This week Jeremy Hunt announced his support for Lord Saatchi’s Medical Innovation Bill. The bill, which reaches a crucial committee stage in the House of Lords tomorrow, makes it easier for dying patients to access untested drugs and treatments on the NHS.
Lord Saatchi’s wife died of ovarian cancer - a terrible disease.
But I am unconvinced that the Saatchi Bill will solve any of the problems currently faced by patients dealing with such terrible diseases.
I am a Consultant Neurologist. I rarely see patiets with ovarian cancer, but I see plenty of patients with rare, devastating neurodegenerative disorders, such as motor neurone disease (think ‘Ice Bucket challenge’) or Creutzfeldt-Jakob disease (including some cases of ‘Mad Cow disease’). These are life-threatening disorders - which currently have no known cure.
I have to explain such disorders to patients and their families and manage their expectations. They are feeling extremely vulnerable. There is the shock both of the diagnosis and how to manage the illness.
When people are desperate they will seek all manner of different options.
It is vitally important that people suffering from such diseases are protected from those who seek to exploit the vulnerable. The law should also encourage genuine, desirable innovation. I am unconvinced that this Bill if passed will do either. I fear it will instead open the door to legal bunfights - and to charlatans.
Patients will be more vulnerable to being exploited like charlatans, like Dr Trossel - who offered ‘stem cells’ for multiple sclerosis (MS).
Another multiple sclerosis treatment that received wide publicity was that of Professor Zamboni, a vascular surgeon from Italy. Zamboni’s team called the condition ‘chronic cerebrospinal venous insufficiency’ (CCSVI) and reported amazing results for venous stenting procedures.
The Lancet reported “…widespread criticism of the media hype associated with the CCSVI hypothesis, which has been partly promoted by some of the investigators and has caused a whirlwind of exaggerated claims and expectations. For example, there is a CCSVI page on Facebook; a newsletter dedicated to the syndrome is sent to thousands of patients with MS …..and, according to a press release about a meeting… in which Zamboni presented his studies, ‘endovascular therapy showed a decrease in the number of disease relapses, a marked reduction in the number of active brain and spinal lesions, and also a clear-cut improvement in the patients' quality of life’.”
There was no randomized evidence to support these claims, and still isn’t.
But as a result of these claims, many patients with MS started asking for this treatment. One of my patients went to Eastern Europe, even though I explained there was not a shred of evidence. At least one patient died and another had to have open heart surgery following the stenting procedures.
In 2012 the US and other regulators sent out warnings about CCSVI. I have not heard a word about CCSVI from a patient or anyone else since.
Is this really the kind of ‘innovation’ that Lord Saatchi wants to promote?
If the Saatchi Bill had been in place in 2010, I could easily have had patients demanding to have such an unproven (and potentially harmful) treatment. Would I be guilty of ‘willful neglect’ for not referring such patients for treatment?
Perhaps I might be thought overly cautious, and opposed to innovation.
Not at all. I was a local investigator in the largest pragmatic treatment trials in Parkinson’s disease (PDMED), epilepsy (SANAD) and stroke thrombolysis (IST3). I strongly support of clinical trials - indeed my own daughter was entered into one even before she was born. Lord Saatchi claims his bill will help innovation, including in urgent situtions such as the Ebola outbreak. But clinical trials can already be expedited in such circumstances. This is exactly what happened when we faced the very real concerns about rising numbers of human BSE cases some years ago. The results were negative - but it happened.
The fact that the government suppot this Bill merely shows how disappointingly low is their understanding of science and medicine. One can only hope that the worst damage of this Bill can be limited by amendments.
The way to promote truly useful innovation is not through poor legislation such as the Saatchi bill, but on improving the infrastructure for proper clinical trials. That is the real way to improve patient care.
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