BY DANIEL GAITAN | firstname.lastname@example.org
“Right to Try” legislation making its way through Congress is outraging some medical professionals, though the bill is being cheered on by many conservative activists.
The U.S. House of Representatives passed a controversial bill this month to allow terminally ill patients to experiment with drugs not approved by the Food and Drug Administration. The bill now heads to the Senate, which passed a similar bill last year.
President Donald Trump, who highlighted the effort in his State of the Union speech, has said he plans to sign the legislation when it reaches his desk.
Supporters of “Right to Try” maintain the measure would make it far easier for seriously and terminally ill patients to access experimental treatments by bypassing regulators. These vulnerable patients are often unable to participate in clinical trials and have little chance of being cured.
Drug companies already allow some patients access to new drugs outside of clinical trials under a program known as “compassionate use” – as long as the FDA approves such requests.
Although the FDA approves the vast majority of compassionate use requests, sometimes companies refuse out of fear that negative results could be used against them by the government or patients injured by their products.
Both the House and Senate bills shield pharmaceutical and drug companies from some legal risk. The FDA would also be prohibited from using lawsuits or complaints to delay or reject a drug for approval — except under outstanding circumstances.
Starlee Coleman, senior policy advisor with the Goldwater Institute, the libertarian think tank that lobbies for widespread adoption of “Right to Try” laws, said the issue really revolves around the role of government.
“We certainly don’t think that the federal government should have a veto stamp over a patient and doctor decision,” Coleman told Life Matters Media. “We think that you shouldn’t have to file an application with the federal government to save your own life.”
However, R. Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin at Madison, called “Right to Try” a “fraud.”
“The very name of the law suggests that we need a law in order to give people the right to try unapproved drugs,” said Charo, an elected fellow of the National Academy of Medicine. “They already have that right.”
Charo told LMM that ”Right to Try” is part of a long-term strategy to chip away at longstanding roles of government.
“This is about the deregulation of the American market,” Charo said. “It tries to roll back what the academic community would call the administrative state — all the protections that we have developed since the 1930s.”
Charo worries the public will become “unwitting guinea pigs” if the FDA is powerless to track patients or monitor the effects of unapproved drugs floating through the system.
“It’s very scary,” Charo said. “There’s a reason we do testing in an organized way that allows us to pick up problems and identify places where the drugs will work.”
Other opponents are concerned “Right to Try” will deter patients from seeking hospice care, cause unnecessary suffering and promote false hope.
Coleman disagrees, partly because she believes patients know “this isn’t a right to a guaranteed cure.”
“We are fighting for them,” she said. “This is for people who need one last shot. We’re going to keep working and pushing as hard as we can until Americans have access to treatments that can help them.”
Although 38 states have enacted their own “Right to Try” laws, only a federal law can curtail the FDA.
That’s why Craig Klugman, a professor of health sciences at DePaul University in Chicago, told LMM that “Right to Try” could unintentionally limit patient autonomy.
“Patient autonomy requires you have sufficient information to make a choice,” Klugman said. “If we’re now going outside our systems of research and clinical trials, we’re not going to get that information.”
According to Klugman, if patients across the nation begin taking unapproved and untested drugs, it will be even more difficult for regulators to recognize side-effects and efficacy. “Right to Try” could also increase spending at the end of life.
Still, with broad Republican support, the House passed its bill just days after four former
FDA commissioners publicly expressed their concerns.
The commissioners, from both Democratic and Republican administrations, maintain that “Right to Try” would erode protections for the most vulnerable.
“There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent,” the commissioners wrote in a joint statement to The Washington Post.
Coleman was disappointed by the letter.
“Let’s have a debate about the issue, but let’s have it on real facts and not hypotheticals,” she said. “This isn’t the first situation that’s ever emerged when people inside the bureaucracy don’t want to see the bureaucracy change.”
Trump voiced support for “Right to Try” during a recent visit to New Hampshire.
“A patient is terminal. There’s good progress made with a certain drug. We’re going to make it possible for that patient to get that drug, and maybe it’s going to work,” Trump said, according to The Washington Post.
– Image courtesy Creative Commons