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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Arcoxia, a medication developed by Merck as a replacement for the withdrawn and discredited Vioxx, may be just as risky for your heart as the older drug.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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Comment on This Article Community Comments (17)
 
 
Posted On Apr 12, 2007
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.
 

 
Mercola Fan
Apprentice User Apprentice User, Joined On 11/2006
Mercola Fan  
Replied

The Herb Doc
Apprentice User Apprentice User Joined On 11/2006
The Herb Doc  
 
Posted On Apr 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!



PepperR23
Savvy User Savvy User Joined On 6/2006
PepperR23  
 
Posted On Apr 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.


Dr. Mercola
Master User Master User Joined On 12/1997
Dr. Mercola  
 
Posted On Apr 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. 



Bill McDougald
Novice User Novice User Joined On 1/2007
Bill McDougald  
 
Posted On Apr 28, 2007
I would suggest that everyone should go to nomorefakenews.com and read the past newsletters going back to the year 2000. I understand that a new drug will be coming out shortly that will make us happy and satisfied no matter what is happening around us. The first stage is the series of anti-depressant drugs. The elites want to have us willingly sign over everything we own to them as they don't believe we deserve to own anything. We need to know how this drug will be delivered to us. Perhaps in the water, even bottled water or perhaps in the food supply. Canada is ususally the testing ground for these things and so this will likely come to Canada first. Notice that Canada had the gun registration law for the purpose of knowing who had the guns so they would know how many police to bring with them when they come to have us sign over our property to them.

 
 
 
Posted On Apr 12, 2007
OK, how about Homeland Security bringing Al Queda in, as consultants and experts, to determine if measures implemented since 9-11 are enough to stop future terrorists attacks?

Or perhaps, DEA and the US Coast Guard, should allow the Columbian Drug Cartels to determine what level of cocaine can and should be shipped into the US, to slow down total use on the streets?

Here's one....it's time for the Alcohol, Tobacco and Firearms folks to expand these tax revenue generating markets, to balance future Federal BLOATED Budgets, and the biggest growth opportunity is among non users in rest homes and elementary schools.

Since Nancy Pelosi is now running foreign policy through Damascus and the Syrian Baathist Party, she should put these Dictatorial Despot THUGS in charge of all Federal Civil Liberty Cases here in America.

"Fox in the Hen House"? 

The chickens long ago were declared "SAFE" by CDC, FDA, WHO, & the UN because they got their Bird Flu Vaccines....

Arrrrgh....






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

The Herb Doc
Apprentice User Apprentice User Joined On 11/2006
The Herb Doc  
 
Posted On Apr 12, 2007
Go Russ!
I am becoming a fan!


A.Butler
Apprentice User Apprentice User Joined On 11/2006
A.Butler  
 
Posted On Apr 12, 2007
Darn Kafkaesquers!!!!!


Russ Bianchi
Savvy User Savvy User Joined On 9/2006
Russ Bianchi  
 
Posted On Apr 12, 2007
Yes, MERCK, Mostly Evil Researchers, Crooks & Kafkaesquers

Merck no doubt remains a proud primary research sponsor of What'sMadaU; Boris Badinoff and Natasha Fatale's Alma Mater...

But don't worry, Mr. Peabody and his boy Sherman, will save Rocky the Flying Squirrel and Bullwinkle Moose in the next exciting episode of:

'For A Few Million$ More'  OR  'Forget The Good, Probably The Bad, But Most Likely The Ugly'.... 



Dr. David Spitz
Apprentice User Apprentice User Joined On 12/2006
Dr. David Spitz  
 
Posted On Apr 14, 2007
Russ, you've said it perfectly. Nothing to add.


Lukane
Apprentice User Apprentice User Joined On 4/2007
Lukane  
 
Posted On Apr 26, 2007
Contract Commandos.  It may not be far away that we have 6 government and law enforcement officers to one working smuck.  Especially if they bring in Chinese, Russian or Middle East trained contractors for private policing like in Iraq.  The FDA Dept of Agriculture could bust anything from Palates sessions to the easter egg hunt.


Witch Doctor
Apprentice User Apprentice User Joined On 9/2006
Witch Doctor  
 
Posted On Apr 27, 2007
Lukane - maybe so if the ones that want to take away our firearms stay in power.

 
 
 
Posted On Apr 12, 2007
The FDA just rejected the application 20-1, and apparently they were unusually harsh in their criticism of Merck according to the story in today's NY Times.
2,300 people just got a reprieve and don't even know it!

 
Bridestein
Savvy User Savvy User, Joined On 12/2006
Bridestein  
Replied

Russ Bianchi
Savvy User Savvy User Joined On 9/2006
Russ Bianchi  
 
Posted On Apr 13, 2007
Well, that was mighty benevolent of an organization who generally can't tell whether it's dark, or if their collective heads are up their collective posterior orifices.
 
But I'm sure they are working on a new prescription drug for that very condition also...   ;-)

Who was the ONE voting in favor of MERCK? 

A NY Times article posted online regarding the vote, late last night (4/12/07, but then taken off line within an hour, and changed around, no doubt after idle lawyer threats) would seem to indicate the sole dissenter's name.

No doubt this Dr. should be the first human trial candidate for CPOS (Collective Posterior Orifice Syndrome) and should be hailed in the annuals of western medicine as a martyr for his DARK cause.

 
 
 
Posted On Apr 12, 2007
They've just let the fox in to the hen house to determine if the hen's should be fed to the foxes or allowed to live.



 
Dr. David Spitz
Apprentice User Apprentice User, Joined On 12/2006
Dr. David Spitz  
 
 
 
Posted On Apr 12, 2007
 

Thank you Dr. Mercola for pointing this out! We must change the face of medicine and quickly!

It is a real shame that in our medical system we can’t at least “borrow” some of the wisdom of the Chinese in formulating so many safe and health promoting formulas for the pains (and healing at the same time) of arthritis and other complications.

As a working Clinical / TCM Herbalist I saw people every day with serious arthritis. It broke my heart to see the pain and suffering these mostly older people were putting up with and still smiling!

Many were suffering with not only arthritis, but with complications from steroids that were the arthritis protocol from there doctors. I tried many things and these two arthritis treatments have had very good results.

There are many other common household things that can help. One of my favorites is Ginger! Externally (as a hand , foot, or full bath) or internally in capsules.


 
The Herb Doc
Apprentice User Apprentice User, Joined On 11/2006
The Herb Doc  
 
 
 
 
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