Insiders' Game, Part 1

I recently attended the Rocky Mountain Workshop on How to Practice Evidence Based Health Care ( http://ebhc.uchsc.edu/). The University of Colorado Health Science Center organizes this world-class event every year (8th annual) west of Denver (Vail this year). Lisa Bero PhD from UCSF presented information from the archives they're developing around documents released from the tobacco industry, the drug industry and other lawsuits (e.g. lead) involving health risk. She discussed the mis-information the tobacco industry has meticulously provided to public for decades (beginning in the 1950's) including confounding ICD-9 code changes for second hand smoke Download cook_et_al. power of paperwork. phillip morris.05.pdf , influencing research Download bero. tobacco industry manipulation of science. 05.pdf, Download malone_bero. chasing the dollar. 04.pdf and legislative tampering  and influence pedalling Download lopipero_bero. tobacco & airlines. 06.pdf .

Bero coauthored a paper on the drug industry promotion of Gabapentin (Neurotin) for pain management & other uses, that were NOT approved or originally intended use of the drug. The paper was published last week in Annals. [Steinman MA et al. Narrative Review: The promotion of Gabapentin: An analysis of internal industrial documents. Ann Intern Med. 2006;145:284-293.Download steinman_bero_et_al. narrative review. gabapentin. aim. 06.pdf ].

Gabapentin was approved by the FDA in the early 1990's for seizure control (anti-epileptic), period. The drug has been promoted by the manufacturer (Parker-Davis, division of Warner-Lambert Co) for 'off-label' uses, particularly pain management in chronic pain conditions, which is illegal. The authors examined internal documents revealed during a lawsuit (David Franklin vs. Pfizer, Inc. & Parker-Davis, Division of Warner-Lambert Co). The details of how the drug companies come to a market strategy, buying opinion and education leader with monies (up to $175,000+ per person) and promoting 'peer-to-peer selling' with the mantra "Medical education drives the market!" The graph on page 286 tells the story of a logarithmic increase in sales in conditions not FDA approved (e.g. migraine, pain, psychiatric disorders) while the epilepsy management is fairly flat (in terms of prescriptions per year from 1994-2000). The company documents line out the strategies and tactics that developed a market for the drug, not just research to change the label use, but to 'disseminate the information as widely as possible through the world literature'... to generate excitement in the market and stimulate off-label prescription. It's a tale of industry manipulation and infiltration in the halls of science & medicine. I have only seen Neurotin (Gabapentin) used for chronic pain management (I don't work with an epileptic population), so I was surprised to find out this is an 'off label' use of the drug.

'Follow the money' in table 2. The paper is a great read ("The Da Vinci Drug?").

Britt

PS. Gabapentin was approved for post-herpetic neuralgia in 2004. Period.