The best way to accumulate statistically significant data is to monitor a large number of people who are ingesting statins. Then in a few years the prescribing physicians can report their results, the researchers correlate the data, and the medical bodies announce the effects of statins on various types of people.
Of course, this is done (on a more limited basis) with clinical trials. But once a drug is approved for general use, there is a powerful disincentive to continue study. Doctors are supposed to report suspected drug-related incidents to the FDA, but this is not the same as a comprehensive study.
Oh, I was being snarky as I watch the population at large paying to be guinea pigs in medical experiments.
Well, that's not the way we are told things happen, but then there's Vioxx, Fen-fen, etc.
Of course, this is done (on a more limited basis) with clinical trials. But once a drug is approved for general use, there is a powerful disincentive to continue study. Doctors are supposed to report suspected drug-related incidents to the FDA, but this is not the same as a comprehensive study.
Isn't that essentially what happened with Viox, Steve?
Well, yes. I'm not following the case too closely, so I don't know if the cardiac side effects were coming in before FDA approval and hidden, or after FDA approval and not reported. Of course Merck would say it's all how you look at the numbers, I suppose. But what's the point of numbers if it depends on how you look at them?
>In article ><[email hidden]>, > > >The best way >to accumulate statistically significant data is to monitor >a large number of people who are ingesting statins. Then >in a few years the prescribing physicians can report their >results, the researchers correlate the data, and the >medical bodies announce the effects of statins on various >types of people.
Of course, this is done (on a more limited basis) with clinical trials. But once a drug is approved for general use, there is a powerful disincentive to continue study. Doctors are supposed to report suspected drug-related incidents to the FDA, but this is not the same as a comprehensive study.
Oh, I was being snarky as I watch the population at large paying to be guinea pigs in medical experiments.
e.g. thalidomide or hormone replacement therapy. I suspect there's many more like that.
I'm willing to grant that sometimes it is innocent--either because the side effects are delayed or rare. And after all, I don't remember exactly what the approval process was like for thalidomide in the U.S. Remember that the vast majority of birth defects were suffered in Europe, and not the U.S. But as in HRT, it is very very hard for a drug company to acknowledge that they really have a problem. Unlike thalidomide, HRT was going on literally for decades before the evidence couldn't be ignored.
>I know I'm pushing it a bit- but, at least to me the moral lines are >becoming blurred.
It's really quite simple. With regards to the concept of the greater population benefitting from the use of a drug (or vitamin, or better food, or whatever) there is no limit to how many people can benefit, and one person's benefit does not preclude another from benefitting.
But, in the case of performance-enhancing drugs in sports, you're talking about the use of substances that have possible deleterious side-effects, which not everyone is willing to risk. There is a limited amount of $$$ available for sports and therefore any additional $$$ one person gains will limit the $$$ available for another. There's not an unlimited supply of 'benefit'.
So long as the governing bodies of 'sport' deem that sport should be fair and that participants should not have to put themselves at extraordinary risk to participate, then any gains attained via performance enhancing drugs in essence defraud those who are not willing to risk their health and who don't cheat.
The lines are only blurred if you don't have a strong moral compass.
I'll leave off the dig about the "moral compass" I know where my points. But I do think the issue is broader than you paint it. I understand the difference between drugs for the health benefit of large populations vs. performance enhancers for sport. My point is that as the use of drugs, recreational, therapeutic, prophylactic, increases so does "societies" tolerance for the use of drugs for a broader spectrum of solutions. And to a large extent sport reflects the mores of society (with some leads and lags of course). So, I am simply positing that as the braoder acceptance of drug use in society for a broadeer range of uses continues to increas
I don't buy your contention that the broader tolerance of drugs in society increases as the use of drugs does. If it did, why is practically the entire sporting world (not just cycling) in such a tizzy over performance enhancing drugs?
It's one thing to accept individual use of recreational or therapeutic drugs, in that it supposedly doesn't harm anyone else, and another thing altogether to accept the use of illegal performance enhancers in sport, which is widely accepted as cheating and therefore not acceptable to the general public.
I might have thought that several years back. But the lines between therapeutic and "lifestyle" drugs is starting to get hazier. I first heard about this with "Prozac Nation", and the suggestion that we would all be happier, smarter on drugs--Ritalin for kids, beta blockers for Kurgan, Viagra for (fill in the blank). There are unfortunate areas of overlap where the nature of this artificial distinction is more obvious--say, ephedrine used innocently as a decongestant, but disallowed as a stimulant. Caffiene is allowed--but only up to an obviously arbitrary maximum level. I don't necessarily think this is (as gds says) a good thing, but it's not all bad either. The reverse sentiment--that drugs are "a bad thing" has doubtless prevented people from seeking easily available medical help, esp. in the mental health field.
The studies are for all cause mortality primarily and for cardiac mortality as a subset.
Yes there are statistical benefits for statins but the actual clinical benefit for the healthy individual is tiny and lower than the rate of side effects. If your friend has a stroke, then they almost certainly have at least one risk factor for cardiovascular disease which makes the benefit of statins greater.
An example of "creative statistics" is a company promoting drug X which reduces disease Y by 50%. Wow - a 50% reduction! But if disease Y has an incidence of 1 in 1,000,000 then you are making 2,000,000 people take X to prevent one case of Y. The company will obviously promote the "50% reduction" line or "without Y, your risks are doubled" line. They won't be telling everyone that Y is rare and that X has a 1 - 2% risk of major bone marrow or liver damage.
gds wrote: > > I know I'm pushing it a bit- but, at least to me the moral lines are > becoming blurred.
It's really quite simple. With regards to the concept of the greater population benefitting from the use of a drug (or vitamin, or better food, or whatever) there is no limit to how many people can benefit, and one person's benefit does not preclude another from benefitting.
But, in the case of performance-enhancing drugs in sports, you're talking about the use of substances that have possible deleterious side-effects, which not everyone is willing to risk. There is a limited amount of $$$ available for sports and therefore any additional $$$ one person gains will limit the $$$ available for another. There's not an unlimited supply of 'benefit'.
So long as the governing bodies of 'sport' deem that sport should be fair and that participants should not have to put themselves at extraordinary risk to participate, then any gains attained via performance enhancing drugs in essence defraud those who are not willing to risk their health and who don't cheat.
The lines are only blurred if you don't have a strong moral compass.
I'll leave off the dig about the "moral compass" I know where my points. But I do think the issue is broader than you paint it. I understand the difference between drugs for the health benefit of large populations vs. performance enhancers for sport. My point is that as the use of drugs, recreational, therapeutic, prophylactic, increases so does "societies" tolerance for the use of drugs for a broader spectrum of solutions. And to a large extent sport reflects the mores of society (with some leads and lags of course). So, I am simply positing that as the braoder acceptance of drug use in society for a broadeer range of uses continues to increas
I don't buy your contention that the broader tolerance of drugs in society increases as the use of drugs does. If it did, why is practically the entire sporting world (not just cycling) in such a tizzy over performance enhancing drugs?
Because a bunch of power mad rats seized an opportunity to savage elite bicyclists, simply for being good at something. Happens all the time in all places. Nothing to do with anyone's actual use of or approach to drugs. I want to see the inside of [censored] Pounds medicine chest.
Of course, this is done (on a more limited basis) with clinical trials. But once a drug is approved for general use, there is a powerful disincentive to continue study. Doctors are supposed to report suspected drug-related incidents to the FDA, but this is not the same as a comprehensive study.
Isn't that essentially what happened with Viox, Steve?
Well, yes. I'm not following the case too closely, so I don't know if the cardiac side effects were coming in before FDA approval and hidden, or after FDA approval and not reported. Of course Merck would say it's all how you look at the numbers, I suppose. But what's the point of numbers if it depends on how you look at them?
Steve
Exactly. It kind of reminds me of the time when one of the big three car makers was doing crash tests of one of their cars, and it didn't perform quite like they expected it to. The spin on it by some PR flack was that the dummies showed evidence of being "slightly dead." I always figured that was one of those binary things: it is or it isn't.
Of course, right now Merck is paying a great deal of attention to numbers.
e.g. thalidomide or hormone replacement therapy. I suspect there's many more like that.
Quoted message said:
But as in HRT, it is very very hard for a drug company to acknowledge that they really have a problem. Unlike thalidomide, HRT was going on literally for decades before the evidence couldn't be ignored.
Steve
The reason I mentioned HRT was that it too was thought to be something that everyone (female) would benefit from, rather like the statins that the OP was talking about.
I'll leave off the dig about the "moral compass" I know where my points. But I do think the issue is broader than you paint it.
Scott said:
It's one thing to accept individual use of recreational or therapeutic drugs, in that it supposedly doesn't harm anyone else, and another thing altogether to accept the use of illegal performance enhancers in sport, which is widely accepted as cheating and therefore not acceptable to the general public.
Widely accepted is a very generic term. Do you perhaps mean widely accepted in your own culture ?
