The Cure for FIP: Beyond the Hype (continued)
WHO SURVIVED (AND WHO DIDN'T)
As stated before, the clinical trial sample comprised a total of 20 cats, aged from 3.3 months to 6.8 years, although 95% were 12 months old or younger, and out of that 95%, 58% were between the ages of 3 to 5 months.
The efficacy of the study is described as follows:
‟Nineteen of the twenty cats treated with GC376 regained outward health within two weeks of initial treatment."
The terminology is puzzling. "Outward health" means appearing healthy as opposed to being truly healthy, and to our knowledge not conventionally measurable, so we can't help but notice an element of subjectivity here, that perhaps has no place in a scientific study.
It is not unusual for cats treated with commercially available medications to regain "outward health" for a couple of weeks, sometimes longer. However, the improvement is often short-lived, as was the case with GC376: disease signs returned 1-7 weeks after primary treatment. 13 of the 19 cats relapsed and became unresponsive to treatment. Eight developed neurological signs, and five abdominal lesions. Again, this is not different from what we observe daily in the field by the experience of our group. Out of the twenty cats in the trial, seven were considered in remission at time of publication (September 13, 2017). That is a 65% failure rate, or a 35% success rate, depending on how you want to look at it, from a narrow field. How success is defined for the study, or remission, for that matter, is a question of interpretation.
There has not been sufficient elapsed time to say if the remission experienced by the seven surviving cats is short-lived or long-lasting. So far, only one cat has reached the one year mark.
THE LUCKY SEVEN (AND THE UNLUCKY THIRTEEN)
The demographics of the seven cats deemed in remission show that five of them are kittens aged 3.3 to 4.4 months. Again, the narrow field restricted to ‟certain presentations" may explain the slant here. One cat (CT21, 10 months old) that is part of the lucky seven had to be treated 17 weeks instead of 12 because of delayed improvement, went into remission, then relapsed 13 weeks later and received more treatment.
Then there is the older cat (CT04, 6.8 years old) with suspected dry FIP. I say suspected – based on definitions by Drs. K. Hartmann et al and D. Addie et al – because diagnosis was made by basic blood tests and the presentation of mesenteric lymph nodes, without CNS involvement. The cat underwent four rounds of treatment, relapsed after each of the first three shorter treatments (2 weeks, 2 weeks, 6 weeks), and was considered in remission after a fourth treatment lasting 12 weeks (total treatment time of 22 weeks).
Dr. A. Legendre published a study in February, 2017, titled "Polyprenyl Immunostimulant Treatment of Cats with Presumptive Non-Effusive Feline Infectious Peritonitis In a Field Study," conducted on a group of 60 cats. These cats had been diagnosed by their veterinarians using usual laboratory-performed diagnostic tests, in a similar fashion as the confirmation model adopted by the UC Davis / Dr. Pedersen's team. Yet, in his article Dr. Pedersen refers to the Legendre study as evidence that ‟Cats with this form of FIP (note: dry, no CNS involvement) have been known to undergo spontaneous remissions." With this, Dr. Pedersen contradicts his own papers of the last 40 years where he insisted that FIP is 100% fatal. We have not witnessed, read, or heard of massive spontaneous remissions in dry FIP before. The peculiar twist presented here by Dr. Pedersen is that if cats with dry FIP are not treated, they die, if they are treated with Polyprenyl Immunostimulant, they go into a ‟spontaneous remission", and if they are treated with GC376, they... die of FIP. Is your head spinning? Ours are.
Nonetheless, what is good for the goose is good for the gander; therefore, if we are to believe Dr. Pedersen, the CT04 dry FIP patient could very well be another case of ‟spontaneous recovery." For all we know, placing the cat under a different therapy, or no therapy at all, may have yielded the same result.
NO PLACEBO GROUP
In the organization of this clinical trial, no placebo group was included. We do approve of this because we feel there are so many cats dying every day of this awful disease, that there is no justification for denying treatment to sick cats for experimentation. This is an interesting position for Dr. Pedersen and UC Davis. Both have repeatedly blasted other research for failing to include a placebo group, deeming the result of said studies inconclusive and unreliable for fault of a control-group. Again, we must point out the double standard, because it IS a double standard: either you believe placebo groups are needed, or you don't, but you cannot change your opinion on the matter when and if it suits your endeavors. This is especially true when we can trace at least 218 cats used for experimentation, all of which were bred for the specific purpose of research, experimentally infected with coronavirus, and part of studies that are directly referenced and linked to the present GC376 study.
There is also an unpublished study referenced in the article that was the basis for exclusion of cats with neurological signs of the disease: ‟Cats with clinical signs indicative of neurologic involvement were excluded from the trial based on earlier unpublished experimental studies with GC376." We do not know how many poor cats were involved in this one, nor do we know their fate. It's highly likely that they all died.
This particular protease inhibitor research comes at a stiff cost, both in terms of lives lost and monetary resources.