Right to Try Law and Misleading the Public
[N]early every time I write about right-to-try, I remark sardonically that opposing right-to-try is perceived by most people the same way as opposing mom, apple pie, and the American flag—or worse, wanting to kill mom, defile apple pie, and shred the American flag. Again, I exaggerate, but not by much.— David Gorski.
The basic idea behind the federal right to try law seems unobjectionable. Would could object to allowing terminally ill patients access to experimental drugs? There are many ethical problems that can only be overlooked if proponents could mislead the public and law-makers about the facts
The story starts like a lot of propaganda campaigns do. A wealthy private entity finds a powerful ideological ally whose interests align with their own. In this case it is a for-profit cancer hospital chain that promotes (and charges a pretty penny for) unproven therapies and the Goldwater Libertarian lobby group. Cancer Treatment Centers of America wants to be able to charge and not be liable for unproven drugs and treatments. Furthermore, under right to try, administering unproven drugs doesn’t require involving a pesky institutional review board (IRB) or their continued oversight. The Goldwater Institute, for their part, wants to diminish the power and existence of regulatory institutions.
It’s a match made in heaven. Both want profit-seekers to be able to sell products unencumbered by scientific and ethical oversight or consumer protection, and, most importantly, without liability for harm. All they have to do is convince the public that the current regulatory regime is on net costing lives because many magical drugs and treatments are inaccessible due to regulatory tape. Nothing could be farther from the truth. But with a little misinformation and game-winning appeals to emotion, in just over 4 years they got what they wanted.
Perhaps the biggest deception was that the FDA already has a compassionate use pathway where there is ethical and scientific oversight and (unlike right to try) patients are covered for any complications that arise. Under the FDA’s compassionate use, terminally ill patients already get access to experimental drugs that have passed Phase I trials and have an application to begin Phase II trials. The normal application pathway takes about a week but there’s an emergency pathway that allows access within 24 hours. The FDA approves over 99% of applications. Right to try doesn’t provide anything that the FDA doesn’t already provide. The only difference is that the patient is left unprotected. This is far from the imagined state of affairs right to try lobbyists would have the public believe.
From the point of view of propaganda and misinformation, one of the main techniques that made the campaign so successful is the techniques of omission and misleading comparison. Omission because the campaign leave out what the FDA compassionate use already does and the protections it affords. Framing because the purported benefits are emphasized without any mention of potential costs. This is a familiar tactic. I tell you is “what about all those lives that might be saved with access to these drugs! We simply can’t say they won’t help. Better to try than not at all.” In your head you’re like, “OMG, how can we deny someone these benefits!” (Despite the fact that this can already be accomplished through the FDA but with oversight and treatment for side-effects.)
Of course this leaves out all the possible harms that could come from a drug or treatment that has only passed a Phase I trial. First of all we know that only 1 in 10 drugs actually make it to market from Phase I. The most likely scenario is that a patient, under right to try, will be charged a ton of money for something that has no effect. But many untested drugs don’t make it to market because of yet-to-be-detected harmful side effects.
So, on the benefits column there’s a 1 in 10 chance that the drug will have benefits that outweigh the harms (still doesn’t mean it will work). But the chances that you will experience harmful side effects is much higher than that. And even if you’re lucky and don’t get the harmful effects, you could end up putting your family in debt for a treatment that does little to nothing. Remember, under right to try, providers aren’t liable for side effects.
For a great overview of the issues associated with the right-to-try law, I strongly recommend David Gorski’s article here: