LYONS, Colo. » Since May, a string of states has passed laws that give critically ill patients the right to try medications that have not been approved by the Food and Drug Administration.

Deemed "Right to Try" laws, they have passed quickly and often unanimously in Colorado, Michigan, Missouri, Louisiana and Arizona, bringing hope to patients like Larry Kutt, who lives in this small town at the edge of the Rocky Mountains. Kutt, 65, has an advanced blood cancer and says his state’s law could help him gain access to a therapy that several pharmaceutical companies are testing. "It’s my life," he said, "and I want the chance to save it."

The laws do not seem to have helped anyone obtain experimental medicine, as the drug companies are not interested in supplying unapproved medications outside the supervision of a clinical trial. But that seems almost beside the point to the Goldwater Institute, the libertarian group behind legislative efforts to pass Right to Try laws in every state. "The goal is for terminally ill patients to have choice when it comes to end-stage disease," said Craig Handzlik, a spokesman for the Goldwater Institute, based in Arizona. "Right to Try is something that will help terminally ill people all over the country."

Legislators in 10 other states will introduce these bills in 2015, Handzlik said, and lawmakers in Kansas, Tennessee, Texas and Wyoming have filed bills or announced intentions to do so. Critics of the laws like Dr. David Gorski, a surgeon in Michigan who blogs about medical issues, call them "a cruel sham."

Releasing unstudied therapies, Gorski said, could cause untold pain in a person’s final days, even hastening death. "They’re far more likely to harm patients than to help them," he said.

A divided federal appeals court ruled in 2007 that patients do not have a constitutional right to medicines that are not federally approved. The next year, the Supreme Court refused to hear an appeal of that ruling, thwarting the hopes of those who would like a federal Right to Try law.

Supporters have popularized their cause by nicknaming the laws "Dallas Buyers Club" bills, invoking the 2013 movie featuring a rodeo competitor who smuggled unapproved treatments to desperate people with AIDS.

The Colorado law, which is similar to ones in other states, permits terminally ill patients who have exhausted their treatment options – including clinical trials – to obtain therapies that have passed at least the first of three FDA investigation phases. The law does not require companies to provide the treatment, nor does it mandate that insurance companies cover it; the law also allows insurance companies to deny all coverage to patients while they use drugs under investigation.

The FDA has a process for helping very ill people receive unapproved treatments, and several pharmaceutical companies said they would continue to ask patients to go through the FDA if they wanted such treatments. "We have an obligation to follow federal laws," said Kellie McLaughlin, a spokeswoman for Janssen Biotech.

Since the 1960s, the FDA has mandated that medications go through a rigorous three-stage investigation before doctors can prescribe them. This process has generated conflict between patient advocacy groups, many of which have expressed deep frustration with the FDA’s lengthy trial period, and supporters of that system, who say it is critical to ensuring safety.

In 1987, as AIDS patients clamored for treatment still under investigation, the FDA created a formal process for granting unapproved therapies to people with exceptional need. Called the "expanded access program" or "compassionate use," the program has changed over the years, but remains the standard way for terminally ill people to request an unapproved therapy after they are rejected from clinical trials.

But the program has been attacked by patients and their families. "We don’t have time to jack around with bureaucratic practices when someone’s life is on the line," said Michelle Wittenburg, 43, who said it had taken doctors and the FDA three weeks to approve an expanded access petition for her best friend, Andrea Sloan. Sloan’s health deteriorated during this time, said Wittenburg, and she died on Jan. 1, 2014, soon after receiving the treatment.

The new laws aim to hasten access to unapproved drugs by eliminating the FDA role in the process: Once a physician and a patient determine that treatment is the right choice – and that other options have been exhausted – the pair approach the drug company for permission.

The FDA does not have a position on the laws, said a spokeswoman, Stephanie Yao, but encourages patients to use the existing expanded access program.

"The agency often allows these submissions to proceed quickly and, in the case of emergencies, over the phone," Yao said. She added that the agency permits about 1,000 people to use unapproved treatments each year.

In Colorado, Kutt, who runs a company that makes altitude simulation equipment, said he could not wait for reform. He has advanced multiple myeloma, and his family has petitioned companies for three therapies: Daratumumab, Elotuzumab and SAR650984. If the companies approve his request, he said, he wants the treatment right away.

"We don’t need any additional obstacles," Kutt said.

Julie Turkewitz, New York Times

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