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Under Pressure, FDA Reveals Deadly Drug Side Effects

The U.S. Food and Drug Administration (FDA) described the risks of several medications in a new report published in its Drug Safety Newsletter for health care professionals.

The move came after the Institute of Medicine (IOM) sharply criticized the FDA in 2006, saying it has “a dysfunctional structure hindering its ability to protect public health.” The Agency has also been criticized for not monitoring drugs after they’re on the market.

The report, which fills one of the FDA’s commitments to the IOM after the criticism, details the side effects from the following drugs:

  • Rituxan, a cancer drug that has been liked to a potentially fatal central nervous system disorder.

  • Provigil, a narcolepsy drug that has been linked to serious skin reactions.

  • Temodar, a brain cancer medicine that has been linked to fatal aplastic anemia.

  • Exjade, a blood infusion drug. Reports of kidney failure, 115 deaths, and hospitalizations are suspected to be linked to the drug, although the deaths are now listed as “due to the underlying disease.”
Consumer group Public Citizen said the FDA’s quarterly Drug Safety newsletter could be “a real service” if it focuses on emerging drug side effects .

U.S. FDA Drug Safety Newsletter Fall 2007, Volume 1, Number 1 

Reuters September 18, 2007



Dr. Mercola''s Comments Dr. Mercola's Comments:

Last year, the Institute of Medicine released a scathing report against the FDA, pointing out serious problems in the federal system for approving and regulating drugs -- and stating that dramatic changes would be required to fix them. (For details on the major problems in the FDA, check out the video I did on this topic.) 

Now the FDA has thrown a bone to the powers-that-be, that, in my opinion, will do little to change the major corruptions going on.

The FDA’s Drug Safety Newsletter, though it does reveal some (quite serious) drug side effects, is far too little and far too late. It is also banking on the fact that health care professionals, to which the newsletter is geared, will actually read the potential side effects and weigh the risks before prescribing the drugs to any more patients.

Of course, no one knows whether this will happen.

But there is an even bigger issue at play here, and that is the misguided intent to trust the FDA’s opinion about drug safety in the first place.

Folks, the primary purpose of the FDA is to get drugs approved, plain and simple.

This is why 80 percent of their resources are geared toward the approval of new drugs, and 20 percent is left to cover everything else, including drug safety (which gets a measly 5 percent of the FDA’s overall budget).

The drug companies, of course, are paying lobbyists large sums of money for this privilege. They own the largest political lobbying force in the United States and by investing hundreds of millions of dollars they can receive billions of dollars in return. The problem is that someone pays for this and that would be the U.S. taxpayer.

When the Prescription Drug User Fee Act came into play in 1992, the drug companies actually started to fund the FDA. In short, with this Act the drug companies began paying money to the FDA so it would review and approve their drugs.

Talk about conflict of interest!

Not to mention the fact that a study published in the Journal of the American Medical Association in 2006 found that conflicts of interest among U.S. FDA drug advisory committee members are common, and also that there is a statistically significant link between such conflicts and voting behavior.

So, please, don't count on the FDA to protect your health. You need to take responsibility for your own health and stop relying on drugs as band-aids to treat your symptoms.

Instead, nip the causes of illness in the bud by taking control of your lifestyle and:
  • Radically cutting back on the nearly 200 pounds of sugar you likely eat each year
  • Not spending 90 percent of your food budget on processed foods
  • Starting to exercise four to five times a week
  • Realizing that your emotional health is a crucial aspect of your overall well-being


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Comment on This Article Community Comments (32)
 
 
Posted On Sep 20, 2007
"IOM concluded the FDA has a "dysfunctional" structure hindering its ability to protect public health".  Need more be said?

 
Patty D
Savvy User Savvy User, Joined On 6/2007
Patty D  
Replied

Katee Roux
Savvy User Savvy User Joined On 7/2007
Katee Roux  
 
Posted On Sep 20, 2007
I copied the same quote to use, Patty.

Is this the understatement of the year, or what?


KathieJamisonCote
Savvy User Savvy User Joined On 4/2007
KathieJamisonCote  
 
Posted On Sep 21, 2007
Excellent quote Patty D!  For the sake of helping put the FDA where it rightfully belongs, I would like to borrow it.

But, my problem is the Institute of Medicine - the most highly regarded medical group out there - (well, I don't hold them in very high esteem as they lie and twist the vaccination information that goes out to the doctors, so that 8-10 of the board members can continue to get the Big Pharma Pay-offs!!!)

.........But to have them knock the FDA - steps in the right direction.  I don't care who knocks who in the huge lying, for-profit-only-matters, dispicably-run-organizations as they all ought to be knocked down!

 
 
 
Posted On Sep 20, 2007
 Dr. Marcia Angell, MD and former editor and chief of the New England Journal of Medicine, remains correct in her many conclusions in her book: 'The Truth About the Drug Companies: How they Deceive Us And What To Do About It' (2006), a pivotal, salient, cogent and must read, treatise, for all Mercolians, in my humble opinion.

Once again, this posted article demonstrates beyond any spin or conjecture to the contrary, how overtly broken, and corrupt, the FDA currently is to it's core.

If it were not for individual great American Heros, like Dr. David Graham, battling the overwhelming forces of darkness at FDA, I'd say all might be lost, however, there remains the 'law of unintended consequences' in play here.

The internet, a government internal project to improve general communication among governmental agencies, is now one catalyst, through sites like Vital Votes, to expose the overt corruption at FDA, and indeed to force positive, proactive, preventative, low cost, health protocols, than sainted Dr. Marcia Angell speaks about in her book.

To YOUR Good Health!

Uncle Russ

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

KathieJamisonCote
Savvy User Savvy User Joined On 4/2007
KathieJamisonCote  
 
Posted On Sep 20, 2007
Well Said Uncle Russ! 
In my book, the FDA should be under a lot more pressure than it is!
The FDA should be run like Comsumer Reports - no advertising, no special interest groups, no buddies who pad pockets..........


Health Freedom
Savvy User Savvy User Joined On 11/2006
Health Freedom  
 
Posted On Sep 20, 2007
KathieJamisonCote, you are correct that the FDA should be run like Consumer Reports, without conflicts of interest.  However, it never will be, as it is a typical government agency, unaccountable to the people for the mission for which it was ostensibly set up.

We need private firms, similar to Consumer's Union and Underwriters Laboratories, to provide sound advice and/or certifications for which foods, drugs, and treatments are beneficial and which ones are detrimental.  Abolish the FDA and allow the free market to compete and and the firms which serve consumers successfully will earn a good reputation and thrive.  Monopolistic, regulatory behemoths will only continue to disappoint, no matter how much they are "reformed" or even if they have a few heroic bureaucrats like Dr. Graham.  They are doomed to fail, by their very nature.

 
 
 
Posted On Sep 21, 2007
THE FDA NEEDS TO BE ABOLISHED!!!!!!!!!!!!

 
BeyondOrganic
Savvy User Savvy User, Joined On 6/2006
BeyondOrganic  
Replied

4maf
Apprentice User Apprentice User Joined On 6/2006
4maf  
 
Posted On Oct 11, 2007

Hurray for our side.  I surely agree, they scare me.


 
 
 
Posted On Sep 20, 2007
The newsletter is to be published quarterly or 4 times a year.  How many people will be adversely affected by dangerous drugs in the time between publication of the newsletters.

Mary

 
mmc88121
Moderator User Moderator User, Joined On 11/2006
mmc88121  
Replied

Katee Roux
Savvy User Savvy User Joined On 7/2007
Katee Roux  
 
Posted On Sep 20, 2007
But it's a start, isn't it?  Especially if it is able to be unbiased.

So much of what is available, especially to the docs, is so biased that they can't make an informed decision on what is safe.  (If any drug could be said to be safe.)

 
 
 
Posted On Sep 20, 2007
Great,.... so now maybe we could keep the pressure on to force a reformation and clean up of what has essentially become another sold out government agency.  .....and while we're at it, why not enforce a clean up of the rest of the federal government here in the USA. .... As Bill Moyers stated on the Charlie Rose show on PBS,... the night before the last presidential election;  "Our present government in Washington has become a cover for corruption."

 
shiva
Savvy User Savvy User, Joined On 10/2006
shiva  
 
 
 
 
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