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A Quick Thread On 'Transparency Tactics'
Remember when Pfizer, Moderna, and AstraZeneca published (some) of their phase 3 trial protocols to great acclaim? https://www.nytimes.com/2020/09/17/health/covid-moderna-vaccine.html
Remember when Pfizer, Moderna, and AstraZeneca published (some) of their phase 3 trial protocols to great acclaim? https://www.nytimes.com/2020/09/17/health/covid-moderna-vaccine.html
That was important, but as @millerbioethics @jsross119 @MichelleM_Mello point out in @statnews the commitments made by pharma CEOs alongside @gatesfoundation stopped short of disclosing protocols, much less trial results and underlying data, as a rule https://www.statnews.com/2020/11/05/transparency-is-needed-for-covid-19-vaccine-trials/
Fast forward to the past ten days, when multiple vaccines have been reported as having efficacy of 90% or more based on interim results and now one ($PFE) completed phase 3 trial. https://www.nytimes.com/2020/11/18/health/pfizer-covid-vaccine.html
And yet all we have to go on are company produced press releases like this:
https://www.sec.gov/Archives/edgar/data/1682852/000119312520293735/d53512dex991.htm
No preprints of publications + certainly none of the underlying data that would enable independent researchers to scrutinize how cases of Covid were counted within the trial.
https://www.sec.gov/Archives/edgar/data/1682852/000119312520293735/d53512dex991.htm
No preprints of publications + certainly none of the underlying data that would enable independent researchers to scrutinize how cases of Covid were counted within the trial.
In this context, I think it's reasonable to ask whether releasing the protocols was a tactic from the get-go, a move designed to buffer these trials against calls for greater openness and transparency.
I would be happily corrected by companies that make the data available. But fear we won't see a publication, much less the underlying data, until after an emergency use authorization is granted by the @US_FDA
And by then it may simply be too late.
And by then it may simply be too late.
Importantly, if companies aren't willing to make more data transparent, regulators should do so.
. @GovCanHealth now has 3 Covid vaccines under review
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/applications.html
. @GovCanHealth now has 3 Covid vaccines under review
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/applications.html
To its credit, it has already released the data it has in respect of remdesivir, which approved back in late July.
You can access that data, with 2 clicks of your mouse, from anywhere in the world from this site:
https://clinical-information.canada.ca/search/ci-rc
You can access that data, with 2 clicks of your mouse, from anywhere in the world from this site:
https://clinical-information.canada.ca/search/ci-rc
Waiting until authorization in the case of a vaccine is IMO too late. @GovCanHealth has the legal authorities it needs to compel disclosure of protocols, interim analyses + other important data *now*, before authorization. We explain the why+how here: https://osf.io/evhnk/
Doing so is essential to enhancing public trust in the vaccine(s) in Q
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Making sure that these claims of vaccine effectiveness (in reducing mild Covid symptoms, NOT transmission or other outcomes of interest like hospitalization rates) stand up to independent scrutiny.
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Making sure that these claims of vaccine effectiveness (in reducing mild Covid symptoms, NOT transmission or other outcomes of interest like hospitalization rates) stand up to independent scrutiny.
