[jlgreco]

It is very hard to say that any patient should be allowed to opt-out of the FDA's regulation because almost without exception every patient that buys into snake-oil thinks it is a good idea that is worth a shot.

How do you distinguish between "this patient is making an informed decision to opt out and use this unapproved drug" and "this patient is an idiot who thinks that throwing money at a "doctor" to mainline bleach will cure his disease"?

[ramanujan]

Three points.

First, many (most?) medical advances seem crazy and kooky because they haven't been tried before. So it's not usually as obvious as "this is a proven scam" vs. "this really works". It's much more frequently "this is unproven". And like Barry Marshall's famous self-experiment with H. pylori, someone has to be first for it to ever get proven.

Second, when the government gets it wrong, it gets it catastrophically wrong. The USDA Food Pyramid recommending "6-11 servings of grain" is still being slavishly followed, and in the fullness of time we might well find it partially responsible for the epidemic of obesity and type II diabetes. The FDA is still doing Phase I/II/III clinical trials despite all the evidence in favor of adaptive trials. And tens of millions of people were irradiated by TSA x-ray scanners fast-tracked through the FDA approval process, scanners criticized by UCSF scientists, scanners which have now (finally) been withdrawn. These errors are magnified in impact because no one can opt-out, because a .gov has a bully pulpit, and because strong political incentives exist to silence criticisms.

Third, if people have the right to euthanasia, or the right to walk near bridges, I do believe they have the right to try what treatments they want. Frankly I don't consider someone else's medical affairs my business, anymore than I'd ask why they had an abortion. You can argue that vaccinations present a public health issue, and I might agree with you there. But otherwise this strikes me as a right to privacy and right to bodily integrity issue.

[jlgreco]

People can inject just about anything they want into themselves (the Controlled Substances Act being the exception). The issue is when 'doctors' get involved and use their position of trust to scam, harm, and kill. These regulations control what doctors and companies can do, not what individuals can do.

btw: "mainlining bleach" is not an exaggeration: http://www.youtube.com/watch?v=H7tkyK8r3yw

[ramanujan]

  People can inject just about anything they want into 
  themselves

Actually, that is expressly not what the Cowan or the earlier Rutherford decision on Laetrile say.

http://www.leagle.com/xmlResult.aspx?page=4&xmldoc=19981...

  In Court, Plaintiff argued that he should have the right to 
  take whatever treatment he wishes due to his terminal 
  condition regardless of whether the FDA approves the 
  treatment as effective or safe, and that to prohibit him 
  from taking the treatment he wishes violates his rights 
  under the United States Constitution.4 The United States 
  Supreme Court previously addressed and rejected this  
  argument in Rutherford. In Rutherford, cancer patients 
  requested the right to use Laetrile, arguing, as does 
  Plaintiff, that for terminally ill patients the 
  effectiveness or safety of the proposed treatment is 
  irrelevant since such treatment is a last chance effort. 
  However, as identified by the Supreme Court in Rutherford, 
  to permit terminally ill patients to seek any type of 
  treatment regardless of the effectiveness of such treatment 
  would create a cottage industry existing solely to provide 
  potential panaceas to highly vulnerable patients. The 
  language of the Supreme Court in rejecting the Laetrile 
  argument is equally applicable here.

  "If history is any guide, this new market would not be long 
  overlooked. Since the turn of the century, resourceful 
  entrepreneurs have advertised a wide variety of purportedly 
  simple and painless cures for cancer, including liniments    
  of turpentine, mustard, oil, eggs, and ammonia; peat moss; 
  arrangements of colored floodlamps; pastes made from   
  glycerin and limburger cheese; mineral tablets; and 
  `Fountain of Youth' mixtures of spices, oil, and suet. In 
  citing these examples, we do not, of course, intend to 
  deprecate the sincerity of Laetrile's current proponents, 
  or to imply any opinion on whether that drug may ultimately 
  prove safe and effective for cancer treatment. But this 
  historical experience does suggest why Congress could 
  reasonably have determined to protect the terminally ill, 
  no less than other patients, from the vast range of self-
  styled panaceas that inventive minds can devise."

I don't know about you, but this argument strikes me as bizarre. Terminal patients are to be protected from their own good from a "drug [that] may ultimately prove safe and effective for cancer treatment" because they might be scammed by "inventive minds"?

The absolute worst case scenario is that they lose some money and die a little sooner. The best case scenario is that they live!

To say that someone else can or should have the power to constrain another human in this way, to keep them from a chance at living, in the name of "protecting" them from doctors or companies...well, we are likely at a fundamental philosophical impasse. Which is why I return to my original point. Feel free to stay in the United States with the FDA. Those with a different cast of mind need a jurisdiction where we can take conscious risks, where we aren't "protected" from medical innovation.

[jlgreco]

The fact that you can currently buy MMS and inject it to your hearts desire says otherwise. You can legally, right now, buy all sorts of medical bullshit that the FDA has not vetted. The court decision you bring up seems clearly aimed at preventing an industry of victimization that could occur if legitimacy were lent without review.

> The absolute worst case scenario is that they lose some money and die a little sooner. The best case scenario is that they live!

No, the worse case scenario is that charlatans, given a license to operate with perceived legitimacy by an "opt-out" system, convince sick people to neglect real treatment for woo. In the vast majority of cases, your best case scenario never happens.

We have a system designed to separate the woo from the real. Despite what one might think from the narrative you paint, human trials are involved in this system and sick people receive experimental treatments every day in a controlled fashion. Perhaps this process could be streamlined, but it must stay in place.