June 6, 2013 by Tamara Piety
GlaxoSmithKline (GSK) is in the news again, albeit this time due to an internecine quarrel at the FDA over studies relating to the diabetes drug Avandia. As reported at Pharmalot, Dr. Tom Marciniak is criticizing the review process for Avandia as flawed because Duke Clinical Research which analyzed some of the prior studies received some funding from GSK for the work. For example he says this:”While the charter and reports describe “collaboration”, the descriptions of the activities in the reports document that GSK controlled the re-adjudication just as it controlled the original adjudication. We should not find it surprising that the results of the two, non-independent adjudications are similar. Furthermore, DCRI and the other contractor, MediciGlobal,were not financially independent of GSK as documented by [publicly] available Web pages.” FDA Report (Go to page 311-12; numbered ¶ 2).
The FDA has fired back with this, as reported at Pharmalot: “We do not accept the view that every investigator or academic research organization that is paid to carry out a study or analysis should be assumed to be biased and will misinterpret or even falsely interpret results in order to favor the sponsoring drug company… In essence, Dr. Marciniak alleges that parties involved in the sponsorship, the re-adjudication, the statistical review, and the inspection of RECORD were all unreliable because of contractual arrangements, flaws in some unrelated matter, or both. We disagree with his assessment.”
The FDA may be a valid point that not all such research is flawed or ought to be dismissed out of hand. However, despite the apparent indignation expressed in this quote it is worth pointing out that a financial conflict of interest is grounds for automatic disqualification of a judge sitting in judgement on a case. For a manager or director of a public corporation it is grounds for (at the minimum) required disclosures and often disqualification of participating in decision-making on an issue that the manager or director has a financial interest in the transaction. Granted, in the case of corporations, disclosure alone is often enough.
Nevertheless, I am not sure we ought to be so sanguine about the problem of a financial interest and a potential conflict of interest when it comes to determining the safety of pharmaceuticals. As Tom McGarity and Wendy Wagner, professors at the University of Texas School of Law have set out in their book “Bending Science,” there is reason to believe that sponsorship may indeed distort the outcomes of scientific research of many types. They focus primarily on environmental issues but these same concerns have been raised by Dr. Marcia Angell about drug companies specifically in “The Truth About Drug Companies,” and about industry funding and public relations generally in books by David Michaels in “Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health” and by Naomi Oreskes and Erik Conway in “Merchants of Doubt.”
The evidence amassed by all of these authors is not trivial. It cannot be easily dismissed as simply generated by an excess of suspicion. The concerns about a financial interest skewing the objectivity and reliability of decision-making are precisely the reasons for conflict of interest policies in a number of areas.