Medical innovation or a risk to responsible clinical care?

Domhnall MacAuleyDomhnall MacAuley is a CMAJ Associate Editor and a professor of primary care in Northern Ireland, UK

 

The “Medical Innovation Bill” could radically change the way doctors make treatment decisions in the UK. Lord Saatchi, in response to the death of his wife from cancer, seeks to change the law to allow doctors to use experimental treatments, a concept that challenges evolved standards of practice. This Private Members Bill, which will be discussed at committee stage in the UK House of Lords on Friday, provoked ongoing discussions among leading doctors highlighting the tension between evidence based medicine and innovative clinical practice.

Medicine has made many mistakes in the past, some of which are listed in the website of the James Lind Library, the brainchild of Iain Chalmers, champion of the randomised controlled trial. While they recognise that doctors have always done their best, patients have been harmed because doctors didn’t have reliable knowledge on the effectiveness of treatment. As scientists, we recognise the need to make decisions based on the best evidence available and, equally important, to identify the harms. But, emotion is a powerful motivation and Lord Saatchi believes these principles may act as a barrier to patients possibly benefiting from innovative yet unproven treatments. When first mooted, those against it, including Robert Francis, who lead the Mid Staffs enquiry, said it would leave patients at the mercy of mavericks and quacks. And, in subsequent discussions, a subheading to an editorial in The BMJ described Lord Saatchi’s Bill as “More a memorial to a deeply missed partner than a contribution to improving cancer care.

Medical practice in the UK is subject to the General Medical Council's guidance in “Good Medical Practice”, which states that in providing clinical care you must: “provide effective treatments based on best medical evidence”. And, in their “Good practice in prescribing and managing medicines and devices” it states that when prescribing an unlicensed medicine you should” be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy”. In medical litigation, the Bolam rule indicates that a doctor will not have acted negligently if he has acted in accordance with responsible medical opinion. But later, the Bolitho case added that a Court, and not just medical opinion, should find it so.

Changes to Saatchi's Bill seem to have modified medical opinion and reduced opposition and it now reportedly has support from the UK government and the GMC.

The real challenge presented by the Medical Innovation Bill is to allow innovative treatment without providing a charter for quacks and charlatans. It has already challenged medical thinking.

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