Neurontin and Suicide

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BMJ 2004;328:1217 (22 May) (From British Medical Journal)

http://bmj.bmjjournals.com/cgi/content/full/328/7450/1217

Pfizer pleads guilty, but drug sales continue to soar

Jeanne Lenzer

New York

Pfizer, the world's largest drug maker, pleaded guilty on 13 May to

numerous civil and criminal charges for illegally promoting the

off-label use of gabapentin (Neurontin). It has agreed to pay a $240m

(£136m; 200m) criminal fine and $152m to state and federal healthcare

programmes. The fine is the second largest given in the industry.

Meanwhile, off-label sales of gabapentin continue to soar, despite

evidence that the drug is not effective for some of the problems it is

used to treat.

lin, 42, a microbiologist and former Harvard research fellow

who worked as a " medical liaison " expert for Warner-Lambert before it

was bought by Pfizer in 2002, filed a whistleblower suit under the False

Claims Act in 1996, charging the company with using " fraudulent

scientific evidence " to promote off-label uses of gabapentin.

Dr lin's suit detailed how the company suppressed study results,

planted people in medical audiences to ask questions intended to put

gabapentin in a good light, lavished perks on doctors, used

ghostwriters, gave generous " consultation fees " to " thought leaders, "

and used psychological profiling of doctors in its successful bid to

move gabapentin to so called blockbuster status (annual sales in excess

of $1bn) ( BMJ 2003;326: 620[Free Full Text]). Dr lin said that

off-label uses accounted for more than 90% of the drug's $2.7bn sales

worldwide last year.

Gabapentin is approved for use as adjunctive therapy only for partial

seizures and for post-herpetic neuralgia. But the company trained staff

to promote it for at least 11 off-label uses, including as monotherapy

for seizures, restless leg syndrome, bipolar disorder, migraines, and

alcohol withdrawal seizures.

" A lot of people say it's a benign drug, " said Dr lin. " But it's

dangerous when patients are [taken off other] drugs that are effective. "

Dr Keats, assistant professor of clinical psychiatry at Eastern

Virginia Medical School, agrees, citing the case of a 16 year old man

who committed suicide in May 2002 while taking gabapentin. " The shocking

aspect of the story is that the manufacturer funded a study and knew as

early as 1998 that Neurontin didn't work in bipolar disorder. But they

didn't publish the results until two years later. Yet we still see it

prescribed for bipolar disorder. "

As part of the settlement agreement, Dr lin will receive $24.6m

under whistleblowing legislation.

The settlement is not a major setback for Pfizer, whose worldwide sales

of gabapentin rose from $1.3bn in 2000 to $2.7bn in 2003.

The company's promotional efforts, Dr lin said, were " profoundly

effective. " He added, " A huge majority of people taking [gabapentin] now

are taking it for the wrong reasons. "