This story was done in collaboration with Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.
For Ed Tessaro, it’s too late to ask for hope.
The 68-year-old Alpharetta resident suffers from ALS, or Lou Gehrig’s disease, a neurodegenerative illness that slowly erodes a person’s control over his muscles and ultimately leads to paralysis and death. There is no cure.
But Tessaro holds out hope for other Georgians afflicted by incurable, deadly diseases. He recently testified at the Gold Dome in favor of House Bill 34, a proposed piece of legislation that would give terminally ill patients the right to try certain drugs that have not yet won approval from the U.S. Food and Drug Administration.
“I’m a patient with a fatal illness,” said Tessaro, who gets around using a blue motorized wheelchair. “Not to be dramatic, but I won’t be here in three years, and others diagnosed today won’t be here. I’m just asking you to look at the fatal disease through the eyes of the person who has it.”
The bill would allow a doctor to petition a drug company on behalf of a dying patient with any illness to use a drug that has passed only through the first of three phases of testing required for FDA approval.
So-called “right to try” bills are sweeping the country, with bills similar to Georgia’s being sponsored in 26 states. Five states — Louisiana, Arizona, Colorado, Missouri and Michigan — passed similar laws in their 2014 legislative sessions.
Critics of the bills fear they are based on emotion rather than medicine and that they flout FDA protocol that protects people from purveyors of snake oil.
“There are a lot of crackpots and rip-off artists out there,” said Arthur Caplan, medical ethicist at New York University’s Langone Medical Center.
Some lawmakers also worry the so-called “right to try” bill may offer only false hope and empty promises to those who are critically ill.
The bill would not force drug companies to provide the drug to patients. It would not call for insurers to pay for it. It would require a doctor’s recommendation, and it could mean that patients lose hospice benefits. It would only give patients the right to try a drug that has been proved safe in an FDA trial.
Rep. Mike Dudgeon, R-Johns Creek, who brought the Georgia bill before the House Health and Human Services Committee, said he recognized that access to a drug does not mean healing from a drug.
“I see this as a step in the process,” Dudgeon said. “In some cases it will make a difference, it will save some lives.”
This is about people’s constitutional liberty, said Kurt Altman, policy consultant with the libertarian-leaning Goldwater Institute in Arizona. These are legitimate drugs, not snake oils, Altman added.
The institute got behind the issue about two years ago after researching the difficulties that terminally ill patients face in gaining access to experimental drugs that they believe could extend or even save their lives.
“Right to try” supporters are challenging an attitude of “this is just the way we’ve always done it,” Altman said of the FDA approval process for drugs.
As it stands, the drug approval process is often as long as 10 years and requires three phases of testing via clinical trials.
The first phase of a clinical trial is usually conducted at several research centers but involves only a small number of patients. It only tests whether the drug is safe to use in humans.
The second phase involves a much larger group of patients and tests whether the drug works in humans. The final phase tests a new drug against standard treatment to see whether it works better than a drug already on the market.
The entire process can take a decade and as much as $1 billion, with drug companies paying for the closely monitored research. Some detractors of the process say that it rewards mainly drugs that will result in blockbuster sales for pharmaceutical companies. People like Tessaro and the 30,000 others with ALS, as well as children with rare cancers and adults with other rare diseases, therefore are not on the drug development radar, they argue.
Caplan said he believes the drug approval process needs revision, but that the “right to try” bills lack the power to change the process meaningfully.
“They don’t create a duty on the part of the drug company, which makes them a ‘right to beg’ bill,” said Caplan. “And it doesn’t give any money for travel, babysitters, an ambulance. Legislators love these bills because they don’t have to spend any money.”
Tessaro, however, said he hopes the committee members don’t buy the “false hope” concern.
“People with this disease don’t suffer from false hope,” he said. “They suffer from no hope. This bill gives them something they can try for, and I don’t see anything false about that.”
House committee members are slated to vote on the bill Monday.
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