Was JAMA's response to this controversy adequate?
Even before this controversy, JAMA had a clear policy about financial disclosure. The relevant section of the authors' instructions reads as follows:
"All authors are required to disclose all potential conflicts of interest, including specific financial interests and relationships and affiliations (other than those affiliations listed in the title page of the manuscript) relevant to the sub ject of their manuscript. Authors should err on the side of full disclosure and should contact the editorial office if they have questions or concerns."12
This is the section that the authors of the antidepressant article presumably read. The crucial phrase in this excerpt is: "relevant to the subject of their manuscript." This phrase allows authors to make their own decisions about what is important to disclose. As discussed above, the JAMA authors used this latitude to decide that their financial relationships were not relevant to the subject of their manuscript.
JAMA's response to this situation was to publish an update on their COI policy: the new policy requires authors to report disclosures in the body of their manuscript at the time of submission rather than in a separate authorship form, which is sometimes received well after the manuscript review process.13
Unfortunately, this policy update does not get to the core of the problem. The core defect in the JAMA policy is that authors are allowed to decide when a financial tie is relevant; the policy revision does nothing to fix this. All it does is make it more likely that journal editors will review the disclosure statement in a timely fashion.
If JAMA were serious about preventing further similar controversies, it would require authors to disclose all financial ties to any health care-related company, whether seemingly relevant or irrelevant to the topic of the article. It would then be up to the readers to decide whether these ties represented true conflicts.
A more definitive solution to the problem of missing disclosures would be to establish an online national "clearing house" that would list the financial ties of all physicians and research grant recipients so that journal editors and readers would be able to check this instantly. Physicians would be man dated to update this every 6 months, and it would be monitored by their respective Boards of Registration in Medicine (I thank Ronald Pies, MD, for this suggestion).
Because JAMA failed to implement a requirement of complete disclosure, the publication got "burned" again, only 6 months after the previously described article was published. In this instance, the journal published an article on the relationship between mi graine headache and cardiovascular disease.14 This epidemiologic study showed a significant association be tween migraines and morbidity and mortality from cardiovascular disease. None of the 6 authors reported that they receive fees from manufacturers of headache and cardiac medications, a story that also received national attention.15
According to news reports,16 Dr Tobias Kurth, the lead author of the study and a Harvard Medical School faculty member, said that the financial ties were irrelevant because the study did not explicitly promote drug treatment for migraines.
However, Dr Catherine DeAngelis, the editor-in-chief of JAMA, disagreed with the authors' assessment and told reporters that she would have published the ties if she had known about them. Again, the litmus test is whether authors might gain financially from results that benefit the companies with which they have ongoing financial relationships. This study highlighted the lethal dan gers of untreated migraines, a finding that would be expected to increase pre scriptions of analgesics and increase profits of the relevant companies. The authors, in turn, potentially stand to benefit from future consultancies or speaking engagements based on the results.
It appears that as long as decisions about the relevance of financial ties are left up to authors, further high-profile embarrassments are in store for our major journals.
This is the first part of a 2-part article. In Part 2, which will appear in a future issue of Psychiatric Times, I will describe a recent event in academic psy chiatry that has been termed "the perfect storm" of conflict of interest. The article at the center of this controversy provides a good starting point for discussing whether journal editors should require disclosure of authorship and compensation.
Dr Carlat is assistant clinical professor of psychiatry at Tufts University School of Medicine in Boston and is editor-in-chief of The Carlat Psychiatry Report. He reports no conflicts of interest regarding the subject matter of this article.
1. Thompson DF. Understanding financial conflicts of interest. N Engl J Med. 1993;329:573-576.
2. Perlis RH, Perlis CS, Wu Y, et al. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry. 2005;162:1957-1960.
3. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326:1167-1170.
4. Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA. 2003;289:454-465.
5. Barrett J, Cowley G. Drug Debate. Newsweek Health [Web exclusive]. July 31, 2006. Available at: http://www.msnbc.msn.com/id/14091979/site/newsweek/. Accessed September 27, 2006.
6. Heres S, Davis J, Maino K, et al. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. Am J Psychiatry. 2006;163:185-194.
7. 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.
8. Urato AC. Antidepressant treatment and relapse of depression during pregnancy [letter]. JAMA. 2006;296:166.
9. Armstrong D. Drug interactions: financial ties to in dustry cloud major depression study. The Wall Street Journal. July 11, 2006:A1.
10. Cohen LS, Nonacs R, Viguera AC, et al. Antidepressant treatment and relapse of depression during pregnancy [reply to letter]. JAMA. 2006;296:166-167.
11. Birnbaum R, Cohen L, Viguera A, Stowe Z. Women's mental health: psychotropic drug use during pregnancy [podcast]. Massachusetts General Hospital Psychiatry Academy. May 17, 2006. Available at: http://www.mghcme.org/webcast_learning.php?uf=0. Accessed September 27, 2006.
12. JAMA Instructions for Authors. 2006. Available at: http://JAMA.ama-assh.org/misc/i4a.pdf. Accessed September 27, 2006.
13. Flanagin A, Fontanarosa PB, DeAngelis CD. Update on JAMA’s conflict of interest policy. JAMA. 2006;296:220-221.
14. Kurth T, Gaziano JM, Cook NR, et al. Migraine and risk of cardiovascular disease in women. JAMA. 2006;296:283-291.
15. Tanner L. JAMA misled again over industry ties. Associated Press. July 19, 2006. Available at: http://www.ahrp.org/cms/content/view/296/55/. Accessed September 27, 2006.
16. Tanner L. Medical journal claims it was misled again. Miami Herald. July 19, 2006. Available at: http://www.miami.com/mld/miamiherald/news/nation/
15071068.htm. Accessed October 6, 2006.