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.
David Franklin, 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 Franklin'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). Dr Franklin 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.
Figure 1.
Whistleblower David Franklin said that Pfizer's efforts to promote gabapentin were “profoundly effective”
Credit: CHITOSE SUZUKI/AP
“A lot of people say it's a benign drug,” said Dr Franklin. “But it's dangerous when patients are [taken off other] drugs that are effective.”
Dr Matthew 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 Franklin 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 Franklin said, were “profoundly effective.” He added, “A huge majority of people taking [gabapentin] now are taking it for the wrong reasons.”