Tuesday, August 22, 2006

The gabapentin story: "Medical education drives this market"

The quote "Medical education drives this market" is attributed to an author of a Parke -Davis business plan found in a legal exhibit in the proceedings of the United States vs Pfizer, and Parke-Davis. Public documents in this case were reviewed and analyzed by Dr. Michael A. Steinman and his colleagues at the San Francisco Veterans Affairs Medical Center in San Francisco and published in the August 15, 2006 issue of the Annals of Internal Medicine. Federal legal action had been taken against gabapentin manufacturer for promoting off-label uses of the drug.

After a physician or medical student or house officer reads this article she should never view certain "CME" activities in the same way.

An important part of the influence campaign of Parke-Davis (P-D)to promote off-label use of gabapentin was though "thought leaders". These physicians are influential physicians often identified by the affiliation with major academic centers. These department chairs, directors of academic training programs or divisions received payments ranging from $10,000 to about $150,000 between 1993 and 1997 in the forms of honoraria, research grants and educational grants. These folks were often the likely role models for house officers , fellows and medical students. This aspect of the multifaceted efforts of P-D to promote non-FDA approved use of gabapentin is the most troubling to me because of the role well respected physicians played. At some early point,a person could have been simply naive and was duped but at some point most had to be complicit at some level.

There are other aspects detailed by the authors including the use of "medical education" companies hired by P-D to ghost write articles and organize meetings, and supply various CME products which were basically advertisements for off-label use of gabapentin.

The full text version of the Annals article is not available until 6 months after publication on line but an excellent review of the article and commentary about both the article and the accompanying editorial can be found in two posts from August 18,2006 on Health Care Renewal.
In addition to outlining the various tactics (advisory boards, consultant meetings, speakers bureaus, programs funded through unrestricted educational grants), Dr Poses raises valid questions about the multiple corporate positions held by the Annals editorial writer as well an academic appointment and how difficult it would seem to be to fulfill the apparently conflicting fiduciary duties that those various roles demand.

The Annals article and Dr. Poses's posts should be part of medical students courses on evidence based medicine. They need to recognize the borders between research,education and promotion which the authors described as "porous". We can hope they will guard these borders better than some-perhaps too many-of their mentors have done. I am grateful to Dr. Steinman and his associates for their work in plowing through some 8000 pages of publicly available documents to give us a "game plan" for selling a drug to physicians. Hopefully this will be as helpful to physicians as giving the offensive play book to the defensive coordinator of a rival football team.

1 comment:

Michael Rack, MD said...

thanks for posting this. I hate it when academics criticize us private practice docs for accepting $10 lunches from drug companies and then go and accept $500 speaking fees ($5000 at major meetings) and $50-100,000 research grants from the drug companies.