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Two weeks ago, I warned that the worst version of a federal right-to-try bill being then considered by Congress was on the verge of passing, thanks to pressure from President Trump, Vice President Pence, and the Koch brothers. At the time, I really had very little hope that anything could stop the bill, given how it had been resurrected from death and brought to the House floor with, in essence, no debate. To no one’s surprise, the bill passed, and on Wednesday with great fanfare. There’s no need to go into the machinations of how that happened today, as I discussed it in depth two weeks ago. Suffice to say that there were two versions of the bill, one passed by the Senate last summer (the worst version, the one that is now law) and the House version, which had been extensively modified in the House Energy and Commerce Committee, chaired by Rep. Greg Walden with input from the FDA, . Rather than try to resolve the differences between the two versions of the bills in conference committee, the House leadership basically pulled various parliamentary maneuvers to bring the Senate version to a vote as is, and it passed.

Patients will likely suffer, and the topic of this post will be how right-to-try can be used to sell snake oil. It’s not as simple as some who have argued against such laws have claimed, but it is not as difficult as proponents of right-to-try retort, either. But first, what is “right-to-try”?

Right-to-try: State laws pressure the federal government

“Right-to-try” is an initiative conceived and spearheaded by the libertarian “think tank” (why I use the scare quotes, I’ll explain momentarily) the Goldwater Institute. Consistent with the libertarian, anti-regulation bent of the Goldwater Institute, the stated idea (or should I say talking point?) is to make it easier for terminally ill patients to access experimental drugs without so much FDA “interference.” To that end, all right-to-try laws contain certain elements, which is not surprising given that they are all based on a legislative template composed by the Goldwater Institute:

  • Anyone with a terminal illness is eligible for right-to-try.
  • Any drug that’s passed phase I trials, has an IND, and is still under clinical trials is eligible for right-to-try.
  • There is no liability for doctors or companies participating in right-to-try.
  • Insurance doesn’t have to pay for right-to-try drugs. (As I’ve discussed on a number of occasions, this provision can also be reasonably interpreted as saying that insurance companies also don’t have to pay for the treatment of complications that might occur as a result of the use of a right-to-try drugs.)
  • Patients wanting right-to-try drugs are on their own when it comes to cost. (A few states—for example, Texas, forbid companies charging for right-to-try drugs.)
  • Drug companies don’t have to provide their experimental drug under right-to-try if they do not wish to. It is this provision that has led some critics to note that “right-to-try” is really more like “right-to-ask,” given that drug companies are under no obligation to provide their experimental drugs to anyone, paid or unpaid.

None of these provisions should be surprising, given the source of the legislative template and most of the propaganda to pass right-to-try. Again, right-to-try is a product of the Goldwater Institute, which tries to paint itself as a libertarian “think tank,” but has never been a true think tank. Rather, it has always been a far , so much so that before he died Barry Goldwater actually wanted his name removed from the group, but backed off because the Institute was dear to his brother. Unfortunately, the press treats the Goldwater Institute as a real think tank . Rather, it’s part of the American Legislative Exchange Council (ALEC), a corporate-funded bill mill.

That’s why, before there was a single right-to-try law passed at the state level in 2014, there was a Goldwater Institute-written legislative template, a pre-written bill that could be (and was) modified as needed by various states to fit into their existing legal and regulatory framework. It’s why all state-level right-to-try laws contain the elements listed above with minor exceptions, including libertarian tropes like elimination of liability for companies and doctors participating in right-to-try, and provisions that basically leave terminally ill patients on their own if things go south. It’s why the Koch brothers’ and . Moreover, the for-profit hospital chain Cancer Treatment Centers of America (CTCA) :

In September 2012, a group of executives from the Cancer Treatment Centers of America reached out to the Goldwater Institute, a small, libertarian think tank named for the former senator and presidential candidate.

Goldwater — which has in past years accepted support from major conservative organizations like the Charles Koch Foundation and Donors Capital Fund — had taken on a wide-ranging libertarian agenda that included activism on campus free speech and school choice. The for-profit hospital chain CTCA also has its own ties to the Koch family.

CTCA and, ultimately, the Goldwater experts believed the FDA’s existing expanded access program — through which the agency approves some 99 percent of requests from dying patients who can’t get into clinical trials but want to try experimental treatments — was too cumbersome.

It was time to do something about it, and a consultant with CTCA, Chuck Warren, coined the term “right to try,” recalled Starlee Coleman, a Goldwater senior adviser.

As the article explains, CTCA and the Goldwater Institute decided to start with the states. The rest is history. I also note that we’ve written about CTCA before. It’s a chain of for-profit cancer hospitals that market “integrative medicine” quackery along with conventional medicine. So, yes, right-to-try was the product of a hospital chain that supplements its income selling quackery like “naturopathic oncology,” , and though the cherry picking of patients.

Of course, even the Goldwater Institute flacks knew that state right-to-try laws had no teeth. The power to approve drugs rests at the federal level, with the Food and Drug Administration (FDA). States can proclaim in their laws that terminally ill patients had a right-to-try experimental drugs, but the FDA still oversees drug approval, and few would be the drug companies with hundreds of millions of dollars invested in an experimental drug would be likely to risk that by providing the drug to patients outside of clinical trials needed to gain FDA approval. Again, the people at the Goldwater Institute who thought of this initiative are not stupid. They knew that state laws were not likely to have any real effect on providing experimental drugs to terminally ill patients, and indeed they have not, as far as I’ve been able to tell, claims by the . Still, one has to grudgingly admire the effort. Getting in only a bit more than four years, with only one veto (in California, where a second try got right-to-try passed) is an impressive achievement.

This brings us to the federal right-to-try law just signed into law last week, specifically the . The main provisions of this law are:

  • Terminally ill patients (as defined by state law in right-to-try states) have the right to bypass the FDA and obtain experimental drugs from the company making them. The FDA is not involved in this decision, nor is there institutional review board (IRB, ethics board) oversight. Basically, critical protections provided by the FDA to patients in clinical trials are not in effect in right-to-try.
  • Drugs eligible for right-to-try need only have passed phase I clinical trials, have an investigational new drug (IND) application with the FDA, and be in phase II clinical testing. As I’ve discussed more times than I can remember, this provision is insanity. Right-to-try advocates (like the Goldwater Institute) have frequently claimed that this assures that the drug to be “tried” is safe, which is nonsense. Phase I trials usually only enroll less than 30 patients, and are designed primarily to screen out drugs with toxicities too severe to continue testing.
  • Doctors prescribing right-to-try drug treatment, pharmacists dispensing the drugs, and companies providing right-to-try drugs are shielded from liability. While fear of liability is not an unreasonable concern regarding experimental therapeutics, the blanket protection from liability goes rather too far in this law.
  • The FDA Commissioner cannot use outcomes from right-to-try drug use in his consideration of whether to approve a new drug for market unless the sponsor (drug company) requests it or the Secretary of Health and Human Services determines that such outcomes are “critical to determining the safety of the eligible investigational drug.” In this case the HHS Secretary must justify this decision in writing. The HHS Secretary can also delegate this decision no lower than to the director of the relevant agency in the FDA in charge of approving the drug under consideration. Anyone want to guess how willing the HHS Secretary will be to do this very often?

Worst of all, right-to-try is entirely unnecessary, given that expanded access programs in the FDA approve >99% of applications to use experimental drugs outside of clinical trials and do so without stripping away scientific and ethical oversight the way that right-to-try does.

Right-to-try: Legalizing the Burzynski practice model

Regular readers of the blog will be familiar with Stanislaw Burzynski, the Polish expat physician who arrived in the US in the early 1970s; discovered peptides he dubbed “antineoplastons,” that, according to him, inhibited cancer growth and metastasis; left his university (Baylor) and started administering them to patients and thereby built up a cult following of people who believed his claims that he could treat hopeless cancers like glioblastoma and diffuse intrinsic pontine glioma (DIPG), when, as I’ve documented more times than I can remember, he could not produce evidence that antineoplastons were effective against any cancer. I don’t feel obligated to go into all the ins and outs of the Burzynski cancer quackery saga here. Anyone interested can read my article in from a few years ago that tells the saga in great detail or peruse the posts here on SBM under the Stanislaw Burzynski tag or at my “friend’s” blog . It’s a sordid, four decade saga of how a cancer quack has managed to charge desperate patients hundreds of thousands of dollars for an ineffective, toxic drug and not only to get away with it, but to be lionized as a hero in alternative medicine circles.

What’s relevant to right-to-try is a tactic that Burzynski’s lawyer, Richard Jaffe, hit upon the late 1990s, when Burzynski was being prosecuted for 75 counts of insurance fraud and violations of the Food, Drug, and Cosmetics Act. As part of this process, Judge Simeon Lake of the U.S. District Court for the Southern District of Texas, ruled that Burzynski’s “continued pretrial release” was contingent upon his administering his drugs exclusively through FDA-approved clinical trials. Under pressure from Representative Joe Barton (R-Texas) and his committee, the FDA entered talks to let Burzynski do clinical trials, even though prosecutors pleaded with FDA officials not to do so because it would undermine their case. Antineoplastons had passed phase I trials by that time; so, at the urging of his lawyer, Burzynski cleverly filed for 72 phase 2 clinical trials for every cancer he wanted to treat. This became his business model for the next 20 years. Patients would be recruited to the Burzynski Clinic largely through promotion by believers on alt med-friendly websites and as a result of a documentary-cum-propaganda film by Eric Merola, be enrolled in one of Burzynski’s phase 2 trials, and be charged tens or hundreds of thousands of dollars in “consulting fees” for the privilege.

It’s not too hard to see where I’m going with this in light of the passage of right-to-try. Basically, right-to-try is Burzynski’s business model, only easier. Why easier? The federal right-to-try law only requires that there be an open IND and there be clinical trials open. Under right-to-try, Burzynski could simply keep doing what he’s doing and not even bother to enroll most of his patients in his phase 2 trials, providing antineoplastons to them under right-to-try and only slowly accruing enough patients to keep his clinical trials appearing viable. Basically, right-to-try has not only functionally legalized the Burzynski practice model, it has facilitated it, making it easier for him to continue. Indeed, as long as he keeps a single phase 2 trial open, I don’t see any reason why he couldn’t just keep doing the bulk of his business in right-to-try and, given that he’s 75 years old, keep doing so until he runs out the clock and either retires or dies.

What about other quacks?

Of course, Burzynski is a special and unique case. Few quacks have a drug that’s passed phase I testing, an IND, and a long history of open clinical trials, no matter how dubious. That’s why, when I see right-to-try critics going on about how treating the terminally ill with quackery is now basically legal, I have to point out that not just any quackery can be administered under right-to-try. Not just any unproven drug can qualify. That doesn’t mean, however, that there is not much harm to be done to the terminally ill.

The first form of quackery that came to mind to me as likely to jump into the right-to-try business included stem cell clinics. I’ve been writing about quack stem cell clinics more than I can remember, and, yes, the FDA has recently tried to crack down on stem cell clinics selling unproven treatments. (I hope it succeeds.) However, some of these stem cell clinics claim to be doing clinical trials. They’re mostly crappy observational clinical trials without a control arm, but they are clinical trials.

Now, imagine, if you will, a stem cell clinic whose doctors want to operate under right-to-try. What would it have to do? First, it would have to get an IND for its stem cell treatment, after which it would have to conduct a phase I trial and show safety. There are a number of stem cell clinics that could, if their doctors so desired, accomplish this. The next step would be to register a phase 2 clinical trial. I don’t pretend that this would necessarily be easy or cheap, because the FDA does need a scientific rationale. I suspect that some stem cell clinics could manage it, though, particularly given that the FDA appears, though its new enforcement initiative, to be encouraging such clinics to treat their cell therapies as drugs and get them approved. Once a phase 2 trial is set up, the treatments could be marketed to patients eligible for right-to-try.

Finally, one could imagine the less scrupulous drug companies clearing out their vaults of drugs that passed phase I but, for whatever reason, were never advanced to phase 2 testing. Reasons for not continuing can be many, ranging from too much expense to insufficient evidence for potential efficacy, but under right-to-try such drugs could be resurrected, their INDs reinstated, and phase 2 trials given the go-ahead.

Will stem cell clinics and drug companies do this? My guess is: Probably not, at least not now. However, remember the purpose of right-to-try. It’s anti-regulation, more than anything else. Its purpose is to weaken the FDA (more on that in a moment), more than anything else. As a result of the law’s libertarian origins, I’ve predicted all along that, once right-to-try became law, its advocates would next work to expand the definition of who’s eligible for right-to-try. First, they’ll do what some have already done in some states and make right-to-try available to the “seriously ill.” After all, why should just the terminally ill “benefit”? The ultimate goal will be to make right-to-try available to basically everyone, at which point the FDA will become beside the point. When and if that happens, that’s when the two strategies above could result in real profits.

Then there’s the issue of how the FDA will implement this law. It’s not a coincidence that, now that the bill has become law, the mask has come off of right-to-try.

Sen. Ron Johnson schools FDA Commissioner Scott Gottlieb on the real purpose of right-to-try

From the very beginning, over four years ago when the first Colorado right-to-try law was being considered, I’ve repeatedly and consistently warned that the real purpose of right-to-try is not and never has been to help terminally ill patients (although in fairness undoubtedly right-to-try advocates believe they are helping terminally ill patients), but rather to weaken the FDA. Whenever I point out that right-to-try is a tool, a step if you will, towards the ultimate dismantling of the FDA, inevitably someone will take umbrage and insist so very, very righteously that, no, that’s not the purpose of right-to-try at all. They also accuse me of a lack of compassion, as though compassion for the terminally ill requires that I buy their dubious arguments and the premises behind them. Now that right-to-try is law, however, the mask is coming off. One of the architects of the federal right-to-try law that President Trump signed on Wednesday, Sen. Ron Johnson, rebuked FDA Commissioner Scott Gottlieb last week. Indeed, the day after President Trump signed the bill into law, Sen. Johnson set Dr. Gottlieb straight on the true purpose of right-to-try, as I discovered in a STAT News article, ““, which reported on a letter written by Sen. Johnson to Dr. Gottlieb in response to remarks that Gottlieb had made about right-to-try two weeks ago entitled . First, Sen. Johnson laid out the “offense” by Gottlieb that riled him up:

In a recent article about right to try, you appeared to suggest that the FDA would need to issue regulations to balance the law’s requirement against “patient protections.” The article quoted you as saying:

  • “In terms of making sure that it balances [access to experimental drugs] against appropriate patient protections . . . with [S. 204], we’d have to do a little bit more . . . in guidance and perhaps in regulation to achieve some of those goals.”
  • “We felt that there were certain aspects of [S. 204] that could be modified to build in additional patient protections, but if you weren’t able to do that legislatively, that there [was] a pathway by which you do that administratively and still remain consistent with the letter and the spirit of this law.”

You later tweeted: “I stand ready to implement [right to try] in a way that achieves Congress’ intent to promote access and protect patients; and build on #FDA’s longstanding commitment to these important goals.”

Silly Dr. Gottlieb! Poor Dr. Gottlieb! He was actually deluded enough (or he deluded himself enough) that right-to-try was about expanding access to experimental therapies for people with terminal illnesses. Dr. Gottlieb, as I’ve discussed, was the “least bad” choice Trump could have made for FDA Commissioner. Sure, he’s a real pharma shill, having more pharma ties than I’ve ever seen in an FDA Commissioner before and is all for “streamlining” drug approval processes (translation: making them easier and less rigorous), but he still exists within a continuum of “normal” among FDA Commissioners, albeit on the conservative end. He’s not a who thinks the free market will take care of drug safety, nor does he think that online rating systems, a “” if you will, would be effective at assuring drug safety. Gottlieb is, in contrast, the sort of FDA Commissioner that any Republican administration might have appointed. He actually believes in the mission of the FDA, as he showed when under his leadership the FDA started on .

Because Gottlieb believes in the mission of the FDA, he understands how bad this new law is, how it will cut the FDA out of the process, leaving terminally ill patients unprotected by institutional review boards (IRBs)—or much of anything else, for that matter. So he tried to say how the FDA would work to implement the law, including trying to do what the FDA is supposed to do and protect patients accessing right-to-try medications. It’s what any responsible FDA Commissioner, even one who was a pharma shill or is very much in favor of “streamlining” FDA approval processes, would do.

Sen. Johnson wasted no time in setting Dr. Gottlieb straight on that score:

As I made clear to my colleagues in the Senate and the House before each body voted on S. 204, this legislation is fundamentally about empowering patients to make decisions in cooperation with their doctors and the developers of potentially life-saving therapies. This law intends to diminish the FDA’s power over people’s lives, not increase it.

I told you so. In the name of patient “empowerment” right-to-try is really about cutting the FDA out of the process of drug companies marketing their wares to desperate patients. Johnson makes that very explicitly clear in no uncertain terms:

It is designed to work within existing FDA regulations, definitions, and approval processes. It is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments. Under this law, the FDA’s oversight with respect to patient safety within a Phase I trial remains unchanged; the current thresholds for successful completion of such a trial phase remains unchanged.

That last bit about phase I trial requirements is a red herring. No one is claiming that right-to-try changes phase I clinical trial requirements. What right-to-try does do is something incredibly dangerous, as I’ve discussed above. It makes any drug that has passed phase I trials and has an active investigational new drug (IND) application and is in ongoing clinical trials eligible for right-to-try.

Let me expand a bit on what I said above about this. It is deceptive as hell to call drugs that have passed phase I “safe,” as I’ve seen right-to-try advocates do more times than I can remember. Phase I trials generally only involve less than 30 patients and are not designed to verify drug safety. Rather, they are designed to detect the worst toxicities and make sure that the drug isn’t too toxic or hazardous to continue to test in phase II and III clinical trials. (There’s a big difference.) Phase I trials also do not demonstrate efficacy. They are not designed to do that, either. Basically, think of phase I trials as a screening test to make sure an experimental drug isn’t too dangerous and might have activity, enough to justify further clinical trials. Only around 10-15% of drugs that pass phase I go on to be approved by the FDA.

Ironically, Sen. Johnson is not entirely wrong in one thing that he asserts. It is true that right-to-try does not provide any new rights that patients didn’t already have before under expanded use programs. It also certainly doesn’t do anything to increase FDA power. After all, the bill’s primary sponsor just told Scott Gottlieb that that the very purpose of the bill was to weaken his agency and that he should, basically, stay out of right-to-try cases.

If that’s not clear enough, Johnson drives home the point. First, he wants as many patients as possible to be eligible for right-to-try:

S. 204, as originally introduced, applied to patients “with a terminal illness,” as defined by state law. I rejected the FDA’s proposed definition—“immediately life-threatening disease or condition”— because it would exclude patients with Duchenne muscular dystrophy, an illness that I explicitly intended to be covered by the legislation. As enacted, S. 204 defines terminal illness as “life-threatening disease or condition,” a definition that exists in current federal regulation. The FDA confirmed that this definition would include patients diagnosed with Duchenne muscular dystrophy.

Of course, state right-to-try laws generally define a “terminal illness” as one that is likely to cause death within six months, although the definition varies somewhat and some states don’t even necessarily require a “terminal” illness. Be that as it may, Sen. Johnson makes it very clear: Right-to-try should victimize apply to as many patients as possible.

Next up, don’t bother me with any outcomes that might reflect badly on the experimental drug:

S. 204 requires that the Secretary of Health and Human Services may not use a clinical outcome associated with the use of an eligible investigational drug to delay or adversely affect the drug’s review or approval, unless use of that clinical outcome is critical to determining safety. This language is not intended to enable the FDA to expand the scope of existing safety determinations about investigational drugs.

No one ever said that it did, least of all Scott Gottlieb, at least as far as I can tell. As mentioned above, the language in the federal right-to-try law bends over backwards to make sure there are no consequences for companies agreeing to provide experimental medications to patients under the law. Indeed, one thing that I didn’t mention is that the original version of Sen. Johnson’s right-to-try bill explicitly banned the FDA from using outcomes from patients using an experimental drug under right-to-try in its consideration. Period. Seriously, I mean this. The original version of Sen. Johnson’s bill would have banned the FDA from even considering outcomes of patients who access right-to-try in its considerations over whether to approve a drug. At least the version that passed allows such consideration, although it requires jumping through some hoops and puts the burden of proof on the FDA, not the company seeking approval for its drug, to show why right-to-try outcomes should be included.

The FDA capitulates

Sadly, the FDA appears to have , although I don’t know that there’s anything else it could have done:

In a separate email to staff Wednesday, Janet Woodcock, who directs the agency’s Center for Drug Evaluation and Research, told staff to direct any inquiries about the new law to drug companies.

“We believe that sponsors are in the best position to provide information on the development status of their products,” Woodcock wrote.

In other words, if Congress is going to cut the FDA out of right-to-try decisions and regulation, screw it all. Patients, don’t call us. Congress has eliminated our authority to deal with this. Call the company that makes the drug you’re interested. Congress cut us out; we can no longer interfere. You’re on your own.

Just yesterday, Gottlieb appeared to be whistling past the graveyard:

The new 'Right to Try' legislation provides another pathway for patients facing life threatening illnesses to access experimental drugs, under physician supervision. This new pathway will provide a second option for sponsors who are willing to make drugs available pre-approval

— Scott Gottlieb, M.D. (@SGottliebFDA)

Compassionate use or “expanded access” programs have long been around, and, as I’ve said many times, the best way to allow access to experimental drugs to the terminally ill or to patients with compelling need outside of a clinical trial before they are approved is through such programs. Such programs ensure the continued involvement of the FDA to protect patients, as well as oversight by an IRB. Right-to-try explicitly cuts the FDA out of the process and has no provision for IRB oversight.

Dr. Gottlieb said basically the same thing later in the same thread:

Ultimately, a burden rests with sponsors developing potentially life-saving or life-extending drugs to consider making these products available, pre-approval, to patients who qualify for access. There's clearly a consensus among American families that patients want these options

— Scott Gottlieb, M.D. (@SGottliebFDA)

In other words, again, the FDA is powerless, thanks to the new right-to-try law. We can’t do anything to force sponsors (drug companies) to make their drugs available before approval.

It goes beyond that, however. On Twitter, stem cell biologist Paul Knoepfler asked:

What happens if a for-profit firm claims they are doing RTT but don't follow the rules. Under the new law can FDA go after them & if not, who will?

— Paul Knoepfler (@pknoepfler)

That’s a very good question indeed. Remember, the intent of the law is to cut the FDA out of the equation as much as possible. How will the FDA actually respond when a company claims to be doing right-to-try but isn’t following the requirements of the law? Given Sen. Johnson’s negative reaction to even the suggestion that the FDA still has a role protecting patients using right-to-try, it would be a politically dicey thing for the FDA to try to intervene too vigorously. Would Gottlieb be up for it? I don’t know.

All is not hopeless. There might be ways that the FDA can get back in, as suggested by Holly Fernandez Lynch of the Department of Medical Ethics and Health Policy at Perelman School of Medicine, University of Pennsylvania, but I’m not sure that I buy some of them:

  1. Clarify that it is not enough to have a life-threatening illness, but rather that the illness should be immediately life-threatening.
  2. Require adverse event reporting not via the right to try law, but rather under the terms of the overarching IND for the drug (this may be tricky, but not entirely implausible).
  3. Clarify what it means for a Phase 1 trial to be completed, i.e., what is success?
  4. Require that sponsors develop contracts with certifying physicians that in order to access the drug, the physician must collect and report safety data.
  5. Specify the sorts of adverse event data that needs to be collected in order to satisfy the requirements of the annual summary.
  6. Post as much information publicly as possible, to help patients and their physicians understand that the unlikelihood that right to try will be helpful.
  7. Encourage patients and companies to utilize the expanded access pathway rather than right to try.
  8. Encourage sponsors and investigators to allow for the broadest clinical trial inclusion consistent with participant safety and scientific integrity.

Senator Johnson just shot down #1 (with extreme prejudice, to boot!) in his letter to Scott Gottlieb. #2 is less plausible than Lynch seems to think, given the “no use of outcomes” provision in the law. #3 is actually a good idea, but won’t really do much more than decrease slightly the number of drugs eligible for right-to-try. In reality #5, 6, 7, and 8 are probably the best bets, although #7 is likely to be a bust, as the FDA really doesn’t have any tools to encourage the use of expanded access rather than right-to-try.

The subtext to all this is, of course, that the FDA doesn’t want to and is basically washing its hands of the problem and dropping it in the lap of drug companies, which is kind of funny if you think about it. After all, right-to-try is supposed to be about more “freedom” for both patients and sponsors. That “freedom” will have a price. For sponsors, it will be to deal with right-to-try requests with no guidance. For patients, however, the price will be financial (sponsors could charge exorbitant prices for their wares), the risk of significant complications, up to and including premature death, from right-to-try.

All this in the name of “freedom.”

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Posted by David Gorski

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