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Unapproved Drugs and ‘Right to Try’ Laws

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Patients Seek ‘Right to Try’ New Drugs - NY Times

 

 

LYONS, Colo. — Since May, a string of states have passed laws that give critically ill patients the right to try medications that have not been approved by the Food and Drug Administration.

Deemed “Right to Try” laws, they have passed quickly and often unanimously in Colorado, Michigan, Missouri, Louisiana and Arizona, bringing hope to patients like Larry Kutt, who lives in this small town at the edge of the Rocky Mountains. Mr. Kutt, 65, has an advanced blood cancer and says his state’s law could help him gain access to a therapy that several pharmaceutical companies are testing. “It’s my life,” he said, “and I want the chance to save it.”

 

The laws do not seem to have helped anyone obtain experimental medicine, as the drug companies are not interested in supplying unapproved medications outside the supervision of the F.D.A. But that seems almost beside the point to the Goldwater Institute, the libertarian group behind legislative efforts to pass Right to Try laws. “The goal is for terminally ill patients to have choice when it comes to end-stage disease,” said Craig Handzlik, state policy coordinator for the Goldwater Institute, based in Arizona. “Right to Try is something that will help terminally ill people all over the country.”

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What is the issue at hand preventing this from being legal in the first place? Is this any kind of slippery slope? Does this present any potential for some kind of an illegal or black-market? Will we see a rise in snake-oil salesman?

This is probably one of the toughest things in the medical field to address.

 

Drug testing is long, difficult process with various legal issues. What happens if the drug causes severe side effects or even death? What about interactions with other drugs or interactions with unrelated conditions that cause problems, or death? Does this create legal issues that may prevent an otherwise drug that eventually would help thousands of other people after going through the current, long drug trials because of lawsuits related to the above?

 

It sounds great - just try it - what have people in desperate situation have to lose is obviously the mindset. But many, difficult issues.

The Libertarian point of view is that a government agency should not be regulating anything one should want to put into their bodies. The risk is that some things pharmaceutical companies produce can and have killed people, instead of helping them.

 

As a Libertarian, I believe people wanting to risk taking these unapproved drugs should be allowed to do so. However, it needs to be clear that, if they do so, the pharmaceutical companies are not legally responsible for the results or side effects of said drugs and the government (aka the rest of us) are not financially responsible to treat those results or side effects.

 

Some "so called" Libertarians want their cake and they want to eat it, too. Drives me nuts.

I believe that if I am facing an end-of-life illness I should be allowed to put anything into my body that I choose that may either: 1) help cure me or B) help me end my life. Not popular with my sister (nurse) but I don't want the government telling me anything at that point in my life.

 

Tort reform limiting liabilities would cure some of this nonsense.

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