Dr. Drew Pinsky responds to allegations he received GlaxoSmithKline payments
By Michelle Castillo
July 4, 2012
(CBS News)
After being accused of taking payments from GlaxoSmithKline to promote the antidepressant Wellbutrin, Dr. Drew Pinksy told CBS News everything he said was in accordance with the law and accurate according to his medical experience.
"In the late 90s I was hired to participate in a 2-year initiative discussing intimacy and depression which was funded by an educational grant by Glaxo Wellcome," Pinksy told HealthPop in a statement. "Services for the non-branded campaign included town hall meetings, writings and multimedia activities in conjunction with the patient advocacy group the National Depresive and Manic Depressive Association (NDMDA). My comments were consistent with my clinical experience."
Pinsky - a board-certified internist, addiction medicine specialist, and radio and television personality - was mentioned in a complaint filed by the U.S. government against the pharmaceutical company, according to the Forbes.
The document states that Pinksy allegedly received two payments in March 2009 and April 2009 from GlaxoSmithKline totaling $275,000 to promote Wellbutrin SR. The Wall Street Journal reported in June 1999, he made statements on "Loveline," a television and radio show he co-hosted, saying that he prescribed Wellbutrin to depressed patients because it "may enhance or at least not suppress sexual arousal" as much as other antidepressants are known to do. Pinsky was also reported to have made comments on other media, including another national radio program called "David Essel - Alive!," Forbes added. In both instances, he did not disclose that he was paid by the company to do so, and he promote uses of Wellbutrin that had not been approved by the Food and Drug Administration.
GlaxoSmithKline recently plead guilty and had to pay $3 billion in the largest settlement of health care fraud in U.S. history, HealthPop reported. The company was charged with unlawful promotion of certain prescription drugs.
Showing posts with label GlaxoSmithKline. Show all posts
Showing posts with label GlaxoSmithKline. Show all posts
Wednesday, July 4, 2012
Monday, July 2, 2012
GlaxoSmithKline Drug giant pleads guilty, fined $3B for drug marketing
Drug giant pleads guilty, fined $3B for drug marketing
By Staff and wire reports
USA Today July 2, 2012
Prescription drug giant GlaxoSmithKline will plead guilty and pay $3 billion to resolve federal criminal and civil inquiries arising from the company's illegal promotion of some of its products, its failure to report safety data and alleged false price reporting as part of the largest health care fraud settlement in U.S. history, the Justice Department announced Monday.
The company agreed to plead guilty to three criminal counts, including two counts of introducing misbranded drugs — Paxil and Wellbutrin — and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration.
Under the terms of the plea agreement, GSK(GSK) will pay a total of $1 billion, including a criminal fine of $956,814,400. The company also will pay $2 billion to resolve civil claims under the federal government's False Claims Act.
"Today's multibillion-dollar settlement is unprecedented in both size and scope,'' Deputy Attorney General James Cole said. "At every level, we are determined to stop practices that jeopardize patients' health, harm taxpayers, and violate the public trust - and this historic action is a clear warning to any company that chooses to break the law."
Prosecutors say GSK encouraged use of Paxil for children although it was not approved for anyone under 18. The company also promoted Wellbutrin for uses besides major depressive disorder, its only approved use. They say that between 2001 and 2007 GSK failed to report on two studies of the cardiovascular safety of Avandia, a diabetes drug.
Glaxo is pleading guilty to these violations of FDA regulations, which are misdemeanors. It has set aside $3.5 billion to cover the cost of the fines and other penalties related to the government's seven-year probe of the company's marketing practices for Paxil, Wellbutrin and Avandia, three of its blockbuster drugs.
The company earlier set aisde $3 billion for legal costs tied to health problems that people taking Avandia and the other medicines are at risk of suffering.
Glaxo has already paid more than $700 million to resolve patient lawsuits, alleging Avandia caused heart attacks and strokes. Many of the Avandia cases have been consolidated before a federal judge in Philadelphia.
By Staff and wire reports
USA Today July 2, 2012
Prescription drug giant GlaxoSmithKline will plead guilty and pay $3 billion to resolve federal criminal and civil inquiries arising from the company's illegal promotion of some of its products, its failure to report safety data and alleged false price reporting as part of the largest health care fraud settlement in U.S. history, the Justice Department announced Monday.
The company agreed to plead guilty to three criminal counts, including two counts of introducing misbranded drugs — Paxil and Wellbutrin — and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration.
Under the terms of the plea agreement, GSK(GSK) will pay a total of $1 billion, including a criminal fine of $956,814,400. The company also will pay $2 billion to resolve civil claims under the federal government's False Claims Act.
"Today's multibillion-dollar settlement is unprecedented in both size and scope,'' Deputy Attorney General James Cole said. "At every level, we are determined to stop practices that jeopardize patients' health, harm taxpayers, and violate the public trust - and this historic action is a clear warning to any company that chooses to break the law."
Prosecutors say GSK encouraged use of Paxil for children although it was not approved for anyone under 18. The company also promoted Wellbutrin for uses besides major depressive disorder, its only approved use. They say that between 2001 and 2007 GSK failed to report on two studies of the cardiovascular safety of Avandia, a diabetes drug.
Glaxo is pleading guilty to these violations of FDA regulations, which are misdemeanors. It has set aside $3.5 billion to cover the cost of the fines and other penalties related to the government's seven-year probe of the company's marketing practices for Paxil, Wellbutrin and Avandia, three of its blockbuster drugs.
The company earlier set aisde $3 billion for legal costs tied to health problems that people taking Avandia and the other medicines are at risk of suffering.
Glaxo has already paid more than $700 million to resolve patient lawsuits, alleging Avandia caused heart attacks and strokes. Many of the Avandia cases have been consolidated before a federal judge in Philadelphia.
Thursday, November 3, 2011
GlaxoSmithKline to pay $3B to settle charges over marketing practices
GlaxoSmithKline to pay $3B to settle charges over marketing practices
GlaxoSmithKline agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.
Negotiations over the terms are ongoing and will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.
The Glaxo settlement would trump the $2.3 billion Pfizer paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly paid the same year over sales of its Zyprexa anti-psychotic medicine. The Bextra accord had been the largest pharmaceutical marketing settlement in U.S. history.
Glaxo to pay $3B to settle U.S. sales, Avandia cases
By Phil Serafino and Makiko Kitamura
November 3, 2011
Bloomberg
GlaxoSmithKline Plc agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.
Negotiations over the terms are ongoing and will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.
The potential settlement brings Glaxo closer to putting years of legal probes behind it. The company set aside 2.2 billion pounds ($3.5 billion) in the fourth quarter last year in anticipation of reaching an agreement on the cases. Glaxo said it will have about 1 billion pounds of its 2.9 billion pounds in total legal provisions remaining after today’s settlement is completed, and it hasn’t decided what to do with the money.
“This news essentially draws a line under a 10-year legal saga,” Gbola Amusa, an analyst at UBS AG in London who recommends buying Glaxo shares, said in an e-mail. “This removes significant uncertainty on ongoing legal issues.”
Glaxo were unchanged at 1,355.5 pence at 10:14 a.m. London time.
Pfizer Settlement
The Glaxo settlement would trump the $2.3 billion Pfizer Inc. paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine. The Bextra accord had been the largest pharmaceutical marketing settlement in U.S. history.
Abbott Laboratories agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said last month.
“Litigation is an ever-present business risk in the pharmaceuticals industry,” Mark Purcell, a Barclays Capital analyst, wrote in a note to investors today. Barclays expects Glaxo will incur legal charges of 150 million pounds a year, Purcell said.
Federal prosecutors began an investigation in Colorado in 2004, later taken over by the U.S. attorney in Massachusetts, into whether Glaxo promoted drugs for unapproved uses, and into ways Glaxo potentially influenced doctors. The probe concerns nine of the company’s best-selling products from 1997 to 2004, including the Advair lung treatment, Glaxo said in its annual report.
Medicaid Rebates
Today’s settlement also covers a U.S. Justice Department probe of Glaxo and a Medicaid rebate program, and a Justice Department investigation into the development and marketing of the Avandia diabetes drug, the company said.
Drugmakers are required to give rebates to Medicaid, the government health insurance program for the poor. The investigation examined how Glaxo reported prices charged to other payers, which are used in calculating the Medicaid rebates.
Regulators said last year that Avandia would be withdrawn from the market in Europe and sales would be limited in the U.S. because of an increased risk of heart attacks.
“This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today,” Chief Executive Officer Andrew Witty said in the statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity.”
Compensation Changes
Earlier this year, Glaxo changed incentive compensation programs for U.S. sales representatives. The company has eliminated the link between sales goals and bonuses, which are now based on selling competency, customer evaluations and overall performance of the representative’s business unit.
Glaxo still faces probes involving the United Nations oil- for-food program, and HIV product sales and marketing in the U.S., JPMorgan Chase & Co. analysts wrote in a note to investors today.
The legal provision, announced in January, led to a loss for Glaxo in the fourth quarter of 2010. Less than three weeks after the provision was disclosed, the company said it would begin a share repurchase for the first time since 2008 to enhance investor returns.
GlaxoSmithKline agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.
Negotiations over the terms are ongoing and will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.
The Glaxo settlement would trump the $2.3 billion Pfizer paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly paid the same year over sales of its Zyprexa anti-psychotic medicine. The Bextra accord had been the largest pharmaceutical marketing settlement in U.S. history.
Glaxo to pay $3B to settle U.S. sales, Avandia cases
By Phil Serafino and Makiko Kitamura
November 3, 2011
Bloomberg
GlaxoSmithKline Plc agreed to pay $3 billion to resolve U.S. criminal and civil investigations into whether the U.K. company marketed drugs for unapproved uses and other matters, its biggest legal settlement.
Negotiations over the terms are ongoing and will be completed next year, the London-based company said in a statement today. The cost is covered by existing legal provisions and will be paid from the company’s cash resources, Glaxo said.
The potential settlement brings Glaxo closer to putting years of legal probes behind it. The company set aside 2.2 billion pounds ($3.5 billion) in the fourth quarter last year in anticipation of reaching an agreement on the cases. Glaxo said it will have about 1 billion pounds of its 2.9 billion pounds in total legal provisions remaining after today’s settlement is completed, and it hasn’t decided what to do with the money.
“This news essentially draws a line under a 10-year legal saga,” Gbola Amusa, an analyst at UBS AG in London who recommends buying Glaxo shares, said in an e-mail. “This removes significant uncertainty on ongoing legal issues.”
Glaxo were unchanged at 1,355.5 pence at 10:14 a.m. London time.
Pfizer Settlement
The Glaxo settlement would trump the $2.3 billion Pfizer Inc. paid in 2009 over the marketing of its Bextra painkiller and other drugs and the $1.4 billion Eli Lilly & Co. paid the same year over sales of its Zyprexa anti-psychotic medicine. The Bextra accord had been the largest pharmaceutical marketing settlement in U.S. history.
Abbott Laboratories agreed to pay at least $1.3 billion to settle claims by the U.S. government and 24 states alleging the company illegally marketed its Depakote epilepsy drug, people familiar with the accords said last month.
“Litigation is an ever-present business risk in the pharmaceuticals industry,” Mark Purcell, a Barclays Capital analyst, wrote in a note to investors today. Barclays expects Glaxo will incur legal charges of 150 million pounds a year, Purcell said.
Federal prosecutors began an investigation in Colorado in 2004, later taken over by the U.S. attorney in Massachusetts, into whether Glaxo promoted drugs for unapproved uses, and into ways Glaxo potentially influenced doctors. The probe concerns nine of the company’s best-selling products from 1997 to 2004, including the Advair lung treatment, Glaxo said in its annual report.
Medicaid Rebates
Today’s settlement also covers a U.S. Justice Department probe of Glaxo and a Medicaid rebate program, and a Justice Department investigation into the development and marketing of the Avandia diabetes drug, the company said.
Drugmakers are required to give rebates to Medicaid, the government health insurance program for the poor. The investigation examined how Glaxo reported prices charged to other payers, which are used in calculating the Medicaid rebates.
Regulators said last year that Avandia would be withdrawn from the market in Europe and sales would be limited in the U.S. because of an increased risk of heart attacks.
“This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today,” Chief Executive Officer Andrew Witty said in the statement. “In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the U.S. to ensure that we operate with high standards of integrity.”
Compensation Changes
Earlier this year, Glaxo changed incentive compensation programs for U.S. sales representatives. The company has eliminated the link between sales goals and bonuses, which are now based on selling competency, customer evaluations and overall performance of the representative’s business unit.
Glaxo still faces probes involving the United Nations oil- for-food program, and HIV product sales and marketing in the U.S., JPMorgan Chase & Co. analysts wrote in a note to investors today.
The legal provision, announced in January, led to a loss for Glaxo in the fourth quarter of 2010. Less than three weeks after the provision was disclosed, the company said it would begin a share repurchase for the first time since 2008 to enhance investor returns.
Tuesday, November 9, 2010
Former Glaxo Lawyer Indicted
I don't think our Judge Judith Hayes of San Diego is going to be happy about this. The Justice Department has indicted a lawyer, Lauren C. Stevens of Durham, N.C.. Hayes doesn't even want lawyers to be criticized on the Internet, much less indicted for concealing evidence and obstructing justice.
Here's what our Judge Hayes had to say on the subject to a woman who criticized a law firm on the Internet:
"Take this law firm off the website...save yourself some trouble. A lawyer does what a lawyer does in every case, and if we had people putting up websites for every lawyer they didn't like we'd have so many websites the Internet would be boggled, if that is something that can happen electronically."
--Court Reporter's transcript April 6, 2009 Dept. 68 San Diego Superior Court
Note to Judge Hayes: The Internet seems to be doing just fine despite the burden of the millions of people who express their views online. What would happen if every victim decided to expose wrongdoing by lawyers? I think the result would be a more reliable justice system in which lawyers turn over evidence instead of hiding it.
November 9, 2010
Former Glaxo Lawyer Indicted
By DUFF WILSON
New York Times
A former vice president and associate general counsel for the British pharmaceutical company GlaxoSmithKline has been indicted on charges of making false statements and obstructing a federal investigation into illegal drug marketing, the Justice Department announced on Tuesday.
The criminal charges are part of the government’s long-promised crackdown on individual executives for their roles in pharmaceutical company cases, which have resulted in billions of dollars in fines and payments by the companies.
Lauren C. Stevens of Durham, N.C., is accused of lying to the Food and Drug Administration in a series of letters in 2003 denying the company had promoted a drug for off-label uses, according to federal prosecutors. She had claimed the company did not have promotional slides the F.D.A. had sought during its investigation, the indictment said...
Here's what our Judge Hayes had to say on the subject to a woman who criticized a law firm on the Internet:
"Take this law firm off the website...save yourself some trouble. A lawyer does what a lawyer does in every case, and if we had people putting up websites for every lawyer they didn't like we'd have so many websites the Internet would be boggled, if that is something that can happen electronically."
--Court Reporter's transcript April 6, 2009 Dept. 68 San Diego Superior Court
Note to Judge Hayes: The Internet seems to be doing just fine despite the burden of the millions of people who express their views online. What would happen if every victim decided to expose wrongdoing by lawyers? I think the result would be a more reliable justice system in which lawyers turn over evidence instead of hiding it.
November 9, 2010
Former Glaxo Lawyer Indicted
By DUFF WILSON
New York Times
A former vice president and associate general counsel for the British pharmaceutical company GlaxoSmithKline has been indicted on charges of making false statements and obstructing a federal investigation into illegal drug marketing, the Justice Department announced on Tuesday.
The criminal charges are part of the government’s long-promised crackdown on individual executives for their roles in pharmaceutical company cases, which have resulted in billions of dollars in fines and payments by the companies.
Lauren C. Stevens of Durham, N.C., is accused of lying to the Food and Drug Administration in a series of letters in 2003 denying the company had promoted a drug for off-label uses, according to federal prosecutors. She had claimed the company did not have promotional slides the F.D.A. had sought during its investigation, the indictment said...
Wednesday, October 27, 2010
Glaxo Case May Not Be Over
October 27, 2010
Glaxo Case May Not Be Over
By DUFF WILSON
New York Times
The government is still following up on GlaxoSmithKline’s manufacturing problems in Puerto Rico after Tuesday’s news that the company would pay $750 million to settle criminal and civil complaints about adulterated products.
For months, federal investigators have talked about a renewed determination to hold company officials, not just corporate entities, accountable for false claims filed with government health programs that buy such products. The federal False Claims Act has recovered billions of dollars for health care fraud, but companies, not executives, are signing the plea deals.
The GlaxoSmithKline case started with a whistle-blower complaint filed six years ago by the plant’s former quality control manager. Her case ended yesterday with a $96 million share of the recovery.
The United States attorney for Massachusetts, Carmen M. Ortiz, was asked in an interview Tuesday whether there could still be any individual accountability in the case. “I really shouldn’t comment specifically in relation to this case,” she replied, “because the investigation is ongoing.”
Does that mean company officials might still be under scrutiny? “The corporate aspect is finally settled,” Ms. Ortiz replied. “I would rather not say anything else.”
One former Glaxo official was singled out in the indictment of the company in the Puerto Rico case – an unnamed person who was hired in April 2003 as the site director of the giant manufacturing facility, and accused of interfering with quality complaints. The person was removed from that job in October 2004.
In most circumstances, however, 2004 would fall outside of the five-year statute of limitations for federal misdemeanor prosecutions.
But the government can pursue individuals under a strict liability standard known as the Park doctrine — a line of prosecution that has many pharmaceutical executives worried.
Named after a 1975 Supreme Court case, that doctrine allows misdemeanor prosecution of company officials for violating the federal Food, Drug and Cosmetic Act whether or not there is evidence the official knew of the violations. The individual needs to be in a position of authority.
Glaxo Case May Not Be Over
By DUFF WILSON
New York Times
The government is still following up on GlaxoSmithKline’s manufacturing problems in Puerto Rico after Tuesday’s news that the company would pay $750 million to settle criminal and civil complaints about adulterated products.
For months, federal investigators have talked about a renewed determination to hold company officials, not just corporate entities, accountable for false claims filed with government health programs that buy such products. The federal False Claims Act has recovered billions of dollars for health care fraud, but companies, not executives, are signing the plea deals.
The GlaxoSmithKline case started with a whistle-blower complaint filed six years ago by the plant’s former quality control manager. Her case ended yesterday with a $96 million share of the recovery.
The United States attorney for Massachusetts, Carmen M. Ortiz, was asked in an interview Tuesday whether there could still be any individual accountability in the case. “I really shouldn’t comment specifically in relation to this case,” she replied, “because the investigation is ongoing.”
Does that mean company officials might still be under scrutiny? “The corporate aspect is finally settled,” Ms. Ortiz replied. “I would rather not say anything else.”
One former Glaxo official was singled out in the indictment of the company in the Puerto Rico case – an unnamed person who was hired in April 2003 as the site director of the giant manufacturing facility, and accused of interfering with quality complaints. The person was removed from that job in October 2004.
In most circumstances, however, 2004 would fall outside of the five-year statute of limitations for federal misdemeanor prosecutions.
But the government can pursue individuals under a strict liability standard known as the Park doctrine — a line of prosecution that has many pharmaceutical executives worried.
Named after a 1975 Supreme Court case, that doctrine allows misdemeanor prosecution of company officials for violating the federal Food, Drug and Cosmetic Act whether or not there is evidence the official knew of the violations. The individual needs to be in a position of authority.
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