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.
