We here at SBM, particularly Jann Bellamy and myself, frequently write about naturopathic licensing laws, noting that naturopaths are relentless. They keep trying and trying to get states to pass laws granting their specialty licensure, and, like the Terminator trying to kill Sarah Connor or her son, they absolutely will not stop, ever, until science-based medicine is dead there are naturopathic licensing laws in all 50 states by 2025. Part of their strategy is that they never give up. No matter how many times a given state legislature denies them what they want, they are soon back, and they keep coming back again and again and again and again until they get the law they want passed. It’s the problem with playing defense, naturopaths can fail as many times as they have resources for, defenders of science-based medicine can’t afford to fail once. Worse, once such laws are passed, naturopaths are back again and again and again and again to keep trying to expand their scope of practice. It never ceases to amaze me that physicians’ groups go ballistic protecting their turf when advance practice nurses lobby to expand their scope of practice to encompass what they are trained for but remain more or less silent when naturopathic quacks push to have the state place its imprimatur on their pseudoscience.
Sadly, I’ve come to the conclusion that “right to try” laws are a lot like naturopathic licensing laws in that respect, only worse. Why worse? Unlike naturopathic licensing bills, right-to-try bills rarely die; most of them pass. In fact, only one right-to-try bill that I’m aware of has ever been successfully resisted and blocked from becoming law, and that required a veto by the governor. I’m referring, of course, to the California right-to-try bill vetoed last fall by Governor Jerry Brown. Amazingly, Brown’s veto held. Well, a new right-to-try bill is back in California, less than a year after the old right-to-try law had been vetoed. Passed in the legislature by overwhelming margins, it’s now back on Gov. Brown’s desk, and he has to decide what to do with it.
Its supporters hope that this time will be different, that this time Gov. Brown will sign the bill. They might be right. The rationale Gov. Brown used when vetoing the bill was that he wanted to wait to see what happened with reform of the FDA Expanded Access (sometimes called “Compassionate Use”) program. It’s quite possible that, despite the FDA moving forward with such reform, right-to-try advocates might persuade the governor that it isn’t enough. They’re wrong. In any case, given the resurrection of the California right-to-try law, now seemed like a good time to review what’s been happening with these laws since last year and discuss the situation in California and at the federal level. It isn’t good for patients or drug development. On the other hand, now that it’s been nearly two and a half years since the first right-to-try law was passed in Colorado, we have time to see just what a sham these laws are.
But first, since it’s been nearly a year since I last discussed right-to-try, let’s review why these laws are so pernicious.
The false promise of right-to-try
Right-to-try laws have been proliferating with kudzu-like tenacity throughout the US since 2014. Since Colorado passed its law in April 2014, the total of states with right-to-try laws on the books has reached 31. That’s an astonishingly high number of nearly identical state laws to have been passed in such a short span of time. It’s not surprising, as you will see. Right-to-try laws give the appearance of helping terminally ill patients, and voting for them lets legislators feel good about themselves without actually confronting hard choices, not to mention to appear to be doing something helpful when they are not. On the surface, they are very, very appealing, to the point where I’ve grimly joked that opposing right-to-try appears akin to advocating disemboweling puppies or being against mom, apple pie, and the American flag. I myself have experienced some of that vitriol, and know from various private conversations that university medical centers and pharma think these laws are a horrible idea. Yet, it is very rare for an official representative to state outright opposition to such laws. (Note: I do not represent my university or cancer center in any way on right-to-try. See? Even I feel obligated to point that out!)
In any case, right-to-try is a movement started by the libertarian Goldwater Institute, ostensibly to give terminally ill patients the “right to try” experimental treatments without interference from the FDA. Indeed, the Goldwater Institute provided the template for these laws, and all right-to-try laws that I’ve examined hew pretty closely to this template (many even use the exact language provided by the Goldwater Institute), with customizations intended to make individual laws fit into the legal and regulatory framework of the state passing them. In reality, right-to-try is a cruel sham. Such laws provide an illusion of providing potential cures to desperately ill and dying patients in the form of experimental drugs when in reality they do nothing of the sort. Instead, they raise the hopes of the patients rallying to persuade their lawmakers to pass these laws and then basically doing nothing for them.
There are several reasons why right-to-try laws are a cruel sham. First and foremost, states do not have authority over drug approval. The FDA does, and federal law trumps state law. That means right-to-try laws are, in essence, meaningless and almost certainly would likely be struck down as unconstitutional if taken to court. On the other hand, it’s hard not to suspect that the Goldwater Institute wants these laws to be challenged in court. Second, it’s incredibly rare that an experimental drug will make the difference between life and death in a terminally ill patient. Yet it is that hope that supporters of right-to-try laws, in particular the Goldwater Institute, have shamelessly exploited to rally patient groups and to persuade legislators to pass these laws all over the nation. Basically, the Goldwater Institute has sold patients and legislators on a lie. It’s very understandable why desperate patients dying of a terminal illness would be willing to try almost anything; exploiting that desperation is a feature, not a bug, of the campaign to pass right-to-try laws.
Worse, even if right-to-try laws actually worked as the Goldwater Institute claims they should work, they would be very dangerous to patients. The reason is simple. The eligibility requirements for a drug to be made available for right-to-try are risibly low and betray a total lack of understanding of how drug development works. Basically, for an experimental drug to be considered for right-to-try, the only requirements are experimental drug (1) have passed phase I trials and (2) still be in clinical trials (e.g., phase II or III). Of course, phase I trials are not designed to test efficacy. Their purpose is to work out optimal dosage, identify the maximal tolerated dose, and identify major side effects. Worse, these trials usually only consist of a few tens of patients, often less than 30. To propose letting seriously ill patients use potentially toxic drugs that have been tested in so few people and not demonstrated to be efficacious and safe is to invite disaster. Moreover, the vast majority of experimental drugs that pass phase I never make it to market.
Basically, the whole right-to-try movement is built on a delusion, namely that there is a river of cures to serious and fatal disease in the pipeline, but that the only reason they aren’t flowing to the people is because of the overly cautious bureaucracy and excessively burdensome regulations of the FDA. If the people could just get the FDA out of the way—or so the delusions go—cures would flow to the people, all courtesy of the magic of the free market, which will sort out problems with safety and efficacy. No, I am not exaggerating. I’ve discussed before in great detail the profoundly deceptive arguments made by libertarians that the FDA is killing patients through its caution.
Of course, right-to-try laws were never really intended to help patients, although patients were sold on the idea that they are. Remember the source. The Goldwater Institute is a profoundly libertarian think tank whose primary goal is to reduce the influence of government; as such, it is opposed to what it views as “excessive regulation,” which, if you read the Goldwater Institute’s website, seems to be nearly all laws or regulations that restrain business, the free market, or personal choice, even reasonable ones. It is thus unsurprising that, consistent with their libertarian origin, right-to-try laws neither require nor provide any financial support for patients, who are basically on their own when it comes to paying what could be the substantial financial charges. Insurance companies and government plans don’t have to pay. Worse, as I’ve pointed out elsewhere, the language of many of these laws could be interpreted as not requiring insurance companies to pay for medical expenses related to complications due to taking the experimental drug. Just as bad, right-to-try laws also strip away many patient protections. For instance, right-to-try laws indemnify doctors recommending an experimental treatment under right-to-try, making it impossible to sue them for malpractice and impossible for state medical boards to discipline them. It doesn’t matter if the suggestion for a right-to-try drug was even appropriate. Finally, given that the FDA, not the states, controls drug approval, drug companies will be highly reluctant to offer experimental drugs under right-to-try without the prior approval of the FDA, and the FDA already has programs for single patient INDs, also known as “Compassionate Use”, to allow patients access to experimental drugs. This process still requires ethical oversight by an institutional review board (IRB), providing another layer of patient protection. Nothing in right-to-try does.
Last year, I challenged the Goldwater Institute through its executive VP Christina Sandefur and other right-to-try supporters to produce a single example of a terminally ill patient who had benefitted from right-to try or who had even been granted access to an experimental drug, basing my challenge on the case of Bob Bardone, who had amyotrophic lateral sclerosis, a fatal degenerative neurological disease also known as Lou Gehrig’s disease. This was a man who moved to Missouri because of its right-to-try law, hoping to gain access to experimental therapies. The short version of the story is: He didn’t. I did a bit of Googling to see if in the interim there had been any patients who received experimental medication under right-to-try. I couldn’t find any. Out of curiosity, I tried again:
@gorskon yes, we are aware of patients being treated
— Christina Sandefur (@cmsandefur) August 24, 2016
Further questioning didn’t produce any specifics, but I’ll keep at it. Maybe I’ll start e-mailing legislators who sponsored right-to-try bills and ask them if they know of anyone who’s benefited, starting in Michigan. Elsewhere, I found out that the Goldwater Institute is claiming that it knows of 40 patients receiving experimental therapies under right-to-try. One of my fears is that those patients are probably in Texas and are probably receiving Stanislaw Burzynski’s antineoplaston therapy, which, while initially seeming to be a potentially promising anticancer treatment, has not produced any convincing evidence that it works for any cancer. These days, it’s quackery. I’ve stated from the beginning how right-to-try is custom-made to benefit a quack like Burzynski, whose ANPS did make it through phase I clinical trials and are, thanks to the FDA’s failure, back in clinical trials again. I have no way of determining if my fears are justified, though.
Be that as it may, despite trying, I have not been able to find a single story of a patient receiving experimental therapeutics under right-to-try, and the Goldwater Institute isn’t giving any details, which leads me to believe that its story is almost certainly a crock. After all, right-to-try is one of its most important initiatives. If there were terminally ill patients benefiting from experimental drugs under right-to-try, you’d expect the Goldwater Institute would be trumpeting the news, and you’d also expect that the patients themselves would be more than happy to let the media do profiles of them. I would certainly expect these things; yet I see nothing. Also, think of it this way. Even if there really are 40 patients receiving an experimental drug under right-to-try, since 2009, the FDA has granted between 936 and 1,873 Expanded Access requests a year and approves the overwhelming majority of requests, including a 300% increase in emergency INDs, which are requests for single patients who don’t have time to complete the regulatory paperwork. Right-to-try, even if it works as the Goldwater Institute claims it wants it to, is having a negligible effect compared to the FDA’s already existing policies—just as I’ve told you it would many times. And that’s if you accept the Goldwater Institute’s estimate of 40 patients at face value, which I most definitely do not. I’d be willing to bet it’s much closer to zero, if not actually zero. Of course, the Goldwater Institute could always prove me wrong.
Right-to-try returns from the grave in California
Having reviewed why right-to-try is a sham, let me now circle back to what’s happening in California:
A bill that would allow terminally ill people to obtain experimental drugs appears headed to Governor Brown’s desk for the second year in a row. Brown vetoed a similar measure last year, but supporters believe conditions are right for him to sign it this time around.
Brown said he vetoed last year’s “Right-to-Try” measure because he wanted time to see how changes to the FDA’s “Compassionate Use” program streamlined the process of getting experimental drugs to terminal patients.
Nearly a year later, the new bill’s supporters say it’s time for California to step in with its own solution, because the modified federal initiative has not reduced the minimum 30-day wait for drugs.
“The process may have to start over if the FDA has even one question,” said the bill’s author, Assembly Majority Leader Ian Calderon (D-Whittier). “Terminally ill patients can still end up waiting weeks and months” for an approval.
Calderon’s measure would allow drug manufacturers to give certain terminally ill people access to drugs not yet approved by the FDA.
Calderon is, of course, parroting the same exaggerated claims made by the Goldwater Institute. In fact, the FDA has actually dramatically simplified the Expanded Access application process, such that, as mentioned above, the result has been a large increase in emergency INDs.
Let’s take a look at the bill, AB-1668 Investigational drugs, biological products, and devices. Reading it over, I see that it’s the same old nonsense, except that it goes even further than a typical right-to-try law. For example, look at the definition of “eligible patient” for right-to-try in AB 1668:
(b) “Eligible patient” means a person who meets all of the following conditions:
(1) Has an immediately life-threatening disease or condition.
(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration.
(3) Has not been accepted to participate in the nearest clinical trial to his or her home for the immediately life-threatening disease or condition identified in paragraph (1) within one week of completion of the clinical trial application process, or, in the treating physician’s medical judgment, it is unreasonable for the patient to participate in that clinical trial due to the patient’s current condition and stage of disease.
(4) Has received a recommendation from his or her primary physician and a consulting physician for an investigational drug, biological product, or device.
(5) Has given written informed consent for the use of the investigational drug, biological product, or device, or, if he or she lacks the capacity to consent, his or her legally authorized representative has given written informed consent on his or her behalf.
(6) Has documentation from his or her primary physician and a consulting physician attesting that the patient has met the requirements of this subdivision.
“Immediately life-threatening disease or condition”? That’s incredibly broad. A severe case of pneumonia could be “immediately life-threatening.” A heart attack is “immediately life-threatening.” A stroke is “immediately life-threatening.” An “immediately life-threatening” illness is not the same thing as a terminal illness. Yet this bill tries to have it both ways, as it defines “immediately life-threatening disease or condition” as “a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months.” That implies something less acute, but “within a matter of months” encompasses more immediately life-threatening diseases as well. Basically, the definition is the very definition of vague double talk that would likely result in court battles over interpretation if anyone ever actually tried to invoke it who didn’t have an undeniable terminal illness. Maybe that was the intention. (Strike the “maybe.”) In any case, this bill, if passed, would be far broader than most of the right-to-try laws I’ve reviewed.
Consistent with the libertarian origins of the bill, AB 1688 does exactly zero to help terminally ill patients access experimental drugs. Check it out:
11548.2. (a) Notwithstanding Section 110280, 111520, or 111550, a manufacturer of an investigational drug, biological product, or device may make available the manufacturer’s investigational drug, biological product, or device to an eligible patient pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient.
(b) A manufacturer may do both of the following:
(1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation.
(2) Require an eligible patient to pay the costs of, or associated with, the manufacture of the investigational drug, biological product, or device.
(c) (1) This article does not expand the coverage provided under Sections 1370.4 and 1370.6 of this code, Sections 10145.3 and 10145.4 of the Insurance Code, or Sections 14087.11 and 14132.98 of the Welfare and Institutions Code.
(2) This article does not require a health benefit plan to provide coverage for the cost of any investigational drug, biological product, or device, or the costs of services related to the use of an investigational drug, biological product, or device under this article. A health benefit plan may provide coverage for an investigational drug, biological product, or device made available pursuant to this section.
So basically AB 1668 allows drug companies to charge whatever they want for a drug that’s only passed the most basic of basic clinical trials, Phase I. It doesn’t require health plans to cover the charges for these experimental drugs. It doesn’t require state government to cover the costs of right-to-try drugs. I even interpret that part about health plans not being required to provide coverages for the “costs of services related to the use of an investigational drug, biological product, or device under this article” to be potentially interpretable as meaning that health plans don’t have to pay for complications due to the use of experimental drugs under right-to-try. The bill also does this:
111548.3. (a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician’s license based on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited independent institutional review board.
111548.5. This article does not create a private cause of action, and actions taken pursuant to this article shall not serve as a basis for a civil, criminal, or disciplinary claim or cause of action, including, but not limited to, product liability, medical negligence, or wrongful death, against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient for harm done to the eligible patient or his or her heirs resulting from the investigational drug, biological product, or device, or the use or nonuse thereof, if the manufacturer or other person or entity has complied with the terms of this article in relation to the eligible patient, unless there was a failure to exercise reasonable care.
In other words, just like the case with all the other right-to-try bills, under AB 1668 a doctor who recommends an experimental drug under right-to-try can’t be sued or disciplined by the state medical board. Neither drug manufacturers nor doctors recommending right-to-try drugs can be sued for liability. Basically, like every other right-to-try law, this bill, if passed, would be a travesty for patients. Under the guise of providing them access to potentially life-saving drugs (which it doesn’t do), AB 1668 basically puts patients with life-threatening illnesses completely on their own. Not very patient-friendly at all. Basically, it tells patients, “You’re completely on your own.”
Perusing other websites about right-to-try, I found nothing to disabuse me of this conclusion. In fact, looking at the FAQ on the Right-to-Try website, I find the same misinformation and lies about right-to-try that I found two years ago. For example:
Q: SOME CRITICS SAY RIGHT TO TRY IS JUST “FEEL GOOD” LEGISLATION THAT WON’T ACTUALLY HELP ANYONE. IS THIS TRUE?
A: No. Right To Try laws give people with terminal illnesses the legal right to use investigational medications years before they might otherwise be available on the market. No one can guarantee that a particular treatment will be effective, but these laws return choice and control over treatment options to where it is most effective: with patients and their doctors.
Actually, it is true. Right-to-try is just “feel good legislation” that won’t help anyone, much less terminally ill patients. Same as it ever was.
Here’s hoping that Gov. Brown shows the same political courage now that he showed last year when the previous right-to-try bill came across his desk. Contrary to how they are portrayed, right-to-try laws are among the most cynical, patient-hostile laws there are. Under the guise of helping terminally ill patients pursue hope, they strip them of many legal protections, open them up to exploitation by drug companies, and sell them false hope.
Meanwhile, let’s take a look at what’s happening at the federal level.
Right-to-try goes federal
The purpose of right-to-try laws is to undermine the authority of the FDA, build pressure for a federal law weakening the FDA, and to provide a pretext for lawsuits designed to challenge the FDA’s authority to regulate drugs. The reason why the Goldwater Institute thinks this year is the time is, as, Alice Bateman-House puts it:
@gorskon Yes but I’m afraid much more support now. Goldwater’s playbook was get laws in at least 25 states & then claim mandate for fed law
— Alison Bateman-House (@ABatemanHouse) August 24, 2016
Personally, I also think that the Goldwater Institute is hoping that a patient will try to access an experimental drug under right-to-try, be denied, and then sue, producing a case that will go all the way to the Supreme Court. Whatever the intent of the Goldwater Institute is regarding the courts, unlike the case at the state level, the Goldwater Institute and right-to-try advocates have had a harder time achieving its aim at the federal level. For example, when right-to-try laws were first starting to be passed at the state level, the Compassionate Freedom of Choice Act of 2014 was introduced. It was basically a quack manifesto, and fortunately it didn’t go anywhere. Of course, the Goldwater Institute’s intent had been the long game all along. So it’s not surprising that another federal bill has been introduced:
A bill introduced in the US Senate on Tuesday becomes the latest legislative effort to expand the ability of terminally ill patients to gain access to experimental medicines. The legislation, which joins a companion bill that was introduced in the House last summer, would prohibit the federal government, including the US Food and Drug Administration, from taking any action to prevent patient access.
The bill, which was introduced by Senator Ron Johnson (R-Wis.), comes after 28 states have passed so-called “Right to Try” laws. These allow patients to leapfrog a drug-development process that takes years before new treatments become available. And the laws reflect rising frustration with an FDA program called expanded access, in which people who are seriously ill can obtain a drug under development, even though they aren’t enrolled in a clinical trial.
This story is from May; since then three more states have passed right-to-try. The federal bill, submitted to the Senate, is S.2912, The Trickett Wendler Right to Try Act of 2016. Fortunately, thus far the bill has been languishing in the US Senate Committee on Health, Education, Labor, and Pensions, as its companion bill, H.R.3012, The Right To Try Act of 2015 has been languishing in the relevant House committee since last summer. Given that this is an election year and not much of anything is happening legislatively (heck, Congress can’t even seem to pass a budget), this bill is unlikely to pass this Congress, but it’s not hard to imagine its being introduced next year, with much more support. Let’s take a look at what it does.
I’m not a lawyer, as we say, but this law is clear enough that I understand what it could do. First, it explicitly states that state right-to-try laws trump the Federal Food, Drug, and Cosmetic Act and the Controlled Substances Act:
(a) IN GENERAL.—Notwithstanding the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Controlled Substances Act (21 U.S.C. 801 et seq.), and any other provision of Federal law, the Federal Government shall not take any action to prohibit or restrict—
(1) the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that—
(A) is intended to treat a patient who has been diagnosed with a terminal illness; and
(B) is authorized by, and in accordance with, State law; and
(2) the possession or use of an experimental drug, biological product, or device—
(A) that is described in subparagraphs (A) and (B) of paragraph (1); and
(B) for which the patient has received a certification from a physician, who is in good standing with the physician’s certifying organization or board, that the patient has exhausted, or otherwise does not meet qualifying criteria to receive, any other available treatment options.
In other words, this bill, if passed, would explicitly federalize each state’s right-to-try law, in the process eliminating the FDA’s ability to protect terminally ill patients from what could be dangerous or inappropriate drugs. Worse, it trusts the states not to produce right-to-try laws that are too dangerous, the sole exception is that it requires that the illness being treated be “terminal.” The problem, of course, is that this bill does not define “terminal.”
(1) NO LIABILITY.—Notwithstanding any other provision of law, no liability shall lie against a producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of an experimental drug, biological product, or device for the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is in compliance with subsection (a).
This clause basically removes federal liability from physicians and drug companies that offer a drug under right-to-try. If a patient suffers because of the inappropriate use of such a drug, the patient (or, given that the patients under this bill have terminal illnesses, the family) has no recourse to sue the manufacturer under federal law, in addition to having no recourse under state law. Add to that the lack of oversight by an IRB, and this law is profoundly anti-patient—just like state right-to-try laws.
(2) NO USE OF OUTCOMES.—Notwithstanding any other provision of law, the outcome of any production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that was done in compliance with subsection (a) shall not be used by a Federal agency reviewing the experimental drug, biological product, or device to delay or otherwise adversely impact review or approval of such experimental drug, biological product, or device.
This clause is clearly intended to address the concern of drug and device manufacturers that if they provide an experimental therapeutic to a patient under right-to-try and the patient suffers complications due to the treatment, the approval of its product might well be adversely impacted. This, of course, is not an unreasonable concern on the part of manufacturers, given that it can easily cost $1 billion to bring a drug or device to market, and by the time the product has passed phase I clinical trials a great deal of that cost has already been invested in development. However, this goes too far. Basically, it says that even if a patient death is clearly due to use of an experimental drug under right-to-try, that death should not be considered by the FDA in deciding whether to approve the drug. Think of it this way. Let’s say dozens of patients die from using an experimental drug under right-to-try. This bill, if passed, would bar the FDA from even considering those deaths in its deliberations over whether to approve the drug.
Basically, the Trickett Wendler Right to Try Act of 2016 would not help terminally patients. It would endanger them. Proponents often ask, “What does a terminally ill patient have to lose?” The answers are simple. They can lose money, perhaps their life savings, given that accessing right-to-try could easily cost tens or hundreds of thousands of dollars. That’s because, when you come right down to it, “right to try” is a misnomer. It’s really “right to buy.” If you’re terminally ill and don’t have the money or the means to raise it, right-to-try will not help you. Worse, thanks to right-to-try, terminally ill patients can lose some of their precious quality time remaining with their loved ones if they suffer complications that place them in a hospital or prematurely kill them.
Right-to-try laws: A cruel sham that is profoundly anti-patient
The California right-to-try bill being considered by Gov. Jerry Brown, like the Trickett Wendler Right to Try Act of 2016 and all of the other right-to-try laws based on the Goldwater Institute template and passed by other states, is profoundly anti-patient. Like the equally ill-advised 21st Century Cures Act, right-to-try bills are based on the delusion that there are oodles and oodles of cures for deadly diseases out there that could save thousands of lives if only the evil government and FDA would step aside and get out of the way of the free market. I say “delusion” because the FDA, despite being underfunded, is actually pretty efficient at new drug approvals, evaluating nearly all new drug applications within 6 to 10 months, an impressive turnaround for such complex assessments. Indeed, the FDA actually acts more rapidly than its European counterparts approving new drugs. Basically, there is no evidence that the FDA hampers overall medical innovation, nor is there evidence that the FDA’s current requirements lead to higher drug prices or cost lives.
None of this is to say that the FDA is perfect. Far from it. Certainly there is a discussion to be had about how, in the case of desperate patients with terminal illnesses, we as a society should balance individual rights versus risk/benefit considerations in making decisions about how freely we allow experimental therapeutics to be used to try to save these patients. It’s not as though we haven’t had this discussion before, either. We had it in the 1980s during the AIDS epidemic, and we’ve periodically revisited it since then. This is another such time, and the FDA has actually responded by vastly simplifying its procedure for granting Expanded Access, and the vast majority of such requests are granted.
It must be reiterated that, as much as right-to-try is enormously popular because no one wants to deny a terminally ill patients his or her “last chance,” the purpose of right-to-try was never to help terminally ill patients. There is no evidence, at least none that the Goldwater Institute has yet produced or that I’ve been able to find anywhere, that right-to-try has allowed a single terminally ill patient to access an experimental drug or helped him or her to live longer, much less that it has saved a single life. Unfortunately, right-to-try has been a cynically successful strategy to weaponize sympathetic patients and basic human empathy for patients facing imminent death to attack and ultimately greatly weaken the FDA.