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Pfizer pays record fine of 2.3 billion

Posted: Wed Sep 02, 2009 8:27 pm
by cheerleader
WASHINGTON (CNN) -- Pharmaceutical giant Pfizer has agreed to pay a record $2.3 billion settlement to resolve criminal and civil liability for illegally promoting certain pharmaceuticals, the Justice Department announced Wednesday.

Pfizer pays record fine to avoid prosecution for illegally promoting certain drugs.

Officials from the Justice Department and the Department of Health and Human Services said the world's largest drug company promoted four drugs for use on certain ailments or at dosages that were not approved by the Food and Drug Administration.

One of those drugs was the anti-inflammatory medication Bextra, which Pfizer pulled off the market in 2005 after it was linked to increasing the risk of heart attacks and strokes.

"Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns," the Justice Department said in a news release.

A Pfizer subsidiary, Pharmacia & Upjohn Company, agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for "misbranding Bextra with the intent to defraud or mislead."

The settlement announcement said Pfizer also illegally promoted the anti-psychotic drug Geodon, the antibiotic Zyvox and the anti-epilepsy drug Lyrica.

Associate Attorney General Tom Perrelli told reporters that recommending drugs for uses not approved by the Food and Drug Administration creates a situation where "public health may be at risk."

"There can be a real danger for patients when medical providers are not provided with accurate and full disclosure concerning a drug's risks and benefits," he said.

The Justice Department said Pfizer sales people created sham requests from physicians asking for information about unapproved uses of certain drugs. The information was then mailed to doctors. Officials said Pfizer also entertained doctors at resorts and encouraged them to prescribe its drugs.

The Justice Department also said the pharmaceutical giant provided kickbacks to health-care providers to encourage them to prescribe other drugs, including Lipitor, Viagra and Zoloft.


Health and Human Services Secretary Kathleen Sebelius said the settlement is historic not only because of the high financial penalty to Pfizer but also because the company will be subject to "the most comprehensive corporate integrity agreement that a drug company has ever signed in the United States."

The terms call for Pfizer to conduct yearly audits and then certify it is in compliance with laws. They also require the company to create a way for doctors to report questionable behavior by Pfizer sales people, and say the company will post information on its Web site about payments and gifts to doctors.

Pfizer issued a statement saying, in part, "We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls."

The Justice Department said the investigation and settlement would not have been possible without the assistance of whistle-blowers who worked at Pfizer. The settlement includes a provision for six of those whistle-blowers to split more than $100 million dollars.
found this interesting, since Jeff's neuro prescribed him one of the drugs Pfizer was pushing- Lyrica -off label for neuropathic pain...did nothing for him except made him nauseous and tired. We threw it out.
cheer

Posted: Thu Sep 03, 2009 3:46 am
by Loobie
But hey, at least I have a Lyrica pad and pencil set :roll:

Posted: Thu Sep 03, 2009 4:39 am
by whyRwehere
Yes, saw that...and people wonder why we are so reluctant to take "medicinal" drugs.

Posted: Thu Sep 03, 2009 6:44 am
by carolew
Wow, this is incredible... very bad indeed, Carole

Posted: Thu Sep 03, 2009 9:08 am
by jimmylegs
part of the reason i turned down trial participation and then my prescribed ms meds in the first place, was because the drugs came from pfizer. i was glad to refuse them my twenty odd thousand per year for the rest of my life, what a scam. would have turned down drugs regardless of company, but i tend to be particularly stubborn about pfizer...

Re: Pfizer pays record fine of 2.3 billion

Posted: Thu Sep 03, 2009 1:59 pm
by NHE
I think that this quote from the cover flaps of the book Selling Sickness by Ray Moynihan and Alan Cassels just about says it all...
Thirty years ago, Henry Gadsden, the head of Merck, one of the world’s largest drug companies, told Fortune magazine that he wanted Merck to be more like chewing gum maker Wrigley’s. It had long been his dream, he said, to make drugs for healthy people - so that Merck could "sell to everyone."
You can read more of my review of this book on the Reading Nook forum.

My own experience: After I was diagnosed I was offered a prescription for neurontin for my neuropathic pain. I did some research on this drug, as I do with all drugs someone thinks I should take (especially when it's optional) and found that the manufacture of neurontin, also Pfizer, was the subject of a class action lawsuit. It seems that they were doing the same thing that Pfizer got busted for this time. Perhaps worse though, they were putting sales reps in with patients when they met with their doctors and not informing the patients as to exactly who this other person was and why they were there. Needless to say, I declined the neurontin. Much later I was also offered a trial sample of Lyrica. I turned that down too. The neuropathic pain that I have in my foot can make it hard to fall asleep sometimes but I can deal with it most of the time.

NHE

Posted: Thu Sep 03, 2009 3:53 pm
by patientx
Perhaps worse though, they were putting sales reps in with patients when they met with their doctors and not informing the patients as to exactly who this other person was and why they were there.
It seems this would violate HIPA laws.

Re: Pfizer pays record fine of 2.3 billion

Posted: Fri Sep 04, 2009 2:09 am
by NHE
patientx wrote:It seems this would violate HIPA laws.
It most likely would now. However, that was in the late '90s. I was diagnosed in the Fall of '99. HIPAA wasn't effective at that time. There were several diferent compliance dates for different parts of the bill. These can be found here. Most were around 2003 to 2005. There are other laws that Pfizer's actions with neurontin violated. I did not follow the lawsuit closely so I don't know what the outcome was in the end.

NHE

Posted: Fri Sep 04, 2009 5:06 am
by Artifishual
I did Lyrica also and it did nothing for me either.