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Dr. Mercola
August 16 2007
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Senior FDA Scientist Removed -- for Voicing Concerns About Avandia

The Food and Drug Administration (FDA) has reportedly removed a senior FDA scientist from work on diabetes drug Avandia because the unnamed scientist voiced concerns about the drug’s safety.

"This new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia," Congressional investigators said in a letter sent to the FDA.

Since 2005, the scientist, a medical officer who was once Avandia’s primary reviewer, believed that Avandia’s risks warranted a strong “black box” warning for its risk of congestive heart failure.

In May 2007, a study in the New England Journal of Medicine found that those taking Avandia had a 43 percent higher chance of having a heart attack.

The scientist was "sidelined after voicing safety concerns," the Congressional letter said, and “was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia.”

The FDA said it did ask for a black box warning for Avandia’s heart risks in June, and an outside advisory panel is meeting to discuss the risks further. The Agency has received the letter, according to FDA spokeswoman Julie Zawisza, and is planning to respond.

Avandia, made by GlaxoSmithKline Plc, brought in more than $3 billion in sales in 2006.

Reuters July 25, 2007


 


Dr. MercolaDr. Mercola's Comments:

The primary reason why this is so tragic is that the drug being manipulated and promoted as a solution for type 2 diabetes is absolutely unnecessary in virtually ALL cases that it is prescribed for. This disease is virtually 100 percent reversible with the appropriate diet and exercise program, as I explained in my video from earlier this year.

Yet the drug companies continue to promote highly profitable drugs for a disease that, in absolutely no way, requires a drug solution. Avandia is starting to resemble the Vioxx (Merck’s painkiller that doubles your risk of a heart attack) catastrophe, as a month after the New England Journal of Medicine revealed that Avandia causes a 43 percent higher risk of heart attack, reports of side effects to federal regulators tripled.

This drug has been on the market for eight years, and studies by the drug’s own maker indicated heart risks before they were exposed by the New England Journal of Medicine study.

At least one FDA scientist also suspected risks well before the study came out, and, not surprisingly, the Agency had him or her removed from their post. The FDA is becoming notorious for protecting the hand that feeds it, at just about any cost -- even the cost of lives lost from taking deadly drugs.

Take the case of Vioxx. After being recalled from the market and causing 55,000 deaths, it was re-approved by, none other than, the FDA. How? Ten of the 32 panel members who voted in favor of Vioxx had blatant ties to the industry.

There is a reason why 80 percent of the FDA’s resources go toward approving new drugs. It’s a classic example of the fox guarding the henhouse.

The FDA will weed out those who are willing to challenge their loyal “customers,” the drug companies. It happened to this FDA medical officer over Avandia; it happened to one of my heroes, Dr. David Graham, over Vioxx, and it’s surely happened to many, many more.

If you would like to voice your opinion about this latest FDA scandal, we were able to uncover contact information for Julie Zawisza, the FDA spokeswoman mentioned in the above article. You can reach her at:

  • Phone: (301) 827 5674 
  • E-mail: julie.zawisza@ocfda.gov
Again, what makes this whole scenario even more maddening is that taking drugs is not the answer to curing type 2 diabetes in the first place. If you are one of the nearly 20 million people in the United States who has type 2 diabetes -- or one of the 45 million with pre-diabetes -- please review How to Finally Make Diabetes Disappear before conceding to taking a potentially dangerous drug like Avandia.

Please spread the word: Type 2 diabetes is not only preventable, it’s curable, if you make some simple lifestyle adjustments.
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Community Comments ( 33 )
 Comment on this Article
  
  
chirocheer
 [ Joined on 08/06 ] [ Posted on July 26, 2007 ]
13 Points        
   
 
Savvy User
NEVER believe the FDA!  I don't believe them about F ood, D rugs, or A nything else, for that matter.

I had to laugh out loud.  The last sentence in the article says, "Glaxo says the drug is as safe as other diabetes medicines."  HA!  That's not saying very much, is it?  Is there such a thing as safe diabetes medicine?

 [ Reply ]
Mercola
  
greentiger
 		[ Joined on 08/07 ]  [ Posted on August 16, 2007]
6 Points        
   
Novice User
  Mercola

I took Mercola's advice and wrote a letter to the FDA (the email address he provided). I thought I'd post it here, and encourage everyone to do the same:

Dear Ms. Zawisza,

I am extremely concerned about the FDA's behavior regarding the recent inquiries into the safety of the diabetes drug Avandia. As you know, this drug, like the Merck's disastrous painkiller Vioxx, can increase the risk of heart attack. And when a senior FDA scientiests working on testing the safety of Avandia voiced concerns about its safety, he was removed. These mafia tactics are chilling.

For many years I had faith and trust in the FDA and its position as defenders of the American public consumer. I lost that faith years ago when again and again I watched the FDA continuously allow dangerous, toxic, and often deadly products bleed into the American market for the simple reason that the powerful drug companies are lining the FDA's pocket.

Enough is enough. Please help restore the American peoples faith in your establishment. I am by no means alone in my belief of the corruption of the FDA. I am an educated, professional, conservative mother and wife, not some hippy flake who latches on to any conspiracy theory that comes my way. I am well read, and can see the blatent unethical and callous activity on the part of pharmecuetical companies for the sake of greed. It breaks my heart that companies can do this to their own people, or any people, but such is the way of the world it seems these days.

I hope that the FDA will choose the right thing to do over the profitable thing to do. There are so few that choose that path. But I guarantee that in doing so, you will not only restore faith in those who are relying on you to keep them safe, but you will also bring back qualities that are sorely lacking in our country. Honesty and integrity. To the FDA. And to yourselves.

Thank you for your time.
  
  
Russ Bianchi
 [ Joined on 09/06 ] [ Posted on July 26, 2007 ]
8 Points        
   
 
Savvy User
GSK - Genocidal Sadistic Kafkaesquers

FDA = Fraud Deceit Always
 [ Reply ]
  
  
annapavlova42
 [ Joined on 02/07 ] [ Posted on July 26, 2007 ]
7 Points        
   
 
Savvy User
As we here in vital votes, realize this article is, most common, and so are the lies and deceit for the same reason $$$.

Thank goodness there are those that are fighting to stop these mass murders.  Unfortunitly, these drugs are and will continue to take there toll.

I really wish I was able to twitch my nose and put an end to all of this.  But in reality, I have not this power. 

But, there are those that are striving to distroy  these nasty minds and reconstruct our world, piece by piece.
 [ Reply ]
Mercola
  
Beeker
 		[ Joined on 05/07 ]  [ Posted on August 16, 2007]
       
   
Novice User
  Mercola

Anna-p. Wishing you were a good witch probably won't do it... We're all in this together. 'Those' people (FDA) are connected to us; and when illness hits one person in the family, it affects the entire family.

We buy big-pharma drugs, buy their shares/stock/bonds (hoping for good returns) and want to see god-like ethics in business (sic). If you look at the mandate of the CEO of any corporation you will see the problem; we're in a capitalistic 'free' economy. We shop for the lowest priced item and expect the highest quality (uuuh, right).

Change comes from within. Real r/evolution in society is being intensely fought at the lowest and highest levels. Each man and woman must look at themselves in the mirror.  Do we want the truth about our bodies and our health, or have others tell us what is right and wrong? We make those decisions moment to moment.
  
  
pinkskittles
 [ Joined on 10/06 ] [ Posted on July 26, 2007 ]
7 Points        
   
 
Savvy User
some people still don't believe in the censorship that exists around food and drugs and why it happens.

more and more evidence like this is important because people still don't get it.
 [ Reply ]
Mercola
  
katieannpc
 		[ Joined on 02/07 ]  [ Posted on July 30, 2007]
       
   
Savvy User
  Mercola
Tina, you got that right! The sad thing is that even if you put it in black and white in front of some people - they still wouldn't believe it. I know too many people who trust their doctors blindly.

 I have been more vocal about my views on health and politics, and people think I'm nuts . They have no clue that they are being poisoned by the very people they trust most and I find that sad.

I wonder how many doctors actually do research on the drugs that are being touted by the reps they see. I bet if they did true research they wouldn't prescribe them!

One more thing, this about vaccines. Does anyone know where to find or how much poison is in the following vaccines?

DTaP (don't know mfger)
DTP - Acell
Polio IPV
Hib Comvax
Hep B
Prevnar

My son had 5 shots at one time at 2 months old - next time they want to shoot my kids up I will be asking them to first shoot the same amount themselves, adjusted for weight of course!

I really do want to know about these. When you are given a prescription for illness as an adult - they can't fight you for not taking it. With vaccines, they try to terrify you. I need to be heavily armed and this is the only place I know to get real information.

Thank you all - and Thank you Dr. Mercola!

Katie
  
  
Katee Roux
 [ Joined on 07/07 ] [ Posted on July 28, 2007 ]
6 Points        
   
 
Savvy User
In college, i learned about the "double blind studies" which are considered "gold standard" by the medical community.  From what was written in my text, i imagined a very scientific, very professional way they must be doing these studies. 

For part of a statistics class, i used the stats given by the drug companies for side effects of 2 SSRIs.  My theory was that, as they are suppose to effect the brain similarly, that their side effects would be similar.  I think i used Wellbutrin & Effexor.  I found the side effects didn't correlate at all.  Then, just to play with my computer program, i put in the numbers from each drug to correlate against their placebos.  They should not have correlated at all, as placebo side effects should be entirely random.  Instead, i found they correlated 100%!!!

This began my distrust of the "gold standard" of the drug companies.  Then, a couple of years later while working in hospital, i observed a drug study done on a psych med with inpatients.  I was appalled as what occurred was nothing like the scientific, professional study described in my college text.  The amount of bias & debate that went on during this "study" was amazing to me.  I've not trusted what drug companies have said since.  It still took me about 10 years (to my shame) to come to the beliefs Dr. Mercola endorses here, however.
 [ Reply ]
  
  
pisces
 [ Joined on 06/06 ] [ Posted on August 17, 2007 ]
4 Points        
   
 
Novice User

This is just another appalling episode in the corruption within our government. As a former Republican for 27 years (I'm now independent) I have watched as both sides of the legislative aisle have destroyed whatever integity this country ever had. Eisenhower had integrity. The next president that had that was Jimmy Carter. Since then, our country has been going into a moral sewer. Our infrastructure (Eisenhower's dream) is falling apart around us and we haven't progressed one step further with our current FDA than when the Bureau of Chemistry was shut down by corporate lobbyists whining about the inconveniences of actually having to produce safe food. Incidentally, Dr. Wiley's scathing Sinclairesque compendium of governmental deceipt and corruption, "The History of a Crime Against the Food Law" was systematically and surreptitiously removed from all bookshelves and libraries. Can't have that truth getting out to the public.

And as if that isn't enough, we now have the Codex Alimentarius, which is about ready to be rammed down everyone's throat, again, in the name of public safety, but driven by corporate greed and a need to control every aspect of your life. As a former staunch Republican, it's difficult to read my own words here and have to come to grips with them, but this fragile house of cards that we have here is in a lot of trouble, my friends, and every time the wind changes, there's always some legislator ready to prop up the illusion again.

As Tommy Lee Jones said to Will Smith in "Men In Black", "There's always an Arquillian Battle Cruiser, or a Corillian Death Ray, or an intergalactic plague that is about to wipe out all life on this miserable little planet, and the only way these people can get on with their happy lives is that they Do... Not... Know about it!

 [ Reply ]
  
  
curious7
 [ Joined on 03/07 ] [ Posted on August 16, 2007 ]
4 Points        
   
 
Apprentice User

We are too silent about this mess in Washington.  We need to be writing to our congressional representatives, and put them in the spotlight so ther can be no excuses such as "I did not know."  Ours is supposed a democracy we are supposed to have free speech, and the right to make a complaint.

That is the way it is supposed to be, reality tell us this is not what really goes on in Washington.  Truth is no one will pay attention, because money speaks louder than truth.  Let us not be fooled, we are in something of a dictatorship.  It is against the law to say how one is healed from this illness or that, unless one says the drugs did it.

If we speak up, they will lock you away, if we remain silent, people will die.  Greed is the title of the day.  I think Hitler would be proud.

 [ Reply ]
  
  
mmc88121
 [ Joined on 11/06 ] [ Posted on July 26, 2007 ]
4 Points        
   
 
Moderator User
What do you expect from an agency that is under the control of the drug companies?

Mary
 [ Reply ]
Mercola
  
katieannpc
 		[ Joined on 02/07 ]  [ Posted on July 30, 2007]
       
   
Savvy User
  Mercola
Lou Dobbs is always shaking his head at the FDA's lack of concern for our food supply. I wrote in that the FDA can't check all the imports because they are too busy in bed with the Pharma companies approving their drugs that we will see some lawyer's ad on tv for!

I bet that one doesn't make it to TV soon. I hope he does investigate the medical stuff - and soon.
  
  
Sheila C
 [ Joined on 12/06 ] [ Posted on July 27, 2007 ]
3 Points        
   
 
Apprentice User
You Americans really need to put in a "whistleblowers" bill to stop this from happening.  This "unnamed scientist" really needs protection as do all persons of this nature.  I bet his life has been a living hell for the last few years.
 [ Reply ]
Mercola
  
Bridestein
 		[ Joined on 12/06 ]  [ Posted on July 27, 2007]
2 Points        
   
Savvy User
  Mercola
Sheila - in fact we've just gotten rid of protection for whistle-blowers - honest! I wish I were joking. Sometimes I feel like the outgoing regime is setting up as much busywork as possible for whoever takes over so there won't be enough time in the next four to eight years to address anything serious or make any big changes.
  
  
"David"
 [ Joined on 08/06 ] [ Posted on July 26, 2007 ]
2 Points        
   
 
Savvy User
....No surprise there then!

Why do people still think that taking any kind of potentially toxic pharmaceutical product, to 'treat' a health problem is going to do anything positive?
 At best it will have no effect on the human organism and usually give you a whole other set of problems that you didn't previously have.

After all, to cover-up a symptom, which is a warning of an underlying problem.....and ignore the cause, is akin to continually sweeping dirt under your carpet.
Eventually ....you end up with one big pile of c... everywhere..... 
 [ Reply ]
  
  
Lloyd Fielder, D.C.
 [ Joined on 06/06 ] [ Posted on July 26, 2007 ]
2 Points        
   
 
Savvy User
Great article for the board.
 [ Reply ]
  
  
etbsndc
 [ Joined on 08/06 ] [ Posted on August 16, 2007 ]
1 Points