The twinkling eyes and smile of Layla Richards shine out from many newspaper front pages today – and for a newsworthy reason. A world first treatment for her Acute Lymphoblastic Leukaemia was tried out by doctors at London’s Great Ormond Street Hospital.
All of this went on without the Medical Innovation Bill or Access to Medical Treatments (Innovation) Bill.
Lord Saatchi has consistently framed the need for his legislation with tales of denials of a potential cure, ‘wasted lives’, ‘cut and drilled’ on traumatic trajectories to death, as an uncaring and purely self-interested medical profession looks on.
‘Current law in relation to medical negligence contributes to this failure. It defines medical negligence as deviation from standard procedure. But as innovation = deviation, then non-deviation = non- innovation.
The result is that all cancer deaths are wasted lives. The deaths, and their attendant tragedies, have not advanced scientific knowledge by one centimetre.
Because all the deceased have received is the standard procedure – the endless repetition of a failed experiment.’
– Lord Maurice Saatchi
The rationale for the legislation was, apparently, and as has been written about extensively, to change the law and in turn encourage more doctors to innovate.
His claims have been repeated in briefing documents, in the press, at meetings, in the House of Lords and the House of Commons.
There is no need to change the law of negligence – as this already permits innovative practice. Nor is there any evidence to suggest any case in negligence has arisen due to responsible innovation in treatment, regardless of the outcome. Indeed there are many examples where the legal position is used expressly to favour an innovative approach.
Those responding to the consultation and responding in an unwaveringly loud chorus against the proposals of any variation of the Bill have made it clear that if there are barriers to innovative treatment, the law of negligence is not the issue. Changing it will not help doctors, and will not help patients. Nor will it be inert. It is a deeply misguided attempt that is not based on evidence – ‘a solution in search of a problem and not very sound solution at that’, surmised the National Assembly for Wales. The interim report of the Accelerated Access Review led by Sir Hugh Taylor makes no mention of the law of negligence or the fear of it as an obstruction to accessing innovative treatments. No legal, medical or research organisation supports this assertion either. The proposals would destroy the law that operates responsively and permissively to allow responsible innovation to happen today.
It is time for Chris Heaton-Harris, Lord Saatchi and the Department of Health to recognise when it’s time to stop and- if truly concerned about patients and access to treatments- assess any of the genuine barriers to access and support a change that would help, rather than harm doctors and patients – children like Layla– in future.
Baby Layla was diagnosed with ALL at 14 weeks. She received a bone marrow transplant and chemotherapy but they were not successful. Shortly before her first birthday all normal treatments were exhausted, and her cancer was incurable. Her parents asked if anything else could be done.
A highly experimental therapy – tried only in mice- used TALEN gene editing technology to enzymatically deactivate genes in healthy donor T cells and precisely edit DNA to create ‘designer ‘cells targeted to the cancer that would withstand the necessary medication. After a 1ml infusion of 50m engineered cells over 10 minutes, a second bone marrow transplant 2 months later and now just 3 months down the line, baby Layla has a restored immune response and has been declared ‘cancer free’. This is the first time- ever- that human cells engineered using this technology have been given back to a patient. The first trial of gene editing therapy was published last year, where an approach using a different DNA editing enzyme was used for HIV.
Layla’s case will require very close follow-up and monitoring to ensure that the therapy is as effective as it appears to be, and a trial is planned for the approach next year.
As Professor Waseem Qasim said: “We have only used this treatment on one very strong little girl and we have to be cautious about claiming this will be suitable for all children. But this is a landmark in the use of new gene engineering technology and the effects on this child have been staggering. If replicated, it could represent a huge step forward in treating leukaemia and other cancers.”
Here’s to Layla and her family – fantastic and all the very best!