Is Your Medical Information Brought to You by Drug Companies?
This week, the New York Times‘ Duff Wilson reports Alan Schatzberg, MD, former president of the American Psychiatric Association and Charles Nemeroff, MD, chairman of psychiatry at the University of Miami medical school, wrote an entire textbook funded and directed by drug giant GSK called Recognition and Treatment of Psychiatric Disorders. In May, the duo sat side by side, beaming, at the APA’s annual meeting in New Orleans, as they signed another book they co-wrote, Textbook of Psychopharmacology, even as the meeting’s daily newspaper reported Schatzberg’s links to Eli Lilly, GSK, Merck, Pfizer, Forest, Takeda, Sanofi-Aventis and eight other companies.
Both psychiatrists were investigated by Congress and stripped of National Institutes of Health (NIH) grants. But in June, Nemeroff colleague Thomas Insel, MD, director of the National Institute of Mental Health (NIMH), assured University of Miami officials Nemeroff could still pull federal grant money, according to the Chronicle of Higher Learning.
The pediatric depression expert, Joan Luby, MD was heavily quoted in theNew York Times magazine’s August article “Can Preschoolders be Depressed?” despite her undisclosed ties to AstraZeneca and other pharma companies. In the March Archives of General Psychiatry she writes that she didn’t previously disclose ties “because they were not relevant to the subject of the article.”
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.
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.
A STING NAILED A COMPANY THE HHS AUTHORIZED TO OVERSEE HUMAN DRUG TRIALS. THE ABSURDITIES IN THE APPLICATION ARE BELLY LAUGH FUNNY, BUT IN THEIR RUSH TO KEEP THE MONEY COMING, THEY APPROVED IT.
The FDA farms out drug and medical device testing. It’s in the hands of the companies hoping to gain approval for their products, but they must first get approval before doing tests on humans. Even here, though, there’s a catch. The FDA doesn’t review the testing plans. That’s done by more for-profit companies, Institutional Review Boards (IRBs). But it gets worse. The IRBs are paid by the companies hoping to gain FDA approval for their products. So, it’s a conflict of interest on top of a conflict of interest.
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.
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.
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