WEDNESDAY, May 30, 2018 (HealthDay News) -- President Donald Trump on Wednesday put his signature on a bill allowing terminally ill patients to try unproven treatments to fight their disease.
Calling access to these drugs a "fundamental freedom," Trump said he hoped it would help save lives, the Associated Press reported.
The "Right to Try" bill passed the Senate in August, and the House passed the bill last week by a vote of 250-169, but not without fierce debate. Republicans contended it would help thousands of very ill Americans find new hope, while many Democrats said it might only provide false hope.
Trump had lauded the proposed measure in his State of the Union address. The new law allows people diagnosed with a life-threatening condition who have tried all other treatment options to receive unproven medicines without going to the U.S. Food and Drug Administration for permission.
The Goldwater Institute, a conservative public policy think tank based in Phoenix, helped craft the new policy and lobbied for the passage. In a statement, institute president Victor Riches said that "federal law now protects the right of dying patients to obtain and use cutting-edge medicines without asking first for government permission."
Laura McLinn has a 9-year-old son, Jordan, with fatal Duchenne muscular dystrophy. In the Goldwater Institute news release, she said, "Jordan and I are grateful to see Right to Try signed into law today. During our more than three-year fight for patients to have this right, Jordan was accepted into a clinical trial for a drug we believe is slowing the progression of his fatal disease. We continued to fight for Right to Try for terminally ill patients who are not in that "lucky 3 percent" of the patient population who make it into trials."
But some experts worry that the new law will also make desperate, frail patients vulnerable to more harm, with FDA oversight taken away.
Without that guidance, "the rest of us doctors are kind of flying blind with respect to things like how much of the drug to give, how to give it, what kind of side effects to look for," Dr. Steven Joffe, professor in medical ethics and health policy at the University of Pennsylvania Perelman School of Medicine, explained to CNN.
"So, by cutting the FDA out of the loop, you are failing to take advantage of the knowledge that it has about how to use the drug," he said. "About 10 percent of the time, the FDA, when it gets requests for expanded access, will say, "Yes, but here is the way you can do it more safely" or "Here is the side effects to look out for."
That guidance is now gone, Joffe said.
There is more on the care of the terminally ill at the U.S. National Institute on Aging.
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