Настроение:	sick
Музыка:	Маркшейдер Кунст (Markscheider Kunst) - Деньги (Способ Обмана)
Entry tags:	covid, smeshnoe

Covid-19: Researcher blows the whistle!
Как это прекрасно
https://www.bmj.com/content/375/bmj.n2635
Covid-19: Researcher blows the whistle on data integrity
issues in Pfizer's vaccine trial

Revelations of poor practices at a contract research
company helping to carry out Pfizer's pivotal covid-19
vaccine trial raise questions about data integrity and
regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer's chairman and chief executive,
Albert Bourla, released an open letter to the billions of
people around the world who were investing their hopes in
a safe and effective covid-19 vaccine to end the
pandemic. "As I've said before, we are operating at the
speed of science," Bourla wrote, explaining to the public
when they could expect a Pfizer vaccine to be authorised
in the United States.1

But, for researchers who were testing Pfizer's vaccine at
several sites in Texas during that autumn, speed may have
come at the cost of data integrity and patient safety. A
regional director who was employed at the research
organisation Ventavia Research Group has told The BMJ that
the company falsified data, unblinded patients, employed
inadequately trained vaccinators, and was slow to follow
up on adverse events reported in Pfizer's pivotal phase
III trial. Staff who conducted quality control checks were
overwhelmed by the volume of problems they were
finding. After repeatedly notifying Ventavia of these
problems, the regional director, Brook Jackson, emailed a
complaint to the US Food and Drug Administration
(FDA). Ventavia fired her later the same day. Jackson has
provided The BMJ with dozens of internal company
documents, photos, audio recordings, and emails.

* * *

Что пфайзеровская вакцина нихера не делает,
все, кажется, уже догадались, и что ее "испытания"
были фальсифицированы, можно было тоже догадаться,
биг фарма иначе не умеет. А вот что оно все целиком
так выплыло в паблик, это неожиданно и приятно.

"You can fool all the people some of the time and some of
the people all the time, but you cannot fool all the
people all the time".

Кстати, на днях буду ставиться Пфайзером,
потому что меня иначе в офис не пустят.
То есть всем понятно, что пфайзер это форма обмана,
но ведь и ковид тоже форма обмана, ничего нового.
Жизнь это форма обмана вообще! Для растамана
жизнь - марихуана.

Походу, к статье приклеили "rapid response"
с дополнительным изобличением гадов.

It's hard to understand how we can trust the safety data
provided by Pfizer [1]; we can see that the official
package insert approved by the FDA for Comirnaty [2]
states that acute allergic reactions (including
anaphylaxis) have been reported only in post-marketing
surveillance (including EUA); while in the real world [3]
the observed rate of acute allergic reactions is close to
2% (1.95% [95% CI, 1.79%-2.13%] ) and the observed rate of
anaphylaxis is close to 1/3700 for mRNA Covid-19 vaccines
(Pfizer 0.027% [95% CI, 0.011%-0.056%]). It's impossible
to miss that in a cohort of 21,700 vaccinated individuals
in a clinical trial.

This observational study has been published online in
March 2021, it was clear that we could question the
authenticity of the safety data published by Pfizer early
in the roll-out of this vaccine.

[1] Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A,
Lockhart S, Perez JL, P'erez Marc G, Moreira ED, Zerbini C,
Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P,
Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, T"ureci Ö,
Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S,
Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001
Clinical Trial Group. Safety and Efficacy of the BNT162b2
mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec
31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub
2020 Dec 10. PMID: 33301246; PMCID: PMC7745181.

https://www.nejm.org/doi/full/10.1056/nejmoa2034577

[2] COMIRNATY(r) (COVID-19 Vaccine, mRNA) suspension for
injection, for intramuscular use; Initial U.S. Approval:
2021; section 6.2 page 13

https://www.fda.gov/media/151707/download

[3] Blumenthal KG, Robinson LB, Camargo CA Jr, Shenoy ES,
Banerji A, Landman AB, Wickner P. Acute Allergic Reactions
to mRNA COVID-19 Vaccines. JAMA. 2021 Apr
20;325(15):1562-1565. doi: 10.1001/jama.2021.3976. PMID:
33683290; PMCID: PMC7941251.

https://jamanetwork.com/journals/jama/fullarticle/2777417

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