In 2012, Ted Harada stunned the medical community by becoming the first person to beat Amyotrophic Lateral Sclerosis (commonly shortened to ALS or called Lou Gehrig’s disease). ALS is a terminal illness that slowly robs victims of their ability to move, swallow, and breathe. According to the ALS Association, over 6,000 people a year are diagnosed with ALS.
Two years into his diagnosis, Ted’s health and quality of life plummeted. As a last resort to slow the disease’s progress, Ted participated in an experimental procedure that was not approved by the FDA. His doctors told him the treatment would not help. The procedure was part of the FDA’s initial testing phase, which is designed to prove only safety, not effectiveness.
The procedure not only helped, but it also worked to deter ALS symptoms. Astonishingly, Ted was no longer dying from ALS. When his health improved, he was ableto play with his children and walk upstairs to put them to bed. Before treatment, he wasn’t able to open a Ziploc bag.Ted’s unprecedented recovery was made possible by Georgia’s right-to-try legislation, which granted him access to an unapproved experimental procedure. Right-to-try laws give terminally ill patients access to potentially lifesaving medical products before they are approved by the FDA.
Ted became one of the cause’s greatest champions. He expressed his gratitude and devotion when he told a Washington Post columnist, “I don’t know why I was picked or why I was chosen... but if I’ve been given this gift, how selfish [would it be] to keep that gift to myself and not do something good with it?” Tragically, he passed away from brain cancer in 2016.
Ted’s message and mission, however, live on in pending federal legislation that aims to expand patient access.
Senate Bill 204 allows terminally ill patients to access experimental procedures without the FDA’s approval. Access would require approval from only the provider, physician, and state government. The bill passed in the Senate last August, and it is currently under review with the House Subcommittee on Health.
Recently, the president and vice president voiced their support of right-to-try legislation. In his State of the Union address, President Trump stated, “It is time for the Congress to give these wonderful Americans the ‘right to try’.” Echoing this sentiment, Vice President Pence called for urgency when he tweeted, “Its about restoring hope and giving patients with life threatening diseases a fighting chance. Lets get this [passing the bill] DONE.”
Although right-to-try laws are gaining popularity and acceptance, they still face considerable opposition. Critics have deemed the reforms to be “false hope,” “fraudulent,” “a sham,” and the result of “partisan politics exploiting terminally ill patients.”
While the critics are quick to denounce right-to-try, they seldom offer an alternative. Instead, they hold that, in the words of New York University Medical Ethicist Arthur Caplan, “This [the current approval process] is a time-consuming, expensive, but appropriate and necessary.”
Although well intended, such rhetoric is misleading and harmful. Right-to-try laws currently exist in red and blue states, making the issue non-partisan. They are carried out voluntarily by medical professionals and providers with willing patient participation. It does not exploit, and it is not fraudulent.
Then there is the perceived need to wait for FDA approval. The FDA approval process requires considerable time, which some terminally ill patients may not have.
Fortunately, even the FDA offers a compromise between urgency and safety. From 2005 to 2014, the FDA approved 99.3 percent of expanded-access applications. These applications, similar to right-to-try laws, also offer patients access to unapproved medical products. When the FDA itself recognizes that complete approval isn’t necessary, who could argue it is?
Most importantly, efforts to restrict right-to-try access harm those in most need of help: the patients. An estimated 30,000 adults have ALS in the United States. Tragically, only 32 were granted access to the same procedure that reversed Ted’s symptoms.
Ted’s story is unprecedented, but with expanded access, it is likely repeatable for ALS and other terminal diseases. With only existing laws and misleading rhetoric standing in the way, what could justify standing in the way of a patient’s right to try? As best I can tell, nothing.