James Doogue

- Covid-19 vaccines and treatments: we must have raw data, now

- Data should be fully and immediately available for public scrutiny

- The lack of access to data is consistent across vaccine manufacturers.

- Underlying data for covid-19 therapeutics are similarly hard to find.

We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public.

"The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data.

In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny."

Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.

Governments are spending trillions of dollars without access covid-19 vaccines and treatments based on questionable research summaries.

The research data needs to be able to be scrutinized by independent players.

Posted by: Timothy Birdnow at 12:22 PM | Comments (3) | Add Comment
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