Federal Agencies Again Resist a Likely COVID Preventative and/or Treatment?
Are Government Health Agencies acting in the best interest of the public?
Dr. Peter McCullough has a new, interesting post regarding a study about a safe and effective, simple, inexpensive nasal spray for the treatment or prevention of COVID-19. This study was a relatively large, double-blind, Randomized Control Trial (RCT).
I haven’t seen or heard a word about this in the mainstream media, even though it was published back in October of 2022. Maybe it’s me.
So, I did a brief investigation, and found out a few surprising things…
The actual spray used in the above study is a product called pHOXBIO. This doesn’t seem to be approved yet by the FDA (surprise), or available in the US. However, the multiple ingredients of pHOXBIO are listed in the study (section 2.1).
An existing US product that you can buy, Xlear, seems to be comparable, and may also provide similar benefits. It contains Xylitol, which is likely the active agent (see below).
Why haven’t you heard more about this US product? Here is a rough chronological history of the interesting story of Xlear and COVID-19…
01-01-20: Very early on it was understood by the medical community that COVID-19 was an upper respiratory affliction.
05-01-20: An in vitro (e.g., lab petri dish) study concluded that Xlear was effective as a COVID preventative and treatment. (Note: For ailments like COVID-19, treating upper respiratory passages with an anti-viral nasal spray makes logical sense.)
06-01-20: Xlear approached the FDA about doing clinical trials on their nasal spray for COVID-19. Initially, the FDA was responsive, but that was short-lived.
07-23-20: A medical commentary (JAMA) enumerated some likely benefits of an appropriate nasal spray for the treatment of COVID-19.
07-29-20: The FTC sent the Xlear company a Warning Letter. It cites several examples of what they say are unsupported assertions about Xlear and COVID-19. For example, the FTC faulted Xlear for making claims without adequate human studies, etc.
It’s puzzling that this complaint came from the FTC, rather than the FDA.
The claims the FTC objects to appear not to have been made by the Xlear company, but by others. Xlear cited scientific research.
For my scientifically mixed audience, I’m saying that the Xlear nasal spray prevented or treated COVID-19. The Xlear company is using the more technically accurate term: that an appropriate nasal spray can block the COVID-19 virus.
I was told that most of Xlear’s nasal spray competitors (e.g., Nielmed, Navage, Blue Willow Biologics, Halodyne) also received FTC or FDA warning letters.
Apparently, Xlear is the only company that is fighting back.
12-02-20: There was another in vitro study that concluded that Xlear was effective as a COVID preventative. It seemed to say that Xylitol was the main active agent.
12-30-20: Evidently the Xlear company continued to go along with the publicity of others about the possible benefits of using Xlear regarding COVID, like this.
10-28-21: The FTC (again, not the FDA!) filed this lawsuit against Xlear for purportedly making claims about it being a COVID preventative or treatment.
Based on how government medical agencies have treated HCL, IVM, etc, this lawsuit could be construed as a back-handed endorsement of Xlear.
07-16-22: The Xlear company legally pushed back against the FTC.
10-01-22: As stated above (at the beginning), this is a relatively large, double-blind, Random Controlled Trial (RCT) of a similar (Xylitol-based) nasal spray. The conclusion was that the nasal spray is highly effective with COVID-19:
“The test agent significantly reduced SARS-CoV-2 infection in healthcare workers, with 62% fewer infections when compared to placebo. It was found to be safe and well-tolerated, and offers a novel treatment option for prophylaxis {prevention} against SARS-CoV-2 infection.”
Note that the FTC is unlikely to give Xlear credit for the positive results in this RCT study, as it used a similar nasal spray, not specifically Xlear.
10-06-22: This intermediate court ruling was against Xlear, denying them some of the information they had asked the government to produce (e.g., FDA data).
01-30-23: The FTC filed a further demand that Xlear pay civil penalties. Xlear has 30 days to respond, and I was unable to find one.
So the question here is: why are medical agencies of the government doing things like this? They automatically say that it is “for the public’s benefit” — but is it?
Yes, there are certain unanswered questions here, but consider that for Xylitol based products like Xlear: a) they have an excellent safety profile, b) it’s likely that an appropriate nasal spray would benefit an upper respiratory infection, c) in vitro tests have demonstrated efficacy years ago, d) now an RCT comes to the same conclusion, e) the consumer cost is small, f) such a product could not only be a treatment but a preventative. So such an option is safe and effective and inexpensive.
Considering all that, why hasn’t the FDA seen that appropriate RCTs were done in mid-2020? or in 2021? or in 2022? What am I missing here?
The FDA’s mission statement says:
The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices… FDA is responsible for advancing public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products to maintain and improve their health.
The FTC’s mission statement says:
The FTC’s mission is to protect the public from deceptive or unfair business practices and from unfair methods of competition through law enforcement, advocacy, research, and education.
Evidently, I am missing something here, as I don’t see the actions/inactions of either of these government agencies, to be genuinely in the best interest of the public.
PS — I just bought some Xlear and Xlear Max to have on hand. Now that I have a reasonable idea of the claims and evidence, it seems to me that the downsides are tiny.
PPS — Here is a reasonable Petition to the CDC started a while back on this topic. It lists several applicable studies that are interesting. Please sign it and pass it on.
