Saturday, March 27, 2010

A Perfect Trifecta

In two prior posts, I discussed some of the deceptive marketing tactics used by Pfizer and Eli Lilly to market their drugs for off-label (non-FDA-approved) purposes, and to balloon the definition of certain psychiatric disorders. These techniques were well documented and became public as a result of settlements with the U.S. Department of Justice.

Eli Lilly, in particular, was in the business of promoting drugs for "bipolar disorder" defined in the loosest possible way to include patients with ordinary agitation, unhappiness, chronic anxiety, self esteem problems, moodiness,and the like. To briefly review the cases:

January, 2009: Eli Lilly pays a settlement to the DOJ of $1.4 billion for concealing side effects and off-label marketing of Zyprexa just as their biggest seller, Prozac was about to go off patent in 2001.

September, 2009: Pfizer agrees to a settlement for $2.3 billion for off label marketing of several drugs including the atypical anti-psychotic Geodon.

To complete a perfect trifecta, I now briefly turn to a third example. In May, 2004, Warner-Lambert agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of its anti-convulsant drug Neurontin. One of the many uses that was touted for this alleged wonder drug was for bipolar disorder.

The reasoning went sort of like this: If some anti-convulsants like Depakote and Tegretol are effective in bipolar disorder, then they all must be. (We are hearing something similar about another one, Topamax, although that one may conceivably pan out).

Of course, that is an illogical and invalid conclusion. It is also noteworthy than benzodiazepines like Valium and Klonopin are very effective anti-convulsants - in fact epilepsy was the initial FDA-approved indication for Klonopin - but no one seems to pushing the idea that benzo's are effective in bipolar disorder. They are generic!

Actually, studies later indicated Neruontin was in fact completely ineffective for bipolar disorder. Nonetheless, the existence of those studies has not stopped psychiatrists from continuing to use it, because clinically they see "results." The results they are seeing, however, have nothing to do with bipolar disorder.

Neurontin is sedating. In fact, one of its main actions in the brain is to affect the neurotransmitter GABA, the very same neurotransmitter affected by benzodiazepines. Therefore, if you give it to a chronically agitated, moody patient whom you misdiagnose as bipolar, it seems to calm them down. Presto change-o, the drug "works."

Of course, after a while, the sedative effect is reduced and Neurontin does not work so well any more, but hey, who said anything about actually following these patients closely and asking a bunch of probing questions?

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