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Right To Try Gives Terminally Ill Options Without FDA Approval

Mike and Gina DeBartoli / Courtesy

Mike DeBartoli (right) and his wife Gina are pictured here. Mike has been living with Amyotrophic lateral sclerosis (ALS) for the past 3.5 years and wants to partake in California's Right To Try law.

Mike and Gina DeBartoli / Courtesy

A new law allowing terminally ill patients the chance to try treatments not yet approved by the federal government begins Jan. 1.

Mike DeBartoli has been living with Amyotrophic lateral sclerosis (ALS) for 3.5 years.

He's lost 25 percent of his body mass over the years and his limbs no longer function like they used to.

“'Course my hands don’t work and my arms are gone. And I can walk but very awkwardly and I’ve fallen quite a bit,” he says.

The former Sacramento firefighter was diagnosed with the neurological disease, also known as Lou Gehrig's disease, on his 51st birthday.

Earlier this year, DeBartoli participated in a clinical trial, but it didn't help his condition.

Now, he wants to use California’s Right to Try Act.

The law allows Californians with a life-threatening disease access to drugs that have not yet been approved by the U.S. Food and Drug Administration.

DeBartoli says he sees no harm in trying those medications or procedures.

“They’ve invested their money and time trying to find a cure so being a lab rat for them is fine for me," he says. "I might get the cure. Who knows."

DeBartoli and his wife, Gina, say they hope the new law will not only lead to treatment for ALS, but also other diseases, like cancer and Alzheimer's.

“That’s why Mike’s out, online looking for new possibilities. So, now we have hope," Gina DeBartoli says. "So, if there is anything that’s coming out that’s in drug trials, pre-FDA approval, we’ll have the chance to get it."

The average life expectancy for someone with ALS is two to five years, leaving DeBartoli with a small window of opportunity.

"If there’s any medication that does come up that shows promise, I’d like to use it as soon as possible and not wait until it goes through the FDA’s program of getting regulated and approved, which takes years and years,” DeBartoli says. 

Californians wanting to use Right to Try must meet eligibility requirements, including having exhausted all other treatment options approved by the FDA, and be recommended by two physicians for the drug, product or device.

Under Right to Try, manufacturers are not required to provide a drug, product or device. Insurers are also not required to cover the cost. 

The law begins January 1.