Media in Trouble: All the news thats UNfit to print!: FDA Shortchanged?

"The information of the people at large can alone make them safe, as they are the sole depositary of our political and religious freedom." --Thomas Jefferson 1810

Friday, July 21, 2006

FDA Shortchanged?

In the middle of this Lebanon-Israeli shitstorm, a wee story broke on NPR that barely got any attention.

David Graham is at it again blowing whistles about the FDA's borderline malfeasance when it comes to approving drugs and keeping them on the market despite data that points to these drugs being unsafe. Yes, this time it is Aventis who pushed through an antibiotic called Ketek. They got approval the old fashioned way, they said they would put a warning about potential liver failure.

This has become sort of commonplace lately. A drug is pushed through the FDA process, where the safety data may not be 100% kosher, but with a little label negotiation and a promise of a safety study, the drug is approved and gets launched into the world market. Then, a few years later, the study is complete and lo and behold, it isn't as safe (or is less safe) than first imagined.

One of the biggest causes of this is the combination of lack of funding and understaffing at the FDA to actually follow the Safety issues while the drug is in development (ie. before it is approved).

So what does it say about the state of affairs when the Head of the Health and Human Services is practicing tax evasion? Shouldn't the people who have to grovel and beg Congress for funding have clean tax records?

$1.2 million in writeoffs could probably fund 1 or 2 or even 3 (on government salaries) more people that could be dedicated to following up on Safety issues BEFORE a drug is even submitted for approval.

$1.2 million could fund 1-3 more auditors, to ensure the company is doing what it is supposed to.

$1.2 million could fund lots of things that are currently viewed as weaknesses in arguably the most important government agency we've got.

I think it's time to find a new Secretary.