The drug glutathione is an antioxidant that is naturally produced in the body to detoxify cells. Such combined forms of drugs not approved by the FDA are currently in the category under review by the Food and Drug Administration.
The FDA has not blocked its use, but the California Pharmacy Board has made it extremely difficult for infertility compounding pharmacies to make it. And for firefighters, restrictions are frustrating.
Pasadena Fire Cpt. David Marquez fought Eton Fire for several days.
“It wasn’t just a single building or a building with fire. It was a massive amount of structures, everything you don’t know about was burning with the power of the wind behind it,” Marquez said.
“They identify this as another 9/11,” Pasadena Fire CPT said. Robert Lewis immediately felt the effects of Eton’s toxins.
“Our nose was running. Only the black ones came out. Our eyes were burning – red, painful, dry cough,” Lewis said. “It just stops breathing all these toxic gases.”
By January 16, a group of healthcare workers, organized by two nonprofits in Northern California, had arrived to provide respiratory treatment to first responders at Eaton Fire Basecamp.
Santa Monica naturopathic doctor Meredith Bull volunteered time to treat them,
As a clinician, it is extremely frustrating to not be able to prescribe substances that you use at home or on a daily basis.
Meredith Bull, Naturopathic Doctor
“Glutathione is made by cells to protect the cells themselves,” Bull said. “It helps to clean up any harmful chemicals that enter any of the cells and what can damage your cell structure.”
She also donated glutathione time and stock to help firefighters at Pallisard station 69.
Glutathione is currently being reviewed by the FDA with other complex substances, such as vitamin B12.
“The FDA says that mixing pharmacies across the country can continue to get worse with these substances until we’ve determined what we’re going to do with these two substances,” said Scott Brunner, CEO of the Pharmacists across the country, and CEO of the Pharmacy Combined Alliance.
Bruner said the California Pharmacy Board is the only country in which access to glutathione is significantly restricted by requiring cost-enactment testing with miniaturized pharmacies. For several years, it was only available in clinical settings.
“As a clinician, it’s extremely frustrating to not be able to prescribe substances that you use at home or on a daily basis, and this is something they need,” Bull said.
At the pharmacy’s first meeting on rewriting compounding regulations, more than 300 written comments were received in opposition, including hospitals such as Cedars Sinai, Kaiser and USC.
“They are above industry standards. They are claiming at every point in this process. If they can show how to make patients safer, that’s a great idea. The board is still unable to declare why they want to exceed those national standards,” Bruner said.
The board argues that California is often at the forefront of public safety, but on February 28, the board made a deep revision to the new language proposed in the regulations, saying:
“After further consideration of this issue, board staff believe that an approach that relies on pharmacists’ knowledge of formulation, including understanding federal law, guidance documents, and national standards, is appropriate.”
“Our concern is, yeah, the California Pharmacy Board, you’re listening to us, but you can call us back to this age where the board is the best and whatever it calls it a professional judgment,” Bruner said.
They want to ensure that formulating pharmacists who follow the rules will not be targeted by the board.
Meanwhile, firefighters hope that these changes will mean better access to glutathione as soon as possible.
“I have one firefighter who knows it got it, and he needs it badly, so he ships it out of state, and it shouldn’t be the norm to go to that length,” Lafd Fire CPT said. Eric Nakamura.
“It doesn’t just limit or severely limit firefighters’ access to certain treatments like glutathione, but it frustrates what it does to other vulnerable patient populations that, as we’ve learned, are desperate to rely on drugstore compound interest,” Marquez said.
For now, firefighters can only get it if the doctor’s office, clinician, or schedule is permitted when the clinician comes.
The Pharmacy Committee held its meeting on March 5th and is voting for the revised compounding rules.
You can read more about the research and research conducted by the Volunteer Fire Foundation and the Integrated Healer Action Network, as well as board presentations on formulation.
Source link