WASHINGTON, March 21 â€” Expert advisers to the government who receive money from a drug or device maker would be barred for the first time from voting on whether to approve that companyâ€™s products under new rules announced Wednesday for the F.D.A.â€™s powerful advisory committees.
Indeed, such doctors who receive more than $50,000 from a company or a competitor whose product is being discussed would no longer be allowed to serve on the committees, though those who receive less than that amount in the prior year can join a committee and participate in its discussions.
A â€œsignificant numberâ€? of the agencyâ€™s present advisers would be affected by the new policy, said the F.D.A. acting deputy commissioner, Randall W. Lutter, though he would not say how many. The rules are among the first major changes made by Dr. Andrew C. von Eschenbach since he was confirmed as commissioner of food and drugs late last year.
Advisory boards recommend drugs for approval and, in rare cases, removal, and their votes can have enormous influence on drug company fortunes.
â€œThe $50,000 threshold is something that we think strikes an appropriate balance betweenâ€? getting smart advisers and reassuring the public that their advice is not tainted, Dr. Lutter said. [full text]
Since when is $50,000 not a lot of money? That’s more than the 2005 median household income for the US, which is $46,326, according to U.S. Census Bureau. How is getting $49,000 from Merck or Pfizer not going to influence a doctor’s opinion as he sits on an FDA panel reviewing Merck’s or Pfizer’s latest product? How about anything over $500? That sounds about right to me.
A new analysis found that records were sketchy and hard to access in two states that require drug companies to publicly disclose payments made to physicians. Many payments exceeded the $100 cap on marketing activities recommended by the American Medical Association and a trade group representing the pharmaceutical industry.
Five states and the District of Columbia have enacted so-called sunshine laws that require companies to report how much money they pay doctors and other health care workers as well as in what form and for what purpose. Such payments can range from consulting fees for clinical trials to meals to “detailing” (paying doctors to let drug-marketing reps talk up their drugs during the workday), some of which can raise concerns about conflicts of interest when doctors are prescribing the companies’ drugs to patients.
The purpose of the laws is to monitor whether money and gifts influence physicians’ decisions when prescribing meds. To determine whether the laws are working, researchers requested data from Minnesota, home of the country’s oldest such law, enacted in 1993, and Vermont, which passed its measure in 2002.
The group reports that it was a challenge just to obtain the documents. In Vermont, the state’s attorney general is charged with collecting the data and tabulating the results for the public. “We thought it meant the public had access to it,” says health services researcher Joseph Ross of the Mount Sinai School of Medicine in New York City, the study’s lead researcher. But he says they waited nearly a year to get detailed information from the state for 2002 to 2004, during which 58 companies reported forking over $5.6 million to health care professionals. [full text]
You have to wonder why the Attorney General’s office of Vermont was not more willing to provide this public information in a timely manner. As the article goes on to detail, when they did finally provide the information, they cloaked $3.4 million of it in what they call payments involving “trade secrets” which can be legally kept hidden from the public.
David says it well here. If we’re serious about medicine and science being untainted and in the best interest of the public, we need to stop letting the pharmaceutical companies grease every doctor’s palm in the country.