By Peter Doshi, senior editor, Fiona Godlee, former editor in chief, Kamran Abbasi, editor in chief
BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o102 (Published 19 January 2022)
Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims. The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.
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regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and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.
The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data. Public battles for drug company data, transparency campaigns with thousands of signatures, strengthened journal data sharing requirements, explicit commitments from companies to share data, new data access website portals, and landmark transparency policies from medicines regulators all promised a new era in data transparency.
Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come. This is morally indefensible for all trials, but especially for those involving major public health interventions.