Healthy Skepticism Library item: 17324
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
FDA’s failures are killing us
The Virginian-Pilot 2010 Feb 27
http://hamptonroads.com.nyud.net/2010/02/fda’s-failures-are-killing-us
Full text:
Researchers at GlaxoSmithKline determined in 2003, 2005 and 2006 that Avandia, a drug used to treat Type 2 diabetes, significantly increases the risk of serious heart problems. The Food and Drug Administration issued a warning in 2007, and a year later – amid mounting evidence of trouble – two of the agency’s top safety officials recommended yanking the medicine from the market.
So, where is Avandia now?
Hundreds of thousands of Americans are still taking it, according to The New York Times – despite internal FDA reports indicating that switching every Avandia patient to an alternate drug could prevent about 500 heart attacks and 300 cases of heart failure each month.
GlaxoSmithKline, meanwhile, is enrolling patients in a new round of clinical trials. The tests are expected to be completed by 2020, but – in what’s apparently intended to be a magnanimous gesture – company officials say they hope to have some information ready by 2014.
The U.S. Senate Finance Committee isn’t waiting. Last week, it released a bipartisan report based on more than 250,000 internal company documents and interviews with employees from GlaxoSmithKline and the FDA.
The results aren’t flattering.
According to the report, executives at the pharmaceutical company “attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”
Sen. Charles Grassley, a Republican from Iowa who helped oversee the inquiry, condemned the FDA’s handling of safety recommendations. He said agency experts who study drugs after they’ve been on the market for a few years are “under the thumb” of FDA officials who approved the drugs and “have a natural interest in defending that decision.”
The FDA has long been overdue for an overhaul. Its responsibilities for overseeing the safety of the nation’s food supply are split in ineffective and nonsensical ways with the Department of Agriculture. Its oversight of the pharmaceutical industry is lax and slow and dangerous, as the Avandia case demonstrates.
Part of the problem is a lack of staff and funding. But a larger flaw, stretching back to the Reagan administration, is a steady de-emphasis of regulation, even when lives are at stake.
Too many industries, over the years, have been left to police themselves, with minimal interference from federal agencies. This arrangement has proven an abysmal failure, again and again. Those who still support it must answer why the financial health of American business is more important than the health of Americans.
As Sen. Max Baucus, a Montana Democrat who worked with Grassley on this report, succinctly put it, “Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.”
So, unfortunately, did the FDA. By the agency’s own estimates, Avandia caused 83,000 heart attacks between 1999 and 2007. That’s a pill simply impossible to swallow.
