WASHINGTON – A bipartisan pair of senators last week applauded passage of legislation meant to improve patient access to experimental treatments, but an NYU medical ethicist dismissed the bill as a political move that will actually result in greater restriction.
The Right to Try Act, introduced by Sens. Joe Donnelly (D-Ind.) and Ron Johnson (R-Wis.), passed unanimously in the Senate on Thursday and is now up for consideration in the House. The legislation allows access to investigational drugs for terminally ill patients who have “exhausted all approved treatment options.” The bill was inspired by state campaigns — 34 states now exercise Right to Try laws.
Donnelly has championed the bill alongside Indianapolis resident Laura McLinn and her son Jordan McLinn, who has incurable Duchenne muscular dystrophy. Jordan is now participating in a clinical trial for an experimental treatment, which the family hopes will slow down progression of the disease.
“I am pleased my bipartisan legislation passed the Senate because it would give families the right to try and the chance to exhaust all options to treat a terminally ill loved one,” Donnelly said in a statement.
Alison Bateman-House, an assistant professor working in the NYU School of Medicine’s medical ethics division who has been following the Right to Try issue for three years, said Thursday that Donnelly’s legislation ignores the biggest hurdle for families seeking experimental treatment: pharmaceutical companies. According to Bateman-House, the legislation wrongfully focuses on the Food and Drug Administration, which she and the school have argued “is no barrier to access.”
“So this is a politically motivated, Libertarian-ideology attempt to rein in the power of the FDA in the guise of trying to help patients. It’s not going to help patients,” she said in an interview.
According to Bateman-House, pharmaceutical companies, particularly startups, either lack the means or are unwilling to provide experimental drugs to patients, even as a last resort. Small startups do not have the funds to pay for lawyers and regulatory staffers, and are also unable to give away experimental drugs. Companies that offer experimental drugs often do not charge the patients.
There’s also a fear, she said, that if patients are given experimental drugs, and there is a death or harmful side effects, that drug will be blamed and FDA approval might be far more difficult in the future. But NYU researchers claim that that fear is a myth, as the FDA, through a years-long audit, claimed that it has never denied approval for a drug based on the results of experimental treatment.
Bateman-House applauded the Right to Try campaigns for bringing awareness to the issue, and allowing doctors and patients to realize that there are alternative treatment options. But she said the legislation, if passed, will only cause confusion. Bateman-House lectures medicinal professionals on how to obtain experimental drugs, and most doctors lack the proper training, she said.
“I think if they’re already confused, and you suddenly say, ‘Hey, there’s this new alternate pathway,’ it’s just going to foster more confusion,” she said. “The drug companies are going to be confused about what the actual rules are, the patient advocates who guide people are going to be confused, and I believe that especially in today’s litigious environment, if people are confused, their default option is to say we’re not going to do it. So I think that less people are actually going to get access to investigational drugs with this law, if it is approved by the House.”
She also pointed out that the legislation specifically states it gives no new powers or rights to patients.
“I am concerned that patients are being used in what is really an ideologically driven quest,” she said. “I think the real goal is to try to clamp back the powers and the authority of the FDA and that patients are being promised that this is going to help them when really that’s not the case.”