoretically possible but unlikely to cause problems with the grafts.

Carol Yates, a Marion, Ohio grandmother, is among patients advised to get tested and has set up a website to give recipients of the suspect tissue a chance to share their concerns with others.

Yates, 47, said her doctor told her in December that BTS bone was used in her neck surgery a year ago.

"All it's done is caused me a lot of worry," Yates said. "I haven't taken the test yet. If it came back positive, I couldn't handle that right now."

Unused body parts linked to the case have been recalled. Companies that process the tissue for medical use are required to test and sterilize it. But still, some patients awaiting operations are scared.

In the past week, two of Pineda's patients have refused donor parts and want to use their own bone for their surgeries. It's a riskier, costlier and more painful option that Pineda said most patients used to shun. He calls their reaction "completely understandable."

"People are worried," Pineda said. "We've been fielding 10 calls a day on this from patients."

It's likely that only a tiny portion of patients who got bone or tissue grafts during the last two years received tissue from BTS, said Robert Rigney, chief executive officer at the American Association of Tissue Banks.

While Rigney hasn't heard of any widespread decline in demand for donor grafts, or in people willing to be donors, he said the case's potential impact "is something we're extremely concerned about."

The FDA and Brooklyn, N.Y., district attorney's office are investigating the case but no charges have been filed. Authorities suspect that a company employee and an associate took bone and tissue from corpses without families' knowledge, paid off New York City-area funeral homes to gain access to bodies, then sold the parts to five processors in Florida, Georgia, New Jersey and Texas.

Rigney said that each year, more than a million Americans have medical procedures using body parts and tissue from more than 25,000 donors.

The association accredits 91 tissue banks nationwide, including a few in Canada. They account for most of the cadaver tissue used for transplants, Rigney said.

BTS was not association-accredited, but the five processing companies that got BTS tissue are, Rigney said. They have strict monitoring and test tissue for communicable diseases, he said. Tissue from about 450,000 donors is rejected each year because it is diseased or otherwise ineligible, he said.

Tissue deemed disease-free is still subjected to sterilizing procedures to make it safe, Rigney said.

There have been only a handful of cases, all in the late 1980s and early 1990s, in which U.S. patients got diseases from tissue donors, he said. One caught HIV and two got hepatitis, but that was before improved blood testing methods that are now used.

FDA spokesman Stephen King said he could not discuss the number of patients and hospitals thought to be involved in the BTS case, or whether any patients have ailments that might be linked with suspect tissue.

New Jersey attorney Patrick D'Arcy said his firm near Atlantic City has been contacted by more than 200 BTS tissue recipients from 25 states, including 10 people who have tested positive for hepatitis. D'Arcy, who is suing BTS for alleged negligence and fraud, said he's still investigating whether the hepatitis cases could have resulted from surgical procedures.

Bobi Milner, a Springfield, Ill., woman who had surgery last year to fix an aging disc in her upper spine, learned last month that her graft came from suspect bone.

Her infectious disease tests came back negative, and Milner said she didn't freak out until she read a local newspaper article detailing the scam's scope. Unwitting donors included former Masterpiece Theater host Alistair Cooke, who died from cancer at age 95 in 2004.

"That's when I realized what the magnitude was," said Milner, 41. "I cried and sobbed the rest of the day. I thought, 'Oh, my God, what's going to happen to me?'"

Cooke "was wonderful on Masterpiece Theater and no offense to his family, but he was an elderly gentleman and he would not be an eligible donor," she said.

Milner worries that if her graft came from someone sick or aged, the bone will deteriorate quickly and she'll need another operation.

Pineda, who was not her surgeon, said that could be a legitimate concern, although metal plates implanted with bone grafts in spine surgery usually bear the pressure and are durable.

    Body parts snatching case reverberates, UT, 18.2.2006, http://www.usatoday.com/news/health/2006-02-18-body-snatching-case_x.htm

Being a Patient

When Trust in Doctors Erodes, Other Treatments Fill the Void

February 3, 2006
The New York Times
By BENEDICT CAREY

A few moments before boarding a plane from Los Angeles to New York in January, Charlene Solomon performed her usual preflight ritual: she chewed a small tablet that contained trace amounts of several herbs, including extracts from daisy and chamomile plants.

Ms. Solomon, 56, said she had no way to know whether the tablet, an herb-based remedy for jet lag, worked as advertised. Researchers have found no evidence that such preparations are effective, and Ms. Solomon knows that most doctors would scoff that she was wasting her money.

Yet she swears by the tablets, as well as other alternative remedies, for reasons she acknowledges are partly psychological.

"I guess I do believe in the power of simply paying attention to your health, which in a way is what I'm doing," said Ms. Solomon, who runs a Web consulting business in Los Angeles. "But I also believe there are simply a lot of unknowns when it comes to staying healthy, and if there's a possibility something will help I'm willing to try it."

Besides, she added, "whatever I'm doing is working, so I'm going to keep doing it."

The most telling evidence of Americans' dissatisfaction with traditional health care is the more than $27 billion they spend annually on alternative and complementary medicine, according to government estimates. In ways large and small, millions of people are taking active steps to venture outside the mainstream, whether by taking the herbal remedy echinacea for a cold or by placing their last hopes for cancer cure in alternative treatment, as did Coretta Scott King, who died this week at an alternative hospice clinic in Mexico.

They do not appear to care that there is little, if any, evidence that many of the therapies work. Nor do they seem to mind that alternative therapy practitioners have a fraction of the training mainstream doctors do or that vitamin and herb makers are as profit-driven as drug makers.

This straying from conventional medicine is often rooted in a sense of disappointment, even betrayal, many patients and experts say. When patients see conventional medicine's inadequacies up close — a misdiagnosis, an intolerable drug, failed surgery, even a dismissive doctor — many find the experience profoundly disillusioning, or at least eye-opening.

Haggles with insurance providers, conflicting findings from medical studies and news reports of drug makers' covering up product side effects all feed their disaffection, to the point where many people begin to question not only the health care system but also the science behind it. Soon, intuition and the personal experience of friends and family may seem as trustworthy as advice from a doctor in diagnosing an illness or judging a treatment.

Experts say that people with serious medical problems like diabetes or cancer are least likely to take their chances with natural medicine, unless their illness is terminal. Consumers generally know that quackery is widespread in alternative practices, that there is virtually no government oversight of so-called natural remedies and that some treatments, like enemas, can be dangerous.

Still, 48 percent of American adults used at least one alternative or complementary therapy in 2004, up from 42 percent a decade ago, a figure that includes students and retirees, soccer moms and truckers, New Age seekers and religious conservatives. The numbers continue to grow, experts say, for reasons that have as much to do with increasing distrust of mainstream medicine and the psychological appeal of nontraditional approaches as with the therapeutic properties of herbs or other supplements.

"I think there is a powerful element of nostalgia at work for many people, for home remedies — for what healing is supposed to be — combined with an idealized vision of what is natural and whole and good, " said Dr. Linda Barnes, a medical anthropologist at Boston University School of Medicine.

Dr. Barnes added, "People look around and feel that the conventional system does not measure up, and that something deeper about their well-being is not being addressed at all."

Healthy and Dabbling

Ms. Solomon's first small steps outside the mainstream came in 1991, after she watched her mother die of complications from a hysterectomy.

"I saw doctors struggling to save her," she said. "They were trying really hard, and I have great respect for what they do, but at that point I realized the doctors could only do so much."

She decided then that she needed to take more responsibility for her own health, by eating better, exercising more and seeking out health aids that she thought of as natural, meaning not prescribed by a doctor or developed by a pharmaceutical company.

"I usually stay away from drugs if I can, because the side effects even of cough and cold medicines can be pretty strong," she said.

The herbal preparations she uses, she said, "have no side effects, and the difference in my view is that they help support my own body's natural capability, to fight off disease" rather than treat symptoms.

If these sentiments are present in someone like Ms. Solomon, who regularly consults her internist and describes herself as "pretty mainstream," they run far deeper in millions of other people who use nontraditional therapies more often.

In interviews and surveys, these patients often described prescription drugs as poisons that mostly mask symptoms without improving their underlying cause.

Many extend their suspicions further. In a 2004 study, researchers at the University of Arizona conducted interviews with a group of men and women in Tucson who suffered from chronic arthritis, most of whom regularly used alternative therapies. Those who used alternative methods exclusively valued the treatments on the "rightness of fit" above other factors, and they were inherently skeptical of the health care system.

Distrust in the medical industrial complex, as some patients call it, stems in part from suspicions that insurers warp medical decision making, and in part from the belief that drug companies are out to sell as many drugs as possible, regardless of patients' needs, interviews show.

"I do partly blame the drug companies and the money they make" for the breakdown in trust in the medical system, said Joyce Newman, 74, of Lynnwood Wash., who sees a natural medicine specialist as her primary doctor. "The time when you would listen to your doctor and do whatever he said — that time is long gone, in my opinion. You have to learn to use your own head."

From here it is a small step to begin doubting medical science. If Western medicine is imperfect and sometimes corrupt, then mainstream doctors may not be the best judge of treatments after all, many patients conclude. People's actual experience — the personal testimony of friends and family, in particular — feels more truthful.

To best way to validate this, said Ms. Newman and many others who regularly use nontraditional therapies, is simply to try a remedy "and listen to your own body."

Opting Out

Cynthia Riley effectively opted out of mainstream medicine when it seemed that doctors were not listening to her.

During a nine-year period that ended in 2004, Ms. Riley, 47, visited almost 20 doctors, for a variety of intermittent and strange health complaints: blurred vision, urinary difficulties, balance problems so severe that at times she wobbled like a drunk.

She felt unwell most of the time, but doctors could not figure out what she had.

Each specialist ordered different tests, depending on the symptom, Ms. Riley said, but they were usually rushed and seemed to solicit her views only as a formality.

Undeterred, Ms. Riley, an event planner who lives near New London, Conn., typed out a four-page description of her ordeal, including her suspicion that she suffered from lead poisoning. One neurologist waved the report away as if insulted; another barely skimmed it, she said.

"I remember sitting in one doctor's office and realizing, 'He thinks I'm crazy,' " Ms. Riley said. "I was getting absolutely nowhere in conventional medicine, and I was determined to get to the root of my problems."

Through word of mouth, Ms. Riley heard about Deirdre O'Connor, a naturopath with a thriving practice in nearby Mystic, Conn., and made an appointment.

In recent years, people searching for something outside of conventional medicine have increasingly turned to naturopaths, herbal specialists who must complete a degree that includes some standard medical training in order to be licensed, experts say. Fourteen states, including California and Connecticut, now license naturopaths to practice medicine. Natural medicine groups are pushing for similar legislation in other states, including New York.

Licensed naturopaths can prescribe drugs from an approved list in some states, but have no prescribing rights in others.

Right away, Ms. Riley said, she noticed a difference in the level of service. Before even visiting the office, she received a fat envelope in the mail containing a four-page questionnaire, she said. In addition to asking detailed questions about medical history — standard information — it asked about energy level, foods she craved, sensitivity to weather and self-image: "Please list adjectives that describe you," read one item.

"It felt right, from the beginning," Ms. Riley said.

Her first visit lasted an hour and a half, and Ms. O'Connor, the naturopath, agreed that metal exposure was a possible cause of her symptoms. It emerged in their interview that Ms. Riley had worked in the steel industry, and tests of her hair and urine showed elevated levels of both lead and mercury, Ms. O'Connor said.

After taking a combination of herbs, vitamins and regular doses of a drug called dimercaptosuccinic acid, or DMSA, to treat lead poisoning, Ms. Riley said, she began to feel better, and the symptoms subsided.

Along the way, Ms. O'Connor explained the treatments to Ms. Riley, sometimes using drawings, and called her patient regularly to check in, especially during the first few months, Ms. Riley said.

Other doctors said they could not comment on Ms. Riley's case because they had not examined her. Researchers who specialize in lead poisoning say that it is rare in adults but that it can cause neurological symptoms and bladder problems and is often missed by primary care doctors.

Dr. Herbert Needleman, a psychiatrist who directs the lead research group at the University of Pittsburgh, said DMSA was the pharmaceutical treatment of choice for high blood lead levels.

Researchers say there is little or no evidence that vitamins or herbs can relieve symptoms like Ms. Riley's. Still, she said, "I look and feel better than I have in years."

Life and Death

Diane Paradise bet her life on the uncertain benefits of natural medicine, after being burned physically and emotionally by conventional doctors.

In 1995, doctors told Ms. Paradise, now 35, that she had Hodgkin's disease. After a six-month course of chemotherapy and radiation, she said, she was declared cancer free, and she remained healthy for five years.

But in 2001 the cancer reappeared, more advanced, and her doctors recommended a 10-month course of drugs and radiation, plus a marrow transplant, she said.

Ms. Paradise, a marketing consultant in Rochester, N.Y., balked.

"I was burned badly the first time around, third-degree burns, and now they were talking about 10 months," she said in an interview, "and they were giving me no guarantees; they said it was experimental. That's when I started looking around. I really had nothing to lose, and I was focused on quality of life at that point, not quantity."

When she told one of her doctors that she was considering an alternative treatment in Arizona, the man exploded, she said.

"His exact words were, 'That's not treatment, that's a vacation — you're wasting your time!' " she said.

And so ended the relationship. With help from friends, Ms. Paradise raised about $40,000 to pay for the Arizona clinic's treatment, plus living expenses while there.

"I had absolutely no scientific reason for choosing this route, none," she said. "I just think there are times in our life when we are asked to make decisions based on our intuition, on our gut instinct, not based on evidence put in front of us, and for me this was one of those moments."

Cancer researchers say that there is no evidence that vitamins, herbs or other alternative therapies can cure cancer, and they caution that some regimens may worsen the disease.

But Ms. Paradise said that her relationship with the natural medicine specialist in Arizona had been collaborative and that she had felt "more empowered, more involved" in the treatment plan, which included large doses of vitamins, as well as changes in diet and sleep routines. After four months on the regimen, she said, she felt much better.

But the cancer was not cured. It has resurfaced recently and spread, and this time Ms. Paradise has started an experimental treatment with an oncologist in New York.

She is complementing this treatment, she said, with another course of alternative therapy in Arizona. She moved in with friends near Phoenix and started the alternative regime in January.

"It's 79 degrees and beautiful here," she said by phone in mid-January. "Let's hope that's a good sign."

For all their suspicions and questions about conventional medicine, those who venture outside the mainstream tend to have one thing in abundance, experts say: hope. In a 1998 survey of more than 1,000 adults from around the country, researchers found that having an interest in "personal growth or spirituality" predicted alternative medicine use.

Nontraditional healers know this, and they often offer some spiritual element in their practice, if they think it is appropriate. David Wood, a naturopath who with his wife, Cheryl, runs a large, Christian-oriented practice in Lynnwood, Wash., said he treated patients of all faiths.

"We pray with patients, with their permission," said Mr. Wood, who also works with local medical doctors when necessary. "If patients would not like us to pray for them, we don't, but it's there if needed."

He added, "Our goal here is to help people get really well, not merely free of symptoms."

That is exactly the sentiment that many Americans say they feel is missing from conventional medicine. Whatever the benefits and risks of its many concoctions and methods, alternative medicine offers them at least the promise of affectionate care, unhurried service, freedom from prescription drug side effects and the potential for feeling not just better but also spiritually recharged.

"I don't hate doctors or anything," Ms. Newman said. "I just know they can make mistakes, and so often they refer you on to see another doctor, and another."

Seeing a naturopath, she said, "I feel I'm known, they see me as a whole person, they listen to what I say."

    When Trust in Doctors Erodes, Other Treatments Fill the Void, NYT, 3.2.2006, http://www.nytimes.com/2006/02/03/health/03patient.html?_r=1&oref=slogin

Abortion rights groups say battle being lost

Sun Jan 29, 2006 11:22 AM ET
Reuters
By Carey Gillam

KANSAS CITY, Missouri (Reuters) - In Wichita, Kansas, abortion rights supporters held a "chili for choice" fund-raising dinner. In Pierre, South Dakota, they plotted strategy in the "Back Alley" meeting hall. And in Minneapolis, volunteers led women past protesters into an abortion clinic.

It was just a typical week in Middle America where the decades-old debate over abortion rights has become a full-blown battle. But even as they continue to raise money and march around state capitols, the view from the pro-choice side is this is a fight they are losing.

The expected Senate confirmation to the U.S. Supreme Court of conservative jurist Samuel Alito, who is favored by anti-abortion advocates, is seen as a key turning point. Yet it is only the latest in a series of blows to abortion rights advocates.

The pro-choice groups find themselves facing a virtual avalanche of state legislation that ranges from laws banning abortions in almost all circumstances to laws limiting the disbursement of birth control and restricting sex education.

President George W. Bush is a vocal supporter of the anti-abortion movement. Conservative church groups across the country increasingly oppose abortion.

"I think Roe in the short term will be dismantled," said Nancy Keenan, president of NARAL Pro-Choice America. "We have an anti-choice president, an anti-choice Congress and now ... with the confirmation of Judge Alito to the Supreme Court, we are seeing the potential for a very right-leaning, anti-choice Supreme Court."

AMERICA DIVIDED

A Pew Research Center survey conducted in November indicated that a majority of Americans see abortion as the most important issue before the Supreme Court, and polling shows that Americans are nearly evenly divided on the topic.

John Green, a senior research fellow at the Pew Forum on Religion and Public Life, said the appointment of Alito and the flood of anti-abortion legislation are tied to the increasing power of conservative religious groups.

"I do think it is a critical moment," Green said. "A lot really hinges on Alito and other judges who may be appointed in the near future. I could imagine in the next 10 years or so there could be steady changes in the law regarding abortion."

Anti-abortion groups say much has changed in the 33 years since the famed U.S. Supreme Court decision in Roe V. Wade cleared the way for legalized abortion. They acknowledge the increased power of religious conservatives in public policy, but say other factors are central to the rise of anti-abortion legislation and what they say is waning public support for abortion.

Among the key factors is enhanced technology, such as 4-D ultra-sound, that allows pregnant women to clearly view the features of the fetus they might abort.

"The technology has allowed someone who before had no face and no voice to become an actual child," said Mary Spaulding Balch, director of state legislation for the National Right to Life Committee. "In the 70s and 80s whenever you debated abortion you talked about the mother. Now the baby is being brought into the debate."

Anti-abortion advocates say research into the speed of fetal development, and claims by some women that abortion has scarred them physically and emotionally, have all helped their cause.

"There is a growing public realization that abortion is an injustice, the destruction of an innocent human life," said American Life League executive director David Bereit.

"The presidency, the House and the Senate are made up of people who claim to be pro-life. With the Supreme Court nomination ... the planets are all aligning."

STATES WEIGH IN

Indeed, all fifty states now have anti-abortion legislation either on the books or in the works, according to both sides. Twenty-six states outlaw abortions for a woman whose pregnancy is at least 12 weeks along. Measures introduced in South Dakota, Tennessee, Indiana and Ohio would ban nearly all abortions even in the first few weeks of pregnancy.

Other state laws under consideration would extend counseling requirements or waiting periods for women seeking abortions, add parental notification requirements, and set new regulations for abortion clinics. There are also measures that would allow pharmacists to refuse to dispense birth control.

Abortion rights advocates say this year's mid-term elections and the 2008 presidential election will be critical to their efforts to turn back these new laws.

So on Thursday they paid $25 a head to eat chili in Wichita, Kansas. On Sunday they showed a film and talked about strategy in Pierre, South Dakota. And every Saturday, they escort women into a Planned Parenthood clinic in Minneapolis.

"It's a mystery to me how we've elected such right-wing lawmakers who are trying to keep government off our backs, but apparently don't mind putting government in our bedrooms," said Thelma Underberg, executive director of NARAL Pro-Choice South Dakota. "I think it is time to get active and push the pendulum back the other way."

    Abortion rights groups say battle being lost, R, 29.1.2006, http://today.reuters.com/news/newsArticle.aspx?type=politicsNews&storyID=2006-01-29T162223Z_01_N27334058_RTRUKOC_0_US-LIFE-ABORTION.xml

Health Care, Vexing to Clinton, Is Now at Top of Bush's Agenda

January 29, 2006
The New York Times
By ROBERT PEAR

WASHINGTON, Jan. 28 — More than 12 years after President Bill Clinton unveiled his plan to remake the nation's health care system, President Bush is moving the issue once again to the top of the national agenda and is expected to push a series of health care proposals in his State of the Union address on Tuesday.

Where Mr. Clinton was driven by a desire to guarantee health insurance for every American, Mr. Bush is focusing primarily on health costs, which he says are swamping employers and threatening economic growth. Where Mr. Clinton favored a larger role for government, Mr. Bush has a fundamentally different philosophy, built on the idea that placing more responsibility in the hands of individuals will create market pressure to hold down costs.

The long-running debate has taken on new urgency as more and more companies find themselves struggling to pay for employee health benefits. Health care costs have been a big factor in the troubles of the domestic auto industry, among others.

But some policy experts, Republicans and Democrats alike, say the Bush proposals, which are built around tax breaks, may further drive up health spending and costs by fueling the demand for health care. Such unintended effects show how difficult it is to apply economic theory to the complexities of the current health care system.

By making health care a prominent theme of his prime-time address to the nation, Mr. Bush hopes to regain the initiative on domestic policy. Success with his health care proposals, after the failure of his effort to overhaul Social Security, would allow the president to build political momentum heading into the midterm elections this fall.

The White House has indicated that Mr. Bush will propose tax deductions for out-of-pocket medical expenses, rules to encourage the use of health savings accounts and incentives for small businesses across the country to band together and buy health insurance, exempt from state regulation.

Regina E. Herzlinger, a professor at Harvard Business School, said: "Insuring the uninsured is a fine objective, but how will this control the health costs that are hobbling our global competitiveness? Health savings accounts will increase coverage, and that's great. But they are being touted as a way to control costs, and I very much doubt that claim."

Democrats see the Bush proposals as a pastiche of old and new ideas that falls far short of what is required to tame the explosive growth in health costs.

Many economists say that the tax code, by subsidizing the purchase of health insurance, has fostered excessive use of health care services, driving up costs. Rather than proposing any limit on this subsidy, Mr. Bush wants to make it more widely available, to people who buy health care and insurance on their own.

Under current law, employers who pay health insurance premiums for employees can deduct the payments as a business expense on their tax returns, and the payments are not counted as taxable income for the employees. But such subsidies are unavailable to people who buy insurance themselves. President Bush sees that difference as unfair.

Allan B. Hubbard, assistant to the president for economic policy, said, "Health care purchased by an employer is done on a pretax basis, before your payroll taxes, before your income taxes. If you work for an employer who cannot afford to provide health insurance and so you go out and buy it, you have to use after-tax dollars."

In an interview, Mr. Hubbard continued: "Another unfairness is that if you buy health care with your insurance, you use pretax dollars. If you pay for it out of pocket, you have to use after-tax dollars. That encourages you to insure health care events that are routine. Insurance was never created to deal with the routine."

People use health savings accounts to pay routine medical expenses and buy high-deductible insurance policies to cover larger expenses. Mr. Bush says this arrangement encourages people to take more responsibility for all aspects of their care, including its cost.

"It's the opposite of federal control," Mr. Bush told a group of small-business owners this month. "It is patient control."

The White House had been hoping to highlight the new Medicare drug benefit as a model, showing how private health plans could deliver better benefits at lower cost than the government. But if Mr. Bush mentions it in his State of the Union address, he will invite catcalls from Democrats.

Senator Richard J. Durbin of Illinois, the assistant Democratic leader, said the drug benefit had become "a fiasco, a disaster," because it was written by Republicans who placed too much trust in private markets.

Representative Nancy Pelosi of California, the House Democratic leader, said, "Health savings accounts are brought to you by the same people who brought you the confusing, special-interest-driven Medicare prescription drug bill."

Health policy experts raise many questions about Mr. Bush's proposals: Would the new tax breaks go to people who already had insurance or would buy it anyway? Would they undermine the system of employer-provided health insurance? Would healthy individuals be more likely to take the new options, leaving employers to pay for sick people with higher health costs?

Stuart M. Butler, a vice president of the conservative Heritage Foundation, said Mr. Bush was focusing more on costs than on coverage for the uninsured. The tax proposals, he said, are "a bit of a gamble," forced on the president by the bizarre politics of health care.

Jonathan Gruber, a professor of economics at the Massachusetts Institute of Technology who worked at the Treasury under President Clinton, said, "The new tax breaks would be expensive and regressive, offering the largest benefits to the highest-income taxpayers."

In diagnosing flaws in the health care system, Mr. Bush could lift whole sentences from Mr. Clinton's address to a joint session of Congress on Sept. 22, 1993.

Opening his campaign for "health security," Mr. Clinton said, "Our medical bills are growing at over twice the rate of inflation." He warned that "rising costs are a special nightmare for our small businesses," and that "health care costs will devour more and more and more of our budget."

The Clinton plan died in Congress, after months of criticism from small businesses, health insurance companies and Republicans, who called it a costly, complex "big government" scheme.

Since then, national health spending has doubled, to $1.9 trillion. Health care now accounts for one-sixth of the nation's economy. Medicare and Medicaid, which accounted for 15.5 percent of federal spending in 1993, now consume almost 21 percent.

In Mr. Bush's first term, the number of people without health insurance increased more than a million a year, to 45.8 million in 2004, the last year for which official figures were available.

Democrats and consumer groups led the campaign for health care legislation in 1993. Now business executives and small-business owners express a similar sense of urgency.

In his recent meeting with small-business owners, Mr. Bush said, "Government policy has got to aim at the increasing cost of health care." The number of uninsured is rising because health costs are going up, he said, "so the government needs to address the cost."

While they are not required to provide health benefits, many large employers are committed to doing so, despite the rapidly rising costs. Employers see health benefits as a way to attract workers and to keep them productive, said E. Neil Trautwein, assistant vice president of the National Association of Manufacturers.

Over the years, many employers have become expert in buying health coverage for employees, and they do not want to drop this responsibility or dismantle the current system.

But employers have been clamoring for policy makers to address the needs of the uninsured. Employers say they indirectly pay for the uninsured, because the cost of their care is factored into the prices charged by hospitals and other health care providers.

"The health care cost crisis has a lot to do with the growing number of uninsured," said Katie W. Mahoney, manager of health policy at the United States Chamber of Commerce.

    Health Care, Vexing to Clinton, Is Now at Top of Bush's Agenda, NYT, 29.1.2006, http://www.nytimes.com/2006/01/29/politics/29health.html?hp&ex=1138597200&en=6b36038d1b170464&ei=5094&partner=homepage

America's health-care crisis

Desperate measures

Jan 26th 2006 | WASHINGTON, DC
From The Economist print edition

The world's biggest and most expensive health-care system is beginning to fall apart. Can George Bush mend it?

GEORGE BUSH had big ideas for his second term. He promised to fix Social Security, America's public pensions system, and revamp the tax code. Despite his best efforts, Social Security reform sank last year. Rejigging the tax code has proved so politically tricky that the White House dare not push it. With almost three years to go, Mr Bush seems less a radical reformer than a struggling lame duck.

White House officials, desperate to show that the president still has a domestic agenda, have now changed the subject—to health care. The buzz in Washington, DC, is that health-care reform will loom large when Mr Bush gives his annual state-of-the-union address on January 31st. Al Hubbard, Mr Bush's top domestic policy adviser, adds that the focus will be on ideas that control costs, boost access and improve quality.

Health care? The idea seems preposterous. How can an administration that is too timid to push tax reform tackle one of the most complicated challenges facing America's economy? What's more, the timing looks terrible. Mr Bush's team is under fire for botching its biggest health-care initiative to date, the introduction of a prescription-drug benefit for elderly people covered by its Medicare programme. Thanks to bureaucratic tangles, thousands of poor old folk have been denied drugs they used to get free, and more than 20 state governments have had to step in to pay for the medicines. Republican lawmakers dread what this fiasco may cost them in November's mid-term elections.

Yet Mr Bush may be able to push more radical change in American health care than anywhere else. Both politicians and the public recognise that spiralling health-care costs are a problem—second only to the Iraq war, according to a recent Wall Street Journal/NBC poll. Those costs are a big reason for the sluggish growth in workers' wages, the widespread perception that America's middle class is being squeezed and the huge job cuts at Ford this week.

America's health system is a monster. It is by far the world's most expensive: the United States spent $1.9 trillion on health in 2004, or 16% of GDP, almost twice as much as the OECD average (see charts 1 and 2). Health care in America is not nearly as rooted in the private sector as people assume (one way or another, more than half the bill ends up being paid by the state). But it is the only rich country where a large chunk of health care is paid for by tax-subsidised employer-based insurance.

This system is a legacy of the second world war, when firms, hamstrung by wage controls, used health insurance as a way to lure in workers. It means that, according to census figures, around 174m Americans get health coverage from their own, their spouse's or their parents' employer. Another 27m buy health insurance individually, for which they do not get a tax subsidy. The government picks up the tab for 40m elderly and disabled Americans (through Medicare) and about 38m poor (through the state-federal Medicaid scheme). That leaves around 46m uninsured, though many of these, whether students or workers, go without insurance by choice. In practice, they get emergency care at hospitals, which is paid for by higher premiums for everyone else.

Set alongside other rich countries, which typically offer all their citizens free (or very cheap) health care financed through taxes, America's system has some clear strengths. Consumers get plenty of choice, and innovation is impressive. One survey of doctors published in Health Affairs claimed that eight of the ten most important medical breakthroughs of the past 30 years originated in America. Equally clearly, the American system has big problems, notably inadequate coverage (no other rich country has armies of uninsured), spotty quality and high cost.

Huge discrepancies lurk within the system. John Wennberg, Jonathan Skinner and Elliot Fisher of Dartmouth College have pointed out that Medicare spends more than twice as much on people in Miami than in Minneapolis, and, if anything, results are better where spending is lower. Up to 30% of Medicare spending, they concluded, is wasted. Poor treatment is rife: a study by the Institute of Medicine has suggested that medical error is the country's eighth-largest cause of death.

For decades, American health-care spending has outstripped income growth, by an average of 2.5 percentage points a year. There have been clear cycles within this trend: for instance, herding employees into managed-care schemes, notably Health Maintenance Organisations (HMOs), which negotiated discounts with doctors and restricted the services available to patients, helped slow down health inflation in the mid-1990s. But voters loathed HMOs, there was a political backlash and in the late 1990s costs shot up again. Although the pace of medical spending has slowed slightly recently (to 7.9% in 2004), spending has risen by 40% since 2000. Typical insurance premiums have gone up by more than 60%.

The great unravelling

With medical inflation far outpacing inflation in general, American firms are scaling back the health coverage they offer. The share of workers who receive health insurance from their own employer has fallen from almost 70% in the late 1970s to around 50% today. In the past five years, the proportion of firms offering medical benefits has fallen from 70% to 60%, with the steepest decline among small firms and those employing the low-skilled.

Those employers who do offer health insurance have pushed more costs on to workers by raising co-payments and deductibles (the expenses before insurance kicks in). Employer-provided health coverage for retirees, once common, has shrunk, although America's big carmakers, including Ford and General Motors, are still hobbled by having to provide it. Mr Hubbard's assessment is stark: “The private market is broken.”

At the same time, the burden on government is about to soar. Add together Medicaid, Medicare and other publicly financed health care, such as that for ex-servicemen, and the public sector already pays for 45% of American health care. (The total is nearer 60% if you include the tax subsidies.) But as America's firms limit their health-care spending and, particularly, as the baby-boomers retire, that share will rise sharply. On current trends, federal spending on health will double as a share of the economy by 2020. That would mean much higher taxes, something Americans do not want to pay.

With employers limiting their exposure and government unable to fund its commitments, America's health system will unravel—perhaps not this year or next, but soon. Few health experts deny this. Nor do they disagree much on the sources of the problem. Health markets are plagued with poor information, inadequate competition and skewed incentives.

Since most bills are paid by a third party (the insurance company or the government), neither patients nor doctors face real pressure to control costs. Overall, Americans pay only $1 out of every $6 spent on their health care out of their own pockets. Doctors are generally paid for individual services and so have an incentive to perform too many procedures. The huge tax subsidies for employer-purchased health insurance encourage expensive care. Rapacious lawyers and the risk of being sued exacerbate the tendency towards unnecessary “defensive” medicine.

The first question is whether to try to make America's imperfect market work better, or to accept that markets cannot work in health care and focus more on government regulation. The second is whether to go for incremental reform or a comprehensive overhaul.

The history of American health policy is littered with failed efforts at radical change. Harry Truman wanted to create a system of national health insurance in the 1940s. When Canada introduced its government-run health system in 1971, many American politicians hoped to do the same. The biggest recent effort was Hillary Clinton's health-care plan of 1993, which mandated health-insurance coverage for all delivered through carefully regulated health alliances with price caps. All these efforts failed, thanks to the enormous power of health-care lobbies and Americans' horror at anything that smacked of “socialised medicine”.

Today's debate is scarred by those failures, though some brave health experts still favour comprehensive reform. The Physicians Working Group, for instance, argues that America has to move to a single-payer system, as in Canada or Britain. Victor Fuchs and Ezekiel Emanuel, two prominent health experts, argued in the New England Journal of Medicine last year that the current mess should be replaced with a universal system of health vouchers funded by a hypothecated VAT. In a new book from the Brookings Institution called “Can We Say No?”, Henry Aaron, William Schwartz and Melissa Cox argue that America will sooner or later have to ration health care, though they are coy about exactly how.

Washington's politicians, however, have shown little appetite for radical change. Their focus is still on expanding coverage rather than controlling costs. The biggest recent policy initiative, the 2003 decision to add drug coverage to Medicare, was the biggest expansion of a government health programme since 1965.

Some states have been thinking more radically. Massachusetts, for instance, may require everyone to have minimum insurance, with the state helping poorer people with subsidies. Maryland has a new law that requires all large employers to spend at least 8% of their payroll on health care, supposedly to prevent the state's Medicaid system having to pick up the tab. Though that particular law has more to do with Wal-Mart-bashing than health care, unions are pushing for similar legislation in 30 states.

The most interesting innovations, however, have come less from think-tanks or politicians' offices than from within the health-care industry. One trend, called “Pay for Performance”, is to shift doctors' and hospitals' incentives towards providing more efficient and better care, by measuring quality and adjusting payments accordingly. According to Karen Davis, president of the Commonwealth Fund, a health-care research foundation, there are now around 100 “Pay for Performance” initiatives in place. Early evidence suggests that they are having some effect.

Patients as consumers

The second shift within the health-care industry has been to change patients' incentives with more cost-sharing and larger deductibles. If patients pay more of the upfront costs of their health care, the argument goes, they will become more discerning consumers. And some of the cost saved by employers can be put into special Health Savings Accounts (HSAs), which workers can tap to pay routine health costs. Once the account is empty, workers are responsible for paying for their health care until their deductible is reached. This should make them think twice before visiting a specialist when they get a sore throat.

The trend towards HSAs was given a big push by a tax change in 2003 that was part of the Medicare drug legislation. Provided that an individual buys health insurance with a high deductible (at least $2,100 for a family), he can put the equivalent amount of money into tax-free accounts, whose balances can accumulate over years.

The number of people with high-deductible plans is still relatively small: only 2.4m in early 2005, according to government figures. But health economists expect HSAs to grow rapidly, as ever more employers offer them to try to control costs. A new survey by consultants at Deloitte shows that in these kinds of plans, in 2004-05, costs rose by less than half as much as in traditional ones.

The Bush agenda picks up both these new trends. Without much fanfare, Medicare too has been introducing its own incentive schemes. Hospitals must now provide proofs of quality to qualify for some Medicare payments. Medicare is also experimenting with bonuses for hospitals and doctors that improve their quality and efficiency. Where Medicare leads, many others may follow.

The White House's main focus, however, is the private market. One goal is legal reform. Mr Bush has already pushed (unsuccessfully) for laws that cap payments for medical malpractice lawsuits. He will keep trying. His health advisers would also like to deregulate the health-insurance market, freeing it from the stifling rules, imposed at state level, that can raise the cost of an insurance plan by as much as 15%.

Chiefly, Mr Bush wants to accelerate the trend towards consumer-driven health care. One uncontroversial idea is to encourage doctors and hospitals to provide more information on the cost of treatment. The other is to cut taxes. Mr Bush's team wants to eliminate the bias in favour of employer-purchased, low-deductible health insurance in America's tax code, not by reducing the existing tax subsidies for employers, but by increasing the tax subsidies for individuals.

This philosophy is conveniently summarised in a new book, “Healthy, Wealthy and Wise”, by three economists with close ties to the White House, Glenn Hubbard of Columbia University (formerly Mr Bush's top economic adviser), and John Cogan and Glenn Kessler of the Hoover Institution at Stanford. They argue that since it is politically impossible to get rid of tax subsidies for employer-based health insurance, the best way to eliminate the tax bias towards high-cost insurance is to make all health spending tax-deductible and expand HSAs. Legal, insurance and tax reform together, they argue, could reduce America's health spending by $60 billion and cut the number of uninsured by between 6m and 20m. Since overall medical spending would slow, the authors reckon their suggestions would cost a modest $9 billion a year.

To an administration that believes the answer to every problem is lower taxes, the appeal of these ideas is obvious. Many health experts, however, are deeply sceptical, both about whether the shift to higher-deductible plans will actually reduce health-care inflation and, even if it does, whether the government should encourage this trend with more tax cuts.

The logic of consumer-driven health care assumes that unnecessary doctor visits and procedures lie at the heart of America's health-care inflation. And it assumes that individual patients can become discerning consumers of health care. Both are questionable. Most American health-care spending is on people with chronic diseases, such as diabetics, whose health care costs many thousands of dollars a year, easily exceeding even high deductibles.

Instead, critics worry that greater cost-consciousness will deter people, particularly poor people, from essential preventive medical care, a trend that could even raise long-term costs. A classic study by the Rand Corporation in the 1970s showed that higher cost-sharing reduced both necessary and unnecessary medical spending in about equal proportion.

Nor is it obvious that people actually behave like discerning consumers in health care, even when they have information. Proximity of hospitals and word-of-mouth reputation often matter more to patients than published quality indicators. Sceptics of consumer-directed care like to point to Bill Clinton, who chose to have his heart surgery in a hospital that New York state rates as having merely average mortality rates for such operations.

The truth is that the shift to consumer-directed health care and greater cost-sharing involves a culture change that may take decades. It will also come at the price of greater inequality. The burden of health spending will be shifted on to those who are sick, and not just because people will pay a greater share of their health costs themselves. High-deductible insurance policies are attractive to the young and healthy. But as these workers leave traditional insurance, the risk pool in other insurance plans will worsen and premiums will rise even faster. The real losers will be poorer workers with chronic illnesses.

American health care has already become more unequal as employers have cut back, and this will continue. The Bush team argue that “fairer” tax treatment will slow cost rises and enable more people to get basic insurance. The opposite is more likely. Bigger tax subsidies for health care are, if anything, likely to raise overall spending. Worse, since most tax breaks benefit richer people most, more tax incentives are likely to bring more inequality. They will also reduce tax revenue and worsen the budget mess.

Mr Bush's health-care philosophy has a certain political appeal. It suggests incremental change rather than a comprehensive solution. It reinforces existing industry trends. And it promises to be pain-free. Unfortunately, it will not work. The Bush agenda may speed the reform of American health care, but only by hastening the day the current system falls apart.

    Desperate measures, E, 26.1.2006, http://www.economist.com/world/displaystory.cfm?story_id=5436968

Medicare Woes Take High Toll on Mentally Ill

January 21, 2006
The New York Times
By ROBERT PEAR

HILLIARD, Fla., Jan. 16 - On the seventh day of the new Medicare drug benefit, Stephen Starnes began hearing voices again, ominous voices, and he started to beg for the medications he had been taking for 10 years. But his pharmacy could not get approval from his Medicare drug plan, so Mr. Starnes was admitted to a hospital here for treatment of paranoid schizophrenia.

Mr. Starnes, 49, lives in Dayspring Village, a former motel that is licensed by the State of Florida as an assisted living center for people with mental illness. When he gets his medications, he is stable.

"Without them," he said, "I get aggravated at myself, I have terrible pain in my gut, I feel as if I am freezing one moment and burning up the next moment. I go haywire, and I want to hurt myself."

Mix-ups in the first weeks of the Medicare drug benefit have vexed many beneficiaries and pharmacists. Dr. Steven S. Sharfstein, president of the American Psychiatric Association, said the transition from Medicaid to Medicare had had a particularly severe impact on low-income patients with serious, persistent mental illnesses.

"Relapse, rehospitalization and disruption of essential treatment are some of the consequences," Dr. Sharfstein said.

Dr. Jacqueline M. Feldman, a professor of psychiatry at the University of Alabama at Birmingham, said that two of her patients with schizophrenia had gone to a hospital emergency room because they could not get their medications. Dr. Feldman, who is also the director of a community mental health center, said "relapse is becoming more frequent" among her low-income Medicare patients.

Emma L. Hayes, director of emergency services at Ten Broeck Hospital, a psychiatric center in Jacksonville, said, "We have seen some increase in admissions, and anticipate a lot more," as people wrestle with the new drug benefit.

Medicare's free-standing prescription drug plans are not responsible for the costs of hospital care or doctors' services. "They have no business incentive to worry about those costs," said Dr. Joseph J. Parks, medical director of the Missouri Department of Mental Health, who reported that many of his Medicare patients had been unable to get medicines or had experienced delays.

At least 24 states have taken emergency action to pay for prescription drugs if people cannot obtain them by using the new Medicare drug benefit. Florida is not among those states.

In an interview, Alan M. Levine, secretary of the Florida Agency for Health Care Administration, said: "We've set up a phone line and an e-mail address for pharmacists. We try to solve these problems on a case-by-case basis. We have stepped in to get drug plans to pay for prescriptions, so people don't leave the pharmacy without their medications."

Federal officials said they were moving aggressively to fix problems with the drug benefit. About 250 federal employees have been enlisted as caseworkers to help individual patients. The government has told insurers to provide a temporary supply - typically 30 days - of any prescription that a person was previously taking. And Medicare has sent data files to insurers, supposedly listing all low-income people entitled to extra help with premiums and co-payments.

But in many cases, pharmacists say, they still cannot get the information needed to submit claims, to verify eligibility or to calculate the correct co-payments for low-income people. And often, they say, they must wait for hours when they try to reach insurers by telephone.

S. Kimberly Belshé, secretary of the California Health and Human Services Agency, said the actions taken by the federal government "have not been sufficient to address the problems that California residents continue to experience."

At Dayspring Village, in the northeast corner of Florida near Jacksonville, the 80 residents depend heavily on medications. They line up for their medicines three times a day. Members of the staff, standing at a counter, dispense the pills through a window that looks like the ticket booth at a movie theater.

Most of the residents are on Medicare, because they have disabilities, and Medicaid, because they have low incomes. Before Jan. 1, the state's Medicaid program covered their drugs at no charge. Since then, the residents have been covered by a private insurance company under contract to Medicare.

For the first time, residents of Dayspring Village found this month that they were being charged co-payments for their drugs, typically $3 for each prescription. The residents take an average of eight or nine drugs, so the co-payments can take a large share of their cash allowance, which is $54 a month.

Even after the insurer agreed to relax "prior authorization" requirements for a month, it was charging high co-payments for some drugs - $52 apiece for Abilify, an anti-psychotic medicine, and Depakote, a mood stabilizer used in treating bipolar disorder.

The patients take antipsychotic drugs for schizophrenia; more drugs to treat side effects of those drugs, like tremors and insomnia; and still other drugs to treat chronic conditions like diabetes and high blood pressure.

"If I didn't have any of those medications, I would probably be institutionalized for the rest of my life," said Deborah Ann Katz, a 36-year-old Medicare beneficiary at Dayspring. "I'd be hallucinating, hearing voices."

Michael D. Ranne, president of the Jacksonville chapter of the National Alliance on Mental Illness, said the use of powerful psychiatric medications "virtually emptied out state mental hospitals" in the 1970's and early 80's. Ms. Katz said she had been "in and out of hospitals" since she was 13.

Sponsors of the 2003 Medicare law wanted to drive down costs by creating a competitive market for drug insurance. They focused on older Americans, not the disabled. They assumed that beneficiaries would sort through various drug plans to find the one that best met their needs. But that assumption appears unrealistic for people at Dayspring Village.

Heidi L. Fretheim, a case manager for Dayspring residents, said: "If I take them shopping at Wal-Mart, the experience is overwhelming for them. They get nervous. They think the clerks are plotting against them, or out to hurt them."

Residents of Dayspring Village see worms in their food. Some neglect personal hygiene because they hear voices in the shower. When nurses draw blood, some patients want the laboratory to return it so the blood can be put back in their veins.

Under the 2003 Medicare law, low-income people entitled to both Medicare and Medicaid are exempted from all co-payments if they live in a nursing home. But the exemption does not apply to people in assisted living centers like Dayspring Village.

Douglas D. Adkins, executive director of Dayspring Village, said: "Some of the pharmacists have been saying, 'No pills unless we get a co-payment.' Well, how are these people going to get the money for a co-payment? They don't have it."

Eunice Medina, a policy analyst at the Florida Department of Elder Affairs, said the state was trying to "find a solution" for people in assisted living centers.

"We are all aware that the next couple of months will be difficult for these clients, and that the possibility of a transition to a nursing home is their only option if prescriptions are not covered in assisted living facilities," Ms. Medina said in a memorandum to local social service agencies.

Luis E. Collazo, administrator of Palm Breeze, an assisted living center for the mentally ill in Hialeah, Fla., said many of his residents were forgoing their medications on account of the new co-payments.

"Because of their mental illness," Mr. Collazo said, "they don't have the insight to realize the consequences of not taking their medications. Without their medicines, they will definitely go into the hospital."

    Medicare Woes Take High Toll on Mentally Ill, NYT, 21.1.2006, http://www.nytimes.com/2006/01/21/politics/21drug.html?hp&ex=1137906000&en=6760ab57e0838a2f&ei=5094&partner=homepage

2 Approaches to the Nation's Obesity Epidemic Coming Up for Review

January 17, 2006
The New York Times
By STEPHANIE SAUL

Two new approaches to weight loss are up for review by federal regulators. And they represent vastly different solutions to the nation's obesity epidemic - for consumers and for the companies behind the drugs.

One, called Acomplia, would be a prescription pill to control appetite by blocking the same brain receptors that stimulate the "munchies" in marijuana smokers. Some financial analysts see Acomplia as the most promising new drug of the year, and they predict multibillion-dollar sales eventually for its maker, the French company Sanofi-Aventis.

The other, with the proposed name Alli, is a weight-loss drug that works by blocking the body's absorption of fat. Since 1999 it has been sold in the United States as the prescription medication Xenical. GlaxoSmithKline is proposing an over-the-counter version, a prescription-quality alternative to the diet remedies available in drugstore aisles and over the Internet.

Glaxo plans to draw on some of the same marketing techniques it used in 1996, when it successfully commercialized Nicorette chewing gum and Nicoderm skin patches, which had formerly been sold only by prescription. But the history of Xenical, which was introduced by Roche in the United States seven years ago to rosy Wall Street forecasts that never fully materialized, may be a cautionary tale for Sanofi and its Acomplia cheerleaders.

If approved, Acomplia and Alli would be the first new developments in weight-loss medicine since the late 1990's. An estimated 200 other possibilities are in the research pipeline as companies seek an elusive cure for obesity. None of the others, however, is close to regulatory review.

Advocates for the obese and overweight, a group that now includes two-thirds of the American population, hope that the over-the-counter availability of Alli and the approval of Acomplia will provide new options, and suggest that the drugs might even be used together by patients who want help losing weight.

"I think if we could get obesity treatments to a situation like cholesterol where there are several different products, where one or two in combination might be successful, at least that would arm physicians with more than they have now," said Morgan Downey, executive director of the American Obesity Association, a patients' advocacy group in Washington.

The Food and Drug Administration has scheduled an advisory panel hearing for Jan. 23 to review Alli. And the F.D.A. could make its decision on Acomplia as soon as next month.

Both drug companies are seeking approval in a difficult regulatory environment, as the F.D.A. is moving cautiously in the wake of the Vioxx debacle. Any diet drug is up against a backdrop of safety issues from the past - most notably problems with the diet drug combination fen-phen. Fenfluramine, the "fen" half of the combination, was withdrawn from the market in 1997 after it was found to cause heart damage.

Xenical has shown itself to be moderately effective and has a long safety record. But Alli - a name the company has proposed because the drug must be allied with a weight-loss program - faces the higher hurdle required when prescription drugs are proposed for sale without a doctor's oversight. "You have to not only provide data that shows it's safe, you have to show that it's safe when it's misused," said Gerald Meyer, a former F.D.A. associate commissioner.

As the F.D.A. weighs Glaxo's proposal, the company is proposing that its sales be restricted to adults 18 and over to prevent misuse by teenagers. And yet, a factor that limits Alli's potential for overuse is its tendency to cause flatulence, diarrhea or even sudden loss of bowel control.

Those side effects are among the reasons Xenical has never lived up to analysts' original forecasts.

Worldwide sales quickly rose to nearly $750 million in 1999, the first year Xenical was available in the United States. As patients realized it was not an obesity cure-all, though, sales fell off and now hover at about $500 million a year worldwide, mainly outside the United States.

As regulators assess Acomplia from Sanofi, analysts see a positive sign in the fact that, as the February date for F.D.A. action on the drug approaches, the agency has not yet announced a hearing by an advisory panel of experts. That could mean regulators have no serious reservations about the drug. In medical conferences, Sanofi has presented data that shows that Acomplia is not just a weight-loss drug but also a way to control a constellation of disorders - high cholesterol, high blood pressure and elevated blood sugar - that frequently accompany obesity.

The only other weight-loss drug approved for long-tem use is Meridia, introduced by Abbott Laboratories in 1997. Some doctors have avoided using it because of its link to increased blood pressure, one of the reasons for its tepid sales. According to IMS Health, Meridia had total United States sales in 2004 of $72 million. Xenical's United States sales in the same year were $102 million, IMS said. Worldwide sales of Xenical were about $500 million, according to Roche, which licensed the drug to Glaxo for over-the-counter marketing.

Glaxo means to promote Alli as not just a pill, but a plan. Consumers who purchase the drug will also get a guide offering weight-loss and exercise tips - including a fat and calories gram counter and a healthy eating guide with menus and shopping lists. They will also be able to log into a free online behavioral support program.

Studies have shown that in combination with a weight-loss program, prescription Xenical led to an average of 12.4 pounds of weight loss in six months, about double the amount lost by patients on the same weight-loss program who were taking a placebo. Those patients took 120 milligrams six times a day.

Steven L. Burton, vice president of weight control products for Glaxo's consumer health division, said studies showed that the over-the-counter dose of 60 milligrams, three times a day, achieves about 80 to 85 percent of the weight lost by those taking the 120-milligram dose.

The prescription version costs about $100 a month, and is generally not reimbursed by health plans. Alli would cost significantly less, although Mr. Burton would not reveal the exact price.

One obesity expert, Dr. Louis J. Aronne of Weill-Cornell Medical Center in New York, said that an over-the-counter version of Xenical would be a welcome substitute for the unproven and, in some cases, dangerous weight-loss remedies currently sold without prescription. Many of those are classified as nutritionals and do not require F.D.A. approval.

"If you look at the products out there right now, it's really a sad state of affairs," Dr. Aronne said. "The way the rules are, there's very little oversight of these products. So given that, I think the entry of something like Xenical would clearly make it the first safe, proven and effective therapy."

Xenical blocks the body's absorption of fat by preventing the gastrointestinal tract from breaking down fats into smaller molecules. The fat that is not absorbed gets flushed down the toilet, the reason for the drug's gastrointestinal side effects. People who eat too much fat risk extreme cases of those effects, one way the drug can alter behavior.

Aside from potential embarrassment, the drug's only known potentially serious side effect is that it also reduces the absorption of some vitamins. But problems can be prevented by taking a multivitamin.

Dr. Sidney Wolfe, who leads the Public Citizen Health Research Group, warns generally against using weight-loss medications. Dr. Wolfe, who is among those expected to testify at the Alli hearing, says that diet and exercise remain the preferable way to lose weight.

But Mr. Downey, of the American Obesity Association, said his group would speak in support of the over-the-counter version.

"I think our point is going to be it's had this track record for some time," Mr. Downey said. "There's been no major safety problems or abuse of it. Converting it to O.T.C. is a different market and it's going to bring a product that's more affordable to more people."

Gbola Amusa, a medical doctor and financial analyst for Sanford C. Bernstein & Company, said his company was not forecasting sales of Alli because of uncertainties and the fact that the revenue would be split by Glaxo and Roche.

Mr. Amusa said he viewed Acomplia as a far more exciting product, and he has predicted that sales could exceed $5 billion by the end of the decade. A number of other analysts have similarly optimistic projections of $2 billion to $5 billion.

Acomplia is a selective cannabinoid blocker, a new class of drug that several companies are researching in the race to manage obesity. Studies have shown that Acomplia, when combined with a weight-loss regimen, resulted in average losses of 19 pounds and 3.5 inches around the waist in patients who took it for one year. Those taking a placebo lost an average of five pounds. A study also found that risk factors for heart disease and diabetes improved, and that Acomplia had fewer serious side effects than Xenical or Meridia, with mild gastrointestinal upset and dizziness in some patients.

Sanofi has not yet indicated its pricing plan for Acomplia. But as a prescription drug, it would presumably cost more than over-the-counter Alli. If Acomplia proves significantly more effective than Alli, price may not be an issue for many of the dieting masses. But researchers have cautioned that Acomplia falls far short of being a magic bullet for losing weight.

"I think over all," Mr. Downey said, "the kind of modest weight loss with Acomplia is less than people thought they might see."

    2 Approaches to the Nation's Obesity Epidemic Coming Up for Review, NYT, 17.1.2006, http://www.nytimes.com/2006/01/17/health/17diet.html

Law Aimed at Wal-Mart May Be Hard To Replicate

January 16, 2006
The New York Times
By REED ABELSON and MICHAEL BARBARO

When the Maryland legislature passed a law last week requiring that its largest employers, including Wal-Mart Stores, spend at least 8 percent of their payrolls on health care, supporters of the measure claimed they had delivered a clear message to corporate America: companies cannot shirk their duty to employees.

"Let's light the torch. Let us lead the way," said Senator Gloria G. Lawlah, a Democrat who sponsored the bill.

Elated union leaders claim that they have lined up legislators in 30 states to introduce similar bills this year - and that the Maryland vote is likely to give their campaign added impetus.

For all the unions' success in Maryland, though, it is doubtful that the campaign will steamroll across the country, policy analysts say. Because the other states' bills are written much more broadly, they are likely to draw more opposition from companies that watched the Maryland debate from the sidelines.

Still, the new Maryland law has already begun to raise the decibel level of the debate over how to handle the nation's growing number of people with no health insurance, which is now at 46 million. Union activists and others say the law focuses more attention on the role of employers in providing the insurance.

"There is now more public consciousness about how large employers do not provide health care," said Anthony Wright, the executive director of Health Access California, a consumer coalition that supported a similar law in California that was narrowly defeated by voters a little more than a year ago.

Only a handful of states, among them Rhode Island, Washington, Colorado and New Hampshire, are likely to seriously consider requiring employers to provide a certain level of coverage, according to health care advocates and union activists.

Maryland's bill, drafted to apply to companies with 10,000 or more employees, actually affects only one company in the state: Wal-Mart Stores, which has come to symbolize corporations that do not provide adequate health benefits to their employees. The laws being contemplated elsewhere, aimed at companies with a thousand or two thousand employees in that particular state, could affect dozens of other corporations, like McDonald's and the CVS Corporation, the drugstore chain.

"The broader the scope of the attack, the broader the counterattack that will be mounted," said Prof. Carl Van Horn, director of the John J. Heldrich Center for Workforce Development at Rutgers University, who does not expect the Maryland law to lead to the passage of similar bills in many other states.

Retailing and restaurant chains, which are most vulnerable to any state law mandating coverage because they employ so many low-income workers, are already preparing an aggressive campaign to prevent lawmakers from passing the legislation outside Maryland. Three trade groups - the National Retail Federation, the National Restaurant Association and the International Franchise Association - have created a coalition to oppose legislation.

"If retailers are hit with this extra cost, this is going to put them in a position to raise prices for consumers or lay off workers," said J. Craig Shearman, vice president of government relations at the retailers' federation.

The Maryland law is likely to face legal challenges to determine whether federal law allows states the authority to mandate health benefits, said J. D. Piro, the chairman of the health law group at Hewitt Associates, a consulting firm.

The Maryland Chamber of Commerce, a business lobbying group, argued that the Maryland bill was pre-empted by the federal Employee Retirement Income Security Act, or Erisa, even though the Maryland attorney general found that the bill did not violate federal law because it imposed no requirements on how companies spend their money. "It's likely this will go to court," Mr. Piro said.

Struggling to balance their own budgets in the face of rising health care costs, some state officials are likely to look favorably on action that would force companies to shoulder more of the bill. "I think they will be looking," said Helen Darling, the president of the National Business Group on Health, an employer coalition based in Washington. "It seems to be a cheap fix."

States are searching for ways to pay for programs like Medicaid, Mr. Piro agreed. "It's a question of who has the money," he said.

Amy G. Rice, a Democrat in the Rhode Island House of Representatives, said the bill that she planned to introduce next week had "a high chance of passing" in the Democratic-controlled state legislature.

"Legislators in both parties are very concerned about the health care crisis in Rhode Island," said Ms. Rice, who cited a poll that found that a majority of the state's residents supported the idea of requiring large corporations to increase spending on health care.

Her bill would require companies with more than 1,000 employees to devote 8 percent of their payroll to health insurance. Ms. Rice estimates that of 38 employers with more than 1,000 employees, only 6 do not meet the 8 percent requirement.

Proponents of similar bills in other states say most companies would not be affected. As a result, they say, companies that do provide coverage may be reluctant to support the efforts of those that do not.

"They won't be the leaders of the opposition," said Mr. Wright, the California advocate who said the majority of the resistance in his state came from fast-food and retailing companies. In fact, some companies may even support the measures. In Maryland, for example, Giant Food, a regional supermarket chain that competes with Wal-Mart, came out in favor of the legislation.

Because it is so narrowly written and may not result in coverage for significant numbers of uninsured people, policy analysts say the Maryland bill cannot be viewed as a model for any states looking seriously at gaps in health care coverage. "The Maryland law is aimed at Wal-Mart, not the issue of the uninsured," said Paul B. Ginsburg, the president of the Center for Studying Health System Change, a nonprofit research group in Washington.

Wal-Mart insures fewer than half of its 1.3 million employees in the United States. According to an internal memo, 5 percent, or roughly 65,000, of its workers rely on state Medicaid plans, compared with 4 percent for other national companies.

Even if other laws apply to significantly more employers, some policy analysts say these measures do not represent long-term solutions to the problem of paying for health care. "I'd rather see the state work with all employers to see if they can come up with incentives to spread the risk among a broader pool," said Laura D. Tyson, dean of the London Business School and former chief economic adviser to President Bill Clinton. "This is a Band-Aid, arbitrary, firm-specific solution to one of the most important policy problems of the United States."

The focus on the issue of low-income workers who cannot afford coverage even when it is offered is important, said Peter V. Lee, the chief executive of the Pacific Business Group on Health. But, he said, the question of who pays for the care for these individuals - the state or the employer - does not address the fundamental problem of rising health care costs in this country, he said.

"All we're doing is playing squeezing the balloon," he said.

    Law Aimed at Wal-Mart May Be Hard To Replicate, NYT, 16.1.2006, http://www.nytimes.com/2006/01/16/business/16walmart.html

President Tells Insurers to Aid Ailing Medicare Drug Plan

January 16, 2006
The New York Times
By ROBERT PEAR

With tens of thousands of people unable to get medicines promised by Medicare, the Bush administration has told insurers that they must provide a 30-day supply of any drug that a beneficiary was previously taking, and it said that poor people must not be charged more than $5 for a covered drug.

The actions came after several states declared public health emergencies, and many states announced that they would step in to pay for prescriptions that should have been covered by the federal Medicare program.

Republicans have joined Democrats in asserting that the federal government botched the beginning of the prescription drug program, which started on Jan. 1. People who had signed up for coverage found that they were not on the government's list of subscribers. Insurers said they had no way to identify poor people entitled to extra help with their drug costs. Pharmacists spent hours on the telephone trying to reach insurance companies that administer the drug benefit under contract to Medicare.

Many of the problems involve low-income people entitled to both Medicare and Medicaid.

In a directive sent to all Medicare drug plans over the weekend, the Bush administration said they "must take immediate steps" to ensure that low-income beneficiaries were not charged more than $2 for a generic drug and $5 for a brand-name drug.

In addition, it said insurers must cover a 30-day emergency supply of drugs that beneficiaries were taking prior to the start of the new program.

In an interview yesterday, Dr. Mark B. McClellan, administrator of the federal Centers for Medicare and Medicaid Services, said that "several hundred thousand beneficiaries who switched plans" in December may have had difficulty filling prescriptions in the last two weeks.

In California, officials estimate that 200,000 of the state's 1.1 million low-income Medicare beneficiaries had trouble getting their medications.

Despite these problems, Dr. McClellan said, Medicare is now covering one million prescriptions a day. With the latest corrective actions, he said, "all beneficiaries should be able to get their prescriptions filled."

In the past, such predictions proved to be premature. New problems appeared as old ones were solved, and some insurers were slow to carry out federal instructions.

Since the program began on Jan. 1, many low-income people have left pharmacies empty-handed after being told they would have to pay co-payments of $100, $250 or more.

About 20 states, including California, Illinois, Ohio, Pennsylvania and all of New England, have announced that they will help low-income people by paying drug claims that should have been paid by the federal Medicare program.

"The new federal program is too complicated for many people to understand, and the implementation of the new program by the federal government has been awful," said Gov. Tim Pawlenty of Minnesota, a Republican. On Saturday, he signed an emergency executive order making the state a "payer of last resort" for the out-of-pocket drug costs.

The Bush administration said it was rushing to provide insurers with correct information about the extra subsidies available to low-income people enrolled in their plans.

"We sent files to all plans providing complete information on dual-eligible beneficiaries" entitled to both Medicare and Medicaid, Dr. McClellan said. "The plans now have all the information in one place."

The new drug benefit is the most significant expansion of Medicare since creation of the program in 1965.

The president of MemberHealth, which offers three national Medicare drug plans, has apologized to pharmacists for problems that plagued the new benefit.

"We expected much more of ourselves, and certainly our performance in the first two weeks was a disappointment," the company's president, Charles E. Hallberg, said in a letter sent Friday to pharmacists. "For that, I want to personally apologize to each of you."

Mr. Hallberg said that druggists "have experienced unacceptable wait times for customer service because we were unable to keep up with the extraordinary call volume."

In an interview, Mr. Hallberg said that 700,000 people had enrolled in his drug plans, marketed under the name Community Care Rx.

Any of the 42 million Medicare beneficiaries can sign up for the new drug coverage. Federal officials say that a surge in enrollments occurred in late December. About 6.2 million low-income people who had drug coverage under Medicaid were automatically enrolled in Medicare drug plans, and some of them have switched to other Medicare plans.

The handling of the drug benefit threatens to become a political liability for Republicans, as older voters and people with disabilities complain that they have been denied essential medications.

Gov. Mike Huckabee of Arkansas, a Republican who is chairman of the National Governors Association, declared a public health emergency.

In Wisconsin, Gov. James E. Doyle, a Democrat, said: "It is outrageous how the federal government has mishandled this program and put thousands of lives at risk. As an emergency measure, the state will step in to ensure that no seniors go without lifesaving medicines."

The Senate Democratic leader, Harry Reid of Nevada, said the mismanagement of the program had had "devastating consequences for seniors." In a letter signed by 34 other Democrats, Mr. Reid said, "We want to know why so many of our constituents have fallen through the cracks." Democrats had predicted many of the problems, he said.

The concern was bipartisan. Senator Judd Gregg, Republican of New Hampshire, said many people had been "turned away at their pharmacies or told that they must purchase the drugs up front and seek reimbursement later."

"These are very vulnerable people who do not have the means to pay for their prescriptions and who cannot go without their medications," Mr. Gregg said.

    President Tells Insurers to Aid Ailing Medicare Drug Plan, NYT, 16.1.2006, http://www.nytimes.com/2006/01/16/politics/16drug.html