The Lancet paper by Mehra et al. (May 22) which claimed that hydroxychloroquine increased mortality in COVID-19 and caused arrhythmias was retracted yesterday.
So was its predecessor in the New England Journal of Medicine.
Both studies were based on inaccessible, and therefore unverifiable data, provided by the Surgisphere corporation.
Unfortunately, the Lancet paper, the subsequent media coverage, and the reaction by some regulatory authorities (notably the UK regulator MHRA) and WHO have all been extremely damaging to the chloroquine and hydroxychloroquine COVID-19 clinical trials. Some studies, including our COPCOV prophylaxis study, which aims to see if these drugs at lower doses may prevent illness (which has yet to be answered, and may still be the case even if these drugs don’t work in treatment), have still not been given permission to restart. All the scientific evidence was put before the MHRA shortly after their decision to issue a notice stating they were minded to suspend the trial, and suggesting we stop enrolment, two weeks ago.
Many important questions will need to be answered in the coming weeks and months, but we would like to use this unfortunate opportunity to make two relevant recommendations which we believe are in the public interest.
- Medical and scientific journals should not accept papers based on inaccessible data
- Regulatory authorities and other agencies responding to such reports should satisfy themselves of the veracity and applicability of published data and the correctness of analyses before they act