WHAT'S THE REAL RISK OF A SERIOUS ADVERSE REACTION?
It is important to recognize there is no objective data supporting claims of positive outcomes. Nor have the true number of doses administered been collected or published. Doses administered, not sold. Further, of the doses administered: how many to the same animal? Of those animals: how many are now deceased? The only published data available supporting the marketing claims are the studies conducted to achieve market approval, which only tested for efficacy, not safety. Under the most choreographed and controlled conditions possible they still only achieved an efficacy rate of 47% in dogs that were young with no health issues (U.S. study analysis by a vet published at MyLameDog.com). Young, healthy animals were used in a clinical trial for a substance intended to treat osteoarthritis.
Why doesn't incident rate data exist? One: lack of transparency from the manufacturer. Two: this substance is in Phase IV clinical trials which means they're collecting that data now from our pets. Any pet parent not informed of this by their veterinarian was denied their right to informed consent.
The manufacturer continues to state the reaction rate is only 1 in 10,000 while providing no substantiation of this figure. Countless families have lost multiple pets in a single household, their experience is a reaction rate of 100%.
What is Incidence Rate and Why Does It Matter?
The incidence rate is the probability that a dog administered Librela could be affected by a suspected adverse drug reaction. A team of independent data scientists analyzed Zoetis claims. A lack of clarity regarding the number of dogs treated (as opposed to doses sold) likely masks a much higher incident rate.
Factoring in the lack of disclosure or transparency from Zoetis, and a victim reporting rate estimated at <5%, all available data yields an incident rate of 1/110. With a victim reporting rate that low it can be reasonably concluded the actual incident frequency is drastically higher than 1/110.
Are incident rates different for cats?
Solensia data has always stuck out because of its alleged* ADR (adverse drug reaction) incidence rate of 0.3% (1 in 333), a full 66% higher than Librela’s alleged* 0.18% (1 in 556). The other blinking red light has been Solensia’s extremely high raw ADR numbers.
Zoetis sells 3.5-4 doses of Librela for every dose of Solensia, so one would expect Solensia’s ADR numbers to be around a quarter (~5,000) of Librela’s (~20,000). Instead, as of this publication, ~10,000 cats have been affected by a Solensia sADR. It’s *double* of what one would expect.
This data demonstrates that these two medications (allegedly) adversely affect both species—thus the problem may lie not with the animals being treated but the monoclonal antibody itself. A high correlation across two species is a significant signal. There are various concepts across disciplines—confirming indicator, convergent validity, etc.—to describe this relationship and its eventual bearing on causality.