In the last few years some 24 states have approved so-called “Right to Try” laws.

These are intended to give terminally ill patients faster and easier access to experimental therapies. But a panel of experts at the World Stem Cell Summit said they are more symbolic than anything. Right to try laws do little to actually help patients get much-needed therapies, they said.

The name is misleading

Modeled after a federal law that allows “compassionate use” of experimental treatments, these laws allow doctors to prescribe investigational medicines in early stage clinical trials.

Beth Roxland, a bioethicist with Johnson & Johnson, says the name of the law is misleading:

“If you look at the actual text of these laws they only say you have the right to “’ask,’” Roxland said. “That right already exists in federal law but neither federal law nor these Right to Try laws say you have the right to access.”

The FDA decides

Aaron Levine from Georgia Tech said just because a state passes a Right to Try law that doesn’t mean it has any legal impact. State laws don’t over rule the Food and Drug Administration’s (FDA) regulation. So the federal government still has authority to stop access.

These laws are interesting in that they are indicative of the growing determination of patients and advocates, Levine said. They often must work around obstacles to access.

Impact on clinical trials

One of the audience members, William Decker from Baylor College of Medicine, said Texas a law allows for experimental treatments as they’ve gone through a Phase 1 safety trial.

“If you know how clinical trials work you know you can get almost any schlock through a Phase 1 trial,” he said. “We saw this as an avenue to promote fraud, and the last thing you should be doing to a dying patient is take their money or divert their attention away from something that might help them.”

Decker and his colleagues argued before the Texas Legislature potential therapies should at least have to go through a Phase 2 trial to make sure they were not only safe also show some benefit s. In the end Texas lawmakers rejected the Phase 2 idea but did say patients could not be charged for the therapy, and there could be no compensation from insurers or anyone else for the manufacturer of the therapy.

Financial incentives

He says removing the financial benefits and incentives pretty much ensured that no company would offer patients a therapy under this law.

Jeanne Loring, a CIRM grantee from the Scripps Research Institute, says that likely won’t stop other clinics in other states:

“Some stem cell clinics are using adipose (stem cells derived from fat) therapy as an option for every disease imaginable and I’m sure some will take advantage of these laws to say it gives them the right to offer these to patients and the patients will pay for them directly. “

Roxland says that may already be happening:

“I think there is some evidence on the stem cell side that companies have popped up in states that have these laws, to make it easier to offer their therapies to patients.”

The panel agreed that in most cases these laws don’t give patients any rights they don’t already have, but do give the appearance of making access easier. They said it’s feel-good legislation, allowing people to feel they are doing something without actually doing anything.

Aaron Levine said that while some companies may try to take advantage of these laws, the most serious ones won’t:

 “Almost any legitimate company that wants an FDA approved product wouldn’t want to take advantage of these laws. It could put their product at risk. Most companies that need to work with the FDA have no incentive to go this route.”

Related Posts

 Third time is certainly charming

An experimental gene therapy with a hairy twist

Gene Therapy Agency Sets up Support