Posted on 11/18/2004 5:50:28 PM PST by neverdem
FDA 'Incapable' of Protecting Public, Federal Reviewer Says
The Associated Press
The American public is "virtually defenseless" if another medication such as Vioxx proves to be unsafe after it is approved for sale, a government drug safety reviewer told a congressional committee Thursday.
"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," said David Graham, who warned that the arthritis drug had been linked to an increased risk of heart attack and stroke.
He told the Senate Finance Committee that there were at least five other drugs on the market today that should be looked at seriously to see whether they should remain there. He cited the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent.
AstraZeneca Pharmaceuticals, maker of Crestor, said it was confident that the drug was safe. "To date, the FDA has not given us any indication of a major concern regarding Crestor," said spokeswoman Emily Denney.
Tim Lindberg, a spokesman for Abbott Laboratories, said "science continues to support the safe use of Meridia to treat obesity, the leading health epidemic in the U.S."
Carolyn Glynn, spokeswoman for Roche Pharmaceuticals, maker of Accutane, said that "it's important to point out that this drug is reserved for a very very serious indication, that it does carry risks and that its very important for physicians, patients, pharmacists to monitor, to conform to all of the risk programs because this drug is extremely beneficial as long as its used safely and appropriately."
GlaxoSmithKline, maker of Serevent, issued a statement saying that it "stands firmly behind" the product, "which is safe and effective when used appropriately and in accordance with labeling and treatment guidelines."
Representatives of Pfizer, the manufacturer of Bextra...
(Excerpt) Read more at washingtonpost.com ...
No mention of RU 486 in the list.. why am I not surprised.
Having said that, the FDA sometimes does seem to look the other way on certain products and then they jump on the public tarring and feathering of other products because of widely publicized anecdotes. The last thing we need is Congress pretending to know anything about how drugs are developed and tested, sticking their dirty little fingers into the process.
Have to say that every drug that requires a prescription is potentially hazardous. That's why they're not distributed over the counter. For that matter, a little Tylenol and a little alcohol and you can kiss your liver goodbye. Psychotropic drugs, used appropriately, save lives, jobs and families. There is a big difference between a little healthy anxiety and a true anxiety disorder. Or maybe you've never had a panic attack while driving 65 mph on the freeway?
Responding to the last sentence in your post. Thank God I have not had an anxiety attack. I am very appreciative that I do not suffer from those anxiety attacks. I am aware that that condition can be very debilitating. However, too many people justify drugs to moderate behavior that should be done with self disipline. Drugs have been prescribed too much for people who don't have the extreme problems that the drugs are very useful for. I have nothing against taking prescribed dugs. I often think even our doctors don't considered the contraindications, especially if a person is taking many different drugs. All people who have to take drugs should educated themselves about the drugs to prevent possible ill effects.
A lot more people are helped by the current level of scrutiny for drug approval, than are hurt by it. One could even make a good argument that looser standards would provide a net benefit. Just because 5 already very sick people die a little sooner as a result of an unforeseen side effect of a relatively new drug, doesn't negate the tremendous benefits most of these provide to tens of thousands of other people -- often extending many of those people's lives.
Absolutely agree.
Ahhhh my doctors favorite. I refuse to take it. The marketing hype scares me to death.
Thank you, but I suspect I am revealing my Freudian side. :)
FDA Issues Warning for Serevent, Advair
Basis of alert: Based on the results of a 28-week study that compared effects of salmeterol in asthma patients with asthma patients not taking the drug. African Americans, in particular, had a significantly higher risk of having a life-threatening asthma attack or asthma-related death when taking Serevent.
WE had to put one of my kids on accutane this year...he had cystic acne very, very badly...as it is he will go through life with some scarring on his chest (family trait..his dad and his brother all had cystic acne)...
It really worked, but oh the expense! Even with good insurance! Even with Generic!
And you have to test the blood once a month too...a very, very powerful drug. The drug has great risk for causing bad birth defects, and is used by people at an age where the girls aren't necessarily smart about it. But it did do a great job at bringing his acne back under control.
But the costs...I wonder why...is it because they need such a cash flow to deal with the lawsuits involved with the drug, or is it because they can get away with it?
Prescribing statins is becoming the standard of care for many patient demographic groups. Your free to decline a prescription. Your doc will be certain to make a note about your refusal.
I looked at the chemical structure of the six statins which were available when Baycol was still on the market. Suffice it to say the structural variation that I saw was quite surprising.
I have no idea. When I needed drugs for myself without any coverage, I called a number of pharmacies and found the prices could vary wildly.
a few months later, she had to go off....cholesterol was elevated...
but then she developed another major health problem.....generalized dystonia....
she swears that it started shortly after she stopped Accutane...
I see no reference of it in the literature....except a "nervous" condition in the side effects category...
long story short.......EVERY drug you put into your body is a toxin of some sort....EVERY one.....
whether it be extra vit. E or Bextra......it has an effect of some sort....
so why are we surprised to find new problems when we take drugs all the time?
Well, you also have the costs of getting through the FDA, and then the liability and risk of the FDA being idiots and banning it or just killing it through an inappropriate "warning."
Remember PPA?
In my family, we have a variety of problems: ADD, Bipolar syndrome, Obsessive-compulsive disorder, and clinical depression.
Using meds not merely a form of escapism for all people.
It's too easy to lump the problems of a person who is unhappy because they are living a lifestyle guaranteed to make them unhappy with people who need meds to function properly.
I have a son who is ADD and has SAD and tried to kill himself last year. My brother without his meds will sit and comb his hair all day fugued out staring at the mirror when the stress gets bad. My niece has both ADD and Bipolar syndrome. My husband has clinical depression and is an adult with ADD.
It's not all in their heads. It's in their bodies. They aren't escaping. They are trying very, very hard to cope well.
There are people out there who want the doctor to give them a magic pill to make their unhappiness go away. Pills don't do that.
But for those who are out there with "mental" problems that are physical illnesses (i.e., aren't of their own creating by lifestyle choices, or short term situational things), medicine is there. A friend of mine started going psychotic because she has developed a massive vitamin b-12 deficiency. My sister-in-law will spend the rest of her days getting medicine to treat her bi-polar condition. There is not much difference, except the meds used. It's still the body causing mental effects.
Don't forget there are real needs, and not everybody is escaping.
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