Saatchi Bill – not useful and potentially dangerous

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

17 Responses to “Saatchi Bill – not useful and potentially dangerous”

  1. Nigel Poole QC April 20, 2014 at 11:46 am #

    Could not agree more. Well said. I only hope that the government will listen to sense rather than the well-intentioned but ill-informed stuff being written in support of the Bill . I am not sure that the ramifications of this Bill are being appreciated and it is disappointing that many representative bodies are not making their views public during the public consultation process.

  2. Keith Walker April 20, 2014 at 1:04 pm #

    Just an analogy – I have a new type of steel here. I think it might hold up this planned primary school building, but we haven’t tested it in a proper manner. However, I’ll give it a go and we’ll see. OK? Er, probably not.

  3. Suzanne WHite April 20, 2014 at 9:18 pm #

    Totally agree with both you and Nigel. But the message needs to get out there.

  4. Terence Waites April 20, 2014 at 11:06 pm #

    Excellent summary. Now we need a real campaign to stop this. Need to encourage everyone to write to MPs and the press. The most concerning bill I’ve seen for a while.

  5. Michael Baum April 21, 2014 at 9:11 am #

    In support of Dr. McCartney’s excellent deconstruction of the bill I would like to make this simple yet unequivocal statement. I started my career in cancer research shortly after gaining my FRCS in 1965 and eventually ended my career on retirement from University College London in 2013. That is close on 50 years experience at “the coal face”
    During that time I held chairs of surgery at Kings College London, the Royal Marsden Hospital as well as UCL. Under my leadership, working with an international group of collaborators, we were responsible for many innovations that directly or indirectly lead to significant improvements in the length and quality of life of women diagnosed with breast cancer. Along with groups in the USA and Italy, we lead the revolution from radical mastectomy to breast conserving surgery thus improving the patient’s quality of life. Perhaps of greater importance was our pioneering work on adjuvant endocrine therapy with antiestrogens (tamoxifen) and aromatise inhibitors. These approaches have contributed to a 30-40% fall in breast cancer mortality in the last 40 years. NEVER ONCE HAVE I ENCOUNTERED INTERFERENCE OR OBSTRUCTION ON LEGAL GROUNDS. There are of course many other obsticals to progress as pointed out by Dr McCartney. In other words changing the law with this bill is not going to accelerate innovation in cancer therapy but might as a result of unintended consequences allow endanger our patients with uncontrolled experimentation.

  6. Darren Conway April 21, 2014 at 9:45 am #

    Whilst I understand the emotional driver that appears to be behind this Bill I fear that it will fail to meet it’s stated objectives. Professor Baum’s comments (above) are instructive.
    My concerns are summarised here – http://www.injuredpatientclaims.co.uk/2014/04/dr-maverick-i-presume/
    I have made submissions, dealing with the substance of the Bill, to the Department of Health website. The matter is to serious to ignore.

  7. John Saunders April 21, 2014 at 8:58 pm #

    I agree with the comments made and Professor Baum’s comments in particular provide authoritative reasons for opposing this proposal. One of its implications would be the pressure on doctors to depart from recognised standards of care, which in practice may be difficult to resist. ‘Plausibility’ begs the question of plausible to whom?

  8. Professor Stephen Kennedy April 29, 2014 at 9:37 pm #

    Unfortunately, Dr McCartney has misunderstood the fundamental purpose of this bill, which seeks to offer patients hope when the evidence base is either lacking or uncertain.

    The bill certainly does not seek to prohibit research but simply recognises that research has provided too few answers.

    Lastly, as someone who helped draft the wording of the bill, it was very important to make ‘quackery’ more, not less, difficult to practise than at present.

    That explains why the bill puts in place measures, such as the requirements to involve a multi-disciplinary team and seek approval from a Responsible Officer, so as to ensure that clinicians act responsibly and only offer biologically plausible innovations.

  9. Charlie Chan April 29, 2014 at 10:34 pm #

    I welcome Dr McCartney’s comments on this important Bill. As she rightly says, much could be done to improve the status quo.

    The Bill is in the process of re-drafting. The consultation is likely to take into account the many comments from patients and doctors. Many of the concerns raised in the consultation have centred on the issue of possible “quackery”.

    The Bill’s critics have suggested that this new piece of legislation might encourage non-scientific “experimental” treatment, which might be viewed as bordering on charlatan behaviour. However, the Bill does have important safeguards to ensure protection for the patient, and scientific advancement.

    Dr McCartney has concerns that this Bill will lead to reduced scientific integrity and a lower emphasis on clinical trials. In fact, the Bill will only protect doctors, who are planning to treat patients, who have exhausted standard treatments AND existing suitable clinical trials.

    For some patients with common life-threatening diseases (e.g. breast cancer, bowel cancer, heart disease), there may be several standard treatments and a multitude of trials. However, for patients with rare diseases, there is often no treatment at all and few if any randomised trials. If one considers the sum total of patients with “rare cancers”, their sum total exceeds the number of new cases of the top 4 cancers every year in the UK. Yet for this significant proportion of rare cancer sufferers, there are few treatments and a dearth of clinical trials.

    For patients, both young and old, with rare diseases, the current scientific model of large randomised clinical trials means that they are predominantly excluded from scientific research and the development of new treatments. It is surely not the right thing to do to ignore this large number of patients, for whom the current status quo is failing.

    An important concept being considered for this Bill is a Central Data Repository, which would record all patients having novel treatments. Ideally, this should be open access to both doctors and patients, so that people are able to learn rapidly about the efficacy, if any, of novel treatments for these difficult clinical problems.

    Rather than inhibiting the development of clinical trials, this data repository can then provide a valuable resource for generating novel hypotheses for new studies. These clinical trials can then underpin any promising benefits shown by patients having innovative treatments.

    Thus, the current status quo of clinical practice, based predominately on the randomised clinical trial, might even be improved, and a sensible balance struck between evidence-based medicine and responsible innovation. As Sir Austin Bradford Hill, one of the godfathers of modern clinical trials, said in 1966 that “Any belief that the controlled trial is the only way would mean not only the pendulum had swung too far but that it had come right off its hook.” Perhaps now this Bill might restore the pendulum into its rightful position.

    Charlie Chan DPhil FRCS
    Consultant Surgeon, Cheltenham

  10. Clark Russell June 11, 2014 at 2:32 pm #

    The introduction and use of alternative therapies is the right way to go. Unfortunately the medical establishment are out of touch on what they are and how to implement them, probably because they have no training in this field. I would assume this is because it would eat into Big Pharma profits from their poisons.

    The medical establishment has had its chance to address the major diseases including cancers and contrary to what some say on here, have not really made that much progress in the the past 20 years.

    For example, take a look at Cancer UK’s dietary guidelines; surprise surprise!, it looks like the NHS and Government’s Eatright Plate, designed by public sector lunatics or people who knew what they were doing, but had to appease the food and Big Pharma industries; take your pick on which one it is.

    Clark Russell

    • Terence Waites June 18, 2014 at 10:14 pm #

      That single statement by Clark Russell summarises neatly why Dr Margaret McCartney still has a lot of work to do to ensure that the thousands like him do not get to influence the legal system and the medical trials system adversely. Science-based medicine has not been under so much pressure, this at a time when it has produced and is still producing some amazing successes. The answer of course is to increase funding of scientific investigation and good trials. The answer is not to turn to “Alternative Medicine”. The alternative to medicine is not medicine, it’s quackery.

      • Clark Russell June 18, 2014 at 10:28 pm #

        I’m afraid Mr Waites,

        It is folk like yourself that are the problem. Science based medicines are doing very little and the trial data is more often than not, manipulated to suppress the actual efficacy of drugs and their side effects. What planet are you living on?

        The system is rotten to the core; run by Big Pharma, not Government or doctors.

        I suggest you read Begley and Ellis 2012 and Marketing Global Healthcare: The Practices of Big Pharma by Kalman Applbaum.

        It’s modern medicine that is garbage; I don’t know what bubble you live in.

        Clark

        Clark

  11. Peggy Banks October 26, 2014 at 12:21 pm #

    I think drugs are often used without proper tsting anyway. I say this because I was given benezodiaipines for quite a few years (without a diagnosis unfortunately). I stopped taking them 20 years ago and I am still waiting for thelast of the effects to clear up.

    • clark russell October 27, 2014 at 8:54 pm #

      Hi Peggy,

      You are correct. Most drugs don’t work as in address the root cause. That’s why they don’t work and Big Pharma know it and that’s why they cook the clinical trial results. The regulatory authorities are scared because of the pressure the drug companies exert on Government.

      Doctors are only a small cog in the big wheel, so their hands are tied. Also doctors have little or no nutrition expertise to be able to recommend much more effective plant based therapies.

      Its a big game of high stakes economics; $800 Billion a year drug profits. Time for the NHS to wake up and smell the coffee.

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