Presenting
the 2009 HealthWatch Award, Nick Ross said, “Iain Chalmers has saved more
people’s lives than anyone else I can think of.” Iain Chalmers,
editor of the James Lind Library, has for the last 30 years championed the need
for health professionals and patients to have access to unbiased evidence on
which to base clinical decisions. His talk on the development of fair tests
of treatments in health care was illustrated with examples going as far back
as 1500BCE, all taken from the James Lind Library’s extensive and publicly
searchable online archives. More details
and the text of his talk below.Some fifty members of HealthWatch and its committee were present at this year’s Annual General Meeting, held on 29th October at the Medical Society of London.
There was a warm welcome back for Peter Wilmshurst, the cardiologist who had received the HealthWatch Award in 2003 for his courage in challenging misconduct in medical research. Dr Wilmshurst is currently being sued over his criticisms of an American trial of a heart implant (see HealthWatch Newsletter issues 72, 73 and 75 from the past 12 months). Dr Wilmshurst’s case has been featured in the national press recently along with calls for reform to England’s libel laws. Referring to his courage in speaking out for science, HealthWatch’s president Nick Ross described Wilmshurst as, “on the side of the angels.” (See below for more about Peter Wilmshurst).
There
was good news for medical students this year. The generous grant from
AJAHMA, which has supported the HealthWatch Student Prize since its inception
six years ago, will soon run out so it was with great pleasure that Walli Bounds
announced that the Medico-Legal Society has agreed to take over funding of the
annual award. The HealthWatch Student Prize encourages healthcare undergraduates
to learn how to critically evaluate clinical research protocols. It invites
students to rank four trial protocols in order of merit and to identify and
explain their strengths and flaws. This year’s winner was Suzanna Jefferson,
a student of medicine at Queen Mary’s University of London. Suzanna’s
entry showed, according to Nick Ross, “a very good understanding”.
Runners-up were Simon Rowland (Imperial), Lauren Ewington (Imperial), Rohit
Narayan (Birmingham) and Ross Mirvis (Imperial). Suzanna received a cheque for
£500, the runners-up each received £100.
Although the competition was originally open to students of nursing and complementary medicine, most entries—and certainly by far the highest quality ones—been from medical students. “We’ve been impressed with some well-reasoned entries,” said Walli Bounds.
Mandy Payne
It is exactly six years since HealthWatch published its position paper on Direct-to-Consumer Advertising of prescription medicines (DTCA). Its author, the late Michael Allen, described it as, “a bad idea” [1]. Now the latest EU “Information to patients” Directive is attracting criticism from health care professionals, scientists, and groups representing consumers and patients who fear that, if approved, it could lead to that “bad idea” becoming a reality in Europe …
Mandy Payne
1. Allen M. Direct to Consumer Advertising of Prescription medicines.
Media interest in cardiologist Peter Wilmshurst’s libel case continues
to grow after his conversation with Justice Secretary Jack Straw in November,
who subsequently announced plans to reform England’s libel laws. (Read
The Times’ report on http://business.
timesonline.co.uk/tol/business/law/article6932252.ece).
Readers may not be aware that Dr Wilmshurst also has a dedicated following among
the scuba diving community. As a medical referee on the UK Sport Diving Medical
Committee, the cardiologist at the Royal Shrewsbury Hospital has published widely
on diving-related clinical problems…
Mandy Payne
The Institute for Science in Medicine (ISM) is a new international
policy group that aims to alert the public and policy-makers to the dangers
of ignoring scientific validation of medical interventions. Many of ISM’s
leaders, who include Edzard Ernst, professor of complementary medicine at the
Peninsula Medical School in Exeter, and David Colquhoun, professor of pharmacology
at University College London, are already promiment bloggers on the subject.
http://www.scienceinmedicine.org/
A book co-authored by HealthWatch’s vice-chairman Keith Isaacson was highly commended at the BMA Medical Book Awards this year. The British Orthodontic Society’s Radiology Guidelines was described as, “...an excellent, well written and concise write-up on the background of clinical dental radiographs and indication for radiographs in clinical orthodontics. It is a must read for all clinical dentists especially those treating children” Keith Isaacson is consultant orthodontist at the North Hampshire Hospital in Basingstoke. He is one of four experts in dental and maxillofacial radiology who authored the book. It is available for £15.00 (inc p&p) online from http://www.bos.org.uk or by telephoning 020 7353 8680.
The Libel Reform Coalition was launched on 10th December 2009 by science and free speech groups including Sense About Science and Index on Censorship. Raymond Tallis, emeritus professor of geriatric medicine and 2007 HealthWatch Awardwinner, commented, “I think the public must now know that they should be afraid, very afraid, of the way the libel laws are being used to suppress challenges to dangerous and fraudulent scientific claims.” A new petition calling for reforms such as a cap on legal costs and damages, and stronger public interest defences to libel, has begun on http://www.libelreform.org
The Times, 10th December 2009. View on http://www.timesonline.co.uk/tol/news/science/medicine/article 6951054/ece
At
the 21st HealthWatch Annual General Meeting, held on 29th October at the Medical
Society of London, chairman James May reported on the activities that HealthWatch
has done, the challenges faced and the successes achieved.Beginning with HealthWatch’s many activites of 2009, I am personally very grateful for all the hard work of the committee. Keith Isaacson is our vice chairman, Gillian Robinson our secretary, Anne Raikes looks after our finances, and other members are David Bender, Susan Bewley, Walli Bounds, Diana Brahams, Malcolm Brahams, John Garrow, John Illman, Caroline Richmond, and Les Rose. Two student members Alison Myers and Ashley Simpson have also attended regularly throughout the year. In addition we are very grateful to Ken Bodman our membership secretary.
The standard of the Newsletter has been very high in the past year. We are profoundly grateful to our editor Mandy Payne and to Caroline Addy, the barrister who proof reads the text for libel. The newsletter is circulated to journalists and members of HealthWatch.
The Student Prize is awarded for the ranking of clinical protocols to promote skills in evidence based medicine amongst medical and nursing students. We are very indebted to Walli Bounds and Gillian Robinson for producing the protocols and for deciding on the winning entries. Our thanks are also due to Joan Gandy who publicises the competition and collects and sorts the correct entries.
The HealthWatch website is well used, averaging 1,200 hits per day. It contains
an archive of previous newsletters as well as position papers on various subjects.
The Google Group is increasingly one of the main ways of developing ideas and
strategies and keeping each other up to date. Members can join the group discussions
by contacting David Bender on david.bender@btinternet.com
The Pittilo Report on the regulation of traditional medicine: The Department of Health is currently consulting the public regarding the Pittilo recommendations for the regulation of Acupuncture, herbal medicine, Traditional Chinese medicine, and other traditional medicines. HealthWatch is concerned that the recommendations focus on regulating the side-effects rather than the supposed effects of these therapies. We encouraged our members to complete the online consultation questionnaires before the 2nd November deadline, in which activity they were helped by guidance available on David Colquhoun’s website:http://www.dcscience.net/?p=2310
RCP ‘Integrated Health Committee’: The Royal College of Physicians has an ‘Integrated Health Committee’ which seems under heavy influence of CAM and the Prince’s Foundation for Integrated Health. We have expressed our concerns in writing and personally to the chair of the committee, Mike Cheshire. This is against the declared purpose of the college to protect the public from misleading health claims. We feel that the association of the College with conferences that promote CAM will be interpreted as the College’s support for CAM. We plan further responses but are encouraged that the College seems to recognise our concerns.
NICE Guidelines on Back Pain: NICE have produced guidelines for the management of chronic lower back pain recommending that acupuncture, osteopathy and chiropractic be used as an adjunct to conventional therapies. We are concerned that the evidence base for this is very thin for acupuncture and non-existent for the manipulative therapies. Three members of HealthWatch, along with Tracey Brown from Sense about Science, have met with Sir Michael Rawlins, chairman of NICE, to express our concerns, and are pleased that he seemed receptive to them.
Whistle-blowing: We have a Whistle-blowers’ support fund set up to help Peter Wilmshurst in his libel case against NMT medical. John Garrow wrote a summary of his case in the last newsletter (HealthWatch Newsletter issue 75, October 2009). Peter is a previous winner of the HealthWatch award for his whistle-blowing activities and may yet win it again if he carries on like this. Details of how to contribute to the support fund are available on the HealthWatch website.
Simon Singh: The science writer Simon Singh has won his right
to appeal the ruling against his use of the word ‘bogus’ in reference
to the British Chiropractors association. In recent months Edzard Ernst has
been prolific in writing articles in journals and magazines regarding the lack
of evidence for claims previously made by the British Chiropractors Association.
‘Integrative Medicine’ Editorial in BMJ: HealthWatch was concerned
that this editorial (1st September 2009) was really promoting CAM and avoiding
questions of efficacy by muddling the physical effects of a treatment with the
interpersonal skills of the clinician. HealthWatch members contributed the majority
of over 50 rapid responses to this article online.
New BMJ group journal “Acupuncture in Medicine”: HealthWatch will
be keeping a close eye on developments with this new journal which on one hand
should encourage good research to be done, but on the other hand seems to give
undue recognition to a field which so far can only claim limited evidential
support.
WHO has responded to homeopathy concerns: The Voice of Young Scientists wrote an open letter to the World Health Organisation expressing their concern about the use of homeopathy in the developing world (see HealthWatch Newsletter issue 74, July 2009). WHO responded by saying that it DOES NOT recommend the use of homeopathy for treating HIV, TB, malaria, influenza and infant diarrhoea.
Homeopathists under pressure: In a German journal a Director of the Society of Homeopaths, Lionel Milgrom, published a long article entitled ‘Homeopathy in the UK and its detractors’. This was explicitly about the pressure homeopaths are feeling in the UK.
Chiropractic under pressure: Chiropractors are also under considerable pressure, principally as a result of their libel action against Simon Singh. Ben Goldacre has reported in the Guardian about the substantial media attention, international petitions, and the work of bloggers that have resulted from this case. Around 1,000 chiropractors have been reported to Trading Standards for making claims that cannot be substantiated. There has also been made public a statement leaked from one chiropractic group, which they sent to all their members warning them to take down their websites in case they were caught advertising services that had no evidence to support them.
This is a summary of the highlights of the last year.
James May
HealthWatch Chairman and GP Principal, London
Iain
Chalmers has devoted the last 30 years to efforts to help ensure that health
professionals and patients have access to unbiased evidence on which to base
their treatment decisions, most famously through his work as one of the co-founders
of the Cochrane Collaboration. He was at the first ever HealthWatch meeting
back in 1992, and since then he’s been a friend and valued critic, and
prepared to make a pointed comment if he ever believes HealthWatch has failed
to apply to itself the standards it expects of others. “It’s important
to be even-handed, for us all to be judged by the same rules. If we depart from
this, then we’ll be open to the accusation of double standards,”
he said by introduction to his talk at the 2009 HealthWatch AGM. Chalmers, who
received a knighthood in 2000 for services to healthcare, applies his passion
for fairness now as editor of the James Lind Library [1], created to help people
understand fair tests of treatments in health care.The article below is based on the talk given by Iain Chalmers at the HealthWatch AGM 2009, and is a fuller version than the one which appeared in the print version of the newsletter, which was edited for reasons of space.
The subject of my talk is explaining fair tests of treatments in health care, and in this we have much unfinished business. I’d like to begin by introducing some of my special heroes in the field. Margaret McCartney, the Glasgow GP who writes a health column for the Financial Times every week [2], was a worthy recipient of last year's HealthWatch Award. I’d include the writers of some of my top books: Smart Health Choices by Judy and Les Irwig [3]. Judy Irwig is a mother, Les Irwig a professor of clinical epidemiology, and their book explains clearly and authoritatively how not to be bamboozled by what you read in the media about health. Know Your Chances [4], in which American doctors Steve Woloshin and Lisa Schwartz explain how to interpret health statistics, is special because an early draft was itself subjected to a randomised controlled trial to see if it actually increased its readers’ knowledge of the subject. Another young British doctor, Ben Goldacre (HealthWatch’s 2006 Award winner), has shaken things up for science knowledge in this country with his Guardian column “Bad Science” [5]. He writes, “Evidence-based medicine, the ultimate applied science… has saved millions of lives, but there has never once been a single exhibit on the subject in London’s Science Museum.”
However his fellow Guardian writer and HealthWatch Award winner, Polly Toynbee, did not make my hero list. As I pointed out in the April 2004 HealthWatch Newsletter [6], she once wrote that randomised clinical trials should be abandoned. “It may be a little less accurate scientifically,” she had written, “but if patients are allowed to choose which treatment they want and every detail of their condition, lifestyle, character and circumstances is fed into the trial data, I doubt if the results would be seriously distorted,” making clear her reluctance to agree to be a “guinea pig”. She completely failed to confront the fact that you often get very different results depending on design of the trial.
A few journalists—among them Nick Ross—understand evidence based medicine, and are prepared to battle against the stereotypes. On the 2nd April 2001 Nick was amongst fifty people who met to consider how to get the public to appreciate randomised controlled trials. There’s a problem with the name: it has so many negatives associated with it. “Randomised” suggests haphazard. “Controlled” implies controlling. “Trials” has legal connotations. It was Nick Ross who suggested, “why not call them fair tests?”
James Lind, a pioneer of fair tests, was a naval surgeon in the 18th Century and a member of the Society of Naval Surgeons (whose members went on to found the Medical Society of London). Like many who favour quantifying outcomes, he was something of an outsider. It’s harder to ask the question, “Is the Emperor wearing clothes?” when you’re a member of the Emperor’s establishment. It’s a problem that remains with us today. No matter how fair the test itself, the interpretation of science continues to be distorted by those who have a vested interest in the results, other than the well-being of patients.
The James Lind Library was launched by the Library of the Royal College of Physicians in Edinburgh in 2003. It has an online archive of illustrative records, from 1550 BCE to the present, illustrating how fair tests developed [2]. These make clear that many of the principles of fair tests that we still use today go back hundreds, even thousands of years.
Conceptualising fair tests of treatments
In an extract of a letter written in 1364 [3], the Italian poet Francesco Petrarca wrote, “I solemnly affirm and believe, if a hundred or a thousand men of the same age, same temperament and habits, together with the same surroundings, were attacked at the same time by the same disease, that if one half followed the prescriptions of the doctors of the variety of those practising at the present day, and that the other half took no medicine but relied on Nature’s instincts, I have no doubt as to which half would escape.”
Treatments with dramatic effects
Even earlier, we have a surgical papyrus dated from around 1550 BCE which has been translated to reveal an explanation of how to reduce a dislocated mandible. It describes exactly what we do today, yet it was written more than 3,000 years ago. You don’t need carefully controlled trials to prove a treatment which is so clearly effective.
Recognizing the needs for controls
In the 10th Century CE, the Baghdad doctor Abu Bakr Muhammad ibn Zakariyya al-Razi (Rhazes), wrote on his experience of treating meningeal inflammation, noting the characteristic symptoms of photophobia, neck stiffness and headache. He wrote, “So when you see these symptoms, then proceed with bloodletting. For I once saved one group [of patients] by it, while I intentionally neglected [to bleed] another group. By doing that, I wished to reach a conclusion.” If this sounds rather barbaric remember it’s the way of thinking that’s important—he realised that he needed an untreated group in order to make an inference about the effects of his treatments.
Prospective experiments
The James Lind Library records a 16th Century example of a within-patient prospective controlled trial. “A kitchen boy fell into a cauldron of almost boiling oil…” wrote the French royal surgeon Ambroise Paré in 1575. “I went to ask an apothecary for the refrigerant medicines that one was accustomed to apply to burns. A good old village woman, hearing that I was speaking of this burn, advised me to apply for the first dressing raw onions crushed with a little salt… I was agreeable to trying the experiment and, truly, the next day, the places where the onions had been had no blisters or pustules, and where they had not been, all was blistered.”
During 18th Century naval campaigns more sailors were being killed by scurvy than by the fighting. One of several recommended treatments at the time was vitriol (sulphuric acid), which was favoured by the Royal College of Physicians of London. Of one of the earliest known reports of a clinical trial, the naval surgeon James Lind wrote in 1753, “…I took twelve patients in the scurvy… Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of their knees. They lay together in one place, being a proper apartment for the sick in the fore-hold; and had one diet common to all.” Lind allocated two sailors with scurvy to each of: “a quart of cider a day; twenty-five gutts of elixir vitriol three times a day; two spoonfuls of vinegar three times a day; a course of sea water… half a pint each day; two oranges and one lemon every day; the bigness of a nutmeg three times a day.” The most sudden and visible effects were seen amongst the seamen taking the fruit.
“Blinding” assessment of outcomes
The report of the homeopathic salt trials in Nuremburg in 1835 contains a detailed description of a randomized double-blind experiment in which participants were given either a homeopathic salt solution or pure distilled snow water. The details of which numbered bottles had contained which liquid were kept sealed until the end of the experiment. The experiences of the participants in the two groups were indistinguishable. One should bear in mind that homeopathic care in the late 18th and early 19th century was almost certainly safer than the bleeding, purging and use of heavy metals by orthodox practitioners.
Recognising the “law of large numbers” and the “limits of oscillation”
The idea of using numerical data to justify conclusions about treatments goes back at least three centuries. Pioneering work on how to apply inferential statistics to therapeutic data in order to make critical judgments on the value of therapies was published in Paris in 1840 by Louis-Dominique-Jules Gavarret. According to his beautifully written Principes Généraux de Statistique Medicale, “Average mortality, as provided by statistics, is never the exact and strict translation of the influence of the test medication but approaches it all the more as the number of observations increases. To be able to decide in favour of one treatment method over another, it is not enough for the method to yield better results: the difference found must also exceed a certain limit, the extent of which is a function of the number of observations.” Hence, the need to estimate what he calls “the limits of oscillation” (confidence intervals).
Confidence in results can be increased by examining the results of multiple trials. A key paper in the history of meta-analysis is Karl Pearson’s 1904 report in the British Medical Journal on “certain enteric fever inoculation statistics” which looked at correlations between typhoid and mortality and the inoculation status of soldiers serving in various parts of the British Empire.
In the early 20th Century important advances in study design were implemented in the USA in a programme of research to assess serum treatments for pneumonia. The trials in the programme demonstrated many of the important features of fair tests, involving large numbers of patients, allocation to treatment or control groups using an unbiased process (alternation), an assessment of the likelihood that observed differences could be explained by chance, and meta-analysis of the results of similar studies.
Recognising reporting bias
The English philosopher and statesman Francis Bacon, in his 1620 “New Instrument for the Sciences” commented, “It is a proper and perpetual error in Human Understanding, to be rather moved and stirred up by affirmatives than by negatives…” This is still as true today, and it can kill. Dr Cowley and his colleagues wrote in 1993 how, in an unpublished study done 13 years before, nine patients had died among the 49 assigned to an anti-arrhythmic drug (lorcainide) compared with only one patient among a similar number given placebos. “We thought that the increased death rate that occurred in the drug group was an effect of chance… The development of the drug was abandoned for commercial reasons, and this study was therefore never published; it is now a good example of ‘publication bias’. The results described here…might have provided an early warning of trouble ahead.” [4] In his 1995 book Deadly Medicine [5], the American author Thomas J Moore estimated that at the peak of their use in the late 1980’s, these widely-used anti-arrhythmic drugs killed as many Americans every year as were killed during the whole of the Vietnam war.”
Recognising the need for a cumulative science
In 1884 Lord Rayleigh, professor of physics in Cambridge and President of the British Association for the Advancement of Science, said, “If, as is sometimes supposed, science consisted in nothing but the laborious accumulation of facts, it would soon come to a standstill, crushed, as it were, under its own weight… The work which deserves, but I am afraid does not always receive, the most credit is that in which discovery and explanation go hand in hand, in which not only are new facts presented, but their relation to old ones is pointed out.”
In 1965 the English epidemiologist and statistician, Austin Bradford Hill, framed the four questions to which readers want answers when reading reports of research: Why did you start? What did you do? What answer did you get? And, what does it mean anyway?
An example that lives up to Bradford Hill’s expectations is the CRASH research into the effects of systematic corticosteroids in acute traumatic brain injury. The research was started because practice varied and a systematic review of existing studies (some of which had never been published) revealed important uncertainty about whether systematic steroids did more good than harm. To address this important uncertainty a large publicly-funded, multi-centre randomized trial—called the CRASH trial—was organised. The results, which were published in the Lancet in 2004 [6] revealed that this treatment had been killing people since it was first used nearly 40 years previously.
The report of the CRASH trial is exemplary because it referred to current uncertainty about the effects of a treatment, manifested in a systematic review of all the existing evidence, and in variations in clinical practice; it noted that the trial was registered and the protocol published prospectively; it set the new results in the context of an updated systematic review of all the existing evidence; and it provided readers with all the evidence needed for action to prevent thousands of iatrogenic deaths.
In summary, science is cumulative, so researchers must cumulate scientifically, using methods and materials to reduce biases and the play of chance. Because researchers still do not do this routinely, people continue to suffer and die unnecessarily.
Iain Chalmers
Editor, James Lind Library
The BBC Food and Farming Awards Farmer of the Year is an “award for someone who has risen to the challenges of farming in the 21st century and is an inspiration to anyone interested in food production and the countryside” [1] . The awards for 2009 were presented by HRH the Prince of Wales at a ceremony on November 25th, and the winner was Andrew Dennis of Woodlands Organic Farm in Lincolnshire.
Woodlands Organic Farm is a mixed farm growing cereals, fruit and vegetables and raising livestock, all in an organic way, using manure from the livestock to fertilize the fields…
David A Bender
Professor of Nutritional Biochemistry
University College London
1. http://www.bbc.co.uk/radio4/features/ffa/2009/categories/ (accessed 29/11/09).
A
new report in the Drug and Therapeutics Bulletin [1] warns that the benefits
and risks of taking daily aspirin may be more finely balanced than previously
thought. Millions of over-50’s could be self-medicating in the belief
they are reducing their risk of cardiovascular disease. Are they in danger?
Keith Isaacson considers the evidence.For many years now a daily low dose of aspirin has been recommended as a method of helping to prevent cardiovascular disease, heart attacks or even strokes. Aspirin affects platelets by making them less sticky and less likely to form a thrombus. The official guidelines of NICE [2], and also Scotland’s equivalent body, the Scottish Intercollegiate Guidelines Network [3], have been advising a regular daily dose of 75mg. As a result large groups of people, maybe millions, are probably taking a daily dose…
Keith Isaacson
Senior consultant orthodontist
North Hampshire Hospital, Basingstoke
Medical
journalist and HealthWatch committee member Caroline Richmond was so furious
when asked to donate to her hospital’s “healing garden” that
she had to protest.University College Hospital and its now-deceased partner, the Middlesex, has looked after my lymphoma for fifteen years. When I sprouted a high-grade lymphoma they saved my life with high-dose chemotherapy and stem cell rescue despite my poor prognosis. Most of the hospital has now been rebuilt. The oncology department hasn’t but plans are afoot. It includes a “healing garden” and a “wellness centre”. I’ve just had an appeal from UCLH cancer services appeal. I have sent this rant to my oncologist, who certainly doesn’t deserve to be ranted against.
Grrr. Is a healing garden one that doesn’t have any fungi or bacteria
in the soil? I think not.
Or which grows poisonous plants (Vinca, Taxus, etc) from which anti-cancer agents
are extracted, and which we patients can chomp on as we wish? Again, I think
not.
And what is a “wellness centre”?…
Caroline Richmond
When Paul Bennett, professional standards director for Boots, told a committee of MPs recently that the pharmacy chain stocks homeopathic remedies for no other reason than that they are popular, BBC News invited GP Sarah Jarvis to discuss with Professor George Lewith, of the Integrated Medicine Research Group at the University of Southampton, the question of whether homeopathy works. See http://www.youtube.com/watch? v=mFtJgCzPgL0.
(The comments that prompted the piece can be read in the Daily Telegraph, 26th November, on http://www.telegraph.co.uk/finance/newsbysector/retailandconsumer/6658864/Boots-we-sell-homeopathic-remedies-because-they-sell-not-because-they-work.html )
Loretta Marron, who reported from Australia for the October issue of the HealthWatch
Newsletter, has sent in one of her recent exposes. Watch her in action on http://blip.tv/file/2747331.
For light relief, Susan Bewley has sent the classic nine minute philosophy on aspects of misrepresentation from Harry G Franfurt on http://www.youtube.com/watch?v=lSbI8MtuBN0.
Comedian Dara O’Briain expounds on his views on alternative therapies on http://www.youtube.com/watch?v=VIaV8swc-fo&feature=related.
Some web clips may include unfortunate language and HealthWatch cannot be held responsible for any offence caused (neither for any injury resulting from uncontrolled laughter).
Mandy Payne