‘Right-to-try’ legislation met with mixed reviews

Although it would give patients access to new drugs, oversight might be lost

What seems like a compassionate Hail Mary for dying patients may not be all it seems, a Rice University health scholar said Monday.

At best, the pending national “right-to-try” legislation to give patients access to unsanctioned medication and treatments is not really needed since wide latitude for experimentation is already in place, including in Texas.

At worst, it could cause harm to by removing federal oversight, Kirstin Matthews, a science and technology policy fellow at Rice University's Baker Institute for Public Policy, said in a statement.

Such laws are “written with good intentions,” Matthews said. But she and others worry they “can be harmful to both patients and public good by delaying the clinical trial process.”

The measure, strongly backed by the Trump administration, seeks to give terminally ill patients the opportunity to try treatments outside the normal channels if they've exhausted all other traditional and federally-approved choices.

Long championed by patient advocates, “rightto-try” laws seek to remove what is seen as cumbersome barriers and delays in treatment authorizations by the federal Food and Drug Administration. The measures — often championed as a humane remedy for those with little other hope — allow doctors to work directly with pharmaceutical companies.

A federal version of the law passed the U.S House last week and still needs to pass the Senate. Currently 38 states have “right-totry” laws on their books, including Texas which passed its effort in 2016.

“The bill will make sure that the federal government does not interfere with state ‘right to try’ laws,” Matthews said in a statement issued Monday. “But in general, ‘right to try’ laws are a bit questionable as the FDA already has expanded access programs that allow patients access to experimental drugs and interventions.”

Critics contend that removing FDA protections can create a potential for fraud and abuse.

Matthews, the author of a 2016 Baker Institute report on the same issue, said the laws potentially focus more on “protecting the physician than ensuring drug or device access to terminally ill patients.”

She also wrote that “right-to-try laws can perpetuate the idea that an experimental drug is worth the risk and potential danger despite the fact that 85 percent of experimental drugs fail during clinical trials.”

In a statement Monday she said patient advocates should work with the FDA and pharmaceutical companies to improve the current system, not scrap it.