In 10 years of working as a reporter, I had never experienced what I did when I met Mike DeBartoli and his wife, Gina. Within 20 minutes of leaving their home and talking about California’s controversial “Right to Try” law, I broke down and cried inconsolably. I find myself thinking about them every day and rooting for his success in finding a treatment that will extend his life.
Mike served 28 years as a firefighter and fire captain in Sacramento, Modesto and other cities. It was two years before his retirement when he was told he had Amyotrophic Lateral Sclerosis, or ALS.
"Most firemen retire and they travel and they fish or hunt, or play golf, but I can’t do any of that," he told me.
Four years ago, on his 51st birthday, he noticed a twitch in his arm. Later, a doctor diagnosed him with ALS, commonly known as Lou Gehrig’s disease.
At first, Mike and Gina wouldn’t accept the diagnosis. But by the third or fourth doctor, they were out of options, he said. In the years since, he lost muscle mass and his most of ability to walk.
“When you fall, it’s not just a fall to the ground,” Mike said. “I don’t—I can’t do a pushup or anything, so when I fall, I fall head first and my head hits the ground first … So every time I stand, the first thing I say is, ‘Don’t fall, don’t fall, don’t fall.’
Most people know of ALS after the Ice Bucket Challenge swept the nation, but in talking to Mike, I found out that, like myself, people don’t know much about the disease.
According to the ALS Association, with about 5,600 diagnoses a year, roughly 30,000 people in America may be suffering from the neurodegenerative disease.
People with the condition, on average, live 3 to 5 years after the first symptoms. For Mike, that was four years ago last month.
“[As firefighters], we saw people die all the time, it’s just part of the job,” Mike said. “I’m not trying to say I’m a hero or anything, but people pass away all the time, and really, it doesn’t affect you until it’s so it’s yourself.
“Then you have like an out-of-body experience. It’s hard to explain. You realize there’s just an end and stuff, so it’s—I don’t know, I can’t even explain it."
The “Right to Try” Law
In September 2015, Assembly Majority Leader Ian Calderon introduced AB159, better known as the “Right to Try” act. The bill, which was passed in 2016, allows patients to request medications that have passed the first of three phases of FDA approval, so long as two physicians agree on a terminal illness diagnosis.
I spoke with Calderon, and he said he sees “Right to Try” as a counterpart to “Right to Die” or Dignity laws.
"I felt that Californians deserved that option to try and do whatever they could try to fight to save their own lives,” Calderon said, “because in the end, that’s our most basic human instinct.”
For years, Mike and Gina searched hard to find a trial that would take him. But because of the strict requirements, Gina said it was difficult for them to get accepted in one.
“I always say he had to be perfectly sick,” Gina said. “Like, he was talking about the criteria—you couldn’t be too sick, you couldn’t be barely sick. You had to fit in that criteria, because they’re looking for the same type of people."
Mike was accepted into one drug trial that, he said, didn’t lead to any improvement in his symptoms. The study was a double blind study, which meant people in the trial were given a proper dose of the experimental drug, a half dose or a placebo.
"The drug didn’t help me at all. I might’ve got the placebo, I don’t know,” Mike said. Even if the drug had been helpful, and his symptoms had improved, he wouldn’t have any more access to that drug.
In 2015, Mike testified in favor of the bill and it passed almost unanimously. However, Governor Jerry Brown vetoed it at the last minute to give the FDA more time to streamline its compassionate use program, which already grants patients access to experimental drugs.
But Calderon says the application process is too lengthy and bureaucratic.
"The problem is the FDA just in general,” Calderon explained. “I mean, the states wouldn’t be having to do any of this if the FDA would just modernize how they approve drugs."
The FDA says it approves almost all compassionate use requests quickly. However, an investigation by The Goldwater Institute, a conservative think tank that has been pushing Right to Try laws in states across the country, criticizes the FDA as a system that is built to fail.
Dr. Adams Dudley, the director at UCSF’s Center for Healthcare Value, disagrees, however. When discussing the issue with him, Dudley told me that by removing the FDA’s oversight, the law could open the door to some dangerous outcomes.
"So now you’ve got these desperate people, who knows what price they’ll pay,” Dudley explained. “Even under the current system, their odds are extremely low that they’ll get some benefit. But now we open up the door to people saying, ‘Well, gosh, I wasn’t going to bother pushing that drug through, because I’m pretty confident it’s not going to make it through the [FDA’s approval].’”
Calderon said he doesn't see that happening, because those companies would face a big backlash.
“There’s no data saying that that’s what they’re going to be doing—that these people are going to be used as guinea pigs,” he said. “I don’t believe that. I tend to think as an American, we’re better than that. I don’t think we would be doing that."
Taking the risk
From what I've researched and covered, pharmaceuticals are not exactly known as a bastion of integrity. Companies as big and well-known as Pfizer have paid billions of dollars in settlements and penalties for illegal marketing practices.
As for doctors, multiple investigations have found many of them get kickbacks from pharmaceuticals to prescribe their drugs.
Despite the fact that drugs will need to pass Phase I of approval by the FDA before patients get access to them, Dudley said it is going to protect those companies from scrutiny.
“If you get through Phase I, that means that the young healthy people who got [the drug] didn’t develop severe toxicity and die,” Dudley explained. “More than 80 percent of the drugs that make it through Phase I, we end up still deciding the toxicities are worse than the benefits."
Mike says he's willing to take that risk as they look for trials.
“Diseases aren’t incurable, they’re only a matter of time and money,” he said. “We can’t really take care of the money, but with right to try, we can take care of the time."