www.re-check.ch

We work with

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methods, tools and ethics �at the intersection between

Investigative Journalism �and �Evidence-Based Medicine (EBM)

they share a

hypothesis-driven approach

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EBM means…

• any course of action needs to be based on the best available up to date scientific evidence.
• When there is uncertainty this needs to be communicated to the patient / public.
• EBM is about what we know, and don’t know. And about being systematical.

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Founders and directors of the non-profit

Re-Check / Investigating and Mapping Health Affairs

Paid contributors with The BMJ

On Twitter -- >> @RecheckHealth / @CatherineRiva / @serenatinari

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Serena Tinari & Catherine Riva– Disclosures

No direct or indirect pharmaceutical and medical devices industry funding

Implicated in projects with academics in US and Canada

Donate and Leak to us: www.re-check.ch

#GIJNHealthGuide and COVID19

• Beware of Oversimplification
• Be Cautious about the Models
• Stick to the Best Available Scientific Evidence
• Provide Context – you need to know what is normal, to say that something is abnormal
• Don’t Fall for the Hype
• Beware of media reporting

https://gijn.org/2020/11/20/top-10-tips-for-investigating-health-care-from-the-experts/

How do you investigate health

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In today’s session we’ll look at

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1. Approval and regulation – pre Covid, and now

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2. With Fabiola Torres: Conflicts of Interest

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#GIJNHealthGuide

The problems of “fast-track” (page 18)

2020-2021 Science and Regulation �by press release

Where are we now?

What does it teach us?

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• Clinical trials must be designed to answer relevant questions
• reduce the likelihood you will get severely ill / go to the hospital / die
• prevent infection and interrupt disease transmission�

-> but none of them were among the trial’s endpoints:

• the trial evaluated mild, not severe disease�<- COVID-19 disease = SARS-CoV-2-positive + at least 1 symptom �(cough, chills, fever, loss of taste or smell, etc.) ��“The primary efficacy endpoints evaluate confirmed COVID-19 cases occurring 7 days or more after the second dose. The final analysis also will include, with the approval of the FDA, secondary endpoints evaluating efficacy based on COVID-19 cases occurring 14 days after the second dose.”�

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What does it teach us?

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• Duration of trials matters

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“The Pfizer-BioNTech vaccine’s efficacy against SARS-CoV-2 peaked at 96.2% at seven days to two months after the second dose and then declined to 83.7% at four months, a preprint from Pfizer has reported. The preprint, which contains the latest data from the original clinical trial, found an average decline in vaccine efficacy of 6% every two months.”

�BMJ 2021; 374 :n1920 doi:10.1136/bmj.n1920

What does it teach us?

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• Emergency Use Approvals (EUA) �as “super accelerated” approvals �might be a bad idea

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“Duration of protection and safety data that could be collected

in a blinded, placebo-controlled manner were limited by the ethical and practical need to immunize eligible initial placebo recipients under EUA and according to public health authority recommendations. Data presented here do not address whether vaccination prevents asymptomatic infection (…)”

August 2021: US government announces boosters

will begin on September 20. Before FDA had ANY data

1 September 2021: Marion Gruber and Philip Krause quit

director and deputy director of

FDA’s Office of Vaccines Research and Review (OVRR)

https://ebm.bmj.com/content/early/2021/08/08/bmjebm-2021-111735

https://restoringtrials.org/covid-19/

https://gijn.org/health-and-medicine-guide-chapter-3/

www.re-check.ch