My son Daniel

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By David Thomas

The Medical Innovation Bill encourages doctors to take responsible risks, if this is what a fully-informed patient wants. Ensuring appropriate safeguards is, of course, vital.

The Bill should be seen as part of a wider picture. Palliation apart, the aim of medicine is to give those suffering from serious conditions the best chance of getting better. A statement of the obvious, perhaps, but in my experience it does not always happen.

My son Daniel, then aged 17, was diagnosed with a life-decimating bone cancer, Ewing’s sarcoma, in 2006. He had the standard treatment and was well looked after. He got into remission and on with his life. But prognosis was dismal.

So, naturally, we scoured the world for possible solutions. I found out about insulin growth factor inhibitors. There was a good deal of excitement about them in the Ewing’s world at the time. Unusually for cancer treatment, there seemed to be few side-effects. There were a number of clinical trials. A principal criterion for Roche’s was that a patient must have disease measurable by scan, standard in oncology so that efficacy can be measured. At that time, Daniel, in remission, had no measurable disease.

But a special diagnostic test, RT-PCR, indicated that he still had microscopic cancerous cells, as was expected. Now was the time to hit those cells, when they were at their weakest and had not mutated. We needed Roche to accept Daniel onto their trial, either by interpreting the criteria flexibly (I’m a lawyer and provided the interpretive ammunition) or by extending them to include RT-PCR–positive patients. If the inhibitor killed Daniel’s microscopic cells, Roche could chalk up a response. The company blanked me. Daniel’s doctor, involved with the UK trial, appeared unwilling to advocate for his patient and felt constrained by confidentiality not to release important information, an intolerable situation.

I turned to the MHRA, the UK clinical trials regulator. My argument was that, with rare conditions (especially involving children), the MHRA had a duty to ensure not only that trials are safe but that they produce as much useful data as possible. Allowing RT-PCR-positive patients onto the trial would increase the data pool. However, the MHRA responded that, safety apart, trial criteria were for the drug company.

I was willing to take the regulator to court. But Daniel then tested negatively in another RT-PCR, in Barcelona. This was great news but it effectively destroyed my legal arguments. We put the inhibitor on the back-burner.

Daniel eventually relapsed. After much failed treatment, he had a different IGF inhibitor but, although he showed some response, his cancer was by now far too powerful. He died in October 2011, just short of his 23rd birthday, a classics student at Oxford, full of dreams and promise and surrounded by love.

Would earlier access to an inhibitor have helped? It is fair to record that overall they have been a disappointment. But there have been some remarkable results. Sadly, the system was not flexible enough to allow Daniel access at the most opportune time. That might just have cost him his life and much suffering (and the NHS tens of thousands of pounds on wasted treatment).

Medical treatment should seek to squeeze every last drop out of current knowledge. There are many aspects to that, not least ensuring that clinical trials are regulated for the benefit of patients, not the convenience of pharmaceutical companies.

Lord Saatchi’s Bill has the laudable aim of putting the interests of seriously ill patients at the heart of decision-making.  Everyone, surely, must support that objective.


David Thomas is a consultant to Bindmans LLP and for several years was legal officer to Child Poverty Action Group. He is a former chair of the RSPCA, trustee of Compassion in World Farming and member of the advisory panel for Burma Campaign UK and is currently a trustee of a Casa Alianza UK, a street children charity.

He has written extensively about legal and related issues, especially in the campaigning context, and used to teach judicial review and human rights law, primarily in the context of welfare benefits.

He is a former member of the Law Society’s mental health and disability committee and of the Legal Services Commission panel advising on the grant of legal aid in public interest cases. He is also a part-time judge. 

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