Monday, November 22, 2004

I want a new drug..

I'm never surprised by the inner workings of our Government, good or bad. But after reading about Vioxx being taken off the market after 27,000 deaths were linked to it and RU-486 getting a warning after 2 people died (not from the drug, but from secondary complications) I was upset.

Warnings about Vioxx had been pouring in from around the world for the last 2 years, warnings the FDA has ignored. I don't feel safe with this system, and felt less safe after reading news reports about why this could have happened.

The makers of RU-486 are based in France and thus aren't allowed to contribute money to any US presidential or other candidate up for re-election. Vioxx is a US manufacturing company and was pulling in about 2.5 billion in sales a year, and were large contributors to GOP campaigns.

Undoubtedly the nature of RU-486 and its use is a big issue, it was barred by the FDA for US use from 1989 to 1993. What if this wasn't an abortion drug from France but a cure for cancer? AIDS? Alzheimer's? These warnings after 2 unrelated deaths would have been a non-issue.

Another issue I read about regarding the FDA is a conflict of interest. Congress has required a "user fee" since 1992 from any drug company wanting a new product evaluated by the FDA. These fees make up more than half of the FDA's CDER annual $500 million budget. (CDER=Center for Drug Evaluation and Research) That makes the FDA seem a little too cozy with the pharmaceutical industry for my taste.

That compared to the hard data from when the "user fee" was introduced just makes it even more of a conflict in my eyes. From 1996 to 2001, the FDA issued about 480 cease-and-desist letters. In the last 4 years, the total has been about 130. Potentially harmful side effects have almost doubled from approved drugs during that time.

But like I said, I'm not surprised. I just feel less safe when I have to take a prescription that is supposed to help me.

Double standards on Drugs

FDA is flexing less muscle

This is off the subject but a well written blog entry about the election and those of us who were upset about it:



Karen Funk Blocher said...

I remember a time when it was said that aspirin would not have been approved under then-current FDA standards. Now the pendulum has swung totally the other way, it seems. And the FDA is only part of the problem. The way drug companies market to doctors and the public, is it any wonder that everyone ends up with the newest, most expensive, least-tested drug instead of older, equally effective, probably safer alternatives?

Thanks for the link!

time is a fire said...

This is a very interesting discussion.

First of all, i got killed in biotech. But I am still confident in its future. I especially like HGSI.

That said, should we have drug regulation at all? The most interesting thing i saw were comments by the american libertarian party on this. (In fact, there policy statements on every issue were a model of clarity.) I think that illegal drugs should be decriminalised. If people want to use them, let them.

I am in favour of maintainig FDA approval for medicine though. THey do try and help the drug companies get effective medicine onto the market. And people want to have confidence in these potent substances they are taking. Placebo effect is one of the best medicines out there and the FDA stamp of approval helps this.

alyceclover said...

Fast forward to 2006, Roche (of Hoffman & La Roche) pharmecuticals did some lying about the Bird Flu vaccine. Money talks. The FDA can be bought. Agree about decriminalizing other drugs. In the beginning Physicans took plants, and such, (like Marijuanna was prescribed by Chinese physicans for nausea, arthritis and stuff) then "man" decided to create drugs with artifical lab created ingredients and the FDA says "no, no" to the original Nature Made medications. Sigh.