Why ZenByCat now supports the use of unregulated versions of GC376 & GS441524 to fight FIP

June 25, 2019

Given the widespread availability of what appears to be effective (though not regulated) versions of GC376 and GS441524 drugs to treat FIP,  ZenByCat no longer believes their use can or should be stopped.   That said, it is important that people realize the risks involved and make informed decisions based on their personal situation.   It also is important not to demonize people or groups, who for various reasons, cannot openly support the use of these drugs.

To summarize briefly, both GC376 and GS441524 were derivatives of human HIV drugs that Dr Neils Pedersen, Dr Yunjeong Kim, and several other researchers, following exhaustive research, tested on real world cats starting in early 2016.  

-The first trial was with GC376.  The purpose was to figure out the dosages and see how cats would tolerate the drug.   While only 5 out of 20 cats made it to long term survival (2.5 years and counting), this low success rate was most likely due to cats getting too low of dosage for too short a period.  

-The second study,  which used GS441524 and started with a 12 week protocol,  had a much greater success rate, with 18 out of 24 cats surviving long term.  

-The 3rd study was a very small group of neurological FIP cases and it determined that raising the dosage seemed to work on these cases as well.

These two drugs are now in the years long process of determining if they can be manufactured on a mass scale, at a price people can afford, without long term or dangerous side effects, and be administered more easily (the current protocols require too many painful injections).   It is still not certain if, or even when, both drugs will make it through this process to ultimately receive FDA approval.   Researchers are working on similar drugs that they hope will be even more effective, cheaper, and easier to administer.   Other research includes searching for a vaccine, finding a simple definitive test for FIP, and possibly even controlling the underlying Corona virus (although that is a long shot).  

Dr Pedersen and the other researchers had published the chemical formulas for these two drugs as part of their studies.   Many companies copied those formulas and started selling these drugs directly to the public earlier this year, protecting themselves by adding a disclaimer saying the drugs were not sold for treating household cats and were for research purposes only..   The first versions were chemically correct but manufactured incorrectly and were ineffective against FIP.   While researchers could not openly help these companies fix these issues, the information was nevertheless released and it seems most of the drugs being sold now are indeed effective.  

When these unregulated drugs first appeared, researchers and online support groups were both morally and legally bound to not promote these companies or their drugs.   Regardless of the motives of these companies, they were stealing intellectual property that other drug companies had spent millions of dollars to develop in the first place.   FIP support groups, that had spent years raising money and working to convince drug companies to spend their money on researching FIP,  could not be seen supporting pirate companies.   This would undermine efforts to get more drugs into the pipeline.   However, with more and more people buying these drugs, and their seeming effectiveness, it became impossible to stop.  Indeed, it became morally untenable to try and stop.  Cats were being saved.  

Leaving all legal and ethical questions about stealing research, etc aside, I want to simply state the risks people are accepting by using these drugs.   To be clear, I am not arguing against their use. but rather hoping to make this process as safe as possible while ensuring people understand all the ramifications of the choices they are making.

Risks using unregulated drugs:

1.  Without FDA or any other governmental approval, there is no governing body regulating or checking the quality or effectiveness of these drugs.   The consumer is completely trusting the company they purchase from.

2.  Because the price for these drugs is so high, many manufacturers are entering this market.   To my knowledge, these are almost all Chinese companies.    In the Chinese market, it is common for companies to push the prices down to compete, increasing pressure to cut corners to be able to make a profit.   Without regulation, companies that are now selling viable drug could begin to sell less effective drugs as the price drops.  This danger only increases as the price is pushed down and applies to any company not bound by a governmental regulator.   This market reality applies to all companies from all countries but currently it just happens that most of the companies selling these drugs are Chinese.

3.  I have seen many people sharing extra vials of drugs with others.    While I understand the strong desire to help desperate forever humans trying to save their FIP cats, this is risky because the drug was purchased for research purposes, comes from an unregulated source, and is being shared to treat someone else's cat.    I am not a lawyer but do believe there is considerable legal risk if someones cat does not make it and they feel they were provided bad drug.   People may trust others not to take legal action against them for trying to help, but they should at least be aware of what they are risking.   To the extent possible, it would be better that people buy their own drugs directly.

4.  I have seen people now buying and using these drugs in oral form.  To be clear, no research has been published to show these drugs work correctly when given orally.   I have seen comments online stating some of the Chinese companies selling the oral form have done studies in China but the extent and results are not public yet.  Finding such oral delivery systems for these drugs is part of the ongoing studies in the US and would definitely be a major advance.   For those who cannot afford the injectable drugs (I have heard the oral medications are about 30% cheaper), or who are having great difficulty giving the injections, this oral form may be their only path.   They should just understand there is less data supporting this delivery methods effectiveness at this time.   They would be participating in a real world drug trial to see how effective oral meds are (a worthy endeavor for sure).

5.  There is a real risk that people will think FIP has been cured (it has not) and stop giving to charities funding research.   These two drugs are a huge breakthrough in the fight against FIP,  but much better, cheaper, and less painful treatments are needed if we are to reach all FIP cats.    

On this last risk, I wish to invite all forever humans to consider supporting ZenByCat (or other groups) and our efforts to continue funding research to end FIP for all cats.  These first drugs would not be available today if people had not donated in the past.  It is hard asking for money but we speak for all FIP cats who cannot ask for themselves.   ZenByCat's main focus is getting the many thousands of people who have been touched by FIP to sign up for $10 a month automatic donations.   Please reach out to me and I am happy to talk about our programs and how we guarantee researchers will get 90% of all money we raise.  

I understand why people are buying and using these drugs and I admit, if I had an FIP cat now I would also buy them.    That said, there are real risks and no guaranteed path to a happy outcome.   The choices facing a forever human with an FIP cat are difficult and personal and financial.  My hope is people will remember that everyone fighting FIP wants the same thing, to save cats from this horrible disease.  

Thank you for reading what are probably way too many words.

Sincerely,

peter

Smokey

All FIP Warriors, both human and feline  






peter@ZenByCat.org

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