Report Blasts FDA Safety Process

[jmjm530]

This has been posted earlier but I thought it deserves its own thread, especially in light of the drugs many of us are on.

Ever wonder why there's so little information available on the long term effects of the drugs we take? Well, who is going to do the studies? Keep in mind most studies are funded by drug companies. Conflict of interest?

Full article here: http://tinyurl.com/oa6wa

Some snippets:

The report backs up calls by some lawmakers for restructuring at the agency in the wake of highly publicized safety problems with popular drugs like Merck`s Vioxx and Pfizer`s Celebrex.

FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues,' stated the report, issued by the Government Accountability Office.

We observed that there is a lack of criteria for determining what safety actions to take and when to take them,' the GAO concluded.

The current structure causes an inherent conflict of interest, lawmakers charge, in which officials who`ve previously deemed a new drug safe may be reluctant to go back on their judgments later.

We suggest that the Congress consider expanding FDA`s authority to require drug sponsors to conduct postmarket studies when additional data are needed,' the GAO stated.



.

[can-do-man]

space says....... I say the FDA and lawyers are slowing down the meds we could be trying!!
----------------------------------------------------------------

I agree, At stage 4 if i want to risk a new drug then the FDA should stay out of it. To many people die every year because of all the red tape

[can-do-man]

As for long term sx effects, my hepatologist already warned me about that being possible. Even said some he thinks some is showing up. He didn't force me to take it. But me being a stage 4 not to many options. Thats why i wonder why some with no or very little damage jump right into this poison.

[Algernon]

Unfortunately, following the long term sides is pretty much up to us--just like monitoring our own treatment seems to be.

I plan on writing to Schering to ask if there have been any studies on long term side effects?   I won't wait by the mailbox for the answer...

[cuteus]

I believe there is a procedure in place by which providers report new side effects or adverse events to the Dept of Health and FDA. I think that consumers can do so also. It seems to me that if the number or address was made more accessible or known, that the data gathered from these reports could be used in the studies of the drugs approved, and assess possible problems before a fatality occurs.

[jmjm530]

Say you've invested X billion dollars into developing a drug and getting FDA approval. Now that drug is driving your companies bottom line with stockholders demanding ever increasing profit projections be met. So where exactly is the internal motivation to re-test your prodcut for safety? After all, you got FDA approval, didn't you.

-- Jim

[Mister beagle bailey]

I agree 100% with you on the FDA and conflict of interest.  It's not just vioxx and celebrex but a long list of drugs approved by the FDA and now are off the market and have law suits pending.

Would like to know who of the FDA is getting paid off for pushing these drugs to market.  This has been a problem for years and the gov. has done nothing to stop it.

Just like the gas problem we have today. I'm watching CNN news as I post and they are showing many Americans using bikes to get around and then shows China with more cars then ever on the road and hardly anyone there using bikes any more.  What is wrong with this picture and our country?  They also say the big oil comanies are shipping much of the oil to China and China is using so much oil that it has caused a imbalance in the market.
Correct me if I'm wrong, why do we have an embargo againist Cuba and the Cubans want freedom as they are always trying to flee and yet we trade and borrow millions of dollars a month from China the largest communist country in the world.  Before long they will own this country because of the money our gov. owes them, and we borrow the money to balance the federal budget.  What is wrong with this picture????

Sorry, just needed to sound off as I'm fed up with it all.

Beagle