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Observations Medical Legislation

The “Saatchi bill” will allow responsible innovation in treatment

BMJ 2014; 348 doi: (Published 15 April 2014) Cite this as: BMJ 2014;348:g2771

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Re: The “Saatchi bill” will allow responsible innovation in treatment

In his discussion of the Medical Innovation Bill, Michael Rawlins [1] refers to Judge Butler-Sloss’s forceful criticism of the Bolam principle while she was president of the High Court’s Family Division because it leaves doctors open to legal action for negligence if they depart from what is regarded as “the standard of care”. We have direct experience of the adverse consequence of an important omission from Judge Butler-Sloss’s judgement.

We co-chaired the MRC Prion-1 trial steering committee at the time (17 Dec 2002) that the father of a young man with variant Creutzfeld-Jakob Disease (vCJD) appealed to the High Court for permission to seek treatment for his son using pentosan polysulphate injected into the brain. The father believed that the drug might slow his son’s decline because it appeared to have done this in an animal model of the disease studied in Japan. Judge Butler-Sloss granted permission for the father to seek treatment for his son [2], and similar judgements were made subsequently in respect of other sufferers of vCJD.

In making her ruling Judge Butler-Sloss suggested that treatment with penicillin might never have been attempted if the Bolam principle had been applied. What she failed to do was to require organised, prospective documentation and publication of the characteristics and progress of patients receiving pentosan polysulphate for vCJD, as had happened with the first series of cases treated with the penicillin [3]. The consequence of this important omission from her judgement has been that patients, their parents, and the people involved in the PRION 1 trial and other related research remained and remain unnecessarily ignorant about the possible benefits and harms of this proposed treatment.

This unsatisfactory state of affairs cannot be allowed to be a feature of any treatments that may become available under the provisions of the Medical Innovation Bill. Rawlins [1] notes that, ‘just because a particular intervention seems to have been effective in an individual patient it cannot be assumed that the results are generalisable’. We regret that he did not go on to call for proper, publicly available documentation to inform decisions made by other patients and those caring for them. Failure to make such evidence accessible was one of the factors that led to the TGN 1412 disaster [4].

Lester Firkins
Iain Chalmers
Co-chairs, MRC Prion 1 trial steering committee

[1] Rawlins MD. “Saatchi Bill” will encourage innovation in treatment. BMJ 2014;348:13.

[2] CJD case: the judgement. BBC News.

[3] Abraham EP, Chain E, Fletcher CM, Gardner AD, Heatley NG, Jennings AM, Florey HW. Further observations on penicillin. Lancet 1941;2:177-189.

[4] Chalmers I. TGN1412 and The Lancet’s solicitation of reports of phase 1 trials. Lancet 2006;368:2206-2207.

Competing interests: No competing interests

23 April 2014
Iain Chalmers
Lester Firkins
James Lind Initiative
Summertown Pavilion, Middle Way, Oxford OX2 7LG