A family photo of Chris Yankus, left, Jacci Zarek, middle, and their son Dustin. Yankus and Zarek want to know why their son was prescribed Neurontin, when there was no solid evidence it was an effective treatment for bipolar disorder.
Drug companies spend billons of dollars each year trying to persuade doctors to prescribe their drugs. There are strict rules about what form that promotion can take. The rules are meant to ensure that drug companies give doctors trustworthy information, so that medications are prescribed appropriately. But drugmakers can get around the rules. In a series of stories, NPR's Snigdha Prakash reports on how one company tried to do that with the antiepilepsy drug Neurontin.
Neurontin as a Bipolar Treatment
Soon after Dustin Yankus was diagnosed with bipolar disorder in 2001, he was prescribed Neurontin. The Food and Drug Administration has never approved the drug as a treatment for bipolar disease, which is also known as manic depression. But as Prakash reports, some literature — paid for mostly by the drugmaker and distributed to doctors — suggested the drug had a favorable effect.
In May 2002, the 16-year-old committed suicide. For the previous eight months, despite his complaints to doctors that the drug wasn't working, Dustin took Neurontin every day. He had a long history of psychiatric troubles, and was being treated with many drugs. It isn't known what role, if any, Neurontin played in Dustin's death. But his parents are left wondering why Dustin's doctors turned to that particular drug, without solid evidence that it worked.
Pfizer, the drug company that now owns Neurontin, says it is a safe drug and has never been linked with suicidal behavior.
Dr. Catherine Clarey, a senior medical director at Pfizer, says more than 10 million prescriptions for Neurontin have been written in the United States since 1996.
She says there is "absolutely no evidence" that Neurontin can cause suicidal behavior.
Hear more about the possible illegal promotion of the drug and the Yankuses' story Jan. 16 on All Things Considered.
The Whistle-Blower Suit
Neurontin was approved for sale in the mid-1990s as a treatment for epileptic seizures. But a lawsuit by a former employee alleges that Parke-Davis has made most of its money off the drug by marketing it to doctors for unapproved uses, in an illegal practice known as "off-label marketing."
Doctors are free to prescribe a drug for unapproved uses, but under FDA law, a company is not allowed to promote a prescription drug for a medical condition without first proving to the FDA that the drug works for that condition and is safe.
The whistle-blower, former salesman David Franklin, charges that the company had a systematic strategy to promote Neurontin for untested uses, such as chronic pain, bipolar disorder and migraine. Franklin, who is suing in federal court in Boston, claims internal documents show the company promoted these uses by paying doctors to attend so-called educational meetings at lavish restaurants and resorts.
Pfizer has declined to comment on the details of the whistle-blower lawsuit, and says it does not engage in off-label marketing practices.
Neurontin continues to be sold mostly for unapproved uses. By Pfizer's own admission, 80 percent of Neurontin's sales are for those uses.