In 2004, Pfizer settled an illegal Neurontin marketing case with the U.S. Justice Department for $430 million.  The original whistleblower complaint was filed by David Franklin, a microbiologist  who had worked for Warner-Lambert (the original manufacturer of Neurontin)  under the False Claims Act. The settlement did not address harm to patients prescribed Neurontin.

There are currently 1,200 lawsuits awaiting trial that were filed by individuals who claim to have been harmed by Neurontin, a drug approved as an adjunctive treatment for epilepsy which was widely prescribed for unapproved, off-label uses. The first case to go to trial, Bulger v Pfizer, involves the suicide of Susan Bulger. The case is being tried in Federal District Court in Massachusetts.

Bloomberg News reports (below) that David Franklin testified:

“I was trained from day one to market the drug illegally…My job was to promote Neurontin and motivate doctors to experiment on patients. After being hired as a medical liaison, I was selling drugs. The uses promoted were from the “snake-oil list” of 13 medical conditions."

Franklin testified that Warner-Lambert officials used a variety of tactics to persuade doctors to prescribe Neurontin for unapproved uses.

"They provided the company’s sales force with a list of ailments that would benefit from Neurontin use, including restless leg syndrome, migraine headaches and withdrawal symptoms from drug and alcohol abuse." He noted that the FDA hadn’t approved the drug for any of those illnesses at the time.

Mark Lanier, the lawyer representing the Bulger family, told jurors that Warner-Lambert executives began the off-label marketing campaign to transform Neurontin into a “blockbuster” medicine generating $1 billion in annual sales. The company estimated that selling it solely as an epilepsy drug would generate only about $50 million in sales.

“The company made a conscious decision to do something illegal — marketing this drug off-label.”

Indeed, illegal, off-label marketing has become "the norm and practice" of the pharmaceutical industry: Clinically insignificant, toxic drugs become blockbuster sellers. That’s because industry spends the most money aggressively marketing the worst drugs–drugs of dubious benefit which pose life-threatening risks.

For example,
Merck: Fosamax,Vioxx
Pfizer: Neurontin, Bextra, Zoloft, Chantix, Geodon
GlaxoSmithKline: Paxil, Avandia
Lilly: Oraflex, Prozac, Cymbalta, Zyprexa
Janssen (J & J): Prepulsid, Risperdal
AstraZeneca: Seroquel
Wyeth: Prempro, Redux (Fen-Phen)

See: https://ahrp.org/cms/images/stories/articles/evidencepropagandawcsj2009.pdf

Posted by Vera Sharav

BLOOMBERG NEWS
Pfizer Unit Marketed Drug Illegally, Ex-Employee Says (Update2)
By Jef Feeley and Margaret Cronin Fisk

July 28 (Bloomberg) — Pfizer Inc.’s Warner-Lambert unit created a list of 13 ailments that its epilepsy medicine Neurontin could treat as part of its promotion of the drug for unapproved uses, a former employee testified.

“I was trained from day one” to market the drug illegally, David Franklin testified. Franklin, who worked as a medical liaison at the Parke-Davis division of Warner-Lambert, said he encouraged doctors to prescribe Neurontin for uses beyond those approved by the U.S. Food and Drug Administration.

“My job was to promote Neurontin and motivate doctors to experiment” on patients, he said today in federal court in Boston. After being hired as a medical liaison, “I was selling drugs,” he said. The uses promoted were from the “snake-oil list” of 13 medical conditions, said Franklin, a microbiologist.

Franklin was the first witness in the trial over claims by the family of Susan Bulger, 39, who hanged herself after taking the drug. Bulger’s family claims Pfizer promoted Neurontin for unapproved uses and failed to warn it could increase the risk of suicide until forced to do so by the government. Bulger started taking the drug in 1999.

The trial of the suit, the first of about 1,200 over Neurontin to go to trial, is expected to last three weeks.

Pfizer fell 59 cents, or 3.6 percent, to $16.03 at 4:15 p.m. in New York Stock Exchange composite trading. Pfizer shares have fallen 9.5 percent so far this year.

Whistleblower Suit

Franklin filed a federal whistleblower complaint in 1997 alleging the company illegally marketed the drug for attention deficit disorder, pain and other unapproved uses. The suit resulted in a $430 million settlement by Warner-Lambert with the U.S. Justice Department in 2004.

Franklin, who worked at Warner Lambert for four months in 1995 before resigning over the company’s off-label marketing practices, received about $25 million as his share under the federal False Claims Act, the government said at the time.

Warner-Lambert officials used a variety of tactics to persuade doctors to prescribe Neurontin for unapproved uses, Franklin told jurors.

They provided the company’s sales force with a list of ailments that would benefit from Neurontin use, including restless leg syndrome, migraine headaches and withdrawal symptoms from drug and alcohol abuse, Franklin said. The FDA hadn’t approved the drug for any of those illnesses at the time, he added.

Suicide Warning

The U.S. Food and Drug Administration in December required all makers of epilepsy drugs, including Neurontin, to add a suicide-risk warning to their labels.

Neurontin didn’t cause Bulger’s suicide, and her doctors didn’t prescribe the drug because of off-label marketing, Pfizer’s lawyer said in his opening.

“There’s no reliable evidence that Neurontin causes suicide or makes depression worse,” said lawyer William Ohlemeyer.

Pfizer’s lawyer also pointed out the off-label marketing practices covered by the Warner-Lambert settlement with the government occurred before the New York-based drugmaker’s 1999 purchase of its rival.

Mark Lanier, a lawyer representing Bulger’s family, told jurors that Warner-Lambert executives began the off-label marketing campaign to transform Neurontin into a “blockbuster” medicine generating $1 billion in annual sales. The company estimated that selling it solely as an epilepsy drug would generate only about $50 million in sales, he added.

‘Conscious Decision’

“The company made a conscious decision to do something illegal — marketing this drug off-label,” Lanier said today in his opening statements.

Bulger’s family, of Peabody, Massachusetts, sued Pfizer and Warner Lambert in August 2007, more than three years after Bulger’s husband and 4-year-old daughter found her body in their basement. Ronald Bulger said he gave his wife four Neurontin pills an hour before she killed herself.

Ohlemeyer noted in his opening statement that Bulger had made at least six other suicide attempts during her lifetime and had battled drug addiction and depression.

The case is Bulger v. Pfizer Inc., 1:07-CV-11426, U.S. District Court, District of Massachusetts (Boston). The suit is part of In Re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629.

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net; Margaret Cronin Fisk in Southfield, Michigan, at mcfisk@bloomberg.net.

Last Updated: July 28, 2009 16:36 EDT