The US has a tough process for drugmakers to follow in order to bring therapeutic treatments to market, and a lengthy one as well. It can take as long as 15 years before the FDA will approve a medication for use, a process that creates anger and frustration from those suffering diseases that could be cured or abated during the long approval cycle. Indiana’s legislature and Governor Mike Pence have tried to bridge the gap by passing a “Right to Try” law that allows patients to make the choice on experimental medication, and which protects manufacturers from liability if the results go poorly. The question raises ethical questions about where the line between mercy and human experimentation may be crossed, but CBS’ Chicago affiliate raises the question about whether this crosses a bureaucratic line with the FDA first:
“This is a great statement about the compassion and care of the people of Indiana for our most vulnerable,” said Gov. Pence.
Supporters of the new law say some gravely ill patients can’t wait for the full FDA approval process that can take up to 15 years.
Opponents say unapproved drugs can do more harm than good.
There is certainly truth to that statement. Even with the rigorous FDA process, including large-scale double-blind testing, mistakes have been made — some of them horrendous, such as Thalidomide and others. Given the interstate commerce applications and the real question about how well informed average consumers can be about the complicated chemistry in medication, the kind of thorough review performed by FDA is necessary, even if it were accomplished by a voluntary trade association (such as Underwriters Laboratories, for instance). Administering drugs outside of those trials before some kind of testing takes place could be seen as human experimentation, at least from an ethics perspective, even if the humans involved give informed consent.
On the other hand, is it any more ethical to watch people suffer and die while red tape ties up treatments that could prevent either or both? The best solution would be to find ways to greatly reduce the approval cycle, which would have the salutary effect of lowering production costs and helping more people more quickly. Absent that, a safe space for both manufacturers and those patients who have not responded to other treatments makes a lot of sense, as long as those patients are fully informed of the potential consequences.
What’s not acceptable is having bureaucrats fight a turf war over the idea:
Although the new law shields drug makers from liabilities, Dr, Barai says the companies may be worried about their future dealings with the Food and Drug Administration.
You mean, like nice drug company ya got there — shame if something happened to it? If pharmaceutical manufacturers have to worry about the FDA treating this like a protection racket, then that’s an even better case for privatizing the FDA’s functions than their impossibly long approval cycles. Let’s hope that common-sense alternatives like “Right to Try” at least get a fair exercise to see whether we can have both the rigor and the access when it’s most needed.