2019 FIP Symposium: PURRsuing FIP and WINNing

Date: Saturday & Sunday, November 16-17, 2019

https://ce.vetmed.ucdavis.edu/symposia-events/winn-symposium-2019

https://ce.vetmed.ucdavis.edu/sites/g/files/dgvnsk4581/files/inline-files/2019%20FIP%20Symposium%20Schedule.pdf

 

UC Davisで開催されるFIPのシンポジウム

もちろん、Dr. Pedersenの講演もあり

 

 

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VIN NEWS(August 21, 2019)に、FIPに関する詳細な記事があります。

VIN:Veterinary Information Network はカリフォルニアのDavisにあり、1991年に設立の獣医師の団体です)

 

Hope, despair fuel black market for drugs in fatal cat disease

Legal treatment for cat disease known as FIP still years away

 

以下、抜粋ですが、

 

Dr. Pedersenによると、中国製のblack marketのGC376やGS-441524の問題点は主にパテントに関するものであって、その有効性ではなく、Dr. Pedersen自身もblack market品で多くの猫がFIPから治癒していることを認めています。

 

Pedersen, who conducted the GS-441524 trials at the University of California, Davis, School of Veterinary Medicine, posted an article on websites for the UC Davis Center for Companion Animal Health and SOCK FIP (Save our Cats and Kittens from Feline Infectious Peritonitis) early this year, alerting colleagues about the existence of Chinese-made compounds.

 

As he sees it, the problem is primarily an issue of patent rights to these compounds, not their efficacy. "I know that hundreds, and perhaps thousands, of cats with FIP have been treated with non-approved GC376 and GS-441524 … and that many cats have been cured of their infection with no more side effects than we described in our published field trials," Pedersen wrote in an email interview with the VIN News Service.

 

しかし、市場が過熱すると、いずれ粗悪品を売り出す会社が出てくるのではないかと危惧しています。

 

But that could change tomorrow, he warns. "Like all black-market drugs, there are bound to be suppliers that are willing to sell drugs that are less than pure or not fully biologically active to desperate consumers. The only truth is 'caveat emptor' — let the buyers be aware."

 

MUTIANの代表者(という)のLuさんによると、MUTIANの有効成分はGSとは完全に別物だそうで、いずれパテントが取れたら明らかにするそうです。

 

Lu took issue with the term "black market" to describe the sale and distribution of Mutian. While the product is referred to as GS by cat owners on FIP Warriors, Lu claims that the active ingredients are "completely different from the molecular formulas in the now published GS patent." He said the company's research is based on GS research, and the company will disclose the formula after its own patent is approved.

 

MUTIANは中国政府の承認を得ており(しかし、VIN Newsが証明書を見せてくれと言っても見せてはくれず)、アメリカのFDAにも申請中とのこと。

 

In addition, Lu said, the company's manufacturing is approved by the Chinese government, and offered to provide a "certificate" from China's equivalent of the FDA, as well as reports. However, Lu did not provide the certificate or reports to VIN News, despite repeated requests.

 

Lu also said that the company is working on approval through the FDA and plans to open "Mutian centers" in the U.S.

 

Dr. Pedersenも正規の臨床試験での成績が限られているため、MUTIANなどの製品の使用経験が集積されることを期待しているそうです。

 

Pedersen said he has no experience with the oral form of GS, which he calls a "Chinese invention." But he wants to know what owners in the field are learning. "Without this source of drugs, the research we have completed would still be contained on the paper pages of our publications," he said.

 

While he neither encourages nor discourages pet owners from buying the antivirals, he strongly encourages members of FIP Warriors who do use the drugs to gather as much data as they can, especially in the case of cats who, like Charlie, have the neurological version.

 

Gilead社は、GS-5734がエボラの薬としてFDAの承認を得るまでは、GS-441524のラインセンスを他社に与える気はないそうです。

 

Gilead, a publicly traded biomedical company that makes drugs for HIV and hepatitis C, owns the patent for GS-441524, which was more effective than GC in treating FIP in clinical trails. GS-441524 is related to a drug Gilead has developed to treat Ebola called GS-5734, or remdesivir.

 

A Gilead spokesperson told the VIN News Service that it is holding off on licensing GS-441524 to other parties for commercial development until remdesivir has FDA approval.

 

これには多くの人が怒っており、Gilead社の株主であるSusan Gingrich(元下院議長のNewt Gingrichの姉)はGilead社のCEOに抗議の手紙を送ったそうです(コピーを議員やトランプ大統領にも)。

 

This inaction angers Gingrich, who is a Gilead shareholder. "Every single day nothing happens, cats are dying all over the world because of FIP," she said. In June, she sent a letter to Gilead chairman and CEO Daniel O'Day (with copies to her elected representatives and President Donald Trump) asking that the company do more to facilitate bringing GS to market.

 

一方、GC-376の場合、カンサス州立大学がパテントを持っていますが、ライセンスをAnivive Lifesciences社に与えたそうです。

 

In the Kansas State case, however, the same researchers tested them against animal viruses and found GC376 is a very strong inhibitor of the FIP virus.

 

Kansas State owns the patent and has licensed development of the compound to Anivive Lifesciences, a privately held biotech company.

 

Anivive Lifesciencesは商品化を目指しており、近々臨床試験を始めるようでHPで参加者を募集をするようです。

 

Dodd confirmed that the company is planning to shepherd GC376 through approvals and commercialization. He did not give a timeline. However, he did provide a link to a trial for FIP, which is identified as "coming soon" on the Anivive website.

 

というわけで、GSよりもGCのほうが、実際に正規品が販売されるのは早くなりそうです。

 

アメリカでもほとんどの州で、未承認の医薬品を獣医師が購入や譲渡するのは認められていないそうですが、実際にはいろいろな方法で飼い主が使用するのをサポートしてくれており、クリニックで注射してくれるところもあるそうです。ただし、獣医師自らが購入しているところはないようです。

 

Pet owners using GS and GC describe a range of veterinarian involvement with their cats' treatments. Some provide supportive care and diagnostics for pets being treated at home. Some teach pet owners to give injections of the medications. Some veterinarians or veterinary technicians inject the drugs at the clinic, usually after the owner signs a waiver absolving the practice of responsibility for adverse reactions to the medications. VIN News is unaware of any cases of veterinarians purchasing GS or GC themselves.

 

獣医師のDr. Diane Addie(ABCDガイドラインの著者)もGCやGSの使用を積極的に勧めてはいないものの、希望者にはサポートしているそうです。ただし、従来からの治療法も勧めているそうです。

 

Addie said she does not actively encourage people to use GC376 or GS-441542, but she will support them if they choose to. She also recommends other treatments — some of them controversial — including antifungals, immunostimulants, anti-inflammatories and feline interferon. She is concerned that these other treatments have gotten lost in the excitement over GS and GC.

 

(前のページにも書いてあるように)今月初めにGilead社が中国の各社にGS-441524の製造を中止するように警告の手紙を送り、2社が販売を中止したため、深刻な品不足になっているそうです。

しかし、その手紙は中国語で書かれていたらしく、本当にGilead社からのものかどうかは定かでないそうです。Gilead社はこの件についてはノーコメントだそうです。

 

Earlier this month, members of the FIP Warriors Facebook group told VIN News that two suppliers selling versions of GS were shutting down after receiving cease-and-desist letters purportedly from Gilead. One member, who asked not to be identified because she advocates the use of compounds that are illegal in the U.S., said the closures are causing a huge supply shortage. If the letters are not from Gilead, she speculated, they could be from one GS seller hoping to deter another.

 

VIN News has not seen the letters, which are said to be written in Chinese, nor been able to confirm their origins. Gilead had no comment about them. These developments highlight another aspect of this precarious moment in the lives of FIP-afflicted cats and their owners: Even as a possible cure dawns on the horizon, it may disappear at any moment.