Congress Passes Right To Try Act: Does This Help or Hurt Patients?
In May 2018, President Trump passed the Right-to-Try-Act into law. When the Act passed into law, many ethicists and scientists within the scientific community questioned how ethical and safe the Right-to-Try Act was. The problem at hand is that patients already have a right to try through the Federal Drug Administration's humanitarian expanded access program. Although the Right-to-Try Act can seem like a viable option to the terminally-ill who are out of options, this opens an avenue for greed and manipulation. The federal Right-to-Try Act will take away the safety protections for qualified patients put in place by the expanded access program.
Expanded access, also known as compassionate use, is an option for terminally-ill patients who have run out of options in terms of plausible and successful clinical trials. To be considered for expanded access, the patient's potential benefits must outweigh the potential risks. The experimental product in which the patient is requesting must also not be at risk of interfering with ongoing trials or product development. Once the patient has submitted an approach out to a company for approval and they are accepted, they must go to the Federal Drug Administration for further guidelines. The FDA will then question whether the risks are worth taking and clinical development interference. In most cases, the FDA does approve expanded access to patients. An IRB (Institutional Review Board) then must sign off for approval. An IRB is a committee that determines how ethical one's research is using research ethics.
The Right-to-Try Act, also known as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, is another avenue one can take in terms of unapproved treatments. The act was officially signed on May 30, 2018. The act helps terminally ill patients, who are out of options such as clinical trials and treatments, to gain access to unapproved drugs. For an unapproved drug to be considered under the Right-to-Try Act, the substance has to have passed Phase I of the FDA. This means that although it is on its way to development, it has not been approved for human consumption yet. The medication must also have a new drug application filed with the FDA as well as having a status of active development. A patient must provide informed consent in writing. The approval of the FDA is also not needed. The decision is between solely the doctor, patient, and company involved in providing the substance, subsequently eliminating the FDA through a majority of the process.
When the Right-to-Try Act first came into law, it was easy to assume that it was a great thing. Terminally ill patients can access unapproved drugs at their own will without having to deal with the often labeled middle man, the FDA. Patients also do not need to consult an IRB for further approval. Although creating more accessibility to unapproved drugs is potentially beneficial and ground-breaking for the terminally ill, eliminating the FDA within the process creates danger. The fact that an IRB's involvement is not needed is dangerous as well because an IRB's job is to make sure all ethical standards are maintained within the potential trial. The Right-to-Try Act also does not have as many data-reporting requirements as expanded access has, creating negligence in data-reporting. It is not a well-kept secret that not every pharmaceutical company has the public's best interest in mind. There have been cases where pharmaceutical companies push medicines inaccurately despite knowing the true dangers of their product. An evident case of this is the opioid crisis. The worst part about it is the opioid crisis was fueled by drugs that were approved. If drugs that are being approved and prescribed today are showing detrimental outcomes, one can only imagine how dangerous it could get within the Right-to-Try Act. It is not about talking down on the Right-to-Try Act. It is about looking out for our terminally ill. To understand further, one must look at the psychology of a terminally ill person. Robert L. Fine, MD, who is a director at the Office of Clinical Ethics for the Baylor Health Care System, speaks on the psychology of the terminally ill in his case studies. He explains how the terminally ill can often exhibit symptoms of delirium, depression, and anxiety from the pressures of impending death. The terminally ill are already a vulnerable target for companies and their products due to a lack of available trials or time, so the mental impact of these illnesses create more of an opportunity for manipulation from companies trying to push patients their last option of potentially harmful medicines. Expanded access is safer in comparison to the Right-to-Try Act. Even though expanded access still involves the use of experimental drugs, the standards of approval are far higher. Expanded access is also more accessible than people think. Most cases get approval and can go through with the full procedure all while being safer following FDA and IRB guidelines. The FDA and IRBs have flaws naturally just like everything else in this universe, so people should at least consider a more ethical and regulated route when considering unapproved medicine.
Since patients with terminal illnesses have a higher risk factor and less time to work with, they are more than likely to jump on a quicker process like the Right-to-Try Act over expanded access. As great as a "quicker" process may sound, the benefits simply do not outweigh the risks. Accessing unapproved medicine through the expanded access program is more plausible because of the ethical concerns taken into account in the process of preparations by the FDA and the IRB's that participate in helping. The FDA and IRB's are not perfect, but they most definitely strive to keep procedures as ethical as possible. Many bioethicists seem to draw the same conclusion when comparing the two programs. Currently there are 41 states that have Right-To-Try laws in place. Fewer than 10 patients have accessed it. Annually, expanded access receives between about 1500-1800 requests per year, concluding that patients prefer the expanded access program already in place.