Pfizer's Neurontin: Epilepsy meds have never been this sexy
Aug 12th 2009 7:30PM
Updated Dec 3rd 2009 4:37PM
Neurontin's saga began over a decade ago, but in 2004, when Warner-Lambert (which Pfizer acquired in 2000) paid a $430 million fine for promoting it off-label as a painkiller, many assumed Pfizer's own headache over. They were wrong. It's 2009 and just recently, on July 27, the first of 1,200 cases relating to Neurontin began.
It was going to be a "very tough" case for the plaintiffs, but they pressed on with lawyer Mark Lanier, winner of the biggest verdict over Merck & Co.'s (MRK) painkiller Vioxx. The plaintiffs are the family of Susan Bulger, 39, who took the drug before hanging herself in 2004. She was found by her five-year-old daughter hanging from an electrical cord in the basement of their home in Peabody, Massachusetts. The family claimed Pfizer promoted the medication for unapproved uses, despite knowing the risks, and didn't warn it could increase the risk of suicide until forced to do so by the government.
The FDA required only in December that all epilepsy medicines add a warning on the label regarding the risk of suicide. This came after its reviewers found an 80 percent increase in suicidal thoughts and behavior in data from 199 studies of 11 drugs. As Bloomberg reported, "Pfizer opposed the warning, saying Neurontin was safe and it was unfair to combine data for medicines that work differently." It still contends there is no link to Neurontin use and suicide.
While Pfizer believed it had a good case, claiming Susan Bulger's suicide was unrelated to its medicine and instead pointing the finger at Bulger's difficult life, it was no doubt relieved when the family agreed to dismiss the suit on July 29, one day after the trial began, after an anonymous donor offered to put $50,000 in a trust for her now 10-year-old daughter. The anonymous mystery donor? Lanier said the man, an acquaintance, is a well-known plaintiff's attorney.
That's when the fireworks in the media began. Jeffrey Kindler, Pfizer's CEO, said that Pfizer is "pleased to have been vindicated in this case." This caused an outburst from Lanier, who called Kindler's comments "outrageous," according to Bloomberg. "All Pfizer got today was a six-month stay of execution. We have 1,200 more of these cases to go."
So just when you thought this leg of the story was over, the one testimony in the shortened trial, if true, sounds like a scene out of Michael Clayton. Opening witness David Franklin, a former marketing employee of Warner-Lambert and the whistle blower in the 2004 Neurontin case, testified that on Monday afternoon a person who presented himself as a detective on behalf of Pfizer came to his home, blocked his driveway and threatened him, his wife and his young daughter. "We were all, quite frankly, terrified," BNET quoted the court transcripts.
Who was this detective? Apparently a former CIA agent named James Danforth who had been employed by Pfizer's lawyers. The lawyers of the pharmaceutical company apologized for anything inappropriate, saying it wasn't the intention. But Lanier claims Pfizer should have contacted Franklin through his lawyer and definitely not a day before his testimony.
Danforth denies any wrongdoing and Pfizer says the incident has been exaggerated to make the company look bad in the media. Pfizer and Danforth were still ordered to stay clear of Franklin. And for now, at least, it seems there will be a break until the next Neurontin trial begins in March.
BNET adds one last thought. "Despite having gone generic years ago, Neurontin's 2008 sales were $387 million." The plaintiff had an explanation for the sales: "Overall, 'off-label' sales of Neurontin have steadily increased since 1998, and from 2000 to the present have consistently remained at 93 percent to 94 percent of all sales. Actual sales for approved uses have declined."
Well, it's certainly true the biggest pharmaceutical in the world, about to get bigger with the Wyeth (WYE) acquisition, is far from being an angel or having its hands totally clean. But would it really risk such behavior for a drug already gone off-patent? If so, what does it say about its behavior regarding the other drugs?
There are far too many mysteries in this case than answers. Who paid off the plaintiffs? Why did a former-CIA agent contact the witness? How much did Pfizer know about increased suicide thoughts, if at all, before the label was added? Did Pfizer cross the line with Franklin, with patients? Maybe some day we'll get partial answers to a few of these questions. I'm not holding my breath.