Mutian GS for FIP, legal or not?
For several weeks, the FIP community has been waiting for an announcement from Mutian that the company had made good on its promise to have FDA approval for its line of GS pills (called Mutian X), as an OTC drug under the FDA’s GRASE program. Mutian US CEO, Zihu Lu, told the attendants at the Winn FIP Symposium in November 2019 that he expected to receive approval by the end of 2019.
For those of us who have refused to be involved in any way, shape, or form, with black market activities – the illegal sales, distribution, and use of GS-441524 – the announcement brought a sense of hope and doubt. Hope, because we all want legal access to a legally produced antiviral for FIP. Doubt, because for those who have a thorough knowledge of the FDA drug process approval, GRASE and OTC rules, such a promise was not going to be fulfilled, not without trying to circumvent laws and regulations. Because let’s face it, if it were that simple, then it would have been done long ago, not just for GS-441524, but also for GC-376.
REMINDER: GS-441524’s patent is owned jointly by Gilead Sciences, Inc. and the Regents of the University of California. GC-376 is licensed to Anivive Lifesciences, Inc. by the Kansas State University (KSU) Institute for Commercialization. Mutian is one of the many suppliers of black market GS-441524 in injectable form.
An interesting debate.
At the Winn Symposium at UC Davis in November 2019, Mutian’s US CEO insisted that Mutian pills were like GS, but different, going as far as saying that they (Mutian) took GS and made it better. However, he remained vague about what was in his version of GS. Dr. Pedersen, miffed at the suggestion that anyone could have come up with a better version of “his” GS, kept asking if Mutian’s active ingredient, the one that inhibits the FIP virus, was an adenine C-nucleoside analog identical to GS-441524, and if it was triphosphorylated. The answer was that the research [by Mutian] was based on GS, but that the Mutian’s compound was a “special design for the cat. So, it’s not actually GS. We changed the compound, and we applied (sic) our own patent.“
Keeping a lid on specifics.
It is worth noting the shroud of secrecy surrounding the active ingredient – the antiviral – in the Mutian pills. Mutian’s Facebook support groups give a lot of information on prices, quantities, and protocols, but very little in terms of what people are truly buying. There is also mention of research conducted worldwide, but nothing is shared, at least not publicly. So buyers have to take it on faith that they are purchasing a GS, or GS-similar, antiviral compound with an active ingredient identical, or very close, to the molecular structure of GS-441524.
Where's the catch?
Dr. David Bruyette of Anivive LifeScience Inc, who had explained the FDA approval process for all attendees the previous day, asked Mutian’s CEO how the company intended to sell an experimental drug for the treatment of FIP with the FDA’s blessing without going through its lengthy approval process. Evidently, following the rules and getting quick approval are mutually exclusive. So there had to be a catch.
The catch is explained by Deb Roberts, a cat mom and blogger who participated in the November 2019 FIP Symposium at UC Davis:
“As an unexpected bonus, I met representatives from Mutian, a China-based company that duplicated the trial drug compound and have been selling it worldwide to FIP cat owners over the past year. There is an oral and an injectable form with dosing based on the weight of the cat, type of FIP, and the cat’s response to the drug. As of December 2019, they are selling it legally in the US as: “A dietary supplement exclusively designed for cats with Feline Infectious Peritonitis (FIP), by boosting their immune system and overall well-being.” In other words, it’s NOT sold as a “drug,” but as a “grass” (sic) or “over-the-counter supplement,” which is how they were able to circumnavigate (sic) the FDA approval process.”
So, there you have it – according to this source, Mutian is selling an unregulated drug disguised as a supplement. If that is true, then Mutian is circumventing the system. That is a dangerous game to play with agencies like the FDA – or the FTC, or the DEA, for that matter. And that is not only illegal; it is also fraudulent.