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Monday, 25 March 2013

Another view of Side Effects - a cautionary tale from Soderbergh

Below are extended comments arising from a Guardian interview by Laura Barnett in the Another View series.

I went to see the Soderbergh film Side Effects expecting a story about drugs and serious side-effects: a version of the Constant Gardner translated from Africa to New York.  Instead I was completely absorbed in a much more complex thriller set within the overlapping worlds of big Pharma, psychiatry, US private medicine, and financial fraud.
The title is very clever, hinting not only at side effects of drugs, but also side effects of lax medical and financial regulation, of a private medical system, of love of money, and of one-to-one interactions of doctor with patient.
A key message of the film: public and professionals should keep an open mind on cause, consequence or incidental link between drugs and side effects.
Jude Law portrays his character Dr Jonathan Banks as flawed but well-meaning and a very astute medical detective when challenged and able to see beyond the US psychiatric culture he is shown as having accepted after training in the UK. When pressed on why has moved to work in the US, he talks about the US as taking a more positive view of health care than the UK, commenting on a greater optimism among US physicians that patients will return to health, rather than his view of the UK where he says clinicians are resigned to illness as the model.
This appears simplistic as Banks also appears drawn by the prospect of greater financial gain within the US private system. He is likely to have moved from a UK NHS, with in the main more severely ill patients referred to him by family doctors, within the UK treatment for all model, in contrast to the US where many of his private outpatients would be likely to be direct self referrals with many nearer the healthy end of the mental health spectrum (ie without GP screening of whom to refer). And in the US having chronic severe disease may lead to patients being no longer able to afford to be seen privately.

This thriller uses a smokescreen of casual interactions among psychiatrists and drug researchers in Pharma, serious risk of powerful drugs, especially in vulnerable patient groups (specifically young people with depression), the judgement of patients and prescribers such as Jude Law’s Dr Jonathan Banks being clouded by financial conflicts in the dominantly private US health system, compounded by direct-to-patient advertising, and the impact of peers on preference for medicines. Both peers as friends of a patient, and advice with little supporting evidence from professional peers such as Catherine Zeta-Jones’s ‘opinion leader’ Dr Victoria Siebert during her contact with Law’s Dr Banks at an educational meeting.
Worth noting that Law’s Dr Banks starts by using an older established treatment for depression with an SSRI (thought to help depression by raising the level of the brain transmitter serotonin at nerve endings). It is only when this appears to be causing unacceptable side effects that he takes advice from Siebert and uses a very new drug - ablixa.
There are several potential risks of private medicine portrayed in the film:
-       Rooney Mara’s Emily threatens to move to another doctor if Jude Law’s Dr Banks does not agree with her treatment preference, a move that would result in loss of income for Banks.
-       A patient’s ‘informed’ consent to take part in a study being run by Law’s Dr Banks (for a personal fee) is biased by being told by Dr Banks that she won’t have to pay for drugs (much more expensive in US) – or tell her health insurance company (with the risk that she would have her premium increased), although Banks does mention his conflict of interest in telling the patient that he is receiving money for carrying out the trial;
-       doctor colleagues ostracize Banks because of concerns about losing business ie patients.
The film raises concerns about US pharma industry strategy to promote selling of drugs, flawed ethics from industry and clinicians in engaging in research ‘studies’ and questions about safeguards in place, especially for new medicines and for people at high risk of side effects, but also at high risks of complications if their disease is not treated.
Side effects can be good or bad – e.g. unexpected and surprising benefit of sildenafil (Viagra) when trialed for angina – or in this film the apparent increase in sex drive associated with a drug prescribed by Jude Law’s character. We see good practice with a dispensing pharmacist listing side effects for Rooney Mara’s Emily – including some unpleasant, others beneficial [although a list spoken too rapidly for a depressed patient to follow].
A better term for harmful effects of drugs is adverse drug reactions (ADRs). These are common and may be serious – estimated in the UK to be a major cause of ~10% of hospital emergency medical admissions or delayed discharges from hospital. The thalidomide scandal led since 1964 in the UK to a yellow card reporting system, with everyone, including patients now empowered to report suspected concerns.
The UK has the advantage of stronger efforts to regulate cost-effectiveness and safety of medicines than shown in the film – joint efforts of:
-       National Institute for Health and Clinical Excellence (NICE) (since 1997; and other agencies in Scotland and Wales);
-       MHRA monitoring system, its suspected adverse drug effect reporting Yellow Card scheme in place since 1964;
-       direct marketing to the public of prescription only medicines being illegal in UK.
-       and in prospect aims from 2015-2016 for a public database of payments from Pharma to health professionals – which would help to reveal conflicts of interest in prescribing, research and medical education
In UK, a new drug such as the ‘ablixa’ in the film would at least during the 2 years after launch have had a ‘black triangle’ warning to prescribers to report any concerns about major or apparently minor adverse drug reactions to the government’s Medicines Agency.
Useful weblinks
Medicines and Healthcare Regulatory Agency Patients concerned about possible drug-related unwanted side effects from psychiatric or other drugs should talk to their doctor or pharmacist. Members of the public can also use the online Yellow Card system to report directly to the government Medicines Agency any serious or worrying problem suspected to be due to a medicine, whether or not mentioned on a patient information leaflet about a drug.
UK All Trials initiative – recommends that all trials should be registered, and full methods and all results reported.

Where science collides with life: short-list for the 2013 Hippocrates Prize

Judges Dalrymple, Shapcott and Highfield at short-listing
A Harvard physician, a rising New Zealand Poet, a BBC Wildlife Poet of the Year from Bristol, and a recent Afghanistan veteran are finalists for this year’s Open International Hippocrates Prize for Poetry and Medicine, at £5000 in both Open and NHS categories, one of the highest value poetry awards in the world for a single poem. Themes ranged from experience of a children’s hospital, to effects of cancer on a friend, the emergency call, and humanity underlying traditional grand rounds.

Now in its fourth year, the short-listed entries for the 2013 Hippocrates Prize for Poetry and Medicine have been selected from over 1000 entries from 32 countries by judges distinguished poet Jo Shapcott, psychiatrist and medical writer Dr Theodore Dalrymple, and Roger Highfield, science writer and Director of External Affairs at the Science Museum Group .

Short-listed poets in the Open Category are American Literature expert Liam Corley from California, Harvard Physician and poet Rafael Campo, from Massachusetts, published poet Matthew Barton from Bristol, in England, and poet, writer and former physiotherapist Sue Wootton from Dunedin in New Zealand.

And competing for the UK NHS 2013 Hippocrates £5000 first prize are family doctor Ann Lilian Jay from LLandysul in Wales, former nurse Ann Elisabeth Gray who runs a care home for dementia in Cornwall, poet and novelist Mary V Williams from Shropshire, hospital chaplain Ian McDowell, from London and midwifery senior lecturer Bella Madden from Milton Keynes.

The winners will be announced at an International Symposium on Poetry and Medicine at the Wellcome Rooms in London on Saturday May 18th.

The judges also agreed 18 commendations in the NHS category and 20 in the Open International category –  1 each from from Ireland, Scotland and Israel, 7 from the USA and 10 from the England, from the Isle of Wight to Yorkshire.

Full list of commended poets, with biographies and notes on inspiration for their poems

Judge Jo Shapcott said: 'The Hippocrates Prize, since its inception in 2009, has quickly established itself as one of the most important international prizes for poetry as well as providing a unique place for poetry and medicine to meet.  Its international reach is reflected in this years prizewinners who come from countries all round the globe, including New Zealand, the USA, Ireland, and Israel.“

She added: “You might imagine that poetry on medical themes would be sad, even grim reading, but far from it.  There was a lively range of subjects and perspectives in this year's batch, and the judges were lucky enough to be debating the merits of some outstanding poems which have in common their sheer brio, skill, and passion, and often an exhilarating deftness in deploying medical language so that it sings.”

Judge Roger Highfield commented 'The Hippocrates Prize for Poetry and Medicine works brilliantly because medicine is where science collides with life. Again and again I found myself transported in mind and spirit to unfamiliar situations where I encountered the memories, experiences and inner emotional worlds of others. I found it enthralling and, at times, disturbing, a powerful reminder of the mysterious way that a few words can herd our thoughts and emotions.'

Judge Theodore Dalrymple remarked “As the Hippocrates Prize once again demonstrates, health care is a fertile source of poetic inspiration. All the poems arise from the need to communicate a deep human experience, and succeed in doing so.”

The awards symposium will consider the relationship between poetry and medicine, with topics including poetry as therapy, using poetry in health professional training, the impact of health and disease on the professional poet and the history of poetry and medicine.

Speakers planned for the awards symposium are from USA, Spain and Switzerland, and the UK.

The Hippocrates Initiative – winner of the 2011 Times Higher Education Award for Innovation and Excellence in the Arts – is an interdisciplinary venture that investigates the synergy between  medicine, the arts, and health.

To attend the Symposium see

Notes to editors
Photos of all of the finalists, along with biographies extracts of their poems are available on request.

For more information, please contact

Awards: In each category there will be: 1st prize £5,000, 2nd prize £1,000, 3rd prize of £500, and 20 commendations each of £50.

The 2013 Hippocrates Anthology of the 46 winning and commended poems will be launched after the Awards Symposium at the Wellcome Rooms in London on Saturday 18th May. Winning and commended poets are entitled to one free copy of that year's anthology.

The Hippocrates Prize judges

Jo Shapcott was born in London. Poems from her three award-winning collections, Electroplating the Baby (1988), Phrase Book (1992) and My Life Asleep (1998) are gathered in a selected poems, Her Book (2000). She has won a number of literary prizes including the Commonwealth Writers' Prize for Best First Collection, the Forward Prize for Best Collection and the National Poetry Competition (twice). Tender Taxes, her versions of Rilke, was published in 2001. Her most recent collection, Of Mutability, was published in 2010 and won the 2011 Costa Book Award. She was awarded the Queen’s Gold Medal for Poetry in December 2011.   Jo Shapcott teaches creative writing at Royal Holloway, University of London.

Theodore Dalrymple is the pen name for Dr Anthony Daniels, who has worked as a doctor in Sub-Saharan Africa, the Gilbert Islands, London and Birmingham, most recently as a psychiatrist and prison doctor. His writing has appeared regularly in the press and in medical publications, including the British Medical Journal, the Times, Telegraph, Observer and the Spectator and he has published around 20 books, most recently The Pleasure of Thinking.

Roger Highfield is the Director of External Affairs at the Science Museum Group. He was born in Wales, raised in north London and became the first person to bounce a neutron off a soap bubble. He was the Science Editor of The Daily Telegraph for two decades and the Editor of New Scientist between 2008 and 2011. Roger has written seven books and had thousands of articles published in newspapers and magazines

Hippocrates Prize Organisers

Donald Singer is Professor of Clinical Pharmacology and Therapeutics, University of Warwick, and President of the Fellowship of Postgraduate Medicine. His interests include research on discovery of new therapies, and public understanding of drugs, health and disease.

Michael Hulse is a poet and translator of German literature, and teaches creative writing and comparative literature at the University of Warwick. He is also editor of The Warwick Review.

His latest publications are: The Secret History (poems, Arc) and The Notebooks of Malte Laurids Brigge (translation of Rilke's novel, Penguin Classics). With Donald Singer he co-founded in 2009 the International Hippocrates Prize for Poetry and Medicine.

2013 Hippocrates Prize is supported by:

The Fellowship of Postgraduate Medicine, a national medical society founded in 1918 and publisher of the Postgraduate Medical Journal and Health Policy and Technology, has supported the Hippocrates Prize since its launch in 2009.

The Cardiovascular Research Trust, a charity founded in 1996, which promotes research and education for the prevention and treatment of disorders of the heart and circulation.

The National Association of Writers in Education, which is supporting the new Young Poets category in the Hippocrates Prize.

Heads Teachers and Industry is also supporting the new Young Poets category in the Hippocrates Prize. HTI is a not-for-profit organisation with over 25 years experience of record of working across business, education and government to raise aspirations and employability of young people.

Thursday, 14 March 2013

Moving the new Personalized Medicine to the Clinic

I am on the Advisory Board for a conference to be held 13-14 May in San Francisco on Personalized Medicine from the perspectives of regulators, biotech and pharma interest, health service funders and patient users of new and emerging technologies in this area.

Trusted doctor-patient relationships form a long recognized key underpinning basis for ensuring as effective as possible disease prevention and treatment. That relationship needs to be supported by a strong evidence base on clinical and cost-effectiveness and safety in use of medicines and supporting diagnostics and devices.

Thanks to economies arising from progress in gene technology (Moore's Law applied to medicine) and advances for exponential increase in active partners in this field (Metcalfe's Law applied to medicine), costs of genetic, genomic and other technologies to stratify diagnosis and treatment choice are becoming increasingly affordable in clinical practice.

The Summit is a one-day conference that will gather biotechnology and pharmaceutical experts and healthcare stakeholders as keynote speakers and panel discussants on legal, regulatory, funding and other key issues that will promote research and development, growth and effectiveness  in the short to medium term horizon for emergence of personalized medicine for clinical care.

The summit is co-hosted by the Personalized Medicine Coalition and Foley & Lardner LLP and is supported by major academic, clinical and industry patrons Life Technologies, Cancer Treatment Centers of America and the California Institute of Regenerative Medicine.

See the Personalized Medicine Summit website for more on the conference and how to register.

Selected papers from the conference will be published in the international journal Health Policy and Technology.

Wednesday, 13 March 2013

Philip Gross joins panel for 18th May, 2013 International Symposium on Poetry and Medicine.

The 4th International Symposium on Poetry and Medicine organised by the Hippocrates Initiative will take place on Saturday 18th May 2013 at the Wellcome Collection rooms in London.

See downloadable Symposium Programme
The symposium will include poster sessions, lectures, round table discussions and poetry readings by TS Eliot Prize-winner Philip Gross and 2013 Hippocrates Awards judge and winner of the Queen's Gold Medal for Poetry, Jo Shapcott).
There will be sessions on historical and contemporary themes, illness and poetry, poetry as therapy, poetry in the education of medical students, nurses and doctors, and poetry as an aid to health professionals. The programme of lectures, round table discussions, poetry readings and the Hippocrates Awards Ceremony will be published on the Symposium website

The winners and commended entrants in the 2013 Hippocrates International, NHS, and Young Poets Awards for Poetry and Medicine will be announced by the judges at the end of the 4th International Symposium on Poetry and Medicine.

The 2013 Symposium Faculty includes:
Theodore Dalrymple (Doctor and writer; 2013 Hippocrates Prize Judging Panel); Michael Hulse (Speaker and Chair; Writing Programme, Warwick): Luz Mar González-Arias (Speaker: University of Oviedo, Spain); Philip Gross (Poet: Professor of Creative Writing, Glamorgan University); Roger Highfield (Director of External Affairs, Science Museum Group, London: 2013 Hippocrates Prize Judging Panel); Anne Hudson Jones (Speaker: Harris L Kempner Professor in Humanities in Medicine, University of Texas Medical Branch, Galveston); Antonios Kousoulis (Speaker, Imperial College, London); Andrew McMillan (Speaker: Liverpool); Hugues Marchal (Speaker: Professor of Modern and Contemporary Literature, Basel University, Switzerland); Cheryl Moskowitz (Speaker, London); Femi Oyebode (Psychiatrist, University of Birmingham); Jo Shapcott (Poet, Royal Holloway College, London; 2013 Hippocrates Prize Judging Panel); Donald Singer (Speaker and Chair; Warwick Medical School); John Riddington Young (ENT Surgeon, West Barton, Bideford).
Keynote speakers
Anne Hudson Jones is Harris L Kempner Professor in the Humanities in Medicine and Professor in the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. She was a founding editor and Editor-in-Chief of the journal Literature in Medicine (John Hopkins University Press), Associate Editor of the Annals of Internal Medicine and has published widely, including a series of essays in the Lancet on literature and medicine.
Hugues Marchal is Assistant Professor of Modern and Contemporary Literature at Basel University. His research includes major interests in relations between poetry and science from 1800 to the present day. He has taught in the USA at Duke University and Johns Hopkins University, and in Paris at 3-Sorbonne. He has published widely on these themes, including the social context of the times.
Register for the Symposium
Submit an abstract for an oral or poster communication

Wednesday, 6 March 2013

Update on 2013 Hippocrates Prize for Poetry and Medicine

The 2013 Hippocrates Prize for Poetry and Medicine now has 3 categories: Open International, UK NHS-related, and Young Poets.

Entries for Young Poets ages 14-18 years remain open until 12 midnight 31st March.  Judging will take place in April.

Short-listing for entries in the Open International and UK NHS-related categories will take place on Monday 25th March in London. The judging panel Jo Shapcott, Roger Highfield and Theodore Dalrymple will prepare a short-list for the top 3 poems in both categories and select 20 further poems in each category for commendation from the over 1000 entries received from 32 countries for the 2013 awards.

Judges Roger Highfield, Jo Shapcott and Theodore Dalrymple
The short-list will be announced during the first week in April. Short-listed and commended poets will be contacted by email. Details of short-listed and commended poets and poems will be posted on tbe Hippocrates Initiative website.
Awards will be announced on 18th May at the 4th International Symposium on Poetry and Medicine at the Wellcome Rooms in London.

Registration and abstract submission are open for the Awards Symposium.

With a 1st prize for the winning poem in each category of £5,000, the Hippocrates Prize is one of the highest value poetry awards in the world for a single poem. In its first 4 years, the Hippocrates Prize has attracted around 5000 entries from 55 countries, from the Americas to Fiji and Finland to Australasia. 

Awards are in an Open category, which anyone in the world may enter, and an NHS category, which is open to UK National Health Service employees, health students and those working in professional organisations involved in education and training of NHS students and staff. 

Co-organizers are medical professor Donald Singer and poet and translator Michael Hulse. The main supporter of the 2013 Hippocrates Prize is UK medical charity the Fellowship of Postgraduate Medicine.

See weblink to register for the Hippocrates in Venice workshop 21-22 September, 2013.

Tuesday, 5 March 2013

Mediterranean diet and Cardiovascular Health

Ramon Estruch, a Spanish researcher on benefits of the Mediterranean diet, will speak in London at a Symposium on Cardiovascular Health on 5th December 2013.

Registration and abstract submission is now open for the Symposium.

Professor Estruch's theme will be outcomes of his multi-centre study reporting that, for patients who already are at high cardiovascular risk, a Mediterranean diet without calorie restriction is more effective than a low fat diet in reducing the occurrence of serious cardiovascular events.

His findings were published in the New England Journal of Medicine at the end of February 2013.

This event is one of a series of Symposia on Cardiovascular Health being held by the CVRT at the rooms of the Medical Society of London, one of the oldest continuing medical societies in the world.

Weblink for 5th December Symposium on Cardiovascular Research.

More on the research by Professor Estruch.

The symposium is being organised by  the Cardiovascular Research Trust.

Saturday, 2 March 2013

Spanish researchers provide evidence for primary prevention of cardiovascular disease by a Mediterranean diet

Professor Ramón Estruch from Barcelona and his colleagues have published in the New England Journal of Medicine results of an important study on the greater value of a Mediterranean diet vs. low fat diet in the prevention of cardiovascular risk.  

In their multi-centre, randomised trial in Spain, 7447 high risk patients with no clinical vascular disease (age range 55-80, 57% women)  were asked to follow one of 3 dietary options:
  • a Mediterranean diet with 
    • extra-virgin olive oil
    • or with  mixed nuts
  • or a control diet with advice to reduce dietary fat.
The primary end point was rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). The trial was stopped early after median follow-up 4.8 years.
What did they find? After adjusting for obvious bias, both Mediterranean diet groups had significantly better outcomes: hazard ratios compared to the control group  (109 clinical events)
- added oil: 0.70 (95% confidence interval [CI], 0.54 to 0.92) - 96 clinical events
- with nuts: 72 (95% CI, 0.54 to 0.96) - 83 clinical events
In other words, the relative risk of serious cardiovascular disease was reduced by one third by following a calorie unrestricted Mediterranean diet vs. a low fat diet. The absolute risk reduction was 3 fewer clinical events for every 1000 patient years of treatment ie ~3 fewer clinical events for every 200 patients following the Mediterranean diet option for 5 years. There were 2-3 future strokes per 1000 patient years of treatment.
Considering the impact of these preventable strokes alone, using UK data as an example, that decrease of 2-3 strokes per 1000 patient years of treatment would represent ~300-450 fewer strokes per year at a saving in direct and indirect health costs, and further societal annual costs of ~£16–25m  [€18-28m].
Of note, patients were supported during the study by regular educational prompts, as well as some free food supplements.
These were clearly patients at high risk from cardiovasular disease either from:
  • type 2 diabetes mellitus or 
  • at least three of 
    • smoking
    • hypertension
    • raised bad (LDL) cholesterol 
    • low good (HDL) cholesterol
    • overweight or obesity
    • family history of premature coronary heart disease
The authors themselves raise the obvious questions whether people not living in a Mediterranean and/or at lower cardiovascular risk would receive similar benefit.
Their results at least however 'support the benefits of the Mediterranean diet for the primary prevention of cardiovascular disease' in patients already at high risk: an important message for policy makers, health professionals, and at least those with the above risk factors for serious vascular events.
Estruch R, Ros E, Salas-Salvadó J et al: the PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med. 2013 Feb 25. [Epub ahead of print]