The FDA’s advisory committee dealt a blow to the agency’s plan to ban compounded glutathione—but the fight is far from over. Action Alert!
Earlier this week, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) met to discuss whether it would recommend compounded glutathione be banned or not. As we reported that day, the great news is that PCAC voted 8-5 (with one abstention) NOT to ban glutathione. This is a significant victory for natural health and a testament to the power of ANH member and other stakeholder advocacy on this issue. It is important to note, however, that the fight is not over. As we mentioned previously, the FDA is not obligated to follow PCAC’s recommendation, and the agency can still move forward with a ban; but doing so will be more difficult without cover from PCAC.
ANH has been involved in the defense of compounded glutathione for years. ANH helped orchestrate the nomination of glutathione to be included in the list of medicines that can continue to be made at compounding pharmacies. Then, this year, when we learned PCAC and the FDA would be meeting to evaluate glutathione, we were only given a month’s notice. In that time, ANH members generated 42,558 messages to Congress, PCAC, and the FDA and more than 6,000 messages to PCAC’s official docket. ANH also submitted a petition from medical practitioners urging continued access.
At the meeting (the full webcast is available here), the case for glutathione was made by A.J. Day, PharmD, Vice President of Clinical Services at the Professional Compounding Centers of America. Doctor Day did an outstanding job both in presenting evidence for the safety and efficacy of glutathione and in poking holes in the agency’s case for a ban.
We reported previously that, in supporting a ban, the agency argued that glutathione caused hepatotoxicity. Doctor Day pointed out that the only evidence cited by the FDA for hepatotoxicity was in a letter to the editor case study which did not show glutathione caused the liver damage; the patients was in fact on three other drugs for Parkinson’s disease.
Doctor Day reviewed the evidence showing safety and efficacy for glutathione in the treatment of cystic fibrosis. Seven clinical trials were discussed, trials which were also reviewed by the FDA. None reported any serious adverse events; the trials suggest positive subjective, patient-reported outcomes (such as less coughing); the majority also showed positive objective outcomes; and all of the trials showed glutathione was more effective than placebo. The only trial that did not show benefit was plagued by other issues: for example, 29 percent of the glutathione group dropped out of the trial, along with 40% of placebo group.
For the FDA to review the very same trials and conclude that glutathione should be banned shows that the agency’s reviewers had tunnel vision, clinging to any minutia they could to support the position they already had. This is anything but a fair and objective review of the evidence.
The FDA also stated that the existence of FDA-approved drugs to treat cystic fibrosis “weighs against” continued access to glutathione therapies. Just what are these drugs? Trikafta is available at $311,503 per year per patient, Kalydeco is available at $300,000 per patient per year, and Orkambi is available at $259,000 per patient per year. These exorbitantly expensive drugs provide 3-14 percent improvement in lung function and come with a laundry list of dangerous side effects.
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.
