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Nothing Has Changed at the FDA Since the Vioxx Debacle

If the headline above startles you, it should, considering those were the very same sentiments voiced yesterday by Dr. David Graham to the House Subcommittee on Oversight and Investigations, investigating the FDA's seeming inability to approve newer, safer drugs and provide better post-marketing monitoring.

The meeting came one day after the FDA finally announced major labeling changes to Ketek, a deadly antibiotic whose very debatable safety is defended as legitimate by Sanofi-Aventis, even though one often-cited study includes fabricated data. Now, Ketek is only approved to treat pneumonia, and not bronchitis or sinus problems.

By the way, one doctor who once worked for the FDA's Center for Drug Evaluation and Research (CDER) told the panel he had warned the agency about the life-threatening effects of Ketek to a patient's liver but his superiors had forced him to tone down his criticisms, prior to the drug's approval.

Unfortunately, the agency's Center for Drug Evaluation and Research (CDER) still treats the pharmaceutical industry as if it were the FDA's main client, Graham says. So there's no more reason today than two years ago to believe the FDA will ever get drug safety right.

Your best and safest bet: Taking ownership of your own health.

USA Today February 13, 2007

USA Today February 12, 2007





 
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Comment on This Article Community Comments (8)
 
 
Posted On May 06, 2007
This post was deleted because it violated our Terms Of Use :
Comment does not pertain to the topic of the article or does not provide value or insight to the discussion. Submit stories or comments linking to affiliate programs, multi-level marketing schemes, or off-topic content or any other system that will result in your personal financial or commercial gain.

 
Katy B
Savvy User Savvy User, Joined On 3/2007
Katy B  
Replied

Reesacat
Savvy User Savvy User Joined On 1/2007
Reesacat  
 
Posted On May 06, 2007
My brother-in-law was one of the 140,000 who had heart attacks.
It came out of the blue with no warning-he was 45, non-smoker.

He thought he was having a bad astma attack, went to
his GP, and next thing was in the hospital getting 2 stents and on ICU
for several days.  He had been on Vioxx for several months prior to
having the heart attack.  We were really puzzled and then the news
about Vioxx came out almost a year later.

 
 
 
Posted On Feb 14, 2007
I agree that the FDA is corrupt, however, they are not entirely to blame. Unfortunately people are flat out lazy. They do not want to do the legwork to take care of themselves. Most people know that their health is linked to their diet, but they want a quick fix...they want a pill! The FDA has made people believe that they are looking out for their best interest, but if people would just look around and take an inventory of our countries health, they might start doing a little research themselves. This is a big problem and I am glad this Dr. and others are questioning the FDA publicly, maybe this will get others to use their brains!

 
Leesh
Apprentice User Apprentice User, Joined On 9/2006
Leesh  
Replied

Russ Bianchi
Savvy User Savvy User Joined On 9/2006
Russ Bianchi  
 
Posted On Feb 14, 2007
I too agree with your comments on bureaucratic laziness, but as to OUTED corrupt entities (FDA or Big Pharma) changing their ways and suddenly becoming accountable for thousands of ANNUAL deaths, short of criminal prosecution, and FRAUD laws piercing corporate shields, with officers or officials doing hard time, as examples (alla ENRON)...don't bet on it.


LindaC528
Novice User Novice User Joined On 2/2008
LindaC528  
 
Posted On May 17, 2008
Right you are, that people are flat out lazy!  I am a product of the 1960s and '70s, and what I can't figure out is, WHERE IS THE OUTRAGE?

Back then, even a whiff of something as outlandish as Codex, as not having the right to purchase vitamins and health supplements, would have sent thousands streaming to their local gov't offices in protest.  There would be "sit-ins," angry crowds, people demonstrating with signs. You don't see this anymore, not even on college campuses!  OR are such things taking place, and our corrupt media is just not covering it?  After all, half of THEIR income comes from Big Pharma spots!  

What is WRONG with us?  Are we getting something more than just flouride in our drinking water that is making us complacent?  Are we still in a stupor of fear, post 9/11?  Have we forgotten how to organize on a local basis?  My concern is that the moral outrage that used to be expressed in concentrated groups is now scattered all across the Internet, in boards such as this.   Posting to such boards is great, but HOW can we make the Powers That Be sit up and take notice until something is DONE about Big Pharma and the FDA?  

 
 
 
Posted On Feb 14, 2007
 Nothing has changed at the Fda and nothing will. Not only are there so many conflicts of interest that it is impossible to get an objective analysis of the drugs they evaulate. The whole system is based on a flawed assumption . That by treating markers of disease you improve outcomes. Many drugs that where consider to be mainstays are show to be ineffective. The most widely prescibed beta blocker atenolol is show to be much less effective at preventing stokes and heart attracts then was assumed. the british medical journal states that only about 15% of the treatments doctors use really have good proof behind them.Most Doctors marginalize the basics Good diet , exercise, adequate omega 3 s ect .Some times I wonder how many deaths where caused by our irrational fear of sunlight.

 
vince_203
Apprentice User Apprentice User, Joined On 9/2006
vince_203  
 
 
 
Posted On Feb 14, 2007
I agree the FDA is corrupt, and most people chose to listen to the comments from their doctor that natural cures are not scientificlly proven to work and are no more than old wives tales.  Many people are waking up to the fact that their doctors are not GOD or even godlike, but are as only as good as they want to be.

mmc88121

 
mmc88121
Moderator User Moderator User, Joined On 11/2006
mmc88121  
 
 
 
Posted On Feb 14, 2007
Dr. David Graham is to be applauded as a true AMERICAN HERO in continuing to expose corruption so insipid, deep, and population HARMING, if not fatal in hundred and thousands of cases per year, by Big Pharma, and at FDA, it is indeed CRIMINAL, and the RICO Act with a Special Prosecutor should be appointed to go after these serial MURDERERS.

 
Russ Bianchi
Savvy User Savvy User, Joined On 9/2006
Russ Bianchi  
 
 
 
 
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