Thursday, 24 April 2014

Guest Post by Professor Michael Baum

Some thoughts on the Saatchi Bill after 45 years of innovation in cancer research.
Professor Michael Baum FRCS, ChM, MD (hc), FRCR (hc)
Professor emeritus of surgery at Kings College London, the Royal Marsden Hospital and University College London
Past President of the British Oncology Association

I started my career as a surgeon involved in cancer research in 1965 as a lowly CRC research fellow and ended my career in 2013 after stepping down from the directorship of the cancer clinical trials group at University College London. I therefore have a very long first hand experience as a surgeon and clinical researcher dealing predominantly with cancer of the breast.
In 1969 I established the first multicentre collaborative clinical trial that was a stepping-stone that ultimately lead to the break from the dogma of radical mastectomy towards a more conservative and humane treatment of the disease. [1,2] However I learnt the hard way about the ethical dilemmas of challenging clinical dogma and the complexity of organizing multi-centre and multinational trials. Building on that experience I studied the scientific rationale and ethics of clinical research and raised sufficient funds to build the first clinical trials centre in Europe that opened its doors in 1981. [3] With that infrastructure we launched a portfolio of clinical trials that continue to this day. Along the way I published extensively on the scientific and moral philosophy that guides clinical trials and human experimentation. [4,5,6,7,8]
Apart from pioneering breast-conserving surgery [9] we were also the first to demonstrate the survival advantage of adjuvant tamoxifen [10] and later went on to be the first to discover that an aromatase inhibitor (Anastrozole) provided even better outcomes than tamoxifen for post-menopausal women. [11] The use of these endocrine agents has lead to a fall of close on 50% in mortality from breast cancer in the UK. [12]
Although the swing to breast conservation has improved quality of life for women with early stage disease, such treatment conventionally involves up to 22 treatments with radiotherapy spread over 6 weeks and as a result is unrealistic for those women who live a long way from radiotherapy centers or those women in resource poor parts of the globe. With that in mind we invented a new technique for delivering radiotherapy at the time of surgery that can be completed in about 30 minutes. We then tested out this treatment by comparing it with conventional whole breast radiation in a trial with the acronym TARGIT. This trial recruited over 3,000 patients from 11 countries over a period of 12 years. The results recently published in the Lancet, [13,14] confirm that for carefully selected patients, the TARGIT approach is equivalent to 6 weeks of daily visits to a radiotherapy centre.
I believe therefore that I am well qualified to pass an opinion on the Saatchi Bill. I categorically state that in over 40 years first hand experience at the “coal face” on innovative research governed according to the highest ethical principles, I have never once experienced any obstacle that could even indirectly be linked to fear of litigation. 
I do not question for one moment the sincerity and good faith of Lord Saatchi in proposing this Bill, but without any knowledge of the logic of scientific discovery or the practice of clinical research, good intentions and new legislation will not speed up the process.
I could write much about the real obstacles to progress but that is another subject altogether but as a taster, this feature that has just appeared in “Pro Publica”, identifies one of the culprits.

1. Edwards MH, Baum M, Magarey CJ, Myson J.  Treatment of early breast cancer:  The organisation of a national trial.  Br J Surg 1971; 58: 861
2. Cancer Research Campaign Working Party. (Baum M).  Trials and tribulations:  thoughts on the organisation of multicentre clinical trials.  Br Med J 1980;280:918-920
3. The ethics of clinical trials and informed consent
In: Clinical Trials in Early Breast Cancer.
Eds: Baum M, Kay R, Scheurlan H
Pub: William Heinemann Medical Books, London 1981

4. CRC Working Party in Breast Conservation (Faulder C, Peckham MJ, Baum M, et al).  Informed Consent:  ethical, legal and medical implications for doctors and patients who participate in randomised clinical trials.  Br Med J 1983; 286:1117-1121
5.Baum M Scientific and/or Empirical Approach to the Logic of Medical Research In: Medical Ethics and/or Ethical MedicinePub: Elsevier, Paris 1989, 146-152

6. Baum M Randomised Trials:  The Case for Science in Medicine
In: Medical Ethics and/or Ethical Medicine
Pub: Elsevier, Paris 1989, 170-179

7. Baum M The epistemology of surgery
In: Doctors' Decisions - Ethical Conflicts in Medical Practice
Ed: Dunstan GR, Shinebourne EA Pub: Oxford University Press, 1989,133-144

8. Baum M The Ethics of Clinical Research
In: Ethics and Law in Health Care and Research
Ed: Peter Bryne Pub: John Wiley & Sons, 1990, 1-7

9. Fallowfield LJ, Baum M, Maguire GP.  Effects of breast conservation on psychological morbidity associated with diagnosis and treatment of early breast cancer.  Br Med J 1986; 293:1331-1334
10. Controlled trial of tamoxifen as adjuvant agent in management of Early Breast Cancer. Interim analysis at four years by the Nolvadex Adjuvant Trial Orginisation. Baum M, Brinkley DM, Dossett JA, et al
The Lancet Feb. 5th, 1983; 257- 261
11. Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trialists' Group, Forbes JF, Cuzick J, Buzdar A, Howell A, Tobias JS, Baum M Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial. Lancet Oncol. 2008 Jan; 9(1):45-53.

12. Early Breast Cancer Trialists' Collaborative Group (Baum M) [a member of the working group]) A systematic overview of all available randomized trials of adjuvant endocrine and cytotoxic therapy.
In: Treatment of early breast cancer: Worldwide Evidence 1985-1990
Eds: Early Breast Cancer Trialists' Collaborative Group (EBCTCG)
Pubs: Oxford University Press

13. Vaidya JS, Joseph DJ, Tobias JS, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. Lancet 2010;376(9735):91-102.
14. Vaidya JS, Wenz F, Tobias JS, Baum M (on behalf of the TARGIT collaborative group) Risk-adapted targeted intra-operative radiotherapy versus whole-breast radiotherapy for breast cancer:5 year results for local control and overall survival from the TARGIT A randomized trial.
Lancet November 11th 2013

Wednesday, 23 April 2014

Opposing the Saatchi Bill

If you support the following statement in opposition to the Medical Innovation Bill, please send a reply tweet to me, or comment on this post stating your name and position (in particular if you act in a representative capacity for a medical, patient or legal body). By doing so you would be indicating your willingness to be added as a signatory to the statement to be sent as a letter to a national newspaper (if time allows, before 25 April when the public consultation closes).   

We oppose the Medical Innovation Bill (aka The Saatchi Bill) which seeks to promote medical innovation by dispensing with current clinical negligence law in relation to decisions to provide treatment. The Bill is well-intentioned but fundamentally flawed.

Current clinical negligence law provides redress to patients who have suffered harm as a result of treatment which would not be supported by any responsible body of medical opinion. This Bill seeks to remove that right of redress where a doctor has taken a decision to treat in what the Bill defines as a "responsible" manner, even when no other doctor would support the treatment actually given. We do not believe that depriving patients of the right of redress is the best way to promote medical innovation.

The Bill is unnecessary. The current law on clinical negligence is no impediment to responsible innovation. It requires only that treatment should be supported by a responsible body of medical opinion, even if the majority of doctors would not support it. Innovative treatment is not negligent unless no responsible body of medical opinion would support it. That is a sensible check on irresponsible experimentation.

The proposed legislation is not well targeted. The Bill does not define "medical innovation". It would remove liability for negligent treatment whether such treatment is innovative, outdated or spurious. 

The Bill has nothing to say about the regulation or funding of innovative treatment.

The Bill does not adequately protect patients, in particular vulnerable patients whose conditions might lead them to look for obscure or untried treatments. It does not require that decisions to treat must be approved by governing bodies, ethics committees or any other doctors, only that the individual doctor making the decision has considered certain matters and has acted in an open and accountable manner.*

Proponents of the Bill have claimed that it will "change medical history" and lead to a cure for cancer. Those claims are misleading and prey on the hopes of those with cancer and their loved ones. This Bill should not become law and the government should look at other ways of promoting responsible medical innovation.

Nigel Poole QC, Kings Chambers, Manchester

For further information see my previous posts

Many many thanks for the positive response to this post and to those below. If I have mis-ascribed you then please let me know. Thanks in particular to Suzanne White and Professor Baum who has also provided a guest post. Already the MDU and APIL have issued statements opposing the Bill, as have solicitors such as Irwin Mitchell. I am hopeful that a letter will appear in a national newspaper on Monday 28 April.

As at 26 April 2014 the following have agreed this statement: Suzanne White, Partner on behalf of Leigh Day Solicitors, Professor Michael Baum, Emeritus Professor of Surgery, UCL and past President of the British Oncology Association, Peter Walsh, CEO Action against Medical Accidents, Matthew Stockwell, President, Association of Personal Injury Lawyers, Stephen Webber, Chairman of the Society of Clinical Injury Lawyers, Catherine Collins, Chair of England Board, The British Dietetic Association
Keith Isaacson, Chairman, HealthWatch, Alan Henness, Director, The Nightingale Collaboration
Laura Thomason, Good Thinking Society, Margaret McCartney, GP, author and broadcaster
Professor John McLachlan, Professor of Medical Education, Durham University, Professor Richard Ashcroft, Professor of Bioethics, QMUL, Professor David Curtis, Honorary Professor of Psychiatry
Kate Rohde, Partner, Kingsley Napley LLP, Edwina Rawson, Partner, Field Fisher Waterhouse LLP
Dr Simon Taylor QC, Amanda Yip QC, William Waldron QC, Henry Whitcombe, Barrister, Dr David Nicholl, Consultant Neurologist, Les Rose, Clinical Research Consultant, Dr Darren Conway, Solicitor
Benjamin Dean, Orthopaedic Registrar, Nuffield Orthopaedic Centre, Oxford, Richard Borrett, Barrister
Lindy Williams, Paula Ashton, Azalea Read, Diane Lyall, Solicitor, Jack Skellington, Roger Fisken, Consultant Physician, Steve Cornforth, lawyer, author and blogger, David Hills, Michelle Beckett, Killian Garvey, Peter Novakovich, Lucy Barker, James T Randall, Jo Brodie, Nicola Jenkins, Caroline Aspinwall
Adam Gyulani-Lancaster, Mark Slater, Partner PSG Solicitors, Tabatha James, David Ratcliffe, S Hart, Ben Harris, Kiri Shala, Roy Omond, David Brims, Andrew Buckley, Robert Kane, Jonathan Hartley, Robert Kane, Darryl Allen QC, Alan Lodge, John Bates, Geoff Silva, David Marshall, Sandra Patton, Muiris Lyons on behalf of Stewarts LLP, Dr Fiona Hamilton, Hamish Morrin, Angelina Curtis, Dr Peter English

*As amended in the House of Lords the requirement is now for a doctor to obtain an opinion from at least one appropriately qualified doctor about the treatment and then to take that into account in a responsible manner.