FDA Panel Says Painkiller Vioxx Should Stay on Market
Merck Would Consider Selling Vioxx Again If Approved
By RANDOLPH E. SCHMID, AP

The painkiller review was set up after Merck & Co. pulled Vioxx from the market last fall because of health concerns.


WASHINGTON (Feb. 18) - The popular painkillers Celebrex, Bextra and Vioxx all pose a risk of heart trouble, but should be available to those who need them, advisers to the Food and Drug Administration said Friday.

The panel strongly favored keeping Celebrex on the market, split over Bextra and favored Vioxx - which is currently not on sale - by a vote of just 17-16.

"The data is very compelling," Vioxx is substantially worse than the others, meeting chairman Alistair J.J. Wood of Vanderbilt University School of Medicine said.

The panelists voted 31-1 to keep Celebrex on sale and, after a revote, favored Bextra 17-13 with two abstaining.

The FDA is not required to follow the recommendations of the panel, but generally does so.

At the opening of the three-day meeting, FDA officials promised a prompt response to the panel's suggestions, which it requested after studies began showing problems with the drugs.

The panelists were unanimous in saying the drugs, known as Cox-2 inhibitors, pose risks of heart trouble. Studies of Bextra were limited, but showed a greater risk than Celebrex, the committee noted.

The advisers suggested restrictions on the drugs such as placing a severe "black box" warning on them, including more patient information with the drugs, restricting which patients could get the drugs and possibly banning direct-to-consumer advertising for the products.

Meeting Chairman Alistair J.J. Wood of Vanderbilt University Medical School said it is important to find some way to help the public better understand the nature of risk.

"People worry about crime and then drive drunk," he said, indicating they don't really understand relative risks.

Dr. Steven Nissen, medical director of the heart center at the Cleveland Clinic said "What we really want is to make sure it's available for patients that need it and is unavailable to patients who whom it's inappropriate."

The FDA's arthritis and drug safety advisory committees, concluding three days of meetings to assess the risks of three popular painkillers called Cox-2 inhibitors, were to address Vioxx and Bextra later in the day. All three drugs have been approved for sale by the government.

The advisers also were set to frame recommendations to the FDA about whether further testing is needed for the drugs and any special warnings or limits placed on them.

"We need to find the unique patients that will benefit from this drug and work out what they need to be told," said Wood.

The committees were asked to assess the drugs after Merck & Co. pulled Vioxx from the market last fall because of health concerns. Since then questions have been raised about Bextra and Celebrex, both made by Pfizer Inc.

The excess risk from Celebrex varied in different studies and the panel didn't seek to determine just how much more hazard a user faces than someone on another drug.

However, the panel was told that no cardiovascular problems were seen at the normal prescription dose of 200 milligrams. Heart trouble began to appear in colon polyp study patients who took 400 milligrams.

Merck stock shot up nearly 12 percent in the minutes following the announcement, increasing $3.35 to $32.20 per share in afternoon trading on the New York Stock Exchange. Pfizer shares rose $1.39, or 5.6 percent, to $26.45 on the NYSE.

Earlier in the meeting, Wood said the safety problems reported in connection with Cox-2 inhibitors exceed those of products that have been withdrawn from the market.

However, since the side effect involving heart attacks, irregular heartbeat and stroke is a relatively common problem, that makes it harder to pin it to the drugs than if it were a rare side effect.

Dr. Peter S. Kim, president of Merck Research Laboratories, had told the FDA committees earlier that new studies indicated the side effects aren't unique to its product.

"There are unique benefits to Vioxx," he said. "The science has progressed and we need to take that science into consideration."

While the committees heard evidence that all drugs in the group can increase the risk of heart attacks, irregular heart beat and strokes, it noted that Vioxx seemed to have more such reports than the other drugs.

On the other hand, Kim said, Vioxx is the only one of the drugs approved for people with certain allergies and did better at preventing the stomach and intestinal problems often caused by over-the-counter painkillers.

Dr. Robert Temple, director of medical policy for the FDA's Center for Drug Evaluation and Research, told the committees on Friday that "the idea of doing a large new study has weight."

"There are some data we'd all like to have, that we don't have," Temple said, including the blood pressure and other effects of the various drugs.

He said a new study might include more than just the Cox-2 drugs, possibly adding such widely used painkillers as ibuprofen, naproxen and diclofenac.

"My main point is that there is a very important need for more information on many of these drugs," Temple said.

02-18-05 17:23 EST

there is a book out called "natural cures and what the FDA doesn't want you to know" .
i haven't read it, (a friend did) , but i've seen it on an infra-mercial a few months back. the author was on, and he was explaining how the FDA will NOT allow ANY natural remedies such as , st. johns wort, vitamin e, zinc, COq10 etc, to be labeled as "treatment, cure, prevention" on there bottles, even though THEY WORK BETTER THAN MEDICATION...
in the book, the author lists 100's of diseases that can be prevented and cured by simple herbs, and vitamins, and the FDA will NOT allow it..there are NATURAL cures for certain cancers,diabetes, stroke, alzhiemers,.
there's also proof that the FDA puts addicting substances in the foods we eat, so we OVER WIEGHT AMERICANS can buy more food, and more diet pills...there are chemicals the fda use that actually make you gain weight, and crave more of the BAD STUFF, keeping med's like lipitor, and provocol on the market for BIG $$$$...and tons and tons of other info.

how many of you truly trust the FDA ?

Dude, about as much as I trust the guy that wrote that book, ahfasdhfhasdhfasfh
He's been banned from all infomercials because of false claims.

HAHAHA WHO BANNED HIM? THE FDA????????? LOL

MEANWHILE, BAYER IS PAYING OUT HOW MUCH IN LAW SUITS FOR "BEYCOL"...AND OTHER DRUG RELATED SUITS...
THERE'S MORE BOOKS ON NATURAL REMEDIES THAT ARE TRUE, AND WORK JUST AS GOOD AS SOME DRUGS....

THE REASON HE WAS BANNED, IS "HE KNEW AND SAID TOO MUCH".....

The FDA's main interest is helping the phamaceuticals make huge profits.

I don't trust the FDA at all. I feel as though we've all been used as guinea pigs for the drug companies and this has to stop. I have taken both vioxx and celebrex and now I have to worry about what it might have done to my heart. It's just not right. No more drugs for me! I'd rather put up with the pain than worry about what's happening to my heart and other vital organs every time I swallow a pill.

ILMD I did the same and sit here today wondering.I do not trust the FDA with anything. Herb you are 100% correct. Our government won't recommend us buying drugs from Canada at a cheaper price because they can not guarentee the safety of it. What a joke, the FDA can not guarentee the safety of the drugs they approve.

Norie, it is a joke and totally ridiculous. Can't be poisoned with cheap drugs from Canada...have to spend big bux to be poisoned by expensive American drugs. How crazy is that!

IT'S AMAZING HOW LONG IT TAKES TO GET A DRUG APPROVED IN THIS COUNTRY...MANY YEARS..

AND PAULA I'M WITH YOU , A DRUG LIKE LIPITOR WILL DEFENITELY LOWER YOUR CHOLESTEROL, SO YOU CAN DIE OF LIVER FAILURE INSTEAD...

You have to be careful with the natural and herbal remedies too. Some are OK, but some are just as dangerous as the regular drugs.

If they are putting Vioxx, Celebrex, etc. back on the market again, who is going to take them after knowing what has been said about them? I wouldn't.

quote:

Originally posted by Mimi:
[qb]You have to be careful with the natural and herbal remedies too. Some are OK, but some are just as dangerous as the regular drugs.

If they are putting Vioxx, Celebrex, etc. back on the market again, who is going to take them after knowing what has been said about them? I wouldn't.[/qb]

Mimi, the people that are crippled from arthritis will continue to take them. They are the people that lobbied to get these meds back on the market.
Just like Paula feels it's worth the risk to NOT take a drug, these people are in so much pain that the ARE willing to take the chance. These drugs made it possible for them to live a normal life, relatively pain free.
And what you said about natural meds is so true. Most of us hear "natural" and think that there is nothing in them that can harm us, when the fact is that many of these herbs are toxic, and one pill too many can kill you. Some, taken in combination with another or and FDA approved drug, can cancel each other out, or can put your life, or the life of an unborn child, in danger. Many pharmaceuticals are dirivatives of herbs and flowers. If anyone feels that natural treatments are the way to go, they must do research and be very very careful. There are just as many adverse reactions to natural remedies.

quote:

Originally posted by BelmontGirl:
[qb]Well, all I can say is the pharmaceutical industry has been so greedy and dishonest, they deserve a kick in their ass, and profits.[/qb]

It's the greed that gets me. I know that this point has been discussed in a previous post, but if they can sell the same meds to other countries at reduced cost, why are WE being extorted? Maybe the RICO act should apply to the drug companies too, lol.

Oh, I agree.
I have always thought it ridiculous that alcohol and cigarettes are are legal and pot isn't.

I see the liberals here are running aound unchallenged..well....that is over...I trust the FDA. And pot should stay illegal.

Mikey, why do you trust the FDA? Their track record is spotty at best.

If I was looking for a doctor, I certainly wouldn't pick one who lost 25% of his patients. I believe that is the percentage of FDA approved drugs recalled over the past 15 years.

The keystone kop is back, spreading FDA approved fertilizer. You may all man your shovels.

Hey Paula..give it a rest... who the hell do you think you are to analyze me...and don't speak for me as to what I believe.

And Bubby go f--- yourself !

quote:

Originally posted by MikeyD:
[qb]I see the liberals here are running aound unchallenged..well....that is over...I trust the FDA. And pot should stay illegal.[/qb]

I am a Republican, and alcohol should be illegal too, as I have seen it alone ruin more lives than pot alone ever will. For every pothead that picked up a joint, the first thing they picked up was a beer. So,if it's true that one thing leads to another, it stands to reason that alcohol is the first in the chain.

maybe the FDA should stop creating "diseases" to PUSH THEIR DRUGS... who ever heard of acid reflux 20 yrs ago??? it was always called "AGIDA" LOL , everybody had it, and everybody dealt w/ it, we changed out diets... now all of a sudden, we need a DRUG for it???
every kid is on ritalin and paxil, ...soon as we feel stressed we all run for anxiety medications...wer'e turning into OVER WEIGHT, DRUG ADDICTED, I-CAN'T-TAKE-LIFE ,WEAK AMERICANS...
OUR GRANDPARENTS WERE TOUGHER THAN NAILS, AND LIVED TO RIPE OLD AGES....