This is the Saatchi Bill .

This is the consultation document  .

Here’s where you can respond  – until 25th April.

Here’s my

Response to Draft Legislation of Medical Innovation Bill.

1. I am  GP in Glasgow. I also write and broadcast for the medical and lay press. I have a strong interest in evidence based medicine and ethics.

2. I believe this bill is unnecessary and potentially dangerous.

3. 1) 1) ‘responsible innovation’ is a misnomer. It is possible to know prospectively that some innovations would be irresponsible, as they are contrary to the best scientific or clinical knowledge. However what is  a ‘responsible innovation’ will only be obvious, in some cases, in retrospect. This description cannot be used reliably to distinguish good and bad practice in medicine.

4. 1) 2) It is currently not negligent for a doctor to depart from the existing range of medical guidelines for a condition.

5. 1)3) This section would support any number of evidence –free interventions in any number of alternative or complementary medicine sectors, as well as those clinics and hospitals promising life saving treatments and breakthroughs despite the absolute lack of trial evidence for their interventions.

6. 4) This paragraph basically allows any doctor to do propose anything and for it to be decreed ‘reasonable’. I am very clearly not a lawyer, but to pretend that this gives patients any protection from naked quackery would be misguided.

7. 5) It is impossible for doctors trying untested treatments to know what the relative risks or benefits of an intervention might be. If doctors knew these, then the intervention would either be accepted medical practice, or not.

8. 5) e) This is quite odd. The treating doctor can decide which opinions on the intervention are appropriate to take into consideration, or not. Who is protecting the patient?

9. 6) One can only have transparency and accountability if one accepts that an experimental intervention is, in fact, an experimental intervention.

10. 7) The decision making can only be transparent if the treating doctor is clear about

–        The experimental nature of the intervention

–        Whether a systematic review has been undertaken to elucidate whether or not this intervention has been trialled before and what the results were

–        What the others in the  ‘multidisciplinary team’ had to say about it

–        What other consultants in the same position would recommend (ie a second opinion)

11. 8) In fact, the only ethical permission in these circumstances would be to treat the intervention as ‘research’ which this section seeks to expressly forbid. If the intervention was treated as research, then

–        This would mean that a systematic review of the current knowledge would be done

–        It would mean that the research question should be stored in the Uncertainties Database DUETS http://www.library.nhs.uk/duets/

–        It should necessitate the need for Ethical Committee oversight, independent of the treating doctors, and protecting the patient

–        It would mean that results were stored and published, so that either a dangerous or ineffective intervention did not continue to be offered needlessly and unknowingly to other patients

12. 8) b) It is also impossible to say what is in the ‘patients best interests’ because the uncertainty of the effectiveness of the intervention has not been acknowledged. It is impossible to know whether the intervention being offered is useful or dangerous. This uncertainty should be shared with patients both present and future.

13. Other points

I am not aware of any need for this law.

This proposed law is not sufficiently capable of protecting patients against medical experimentation which may cause continued and repeated harm, either within complementary or orthodox medical practice.

14. There are however things that could make the situation regarding research at the end of life better for patients now and in the future.

– medical ethics committees tend to run very slowly. There should be capacity for faster turnaround. Some of this is due to the lack of funding and voluntary nature of participation

. -research is still sometimes done without a systematic review first, which may negate the need for further trials, see http://www.bmj.com/content/313/7069/1390, https://www.researchgate.net/publication/11550627_Lessons_for_research_ethics_committees

– medical ethics committees sometimes will continue to approve trials where good evidence either for or against an intervention already exists, potentially harming patients , http://jme.bmj.com/content/28/1/1.full

-medical ethics committees will sometimes not approve trials where consent may be difficult to obtain, but the end result is that people are left unprotected because important questions never get answered, subjecting people to unnecessary risks.http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(03)14164-5/fulltext

In summary

The proposed law is unnecessary and potentially dangerous.

There are improvements that should be made in terms of clinical research at the end of life, but this bill does not address them.

Margaret McCartney 19/4/14