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FDA Breaks its Own Rules in Considering Merck Painkiller

An FDA advisory panel is meeting to review the arthritis medication Arcoxia and vote on whether it is safe and effective.

However, the panel includes three doctors with financial ties to the drug industry, even though it is meeting less than a month after the FDA proposed a stricter conflict-of-interest policy for outside experts.

The panel is not bound by the tougher rules because they have not been officially adopted yet, but many have criticized the FDA's actions and say that the rules should have been followed anyway.

Arcoxia, a medication developed by Merck as a replacement for the withdrawn and discredited Vioxx, may be just as risky for your heart as the older drug. Concerns about cardiovascular safety forced Merck to stop selling Vioxx in September 2004.

Arcoxia has been marketed as a safer compound, but critics point out that Merck's largest trial of Arcoxia simply showed that it has the same heart risks as a drug called diclofenac. Some research indicates that diclofenac may be as risky to the heart as the lower marketed dose of Vioxx.

Drug trials comparing Arcoxia with naproxen found a 60 percent to 70 percent higher risk of cardiovascular events with Arcoxia.

Los Angeles Times April 12, 2007

USA Today April 9, 2007


Dr. Mercola's Comment:

You might remember that this is history repeating itself as two years ago  Vioxx was reapproved by the FDA advisory committe that was loaded with panel members with drug company ties. It should become obvious to you by now that massive conflict of interest is the rule, not the exception, at the FDA.

Now pressure has been mounting at the FDA to reconsider Arcoxia, based on growing concerns by some medical experts who have dubbed it the son of Vioxx.

But in one more case of stacking the deck in favor of the drug company cartel, the FDA has allowed doctors with conflicts of interest to serve on the advisory committee, something expressly forbidden in new rules levied by the agency itself.

Although these rules are not technically in effect yet, this move demonstrates the agency's insincerity in passing them in the first place. This shows, once again, how the agency still protects the industry it regulates.

It's also somewhat ironic that it was the massive conflicts of interest involved in an advisory committee's voting on Vioxx, Bextra and Celebrex more than two years ago that led to these new rules being proposed in the first place. So far, at least, little has apparently changed, and you shouldn't lower your guard one tiny bit when it comes to trusting the purported safety of a drug.

Another reminder, you don't need a toxic drug to treat your pain when there are many alternatives that are just as effective and safer for your health.

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Article's Comment     ( 18 Comments )
 
 
 +43 Points           
 
Author of the Article
BY Mercola Fan   
  
[ Joined on 11/06 ]
[ Posted on April 12, 2007 ]
Post Reply
ALERT!!

The FDA is getting ready to vote on a proposal that will ban health supplements. Even herb gardens and raw juice will be classified as a drug.

The FDA will decide whether herbs, supplements, vitamins or simple devices like massage stones are to be regulated as drugs and medical devices. If the FDA experts decide that these things are to be reclassified they will be regulated out of existence.
 

Read Full Article at Health Freedom Action Alert
Then, go to the link for the FDA comments and let the FDA know that you do not want this regulation to go into effect. Be specific and explain why you think this regulation is ridiculous.
Only with public outrage will the FDA back down on this crazy regulation.
 
 

 +17 Points           
 
Author of the Article
BY Dr. Mercola   
  
[ Joined on 12/97 ]
Author of the Article [ Posted on April 12, 2007 ]
 
I had my FDA attorney at one of largest firms in Washington DC review this and he is not at all convinced that this is a real issue.  His comments:

The bill refers to compounding pharmacies and is being pushed by the pharmaceutical companies.  The pharma companies are concerned that there is a lot of illegal compounding of its prescription drugs going on in the marketplace.  The bill actually is unnecessary because FDA has the authority to pursue compounding pharmacies that are producing unapproved new drugs but the agency does not have the resources to pursue these pharmacies and have generally left it to the individual state pharmacy boards to enforce. 


The proposed law would most definitely clarify FDA's jurisdiction but I am not sure if it will have much of a practical effect because of a resources issue.  As you know, Congress likes to pass laws but does not always provide the additional funding necessary to enforce it.
 
I have some mix feelings about publicly making a lot of hay of this issue.  One is that FDA, in reality, already has jurisdiction over this issue if it so chooses to use it, thereby, it would call unnecessary attention to pharmacies that are compounding natural hormone products. 


 +9 Points           
 
Author of the Article
BY Christopher Gussa "The Herb Doc"   
  
[ Joined on 11/06 ]
Author of the Article [ Posted on April 12, 2007 ]
 
 

Ho-Hum No need to panic.

The FDA has tried this same maneuver many many times.

We have never been as prepared to kill it as we have this time anyway.

It’s dead!

Not that we don’t need to watch as they are criminals, but have a little faith please!

I say let’s get the war started if it comes down to something like that. I am talking about clubs, torches, and pitchforks! And it would happen or this is not the USA!


 +5 Points           
 
Author of the Article
BY PepperR23   
  
[ Joined on 06/06 ]
Author of the Article [ Posted on April 12, 2007 ]
 
Mercola FAN, I sent my enraged comment to the FDA today!  I feel that all the wonderful strides that many of us have made in finding natural cures that really work, instead of years of medications that rob us of our quality of life, are about to be sabatoged by our government officials in the quise of protecting us.  Dr Mercola is to be congratulated!  He is making an impact and the powers that be are trying to bring down his work and the work of others like him.

 +5 Points           
 
Author of the Article
BY LM36   
  
[ Joined on 12/06 ]
Author of the Article [ Posted on April 12, 2007 ]
 
Thanks for bringing up the topic Mercola FAN.  I am not sure why Dr. Mercola has not posted anything yet regarding Docket #2006D-0480 Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.  I also read www.newstarget.com and they are all over this subject!  I have already sent my comments to the FDA and encourage all Mercolans to do so.  Our pursuit of health is in jeopardy if something like this gets approved by Congress.  For the time being we should be focusing on the war that is in front of us, namely vitamins, supplements and herbs being regulated by the FDA.  We do not need the corrupt FDA taking control over health promoting products including everything from massage oils to Vitamin C.  This government agency obviously has enough problems trying to regulate the pharmaceutical industry!  Forget about Vioxx and Celebrex for the moment and concentrate on how this Docket might impact our health movement.