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FDA Moves to Ban Key to Alzheimer’s?

FDA Moves to Ban Key to Alzheimer’s?

Evidence is accumulating that glutathione plays an important role in age-related diseases like Alzheimer’s and Parkinson’s. So why is the FDA pursuing a ban on it? Action Alert!

Recently we told you about the FDA’s threat to compounded glutathione, the body’s most important antioxidant that is useful for a variety of health conditions. In fact, ahead of the meeting of its advisory committee, the FDA has already asked the committee to recommend against it—see our related article this week for more discussion about that. One of the most promising applications of glutathione is in age-related cognitive decline leading to diseases like Alzheimer’s and Parkinson’s. Prevalence of these conditions is forecasted to explode in the coming years, and drug candidates to treat them keep failing. If the FDA moves forward with a ban on compounded glutathione, they will be eliminating one of our best hopes at curbing the tide of these neurodegenerative diseases.

Alzheimer’s and neurodegenerative diseases are huge issues. Dementia is expected to triple by 2050 (dementia is a general term for decline in cognitive skills; Alzheimer’s is a specific disease that accounts for 60-80 percent of dementia). Two thirds of Americans with Alzheimer’s are women; older Black Americans are twice as likely and older Hispanics are 1.5 times as likely to have Alzheimer’s than older whites. The cost of treating neurodegenerative diseases exceeds $655 billion a year. Big Pharma has, so far, utterly failed to produce treatments to stem the tide of these diseases (more on this below). If a simple, affordable treatment like glutathione shows promise, it could be a game changer.

The fact is, recent investigations show incredible promise for glutathione and neurodegenerative disease. Oxidative stress is widely believed to be an important component in the pathology of Alzheimer’s, Parkinson’s, and cognitive impairment generally. Oxidative stress is a term used to describe the level of oxidative damage in cells caused by reactive oxygen species (ROS). ROS levels are kept low by antioxidants like glutathione and vitamins E and C. The brain is particularly susceptible to oxidative stress due to the high metabolism required to maintain the activity of the synapses.

Studies have found that Alzheimer’s patients have decreased levels of glutathione. Other research has shown that depleted levels of glutathione in patients with Alzheimer’s and mild cognitive impairment is linked with decreased executive function. In vitro and animal studies suggest that glutathione depletion results in loss of neurons, which is characteristic in neurogenerative diseases like Alzheimer’s and Parkinson’s. Preventing this neuronal damage is therefore a “potential therapeutic target to prevent or reduce neurodegeneration.”

This should all be welcomed as good news, particularly since glutathione is generally safe and well-tolerated by patients. There have been a number of failures in Alzheimer’s drug development, in addition to recent controversy surrounding the FDA’s approval of a drug, Aduhelm, that does not appear to be particularly effective. But the sad fact is that these failures, and the approval of a bad drug, signal why the FDA is contemplating a ban on glutathione. The market for a drug to treat Alzheimer’s is enormous, and the agency wants to remove any potential competition from affordable, natural substances like glutathione that could cut into those profits. It also appears that the FDA is protecting glutathione for the drug industry: there are several clinical trials looking at glutathione for Alzheimer’s, Parkinson’s, and mild cognitive impairment. Drug approval for glutathione would mean a monopoly for Big Pharma on most forms. We believe the agency pulled a similar stunt when it attacked brain health supplements (vinpocetine and picamilon) to clear the way for a blockbuster drug that turned out to be a flop.

All of this is why we need to protect compounded glutathione at all costs from an FDA ban. To recap how we got here: the FDA has, for the last few years, been going through a process to determine what medicines can and can’t be made at specialized pharmacies that make custom medicines for patients. An FDA advisory committee (the Pharmacy Compounding Advisory Committee, or PCAC) has met several times to discuss various medicines and make recommendations to the FDA. This committee has routinely voted to ban natural medicines from being used at these specialized pharmacies. On June 8th, PCAC is meeting to discuss whether glutathione can continue to be used for individualized medicines.

Keep in mind that there are no commercially available glutathione drugs; a ban would mean the loss of compounded glutathione in almost all forms, including IVs, sublingual, intranasal, and more. This is crucially important because oral glutathione, which can be purchased in supplement form, is not absorbed well, with some studies suggesting that blood levels of glutathione cannot be increased by taking it orally.

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 CongressPlease send your message immediately.

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