On May 30, 2018, President Trump signed the right-to-try bills. This legislation gives people with life-threatening diseases the right to use unapproved experimental drugs.
The driving force of legislating this new right is miracle discourse and hope. Hugging a boy with muscular dystrophy, Trump exclaimed that hundreds of thousands of lives will be saved with his signature. It is difficult to be opposed to hope, especially if people are terminally ill and in a desperate situation. But in this case the hyperbolic language is deceptive. The so-called right does not give access to patients. They must to ask pharmaceutical companies, and the companies decide. It is a right to beg. It is also dangerous and risky. The legislation assumes wrongly that experimental drugs in clinical trials are safe and potentially produce miracles. We do not know. Most probable, more patients will be harmed than helped. The legislation is furthermore dangerous since it may undermine the science that is needed to investigate medication and determine its safety and efficacy. Expanding access may also deter people to enroll in clinical trials; why wait and risk placebo if you can get the new drug now? Finally, it undermines public regulation to protect patients. Oversight (and agencies as the FDA) has been created and expanded for a reason. Many scandals involving drug manufacturers, scientists, and medical professionals have highlighted the need for regulation. Without any governmental oversight abuse and fraud in medicine will continue to occur, particularly now that healthcare is regarded as ‘industry.’ The ultimate scandal is that the legislation is completely superfluous. Since a long time, the FDA has already pathways to expedite access to experimental treatments, approving the overwhelming majority of requests within a very short period of time.
So, why is this right to try legislated? The answer has nothing to do with miracles, patients or healthcare. It is just a political move to scale down government regulation. The Goldwater Institute that promoted the legislation, sponsored by the Koch Brothers, wants to weaken the FDA and open the market for drugs that are not supported by research evidence. The individual consumer should take the risk. Commerce is promoted with the noble language of hope, miracles and health. We wait for the next thalidomide or DES scandal to realize that the deplorables are again the victims.