Not long after he was diagnosed with ALS, Jim Barber clung to a small dose of hope: The East Bay resident became eligible to enter a 5-year-long clinical trial for a drug that sought to slow the progression of the incurable neurodegenerative, life-sapping disease.
While the drug didn’t work and Barber’s muscle-weakening disease has worsened, his plight sums up the emotional dilemma over a pair of bills winding their way through the California Legislature that would give desperate patients more chances for long-shot cures.
The so-called Right To Try legislation would allow terminally ill patients who have exhausted all other options the opportunity to try experimental drugs, products or devices that have not been approved by the U.S. Food and Drug Administration.
“It underscores the notion that patients want to — ought to — have a voice in the process of developing effective treatment for their diseases,” said Barber, whose speech is noticeably slowed because of his ALS, also known as Lou Gehrig’s disease.
Yet some experts warn that providing unregulated treatments for those desperately searching for ways to extend their lives is not only taking advantage of their emotional state but could also harm dying patients. Others call it merely a symbolic gesture, saying drug manufacturers are unlikely to voluntarily participate outside of an existing FDA program that provides expanded access to experimental drugs, and health insurers are unlikely to cover the costs.
Senate Bill 149 by Sen. Jeff Stone, R-Temecula, and Assembly Bill 159 by Assemblyman Ian Calderon, D-Whittier, are similar to legislation passed by 21 states since last year — 16 this year alone.
So far, both California bills have sailed through their respective chambers and will likely be combined into a single bill, the two lawmakers say. Gov. Jerry Brown has not yet indicated whether he will sign the legislation into law.
Proponents say patients fighting for the bills can’t get into clinical trials and certainly don’t have time to wait for the FDA’s years-long drug-approval process.
Nor, they say, will these patients tolerate the red tape that can complicate the FDA’s “expanded access” program, which provides experimental drugs to patients with life-threatening illnesses.
A Right To Try law would give thousands of California patients “some control over their destiny,” said Kurt Altman, national policy adviser for the Arizona-based Goldwater Institute, which has been lobbying for Right To Try laws around the country.
“This just helps bring the decision to where it belongs: between a doctor and a patient,” Altman said. “I like to say that it’s not a Democrat or a Republican issue — it’s really a human issue.”
Altman acknowledges that so far drug manufacturers have yet to provide any patient with an experimental drug or product in any of the six states where Right To Try laws are actually in effect.
“But once somebody does pioneer this, it will be used again and again,” he said.
In California, both bills would require patients to get written permission from their physicians to take the experimental medication, which must have cleared its Phase I FDA clinical trial and be moving forward. Each measure would remove any liability from the manufacturer providing the treatment, as well as the physician or hospital involved.
The bills, however, don’t force drug manufacturers to provide the drugs. Nor do they require health insurance plans to provide coverage.
The Pharmaceutical Research and Manufacturers of America, which has taken no formal position on the matter, has expressed concern that the wider use of experimental drugs could complicate the FDA approval process.
Groups representing oncologists and nurses are opposed, the first group arguing that the legislation could harm patients while the nurses say it’s toothless without drug companies on board.
The California Medical Association does not support the legislation but dropped its opposition to Calderon’s version after it was tweaked to enhance protection for doctors.
Stone, a practicing pharmacist who has long criticized the time it takes to get a new drug to market, believes the need for such a law is obvious.
“Why would I not want to get that drug and lose that last-ditch effort to try to save my life?” he said, adding that many of his terminally ill pharmacy customers have sought treatment in foreign countries.
“If it were me or somebody in my family,” Calderon said, “I think we’d want the opportunity to try to save our own lives.”
The FDA has not taken a position on any Right To Try legislation. But agency spokeswoman Sarah Peddicord said the FDA “is not a barrier to accessing investigational drugs or medical devices.” Rather, it is “an important part of the process” to ensure patients are adequately protected from receiving a potentially harmful or ineffective treatment.
The FDA in February announced it is taking steps to simplify and more clearly communicate how physicians can request to get their patients experimental drugs. Peddicord wouldn’t comment when asked if the change was a response to the growing wave of Right To Try legislation.
David Magnus, a Stanford professor of biomedical ethics, calls the legislation “a tricky issue” that concerns many in his field. With Right To Try laws, he said, patients “could be harmed by the drugs, and their quality of life could be lower — and they could also die earlier.”
“As a society, we don’t deal very well with the idea that people die, so when a patient gets sick and is dying, people want an answer,” Magnus said. “They want to be cured — they demand and expect that.”
Contact Tracy Seipel at tseipel@mercurynews.com or 408 920-5343 and follow her at Twitter.com/taseipel.