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‘Right to try’ drive seeks to provide dying with unapproved drugs

June 11, 2015

Originally written by Victoria Colliver for San Francisco Chronicle

Two bills would give terminally ill Californians who have exhausted their treatment options the right to try unapproved medications. Both have received bipartisan support, with one already heading to the state Senate after making it out of the Assembly last week.

Seventeen states have approved similar laws, while California is among as many as 15 states that have proposed legislation. Governors in Florida, Nevada and Illinois have right-to-try bills on their desks, and Arizona voters have approved a ballot measure to give patients the option.

“It’s truly a national movement through the states,” said Kurt Altman, national policy adviser and general counsel with the libertarian Goldwater Institute, which has helped lawmakers draft their bills.

Altman said the goal is to give patients “a last opportunity, a last chance.”

Patients who try experimental therapies typically do so through clinical trials, structured research programs designed to test new medications. But many patients fail to meet the trial criteria, can’t find an appropriate trial or are otherwise ineligible.

The right-to-try movement attempts to make available to them currently unapproved therapies that are typically offered only on a case-by-case basis through special programs dubbed “compassionate use” or “expanded access.” The process of being accepted into them can consume vast amounts of time these patients say they simply don’t have.

Nick Grillo, 54, of San Francisco, who has amyotrophic lateral sclerosis, a fatal neurodegenerative disease known as ALS, thinks offering dying people access to potentially lifesaving drugs should be the rule, not the exception.

“This is essentially what these right-to-try laws are all about: the American people telling our federal government that they are exercising excess power and that we will no longer sit and wait (or lay back and die) waiting for them to self-correct,” Grillo said in an e-mail, which he used to communicate because ALS has made it difficult for him to speak.

Experimental drug

Only one drug, Riluzole, has been approved to treat ALS, and it typically has been found to extend life expectancy by just a few months.

Grillo, who can no longer walk or stand, wants access to an experimental drug from a small biotech company in Pasadena that has shown promise in a small group of trial patients by appearing to slow symptoms. The company, Genervon Biopharmaceuticals, has petitioned the U.S. Food and Drug Administration to bypass large-scale trials and make the drug available to ALS patients who want it.

Stories like Grillo’s have helped propel legislation by Republicans and Democrats alike in such politically diverse states as Arkansas, Louisiana, Maine, Minnesota, Montana, Utah and South Dakota.

Assemblyman Ian Calderon, D-Whittier (Los Angeles County), and state Sen. Jeff Stone, R-Temecula (Riverside County), introduced the separate right-to-try bills in California.

While Calderon’s Assembly Bill 159 made it through the Assembly on a 69-2 vote, Stone’s Senate Bill 149 is stalled in theSenate Appropriations Committee. If a version of the legislation passes both houses, it could reach the governor’s desk by late summer or early fall.

Calderon said he learned about right-to-try when researching the aid-in-dying issue, the subject of a controversial bill that would allow terminally ill Californians to end their lives with doctor-prescribed drugs.

Both issues come down to patient choice and freedom, he said.

“This is not a Democratic issue or a Republican issue,” Calderon said. “This is a human issue dealing with our very real mortality.”

Calderon’s bill includes provisions that protect doctors from liability, requires a physician board to review decisions, and asks patients to sign informed consent paperwork. Health insurance companies would not be required to cover the treatments. Calderon said drug companies typically pick up the costs of treatment, although the bill does not require them to do so.

Modest opposition

Goldwater Institute officials say right-to-try legislation nationwide has encountered only modest opposition, mainly from doctors concerned that allowing patients access to these drugs would disrupt the clinical trial process.

The California Medical Association opposes both bills but appears poised to lift its opposition of Calderon’s legislation after provisions were added to protect doctors and patients. The California Nurses Association also opposes the bills.

Stephanie Roberson, legislative advocate for the nurses union, said these bills provide “false hope” to patients and may jeopardize their safety.

“We don’t want patients given the green light to take a medication that may make their quality of life even worse,” Roberson said. “Just because they are in the final six months doesn’t make it OK to experiment with their lives.”

To Grillo, the concept of safety is different to dying patients who lack options and who are willing to take the risk. He said the drugs still must go through initial safety trials.

“History is studded with uprisings of the people fighting the powers that be,” he wrote. “Has this really ever turned out to be a bad thing?”



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