Evidence and desperation in off-label prescribing: recombinant factor VIIa

BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.d7926 (Published 16 January 2012)
Cite this as: BMJ 2012;344:d7926

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A useful account. Thank you.

I discerned two groups of reasons to explain off-label prescribing here: lack of evidence, and the rest.

As far as the readily available information about factor 7a is concerned (the Annals review and the Cochrane review), if you are a believer in statistical significance then there is insufficient evidence of mortality difference if using factor 7a compared with not using it, and there is a harm from increased thromboembolic morbidity of 0-5%.
If you’re not such a believer, then the best estimates for mortality difference with factor 7a compared with no factor 7a are either 11% reduction from one review, or no difference from another. If that accurately captures the evidence, it seems tilted towards it being beneficial, but not overwhelmingly. Those effect measures may need adjusting if too much of the research was controlled by the drug's maker.

Now the rest of the reasons:
The authors suggest anyone wishing to promote adherence to evidence in this context (of uncertainty) thus needs to contend with both genuine uncertainty and the powerful force of desperation.
I’d suggest anyone practising under the influence of uncertainty and desperation needs to contend with codes of conduct. In the authors’ bailiwick the Medical Board of Australia’s Code of Conduct requires:
2.2.6 Providing treatment options based on the best available information.
2.2.10 Making responsible and effective use of the resources available to you.
5.2.1 Ensuring that the services you provide are necessary and likely to benefit the patient.

‘Potent ancillary logics’, ‘mistaking temporal with causal relationships’, invoking the rule of rescue even if the medicine seems not rescue, inadequately rehearsed, rushed, irrational decision making, and egotism are probably all trumped by ‘best available information’.
Serious or repeated failure to meet the code's standards can affect your medical registration.

Competing interests: None declared

P Grant, Physician

retired, Sydney, Australia

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