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.
I agree...tooo many doctors treating unhappiness like it was depression....
To be happy, you need to do the right things.
Our culture is not encouraging that enough.
Therefore, we want a magic pill instead of doing the right things, cause the right things would interfere with something else we want to do.
And we want instant gratification, to boot.
What a strange world we live in.
My advice to most people is to throw away their TV, listen to their kids, put their family on the high priority track, and learn to be grateful. Sure changes your outlook on life!
IMHO I believe that's already happened and is happening even now. One of the hidden fatalities against these law suits are products that never come to be, or that may only come into being many, many years down the road.
Money that companies would have used in R&D, et. al. gets gobbled up paying up, buying off, and/or going to court. The ultimate winner? The tort lawyers. The ultimate victim? The person whose quality of life would have been improved (dramatically) for the better.
Not on the list because the list is of drugs designed to treat a disease state, not kill someone. RU486 is designed to kill someone, not treat a disease state.
Heh... touche. (I keep reverting to that "okay where is the pregnancy is a DISEASE mentality" when I read this media garbage too much)
Liberals and the subset called democrats believe pregnancy is an 'elective disease' ... if a woman wants it to be a disease, she's infected and abortion is the cure; if she's happy, she's pregnant.
I heard this guy all over the news today. Frankly he sounds like someone with an agenda, ala Richard Clarke. If he's bashing Accutane than I don't believe a word he says. The drug has been used for decades, is a near miracle drug for many people, and should not be pulled. Sure there are some risks, and they were known 20 years ago and taken into consideration throughout the course of the treatments.
Utopians and lawyers are a destructive combination.
IIRC (and I may not be), they found something like a 50% increased risk of heart attacks in those that took Vioxx for more than 18 months straight.
Really though, the recall of Vioxx is no big deal to the overwhelming majority of arthritis sufferers. Vioxx, Celebrex and other members of that class of medicines are not any better at controlling arthritis pain than plain old Advil or Aleve. Their only real benefit is that they don't cause upset stomachs in patients prone to that sort of thing.
Exactly. It's the reason we have little flu vaccine this year. It was outsourced to escape trial lawyers
But this article is a way over the top. Accutane has been on the market for over 20 years. Does it have side effects? Yes. But compared to the average birth control pill, these effects are doodly. BCP are way more dangerous but you won't hear about that.
All in all I would trust the FDA more than Congress. Back in the 80's the Congress listened to Jack Klugman's (he played Quincy on the TV show and did an episode on orphan drugs) testimony on orphan drugs before making their decision. That is very scary.
"Merck finally had to acknowledge the truth, but only by accident. The company undertook a large, randomized trial of 2,600 patients with colon polyps in hopes of proving that Vioxx could help their condition. In the process, though, Merck discovered that 3.5 percent of patients taking Vioxx suffered heart attacks or strokes as against 1.9 percent taking a placebo. Merck at last did the right thing by voluntarily and abruptly taking Vioxx off the market."
A better, more accurate, statement would be:
"They do not cause or aggravate bleeding ulcers, as do NSAIDS."
Hope that helps.
DG
Actually folks still suffered bleeding ulcers with Cox-2 inhibitors. Their selling point was that they reduced the incidence of major GI bleeds from about 25% in folks still taking older NSAIDs to about 20%, IIRC. That's still a lot of emergency transfusions, emergency procedures and traditional open surgery avoided.
Thanks for the link.
This sort of thinking is the problem with the way the FDA approves pharmaceuticals and the way trials are done. Medications can behave very differently for different people. Aleve is wonderful for my migraines, but did little for bursitis. Celebrex was wonderful. However, for my father, Celebrex was worthless and caused problems. [He went onto Vioxx for a couple of years...and then had a heart attack... :-( ]
The statistics and theories don't account for the personal variation in efficacy. While the average advantage for most people is merely the lack of aggravating an ulcer, there is a great difference in individual response in terms of effectiveness, too--varying from patient to patient for a single medication, as well as from one medication to another in a single patient.
Me too, except that it has the side effect of lowering my cholesterol level to Olympic athlete levels.
Gimme another slice of bacon, please.
serevent alone is the problem. We usually use ADvir which has steroids in it.
The increase in death is similar to that found with inhalers: You stop the initial attack, but six hours later, get the more severe edema with spasm that doesn't respong to bronchodilators.
Also, Serevent is not used "as needed". It is used constantly, so those using serevent are the more severe cases of asthma, i.e. those who are supposed to be on steroids. So wait for the Advir studies come out first.
I use serevent because I can't tolorate Albuterol, and rarely need a bronchodilator as long as I take my steroid inhaler. About the only place I use it is when I go to Walmart, which for some reason makes me wheeze, probably the cleaning fluid they use to clean the place.
And there are those asthmatics who refuse to take steroids because of the nasty side effects. I'd rather be wheezing and steroid free. With a serevent inhaler, for the first time in my life, I felt like I didn't have asthma. Then when the inhaler was deemed an ENVIROMENTAL hazard, the company switch to the discus, which dumps some powder on my tongue, but isn't anywhere near as effective, but still better than Advair!! I would rather take my chances with serevent than with any steroid drug!!! Wish we could sign a form releasing the drug company from responsibility if we chose to use their product.
My doctors are always prescribing a drug instead of promoting a healthy lifestyle, diet and exercise (groan!). I have to take MORE coumadin, MORE lipitor, when to me it looks like my cholesterol is doing fine. I refuse to take MORE until I can prove my diet is taking care of it, or will take care of it when I get serious about it. I don't eat a lot of crap.
Steroids taken systemically (as a pill or a shot) can have nasty side effects. Inhaled steroids are similar to using steroid creams on the skin: they do not have systemic side effects. And, it is NOT recommended to use Serevent without inhaled steroids. Believe me.
No kidding! I was on Vioxx and got a bleeding ulcer. Four units of blood later, I am still alive, but I'll never take anything like that ever again.
I can give a list of serious problems resulting from prescription drugs in people I know. As a matter of fact, my mom's life is a living hell right now because of them. Her problems spill over onto all the family. People are stupid to not question the safety of drugs.
I still have major problems w/ the inhaled steriods. You wouldn't want to be around me when I've had them!!
Thalidomide
At any rate, best of luck to you with managing your asthma.
That was an unusual case (and also a very old one, which happened under much more primitive research technology than is in current use), but my point still holds. The level of scrutiny and standards of proof currently required for new drug approval delay new drugs by years -- and most of those drugs have benefits that far outweigh their incidence (if any) or serious side effects. All the people who died or suffered serious harm due to those delays need to be offset against the few who are harmed or killed by the occasional premature approval of a drug that turns out to have serious problems.
Lots of innocent people have gotten killed in Iraq since the U.S. military went in, but only loony leftists fail to offset that number against the much greater number of innocent people who were getting killed every year before we went in, and would have continued getting killed if we had stayed out.
Check the records. Thalidomide was never approved by the FDA which was then under much stricter scrutiny standards than today. It was never sold in the US until recent years as a treatment for leprosy --- Hanson's Disease. The damage in the 1950s and 60s was done primarily in Western Europe and Canada where the drug was rushed through the approval process. The only Americas damaged by Thalidomide (actually their children)were those who obtained the drug in either Europe, Mexico or Canada.
I would argue that with mass marketed drugs, approval should always error on the side of caution. The FDA used to do that and in just that one case of Thalidomide , saved many hundreds of thousands of people from a very grisley fate. Today, I have my doubts they excersice the proper caution.
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