Novartis Accused of Paying Kickbacks to Boost Exjade Sales
By Christie Smythe
Bloomberg Business Week
January 08, 2014
A Novartis AG (NOVN) unit was accused by the U.S. and a group of states of paying kickbacks to a specialty pharmacy to boost sales of Exjade, an iron-control drug that can cause kidney and liver failure.
U.S. District Judge Colleen McMahon in Manhattan today unsealed a complaint filed against Novartis Pharmaceuticals Corp. by the U.S., 26 states and the District of Columbia alleging that the drugmaker had paid kickbacks to BioScrip Inc. (BIOS:US) to encourage patients to refill prescriptions.
Separately, federal and state officials announced that the Elmsford, New York-based specialty pharmacy agreed to pay $15 million to resolve the claims against it.
Federal and state officials alleged that government health programs Medicare and Medicaid paid tens of millions of dollars in reimbursements based on false claims for the drug.
“This arrangement between Novartis and BioScrip was dangerous for patients and is against the law,” New York Attorney General Eric Schneiderman said in a statement. “Our lawsuit against Novartis and our agreement with BioScrip send a clear message: Drug companies cannot pay pharmacies to promote drugs directly to patients.”
Kickbacks, Calls
According to the complaint, Novartis paid kickbacks to BioScrip from February 2007 to May 2012 in the form of patient referrals and rebates. To hold up its end of the bargain, BioScrip made tens of thousands of calls to patients to try to convince them to keep taking the drug, federal and state officials alleged.
Julie Masow, a spokeswoman for Basel, Switzerland-based Novartis, said in an e-mailed statement that the company disputes the allegations in the complaint related to its interactions with BioScrip and intends to defend itself.
The company “is dedicated to improving patient health and supports patient medication adherence programs,” including outreach by pharmacies, Masow said.
Exjade was approved by the U.S. Food and Drug Administration in November 2005 to treat chronic iron overload due to blood transfusions, according to the complaint. In January 2010, the agency required the drug to feature a “black box” warning highlighting the potential for kidney failure, liver failure and gastrointestinal hemorrhage that in some cases were fatal, according to the complaint.
Increasing Refills
Novartis wanted to increase the refills of the drug because “its own market research had shown that a significant percentage of physicians and patients were opting to discontinue Exjade therapy” because of side effects, the officials said in the complaint.
In late February 2007, Novartis told BioScrip that because it generated lower levels of refills compared with other pharmacies, it had been placed on a “performance improvement plan,” according to the complaint.
Novartis “expects that the specialty pharmacies it works with conduct vital patient outreach in a manner wholly consistent with NPC’s commitment to patient care,” Masow said. “BioScrip reached out to patients using its own protocols to provide education, counseling and information about proper administration of the medicine and to fulfill prescriptions that have been prescribed by a patient’s treating physician.”
Officials are seeking triple damages against Novartis and civil penalties under the False Claims Act.
The case is ABC v. DEF, 1:11-cv-08196, U.S. District Court, Southern District of New York (Manhattan).
Showing posts with label drug companies. Show all posts
Showing posts with label drug companies. Show all posts
Sunday, January 12, 2014
Friday, January 25, 2013
Big Pharma consists of very rich "takers" who succeed through fraud, and then get congress to reward them half a billion dollars
Big Pharma buys off the Senate An eleventh hour loophole in the "fiscal cliff" deal confirms our worst suspicions about how Congress operates
BY BILL MOYERS AND MICHAEL WINSHIP
BILLMOYERS.COM
JAN 25, 2013
The inauguration of a president is one of those spectacles of democracy that can make us remember we’re part of something big and enduring. So for a few hours this past Monday the pomp and circumstance inspired us to think that government of, by, and for the people really is just that, despite the predatory threats that stalk it.
But the mood didn’t last. Every now and then, as the cameras panned upward, the Capitol dome towering over the ceremony was a reminder of something the good feeling of the moment couldn’t erase. It’s the journalist’s curse to have a good time spoiled by the reality beyond the pageantry. Just a couple of days before the inaugural festivities, The New York Times published some superb investigative reporting by the team of Eric Lipton and Kevin Sack, and their revelations were hard to forget, even at a time of celebration.
The story told us of a pharmaceutical giant called Amgen and three senators so close to it they might be entries on its balance sheet: Republican Minority Leader Mitch McConnell, Democratic Senator Max Baucus, chair of the Senate Finance Committee, and that powerful committee’s ranking Republican, Orrin Hatch. A trio of perpetrators who treat the United States treasury as if it were a cash-and-carry annex of corporate America.
The Times story described how Amgen got a huge hidden gift from unnamed members of Congress and their staffers. They slipped an eleventh hour loophole into the New Year’s Eve deal that kept the government from going over the fiscal cliff. When the sun rose in the morning, there it was, a richly embroidered loophole for Amgen that will cost taxpayers a cool half a billion dollars.
Amgen is the world’s largest biotechnology firm, a drug maker that sells a variety of medications. The little clause secretly sneaked into the fiscal cliff bill gives the company two more years of relief from Medicare cost controls for certain drugs used by patients who are on kidney dialysis, including a pill called Sensipar, manufactured by Amgen.
The provision didn’t mention Amgen by name, but according to reporters Lipton and Sack, the news that it had been tucked into the fiscal cliff deal “was so welcome, that the company’s chief executive quickly relayed it to investment analysts.” Tipping them off, it would seem, to a jackpot in the making.
Amgen has 74 lobbyists on its team in Washington and lobbied hard for that loophole, currying favor with friends at the White House and on Capitol Hill. The Times reporters traced its “deep financial and political ties” to Baucus, McConnell and Hatch, “who hold heavy sway over Medicare payment policy.”
All three have received hefty campaign donations from the company whose bottom line mysteriously just got padded at taxpayer expense. Since 2007, Amgen employees and its political action committee have contributed nearly $68,000 to Senator Baucus, $73,000 to Senator McConnell’s campaigns, and $59,000 to Senator Hatch.
And lo and behold, among those 74 Amgen lobbyists are the former chief of staff to Senator Baucus and the former chief of staff to Senator McConnell. You get the picture: Two guys nurtured at public expense, paid as public servants, disappear through the gold-plated revolving door of Congress and presto, return as money changers in the temple of crony capitalism.
Inside to welcome them is a current top aide to Senator Hatch, one who helped weave this lucrative loophole. He used to work as a health policy analyst for — you guessed it — Amgen.
So the trail winds deeper into the sordid swamp beneath that great Capitol dome, a sinkhole where shame has all but disappeared. As reporters Lipton and Sack remind us, just weeks before this backroom betrayal of the public interest by elected officials and the mercenaries they have mentored, Amgen pleaded guilty to fraud. Look it up: fraud means trickery, cheating and duplicity. Amgen agreed to pay $762 million in criminal and civil penalties; the company had been caught illegally marketing another one of its drugs.
The fact that their puppet master had been the subject of fines and a massive federal investigation mattered not to its servile pawns in the Senate, where pomp and circumstance are but masks for the brute power of money.
Peter Welch, Vermont’s Democratic congressman, has just introduced bipartisan legislation to repeal the half billion-dollar giveaway to Amgen. Its co-sponsors include Republican Richard Hanna of New York and Democrats Jim Cooper of Tennessee and Bruce Braley of Iowa.
The Amgen deal “confirms the American public’s worst suspicions of how Congress operates,” Representative Welch told us this week. “As the nation’s economy teetered on the edge of a Congressional-created fiscal cliff, lobbyists for a private, for-profit company seized an opportunity to feed at the public trough. It’s no wonder cockroaches and root canals are more popular than Congress.”
In his inaugural address, Barack Obama said the commitments we make to each other through Medicare, Medicaid, and Social Security don’t make us a nation of takers. But the actions of Amgen and its cronies under the dome on Capitol Hill show who the real takers are — not those who look to government for support in old age and hard times but the ones at the top whose avarice and lust for profit compel them to take as much as they can from that government at the expense of everyone else.
Bill Moyers is managing editor of the new weekly public affairs program, "Moyers & Company," airing on public television. Check local airtimes or comment
Sunday, August 12, 2012
This San Diego doctor accepts checks from drug company representatives
I had an interesting experience on July 24, 2012 when I drove a friend to the doctor.
The receptionist said the doctor doesn't accept checks, so my friend paid with a credit card.
Then I saw one of those drug company representatives walk through the door. If you don't know what I mean, then you might have a particularly ethical doctor. The representatives are young and good-looking. This one was a man in a suit with the posture as straight as a marine's. He strode in pulling his black case on wheels, and was immediately ushered inside.
In my experience, the representatives are more often very attractive young women.
As I was leaving, I noticed a check lying on the receptionist's desk. I saw it was for $30.00. Apparently the doctor does accept checks--from drug representatives. I assume he was being paid to listen to the agent.
The receptionist saw me looking at the check, and she grabbed it quickly, then she couldn't seem to think of any good place to hide it, so she set it back down.
Years ago I had a neighbor who was prescribed an off-label drug (meaning used for a condition for which it was not approved by the FDA) she didn't need. That doctor's office was crawling with representatives almost all the time. Both the drug company and the doctor got in trouble with the law.
I wonder if my friend's doctor will prescribe unnecessary drugs after his discussion with the drug company agent.
The receptionist said the doctor doesn't accept checks, so my friend paid with a credit card.
Then I saw one of those drug company representatives walk through the door. If you don't know what I mean, then you might have a particularly ethical doctor. The representatives are young and good-looking. This one was a man in a suit with the posture as straight as a marine's. He strode in pulling his black case on wheels, and was immediately ushered inside.
In my experience, the representatives are more often very attractive young women.
As I was leaving, I noticed a check lying on the receptionist's desk. I saw it was for $30.00. Apparently the doctor does accept checks--from drug representatives. I assume he was being paid to listen to the agent.
The receptionist saw me looking at the check, and she grabbed it quickly, then she couldn't seem to think of any good place to hide it, so she set it back down.
Years ago I had a neighbor who was prescribed an off-label drug (meaning used for a condition for which it was not approved by the FDA) she didn't need. That doctor's office was crawling with representatives almost all the time. Both the drug company and the doctor got in trouble with the law.
I wonder if my friend's doctor will prescribe unnecessary drugs after his discussion with the drug company agent.
Wednesday, July 4, 2012
Dr. Drew Pinsky responds to allegations he received GlaxoSmithKline payments
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.
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.
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.
Tuesday, June 5, 2012
Do doctor-payment sunshine laws work?
Since the disclosure of information was to state agencies, not the general public, the state laws were less likely to influence doctors' behavior, one expert not involved in the research noted.
Do doctor-payment sunshine laws work?
By Andrew M. Seaman
Jun 4, 2012
(Reuters Health)
The mere passage of a law that requires drug companies to disclose how much money they pay doctors may not change physician prescribing practices, suggests a new study.
In two states that passed so-called sunshine laws requiring drugmakers to disclose payments, doctors' choices of which drugs to prescribe for their patients did not differ much from those of peers in states without such a law.
However, since the disclosure of information was to state agencies, not the general public, the state laws were less likely to influence doctors' behavior, one expert not involved in the research noted.
"It was a way of doing a quick analysis to even see if there was an impact we could measure," said Kavita Nair, the study's senior author and a associate professor at University of Colorado School of Pharmacy in Aurora.
Nair and her colleagues said they were trying to gauge the potential effect of a nationwide disclosure requirement.
The Affordable Care Act -- the broad overhaul of the U.S. healthcare system passed in 2010 -- includes a provision that requires drug companies to report certain payments made to doctors. Drug companies may pay doctors for, among other things, consulting, speaking fees or travel.
The reasoning behind disclosure requirements, according to the researchers, is that doctors will shy away from taking money or gifts that might influence their prescribing choices if the information is reported publicly.
In a letter to the Archives of Internal Medicine, Nair's team said they decided to look at the experiences of Maine and West Virginia -- states that each enacted sunshine laws in 2004...
Overall, "there were negligible to small effects of the disclosure laws in Maine and West Virginia for both statins and SSRIs," Nair's group concluded...
"This doesn't even present a bird's-eye view," said Charles Ornstein, who has looked at the issue of payments to doctors at ProPublica, a non-profit investigative news organization in New York.
Ornstein told Reuters Health that both Maine and West Virginia do not make their disclosures available online. And, he added, companies did not start disclosing how much they paid doctors until 2009 (the end of Nair's study period)...
"I think as more companies report, and this information has been out there a little longer, you'll see studies that are done with a little more robustness than this one," said Ornstein.
Dr. Jerome Kassirer, a distinguished professor at the Tufts University School of Medicine, said the information also needs to be accessible to researchers.
Kassirer, who has looked at the relationships between doctors and big business, told Reuters Health that the debate comes down to a conflict of interest.
"If I'm going to take advice form a doctor on a new drug or any kind of procedure, I'd like the advice from someone who is not conflicted," said Kassirer...
Do doctor-payment sunshine laws work?
By Andrew M. Seaman
Jun 4, 2012
(Reuters Health)
The mere passage of a law that requires drug companies to disclose how much money they pay doctors may not change physician prescribing practices, suggests a new study.
In two states that passed so-called sunshine laws requiring drugmakers to disclose payments, doctors' choices of which drugs to prescribe for their patients did not differ much from those of peers in states without such a law.
However, since the disclosure of information was to state agencies, not the general public, the state laws were less likely to influence doctors' behavior, one expert not involved in the research noted.
"It was a way of doing a quick analysis to even see if there was an impact we could measure," said Kavita Nair, the study's senior author and a associate professor at University of Colorado School of Pharmacy in Aurora.
Nair and her colleagues said they were trying to gauge the potential effect of a nationwide disclosure requirement.
The Affordable Care Act -- the broad overhaul of the U.S. healthcare system passed in 2010 -- includes a provision that requires drug companies to report certain payments made to doctors. Drug companies may pay doctors for, among other things, consulting, speaking fees or travel.
The reasoning behind disclosure requirements, according to the researchers, is that doctors will shy away from taking money or gifts that might influence their prescribing choices if the information is reported publicly.
In a letter to the Archives of Internal Medicine, Nair's team said they decided to look at the experiences of Maine and West Virginia -- states that each enacted sunshine laws in 2004...
Overall, "there were negligible to small effects of the disclosure laws in Maine and West Virginia for both statins and SSRIs," Nair's group concluded...
"This doesn't even present a bird's-eye view," said Charles Ornstein, who has looked at the issue of payments to doctors at ProPublica, a non-profit investigative news organization in New York.
Ornstein told Reuters Health that both Maine and West Virginia do not make their disclosures available online. And, he added, companies did not start disclosing how much they paid doctors until 2009 (the end of Nair's study period)...
"I think as more companies report, and this information has been out there a little longer, you'll see studies that are done with a little more robustness than this one," said Ornstein.
Dr. Jerome Kassirer, a distinguished professor at the Tufts University School of Medicine, said the information also needs to be accessible to researchers.
Kassirer, who has looked at the relationships between doctors and big business, told Reuters Health that the debate comes down to a conflict of interest.
"If I'm going to take advice form a doctor on a new drug or any kind of procedure, I'd like the advice from someone who is not conflicted," said Kassirer...
Tuesday, January 17, 2012
US to Force Drug Firms to Report Money Paid to Doctors
US to Force Drug Firms to Report Money Paid to Doctors
January 17, 2012
by: Robert Pear
The New York Times News Service
To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.
Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.
Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.
Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.
The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.
Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.
Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.
The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.
Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.
Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.
The new requirements, or something very similar, will take effect soon; in fact, they are overdue. Under the new health care law, the administration was supposed to establish payment-reporting procedures by Oct. 1, 2011. The public will have until Feb. 17 to comment on the proposals, which are broadly consistent with the expectations of industry and consumer groups. After considering the comments, Medicare officials will issue final rules with the force of law.
Consumer advocates have long demanded details of the financial ties between doctors and drug and device companies.
Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”
In an introduction to the proposed rules, the Obama administration says that patients can benefit when doctors and the industry work together to develop life-saving drugs and devices. But, it said, these relationships can also “lead to conflicts of interests that may affect clinical decision-making” and “threaten the underlying integrity of the health care system.”
The administration does not try to define the difference between proper and improper payments. It says simply that public reporting of the financial ties between doctors and drug and device companies “will permit patients to make better-informed decisions when choosing health care professionals and making treatment decisions.”
The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul.
“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.
Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.
“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said.
Matthew D. Bennett, a senior vice president of the Pharmaceutical Research and Manufacturers of America, said the industry “supported transparency of physician payment information.” However, he said, it is important that payment data be presented in a proper context, emphasizing that interactions between doctors and drug companies played a critical role in improving care, educating doctors and fostering appropriate use of medicines.
Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.
Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing.
The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks.
The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery.
January 17, 2012
by: Robert Pear
The New York Times News Service
To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.
Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.
Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.
Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures. Analyses by The New York Times and others have found that about a quarter of doctors take cash payments from drug or device makers and that nearly two-thirds accept routine gifts of food, including lunch for staff members and dinner for themselves.
The Times has found that doctors who take money from drug makers often practice medicine differently from those who do not and that they are more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.
Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.
Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.
The Obama administration estimates that more than 1,100 drug, device and medical supply companies will have to file reports, generating “large amounts of new data.” Federal officials said they would inspect and audit drug company records to make sure the reports were accurate and complete.
Companies will be subject to a penalty up to $10,000 for each payment they fail to report. A company that knowingly fails to report payments will be subject to a penalty up to $100,000 for each violation, up to a total of $1 million a year.
Top executives are potentially liable because a senior official of each company — the chief executive, chief financial officer or chief compliance officer — must attest to the accuracy of each report.
The new requirements, or something very similar, will take effect soon; in fact, they are overdue. Under the new health care law, the administration was supposed to establish payment-reporting procedures by Oct. 1, 2011. The public will have until Feb. 17 to comment on the proposals, which are broadly consistent with the expectations of industry and consumer groups. After considering the comments, Medicare officials will issue final rules with the force of law.
Consumer advocates have long demanded details of the financial ties between doctors and drug and device companies.
Allan J. Coukell, a pharmacist and consumer advocate at the Pew Charitable Trusts, said: “Patients want to know they are getting treatment based on medical evidence, not a lunch or a financial relationship. They want to know if their doctor has a financial relationship with a pharmaceutical company, but they are often uncomfortable asking the doctor directly.”
In an introduction to the proposed rules, the Obama administration says that patients can benefit when doctors and the industry work together to develop life-saving drugs and devices. But, it said, these relationships can also “lead to conflicts of interests that may affect clinical decision-making” and “threaten the underlying integrity of the health care system.”
The administration does not try to define the difference between proper and improper payments. It says simply that public reporting of the financial ties between doctors and drug and device companies “will permit patients to make better-informed decisions when choosing health care professionals and making treatment decisions.”
The new standards carry out legislation championed by Senators Charles E. Grassley, Republican of Iowa, and Herb Kohl, Democrat of Wisconsin. The legislation was included in the 2010 health care overhaul.
“The goal is to let the sun shine in and make information available to foster accountability,” Mr. Grassley said.
Christopher L. White, executive vice president of the Advanced Medical Technology Association, which represents makers of medical devices, said the payment data could be used by federal law enforcement agencies, plaintiffs’ lawyers and whistleblowers.
“Some companies fear that doctors may no longer want to engage in consulting arrangements, and such reluctance could chill innovation,” Mr. White said.
Matthew D. Bennett, a senior vice president of the Pharmaceutical Research and Manufacturers of America, said the industry “supported transparency of physician payment information.” However, he said, it is important that payment data be presented in a proper context, emphasizing that interactions between doctors and drug companies played a critical role in improving care, educating doctors and fostering appropriate use of medicines.
Medicare and Medicaid, the programs for older Americans, the disabled and the poor, spend more than $100 billion a year on drugs and devices.
Although the Congressional Budget Office does not predict immediate savings, it has said that, “over time, disclosure has the potential to reduce spending,” by reducing instances of overprescribing.
The law also requires drug and device companies to report the amount of “any ownership or investment interest” held by doctors or their immediate family members, other than holdings of publicly traded stocks.
The administration intends to apply the same disclosure requirements to doctor-owned companies that distribute medical devices. Such companies allow doctors to benefit financially from sales of devices they use in surgery.
Saturday, December 24, 2011
Patient advocacy group funded by success of painkiller drugs, probe finds
Patient advocacy group funded by success of painkiller drugs, probe finds
By Charles Ornstein and Tracy Weber
Washington Post
December 23, 2011
The news about narcotic painkillers is increasingly dire: Overdoses now kill nearly 15,000 people a year — more than heroin and cocaine combined. In some states, the painkiller death toll exceeds that of car crashes.
The head of the Centers for Disease Control and Prevention has declared the overdoses from opioid drugs like OxyContin an “epidemic.” And a growing group of experts doubts that they work for long-term pain.
But the pills continue to have an influential champion in the American Pain Foundation, which describes itself as the nation’s largest advocacy group for pain patients. Its message: The risk of addiction is overblown, and the drugs are underused.
What the nonprofit doesn’t highlight is the money behind that message.
The foundation collected nearly 90 percent of its $5 million funding last year from the drug and medical-device industry — and closely mirrors its positions, an examination by ProPublica found.
Although the foundation maintains it is sticking up for the needs of millions of suffering patients, records and interviews show that it favors those who want to preserve access to the drugs over those who worry about their risks.
Some of the foundation’s board members have extensive financial ties to drugmakers, ProPublica found, and the group has lobbied against federal and state proposals to limit opioid use. Painkiller sales have increased fourfold since 1999, but the foundation argues that pain remains widely undertreated.
The group says industry money has had no effect on its advocacy.
“I’m convinced with every shred of my body that our interest is improving the lives of people affected by pain,” said Will Rowe, the foundation’s chief executive, “and we want to do that the best way we can.”
The problem isn’t opioids, Rowe and other group leaders say. It’s poorly trained doctors who prescribe them too easily or in excess.
Yet, critics say the Baltimore-based foundation is making it harder to address a major public-health problem.
“If you were a drug company, wouldn’t it be smart to make it look like you had a patient-oriented group?” said Gary Franklin, a Washington state official who tussled with the foundation over new restrictions on high-dose painkillers.
Its funding makes the group “one and the same” with the pain industry, Franklin said.
ProPublica’s review found that the foundation’s guides for patients, journalists and policymakers play down the risks associated with opioids and exaggerate their benefits. Opioids, derived from the opium plant, reduce the perception of pain by attaching to opioid receptors in the brain, spinal cord and elsewhere in the body.
Some of the foundation’s materials on the drugs include statements that are misleading or based on scant or disputed research.
The group’s board includes some patients but also doctors who are paid to speak and consult for drug companies, a researcher whose clinic has relied on their funding for survival and a public-relations executive whose firm represents them.
Last year, one board member was the lead author of a study about a Cephalon drug. Cephalon sponsored the study, and its employees were co-authors. The study found that the drug, Fentora, was “generally safe and well-tolerated” in non-cancer patients even though it is only approved for severe cancer pain...
By Charles Ornstein and Tracy Weber
Washington Post
December 23, 2011
The news about narcotic painkillers is increasingly dire: Overdoses now kill nearly 15,000 people a year — more than heroin and cocaine combined. In some states, the painkiller death toll exceeds that of car crashes.
The head of the Centers for Disease Control and Prevention has declared the overdoses from opioid drugs like OxyContin an “epidemic.” And a growing group of experts doubts that they work for long-term pain.
But the pills continue to have an influential champion in the American Pain Foundation, which describes itself as the nation’s largest advocacy group for pain patients. Its message: The risk of addiction is overblown, and the drugs are underused.
What the nonprofit doesn’t highlight is the money behind that message.
The foundation collected nearly 90 percent of its $5 million funding last year from the drug and medical-device industry — and closely mirrors its positions, an examination by ProPublica found.
Although the foundation maintains it is sticking up for the needs of millions of suffering patients, records and interviews show that it favors those who want to preserve access to the drugs over those who worry about their risks.
Some of the foundation’s board members have extensive financial ties to drugmakers, ProPublica found, and the group has lobbied against federal and state proposals to limit opioid use. Painkiller sales have increased fourfold since 1999, but the foundation argues that pain remains widely undertreated.
The group says industry money has had no effect on its advocacy.
“I’m convinced with every shred of my body that our interest is improving the lives of people affected by pain,” said Will Rowe, the foundation’s chief executive, “and we want to do that the best way we can.”
The problem isn’t opioids, Rowe and other group leaders say. It’s poorly trained doctors who prescribe them too easily or in excess.
Yet, critics say the Baltimore-based foundation is making it harder to address a major public-health problem.
“If you were a drug company, wouldn’t it be smart to make it look like you had a patient-oriented group?” said Gary Franklin, a Washington state official who tussled with the foundation over new restrictions on high-dose painkillers.
Its funding makes the group “one and the same” with the pain industry, Franklin said.
ProPublica’s review found that the foundation’s guides for patients, journalists and policymakers play down the risks associated with opioids and exaggerate their benefits. Opioids, derived from the opium plant, reduce the perception of pain by attaching to opioid receptors in the brain, spinal cord and elsewhere in the body.
Some of the foundation’s materials on the drugs include statements that are misleading or based on scant or disputed research.
The group’s board includes some patients but also doctors who are paid to speak and consult for drug companies, a researcher whose clinic has relied on their funding for survival and a public-relations executive whose firm represents them.
Last year, one board member was the lead author of a study about a Cephalon drug. Cephalon sponsored the study, and its employees were co-authors. The study found that the drug, Fentora, was “generally safe and well-tolerated” in non-cancer patients even though it is only approved for severe cancer pain...
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.
Wednesday, March 9, 2011
Influential research misses financial conflicts
Influential research misses financial conflicts
By Frederik Joelving
Mar 9, 2011
Reuters
Scientists who review large sets of drug trials for medical journals often ignore financial conflicts that might warp the evidence, according to a study out Tuesday.
That's more than just an academic problem, experts say, because the reviews are considered just about the strongest evidence that medical science can muster.
"It influences how physicians make decisions and how guideline panels come up with their guidelines," said Brett D. Thombs, of McGill University and the Jewish General Hospital in Montreal, whose findings are published in the Journal of the American Medical Association (JAMA).
Thombs' team found that of 29 reviews, or "meta-analyses," of earlier drug trials -- culled from top journals like JAMA and The Lancet -- only two reported who had funded the original trials included in the review.
And none of the reviews mentioned whether the authors reporting on those trials had been paid by drugmakers.
Such financial ties have been linked to research inflating the benefits of new drugs and downplaying the risks, said Thombs.
For instance, according to a 2008 report, only half the trials on antidepressants sent to the U.S. Food and Drug Administration, which approves new drugs, got a positive review by the agency.
By contrast, from the medical literature it appeared that more than 90 percent of the trials favored the drugs, because the majority of those that were unfavorable simply never got published...
By Frederik Joelving
Mar 9, 2011
Reuters
Scientists who review large sets of drug trials for medical journals often ignore financial conflicts that might warp the evidence, according to a study out Tuesday.
That's more than just an academic problem, experts say, because the reviews are considered just about the strongest evidence that medical science can muster.
"It influences how physicians make decisions and how guideline panels come up with their guidelines," said Brett D. Thombs, of McGill University and the Jewish General Hospital in Montreal, whose findings are published in the Journal of the American Medical Association (JAMA).
Thombs' team found that of 29 reviews, or "meta-analyses," of earlier drug trials -- culled from top journals like JAMA and The Lancet -- only two reported who had funded the original trials included in the review.
And none of the reviews mentioned whether the authors reporting on those trials had been paid by drugmakers.
Such financial ties have been linked to research inflating the benefits of new drugs and downplaying the risks, said Thombs.
For instance, according to a 2008 report, only half the trials on antidepressants sent to the U.S. Food and Drug Administration, which approves new drugs, got a positive review by the agency.
By contrast, from the medical literature it appeared that more than 90 percent of the trials favored the drugs, because the majority of those that were unfavorable simply never got published...
Tuesday, November 9, 2010
U.S. doctors still too cozy with drug industry: report
U.S. doctors still too cozy with drug industry: report
By Julie Steenhuysen
Nov 9, 2010
Reuters
Doctors in the United States are still too cozy with drug companies, although they have managed to break some of those ties, U.S. researchers said on Monday.
The team at Harvard University and Massachusetts General Hospital did a national survey of 1,900 primary care doctors in 2009 about their contacts with drug companies.
They found 84 percent reported some type of relationship with drug companies, compared with 94 percent in 2004.
About two thirds accepted drug samples, 70 percent accepted food or beverages from drug companies and 14 percent accepted payment in exchange for their professional services, they reported in the Archives of Internal Medicine.
"We found a significant decline overall in the percentage of physicians who have relationships with industry," Eric Campbell of Massachusetts General, who led the study, said in a telephone interview.
In the team's first study of industry ties in 2004, getting drug samples or accepting lunches or other food from drug company salespeople were most common, followed by payments from drug companies for attending medical meetings or continuing education seminars.
Since then, several government and academic groups have pressured doctors to sever their ties to drug companies.
Members of Congress, including Senator Charles Grassley, an Iowa Republican, have been pushing to limit the influence of drugmakers over the practice of medicine after a probe showed a noted Harvard neuroscientist had failed to disclose payments from drug companies...
By Julie Steenhuysen
Nov 9, 2010
Reuters
Doctors in the United States are still too cozy with drug companies, although they have managed to break some of those ties, U.S. researchers said on Monday.
The team at Harvard University and Massachusetts General Hospital did a national survey of 1,900 primary care doctors in 2009 about their contacts with drug companies.
They found 84 percent reported some type of relationship with drug companies, compared with 94 percent in 2004.
About two thirds accepted drug samples, 70 percent accepted food or beverages from drug companies and 14 percent accepted payment in exchange for their professional services, they reported in the Archives of Internal Medicine.
"We found a significant decline overall in the percentage of physicians who have relationships with industry," Eric Campbell of Massachusetts General, who led the study, said in a telephone interview.
In the team's first study of industry ties in 2004, getting drug samples or accepting lunches or other food from drug company salespeople were most common, followed by payments from drug companies for attending medical meetings or continuing education seminars.
Since then, several government and academic groups have pressured doctors to sever their ties to drug companies.
Members of Congress, including Senator Charles Grassley, an Iowa Republican, have been pushing to limit the influence of drugmakers over the practice of medicine after a probe showed a noted Harvard neuroscientist had failed to disclose payments from drug companies...
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.
Tuesday, October 19, 2010
Drug Companies Hire Troubled Doctors As Experts
October 19, 2010
Drug Companies Hire Troubled Doctors As Experts
NPR Staff and ProPublica
Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of the companies' drugs.
But an investigation by ProPublica has uncovered hundreds of doctors receiving company payments who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.
To vet the industry's handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. The companies include Lilly, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.
Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.
That is something not all companies do.
"Without question, the public should care," said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. "You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn't displayed good judgment in the past?"...
Drug Companies Hire Troubled Doctors As Experts
NPR Staff and ProPublica
Drug companies say they hire the most-respected doctors in their fields for the critical task of teaching about the benefits and risks of the companies' drugs.
But an investigation by ProPublica has uncovered hundreds of doctors receiving company payments who had been accused of professional misconduct, were disciplined by state boards or lacked credentials as researchers or specialists.
To vet the industry's handpicked speakers, ProPublica created a comprehensive database that represents the most accessible accounting yet of payments to doctors. Compiled from disclosures by seven companies, the database covers $257.8 million in payouts since 2009 for speaking, consulting and other duties. The companies include Lilly, Cephalon, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck and Pfizer.
Although these companies have posted payments on their websites — some as a result of legal settlements — they make it difficult to spot trends or even learn who has earned the most. ProPublica combined the data and identified the highest-paid doctors, then checked their credentials and disciplinary records.
That is something not all companies do.
"Without question, the public should care," said Dr. Joseph Ross, an assistant professor of medicine at Yale School of Medicine who has written about the industry’s influence on physicians. "You would never want your kid learning from a bad teacher. Why would you want your doctor learning from a bad doctor, someone who hasn't displayed good judgment in the past?"...
Thursday, March 5, 2009
Victory bittersweet for drug liability case victim
By JOHN CURRAN
March 5, 2009
MARSHFIELD, Vt. (AP) — A Vermont musician who lost her arm after a botched drug injection says the U.S. Supreme Court's decision to uphold a $6.7 million verdict against the pharmaceutical company that made the drug is a victory for consumers.
"I just feel really good for what this means for the whole country," said Diana Levine, 63. "The money, to me, means the company was held accountable for something that didn't need to happen, number one.
"So hopefully, they'll learn their lesson from it and change the label so this doesn't happen to any more people," she said.
Rejecting calls for limits on lawsuits against drug companies, the high court on Wednesday upheld the award against Wyeth Pharmaceuticals, the maker of anti-nausea drug Phenergan. In a 6-3 ruling, the court turned away Wyeth's claim that U.S. Food and Drug Administration approval of the drug and its warning label should have shielded the company from Levine's suit.
Levine's nightmare began in 2000.
Suffering from a migraine headache, she went to a local clinic and was given painkillers and received an intramuscular injection of Phenergan. When she still felt nauseated, she was given an "IV-push" of the drug, with the second injection accidentally puncturing an artery. Gangrene set in. Several weeks later, her right arm was amputated.
"It basically took away my whole musical identity. I'd been playing music for 30 years, working with kids, writing songs. I played guitar, piano, bass in a rock band. I couldn't do any of those things anymore," she said.
She lost more than her music and her livelihood.
Suddenly, what was routine became a challenge. The drawers in her 150-year-old farmhouse needed two hands to be opened. A left-hander, she still had one hand to use, but she relied on it to compensate so much that she injured it with overuse.
She couldn't shovel or scrape ice off the windshield of her car, a real hardship in rural Vermont. In summer, she can't open a window without help.
"Nobody, nobody understands what it's like to just operate with one hand. Everything you do requires two hands, even when you think you only need one," she said.
For years, Levine wondered whether Wyeth would ever be held accountable.
On Wednesday, it was.
In the majority opinion, Justice John Paul Stevens said Wyeth could "unilaterally strengthen its warning," especially after it learned of at least 20 cases before Levine's injury in which an injection led to gangrene and amputation.
By JOHN CURRAN
March 5, 2009
MARSHFIELD, Vt. (AP) — A Vermont musician who lost her arm after a botched drug injection says the U.S. Supreme Court's decision to uphold a $6.7 million verdict against the pharmaceutical company that made the drug is a victory for consumers.
"I just feel really good for what this means for the whole country," said Diana Levine, 63. "The money, to me, means the company was held accountable for something that didn't need to happen, number one.
"So hopefully, they'll learn their lesson from it and change the label so this doesn't happen to any more people," she said.
Rejecting calls for limits on lawsuits against drug companies, the high court on Wednesday upheld the award against Wyeth Pharmaceuticals, the maker of anti-nausea drug Phenergan. In a 6-3 ruling, the court turned away Wyeth's claim that U.S. Food and Drug Administration approval of the drug and its warning label should have shielded the company from Levine's suit.
Levine's nightmare began in 2000.
Suffering from a migraine headache, she went to a local clinic and was given painkillers and received an intramuscular injection of Phenergan. When she still felt nauseated, she was given an "IV-push" of the drug, with the second injection accidentally puncturing an artery. Gangrene set in. Several weeks later, her right arm was amputated.
"It basically took away my whole musical identity. I'd been playing music for 30 years, working with kids, writing songs. I played guitar, piano, bass in a rock band. I couldn't do any of those things anymore," she said.
She lost more than her music and her livelihood.
Suddenly, what was routine became a challenge. The drawers in her 150-year-old farmhouse needed two hands to be opened. A left-hander, she still had one hand to use, but she relied on it to compensate so much that she injured it with overuse.
She couldn't shovel or scrape ice off the windshield of her car, a real hardship in rural Vermont. In summer, she can't open a window without help.
"Nobody, nobody understands what it's like to just operate with one hand. Everything you do requires two hands, even when you think you only need one," she said.
For years, Levine wondered whether Wyeth would ever be held accountable.
On Wednesday, it was.
In the majority opinion, Justice John Paul Stevens said Wyeth could "unilaterally strengthen its warning," especially after it learned of at least 20 cases before Levine's injury in which an injection led to gangrene and amputation.
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