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If Elected ...

Clinton Details Premium Cap

in Health Plan

March 28, 2008
The New York Times
By KEVIN SACK

Senator Hillary Rodham Clinton said in an interview on Wednesday that if elected president she would push for a universal health care plan that would limit what Americans pay for health insurance to no more than 10 percent of their income, a significant reduction for some families.

In an extensive interview on health policy, Mrs. Clinton said she would like to cap health insurance premiums at 5 percent to 10 percent of income.

The average cost of a family policy bought by an individual in 2006 and 2007 was $5,799, or 10 percent of the median family income of $58,526, according to America’s Health Insurance Plans, a trade group. Some policies cost up to $9,201, or 16 percent of median income.

The average out-of-pocket cost for workers who buy family policies through their employers is lower, $3,281, or 6 percent of median income, according to the Kaiser Family Foundation, a health research group.

A cap on premiums has been part of Mrs. Clinton’s universal coverage proposal since she announced it in September. Her published plan did not disclose her thinking on where to place the cap. She also said in the interview that she preferred to set the limit at a single level for all Americans rather than varying it by income.

Mrs. Clinton, a New York Democrat, set out a comprehensive approach to her signature issue of health care in three speeches last year, but she has been criticized for not providing details on several crucial components. She largely continued that approach in the interview, saying she would leave particulars like the eligibility criteria for her proposed health insurance tax credits to negotiations with Congress.

But she did discuss her thinking on other questions, including the premium cap, and expressed openness to measures she had not previously embraced.

She said, for instance, that it “might be appropriate” to require insurers to spend a heavy proportion of every premium dollar on health care as opposed to overhead and profit. Several governors, including Arnold Schwarzenegger of California and Edward G. Rendell of Pennsylvania, have proposed requiring that insurers spend 85 percent of premiums on health care.

Without specifying a number, Senator Barack Obama, Mrs. Clinton’s rival for the nomination, has backed that general concept.

Mrs. Clinton also she said if she could not generate the money needed to pay for universal coverage through other means, she would not object to raising the excise tax on tobacco products, which Congress last increased in 1997 to 39 cents a pack.

“I’m a big believer in raising tobacco taxes,” Mrs. Clinton said when asked whether an increase should be on the table. “You know, when we were working on the Children’s Health Insurance Program, that’s the funding stream that the Congress came up with, which was bipartisan, which worked out very well. At some point, there’s going to be diminishing returns. But, sure, why not? I don’t have any objection to that.”

As in her debates with Mr. Obama and other contenders, Mrs. Clinton displayed an easy command of health policy in the 45-minute interview, conducted in a basement meeting room in the Midtown Manhattan tower that houses her Senate office. Her voice hoarse, she conceded some weariness from the lengthy campaign, saying her decision to take off the Easter weekend had only allowed exhaustion to set in. But despite calls by some Democrats for her to abandon the race, she gave no hint that she was viewing her campaign in the past tense.

Mrs. Clinton presented a confident defense of her call for universal coverage, saying it reflected not only a moral imperative, but also the best chance to reduce costs and improve quality.

“I know that there are a lot of experts who may disagree about how to get to universal health care,” she said. “But they agree with me that in the absence of universal health care it’s very difficult to control costs, and it’s extremely hard to incentivize quality improvements at the level you need to really see results.”

Though that view is not shared by Senator John McCain or any of the rivals he vanquished to secure the Republican nomination, Mrs. Clinton said she thought that “the time is right” to build a bipartisan consensus to reorganize the health system.

She pointed to a growing demand for change by businesses, which bear the brunt of rising premiums, and to the support by some Republicans for a Senate bill that, like her proposal, would require individuals to buy policies and toughen regulation of the insurance industry.

“There is going to be increasing pressure, because left alone, we’re going to have more and more uninsured people and more and more underinsured people and continuing costs and decreasing quality,” she said.

Asked whether her proposal reflected the will of the entire country or just the leanings of voters in Democratic primaries, Mrs. Clinton said, “Well, I think it’s where the country can be.”

The proposal to cover all 47 million uninsured people would maintain the private insurance system and mandate coverage for all legal residents. She would require insurers to cover every applicant regardless of age or health status. Government insurance similar to Medicare would be available to all consumers.

Refundable tax credits would help make the newly mandatory policies affordable for low- and middle-income workers. Small businesses would receive tax credits to encourage them to offer insurance to employees. Large companies would either have to offer health benefits or pay into a pool that would finance subsidized coverage.

Mrs. Clinton has pegged the cost of her plan at $110 billion. About half would come from savings generated by improvements in prevention, chronic disease management and electronic record keeping. The remainder would be produced by rolling back President Bush’s income tax cuts on people earning more than $250,000 a year.

Mrs. Clinton’s campaign Web site says she would cover the uninsured “with no overall increase in health spending or taxes.” She said in the interview that rolling back the Bush tax cuts “should not be rightly labeled as a tax increase” because without Congressional action the cuts are to expire on Jan. 1, 2011.

Mr. Obama, of Illinois, also aspires to provide universal coverage, but he would mandate coverage only for children. He has said consumers should not be required to buy policies until costs can be reduced enough to make premiums affordable. He has suggested that affordability is the sole reason people do not buy health insurance.

Mrs. Clinton called that argument “just specious.” She maintains, and many health economists agree, that a share of the uninsured are “free riders,” typically young and healthy workers who can afford coverage but choose to spend on other priorities.

She pointed out that millions of qualified Americans, many of them children, remained unenrolled in government programs that would provide free or heavily subsidized policies. “You can make it affordable, but unless you have some requirement you’re not going to get everybody into the system,” she said.

As in past interviews and debates, Mrs. Clinton refused to specify how she would enforce her mandate. She has previously said that garnisheeing wages would be one option, but has declined to say whether it would be the preferred one. She did say, however, that the uninsured could be detected by employers and government agencies and then enrolled automatically.

There would be “a long grace period” to enroll, she said. At some point, it might be necessary to impose penalties to encourage compliance, as is the case in Massachusetts, the lone state with a mandatory coverage plan. “Probably eventually,” she said, “but I don’t want to set a time frame.”

As with many elements of her plan, Mrs. Clinton’s ability to lower costs so that premiums would not exceed 10 percent of income is speculative. “I think her plan is realistic at close to 10 percent, but I don’t think it’s realistic at 5 percent,” said Jonathan Gruber, a health economist at the Massachusetts Institute of Technology who generally supports her approach.

Mr. Gruber also questioned not varying the premium cap according to income.

Mrs. Clinton said reducing the cost of health care would be crucial to the next president’s ability to keep Medicare solvent. The program’s trustees projected this week that the Medicare Hospital Insurance Trust Fund would be exhausted in 2019.

She said she would allow Medicare to negotiate lower drug prices and would “rein in” government subsidies for private Medicare Advantage plans. She said she would resist increasing payroll taxes or cutting benefits until trying a broad range of cost controls.

“We have so much unnecessary cost in our system,” Mrs. Clinton said. “It’s heartbreaking how much we spend on things that don’t produce a doctor at a bedside or a nurse taking care of a patient or any particularly good outcome.

“So I’m reluctant to put more money into a broken system. And it’s not only Medicare. It’s our entire health care system — without significant reforms. I think that would be an unbelievably bad decision.”

Clinton Details Premium Cap in Health Plan, NYT, 28.3.2008, http://www.nytimes.com/2008/03/28/us/politics/28clinton.html

Study Ties Genetic Variations

to Schizophrenia

March 28, 2008
The New York Times
By BENEDICT CAREY

A new study has found that rare and previously undetectable genetic variations may significantly increase the risk that a person will develop schizophrenia.

Experts said the study, while not identifying the cause of the disorder, provided a striking demonstration of how new gene-scanning technology can open a new frontier in the quest to understand the biology of mental disorders.

Until now, researchers had focused on finding common and known genetic variations that, when acting in some combination, might increase the risk for schizophrenia. They have had little success. The new analysis, to be published Friday in the journal Science, detected extremely rare and unknown mutations that turned up three to four times as often in people with schizophrenia as in those without it.

The findings point scientists to previously unappreciated developmental problems that may help them develop more effective treatments, experts said.

Researchers have tried for generations to understand the biological underpinnings of schizophrenia, which affects 1 percent of the population, causing scrambled thinking and delusions. They have analyzed how drugs prescribed for the disorder affect brain cells. They have run large genetic studies, looking in vain for some shared pattern.

The new study suggests that, if anything, the genetics of the disorder are even more complex than many had presumed. But if replicated, experts said, the study’s results will significantly alter the course of psychiatric research.

“This paper represents a paradigm shift in the way we think about identifying genes in schizophrenia,” said Dr. Matthew State, director of the neurogenetics program at Yale University School of Medicine, who was not involved in the research. “That is what the authors say in the paper, and it’s true.”

Dr. Samuel Barondes, a professor of psychiatry at the University of California, San Francisco, said the new findings in no way disproved the idea that multiple common variations could act together to increase schizophrenia risk. Studies searching for such dark conspiracies of genes are under way and still promising.

“But this new work is not business as usual, in any way, and can lead to real insight,” Dr. Barondes said. “This is a field that has been grasping for straws, and this study is one big straw.”

In the study, a collaboration that included the National Institute of Mental Health, the University of Washington, Seattle, and Cold Spring Harbor Laboratory, investigators analyzed blood samples from 150 people with a diagnosis of schizophrenia and 268 without a psychiatric disorder. Using new high-resolution techniques that quickly scan the entire human DNA map, the researchers looked for rare variations that disrupted the function of genes. Some of these mutations are inherited; others occur spontaneously during or near conception.

They found 53 such mutations over all and reported that the mutations that disrupted genes were three times as likely to turn up in people with schizophrenia as in those without it. A similar analysis, in 83 people who developed a rare form of schizophrenia that strikes in childhood, found that those patients were four times as likely as healthy people to have a rare gene-altering mutation.

The mutations varied from person to person but were concentrated in genes known to be involved in brain development.

“The take-home message is that there’s a new way to search for genetic links, and this new method goes straight to the underlying biology,” said the senior author, Jonathan Sebat, an assistant professor of genetics at Cold Spring Harbor Laboratory.

Mary-Claire King, a co-author and a professor of medicine and genomic sciences at the University of Washington, said the findings helped explain several facts about schizophrenia, including why genetic selection has not caused it to disappear.

“A constant influx of new mutations that occur purely by chance, out of the blue, can explain the persistence of schizophrenia in all parts of the world and throughout human history,” Professor King said.

One of the mutations identified in the study, for instance, distorts a protein that is involved in guiding neurons to their proper places during brain development. Another mutation that turned up changes the shape of a molecule that transports glutamate, a chemical that excites neurons and is heavily involved transmitting signals between brain cells.

Both mutations are processes that biologists can explore to learn about the causes of schizophrenia, and possibly other mental problems. The glitches, too, may well act in concert with other gene variations. But gene-scanning technology is improving so quickly that subsequent studies should help clarify those interactions, experts said.

“My dream,” Dr. Sebat said, “is that we’ll do this kind of high-resolution analysis across tens of thousands of people and have full catalogs of variations that will tell us something not only about schizophrenia but about bipolar disorder, autism, depression, all of these disorders.”

Study Ties Genetic Variations to Schizophrenia, NYT, 28.3.2008, http://www.nytimes.com/2008/03/28/science/28gene.html

U.S. to Study Drug for Suicide Links

March 28, 2008
The New York Times
By THE ASSOCIATED PRESS

WASHINGTON (AP) — The Food and Drug Administration said Thursday that it was investigating a possible link between Merck’s best-selling drug Singulair and suicide.

The agency said it was reviewing a handful of reports involving mood changes, suicidal behavior and suicide in patients who had taken Singulair, the popular allergy and asthma drug.

Merck has updated the drug’s labeling four times in the last year to include information on a range of reported side effects, including tremors, anxiousness, depression and suicidal behavior.

The F.D.A. said it had asked the company, based in Whitehouse, N.J., to dig deeper into its data on Singulair for evidence of possible links to suicide. The agency said it had not established a “causal relationship” between Merck’s drug and suicidal behavior. An agency spokeswoman said the review was prompted by three or four suicide reports it had received since last October.

It could take up to nine months before agency scientists can draw any conclusions, the F.D.A. said in a posting to its Web site.

Merck officials stressed that the agency’s inquiry was based on reports, not clinical studies, which are the standard tool for evaluating drug safety. The company said none of the 11,000 patients enrolled in 40 Singulair trials had committed suicide.

Millions of patients in the United States take Singulair, which was first approved in 1998 and had sales of $4.3 billion last year.

    U.S. to Study Drug for Suicide Links, NYT, 28.3.2010, http://www.nytimes.com/2008/03/28/business/28merck.html

Rethinking Is Urged on a Vaccine for AIDS

March 26, 2008
The New York Times
By LAWRENCE K. ALTMAN

WASHINGTON — Researchers must go back to the drawing board before they can develop an effective vaccine against H.I.V., AIDS experts said at a scientific meeting on Tuesday.

And Dr. Anthony S. Fauci, the top federal official responsible for AIDS research, agreed that more fundamental knowledge is needed about H.I.V. and the way the body and experimental vaccines respond to it before the goal of a licensed H.I.V. vaccine can be reached. Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, pledged to re-evaluate the use of all $1.5 billion his agency spends on AIDS research to come up with the necessary money.

“Everything is on the table,” Dr. Fauci said at the one-day meeting, a Town Hall-type discussion for vaccine researchers on how best to spend federal H.I.V. vaccine money in light of a budget that has been flat for several years.

“There is not an immediate solution to the problem,” Dr. Fauci said in an interview. But, he also said, the budgetary constraints mean that “we are going to have to justify what we are doing” and determine what steps to take after further discussions in smaller meetings with researchers.

The reassessment comes after last September’s widely publicized failure of what had been the most promising candidate for an H.I.V. vaccine. Many health officials believe that an effective vaccine would be the most crucial weapon in stopping the H.I.V. pandemic.

Scientists do not have a full understanding of why the vaccine failed, or why it was possibly harmful, in two large trials in the United States and South Africa. Dr. Fauci’s institute helped pay for the trials of the vaccine, which was made by Merck. Such failures have led a number of scientists to challenge the direction of federal H.I.V. research.

On Tuesday, the AIDS Health Care Foundation called for the suspension of money for H.I.V. vaccine research and reallocating resources into effective H.I.V./AIDS prevention, testing and treatment strategies.

But Dr. Fauci strongly rejected the proposal. “Under no circumstances will we stop AIDS vaccine research,” Dr. Fauci said at the conclusion of the meeting.

Dr. James Hoxie of the University of Pennsylvania echoed the belief of many other participants by saying, “we are not close to having a vaccine” and “there is a tremendous need for innovation” in developing one.

Experts at the meeting also said that Dr. Fauci’s agency needed to support efforts to further develop animal models of human H.I.V. The experts also urged greater cooperation between AIDS scientists who work on such animal models and those who are trying to develop an H.I.V. vaccine for humans.

A crucial issue is supporting younger researchers to replace the cadre of veteran AIDS scientists, many of whom are working beyond traditional retirement age. Dr. Fauci said a first step would be to pare existing projects to immediately provide $10 million to $15 million for about 30 grants to be awarded to scientists who propose novel ideas. Some of the grants would be used to support young researchers, he said.

Some scientists support conducting large vaccine trials in humans before all the fine points of the vaccine research are complete in animals because of the urgency of the pandemic.

Others urge caution out of fear that failures could destroy confidence among uninfected people most at risk who would be needed as volunteers in future trials.

Equally vocal groups call for testing everything as soon as the research shows promise because of the urgent need for a vaccine.

Dr. Warner C. Greene, a co-chairman of the meeting and director of the Gladstone Institute of Virology and Immunology in San Francisco, said he hoped that a century from now, historians looking back on the AIDS pandemic would view Tuesday’s meeting as a turning point.

    Rethinking Is Urged on a Vaccine for AIDS, NYT, 26.3.2008, http://www.nytimes.com/2008/03/26/health/policy/26HIV.html

Cigarette Company Paid for Lung Cancer Study

March 26, 2008
The New York Times
By GARDINER HARRIS

In October 2006, Dr. Claudia Henschke of Weill Cornell Medical College jolted the cancer world with a study saying that 80 percent of lung cancer deaths could be prevented through widespread use of CT scans.

Small print at the end of the study, published in The New England Journal of Medicine, noted that it had been financed in part by a little-known charity called the Foundation for Lung Cancer: Early Detection, Prevention & Treatment. A review of tax records by The New York Times shows that the foundation was underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands.

The foundation got four grants from the Vector Group, Liggett’s parent, from 2000 to 2003.

Dr. Jeffrey M. Drazen, editor in chief of the medical journal, said he was surprised. “In the seven years that I’ve been here, we have never knowingly published anything supported by” a cigarette maker, Dr. Drazen said.

An increasing number of universities do not accept grants from cigarette makers, and a growing awareness of the influence that companies can have over research outcomes, even when donations are at arm’s length, has led nearly all medical journals and associations to demand that researchers accurately disclose financing sources.

Dr. Henschke was the foundation president, and her longtime collaborator, Dr. David Yankelevitz, was its secretary-treasurer. Dr. Antonio Gotto, dean of Weill Cornell, and Arthur J. Mahon, vice chairman of the college board of overseers, were directors.

Vector issued a press release on Dec. 4, 2000, saying that it intended to give $2.4 million to Weill Cornell to finance Dr. Henschke’s research. Articles in Business Week and USA Today mentioned the gift. No mention was made of the foundation, begun so hastily that its 2000 tax return stated “not yet organized.”

Paul Caminiti, a Vector spokesman, confirmed that the company donated $3.6 million to the foundation over three years. The company “had no control or influence over the research,” he said.

Prominent cancer researchers and journal editors, told of the foundation by The Times, said they were stunned to learn of Dr. Henschke’s association with Liggett. Cigarette makers are so reviled among cancer advocates and researchers that any association with the industry can taint researchers and bar their work from being published.

“If you’re using blood money, you need to tell people you’re using blood money,” said Dr. Otis Brawley, chief medical officer of the American Cancer Society. The society gave Dr. Henschke more than $100,000 in grants from 2004 to 2007, money it would not have provided had it known of Liggett’s grants, Dr. Brawley said.

In an e-mail message, Drs. Henschke and Yankelevitz wrote, “It seems clear that you are trying to suggest that Cornell was trying to conceal this gift, which is entirely false.”

“The gift was announced publicly, the advocacy and public health community knew about it, it is quite easy to look it up on the Internet, its board has independent Cornell faculty on it, and it was fully disclosed to grant funding organizations,” they wrote, adding that the Vector grant represented a small part of the study’s overall cost. The foundation no longer accepts grants from tobacco companies, they wrote.

In the Vector press release, Dr. Henschke was quoted as saying that, thanks to the Vector grants, “we have raised the initial funding needed to support this important research and data collection on the effectiveness of spiral CT screening.”

Dr. Gotto said in an interview that Dr. Henschke, Dr. Yankelevitz and another colleague set up the foundation initially without the university’s approval, which he said faculty members are allowed to do. He and Mr. Mahon joined the board some weeks or months after its creation to ensure that the Vector grants were handled correctly, he said.

“If we had been approached, we would not have set up the foundation,” Dr. Gotto said. “We would have accepted the gift directly. We think we behaved honorably. There was no attempt to set up a foundation to hide tobacco money.”

Days earlier, Andrew Ben Ami, assistant secretary of the foundation, said in an interview he would not disclose the source of the charity’s financing at the request of the university.

In another interview before Dr. Gotto agreed to speak, Mr. Mahon, another foundation director, said he did not know the source of the funds.

Dr. Robert C. Young, chancellor of the Fox Chase Cancer Center in Philadelphia and chairman of the Board of Scientific Advisors of the National Cancer Institute, said he had never heard of the Vector grants. “As someone who really hung around the inner sanctum of cancer research, I have never heard anybody — anybody — ever say anything about this,” Dr. Young said.

Dr. Jerome Kassirer, a former editor of The New England Journal of Medicine and the author of a book about conflicts of interest, said he believed that Weill Cornell had created the foundation to hide its receipt of money from a cigarette company. “You have to ask yourself the question, ‘Why did the tobacco company want to support her research?’ ” Dr. Kassirer said. “They want to show that lung cancer is not so bad as everybody thinks because screening can save people; and that’s outrageous.”

Dr. Henschke’s work, while controversial among cancer researchers, has been embraced by many lung-cancer advocacy organizations, which have pushed for legislation in California, New York and Massachusetts to create trust funds to pay for lung cancer screening — often with language tailored to benefit Dr. Henschke’s group.

In New York, a bill would create a $10 million fund “to carry out lung cancer early detection research using computer tomography (CT) scanning” at a place “that was established by the multi-institutional, multi-disciplinary research program that began at 22 sites in the state in the year 1991,” a description that could only fit Dr. Henschke’s group.

But the disclosure that Dr. Henschke’s work was in part underwritten by grants from a cigarette maker will undercut those efforts, prominent cancer researchers said.

“She’s the biggest advocate for widespread spiral CT screening,” said Dr. Paul Bunn, a lung cancer expert and executive director of the International Association for the Study of Lung Cancer. “And now her research is tainted.”

Corporate financing can have subtle effects on research and lead to unconscious bias. Studies have shown that sponsored research tends to reach conclusions that favor the sponsor, which is why disclosure is encouraged. The tobacco industry has a long history of underwriting research — sometimes through independent-sounding foundations — to make cigarettes seem less dangerous.

Since 1999, Dr. Henschke has asserted that annual CT scans of smokers and former smokers would detect lung cancer when tumors are small enough to be cured, preventing as many as 80 percent of the 160,000 deaths a year from lung cancer, by far the biggest cause of cancer deaths in the United States.

Her 2006 study said that, after screening 31,567 people from seven countries, CT scans uncovered 484 lung cancers, 412 of them at a very early stage. Three years later, most of those patients were still alive, and she projected that 80 percent would be alive after 10 years and assumed that they would have died without the screens.

Critics question both her survival projections and her assumption that all would have died without screening. Indeed, most in the cancer establishment say that Dr. Henschke has yet to prove her case. CT scans have radiation risks and sometimes detect cancers that would not have progressed, leading to risky procedures like biopsies and lung surgery when not needed.

To settle the dispute, the National Cancer Institute started in 2002 the $200 million National Lung Screening Trial comparing death rates among 55,000 people randomly assigned to have CT scans or chest X-rays. Results are not expected until 2010. Dr. Henschke has asserted that allowing hundreds of thousands of people to die in the meantime is unethical.

The Cancer Letter, a newsletter, recently reported that Drs. Henschke and Yankelevitz had failed to disclose in articles and educational lectures a patent and 10 pending patents related to CT screening and follow-up. General Electric, a maker of CT scanners, licensed the issued patent beginning in 2001.

Jonathan Weil, a Weill Cornell spokesman, said Dr. Henschke did not disclose the patents in some articles and lectures because she did not deem them relevant.

On Monday, The Journal of the American Medical Association published corrections about unreported financial disclosures from Drs. Henschke and Yankelevitz. The patent and pending patents reported by The Cancer Letter “are relevant to these publications,” an editors’ note stated. Editors at the journal were not aware of Dr. Henschke’s association with Liggett, said Dr. Catherine D. DeAngelis, the journal’s editor in chief.

“I would never publish a paper dealing with lung cancer from a person who had taken money from a tobacco company,” Dr. DeAngelis said.

Universities are responsible for policing conflicts of interest and, in many cases, the required disclosures of their faculty. But Weill Cornell shared in the proceeds of Dr. Henschke’s patent and pending patents, and university officials were on the foundation board.

“We have a very strict oversight policy” for conflicts of interest, Dr. Gotto of Weill Cornell said. He dismissed any suggestion that the university could not police and benefit from faculty members’ financial deals.

But Dr. Kassirer said, “The problem is that universities, because they’re so conflicted themselves, ignore the conflicts of interest of their faculty.”

Legislation being considered in Congress would require drug and device makers to post registries of payments to doctors.

An increasing number of doctors and institutions are setting up foundations to accept money from companies without having to disclose its source, said Dr. Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education.

“This is the third time in the past few weeks that one of these has been identified to us,” said Dr. Kopelow, whose organization is investigating how widespread the practice is.

Laurie Fenton Ambrose, president and chief executive of the Lung Cancer Alliance, a nonprofit patient advocacy group, said she still trusted Dr. Henschke and still believed in widespread CT scanning to prevent lung cancer deaths.

    Cigarette Company Paid for Lung Cancer Study, NYT, 26.3.2008, http://www.nytimes.com/2008/03/26/health/research/26lung.html?hp

Gap in Life Expectancy Widens for the Nation

March 23, 2008
The New York Times
By ROBERT PEAR

WASHINGTON — New government research has found “large and growing” disparities in life expectancy for richer and poorer Americans, paralleling the growth of income inequality in the last two decades.

Life expectancy for the nation as a whole has increased, the researchers said, but affluent people have experienced greater gains, and this, in turn, has caused a widening gap.

One of the researchers, Gopal K. Singh, a demographer at the Department of Health and Human Services, said “the growing inequalities in life expectancy” mirrored trends in infant mortality and in death from heart disease and certain cancers.

The gaps have been increasing despite efforts by the federal government to reduce them. One of the top goals of “Healthy People 2010,” an official statement of national health objectives issued in 2000, is to “eliminate health disparities among different segments of the population,” including higher- and lower-income groups and people of different racial and ethnic background.

Dr. Singh said last week that federal officials had found “widening socioeconomic inequalities in life expectancy” at birth and at every age level.

He and another researcher, Mohammad Siahpush, a professor at the University of Nebraska Medical Center in Omaha, developed an index to measure social and economic conditions in every county, using census data on education, income, poverty, housing and other factors. Counties were then classified into 10 groups of equal population size.

In 1980-82, Dr. Singh said, people in the most affluent group could expect to live 2.8 years longer than people in the most deprived group (75.8 versus 73 years). By 1998-2000, the difference in life expectancy had increased to 4.5 years (79.2 versus 74.7 years), and it continues to grow, he said.

After 20 years, the lowest socioeconomic group lagged further behind the most affluent, Dr. Singh said, noting that “life expectancy was higher for the most affluent in 1980 than for the most deprived group in 2000.”

“If you look at the extremes in 2000,” Dr. Singh said, “men in the most deprived counties had 10 years’ shorter life expectancy than women in the most affluent counties (71.5 years versus 81.3 years).” The difference between poor black men and affluent white women was more than 14 years (66.9 years vs. 81.1 years).

The Democratic candidates for president, Senators Hillary Rodham Clinton of New York and Barack Obama of Illinois, have championed legislation to reduce such disparities, as have some Republicans, like Senator Thad Cochran of Mississippi.

Peter R. Orszag, director of the Congressional Budget Office, said: “We have heard a lot about growing income inequality. There has been much less attention paid to growing inequality in life expectancy, which is really quite dramatic.”

Life expectancy is the average number of years of life remaining for people who have attained a given age.

While researchers do not agree on an explanation for the widening gap, they have suggested many reasons, including these:

¶Doctors can detect and treat many forms of cancer and heart disease because of advances in medical science and technology. People who are affluent and better educated are more likely to take advantage of these discoveries.

¶Smoking has declined more rapidly among people with greater education and income.

¶Lower-income people are more likely to live in unsafe neighborhoods, to engage in risky or unhealthy behavior and to eat unhealthy food.

¶Lower-income people are less likely to have health insurance, so they are less likely to receive checkups, screenings, diagnostic tests, prescription drugs and other types of care.

Even among people who have insurance, many studies have documented racial disparities.

In a recent report, the Department of Veterans Affairs found that black patients “tend to receive less aggressive medical care than whites” at its hospitals and clinics, in part because doctors provide them with less information and see them as “less appropriate candidates” for some types of surgery.

Some health economists contend that the disparities between rich and poor inevitably widen as doctors make gains in treating the major causes of death.

Nancy Krieger, a professor at the Harvard School of Public Health, rejected that idea. Professor Krieger investigated changes in the rate of premature mortality (dying before the age of 65) and infant death from 1960 to 2002. She found that inequities shrank from 1966 to 1980, but then widened.

“The recent trend of growing disparities in health status is not inevitable,” she said. “From 1966 to 1980, socioeconomic disparities declined in tandem with a decline in mortality rates.”

The creation of Medicaid and Medicare, community health centers, the “war on poverty” and the Civil Rights Act of 1964 all probably contributed to the earlier narrowing of health disparities, Professor Krieger said.

Robert E. Moffit, director of the Center for Health Policy Studies at the conservative Heritage Foundation, said one reason for the growing disparities might be “a very significant gap in health literacy” — what people know about diet, exercise and healthy lifestyles. Middle-class and upper-income people have greater access to the huge amounts of health information on the Internet, Mr. Moffit said.

Thomas P. Miller, a health economist at the American Enterprise Institute, agreed.

“People with more education tend to have a longer time horizon,” Mr. Miller said. “They are more likely to look at the long-term consequences of their health behavior. They are more assertive in seeking out treatments and more likely to adhere to treatment advice from physicians.”

A recent study by Ellen R. Meara, a health economist at Harvard Medical School, found that in the 1980s and 1990s, “virtually all gains in life expectancy occurred among highly educated groups.”

Trends in smoking explain a large part of the widening gap, she said in an article this month in the journal Health Affairs.

Under federal law, officials must publish an annual report tracking health disparities. In the fifth annual report, issued this month, the Bush administration said, “Over all, disparities in quality and access for minority groups and poor populations have not been reduced” since the first report, in 2003.

The rate of new AIDS cases is still 10 times as high among blacks as among whites, it said, and the proportion of black children hospitalized for asthma is almost four times the rate for white children.

The Centers for Disease Control and Prevention reported last month that heart attack survivors with higher levels of education and income were much more likely to receive cardiac rehabilitation care, which lowers the risk of future heart problems. Likewise, it said, the odds of receiving tests for colon cancer increase with a person’s education and income.

    Gap in Life Expectancy Widens for the Nation, NYT, 23.3.2008, http://www.nytimes.com/2008/03/23/us/23health.html?hp

Why Hospitals Want Your Credit Report

Many Are Using Personal Data
To Assess Your Ability to Pay;
Concerns About Denial of Care

March 18, 2008
The Wall Street Journal
Page D1
By SARAH RUBENSTEIN

In a development that consumer groups say raises privacy issues, a growing number of hospitals are mining patients' personal financial information to figure out how likely they are to pay their bills.

Some hospitals are peering into patients' credit reports, which contain information on people's lines of credit, debts and payment histories. Other hospitals are contracting with outside services that predict a patient's income and whether he or she is likely to walk away from a medical bill. Hospitals often use these services when patients are uninsured or have big out-of-pocket costs despite having health insurance.

Hospitals say the practice helps them identify which patients to pursue actively for payment because they can afford to pay. They say it also allows them to figure out more quickly which patients are eligible for charity care or assistance programs.

Administrators also argue that these credit checks can help them minimize losses. In 2006, nearly 5,000 community hospitals provided uncompensated care costing $31.2 billion, the vast majority of it charity care or unpaid patient bills, according to the American Hospital Association.

Hospitals have "a limited amount of resources that are available to actually execute the collection process," says Karen Godfrey, who runs revenue management at Baptist Health South Florida, a Miami system of five nonprofit hospitals that is likely to adopt one of these systems soon. "You want to concentrate on the ones that have the ability to pay."

Consumer advocates say the practice creates the potential for hospitals to misuse the information by denying or cutting back on patients' care if they can't pay. Hospitals say that doesn't happen. Hospitals often ask patients for permission to access their financial records, but such authorization is sometimes buried in the fine print. What's more, hospitals could scour a patient's financial records for credit lines and encourage the patient to tap them, despite high interest rates or other costs. "It has the potential to put people at risk financially," says Mark Rukavina, executive director of the Access Project, a research and advocacy group that focuses on medical debt.

Some hospitals that have begun checking patients' financial information will do so when they first register for treatment, while other hospitals hold off until after patients have received care. By law, hospitals aren't allowed to turn away patients in an emergency. Private hospitals typically aren't required to provide nonemergency treatment, while public hospitals are often required to give nonemergency care that's medically necessary, depending on local laws.

Consumers' credit reports are maintained at the three major credit bureaus, which determine credit-worthiness using criteria such as the well-known FICO score. But while a snapshot of how much credit you have available and your debt-payment history might help predict the likelihood of your repaying, say, a car loan, it's less reliable when it comes to medical-bill payments.

"Health care is always considered that last, almost discretionary, spending," says Stephen Mooney, senior vice president of patient financial services at Tenet Healthcare Corp., the Dallas for-profit hospital company.

To address this problem, Equifax Inc., one of the credit bureaus, has developed a separate credit score specific to health care that aims to predict if a patient can be expected to repay medical bills. The health-credit score is a number derived from a patient's traditional credit report. Equifax developed it by matching up a cross section of hospital payment records with patients' credit reports to look for common patterns.

SearchAmerica Inc. is a company that mines credit bureaus for data on behalf of its hospital clients, which it says have doubled in number to 900 since 2005. As patients register for treatment, the company advises hospitals on whether they are likely to qualify for financial assistance. SearchAmerica also generates a health-care credit score, which factors in a patient's history of paying hospital bills. After the patient receives care, the company factors in the size of the bill and tells the hospital how likely it is that the patient will pay.

Tenet, Fair Isaac Corp., developer of the widely used FICO score, and a venture-capital firm have each contributed $10 million to a start-up called Healthcare Analytics Inc. that is assembling bill-collection data from hospitals to develop methods for predicting patients' payment habits. The firm is analyzing the impact of health-care-specific factors such as insurance-plan design.

The Health Insurance Portability and Accountability Act, or Hipaa, a federal law that has patient-privacy provisions, doesn't bar hospitals from providing patient payment histories to consumer reporting agencies. SearchAmerica says it is required by its contracts with the hospitals to keep the information private. The company says it does not receive any medical information from the hospitals.

One institution -- Orlando Regional Healthcare, a nonprofit system of seven hospitals in Florida -- in 2007 changed its collection practices based on the new health-care credit scores. After patients receive care, the hospital system assigns them an Orlando Regional Risk Score by combining their Equifax health-credit score with any payment history at Orlando Regional. The patients are then categorized as low, medium or high risk.


The hospital figures there's little to be gained from applying more pressure to either low- or high-risk patients. But "we're trying to work with that [medium-risk] population more to try to find some method of payment," says Keith Eggert, Orlando Regional's vice president of revenue management.

Before adopting its new system, Orlando Regional says it sent three billing notices to all patients and waited 65 days before turning unpaid bills over to collection agencies. Now hospital employees call patients on day 15 who are considered at a medium risk of not paying, then call them back at 30-day intervals. The hospital also waits 120 days before turning those cases over to collection agencies.

Charity care at Orlando Regional also has grown to $60 million in treatment costs in 2007, up from $49 million a year earlier.

It's unclear how much latitude hospitals have to legally check a patient's financial information. Under the Fair Credit Reporting Act, hospitals are allowed to obtain patients' credit reports if they get their permission, says Rebecca Kuehn, an assistant director in the Federal Trade Commission's division of privacy and identity protection. And after a patient owes money, the hospital becomes a creditor and has strong grounds for checking a credit report even without permission, especially when a bill is long overdue, she says.

But Equifax and some other industry officials argue that a hospital typically takes on the role of creditor the minute a patient walks in the door, and thus has the right to check credit reports without specific permission before care is delivered. Ms. Kuehn says federal law seems to support that view, though it's hard to be sure without knowing the specific circumstances in which hospitals are pulling the reports prior to treatment. Credit bureau Experian Group Ltd. says it requires hospitals to get authorization for credit checks.

Some patients are uncomfortable with the practice. After being treated for heart problems, and his wife received treatment for lung cancer, Ralph Carter says the New Hanover Regional Medical Center in Wilmington, N.C., suggested he fill out an "extended payment application" to stretch out the family's payments on what their insurance didn't cover. Mr. Carter declined, saying the application asked for information on wages, bank accounts and monthly bills. It also asked for permission to check his credit reports.

"They had no business knowing the information," says Mr. Carter. He says he feared the hospital might take legal action to force him to make larger payments. Hospitals say patients' fears are largely misplaced. They say the personal financial information helps them avoid badgering patients who deserve charity care.

"If people have no ability [to pay] and we're able to determine that, then we have zero reason to put burdens on them that won't lead to any reasonable revenue," says Wayne Sensor, chief executive of Alegent Health, an Omaha, Neb.-based nonprofit system with nine hospitals.

One beneficiary was Shirley Lemm, an uninsured patient from Nebraska, who received free surgery at Alegent to fix severe knee problems after being turned down for treatment elsewhere. Ms. Lemm says she provided detailed financial information, which Alegent verified using a credit report from credit bureau Experian. Although Alegent got Ms. Lemm's permission when she signed a financial-assistance application, Ms. Lemm says she didn't realize the health system pulled her credit data. No matter, she says: "I finally got some help."

Health-credit scores provided to hospitals by firms like Equifax and SearchAmerica aren't accessible to the patients themselves. Both firms say hospital credit inquiries do not adversely affect patients' traditional credit reports.

    Why Hospitals Want Your Credit Report, WSJ, 18.3.2008, http://online.wsj.com/article/SB120580305267343947.html?mod=hpp_us_inside_today

1 in 4 Teen Girls Has Sexual Disease

March 11, 2008
Filed at 12:39 p.m. ET
By THE ASSOCIATED PRESS
The New York Times

CHICAGO (AP) -- At least one in four teenage girls nationwide has a sexually transmitted disease, or more than 3 million teens, according to the first study of its kind in this age group.

A virus that causes cervical cancer is by far the most common sexually transmitted infection in teen girls aged 14 to 19, while the highest overall prevalence is among black girls -- nearly half the blacks studied had at least one STD. That rate compared with 20 percent among both whites and Mexican-American teens, the study from the federal Centers for Disease Control and Prevention found.

About half of the girls acknowledged ever having sex; among them, the rate was 40 percent. While some teens define sex as only intercourse, other types of intimate behavior including oral sex can spread some infections.

For many, the numbers likely seem ''overwhelming because you're talking about nearly half of the sexually experienced teens at any one time having evidence of an STD,'' said Dr. Margaret Blythe, an adolescent medicine specialist at Indiana University School of Medicine and head of the American Academy of Pediatrics' committee on adolescence.

But the study highlights what many doctors who treat teens see every day, Blythe said.

Dr. John Douglas, director of the CDC's division of STD prevention, said the results are the first to examine the combined national prevalence of common sexually transmitted diseases among adolescent girls. He said the data, from 2003-04, likely reflect current rates of infection.

''High STD rates among young women, particularly African-American young women, are clear signs that we must continue developing ways to reach those most at risk,'' Douglas said.

The CDC's Dr. Kevin Fenton said given that STDs can cause infertility and cervical cancer in women, ''screening, vaccination and other prevention strategies for sexually active women are among our highest public health priorities.''

The study by CDC researcher Dr. Sara Forhan is an analysis of nationally representative data on 838 girls who participated in a 2003-04 government health survey. Teens were tested for four infections: human papillomavirus, or HPV, which can cause cervical cancer and affected 18 percent of girls studied; chlamydia, which affected 4 percent; trichomoniasis, 2.5 percent; and herpes simplex virus, 2 percent.

Blythe said the results are similar to previous studies examining rates of those diseases individually.

The results were prepared for release Tuesday at a CDC conference in Chicago on preventing sexually transmitted diseases.

HPV can cause genital warts but often has no symptoms. A vaccine targeting several HPV strains recently became available, but Douglas said it likely has not yet had much impact on HPV prevalence rates in teen girls.

Chlamydia and trichomoniasis can be treated with antibiotics. The CDC recommends annual chlamydia screening for all sexually active women under age 25. It also recommends the three-dose HPV vaccine for girls aged 11-12 years, and catch-up shots for females aged 13 to 26.

The American Academy of Pediatrics has similar recommendations.

Douglas said screening tests are underused in part because many teens don't think they're at risk, but also, some doctors mistakenly think, '''Sexually transmitted diseases don't happen to the kinds of patients I see.'''

Blythe said some doctors also are reluctant to discuss STDs with teen patients or offer screening because of confidentiality concerns, knowing parents would have to be told of the results.

The American Academy of Pediatrics supports confidential teen screening, she said.

------

On the Net:

CDC: http://www.cdc.gov

American Academy of Pediatrics: http://www.aap.org

    1 in 4 Teen Girls Has Sexual Disease, NYT, 11.3.2008, http://www.nytimes.com/aponline/us/AP-Teen-STDs.html

Colonoscopy Study Finds a Growth More Dangerous Than Polyps

March 5, 2008
The New York Times
By DENISE GRADY

An easily overlooked type of abnormality in the colon is the most likely type to turn cancerous, and is more common in this country than previously thought, researchers are reporting.

The findings come from a study of colonoscopy, in which a camera-tipped tube is used to examine the lining of the intestine. Generally, doctors search for polyps, abnormal growths that stick out from the lining and can turn into cancer. But another type of growth is much more dangerous, and harder to see because it is flat or depressed and similar in color to healthy tissue.

Japanese researchers became concerned about these flat lesions in the 1980s and ’90s, but studies here had mixed results and American doctors tended to think that flat growths were less common and less dangerous in the United States.

The new study, to be published Wednesday in the Journal of the American Medical Association, suggests otherwise.

Some doctors in this country were already alert to flat lesions, but the findings will pose a challenge to others, because it takes a trained and vigilant eye to see the growths and special techniques to remove them. The results also mean it is especially important that patients take the harsh laxatives that many dread in advance of the test. The flat lesions, hard to find even under the best conditions, will be impossible to see if any waste is left in the bowel.

Colon cancer is the second-leading cause of cancer death in the United States, after lung cancer, with about 154,000 new cases detected and 52,000 deaths a year. It is one of the few cancers that is totally preventable if precancerous growths are found and removed; it can also be cured with surgery alone if found early enough.

People who have just had a colonoscopy should not rush to schedule another one just to look for the flat growths, doctors said.

“I don’t think people have to panic that they’ve somehow been neglected and had poor care,” said Dr. David A. Rothenberger, deputy chairman of surgery at the University of Minnesota.

But he and other experts emphasized that people should see a doctor any time they have persisting symptoms that could indicate colon cancer, like rectal bleeding or a change in bowel habits — no matter how recently they had a colonoscopy. The test is highly reliable, but not perfect, doctors say.

Some doctors who perform colonoscopy just are not good at seeing flat lesions, but may improve with training and practice, said Dr. Douglas K. Rex, a gastroenterologist and professor of medicine at Indiana University.

“I think there are people who expect everything in there to be shaped like a golf ball,” he said. “It’s not.”

Dr. David Lieberman, chief of gastroenterology at Oregon Health and Science University, who wrote an editorial accompanying the study, said: “I think there will be some surprise. There has been in general some skepticism in the United States about how common flat and depressed lesions are and how important they are. So I think this study, coming from the United States and from a good group of investigators, will be a wake-up call to a lot of physicians and will prompt people to be looking for these lesions.”

The study, of 1,819 military veterans, mostly men, found that 9.35 percent had flat lesions, and those lesions were five times as likely as polyps to contain cancerous or precancerous tissue. Depressed or indented lesions were the least common but the most risky. Together, the flat or depressed lesions accounted for only 15 percent of the potentially cancerous growths found in the study, but were involved in half of the cancers. Once the doctors spotted the flat lesions, they sprayed a bluish dye on them to see their outlines better and remove them completely.

The first author of the study, Dr. Roy M. Soetikno of the Veterans Affairs Palo Alto Health Care System said, “The message for doctors is, Here is a large amount of data showing that these precursors of cancer, always believed to be a Japanese disease, are actually a disease here, and are important, because they are much more likely to be cancerous, and doctors need to spend the time to provide quality colonoscopy.”

The message to patients, Dr. Soetikno said, is that when preparing for colonoscopy, they must follow instructions to the letter and take the hated laxatives to make sure their bowels are empty so that doctors can see the lining.

If any waste remains, flat lesions will be buried by it. Studies have shown that in about a quarter of all colonoscopies, the bowel preparation is inadequate.

Dr. Rex said that male veterans tended to have more precancerous colon growths than other groups, so the rate of flat lesions in women or the general population might not be quite as high as those in the study.

Dr. Soetikno and his colleagues started an exchange program with doctors in Japan to learn their techniques for recognizing and removing the flat lesions.

American doctors should learn from overseas colleagues more often, Dr. Rothenberger said, adding, “We tend to get very smug about our abilities.”

The quality of colonoscopy has become a delicate issue, because an article in The New England Journal of Medicine in December 2006 found that some doctors were 10 times better than others at finding precancerous polyps. A major factor in their success was taking enough time to examine the colon thoroughly, as opposed to rushing through the procedure. Doctors who miss polyps would almost certainly miss flat lesions as well because they are harder to see. The new study underscores the need for careful examinations, because the flat lesions are more dangerous.

The study also raises doubts about whether “virtual colonoscopy,” performed by a CT scanner, will ever be able to take the place of the colonoscope inserted into the rectum, as many patients had hoped. The problem is that CT scans use X-rays to reveal shapes, and find polyps because they stick out. Flat lesions are unlikely to show up in such scans.

Studies show that from 0.3 percent to 0.9 percent of patients develop colon cancers within just a few years of having a colonoscopy and polyp removal — exactly what the procedure is supposed to prevent. Some doctors think that flat lesions, missed entirely during the colonoscopy or not fully removed, may account for some of these apparent failures.

Dr. Robert Smith, the director of screening for the American Cancer Society, said flat lesions were “a vexing issue” that had provoked a lot of arguments among doctors.

“This paper shows they’re more prevalent than we believed, and also quite serious with regard to the presence of features associated with an elevated risk of cancer,” Dr. Smith said.

The difficulty facing patients is how to be sure their doctors are doing a good job. Professional groups have issued guidelines about the best way to perform a colonoscopy, but they are recommendations, not rules. The groups also urge doctors to track their own success rates at finding precancerous growths to see how they measure up to standards, but even if they do keep track, the doctors do not have to share the data with anyone. And many people are loath to ask about it. The doctor wielding the scope is the last person most patients would want to offend.

“The patient really has no way to act as an informed consumer,” Dr. Smith said. “You can’t call up a facility and say, ‘By the way, is my doctor any good?’ or, ‘Tell me who the best one is.’ ”

He added: “For some physicians there is an expectation of trust, and it is offputting to have a patient request documentation of competence. However, some physicians know patients are hearing about these issues and are not offended by questions about performance and errors.”

    Colonoscopy Study Finds a Growth More Dangerous Than Polyps, NYT, 5.3.2008, http://www.nytimes.com/2008/03/05/health/research/05cancer.html?hp

Mental health crisis in N.O.

4 March 2008
USA Today
By Rick Jervis

NEW ORLEANS — Bernel Johnson showed all the signs.

He was diagnosed by a psychiatrist as aggressive, homeless and schizophrenic. He was kicked out of a Salvation Army homeless shelter late last year for holding a fork to a fellow resident's throat. On Jan. 4, Johnson was committed to a psychiatric facility for causing a disturbance at a bank. He was released and, a few weeks later, attacked New Orleans police Officer Nicola Cotton, 24, in a parking lot.

Johnson wrestled Cotton's service handgun from her and shot her 15 times, killing the officer, police said. Johnson remains in jail without bond, charged with first-degree murder.

New Orleans health and law enforcement officials say more cases such as this could unfold if the city's mental health crisis isn't resolved soon. Since Hurricane Katrina ravaged the city 2½ years ago, the number of public mental health facilities and community outreach centers has decreased dramatically, leaving the mentally ill without medication and monitoring.

Cotton's slaying, another recent high-profile killing involving a mentally ill suspect and an increased percentage of mentally ill inmates at Orleans Parish Prison have galvanized state and local health agencies into trying to resolve the crisis. Last week, state health officials unveiled a $90 million plan to improve the city's mental health facilities, including community-based treatments and housing subsidies for the mentally ill.

Cotton's killing was one of at least eight slayings since Katrina involving mentally ill people, says Orleans Parish Criminal District Court Judge Arthur Hunter, who also runs the state's only Mental Health Court.

"Nos. 9 and 10 could happen at anytime, anyplace," he says. "This is more than just a public crisis. This is a dangerous situation."

One of the casualties of Katrina's 2005 floods was Charity Hospital, a state-run facility that housed a psychiatric ward equipped with 140 inpatient beds and round-the-clock psychiatrists and social workers. It was the bulwark here for treating mentally ill patients, particularly those with violent tendencies, says Jeffrey Rouse, the Orleans Parish deputy coroner and psychiatrist who diagnosed Johnson in January. The hospital has been closed since Katrina.

'Treatment system collapses'

Now, instead of being treated at Charity, mentally ill criminal suspects often are arrested, burdening the city's overtaxed judicial system, Rouse says. That worsens the problem for patients, who may not get proper medication or monitoring in jail, he adds. The patients usually suffer from schizophrenia, bipolar disorder or depression.

"When your regular mental health treatment system collapses, the patients become criminalized," Rouse says.

Besides Cotton's killing, there was an incident last month involving a mentally ill suspect. Latina Williams, 23, a nursing student, gunned down two classmates at Louisiana Technical College in Baton Rouge on Feb. 8 before killing herself. Williams had shown signs of paranoia and had called a crisis counselor the morning of the shooting to say she was planning to kill herself.

New Orleans has a smaller prison population today than before Katrina, but an increasing percentage of those arrested have been mentally ill, says Sam Gore, a physician and medical director for the Orleans Parish Criminal Sheriff, which runs the city's jails.

"We've clearly noticed there's been an increase in demand for psychiatric treatment post-Katrina," Gore says.

Currently, Orleans Parish Prison, which has 60 psychiatric inpatient beds, is the city's biggest public ward for treating the mentally ill, Hunter says.

The patients get some treatment at the prison but are released without further monitoring, Hunter says.

"They have to get arrested to get any type of treatment," he says. "It makes no sense."

The lack of services comes as mental illness generally has multiplied in New Orleans. The percentage of the city's population showing some sign of mental illness has doubled from 6% before Katrina to 12% today, estimates Kevin Stephens, director of the city's health department.

Illness afflicts homeless

Mental illness also is rampant among the city's homeless, whose population has spiked since the storm from 6,200 to 12,000 today, says Sam Scaffidi of the New Orleans Police Homeless Assistance Unit. Under the Interstate 10 overpass at the corner of Claiborne Avenue and Canal Street downtown, homeless encampments have multiplied since Katrina into a sprawling colony of tents, soiled sleeping bags and cardboard caves.

Scaffidi says the number of mentally ill homeless people he encounters each day around the city has increased from about 10 before Katrina to more than 20 today.

Like the woman under the bridge who defecates each day into a bucket and throws it into Canal Street, yelling at anyone who passes near her, Scaffidi says. Or the woman in the French Quarter who drinks bottle after bottle of vodka and blocks the doorways of shops. Both women show signs of schizophrenia and have been arrested, he says. A few days later, they're back on the street, he adds.

Though the vast majority of homeless are harmless, some show violent traits, Scaffidi says. On Feb. 14, a 42-year-old homeless man living under the interstate stabbed another homeless man in the back and fled, police said. The victim survived.

"It's frustrating," says Scaffidi, a 10-year veteran of working with the homeless. "How do I talk to a person and convince him to get help when I have nowhere to bring him?"

State health officials are considering enhancing the city's community outreach centers, which monitor patients over weeks and months, and increasing affordable and public housing to get some of the patients off the streets, says William Payne, assistant secretary at the state Department of Health and Hospitals.

"There is significant demand and the demand currently exceeds the capacity to address it," Payne says. "It's clearly a critical situation."

    Mental health crisis in N.O. , UT, 4.3.2008, http://www.usatoday.com/news/nation/2008-03-04-katrina-health_N.htm

Editorial

The Global AIDS Fight

February 29, 2008
The New York Times
 

Congress and the White House are preparing to ramp up spending on programs to combat AIDS and related diseases around the world while removing some of the ideological blinders that have long undermined the effort to slow the spread of the AIDS virus. It will be a welcome strengthening of a foreign aid program that was already one of the shining accomplishments of the Bush administration.

The House Foreign Affairs Committee this week approved a bipartisan compromise, crafted in negotiations between House leaders and the White House, that would authorize a hefty $50 billion over the next five years to support campaigns against AIDS, tuberculosis and malaria. This represents a huge increase over the $19 billion appropriated in the first five years of the program and a significant increase over the new funding requested by President Bush. The president had originally proposed $30 billion over five years, primarily to fight AIDS, whereas the new bill would authorize perhaps $37 billion to $41 billion to the AIDS struggle.

The administration’s program started small five years ago to meet a perceived emergency as the AIDS epidemic spread out of control. It has already provided drug treatment to almost 1.5 million men, women and children and supportive care to millions of others. The focus for the next five years will be on making some of the initial gains sustainable.

In one farsighted move, money will be used to train some 144,000 new health care workers over the next five years to care for people infected with H.I.V., the virus that causes AIDS. That is at best a start on easing the severe shortage of health care workers in the developing world, which some estimates peg in the millions. Other donor nations will need to contribute to the training effort as well.

The most troublesome ideological constraint on the program — a requirement that one-third of the funds used for prevention services be spent on abstinence education — has been greatly eased. The bill calls for a balanced prevention program that would promote abstinence until marriage and fidelity thereafter, as well as condoms. It requires countries to report if abstinence and fidelity funding falls below a certain percentage, but it sets no firm percentage that has to be met.

The House is expected to pass the bill in the near future, and the Senate is considering its own version. Although some Republicans are grumbling over the amount of money proposed, it is important that Congress appropriate the full $50 billion if possible. Even that sum would almost certainly not provide universal access to treatment for all people infected with H.I.V., a goal that the major industrialized nations claim to be pursuing.

    The Global AIDS Fight, NYT, 29.2.2008, http://www.nytimes.com/2008/02/29/opinion/29fri1.html

Daring to Think Differently About Schizophrenia

February 24, 2008
The New York Times
By ALEX BERENSON

NORTH WALES, Pa. — SCIENTISTS who develop drugs are familiar with disappointment — brilliant theories that don’t pan out or promising compounds derailed by unexpected side effects. They are accustomed to small steps and wrong turns, to failure after failure — until, in a moment, with hard work, brainpower and a lot of luck, all those little failures turn into one big success.

For Darryle D. Schoepp, that moment came one evening in October 2006, while he was seated at his desk in Indianapolis.

At the time, he was overseeing early-stage neuroscience research at Eli Lilly & Company and colleagues had just given him the results from a human trial of a new schizophrenia drug that worked differently than all other treatments. From the start, their work had been a long shot. Schizophrenia is notoriously difficult to treat, and Lilly’s drug — known only as LY2140023 — relied on a promising but unproved theory about how to combat the disorder.

When Dr. Schoepp saw the results, he leapt up in excitement. The drug had reduced schizophrenic symptoms, validating the efforts of hundreds of scientists, inside and outside of Lilly, who had labored together for almost two decades trying to unravel the disorder’s biological underpinnings.

The trial results were a major breakthrough in neuroscience, says Dr. Thomas R. Insel, director of the National Institute of Mental Health. For 50 years, all medicines for the disease had worked the same way — until Dr. Schoepp and other scientists took a different path.

“This drug really looks like it’s quite a different animal,” Dr. Insel says. “This is actually pretty innovative.”

Dr. Schoepp and other scientists had focused their attention on the way that glutamate, a powerful neurotransmitter, tied together the brain’s most complex circuits. Every other schizophrenia drug now on the market aims at a different neurotransmitter, dopamine.

The Lilly results have fueled a wave of pharmaceutical industry research into glutamate. Companies are searching for new treatments, not just for schizophrenia, but also for depression and Alzheimer’s disease and other unseen demons of the brain that torment tens of millions of people worldwide.

Driving the industry’s interest is the huge market for drugs for brain and psychiatric diseases. Worldwide sales total almost $50 billion annually, even though existing medicines have moderate efficacy and have side effects that range from reduced libido to diabetes.

The glutamate researchers warn that their quest for new treatments for schizophrenia is far from complete. The results of the Lilly trial covered only 196 patients and must be validated by much larger trials, the last of which may not be finished until at least 2011. Other glutamate drugs are even further away from approval. And even if the drugs win that approval, they may be viewed skeptically by doctors who have been disappointed by side effects in other drugs that were once been hailed as breakthroughs.

Still, for Dr. Schoepp, the drug’s progress so far is cause for celebration — and relief.

“I don’t think people appreciate how much money, time and good technical research goes into what we do,” he says. “Sometimes, people think the idea is the thing. I think the idea can be the easy part.”

LILLY continues to develop LY2140023 and has begun a trial of 870 patients that is scheduled to be completed in January 2009. But Dr. Schoepp is no longer involved in its development. He left Lilly in April to become senior vice president and head of neuroscience research at Merck, where he oversees a division of 300 researchers and support staff members.

Dr. Schoepp’s new base is a modest office on the top floor of a four-story Merck building here in North Wales, north of Philadelphia. He has a view of the building’s big front lawn and a busy two-lane road called the Sumneytown Pike. The huge Merck research complex called West Point, where 4,000 scientists and support staff members work, is less than a mile to the north.

For Dr. Schoepp, 52, the Merck job is the latest stop in a research career that began at Osco Drug’s store No. 807 in downtown Bismarck, N.D. He grew up in Bismarck in a working-class family; at 16, he started working at the Osco, which has since closed. He quickly decided to become a scientist.

“I just found it fascinating,” he says. “I was hungry for science.” While reading a magazine for pharmacists, he noticed an ad for a free pamphlet published by Merck called “Pharmacists in Industry.” He wrote away for the pamphlet, which convinced him that he could have a career developing medicines.

He applied to North Dakota State University, where he focused on psychopharmacology, a discipline that studies the way chemicals affect the brain. “I was really interested in psychiatric disorders,” he says. “I fell in love with dopamine.”

His love affair was so consuming that his wife joked that “dopamine” would be his daughter’s first word.

Although scientists sometimes decide to study a disease because of problems it has caused among family members, Dr. Schoepp says his fascination with mental illness has been purely academic. “My family has more heart disease than anything else,” he says.

After graduating from North Dakota State, he received a scholarship to a doctoral program in pharmacology and toxicology at West Virginia University. He graduated in 1982. Nearly five years later, he joined Lilly, which was about to introduce Prozac, the first modern antidepressant — a drug that changed both psychiatry and the public perception of depression and mental illness.

Prozac became a blockbuster almost instantly after Lilly introduced it in 1987, making the company one of the most visible players in Big Pharma and giving it room to invest in long-shot scientific research. Ray Fuller, a Lilly scientist who was a co-discoverer of Prozac, encouraged Dr. Schoepp to focus his attention on glutamate.

Glutamate is a pivotal transmitter in the brain, the crucial link in circuits involved in memory, learning and perception. Too much glutamate leads to seizures and the death of brain cells. Excessive glutamate release is also one of the main reasons that people have brain damage after strokes. Too little glutamate can cause psychosis, coma and death.

“The main thoroughfare of communication in the brain is glutamate,” says Dr. John Krystal, a psychiatry professor at Yale and a research scientist with the VA Connecticut Health Care System.

Along with Bita Moghaddam, a neuroscientist who was at Yale and is now at the University of Pittsburgh, Dr. Krystal has been responsible for some of the fundamental research into how glutamate works in the brain and how it may be implicated in schizophrenia.

Schizophrenia affects about 2.5 million Americans, about 1 percent of the adult population, and it usually develops in the late teens or early to mid-20s. It is believed to result from a mix of causes, including genetic and environmental triggers that cause the brain to develop abnormally.

The first schizophrenia medicines were developed accidentally about a half-century ago, when Henri Laborit, a French military surgeon, noticed that an antinausea drug called chlorpromazine helped to control hallucinations in psychotic patients. Chlorpromazine, sold under the brand name Thorazine, blocks the brain’s dopamine receptors. That led the way in the 1960s for drug companies to introduce other medicines that worked the same way.

The medicines, called antipsychotics, gave many patients relief from the worst of their hallucinations and delusions. But they also can cause shaking, stiffness and facial tics, and did not help the cognitive problems or the so-called negative symptoms like social withdrawal associated with schizophrenia.

In the 1980s, drug companies looked for new ways to treat the disease with fewer side effects. By the mid-1990s, they had introduced several new schizophrenia medicines, including Zyprexa, from Lilly, and Risperdal, from Johnson & Johnson. At the time, the new medicines were hailed as a major advance — and the companies marketed them that way to doctors and patients.

In fact, the new medicines, called second-generation antipsychotics, had much in common with the older drugs. Both worked mainly by blocking dopamine and had little effect on negative or cognitive symptoms. The newer medicines caused fewer movement disorders, but had side effects of their own, including huge weight gain for many patients. Many doctors now complain that the companies oversold the second-generation compounds and that new treatments are badly needed.

“People say that there are drugs to treat schizophrenia,” says Dr. Carol A. Tamminga, professor of psychiatry at the University of Texas Southwestern, in Dallas. “In fact, the treatment for schizophrenia is at best partial and inadequate. You have a cadre of cognitively impaired people who can’t fit in.”

WHILE most of the industry focused on second-generation medicines during the 1980s and 1990s, a handful of academic and industry researchers found intriguing hints that glutamate might provide an alternative treatment pathway.

Psychiatrists and neuroscientists have wondered about a possible connection between glutamate and schizophrenia since the early ’80s, when they first learned that phencyclidine, the street drug commonly called PCP, blocks the release of glutamate.

People who use PCP often have the hallucinations, delusions, cognitive problems and emotional flatness that are characteristic of schizophrenia. Psychiatrists noted PCP’s side effects as early as the late 1950s. But they lacked the tools to determine how PCP affected the brain until 1979, when they found that it blocked a glutamate receptor, called the NMDA receptor, that is at the center of the transmission of nerve impulses in the brain.

The PCP finding led a few scientists to begin researching glutamate’s role in psychosis and other brain disorders. By the early 1990s, they discovered that besides triggering the primary glutamate receptors — NMDA and AMPA — glutamate also triggered several other receptors.

They called these newly found receptors “metabotropic,” because the receptors modified the amount of glutamate that cells released rather than simply turning circuits on or off. Because glutamate is so central to the brain’s activity, directly blocking or triggering the NMDA and AMPA receptors can be very dangerous. The metabotropic receptors appeared to be better targets for drug treatment.

“Rather than acting as an all-or-nothing signal, they fine-tune that signal and modulate that signal,” said P. Jeffrey Conn, director of a Vanderbilt University drug research program. “It’s really an attempt to be very subtle in the way that you regulate the system.”

During the 1990s, molecular biologists discovered genes for eight metabotropic glutamate receptors, which were located at different places inside nerve cells and had different structures. The finding allowed for the possibility that drug companies could create chemicals to turn them on and off selectively, rather than hitting all of them at once.

For Dr. Schoepp and others, finding the receptors was only the first part of the struggle. They also had to find chemicals that would either block or trigger the receptors selectively. At the same time, the chemicals had to be relatively easy to formulate and capable of crossing the blood-brain barrier, which protects the brain from being easily penetrated by outside agents.

The work was arduous, but the Lilly scientists made slow progress. In 1999, Dr. Schoepp and two other scientists published a 46-page research paper that detailed scores of different chemicals that produced reactions at the glutamate sites.

At about the same time, scientists at Yale, led by Dr. Moghaddam, were demonstrating that activating metabotropic glutamate receptors in rats could reverse the effects of PCP — a seminal finding, providing the first proof that altering the path of glutamate transmission in the brain might help relieve the symptoms of psychosis.

Although the finding in rats was promising, developing animal models for schizophrenia and other brain diseases is extremely difficult, said Paul Greengard, professor of molecular and cellular neuroscience at Rockefeller University.

Even when compared with diseases like cancer, brain disorders are notoriously complex. Scientists have only a limited understanding of the chemistry of consciousness, or of how problems in the brain’s electrical circuitry affect the ability to form memories, learn or think.

“We do not know with any of these neuropsychiatric disorders what the ultimate basis is,” Dr. Greengard says. “Let’s say you could find that too much of protein X was involved in schizophrenia. Would you then know what schizophrenia is? You would not.”

Nonetheless, the findings in rats were promising. Those studies, as well as Dr. Krystal’s tests in 2001 of volunteers given ketamine, a drug that has effects similar to PCP, hinted that the glutamate drugs might help to treat the cognitive and negative symptoms of schizophrenia. Drugs currently on the market do little to treat those symptoms.

Even before the findings at Yale, Lilly had put its first metabotropic glutamate receptor compound into human testing. Researchers initially tested the drug on patients with panic disorder, and it showed some positive results. But Lilly stopped human testing of the drug in 2001 when long-term testing in animals showed that it caused seizures.

Even so, Lilly decided that it had enough evidence to justify tests of another chemical compound, LY404039, that affected the same receptors.

“They had to take a risk on letting these drugs be tested on models or for disorders that were justified purely on pretty basic science,” Dr. Krystal says. “There is nothing with these drugs that is straightforward or makes developing them a basic path.”


When it tried to test LY404039 in humans, the company ran into yet another hurdle. The human body didn’t easily absorb it. So Lilly created a drug that the body could absorb, LY2140023, which is metabolized into LY404039 in the body.

Bingo. LY2140023 was the drug that got Dr. Schoepp jumping out of his office chair in 2006, nearly three years after the first trials in humans began. In the Lilly test, the drug was slightly less effective over all than Zyprexa, which is considered the most effective among the widely used schizophrenia treatments.

But LY2140023 also appeared to have fewer side effects than Zyprexa, which can cause severe weight gain and diabetes. The new drug also appeared to improve cognition, something that existing treatments don’t do, said Dr. Insel of the National Institute of Mental Health.

IF Lilly’s new round of tests confirms the drug’s efficacy by early next year, the company is likely to move ahead to an even larger clinical trial, involving thousands of patients, that could lead to federal approval for the compound. Still, approval is at least three to four years away, and other big drug makers are already scrambling to compete with Lilly.

In January, Pfizer agreed to pay Taisho Pharmaceutical, a Japanese company, $22 million for the rights to develop Taisho’s glutamate drug for schizophrenia. Taisho will receive more payments if the drug moves forward in development.

Since it hired Dr. Schoepp, Merck has also been moving aggressively. It has struck two deals since December to work with Addex Pharmaceuticals, a Swiss company, to develop glutamate drugs for schizophrenia, Parkinson’s and other diseases. Merck has paid Addex $25 million so far, with more payments to come if the drugs move forward.

Another glutamate drug, meanwhile, has been shown in preclinical studies to reverse mental retardation in adult rats, a finding that previously appeared impossible, Dr. Insel said.

Dr. Steven M. Paul, the president of Lilly Research Laboratories, says Lilly expects competition in glutamate research to intensify. “We’d like to believe we have a head start here, and hopefully a good head start,” he says. “But this area will heat up here; this will be an area where there will be a lot of investment.”

For Dr. Schoepp, the sudden interest in glutamate is exciting, and he acknowledges that he eagerly awaits the results of the large Lilly trial early next year. And what if the drug fails in that trial, after all the work that he and scientists around the world have put in?

“I would probably go out and have a beer,” he says. “You have to define failure. If you collect information and it tells you what you need to know, you’re not a failure.”

    Daring to Think Differently About Schizophrenia, NYT, 24.2.2008, http://www.nytimes.com/2008/02/24/business/24drug.html

Health Plans

Lacking Cure, a New Tack on a Muscle Disease

February 20, 2008
The New York Times
By REED ABELSON

For more than four decades, on telethons featuring celebrity performers and children in wheelchairs, Jerry Lewis has been raising money each Labor Day for the Muscular Dystrophy Association and the disease that helped make “poster child” part of the American idiom.

On the most recent telethon, which was staged in Las Vegas and raised $63.8 million, the “Law and Order” actress Mariska Hargitay spoke of patients’ “hope that M.D.A. research will lead to treatments and cures.” Mr. Lewis, who has never disclosed why he chose this disease as his cause, once again closed the broadcast with an emotional rendition of the song “You’ll Never Walk Alone.”

But for all the money collected toward a cure, Duchenne muscular dystrophy, the most common form of the disease, still confines thousands of boys in this country to wheelchairs in their early teens. Many do not live past their 20s.

It is a stark reminder of how American medicine — with its focus on breakthrough treatments — can sometimes fail a complex, rare and stubbornly uncurable disease. Single-minded in their pursuit of a cure, doctors and researchers for years all but ignored the necessary and unglamorous work of managing Duchenne (pronounced doo-SHEN) as a chronic condition.

The approach is changing at a few medical centers, which are focused on making better use of available therapies to eke out longer lives for their patients. Rather than concentrate only on a cure, some researchers are now intent on developing drugs that may alleviate the effects of the disease.

But, absent a cure, too many doctors around the country still assume there is little or nothing that can be done for the muscle-wasting condition, parents and specialists say.

“We’re in a stone age with Duchenne,” said Dr. Linda H. Cripe, a pediatric cardiologist at the Cincinnati Children’s Hospital Medical Center. She describes Duchenne patients as “a group of kids that pediatric medicine had forgotten, a group of lost boys.”

Among those is Josh Winheld, who years ago served as the Muscular Dystrophy Association’s poster boy in Southeastern Pennsylvania. Now, at age 29, Mr. Winheld is among the oldest Duchenne patients seen at the Children’s Hospital of Philadelphia, in part because of the unusually close oversight of his doctors. But the recent discussion of new drugs, however promising, holds little hope for him because he is already almost completely paralyzed.

“I feel totally lost,” he said.

Using a ventilator to help him breathe and a defibrillator to regulate his heart, and nourished by a feeding tube, he is able to move his head and operate his motorized wheelchair with a slight movement of his fingers.

He lives outside of Philadelphia with his parents and requires around-the-clock care. His medical expenses are covered by a combination of his parents’ private insurance and state assistance.

Duchenne is caused by a mutation of the gene for dystrophin, a protein in muscle. The disease occurs almost exclusively in males, about once in every 3,500 live births, and occurs about a third of the time when there is no family history of the disease.

With the discovery of the gene in 1986, most of the research attention and financing focused on gene therapy — coming up with a way to cure the disease by replacing the defective gene.

“There was great hope at the time,” recalled Mr. Winheld, who has his own blog (winheldsworld.blogspot.com) and is publishing his memoirs. “We always thought ‘cure.’ ”

But the size of the gene and the variety of mutations have made even diagnosis problematic and researchers are now looking elsewhere for an answer.

The lack of interest in the mundane has also slowed progress in knowing what available therapies are the most useful. Large pharmaceutical companies often ignore a rare disease like Duchenne, and they are unwilling to undertake further research into treatments like steroids, where any benefits they show are shared by other manufacturers.

“The economics aren’t there,” said Charles Farkas, head of the health care practice in the Americas for Bain & Company.

The current focus has changed to trying to identify the patient’s mutation and then using a cocktail of different drugs tailored for that specific mutation.

“For too long, I was stuck on it as the home run or nothing,” said H. Lee Sweeney, a professor and medical researcher at the University of Pennsylvania School of Medicine, who is among the researchers now taking a different approach. “The home run may skip the next two generations of these kids,” he said.

Others are pushing doctors to focus on making the best use of what therapies are now available. “For a very long time, this disease was no hope and no help,” said Patricia Furlong, founding president of Parent Project Muscular Dystrophy, a nonprofit group in Middletown, Ohio, who lost two sons to the disease. Her group has been instrumental in prodding doctors to concentrate on helping existing patients.

And it is often the parents who insist the doctors keep trying.

Two years ago, a 16-year-old Duchenne patient named Anthony Hoel stopped walking. His doctors in Minneapolis assumed there was nothing they could do and told Anthony’s father, Tom, to accept the fact that his son would be in a wheelchair. The doctors “were content to follow the old rule book,” said Tom Hoel.

About a week after corrective surgery and extensive rehabilitation at Cincinnati Children’s Hospital, Anthony, now 18, walks with the aid of leg braces.

“He is a real success story,” said Dr. Brenda Wong, Anthony’s doctor at Cincinnati.

The challenge for Josh Winheld’s doctor, Richard Finkel, in caring for someone whose disease is advanced is to keep a close watch on his patient so he can quickly address any problems.

During a recent visit, for example, a nutritionist went over Josh’s diet, making sure he got enough calories but not too much liquid to stress his heart, while Dr. Finkel examined Josh carefully and tried to determine if there were any changes in his condition.

Dr. Finkel is also among the doctors studying a new drug aimed specifically at a mutation that causes about 15 percent of the cases. Clinical trials for the drug, PTC124, are expected to begin enrolling patients early this year.

To date, the greatest progress has been through the use of steroids. But exactly when steroids should be started, which work best and how best to manage the side effects still remain unclear.

And unlike their counterparts in cystic fibrosis, a disease where specialists have successfully stretched life expectancy for patients well into their adulthood, doctors have been slow to develop clear standards of care and aggressively track the results of varying treatments to determine how best to manage the disease.

“We’ve had the tools, and we haven’t used them as effectively,” acknowledged Dr. Finkel.

The result is that patients are often treated much later than they should be, with some doctors referring a patient to a cardiologist only after he has developed heart failure or waiting too long to start a patient on steroids.

The Muscular Dystrophy Association, which raises tens of millions each year through Jerry Lewis’s telethon and other efforts, has also been criticized for a lack of focus on the specific needs of patients with Duchenne.

The organization finances some 225 clinics across the country, including the one at Children’s Hospital of Philadelphia. While Duchenne is the most common of the dystrophies, the association also raises money and provides services for more than three dozen conditions, including amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

The association has no direct oversight of the clinics, some of which may have little experience in treating a patient with Duchenne.

Dr. Valerie A. Cwik, the association’s medical director, says the group is now working to create a formal research network to gather and share information about Duchenne. “People have recognized there are gaps in our knowledge of this disease,” she said.

There is also a federal effort under way to draft recommendations to treat Duchenne. The Centers for Disease Control and Prevention says these recommendations are likely to be made public late this year or early next year. “That is going to go a long way to standardize care,” Dr. Cwik said.

And even as experts say there is significant promise in some of the new drugs being studied, doctors like Dr. Wong at Cincinnati say they need to remain committed to making the seemingly small advances that buy patients like Anthony Hoel more time on his feet, or give Josh Winheld a chance to complete his graduate degree once his memoirs are published.

“The outcome can be changed if you tweak little, little details,” Dr. Wong said.

    Lacking Cure, a New Tack on a Muscle Disease, NYT, 20.2.2008, http://www.nytimes.com/2008/02/20/business/20dystrophy.html?hp

US Cancer Deaths Rose by 5, 400 in 2005

February 20, 2008
Filed at 3:02 a.m. ET
By THE ASSOCIATED PRESS
The New York Times

ATLANTA (AP) -- U.S. cancer deaths rose by more than 5,000 in 2005, a somewhat disappointing reversal of a two-year downward trend, the American Cancer Society said in a report issued Wednesday.

The group counted 559,312 people who died from cancer.

The cancer death rate among the overall population continued to fall, but only slightly, after a couple of years of more dramatic decline.

In 2005, there were just under 184 cancer deaths per 100,000 people, down from nearly 186 the previous year. Experts said it wasn't surprising that the rate would stabilize.

The cancer death rate has been dropping since the early 1990s, and early in this decade was declining by about 1 percent a year. The actual number of cancer deaths kept rising, however, because of the growing population.

So it was big news when the rate dropped by 2 percent in both 2003 and 2004, enough to cause the total number of cancer deaths to fall for the first time since 1930.

President Bush and others hailed that as a sign that federally funded research was making strides against the disease.

But now the death rate decline is back to 1 percent. And the 2005 numbers show annual cancer deaths are no longer falling, but are up more than 5,400 since 2004.

''The declining rate was no longer great enough to overcome the increase in population,'' said Elizabeth Ward, a co-author of the cancer society report

Officials with the organization say they don't know why the decline in the death rate eased.

It may be that cancer screenings are not having as big an effect as they were a few years ago, said Dr. Peter Ravdin, a research professor in biostatistics at the University of Texas M.D. Anderson Cancer Center in Houston.

One possible example: In 2004, the largest drop in deaths among the major cancers was in colorectal cancer. Experts gave much of the credit to colonoscopy screenings that detect polyps and allow doctors to remove them before they turn cancerous. They also mentioned ''the Katie Couric effect'' -- a jump in colonoscopy rates after the ''Today'' show host had the exam on national television in 2000.

In the new report, the colorectal cancer death rate decreased by about 3 percent from 2004 to 2005, after plunging 6 percent from 2003 to 2004.

Colorectal cancer screening rates through 2003 did not show a decline. But it's possible they have fallen since then, Ravdin said.

Cancer society officials have also voiced concern that cancer deaths may increase as Americans lose health insurance coverage and get fewer screenings.

The good news is the cancer death rate is still declining, and that since the early 1990s is down more than 18 percent for men and more than 10 percent for women. Those reductions translate to more than half a million cancer deaths avoided, according to the cancer society.

Experts attribute the success to declines in smoking and to earlier detection and more effective treatment of tumors.

------

On the Net:

American Cancer Society report: www.cancer.org/statistics

    US Cancer Deaths Rose by 5, 400 in 2005, NYT, 20.2.2008, http://www.nytimes.com/aponline/us/AP-Cancer-Deaths.html

Reports of Gunman’s Use of Antidepressant Renew Debate Over Side Effects

February 19, 2008
The New York Times
By BENEDICT CAREY

Steven P. Kazmierczak stopped taking Prozac before he shot to death five Northern Illinois University students and himself, his girlfriend said Sunday in a remark likely to fuel the debate over the risks and benefits of drug treatment for emotional problems.

Over the years, the antidepressant Prozac and its cousins, including Paxil and Zoloft, have been linked to suicide and violence in hundreds of patients. Tens of millions of people have taken them, and doctors say it is almost impossible to tell whether the spasms of violence stem in part from drug reactions or the underlying illnesses.

“It’s a real chicken-and-egg sort of situation,” said Dr. Jane E. Garland, director of the Mood and Anxiety Disorders Clinic at BC Children’s Hospital in Vancouver, British Columbia.

Dr. Garland said some people could and did become agitated and unpredictable in response to the drugs, usually just after starting to take them or soon after stopping.

“But it’s hard to make a case for a withdrawal reaction here, because Prozac comes out of the system gradually,” she said.

The girlfriend, Jessica Baty, said in an interview on CNN that Mr. Kazmierczak took Prozac to battle anxiety and compulsive behavior but that it “made him feel like a zombie and lazy.”

She said that in the days leading up to the shooting he was not behaving erratically, as university officials had suggested.

Much of the debate over the side effects of antidepressants focuses on erratic behavior like the cautious college student who stabs herself or the good husband and father who buys a gun and shoots himself.

The drug labels warn about agitation and severe restlessness, and display a prominent caution that the medications increase the risk of suicidal thinking and behavior in some children and young adults.

Psychiatrists said Monday that stopping an antidepressant could cause effects like lightheadedness, nausea and agitation as the brain adjusted. Among the most commonly prescribed drugs, Prozac is the least likely to cause withdrawal effects because it stays in the system longest, the doctors said.

“A small dose of Prozac is what you might use to block withdrawal symptoms when you take a patient off one of the other drugs,” said Dr. Donald Klein, an emeritus professor of psychiatry at Columbia who has consulted with drug companies.

Sara Bostock, of Atherton, Calif., whose daughter committed suicide shortly after taking Paxil, acknowledged that the interaction between drug effects and underlying emotional distress was hard to untangle.

Ms. Bostock wrote in an e-mail message, “As an observer and suicide survivor, my main wish is that medical professionals, regulatory authorities and other scientists will examine closely the entire medical and treatment history of the perpetrators of these violent incidents in which innocent people are victims.”

She is a founder of ssristories.com, a Web site that has tallied 2,000 news reports of violent acts in which people were thought to be taking antidepressants or had recently stopped them.

“If it weren’t for us, many of these stories would be lost to oblivion forever,” Ms. Bostock said.

Psychiatrists say the debate on such side effects, particularly suicide in the last four years, has driven many patients from drugs that could help save their lives. The psychiatrists emphasize that patients should be closely monitored for changes in behavior when starting or tapering off a medication.

Advocates on both sides agree that catalogs of violent acts are not enough and that news reports are incomplete. Only more thorough investigation and careful tracking of drug side effects, they say, will clarify the links between drug treatment and violent behavior.

Dr. Michael Stone, a professor of clinical psychiatry at Columbia, maintains a database of 1,000 violent crimes, including mass murders, going back decades. In many cases the accused had stopped taking drugs for schizophrenia, Dr. Stone said.

“I only have a handful of cases,” he added, “where the person was on an antidepressant.”

    Reports of Gunman’s Use of Antidepressant Renew Debate Over Side Effects, NYT, 19.2.2008, http://www.nytimes.com/2008/02/19/us/19depress.html

Midlife Suicide Rises, Puzzling Researchers

February 19, 2008
The New York Times
By PATRICIA COHEN

Shannon Neal can instantly tell you the best night of her life: Tuesday, Dec. 23, 2003, the Hinsdale Academy debutante ball. Her father, Steven Neal, a 54-year-old political columnist for The Chicago Sun-Times, was in his tux, white gloves and tie. “My dad walked me down and took a little bow,” she said, and then the two of them goofed it up on the dance floor as they laughed and laughed.

A few weeks later, Mr. Neal parked his car in his garage, turned on the motor and waited until carbon monoxide filled the enclosed space and took his breath, and his life, away.

Later, his wife, Susan, would recall that he had just finished a new book, his seventh, and that “it took a lot out of him.” His medication was also taking a toll, putting him in the hospital overnight with worries about his heart.

Still, those who knew him were blindsided. “If I had just 30 seconds with him now,” Ms. Neal said of her father, “I would want all these answers.”

Mr. Neal is part of an unusually large increase in suicides among middle-aged Americans in recent years. Just why thousands of men and women have crossed the line between enduring life’s burdens and surrendering to them is a painful question for their loved ones. But for officials, it is a surprising and baffling public health mystery.

A new five-year analysis of the nation’s death rates recently released by the federal Centers for Disease Control and Prevention found that the suicide rate among 45-to-54-year-olds increased nearly 20 percent from 1999 to 2004, the latest year studied, far outpacing changes in nearly every other age group. (All figures are adjusted for population.)


For women 45 to 54, the rate leapt 31 percent. “That is certainly a break from trends of the past,” said Ann Haas, the research director of the American Foundation for Suicide Prevention.

By contrast, the suicide rate for 15-to-19-year-olds increased less than 2 percent during that five-year period — and decreased among people 65 and older.

The question is why. What happened in 1999 that caused the suicide rate to suddenly rise primarily for those in midlife? For health experts, it is like discovering the wreckage of a plane crash without finding the black box that recorded flight data just before the aircraft went down.

Experts say that the poignancy of a young death and higher suicide rates among the very old in the past have drawn the vast majority of news attention and prevention resources. For example, $82 million was devoted to youth suicide prevention programs in 2004, after the 21-year-old son of Senator Gordon H. Smith, Republican of Oregon, killed himself. Suicide in middle age, by comparison, is often seen as coming at the end of a long downhill slide, a problem of alcoholics and addicts, society’s losers.

“There’s a social-bias issue here,” said Dr. Eric C. Caine, co-director at the Center for the Study of Prevention of Suicide at the University of Rochester Medical Center, explaining why suicide in the middle years of life had not been extensively studied before.

There is a “national support system for those under 19, and those 65 and older,” Dr. Caine added, but not for people in between, even though “the bulk of the burden from suicide is in the middle years of life.”

Of the more than 32,000 people who committed suicide in 2004, 14,607 were 40 to 64 years old (6,906 of those were 45 to 54); 5,198 were over 65; 2,434 were under 21 years old.

Complicating any analysis is the nature of suicide itself. It cannot be diagnosed through a simple X-ray or blood test. Official statistics include the method of suicide — a gun, for instance, or a drug overdose — but they do not say whether the victim was an addict or a first-time drug user. And although an unusual event might cause the suicide rate to spike, like in Thailand after Asia’s economic collapse in 1997, suicide much more frequently punctuates a long series of troubles — mental illness, substance abuse, unemployment, failed romances.

Without a “psychological autopsy” into someone’s mental health, Dr. Caine said, “we’re kind of in the dark.”

The lack of concrete research has given rise to all kinds of theories, including a sudden drop in the use of hormone-replacement therapy by menopausal women after health warnings in 2002, higher rates of depression among baby boomers or a simple statistical fluke.

At the moment, the prime suspect is the skyrocketing use — and abuse — of prescription drugs. During the same five-year period included in the study, there was a staggering increase in the total number of drug overdoses, both intentional and accidental, like the one that recently killed the 28-year-old actor Heath Ledger. Illicit drugs also increase risky behaviors, C.D.C. officials point out, noting that users’ rates of suicide can be 15 to 25 times as great as the general population.

Jeffrey Smith, a vigorous fisherman and hunter, began ordering prescription drugs like Ambien and Viagra over the Internet when he was in his late 40s and the prospect of growing older began to gnaw at him, said his daughter, Michelle Ray Smith, who appears on the television soap “Guiding Light.” Five days before his 50th birthday, he sat in his S.U.V. in Bloomfield Hills, Mich., letting carbon monoxide fill his car.

Linda Cronin was 43 and working in a gym when she gulped down a lethal dose of prescription drugs in her Denver apartment in 2006, after battling eating disorders and depression for years.

Looking at the puzzling 28.8 percent rise in the suicide rate among women ages 50 to 54, Andrew C. Leon, a professor of biostatistics in psychiatry at Cornell, suggested that a drop in the use of hormone replacement therapy after 2002 might be implicated. It may be that without the therapy, more women fell into depression, Dr. Leon said, but he cautioned this was just speculation.

Despite the sharp rise in suicide among middle-aged women, the total number who died is still relatively small: 834 in the 50-to-54-year-old category in 2004. Over all, four of five people who commit suicide are men. (For men 45 to 54, the five-year rate increase was 15.6 percent.)

Veterans are another vulnerable group. Some surveys show they account for one in five suicides, said Dr. Ira Katz, who oversees mental health programs at the Department of Veterans Affairs. That is why the agency joined the national toll-free suicide hot line last August.

In the last five years, Dr. Katz said, the agency has noticed that the highest suicide rates have been among middle-aged men and women. Those most affected are not returning from Iraq or Afghanistan, he said, but those who served in Vietnam or right after, when the draft ended and the all-volunteer force began. “The current generation of older people seems to be at lesser risk for depression throughout their lifetimes” than the middle-aged, he said.

That observation seems to match what Myrna M. Weissman, the chief of the department in Clinical-Genetic Epidemiology at New York State Psychiatric Institute, concluded was a susceptibility to depression among the affluent and healthy baby boom generation two decades ago, in a 1989 study published in The Journal of the American Medical Association. One possible reason she offered was the growing pressures of modern life, like the changing shape of families and more frequent moves away from friends and relatives that have frayed social support networks.

More recently, reports of a study that spanned 80 countries found that around the world, middle-aged people were unhappier than those in any other age group, but that conclusion has been challenged by other research, which found that among Americans, middle age is the happiest time of life.

Indeed, statistics can sometimes be as confusing as they are enlightening. Shifts in how deaths are tallied make it difficult to compare rates before and after 1999, C.D.C. officials said. Epidemiologists also emphasize that at least another five years of data on suicide are needed before any firm conclusions can be reached about a trend.

The confusion over the evidence reflects the confusion and mystery at the heart of suicide itself.

Ms. Cronin explained in a note that she had struggled with an inexplicable gloom that would leave her cowering tearfully in a closet as early as age 9. After attempting suicide before, she had checked into a residential treatment program not long before she died, but after a month, her insurance ran out. Her parents had offered to continue the payments, but her sister, Kelly Gifford, said Ms. Cronin did not want to burden them.

Ms. Gifford added, “I think she just got sick of trying to get better.”

    Midlife Suicide Rises, Puzzling Researchers, NYT, 19.2.2008, http://www.nytimes.com/2008/02/19/us/19suicide.html?hp

Study Finds Cancer Diagnosis Linked to Insurance

February 18, 2008
The New York Times
By KEVIN SACK

ATLANTA — A nationwide study has found that the uninsured and those covered by Medicaid are more likely than those with private insurance to receive a diagnosis of cancer in late stages, often diminishing their chances of survival.

The study by researchers with the American Cancer Society also found that blacks had a higher risk of late diagnosis, even after accounting for their disproportionately high rates of being uninsured and underinsured. The study’s authors speculated that the disparity might be caused by a lack of health literacy and an inadequate supply of providers in minority communities. The study is to be published online Monday in The Lancet Oncology.

Previous studies have shown a correlation between insurance status and the stage of diagnosis for particular cancers. The new research is the first to examine a dozen major cancer types and to do so nationally with the most current data. It mined the National Cancer Data Base, which began collecting information about insurance in the late 1990s, to analyze 3.7 million patients who received diagnoses from 1998 to 2004.

The widest disparities were noted in cancers that could be detected early through standard screening or assessment of symptoms, like breast cancer, lung cancer, colon cancer and melanoma. For each, uninsured patients were two to three times more likely to be diagnosed in Stage III or Stage IV rather than Stage I. Smaller disparities were found for non-Hodgkins lymphoma and cancers of the bladder, kidney, prostate, thyroid, uterus, ovary and pancreas.

When comparing blacks to whites, the disparities in late-stage diagnosis were statistically significant for 10 of the 12 cancers. Hispanics also had a higher risk but less so than blacks.

The study’s authors concluded that “individuals without private insurance are not receiving optimum care in terms of cancer screening or timely diagnosis and follow-up with health care providers.” Advanced-stage diagnosis, they wrote, “leads to increased morbidity, decreased quality of life and survival and, often, increased costs.”

The study cites previous research that shows patients receiving a diagnosis of colon cancer in Stage I have a five-year survival rate of 93 percent, compared with 44 percent at Stage III and 8 percent at Stage IV.

“There’s evidence that not having insurance increases suffering,” said Dr. Otis W. Brawley, the American Cancer Society’s chief medical officer.

Not all cancer researchers believe that comprehensive screening and early detection is universally constructive. They argue that with certain cancers, like melanoma and prostate cancer, it can lead to misdiagnosis and overdiagnosis, with doctors identifying and treating tumors that may never cause serious problems. In some of those cases, surgery and drug therapies may actually shorten lives.

“Do these findings mean that patients without insurance are being diagnosed too late, or that insured patients are being excessively diagnosed?” said Dr. H. Gilbert Welch, a professor at Dartmouth who studies the usefulness of medical procedures. “And if it does mean that too many are being diagnosed late, we don’t know if it’s the problem of not being insured or a problem of cultural norms and patient education.”

Dr. Brawley said that the cancer society, the largest and wealthiest of the disease-centered philanthropies, received no more than 5 percent of its $1 billion in revenues from corporate donations, including some from medical suppliers and drug-makers that stood to profit from expanded screening. He said the group had rejected contributions from companies it considered directly connected to its research, and that he saw no conflict in the study on cancer and insurance.

The cancer society, Dr. Brawley said, has been conservative in its screening recommendations, which vary by cancer type and age. The study’s results, he said, would encourage broader screening for breast, colon and cervical cancers, where early detection has reduced death rates, but not necessarily for other cancers.

    Study Finds Cancer Diagnosis Linked to Insurance, NYT, 18.2.2008, http://www.nytimes.com/2008/02/18/health/18cancer.html

Inquiry Into Medical Rate Setting

February 13, 2008
By REUTERS
The New York Times

Attorney General Andrew Cuomo of New York said on Wednesday that he is conducting an industrywide investigation of health insurers into allegations that reimbursement rates were manipulated to defraud consumers.

At the center of the scheme is Ingenix, the nation’s provider of health care billing information, which serves as a conduit for rate data to the largest insurers in the country, Mr. Cuomo said in a statement.

Mr. Cuomo intends to sue Ingenix, its parent, UnitedHealth Group, and three additional subsidiaries.

UnitedHealth said it was in ongoing talks with Cuomo’s office and would continue to cooperate fully.

Mr. Cuomo has issued 16 subpoenas to the nation’s largest health insurance companies, including Aetna, Cigna and Empire Blue Cross/Blue Shield.

The subpoenas to insurers request documents on how they compute reasonable and customary rates, and communications between Ingenix and the insurers on the issue, among other information, Mr. Cuomo said.

A six-month investigation found that Ingenix operates a “defective and manipulative” database that most major health insurance companies use to set reimbursement rates for out-of-network medical expenses, Mr. Cuomo said.

The probe found that two other UnitedHealth subsidiaries used data provided by Ingenix to keep reimbursement rates artificially low and thereby force patients to assume more of the costs.

“Getting insurance companies to keep their promises and cover medical costs can be hard enough as it is,” he said. “But when insurers like United create convoluted and dishonest systems for determining the rate of reimbursement, real people get stuck with excessive bills and are less likely to seek the care they need.”

According to Mr. Cuomo’s office, Ingenix used insurers’ billing information to calculate a “reasonable and customary” rate for individual claims, generally taking into account the type of service, physician, and geographical location.

But the investigation found such rates produced by Ingenix were lower than the actual cost of typical medical expenses.

UnitedHealth’s insurance plans also hid their connection to Ingenix from plan members, Mr. Cuomo said.

In a statement, UnitedHealth said: “UnitedHealth Group recognizes the excellent health care delivered to patients by the physicians of New York and is committed to fair and appropriate payment for physicians, the state’s other health care providers and consumers,” UnitedHealth said in a statement.

Representatives of Aetna, Cigna and Empire Blue Cross said they would cooperate with Mr. Cuomo’s office.

Several physician and patient advocacy groups applauded the attorney general’s inquiry.

The investigation “calls into question the validity of a system that health insurers have used for years to reimburse physicians and their enrolled members,” Nancy Nielsen, president-elect of the American Medical Association, said in a statement.

UnitedHealth shares were off $1.76, or 3.7 percent, to $46.51 in afternoon trading on the New York Stock Exchange. Shares of most other health insurers were down less sharply.

A Wachovia analyst, Matt Perry, said that large-scale managed care industry investigations have historically taken years to play out and that any resulting fines have tended to be minor.

“If insurers are forced to reimburse out-of-network providers at a higher rate, they will likely expand their networks to include more doctors and/or raise premium rates to their customers to offset higher costs,” Mr. Perry said in a research note.

For UnitedHealth, the New York investigation comes only a few weeks after California regulators said they were seeking to fine a different UnitedHealth unit up to $1.3 billion over allegations of claims violations.

“UnitedHealth is fighting to stem attrition of customers and can ill-afford this latest salvo of negative headlines,” a Goldman Sachs analyst, Matthew Borsch, said in a research note.

    Inquiry Into Medical Rate Setting, NYT, 13.2.2008, http://www.nytimes.com/2008/02/13/business/reuters-health.html?hp

Scientists Find New Receptor for H.I.V.

February 11, 2008
The New York Times
By LAWRENCE K. ALTMAN

SAN FRANCISCO — Government scientists have discovered a new way that H.I.V. attacks human cells, an advance that could provide fresh avenues for the development of additional therapies to stop AIDS, they reported on Sunday.

The discovery is the identification of a new human receptor for H.I.V. The receptor helps guide the virus to the gut after it gains entry to the body, where it begins its relentless attack on the immune system.

The findings were reported online Sunday in the journal Nature Immunology by a team headed by Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.

For years, scientists have known that H.I.V. rapidly invades the lymph nodes and lymph tissues that are abundant throughout the gut, or intestines. The gut becomes the prime site for replication of H.I.V., and the virus then goes on to deplete the lymph tissue of the key CD4 H.I.V.-fighting immune cells.

That situation occurs in all H.I.V.-infected individuals, whether they acquired the virus through sexual intercourse, blood transfusions, blood contamination of needles and syringes, or in passage through the birth canal or drinking breast milk.

The findings appear to provide some, if not the main, answers to how and why that situation occurs.

Dr. Warner C. Greene, an AIDS expert and the director of the Gladstone Institute of Virology and Immunology here who was not involved in the research, said the findings were “an important advance in the field.”

“They begin to shed light on the mysterious process on why the virus preferentially grows in the gut,” Dr. Greene said in an interview.

Dr. Fauci, James Arthos, Claudia Cicala, Elena Martinelli and their colleagues showed that a molecule, integrin alpha-4 beta-7, which naturally directs immune cells to the gut, is also a receptor for H.I.V. A protein on the virus’s envelope, or outer shell, sticks to a molecule in the receptor that is linked specifically to the way CD4 cells home in on the gut, the researchers said.

Binding of the virus to the integrin alpha-4 beta 7 molecule stimulates activation of another molecule, LFA-1, which plays a crucial role in the spread of the virus from one cell to another. The actions ultimately lead to destruction of lymph tissue, particularly in the gut.

Several other receptor sites for H.I.V. are known. The most important is the CD4 molecule on certain immune cells; the molecule’s role as an H.I.V. receptor was identified in 1984.

Two other important receptors, known as CCR5 and CXCR4, were identified in 1996. CCR5 is a normal component of human cells and acts as a doorway for the entry of H.I.V. People who lack it because of a genetic mutation rarely become infected even if they have been exposed to H.I.V. repeatedly.

“The work we did took nearly two years, and there’s little doubt that what we have found is a new receptor,” Dr. Fauci said in an interview after giving a lecture here, adding that “we certainly have to learn a lot more about it.”

Scientists have sought to identify receptors because they offer targets for the development of new classes of drugs.

For example, last year the Food and Drug Administration approved for AIDS treatment a Pfizer drug, Selzentry or maraviroc, which works by blocking CCR5.

Dr. Fauci said he hoped his team’s findings would encourage other scientists from different disciplines to explore new ways to attack H.I.V.

A number of experimental drugs that block the integrin alpha-4 beta-7 receptor are being tested for the treatment of autoimmune disorders. Dr. Fauci said such drugs should also be studied for their potential benefit in AIDS treatment.

Organization of new trials in the next year or so could test such drugs in animals and humans to determine their safety and effectiveness against H.I.V., Dr. Fauci said.

One candidate is a drug, Tysabri or natalizumab, that is marketed for treatment of multiple sclerosis, Dr. Fauci said. Biogen/Elan makes Tysabri.

If trials for H.I.V. are successful, Dr. Fauci said, the drugs could be added to existing treatment regimens.

    Scientists Find New Receptor for H.I.V., NYT, 11.2.2008, http://www.nytimes.com/2008/02/11/health/11aids.html