September 7, 2009 Pfizer to Pay Record Fine in Fraud Probe _http://www.drrathresearch.org/health_news/ohn_090709_pfizer.html_ (http://www.drrathresearch.org/health_news/ohn_090709_pfizer.html) In what it calls the largest health-care fraud settlement in U.S. history, the Justice Department said Wednesday that pharmaceutical giant Pfizer Inc. and a subsidiary have agreed to pay a $2.3 billion penalty for illegally promoting certain drugs. Those drugs included _Bextra_ (http://www.medicinenet.com/script/main/art.asp?articlekey=22063) , part of a group of painkillers called _Cox-2 inhibitors_ (http://www.medicinenet.com/script/main/art.asp?articlekey=95210) , which Pfizer pulled from the market in 2005 after reports of potential _heart_ (http://www.medicinenet.com/script/main/art.asp?articlekey=3668) risks to patients. The other drugs were _Geodon_ (http://www.medicinenet.com/script/main/art.asp?articlekey=19178) , an _antipsychotic_ (http://www.medicinenet.com/script/main/art.asp?articlekey=11993) ; _Zyvox_ (http://www.medicinenet.com/script/main/art.asp?articlekey=45189) , an _antibiotic_ (http://www.medicinenet.com/script/main/art.asp?articlekey=8121) ; and Lyrica, an anti-epileptic drug, the Justice Department said in a news release. In each case, the Justice Department accused Pfizer of marketing the drugs for uses other than those approved by the U.S. _Food and Drug Administration_ (http://www.medicinenet.com/script/main/art.asp?articlekey=8468) , a practice called "off-label" use. According to the news release, the Food, Drug and Cosmetic Act stipulates that a company must "specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called 'off-label' uses." Pfizer promoted Bextra for several uses and dosages not sanctioned by the FDA due to safety concerns, the Justice Department said. As part of the settlement, Pfizer also agreed to enter into a so-called "expansive corporate integrity agreement" with the Department of Health and Human Services' Office of Inspector General. That agreement calls for the establishment of "procedures and reviews" designed to prevent a similar occurrence, the agency said. "Today's landmark settlement is an example of the Department of Justice's ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud," Associate Attorney General Tom Perrelli said in the news release. Kathleen Sebelius, secretary of the _Department of Health and Human Services_ (http://www.medicinenet.com/script/main/art.asp?articlekey=10711) , said: "The Department of _Health and Human Services_ (http://www.medicinenet.com/script/main/art.asp?articlekey=10712) will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste." In a statement, Pfizer general counsel Amy W. Schulman said the agreement ends all "material pending matters" with the Justice Department. "This gives us a very important opportunity to put final closure on the universe of material open items involving our U.S.-based operations," she said, Bloomberg News reported. Author: HealthDay staff Source _http://www.medicinenet.com/_ (http://www.medicinenet.com/) Comments:
The largest drug maker in the world pleaded guilty to the U.S criminal charges for illegal promotion of three of its drugs. Although $2.3 billion fine is largest health care settlement in the U.S history, it is not the one-of-a-kind for Pfizer. Judges call Pfizer a “repeating corporate cheat”, for the company has been pitching drugs to patients and doctors for unapproved conditions, and is caught doing so, for more than once. Last October, Arizona and 31 other states reached a $60 million settlement with Pfizer over its promotion of Bextra, Celebrex, and another anti-inflammatory drug. Sales and marketing executives at Pfizer are accused of promoting Bextra for acute pain, surgical pain and other unapproved uses. Bextra was later withdrawn from the market for the severity of its side effects, including heart attacks and like. Bextra is of the same class as Merck’s Vioxx (cox-2 inhibitor) and another similar drug Celebrex, from Pfizer. Vioxx was withdrawn in 2005, while Celebrex continues to be promoted and sold despite accusations in 2009 that efficacy results of Celebrex were fabricated and some were never submitted to the FDA. Unfortunately though, current settlement and guilty plea is not expected to hurt Pfizer's ability to sell drugs in the future. This is one more support to Dr. Rath's work. For more than a decade, Dr. Rath has been fighting to expose unethical practices and motives utilized by pharmaceutical companies only to increase their profits than to help patients. Please read more about Dr. Rath's crusade in the book “Road Map to Health” as well as at _http://www4.dr-rath-foundation.org/_ (http://www4.dr-rath-foundation.org/) -------------- next part -------------- An HTML attachment was scrubbed... URL: /pipermail/attachments/20090910/c7a877ab/attachment.html _______________________________________________ Biofuel mailing list Biofuel@sustainablelists.org http://sustainablelists.org/mailman/listinfo/sustainablelorgbiofuel Biofuel at Journey to Forever: http://journeytoforever.org/biofuel.html Search the combined Biofuel and Biofuels-biz list archives (70,000 messages): http://www.mail-archive.com/biofuel@sustainablelists.org/
