Advocates Cheer Trump Boost of ‘Right to Try’ Experimental Medical Treatments
Proposal aims to let terminally ill patients bypass FDA trials, take unapproved drugs in U.S. instead of having to go overseas
Advocates of the “Right to Try” movement hope a State of the Union shoutout by President Donald Trump will build momentum for legislation to let dying patents bypass government red tape to use experimental drugs in the U.S.
Naomi Lopez Bauman, director of health care policy at the libertarian Goldwater Institute, said the president’s endorsement during his Tuesday address to the nation will help.
“I really do think there’s a lot of commitment to getting this law over the finish,” she said. “It’s just a tremendous boost and tremendously important to these patients who are facing life-threatening illnesses … This is something that the American people want and not only that, it’s unconscionable not to let someone try to save their lives.”
Trump told Congress and the nation that patients with no other options should not have to wait for the Food and Drug Administration’s (FDA) slow-moving approval process.
“People who are terminally ill should not have to go from country to country to seek a cure,” he said. “I want to give them a chance right here at home. It’s time for the Congress to give these wonderful, incredible Americans the ‘Right to Try.'”
The Senate has passed Right to Try legislation, sponsored by Sen. Ron Johnson (R-Wis.), and 38 states have passed similar laws. But the measure has not come up for a vote in the House of Representatives.
Robert Graboyes, a senior research fellow at George Washington University’s Mercatus Center, said the best way to understand the Right to Try movement is to watch “Dallas Buyers Club.” The 2013 film is based on the real-life story of Ron Woodroof, a Texas AIDS victim in the 1980s who smuggled unapproved drugs from Mexico to treat his disease and help other victims.
Graboyes said Right to Try policies could be a lifeline to people who otherwise would die — and it could help drug companies gather research data faster.
“It’s a humane idea for people in that situation,” he said. “But beyond that, it’s an opportunity to test drugs at an earlier stage than they otherwise could.”
Critics of the idea argue it is unnecessary and could hurt efforts to bring new drugs to market.
Allison Bateman-House, a professor at New York University’s Langone Medical Center, told LifeZette there already is a way for terminal patients to get experimental drugs. The FDA itself has a program called Expanded Access, also called Compassionate Use. The agency, she said, approves more than 99 percent of the requests it gets under this initiative.
“There is a path. It works,” she said. “Tens of thousands of people use it. The big issue is that it’s confusing.”
Bateman-House said proposals like Right to Try would only add to the complexity, however. “Obviously, if you bring in a second path, it is going to increase confusion,” she said.
Not only that, Bateman-House said, but passing the law might siphon away participants in drug trials that often already are not full. She warned that would slow drug development for the general public.
Bateman-House said the law would not even achieve its main aim of putting experimental drugs into the hands of patients looking for a last resort. No ethical pharmaceutical company would agree to go outside the FDA system she said, adding that Jansen Pharmaceuticals recently updated its policy in that direction.
Right to Try supporters have a different view.
“It doesn’t really hold. It’s easy to get caught in the bureaucracy,” Graboyes said.
Bauman, of the Goldwater Institute, argued that the Expanded Access program does not work very well and places too much burden on patients to persuade busy doctors to fill out forms.
“It takes many, many hours,” she said. “Imagine a patient at their worst time having to get doctors to spend dozens and dozens of hours on paperwork.”
But Bateman-House said the only difference between Expanded Access and the path Right to Try advocates want to create is that it cuts the FDA out. That is troubling, she said, because the FDA has access to drug company data and other expertise that doctors lack. The agency actually can help tweak medication to give patients the best chance, she added.
“It sort of boggles the mind that patient advocates would want to take the FDA out of that process,” she said.
But Bauman said status quo advocates mostly want to preserve their power. “There are some interests that don’t want to relinquish any real or perceived authority of the FDA,” she said.