Pharmaceutical board postpones decision on drug that helps firefighters

The most compelling testimonies came from patients who felt the changes to the regulations would increase their suffering, and from firefighters who said their careers and lives could be shortened.

Segui, of the Petaluma Fire Department, was part of a strong Sonoma County contingent at the meeting. The group included Gabe Stirnus, a paramedic and fire captain with the Sonoma Valley Fire District. Stirnus told the board how his 26 years as a firefighter exposed him to toxic substances that left him with a chronic cough.

The cough, he said, was successfully treated with nebulized (inhaled) glutathione — a treatment that is no longer available because “this board has intimidated pharmacists in California to the point where they are afraid to prepare this medicine for us.”

Stirnus told the board that after spending long weeks this summer “in a forest fire environment” and with no alternative treatment for his lungs, “without surprise, the cough came back.”

Another Sonoma County firefighter who gave his name as Justin spent three weeks battling wildfires in California this summer.

“I coughed up all kinds of black garbage,” he told the board. “My lungs were constricted. I was wheezing.”

Glutathione nebulization treatment “relieved a lot of the symptoms I was experiencing.”

The six-year veteran firefighter speculated, “You know, I might not make it another 20, 30 years. I might not make it to retirement,” before strongly urging the board to “reconsider” its stance on Category 1 substances.

Compounding is the pharmaceutical process of combining ingredients to create a medicine tailored to the needs of an individual patient — a medicine not available at a regular CVS or Walgreens store.

In June, the board proposed a complete ban on mixing Category 1 substances. The plan provoked such a strong reaction that the board backed down. A little. Before the last two meetings, the board presented revised regulations that would allow such mixing.

Even the revised regulations “will dramatically increase costs, potentially to the point that some formulations will be unmanageable or unavailable,” said Tenille Davis, chief advocacy officer for the Alliance for Pharmacy Compounding.

Access is already a problem

Serpa and board chairman Seung Oh, a San Diego pharmacist, said during the meeting that ensuring patients have access to prescription drugs is a top priority.

However, as Crystal Frost noted in a public statement, that access has already been severely curtailed — as a result of aggressive disciplinary action by a law enforcement agency.

Frost, a Southern California composer and writer, relies on weekly glutathione infusions to manage Lyme disease. She is the founder of StoptheBOP.com and also started a Change.org petition to preserve access to sterile compounds that now has nearly 5,000 signatures.

“Listeners should know that nebulized glutathione is no longer available” throughout California, she added.

That’s the case at Wild Oak Medicine in Santa Rosa, a naturopathic practice run by Dr. Jen Riegle and her husband, Dr. Chris Holder.

Beginning in 2023, Riegle led a pair of pilot studies focused on glutathione, measuring the effectiveness of glutathione treatment in reducing toxin levels in two small groups of area firefighters.

She described the results of the study, conducted in partnership with Integrative Healers Action Network and another Santa Rosa nonprofit, the Volunteer Fire Foundation, as “extremely encouraging.”

In addition to giving glutathione to firefighters, Riegle has prescribed nebulized glutathione to patients with certain lung conditions — asthma, chronic cough caused by long COVID-19 and coughs “caused by conditions where they were exposed to some type of chemical — miners, even construction workers.”

However, nebulized glutathione has not been available in her office since July 2023, when she received her last shipment from Koshland Pharmacy in San Francisco, which was sued by the Board of Pharmacy.

At the end of the nine-day trial, Administrative Judge Michael Starkey found that Koshland had committed some minor violations that he described as “primarily technical in nature.”

As for the board’s most serious accusation, Starkey ruled that it failed to prove that “any specific aspect of the ingredients used was unacceptably unsafe” or that “Koshland’s methylcobalamin and glutathione preparations were adulterated.”

In a further brief to the board, Koshland’s attorney, Derek Davis, also a registered pharmacist, invited board members to review expert testimony provided on his client’s behalf at the hearing “to better understand how board staff repeatedly mischaracterized Category 1 substances as ‘hazardous’ when, in fact, FDA guidance and USP analyses demonstrate safety on multiple levels.”