FDA - "We are incapable of protecting the public"

[Kirby]

NEW DRUG FEARS
New criticism: Some researchers are blasting the FDA for its handling of Baycol, a cholesterol-lowering statin that Bayer AG withdrew in 2001. A new study finds that the risks were far greater than had been believed.


(AP) -- New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.
.......
On Thursday, Dr. David Graham, associate director of science in the FDA's Office of Drug Safety, told a Senate panel that the FDA was incapable of protecting the public, and that dangerous drugs are being sold now. Bextra and AstraZeneca PLC's statin, Crestor, were among the five he named.

http://www.cnn.com/2004/HEALTH/11/22/risky.drugs.ap/index.html

 

[Bryan330i]

I think it's reasonable to say there are risks with advancement. If we want better and more advanced drugs I don't see any way around some additional risk of the unknown. Either that or we just stop and stick with aspirin and vodka.

 

[jrt67ss350]

I think it's reasonable to say there are risks with advancement. If we want better and more advanced drugs I don't see any way around some additional risk of the unknown. Either that or we just stop and stick with aspirin and vodka.

I agree. People need to understand that there are potential risks and side-effects to any medications that we take - the art of medicine in most cases is not an endeavor that can fix all of your ills without any added risks. Just because a medication has a potential risk doesn't mean it's a horrible medication - it just needs to be used with caution, and prescribing doctors need to help the patient evaluate the potential risks and benefits before placing them on the medication. Bextra (the same type of drug as the recently pulled Vioxx) provides great relief from the pains of arthritis and musculoskeletal inflammation for lots of patients - I've seen it personally. Many of these patients may be willing to take the chance with a certain risk of developing heart disease if that means they can live their daily lives in a more normal way. Others may not want to take that risk. IMO, it should be up to the patient, but the patient needs to be completely informed about the potential risks and benefits.

Could the FDA do a better job "protecting" Americans? Probably, but adding more regulations and stipulations to the current requirements for drug development is probably not the answer - it already takes years and ungodly amounts of money to come to market with a new drug. The entire system probably needs to be revamped from the ground-up if changes are to be made.

However, I think the most important change that needs to be made is that as doctors, we need to take the time to do a better job educating our patients about their medications and make sure they understand all of the potential risks so that they can better evaluate whether or not they want to be take a particular medication.

::Steps down off soapbox::

 

[Kirby]

I agree that the last thing we need are additional regulations or another government agency to monitor the FDA, slow down clinical trial phases, etc. Justin's right, it's all about risk vs. benefit. and educating the consumer.

But what about the issue that the pharms know about and suppress a serious risk after the drug has been on the market a few years, primarily due to financial impact? Could there be some sort of incentive to the pharms to annouce problems/pull product more quickly, like a tax break to mitigate R&D and production investment losses?

Was this a responsible statement for an FDA representative to make to congress?

 

[MrElussive]

I think it's reasonable to say there are risks with advancement. If we want better and more advanced drugs I don't see any way around some additional risk of the unknown. Either that or we just stop and stick with aspirin and vodka.

Mmmmmmmmmm, vodka.................