States Move to Expand Experimental Drugs for Some
DENVER (AP) — Frustrated by federal delays getting experimental medications to terminally ill patients, some states are forging so-called "Right To Try" legislation to allow access to the drugs without federal approval.
Colorado is poised to become the first state to enact the proposal when Gov. John Hickenlooper signs it into law Saturday in Fort Collins. The bill passed unanimously through the Colorado Legislature after emotional testimony from relatives who told harrowing stories of seeking federal permission in vain to access experimental drugs.
"When you're terminal and there's a drug out there that might help you, it can seem that the obstacles to get that drug are insurmountable," said Sen. Irene Aguilar, a physician who co-sponsored Colorado's bill.
Aguilar dubbed the measure the "Dallas Buyers Club" bill, after the movie about a determined AIDS patient who smuggled treatments from Mexico because they weren't cleared for use in the United States.
"Right To Try" bills await governors' signatures in Louisiana and Missouri, and Arizona voters will decide in November whether to set up a similar program in that state.
The legislation clears the way for drug companies to provide experimental medications to patients outside of clinical trials. But drugmakers would not be required to do so.
Colorado's bill got a careful no-comment from doctors' groups, hospitals and health insurers. The bill was amended to clarify that health-care providers and insurers aren't liable for any adverse effects in a patient who gets access to a drug outside clinical trials and then gets sick or dies.
Patients and relatives who support "Right To Try" laws insist they're willing to accept any amount of risk to gain access to experimental drugs.
Among them is Keith Knapp of Sacramento, California, whose wife, Mikaela Knapp, died last month of a rare form of kidney cancer. The Knapps tried in vain to access investigational drugs through existing "compassionate use" guidelines, which require permission from the U.S. Food and Drug Administration.
"You just get caught in the bureaucracy of it all," Keith Knapp said Friday.
But critics of "Right to Try" abound. Dr. David Gorski, a surgical oncologist and editor of the blog Science Based Medicine, insists "Right To Try" proposals are simply feel-good measures that won't help many patients.
"These proposals are built on this fantasy that there are all these patients out there that are going to be saved if they could just get access to the medicine," Gorski said. "In reality, the patients that might be helped are very few, while the number of patients who could be hurt by something like this are many."
But supporters insist the states should push the envelope on clinical trials to speed up the work of federal drug regulators.
"It's so basic, the right to fight for your own life," said Darcy Olsen, president of the Phoenix-based Goldwater Institute, a conservative think-tank that promotes "Right To Try" legislation.
House Bill 1281: http://goo.gl/U0OWi3