[quote]orion wrote:
DrSkeptix wrote:
Tiribulus wrote:
Not necessarily taking sides, but the environment for a true comparison doesn’t exist because we’ve never had a thoroughly market based medical industry.
What you’re asking him to do overlooks that fact. How can somebody explore their options without the FDA if the FDA has seen to it that no such options exist? The market has never had to handle what you’re talking about exactly because of the very FDA you’re now telling him to forgo in his research.
You’re assuming the truth of your assertion on the basis that it simply is, but that does not address what might have been in the marketplace in the absence of an FDA style agency.
What might have been in the marketplace in the absence of an FDA style agency?
Oh? OK. How another hypothetical that proves my contention?
Let’s say a woman is pregnant and has terrible nausea…a common event. In our mythical country, there is no FDA, but there is free access to new products. There is a product, which is advertized for the relief of the nausea of pregnancy. It works perfectly, and it is only a little sedating, so nightly use is possible. It has been in use in England and Europe for years, and is beating out the competition. In Canada, it is already in use and drug company representatives have started to drop off samples in doctors’ office.
So we have it all: no FDA-style agency to regulate a medicine, in use for years elsewhere, effective and beating the competition in a competitive free market. Pregnant women in the US deserve to be able to buy it as informed consumers.
…
Only this is not a hypothetical.
Thalidomide had been in use in Europe and England, it was there deemed safe and effective, and “detail men” had started sampling in Canada and the company wanted clearance in the United States. Studies in pregnant rabbits even confirmed safety.
Only one reviewer, a woman, at the US FDA stopped thalidomide. She said the information was inadequate, and she had just read some reports on a rare congenital abnormality, amelia, occurring in Europe. The drug company denied any connection.
She stopped Thalidomide from approval. (It turned out that metabolism in rabbits is different to that of humans.) The US avoided the epidemic of malformed babies.
So, there were places and times where market forces in the pharmaceutical industry were unrestrained, contrary to your assertion, and the risks of that market could not have been predicted by consumers.
I can tell you that drug companies, were they not thus contrained to perform studies and pass FDA, would be selling snake oil and thalidomide-equivalents to the unsuspecting public.
(And hence my homework assignment to orion, for which he seems to need more that 5 minutes on the internet to answer my subterfuge.)
Yes, that is their one big success story.
[/quote]
No. Actually, there are dozens of such success stories…you just have not heard of them. There are medicines, procedures and devices, all with some initial enthusiasm, or challenging scientific theory, or positive anecdote, which have proven useless and/or harmful in careful human studies, and denied approval.
I don’t know. Do you?
While you are at it, how many people were spared useless, harmful and expensive drugs?
A fair question. It is actually under review.
Incidentally, in such a situation, your death or experience would have to be recorded and analyzed by an agency like the FDA. Online chat rooms would not do at all.
But in the 1960s, that was also the case, but not to degree currently, because of the Thalidomide experience. If pregnant women can learn from the public experience, the FDA performed one of its jobs.
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Now then, orion, if information in the age of the internet is so readily accessible, without government, and any rational economic unit can decide for himself the utility of a medicine, will you buy Tarceva for pancreas cancer?
Practice, not theory, please. Or praexis if you prefer; does your policy actually achieve the desired goals?