A Win for Liberty

 

Add another check mark in the column of Good Trump! Today President Trump signed the Right to Try Act of 2017 expanding access to unapproved and experimental, but potentially life-saving medications for terminally ill patients.

Upon signing the bill POTUS issued the following statement:

People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home.

Well said, sir, and kudos on striking a blow for liberty.

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  1. Arahant Member
    Arahant
    @Arahant

    Well, God bless him. As you say, another victory for liberty for now.

    • #1
  2. Boss Mongo Member
    Boss Mongo
    @BossMongo

    Outstanding.  Thank you, Jamie.

    • #2
  3. Rodin Member
    Rodin
    @Rodin

    This needs to be expanded to other conditions which may not be terminal but for which there is no established therapeutic protocol and the condition is preventing even minimal functioning. Examples include children with debilitating seizures that are now getting some effective treatment with canabidol. Marijuana needs to be moved off of Schedule I to enable more research.

    • #3
  4. Chris O. Coolidge
    Chris O.
    @ChrisO

    I have a fraternity brother with ALS and don’t really know at this point what may be done, but he was hoping for this.

    • #4
  5. Matt Balzer Member
    Matt Balzer
    @MattBalzer

    As long as the topic is up, I have to ask: why would it take this long to get this signed into law? Alternately, why do we even need a law to cover this?

     

    • #5
  6. Arahant Member
    Arahant
    @Arahant

    Matt Balzer (View Comment):

    As long as the topic is up, I have to ask: why would it take this long to get this signed into law? Alternately, why do we even need a law to cover this?

    Because we have other laws which established the FDA to write the rules and regulations regarding treatments, and they wrote rules and regulations that said, “You can’t do that.” So, Congress and the PotUS are saying, “Yes, you can.”

    • #6
  7. Henry Castaigne Member
    Henry Castaigne
    @HenryCastaigne

    Arahant (View Comment):

    Matt Balzer (View Comment):

    As long as the topic is up, I have to ask: why would it take this long to get this signed into law? Alternately, why do we even need a law to cover this?

    Because we have other laws which established the FDA to write the rules and regulations regarding treatments, and they wrote rules and regulations that said, “You can’t do that.” So, Congress and the PotUS are saying, “Yes, you can.”

    So limiting freedom limits human flourishing. Who knew?

    • #7
  8. tigerlily Member
    tigerlily
    @tigerlily

    I agree – this is a win for liberty. Like Matt Balzar though I wonder why this wasn’t done years ago – it has always seemed like a no-brainer to me. Here’s something a little weird. The bill passed in the Senate by unanimous consent, but in the House the vote was 250-169 with all Republicans voting for it and most Democrats opposed.

    • #8
  9. Jamie Lockett Inactive
    Jamie Lockett
    @JamieLockett

    In politics, for some reason, the low hanging fruit is often the hardest to pick. 

    • #9
  10. Jamie Lockett Inactive
    Jamie Lockett
    @JamieLockett

    In all seriousness, this is the kind of all risk no reward bill we rarely see anymore. On one side you have a small constituency of patients and their families and the other massive lobbying interests of established treatment providers. 

    This is one of those instances where Trumps gut lead him to the common sense, liberty maximalist position. 

    Sure it’s not eliminating the FDA but it’s a start. 

    • #10
  11. Ed G. Member
    Ed G.
    @EdG

    Why only for terminals? It seems that one shouldn’t have to wait until the terminal stage in order to make this choice. Even if one’s condition will never be terminal, aren’t the stakes even lower? So why not have this option for less threatening conditions too?

    I think a reasonable answer is that in general the field of medicine and pharmaceuticals isn’t well suited to a caveat emptor approach; even for relatively benign conditions some remedies can cause significant harm; the cost and time spent in certification is better than the cost and time spent in endless lawsuits or even in genuine harm before the effects are generally known . 

    Better, I think, would be a general  consumer right to knowingly accept the risk of an unapproved product or treatment, with specific penalties for misrepresentation by the providers. But that carries its own risks, i.e. that some remedy ends up doing harm to a significant number of people before the effect is discovered and communicated.

    • #11
  12. Jamie Lockett Inactive
    Jamie Lockett
    @JamieLockett

    Ed G. (View Comment):

    Why only for terminals? It seems that one shouldn’t have to wait until the terminal stage in order to make this choice. Even if one’s condition will never be terminal, aren’t the stakes even lower? So why not have this option for less threatening conditions too?

    I think a reasonable answer is that in general the field of medicine and pharmaceuticals isn’t well suited to a caveat emptor approach; even for relatively benign conditions some remedies can cause significant harm; the cost and time spent in certification is better than the cost and time spent in endless lawsuits or even in genuine harm before the effects are generally known .

    Better, I think, would be a general consumer right to knowingly accept the risk of an unapproved product or treatment, with specific penalties for misrepresentation by the providers. But that carries its own risks, i.e. that some remedy ends up doing harm to a significant number of people before the effect is discovered and communicated.

    Because it could get passed and the risks are mitigated by the eventual terminal diagnosis. 

    • #12
  13. Ed G. Member
    Ed G.
    @EdG

    Jamie Lockett (View Comment):

    Ed G. (View Comment):

    Why only for terminals? It seems that one shouldn’t have to wait until the terminal stage in order to make this choice. Even if one’s condition will never be terminal, aren’t the stakes even lower? So why not have this option for less threatening conditions too?

    I think a reasonable answer is that in general the field of medicine and pharmaceuticals isn’t well suited to a caveat emptor approach; even for relatively benign conditions some remedies can cause significant harm; the cost and time spent in certification is better than the cost and time spent in endless lawsuits or even in genuine harm before the effects are generally known .

    Better, I think, would be a general consumer right to knowingly accept the risk of an unapproved product or treatment, with specific penalties for misrepresentation by the providers. But that carries its own risks, i.e. that some remedy ends up doing harm to a significant number of people before the effect is discovered and communicated.

    Because it could get passed and the risks are mitigated by the eventual terminal diagnosis.

    Agreed, but “terminal” doesn’t mean imminent. There’s plenty of room for long term harm even to terminals. Plus, I believe that in practice the physician certification required will get easier and easier to obtain making this exception much like the practice of fast and loose prescriptions for pain killers and anti depressants.

    • #13
  14. Jamie Lockett Inactive
    Jamie Lockett
    @JamieLockett

    Alright folks, it’s been fun but I’m outta here. See you on the next thread. 

    • #14
  15. Tom Meyer, Common Citizen Contributor
    Tom Meyer, Common Citizen
    @tommeyer

    It’s an extremely good thing that more people will have access to potentially life saving or enhancing medicine. That said, there’s a case that this particular legislation* wasn’t the best way to accomplish this:

    First, there are already options for the terminally-ill to receive experimental treatments that were not yet approved by the FDA. One option is to participate in a clinical trial for a drug up for approval. As of 2016, more than 40,000 Americans were in clinical trials (far more than any other country).

    When/if this is not available, the FDA  has an Expanded Access program that allows “the use outside of a clinical trial of an investigational medical product.” As the briefing @jamielockett linked to noted, this is a small program that only approves 1,200 people a year. However, 99.3% of applications to the program were approved.

    While I imagine the program could be expanded/amended/improved to allow more participants, the sky-high approval rate suggests that there isn’t a huge unmet demand.

    * For clarity’s sake, if blame is warranted in this, it lies on Congress.

    • #15
  16. Tom Meyer, Common Citizen Contributor
    Tom Meyer, Common Citizen
    @tommeyer

    Second, this bill has far fewer consumer protections* than other programs like the Expanded Access program. For example, it guarantees that, sponsors and manufacturers under this program have “no liability in a cause of action.” It also limits the FDA’s ability to intervene if new clinical evidence comes up that calls the experimental drug’s safety or efficacy into question. Most other programs require that the drugs be administered at a reduced cost (if any).

    Given how desperate terminally-ill people can be it seems some vigilance against fraud and abuse is warranted.

    * Or, if you prefer, state-mandated requirements on doctors and pharmaceutical developers.

    • #16
  17. Rodin Member
    Rodin
    @Rodin

    Jamie Lockett (View Comment):

    In politics, for some reason, the low hanging fruit is often the hardest to pick.

    Usually because it is so self-evident that political schemers want to package it with something that is neither self-evident nor benign.

    • #17
  18. A-Squared Inactive
    A-Squared
    @ASquared

    Tom Meyer, Common Citizen (View Comment):
    First, there are already options for the terminally-ill to receive experimental treatments that were not yet approved by the FDA. One option is to participate in a clinical trial for a drug up for approval.

    One obvious problem with participating in a clinical trial is you don’t know if you will be getting the drug or the placebo.

    Now, you could argue that this law may make it more challenging to get people to participate in a clinica trial, but that is a different argument.

    Also, in some of the coverage, I’ve read that you may not be selected to participate in a clinical trial if you are too close to death, which would make sense because if you are nearly dead, the drug may work but you may be too far gone.

    Update: actually the bill seems to allow access only for people ineligible for clinical trials.

    From the link in the OP

    “The bill amends Federal law to allow certain unapproved, experimental drugs to be administered to terminally ill patients who have exhausted all approved treatment options and are unable to participate in clinical drug trials.”

    • #18
  19. A-Squared Inactive
    A-Squared
    @ASquared

    Tom Meyer, Common Citizen (View Comment):
    Second, this bill has far fewer consumer protections* than other programs like the Expanded Access program. For example, it guarantees that, sponsors and manufacturers under this program have “no liability in a cause of action.” It also limits the FDA’s ability to intervene if new clinical evidence comes up that calls the experimental drug’s safety or efficacy into question. Most other programs require that the drugs be administered at a reduced cost (if any).

    A) I don’t think drug companies should have liability for people who voluntarily take experimental drugs. 

    B) The drugs under discussion have already passed FDA level 1 safety trials

    from link in OP

    • Eligible drugs must have undergone the Food and Drug Administration’s (FDA) Phase I (safety) testing.
    • #19
  20. Tom Meyer, Common Citizen Contributor
    Tom Meyer, Common Citizen
    @tommeyer

    A-Squared (View Comment):

    Update: actually the bill seems to allow access only for people ineligible for clinical trials.

    From the link in the OP

    “The bill amends Federal law to allow certain unapproved, experimental drugs to be administered to terminally ill patients who have exhausted all approved treatment options and are unable to participate in clinical drug trials.”

    Correct. My point is that the Expanded Access program is also intended for people not in clinical trials:

    Expanded access, sometimes called “compassionate use,” is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices.

    Wherever possible, use of an investigational medical product by a patient as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. However, when patient enrollment in a clinical trial is not possible (e.g., a patient is not eligible for any ongoing clinical trials, or there are no ongoing clinical trials), patients may be able to receive the product, when appropriate, through expanded access.

    At the most, this bill expands patient access to unproven medicines outside of clinical trials (but does so with fewer consumer protections).

    • #20
  21. Tom Meyer, Common Citizen Contributor
    Tom Meyer, Common Citizen
    @tommeyer

    A-Squared (View Comment):

    A) I don’t think drug companies should have liability for people who voluntarily take experimental drugs.

    Certainly, any liability they have should be extremely limited. I don’t think there should be no potential liability.

    A-Squared (View Comment):

    Eligible drugs must have undergone the Food and Drug Administration’s (FDA) Phase I (safety) testing.

    True, but this is (intentionally) a very limited standard. To pass phase one testing, you must:

    1. Show efficacy in petrie dishes and/or animals
    2. Show that you can administer the drug to humans in some dose without serious side effects.

    Now, this isn’t nothing and if we’re talking about potentially-life-saving stuff, then it might make all the difference. It’s not very likely to, though.

    • #21
  22. Mike H Coolidge
    Mike H
    @MikeH

    A-Squared (View Comment):

    Tom Meyer, Common Citizen (View Comment):
    First, there are already options for the terminally-ill to receive experimental treatments that were not yet approved by the FDA. One option is to participate in a clinical trial for a drug up for approval.

    One obvious problem with participating in a clinical trial is you don’t know if you will be getting the drug or the placebo.

    Now, you could argue that this law may make it more challenging to get people to participate in a clinica trial, but that is a different argument.

    Also, in some of the coverage, I’ve read that you may not be selected to participate in a clinical trial if you are too close to death, which would make sense because if you are nearly dead, the drug may work but you may be too far gone.

    Update: actually the bill seems to allow access only for people ineligible for clinical trials.

    From the link in the OP

    “The bill amends Federal law to allow certain unapproved, experimental drugs to be administered to terminally ill patients who have exhausted all approved treatment options and are unable to participate in clinical drug trials.”

    So you’re only allowed to get the drug if you’re not allowed to possibly get the placebo? That blows. Hopefully everyone can at least get the real drug after they undergo a trial.

    • #22
  23. James Gawron Thatcher
    James Gawron
    @JamesGawron

    Jamie,

    In light of what just happened in Britain over Alfie Evans, Trump & Congress are right on the money. The absurdity of NHS to literally condemn the child to die on schedule when a helicopter, an accredited experimental treatment, and a government that would go so far as to offer him citizenship were all waiting outside his prison hospital door, was painful beyond reason.

    We rarely feel this way or are allowed to feel this way anymore but the old red, white, and blue is still the best hope of mankind.

    Regards,

    Jim

    • #23
  24. A-Squared Inactive
    A-Squared
    @ASquared

    Mike H (View Comment):
    So you’re only allowed to get the drug if you’re not allowed to possibly get the placebo? That blows. Hopefully everyone can at least get the real drug after they undergo a trial.

    If you are in the clinical trial, yes.  Clinical trials are double blind studies where neither the physician nor the patient knows if they getting the trial drug or the placebo.  

    The right to try would allow you to take the drug being tested and know you are receiving the drug but with no evidence that it works (just the knowledge that nothing else has worked.)  

    Once the drug is approved and marketed, people who buy the drug get the drug.  

    • #24
  25. A-Squared Inactive
    A-Squared
    @ASquared

    Tom Meyer, Common Citizen (View Comment):

    A-Squared (View Comment):

    A) I don’t think drug companies should have liability for people who voluntarily take experimental drugs.

    Certainly, any liability they have should be extremely limited. I don’t think there should be no potential liability.

    So, I’m researching a drug and I’m in the middle of drug trials to ensure the drug is effective and safe.  You come to me with the law behind you and say I’m required to let you use this untested drug.  Now, if something goes wrong, you want to be able to sue me for reactions that probably would have been discovered in a full trial.

    No drug manufacturer in the world is going to sign up for that “heads you win, tails I lose” bet.  

    • #25
  26. A-Squared Inactive
    A-Squared
    @ASquared

    But I do agree with the failing NY Times that the benefits of the legislation are being overblown.

    The new national law — like similar laws in more than three dozen states — allows patients and doctors to ask drug companies directly for access to the experimental drugs, rather than wait for approval by the agency.

    Colorado enacted the first right-to-try law in 2014. Since then, “there have been no documented cases of anyone receiving access, because of a right-to-try law, to an experimental product that would not have been available via the F.D.A.’s expanded access program,” a 2017 study by researchers from New York University concluded.

    But it’s Trump.  He will always brag that everything he does is the best thing anyone on earth has ever done, so I treat every claim Trump makes about something being the best thing anyone on earth has ever done with an appropriately massive dose of skepticism. 

    This is still a good law with no downsides and some potential upsides.  It doesn’t have to save hundreds of thousands of lives to be a no-brainer.

    • #26
  27. Tom Meyer, Common Citizen Contributor
    Tom Meyer, Common Citizen
    @tommeyer

    A-Squared (View Comment):

    So, I’m researching a drug and I’m in the middle of drug trials to ensure the drug is effective and safe. You come to me with the law behind you and say I’m required to let you use this untested drug.

    Drug companies are not required to let you use the drug; it’s at their discretion.

    A-Squared (View Comment):
    Now, if something goes wrong, you want to be able to sue me for reactions that probably would have been discovered in a full trial.

    Again, I think the ability to sue drug manufacturers for participating in these programs should be very limited. The bill prohibits it outright.

    • #27
  28. Tom Meyer, Common Citizen Contributor
    Tom Meyer, Common Citizen
    @tommeyer

    A-Squared (View Comment):

    But it’s Trump. He will always brag that everything he does is the best thing anyone on earth has ever done, so I treat every claim Trump makes about something being the best thing anyone on earth has ever done with an appropriately massive dose of skepticism. 

    It’s not just Trump; hell, it’s barely Trump.

    Nearly all of conservative media is downplaying — if not outright hiding — the existence of the Expanded Access Program, which already makes unproven drugs available to the terminally-ill. 

    If people wish to argue that this program is inadequate or in need of reform, please go right ahead.

    • #28
  29. A-Squared Inactive
    A-Squared
    @ASquared

    Tom Meyer, Common Citizen (View Comment):
    Again, I think the ability to sue drug manufacturers for participating in these programs should be very limited. The bill prohibits it outright.

    I’m EXTREMELY skeptical that any liability would be appropriate, but I need an example of when you think it would be ok for a terminally ill patient to sue a drug company for allowing the terminally ill patient who was informed of the risks and asked to use an untested drug before I give any further opinion.  

    • #29
  30. A-Squared Inactive
    A-Squared
    @ASquared

    Tom Meyer, Common Citizen (View Comment):
    If people wish to argue that this program is inadequate or in need of reform, please go right ahead.

    But they just reformed it.  

    At best, your complaint is, they should be saying they expanded access, not created access.  I agree with that.  

    If you have three months to live, I think they should be giving you whatever drugs you want without a lot of red tape.  I’m not all that worried about the risks of being addicted to oxycontin for the last three months of your life.  

    • #30

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