Difference between revisions of "Does the FDA's regulatory monopoly kill large numbers of people? No."

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{{DES | des = Libertarians and other [The Drug Industry|drug industry] shills have long accused the FDA of causing deaths through slow approval and overregulation.  That's an illusion due to a trolley problem, 20-20 hindsight, and ignoring the deaths that would be due to ineffective drugs.  Imagine if the FDA was allowed to regulate [[The Tobacco Industry]], with 300,000 or more US deaths per year. | show=}}
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{{DES | des = Libertarians and other [[The Drug Industry|drug industry]] shills have long accused the FDA of causing deaths through slow approval and overregulation.  That's an illusion due to a trolley problem, 20-20 hindsight, and ignoring the deaths that would be due to ineffective drugs.  Imagine if the FDA was allowed to regulate [[The Tobacco Industry]], with 300,000 or more US deaths per year. | show=}}
 
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First, drugs approval for a disease is a trolley problem.  Both action and inaction result in deathsBut until safety and efficacy are known, you cannot know how many lives would be saved or lost, and you cannot make a reasoned choice of which track to choose.  Unless you know and choose the wrong track deliberately, you cannot be said to have killed people.  Until then, the responsibly for the deaths is due to the situation that creates the trolley problem.
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Second, AFTER safety and efficacy are known, you can assign blame with 20-20 hindsight for that one case.  But no approval strategy can be perfect: there will always be cases where the strategy is wrong, and cherry-picking a few cases does not make a good argument.  The question is whether the strategy is overall better than none: and the long history of fraudulent and harmful medications shows that requiring safety and efficacy is a good strategy.  We need only look at the example of [[The Tobacco Industry]] to see that vastly more lives could be saved by regulation than the FDA has ever been accused of killing.
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Third, we DO have examples of unregulated drugs in the US, and they are not good. The entire [[Alternative Medicine]] and nutritional supplements industries consist of generally ineffective treatments and products that are often harmful.  For example: [[FDA ban nearly wiped out deaths, poisonings from ephedra]].  "Using data from the National Poison Data System, the researchers found that ephedra poisonings peaked at 10,326 in 2002 and then began a significant decline to 180 by 2013."
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From [[Ineffective FDA criticism by "Professors Of Liberty"]]
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> According to George Hitchings, co-winner of the 1988 Nobel prize in medicine, the FDA's 5 year delay in approving the anti-bacterial drug Septra cost 80,000 lives.
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I don't believe it. First of all, Septra is just a combination of two already well known, well used and approved drugs, Trimethoprim and
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sulfamethoxazole in a ratio of 20:1. Even if the combination was not approved for marketing, any MD could prescribe it and have a pharmacy
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make it up. It's used for a lot of not very serious infections (uncomplicated urinary tract infections, bacterial respiratory tract
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infections, shigellosis). In any case, the one serious disease it is used for is P.carinii, a severe and life threatening infection in
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patients with AIDS. But claiming that 16,000 people die a year from P.carinii because there was no Septra is bogus, (a) because other
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equally effective treatments exist (pentamidine), (b) because Septra could always be given just as it often is now, as two doses orally of
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already approved drugs, (c) You don't tell us how many of these 80,000 would have died anyway, from other causes (they had AIDS, remember?).
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> During their 10 year delay in allowing propanolol, a beta-blocker for treating angina and hypertension and preventing the recurrence of heart attacks, the FDA let approximately 100,000 Americans die by withholding that treatment from them.
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100,000? Where on earth do you get these figures???? Propanolol (more commonly known as Inderal) is most commonly used to treat hypertension and angina. Effective treatments existed prior to propanolol and are still used today, and angina is not life threatening. The only people who would die without propanolol are those who do not respond to any other drugs or to those who have life threatening arrhythmias, when it has to be given intravenously. Many of these die anyway, because intravenous propanolol is not found on any street corner, no doubt because the FDA is holding up the approval of your basic $0.75 intravenous Inderal vending machine: deposit coins, insert arm, wait, remove.
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Anybody else remember the private, independent certification company CARF that certified Narconon (a bogus drug treatment program which fronts for the Scientologists) as safe and effective?  It was [http://www.voxeu.org/article/patents-and-global-diffusion-new-drugs a key step in getting it installed in Oklahoma.]
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Patents and the global diffusion of new drugs "Long launch lags are common, and nearly 40% of these drugs became commercially available in only 10 or fewer of the countries studied.  Limited diffusion of these innovations translates into foregone health benefits for large numbers of people, and is particularly frustrating because the R&D cost of discovering and developing these new drugs has already been sunk." So private business ALSO is responsible for long lag times for drugs reaching patients. If you read the article carefully, it talks about tradeoffs.  The same is true of FDA policies: they involve tradeoffs. Until libertarians make up their minds about intellectual property (patents), they have no consistent way to criticize policy tradeoffs.

Latest revision as of 16:36, 31 January 2021