Masters of Health Magazine July 2022 | Page 61

The FDA complains that it is difficult to assess the effects of glutathione for cystic fibrosis without very large population samples and long-term studies of at least six months. Yet the trials on which the approval of Trikafta was based were a 24-week trial of 403 patients and a four-week trial of 107 patients—and this was for drug approval of a novel pharmaceutical compound! Glutathione is well characterized, made by the human body, and has been used in clinical practices for over 30 years. The FDA apparently thinks that compounded drug products should be held to a higher standard than FDA-approved drugs!

Doctor Day performed a similar analysis showing the benefits and safety of glutathione in chemotherapy patients.

All of this shows what an absolute sham this entire process is. The analysis of the cystic fibrosis drugs is instructive. To us, it seems obvious that this is the entire reason the FDA is recommending bans not just for glutathione but for many other natural medicines: they compete with very expensive pharmaceutical drugs that are dangerous and not very effective. If glutathione remains available, fewer people will shell out the money for these expensive treatments, and Big Pharma’s profits suffer. Remember: the FDA receives 45% of its operating budget directly from drug companies in the form of “user fees” (used for the approval of new drugs, biologics and devices), but 65% of the funding for human drug regulatory activities are derived from user fees. The FDA is clearly looking out for the interests of its pharmaceutical benefactors.

When voting was completed, each voting member stated their vote for the record and had the option of explaining their vote. We think it is worth reviewing the response of one of the voting members, Dr. William Calhoun:

It’s safe, there’s really no risk to public health. It’s an endogenous substance. Personally, I found the agency’s review of the efficacy superficial and narrow, and I found their conclusions dismissive of the positive data that existed because the outcome wasn’t something they were interested in looking at or sometimes because of relatively small sample size[s]. But I think the weight of evidence suggests there are at least some uses for glutathione. So, in order to maintain availability, I voted yes.

We applaud the seven other PCAC members who also voted to maintain consumer access to compounded glutathione. But we must remain vigilant. We don’t know when, but the FDA will issue a proposed rule at some point either banning glutathione or allowing patient access. We must keep up the pressure and make the agency do the right thing.

Action Alert! 

Write to the FDA and Congress, urging continued access to compounded glutathione. Please send your message immediately.