from our friends at nbclosangeles.com:
After the recent fires exposed first responders to wide-ranging toxins, some are turning to a compounded breathing treatment. But they’ve learned it’s extremely difficult to obtain in California.
The California Board of Pharmacy has taken steps to make the compounded form of glutathione, a breathing treatment for firefighters, hard to access.
The drug glutathione is an antioxidant produced naturally in the body to detoxify cells. The compounded form of the drug, which as such is not FDA-approved, is in a category currently under review by the Food and Drug Administration.
While the FDA has not blocked its use, the California Board of Pharmacy has made it very difficult for sterile compounding pharmacies to make it. And for firefighters, the restrictions are frustrating.
Pasadena Fire Cpt. David Marquez battled the Eaton Fire for days.
“This wasn’t just a single building or a few buildings on fire. This was a massive amount of structures, and all the things that you don’t know that are in there burning with the power of the wind behind it,” said Marquez.
“They’re equating this to another 9/11,” said Pasadena Fire Cpt. Robert Ruiz, who felt the effects of the toxins from the Eaton Fire immediately.
“Our noses were running, just the black stuff coming out. Our eyes were burning — red, sore. Dry cough,” Ruiz said. “Just non-stop breathing of all those toxic gases.”
By Jan. 16, a group of healthcare practitioners organized by two non-profits in Northern California arrived to help, offering breathing treatments to first responders at the Eaton Fire basecamp.
Santa Monica naturopathic doctor Meredith Bull volunteered her time to treat them, using nebulized glutathione.
“It’s quite frustrating as a clinician to not be able to prescribe the substance for them to use at home and on a daily basis, which is what they need.”
Meredith Bull, naturopathic doctor
“Glutathione is made by the cells to help protect the cells themselves,” Bull said. “It helps clean up noxious chemicals that get into the cells or anything that might damage cellular structure.”
She has also donated her time and stock of glutathione to help firefighters at Station 69 in the Palisades.
Glutathione is currently under review by the FDA with other compounded substances, like vitamin B12.
“The FDA says until it has finalized what it’s going to do on those two substances, compounding pharmacies across the country can continue to compound with these substances,” said Scott Brunner, who represents pharmacists nationwide as the CEO of the Alliance for Pharmacy Compounding.
Brunner said California’s Board of Pharmacy is the only one in the country that has heavily restricted access to glutathione by requiring cost-prohibitive testing by small compounding pharmacies. For several years, it’s only been available in a clinical setting.
“It’s quite frustrating as a clinician to not be able to prescribe the substance for them to use at home and on a daily basis, which is what they need,” said Bull, adding the recommended protocol is twice a day for 30 to 60 days.
At the Board of Pharmacy’s first meeting on rewriting its compounding regulations, it received more than 300 written comments in opposition, including from hospitals like Cedars Sinai, Kaiser, and USC.
“They are going beyond what is the industry standard. We have asserted at every point in this process … that’s a great idea if you can demonstrate to us how that makes patients safer, and the board has yet to be able to enunciate a reason for wanting to exceed those national standards,” said Brunner.
The board has maintained that California has often been at the forefront of public safety, but on Feb. 28, the board made deep revisions to its proposed new language in the regulations, stating:
“After further consideration of the issue, Board staff believe that an approach that relies on a pharmacist’s knowledge of compounding, including an understanding of federal law, guidance documents, and the national standards is appropriate.”
“Our concern is, yeah, California Board of Pharmacy, you heard us, but you’re returning us to this era in which the board is supreme, and it can call unprofessional judgment whatever it wants to call it,” said Brunner.
They want assurances that compounding pharmacists following the rules will not be targeted by the board.
Meanwhile, firefighters are hopeful these changes will mean better access to glutathione as soon as possible.
“I have one firefighter I know that got it, and he’s getting it shipped from out of state because he needs it so badly, and to go to those kinds of lengths shouldn’t be the norm,” said LAFD Fire Cpt. Eric Nakamura.
“It isn’t just that it restricts or severely limits firefighter access to one particular treatment like glutathione, but as we’ve learned, it’s frustrating what it does to other vulnerable patient populations who desperately rely on compounding pharmacies,” said Marquez.
For now, firefighters can only get it when their schedule allows, at a doctor’s office, a clinic, or when a clinician comes to them.
The Board of Pharmacy is meeting on March 5 to vote on the revised compounding regulations.
You can read more about the studies and research conducted by the Volunteer Fire Foundation and the Integrative Healers Action Network as well as the board’s presentation on compounding.