HealthLawProf Blog

McCain's Health Plan

USAToday runs a short story on McCain's proposed health care plan.  David Jackson writes,

McCain, the presumptive GOP presidential nominee, wants everyone to get a tax credit to either buy insurance or offset the taxes on health care coverage obtained through work. The Arizona senator says variety and competition will help bring down costs. Bush has a similar tactic, offering tax deductions for health care costs.

"My approach to transforming health care is to put families in charge," McCain said Monday at Miami Children's Hospital in Florida, a possible swing state this fall.

Reuters news service provides more details on his plan and states,

On a campaign swing to highlight his health care proposals, the Arizona senator said he wanted to put individuals in charge of their health care, foster competition in insurance markets and reduce the prevalence of employer-based plans.  "Americans need new choices beyond those offered in employment-based coverage. Americans want a system built so that wherever you go and wherever you work, your health plan goes with you," McCain said at a Tampa cancer research hospital.

At the heart of McCain's plan is a tax credit of $2,500 for individuals and $5,000 for families that could be used to leave an employer-based plan and purchase cheaper, more suitable insurance on the open market -- creating competition that would lower the price.

"Insurance companies could no longer take your business for granted, offering narrow plans with escalating costs. It would help change the whole dynamic of the current system, putting individuals and families back in charge," he said. . . .

Clinton called McCain's approach "radical" and suggested it could force millions to lose their employer-based insurance.  "The McCain plan eliminates the policies that hold the employer-based health insurance system together, so while people might have a 'choice' of getting such coverage, employers would have no incentive to provide it," she said in a statement.

McCain said he would not force anyone to leave an employer-based program and would seek solutions for those with pre-existing medical conditions, including creating gap coverage and working with states that create insurance pools for high-risk individuals.

"Those without prior group coverage and those with pre-existing conditions do have the most difficulty on the individual market, and we need to make sure they get the high-quality coverage they need," McCain said. . . .

Elizabeth Edwards responds to McCain's health care plan here.  Hint:  She is not a big fan.

Future of Health Care Reform - The Lobbyists

Firedoglake reports on the latest survey completed by Columbia Journalism Review on the large amounts of money spent by health insurance companies to their lobbyists.  Christie Hardin Smith writes,

According to this CJR report, regarding a series of studies from Health Care Week and other industry groups, the health care industry, drug manufacturers and other related industry groups are doing everything they can to insure there are no changes to their current profit margins:

The insurance companies, of course, think the system is just fine, and they spent heavily to keep the status quo. Health Plan Week, an insurance industry trade pub, took a hard look, revealing that overall health insurance payments to lobbyists soared last year and are likely to grow again in the next couple of years as health reform becomes the biggest issue. A large percentage of that money, the magazine found, was focused on the Medicare Advantage issue, which was front and center last year. Analyzing disclosure forms from the Senate’s public records office, Health Plan Week found that fifteen health plans paid lobbyists more than $22 million in 2007, up from $18 million in 2006, a hefty chunk of change by any measure. WellCare Health Plans, a big seller of Medicare Advantage products that has gotten in trouble with regulators for its questionable sales practices, quadrupled its spending to $320,000 and paid half of that amount to the Washington law firm to plead its case on Medicare issues. Health Net and Tufts Health Plan more than doubled their spending, while insurance biggies like CIGNA and UnitedHealth Group substantially increased their lobbying budgets. Blue Cross and Blue Shield plans spent nearly $10 million....

A press release just issued by the Center for Responsive Politics further reinforces the money and health care story. Its message: Special interests spent $17 million for every day Congress was in session, and the drug industry spent most of all, paying lobbyists 25 percent more than they did last year. Did Harry Reid forget to mention them? Drug companies spent some $227 million on lobbying activities. The insurance industry was right behind with $138 million, and not far down was the hospital and nursing home industry, which spent some $91 million. When the Center pulled apart spending by organization, Pharma, the American Medical Association, and the American Hospital Association ranked three, four, and five on its list of top spenders. It’s too bad that the Center’s latest numbers haven’t gotten more press. For they, too show, the rocky path ahead for health reform. . . .

Health care isn't just about prenatal care and cancer exams, although both are very important. It's also about vaccines and control of dangerous contagions. And we don't have a handle on any of this because we've put profit ahead of care (YouTube)...way ahead. Think it can't be you? Think again...

The New Romance: Marrying for Health Insurance

Kaiser Family Foundation poll shows that approximately 7 percent of the population marries for health insurance.  The LATimes reports further on their findings,

Some people marry for love, some for companionship, and others for status or money. Now comes another reason to get hitched: health insurance.  In a poll released today, 7% of Americans said they or someone in their household decided to marry in the last year so they could get healthcare benefits via their spouse.

"It's a small number but a powerful result, because it shows how paying for healthcare is reflected not only in family budgets but in life decisions," said Drew E. Altman, president of the Kaiser Family Foundation, which commissioned the survey as part of its regular polling on healthcare.

On a broader scale, the survey found that healthcare costs outranked housing costs, rising food prices and credit card bills as a source of concern. Twenty-eight percent of those surveyed said they had experienced serious problems because of the cost of healthcare, compared with 29% who had problems getting a good job or a raise. Gasoline prices were the top economic worry, with 44% saying they had serious problems keeping up with increases at the pump.  . . . .

Healthcare inflation has been rising at about twice the rate of economic growth, and it's unclear how much of a difference better prevention, computerized medical records and other ideas for containing costs might prove to be.

But with employer-based health insurance averaging $12,000 for family coverage and $4,500 for individuals, the public concern with costs is understandable. Nearly a fourth of Americans said they had decided to keep or change jobs in the last year because of health insurance.

What surprised researchers was that such costs had become a factor in marriage decisions. "We should have asked about divorce," said Altman, joking.

Those who cited health insurance as a factor in deciding to marry tended to have modest incomes. About 6 in 10 were in households making less than $50,000 a year, said Mollyann Brodie, who directs Kaiser's opinion research. They also were younger, with 4 in 10 between 18 and 34.

"We don't know a lot more about them," Brodie said. "Just that they answered that of all the reasons for getting married, [health insurance] was also a reason, was surprising." . . .

The Kaiser polling, conducted April 3-13, surveyed a nationally representative sample of 2,003 adults, and has a margin of error of plus or minus 3 percentage points.

Banning Medical Freebies

The New York Times yesterday reported that the Association of Medical Colleges has recommended  a ban on free  items, including food, gifts, trips, and "ghost-writing services" from pharmaceutical companies and medical device manufacturers.  Gardiner Harris writes      

The proposed ban is the result of a two-year effort by the group, the Association of American Medical Colleges, to create a model policy governing interactions between the schools and industry. While schools can ignore the association’s advice, most follow its recommendations.  Rob Restuccia, executive director of the Prescription Project, a nonprofit group dedicated to eliminating conflicts of interest in medicine, said the report would transform medical education. “Most medical schools do not have strong conflict-of-interest policies, and this report will change that,” Mr. Restuccia said. The rules would apply only to medical schools, but they could have enormous influence across medicine, said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “We’re hoping the example set by academic medical colleges will be contagious,” Dr. Rothman said.

Drug companies spend billions wooing doctors — more than they spend on research or consumer advertising. Medical schools, packed with prominent professors and impressionable trainees, are particularly attractive marketing targets. So companies have for decades provided faculty and students free food and gifts, offered lucrative consulting arrangements to top-notch teachers and even ghost-wrote research papers for busy professors.  “Such forms of industry involvement tend to establish reciprocal relationships that can inject bias, distort decision-making and create the perception among colleagues, students, trainees and the public that practitioners are being ‘bought’ or ‘bribed’ by industry,” the report said.

A group of influential doctors decried these practices in a 2006 article in The Journal of the American Medical Association, and said that medical schools should ban them. In the article’s wake, the medical college association created a task force.

With Dr. Roy Vagelos, a former Merck chief executive, serving as the task force’s chairman and the chief executives of Pfizer, Eli Lilly, Amgen and Medtronic on the roster, some who advocate for greater restrictions on industry influence in medicine predicted that the report would be weak. They were wrong. . . . .

It recommended that schools set up centralized systems for accepting free drug samples or “alternative ways to manage pharmaceutical sample distribution that do not carry the risks to professionalism with which current practices are associated.” It suggested that schools audit independently accredited medical education seminars given by faculty “for the presence of inappropriate influence.” And it said the rules should apply to faculty even when off-duty or away from school.

Speakers’ bureaus and drug samples are pillars of the industry’s marketing operations, and many medical school professors have resisted efforts to restrict them. Only a handful of medical schools presently bar faculty members from serving on speakers’ bureaus, so if this recommendation is widely adopted, it could transform the relationship between medical school faculty and industry, and it could change substantially the way medical education is routinely delivered.

Indeed, the chief executives of Pfizer and Eli Lilly dissented from the report’s recommendation regarding speakers’ bureaus. “We continue to believe that these types of programs, which are subject to clear regulations regarding their content, can be worthwhile educational activities,” wrote Jeffrey B. Kindler of Pfizer and Sidney Taurel of Lilly. . . .

Today's Times has an editorial approving of the ban and urging further reform,

Outright bans would be imposed on personal gifts, industry-supplied food and meals, free travel that is not reimbursement for services and payment for attending industry-sponsored meetings. Also outlawed are the notorious ghostwriting services, in which a drug company drafts a journal article and then persuades a respected academic to sign on as the lead author, giving it a gloss of objectivity that it may not deserve.

Free drug samples, though not banned, would generally have to be accepted by a central pharmacy, presumably capable of assessing their value, not by individual doctors more susceptible to sales pitches.

Unfortunately, the task force, appointed by the Association of American Medical Colleges, flinched on some important issues.  It urged medical schools to “strongly discourage” faculty from participating in industry speakers’ bureaus, which pay influential doctors to promote the benefits of products, but it stopped short of calling for a complete ban on the highly dubious practice.

Similarly, the group did not call for an end to industry subsidies of continuing medical education programs that doctors must take to retain their licenses. Instead, it simply proposed steps to audit the content of the programs and ensure that they are scientifically objective. It is hard to see why doctors should not pay the full cost of their own continuing education.

Reminder Text Messages to Teens for Meds

The Cincinnati Enquirer reports today on a new program by Cincinnati Children's Medical Center to help remind teenagers to take their medications - text messages.   Peggy O'Farrell writes,

Tylor Thomas, 16, has never counted how many text messages he gets in a day, but it's a lot.  Tucked in among all those shout-outs from friends, one potentially lifesaving message arrives every morning around 9 for the Winton Hills teen.  "They just text me and tell me, 'Hi. Don't forget to take your asthma meds,' " Tylor said.  He's one of a handful of teens participating in a Cincinnati Children's Hospital Medical Center pilot project to determine how well text-message reminders work to help teens manage their asthma.

If text messages are an effective solution for asthma management, there's no reason they won't work for patients with diabetes or other chronic illnesses, said Maria Britto, an adolescent medicine specialist at Children's.  Britto, director of the center for innovation in chronic disease care and assistant vice president for chronic disease programs at Children's, coordinates the pilot project.  Whether they're 16 or 60, patients with chronic diseases aren't good about sticking to their treatment regimen, experts say. Only about half take their medicine when they're supposed to, the way they're supposed to, Britto said.

"The longer you have to take the medicine, the lower your adherence rate is. If you have strep throat, the doctor gives you an antibiotic and tells you to take it for 10 days, and it's not a big deal. But if it's a medication you have to take every day for a long time and it has side effects you don't like, you're not going to take it every day," she said.  Teens are a tricky patient population, as any parent can attest. Sometimes not taking their medicine is an attempt at independence.  More often, they just forget.

"One of the barriers to adherence is the fact that many asthma medications really work over the long term, in that they prevent symptoms from happening," said Dennis Drotar, a psychologist at Cincinnati Children's. "But teenagers live in the short-term, so today and tomorrow are more important than not having an asthma attack six months from now."  Tylor was diagnosed with asthma when he was about 3. His symptoms are pretty well controlled, but he uses an inhaler once a day to prevent asthma attacks.

Between school, playing on the basketball team and singing in the Miami Baptist Church choir, it's easy to forget about his inhaler.  "Sometimes, like if I'm playing, I'll skip it. If I need it later, then I'll take it," Tylor said.  Text messaging teens to take their medicine seemed like a natural fit, Britto said, especially once she and her colleagues noticed their patients were constantly texting, even during office visits.  It's a preferred form of communication, and it's so common that their friends won't notice they're getting one more message. . . .

Most texts are medication reminders. But as the new system takes hold, Britto said, the possibilities are endless, including sending appointment reminders and test results.

"We could send out messages about other issues, like avoiding triggers, or not going outside when there's a smog alert or the pollen count's too high. Or if someone is trying to quit smoking or change another behavior, we could send out messages," she said.

Marijuana and Organ Transplants

The Associated Press reports on an individual in need of a liver transplant but who was refused one dur partially to the fact that he used marijuana legally.  The AP states,

Timothy Garon’s face and arms are hauntingly skeletal, but the fluid building up in his abdomen makes the 56-year-old musician look eight months pregnant.  His liver, ravaged by hepatitis C, is failing. Without a new one, his doctors tell him, he will be dead in days. But Garon has been refused a spot on the transplant list, largely because he has used marijuana, even though it was legally approved for medical reasons.  “I’m not angry, I’m not mad; I’m just confused,” said Garon, lying in his hospital bed a few minutes after a doctor told him the hospital transplant committee’s decision Thursday.

With the scarcity of donated organs, transplant committees like the one at the University of Washington Medical Center use tough standards, including whether the candidate has other serious health problems or is likely to drink or do drugs.  And with cases like Garon’s, they also have to consider — as a dozen states now have medical marijuana laws — if using dope with a doctor’s blessing should be held against a dying patient in need of a transplant.

Most transplant centers struggle with how to deal with people who have used marijuana, said Dr. Robert Sade, director of the Institute of Human Values in Health Care at the Medical University of South Carolina.  “Marijuana, unlike alcohol, has no direct effect on the liver. It is, however, a concern ... in that it’s a potential indicator of an addictive personality,” Sade said.

The Virginia-based United Network for Organ Sharing, which oversees the nation’s transplant system, leaves it to individual hospitals to develop criteria for transplant candidates.  At some, people who use “illicit substances” — including medical marijuana, even in states that allow it — are automatically rejected. At others, such as UCLA Medical Center, patients are given a chance to reapply if they stay clean for six months. Marijuana is illegal under federal law. . . . .

Dr. Brad Roter, the Seattle physician who authorized Garon’s pot use for nausea, abdominal pain and to stimulate his appetite, said he did not know it would be such a hurdle if Garon were to need a transplant.  That’s typically the case, said Peggy Stewart, a clinical social worker on the liver transplant team at UCLA who has researched the issue. “There needs to be some kind of national eligibility criteria,” she said.  The patients “are trusting their physician to do the right thing. The physician prescribes marijuana, they take the marijuana, and they are shocked that this is now the end result,” she said.  No one tracks how many patients are denied transplants because of medical marijuana use.

Pro-marijuana groups have cited a handful of cases, including at least two patient deaths, in Oregon and California, since the mid- to late 1990s, when states began adopting medical marijuana laws.  Many doctors agree that using marijuana — smoking it, especially — is out of the question post-transplant.  The drugs patients take to help their bodies accept a new organ increase the risk of aspergillosis, a frequently fatal infection caused by a common mold found in marijuana and tobacco. . . .

Dr. Jorge Reyes, a liver transplant surgeon at the UW Medical Center, said that while medical marijuana use isn’t in itself a sign of substance abuse, it must be evaluated in the context of each patient.  “The concern is that patients who have been using it will not be able to stop,” Reyes said.
Dale Gieringer, state coordinator for the California chapter of NORML, the National Organization for the Reform of Marijuana Laws, scoffed at that notion.  “Everyone agrees that marijuana is the least habit-forming of all the recreational drugs, including alcohol,” Gieringer said. “And unlike a lot of prescription medications, it’s nontoxic to the liver.”  . . .

Abstinence-Only Debate

I am surprise there is much of a debate but apparently Congress is still wondering whether it is worth the many millions (ok, 1.3 billion and counting) dollars to continue to support abstinence-only sex education.  The LA Times reports,

Continued federal funding of abstinence-only sex education in public schools was debated before a House committee Wednesday amid questions about whether the government should sponsor a program that many experts say doesn't work.  Most of the 11 witnesses who appeared before the House Committee on Oversight and Government Reform advocated instead for comprehensive programs that include information about how teenagers can protect themselves from pregnancy or disease if they choose to engage in sexual activity.  "The concern that many of us have with abstinence-only programs is the idea that one size fits all," said Rep. Eleanor Holmes Norton (D-D.C.), a member of the panel. . . .

Proponents of abstinence education argued that society should set high standards for teenage sexual behavior. They would prefer, they said, that programs focus on the emotional, physical and societal repercussions of sex outside of marriage.

But several witnesses emphasized that despite 11 years of federally funded abstinence programs, at a cost of more than $1.3 billion, teens are still having sex and becoming infected with sexually transmitted diseases. Those who support comprehensive plans said teens should get the information they need to protect themselves.  A study released in December by the Centers for Disease Control and Prevention showed a rise in the teenage pregnancy rate in 2006, the first such increase in 15 years. Between 1991 and 2005, the rate dropped 34%.  When the government began funding abstinence-only sex education in 1996, 49 of 50 states signed up for such programs. California did not, and it has never sought such funding. Currently, only 33 states receive federal funds for the programs.

"Seventeen states have now said they will not accept funding," said Dr. Georges Benjamin, director of the American Public Health Assn. "For a health department to give up funding is a very important fact."  "Some states have looked at the federal requirements as the federal government telling them they had to only do it one way, and they didn't like it," said the committee chairman, Rep. Henry A. Waxman (D-Beverly Hills).

The federal government funds sex education programs that align to several requirements, including exclusively teaching that abstinence is the only way to avoid out-of-wedlock pregnancies and sexually transmitted infections and that sexual relations are acceptable only within a married, monogamous relationship. . . .

An October 2006 report by the Government Accountability Office found errors in the accuracy of information provided in some abstinence programs. The study was unable to reach any conclusions about the effectiveness of abstinence programs.

Another study, released Tuesday by the Heritage Foundation, a Washington-based conservative policy research center, reviewed 15 programs focused on abstinence education and found that in 11 of them, teenage sexual activity was significantly delayed or reduced. Several witnesses at the hearing questioned whether that study had been properly reviewed before publication.

Genetic Discrimination Bill Passes Senate

The Genetic Information Anti-Discrimination Act (GINA) passed the Senate yesterday.  The House is epxected to approved GINA quickly and President Bush has indicated he will sign it.  The New York Times reports,

People learning through genetic testing that they might be susceptible to devastating diseases wouldn't also have to worry about losing their jobs or their health insurance under anti-discrimination legislation the Senate passed Thursday.  The 95-0 Senate vote sends the Genetic Information Nondiscrimination Act back to the House, which could approve it early next week. President Bush supports the legislation.

The bill, described by Sen. Edward Kennedy as ''the first major new civil rights bill of the new century,'' would bar health insurance companies from using genetic information to set premiums or determine enrollment eligibility. Similarly, employers could not use genetic information in hiring, firing or promotion decisions. . . .

Genetic testing could lead to early, lifesaving therapy for a wide range of diseases with hereditary links such as breast and prostate cancer, diabetes, heart disease and Parkinson's disease.  ''But right now the ability to realize those goals is somewhat limited'' because of patients' fears that the information will be used against them, said Dr. David Herrington, a professor of cardiology at Wake Forest University and spokesman on genetic issues for the American Heart Association. The legislation ''will help them both be more willing to participate in research and avail themselves of the benefits of genetic testing.''

Congressional efforts to set federal standards to protect people from genetic discrimination go back more than a decade, to a time when there were only a small number of genetic tests. But now, with the mapping of the human genome in 2003, people have access to far more information about their hereditary disposition to such crippling afflictions as cystic fibrosis, Huntington's disease or Lou Gehrig's disease.

Bill sponsors said that has increased the likelihood that a prospective health insurance company or employer will reject a person because of concerns that person will suffer a costly disease in the future. . . .

A compromise worked out earlier this week tightens language to ensure there is a ''firewall'' between the part dealing with health plans and the section regarding employment, so as to discourage inappropriate claims.  It also makes clear that, while individuals are protected from discrimination based on genetic predisposition, insurance companies still have the right to base coverage and pricing on the actual presence of a disease.  ''We certainly improved the bill from a liability standpoint,'' said Coburn, an obstetrician. He said he was an adamant supporter of the legislation ''if it is not designed to feed the trial lawyers.'' . . .

Knowledge Concerning Medicare Part D's Cost Sharing

The Journal of the American Medical Association has posted the results of a recent study concerning the knowledge of Medicare Part D participants about various cost sharing aspects of this program.  The abstract describes the study and the results,

Design, Setting, and Participants Telephone interviews were conducted in 2007 in a stratified random sample of community-dwelling Kaiser Permanente-Northern California Medicare Advantage beneficiaries aged 65 years or older, with a gap in coverage if they exceeded $2250 in drug costs (N = 1040; 74.9% response rate). Half were selected to have reached the gap in 2006. In the source population of Medicare Advantage Prescription Drug plan beneficiaries, 8% entered the coverage gap in 2006. Models were adjusted for individual characteristics and weighted for sampling proportions.  ^{. . . . .}

Results An estimated 40% (95% confidence interval [CI], 35%-45%) of beneficiaries were aware that their drug plan in 2006 included a coverage gap; knowledge of the gap was greater among individuals who reached the gap during the year. Approximately 36% (95% CI, 32%-41%) of beneficiaries reported at least 1 of the following responses to drug costs: cost-coping behavior (26%), reduced adherence (15%), or experiencing financial burden (7%). In multivariate analyses, beneficiaries with lower household income more frequently reported cost responses (difference of 14.5 percentage points for < $40 000/y vs $40 000/y [95% CI, 3.6-25.4 percentage points]). Compared with beneficiaries who were unaware of having a coverage gap, those who were aware more frequently reported any cost response (difference of 11.3 percentage points [95% CI, 0.8-21.9 percentage points]), but had fewer reports of borrowing money or going without necessities (difference of 5.5 percentage points [95% CI, 1.1-10.0 percentage points]). 

Conclusions Beneficiaries in this Medicare Advantage plan have limited knowledge of Part D cost sharing and often report behavioral responses to drug costs. Limited knowledge is associated with fewer reports of cost responses overall, but more reports of financial burden. 

Growing Heart Cells

National Public Radio's Morning Edition reported on a new development in the embryonic stem cell research arena.  Here is a brief overview:

A team of scientists in Canada has developed an efficient way to produce heart cells from human embryonic stem cells, a significant step for potential organ repair. But the study must move to trials with laboratory animals before the cells can be used with human patients.

Although the cells are not quite ready for use in human patients, the story reported that the scientists believe that these cells can be used to test heart medications before those medications are tested in humans. 

Preconception Diet and Sex of Baby

The Associated Press reports on a study completed in England showing that women may be able to influence their sex of their child through their preconception diet.  CNN.com picks up the story and states,

Women can influence the gender of their child with what they eat before they conceive, according to new research that lends scientific support to age-old superstitions about pregnancy. 

The study of 740 women showed that higher calorie intake led to a higher probability of a male birth. The discovery shows higher calorie intake prior to conception can significantly increase the chances of having a son while women on restricted diets are more likely to produce daughters.

   

Scientists at Britain's Oxford and Exeter Universities, who studied eating habits of 740 women during their first-time pregnancies, say that their findings seem to back certain traditional links between diet and gender while disproving others. . . .

   "If you want a boy, eat a healthy diet with a high calorie intake, including breakfast," she told New Scientist magazine.   "Of women eating cereals daily, 59 percent had boys, compared with only 43 percent who bore boys in the group eating less than a bowlful per week."

The researchers said that a higher calorie intake prior to conception can increase the chances of having a son from ten to 11 boys in every 20 births, according to the study published in the Proceeding of the Royal Society B.   

They said it could explain why male births in richer countries are experiencing a slight reduction.

Genetic Discrimination and Congress

The New York Times reports today on Congress' efforts to confront genetic discrimination.  Andrew Pollack reports,

Congress reached an agreement clearing the way for a bill to prohibit discrimination by employers and health insurers on the basis of genetic tests. Senator Tom Coburn, an Oklahoma Republican who had been almost single-handedly holding up action on the bill, said in an interview Tuesday that most of his concerns had been resolved and predicted that the bill would pass soon. Senator Edward M. Kennedy, who is chairman of the Senate Health Committee, said a bipartisan agreement had been reached to move the bill to the Senate floor.

Proponents say the new law, more than a dozen years in the making, would help usher in an age of genetic medicine, in which DNA tests might help predict if a person is at risk of a disease, allowing action to be taken to prevent it.

Some of the tests already exist, like one for breast cancer risk, and new ones are being introduced almost every month. But backers of the legislation say many people are afraid of taking such tests because they fear the results would be used to deny them employment or health insurance.  “This bill removes a significant obstacle to the advancement of personalized medicine,” said Edward Abrahams, the executive director of the Personalized Medicine Coalition. His group is an organization of drug and diagnostic companies, academic institutions and patient groups that advocate using genetic information to choose the most appropriate treatment for each patient.

The agreement would end a 13-year odyssey for the bill, first proposed in 1995 by Louise Slaughter, a House Democrat from western New York, who has been promoting it ever since.
The bill, called the Genetic Information Nondiscrimination Act, or GINA, has had broad support in Congress but has never managed to pass both houses in the same session.

It passed the Senate by votes of 95 to 0 in 2003 and 98 to 0 in 2005 but was kept from a vote in the House by Republican leadership. Last year, with Democrats newly in control, the House approved the bill 420 to 3. But this year Senator Coburn had placed a hold on the bill, preventing the Senate from voting on it.

One of Senator Coburn’s main concerns was that the bill might subject employers to civil rights lawsuits stemming from disputes over medical coverage. And employers that also finance their own health insurance, he said, might be sued twice. “We would have created a trial lawyers’ bonanza,” he said.  Senator Coburn, a medical doctor, had called for a “firewall” between the employer and insurance sections of the bill. “We withstood all the criticism we got from lots of people, and now we got it fixed,” he said. . . .

GINA would make it illegal for health insurers to raise premiums or deny coverage based on genetic information, and would prohibit employers from using such information for decisions on hiring, firing, promotions or job assignments. Genetic information, for the law’s purposes, would include not only tests that determine variations in a person’s DNA, but also a family history of a particular disease. But GINA does not prohibit discrimination once someone already has a disease, and some experts said such protection would have to be the next step. . . .

Some experts, while welcoming the bill, said it did not go far enough.

Mark A. Rothstein, director of the bioethics institute at the University of Louisville School of Medicine, said GINA did not cover life insurance and long-term care insurance and that there already were legal ways for prospective employers to gain a job candidate’s health information.  “GINA promises more than it delivers,” he said.

Growing Body Parts

In Slate.com, William Saleton reports on the latest military advance - growing body parts.  He writes,

The regeneration of lost body parts has just moved from science fiction to U.S. military policy.  Yesterday the Department of Defense announced the creation of the Armed Forces Institute of Regenerative Medicine, which will go by the happy acronym AFIRM. According to DOD's news service, AFIRM will "harness stem cell research and technology … to reconstruct new skin, muscles and tendons, and even ears, noses and fingers." The government is budgeting $250 million in public and private money for the project's first five years. NIH and three universities will be on the team. . . .

If you've been following Human Nature for the past three years, you know that tissue regeneration is well underway. The military has been working on regrowing lost body parts using extracellular matrices. Scientists in labs have grown blood vessels, livers, bladders, breast implants, and meat. This year they announced the production of beating, disembodied rat hearts. At yesterday's press conference, Army Surgeon General Eric Schoomaker explained that our bodies systematically generate liver cells and bone marrow and that this ability can be redirected through "the right kind of stimulation." . . . .

The wars in Iraq and Afghanistan, waged in large part through improvised explosive devices, have produced nearly 1,000 U.S. military amputees. Many other service members have lost eyesight or suffered burns or spinal-cord damage. We all want to help these young people recover. We've seen inspiring stories of doctors outfitting them with prosthetic limbs. If only we could make them truly whole again. And now we can.

At the press conference, Schoomaker displayed pictures of a wounded Marine whose disfigured features could be restored only through tissue regrowth. He vowed to "redefine the Army and military medicine." The Defense Department's assistant secretary for health declared a goal of "getting these people up to where they are functioning and reintegrated, employed, [and] able to help their families and be fully participating members of society."

It's a familiar and worthy goal. And it has to be, because in the larger context of human history, its job is to ease us across the mind-blowing threshold of human regeneration. If my daughter loses a tooth, she may be able to grow it back. If my son loses a finger, the work pioneered by AFIRM early in his life may be able to help him.

Warfare will never be the same again, either. American military medicine is already saving the lives of soldiers who would have died in previous conflicts. Yesterday's death is today's wound. Now we're raising the ante: Today's permanent wound will be tomorrow's bad memory. Blow off our fingers, and we'll grow them back.

Further down the road, other possibilities will emerge. If we can restore a soldier's original muscle strength, we can probably add to it. The military is already encouraging soldiers to get LASIK, which improves some people's eyesight beyond 20/20. It's hard to believe we won't continue to improve that surgery and systematize it across the armed forces. Most of us civilians will face these revolutions when we're ready. By then, like AFIRM, they'll already be here.

Life Expectancy Drops for American Women

The Washington Post reports today on an unexpected drop in American women's life expectancy in a study conducted by PLoS Medicine.  The study also shows a smaller decline in life expectancy for men as well.  David Brown writes,

For the first time since the Spanish influenza of 1918, life expectancy is falling for a significant number of American women.  In nearly 1,000 counties that together are home to about 12 percent of the nation's women, life expectancy is now shorter than it was in the early 1980s, according to a study published today.

The downward trend is evident in places in the Deep South, Appalachia, the lower Midwest and in one county in Maine. It is not limited to one race or ethnicity but it is more common in rural and low-income areas. The most dramatic change occurred in two areas in southwestern Virginia (Radford City and Pulaski County), where women's life expectancy has decreased by more than five years since 1983.

The trend appears to be driven by increases in death from diabetes, lung cancer, emphysema and kidney failure. It reflects the long-term consequences of smoking, a habit that women took up in large numbers decades after men did, and the slowing of the historic decline in heart disease deaths.  It may also represent the leading edge of the obesity epidemic. If so, women's life expectancy could decline broadly across the United States in coming years, ending a nearly unbroken rise that dates to the mid-1800s.

"I think this is a harbinger. This is not going to be isolated to this set of counties, is my guess," said Christopher J.L. Murray, a physician and epidemiologist at the University of Washington who led the study. It is being published in PLoS Medicine, an open-access journal of the Public Library of Science.  Said Elizabeth G. Nabel, director of the National Heart, Lung and Blood Institute of the National Institutes of Health: "The data demonstrate a very alarming and deeply concerning increase in health disparities in the United States."  The study found a smaller decline, in far fewer places, in the life expectancy of men in this country. In all, longevity is declining for about 4 percent of males.  The phenomenon appears to be not only new but distinctly American.   "If you look in Western Europe, Australia, Japan, New Zealand, we don't see this," Murray said. . . .

Life expectancy is not a direct measure of how long people live. Instead, it is a prediction of how long the average person would live if the death rates at the time of his or her birth lasted a lifetime.  For that reason, life expectancy can dip or rise abruptly. The death rate from the Spanish flu was so high, especially among the young, that life expectancy fell by about seven years in 1918. But it rebounded quickly when the epidemic was over. . . .

In the study, Murray and collaborators at the Harvard School of Public Health examined mortality and cause-of-death data for the United States from 1961 through 1999. They divided the country into 2,068 units, including cities, counties or combinations of counties . . . .

Illinois Court Rules on Sterilization of Mentally Disabled Woman

The Chicago Tribune reports on a recent decision by the Illinois Appellate Court that denied a request to sterilize a mentally disabled woman against her will.  Michael Higgins writing for the Tribune states,

Disability rights advocates and medical ethicists praised a precedent-setting ruling Friday by the Illinois Appellate Court denying a bid to sterilize a mentally disabled woman against her will.

The woman, identified only as K.E.J. in court records, isn't capable of raising a child on her own, but her guardian failed to prove that sterilization would be in her best interests, a three-judge panel in Chicago ruled unanimously.

"Tubal ligation is a particularly drastic means of preventing a mentally incompetent ward from becoming pregnant," Judge Joseph Gordon wrote in the 36-page opinion. There are "less intrusive and less psychologically harmful [birth-control] alternatives."

The ruling was the first appellate opinion on the issue in Illinois. "It's extraordinarily significant" because it guarantees the disabled a court hearing, said Katie Watson, a Northwestern University professor who wrote a friend-of-the-court brief in the case on behalf of about two dozen medical ethicists.  "In the past, this was a decision that could be made between a guardian and a doctor," she said. "The decision must be moved into the light."  The ruling means a guardian must go through some "significant legal hoops" before a court will order sterilization, said the woman's attorney, John Whitcomb of Equip for Equality, a disability rights group. . . .

Thanks to Cara at Feministe for the link.

Health Care Stories

RoCali at Daily Kos shares his health care story and asks that others write in to share their stories as well.  The goal is to educate those individuals who still seem to believe that people without health insurance or who become ill are somehow at fault for any failures of the health care system to provide coverage.  RoCali writes,

Here's one story of how living the American dream became a tale of waking up in the American medical insurance nightmare.  This is only one story of millions that are developing right now and the millions that are yet to evolve. I know many of you have your own tale and I would be grateful if you would share it.  Sometimes we start feeling that maybe this was our fault, that we alone got sucked down into this morass, buying into the hype that if we had been smarter or more industrious we could have avoided this.  Let's remind ourselves that we are not some aberrent failure, but rather we got caught in a broken system. 

About 15 years ago, I was 35, working in a local law firm, raising two children, and had a home in a nice family neighborhood. One day, I woke up not feeling so well.  It's that simple when I look back, to recognize the starting point at which my life began to veer off the path I had so carefully laid.  I felt tired and achey.  A couple of days later, a terrible pain started in my back and after a few hours, my fever spiked to 106. I was admitted to the hospital, delirious.  It seemed like no big deal to me when it was determined I had a severe kidney infection.  I was in the hospital for a couple of weeks, yet when I was released I still had an infection, although I was stable.  I had begun a ten year battle to rid my body of a super-infection.  As happens in dominoes and houses of cards, things began to fall in a pattern.

My super-infection battle encompassed repeated bouts of pneumonia, kidney infections, and bizarre systemic infections.  Then came the diagnosis of an auto-immune disorder, followed by muscle and nerve problems in my shoulders, and then joint problems in my hands, feet, and knees.  Recently, after breaking my back and some ribs, it was determined that I have severe osteoporosis, just weeks before my 50th birthday.  Over these years, I had numerous hospitalizations, surgeries, treatments, therapies, and incurred massive medical bills.   When I first lost my job, I was relieved that my spouse's insurance would cover me.  That insurance left with my spouse, who tired of the stress right after we went bankrupt seven years ago. 

The only asset I managed to save between bankruptcy and divorce was the home my children were raised in.  I had to sell it about four years ago when my COBRA insurance ran out and I was forced to turn to HIPPA for medical insurance coverage.  HIPPA was the only program I could find for a middle aged woman with extensive pre-existing conditions.  The premiums were more than double my COBRA payments, with less coverage and much higher deductibles and co-pays.  Each year, HIPPA has lowered my coverage and/or increased my out-of-pocket expenses.  From the equity I garnered when selling my home, I can cover another ten months, possibly, of premiums and co-pays.  I'm still only able to work a few hours a week and that is not likely to change in the immediate future.  At times, I have tried to increase my working hours, only to suffer serious health deteriorations shortly after, setting me back months or even years.  My retirement accounts have long since been spent.  My health care premiums for this are now over $600 per month.  My co-pays for medication alone are about $630 per month at this time.  Without insurance, the costs of just my medications exceed $3,000 per month, so letting health insurance go is not a palatable option.

Please, don't misunderstand me.  I am not laying all these personal details out so someone will say, "oh, how sad."  The point I'm attempting to make here is how easily this can happen, in the blink of an eye, to any of us.  No matter how hard you work, how smart you are, or what great physical shape you keep yourself in, all it takes is an unfortunate moment and the landscape of your life is dramatically altered.  I'm spending my days being grateful I've managed thus far, unlike so many of my fellow citizens who could not keep up and have fallen by the wayside, some to their death. I am truly one of the lucky ones.  I have had a supportive family and sufficient assets to bring me through thus far.  But so many of our neighbors, friends, and co-workers have not been as fortunate as I.  They had nothing to fall back on, they are alone, they are in pain, they are ill, they are frightened, and they see no place left to turn. . . . .

In the wealthy and powerful nation called America, the divide between classes continues to grow.  Many of those that live on the better side of that divide are woefully ignorant of the plight of the other side.  The growing divide is particularly evident in matters of health.  While our nation claims the best medical technology and advances, that is little comfort to the large number of citizens that cannot afford such miraculous treatment.  It's a bit like holding a loaf of bread just beyond the starving person's reach, tantalizing, frustrating, and often breeding despair.  Yet a certain segment of our population remains oblivious.  Their attention is garnered only when their pocketbook is directly affected by taxation or when the unthinkable happens to even them.  They also do not realize the subtle ways this disaster costs them on a daily basis, through increased costs, decreased production in the workplace, and other long-reaching effects of a lack of adequate medical care on a large populace.

Please, share your story with me.  Let's join our voices together until even the other side of the divide cannot help but hear and acknowledge the tumult.  Every time we step in the voting booth, we need to remember the millions of voices asking, not for charity, but begging for a fair shake.  We also need to remember the voices that have been silenced and we bear the responsibility for speaking out in their names.  Disparity thrives best in shadow and silence.  Let us throw the light on this issue and raise our collective voices, if not for ourselves, for those who can't.

Plastic Bottles/BPA Update

The New York Times updates the recent concern Congress and the Canadian government have shown over the use of BPA (bisphenol-A) in many plastic children's items - including baby bottles and other products that children put in their mouths.  Ian Austin provides this information,

The Canadian government moved Friday to ban polycarbonate infant bottles, the most popular variety on the market, after it officially declared one of their chemical ingredients toxic.  The action, by the departments of health and environment, is the first taken by any government against bisphenol-a, or BPA, a widely used chemical that mimics a human hormone. It has induced long-term changes in animals exposed to it through tests.

Also on Friday, Senator Charles E. Schumer, Democrat of New York, said he intended to introduce on Monday a bill that would ban many uses of BPA-related plastics. It would prohibit them in all children’s products, including nonfood items they may put in their mouths, as well as in any product used to contain food or beverages. . . .

But in Washington, Steven G. Hentges, the head of the American Chemical Council’s polycarbonate group, told reporters in a teleconference: “We do not think that bans on bisphenol-a are based on science.”  Shannon Jenest, a spokeswoman for Philips Avent, which makes bottles from polycarbonate and other materials, said she “wouldn’t see us challenging” the Canadian health department. . . .

Most of Canada’s major retailers, including the Canadian units of Wal-Mart and Sears, have rushed to remove food-related BPA products from their stores. The country’s largest druggist, Shoppers Drug Mart, took the step at its 1,080 stores on Friday.

Senator Schumer said in an interview that he was prompted to act by the Canadian announcement and a report from the United States Department of Health and Human Services  this week, which endorsed a scientific panel’s finding that there was “some concern” about the health effects of the chemical.   “It’s better to be safe than sorry,” he said. “There are alternatives.” Senator Schumer added that his bill would give industry a substantial amount of time to switch to other plastics.

Children's Health Care Update - Some Good News

The New York Times reports that the Bush Administration has suffered a setback in its attempt to restrict the States ability to expand the availability of SCHIP funds to middle-income families.  President Bush had issued an August 17th Directive placing rather difficult to meet preconditions on the States before the States could expand their SCHIP programs.  Robert Pear writes,

The Bush administration violated federal law last year when it restricted states’ ability to provide health insurance to children of middle-income families, and its new policy is therefore unenforceable, lawyers from the Government Accountability Office said Friday.

      

The ruling strengthens the hand of at least 22 states, including New York and New Jersey, that already provide such coverage or want to do so. And it significantly reduces the chance that the new policy can be put into effect before President Bush leaves office in nine months.

At issue is the future of the State Children’s Health Insurance Program, financed jointly by the federal government and the states. Congress last year twice passed bills to expand the popular program, and Mr. Bush vetoed both.  State officials of both parties say the policy, set forth in a letter to state health officials on Aug. 17, has stymied their efforts to cover more children at a time when the number of uninsured is rising and more families are experiencing economic hardship.

In a formal legal opinion Friday, the accountability office said the new policy “amounts to a marked departure” from a longstanding, settled interpretation of federal law. It is therefore a rule and, under a 1996 law, must be submitted to Congress for review before it can take effect, the opinion said.  But Jeff Nelligan, a spokesman for the federal Centers for Medicare and Medicaid Services, said, “G.A.O.’s opinion does not change our conclusion that the Aug. 17 letter is still in effect.”  The letter told states what steps they needed to take to be sure the children’s health program would not displace or “crowd out” private coverage under group health plans. The White House cited the policy as a justification for rejecting a proposal by New York State to cover 70,000 additional youngsters.

What happens next is not clear. New York, New Jersey and several other states have filed lawsuits challenging the Bush administration policy. In addition, Congress may consider legislation to suspend the directive. . . .

The 1996 law, the Congressional Review Act, was enacted to keep Congress informed about the rule-making activities of federal agencies. If Congress objects to a new rule, it can pass “a joint resolution of disapproval,” which the president can sign or veto.  Under the Aug. 17 directive, states cannot expand the Children’s Health Insurance Program to cover youngsters with family incomes over 250 percent of the federal poverty level ($53,000 for a family of four) unless they can prove that they already cover 95 percent of eligible children below twice the poverty level ($42,400).  Moreover, in such states, children who lose or drop private coverage must be uninsured for 12 months before they can enroll in the Children’s Health Insurance Program, and co-payments in the public program must be similar to those in private plans. . . .

The Justice Department contends that the letter is “merely a general statement of policy with nonbinding effect,” But Gary L. Kepplinger, general counsel of the accountability office, said administration officials had treated it as “a binding rule.”

African American Bone Marrow Donors Needed

Wolfrum at Shakespeare's Sister posts a call for more more bone marrow donors, particularly African American donors.  He writes,

When I recovered from the shock of learning that my Mom had acute myeloid Leukemia, I set to work on learning more about it, and trying to find what part I could play.  It was evident early on that my Mom would need a bone marrow transplant to survive more than one or two years. AML is a vicious disease that can only be repressed by intense chemotherapy. It comes back, and the chemo treatments quickly lose potency. So I saw the part I would play, and knew it would be a lifetime endeavor.

With the help of Pat Conlee of the National Marrow Donor Program, I began to learn about the bone marrow registry. I worked with Conlee, my Father and friends and family to put together a bone marrow drive for my mother in Victorville, Calif. But I knew that was not to be a one-time effort, and that the NMDP needed help from wherever it could find it.  As I learned about the NMDP, one fact struck me extremely hard. For Caucasians in need of a bone marrow transplant, 88 percent find a suitable donor. For African-Americans, that number tumbles to 60 percent. . . .

According to the NMDP, there are just 11 million people on the bone marrow donor registry. And that's not in the U.S. That's in the world. In the U.S., there are five million white people on the registry. There are 500,000 blacks. There lies the difference between the 88 percent and 60 percent figures . . . .

To put a face to issue, let me point to my friend Emru Townsend. In December, Townsend - of Montreal - was told that he had AML, as well as a disorder called monosomy 7. He was told he needed a bone marrow transplant to survive. He was also told that due to his African-Caribbean heritage, his chances of finding a donor were much less than if he were white.

But Townsend did not waste his time with self-pity. He immediately began to champion the cause, and his efforts to get more blacks on Canada's bone marrow registry have been covered in newspapers, radio and on television. He is a true inspiration, going so far as spending days working to get his message out while he is receiving chemotherapy. And he is still without a matching donor. His site - HealEmru.com - tells his story and has valuable information on how one can get on the bone marrow registry . . . .

In the U.S., one of the reasons for the lack of donors of all races is likely the cost. It costs $52 to get on the registry, but that amount falls to $25 for African-Americans due to the need. But even if an African-American doesn't have a dime to spare, if they want to get on the registry, they will not be turned away. But this is why donations are always eagerly accepted by the NMDP to help defray the costs of the tissue typing necessary.

The process for donating is simple - all it takes is a few swaps from a person's inner cheek, filling out some paperwork, and it's done. If you are called as a potential match, you will be given a battery of tests (free of charge) that will see if you are in good health and able to donate. The donating process consists of taking some marrow from your spine (under local anesthesia) and does not entail an overnight stay in a hospital. Generally, some minor discomfort for a day or two is the full price that has to be paid for saving a life. . . . .

Wolfrum's piece provides a list of helpful weblinks as well.

Wyden's Health Care Plan Video

Ezra Klein points out the surprisingly good health care video produced in support of Senator Ron Wyden's health care plan, known as the Wyden Bennett plan or Healthy Americans Act.  The Act proposes to de-link health insurance from employment.  The video is rather bittersweet (it is sad what people do for health insurance).  It is also rather funny - I am sure that all of us have worked at jobs where we would rather not be and have considered engaging in some slightly unprofessional behavior at times . . . . ok, perhaps it is just me. 

Here is some background on the Wyden Bennett Act/Healthy Americans Act:

The Healthy Americans Act would guarantee every American universal, affordable, comprehensive, portable, high-quality, private health coverage that is as good or better than Members of Congress have today.  The Act includes tough cost containment measures - and would save Americans $1.45 trillion over the next decade.  All 46 million uninsured Americans would be covered, for the same funds currently spent by Americans on health care.  And every American will feel secure, knowing that your health care won't ever go away.

There are, of course, many details.  Here's a few of the highlights. 

The Healthy Americans Act:

• guarantees you private health care coverage that doesn't go away, even if you change jobs, lose your job, retire, go to school, or become too sick to work.
• provides a generous benefit equal to those of Members of Congress
• ensures that everyone has affordable health care coverage, including meaningful assistance to low-income Americans.
• puts you in charge of your health care choices, not your employer
• makes sure that everyone has the same affordable coverage options, no matter your age, gender, genetic information, or pre-existing health conditions
• saves $1.48 trillion over 10 years through tough cost containment
• provides incentives for individuals and insurers to focus on prevention, wellness and disease management
• creates meaningful and easy-to-understand wellness statistics so that Americans can compare health care plans
• is fully paid for by spending the $2.2 trillion currently spent on health care in America.

More information about the Act is available at Senator Wyden's website.

Vioxx Deaths, Merck's Data and Ghostwriters

Guardian reports on the bad data provided by Merck and the New York Times follows up with a review of yesterday's Journal of the American Medical Association piece discussing ghostwriters for medical articles on Merck data and analysis. Sarah Boseley for the Guardian writes,

A multinational drug company that made a painkiller that had to be withdrawn from sale because it was found to cause heart attacks may have hidden the death rate from the authorities for several years, it was claimed yesterday. Internal company documents released during litigation in the US suggest that Merck, makers of Vioxx, gave the US Food and Drug Administration only selected data on deaths in its clinical trials, and failed to include people who had a fatal heart attack soon after coming off the drug. . . . .

Bruce Psaty and Richard Kronmal, from the University of Washington in Seattle, say that internal company records from 2001 give 34 deaths among the 1,069 Vioxx patients from two of the Alzheimer's trials and 12 among the 1,078 on placebo - a threefold increase among those on the drug. But the published data of the first study in 2004 stated there were 11 deaths which were "non drug-related" among 346 Vioxx patients, and two among those on placebo. In the second study published in 2005 there were said to be 24 deaths among 725 Vioxx patients and 15 among the 732 on placebo, with 17 and two more respectively within 14 days of the last dose. But, say the researchers, neither study analysed the mortality data.

In July 2001, Merck had reported mortality data to the FDA. Psaty and Kronmal wrote that "deaths that had occurred more than 14 days after discontinuation of the trial drug apparently were not included". When the FDA questioned the figures, in December 2001, it emerged that there was no independent data. The second journal paper reveals that manuscripts for scientific journals were written by Merck employees. Doctors attached to leading universities would then be invited to take authorship. Some, but not all, declared financial support from industry.

The New York Times provides more details on the ghostwriters for Merck and suggested reforms for medical publishers by the Journal of the American Medical Association,

The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.  The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals. The article cited one draft of a Vioxx research study that was still in want of a big-name researcher, identifying the lead writer only as “External author?”   . . . .

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread.  “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” said Dr. Ross, whose article, written with colleagues, was published Wednesday in JAMA, The Journal of the American Medical Association. and posted Tuesday on the journal’s Web site.

Merck acknowledged on Tuesday that it sometimes hired outside medical writers to draft research reports before handing them over to the doctors whose names eventually appear on the publication. But the company disputed the article’s conclusion that the authors do little of the actual research or analysis.  The final work is the product of the doctor and “accurately reflects his or her opinion,” said a Merck lawyer, James C. Fitzpatrick.

And at least one of the doctors whose published research was questioned in Wednesday’s article, Dr. Steven H. Ferris, a New York University psychiatry professor, said the notion that the article bearing his name was ghostwritten was “simply false.” He said it was “egregious” that Dr. Ross and his colleagues had done no research besides mining the Merck documents and reading the published journal articles. In an editorial, JAMA said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx.  “It is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors,” the editorial said.

The editorial called upon medical journal editors to require each author to report his or her specific contributions to articles. “Journal editors also bear some of the responsibility for enabling companies to manipulate publications,” the editorial said.  JAMA itself published one of the Vioxx studies that was cited in Dr. Ross’s article. . . . .

Although the role of pharmaceutical companies in influencing medical journal articles has been questioned before, the Merck documents provided the most comprehensive look at the practice yet, according to one of the study’s four authors, Dr. David S. Egilman, a clinical associate medical professor at Brown University. . . .

One paper involved a study of Vioxx as a possible deterrent to Alzheimer’s progression.  The draft of the paper, dated August 2003, identified the lead writer as “External author?” But when it was published in 2005 in the journal Neuropsychopharmacology, the lead author was listed as Dr. Leon J. Thal, a well-known Alzheimer’s researcher at the University of California, San Diego. Dr. Thal was killed in an airplane crash last year.  The second author listed on the published Alzheimer’s paper, whose name had not been on the draft, was Dr. Ferris, the New York University professor. Dr. Ferris, reached by telephone Tuesday, said he had played an active role in the research and he was substantially involved in helping shape the final draft.  “It’s simply false that we didn’t contribute to the final publication,” Dr. Ferris said.

A third author, also not named on the initial draft, was Dr. Louis Kirby, currently the medical director for the company Provista Life Sciences. In an e-mail message on Tuesday, Dr. Kirby said that as a clinical investigator for the study he had enrolled more patients, 109, than any of the other researchers. He also said he made revisions to the final document.  “The fact that the draft was written by a Merck employee for later discussion by all the authors does not in and of itself constitute ghostwriting,” Dr. Kirby’s e-mail message said.

The current editor of the journal Neuropsychopharmacology, Dr. James H. Meador-Woodruff, the chairman of psychiatry at the University of Alabama, Birmingham, said he was not the editor in 2005 but planned to investigate the accusations. “Currently, we have in place prohibitions against this,” Dr. Meador-Woodruff said.

Plastic Baby Bottles, BPA and the FDA

Reuters reports on the National Toxicology Program's findings of the potential danger posed to young children from the chemical bisphensol A, a chemical used in such items as baby bottles and also recently approved by the FDA as safe in products used by infants and children.  Will Dunham writes,

Based on draft findings by the National Toxicology Program, part of the U.S. National Institutes of Health, senior congressional Democrats asked the Food and Drug Administration to reconsider its view that the chemical bisphenol A is safe in products for use by infants and children.  The chemical, also called BPA, is used in many baby bottles and the plastic lining of cans of infant formula.The National Toxicology Program went further than previous U.S. government statements on possible health risks from BPA.

It said: "There is some concern for neural and behavioral effects in fetuses, infants and children at current human exposures." The findings expressed concern about exposure in these populations, "based on effects in the prostate gland, mammary gland, and an earlier age for puberty in females." . . . .

The National Toxicology Program said laboratory rodents exposed to BPA levels similar to human exposures developed precancerous lesions in the prostate and mammary glands, among other things.  "The possibility that bisphenol A may impact human development cannot be dismissed. More research is needed," the agency said.  Bisphenol A is used in the production of polycarbonate plastics and epoxy resins and can be found in food and drink packaging as well as compact discs and some medical devices. Some dental sealants or composites contain it as well.

The National Toxicology Program expressed "negligible concern" that exposure of pregnant women to BPA causes fetal or neonatal death, birth defects or reduced birth weight and growth in babies. It also had "negligible concern" that exposure causes reproductive problems in adults. . . .

In Canada, the Globe and Mail newspaper said the Canadian health ministry was ready to declare BPA a dangerous substance, making it the first regulatory body in the world to reach such a determination. The newspaper said the ministry could announce the decision as soon as Wednesday. . . .

This follows yesterday's news from the New York Times that Senators from both parties believe the FDA is underfunded.

The Food and Drug Administration needs far more money than the White House has proposed for next year, senators of both parties said Tuesday.  “To us, it’s clear that they’re seriously underfunded,” Senator Herb Kohl, Democrat of Wisconsin, said after a hearing of the Appropriations subcommittee, headed by Mr. Kohl, that oversees the agency’s spending.  The subcommittee’s ranking minority member, Senator Robert F. Bennett, Republican of Utah, agreed with Mr. Kohl and tried at the hearing to get the food and drug commissioner, Dr. Andrew C. von Eschenbach, to say how much more the agency could use wisely. . . .

The Senate passed a budget resolution last month that would make the F.D.A.’s allocated budget — that part of its spending that comes from taxpayer revenue, as opposed to user fees paid by drug and medical device manufacturers — $375 million greater in 2009 than this year. That would be a 20 percent increase, and Dr. von Eschenbach said he did not believe that the agency could absorb so large an addition in one year.

A report last year by a panel of outside advisers to the agency said American lives were in danger because the F.D.A. did not have the money, the staff or the scientific expertise to protect them. And in a speech last month, Dr. von Eschenbach acknowledged that the F.D.A. “may fail in its mission to protect and promote the health of every American” and that “peril exists.”  But he was far less pessimistic in his testimony on Tuesday.  “I believe we have been eminently successful up to this period of time,” Dr. von Eschenbach said. “We are the world’s gold standard.  “But if we want to continue that level of excellence,” he added, “we must change.”

The Bush administration has proposed increasing the agency’s allocated budget next year by 3 percent, to some $1.8 billion, not enough to pay even for increased costs. Dr. von Eschenbach spoke Tuesday about plans to hire up to 700 new employees for the F.D.A. staff, but he acknowledged that the agency would not have the money to do any hiring next year if the president’s budget was adopted without changes by Congress. . . .

Perhaps the FDA's problems go deeper than lack of funding . . .