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posted by janrinok on Friday June 01 2018, @02:26AM   Printer-friendly
from the lame-shall-walk-and-blind-shall-see dept.

Trump signs 'right to try' drug bill

President Trump signed a bill Wednesday allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans.

"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families.

Trump thanked lawmakers sitting in the audience who sponsored the bill, including Sen. Joe Donnelly, a vulnerable Democrat up for reelection in Indiana.

Also at CNN.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Texas Sanctions FDA-Unapproved Stem Cell Therapies
Drug Approvals Sped Up in 2017

Also submitted by mrpg


Original Submission

 
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  • (Score: 4, Interesting) by Runaway1956 on Friday June 01 2018, @02:48AM (13 children)

    by Runaway1956 (2926) Subscriber Badge on Friday June 01 2018, @02:48AM (#687042) Journal

    Informed consent. The doctor, researcher, or village quack who withholds critical information can be put on trial for fraud. All this bill seems to do, is to give the patient the right to decide.

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  • (Score: 0) by Anonymous Coward on Friday June 01 2018, @02:51AM (9 children)

    by Anonymous Coward on Friday June 01 2018, @02:51AM (#687045)

    Definitely nothing that can go wrong with a patient that thinks there is no hope, being handed a 276 page tome in 7pt font all caps and told: "sign here in the next 5 minutes or you no longer qualify to be trying this thing; this is your informed consent form"
    Definitely nothing that can go wrong there... no sir-ee...

    Aren't you the same guy who keeps railing about people who get fsck'ed over by farcebook after not reading the TOS and how it's all their own fault?

    • (Score: 4, Informative) by qzm on Friday June 01 2018, @02:54AM (2 children)

      by qzm (3260) on Friday June 01 2018, @02:54AM (#687046)

      So, you would rather the national legal system blocked the Terminal patients right to decide?
      You are certain that a single one-law-fits-all solution 'is in the best interestes of the individual'?
      Interesting...

      Of course this is more likely a 'The Chinese are steamrollering us on medical research, so we need to loosen things up a bit' Bill, but hey.

      • (Score: 2, Insightful) by Anonymous Coward on Friday June 01 2018, @03:08AM (1 child)

        by Anonymous Coward on Friday June 01 2018, @03:08AM (#687056)

        I wouldn't like a system where the law blocks a patient's right to decide as such. I would like to see more safeguards built in for abuses that have been committed in the past in schemes that are similar to this and for which we have good historical data that they will happen again.
        Those safeguards were not in place before this bill was signed (this isn't about D vs R), but more crucially they also are not introduced with this bill which opens up the possibilities and -dare I say- probabilities of those abuses.
        This bill just opens the door to the west going: "Hey you guys, just go and grab some land over there and feel free to shoot anyone that stands in your way"
        There for sure are beneficiaries of this bill, terminal patients aren't it. They will be used as cheap lab-rats without any form of protection because "they signed this X hundred pages of legalese that now shows they gave /informed/ consent". It's that "being used as cheap lab-rats" that I am very, very worried about...

        • (Score: 0) by Anonymous Coward on Friday June 01 2018, @05:51AM

          by Anonymous Coward on Friday June 01 2018, @05:51AM (#687119)

          I remember about 20 years ago people were pushing hard for something like this. I guess people can push to take it away. Whatever.

          Sucks to have a long memory

    • (Score: 2, Troll) by Runaway1956 on Friday June 01 2018, @02:58AM (3 children)

      by Runaway1956 (2926) Subscriber Badge on Friday June 01 2018, @02:58AM (#687050) Journal

      You haven't described "informed consent" - you have however described coercion and probably fraud. Which part of "informed consent" are you having problems with? The typical terminal illness takes months or years to run it's course. There is time to research, if one wishes to research.

      • (Score: 1, Informative) by Anonymous Coward on Friday June 01 2018, @03:20AM (2 children)

        by Anonymous Coward on Friday June 01 2018, @03:20AM (#687061)

        When was the last time you read the little piece of paper that comes with your meds (and unfolds to something the size of your mattress)? When was the last time you actually read the piece of paper you get when you go to a doctor in the US that says you consent to treatment? When was the last time you read FB's TOS?

        You're muddying the water suggesting that I do not understand 'informed consent' but that's not the point here... Farcebook users also give 'informed consent' but that means jack crap in practice. And it's this "in practice" that we need to protect against. Sure, they can check the boxes and be 'within the law' but that still doesn't make the behavior ethical.

        We have a multitude of past behaviors where these types of schemes that involve 'informed consent' have been exploited by those in the power position and there is no protection against that in this bill.
        I could be testing cyanide pills on people and bury the fact that there is a 99.9% mortality rate with partaking in the experiment, deep, deep in the informed consent document and I would literally get away with murder in this case... and you would be there going "yeah, this person should go scott-free" because the people gave 'informed consent'.

        What's so wrong with the current state of affairs? Why do we need more bodies (literally and figuratively) earlier and earlier in this process of drug approvals? Let me tell you: because it's expensive to do so and it bloody well should be. These are things where I want people to dot the i's and cross the t's. It is cost for drug manufacturers that is driving this, not 'helping the terminally ill' or providing them with hope... they want to lower that cost with cheap lab-rats.

        • (Score: 3, Insightful) by jmorris on Friday June 01 2018, @04:23AM

          by jmorris (4844) on Friday June 01 2018, @04:23AM (#687082)

          When was the last time you read the little piece of paper that comes with your meds

          When they prescribe something for the first time. Don't you RTFM? Some of those drugs can KILL YOU if you don't read and pay heed to those warnings. Are you a fricking End User or something? You are what is wrong with America! You want somebody to do your thinking and deciding for you. Freedom is too much responsibility.

          When was the last time you read FB's TOS?

          Never, no FB account. But I know a TOS or EULA ain't worth squat legally so I don't really bother with them generally. Tech companies are going to screw you regardless of what they say anyway, any information you give them will be used against you and you have zero recourse unless you have a few hundred thousand dollars lying around without a better use than a likely pointless legal exercise.

          But yeah, I support this bill. It takes a minimum of a decade to get a drug through the FDA's normal path. Everybody obsesses over people who die from a drug that doesn't work because they can see those dead bodies, see they died as a result of a bad drug, people can be sued, lose their jobs over it, etc. The FDA does likewise, taking a nobody will get fired for ordering another round of clinical trials just to be extra sure stance. But everybody is forgetting the unseen piles of bodies, those who died waiting. Take the next big drug approval, listen to them talk about how many lives per year it will save. Now consider that for every year that could have been saved in the approval process that many people could have been saved, that many people died waiting.

          Yes, many drugs fail in testing, some in really splashy and embarrassing ways that can end the pharma company responsible for the failure. So yes we do need an approval process, we need testing, we need to make sure stuff really works before going from the lab to widescale production. We also need to keep the people who are dying from these diseases in mind as well. Especially when we are talking about terminal conditions with no current treatment. It isn't the end of the world if the next big wiener pill gets delayed, but cancer kills people. F*ck cancer.

        • (Score: 2) by Runaway1956 on Friday June 01 2018, @03:02PM

          by Runaway1956 (2926) Subscriber Badge on Friday June 01 2018, @03:02PM (#687264) Journal

          The first line of Jmorris' reply is apt here. I read medical brochures, the warnings, etc. I read them sometimes before I became a parent. When my little boys were due for inoculations, I started reading those things diligently. I was involved, and felt that I really needed to be informed. That has carried over into my more mature years. Doc wants to give me oxycodone? I've read that a few times - and I've turned it down a couple times. "Hell, Doc, I'm not really hurting. I'll just get some aspirin, or tylenol, or something." I've still got a bottle of etodolac, I guess it's a generic for Lodine. Shit makes me sick, so I didn't take them. Of course, the warnings actually warned about that. Take 'em on a full stomach, or suffer the consequences. Problem was, soon after I took the pill, I had an empty stomach again. I read.

          I understand what you are saying about sneaky "contracts", but we also have a judiciary system that has ruled against those iron clad contracts sometimes.

          Granted, this isn't the best of times in America's history to challenge unjust contracts, but it has happened, and it will happen again. You've noticed all the activists, up in arms against Farcebook, and others? The pendulum swings in both directions, and Trump isn't going to stop is swinging. Slow it down a little, if he really tries, but he ain't stopping it.

    • (Score: 1, Funny) by Anonymous Coward on Friday June 01 2018, @03:01AM (1 child)

      by Anonymous Coward on Friday June 01 2018, @03:01AM (#687052)

      I suspect that you may be an ancient Greek alchemist or some such. Today we have "volumes", rather than tomes.

      • (Score: 1, Funny) by Anonymous Coward on Friday June 01 2018, @03:24AM

        by Anonymous Coward on Friday June 01 2018, @03:24AM (#687062)

        I'm chiseling as fast as I can on this tablet...

  • (Score: 0) by Anonymous Coward on Friday June 01 2018, @03:29AM (2 children)

    by Anonymous Coward on Friday June 01 2018, @03:29AM (#687066)

    I find your signature concerning. Have you considered talking to a professional about this virtue signaling of yours?

    • (Score: 0) by Anonymous Coward on Friday June 01 2018, @04:30AM

      by Anonymous Coward on Friday June 01 2018, @04:30AM (#687084)

      (psst! The wimangry pills did not work. Ascii art of firearms is all that is left of his manhood. Have some mercy!)

    • (Score: 2) by Runaway1956 on Friday June 01 2018, @03:08PM

      by Runaway1956 (2926) Subscriber Badge on Friday June 01 2018, @03:08PM (#687267) Journal

      Your concern is a "good thing". Stay concerned. And, no, I won't be talking to any "professionals", thank you very much. Maybe you will feel better with a nice, new, comfy T-shirt https://www.gruntstyle.com/products/i-am-the-weapon [gruntstyle.com]