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Pfizer fined for pushing epilepsy drug

Posted by almondjoy on May 13, 2004, at 23:19:54

http://money.cnn.com/2004/05/13/news/fortune500/pfizer.reut/index.htm?cnn=yes

Pfizer fined $430M in Neurontin case
No. 1 drugmaker pleads guilty for pushing epilepsy drug for other, unapproved uses.
May 13, 2004: 3:45 PM EDT

WASHINGTON (Reuters) - Pfizer Inc. agreed to pay $430 million and plead guilty to criminal charges for illegally marketing an epilepsy drug for unapproved uses such as migraines and pain, U.S. prosecutors said Thursday.

The company's Warner-Lambert division promoted the drug, Neurontin, for uses it had no scientific evidence to support, and even in cases where the drug was shown to be ineffective, prosecutors said.

For example, the company promoted Neurontin for treating bipolar disease, even though a study showed a placebo worked as well or better than the drug for manic depression.

"Warner-Lambert's promotional efforts were a highly organized and deliberate attempt to circumvent federal restrictions on marketing,'' Associate Attorney General Robert McCallum told a news conference in Washington.

The $240 million criminal portion of Pfizer's payment is the second largest criminal fine for a health-care fraud case, McCallum said.

TAP Pharmaceuticals, a venture of Abbott Laboratories Inc. and Takeda Chemical Industries Ltd., agreed in 2001 to pay $290 million over charges it illegally marketed a prostate cancer drug.

The Justice Department and attorneys general of all 50 states agreed to the Neurontin settlement with Pfizer.

The settlement won't have a big financial impact on Pfizer, the world's largest drugmaker with more than $45 billion in sales last year. The company has already set aside funds needed for the settlement.

Still, Pfizer (PFE: down $0.40 to $35.31, Research, Estimates) stock fell more than 1 percent in late New York Stock Exchange trading.

The case originated from a lawsuit filed in late 1996 by whistle-blower David Franklin, who had worked for Warner-Lambert before it was acquired by Pfizer in 2000.

Franklin said the company used a variety of schemes to illegally pump up sales of Neurontin -- a drug that remains one of Pfizer's biggest sellers with 2003 sales of $2.7 billion.

According to court documents, a May 1996 voicemail message from a top marketer to "medical liaisons'' in the Northeast was like a call to arms: "When we get out there, we want to kick some ass, we want to sell Neurontin on pain.''

Under federal regulations, companies may market and promote drugs only for uses approved by the Food and Drug Administration, although doctors can prescribe drugs to treat other uses. Companies have been increasingly scrutinized by regulators for "off-label'' marketing.

"This is a big chunk of money, and sends a warning shot to the drug industry that companies and their sales representatives had better be careful not to promote unauthorized uses of their medicines to doctors,'' said David Moskowitz, an analyst for Friedman, Billings, Ramsey & Co.

Pfizer said in a statement "the allegations and conduct pertain solely to Warner-Lambert practices'' before it was acquired by Pfizer.

Franklin accused Warner-Lambert of hiring an outside firm to write at least 20 articles for medical journals that extolled unauthorized uses of Neurontin and then paid doctors for use of their names as authors of the reports, according to court documents.

Moreover, Franklin told investigators that Warner-Lambert trained its sales representatives how to hype unauthorized uses of Neurontin, including one meeting in which a senior company official suggested what to tell doctors.

"We need to be holding their hand and whispering in their ear, 'Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything'," according to a 2002 New York Times story detailing Franklin's allegations.

The U.S. Attorney's Office in Boston, which spearheaded prosecution of the case, will receive $240 million of the settlement for criminal violations of the Food, Drug and Cosmetics Act.

Franklin will receive about $24.6 million.

Another $152 million will be distributed to the states and federal government for Medicaid violations. Other sums will be distributed to state health agencies and departments, while $28 million will be used for a national advertising campaign and remediation program to be overseen by state attorneys general.


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poster:almondjoy thread:346631
URL: http://www.dr-bob.org/babble/20040510/msgs/346631.html