Do You Have Fibromyalgia? Drug Company Hopes So.

by Martha Rosenberg

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Even as new reports surface about fake medical articles Pfizer planted to sell seizure drug Neurontin for unapproved uses from 1995 to 2002, it looks like deja vu all over again.

Pfizer gave nonprofits $2.1 million in grants in 2008 for medical courses about the pain-and-fatigue ailment fibromyalgia for which its Neurontin follow-up pill, Lyrica, just happens to be approved.

Lyrica (pregablin), facetiously called Son of Neurontin at Pfizer, was discovered by Northwestern University chemist Richard Silverman in 1989, earning the university a cool $700 million when it sold royalties in late 2007.

It is funding the $100 million Richard and Barbara Silverman Hall for Molecular Therapeutics & Diagnostics, under construction now, which will employ 245 faculty, staff and research assistants and hopefully lead to other promising molecules.

Like Neurontin (gabapentin), Lyrica (Pregablin) is an antiepilepsy drug (AED) that modulates calcium channels to dampen the excitability of nerve endings and seizure activity. And, like Neurontin which made $3 billion a year from unapproved uses like bipolar disorder, attention deficit disorder and restless legs syndrome, Pfizer has high hopes for its "crossover appeal."

Lyrica was approved in 2006 for partial onset seizures and nerve pain associated with diabetes and shingles. But the FDA's approval of Lyrica as the first drug for fibromyalgia in 2007 is what kicked sales up 37 percent in the third quarter to $465 million.

Fibromyalgia, with no clear cause, blood test, definition or cure "is almost a textbook definition of an unmet medical need," enthused Pfizer VP Ian Read in a conference call to analysts when the drug first launched.

No kidding! Datamonitor predicts the fibro market can be "grown" from $400 million to $2 billion thanks to all the people who don't know they have it yet.

And even before the name Lyrica appeared, Pfizer's initial "unbranded" campaign of public service announcements in conjunction with the National Fibromyalgia Association--are you listening broadcast executives? PSAs?-- that featured people describing their symptoms and hawking the web site www.fibrohope.org moved script big time.

(Think Merck's "unbranded" HPV vaccine Gardasil campaign.)

Despite a temporary Lyrica scare in 2001when Pfizer had to freeze patient trials because mice developed cancerous tumors--luckily the rats didn't--Lyrica was well received by the medical community.

Except they were all on the same team.

"Well tolerated," said Pfizer paid doctors in Arthritis and Rheumatism in 2005.

"Proven efficacy" and "No new adverse events," said Pfizer paid doctors in Drugs of Today in 2005 and 2007.

And, "Durability of effect for relieving FM pain," said Pfizer paid doctors in the journal Pain in 2008.

Actual Lyrica users were less effusive, reporting memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and even two deaths on askapatient.com. And the FDA added suicide warnings to all AEDs in 2008.

Nor is the bad press over for Pfizer. The News Tribune reported Pfizer reps made over 200 visits to Western State Hospital, a mental hospital in Tacoma, Washington, within four years--"That's where our customers are," snapped then company spokesman Bryant Haskins--where 118 prescriptions for Pfizer's controversial drug Geodon were ordered in just one day.

And after paying $430 million in 2004 to settle Neurontin criminal charges, it agreed to pay $2.3 billion just last month for improper marketing of its painkiller, Bextra which was so dangerous it was withdrawn in 2005. Who can say incorrigible?

Few even noticed the repeat offense as Pfizer acquired rival Wyeth at the same time whose Fen Phen and Premarin travail make Pfizer's profile look like Sir Galahad's.

Hopefully, when Pfizer adds social phobia and general anxiety to conditions Lyrica can treat, it will remember to add headache. It will need a lot for itself.

Martha Rosenberg is a columnist/cartoon who writes about public health.

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