Can Right to Try Laws be Justified?

“We will be saving — I don’t even want to say thousands, because I think it’s going to be much more, thousands and thousands, hundreds of thousands. We’re going to be saving tremendous numbers of lives.”(Qui, 2018). This is the speech made by the president of the U.S., Donald Trump when he signed the bill of “right to try” (RTT) law in 2018. RTT law permits the terminal ill patients to use the medical treatments that have already passed the phase 1 of clinical testing, without getting the permission of Food and Drug Administration (FDA) (Working Group on Compassionate Use and Pre-Approval Access, 2018). FDA is a governmental organization which examines the efficiency and safety of medical treatment through clinical testing, before entering the market (ibid.). Therefore RTT law approves the terminal ill patients to access the medical treatments that have not finished the clinical testing and are not investigated by FDA. By this law, terminal ill patients can receive unapproved medical products from the pharmaceutical company. Thus, literally they will gain the right to try. The law seems to be beneficial but there are some objections, and the opinion towards this law is still controversial. Hence, in this paper we will briefly look at the context in the process of accepting this law. Then suggest the main arguments of pros and cons. Finally, I will examine the plausibility of these arguments.
RTT law started to be enacted as state laws, after FDA established the program called Expanded Access (EA). EA is a system that permits the patient who has fatal disease to access to the medical products that are in the phase 2 or 3 by FDA permitting (ibid). The difference between RTT law and EA is that EA requires the evidence that suggests the safety of the medical products and is necessary to submit it to FDA, when providing the unapproved treatments to the patients (Carrieri et al.2018, p.65). Thus, FDA judges whether the products can be provided or not to the patients in the program of EA. Intervention of FDA is the great difference between EA and RTT law.
From 1970s, the U.S. patients demanded the access to the medical treatments that are in the clinical stage (WGCUPA, 2018). It was because there were some difficulties in receiving the unapproved treatments back then. The standard way to gain access was to participate in the randomized controlled trial (RCT). However, the terminal ill patients could not join this trial and there were risks that the patients are accounted to the control group. In short, the probability of accessing to the unapproved medicine was limited (Carrieri et al. 2018, p. 65). Therefore, the patients required an unlimited access to the unapproved treatments. From these context, RTT law has begun to be enacted in some states. The first law was enforced in Colorado in 2014(WGCUPA, 2018). In present situation, 40 states have enacted this law (ibid.). However, there are still more objections than proposition to this law so we will look through the pros and cons.
Propositions of RTT insists 3 arguments. The arguments are about the body autonomy of the patients, the safety of the unapproved drugs, and the relaxation of the mental burden of the patients. The argument of the body autonomy is the idea that does not admit the interference of the government and FDA for the sake of expanding the patients’ right to their life. It is because the intervention of FDA and the government would delay the patients’ access to the medical products and deprive their right to their life (Carrieri et al. 2018, p. 66). At the same time, advocates of RTT refute to the opposition that it is inconsistent to not admit RTT law in the state where the physician assisted suicide is approved. For the state is prohibiting not 100% unsafe medicine, though permitting 100% unsafe medicine (ibid.). Thus, the proposition’s argument as to guarantee the right to life of patients rest on the firm principle of libertarianism that pursues freedom and eliminates the governmental interference.
They also insist that the medicine that has passed the phase 1 is sufficiently safe. In fact, the people who argues about the safety claims that it is worthless and waste of time to examine the medical treatment that has passed the phase 1 and its effectiveness and safety were already confirmed (ibid.). Rather they criticize FDA for depriving the precious time of terminal ill patients and its health care providers. Hence, supporters affirm RTT law by asserting that it is harmful for the terminal ill patients to not provide the medical products that have already secured safe.
Finally, the argument about reducing the mental burden of the patients. This type of arguments hold that adding an option of accessing to unapproved drugs will be beneficial not only for the patients but for the health care providers. Out of options talk often becomes a huge mental burden for the terminal ill patients and health care providers but RTT provides a choice to the patients. This gives hopes to the patients and will connect to the empowerment of the patients. Therefore, adding an option will become a great benefit for the patients (ibid.).
On the other hand, there are some objections to this law. There are mainly 2 arguments and these are about the criticism to the facade systems of RTT law and about the choice of patients. When FDA stops to intervene in receiving unapproved drugs, the right to its drugs will become unsubstantial. By RTT law, the terminal ill patients will directly access to the drugs from the pharmaceutical company and not via FDA. However the law itself cannot force the company to sell their unapproved products (Kase, 2015; Carrieri et al. 2018, p. 66). Meaning that whether the patients can receive the treatment or not is totally up to the company. Despite, from the below reason, it is obvious that most of the company will not provide drugs to the patients. It is because that if the patients would suffer from the unapproved drugs, there is a possibility that it influences on the reputation of its drugs and what is worth it might influence on the survival of the company (Carrieri et al. 2018, p. 66). Thus, RTT law is formally allowing the patients to access to the drugs but substantially not, because it depends on the judgment of the company. On the other hand, under the EA program, the company must agree to provide its products in the first place and even they disagree, FDA will endeavor to be provided with the company (Hobein et al., 2015; Carrieri et al. 2018, p. 67). Thus, oppositions criticize that eliminating FDA will make the pre-approval access facade.
Lastly, the argument about the choice of the patients. This is especially from the point of informed consent. From the RTT law, there is a risk that the voluntarily will of the patient will not be well made. In the U.S. and many other countries, there is a social norm called ‘fighting spirits’ which suggests a fighting attitude toward the chronic or incurable disease (Carrieri et al. 2018, p. 67). Not only the patients but also their parents and health care providers can be governed by these norms. In the terminal ill care, patients and their parents are likely to be blind for the sake of ‘hoping to get better’ and requires only for the other medical treatments (ibid., p. 68). Health care providers may exaggerate the effectiveness of the unapproved treatments than actual and may not suggests the palliative care to the patients (ibid.). In fact, according to the recent research, 80% of the Americans answered that they haven’t been informed about the palliative care and the both patients and the health care providers considers it negatively as a symbol of giving up (ibid.). Under the norms that denies palliative care, the patients and the health care providers van be swayed by them and become difficult to make voluntarily wills. Thus, the informed consent cannot be well formed.
These are the pros and cons about the RTT laws. Finally, I would like to examine the plausibility of the arguments. I believe the safety of the unapproved products cannot be determined because it can be both said that the products of phase 1 is safe or unsafe. There is no 100% safe and unsafe so this part is difficult to judge its plausibility. The main part of this controversial issue is, I believe, to think about the terminal ill care. Before requiring the unapproved medicine, we need to make it clear and to give a reasonable reason as to the negative images of the palliative care. It is a matter of fact that our choices are often swayed by others as long as we belong to the community. However, in the terminal care, it is necessary to try to make the will of the patients pure because the terminal ill patients are in the ending of their life. They need to decide how they will end up their precious story. Thus, I think in the first place it is significant for the society to become neutral against any care including palliative care. Once the society becomes neutral, it is reasonable to add new options such as RTT laws as one of the options that can be chosen by voluntarily and pure wills.

References
・Carrieri, Daniele; Peccatori, A. Fedro; and Boniolo, Giovanni, 2018: “The ethical plausibility of the ‘Right To Try’ laws.”, Critical Reviews in Oncology/Hematology, vol 122, pp. 64-71.
・Holbein, E. M. Blair; Berglund, P. Jelena; Weatherwax, Kevin; and Gerber, E. David, 2015: “Access to Investigational Drugs: FDA Expanded Access Programs or“Right-to-Try” Legislation?. ”, Clinical and Translational Science, vol 8 issue 5, pp. 526-532.
・Kase, M.Natalie, 2017: “Do Right to Try Laws Undermine the FDA'S Authority? An Examination of the Consequences of Unlimited Access to Unapproved Drugs.”, Journal of Legal Medicine, vol 36 issue 3-4, pp. 420-441.
・Qiu, Linda. “Trump Oversells New 'Right to Try' Law.” 30 May 2018, The New York Times, www.nytimes.com/2018/05/30/us/politics/fact-check-trump-right-to-try-law-.html. Accessed 4 Apr. 2018.
・Working Group on Compassionate Use and Pre-Approval Access, 2018, Department of Population Health, The New York University School of Medicine, med.nyu.edu/pophealth/divisions/medical-ethics/compassionate-use. Accessed 4 Jul. 2018.