Wednesday, July 26, 2006

Won't Get Fooled Again, Again, Again

In mid-July, there were three well-publicized cases in which authors of scholarly articles in prominent medical journals failed to disclose important financial arrangements that may have affected what they wrote. In fact, each case was so well-publicized that I thought it did not need additional comment from Health Care Renewal.

The cases were:
  • An article published in JAMA in February found that withdrawing anti-depressants from pregnant women was associated with relapse of depression [Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295:499-507.]. A letter published in JAMA in July revealed that "all 9 0f the physician coauthors have been paid by antidepressant manufacturers, while only 2 reported disclosures." (See coverage from the Wall Street Journal, available through the Pittsburgh Post-Gazette here.)
  • An article was published in Neuropyschopharmacology in July about vagus nerve stimulation as a treatment for depression [Nemeroff CB, Mayberg HS, Krahl SE. VNS therapy in treatment-resistant depression: clinical evidence and neurobiological mechanisms. Neuropsychopharmacology 2006; 31, 1345–1355.] The Wall Street Journal discovered that eight of the article's nine authors had financial ties to Cyberonics Inc, the manufacturer of the device. The ninth author is an employee of the company, which was disclosed." (See previous post on Cyberonics here.)
  • An article published in JAMA in July found an association between migraine headaches and the risk of cardiovascular disease and stroke for women [Kurth T, Gaziano JM, Cook NR et al. Migraine and the risk of cardiovascular disease in women. JAMA 2006; 296: 283-291]. The editor of JAMA then discovered that all six authors of the study had financial ties to makers of treatments for migraines or heart-related problems, but did not disclose these relationships, (see the JAMA corrections here, AP here, and PharmaGossip here.)
What has been remarkable is the editorial response to these cases in two of the US most widely-read newspapers.
By Jennifer Washburn in the Los Angeles Times,

Most of us place enormous faith in our universities. We trust that they are autonomous, independent institutions committed to education, scholarship, academic freedom and the production of knowledge free from the influence of special interest groups. Right?

Wrong. In the last 25 years, the United States has given birth to a market-model university, one where professors increasingly work 'for hire.'

Each university is afraid to tighten its rules for fear that this might drive talented faculty (and industry dollars) to other schools with more lax policies. But until the top U.S. research universities collectively adopt one rigorous, uniform policy, their autonomy will continue to erode.
By an anonymous editorial writer in the New York Times, (via the Houston Chronicle),
Leading medical journals seem to be having a difficult time disentangling themselves from the pharmaceutical and medical device industries. If they cannot stop printing articles by scientists with close ties to these businesses, they should at least force the authors to disclose their conflicts of interest publicly so that doctors and patients are forewarned that the interpretations may be biased.
It seems imperative that more muscle be put into forcing disclosure and publication of conflicts of interest. If all leading journals agreed to punish authors who fail to reveal their conflicts by refusing to accept further manuscripts from them, a lot more authors would be inclined to fess up. Better yet, journals should try much harder to find authors free of conflicts. That is the best hope for retaining credibility with doctors and the public.
And by Benedict Carey in the New York Times,
Companies don’t just hire doctors to do research — a practice that in theory ought to help keep businesses scientifically honest — they also trade on the researchers’ names. Like producers shopping a new a movie, they go for star power, an A-list cast with names that themselves sell a product, and pull other doctors along, even when the evidence for a treatment is not strong.

One of the supposed strengths of American science is that it is decentralized and diverse: there are dozens of top researchers who are competitive and critical, enforcing a high standard. But when many or most of the leading figures are playing for the same team — an all-star team — that lineup itself may carry the day, regardless of the science.
With this topic finally getting widespread notice in medical journals and in the main-stream media, I hope it is not hopelessly naive to expect some action. At the very least, we need much more rigorous disclosure requirements for authors of articles in medical journals, and generally for people who bill themselves as academics writing or speaking about medical and health care issues in any venue. In addition, we need broadly based rules about conflict of interest that apply to all people who make decisions in health care.

[For the theme music, go here.]

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