Transparency and disclosure are the key elements necessary to ensure that the public and other clinicians can fairly evaluate the scientific and academic work that achieves publication. Having all the necessary financial disclosures and “competing interests” is important for colleagues and the public to consider in determining whether any potential bias exists on the part of authors of scholarly papers and published clinical studies.
In some rare instances, individuals associated with the pharmaceutical industry or medical device industries have failed to disclose such “interests,” in part because of unclear policies by the journals. These few instances have led to a movement, which maintains that such failures are part of a bigger problem: conflicts of interest.
Interestingly, one of the leaders of this movement, Adriene Fugh-Berman, M.D., recently may have attempted to discount her own “interests” in an article she authored in PLoS Medicine, which we covered last week. Berman, who directs PharmedOut, a radical group calling for the end of all industry-physician collaboration including commercially sponsored continuing medical education (CME), she may have failed to disclose that at the time of writing and publishing her article, that she was still a paid expert hired by plaintiffs’ attorneys in the lawsuit.
According to our understanding Berman was hired to dig through 1,500 documents, which alleged that Wyeth used ghostwriting to aid in the development of breast cancer while taking the menopausal hormone therapy Prempro (conjugated equine estrogens [CEEs] and medroxyprogesterone acetate [MPA]). In her disclosure she specifically stated she was not paid for any part of the research in writing the paper.
In response to this failure, an attorney from Williams & Connolly representing Wyeth sent a letter to Virginia Barbour, Editor of PLoS Medicine, conveying her concerns about Berman’s article. The letter asserts that the article failed to disclose the extent of Berman’s and the journals own “competing interests.” As a result, the attorney asked that PLoS fully disclose the nature of the journal’s and Berman’s ties to plaintiffs’ attorneys.
Specifically, the letter noted that Berman is still a paid expert witness for lawyers representing plaintiffs both referred to in her article and in at least six active cases. “In addition, the company referred to in her article, Wyeth, is a defendant in all of these cases.” Consequently, the letter asserted, “the omission of these material facts renders the disclosure incomplete and misleading.”
What is also problematic about the article is that PLoS Medicine “fails to make any disclosure of its own relationship to plaintiffs’ lawyers.” In particular, the fact that “PLoS Medicine itself has sued Wyeth for access to the documents cited in Berman’s article.” This material fact is significant considering the journal’s legal counsel in those matters, “Public Justice P.C., is led by many of the same plaintiffs’ lawyers suing Wyeth.” These lawyers included “Public Justice Secretary Esther Berzofsky and Board members Kenneth Suggs, Roberta Ashkin and James Szaller.
Consequently, it was these very same lawyers who Berman took “all the documentation of ghostwriting in her paper” from and whose research served as “an invaluable resource in preparing her paper.” As a result, Berman’s article and PLoS Medicine merely served “the current and future interests of plaintiffs’ lawyers suing Wyeth. Evidence of this fact is plain and simple: Kenneth Suggs (listed above) filed Berman’s article as evidence in one of the hormone therapy (HT) cases “just one scant day after it was published” in PLoS Medicine.
Another clear problem highlighted in the letter was that Berman ignored the fact that the published “manuscripts were subject to rigorous peer-review by outside experts on behalf of the medical journals that published them, and that their integrity and scientific rigor have been recognized by multiple courts.”
The facts listed above showed that “Plaintiffs’ lawyers appear to be using PLoS Medicine as an ostensibly independent third party to attack Wyeth as part of their legal strategy.” What makes this strategy problematic is that “while criticizing Wyeth for its past disclosure policies, PLoS Medicine and Berman fail to disclose fully the legal and financial relationships they enjoy with these lawyers today.”
Accordingly, Williams and Connolly asked that PLoS Medicine and Berman be more forthcoming about their “competing interests,” and asked that each of them correct their mistakes from the incomplete disclosures on September 7, 2010 article.
In response to this letter, Virginia Barbour commented on the PLoS website that the journal “has a long-standing interest in the practice of ghostwriting, which predates the journal’s intervention in the release of documents from the Wyeth Prempro litigation.” She asserted, “PLoS Medicine has an interest in documenting ghostwriting and its negative effects.” Barbour then clarified that the only reason the journal “intervened in the Prempro case was solely because of their interest in unmasking this practice.”
She noted that there is “no professional, financial, legal or other relationship with the plaintiffs or their lawyers in any of the cases that Wyeth is defending, or in any other past or ongoing legal case.” Barbour also stated that the journal, unlike Berman, “received no payment from the plaintiffs or their lawyers.” She also stated, “None of the lawyers who represented PLoS Medicine in its Motion to Intervene to obtain the documents represent any of the plaintiffs suing Wyeth.”
Concerning Dr. Berman, Barbour noted that “even if she is still an expert witness that would not have affected their decision to publish this article.” The only difference is that “it would have altered the declaration made on the article.” In her own defense, Berman admitted that she used “an incorrect verb tense in reference to her service as a paid expert witness on behalf of the women involved in lawsuits against Wyeth; she has been and currently is an expert witness.”
Another comment on this issue from the European Medical Writers Association noted, “Although using ghostwriters to insert unwarranted marketing messages into papers is unacceptable, there is no evidence to suggest it is common. Statements such as “Industry-funded marketing messages may infest articles in every medical journal” are therefore entirely speculative and in no way supported by evidence.”
Ultimately, if PloS Medicine has such a “strict competing interest’s disclosure policy” as Barbour suggested, then why did they let Berman slip through the cracks with her “incorrect verb tense?” It seems clear from this case that the new COI rules only apply to some, and in this case not the journal or those supporting its beliefs.