The healthcare system has been known to contradict itself. On one hand, it states that everyone has the right over their autonomy, but on the other hand what we do, or do not do, to our bodies is highly regulated. The Right to Try law means giving terminally ill patients access to drugs that have passed phase 1, the phase when the drug has been approved by the FDA to be tested humans, of the FDA approval process without FDA oversight. The ‘Right to Try’ movement questions the Food and Drug Agency (FDA) authority to limit access to treatment for the terminally ill; making it not only an ethical question but also a political one at the state level. This paper will discuss the arguments for and against government intervention in healthcare treatments by comparing and contrasting the principles of healthcare policy. This topic brings up some argumentative questions, for example, does this prohibit any and all government intervention? If not, to what extent is the government allowed to protect its citizens from harm? If the Right to Try in passed who bears the costs of the trials? This stands as a critical issue because millions of people die from terminal illnesses every year, and many mighty struggle to qualify for clinical trials. Less than 3% of terminally ill patients are accepted into clinical trials; trials that are potentially life-saving. Although there are many benefits and risks in passing the Right to Try law, if the Right to Try Law is passed this sustains the individual's right to autonomy. Even though treatments cannot be guaranteed to be effective, the Right to Try laws return the control and choice of treatment options to the patient and their physician, where it is most effective.
Summarize your Findings
In May 2014, Colorado became the first state to pass a Right to Try law. Three years later, 37 out of 50 states have followed suite. Before the Right to Try law emerged, non-FDA approved drugs were not available for use because they were deemed unsafe The primary method for terminally ill patients to gain access to these drugs was to enroll in a clinical trial during phase II or phase III testing. Nevertheless, there are many ways a patient could be eliminated from a study, such as age, and stage of illness. The patient's physician is also involved in the enrollment with having to fill out copious amounts of paperwork for, the paperwork on average, takes over 100 hours. If the FDA approves the patient, then the application must then be approved by the Institutional Review Board (IRB).The IRB’s purpose is to review research protocols to ensure that participants are protected from harm and that their rights are not being violated. Once authorized, then the patients receives the drug, but the issue of payment still stands; fortunately many pharmaceutical companies do donate the drugs to participants. This is a long and tedious process for a terminally ill patient. However, this system becomes dramatically shorter and more direct if states enforce the Right to Try law. The physician and patient would directly interact with the pharmaceutical companies to receive the experimental drugs. The Right to Try law protects drug manufacturers from lawsuits, diminishing the fear of facing legal action because the drug did not work. The FDA argues that these barriers exist to protect patients from side effects. It raises the question whether the FDA wants to protect the consumers or itself. Proponents of the Right to Try laws believe that, “the right to preserve one's life is fundamental and all other political concerns are entirely unimportant.” The Right to Try laws do not eliminate all risks, there is awareness that these drugs could potentially cause pain, shorten an already endangered life, and can decrease lucidity. Nonetheless, it gives patients more control to assess the risks and benefits.
A common justification for government intervention regarding unapproved treatments is that people may not be well-educated regarding these treatments and thus are not capable of accurately judging the risks. Another governmental concern is that the prospect of imminent death may distort a patient's abilities to clearly review the consequences of the potential treatment. Patients and their families are in vulnerable positions and are not able to make an objective decision about their health care, this places a questions of the quality of informed consent. Although these concerns are reasonable, they undermine one's power of maintaining personal autonomy.
Analyze your findings:
There is no need for medical paternalism. By not passing the Right to Try law the government is placing personal autonomy at risk. The issue with the FDA’s concern is that it is not taking the patient's true interests into consideration. The policymakers cannot and do not accurately represent the people's interests. Patients are complex beings in that their interests are completely subjective and are unknown to the government policy makers. For example, social and medical cases widely differ from patient to patient; one might favor quality of life over a longer life, or vice versa. These ideologies cannot be accounted for by the FDA or other policy makers. The FDA takes on a role of paternalism. The FDA and policymakers frequently question patients’ abilities to make informed and conscious health care decisions. They believe that they know what is best since they have the knowledge and resources. Patients do indeed have the knowledge and skills that the government's believes they lack. Decisions are not made in isolation but with medical professionals who are able to predict the consequences of each action, assist patients in interpreting medical information, and offer technical information on the alternative treatment that the patient is seeking. It is the provider’s responsibility to be fully informed on the topic and be able to explain it in full detail the process, benefits, and risks to the patient and friends and family so they can comprehend that information to make a decision. Ethically, physicians are not able to make the decision for the patient since that takes away from the patient's autonomy, and they do not possess the complex interests of the patient. Why should the government be able to? Families and friends are also there to help guide the patient in making a clear decision and are there to question the rationality of each decision the patient wishes to make.
By denying or questioning the patient's ability to try unendorsed treatments may be seen as protecting the patients from unforeseen consequences by the government. In reality, the government is questioning and not respecting the patient's decision, and further discounting how the patient balances the financial, physical and emotional costs of potential treatment. Policy makers cannot make these judgements without assuming certain things about the patients. Terminally ill patients, who this law is catered to, are aware of the extreme consequences, especially with the imminence of death. No situation is dire enough for the government to override a patient's basic right to make their own healthcare decisions. Although there are concerns about the quality of the treatment, equity, informed consent and whether the patient can clearly make these positions, the principle of autonomy and personal choice have such a strong foundation that the government’s concerns are insignificant when it comes to the debate against increasing patient access to experimental treatment. The central matter in this discourse is how significant is government involvement in individual choice and interests concerning medical decisions. Patients should be given full control to make their decisions regarding their own health, with guidance from their physicians and support system.