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.
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.
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