We discovered further similarities between the Kansas City Court Report and our dealings with Tamiflu.
The legal report underscored a crucial point: "In its press release announcing emergency use authorisation for its COVID-19 vaccine, Pfizer did not disclose that it had excluded immunocompromised individuals from its COVID-19 vaccine trials.”
Instead, in “Important Safety Information” in its press release, Pfizer noted that
“[i]mmunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine.”
The 2001 Weliver trial, published in JAMA, investigated the efficacy of oseltamivir in preventing the spread of influenza to household contacts of influenza-infected index cases. Only when we had access to the CSR (WV15799) could we assess the full extent of the exclusions.
A second point in the Kansas legal report was that Pfizer only tested the booster shot on twelve 65-to-85-year-old trial participants and did not test it on any participant older than 85.
In 2015, Professor Nick Phin, Interim Director for the Centre for Infectious Disease Surveillance and Control and Dr Rachel Moll of PHE wrote in the BMJ that “There is now convincing evidence and analysis to support the post-exposure use of antiviral prophylaxis in certain circumstances.”
Our response stated that we were unsure where their statement “a situation akin to a nursing home” had arisen from. We did not make such a statement in the Cochrane review or the corresponding BMJ review.
Trial WV 15799 was done in households with a minimum of 2 and a maximum of 8 contacts. Nine hundred sixty-two family contact members of 377 index cases were randomised and given Tamiflu or placebo for seven days (all index cases were left untreated apart from symptomatic relief). The information available from the clinical study report shows that index cases were aged 26-30; only five were elderly. Of the 962 contacts, the mean age was 34 years, and as a result of the exclusion, only 17 (1.8%) aged 65 or over were included.
Therefore, we did not consider this population ‘akin’ to a nursing home population and consider this study not applicable to one, given the exclusions and the small number of individuals included over the age of 65.
The Kansas legal report highlights that Pfizer should not have represented that the booster was safe for 65- to 85-year-olds after only testing 12 trial participants in that age range, and similarly, wasn't safe for immunocompromised patients.
The lack of pragmatic trials for tamiflu and COVID-19 is a deliberate tactic to mask harm. None of this matters to the marketing department—with the suitcase in hand, tamiflu was for everyone despite the exclusions, as were the COVID-19 vaccines.
The TTE geezers have little in their suitcase beyond a lot of past experiences that keep cropping up.
Maryanne Demasi is questioning whether FDA could carry our due process in 22 days:
Did FDA fully analyse Pfizer trial data in 22 days? Impossible, says expert
https://blog.maryannedemasi.com/p/did-fda-fully-analyse-pfizer-trial
Best wishes, Tom
Dear TTE geezers - a suitcase full of past experience is worth three times its weight in (BigPharm) gold. In other fields of endeavour, such suitcases full of past experiences are equally valuable and ought not to be discarded because they're too weighty and complicated ...