- Carl Heneghan, professor of evidence based medicine,
- Ben Goldacre, senior clinical research fellow
The need for such trials has been recognised for almost 100 years
Because of the disputed effectiveness of neuraminidase inhibitors for flu, the UK Department of Health asked the Academy of Medical Sciences and the Wellcome Trust to report on their role in future pandemics.1 “Prepare to conduct pandemic flu trials in hospitals now,”2 stated the report’s press release, highlighting the failures in the 2009 pandemic to conduct trials among high risk patients and those admitted to hospital.
Calls for trials in pandemics are far from new and have long been ignored. Indeed, as far back as 1999 the outgoing health secretary Frank Dobson told doctors they should not prescribe zanamivir (Relenza); instead he ordered trials in patients at high risk of flu complications.3 After Spanish flu, a 1919 JAMA editorial stated the need to formulate experiments to verify hypotheses4 and, similarly, a 1919 US influenza vaccine trial reported, “the necessity of properly controlled experiments to determine the value of prophylactic remedy during an epidemic.”5
Hundreds of millions of people were infected with influenza in 2009, and yet we cannot find a published randomised trial conducted in hospital patients. In 2010, a review of Roche’s 2009 pandemic response outlined the importance of two randomised trials of oseltamivir in Canadian intensive care units.6 Clinical trials.gov reports that one of these studies (NCT00844155) was withdrawn and the second (NCT01010087) recruited 59 patients but has been terminated, with no published results available four years after completion. For primary care research, oseltamivir (Tamiflu) was distributed directly to patients’ homes during the UK pandemic after telephone contact. This situation is ideally suited, administratively, to randomisation, but again no trial was conducted.
Read more of the editorial at the BMJ