Posted on 11/18/2004 1:39:13 PM PST by Tarantulas
WASHINGTON (Reuters) - The U.S. Food and Drug Administration (news - web sites) failed the public in its oversight of Merck & Co Inc.'s (NYSE:MRK - news) withdrawn painkiller Vioxx and is "incapable of protecting America" from another dangerous drug, an agency researcher told Congress on Thursday.
David Graham, an FDA (news - web sites) scientist who had warned about the heart risks of Vioxx, called the FDA's actions "a profound regulatory failure."
Concerns about a possible link between Vioxx and heart problems were building during the drug's more than four years on the market. The FDA required a warning about heart risks but felt the drug's benefits made it worth keeping on the market.
Merck Chief Executive Raymond Gilmartin said the company had believed wholeheartedly in Vioxx and had followed a rigorous scientific procedure every step of the way.
"In fact, my wife was taking Vioxx, using Vioxx, up until the day we withdrew it from the market," Gilmartin told the Senate Finance Committee.
Merck withdrew Vioxx, which was taken by millions of Americans, on Sept. 30 after a study showed the drug doubled heart attack and stroke risk.
"I would argue the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenseless," said Graham, associate director for science in the FDA's Office of Drug Safety.
Committee Chairman Charles Grassley, an Iowa Republican, said he was concerned the FDA had a "far too cozy" relationship with drug companies and suggested an independent office of drug safety might be needed.
Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said the agency "worked actively and vigorously with Merck to inform public health professionals of what was known regarding (cardiovascular risk) with Vioxx and to pursue further definitive investigations."
Kweder also declined to fault Merck: "I believe that Merck acted responsibly once the problem was recognized."
Graham told the committee he felt pressured by supervisors to water down his findings from a study of patient insurance records that Vioxx users had a 50 percent greater chance of heart attack and sudden cardiac death than people who took Pfizer Inc.'s (NYSE:PFE - news) rival medicine Celebrex.
Graham named five medicines currently on the market that he believes need closer scrutiny for safety: Abbott Laboratories Inc.'s (NYSE:ABT - news) weight-loss drug Meridia, AstraZeneca Plc's (AZN.L) cholesterol-lowering drug Crestor, Pfizer Inc.'s (PFE.N) painkiller Bextra, Roche's (ROG.VX) acne drug Accutane, and GlaxoSmithKline Plc's (GSK.L) asthma drug Serevent.
Kweder disagreed. "I do not have reason to believe that set of five drugs is specifically more concerning," she said.
In a statement on Wednesday, acting FDA Commissioner Lester Crawford said Graham had violated long-standing procedures for publishing scientific findings when he submitted his research to a medical journal without FDA clearance.
Grassley said Crawford's statement appeared intended to intimidate a witness on the eve of a hearing.
Sen. Orrin Hatch (news, bio, voting record), a Utah Republican, urged fellow senators to keep an open mind, saying, "Today some are trying to punish one drug company for acting appropriately within the framework of our regulatory system."
But Grassley said Vioxx was the second example this year of the FDA not respecting its own scientists. Another FDA reviewer, Dr. Andrew Mosholder, had warned that antidepressants were linked to suicidal behavior in pediatric patients, but supervisors initially kept him from making those views public.
"Now we have scientists in this particular (Vioxx) case who are being harassed within the agency because of sticking to their own science," Grassley said.
He also faulted Merck for aggressively marketing Vioxx for nearly two years between submitting results of a trial to the FDA in June of 2000 showing a higher incidence of cardiac problems with Vioxx, and the FDA approving a new label detailing those risks in April 2002.
Merck's Gilmartin insisted the company had acted properly with Vioxx. "Over the past six years, we have promptly disclosed results of numerous Merck-sponsored studies to the FDA, physicians, the scientific community and the media," he said.
By the way, if the FDA did have any responsibility here, shouldn't some, oh, few billions of the upcoming lawsuits be directed towards the agency and its employees?
No, of course not. The government is never the problem, we must sue Merck and send it into the ground.
/sarcasm
Someone pointed out earlier this week that aspirin kills more people that Vioxx, but you never hear anyone complain about it.
And yet thousands have died taking Viagra and it's not news. How many died taking Vioxx?
And aspirin protects many more people from heart disease.
"Someone pointed out earlier this week that aspirin kills more people that Vioxx, but you never hear anyone complain about it."
That's a myth, unless you can provide better support than "someone pointed out earlier this week".
This is a good one.
The FDA is criticized all the time by the left for not releasing drugs fast enough.....
and when there's problem for releasing drugs to the public too fast.
nick
This shouldn't be a surprise to anyone, simply because the number of people who use Vioxx is tiny compared to the millions of Americans who take aspirin periodically.
Well, according to the FDA (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3882b1_02_E-Acetaminophen%20National%20Mortality%20Data.pdf) acetaminophen (Tylenol) kills 458 people yearly. It's easy to overdose on.
I don't know that there really is anyone to get mad at. In order to be really safe, the FDA would have to test every drug on a group of hundreds of thousands of people for about twenty years before being able to conclusively say that the drug is safe. This is impossible, and even then it would still put those people's lives at risk.
Because the clinical trials have a sample size of a few thousand rather than a few million and because they are of shorter duration than many patients will actually take the drug, there will always need to be recalls. There are some drugs with side effects that aren't statistically likely to show up in the smaller sample size of clinical trials or side effects that do not develop until years on the drug, or both.
This cannot be said enough. This is a proof that the market can take care of itself, because it is in the company's interest to market relatively safe drugs. The other thing not mentioned is the types of tests they were running. They were using doses higher than prescribed, so just as long as someone was taking the prescribed amount, there should have been no significant increase in risk.
Whatever the spin of the article, FDA has been in bed with Government for decades.
Do a search for which ousted party "biggies" the Pharmaceutical companies are supporting through their years out of office. Take note of where the Republican out-of-office guys were employed at huge salaries until the Republicans got back in office and you will know that whichever is in office the pharamaceutical greed can still be satisfied and everything okayed because of the "favor" they have.
vioxx? HELLO? A young lady recently died from RU486! Where are the committee meetings? Where are the press releases? Where'e the self-righteous, self-promoting, faux-courageous grand-standing public servanthood? Aren't the pockets deep enough over there? Who's keeping you away from that one?
Agonizing, as the liver fails and there's no way to reverse the damage (if n-acetylcysteine and activated charcoal, etc., fail to do the trick)... Sad to see someone regret a suicidal or parasuicidal attempt and find that there's no way to save her (usually females)... and the last days so painful. Even with a liver transplant, the long-term prognosis is often not too good.
Yet the FDA leaves it on the market. Perhaps they should consider putting a few others that weren't so bad back on. They are too often more aggressive than necessary based on scantest of data.
Just my two cents, not any professional opinions or anything. :-)
acetaminophen (Tylenol)
You've got to be careful with that stuff! It stresses the liver, and if you have a damaged one (from too much booze, hepatitas, etc.) you will REALLY do a lot more damage! Even if your liver is o.k., it can damage it if you take too many every day.
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