Friday, September 23, 2011

My blog has moved to new Wordpress site

I have moved my blog to this Wordpress site here. You'll also be able to access the new blog via my website. Although I will no longer posting here, I look forward to hearing from you at my new location. Thanks for your continued interest and support!

Wednesday, September 14, 2011

Coverage of Rick Perry's vaccine misadventure misses the point

Recent media coverage of the heated debate over Texas Governor Rick Perry's endorsement of mandatory HPV vaccinations for school-age girls in his state seems to be missing a few crucial points. First, many of the medical groups who strongly endorsed the vaccine to prevent cervical cancer received funding from Merck, the maker of the vaccine in question, Gardasil. And two, Merck's aggressive marketing campaign to sell the vaccine as a preventative measure against a relatively rare type of cancer (cervical cancer) in middle-class teenage girls completely ignored poorer populations that are at much higher risk of developing this cancer.

Such concerns were amplified in a thoughtful 2009 paper in the Journal of the American Medical Association(JAMA), and reported by Gary Schwitzer's Healthnews blog and Gooznews.

As the JAMA researchers noted:
As marketing of this HPV (short for human papilloma virus) vaccine demonstrates, pharmaceutical company campaigns can undercut the most cost-effective and appropriate use of new agents to the detriment of adolescent health. By making this vaccine's target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to all adolescents maximized, and the subpopulations most at risk practically ignored.

Recent news reports do mention that Perry himself had substantial conflicts of interest when he signed an executive order mandating HPV vaccines for school-age girls, making him the only governor in the union to do so. As the San Francisco Chronicle notes, Perry has received at least $23,500 in campaign contributions from Merck, including $5,000 in 2006, the year before he ordered girls throughout the state to take the HPV vaccine. Merck also has donated about $500,000 to the Republican Governors Association, a group which Perry headed twice and has been among his most generous campaign donors. As the Chronicle and the New York Times also point out, Perry issued the executive order at a time when his former chief of staff was a lobbyist for Merck.

But the Times article fails to note the egregious conflicts of interest among key physician groups that strongly endorsed the vaccine for school-age girls. As the 2009 JAMA article pointed out, Merck provided educational grants to groups like the American College of Obstetricians and Gynecologists, the American Society for Colposcopy and Cervical Pathology (ASCCP), the Society of Gynecologic Oncologists (SGO), and the American College Health Association (ACHA), all of whom strongly recommended the vaccine in school-age girls.

The recent coverage also doesn't explore the public health costs and benefits of mandating vaccines for affluent school-age girls, which, as Gooznews notes, doesn't make a lot of financial sense. About 3,600 women die from cervical cancer every year -- compared to approximately 40,000 who die from breast cancer annually. Yet Merck itself estimated it would cost $1.4 to $1.6 billion to immunize young girls from the disease, which can be picked up fairly easily (and much more cheaply) with regular pap smears.

As the JAMA researchers were the first to note, it would make far more sense to spend the money paying for pap smears for poorer women who have multiple partners but no health insurance.

I have to say I find it ironic that Perry is being lambasted by his Republican rivals for mandating something they say should have been left up to families to decide, which is the primary focus of today's Times piece. But I wish the media would use this opportunity to explore the public health ramifications of allowing a drug manufacturer to aggressively target the wrong population for an expensive and possibly unnecessary vaccine.

Thursday, September 8, 2011

French lawmakers may mandate conflict of interest disclosures

At a time when our own government has stepped back from requiring true transparency about conflicts of interest in medicine, French lawmakers seem to be heading in a much bolder direction. According to Nature Medicine, the French national assembly is considering a bill that would require that conflicts are publicly disclosed by the country's regulatory agencies and made available to consumers.

In other words, instead of relying on the discretion of universities to disclose when their government-funded researchers get financial compensation from drug makers and other companies, as our own National Institutes of Health now does, the French would require their regulatory counterparts to publicly disclose all such conflicts of interest and face monetary sanctions if they don't.

This strikes me as a wonderful idea, since it takes the decision about disclosure out of the hands of academic institutions that are increasingly reliant on industry funding -- see here-- and puts it where it belongs -- in the hands of agencies like the NIH and FDA that use taxpayer money to fund and regulate research for the public good.

As has been widely reported, of course, the NIH recently tacked in the opposite direction under pressure from university lobbyists -- see here. Instead of requiring universities to disclose their faculty's conflicts of interest on a publicly available website, the newly announced rules gives schools the option to conceal financial conflicts of interest, according to Sheldon Krimsky, a professor of ethics at Tufts University School of Medicine.

Amazingly enough, most of France's nonprofit private health insurers appear to support that country's proposed new rules about disclosure. Etienne Caniard, president of Mutualité Française, a federation of these insurers, told Nature Medicine that:

“This proposal will help uncover the sectors where the state has given free rein to the pharmaceutical industry and where it should take its responsibility and regain control, such as continuous medical education,” he says.

Can you imagine the big for-profit health insurers in this country taking a similar stance? Dream on!

Wednesday, August 24, 2011

New NIH rules about conflicts of interest are a swiss cheese of loopholes

The newly announced rules on financial conflicts of interest among federally funded researchers are certainly an improvement on the existing regulations issued by the National Institutes of Health in 1995 (which were never enforced anyway). But as ethicists and consumer advocates note -- see here and here -- they fall short of true reform largely because they continue to leave the reporting and management of financial conflicts up to the discretion of institutions who are themselves increasingly dependent on private-sector funding and thus imprisoned by their own conflicts of interest.

Why is this a problem? As Greg Petsko, a researcher at Brandeis University who is studying Parkinson's and Lou Gehrig's disease, recently explained to me: "“If you are accepting any sort of reimbursement or personal funds from any organization that might benefit from what you’re doing scientifically or from public statements you’re making, you have a moral obligation to make that connection clear so people can decide for themselves how much weight they want to give what you’re saying.”

In other words, studies show that financial conflicts can sway the judgement of doctors and researchers who receive federal funding, and it is important that the public know just exactly what those conflicts consist of - so they can make up their minds about how valid the science conducted by these conflicted researchers is.

Yet the new rules promulgated by the NIH don't make it easy for consumers to find out about such conflicts of interest. When the revisions were first proposed, they contained a provision requiring universities to disclose their researchers' conflicts of interest on a publicly available website. But that provision has been dropped under pressure from university and industry lobbyists, and instead institutions can decide for themselves how they want to release conflict of interest information. The only requirement is that if someone inquires about a specific researcher's conflict, the institution has five business days to respond -- see here.

Under the new rules, institutions now have to disclose more information about their researchers' conflicts. Previously, each institution only has to report that there was a conflict to the funding agency and note that it was being managed, and there are many instances when universities didn't even do that and were never sanctioned for their failure to disclose. For example, Brown University School of Medicine never bothered to disclose to the NIH the hundreds of thousands of dollars in personal consulting and speaking fees that Dr. Martin Keller, then chief of psychiatry at Brown University, was receiving from drug companies each year, despite the fact that Keller was receiving millions of dollars in federal research funds from the National Institute of Mental Health -- see Boston Globe article I wrote here. But neither Brown nor Keller were ever publicly sanctioned for that failure to disclose.

Under the new rules, institutions are now supposed to disclose more information about the conflicts, including the specific holdings or financial interest, the value of the conflict, how this relates to the research in question and why it is deemed to be a conflict of interest. But again, how they disclose this information to the public is up to them, and if past history is any guide, there will be little enforcement of such rules by the NIH itself. As Sally Rockey, the NIH deputy director for extramural research, acknowledged in a brief teleconference about the rules yesterday, the federal agency has never terminated a grant because of non-compliance -- see here.

Dr. Bernard Carroll, writing in Health Care Renewal, points up another loophole with the new rules:
The revised regulations do not close the regulatory loophole through which Charles Nemeroff strolled when he moved from Emory to the University of Miami. We covered that incident several times on this blog last year. Though Nemeroff was under a 2-year sanction and banned from participating in NIH-funded research at Emory, his friend Thomas Insel, Director of NIMH, assured the dean of the medical school at Miami that Nemeroff was in good standing to apply for NIH funding when he moved from Emory. To underline the point, Insel displayed the bad judgment of appointing Nemeroff to 2 new NIMH review committees.Do today’s revised regulations prevent a repeat of this administrative travesty? No, they don’t. There is some mention of ensuring oversight if a sanctioned investigator wishes to transfer a grant to a new institution, but nothing to prevent the Nemeroff-Insel dance from being repeated.

One can't help but wonder if the weakened NIH regulations are part of the massive rollback in federal regulations by the Obama administration that I recently read about. What happened to our President's spine?

Wednesday, August 10, 2011

What's behind the growing rate of scientific retractions?

The retraction of studies in medical and scientific journals has surged in the last decade, according to separate analyses done by the Wall Street Journal and Retraction Watch.

In its page-one article today, the Journal noted that while just 22 retraction notices appeared in 2001, there were 139 in 2006, 339 last year and 210 so far this year. Retraction Watch, in a blog celebrating its one-year anniversary, said it has recorded 200 retractions over the last 12 months, compared to an annual average of about 80 over the previous 10 years.

Why are retractions on the rise? According to the WSJ, some journals argue that the increase indicates their rising vigilance in detecting errors. Others blame the increasingly competitive environment for research grants and career advances in science and medicine.

I would point to two other key factors. First and foremost, there's the pressure that the pharmaceutical and medical device industry exerts on researchers to come up with positive findings in clinical trials. (This starts with cherry-picking pliable researchers for specific studies and ensuring their cooperation with lucrative speaking and consulting gigs and then having the studies themselves ghost-written to make the drug or medical device in question look safer and more effective than it really is). This is known to have happened with clinical trials for Paxil (which Side Effects focuses on), Celexa, Zoloft, Vioxx and Avandia and several medical devices including a widely used bone growth product made by Medtronics (which The Spine Journal just devoted an entire special issue to).

This kind of industry-academia collusion, of course, has been going on for awhile. What's different now is the heightened scrutiny of scientific misconduct by the media and the steady drumbeat of blogs like Retraction Watch, POGO and Pharmalot. As a result, many journals are now adopting a tougher line and investigating errors more thoroughly. And that's exactly how it should be.

Wednesday, August 3, 2011

With Big Pharma on campus, who is looking after the public interest?

Medicare and social services for vulnerable Americans are not the only programs on the chopping block with Washington's deal to raise the debt ceiling and cut trillions of dollars in government spending. Looming ahead may be deep cuts in funding for medical and science research, and that raises the specter of growing collaboration between academic centers and industry, including pharmaceutical and medical device companies.

Even before the debt deal was reached, partnerships between Big Pharma and universities have been on the rise, according to an article in the current issue of Chronicle of Higher Education. The article, Big Pharma Finds a Home on Campus, details this growing collaboration and the "many new ethical and practice questions" it raises, including the increasing potential for conflicts of interest.

There may be some beneficial outcomes to these partnerships in the development of drugs to treat intractable diseases. But what concerns many is this: how can institutions that are increasingly reliant on funding from private companies do an adequate job of policing conflicts of interest among their own faculty? It's akin to having the fox guard the chicken coop.

"I'm not sure that universities can police conflicts of interest when they become so reliant on [private sector] funding," said Peter Conrad, Harry Coplan Professor of Social Sciences at Brandeis University and author of The Medicalization of Society. According to Conrad and others, academic centers are already doing a poor job of enforcing their own conflicts of interest policies. He points to the "slap on the wrist" Harvard Medical School gave Joseph Biederman for failing to disclose millions of dollars in financial ties to drug makers; see background here.

"Biederman used his name and position as a way of promoting the use of antipsychotics for childhood bipolar disorder," Conrad said. "He was basically an entrepreneur for the bipolar diagnosis in children and using drugs that have not been tested and approved for children."

Conrad believes such conflicts of interest will only worsen in the coming years as federal research money becomes scarcer and universities turn to industry to keep their science labs humming.

"I think this is just the beginning of the privatization of research," he says. "It's representative of the tilt in society towards business interests over public interests." Conrad cited the recent Supreme Court decision that allows corporations to give as much money as they want to political candidates an another example of that tilt toward allowing commercial interests to take precedence over public interests.

Indeed, university and industry lobbyists have already succeeded in convincing the federal government to drop a key provision in the proposed new NIH guidelines for conflicts of interest among federally-funded researchers. According to Nature, a cornerstone of the new guidelines — a series of publicly accessible websites detailing financial conflicts among academic researchers — has now been dropped.

Consumer advocates have roundly criticized the move. "It greatly diminishes the amount of vigilance that the public can exercise over financially conflicted research being funded by the NIH," said Sidney Wolfe, director of the Health Research Group at Public Citizen, in Nature.

My guess is that universities didn't want that much transparency out of fear it might embarrass their star faculty rainmakers and stifle lucrative partnerships with industry. After all, why bite the hand that feeds you?

Wednesday, July 20, 2011

Tougher NIH rules about financial conflicts in danger of being watered down

I realize this is the dead of summer and every journalist who isn't on vacation is captivated by the Murdoch phone-hacking scandal. But while everyone is looking the other way, the National Institute of Health's proposed new rules about the disclosure of financial conflicts of interest may be watered down.

The sticking point, according to the Project on Government Oversight (POGO), is a proposed rule that would require government-funded researchers to publicly disclose potential conflicts of interest to consumers. POGO officials say that the Office of Management and Budget (OMB), which has been reviewing the proposed changes for months, may weaken or eliminate the public disclosure requirement due to pressure from industry and university officials. In a letter to OMB July 11, POGO's executive director Danielle Brian and staff scientist Ned Feder called on the OMB to make sure that requirement remains in the new guidelines.

Why does this matter? Because it's vitally important for consumers to know if researchers and doctors' judgments are being swayed by industry largesse or other conflicts that could influence their work. One would think the federal agency that supports most medical research in this country (National Institutes of Health) would be playing a key role in making such conflicts of interest transparent. Think again. Even though current NIH guidelines calls for universities to report to the granting agency significant financial conflicts (more than $10,000 annually) among faculty who have NIH grants, neither the institutes nor the universities have bothered to adhere to these 16-year-old guidelines.

Case in point: Dr. Helen Mayberg, a neurologist at Emory University School of Medicine, and a principal investigator on five federally funded research projects. As I've blogged about before here and here, since she came to Emory in 2003, Mayberg has earned tens of thousands of dollars consulting for medical device companies and being an expert witness in death penalty cases, always on the side of prosecutors bent on execution. Mayberg was one of eight authors of a 2006 study who failed to disclose consulting ties with Cyberonics, the maker of the electronic device their paper touted as being effective in treating depression. Because of this egregious failure to disclose, the lead author of the study, Dr. Charles Nemeroff, then chair of psychiatry at Emory, was forced to step down as editor in chief of the journal Neuropsychopharmacology, which published the paper -- see background here.

Mayberg has also attracted notoriety for testifying (always for the prosecution) in more recent death penalty cases than almost any other doctor in the country. Mayberg's job in these cases is to raise doubts about the validity of scans that show brain damage in defendants on death row, and critics say her testimony often contradicts her own published research on brain scans. But she earns a pretty penny doing so. According to a psychiatrist who also testifies in such cases, Mayberg probably earns more than $50,000 per case. In 2009, she acknowledged testifying in at least five of these cases, which potentially adds up at least $250,000 in one year alone.

These are significant conflicts of interest that Emory should have reported to the NIMH, especially since Mayberg took over as principal investigator on two major studies that used to be led by Nemeroff: the mood and anxiety disorders initiative, a collaboration between NIMH (which put up $2.1 million last year alone) and GlaxoSmithKline, to develop a new generation of antidepressants, and another $1.8 million study called predictors of antidepressant treatment response. After Nemeroff stepped down from these NIH-funded projects in the wake of his own failures to disclose, the NIH instituted tighter rules on approving grants to Emory, including more documentation on researchers' outside activities and potential conflicts of interest, according to The Atlanta Journal-Constitution.

Yet according to NIMH records obtained under the Freedom of Information Act, "no financial conflicts of interest were identified to NIMH by Emory University about Dr. Helen Mayberg with regard to NIH-funded research projects in which she is listed as the principal investigator." It doesn't look like the NIH has enforced its own tougher requirements in the wake of the Nemeroff affair. All I could get out of an NIH spokeswoman was this: "NIH will neither confirm nor deny matters relating to compliance which may be under review." Does that mean the failure of Emory to disclose Mayberg's myriad conflicts is under review? The NIH won't say.

This is precisely why we need a public disclosure requirement in the new regulations governing scientific conflicts of interest. Taxpayers have a right to know what their publicly funded investigators -- in the case of Mayberg, someone who is in charge of millions of dollars in grants -- are up to.