“[Right-to-try laws are] placebo legislation. They
make lawmakers feel good, but they do nothing concrete to help actual
patients…[They are] a cruel sham and a scam.”
— David Gorski M.D., oncologist
It sounds so obvious, at first blush. Someone’s dying, someone you’re close to. Their doctor tells them there’s no known cure, but then they discover online an experimental drug, unapproved by the Food and Drug Administration (FDA), which — sez right here! — may be a cure. Sure it’s expensive. But come on, what’s to lose, other than money? It’s a life we’re talking about…
(“Experimental drug,” in this context, is one that has passed the FDA’s comparatively undemanding Phase 1 of the three successive clinical trials required for FDA approval; less than 10% of drugs that make it through Phase 1 are ultimately approved.)
This “health freedom” argument is what has motivated lawmakers both federally and in 41 states, including California, to pass “right-to-try” laws in the last five years. So, mostly, we now have the right to choose pretty much whatever treatment we want, absent interference from a nanny-state government. Sounds pretty reasonable, right?
Counter arguments include:
The FDA was set up to screen out quack remedies and treatments. By bypassing its authority, we might as well go back to snake oil and voodoo witch doctors.
Drug companies aren’t obligated to provide an unapproved — beyond Phase 1 — drug (so in that sense, “right-to-try” is really “right-to-ask”). However, they have every incentive to do so, since they can charge whatever they want (except in Texas), and they can’t be sued for any harm caused by the drug.
Indeed, an unscrupulous drug company can choose to forego the long and expensive FDA testing procedure beyond the comparatively simple Phase 1, and market its unproven product to desperate customers.
Of course, medical insurance doesn’t pay for experimental drugs. Nor, by most interpretations, does it pay for treatments arising from bad outcomes from such drugs.
It’s pretty easy to find, online, examples of the abuse of sounds-good “health freedom.” Researching this column, for instance, I kept coming upon references to the “Gonzalez Protocol,” which seems to be the poster child for those who oppose health freedom/right-to-try laws. The late Nicholas Gonzalez was an NYC physician who treated terminally ill cancer patients unconventionally, using the body’s own pancreatic enzymes. Turns out, his patients survived about a third as long as those treated with conventional chemotherapy. Similarly, the Stanislaw Burzynski Clinic — check it out — sounds pretty sketchy. And then there’s laetrile (synthesized from amygdalin, found in apricot pits and almonds), which has been peddled as a cancer treatment for over a century, despite a cure rate approximating zero. It can also cause cyanide poisoning.
If you’ve gotten this far, you’ve probably noted the parallels with the current vaccination controversy. The government has a duty to protect both the welfare of children and the community at large in preventing previously common diseases. In my mind, this duty trumps the rights of well-meaning parents. Similarly, by undermining the authority of the FDA to regulate new drugs via their painstaking, decade-long approval process, we’re opening the door to a quack medicine free-for-all. Health laws are set up to protect us from contaminated foodstuffs, diphtheria-laden water, dangerous drugs (remember Thalidomide?) and quack cures. Do we really want to emasculate this process?
And yet…I try to put myself in the shoes of someone with a terminal cancer, say, having discovered a promising (according to the website!) treatment or drug that hasn’t been approved by the FDA. I’ve researched it best I can, and want to try it. Do I really want to be told, “Sorry, you can’t get this until it’s fully tested — come back in ten years, see if it’s one of the 10% that made it through the approval process!”? Yeah, thanks guys.