Wednesday, June 16, 2004

Editorial in The Lancet

Pertaining to the controversy surrounding the use of certain antidepressant medications in children, there is an editorial  in the latest issue of The Lancet
(Volume 363, Number 9425, 12 June 2004).  The title of the editorial, Is GSK guilty of fraud?, is a bit provocative.  Unfortunately, they do not really answer the question they raise.  The question, of whether the behavior of the company constitutes fraud, is a legal one.  It is hard to fault a medical journal for not providing a legal analysis, since that is not their mission.  The editorial concludes with a recommendation that GSK open their entire archive of information to public analysis.  This recommendation is within the scope of The Lancet's mission, which is to enhance public health.  They reiterate the call for pharmaceutical companies to register and publish the results of all studies, regardless of the results.  They also point out an important bioethical issue:

By moving the issue into the public sphere, the pharmaceutical industry may be forced to acknowledge that all its results, whether positive or negative, are obtained only by virtue of the voluntary cooperation of the public.

This is a restatement of a point they made in an earlier editorial:

On an individual level, doctors and pharmaceutical company employees must remember that without the trust of trial volunteers and patients medical research and practice will become impossible.

We can leave to the legal profession the question of whether fraud occurred.  Personally, I don't think so, because, as far as I can tell at this point in time, the company complied with all legal requirements for reporting their findings.  The more important question is whether they committed an ethical violation.  As The Lancet  points out, all of their research data are obtained via cooperation of the public.  On an ethical level, this means that the company has a reciprocal obligation to the public.  If the public cooperates with the company, the company should cooperate with the public. 

The complication, I suppose, is that interpretation of research studies is not a straightforward process.  There is a strong likelihood that the general public will not be able to interpret the findings accurately.  This is especially true with the earliest studies.  When a drug first is developed, nobody knows yet how best to use it.  Thus, there is a fair chance that the first studies will not show the drug in its best light.  It is understandable that a company would be reluctant to publish such data.  The point made by The Lancet  is that pharmaceutical companies have an obligation to make these data public, even if the data may be misinterpreted.  If it takes time and effort to get people to understand how to interpret the studies, then part of the company's duty to the public is to take that time and effort. 

Update: see A.M.A. Urges Disclosure on Drug Trials from NYT, for the AMA position on this.