We give them licenses, patents, and subsidies for this?
What's It Going to Take to Lock Up Drug Company Execs?
Pill companies -- major contributors to politicians' campaigns -- get subsidies for research, monopoly patents for a mere filing fee, and limits on their liability. Doctors get licenses that keep out competent competition. Instead of interfere, perhaps government should allow competition, enforce truth in advertising, and charge full market value for any permit it grants -- all together a major part of geonomic reform. This 2009 article was posted on AlterNet Jan 16. The writer is a clinical psychologist and author of Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy.
By Bruce E. Levine, Ph.D.After reading "The Neurontin Legacy -- Marketing through Misinformation and Manipulation" in the January 8, 2009 issue of the New England Journal of Medicine (NEJM), one may conclude that (1) America's prisons would be put to better use incarcerating drug company executives instead of pot smokers, and (2) society may need a return of public scorn via the pillory for those doctors who are essentially drug-company shills.
The NEJM, perhaps the most influential American medical journal, stated "drastic action is essential to preserve the integrity of medical science and practice and to justify public trust."
Neurontin was approved by the Food and Drug Administration (FDA) in 1993 in doses of up to 1800 mg per day as adjunctive therapy for partial complex seizures. Annual sales of Neurontin increased from $98 million in 1995 to nearly $3 billion in 2004.
Parke-Davis (a division of Warner-Lambert purchased by Pfizer in 2000) marketed Neurontin off-label to doctors for uses not approved by the FDA. Doctors can legally prescribe drugs for uses not approved by the FDA. A Parke-Davis whistle blower showed how off-label marketing created the Neurontin bonanza.
In 1996, David Franklin, a young biologist, took a sales representative position for Parke-Davis. A company executive informed him and his fellow sales reps:
“We can't wait for [physicians] to ask. We need [to] get out there and tell them up front. Dinner programs, CME [continuing medical education] programs, consultantships all work great, but don't forget the one-on-one, holding their hand and whispering in their ear: Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don't want to see a single patient coming off Neurontin before they've been up to at least 4800 mg/day. I don't want to hear that safety crap either; every one of you should take one just to see there is nothing, it's a great drug."
Franklin left Parke-Davis and filed suit, alleging that off-label marketing of Neurontin constituted false claims designed to elicit payments from the federal government. In 2004, Warner-Lambert resolved criminal charges and civil liabilities by agreeing to plead guilty and pay $430 million -- less than 15 percent of the $3 billion the drug company had grossed on Neurontin in 2004.
The current New England Journal of Medicine article concluded that Parke-Davis’ marketing of Neurontin involved "the systematic use of deception and misinformation to create a biased evidence base and manipulate physicians' beliefs and prescribing behaviors."
And let's not kid ourselves about the innocence of doctors. The tactics used by Parke-Davis and other drug companies to manipulate doctors make it clear that too many doctors have been willing participants in the corruption of their profession.
The NEJM discusses some of the practices used by Park-Davis (and commonly used by other drug companies): recruit local physicians who are then trained and paid to serve as speakers in "peer-to-peer selling" programs; financially cultivate renowned professionals, so-called "thought leaders;" financially influence academics with educational grants, research grants, and speaking opportunities worth hundreds of thousands of dollars; create drug "advisory boards" to launder pay offs to "friendly" physicians; provide doctors employed by medical-education companies with "unrestricted educational grants" to produce programs that promote off-label (unapproved) uses of drug; fund doctors' "research" that in fact is designed and commissioned to promote a specific drug; and credit doctors as authors for ghost-written research articles that downplay drug ineffectiveness or lack of safety.
The New England Journal of Medicine is now warning physicians that medicine's corruption by drug companies has threatened public confidence in their profession. If those physicians who are not drug-company shills want to save their profession, they might want to start taking aggressive actions against their colleagues who are on the take. Perhaps it will help motivate clean physicians to be reminded that history shows that any institution -- no matter how large and powerful -- can arrogantly cross those lines leading to its demise.
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