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

P Doshi, F Godlee, K Abbasi - bmj, 2022 - bmj.com
P Doshi, F Godlee, K Abbasi
bmj, 2022bmj.com
In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light
that governments around the world had spent billions stockpiling antivirals for influenza that
had not been shown to reduce the risk of complications, hospital admissions, or death. The
majority of trials that underpinned regulatory approval and government stockpiling of
oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those
that were published were ghostwritten by writers paid by the manufacturer, the people listed …
In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied. 1 2 3 4
The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data. 5 6 Public battles for drug company data, 7 8 transparency campaigns with thousands of signatures, 9 10 strengthened journal data sharing requirements, 11 12 explicit commitments from companies to share data, 13 new data access website portals, 8 and landmark transparency policies from medicines regulators 14 15 all promised a new era in data transparency.
bmj.com