This week, California Governor Jerry Brown vetoed a bill, AB 159, that would have allowed terminally ill patients to access experimental treatments that have not yet been approved by the FDA.
Although advocated for as allowing freedom and choice for individuals facing , so-called “right to try” bills allow patients access to dangerous drugs whose safety is not yet proven, and clear the way for profiteers and alternative medicine practitioners to wring money—often hundreds of thousands of dollars—out of the dying and their desperate families, all without any legal protection.
From the San Jose Mercury News:
“Patients with life threatening conditions should be able to try experimental drugs, and the United States Food and Drug Administration’s compassionate use program allows this to happen,” Brown wrote in a signing message to lawmakers. “Before authorizing an alternative state pathway, we should give this federal expedited process a chance to work.”
“The bill was opposed by the Association of Northern California Oncologists, who warned that providing unregulated treatments for people desperately trying to extend their lives takes advantage of their frailty.”
Lamenting the “cruel sham” that is “right to try” legislation, surgical oncologist David Gorski details the misunderstandings that sustain them:
Basically, right-to-try laws all follow the same template provided by a libertarian think tank, the Goldwater Institute. The idea is to make it easier for terminally ill patients to access experimental drugs and devices. 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. In addition, they provide no financial support for patients, who are basically on their own when it comes to paying what can be the substantial financial charges. In addition, right-to-try laws 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. That’s even leaving aside the fact that drug approval is controlled by the federal government, and 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.
Over the last year and a half, state legislature after state legislature, believing, based on the dishonest propaganda of advocates who claim that the FDA is killing people and the Goldwater Institute cynically featuring the sympathetic stories of dying patients (particularly those with Lou Gehrig’s disease) to advance its agenda, has fallen under the spell of right-to-try. It passed in Michigan last year, sneakily pushed through the legislature. Over the last year, state after statepassed these ill-advised laws. Not surprisingly, several months ago and more than a year after the first of these laws passed, right-to-try advocates couldn’t point to a single patient helped by these laws, and even patients were starting to realize that they’ve been sold a bill of goods in the name of an antiregulatory fervor to weaken the FDA, which was the real reason all along for these laws. The Goldwater Institute just used terminally ill patients to lobby state legislatures, that and the fact that most people don’t understand drug development and think that the arguments for right-to-try sound reasonable because of it. It’s no wonder that patients feel betrayed and disappointed. Right-to-try laws, by their very design, create false expectation and false hope.
Because of the widespread misunderstanding of drug approval (specifically the primacy of the FDA over any state law) and the lack of attention paid to the patient-hostile provisions of the Goldwater Institute template for right-to-try laws that strip away legal protections and greatly weaken the right to legal recourse in the case of harm, these laws have passed 24 states. California would have been the 25th.
In actuality, given the small proportion of drugs that make it successfully through the whole regulatory process after phase I, patients with terminal illnesses are far more likely to be harmed then helped by releasing experimental drugs that have only passed phase I trials. The frequent retort is that these patients are terminally ill and things can’t get worse, but there is something worse than being terminally ill. It’s being terminally ill and exhausting the last of your finances and even going into debt. It’s being terminally ill and harming yourself so that your are less able to do what you want to do in your short remaining time. It’s being terminally ill and dying sooner than you have to.
Read his full post here.