The American Psychiatric Association has been reeling for over a week from allegations regarding ghostwriting and a textbook they published some years ago with help from Scientific Therapeutics Information. GlaxoSmithKline paid for the book, which one critic now calls “an advertisement for Paxil.”
Still, some may wonder, “So what? Why should I care about ghostwriting?”
Consider Dustin Yankus, a teenager who was diagnosed with bipolar disorder in 2001. To control his condition, Dustin’s doctors gave him Neurontin, an anticonvulsant taken by epileptics.
In May 2002, the 16 year-old boy committed suicide.
Dustin’s parents were left wondering why their child was prescribed Neurontin when there was no solid evidence it was effective for bipolar disorder.
They got some answers in 2004 when Pfizer fessed up to charges brought by a whistleblower, David Franklin. The company pleaded guilty to two felonies and paid $430 million in penalties for fraudulently promoting Neurontin for unapproved uses including…you guessed it…bipolar disorder.
To promote sales, Pfizer crafted ghostwritten material and orchestrated an “echo chamber” of positive findings for Neurontin to treat bipolar disorder. From this month’s editorial in the International Journal of Occupational and Environmental Health:
In this case, from 1998 to 2007 Pfizer organized the publication of 15 case series and six case reports that claimed Neurontin was effective for the treatment of bipolar disorder. In addition, nine letters to the editor mimicked these publications. To legitimize the off-label use of Neurontin, Pfizer manufactured the publication of review articles citing the case reports. These concluded that Neurontin was safe and effective for the treatment of bipolar depression.
The result of the ghostwriting campaign? Success! Sales of Neurontin skyrocketed from $97.5 million in 1995 to $2.3 billion in 2003. Almost 90 percent of these prescriptions were for unapproved uses, like bipolar disorder.
At the time of Dustin’s death, a senior medical director at Pfizer told NPR that there is "absolutely no evidence" that Neurontin can cause suicidal behavior.
But five years after Dustin killed himself, an FDA panel of experts met to discuss Neurontin’s side effects. They recommended that Pfizer update the label for Neurontin.
The label now carries this warning, written in bold:
Like other antiepileptic drugs, NEURONTIN may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Update: Friends and family created a Facebook memorial for Dustin Yankus. He can be found here, frozen in time, forever 16.
Paul Thacker is a POGO Investigator.
- Pfizer's profile in the Federal Contractor Misconduct Database (FCMD)
- FCMD entry: Illegal Marketing of Neurontin
Image by Amanda M Hatfield, used under Creative Commons License.