Five questions to Gilead Sciences.
It is a safe assumption that every single parent of a FIP cat wants the same thing: safe and effective drugs against Feline Infectious Peritonitis. In light of the recent developments in the FIP community regarding treatment with unregulated substances, I think it is only fair to find answers from those who are directly involved. Who better to ask than Gilead Sciences, Inc?
First of all, a quick summary of the current situation:
At the core of the issue is the published research by UC Davis/Niels C. Pedersen, Gilead/Michel Perron, et al. and its misappropriation by foreign outfits into a counterfeit, black market substance sold worldwide.
Here are five questions to Gilead Sciences, Inc:
• On June 17, 2019, a letter written by Mrs. Susan Gingrich (Founder of the Bria Fund for FIP Research and WINN Foundation board member) informed Gilead Sciences of the existence of a black market illegal version of their patented GS-441524 nucleoside analog for the treatment of cats with FIP. Black market sellers rely on their buyers' perception that the counterfeit product is equal to Gilead's GS-441524. UC Davis and Dr. Pedersen provide such validation in a released statement dated June 18, 2019.QUESTION #1 Does Gilead Sciences, Inc. agree with UC Davis and Dr. Pedersen's advice for the treatment of sick cats with illegal/counterfeit black-market substances sold as GS-441524 (a stolen property of Gilead) in terms of:
• Black-market sellers rely on the perception that their substance is safe and effective to convince buyers to disregard the illegal/stolen property/unregulated part. Dr. Pedersen states that GS-441524 is safe and effective "We now know that hundreds, if not thousands, of cats around the world are now being successfully treated for FIP using black market obtained drugs. These favorable responses appear to confirm our own published research [...].", and another researcher has pronounced it "the cure for FIP," thus validating the safety and effectiveness of a black market version in the eyes of the consumers.
QUESTION #2 Does Gilead Sciences, Inc. support the above mentioned claims, and if so, did they conduct any of the following tests/studies of the use of GS-441524 in cats in compliance with the FDA: – Safety with analysis of side effects? – Efficacy in feline infectious peritonitis? – Development of substance resistance? If that is the case, is any part of this information available to the public in any form?
• Gilead Sciences, Inc. provided its proprietary GS-441524 to UC Davis as a sponsor of the field study "Efficacy and safety of the nucleoside analog GS-441524 for treatment of cats with naturally occurring feline infectious peritonitis". The published result of this study is the foundation upon which the black market is built, i.e., the illegal trade of Gilead's stolen property. The assistance provided by Dr. Pedersen to users of the counterfeit GS-441524 gives a false sense of safety, security and consumer protection, and supersedes any reservations cat owners may have due to the illegal source of the black market substance.
QUESTION #3 Did Gilead Sciences, Inc. authorize Dr. Pedersen and UC Davis to: – promote the use of the GS-441524 substance in cats; – treat diseases in owned animals (not enrolled in a field study or clinical trial) under the UC Davis umbrella; – offer advice and various forms of assistance on where to find and purchase the black market counterfeit version of GS-441524?
Gilead Science's website features a strong commitment to fighting counterfeit drugs and illegal substances. The statement includes: " [Gilead's] Anti-Counterfeiting Team uses measures to detect, stop, deter, and report illicit sales of counterfeit medicines."
QUESTION #4 Does Gilead Science intend to act against the illegal trade of their stolen and counterfeit GS-441524 substance beyond the cease and desist letters sent to selected chemical laboratories known to be part of the supply chain? If so, how do they intend to control the black market counterfeiting of their property?
QUESTION #5 And last but not least, the fundamental question for the entire FIP community: does Gilead Sciences, Inc. have plans to file an NDA with the FDA for the use of GS-441524 substance for the treatment of FIP in cats, and if yes – when?
Since I would really like to hear what Gilead has to say, I am sending the link to their PR/press department. Any answers to my questions and proactive measures to control the black market versions of GS-441524 would undoubtedly go a long way towards clearing the confusion and rampant misinformation that keep swirling around in the FIP community.