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OKLAHOMA CITY (AP) — Ted Harada says that, statistically, he shouldn't be alive today.
The 43-year-old former manager for FedEx in Atlanta was diagnosed with amyotrophic lateral sclerosis, or Lou Gehrig's disease, in August 2010, and the average lifespan for someone with the disease is two to five years after diagnosis.
Harada was accepted into a clinical trial for ALS patients that involved an experimental medical procedure, and he said it dramatically slowed the disease's progression.
"I still have ALS. But I'm alive and enjoying my family," Harada said. "Someone who is dying with no other option should be allowed to take that educated, elevated risk. It's not guaranteed, it's just a right to try."
Oklahoma is considering legislation akin to laws passed by several other states meant to make it easier for terminally ill patients who may not qualify for a clinical trial to nevertheless get access to the same kinds of experimental drugs and procedures. Known as the "Right to Try Act," the bill is pending on the floor of the Oklahoma House after getting a House committee's unanimous approval.
Terminally ill patients who have exhausted conventional treatment options often struggle to obtain potentially lifesaving experimental medications. Only 3 percent of terminally ill patients are currently enrolled in clinical trials like the one Harada was part of, according to the Goldwater Institute, a conservative public policy group pushing for passage of the Oklahoma measure.
The U.S. Food and Drug Administration allows people to request permission to access investigational medicines, but the process has historically taken hundreds of hours of paperwork and months to complete.
Right to Try legislation gives terminally ill patients the option of obtaining medications or devices that have passed the first of multiple phases in an FDA approval process but are not yet on pharmacy shelves. The legislation would expand access to potentially lifesaving medications years before patients would normally be able to access them, according to the bill's supporters.
"It's a Hail Mary in the end," said Rep. Richard Morrissette, an Oklahoma City Democrat and author of the Oklahoma measure. "It gives us that opportunity to try."
The FDA introduced guidelines to help streamline expanded access to investigational drugs because some patients and physicians had expressed concerns that they were too difficult to obtain. But the Goldwater Institute and other critics say the FDA's efforts are too little, too late.
"It isn't good enough," said Kurt Altman, the group's national policy adviser and general counsel. "That will certainly encourage doctors to do this more often. But the process still takes a while."
Morrissette said the FDA's bureaucratic foot-dragging is the reason states are passing their own laws to give patients greater access to experimental treatments. Oklahoma is among 29 states where such legislation has been proposed, according to the Goldwater Institute.
The Right to Try movement has its critics, who say it's a feel-good campaign that won't help dying patients. Such laws don't require drugmakers to provide their drugs outside of federal parameters, and these companies would be wary of doing anything to endanger drugs on which they may be spending millions of dollars to bring to market.
A federal court ruled in a 2003 lawsuit that terminally ill people don't have a right to access experimental drugs, and the Supreme Court declined to consider an appeal.
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Online:
House Bill 1074: http://bit.ly/1EQY93v
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