Do not fall victim to Pharma & Medical Research

Humans species are used as experiments for research to either extend life or end ones life.

Article by: ROBERT PEAR , New York Times

WASHINGTON – To head off medical conflicts of interest, the Obama administration is poised to require drug companies and manufacturers of medical devices 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. Federal officials said the disclosures would increase the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Minnesota has required pharmaceutical companies — but not device makers — to report payments they make to local physicians since 1993. The reports are filed annually with the state Board of Pharmacy.

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 drugmakers 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 federal standards, if a company has even 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 website 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.

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.

Minnesota is a hub of medical technology firms that would be subject to the reporting requirements. Medtronic, the world’s largest medical technology company, already voluntarily divulges financial relationships with doctor-consultants on its website.

The Fridley-based company began disclosing those relationships in June 2010. In the first quarter of that year alone, Medtronic paid millions in royalties and consulting fees to more than 200 doctors around the country, including 13 in Minnesota.

The company’s voluntary disclosure came after the medical products giant caught heat for making payments that, for some, create the appearance of a conflict of interest. Medtronic and the rest of the industry, however, defend the practice of working with physicians as crucial to product development and improvement.

Disclosure requirements alone provide no guarantee of complete transparency. The University of Minnesota recently determined that one of its doctors violated ethics policies by failing to consistently disclose work he did for Medtronic that yielded more than $1 million in fees. Other studies of the issue across the country have shown uneven reporting of such relationships by doctors.

Related articles

• US to Force Drug Firms to Report Money Paid to Doctors – New York Times (nytimes.com)
• Medtronic Agrees to $23.5 Million Settlement in Kickback Case (nytimes.com)
• U.S. to tell drugmakers to disclose payments to doctors (mercurynews.com)
• Pharma to Report Money Paid to Doctors (and where you can check on your doctor now) (beyondmeds.com)