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Lyrica, Cymbalta Fibromyalgia Promotions Questioned

Feb 9, 2009 | Parker Waichman LLP

Two drug makers are spending a fortune to promote medications for a disease that some doctors say may not even exist.  According to the Associated Press, Eli Lilly and Pfizer have donated more than $6 million to nonprofit groups to spread information about fibromyalgia in an effort to boost sales of  Cymbalta and Lyrica.

Fibromyalgia, defined as a chronic, widespread pain condition of unknown origin, is a controversial diagnosis.   No biological tests exist to diagnose fibromyalgia, and the condition cannot be linked to any environmental or biological causes.  While the Associated Press said that doctors agree that suffers' symptoms are real, they don't agree that a disorder called fibromyalgia is behind them.  But real or not, there is obviously a huge market for fibromyalgia treatments.

Pfizer's Lyrica was the first prescription medication approved to treat fibromyalgia, though no one can explain exactly how it works. Lyrica was first approved to treat epilepsy.  In 2004, the drug was reviewed by the Food & Drug Administration (FDA) as a remedy for diabetic nerve pain.  According a  New York Times report published last January, the reviewers recommended against approving the drug, citing its side effects.  Lyrica causes weight gain and edema, or swelling, as well as dizziness and sleepiness.

But the FDA ignored the advice of Lyrica reviewers, and approved it anyway.  Then Pfizer asked the FDA to expand the approved uses of Lyrica to include the treatment of fibromyalgia, and the agency did so in June 2007.  According o the Times report, in clinical trials, patients taking Lyrica reported that their pain fell on average about 2 points on a 10-point scale, compared with 1 point for patients taking a placebo. About 30 percent of patients said their pain fell by at least half, compared with 15 percent taking placebos.

Pfizer’s success has encouraged other drug makers to seek approval for their own fibromyalgia drugs.  Eli Lilly's antidepressant Cymbalta received such approval last June.

According to the Associated Press, both drug makers are spending big bucks to promote not only their drugs, but fibromyalgia as well.  According to the report, key components of their marketing onslaught include more than $6 million in grants to nonprofit groups to pay for fibromyalgia medical conferences and educational campaigns.  And that was only in the first three quarters of 2008, the Associated Press said.   It's also more than the drug makers gave towards Alzheimer's Disease and diabetes, which are universally recognized as real diseases.

One doctor interviewed by the Associated Press called Eli Lilly's and Pfizer's fibromyalgia promotion efforts "disease mongering".  That doctor, Frederick Wolfe,  was lead author of the guidelines defining fibromyalgia in 1990, but now doubts the very existence of the disease.

Despite such concerns over the tactics used by Eli Lilly and Pfizer, they do seem to be working.  According to the Associated Press, between the first quarter of 2007 and the fourth quarter of 2008, sales rose from $395 million to $702 million for Lyrica, and $442 million to $721 million for  Cymbalta.


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