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Highlights of Newsletter no 90, July 2013

NEWS: RIAT moves for trial transparency Pressure on pharmaceutical companies to make available their unpublished clinical trial data moved up a gear in June with the launch of the RIAT (Restoring Invisible and Abandoned Trials) initiative by British Medical Journal, PLoS and researchers.1 It is a call to action to companies and academic funders to publish, or update already published, findings from trials they sponsored. The initiators of RIAT say they will make public all the confidential information they hold about missing and abandoned trials in one year’s time if trial sponsors fail to publish it themselves. This latest news is a high point from the AllTrials campaign’s roller-coaster ride of recent months. A low came on 25th April when the European Court issued an injunction stopping the European Medicines Agency from releasing information from clinical trials conducted by two pharmaceutical companies, InterMune and AbbVie, who had challenged the EMA’s decisions to grant access to clinical study reports from drug trials.2 The wider effect of the injunction has been to chill other requests for clinical trial information. There are at least 100 pending requests seeking trial results. The outlook improved on 29th May when MEPs voted unanimously in favour of proposals to increase the transparency of clinical trials.3 UK Labour MEP and Health Spokesperson Glenis Willmott drafted the report which includes obligations for clinical trial sponsors to publish their Clinical Study Reports. Commenting on the EMA injunction, Peter Doshi, Fellow in Comparative Effectiveness Research, Johns Hopkins University, said: “I am not aware of any evidence that any harm to public health has ever resulted from the sharing of clinical trial data.” Mandy Payne References 1. Sense About Science. 328/riat-initiative-for- publication-of-historical-clinical-trial-findings 2. EMA. _and_events/news/2013/04/news_detail_001779.jsp 3. New
Fiona Godlee, editor in chief of the British Medical Journal since 2005, and the journal’s first
female editor, has agreed to be accept the 21st HealthWatch Award at this year's Annual General
Meeting. Mark your diaries for the evening of Thursday 24th October at the Medical Society of London
Plans for new Exeter CAM post
Complementary and Alternative Medicine could soon have more research devoted to it. There are
moves to establish a new post at Exeter University to continue the pioneering work of Prof Edzard
Ernst who retired earlier this year. HealthWatch’s President, Nick Ross, has been in discussions with
Exeter’s Medical Dean, Steve Thornton, since Prof Ernst first announced he would be stepping down,
and together with the science writer Simon Singh has been seeking potential candidates and
Nick Ross
It was with enormous sadness that the HealthWatch Committee learned recently that our good friend and former treasurer, John Hanford, died on 3rd March 2013. John was well loved by all who knew him through HealthWatch. His friends echoed the sentiments expressed by Walli Bounds who remembered him as “a thoroughly nice and decent man, and a very effective treasurer”. He was originally introduced to HealthWatch by his long-standing friend John Garrow, then chairman of HealthWatch, who writes: “Our family moved into a house on Pinner Hill because I was going to work in the new MRC hospital in Harrow instead of going into St Bartholomews Hospital, and Katharine wanted to work as a GP in Watford. We soon discovered that there were no children on the hill—our neighbours were all elderly and affluent people who had been ‘Something in the City’. No one played with toys. “It was therefore wonderful when after a few weeks the Hanford family took over the house exactly opposite ours, and their children were of the same age as ours. Our two families got on very well, and (best of all) John modestly said he was quite familiar with financial records, and could probably act as the HealthWatch treasurer. He did have some slight problems with the records, because something in the punctuation seemed to be missing. I was able to help, because when he saw an entry £749 he thought that represented Seven hundred and forty-nine thousand pounds, (or even £749 million), but of course it was just £749. It was revealed that John was a director of a company that provided international pipelines, so his ledgers dealt only in millions of pounds. “The Hanfords were good friends for our family, and John was a very good friend to HealthWatch. As we all got older our children disappeared from the nest, and the Hanford parents went on long trips overseas, so he could not maintain the job of treasurer. We have been lucky again with the volunteer who has taken over this role.” Mandy Payne NEWS IN BRIEF Cambridge University Press have agreed to sponsor the 2014 HealthWatch Student Prize. They will take over from past HealthWatch chairman Professor John Garrow, for whose kind sponsorship of the 2013 prize we thank him. Nominations are now open for the 2013 John Maddox Prize for Standing up for Science. Sir John Maddox, whose name the prize commemorates, was a passionate and tireless champion and defender of science, engaging with difficult debates and inspiring others to do the same. As a writer and editor, he changed attitudes and perceptions, and strove for better understanding and appreciation of science throughout his long working life. The prize is a joint initiative of Nature, where Sir John was editor for 22 years; the Kohn Foundation; and Sense About Science, where Sir John served as a trustee until his death in 2009. The prize: £2000. The award is presented in November and an announcement of the winner will be published in Nature. Nominations online. The Department for Work and Pensions is under investigation for administering questionable psychometric tests to the unemployed, allegedly under threat of loss of benefits if they did not complete them, reports the Guardian. The Health and Care Professions Council (HCPC) is investigating why jobcentres were permitted to trial the 48-question character test, called My Strengths, which was devised by the government's Behavioural Insights Team but has been criticized by psychologists as lacking in concrete evidence. Guardian, 19 June 2013. 2013/jun/19/health-watchdog-investigates-psychometric-tests The NHS has been criticized for taking payments from companies in exchange for access to pregnant women, such as via the distribution of “Bounty Bags”. The Bounty company reportedly pays the NHS £2.3m a year for the right to distribute 2.6 million bags of samples and advertisements, and sales staff collect commercially valuable data from mothers still in the maternity ward. Writing in the British Medical Journal, Glasgow GP and past HealthWatch Award-winner Margaret McCartney says, “The lack of knowledge about what signing over your details means is troubling in a hospital environment, which should take consent and confidentiality seriously. The hours after birth are hardly an optimal time to obtain formal consent. And is the presence of a non-essential Bounty worker on the ward desirable?” BMJ 2013;346:f3448 (28 May 2013) A global movement is calling for an end to industry-promoted disease-mongering that manipulates health concerns and harms through practices that medicalise normal life. Learn more about the Call to Action on Selling Sickness on their website. Two new books just published will be of interest to HealthWatch members: Me Medicine vs. We Medicine: Reclaiming Biotechnology for the Common Good by Donna Dickenson, is published 3 July by Columbia University Press (hardcover, 304 pages, £19.95 (£14.00 Kindle). Dickenson writes, “Backed up by the glamour of new biotechnologies such as direct-to-consumer genetic testing or neurocognitive enhancement, personalized medicine—what I call “Me Medicine”—appears to its advocates as the inevitable and desirable way of the future. By contrast, what I term “We Medicine”—public health programs such as flu jabs or childhood vaccinations—is widely distrusted and highly vulnerable to austerity cutbacks.” Crime, how to solve it and why so much of what we’re told is wrong by Nick Ross was published 29 May by Biteback Publishing. (Hardcover, 384 pages. RRP £17.99, £8.75 Kindle). Nick Ross’ new book draws on evidence-based medicine as a model to review social policy, in this case crime. Based on his twenty years experience working with victims and police, and ten years research to find out what makes crime rates ebb and flow, he proposes a radical re-think of crime policy and exposes the way that facts about crime are continually manipulated to serve the needs of politicians and the media. CLINICAL: Cancer: what’s in a name? Cancer. The word never fails to conjure in the public imagination the vision of a long lingering painful death; which is now often not the case. Even just a few decades ago most patients with cancer were diagnosed at a late stage and treatment options were limited. Hence, cancer was almost always a deadly disease and unlike other deadly diseases such as infections and cardiovascular diseases, death followed a protracted period of suffering. This has undoubtedly contributed to the general perception of cancer. However, rapid advances in diagnostics, surgery and oncology has resulted in a much higher proportion of cancers being detected at an early stage and patients being cured. In some instances, such as some cancers of the testis and childhood leukemias, even patients with advanced disease can be effectively treated and cured of the disease… Murali Varma Consultant Histopathologist University Hospital of Wales Cardiff SLIMMING: Selling more than just weight loss “Alizonne has transformed my life”—weight reduction, skin retraction and contour shaping without surgery. The words headlined an advertisement in the Metro paper on January 14th. My initial reaction was that this was promoting the lipase inhibitor Orlistat, which is marketed as a prescription medicine under the name Xenical, and sold over-the-counter under the trade name Allitame. There is good evidence for the efficacy of Orlistat in weight loss regimes. However, when I went online to, I discovered I had confused the similar-sounding names. Alizonne is a completely different approach to weight loss… David A Bender Emeritus Professor of Nutritional Biochemistry University College London Alizonne’s medical director and physician, Dr Mark Palmer, was invited to respond to points made in the article opposite and we are pleased to publish his comments in full in our print edition WOMEN’S HEALTH: Egg-freezing: a note of caution In a recent essay published in the Wall Street Journal,1 Sarah Elizabeth Richards, author of the book, Motherhood Rescheduled,1 encourages women to ward off age-related infertility by simply freezing their eggs—like she did. Between the ages of 36 and 38, Richards spent $50,000 to freeze 70 eggs that she plans to thaw, fertilize and insert into her uterus when she is 44 or 46. “Egg freezing,” she said, “stopped the sadness that I was feeling at losing my chance to have the child I had dreamed about my entire life.” Still looking for a mate at 40, Richards says she now clicks onto and has the confidence to tell men that she can “have kids whenever I want.” While Richards’ decision appears to have clearly provided her with a sense of hope and temporary emotional equilibrium, it may very likely prove to be illusory. Sadly, as millions of women can attest, including me, the vast majority of assisted reproductive technologies (ART) fail: In 2012, of the 1.5 million treatments reported globally, approximately 1.1 million failed––a 77 per cent failure rate.2 In the United States in 2010, the overall failure rate was 68 per cent.3 … Miriam Zoll Writer Award-winning US writer Miriam Zoll’s new book, Cracked Open: Liberty, Fertility and the Pursuit of High Tech Babies was published 1 April 2013 by Interlink Books, paperback £12.99). Her article shown here originally appeared on the American reproductive health website RH Reality Check and appears with the author’s kind permission. References (and continued on facing page) 1. 2. ART factsheet. European Society for Human Reproduction and Embryology. See: Author’s note: derived from figures in 3rd paragraph: 350,000 live births out of 1.5 million treatments; hence 1,150,000 million = 76.6% of attempts do not result in live births. 3. 2010 Assisted Reproductive Technology Report. US CDC. See: Authors’ note: derived from figures of 147,260 cycles performed resulting in 47,090 live births; hence 100,170 = 68.1% of attempts do not result in live births. RESEARCH: Where is the line between poor and unethical research? Indian homeopaths recently published a clinical trial1 aimed at evaluating homeopathic treatment in the management of diabetic polyneuropathy. The condition affects many diabetic patients; its symptoms include tingling, numbness, burning sensation in the feet and pain, particularly at night. The best treatment consists of adequate metabolic control of the underlying diabetes. The pain can be severe and often does not respond adequately to conventional pain-killers. It is therefore obvious that any new, effective treatment would be more than welcome… Edzard Ernst Emeritus Professor of Complementary Medicine Exeter University This article first published 4th June 2013 in Edzard Ernst’s blog and appears here with his kind permission LAST WORD: Speech is freer: a new law is born This time four years ago the science writer, Simon Singh, was fighting a libel action brought against him by the British Chiropractic Association in response to his comments about chiropractic in a newspaper article. On 18th May 2009 a group of well-known scientists, comedians and writers assembled at the Penderel’s Oak pub in Holborn, London, on the initiative of young lawyer David Allen Green, to object to the treatment of scientists. The atmosphere was very different, though no less exhilerating, in the basement of that very same pub on the evening of 16th May 2013. Sense About Science hosted the party and the now victorious Simon Singh unveiled a brass plaque which commemorates the historic event and what happened next. As most HealthWatch members now know, the original 2009 meeting led to the formation of the Libel Reform Campaign—a coalition of three charities: Index on Censorship, English PEN and Sense About Science, who together led a general protest against the use of libel to stifle valid scientific comment. The LRC’s call to reform England’s libel laws grew to involve 60,000 bloggers, publishers, scientists and authors and more than 100 organizations including including Citizens Advice, Nature, Mumsnet, Global Witness, Which?, Amnesty, Society of Authors and the Royal College of GPs in what has been described as one of the most successful campaigns of the 21st century. The Defamation Act became law on 25th April 2013. The new bill’s provisions include: · A statement is not defamatory unless it has caused or is likely to cause serious harm to the · Commercial entities must show that the words complained of caused or are likely to cause · The time period to bring a libel action starts with the first publication and cannot be restarted with subsequent publications, unless the material is published in a materially different manner. · A libel action against a person who does not live in Europe can only be heard in London if the claimant can show that England is the most appropriate place. The guests who celebrated in the packed basement of the Penderel’s Oak last month heard statements from supporters including celebrities Dara O’Briain and Professor Brian Cox, who exclaimed, “I’m amazed that rational thought should be a niche activity!”; MPs Evan Harris and Rob Flello, as well as Simon Singh and some of their fellow victims of libel actions, among them Dr Peter Wilmshurst, consultant cardiologist and defendant in NMT Medical vs Wilmshurst. Peter Wilmshurst’s optimism was cautious: “I hope that the Defamation Act will make it easier for scientists, doctors and others to openly discuss concerns of public interest without being sued for libel, but I fear that so long as the legal process in England remains unbelievably expensive, those with the most money will continue to silence ordinary people with limited resources who wish to raise concerns.” Mandy Payne Further information A new document: “Libel Reform: what next?” is available from Sense About Science: For a link to photographs of the party at Penderel’s Oak pub go to: Opinions expressed in letters and articles published in the HealthWatch Newsletter belong to the authors and do not necessarily reflect the views of HealthWatch. The editor reserves the right to amend text if necessary but will, where possible, consult the author to ensure accuracy is maintained. Letters and articles for publication are welcomed and should be sent to the Editor by e-mail to: [email protected]


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