Hyperbole aside, if "Dr" Smacktoward did actually develop a cheap and effective therapy that actually worked, the prior restraint employed by the FDA would likely keep it off the market. The same technique employed against snake oil may also be applied to real cures that might provide cost-effective competition to multibillion-dollar blockbuster patent medicines.
Yes, that's right; if you believe that you truly have developed a remarkable healing elixir in your garage, the burden is on you to obtain scientifically valid proof that it does what you claim it will do before you can go around selling it to people.
Whether or not you see this as a horribly unjust burden imposed by an unfeeling government will probably depend on whether you are the inventor or the person the inventor was planning on selling it to.
If you apply that standard to other products, such as software, what happens? If you cannot distribute software that is certifiably bug-free and algorithmically correct, that is warranted to be fit for a specific purpose, what happens? If you cannot sell a car if it cannot go 70 miles-per-hour, consuming fuel at 50 miles-per-gallon, and have zero fatalities in a head-on collision, what happens?
too bad they are not as rigorous with the food we eat. One example is that they don't even have the resources to check if the food manufacturers claims are true (you can't be sure what type of fish you eat nowadays).
This is a really critical point. People who are pro-regulation are under the premise that regulation actually does protect people. There are countless examples to the contrary.
(The finance sector is even much worse than the FDA in this regard---for example Bernie Madoff was regulated, leading people to think their money was safe with him---but in some ways, the FDA is just as bad.)
Of course it can help, some. I'm not going to deny the obvious. But it's highly imperfect, and it often hurts.
The only way to know it actually works is to do the necessary science, which unfortunately isn't cheap but them's the breaks. Stopping bad medication from being on the market saves lives, even if it prevents the occasional good one.
The FDA introduces a bootstrapping problem wherein the proceeds from selling a potential remedy cannot be used to test it, and no one other than the inventor can test it, because the product cannot be sold until after it is tested.
In any case, the only hurdle to selling should be "does it do harm?", and "does it work as advertised?" can be determined later, if and only if there is any doubt among the consumers.
Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. Think Consumer Reports or Underwriters' Laboratories. If a problem is found, a recall may occur. If none are evident, the testing body grants its approval to use its trademarks on the product. People look for that trademark from the trustworthy third party.
If the FDA did not apply prior restraint, and tested products already available to the consumer, it could regulate the usage of the phrase "FDA-approved" and make perfectly safe everyone who buys only the medicines bearing that approval for the purposes which have been tested.
> In any case, the only hurdle to selling should be "does it do harm?", and "does it work as advertised?" can be determined later, if and only if there is any doubt among the consumers.
Laws don't operate under the principle of what should be, they are past agreements hammered out by negotiation, not logic. You don't get to say what the hurdle "should" be, that's already been agreed upon and set and it's unlikely to change because a few don't like it.
> Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. If a problem is found, a recall may occur.
Sometimes, sometimes not, it entirely depends on the law in those areas. Recalls don't help people who are dying from bad medication, the FDA's role is preventative, not reactionary.
> If the FDA did not apply prior restraint
That's their job, it's why they exist.
> and tested products already available to the consumer,
Then they'd be useless.
> it could regulate the usage of the phrase "FDA-approved" and make perfectly safe everyone who buys only the medicines bearing that approval for the purposes which have been tested.
Sorry, but their job is to protect people who don't have the information/brains to protect themselves, which in the field of medicine is practically everyone. This solution is simply a libertarian fantasy that has no chance of working in the real world. As the other poster said, see homoeopathy as an example, consumers aren't smart enough to not kill themselves with idiocy, even the rich ones like Steve Jobs.
Federal law requires manufacturers and importers to test many consumer products for compliance with consumer product safety requirements. Based on passing test results, the manufacturer or importer must certify the consumer product as compliant with the applicable consumer product safety requirements in a written certificate that it must provide to retailers, distributors and, upon request, to the government.
As a point of order, you cannot refute a "there exists" assertion with any number of counterexamples.
My point was that it doesn't have to work in the way that the FDA (and other examples of other regulatory agencies) currently function, and your response did not address that.
The scientific community regards homeopathy as nonsense,[11] quackery[12][13][14] or a sham,[15] and homeopathic practice has been criticized as unethical.[16] The axioms of homeopathy are long refuted[17] and lack any biological plausibility.[18] Although some clinical trials produce positive results,[19][20] systematic reviews reveal that this is because of chance, flawed research methods, and reporting bias.[21][22][23][24] The postulated mechanisms of action of homeopathic remedies are not only scientifically implausible[21][25][26][27] but precluded by the laws of physics.[28]
"does it do harm?"
yes, it exists, so it prevents people from accessing real medicine. It is a distraction.
Steve Jobs is a good example...
"Despite his diagnosis, Jobs resisted his doctors' recommendations for medical intervention for nine months,[174] instead consuming a pseudo-medicine diet in an attempt to thwart the disease. According to Harvard researcher Ramzi Amri, his choice of alternative treatment "led to an unnecessarily early death."[206] Cancer researcher and alternative medicine critic David Gorski "disagreed with Amri's assessment," stating, "My best guess was that Jobs probably only modestly decreased his chances of survival, if that."[209] Barrie R. Cassileth, the chief of Memorial Sloan–Kettering Cancer Center's integrative medicine department,[210] said "Jobs’s faith in alternative medicine likely cost him his life.... He had the only kind of pancreatic cancer that is treatable and curable.... He essentially committed suicide."[211] According to Jobs's biographer, Walter Isaacson, "for nine months he refused to undergo surgery for his pancreatic cancer – a decision he later regretted as his health declined."[212] "Instead, he tried a vegan diet, acupuncture, herbal remedies and other treatments he found online, and even consulted a psychic. He also was influenced by a doctor who ran a clinic that advised juice fasts, bowel cleansings and other unproven approaches, before finally having surgery in July 2004."
Yet, it still exists, and people are still buying it, using it, and buying into it. That is an indication the free market doesn't work in drugs. I can go on and on and on, but we need to be protected from ourselves.
So you're advocating doing harm to my life (by blocking legitimate medicine), for the sake of supposedly protecting irrational hippies from themselves (which you may be able to do in this one area---but what about all the other ways they harm themselves)?
I can make my own decisions. Just like 99% of rational people, who are able to judge for themselves that homeopathy is nonsense.
Nobody is blocking legitimate medicine. It is just asked that you prove that it is legitimate medicine before you are allowed to sell it as medicine. That way consumers don't go into a store, find 30 "cures" 3 of which have actual evidence that they work. They might harm themselves by taking the treatment that doesn't work, thus delaying access to the evidence based treatment.
> Just like 99% of rational people, who are able to judge for themselves that homeopathy is nonsense
Rational people fall for pseudo science too, especially if it has a good salesperson behind it. Most people believe what others tell them without questioning. Very few look at the world skeptically. We need to blame the scam artist not the victim.
> The FDA introduces a bootstrapping problem wherein the proceeds from selling a potential remedy cannot be used to test it
To the extent that approval requirements applied by the FDA under the Food, Drug, and Cosmetics Act do that with remedies (which aren't at issue in this case, as it is about a diagnostic device not a tretment), that isn't what happened here, as demonstrated by the fact that the FDA allowed 23andMe to continue to operate for years after issuing the June 2010 letter in which they first raised the issue that the PGS fell within the FDA's regulatory ambit and that various approvals were needed to continue marketing it the way it was marketed.
The "stop now" letter wasn't set until 23andMe stopped working with the FDA toward meeting the requirements, so 23andMe in fact was able, had it chosen to do so, to use the funds from selling its device to test it.
> and no one other than the inventor can test it, because the product cannot be sold until after it is tested.
The FD&C Act doesn't prevent covered "remedies" (etc.) from being sold before they are tested, it prevents them being sold to prevent, treat, or diagnose disease until they've been tested. Products can be sold for, e.g., research purposes before being approved (and, in fact, often are -- one of the suppliers to 23andMe and other genetic testing services was dinged by the FDA for knowingly selling to 23andMe and other genetic testing services products for diagnostic use which were not yet cleared for such use but which were allowed for research use [1].)
> In any case, the only hurdle to selling should be "does it do harm?", and "does it work as advertised?" can be determined later, if and only if there is any doubt among the consumers.
This approach was tried in the health space for many, many years, and the results were deemed unacceptable. Of course, you may have a different opinion of what is desirable than that which motivated the Food, Drug, and Cosmetics Act, but simply asserting that the rules should be different is unconvincing.
> Elsewhere in consumerland, the product is sold, and independent testing is performed on off-the-shelf samples. Think Consumer Reports or Underwriters' Laboratories.
That's true for some consumer products, and its not true for others, generally driven by perceived risk levels.
While I agree that stopping bad medication from being on the market saves lives, medication is not at stake in the case of 23andMe. Information is what's at stake.
