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Country Discussion Topics
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Read how the FDA protects you.
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Larry IowaEngineer    Posted 12-10-2004 at 17:52:53       [Reply]  [No Email]
NOT!!!

They are protecting the big durg companies profits!

Read the Congressional Testimony November 18, 2004 of David J. Graham, MD, MPH before Senate Finance Committee on VIOXX at the link below. It says, in effect, that VIOXX has killed 100,000 people in the last few years from heart attacks. And Dr. Eric Topol at the Cleveland Clinic recently estimated up to 160,000 cases of heart attacks and strokes due to Vioxx, in an article published in the New England Journal of Medicine.

I could say much more but no point in just ranting uselessly. :-(


Bkeepr -- u r off base    Posted 12-11-2004 at 07:18:08       [Reply]  [No Email]
The FDA does a pretty good job of balancing competing problems. On one hand, they get beat up because they're too slow and cautious and keep possible good drugs off the market. Then on the other hand, they get beat up when something slips through too quickly. They have to allow and encourage getting the break-through drugs through the process as quickly as possible, while at the same time stopping the snake oil. All based on probabilies and statistics, since it is impossible to run a clinical trial with everyone.

Don't put a lot of stock into some of these reports you read, they're typical one-sided poorly researched yellow journalism.

Go read about some of the FDA successes (there are lots, which is the real reason why we have the safest yet most advanced drugs IN THE WORLD.) This is tough work, and while they certainly aren't perfect, they do alright.

Tom A


Then you did not read the    Posted 12-11-2004 at 16:30:46       [Reply]  [No Email]
Here are some excerpts from the Congressional Testimony. If they are not evidence that something is VERY wrong in FDA then I just do not understand why they are not.

Prior to approval of Vioxx, a study was performed by Merck named 090. This study found nearly a 7-fold increase in heart attack risk with low dose Vioxx. The labeling at approval said nothing about heart attack risks.

The response from senior management in my Office, the Office of Drug Safety, was equally stressful. I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting, and also noted that Merck needed to know our study results.

An email from the Director for the entire Office of New Drugs, was revealing. He suggested that since FDA was "not contemplating" a warning against the use of high-dose Vioxx, my conclusions should be changed. CDER and the Office of New Drugs have repeatedly expressed the view that ODS should not reach any conclusions or make any recommendations that would contradict what the Office of New Drugs wants to do or is doing. Even more revealing, a mere 6 weeks before Merck pulled Vioxx from the market, CDER, OND and ODS management did not believe there was an outstanding safety concern with Vioxx.

Rezulin was a drug used to treat diabetes. It also caused acute liver failure, which was usually fatal unless a liver transplant was performed. The pre-approval clinical trials showed strong evidence of liver toxicity. The drug was withdrawn from the market in the United Kingdom in December 1997. With CDER and the Office of New Drugs, withdrawal didn't occur until March 2000.

The big picture. The problem you are confronting today is immense in scope. Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.


there are zealots and    Posted 12-12-2004 at 15:36:23       [Reply]  [No Email]
disgruntled employees in every organization. Many don't ever see the big picture, just their little piece, and know not of what they speak. If you're looking to prove any point, you can find one of these...just because somebody testifies before Congress don't make it so!!

I stand by my earlier statement: the FDA does a darn good job in a virtually no-win business.

Bkeepr
who has no connection with the FDA, but who has studied the pharmaceutical industry


screaminghollow    Posted 12-10-2004 at 20:48:39       [Reply]  [No Email]
It baffles my mind, that something like that got through all the gov't mandated trials and studies. I am also amazed at the fact that there are so many outfits selling those bogus breast enlargement creams and "manhood enlarging pills." They do keep some of the snake oils off the market. Somewhere I used to have a bottle of some ancient patent medicine, Packers coal tar tonic. It was supposed to be good for despair, hair loss, dyspepsea, vapors and who knows what else. I understand it had kerosene and opium.

But come to think of it, deep in the recesses of a little family owned pharmacy, I recently saw a tin of Doan's back pain pills. I bet they have some Carter's little liver pills too!.


hay    Posted 12-11-2004 at 03:25:46       [Reply]  [No Email]
now that you mention some of the older "medicines", do you remember Syrup of Black Draught? some really nasty stuff. i don't even remember what it was suppose to cure.


Cosmo    Posted 12-11-2004 at 04:16:52       [Reply]  [No Email]
Syrup of Black Draught would break a child of the habit of saying he was sick just to get out of going to school. It did me anyhow.:)


DEADCARP    Posted 12-10-2004 at 20:07:39       [Reply]  [No Email]
oh you thought maybe the drug companies were looking out for us? bwahahahaha! you know how long thalidomide has been illegal for deforming babies? what- 40 years? well they still sell it in africa! "where money's involved, we don't let race stand in our way."


Pitch    Posted 12-11-2004 at 02:07:52       [Reply]  [No Email]
Things like that get thru because the FDA is a regulatory agency not a research or investigative agency. They just slog thru research and reports submitted by who/The drug companies and it is not untill years later when the anecdotal evidence from the field starts filtering in that problems are dicoverd.


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