Wednesday, 18 November 2015

Ministerial Response to Off Patent Bill

Please see response below from the Department of Health to the letter that was published in that austere British broadsheet, The Telegraph, earlier this month. The DoH's response, although predictable, is surprisingly clear and sensible. The signatories, including Prof G, clearly didn't think through all of the issues. Obviously we need more discussion and clarity about the use of the terms 'off-label', 'off-license', 'off-patent' and 'repurposing'. Prof G now feels quite foolish about how naive he was in formulating, and taking, a public position on the Off Patent Drugs Bill. Let's hope he learns from this experience.


SIR – The Government must act in order to address the widespread variation in access to low-cost, clinically effective treatments.
On November 6, Nick Thomas-Symonds’s Off-Patent Drugs Bill will be debated in the House of Commons. By reducing the barriers to the availability of repurposed drugs on the NHS, this Bill has the potential to save lives.
We fully endorse the principles of this Bill and hope the Government will support it so that it becomes law. It could benefit hundreds of thousands of people – some of whom currently face limited treatment options – with a range of diseases, including cancers of breast, prostate, brain and blood, as well as multiple sclerosis, Parkinson’s disease and Alzheimer’s disease.
It is vital to have a mechanism in place to ensure that drugs that have been shown to be clinically effective in a new way can be made routinely available to patients who need them.
Dr Giles Maskell
President, Royal College of Radiologists
Ian K Ritchie
President, Royal College of Surgeons of Edinburgh
Professor J Michael Dixon
Professor of Breast Surgery, University of Edinburgh
Professor Ian Smith
Head of Breast Unit, Royal Marsden
Sir John Burn
Professor of Clinical Genetics, Newcastle University
Dr Jeremy Chataway 
National Hospital for Neurology and Neurosurgery
Professor Jack Cuzick
Head, Centre for Cancer Prevention
Director, Wolfson Institute of Preventive Medicine, Queen Mary University of London
Professor Susan Short 
Professor of Clinical Oncology and Neuro-Oncology, Leeds Institute of Cancer and Pathology, St James's University Hospital
Professor Gavin Giovannoni
Professor of Neurology, Barts and the London School of Medicine and Dentistry
Dr Alistair Blair
Chief Clinical Officer, NHS Northumberland CCG and GP
Professor Andrew Tutt
Professor of Oncology, King's College London
Head of the Division of Breast Cancer Research, Institute of Cancer Research, London
Dr Klaus Schmierer
Reader in Clinical Neurology and Consultant Neurologist (Hon), Blizard Institute (Neuroscience), Queen Mary University of London, Royal London Hospital (Barts Health NHS Trust)
Professor Sanjeev Krishna 
Institute for Infection and Immunity, St George's, University of London
Professor David A Walker
Professor of Paediatric Oncology, Children's Brain Tumour Research Centre, University of Nottingham
Dr Richard Baird
Academic Consultant in Experimental Cancer Therapeutics, University of Cambridge
Honorary Consultant in Medical Oncology, Addenbrooke's Hospital
Professor Graham T Layer
Consultant General and Breast Surgeon, Royal Surrey County Hospital
Visiting Professor of Surgical Sciences, Surrey University
Professor Johann de Bono
Head of the Division of Clinical Studies, Institute of Cancer Research, London
Professor Robert Coleman
Yorkshire Cancer Research Professor of Medical Oncology, Academic Unit of Clinical Oncology, Weston Park Hospital, University of Sheffield
Professor Robert Huddart
Professor of Urological Cancer, Institute of Cancer Research, London
Professor Gareth Evans
Professor of Genomic Medicine and Cancer Epidemiology/ Honorary Consultant Clinical Geneticist, Manchester Centre for Genomic Medicine, University of Manchester
Professor Ian Judson
Professor of Cancer Pharmacology, Institute of Cancer Research, London
Professor Peter Schmid
Centre Lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London
Dr Marc Tischkowitz
Reader and Honorary Consultant Physician in Medical Genetics, Department of Medical Genetics, University of Cambridge
Professor Anthony Howell
Professor of Medical Oncology/ Research Director, Genesis Breast Cancer Prevention Centre, University Hospital of South Manchester NHS Foundation Trust
Professor Carlo Palmieri
Professor of Translational Oncology, Clatterbridge Cancer Centre, University of Liverpool
Dr Alistair Ring
Consultant Medical Oncologist, Royal Marsden NHS Foundation Trust
Dr Ellen Copson
Associate Professor in Medical Oncology and Honorary Medical Oncology Consultant, University Hospital Southampton Foundation NHS Trust
Dr Sacha Howell
Senior Lecturer and Honorary Consultant in Medical Oncology, University of Manchester
Department of Medical Oncology, Christie NHS Foundation Trust
Professor Adrian L Harris
Professor of Medical Oncology, Department of Oncology, Oxford University
Dr Nick Turner
Team Leader in Molecular Oncology, Institute of Cancer Research, London
Professor Trevor Powles
Medical Director, Cancer Centre London
Professor D J Dodwell
Institute of Oncology, St James Hospital
Stephen R D Johnston
Professor of Breast Cancer Medicine and Director of Breast and Plastics Clinical Business Unit, Royal Marsden NHS Foundation Trust
Professor Nandita de Souza
Professor of Translational Imaging, Institute of Cancer Research, London
Professor Devinder Kumar
Department of Surgery, St George's, University of London
Charlie Chan
Consultant Surgeon, Cheltenham Nuffield Hospital
Dr Matt Williams
Consultant Neuro-Oncologist and Honorary Clinical Lecturer, Imperial College
Dr Adrian Harnett
Consultant Clinical Oncologist, Norfolk and Norwich University Hospital NHS Foundation Trust
Honorary Senior Lecturer, University of East Anglia
Professor Mark Hull
Professor of Molecular Gastroenterology and Consultant Gastroenterologist, University of Leeds and Leeds Teaching Hospitals Trust
Professor C Oliver Hanemann
Plymouth University Peninsula Schools of Medicine and Dentistry


13 comments:

  1. What a slap down. Shame on you all. You have wasted a golden opportunity that may not come around again in a hurry. You have let down the MS community.

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    1. Excuse me. Before you start berating ProfG get your facts straight!

      The Bill was devised by an MP and not ProfG and we were never consulted . If you in fact read what ProfG believes would have been the way forward, it would not be this bill, it was always flawed and we knew that however, having it debated propertly would have aired these flaws, such that something more sensible could hav It was anti-business and if there was incentivising actions like an altered orphan drugs act then you would be encouraging ing pharma to pay for the trials

      However, it is all well an dandy for doctors to prescribe off-label, but based on what evidence?. One phase II, one phase III data and who will colate the safety data because it may not be safe in MS, but you wait for the case reports to appear.

      Should I suggest you all run down to your local GPs and get on amiloride as there has been one good EAE experiment and a phase I/II.

      Should I suggest all PPMSers go to their GPs and rneuros and demand rituximab as there is the trial data from one phase II trial and the ocreluzimab data for 1 phase III that if you have gadolium positive lesions and have a short disease duration and below 50 then it is clear that this will have some benefit. This seems pretty solid to me

      However will GPPs pay for this....no because they will protect their budgets and rituximab is not cheap, and will the trusts pay for it because it has not been NICEd

      We have had a few people treated this way but then the Hospital said no or people had to pay for it themselves.

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  2. MD I suggest you send Prof G on a course in translational politics. Naive is an understatement.

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  3. I am suitably chastised. What do you want me to do; self flagellate in public?

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    1. I remain impressed by your activism and desire to do better.

      Maybe a little bit collaboration with lawyers or lawyerly types (pollies and/or policy makers) when it comes to proposed legislation and its effects lol.

      I had a prominent Australian neurologist give my partner advice about breast cancer risk once. I believe you know the neurologist in question (out of the many australian neurologists you know). I took about 80 hours out of my life, wrote an 8 page evidence based paper showing that the breast cancer risk in my partner's situation has actually been found to be slighly less than for general population, ran it past my partner's old oncologist and her haemo, then, with my parnter's permission, sent it to the neurologist and tore the neurologist to shreds for using my partner's past medical history to scare her without foundation. I invited the neurologist to speak with my partner's oncologist and haematologist about the issues and provided their contact details. Suggested that the neurologist refer future patients facing similar issues to oncologists rather than providing advice on things outside the sphere of neurological expertise. I received a 5 line response back, to the effect of 'Thank you for your letter, I'm glad you decided to research the issue and consult with other professionals. Still, I feel it is my responsibility to warn patients about theoretical cancer risks."

      That neurologist, I'm sure, neither beat themselves up over causing my partner excessive disabling fear over a 2 week period nor did the neurologist feel like they should be chastised. I suspect the neurologist may still be fulfilling their "responsibility" to warn patients with prior cancer history about theoretical cancer risks instead of sending them to oncologists/haemos. My partner was terrified for 2 weeks until I dragged her to see her oncologist and haemo.

      ....

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    2. That neurologist, I'm sure, neither beat themselves up over causing my partner excessive disabling fear over a 2 week period nor did the neurologist feel like they should be chastised. I suspect the neurologist may still be fulfilling their "responsibility" to warn patients with prior cancer history about theoretical cancer risks instead of sending them to oncologists/haemos. My partner was terrified for 2 weeks until I dragged her to see her oncologist and haemo.

      Why should you be chastised? You identified a problem, backed the wrong horse, no one suffered as a result (other than perhaps your pride a little bit) - but the problems that prompted the initial letter that you signed remain and need resolution. What's the next step? (activism is admirable but time consuming lol).

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    3. Just thought I'd mention my neurologist diagnosed my breast cancer after a leading specialist cancer hospital missed it.

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    4. yes so now all neurologists should give breast cancer advice?

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    5. If mine didn't I would be dead. He doesn't specialise in MS, but he saved my life.

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  4. Maybe Sir Chatalot can join you? You could even do it raise money for the MS Society.

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  5. Well I for one am heartened by the response, as it sounds like there is a real desire to get 'off x n' drugs which could be/there is evidence for, being prescribed, and that htere is a mechanism being worked out. Don't self flagellate too much, ProfG, without publication of the letter you - and we - may not have learnt all of what is in the response, for quite some time yet.

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  6. Hansard's reported on the bill debate which was held on 6th November.

    I read this in it's entirety, and one of the MP's, who was also a doctor, stressed that prescribing a re-purposed drug could result in potential claims against her personally if something went wrong. She wanted the bill passed so that she could help her patients without suffering financially should the drug prove damaging.

    Perhaps the secretary of state can give indemnity to GP's who prescribe re-purposed drugs where circumstances suggest some benefits might apply? As this is extremely unlikely, some other course of action needs to be identified and debated.

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    1. This is obviously, the main concern for doctors and there nneds to be action on this indemnifying doctors who treat-off label where evidence suggests it could be of benefit without the legal threat should there be an adverse event.

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