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posted by Fnord666 on Tuesday January 09 2018, @11:31PM   Printer-friendly
from the give-it-a-try dept.

Groups funded by Charles and David Koch have launched ad campaigns aimed at urging Congress to pass legislation that would make it easier for terminally ill patients to try experimental treatments. The bill passed the Senate unanimously, but FDA Commissioner Scott Gottlieb told the House in October (archive) that the FDA already approves 99% of requests for expanded access/compassionate use, and that the primary roadblock is not the FDA, but drug supply constraints. He said that pharmaceutical companies do not continuously manufacture a drug undergoing clinical trials, but instead produce "discontinuous batches":

Several deep-pocketed political advocacy groups founded by Charles and David Koch are ramping up their advocacy before Congress on a niche issue: access to experimental drugs.

On Monday, several Koch-backed groups, including Freedom Partners and Americans for Prosperity, launched an ad campaign urging Congress to pass so-called "right-to-try" legislation, which aims to help terminally ill patients access experimental treatments that haven't yet been approved by the Food and Drug Administration. The Senate unanimously passed a right-to-try bill from Sen. Ron Johnson (R-Wis.) last August, but it has since stalled in the House. Supporters, including lawmakers on Capitol Hill and other off-the-Hill advocates, are focusing their efforts this month on the Energy and Commerce Committee, which would likely have to clear the legislation before the full House could vote on it.

The new ad campaign — also sponsored by Generation Opportunity and The LIBRE Initiative — directly addresses Congress, saying at the end of one commercial, "Congress, give patients a chance. Pass right to try." In addition to a series of digital ads focused on D.C. and key congressional districts, the campaign will include lobbying efforts by the groups, according to a press release. In a letter sent Monday to Committee Chairman Greg Walden (R-Ore.), executives wrote, "We strongly urge your committee to act expeditiously to approve Right to Try legislation and send the bill to the House Floor for a full vote."

Johnson told STAT he's doing everything he can this month to get the legislation passed, and suggested the vice president might become even more engaged. Vice President Mike Pence has supported right-to-try efforts since he signed a similar law as governor of Indiana.

S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Texas Sanctions FDA-Unapproved Stem Cell Therapies
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Drug Approvals Sped Up in 2017


Original Submission

Related Stories

What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry 33 comments

President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.

According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.

Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.

The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.


Original Submission

FDA Nominee is a Proponent of "Adaptive Trials" 21 comments

Scott Gottlieb, President Trump's nominee to run the FDA, is a proponent of adaptive clinical trials, which would allow adjustments of trials as they are ongoing:

In 2006, Scott Gottlieb, then a deputy commissioner at the U.S. Food and Drug Administration (FDA), stood before an audience of clinicians and researchers to sing the praises of a new approach to drug trials. Instead of locking in a study's design from the start, researchers could build in options that would allow them to adjust along the way, based on the data they had collected. They could make the trial larger or smaller, for instance, add or remove arms, or change how incoming patients get assigned to them. Gottlieb predicted such adaptive trial designs, the topic of the conference he attended that distant summer in Washington, D.C., would "tell us more about safety and benefits of drugs, in potentially shorter time frames."

This week, as President Donald Trump's nominee to head FDA, Gottlieb sat before Republican lawmakers hungry for promises of "shorter time frames" for drug and device approvals, and again expressed his zeal—repeatedly—for adaptive trial designs. If confirmed to be FDA's head, as expected, Gottlieb suggested he'd promote wider use of the approach.

But for all their promise, many adaptive trial features still aren't commonplace. And Gottlieb will face a number of obstacles to encouraging their wider use, experts tell ScienceInsider.


Original Submission

Texas Sanctions FDA-Unapproved Stem Cell Therapies 12 comments

Texas has approved a "right-to-try" law that will allow patients access to experimental treatments as a last resort, but without FDA oversight:

Texas Governor Greg Abbott yesterday signed a bill allowing clinics and companies in the state to offer people unproven stem cell interventions without the testing and approval required under federal law. Like the "right to try" laws that have sprung up in more than 30 states, the measure is meant to give desperately ill patients access to experimental treatments without oversight from the U.S. Food and Drug Administration (FDA).

In a state where unproven stem cell therapies are already offered widely with little legal backlash, bioethicists and patient advocates wonder whether the state's official blessing will maintain the status quo, tighten certain protections for patients, or simply embolden clinics already profiting from potentially risky therapies.

"You could make the argument that—if [the new law] was vigorously enforced—it's going to put some constraints in place," says Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, who last year co-authored a study documenting U.S. stem cell clinics [DOI: 10.1016/j.stem.2016.06.007] [DX] marketing directly to consumers online, 71 of which were based in Texas. But "it would really be surprising if anybody in Texas is going to wander around the state making sure that businesses are complying with these standards," he adds. Either way, Turner says there's "powerful symbolic value" in "setting up this conflict between state law and federal law."

But are the rights of stem cells being protected?


Original Submission

University Could Lose Millions From “Unethical” Research Backed by Peter Thiel 77 comments

Questionable herpes vaccine research backed by tech heavyweight Peter Thiel may have jeopardized $15 million in federal research funding to Southern Illinois University School of Medicine. That's according to documents obtained by a Freedom of Information Act request by The State Journal Register.

In August, Kaiser Health News reported that Thiel and other conservative investors had contributed $7 million for the live-but-weakened herpes virus vaccine, developed by the late SIU researcher William Halford. The investments came after Halford and his private company, Rational Vaccines, had begun conducting small clinical trials in the Caribbean nation of St. Kitts and Nevis. With the off-shore location, Rational Vaccines' trial skirted federal regulations and standard safety protocols for human trials, including having approval and oversight from an institutional review board (IRB).

Experts were quick to call the unapproved trial "patently unethical," and researchers rejected the data from publication, calling the handling of safety issues "reckless." The government of St. Kitts opened an investigation into the trial and reported that health authorities there had been kept in the dark.

Source: https://arstechnica.com/science/2017/11/university-could-lose-millions-from-unethical-research-backed-by-peter-thiel/


Original Submission

"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight? 34 comments

Unregulated herpes experiments expose 'black hole' of accountability

Recent revelations that a U.S. researcher injected Americans with his experimental herpes vaccine without routine safety oversight raised an uproar among scientists and ethicists. Not only did Southern Illinois University researcher William Halford vaccinate Americans offshore, he injected other participants in U.S. hotel rooms without Food and Drug Administration oversight or even a medical license. Since then, several participants have complained of side effects.

But don't expect the disclosures after Halford's death in June to trigger significant institutional changes or government response, research experts say. "A company, university or agency generally does not take responsibility or take action on their own to help participants, even if they're hurt in the trial," said Carl Elliott, a professor in the Center for Bioethics at the University of Minnesota. "These types of cases are really a black hole in terms of accountability." The federal government once scrutinized or even froze research at universities after learning of such controversies. Now, experts said, the oversight agencies tend to avoid action even in the face of the most outrageous abuses.

Experts said the U.S. regulatory agencies are especially unprepared to deal with off-the-grid experiments like Halford's. He recruited subjects through Facebook and in some cases didn't require signed consent forms, or informed participants outright that the experiments flouted FDA oversight. These patients, many who struggle with chronic, painful herpes, proceeded anyway in their quest for a cure. After Halford's offshore trial, Peter Thiel, a libertarian and adviser to President Donald Trump, pitched in millions of dollars for future research.

Previously: Hopes of Extended Lifespans Using Transfusions of Young People's Blood
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel


Original Submission

Drug Approvals Sped Up in 2017 4 comments

New drug approvals hit 21-year high in 2017

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose in the European Union.

The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world's second biggest market behind the United States.

Yet the world's biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies. Consultancy Deloitte said last month that projected returns at 12 of the world's top drugmakers were at an eight-year low of only 3.2 percent.

Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.

Food and Drug Administration Commissioner Scott Gottlieb has indicated that it might be time to revise the Orphan Drug Act of 1983.


Original Submission

Former FDA Commissioner Scott Gottlieb Joins Pfizer Board of Directors 14 comments

Scott Gottlieb walks through the revolving door to the Pfizer board

The revolving door turns again. After a two-year stint running the Food and Drug Administration, Scott Gottlieb has joined the board of directors at Pfizer, giving the world's largest drug maker crucial insights into the inner workings of the Trump administration as it attempts to contain national angst over the rising cost of medicines.

And in doing so, Gottlieb is also picking up where he left before joining the agency, since he had been on the board of several smaller pharmaceutical companies and was also a partner at a venture capital firm that invests in life sciences companies.

"This is classic and it's not surprising," said Sidney Wolfe, a founder of Public Citizen Health Research Group and a long-time FDA watchdog, who had expressed concern about Gottlieb's ties to industry before joining the agency. "Philosophically, he's returning to the ecosystem where he's most comfortable. And he'll get paid very well for it, too."

Also at Financial Times.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Drug Approvals Sped Up in 2017
Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation
FDA Labels Kratom an Opioid
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated] (including Pfizer)
U.S. to Make More Drugs Easily Available, Cutting Role Docs Play


Original Submission

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  • (Score: 0) by Anonymous Coward on Tuesday January 09 2018, @11:36PM (12 children)

    by Anonymous Coward on Tuesday January 09 2018, @11:36PM (#620267)

    So which one of these bastards is dying? Have they tried the Rockefeller first breast milk regime? Or the Peter Thiel Vampirism? Have they given "Goat Gland Science" a try? Would be nice to have a right to dry!

    • (Score: 5, Insightful) by bob_super on Wednesday January 10 2018, @12:20AM (9 children)

      by bob_super (1357) on Wednesday January 10 2018, @12:20AM (#620277)

      They're billionaires, they can get any drug they want, FDA or not...

      I'm struggling to find the selfish-evil angle ... It's the Koch, so there has to be one. Can someone help?

      • (Score: 3, Insightful) by mmcmonster on Wednesday January 10 2018, @12:32AM (5 children)

        by mmcmonster (401) on Wednesday January 10 2018, @12:32AM (#620279)

        They own the drug companies.

        The companies will charge $10k/dose or (much) higher, as there is a small lot size.

        Billionaire drug company owners get richer.

        Health care premiums go up for everyone to cover $1M extra in drugs to keep a single patient alive an extra week (or statistically not any longer than without the medication).

        • (Score: 4, Insightful) by takyon on Wednesday January 10 2018, @12:46AM (4 children)

          by takyon (881) <{takyon} {at} {soylentnews.org}> on Wednesday January 10 2018, @12:46AM (#620285) Journal

          The FDA man says they already approve 99% of the expanded access requests.

          I'm not sure the patients are always paying for the experimental drugs. They might be getting them free of charge so that the companies can gather data. But even if they are paying, how does the bill change anything?

          --
          [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
          • (Score: 2) by Pino P on Wednesday January 10 2018, @03:21PM (1 child)

            by Pino P (4721) on Wednesday January 10 2018, @03:21PM (#620483) Journal

            The FDA man says they already approve 99% of the expanded access requests.

            How often has cannabidiol (CBD) oil for seizure disorders fallen in the 99%? Or is it in the 1% because of the stigma and DEA red tape around other extracts from cannabis that do get you high, unlike CBD?

            • (Score: 2) by t-3 on Wednesday January 10 2018, @07:28PM

              by t-3 (4907) on Wednesday January 10 2018, @07:28PM (#620585)

              CBDs do get you high, they're just subtler than THC. I've had some more THC strains that were very enjoyable.

          • (Score: 2) by Immerman on Wednesday January 10 2018, @04:03PM

            by Immerman (3985) on Wednesday January 10 2018, @04:03PM (#620498)

            What's the delay in approval? Government bureaucracy + terminal patients desperate enough to try experimental treatments could equal an awful lot of people dying before treatment begins - or just having their ailment advance to the point where they no longer make such good guinea pigs.

            I think most experimental treatments are paid for by the patient (which is appalling - you shouldn't have to pay for the privilege of playing guinea pig for some billion-dollar medical company). And of course insurance doesn't cover experimental treatments.

            There is of course also the distinct possibility that the real gains have nothing to do with the stated purpose of the bill - e.g. section 231, subsection R requires insurers to pay for experimental treatments, which could greatly increase the number of people getting them. Or alternately, some buried loophole could allow the sale of "experimental" snake oil. One would hope the bad press would discourage such behavior, but estimates are that as many as half of all FDA approved drugs are already not substantially more effective than a placebo when independently tested, so snake-oil sales are clearly thriving even within the existing regulatory structure - and if you know you're selling snake oil, why pay for all that fraudulent testing?

          • (Score: 0) by Anonymous Coward on Saturday January 13 2018, @03:14PM

            by Anonymous Coward on Saturday January 13 2018, @03:14PM (#621817)

            I haven't read the bill, but what concerns me is that they will try and use it to get desperate people to pay to be part of drug trials, or even just pay for unproven treatments which probably don't work. Patients taking part in trials really shouldn't be paying because it biases the trials towards those who can pay, this can affect outcomes as rich people tend to be healthier, and if patients are actually part of a trial, they may be in the placebo group, and not getting the drug anyway.

      • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @12:34AM

        by Anonymous Coward on Wednesday January 10 2018, @12:34AM (#620280)

        I wonder how much money the drug cartels will charge for these experimental medicines/treatments. I'm guessing 10000% markup.

      • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @08:28AM

        by Anonymous Coward on Wednesday January 10 2018, @08:28AM (#620386)

        I'm struggling to find the selfish-evil angle ... It's the Koch, so there has to be one. Can someone help?

        I think in this case there really isn't that much of one. Both patients and researchers would have more leeway. The only positive for drug companies is that it would be easier for them to test new drugs on people, at least small number of people. They are also less likely to be sued if something terrible happens because you know, the patients were on their way out anyway.

        So no, this is not charity, but this is one of the few cases where government regulation can be removed without causing damage. But this regulation wasn't in place because "government wants control". It came into effect because of things like https://en.wikipedia.org/wiki/Thalidomide#Birth_defects_crisis [wikipedia.org]

      • (Score: 1, Insightful) by Anonymous Coward on Wednesday January 10 2018, @07:35PM

        by Anonymous Coward on Wednesday January 10 2018, @07:35PM (#620590)

        I'm struggling to find the selfish-evil angle ... It's the Koch, so there has to be one. Can someone help?

        I'm glad you asked! Here it is (hold on to your hat):

        They want to sell drugs without that pesky science part. Here's how it works:

        1. Make drug xyz that might or might not work.
        2. Save $$$ by skipping the testing phase for the normal FDA approval process.
        3. Given a large enough population of those taking drug xyz under "right to try," there will be enough in the population who get better while taking drug xyz.
        4. Plaster these stories of individuals experiencing miraculous recovery all across the mainstream press and make sure people understand that the FDA are the bad guys.
        5. Sell drug xyz to anybody who thinks they might have a related condition.
        6. Profit!

        If I must insert a ??? step, it should go between steps 4 and 5. That's where some astroturf group of suffers of whatever condition go full victim in the press. Those evil naughty bad guys at the FDA are killing patients!

        However, this ??? step is always ongoing. It's how we got here after all.

        Oh, I forgot step 7: anybody drug xyz doesn't help is just doing it wrong. They're morally evil wicked failed drug seeker addicted whatever.

        (With astounding cognitive dissonance that only a human could manage, people using these right to try laws will not be "drug seekers" because "drug seekers" are evil bad no good naughty wicked failed unpeople.)

    • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @01:30AM

      by Anonymous Coward on Wednesday January 10 2018, @01:30AM (#620293)

      Don't they mean "Right to Try on Peasants"?

    • (Score: 1) by khallow on Wednesday January 10 2018, @05:01PM

      by khallow (3766) Subscriber Badge on Wednesday January 10 2018, @05:01PM (#620514) Journal

      So which one of these bastards is dying?

      Q: Who isn't dying? A: the people who are already dead.

  • (Score: 2, Funny) by Justin Case on Wednesday January 10 2018, @12:36AM (9 children)

    by Justin Case (4239) on Wednesday January 10 2018, @12:36AM (#620281) Journal

    1. Money is bad.

    2. Kochs have money.

    Therefore: Kochs are bad.

    3. "Right-to-try" is backed by Kochs.

    Therefore: "right-to-try" is bad.

    No point discussing the actual pros and cons of the actual issues when the logic is this straightforward and simple.

    • (Score: 3, Insightful) by takyon on Wednesday January 10 2018, @12:44AM

      by takyon (881) <{takyon} {at} {soylentnews.org}> on Wednesday January 10 2018, @12:44AM (#620284) Journal

      Ok, so "Evil-Backed Groups Urge Congress to Pass 'Right to Try' Legislation". But does that mean the legislation is evil? Not necessarily.

      It does look like it's unnecessary. This is an area where you would expect Gottlieb (evil?) to be supportive since he wants drug development to move faster. But he's just "meh".

      --
      [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
    • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @01:04AM (1 child)

      by Anonymous Coward on Wednesday January 10 2018, @01:04AM (#620286)

      How in the world does the Federal Government have the authority to forbid individuals from trying such treatments, anyway?

      It makes no sense.

      • (Score: 2) by Pino P on Wednesday January 10 2018, @03:23PM

        by Pino P (4721) on Wednesday January 10 2018, @03:23PM (#620484) Journal

        How in the world does the Federal Government have the authority to forbid individuals from trying such treatments, anyway?

        The opinion of the Supreme Court of the United States in Lopez v. Gonzales, 549 U.S. 47 [wikipedia.org], explains the reasoning.

    • (Score: 5, Interesting) by NewNic on Wednesday January 10 2018, @01:06AM

      by NewNic (6420) on Wednesday January 10 2018, @01:06AM (#620288) Journal

      Be realistic: for the most part, the people offering these treatments are going to be snake-oil salesmen.

      --
      lib·er·tar·i·an·ism ˌlibərˈterēənizəm/ noun: Magical thinking that useful idiots mistake for serious political theory
    • (Score: 5, Informative) by bob_super on Wednesday January 10 2018, @01:47AM (2 children)

      by bob_super (1357) on Wednesday January 10 2018, @01:47AM (#620301)

      1. Money is bad.

      2. Kochs have money.

      Therefore: Kochs are bad.

      Wrong way to read it. The Kochs consistently do "bad" things with their money.
      The problem isn't the money itself being bad, it's specifically how they optimize getting more of it at people's expense, and how they use it for Fuck-You causes.

      I can't say I understand how these kinds of people just go to their very comfy bed every night knowing that so many people just plain associate their family name with being evil. I know money numbs you, and "they're just jealous" probably helps... But many people are not jealous, just plain appalled.

      • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @06:34AM

        by Anonymous Coward on Wednesday January 10 2018, @06:34AM (#620364)

        Life is a game to get the most and be remembered the longest. Those other guys are just upset they suck at it. They're too weak to ever be important thus they don't matter anyway.

      • (Score: 2) by ilsa on Wednesday January 10 2018, @08:57PM

        by ilsa (6082) on Wednesday January 10 2018, @08:57PM (#620624)

        I would guess that it's because they dehumanize the people below them and consider them inconsequential. After all, if they amounted to anything, they'd already be rich, right?

    • (Score: 5, Funny) by aristarchus on Wednesday January 10 2018, @02:33AM (1 child)

      by aristarchus (2645) on Wednesday January 10 2018, @02:33AM (#620315) Journal

      Your syllogism is flawed:

      1. Kochs are bad.

      2 Kochs have Money.

      Sub-conclusion one: Therefore: Money is the source of all evil.

      Further premise: "Right-to-try" is backed by Kochs.
      Further axiom: Whatever is backed by the Kochs cannot be good.
      Summa cum Loudly Conclusion: Therefore: "right-to-try" is bad.

      Corrolary: When rich people try to do medicine, they are either facing the insignificance of their puny lives in the face of their impending demise. Or, they stand to make a shitload of money.

      Nota Bene: I expect khallow will be along shortly to toady up and defend the richies. After all, what wrong have they done, besides be successful? Don't hate me because I'm beautiful, bro!

      Quod erat Demonstrandum, with flourishes.

      • (Score: 1) by khallow on Wednesday January 10 2018, @02:50PM

        by khallow (3766) Subscriber Badge on Wednesday January 10 2018, @02:50PM (#620473) Journal

        I expect khallow will be along shortly to toady up and defend the richies.

        Clocking in! So defend the richies from what? Shouldn't there be some sort of attack on them in the first place? Yea, we get Koch brothers bad. Not feeling the care.

        When rich people try to do medicine, they are either facing the insignificance of their puny lives in the face of their impending demise. Or, they stand to make a shitload of money.

        Insignificance is relative. The insignificance of that is far less than the insignificance of posting drivel. And such things have the potential for far reaching changes to the cosmos too (simply because life and the things it can create have this potential). So it may not be as insignificant as it appears to you. I'm not holding my breath for cosmic significance, but odds are better with supporting medical discoveries.

  • (Score: 3, Interesting) by MichaelDavidCrawford on Wednesday January 10 2018, @12:42AM

    by MichaelDavidCrawford (2339) Subscriber Badge <mdcrawford@gmail.com> on Wednesday January 10 2018, @12:42AM (#620283) Homepage Journal

    I agree with the Koch brothers

    In Canada and I expect other countries the drug companies have compassionate drug programs that offer greatly reduced prices for low income people

    --
    Yes I Have No Bananas. [gofundme.com]
  • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @01:35AM (13 children)

    by Anonymous Coward on Wednesday January 10 2018, @01:35AM (#620296)

    I have not wanted to live for at least 7 years, but people are determined to make my exit as painful and as horrible as possible because I am being selfish for wanting to die, despite the horror that is the violence of their behavior, the Cock brothers are the reason we cannot have nice things, they are sadistic, psychopaths and should never be listened to ever under any circumstances

    • (Score: 2) by aristarchus on Wednesday January 10 2018, @03:03AM (5 children)

      by aristarchus (2645) on Wednesday January 10 2018, @03:03AM (#620323) Journal

      I have not wanted to live for at least 7 years,

      Things may seem dark now, when you are fifteen years old. But it gets better. Then it gets worse, much, much worse. Wait until 2400 years old you be! That youngster Yoda was right.

      • (Score: 1, Insightful) by Anonymous Coward on Wednesday January 10 2018, @03:14AM (4 children)

        by Anonymous Coward on Wednesday January 10 2018, @03:14AM (#620327)

        well you sure learned me douche bag, I to can argue like a 4 year old

        • (Score: 2) by aristarchus on Wednesday January 10 2018, @04:26AM (3 children)

          by aristarchus (2645) on Wednesday January 10 2018, @04:26AM (#620338) Journal

          So how could you have wanted to die for seven years, if you are only a 4 year old? Where's your mama? (BTW, when you use a word that sounds like "2" to mean "also", the proper spelling is "too", double 'o's. No wonder you want to die, with atrocious spelling like that! Or did you mean "I toucan argue"? But that makes even less sense. )

          • (Score: 3, Insightful) by c0lo on Wednesday January 10 2018, @07:48AM (2 children)

            by c0lo (156) Subscriber Badge on Wednesday January 10 2018, @07:48AM (#620381) Journal

            What have you done with my "-1 Insensitive" mod, magister?
            Where did you placed it, I can't find when I need it.

            --
            https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
            • (Score: 2) by aristarchus on Wednesday January 10 2018, @08:22AM (1 child)

              by aristarchus (2645) on Wednesday January 10 2018, @08:22AM (#620385) Journal

              Nebát se a nekrást. C0lo, you must be more careful with your true identity. I mean, who else could reference "Der Selbstmord als sociale Massenerscheinung der modernen Civilisation", but someone who knew of Tomáš Garrigue Masaryk? But it is alright. We are safe from adolescent Americans what with their genius and illiteracy.

              • (Score: 2) by c0lo on Wednesday January 10 2018, @02:16PM

                by c0lo (156) Subscriber Badge on Wednesday January 10 2018, @02:16PM (#620461) Journal

                C0lo, you must be more careful with your true identity.

                I'm sorry to inflict the mystery of my native country on you, magister, I sincerely hope you aren't going to develop an obsession over the matter.
                But I promise I'll be the last to deprive you of one of the few mysteries of this world, not circumscribed by The Truth nor let aside of it. A full life need them as much as, some argue, the ἱερόφάνεια.

                Masaryk

                Ah, a good fellow him. A bit boring if you ask me, way too rationalist, needed lotsa beer to transcend the experience.

                Mostly missing the... mmm... how to put it?... "automatisme psychique pur par lequel on se propose d’exprimer ... le fonctionnement réel de la pensée. Dictée de la pensée, en l'absence de tout contrôle exercé par la raison, en dehors de toute préoccupation esthétique ou morale" side of life (yeah, yeah, I know, "El sueño de la razón produce monstruos" - like the pretense of being rational produces something else)

                Lacking that, one may make use of creations in the vein of your almost neighbor, Menippus of Gadara. (mmmm... maybe I do need to find some time to read Rabelais and his world [wikipedia.org])

                )sorry, badly in need for some sleep. I don't expect the above to be coherent or make sense when read)

                --
                https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
    • (Score: 1) by Sulla on Wednesday January 10 2018, @04:14AM (2 children)

      by Sulla (5173) on Wednesday January 10 2018, @04:14AM (#620336) Journal

      What is stopping you from going to oregon and getting assisted suicide?

      --
      Ceterum censeo Sinae esse delendam
      • (Score: 1, Insightful) by Anonymous Coward on Wednesday January 10 2018, @04:53AM (1 child)

        by Anonymous Coward on Wednesday January 10 2018, @04:53AM (#620342)

        Yep, it's the Soylentil Suicide Prevention Squad in action! Why don't you just go kill yourself? Preferably in a way the Kock(sucker) Bros. can profit from it?

        • (Score: -1, Troll) by Anonymous Coward on Wednesday January 10 2018, @06:36AM

          by Anonymous Coward on Wednesday January 10 2018, @06:36AM (#620365)

          Sometimes suicide is the saner option.

    • (Score: -1, Troll) by Anonymous Coward on Wednesday January 10 2018, @05:31AM (1 child)

      by Anonymous Coward on Wednesday January 10 2018, @05:31AM (#620348)

      The Koch Brothers are in no way responsible for the endless complete failure that is your worthless life.

      • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @06:04AM

        by Anonymous Coward on Wednesday January 10 2018, @06:04AM (#620356)

        Oh, I think they are! They closed the Mill that my Pappy, and my Uncle, and my Grandpappy made a living at as middle-classed Americans, with a Union. All that is gone, and my life is a complete failure, thanks to the Cock (suckers) Brothers. At least they did not fund the Stable Genius.

    • (Score: 2) by turgid on Wednesday January 10 2018, @09:19AM

      by turgid (4318) Subscriber Badge on Wednesday January 10 2018, @09:19AM (#620401) Journal

      It's about 99% likely that you have an illness that can be treated using modern medicine and adjustments to your lifestyle. I'm a bit busy just now to go looking for lots of links, but here's a start

      https://www.theguardian.com/society/2018/jan/07/is-everything-you-think-you-know-about-depression-wrong-johann-hari-lost-connections [theguardian.com]

    • (Score: 1) by khallow on Wednesday January 10 2018, @02:56PM

      by khallow (3766) Subscriber Badge on Wednesday January 10 2018, @02:56PM (#620477) Journal

      I have not wanted to live for at least 7 years

      Depression is a thing that has nothing to do with the Koch brothers. Sorry, you feel that way, but you'd feel that way anyway.

      the Cock brothers are the reason we cannot have nice things, they are sadistic, psychopaths and should never be listened to ever under any circumstances

      Then don't listen to them. Nobody is forcing you to. I get that you can't fully control how or what you feel. But nobody else will do better.

  • (Score: 2) by HiThere on Wednesday January 10 2018, @01:47AM (1 child)

    by HiThere (866) Subscriber Badge on Wednesday January 10 2018, @01:47AM (#620302) Journal

    It often turns out that the bill means the exact opposite of the title, but I think people should be allowed to try pretty much anything they want to cure themselves, as long as it doesn't impact others. This doesn't mean I think insurance should pay for "experimental" treatments. But if someone who is adult and mentally competent wants to try injected sugar of lead as a treatment for a broken leg, that's fine with me as long as I don't pay for it.

    OTOH, would anyone who was mentally competent want to try such a treatment....ok, that was exaggeration to make the point, but if they want to try crushed apricot kernels as a cancer treatment, that's fine with me. If one of those treatments starts shows significant positive effects, they can design a double blind replication.

    --
    Javascript is what you use to allow unknown third parties to run software you have no idea about on your computer.
    • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @02:03AM

      by Anonymous Coward on Wednesday January 10 2018, @02:03AM (#620308)

      Adult and competent... You should not include contradictory terms in your test

  • (Score: 3, Funny) by realDonaldTrump on Wednesday January 10 2018, @02:02AM (11 children)

    by realDonaldTrump (6614) on Wednesday January 10 2018, @02:02AM (#620307) Homepage Journal

    The opioid crisis is the worst drug crisis in American history. I proclaimed it a Public Health Emergency. Addressing it will require all of our effort, and it will require us to confront the crisis in all of its very real complexity. It is time to liberate our communities from the scourge of drug addiction. We can be the generation that ends the opioid epidemic. We can do it.

    One of the things our administration will be doing is a massive advertising campaign to get people, especially children, not to want to take drugs in the first place because they will see the devastation and the RUINATION it causes to people and people’s lives. There is nothing desirable about drugs. They are bad. We want the next generation of young Americans to know the blessings of a drug-free life.

    • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @02:07AM (5 children)

      by Anonymous Coward on Wednesday January 10 2018, @02:07AM (#620310)

      Are you certain that it is happening? how can you know, you need to have first hand experience to truly understand like going to the boarder, you cannot know a thing until you have been to it.

      • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @03:05AM (4 children)

        by Anonymous Coward on Wednesday January 10 2018, @03:05AM (#620324)

        Does the boarder get room, or just the board? Or, possiblly, did your illiterate self mean "Border"? Hate to brake it to you, but their too different words.

        • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @03:17AM (3 children)

          by Anonymous Coward on Wednesday January 10 2018, @03:17AM (#620328)

          congragts your defending the orange monkey

          • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @05:11AM (2 children)

            by Anonymous Coward on Wednesday January 10 2018, @05:11AM (#620345)

            I want an opiod boarder, or a board with opiates on it. Or an orange monkey on a board, Old Skool, all Braveheart with the Trumpster! Yeah! Drawing and quartering is just too good for some traitors. Besides, he would probably tweet that it was the greatest execution ever, with the largest crowds. And, he would probably be right.

            • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @06:08AM (1 child)

              by Anonymous Coward on Wednesday January 10 2018, @06:08AM (#620357)

              First thing that opiods take, is your sens of restraint. Then, they take your sense of smell! When you are high, farts smell like roses! And then they take your sense of immobility, you cannot tell that you haven't moved for 18 hours! And finally, they take your ability to spell. Trump. Drumpf. Hillarity. Sallad. Word Salad. Suddenly you are the Gratest! You are making Ameriga Freight Against! Mind! Trying! T% Think. . . . W@hyu does Takyon keep posting all these Alzheimer stories, anyway?

              • (Score: 2) by c0lo on Wednesday January 10 2018, @07:55AM

                by c0lo (156) Subscriber Badge on Wednesday January 10 2018, @07:55AM (#620382) Journal

                W@hyu does Takyon keep posting all these Alzheimer stories, anyway?

                I can try an elaborate answer, but my hands shake too much and...
                ... ummm... for some reason I can't actually remember what we were talking about...
                I do vaguely recall I somehow like those stories

                (grin)

                --
                https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
    • (Score: 4, Informative) by captain normal on Wednesday January 10 2018, @06:31AM (3 children)

      by captain normal (2205) on Wednesday January 10 2018, @06:31AM (#620363)

      Ronny and Nancy tried that approach over 35 years ago. Called it "Just Say No". It didn't work very well for the country. Did wonders for the cocaine dealers and the cartels though. Also the Taliban warlords Were given free reign to produce and export huge amounts of opium through Pakistan. (https://en.wikipedia.org/wiki/Operation_Cyclone).

      --
      "If men were angels, government would not be necessary." James Madison
      • (Score: 2) by realDonaldTrump on Wednesday January 10 2018, @08:45AM (2 children)

        by realDonaldTrump (6614) on Wednesday January 10 2018, @08:45AM (#620389) Homepage Journal

        I inherited a mess. As you know. Doctors handing out drugs like candy, like they were candy. Drugs coming in across our borders, from Canada and Mexico. I proclaimed a public health emergency. Like Chris Christie, Governor Christie, wanted me to. I asked Congress for money to build the Wall. I want to hire more guys into my Customs & Border Patrol (JOBS).

        I'm bringing in Alex Azar -- I nominated him -- to run my Health & Human Services. Trust me, nobody knows more about drugs than Alex, you're going to love him. He's done a beautiful job in Dubya's Health & Human Services and at Eli Lilly.

        And I'm getting very tough on Pakistan. They need to respect the United States! The United States has foolishly given Pakistan more than 33 billion dollars in aid over the last 15 years, and they have given us nothing but lies & deceit, thinking of our leaders as fools. They give safe haven to the terrorists we hunt in Afghanistan, with little help. No more!

        • (Score: 2) by realDonaldTrump on Wednesday January 10 2018, @09:04AM

          by realDonaldTrump (6614) on Wednesday January 10 2018, @09:04AM (#620394) Homepage Journal

          One more thing, I have @ElChap0Guzman locked up. El Chapo and the Mexican drug cartels were using the border unimpeded like it was a vacuum cleaner, sucking drugs and death right into the U.S. He tweeted to me, "keep fucking around and I’m gonna make you swallow your bitch words you fucking whitey milkshitter @realDonaldTrump." Which he tweeted in Spanish (Mexican). But I locked him up. I'm the only guy who could do that. I'm WINNING!

        • (Score: 3, Interesting) by Pino P on Wednesday January 10 2018, @03:31PM

          by Pino P (4721) on Wednesday January 10 2018, @03:31PM (#620488) Journal

          If you want to end the opioid crisis, treat cannabis like alcohol. Let the several states exercise their right under the 21st Amendment to regulate trade in cannabidiol (CBD), tetrahydrocannabinol (THC), and hemp fiber as they see fit. This creates JOBS for hemp farmers, JOBS for manufacturers of hemp products, and local JOBS for licensed dealers. If you feel like getting tough, get tough on the DEA for not descheduling the parts of cannabis that don't get you high.

          Hemp will make American-made workwear strong again. CBD will make people with seizure disorders safe again. This is how you Make America Great Again®.

    • (Score: 2) by DeathMonkey on Wednesday January 10 2018, @07:41PM

      by DeathMonkey (1380) on Wednesday January 10 2018, @07:41PM (#620591) Journal

      Addressing it will require all of our effort..

      And seeing as how you're expending zero effort to address it now that's like infinity more effort!

  • (Score: 3, Insightful) by crafoo on Wednesday January 10 2018, @02:07AM (1 child)

    by crafoo (6639) on Wednesday January 10 2018, @02:07AM (#620309)

    Drug companies will gain valuable information about the effects and efficacy of their experimental drugs. They can pass this law, but with the caveat that the drugs must be made available for experimental use for free.

    • (Score: 2) by PartTimeZombie on Wednesday January 10 2018, @02:27AM

      by PartTimeZombie (4827) on Wednesday January 10 2018, @02:27AM (#620313)

      Why would they do that?

      The whole point of the lobbying is so the Koch brothers can make more money, not less.

      I think you've misunderstood how US politics works.

  • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @05:08AM

    by Anonymous Coward on Wednesday January 10 2018, @05:08AM (#620344)

    this is more about getting some sort of product into a Phase I clinical trial. then get fast-track approval. er, company being able to bill Medicare/Meducaid at $100k/dose because "see, it's safe!!!". At least. that gives enough plausible deniability to get out of being sued. There will probably be some license aggreement signed that compels patient to go to mediation if he or his survivors have problems with things.

    But really its about teying to suck all the money out of Medicare/Medicaid.

    Martin Shkreli bro-nods his approval. Dead patients have a hard time argiing against whether another treatment might have been more appropriate, as do Cancer Centers of America shareholders, et al.

  • (Score: 0) by Anonymous Coward on Wednesday January 10 2018, @09:59AM

    by Anonymous Coward on Wednesday January 10 2018, @09:59AM (#620412)

    Because even the ultra rich do get sick occasionally.

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