By Lindsay Marie
The right-to-try discussion began heating up again after President Trump voiced his support for the measure during his State of the Union address. Right-to-try allows terminally ill patients to try potentially lifesaving medicines that have passed basic safety testing with the FDA but are not on pharmacy shelves yet.
On Tuesday, February 5th, several hundred opponents of right-to-try sent a letter to the leaders of the House Energy and Commerce Committee expressing their strong opposition to the right-to-try legislation currently under consideration by the committee. The majority of the letter focused not on the patients the bill would affect but on how it could potentially weaken a bureaucracy.
Opponents believe that terminally ill patients deserve protection and that the bill gives them false hope. The right for terminally ill patients, alongside their personal medical professionals, to choose the best possible option given their specific situation, deserves protection. Right-to-try legislation isn’t about providing patients hope; it’s about putting them before the bureaucracy and ensuring they have freedom of choice.
Few Good Traditional Options
When it comes to treatment options, terminally ill patients, such as those diagnosed with cancer, have relatively few choices. Although they are two of the most-utilized treatments for cancer, chemotherapy and radiation therapy can cause severe adverse events, including death. Chemotherapy and radiation therapy can be useful in shrinking tumors because they cause cell death. Unfortunately, the two treatments are not able to differentiate between healthy cells and cancerous cells, which leads to healthy cells dying as well.
Frequent adverse effects of chemotherapy include nerve and muscle problems, kidney problems, mouth sores and painful swallowing, low blood cell counts, infection, and bleeding. Adverse effects caused by radiation therapy vary depending on location but can include secondary cancer, swelling of the brain, seizures, nerve damage, bone death, scar tissue in the lungs, congestive heart failure, and osteoporosis.
Given the data regarding severe adverse events from the FDA and study statistics, one could argue that traditional treatment options currently available to cancer patients reduce the patient’s quality of life, may hasten their death, and ultimately give them false hope. Ironically, those are reasons cited by right-to-try opponents for disallowing patients the right to choose the right treatment course for them if that includes non-traditional treatments, considered “experimental,” or just not approved by the FDA yet.
The experimental treatments that patients would be allowed to try under the proposed right-to-try legislation have already completed Phase I clinical trials which identify safety risks, pharmacological effects, toxicity, and dose ranges. The passage of Phase I indicates that the treatments have been deemed safe by doctors, have passed safety trials per the FDA’s guidelines, and are allowed to move into Phase II trials.
Phase II trials evaluate the efficacy and, in the case of cancer treatments, if the treatment works for a particular type of cancer. Depending on the drug a patient is seeking, Phase II data may not yet be available.
The lack of FDA approval or the lack of published Phase II data for a particular treatment is not equivalent to the finding that the drug is ineffective. However, it’s the absence of FDA approval and efficacy data that opponents cite as a reason to disallow patients the ability to make decisions regarding their personal health.
Right-to-Try and Self-Determination
It’s difficult to comprehend how one individual’s interest in efficacy could supersede a terminally ill patient’s right to self-determination. As President Reagan once said, “Government exists to protect us from each other. Where government has gone beyond its limits is in deciding to protect us from ourselves.” If life is an inalienable right, no one, including the government, should be able to prevent a terminally ill patient from attempting to sustain or prolong it.
Even the Supreme Court has recognized the right of an individual to independently make certain kinds of life decisions such as marriage, contraception, child rearing, family relationships, and procreation as an aspect of individual liberty. A terminally ill patient’s choice of particular medical treatment should be no less entitled to protection than a couple’s choice of contraceptive.
Right-to-try legislation is about putting the patient before the bureaucracy. It’s about ensuring terminally ill patients have freedom of choice when it comes to treatments that could prolong their lives. It’s about giving patients alternatives when they may be considering forgoing treatment altogether due to the potential adverse effects caused by traditional options. It’s about protecting individual liberty and rights.
As John Stuart Mill wrote, “The only freedom which deserves the name is that of pursuing our own good in our own way, so long as we do not attempt to deprive others of theirs or impede their efforts to obtain it.” If critics are against trying medications deemed experimental, then they themselves should not try them, but they should not obstruct other patients and their doctors from making that same decision for themselves.