Treating soldiers with unlicensed drugs

It was reported recently that British soldiers in Afghanistan and Iraq are being treated with an experimental blood clotting agent that has not been licensed for general use in the National Health Service.

The drug in question, NovoSeven Recombinent Factor VIIa, developed by the Danish pharmaceutical giant Novo Nordisk, is licensed to stem bleeding in haemophiliacs, and is being considered now as a possible treatment for heavy bleeding associated with severe trauma and head injuries, and perioperative patients undergoing caesarian sections and hip replacements.

The Liberal Democrat chairman of the House of Commons Select Committee on Science and Technology, Phil Willis MP, who brought this supposed scandal to the fore, is described by Anthony Cox, pharmacology expert and author of the excellent Blacktriangle blog, as being hypocritical, and I agree with this asssessment. If a drug that has been through extensive tests, licensed for use in some situations and found to be effective, were not given to battlefield trauma patients, the media would have a field day.

There are, of course, serious ethical issues involved in prescribing unlicensed medications. Take, for example, the furore surrounding the anti-cancer drug, Herceptin. The big issue with Herceptin is cost, and this must be bourne in mind also with NovoSeven, which is hugely expensive. But there are also ethical and moral issues at stake if physicians know a potentially life-saving drug to be available, and refuse to administer said drug to patients solely on the grounds that a license has yet to be issued. The are damned if they do, and damned if they don’t, and so too are non-clinicians and politicians who are responsible for making decisions on what treatments are licensed and funded for use within the NHS.

Drugs are used routinely in the NHS for unlicensed indications, there are clearly defined protocols in place to deal with such situations, and the General Medical Council‘s guide to Good Practice in Prescribing Medicines allows the prescribing of medications outside the specific terms of their licenses.

The Ministry of Defence has used NovoSeven twice in Iraq, and in both cases soldiers’ lives were saved. The MOD should be applauded for their good sense.