Swine flu – a new case for Evidence Based Medicine

It is winter now in Australia and what is feared will be happening in the northern hemisphere when winter arrives, is already the case in the southern hemisphere. Swine flu is becoming more virulent and the necessity to test the vaccines that have been developed since the outbreak of swine flu becomes more urgent. Two pharmaceutical companies in Australia have begun human trials and many volunteers have signed up. Among the volunteers are 400 children, some of them under one year old. It seems logical to test the vaccine on children, since they proved to be one of the most vulnerable groups. The question however is, if it is ethical to involve children in such a trial? Randomized Controlled Trials, the form of testing that is presumably used here, are ethically difficult at the best of times. And at a time of panic and under time pressure they can be outright dangerous and ethically not permissible. If the vaccine is to make sense at all, it needs to be on the market soon. How can anyone know what possible long-term implications of the vaccine might be? Is it already secure enough to subject children to it? How important is it for the two competing pharmaceutical companies in Australia to have their product approved over that of the competitor. One company already has orders for the vaccine from the government, while the other one claims that their vaccine is safer and that they could be done with trials in a matter of weeks, while the other company needs at least a couple of months. Is clinical equipoise, the standard that the medical community has to be in genuine uncertainty over whether or not the treatment will be beneficial, still maintained when the pharmaceutical companies perform and therefore influence the trial? In light of the Tamiflu disaster in Great Britain, is the question of the ethicality of human trial seven of interest to the wider population, even though it should be?

See two related articles from The Times Online, here and here.

Read more:

Evidence in Medicine and Evidence-Based Medicine
By John Worrall , London School of Economics
(Vol. 2, November 2007)
Philosophy Compass

Back to Basics in Bioethics: Reconnecting Patient Autonomy with Physician Responsibility
By Antonio Casada de Rocha, University of the Basque Country
(Vol. 3, December 2008)
Philosophy Compass