Monday, June 29, 2009
Thursday, June 25, 2009
Tuesday, June 23, 2009
Daily Kos is starting to quote me quite a bit . . .
A number of companies made headlines recently by trying to boost their profits through illegal drug marketing schemes, cheating on their taxes or skimping on safety, according to Peter Rost, former vice president of marketing for Pfizer and author of the book "Whistleblower."
Pfizer was recently fined $430 million for attempting to defraud a government program. Schering Plough paid a $500 million fine for manufacturing violations and $345 million for improper marketing of Claritin, an allergy drug, Rost says. The U.S. tax authority, the Internal Revenue Service, has demanded that drug company GlaxoSmithKline pay $7.8 billion in back taxes, while Merck may be facing $2 billion in back tax payments.
Full article.
Pfizer was recently fined $430 million for attempting to defraud a government program. Schering Plough paid a $500 million fine for manufacturing violations and $345 million for improper marketing of Claritin, an allergy drug, Rost says. The U.S. tax authority, the Internal Revenue Service, has demanded that drug company GlaxoSmithKline pay $7.8 billion in back taxes, while Merck may be facing $2 billion in back tax payments.
Full article.
What really happened with Bextra and off-label marketing inside Pfizer?
Find out in this article by Jim Edwards.
Monday, June 22, 2009
Friday, June 19, 2009
Pfizer district manager was to be sentenced on June 11 for obstruction of justice: What happened?
A former district sales manager for Pfizer was convicted on March 16, 2009, in federal court of obstruction of justice.
Thomas Farina, 42, of Fairport, NY, was found guilty following a five day trial in Boston.
Prosecutors said evidence presented during the trial proved that in the summer of 2004, Farina caused a sales representative under his direction to alter documents and backdate the alterations on his computer to delete the evidence of the promotion of a drug for uses and dosages for which it was not indicated or approved for promotion by the U.S. Food and Drug Administration.
The evidence demonstrated that Farina instructed his sales representative on how to change the clock and date setting on the computer, and then alter and re-save the documents in order to make the sanitized documents appear to have been last modified at an earlier time.
Sentencing was scheduled for June 11.
But there are no news out there.
Farina faced up to 20 years imprisonment, to be followed by three years of supervised release and a $ 250,000 fine.
Thomas Farina, 42, of Fairport, NY, was found guilty following a five day trial in Boston.
Prosecutors said evidence presented during the trial proved that in the summer of 2004, Farina caused a sales representative under his direction to alter documents and backdate the alterations on his computer to delete the evidence of the promotion of a drug for uses and dosages for which it was not indicated or approved for promotion by the U.S. Food and Drug Administration.
The evidence demonstrated that Farina instructed his sales representative on how to change the clock and date setting on the computer, and then alter and re-save the documents in order to make the sanitized documents appear to have been last modified at an earlier time.
Sentencing was scheduled for June 11.
But there are no news out there.
Farina faced up to 20 years imprisonment, to be followed by three years of supervised release and a $ 250,000 fine.
Pfizer Executive Sentenced for Off-Label Marketing: USDOJ Press Release Conceals Pfizer Name
FOR IMMEDIATE RELEASE
JUNE 18, 2009
WWW.USDOJ.GOV/USAO/MA
CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356
E-MAIL: USAMA.MEDIA@USDOJ.GOV
PHARMACEUTICAL COMPANY MANAGER SENTENCED FOR OFF-LABEL MARKETING
BOSTON, MA - A Branchburg, NJ, woman was sentenced today for 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.
Acting United States Attorney Michael K. Loucks; 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 A. Rice, Special Agent in Charge of the U.S. Food and Drug Administration, Office of Criminal Investigations, Metro Washington Field Office, Special Prosecution Staff; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations - Northeast Field Office; and Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has been sentenced by United States Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to an Information charging her with distribution of a misbranded drug.
At the plea hearing, prosecutors told the Court that, had the case proceeded to trial the Government’s evidence would have proven, the following:
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. 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.
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.
Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the United States FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”
Bextra was withdrawn from the market in April 2005.
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 U.S. Food and Drug Administration, Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, and the Office of Inspector General for the United States Postal Service. It was prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Loucks’ Health Care Fraud Unit.
JUNE 18, 2009
WWW.USDOJ.GOV/USAO/MA
CONTACT: CHRISTINA DiIORIO-STERLING
PHONE: (617)748-3356
E-MAIL: USAMA.MEDIA@USDOJ.GOV
PHARMACEUTICAL COMPANY MANAGER SENTENCED FOR OFF-LABEL MARKETING
BOSTON, MA - A Branchburg, NJ, woman was sentenced today for 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.
Acting United States Attorney Michael K. Loucks; 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 A. Rice, Special Agent in Charge of the U.S. Food and Drug Administration, Office of Criminal Investigations, Metro Washington Field Office, Special Prosecution Staff; Jeffrey Hughes, Special Agent in Charge of the U.S. Department of Veterans Affairs, Office of Inspector General, Office of Investigations - Northeast Field Office; and Joseph Finn, Special Agent in Charge of the United States Postal Service, Office of Inspector General, Boston Field Office, announced today that MARY HOLLOWAY, age 47, of Branchburg, New Jersey, has been sentenced by United States Magistrate Judge Judith Dein to pay a $75,000 fine and twenty-four months of probation after pleading guilty to an Information charging her with distribution of a misbranded drug.
At the plea hearing, prosecutors told the Court that, had the case proceeded to trial the Government’s evidence would have proven, the following:
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. 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.
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.
Acting United States Attorney Michael K. Loucks said, “We will continue to hold individuals responsible for their conduct in promoting pharmaceutical drugs outside of the uses for which they have been found to be safe and effective by the United States FDA. The conduct at issue here undermined the FDA’s regulatory scheme and put patients at risk for the purpose of pursing profits for the individual and the pharmaceutical company.”
Bextra was withdrawn from the market in April 2005.
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 U.S. Food and Drug Administration, Office of Inspector General for the Department of Veterans Affairs, the Defense Criminal Investigative Service, and the Office of Inspector General for the United States Postal Service. It was prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Susan M. Poswistilo of Loucks’ Health Care Fraud Unit.
Thursday, June 18, 2009
Reese Witherspoon plays "Pharm Girl" in new movie
Reese Witherspoon proves a "Pharm Girl" at heart
LOS ANGELES (Hollywood Reporter) - Reese Witherspoon is going into the pharmaceutical business with Universal Pictures.
The studio is developing "Pharm Girl," an aspirational comedy centring on one woman's odyssey through the drug industry.
"Bad Santa" screenwriters Glenn Ficarra and John Requa are writing the screenplay and in talks to direct. Witherspoon is producing via her Type A banner and will play the lead role.
The project concerns a woman who gets a job at a pharmaceutical powerhouse and begins to see the underbelly of the industry as she rises through the company's ranks.
The modern pharmaceutical industry has played a villainous role in a number of Hollywood pics, among them "The Fugitive." Several years ago it was at the centre of a conspiracy in the thriller "The Constant Gardener."
LOS ANGELES (Hollywood Reporter) - Reese Witherspoon is going into the pharmaceutical business with Universal Pictures.
The studio is developing "Pharm Girl," an aspirational comedy centring on one woman's odyssey through the drug industry.
"Bad Santa" screenwriters Glenn Ficarra and John Requa are writing the screenplay and in talks to direct. Witherspoon is producing via her Type A banner and will play the lead role.
The project concerns a woman who gets a job at a pharmaceutical powerhouse and begins to see the underbelly of the industry as she rises through the company's ranks.
The modern pharmaceutical industry has played a villainous role in a number of Hollywood pics, among them "The Fugitive." Several years ago it was at the centre of a conspiracy in the thriller "The Constant Gardener."
Wednesday, June 10, 2009
Movie about Pfizer and Viagra salesman based on Reidy's book "Hard Sell"
Jake Gyllenhaal and Anne Hathaway will do a movie based on former Pfizer sales rep Jamie Reidy’s book “Hard Sell: The Evolution of a Viagra Salesman.”
I can't wait to see that one . . . the movie will be called “Love and Other Drugs.”
Much congratulations to my friend Jamie on landing this deal.
This is what Jim Edwards over at BNet writes:
In the book, Reidy claimed he was the company’s No. 1 Viagra salesman, and that he employed a comical variety of unethical tactics to make his sales. Among them:
… he persuaded doctors to attend “Pizza-and Dash” events at which Pfizer would buy doctors’ families fast food in return for face-time with the physician. Reidy used the Pizza-and-Dash outings to collect doctors’ signatures, which he would then use to convince Pfizer he was working when he was actually goofing off.
In another chapter he describes Pfizer’s internal logic for avoiding blame for the deaths of some patients who had taken Viagra. It was the exertion of the sex that killed them, Reidy claimed the company argued, not Viagra.
Reidy was fired as a sales training exec by Eli Lilly when the book was published.
It’s not clear how much internal Pfizer stuff will make it into the movie. While the book focused on the often hilarious nonsense that Reidy had to endure from doctors, colleagues and his employer, the Hollywood Reporter says of the movie:
Gyllenhaal will play the salesman, who begins a relationship with a woman who has Parkinson’s (Hathaway) while on one of his sales calls. Their love story plays out in the political and social context of the time.
Get me rewrite!
I can't wait to see that one . . . the movie will be called “Love and Other Drugs.”
Much congratulations to my friend Jamie on landing this deal.
This is what Jim Edwards over at BNet writes:
In the book, Reidy claimed he was the company’s No. 1 Viagra salesman, and that he employed a comical variety of unethical tactics to make his sales. Among them:
… he persuaded doctors to attend “Pizza-and Dash” events at which Pfizer would buy doctors’ families fast food in return for face-time with the physician. Reidy used the Pizza-and-Dash outings to collect doctors’ signatures, which he would then use to convince Pfizer he was working when he was actually goofing off.
In another chapter he describes Pfizer’s internal logic for avoiding blame for the deaths of some patients who had taken Viagra. It was the exertion of the sex that killed them, Reidy claimed the company argued, not Viagra.
Reidy was fired as a sales training exec by Eli Lilly when the book was published.
It’s not clear how much internal Pfizer stuff will make it into the movie. While the book focused on the often hilarious nonsense that Reidy had to endure from doctors, colleagues and his employer, the Hollywood Reporter says of the movie:
Gyllenhaal will play the salesman, who begins a relationship with a woman who has Parkinson’s (Hathaway) while on one of his sales calls. Their love story plays out in the political and social context of the time.
Get me rewrite!
Thursday, June 04, 2009
Wednesday, June 03, 2009
Tuesday, June 02, 2009
Today's quote from an idiot and the response.
From CNBC, Mad Money:
Jim: I started purchasing Pfizer [PFE 14.76 --- UNCH (0) ] early this year because of the acquisition of Wyeth [WYE 44.69 --- UNCH (0) ]. With the acquisition it was said that PFE would be able to see some great profits and returns from the deal. Now with health care and pharma being on Obama's hit list, how could this impact PFE's stock and will it? Thank you for your time and a great big Army Booyah! --Jerome
Cramer says: “Thank you for serving…Pfizer I just don’t think has anything going for it. I don’t think the merger’s going to matter. I think it’s a deadweight stock, and I don’t want you buying Pfizer.”
Jim: I started purchasing Pfizer [PFE 14.76 --- UNCH (0) ] early this year because of the acquisition of Wyeth [WYE 44.69 --- UNCH (0) ]. With the acquisition it was said that PFE would be able to see some great profits and returns from the deal. Now with health care and pharma being on Obama's hit list, how could this impact PFE's stock and will it? Thank you for your time and a great big Army Booyah! --Jerome
Cramer says: “Thank you for serving…Pfizer I just don’t think has anything going for it. I don’t think the merger’s going to matter. I think it’s a deadweight stock, and I don’t want you buying Pfizer.”
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