Here we go again.
Remember how I frequently say that naturopaths are relentless, how, whenever they attempt to get a naturopathic licensing bill passed in a state and fail, they’re soon back to try again. Basically, they keep trying until they succeed, and once they succeed, it’s game over for keeping their quackery from having the imprimatur of the state. Perhaps my favorite metaphor for this is that of the killer in a 1980s slasher flick, like Jason or Michael Myers, who frequently “dies” ta the end of one movie, only to come back the next movie to mow down another bunch of hapless teens. The difference, of course, is that right-to-try bills rarely die; most of them pass.
It turns out that advocates of “right-to-try” laws are a lot like that. Right-to-try laws have been proliferating with kudzu throughout the US since 2014. It’s not surprising, as you will see. They give the illusion 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. So I wasn’t surprised to learn that, after Governor Jerry Brown did the right thing and vetoed a right-to-try bill in California last fall, a new bill appears on the verge of finding its way to his desk again, with its supporters hoping 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 given the FDA an opportunity to reform its Compassionate Use program as it has been doing.
It’s been a while since I’ve written about “right-to-try.” In fact, the last post about it appears to be the one I wrote praising Gov. Brown’s veto (time flies!), noting that he was the only Governor thus far with the courage to veto this ill-advised bill. In any case, right-to-try is a a movement started a couple of years ago by the libertarian Goldwater Institute, ostensibly to let terminally ill patients try experimental treatments without interference from the FDA. In reality, right-to-try is a cruel sham. Such laws give the illusion of providing potential cures to desperately ill and dying patients in the form of experimental drugs when in reality it does nothing of the sort, raising 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. The first thing you should know about them, though, is that they all follow the same basic template originated by the Goldwater Institute. Next, states do not have authority over drug approval. The FDA does, and federal law and regulations trump state law. It’s also incredibly rare that an experimental drug will make the difference between life and death in a terminally ill patients. Yet it is that hope that supporters of right-to-try laws, in particular the Goldwater Institute, have shamelessly exploited to persuade legislators to pass these laws all over the nation. Worse, the requirements are risibly low and betray a total lack of understanding of how drug development works in that they only require that the experimental drug (1) have passed phase I trials and (2) still be in clinical trials. 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, they usually only consist of a few tens of patients, often less than 30. To propose letting seriously ill patients drugs that have been tested in so few people and not demonstrated to be efficacious and safe is to invite disaster. Finally, consistent with their libertarian origin, right-to-try laws provide no financial support for patients, who are basically on their own when it comes to paying what can be the substantial financial charges. They also strip away patient protections, making it virtually impossible for a patient injured using such a drug to sue either the drug company or the physician administering the drug. Finally, given that the FDA, not the states, controls drug approval, drug companies will be highly reluctant to offer such drugs without the 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.
I once challenged the Goldwater Institute and 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. 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. Maybe I’ll Tweet at the Goldwater Institute’s flacks again and see if they can provide me with an example. The last time I did that, the excuse was that the laws were new. They’re not so new any more. It’s been two and a half years since the first one was passed. There are now 30 of them or so. That excuse won’t fly any more. In reality, 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. Oh, and to stoke hostility directed at the FDA. That’s very important to the Goldwater Institute.
In any event, I was surprised to note that I haven’t written a post that is primarily about “right to try” laws in 2016. It’s been almost a year since I discussed the issue. So now is as good a time as any, and the progress of the California law is as good an excuse as any to write about this scam again. So let’s 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.
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.” “Immediately life-threatening” 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. In any case, this bill, if passed, would be far broader than most of the ones I’ve reviewed.
Consistent with the libertarian origins of the bill, AB 1688 doens’t do what we in the biz call jack shit 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. It 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, 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, this bill is 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.
And they’re enormously popular because everyone wants to help terminally ill patients and so few patients understand clinical trials and drug development. I don’t know if Gov. Brown will have the courage to veto the bill a second time, and, even if he does, it’ll be back next year, and the year after that, and eventually a future governor will likely sign it. The sham will continue to deceive patients with terminal illnesses and their families.