Posted on 11/18/2004 8:21:00 PM PST by Kaslin
WASHINGTON -At least five medications now sold to consumers pose such risks that their sale should be limited or stopped, said a government drug reviewer who raised safety questions earlier about the arthritis drug Vioxx.
In testimony Thursday before the Senate Finance Committee, Food and Drug Administration (news - web sites) reviewer David Graham cited Meridia, Crestor, Accutane, Bextra and Serevent. Drug makers defended the use and safety of their products.
Graham contended the country is "virtually defenseless" against a repeat of the Vioxx debacle. Dr. Steven Galson of the FDA (news - web sites) rejected that comment as having "no basis in fact."
Merck & Co. pulled Vioxx from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.
The committee chairman, Sen. Charles Grassley (news, bio, voting record), suggested an independent board of drug safety may be needed to ensure the safety of medications after FDA approval. An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency disdained, rather than listened to, its own reviewers.
Graham contended that FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.
In his view, the five most worrisome drugs that demand speedy action:
_Meridia, a weight-loss drug. He said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke among people taking it. "I don't think Meridia passes that test," Graham said.
_Crestor, an anti-cholesterol drug. He said the government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor. Two of three other statin competitors prevent heart attack and stroke and do not cause renal failure, he said.
_Accutane, an acne drug linked to birth defects. Graham said the drug represents a 20-year "regulatory failure" by the FDA and sales should be restricted immediately.
_Bextra, a painkiller. Graham said the drug poses the same heart attack and stroke risk as Vioxx. He recommended designing studies to look at the drug's cardiovascular risks.
_Serevent, an asthma treatment. He said the drug was shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma. GlaxoSmithKline, told by the FDA to do a large, clinical trial, begged off. "We've got case reports of people dying, clutching their Serevent inhaler," Graham said. "But Serevent is still on the market."
Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency already has taken steps to alert consumers to those drugs' safety concerns. That includes heightened warnings for Serevent; a tougher risk-management plan to ensure pregnant women don't use Accutane; and an upcoming advisory committee hearing regarding Bextra.
"Each of these do have special safety issues, but they're under evaluation and we're watching them carefully," Galson said.
Tim Lindberg, a spokesman for Abbott Laboratories, said "science continues to support the safe use of Meridia to treat obesity."
AstraZeneca PLC, maker of Crestor, has confidence in the drug, spokeswoman Emily Denney said. "To date, the FDA has not given us any indication of a major concern regarding Crestor," she said.
Carolyn Glynn, spokeswoman for Roche Holdings AG, a maker of Accutane, acknowledged that the drug carries risk and said it is reserved for serious cases. "This drug is extremely beneficial as long as it's used safely and appropriately," she said.
Susan Bro, a Pfizer spokeswoman, said Bextra did not increase the risk of serious cardiovascular events in a recent analysis of nearly 8,000 arthritis patients who took the drug from six weeks to 52 weeks. She said Bextra has been found to be safe and effective when used as indicated.
GlaxoSmithKline, maker of Serevent, issued a similar statement about its product.
In his testimony, Graham said the FDA's Office of New Drugs unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not.
That rule does not protect consumers, Graham told the Senate committee. "What it does is it protects the drug," he said.
Grassley accused the FDA of attempting to intimidate Graham. Sen. Jeff Bingaman (news, bio, voting record), D-N.M., urged President Bush (news - web sites) to name a new leader at the FDA, where Lester Crawford is the acting commissioner.
Graham said he fears continued intimidation.
"I was frightened before," he told reporters after the hearing. "Senior management at the FDA did everything in their power to intimidate me prior to my testimony," he said.
T O B A C C O ! ! !
This drug is marketed in spite of its known tendency to cause birth defects because it is extremely effective. There are already strong restrictions on its use for anyone who might become pregnant. But a guy I knew who was a lawyer in his 50's had trouble getting a prescription for it because of all the bad publicity, although it was recommended for the serious skin condition he had.
You gonna get a lot of flak for this from the smokers
My daughter took accutane and had to jump through hoops, including monthly blood work.The prescription had to be filled within 7 days of being written despite the insurance saying it hadn't been a month yet and you aren't allowed 2 in 30 days. And she was given a huge notebook to study. How much more restricted can it get?
Alcohol?!
Don't bother me none. I use to be one of them....for over 25 years. I use to smoke 3.5 packs a day, and 5 packs on the weekends. But I quit cold turkey almost 25 years ago, and haven't inhaled smoke since........and very grateful that I did. Do you know how much a pack of cigarettes cost these days? Two packs can pay for a good lunch!
I am a smoker, and you'll get no flack from me.
Smoking is not healthy for you and I can agree with that position; however, my dad was a 3 pack a day smoker for 45 years. What killed him? Prostate cancer; not lung cancer, emphysema, or any of the other so-called "smokers diseases".
If it is as harmful as people say, then ban it outright.
Otherwise, quit with the incremental steps and the outright discrimination against users of a LEGAL product.
I think that a big problem is the simple fact that people want a "cure" right now, for whatever ails them.
First off, let me say that I hate going to the Dr or hospital, or taking medicine, unless I absolutely have to. Anymore, it seems that this sort of attitude has become the exception, rather than the rule. I realize that I problably wait too long before seeing a Dr, but I guess I always want to be sure that I'm really sick before going, so I don't waste the time of either myself or my Dr.
But the problem is that people want a miracle cure, usually in the form of a pill. The thing people seem to have forgotten is the fact that when you take drugs, they will always have additional effects on your body. Many of those are unpleasant. Or sometimes, even dangerous. The key is determining a cost/benefit ratio.
In my case, I took celebrex, then viox, but neither one really helped me very much. I wound up going back to ibuprofin. I'm glad I did.
Mark
I took BEXTRA for about 3/mo at $100.00 a month had to quit the damn stuff made me swell up like crazy. Read the paper w/side effects Guess what???? Thats right.
Good luck! Hang in there! Try sunflower seeds for the hand-to-mouth fixation.
I have, like you, been an on-and-off smoker since the age of 13 (37 now). I have never, however, smoked more than a pack a day - mostly less than 1/2 a pack a day.
Also, I smoke light 100's, and I rarely get past 1/2 a cigarette before crushing it out.
It is a terrible habit, and almost impossible for the "average joe" to break. Hang in there, and don't let a little slip or two deter you from your goal.
I don't know anything about Graham, but I'm a bit leery of anybody who is trying to get an FDA-approved drug pulled for one reason - once a drug loses FDA approval, it's a lot easier to win a lawsuit against the makers of that drug. It wouldn't be a shock to me if the trial lawyers were behind this.
Ping
I'm not a smoker, I have tried though, but I couldn't see the benefit and to tell you the hacking cough that resulted from it got on my nerves and it was easy for me to stop it before it became a habit.
Congratulations on your being able to quit after having smoked so many packs a day for such a long time. That shows when there's a will there is a way
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.