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Thread: The right to try

  1. #1

    The right to try

    A while ago there was thread (I think is lost at the moment) where the idea of creating an "FDA free zone" was discussed.

    Here I see the idea is alive & kicking:

    The Right to Try bill is making its way through the (now infamous) Arizona State Legislature. The basic premise of the Bill is that patients with fatal and incurable diseases should be able to choose for themselves whether or not to try an experimental drug. The Bill's authors state that they should not be constrained by the FDA's approval process. - See more at: http://www.neuralstem.com/neuralstem....DtUVGbuT.dpuf

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  2. #2
    The Neuralstem article got much of this right. I spoke to several of the sponsors of this bill, based on our GOP majority, this bill will most likely be referred to the voters as early as our 2014 General election -- provided sine die happens in time.

    So here are some facts about the bill and its net effect:

    1. It would apply to a very narrow definition of "terminally ill."
    2. It would require a prescribing physician for the drug/device/treatment. Few doctors will be able to do this with their insurance carrier's blessing.
    3. The supplier of the drug/device/treatment is not required to provide it outside of their study.
    4. The patient's insurance carrier is not obligated to pay for drug/device/treatment nor its associated costs.
    5. The bill is, on its face, unconstitutional. FDA authority on such matters is clearly spelled out in federal law and the Fed could exercise preemption. Look as how we're handling marijuana in the US. It's mercurial at best.

    I am always deeply suspicious of any bill with the Goldwater Institute's imprimatur upon it. While some of the co-sponsors are friends, there are several I am currently, very actively working to see defeated for their extremist positions. It will not, in it current form, apply in any way to us. It's a very short bill, you can read it yourself.

    http://www.azleg.gov/legtext/51leg/2...s/hcr2005p.pdf
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  3. #3
    Thank you Jen for taking the time to look into it.

    I went to read the bill and it is clear that the way it is framed at the moment it will not be applicable to SCI experimental therapies.

    Also, if I get it right, the therapy must have successfully completed phase one clinical trial.

    Here is an other article on the bill:

    http://freebeacon.com/the-right-to-try/

    Then according to the Goldwater Institute, similar laws are under consideration by lawmakers in Colorado, Louisiana and Missouri, and legislators in California and Massachusetts have expressed interest.

    I wonder how would that be different from what the AIDS people did as they had access to non FDA approved therapies which tured out to be efffective and saved many lives?

    Paolo
    In God we trust; all others bring data. - Edwards Deming

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