FWD:Neurontin Makers Reach Settlement

RSD In the News : FWD:Neurontin Makers Reach Settlement
Choose another message board
Prev Discussion Next Discussion Delete

Reply
Recommend Delete Message 1 of 1 in Discussion

From: byrd45 (Original Message) Sent: 6/10/2005 4:09 PM
NEURONTIN MAKERS REACH SETTLEMENT



Pfizer to Pay $430 Million for False Drug Marketing
Reuters Health Information 2004. Â 2004 Reuters Ltd.

MIAMI (Reuters) May 13 -

Pfizer Inc has 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 on Thursday.

The allegations were made in a lawsuit filed in late 1996 by whistle-blower David Franklin, who had worked for the maker of epilepsy drug Neurontin, Warner-Lambert, before it was acquired by Pfizer in 2000.

The U.S. Department of Justice and attorneys general of all 50 states agreed to the settlement.

Franklin, who filed his whistle-blower suit after resigning from Warner-Lambert in 1996, accused the company of using 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 so-called "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 are allowed to 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.

Shares of Pfizer fell 1 percent in late morning trade.

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

According to court documents, 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.

The strategy allowed the drugmaker to hide its role in promoting the off-label usages, Franklin charged in his lawsuit.

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 the case, will receive $240 million of the settlement for criminal violations of the Food, Drug and Cosmetics Act.

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.

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

Shares of Pfizer were down 41 cents at $35.30 in late morning trade on the New York Stock Exchange."

Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world. .

Notes From Keith - Thanks to Reuters Group for sending out this bulletin

There is a companion article on this whole Neurontin Issue in our Medical Articles section of the website that explains in more detail how this all came about, especially in regards to the statement below;

"According to court documents, 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."