Maybe this is what you get when you pay $2.3 billion to the government--the Pfizer name kept out of the press?
FOR IMMEDIATE RELEASE
MARCH 30, 2009
WWW.USDOJ.GOV/USAO/MA
CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356
E-MAIL: USAMA.MEDIA@USDOJ.GOV
PHARMACEUTICAL COMPANY MANAGER PLEADS GUILTY TO OFF-LABEL MARKETING
BOSTON, MA - A Branchburg, NJ, woman agreed to plead guilty to violating the Food, Drug and Cosmetic Act, for marketing the drug Bextra for uses and dosages that were not approved by the Food and Drug Administration.
United States Attorney Michael J. Sullivan; Warren T. Bamford, Special Agent in Charge of the Federal Bureau of Investigation, Boston Field Division; Susan J. Waddell, Special Agent in Charge of the Department of Health and Human Services, Office of Inspector General; Leigh-Alistair Barzey, Resident Agent in Charge of the Defense Criminal Investigative Service; Kim Rice, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations - Northeast Field Office; Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office; and Drew Grimm, Special Agent in Charge of the U.S. Office of Personnel Management, Office of Inspector General - Eastern Operations, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has plead guilty to a one count Information charging her with distribution of a misbranded drug.
According to the Information from approximately November 2001, through April 2005, HOLLOWAY was employed as a Regional Manager at a pharmaceutical company and was responsible for sales in her region of the drug Bextra. Bextra was a Cox-II inhibitor and had been approved in by the Food and Drug Administration (FDA) in November 2001 for the signs and symptoms of osteoarthritis, adult rheumatoid arthritis, at 10 mgs and primary dysmennorhea at 20 mgs, twice a day as needed. The Information charges that, in 2001, the FDA specifically denied the request of the pharmaceutical company to approve it for acute pain, including the pain of surgery. The FDA told the pharmaceutical company that it could not approve it for these other indications because the safety in these other uses had not been established. Specifically, the FDA was concerned about the results of a study in which there was an excess of cardiovascular events in patients who had undergone coronary artery bypass graft surgery and used Bextra. Bextra was withdrawn from the market in April 2005.
HOLLOWAY was aware of the FDA’s safety concerns, but that she nonetheless had her sales staff of approximately 100 employees sell Bextra for precisely the uses that the FDA refused to approve. For example, HOLLOWAY trained and encouraged her sales teams to promote Bextra by obtaining protocols from doctors that instructed that Bextra be used for the pain of surgery, an unapproved use, and at 20 mgs, an unapproved dose. HOLLOWAY also instructed her staff to market Bextra for use before, during and after surgery to reduce the risk of deep vein thrombosis, which is a form of life threatening blood clots, even though she knew there were no studies showing that Bextra was safe and effective for this use. Finally, HOLLOWAY encouraged her staff to make false safety claims about Bextra in order to sell the drug.
HOLLOWAY faces up to six months’ imprisonment, to be followed by not more than 3 years of supervised release and a maximum fine of $100,000 or twice the amount of gross loss or gross gain.
The case was investigated by the Federal Bureau of Investigation, the Office of Inspector General for the Department of Health and Human Services, Special Prosecutions Staff for the Food and Drug Administration, the Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, the Office of Inspector General for the United States Postal Service and the Office of Inspector General for the U.S. Office of Personnel Management. It is being prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Sullivan’s Health Care Fraud Unit.
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2 comments:
This is hard to believe. Of course the everage person would not know but those who know the biz can figure it out by the names of drugs mentioned. But that is not the point, of course. These individuals should be jailed, period. Maybe things will change with Obama admin. He already is quated to have said to bankers" I and my administration are all that is standing between you and the pitchforks". I am sure not even him beleives that America is about to have an uprising/revolution, but he knows as you and I know there are ripe conditions for it. In the past near or far, many revolutions were triggered for lesser evil that what we see today, done by the bankers and bigpharma crooks and many others. Folks there is a real possibility that we have a massive OCC (Organized Corporate Crime) along with the traditional "regular" OC (organized crime). What you see in this piece is a report on OCC done by Pfizer Co and individuals involved. It is as organized crime as it can be. The mafia has nothing on these charaters. The difference is that OCC doers rarely go to jail. This must change or the pitchforks will come out. No admin. will be able to get between them and us. It better not for it should be on our side.
These government shakedowns of drug companies are getting OUT OF HAND! The dosages and 'acute pain' indications were recognized by the rest of the world because of all the data that was out there. The indications and dosages weren't recognized by the FDA here, and that's something that needs to be pointed out. But to ignore what's in the literature and what's going on in the rest of the world? Does the FDA think docs should have blinders? Or is it only the insurance companies that get to tell u what to give (no, you can't give the expensive drug, use the unproven cheap generic instead) with impunity from the AG's of this country. It's all about money- what can the government shake out of the drug companies.
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