Our latest progress report on projects HealthWatch has been involved in, and other stories about evidence in health care.
“Make it public”: transparency campaign success
The UK is to become the first country worldwide to ensure that all clinical trials are registered and their results reported, with clinical trials registered centrally and a government agency checking whether their results have been made public. A new national strategy was published on 1 October by the UK’s Health Research Authority in response to sustained campaigning by patient, transparency and health groups including TranspariMED – with whom HealthWatch partnered on this issue - and Cochrane, Universities Allied for Essential Medicines and AllTrials, as well as a 2018-19 parliamentary enquiry into unreported clinical trials that highlighted research waste at UK universities and in the NHS.
In future, the Health Research Authority (HRA) will itself directly register clinical trials based on data submitted during ethics approval. All clinical trials will be expected to report their results within 12 months and include ‘lay summaries’ for non-expert readers. Publicly available monitoring data will keep the pressure on trial sponsors, as will sanctions – ethics approval may be refused for further studies.
This new long-term strategy covers all interventional clinical trials, including not only medicines but medical devices, surgical techniques, public health measures, and behavioural therapies. Till Bruckner, founder of TranspariMED and a member of HealthWatch, said: “In future, decision-makers in other countries, notably in continental Europe, can no longer argue that it is impossible to prevent research waste in clinical trials.”
Royal College of Surgeons to sponsor our student prize
We are delighted to be able to announce our new sponsor for the 2021 HealthWatch Student Prize. The Royal College of Surgeons of England (RCS) works to enable surgeons to achieve and maintain the highest standards of surgical practice and patient care, so they are solid match for our competition which encourages students to appreciate evidence in health care. The RCS have generously agreed to support our next competition, which was launched on 10 December. Deadline for entries to the competition is 23:59 on Friday 30 April, so don’t leave it too late - find out more here.
Charities Commission is challenged to meet its statutory duty
Charities whose activities could harm those who turn to them for help, continue to escape sanctions despite pressure on their regulator to act. Les Rose, HealthWatch committee member, writes in his latest blog about his attempts to press the Charity Commission to meet its statutory duty to ensure that all charities provide a public benefit. Since July 2019 Les has raised official complaints about eight UK charities, supplying evidence that they promote practices that could endanger or exploit the sick, vulnerable and/or desperate.
While Charity Commission management have assured complainants that they are giving high priority to the problem of charities failing in their public duty, the glacial speed of action – if indeed there is any being taken, as there is no transparency in the process and no outcomes to be seen – means the public continue to be misled and harmed unnecessarily. Of particular concern is that the Commission’s responses to complaints refer to discourse with legal advisors but fail to acknowledge the need for any scientific input. There will be more from HealthWatch on this subject in 2021.
Advance in treatment following breast cancer surgery
There was good news from breast cancer researchers in August, who published their finding that a single shot of radiotherapy given during surgery is just as effective as the conventional series of whole breast radiotherapy (WBRT) sessions that women traditionally have to endure after tumour removal in early breast cancer. The new technique is called targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT), and is an attractive alternative to the uncomfortable, costly and inconvenient post-operative WBRT courses currently offered.
And there is more. A course of WBRT increases a woman's risk of dying from cardiac events and lung cancer. But the new study found that TARGIT-IORT was linked with far fewer such deaths than was the traditional WBRT programme.
Surgeon and co-researcher Michael Baum notes that these data also have profound relevance for the practice of population screening for breast cancer, because they shed new light on a rarely-publicised result of routine mammographic screening. “Sixty per cent of the cases recruited for this study had been screen detected, and we know about half of screen-detected cancers are over-diagnosed," he says. This means that a sizeable proportion of women receiving potentially hazardous treatments for breast cancer have tumours that might never have harmed them, had they not been found by screening. "Over-diagnosed women have been bearing the brunt of the lethal toxicity of treatment for a disease that if left alone would never have progressed,” he explains. "This excess mortality is now revealed for those patients who have been subjected to WBRT not only in this study but ever since population screening was introduced."
"Pseudoscience kills", warns international collaboration of 2,750 doctors and scientists from 44 countries
More than two and a half thousand scientists and medical experts from 44 countries have come together to warn of the dangers of pseudoscience, and to urge lawmakers to close the legal loopholes that allow quack medicine to flourish. Their ‘Manifesto Against Pseudo-Therapies’, published internationally on 19 October, highlights cases in which patients have died as a result of taking unproven or disproven medicines. The current Covid-19 pandemic has contributed to the problem by cultivating an “infodemic” of pseudoscientific health claims that could threaten more lives.
The manifesto is an international collaboration of ten scientific associations across Europe, including HealthWatch. One focus is the European directive 2001/83/CE, which allows the sale of homeopathic products as if they were medicines. The manifesto calls on the EU Parliament to repeal this directive in the interests of protecting consumers, and to introduce laws preventing the sale of ineffective treatments.
My love-hate relationship with HealthWatch-UK
In an online seminar, HealthWatch chair Susan Bewley reflects on HealthWatch’s history and future. Thirty years ago the quackbusting group “Campaign Against Health Fraud (CAHF)” was formed to tackle the problem of charlatans who mislead, defraud and offer false hope to cancer patients. Following complaints that the name was provocative, a name change and charity registration followed, and HealthWatch was born. Since then our scope has widened to fight bad science in all areas of health care. Where are we now? On 19 November Dr Bewley, an emeritus professor of obstetrics, presented and led a discussion in a 1hr free online seminar, arranged and hosted by the non-profit Consilium Scientific. To watch the recording of this and other events in the series go to this link and log in using seminars2020 as both username and password.
First Do No Harm – next steps
An All Party Parliamentary Group was launched on 16 December to build support to implement the recommendations made in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety (IMMDS) Review published this summer (known as The Cumberlege Report). The report’s recommendations concerned support for those who have suffered grievous harm as a result of medical interventions and devices, and actions to reduce the risk of avoidable harm in future. They include the appointment of a Patient Safety Commissioner for England, and it seems that positive discussions have been had with the Government on this point. There is more information at FirstDoNoHarmAPPG.org.uk
John Maddox Prize 2020
When communicating sound science gets difficult, it takes courage to walk towards the public. The John Maddox Prize 2020 was awarded to some extraordinary people who have done just that. Anthony Fauci, Director of the US National Institute of Allergy and Infectious Diseases (NIAID), and Salim S Abdool Karim, an infectious diseases epidemiologist and Director of the Centre for the AIDS Programme of Research in South Africa, impressed prize sponsors Nature and Sense About Science by going above and beyond the line of duty as advisors, talking the public through the uncertain science behind Covid 19. A worthy winner in the Early Career Scientist category was Anne Abbott, a neurologist from Monash, Australia. She took on a multi-million-dollar industry when she determinedly challenged established treatment for carotid stenosis with her research showing that, for symptom-free patients, lifestyle changes were more effective at reducing stroke than the costly surgical procedures traditionally used. The full one-hour event is on Youtube.
New paper from the Declaration to Improve Biomedical and Health Research
The international group of academics behind the Declaration to Improve Biomedical and Health Research – to which HealthWatch is a signatory – has published a new review paper spelling out practical measures. "Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps", in the Journal of the Royal Society of Medicine, proposes three actions to improve transparency and mitigate against bias: (1) mandatory registration of interests by those involved in research; (2) that journals support the ‘registered reports’ publication format; and (3) that comprehensive study documentation for all publicly funded research be made available on a World Health Organization research repository. The authors invite feedback on the proposed actions and invite others to join in calling for their implementation.
Positive impact from call for EMA transparency
Last summer HealthWatch joined 27 organizations and academics in a letter calling on the European Medicines Agency remove a key barrier to citizen’s requests for information that should be publicly available. The campaign was organised by the transparency non-profits Access Info Europe and TranspariMED. It has finally begun to bear fruit – Access Info Europe have informed us that they had a call with EMA’s representatives on 14 September which is expected to be the start of an ongoing open conversation about how to advance the public’s right to transparent information, in an appropriate balance with protection of privacy and commercial interests. Read more about the letter here.
Online guide for journalists investigating health and medicine
A new online resource aims to equip journalists with the tools and knowledge to independently assess the evidence, critically appraise the risk-benefit ratio of any given product or policy, and expose corruption and malpractice. “Investigating Health and Medicine”, has been written by medical investigative journalists Serena Tinari and Catherine Riva for the Global Investigative Journalism Network (GIJN). The manual explains evidence-based medicine, how to assess evidence, drug development and regulation, safety reporting, and corporate influence. Find the Guide online here. Also downloadable as a 92-page pdf.
Favourite reads of 2020 – articles that made us think
Pandemic Science Out of Control, by Jeanne Lenzer and Shannon Brownlee, Issues in Science and Technology, 28 April 2020. How scientific integrity became another casualty of the pandemic – wise words that still stand months later.
Against pandemic research exceptionalism, by Alex John London and Jonathan Kimmelman, Science 01 May 2020. London and Kimmelman spell out five critical conditions to make research informative and of value to society.
Covid-19’s known unknowns, editorial in the BMJ, 19 October 2020. Why “The more certain someone is about covid-19, the less you should trust them”.
Five rules for evidence communication by Michael Blastland and colleagues, in Nature, 18 November 2020. The stats experts advise: “Avoid unwarranted certainty, neat narratives and partisan presentation; strive to inform, not persuade”.