MENU

Reason.com

Free Minds & Free Markets

'Right to Try' Bill Fails, Despite Concessions

"The House will not let this be the end," Majority Leader Kevin McCarthy said Tuesday night.

Laura McLinn, of Indianapolis, her son Jordan, 7, and Sen. Ron Johnson, R-Wis., pose for a picture after a news conference in Dirksen Building, May 10, 2016, on theLaura McLinn, of Indianapolis, her son Jordan, 7, and Sen. Ron Johnson, R-Wis., pose for a picture after a news conference in Dirksen Building, May 10, 2016, on theHouse Republicans failed yesterday to garner the votes they needed to pass a heavily modified version of the Senate's "Right to Try" bill. The legislation would have brought the U.S. one step closer to allowing terminally ill patients more freedom to test unapproved pharmaceutical products.

The House needed a two-thirds majority to pass the bill, as Republicans had suspended the rules in order to prohibit amendments being added on the House floor. The bill failed to reach that threshhold; the final tally was 259–140.

Right-to-try laws create a legal mechanism for patients and their doctors to request experimental treatments without first being enrolled in a clinical trial or getting permission from the Food and Drug Administration (FDA). Thirty-eight states have passed such bills, but until federal law changes no pharmaceutical company has an incentive to operate outside the FDA's purview.

Under the most recent House version of the bill, introduced by Energy and Commerce Committee Chairman Greg Walden (R-Ore.) and Health Subcommittee Chairman Michael C. Burgess (R-Texas), licensed physicians would be able to request a drug from the company that makes it so long as the drug had passed Phase I clinical trials. The bill does not require drug application sponsors or manufacturers to provide the drug. If they do opt to provide the treatment to a physician, the drug maker would be responsible for reporting the transaction to the FDA.

Walden and Burgess announced on March 10 that they'd added several others layers of regulatory compliance atop the more loosely written Senate bill that passed last August. Specifically, Walden and Burgess say their version of the bill would:

  • establish a robust informed consent to access unapproved drugs;
  • specify that any unapproved drug being used must have an active FDA application and not be the subject of a clinical hold by the FDA;
  • require the sponsor and manufacturer to notify the FDA after they make an unapproved drug available to an eligible patient;
  • guard patients from purposefully misbranded or mislabeled drugs;
  • provide liability protections for participating manufacturers, sponsors, physicians, clinical investigators, and hospitals unless there is reckless or willful misconduct, gross negligence, or an intentional tort;
  • obligate sponsors and manufacturers to report adverse events in real time to the FDA; and
  • provide certainty to manufacturers about how the FDA will use patient outcomes when evaluating new drug applications.

These changes were intended to address several of the criticisms levied against right-to-try legislation by certain patient groups and medical ethicists, who have insisted throughout the debate that the FDA's "expanded access" program adequately serves terminally ill patients who have exhausted their options and want to try an experimental treatment. The NYU School of Medicine Working Group on Compassionate Use and Pre-Approval Access, for instance, has argued that because the FDA approves 99 percent of expanded access applications, there's no reason to cut the agency out of the process.

The House bill sought to strike a compromise by requiring doctors and drug manufacturers to notify the FDA of adverse events in real time, and by allowing the FDA to take those events into consideration when reviewing drug applications. Nevertheless, Democratic leaders in the House led a charge against the bill.

In February, dozens of patient groups asked Congress to vote down the bill, arguing that the recently passed Food and Drug Administration Reauthorization Act had already helped streamline the Institutional Review Board process and empowered the FDA to make clinical trials more inclusive. (Patients who wish to access an experimental treatment either under the FDA's current program or the House version of the Right to Try bill would first need to be rejected for a clinical trial.)

Proponents of right to try, which include many libertarian organizations as well as many patient groups, say that even though the FDA's application process for compassionate use has been simplified in the last decade, it may still be arduous enough to deter terminally ill patients and their doctors from applying.

"If 99 percent of requests are approved, what's hidden in that number—assuming it's true—is how many requests are never made because of how many doctors don't have the time, resources, or willingness to build a case," says Robert Graboyes, a health care researcher at the Mercatus Center.

Other proponents of right to try have argued that the commonly accepted idea that patients have a "right to die"—to intentionally take drugs that will speed death, or to refuse treatment for a terminal illness altogether—applies to unapproved therapies as well.

As noted above, the House version of the law would require any drug used have gone through at least phase I of an FDA clinical trial. Phase I is intended to provide baseline evidence of safety by determining the maximum dose that can be administered to a human patient without dangerous side effects. Phase I is not intended to assess how well a drug works (though it sometimes provides a glimpse).

The House version of the bill also limits eligibility to patients suffering "a disease or condition in which there is reasonable likelihood that death will occur within a matter of months; or a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death." The Senate version of the bill applies to patients with "life-threatening" illnesses, which the FDA argued was too broad a category.

House Republicans declared Tuesday that they would attempt to revive the bill. "The House will not let this be the end," Majority Leader Kevin McCarthy said in a statement. "We will try again, pass legislation, and bring hope to those whose only desire is the right to try to live."

Reason.tv profiled the Right to Try movement back in 2015:

Photo Credit: Tom Williams/CQ Roll Call/Newscom

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  • Eidde||

    "The House needed a two-thirds majority to pass the bill, as Republicans suspended the rules in order to prohibit amendments being added on the House floor. The bill failed to reach that threshhold and the final tally was 259-140."

    Of, for crying out loud, are they trying to pass a bill or not?

    When Congress fails to pass a bill which is supposedly supported by the majority party, my presumption is that they don't actually want a statute, they want a campaign issue ("vote for us and maybe next time we'll pass this for real!").

  • EscherEnigma||

    I'm right there with you. 65% of votes were "aye", but it didn't pass because the party that claims they want it changed the rules to require a higher standard?

    Does someone have an explanation for why this was a good idea? With that kind of majority, surely they could have, I don't know, just voted down any poison-pill amendments?

  • loveconstitution1789||

    Nanny-State 101: Bureaucrats cannot have The People deciding what is best for them. Not only would Americans realize how worthless government is and not fall for these legislative schemes again but tens of thousands of bureaucrats would be laid off because their jobs are superfluous.

  • CE||

    What I want to know is why it doesn't have 100% support.
    What kind of control freak cretins would stop a terminally ill patient from trying any possible remedy at all?
    What's the downside, they die? That was already going to happen.

  • loveconstitution1789||

    These politicians and bureaucrats are 100% fine with allowing a national debt of $64,035 per person to exist.

    Its harder to find one who isn't a complete shitbird.

  • Diane Reynolds (Paul.)||

    We voted against the bill because it didn't go far enough.

  • Robert||

    Did you read the link to the rule?

  • EscherEnigma||

    Yep. It doesn't explain why anyone thought it was a good idea in this case.

  • Robert||

    Obviously it was a move to bring it to a quick vote instead of being subject to the usual run of biz. They moved to suspend the rules because they thought they had at least a good chance to win. The cost was the add'l requirement. This was not a deliberate scuttling.

  • Half-Virtue, Half-Vice||

    Irradiate the House of Congress, let's see how they feel about it then.

  • Jerryskids||

    Do we have a list of the names of those 140 legislators who literally just voted in favor of letting sick people die? How can they sleep at night, how can they live with themselves, how evil are they, how badly must they hate women and children and people of color that they would see these people desperately clutching at straws and then snatch the straw from their dying hands? For shame!

  • Jerryskids||

    You just know if you check the list against the FEC campaign donations database that all these people are in the pocket of Big Pharma.

  • BestUsedCarSales||

    I like to imagine the 140 against are the people who sit next to their mother as she is dying. She is in a hazy agony from the cancer consuming her, too tired to react much but the pain still undulled. These congressmen hold their mother's wilted hand and tell her to take and Advil and tough it out.

  • LarryWilson||

    Actually, "Big Pharma" would stand to gain from passing this legislation. They could pass off all kinds of garbage therapy as "experimental" and make bank.

  • loveconstitution1789||

    Yup. Companies want to kill people.

    You understand that experimental drugs would probably be free or super cheap since its hard for companies to sell murder as a reason to use their products.

  • Microaggressor||

    This would introduce more competition, and Big Pharma doesn't stand to gain from more competition.

  • LarryWilson||

    Since these kinds of experimental treatments are almost always patented and held by a single entity, there is no chance they would be reasonably affordable.

    There would be no reason to sell hope at an affordable price.

  • hello.||

    Since the drug would have no value until it received FDA approval and a stockpile of successfully treated patients may help in the FDA approval process there would be very incentive to make the drugs accessible. Understanding actual financial incentives is hard when you never advanced beyond Saturday morning cartoon villains as your comprehension level.

  • Microaggressor||

    Politicians are scum. This has the stench of rent seeking. I hope their personal gains are worth the cost of human life.

  • Sevo||

    "Do we have a list of the names of those 140 legislators who literally just voted in favor of letting sick people die?"

    They're all Libertarians. That's the only party dedicated to letting people die. Tony tells us that constantly

  • BestUsedCarSales||

    This is as much the war on drugs as the more famous one. The underlying issue is full government control over what you do with your body. They affirm here that even as you lay dying you do not have choice.

  • Citizen X - #6||

    Christ, what assholes.

  • loveconstitution1789||

    ^this in a nutshell.

  • Leo Kovalensky II||

    I don't normally like the hyperbole of politics; so and so just voted for people to die.

    This may be the one case where it actually applies. The 140 (as they should be forever known) should literally have to go door to door in the districts telling their constituents how they voted on this.

  • Citizen X - #6||

    Better yet, they should have to go room to room in an oncology ward, wearing t-shirts that say FUCK YOU.

  • Fist of Etiquette||

    In February, dozens of patient groups asked Congress to vote down the bill, arguing that the recently passed Food and Drug Administration Reauthorization Act had already helped streamline the Institutional Review Board process and empowered the FDA to make clinical trials more inclusive.

    That's messed up.

  • Eidde||

    Stockholm Syndrome?

  • Eidde||

    "I have a kind master who doesn't beat me any more, and he says I don't need so-called 'freedom,' he'll make sure I get what I need."

  • Hugh Akston||

    Terminal patients don't hold much sway with congresscritters because they won't be around to vote in the next election.

  • Eidde||

    They have relatives, you know.

    (I know you're being sarcastic)

  • Eidde||

    Notice the argument - Congress doesn't have to specifically approve right to try because if they ask nicely (and go through some extra hassle), patients will get that privilege from the FDA.

    If that's true (and I'm not saying it is), then the opponents are simply standing up for the principle that no matter how sick and desperate you are, you have no rights the government is bound to respect but you have to depend on the benevolence of a government agency to do what you ought to be free to do.

    And in future the government agency can decide to become less generous in granting petitions.

  • Eidde||

    If nothing else, Congress could simply pass the bill on "the buck stops here" grounds.

    I mean, if it leads to the same outcome, what are they afraid of? That alleged "mere 1%" of FDA denials?

  • Diane Reynolds (Paul.)||

    This is disappointing.

  • loveconstitution1789||

    Nothing like thinking you have to beg government to help yourself in medical dilemmas.

    Part of the solution is just refusing to give government that power. Just say no.

  • Pro Libertate||

    Ye gods. I thought this was a shoe-in. Why on Earth would they do anything other than give people a chance?

    I may very well need this option if my GBM comes back. I have other options, maybe, but why can't people decide for themselves?

    This pisses me off to no end.

  • Diane Reynolds (Paul.)||

    It took power out of someone's hands.

  • Pro Libertate||

    If they keep this up, I'll become more libertarian than you can possibly imagine.

  • LarryWilson||

    Given these are literally unproven therapies, it would be wholly unethical to describe them as offering a "chance" of survival.

  • Citizen X - #6||

    Damn, i can't tell which is worse - your grasp of ethics or your grasp of statistics.

  • LarryWilson||

    It's clear you are confused about a lot of stuff.

    So, try to make a case or got back to buttfucking your blow up ventriloquist straw man doll.

  • hello.||

    Coming from somebody whose only argument is literally the slippery slope fallacy thinly disguised as the precautionary principle. Go fuck yourself you piece of shit. Die slow.

  • LarryWilson||

    This legislative posturing shows the dissonance of both the GOP and the Dems.

    The Dems generally claim healthcare is a right. The GOP claims it is not.

    The GOP then tries to pass legislation defining a specific kind of healthcare (the most futile kind, ironically), as a right, and the Dems oppose it.

    The real problem here is that this legislation will do nothing more than 1. Sell false hope, and 2. Spawn a multi-billion dollar industry of snake oil sales dressed up as "experimental treatment." There will be essentially no liability for these snake oil manufacturers, and it will drive up the cost of our already expensive health care.

    The only rational thing I saw come of this is that someone finally understood that defining healthcare as a right did not mean that someone was required to provide it to you. That is the only thing so far I've seen Rand Paul get wrong.

  • Eidde||

    Only the mighty hand of the federal government prevents physicians for writing prescriptions for snake oil!

  • Eidde||

    And of course, a certain number of these "experimental treatments" will at some point get FDA approval, and the question in such cases is whether patients have the right to such treatments before their death, rather than after their deaths at which time the FDA will find the given medicine safe and effective.

  • loveconstitution1789||

    The internet makes peer reviews of experimental medicine a really great thing. Decades ago, people who have to completely trust companies and government.

    Now people can make decision for their healthcare based on real time real person experiences and how experimental drugs worked for them.

  • LarryWilson||

    Except there are limitations to this in most of clinical research, and that is another point of contention.

    One of the key elements of effective research is blinding, where the researcher and patient do not know if they received the experimental treatment or a placebo. This is required to minimize bias and to ensure that the researcher does not handle patients differently who received the experimental therapy differently from those who received placebo.

    I think you can see the issue here relative to your comment, and there is a placebo effect. In one of our clinical trials, part of the investigation included asking the patient or their family if they thought they received the investigational drug or a placebo. More than half of the people who received placebo stated they believed they received the investigational drug.

    Next, by making it a "right" to receive investigational therapies will make it impossible to recruit patients to participate in blinded clinical trials, a process essential to gathering objective data. No patient will take a risk of receiving placebo if they can demand the investigational therapy.

    Remember, as the legislation was written, it would allow investigators to provide the drug outside the clinical trial. Well, if no one wants to be in a clinical trial, then there will be no availability of the drug outside that clinical trial.

  • hello.||

    The drug has to already be in Phase I and there are copious limitations on the type of patients who can even request the experimental therapy you lying piece of shit.

  • LarryWilson||

    We could expect a minuscule number of these experimental therapies to ever show enough efficacy to be approved; since these providers of experimental therapy can now make millions selling unproven therapies, they lose the incentive to prove their product actually works.

    They could drag out the 'experimental' designation of their therapy for the duration of the patent.

    I worked on one clinical trial that took 30 years from initial discovery to an eventual refusal of the FDA to approve the drug even after agreeing to fast-track approval based on Phase III findings.

  • hello.||

    We could expect a minuscule number of these experimental therapies to ever show enough efficacy to be approved; since these providers of experimental therapy can now make millions selling unproven therapies, they lose the incentive to prove their product actually works.

    Yeah because selling working therapies to millions of patients once a drug is approved pales in comparison to those fat stacks that could be made selling a few hundred patients that are within a year of death a drug that is still in development. Especially if the drug doesn't work, because word of that would certainly never leak out.

    How about this you fucking piece of subhuman shit? You can sit there on your death bed with a FDA bureaucrat's cock down your throat thanking him for saving you from the scourge of trial drugs and everybody else can tell you to go fuck a goat and take the risk on a longshot therapy in the last weeks of their life.

  • loveconstitution1789||

    Except, of course, when government officials want to add syphilis to the snake oil and test it on unsuspecting people.

  • Pro Libertate||

    I have a friend with the same disease that I have who got polio injected into her brain.

  • loveconstitution1789||

    Are you serious? What disease and how would an injection of polio into the brain be a possible remedy?

  • Pro Libertate||

    Glioblastoma. Duke is running a trial. The polio virus is mutated so you don't get polio, and it's slowly injected into the tumor. When it works, the immune system attacks the tumor and the polio.

    60 Minutes has highlighted the study a few times over the years.

  • LarryWilson||

    I'm assuming you are referring to the Tuskegee Experiments.

    Those patients were not testing syphilis on patients. They were merely monitoring the progress of the disease in people who already had it during a time when there was no known cure.

    The failure of ethics came when it was discovered in other trials that penicillin was a cure, and it was not offered to the patients. They were not refused the opportunity to receive penicillin, they were simply not informed that it was an option.

  • LarryWilson||

    Correction; "those providers were not testing syphilis on patients."

  • hello.||

    Those patients were not testing syphilis on patients. They were merely monitoring the progress of the disease in people who already had it during a time when there was no known cure.

    Actually, you lying piece of fascist dogshit, the physicians lied to the patients about the study by pretending they were offering free medical care and never informing them that they were part of a study THEN withheld treatment for over 20 years after the cure was known AND prevented the patients from accessing treatment at other clinics that would have properly diagnosed and treated them.

    The fact that you are defending the most notoriously unethical human experiment in the history of this country says everything anyone needs to know about you. I hope beyond hope that you die of something unbelievably slow and painful.

  • LarryWilson||

    Incorrect...except for the part where you simply repeated what I said.

  • Pro Libertate||

    All I want is the option.

  • Citizen X - #6||

    You can't have the option because, per LarryWilson, if a new treatment is untried, there's no chance it will work.

  • LarryWilson||

    Yeah, that's not what I said, but it's clear a complete moron like you can't make an argument without first deploying a logical fallacy...so, good luck with that.

  • hello.||

    Right what you actually said is that if a new treatment is untried you should be denied access to it regardless of the efficacy. That was shortly before you defended the Tuskegee experiments. Because a complete piece of subhuman shit like you can't make an argument without first lying.

  • LarryWilson||

    This is not an issue of denying access. Your argument is patently non-libertarian.

    Next, I never defended the Tuskegee experiments; I correct the misrepresentation.

    Sweet pete you are fucking stupid.

  • Lowdog||

    What, really, is the point of the FDA? I mean, what do they actually accomplish? I'd like to hear some success stories. Because I've noticed that it takes tons of R&D money to get a new treatment approved, yet there are still plenty of examples where it's eventually discovered that approved drugs are hazardous and need to be pulled from circulation.


    We see this time and again with gov't agencies: they are created and billed as a way to prevent X, but then they actually don't prevent X, and have a ton of harmful/expensive/etc unintended consequences. We could save ourselves a bunch of money, be no less safe, and avoid all the other unintended negatives, if the entire agency was shut down.


    And people say I'm a nihilist because I don't think the government should be doing all the things it's doing.

  • loveconstitution1789||

    FDA protects people from harmful drugs and food except when it doesn't.

  • Eidde||

    There is certainly a role for a government database, based on work by government scientists, about the safety and efficacy of various drugs.

    If the government scientists haven't found a drug safe or effective, an FDA WARNING could be placed on the drug in question to help adult patients and their physicians make informed choices. The could of course, under what I'm suggesting, choose to disregard the warning if they think they have better information or make a different calculation of the cost-benefit ratio.

    And...wait for it...there should be at least some restrictions on making unapproved drugs available to kids (including children in the womb).

  • Pro Libertate||

    We need a UL (or more than one) for drugs.

  • hello.||

    What, really, is the point of the FDA? I mean, what do they actually accomplish?

    According to Tuskegee experiment apologist LarryWilson, they stand as the only line of protection between patients within months of their death and cartoon character pharmaceutical company CEOs who would sell them sugar pills that are in Phase I clinical trials.

GET REASON MAGAZINE

Get Reason's print or digital edition before it’s posted online