What Docs Didn't Know About Pfizer's Neurontin

Here’s a depressing exchange in the litigation on Pfizer’s anti-seizure med, Neurontin. It’s between the doctor of Susan Bulger, who killed herself after taking the pill. Her family claims Pfizer knew the drug caused suicidal thoughts in some people but sat on information:

Last year, Bulger’s doctor, Dino Crognale testified in a deposition:

Q. When you prescribe a medication, do you want to know what the affect that medication has on the neurochemistry?
A. I do.
Q. And if Neurontin is known to deplete serotonin, is that something you would want to know?
A. Yes.
Q. Did you know that 5.3 percent of the population in the original clinical trials of Neurontin reported depression as an adverse event?
A. No, I did not know that.
Q. Did you know that of the 5.3 percent, equated to 78 people, that 19 of them had no prior history of depression?
A. I did not know that.
Q. And did you know that 22 of the patients required pharmacological treatment for their depression during the clinical trials?
A. No.
Q. Is that information you would have liked to have known?
A. Yes.
Q. Would you have liked to have known that there were suicidal attempts in the clinical trials of Neurontin?
A. That would have been helpful.

• Download documents in Bulger v. Pfizer here.

You might have thought that Pfizer’s troubles with Neurontin were finally being confined to an historical footnote. The company famously paid $430 million in 2004 for promoting it off-label as a painkiller. Much of the plaintiffs’ case is a rehash of stuff from the 2004 case, including the federal “information” that Pfizer settled, which is an exhibit to the case. The trial starts July 27, per Bloomberg.

Pfizer argues that Bulger had a history of mental disorders, and suffered from “physical and mental abuse, long-term substance abuse and addiction to cocaine, heroin, Methadone and Oxycontin.” Her family therefore cannot prove that Neurontin alone triggered her suicide, the company says.

Mass. U.S. District Judge Patti B. Saris said it’s “a very tough case because of her personal history.” With that statement she joins Delaware Judge Joseph Slights III, who expressed a similar sentiment over whether plaintiffs could ever prove AstraZeneca’s Seroquel caused weight gain if plaintiffs had complicating factors.

Surprise fact: Despite having gone generic years ago, Neurontin’s 2008 sales were $387 million. Why? Here’s one reason, the plaintiffs claim:

Overall, “off-label” sales of Neurontin have steadily increased since 1998, and from 2000 to the present have consistently remained at 93% to 94% of all sales. Actual sales for approved uses have declined.

• Previously:
• Wyeth Q2: Ah! So That’s Why Pfizer’s Buying This Company
• Pfizer Q2: All But 3 Drugs in Decline; R&D Spend Lowest Since 2007
• Did Pfizer Violate Foreign Corrupt Practices Act in Philippine “Bribe” Flap?
• Pfizer Exec Gets 6 Months’ Home Confinement for Off-Label Bextra Sales
• Pfizer Will Fall Under Philippines Price Control; Company Ads Deny “Bribe” Attempt
• “Bribe” or No, Pfizer May Get Its Way in Philippines
• Pfizer “Bribe” Scandal in Philippines Heats Up; Company Offered Posters to the President
• UPDATED: Pfizer Accused of “Bribe” to Stave Off Price Control Law in Philippines
• Pfizer Catches Flak for Giving Drug Discounts to Some But Not All Filipinos
• Pfizer to Close S.F. Biotech Center in Favor of Unit Accused in Patent Suit
• Pfizer Patent Suit Could Make Elan Bapineuzamab Talks Go a Whole Lot Easier
• Pfizer’s Foreign Viagra Ads: Mailman Jokes; Space Sperm and the Fountain of Youth
• Why Pfizer’s Generics Unit Faces an Uphill Battle