No medical innovation without accessible documentationBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3151 (Published 14 May 2014) Cite this as: BMJ 2014;348:g3151
Rawlins refers to Judge Butler-Sloss’s forceful criticism of the Bolam principle while she was president of the High Court’s Family Division—that it leaves doctors open to legal action for negligence if they depart from what is regarded as “the standard of care.”1 We have direct experience of the adverse effects of an important omission from her judgment.
We co-chaired the Medical Research Council’s PRION-1 trial steering committee when the father of a young man with variant Creutzfeldt-Jakob disease appealed to the High Court for permission to seek treatment for his son using pentosan polysulphate injected into the brain. The father hoped that the drug might slow his son’s decline because it seemed to have done this in an animal model of the disease studied in Japan. Butler-Sloss granted this permission,2 and similar judgments were later made for other patients with the disease.
But Butler-Sloss did not require organised prospective documentation and publication of the characteristics and progress of patients receiving this treatment. Consequently, patients, their parents, and those involved in the PRION-1 trial and other related research remain ignorant about the possible benefits and harms of this proposed treatment. We agree with Rawlins that this must not be the case for treatments that may become available under the provisions of the Medical Innovation Bill. Failure to make such evidence accessible was one of the factors that led to the TGN1412 disaster.3
Cite this as: BMJ 2014;348:g3151
Competing interests: None declared.
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