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Old 12-08-2005, 04:52 PM   #1
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Prescription Drug Side-Effects

In the January 2006 issue of Consumer Reports, there is an interesting article entitled "Prescription for Trouble." It's interesting in that it reveals many of the shenanigans, misleading claims, false advertising, and the overall failure to adequately report adverse drug reactions and side-effects.

One thing that I found particularly interesting was the following:

DOCTORS FAIL TO REPORT

"Physicians are supposed to voluntarily report any serious drug reactions to the FDA's MedWatch program, where researchers look for signals that a medication might be causing problems. But only 1 to 10 percent of such incidents are ever reported, various studies have estimated. An FDA analysis found that pharmacists and, to a lesser extent, consumers each filed far more MedWatch reports than did physicians in fiscal 2004. Nurses filed about as many as doctors."

"The FDA's drug-safety and risk management advisory committee has recommended that the agency actively search databases for signs of trouble. Until now, the FDA has consistently underinvested in such high-tech information gathering, reported by Scott Gottlieb, M.D., the FDA's deputy commissioner for medical and scientific affairs, in the July/August 2005 issue of Health Affairs."

So, did you notice where it said that only 1 to 10 percent of adverse reactions are ever reported? Hmm, kind of makes you wonder, doesn't it? Now, the claim is that only 2 to 3 percent of people suffer side-effects from statins. Well, given the fact that such a small number of cases are actually reported, my best guess is that the true figure is considerably higher, probably closer to 20 to 30 percent. That sounds far more believable.
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Old 12-08-2005, 06:19 PM   #2
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Re: Prescription Drug Side-Effects

Quote:
Originally Posted by ARIZONA73
In the January 2006 issue of Consumer Reports, there is an interesting article entitled "Prescription for Trouble." It's interesting in that it reveals many of the shenanigans, misleading claims, false advertising, and the overall failure to adequately report adverse drug reactions and side-effects.

One thing that I found particularly interesting was the following:

DOCTORS FAIL TO REPORT

"Physicians are supposed to voluntarily report any serious drug reactions to the FDA's MedWatch program, where researchers look for signals that a medication might be causing problems. But only 1 to 10 percent of such incidents are ever reported, various studies have estimated. An FDA analysis found that pharmacists and, to a lesser extent, consumers each filed far more MedWatch reports than did physicians in fiscal 2004. Nurses filed about as many as doctors."

"The FDA's drug-safety and risk management advisory committee has recommended that the agency actively search databases for signs of trouble. Until now, the FDA has consistently underinvested in such high-tech information gathering, reported by Scott Gottlieb, M.D., the FDA's deputy commissioner for medical and scientific affairs, in the July/August 2005 issue of Health Affairs."

So, did you notice where it said that only 1 to 10 percent of adverse reactions are ever reported? Hmm, kind of makes you wonder, doesn't it? Now, the claim is that only 2 to 3 percent of people suffer side-effects from statins. Well, given the fact that such a small number of cases are actually reported, my best guess is that the true figure is considerably higher, probably closer to 20 to 30 percent. That sounds far more believable.
Hmmm, quite interesting. I think alot of the drs. don't report many side effects because they feel many folks just THINK they are having a drug side effect, or feel what they are experiencing is minor. Guess if we have a side effect, we have to half die before they consider it important enough to report. Oh well, to be honest, it doesn't surprise me at all.

Are U guys ready for the snow tonight? We are suppose to get about 8", oh the joys of New England. Take care, and TTYL.....

 
Old 12-08-2005, 07:17 PM   #3
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Re: Prescription Drug Side-Effects

Quote:
Originally Posted by JJ
Hmmm, quite interesting. I think alot of the drs. don't report many side effects because they feel many folks just THINK they are having a drug side effect, or feel what they are experiencing is minor. Guess if we have a side effect, we have to half die before they consider it important enough to report. Oh well, to be honest, it doesn't surprise me at all.

Are U guys ready for the snow tonight? We are suppose to get about 8", oh the joys of New England. Take care, and TTYL.....
Yes JJ, I think you're right. Only when the side effect is quite serious will they even consider reporting it. Otherwise, they're most likely to dismiss it, and attribute it to something else.

Oh yes, we're expecting some snow late tonight, with accumulations of up to 3-6 inches.
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Old 12-08-2005, 07:30 PM   #4
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Re: Prescription Drug Side-Effects

Mg Health,

The Consumer Reports article did mention inadequacies within the FDA too. And, as far as specifically targeting statins, you are correct. They didn't. But it does make you wonder, doesn't it? The frequency of side effects associated with these drugs must surely be greater than what is claimed.
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Old 12-08-2005, 09:00 PM   #5
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Re: Prescription Drug Side-Effects

Quote:
Originally Posted by ARIZONA73
Mg Health,

The Consumer Reports article did mention inadequacies within the FDA too. And, as far as specifically targeting statins, you are correct. They didn't. But it does make you wonder, doesn't it? The frequency of side effects associated with these drugs must surely be greater than what is claimed.
The FDA is a government body and by nature a lacking and comonly inept body!

Yes, it makes me wonder about the possibility that the reported side effects statistics are being undervalued. We deserve to know the real numbers - whether bad or good, so we can make better medical decisions.

 
Old 12-08-2005, 11:20 PM   #6
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Re: Prescription Drug Side-Effects

Arizona,

I haven't seen any stats for the U.S. that estimate the amount of under-reporting - no one has these stats - it's very hard to estimate what is 'NOT' happening... But if it is any indication, Health Canada estimates that only 1 to 10 percent of adverse drug reactions are reported - however, this estimate is probably very inaccurate...

I read an article from the University of Florida that explains serveral reasons why doctors under-report ADRs:

a) they are too busy
b) no one thinks that their one report will make a differrence
c) and this is the one I mostly think is the reason: they are afraid of malpractice suits and are very reluctant to do ANYTHING that will expose them to liability.

I can't blame them for (c) - there are so many malpractice lawyers that would ruin their careers for the slightest mistake...

Fear of liability is also why so many doctors nowadays will refuse to have you as a patient if you do not take their advice, or refuse prescriptions they think you should have.

HubbleRules

Last edited by HubbleRules; 12-08-2005 at 11:48 PM.

 
Old 12-09-2005, 05:53 PM   #7
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Re: Prescription Drug Side-Effects

I agree 100%. I think that if you complain to your doctor, he or she will enter the information about the drug you are having a problem with in YOUR FILE-and most likely write a prescription for a similar drug. BUT, I's be surprised if a MedWatch form was filled out each time....and that's not fair play in my book.
The problem is that there is just so much money involved. Also, lets face it-if you knew ALL the true facts.....I don't think there would be as much money involved.

 
Old 12-09-2005, 07:53 PM   #8
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Re: Prescription Drug Side-Effects

Quote:
Originally Posted by Imacarbuff
I agree 100%. I think that if you complain to your doctor, he or she will enter the information about the drug you are having a problem with in YOUR FILE-and most likely write a prescription for a similar drug. BUT, I's be surprised if a MedWatch form was filled out each time....and that's not fair play in my book.
Well, I think you're quite right about that. Most doctors either don't have the time, or just don't bother to take the time to report side effects. So, most side effects simply aren't reported, which leads me to believe that they are generally much higher than we are told. And, in the case of statins, I'd bet that side effects are a lot closer to 20-30%, as opposed to the figure most often quoted and reported by the drug companies, which is just a mere 2-3%. That, to me, sounds rather absurd.
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