Arizona to Vote on Making Experimental Drugs Available to the Terminally Ill

Robert Pratta/Reuters

The story of Brittany Maynard, a terminally ill woman who spent her last days this October advocating for Americans' right to die before taking her life on November 1, has re-energized discussions surrounding end-of-life rights. Coincidentally, Arizona votes today on whether to allow its dying patients to use medications that have passed the first round of tests but not been approved by the Food and Drug Administration (FDA). If the measure is approved, which polls suggest it will be, Arizona will join only a handful of states that have adopted similar "right to try" legislation.

Arizona's Proposition 303 was spearheaded by Goldwater Institute, a libertarian organization named after the late U.S. Senator Barry Goldwater that advocates on behalf of patient choice. "Our objective is to look at different problems out there and come up with solutions that are liberty-based solutions," Victor Riches, the group's vice president for external affairs, told Bloomberg. "These individual patients have a right to try a medication to try to save their own life." The organization is also responsible for getting sympathetic lawmakers to introduce the legislation in the states where it is currently law.

The drug approval process that we are familiar with today was born in 1962 due to the outrage surrounding thalidomide, a medication prescribed to pregnant women suffering from morning sickness that caused thousands of birth defects in a handful of countries, including the U.S. In reaction to that scandal, Congress began requiring companies to conduct rigorous clinical trials to ensure a drug is effective and safe before it is put on the market—a process that may take 10 or more years to complete.

While the FDA offers a program known as Compassionate Use that allows terminally ill patients to obtain unapproved drugs, some argue that the caveats make it insufficient. Not only do unapproved drugs have to pass the FDA's phase one testing (a preliminary safety test which right-to try-laws also require), but the agency also demands various approvals that can take 100 hours of paperwork. The process of getting a new drug approved through the Compassionate Use program could take several months in total—time, critics argue, the terminally ill do not have. The program also dictates that a doctor cannot prescribe an unapproved drug unless a patient has exhausted all other options.

Though many have advocated for a change to the FDA's rules, legislation is just starting to be passed. From economist Milton Friedman, who wrote in a 1973 column in Newsweek that "the cost of delaying a beneficial innovation is something like 10 to 100 times the value of avoiding a thalidomide-type mistake," to 21-year-old Abigail Burroughs who died of cancer in 2001, but not before lobbying for better access to experimental drugs—there has been no shortage of vocal backers of such legislation.

Colorado was the first state to approve a right to try law earlier this year, followed by Louisiana, Missouri and Michigan. Though these laws passed with bipartisan support, the legislation has seen its fair share of detractors.

Many critics within the medical community worry that skipping the subsequent rounds of testing—which help doctors determine safety, efficacy and proper dosing—will expose patients to unknown risks. They also worry that right-to-try laws will give dying patients false hope since only 10 percent of drugs are deemed worth the risk and make it through clinical trials.

But the concern extends beyond the patients themselves. Phase one clinical trials, which test a substance's toxicity, usually include the very people who would want to take advantage of right-to-try laws. Phase one volunteers are usually ill and do not expect to live using conventional methods of treatment. Some critics fear right-to-try will discourage them from participating in clinical trials and will ultimately impact the testing of all drugs.

In a statement to the Washington Post, the FDA said that the agency is concerned about any efforts that may undermine the "congressionally-mandated authority and agency mission to protect the public from therapies that are not safe and effective." The legality of state laws impinging on the FDA's exclusive jurisdiction over the regulation of drugs is murky and litigation over the constitutionality of state right to try laws may be in the future.

Arizona will be the first state to refer the legislation to a popular vote. According to recent polling numbers from MBQF Consulting, around 77 percent would vote in favor of right-to-try, 15 percent would vote against it and 7 percent are undecided. If passed, Arizona would be the fifth state to pass such legislation. And the Goldwater institute does not intend to stop there—the group plans to launch efforts in 10 new states next year.

As the response to Maynard's passing highlighted, many believe more should be done to help America's terminally ill population. Maynard, who was diagnosed with brain cancer back in April and given only six months to live, moved to Oregon from California in order to access the state's right-to-die options, which allows the terminally ill to commit suicide or receive assistance in order to do so. This "right to die" option, like "right to try," only exists in a handful of states.

Maybe Arizona will be the latest to fulfill Maynard's wish to provide more end of life options to America's terminally ill, whether it is the right to die or the right to fight to continue living.