Wednesday, July 08, 2009

A Peabody Award for a Show Featuring Nemeroff's Pontifications

All things that fall must converge?

The escapades of the former Emory University Chair of Psychiatry, Dr Charles Nemeroff, now have gotten quite a lot of press, but we were writing about some of them here on Health Care Renewal before the good doctor became so well-known. Dr Bernard Carroll, for instance, posted here and here, and I posted here (with links backward).

We have also posted about how well-intentioned public broadcasters seem to have got caught up in the web of health care conflicts of interest. Here we talked about how a drug company ended up funding a special on obesity, and here we talked about the involvement of a device and a drug company in the "Mysterious Human Heart."

In late June, the Columbia Journalism Review included an article by Paul Scott about how a US Public Broadcasting System show won an illustrious Peabody award for a show featuring Dr Nemeroff pontificating about depression.

Last May, a Peabody was awarded to the film Depression: Out of the Shadows, a documentary which aired in 2008 on PBS, was produced by Twin Cities Public Television and WGBH Boston, and was written and directed by Minneapolis-based filmmaker Larkin McPhee.

But where her film was generous in its inclusion of heartbreaking personal stories about depression, its broad survey of the science of the illness included frequent appearances by Charles Nemeroff, M.D., a leading—some say powerful—mood disorders researcher from Emory University. Last fall, Nemeroff also became one of the most prominent psychiatrists to be rebuked for failing to disclose funds earned from the drug industry.

Last October, Senator Charles Grassley of Iowa notified Emory that Nemeroff had received $2.8 million from drug companies between 2000 and 2007, $1.2 million of which he failed to report to the university, as he was required to do according to federal rules. To reduce their risk of bias, National Institutes of Health (NIH) researchers must limit to $10,000 their annual receipt of payments from the makers of drugs they are studying. As the lead investigator for a five-year, $3.95 million federal grant to study Paxil and other GlaxoSmithKline drugs, Nemeroff pocketed seventeen times the NIH limit from GSK in 2004 alone, and exceeded his limit every year from 2003 through 2006, without informing his employers. Following his rebuke, Nemeroff lost his chairmanship at Emory, saw $9.2 million in NIH funds meant for Emory frozen, and was banned from federal research for two years.

Some might argue that little about this episode matters, since Nemeroff’s downfall took place in October and Depression: Out of the Shadows aired five months earlier. Yet a simple Google search would have alerted McPhee to the fact that Nemeroff, though the author of hundreds of research papers and well respected in his field, has been dogged by conflict of interest allegations for years. In 2003, he came under fire for praising three pharmaceutical products in the journal Nature Neuroscience without disclosing he held a financial stake in their success, one of which he held the patent on.

Three years later, Nemeroff resigned from his editorship of the journal Neuropsychopharmacology after The Wall Street Journal reported he held an undisclosed financial stake in a treatment for depression he praised in an article. Nemeroff is either great at making excuses for his conduct or extremely unlucky. Following his 2003 misstep, he blamed the journal in question for not requiring him to mention his conflicts. Following his omission in 2006, Nemeroff blamed a clerical error. Following his rebuke by Sen. Grassley, Nemeroff told his employers he did not realize that drug-industry sponsored continuing education appearances were payments requiring disclosure.

All defenses aside, by the time of production for Depression: Out of the Shadows, his drug industry entanglements were both widely distributed and widely known. “With financial ties to nearly two dozen drug and biotech companies,” wroteShannon Brownlee in The Washington Monthly in 2004, “Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest.”

That PBS producers either did not know about Nemeroff’s drug industry entanglements or did not believe they tainted his discussion of the science of depression is disappointing.

But what made the praise bestowed on this PBS documentary particularly troubling were the erroneous, drug-industry serving statements made by Nemeroff within the film—statements which had the potential to negatively affect public health, and which the documentary left unchallenged. During a segment on the FDA’s 2004 decision to require “black box” safety warnings stating that antidepressants can increase the risk of suicide in children and teenagers, a risk it extended in May of 2007 to users under twenty-five, Nemeroff seized the occasion to claim that the federal safety warning was mistaken.

He did so by citing a 2007 study partially funded by Pfizer and published in The American Journal of Psychiatry, a paper ostensibly linking the warning with a subsequent increase in teen suicides. “The FDA put a black box warning for all age groups,” Nemeroff said in the documentary. “I believe this was a mistake, because in hastening our awareness, what we’ve shown is there’s been a marked drop in prescriptions of antidepressants, particularly for children and adolescents…and an increase in suicides and suicide attempts.”

But as critics quickly pointed outto The Boston Globe and The New York Times, the increase in suicides Nemeroff described actually occurred a year before a drop-off in antidepressant use. (You can’t blame a rise in suicides in 2003 on a drop off in prescriptions in 2005.) At the time, most parties to this debate agreed that the question of whether black-box warnings were inadvertently dangerous would not be further clarified until the release of Centers for Disease Control suicide data from 2005.

That data came out a month later, and showed that suicides have fallen overall; a follow-up report showed that suicides have fallen among youth specifically. The total number remains higher than in 2003, but less than in 2004, when the FDA warning went into effect.Given the complexity of epidemiological data and the rarity of suicide, those findings prove little except that any effort to link an uptick in suicides to reduced prescribing of antidepressant medications to children and teenagers is not supported by the epidemiological data.

Mr Scott concluded, memorably,

Something about the simultaneously complex and sympathetic nature of mental health reporting is making reputable journalistic organizations and well-meaning reporters sloppy.

Were health care journalists to dig deeper into the financial entanglements of some of the "key opinion leaders" who may be so eager to appear in well-meaning, and at times feel-good documentaries, the public might learn more about the web of conflicts of interest that now ensnares health care. They might also learn how much of what appears to be health care education is just marketing in disguise. That marketing is often of expensive, and not terribly effective treatments. Realizing that many seeming miracle cures aren't might lead to the skepticism that could help us control health care costs without hurting patients.

1 comment:

Kris said...

As a producer who just completed a documentary on a controversial disease rife with researcher conflicts (Lyme disease), I can say from firsthand experience that it's extremely difficult to tell which opinion leaders have conflicts in our current medical disclosure system.

It took me two years of research to ferret out all the financial streams that led to the corruption of the disease definition, the tests, and the treatments for our disease of interest.

Here are my observations on why it's so difficult for journalists:

#1: The "honor system" for financial disclosures doesn't work. There are a million loopholes to exploit, and studies show that medical researchers tend to deny that they can be influenced by money, so they don’t list everything.

For example, with Lyme disease, the lead author of the Lyme treatment guidelines only began disclosing his commercial revenues AFTER the Attorney General of CT began investigating these conflicts. The honor system only works if there’s an enforcement mechanism. Certainly the Physicians Sunshine Act would help, but it's an incomplete solution, given my next point…

#2: The format of disclosures -- a list of company names and grant numbers -- does not shed light on the nature of conflicts.

With Lyme disease, simply listing the name of a multinational pharmaceutical, such as Baxter, doesn’t educate journalists on the nature of the conflict. A journalist driven by the 24-hour-news-cycle might say, "Oh, Baxter doesn't sell antibiotics that treat Lyme, so that's not an important conflict.”

But what we realized after studying the entire history of Lyme, was that the authors of the Lyme disease guidelines had been focused on lucrative vaccines, not cures (cheap antibiotics), for 20 years, and that they defined the disease symptoms and tests to make a weak vaccine look better on paper. While the first vaccine was removed from the market, these authors/“disease definers” are now vying for the 2nd generation vaccine trials. If these “disease definers” admit that their first definition was flawed; that Lyme can remain dormant in a body for a decade then reactivate; and that the tests that they own patents on are inaccurate; they’ll never get the new vaccine trials past the IRB safety boards and they could spend the rest of their lives in court. (For more details, read “Cure Unknown: The Making of the Lyme Epidemic”.)

#3: Television channels, including PBS, are heavily financed through pharmaceutical companies, or foundations closely allied with Big Pharma. Any documentaries that challenge medical dogma and Big Pharma profits have very little chance of ever getting on the air.

The only way we could get our film funded was through motivated individuals who had been harmed by this medical misinformation. It was a grassroots movement of people voted who for change with their wallets.