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Sunday, February 28, 2016
Hawaii Right to Try Legislation Receives Bipartisan Support
By Selected News Articles @ 5:34 PM :: 2750 Views :: Health Care

Hawaii Right to Try Legislation Receives Bipartisan Support

by Dustin Siggins, Heartland Institute, February 28, 2016

Hawaii may become the 25th state to adopt a “right to try” law, legislation that would enable medicine and medical device manufacturers to offer eligible terminally ill patients “investigational drugs” and “experimental treatments” the U.S. Food and Drug Administration (FDA) has not fully approved.

Although neither bill would override federal agency rules, House Bill 1013 and Senate Bill 2181 would create a path under state law for terminally ill patients to try drugs and devices that have passed one round of FDA testing.

Five Democrats in each chamber are sponsoring the legislation, for which at least one Republican in each house has voted in committee, though the bills are not identical. HB 1013, referred to the House Judiciary Committee on February 18, resembles an active Maryland right to try bill that defines an “eligible patient” as a person with documentation proving he or she has received a terminal diagnosis and a physician’s recommendation to try experimental treatment, consented to the new treatment, and has already considered all treatment options currently approved by FDA.

The Senate version, referred to the Senate Judiciary and Labor committee on February 11, defines an eligible patient as one who meets the above criteria and has “been unable to participate in a clinical trial within one hundred miles of the patient’s home address” or one who has “not been accepted to the clinical trial within one week” of completing the application process.

Payments and Penalties

Keli’i Akina, president and CEO of the Grassroot Institute of Hawaii, says state lawmakers are taking care to specify who would be obligated to pay for experimental treatments under the right to try legislation and whether doctors and drug developers would be liable if treatment fails.

“The Hawaii [bill] is still a work in progress, and both committees that have passed it have attempted to refine some of the definitions involved, especially in regards to who qualifies as an eligible patient and what constitutes informed consent,” Akina said. “The current incarnation of the bill in the Hawaii legislature is careful to specify that health plans, insurers, and government agencies are not responsible for paying for treatment. There are also efforts to clearly limit the manufacturer’s and doctor’s liability under the law when a patient chooses to pursue experimental treatment.”

The current FDA approval system penalizes drug developers when their products fail to cure terminal illnesses, creating a disincentive for them to offer their drugs outside of FDA’s strict compassionate-use process, says Christina Sandefur, executive vice president at the Goldwater Institute.

“The biggest fear among drug makers is that participation in compassionate use could endanger clinical trials that typically go on for more than a decade and cost in excess of $1 billion,” Sandefur said. “If the already terminal patient dies after taking the treatment—which can happen; the patient is terminal and the treatment is a long shot—that counts against the drug in clinical trials, and the FDA can and has suspended clinical trials because of the death of a patient in a compassionate-use case.”

No Time to Lose

Right to try laws are designed to accelerate the process by which terminally ill patients can try treatments restricted by FDA. Sandefur says the federal agency’s approval process can take more than a decade.

“Millions of Americans are dying this year from terminal illnesses for which there are treatments and cures,” Sandefur said. “The problem is that the FDA has a very archaic process for approving treatments for people with life-threatening diseases. The FDA’s process is designed to help people 15 years from now, not today. You don’t walk around with a 15-year-old phone in your pocket, and when your life is on the line, you shouldn’t be forced to settle for 15-year-old treatments.”

Sandefur says former San Diego State University professor David Huntly might have beaten his terminal illness had FDA’s drug-approval process not been so slow.

“Two years ago, a man named David Huntley was diagnosed with Lou Gehrig’s disease,” Sandefur said. “He was an ironman athlete, a professor, and a father, and he wasn’t about to go down without a fight. In 2015 he testified, ‘Without any treatment, I will pass in six to nine months. How is keeping me from investigational treatments saving my life? … At the very least, it gives me something to fight back against this horrendous disease.’ Dr. Huntley never got access to the treatment he sought, and he passed on a few months ago.”

‘Gut-Level Sense of Freedom’

Akina says because many in Hawaii have a “strong sense of dependence on the federal government,” right to try laws have yet to gain broad-based support, but the Hawaii bills have potential to unite people across party lines.

“Right to try laws appeal to a gut-level sense of freedom and individual rights, regardless of what the prevailing political makeup of that state may be,” Akina said. “The idea that the federal government can prevent someone fighting a terminal diagnosis from trying anything and everything to survive goes against our fundamental notions of individual liberty and compassion. That’s what makes this one of the issues that can unite people from across the political spectrum.”

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