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regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and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.
While the truth about Tamiflu emerged only after years of exhaustive work by the Cochrane review group and investigative journalists, the machinations behind remdesivir’s rapid climb were evident at an early stage. On 29 April, the same day as a trial was published showing no significant effect of remdesivir among patients in hospital, remdesivir’s manufacturer rushed out interim findings of a more favourable trial by press release and with full White House honours. The much vaunted but minimal benefits shown in severely ill people were used to justify FDA approvals and worldwide purchase. Now a much larger trial has found little or no benefit in hospital patients, and a BMJ Rapid Recommendation, produced in collaboration with the World Health Organization and Magic App, has come down against use of remdesivir in patients with covid-19 of any severity.
…Science by press release, on the basis of interim or ad hoc analyses, and without access to the data, also afflicts our knowledge about the covid-19 candidate vaccines. Patients and the public deserve better than this. So do health professionals. Pandemic or no pandemic, decisions must be based on scrutiny of the full data from trials that are independent of drug and vaccine manufacturers.
Scientists who advised the World Health Organization on its influenza policies and recommendations—including the decision to proclaim the so-called swine flu a “pandemic” had close ties to companies that manufacture vaccines and antiviral medicines like Tamiflu, a fact that WHO did not publicly disclose.