The FDA is once again threatening personalized medicines, this time glutathione, a crucial antioxidant. Action Alert!
Your ability to use personalized glutathione, an antioxidant that is essential to life, is in jeopardy. An FDA committee that has already voted to ban many natural medicines is meeting soon (June 8th) to decide whether compounding pharmacies can continue to make glutathione in any form, including IVs, inhaled forms, suppositories, and nasal sprays. Glutathione helps patients with a wide variety of ailments, including liver disease, cancer, stroke, and autism. We must let the FDA and the committee know that patients need this treatment.
A glutathione ban would be a disaster. It has many medical applications and there is no commercially available glutathione drug, so a ban would mean no more glutathione in these forms. Glutathione is used widely by integrative experts for a variety of conditions because of its role in reducing oxidative stress—an imbalance between free radicals and antioxidants in the body.
Glutathione’s usefulness is backed by dozens of studies for a multitude of conditions:
- Cancer treatment. Glutathione helps reduce the side effects of chemotherapy.
- Parkinson’s Disease. Glutathione treatment has been shown to improve symptoms in Parkinson’s patients. This is likely because these patients are commonly deficient in glutathione.
- Pulmonary disease. One review concluded that glutathione inhalation therapy is an effective treatment for a variety of pulmonary diseases and respiratory conditions. Other studies further support glutathione for these purposes.
- Immune enhancement. Not only is glutathione key in reducing oxidative stress, it is also essential to proper immune function as a signaling molecule. This is one of the reasons glutathione can help patients with diseases like tuberculosis.
- Autism Spectrum Disorder. Autistic patients are known to suffer from oxidative stress, inflammation, and immune system dysfunction. These physiological issues can lead to emotional and behavioral disturbances. Studies have demonstrated glutathione’s ability to help autistic patients.
- COVID-19. Research has shown that COVID patients have increased oxidative stress and glutathione deficiency. Glutathione deficiency has been shown to play a major role in COVID-19 mortality.
Glutathione is also key to detoxification. This is incredibly important. Because many toxic exposures cannot be avoided in today’s world, we must detoxify and remove harmful compounds from our body. Glutathione is critical to Phase 2 detoxification, which is geared towards moving broken-down toxins from Phase 1 detox out of the body (see more on this here).
How did we get here? The FDA’s Pharmacy Compounding Advisory Committee (PCAC) advises the agency in writing new rules regarding what supplements and drugs can be made individually, for patients with specific needs, by compounding pharmacies. PCAC has met a handful of times over the last few years, and as we’ve noted elsewhere, the track record is not good. The committee has voted to ban almost every compounded natural treatment put before it, including curcumin, boswellia, and aloe vera—usually following the FDA’s recommendation. PCAC meetings are the first step in the FDA’s process; after PCAC makes a recommendation, the FDA will issue a proposed rulemaking, on which the public can comment, to either allow or ban ingredients.
ANH-USA and allies nominated glutathione to be included in the list of substances (the “Bulk Drug List”) that can continue to be made at traditional compounding pharmacies. In 2018, the FDA was preparing to consider glutathione. ANH, with the help of the natural health community, submitted twelve pages of scientific citations supporting glutathione’s inclusion on the Bulk Drug List. The agency seemed to back off, issuing an interim policy listing glutathione among other medicines that were under evaluation but could still be compounded while the agency concluded its evaluation. Now that glutathione will be discussed by PCAC, the agency may be posed to move forward with a ban.
Individualized medicines made at specialized pharmacies are used by patients with special needs as alternatives to commercially available drugs and products or when no such drugs or products are available. There are a variety of reasons: some patients may need customized dosages, a different delivery form (due to trouble swallowing pills for example), or a special formulation to avoid allergens. Over the years, the FDA has been systematically whittling down the medicines that can be made at these pharmacies, so much so that it will be a miracle if they can stay in business.
Integrative medicine is predicated on a doctor’s ability to treat the individual needs of a patient with a tailored regimen, which often means going outside of the one-size-fits-all paradigm. Banning one medicine after another from being made at a compounding pharmacy is reducing your doctor’s ability to heal you.
Action Alert! Use the form below to post a message to regulations.gov defending glutathione; you will also send a message to the FDA, PCAC, and Congress. Please send your message immediately.