Article: Son of Neurontin Meets the Fibromyalgia Epidemic

Evanston, IL

Who says technology transfer doesn't pay?

Pregablin, discovered by Northwestern University chemist Richard Silverman in 1989 to become Pfizer's Lyrica, earned the university a cool $700 million when it sold royalties in Dec. 2007.

The nerve pain-cum-seizure pill is funding the $100 million Richard and Barbara Silverman Hall for Molecular Therapeutics & Diagnostics--currently a hole in the ground on the way to the student union--which will employ 245 this fall. Views of Lake Michigan and the duck pond included.

And, thanks to FDA approval in 2007 of Lyrica as the first US drug for the pain condition fibromyalgia, it may earn as much as its molecular relative--Pfizer's Neurontin (gabapentin)--which made $3 billion before its patent ran out in 2004.

No wonder they call Lyrica son of Neurontin.

Which is not say there haven't been setbacks along the way.

In 2001, Pfizer had to freeze pain trials and restrict pregablin in patients when test mice developed cancerous tumors. Profit warning! But when rats didn't follow suit, Toni Hoover, a vice president with Pfizer's now defunct Ann Arbor, MI labs told the Detroit News the scare was over and that "The FDA has found that the benefit of taking the drug outweighs any risk." Whew.

Pfizer brass failed to embrace Silverman the way it embraced the $564 million he made for them in Lyrica's first three months. ("They had a launch party for the drug, and I asked to come. Nope. No party for me. They take your stuff and tell you to go away," he told the Chicago Tribune.)

And Lyrica's not approved for the "social phobia" detailed in Pfizer original marketing plans. Yet.

But as long as pharma can get a drug approved in advance of its uses and people will take an antipsychotic for the blues or a seizure med for migraines, Lyrica has a future.

Initial articles about Lyrica which, like Neurontin, is an anti-seizure drug that modulates calcium channels to dampen the excitability of nerve endings, were positive.

"Well tolerated," said Arthritis and Rheumatism in 2005.

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

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

Unfortunately the articles were all written by Pfizer paid doctors.

Actual users of Lyrica report memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and itching and a lot of I'd-rather-have-my-fibro-symptoms-back-if-this-is-the-cure on askapatient.com. P.S. There are two deaths.

Of course its no secret that Pfizer's blockbusters Viagra, Zoloft and Lipitor are history and its pipeline is bare. In January, it announced it was losing 800 of its researchers and buying Wyeth (no danger of getting new researchers there.)

Nor can its gravy train of antibiotics in food animals--pun intended--last much longer with residues found in meat, water and even crops and world recognition of antibiotic resistance.

Just as people were forgetting that Pfizer paid $430 million in 2004 for criminally promoting Neurontin for bipolar disorder, attention-deficit disorder and other unapproved disorders, an article in the January 9 New England Journal of Medicine titled "The Neurontin Legacy--Marketing through Misinformation and Manipulation," shows it's de'j� vu all over again.

Nor is Lyrica the only game in town anymore for fibromyalgia since the FDA approved Lilly's antidepressant Cymbalta in 2008 and Forest Laboratories' antidepressant Savella in January.

Now Americans can choose between an antidepressant with a black box warning for suicide and a seizure medication for a disease they didn't know they had--or was an epidemic--ten years ago!

Lyrica itself was slated for an FDA suicide warning until a 92-page appeal from Pfizer that called the suicide stats "an exaggeration of risk that is introduced by ascertainment bias" and cautioned against "overwarning...patients and prescribers" so that they "underestimate the risks of declining treatment"--especially at the cash register.

As Northwestern students negotiate the snow and construction at the future home of the Richard and Barbara Silverman Hall for Molecular Therapeutics & Diagnostics, any pain they're feeling is from all-nighters, all-you-can-drink nights and the cold--not fibromyalgia. Nor will many remember Lyrica when classes start in the new hall. Especially since a building can't be withdrawn.