Why we shouldn’t try “Right to Try”

In Trump’s 2018 State of the Union, he urged Congress to pass the legislation euphemistically called “Right to Try” allowing terminal patients to take drugs or pursue experimental treatments in the early experimental stages. While this sounds like a great idea because no one wants to deny a patient hope, there are serious problems with the legislation as written.

Before I go into criticisms of the bill, let me say I am all for self-determination. Someone should be able to do with their body what they wish. So, prima facie, I support allowing patients (and others) to try whatever they want given they are able to make an informed decision.

BUT, this bill does not require doctors to warn the patients about the risks of taking a drug that has not yet been found to be effective. Indeed, though there is lip service to informed consent, it does the opposite. The bill waives all liability on the part of the manufacturers, distributors, or prescribing physicians. So a doctor can tell a patient that the patient has exhausted all available treatment options, the patient will die unless the patient wants to take this “promising new drug” that has just entered Phase II testing. In that scenario, many patients and their families will agree to do whatever they can to take this new drug or experimental treatment.

If the same patient were in the clinical studies, they would receive the treatment gratis. They would also be given a full rundown of the potential risks. They would be aware that 80% of drugs never make it past Phase II testing. That said, the “right to try” bill doesn’t put the patient in the clinical test group. So all the requirements that are needed for human testing do not apply. The patient would likely have to pay for the drugs/ treatment. This payment would come from the patient or the patient’s family’s assets as insurance isn’t going to cover something that has yet to be shown to be effective.

Some argue that the patient is terminal, so what is there to lose? There is everything to lose. The drug might hasten the patient’s death. It might destroy the quality of life for the life that patient has left. If someone told me that I had six months to live, I have options. I could go untreated, where most of that time I could interact with my loved ones, savor my favorite foods, listen to my favorite music, put my affairs in order, and live — even if for a short time. Or I could take a drug that most likely will not give me any more time, and could also make it so those six months are spent in excruciating pain. Given those options, I would opt for the time untreated. When one has a limited amount of time left and knows it, making any of that limited time more painful is a very serious loss.

Again, if people are fully informed of the risks, I think they should be able to do whatever they wish with their bodies. If they want to take an experimental drug, fine. If they want to try alternative treatments, fine. If they want to partake in marijuana, fine. If they want to end their life, that should be fine too. Ironically, on the last two points, the administration vehemently opposes individual choice in these matters — so their commitment to the “right to try” has nothing to do with the liberty to do what one wishes with one’s body.

As written, this bill allows medical providers to give patients false hope and sell an untested regimen without any requirements that the provider make sure that the patient truly understands the gravity of the decision before them. Now, there will be many medical professionals who will do their best to inform the patients even without that requirement. And there will be others who in their capacity as medical professionals are loathe to give up and will, without intentional malice, focus more on potential benefits and downplay the risks involved in an untested treatment. The enthusiasm of providers in this category, even if they say that the drug is not yet been shown to be effective, can preclude a truly informed decision since the patient is not made fully aware of the risks involved.

It should be noted that the FDA already has a process in place for expanded access to allow patients to get treatments that are still in the testing phases. The FDA approves 99% of the requests it receives. But when the FDA is involved (unlike this legislation) not only are patients more formally informed, but they are kept abreast of changes that might be recommended during a trial (say dosage changes).

Finally, the patient’s outcomes are reported back to the FDA. With the “right to try” legislation, however, the FDA cannot use any adverse outcomes of patients “trying” the untested drugs in evaluating the treatment. So, even if every patient taking something under the “right to try” legislation immediately dies; the FDA cannot account for those deaths when determining whether or not to approve the drug. Prescribing doctors will not be informed of the complications experienced by patients other than those they see themselves. Now it could be that those in the “right to try” group have other complications beyond those in the Phase II trials; but if the patients are willing to risk their remaining days on an untested treatment, the results of their experiences should be considered so future patients can make informed decisions as well.

In conclusion, while I firmly believe that a person should be able to make their own medical decisions — including bad medical decisions — I believe that these decisions should be without coercion and with full knowledge of the risks and benefits. Without these safeguards in place (and the “no liability” clause precludes these safeguards), we should not try the so called “right to try”.

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