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Read the latest HealthWatch newsletter:  Issue 108, Autumn 2018

Symposium 17 JuneAs a member of HealthWatch you believe in evidence-based healthcare. But what evidence do we need to justify the introduction of new medical devices or implants? How can we make sure it is obtained and disseminated? How should the system be regulated?

Recent publicity has made it clear that implants such as surgical mesh and silicone breast implants are poorly evidenced and probably poorly regulated. How should HealthWatch respond? Where should we be pressing for action?

These are the topics of our free HealthWatch Symposium on 17th June 2019 in central London: Evidence, Healthcare and Medical Devices & Implants.

We have some top-flight invited speakers, but most of the afternoon will be based on group discussions – and we would like many members of HealthWatch to be part of those discussions.

Could you join us for this event, and help HealthWatch focus its attention where it will be most effective?

To find out more and register for the symposium, read our full announcement and programme.

John Kirwan

Symposium Coordinator

Free

Registration for the HealthWatch Symposium 2019: Evidence, Healthcare and Medical Devices & Implants is now open to members and student members!

It takes place on Monday 17 June 2019 from 1pm to 4.30pm at St Luke's Community Centre in central London. Giving presentations, we have:

  • Prof Carl Heneghan, professor of Evidence-Based Medicine and Director of the Centre for Evidence-Based Medicine, Oxford University, Oxford
  • Deborah Cohen, investigative Journalist, British Medical Journal and BBC, London
  • Prof Peter McCulloch, professor of Surgical Science and Practice and Chair of the IDEAL Collaboration, Oxford University, Oxford

The aim of the symposium is to clarify the current issues facing evidence based healthcare in the field of implants and medical devices and to identify areas where organisations (including HealthWatch) might most productively concentrate their efforts.

The latest version of the (still developing) programme is available on the HealthWatch web site here and you can jump straight to registration at Eventbrite here - click on Register then Checkout.

Click here for details and registration

We have an impressive set of introductory speakers and of discussion group participants, and the symposium offers us a real opportunity to bring some clarity of thinking to a difficult area.

Your input to the process, through full participation in the discussion groups and feedback, means you will be an active participant in the process, not just a passive audience member.

We are particularly keen that student members take up some of our places, and can offer up to £30 support towards travel costs for those from outside London who need it.

There are only 40 places available (over and above our invited speakers and discussants), so please register soon if you want to secure a place.

John Kirwan

Symposium Coordinator

Thousands of unnecessary mastectomies may have resulted among women persuaded to take part in the government’s AgeX study, claims a report by HealthWatch experts published today in the British Medical Journal. The study, announced as “the biggest randomized controlled trial in history”, has already invited over a million women to undergo mammographic screening for breast cancer without first checking they understand the test could harm as well as benefit.

Findings of an eight-year investigation into AgeX by HealthWatch experts and concerned citizens, are published today in an analysis in the British Medical Journal (cite: BMJ 2019;364:l1293 doi:10.1136/bmj.l1293. A full text version can be accessed here). It describes a poorly designed and scrutinized trial which exposes women to foreseeable harm while being unlikely to produce useful data. AgeX randomizes women to receive an extra mammogram on either side of the currently offered 50-70 age range in order to assess the effect on breast cancer mortality. It began in 2009 with an initial target of 1.1 million women. It could continue beyond 2026. Since its inception, evidence has accumulated that mass mammographic screening of healthy women offers little or no benefit, and has substantial harms. But instead of holding back, the trial has only grown in size to an estimated 6 million. Although protests led to better leaflets, women continue to be invited without checks that they understand the risks and that they are taking part in research.

The HealthWatch investigation into AgeX was triggered in 2011 when medical writer Mitzi Blennerhassett deduced from some small print that a screening invitation she received at age 72 was not routine but part of a clinical trial. Knowing that international ethical standards for human experiments say that participants must be told that they are in a trial and given details of benefits and harms in language they can understand, she decided to find out more. Her letters to NHS departments received either cursory replies or contradictory information. Over the following years she was joined by Susan Bewley (emeritus professor of obstetrics and women’s health, Kings College London, and HealthWatch trustee) and Mandy Payne (freelance editor of the HealthWatch Newsletter). They found:

  • It took three freedom of information requests to obtain the study protocol that was barely 7 pages long*.
  • The triallists had specified from the outset that informed consent would not be sought, i.e., there would be no explicit check that women presenting for screening fully understood the risks.
  • The Principal Investigator of the study is not a scientist or doctor, but has a degree in Ancient History and Classical Civilisation and her medical doctorate and professorship are both honorary.
  • The proposed trial was implemented without having been properly peer-reviewed. Instead of receiving independent academic and scientific scrutiny it was passed by an internal Department of Health committee.
  • No body appears to admit full responsibility for the scientific content and oversight of the trial. In responses to letters inquiring on this question, it seems to be passed around between the AgeX investigators, the sponsor (Oxford University), and the Research Ethics Committee (REC).

How can mammograms harm women? Many “positive” screens result from discovery of tiny, microscopic tumours that will never grow, or grow so slowly that they would not have gone on to harm a woman in her lifetime. However, once detected, this is followed by surgery or radiation. The tests and diagnoses cause fear and anxiety. Cancer treatments are highly toxic, and may cause pain, disfigurement and even trigger new cancers. Some women are harmed who would have remained healthy but for the screening. At best, the woman survives a frightening diagnosis and “lives with cancer” for the rest of her life. Screening has not been shown to save lives when all-cause mortality is considered, and it increases the chance of mastectomy. It has not been shown to reduce the most advanced and aggressive cancers. Fortunately, today’s treatments for breast cancer are much better than forty years ago, and most women diagnosed via symptoms have effective treatment.

Lead author Susan Bewley says “Good researchers would welcome openness and scrutiny. We call on scientists and researchers worldwide to examine the detail and judge the value of this enormous trial that was not competitively funded, nor properly peer reviewed, which has a changing rationale, protocol and endpoints, and which does not seek explicit informed consent from the ever-growing number of women recruited.”

Commenting on the BMJ paper, leading breast cancer surgeon and researcher Professor Michael Baum, who was one of the original architects of the breast screening programme, but who now believes it does more harm than good, said “Whilst the world’s scientific community has woken up to the fact that screening for breast cancer does not save lives or for that matter save breasts, the monstrous AgeX trial is recruiting over 6,000,000 women to an RCT to extend the age group for screening to 47-79. The cost to the exchequer is huge, never mind the cost of managing the physical and psychological outcomes of over-diagnosed cases. This paper by Bewley, Blennerhassett and Payne is timely and AgeX should be shut down. The hubris of the non-clinical epidemiologists running this study, who never have to look a woman in the eye after a ‘positive’ mammogram, is unspeakable.”

The authors of the BMJ paper call for an inquiry into the research governance gaps that this investigation has exposed. Further information on the trial, including documents obtained as a result of freedom of information requests, are now available on the HealthWatch website in a detailed update.

Important note:

HealthWatch, in common with many international experts, believes the evidence does not support benefit of mass mammographic screening of symptom-free average-risk women. However, women at high risk, e.g. with a family history of breast cancer, DO benefit from close monitoring. Any women with breast symptoms should seek medical advice as soon as possible.

Some key facts and numbers:

  • 2009 – the trial of extending the age range for breast screening in England begins
  • 2011 – the existence of the trial of extending the age range for breast screening in England is announced publicly, in response to a public letter in BMJ from Susan Bewley to the Cancer ‘tsar’ Mike Richards
  • 2016 – the protocol for the AgeX trial is finally made freely available online for the general public – by now it is in at least its 4th iteration in operation
  • 50-70 – the standard age range offered breast screening currently by NHS
  • 47-49, and 71-79 – extra age ranges in AgeX
  • 7 – the number of pages in the original AgeX trial protocol
  • 2 – the number of scientific references in the original AgeX trial protocol
  • 3 – the number of freedom of information requests made before the original protocol was released to HealthWatch investigators, in 2014
  • 1 million – the original target for the number of women to be included in the study
  • 6 million – the current new target number of individual women proposed to be included in the study (to include participants and unscreened controls)
  • 1 million – the number of women who had, by end of 2016, received an extra mammogram as part of AgeX
  • 1 in 10 – the chance of a woman aged 50+, who takes part in the standard breast screening programme over the course of 11 years,** having a false alarm after a mammogram and unnecessarily having additional testing or tissue removed (biopsy)
  • 1 in 200 – the chance of a woman aged 50+, who takes part in the standard breast screening programme over the course of 11 years,** unnecessarily having partial or complete removal of a breast
  • 22 in 1000 – the risk of dying of cancer for a woman aged 50+ over the course of 11 years regardless of whether or not she attends standard breast screening**

*A protocol is the detailed “recipe” for how a clinical trial is conducted - protocols are commonly 50-200 pages of dense and highly detailed text that has been written and checked many times. The NHS Health Research Authority website encourages researchers to make protocols publicly available in the interests of transparency https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/

**https://www.harding-center.mpg.de/en/fact-boxes/early-detection-of-cancer/breast-cancer-early-detection

17 JuneThe 2019 annual HealthWatch symposium is on its way. The topic will be "Evidence, healthcare and medical devices" as the issue of evidence for implants and devices is an important area, poorly understood and regulated. Last year the Committee decided to turn strategic attention to this over the next few years.

The symposium is being coordinated by John Kirwan. We are delighted to be pinning down speakers (inc Carl Henegan who wrote this piece about the vaginal mesh scandal) and workshop subjects.

It will be held on the afternoon of Monday June 17th in London (in an accessible venue near overground and underground).

Further details to follow – but please book the slot in your diaries NOW

Susan Bewley

Chair of Trustees, HealthWatch

The 2019 HealthWatch student prize competition for critical appraisal of clinical research protocols is open! Starting now… you have three months to write, refine and perfect your entry, but don't leave it until the last minute!

Cash prizes

There are two first prizes of £500 each, one for medical and dental students and one for students of nursing, midwifery and professions allied to medicine. Up to five runner-up prizes of £100 will be awarded in each class. Prize winners will be invited to attend the HealthWatch Annual General Meeting in October to receive their prizes.

How to enter

The competition consists of four hypothetical research protocols: your task is to rank the protocols in order from that most likely to provide a reliable answer to the stated aims of the trial to that least likely to do so. You then have to explain your ranking in no more than 600 words.

Please pass on to any students, organisations, colleges, universities, etc you think might be interested.

Your entry must be submitted before 23:59 BST on Tuesday 30 April 2019. Entries received after that time will not be considered. Find out more and enter here. The full terms and conditions, with the competition protocols for you to read, can be found here

Free student membership

Whether you enter the competition or not, if you are a full-time student, please consider taking advantage of our offer of free Student Membership of HealthWatch.

The Autumn 2018 issue of the HealthWatch Newsletter is now online here!

The HealthWatch Newsletter is free to read and download. HealthWatch members will shortly receive their personal printed copy of the newsletter if they have opted to do so.

Featured in this issue:

Join us by becoming a member of HealthWatch and a supporter of science and integrity in healthcare.

Free

HealthWatch was fighting ‘fake news’ in relation to health before the term was invented. As the converse of evidence-based medicine, it is the focus of HealthWatch's existence.

Earlier this year, a team at MIT published a report that revealed that false news actually travels faster than truth online.

Beyond acknowledging that we have a problem, can we do anything to correct it?

Following in the footsteps of previous popular HealthWatch debates, we have organised a meeting for 19.00 on Thursday, 4 October 2018 to discuss ways to combat mis- and dis-information. (We are consigning ‘fake’ to Trump and Twitter.)

It will be led by two researchers with a special interest in the subject:

Geoff Walton, from Manchester Metropolitan University has studied how young how people form judgements on online information, and

Jens Koed Madsen from the University of Oxford, who is passionate about the potentially harmful effects of misinformation and is trying to model how we might intervene to modify such information or beliefs.

They will be joined by award-winning medical journalist and GP, Faye Kirkland.

We also hope to invite authors, researchers and representatives of institutions concerned with the issues involved to come to offer informed contributions from the floor.

Chair: Susan Bewley, Professor of Women's Health, King's College London, Chair of HealthWatch

Attendance, at the lecture theatre, of King’s College (Franklin Wilkins building) in Stamford Street, near Waterloo, is free and open to all: Book your place now (free)

Details

Date Thursday 4 October 2018
Time

19:00 to 20:45 BST

Doors open at 18:30

Venue

King’s College London, Waterloo Campus, Room B5, Franklin-Wilkins Building, Stamford Street, London SE1 9NH

See map below

Accessibility information

Map

As usual, attendance at the HealthWatch AGM and presentations is free and open to all. If you would like to stay for the dinner, however, this must be pre-booked and paid for in advance, see the agenda below. While all are welcome to attend the AGM, only members may vote.

Date: Wednesday 31 October 2018

Time: 19:00 (drinks reception from 18.30 — see below for full agenda)

Location: The Medical Society of London, Lettsom House, 11 Chandos Street, Cavendish Square, LONDON W1G 9EB (see map)

HealthWatch Award 2018: Dr Sarah Wollaston MP
The 2018 HealthWatch Award will be presented to Dr Sarah Wollaston MP.

Sarah Wollaston is that rare politician: a scientifically literate and sceptical MP. She consistently uses her background as hospital doctor, GP and forensic examiner for the police, to bring a logical and dispassionate analysis to social problems and affairs of state.

Even more precious, she will change her mind in the face of new, sound evidence. Her track record includes advising on the ill-considered Saatchi Bill, supporting minimum-unit pricing for alcohol, chairing the government’s Health Select Committee, and defending patients’ confidential information. She has always maintained the highest level of personal integrity. HealthWatch applauds her.

Sarah will give a talk entitled, From GP to MP: How to Lose Friends but try to Influence People

Agenda

18:30 Reception for the AGM and Award ceremony.

19:00 Annual General meeting of HealthWatch (only members of HealthWatch may vote, but non-members are welcome to attend).

19:30 Presentation of awards to the winners of the 2018 Student Prize competition for critical analysis of clinical research protocols.

19:40 Presentation of the 2018 HealthWatch Award to Dr Sarah Wollaston (see above).

20:30 Buffet dinner (£45.00 per person). To order your buffet dinner, please click here Book buffet dinner

Nominations for Committee

Our constitution requires that nominations for officers and members of the committee should be submitted not less than 28 days before the AGM.

Any member of HealthWatch can nominate an officer or ordinary member for the committee. Nominations should be seconded by another member, accompanied by a letter from the person nominated to state s/he accepts, and sent to the Secretary, Prof David Bender or by post to 8 Eagle Close, AMERSHAM HP6 6TD before 3rd October.

Motions for discussion

Motions for discussion at the AGM should be sent to the Secretary, Prof David Bender or by post to 8 Eagle Close, AMERSHAM HP6 6TD before 3rd October.

The deadline for the Summer issue of the HealthWatch Newsletter will soon be here and we're already collecting articles and letters from our members, friends, supporters and interested readers.

The HealthWatch Newsletter in pdf format is openly accessible online immediately on publication so that our contributors can benefit from as wide an audience as possible, and may share their work freely.

For our Summer issue we are looking for topical and thought-provoking material from new contributors. Opinions, book reviews, letters commenting on current issues of interest are also welcomed for consideration.

Please send your articles by 1st July for target publication date around August. For more information and details of how to submit please see our Information for Authors page.

A letter to The Times signed by 15 HealthWatch experts and supporters sparked a deluge of media coverage when it urged women offered catch-up after missed breast screening invitations to “look this gift horse in the mouth”.

IMG 20180517 181112HealthWatch chair, Susan Bewley, professor of women’s health at King’s College London, penned the letter on learning the news that an estimated 450,000 women aged 68-70 had not been invited to routine NHS mammography screenings because of an IT failure dating back to 2009. Jeremy Hunt, the health secretary, had claimed that between 135 and 270 women might have had their lives shortened as a result.

These figures, based on statistical modelling, were disputed by many in the medical and statistical community, and Bewley’s letter quickly gathered signatories from among HealthWatch supporters including Michael Baum, who as professor emeritus of surgery at University College London was an architect of the original breast screening programme in the 1980s.

"Breast cancer screening mostly causes more unintended harm than good"

The letter, headed “Screening ‘flaw’”, appeared on Saturday 5th May and was accompanied by a page 9 article by Chris Smyth, The Times’ Health Editor, titled “Women are urged to avoid catch-up breast screening”. It quoted from Bewley’s letter, “The breast screening programme mostly causes more unintended harm than good, which is slowly being recognised internationally. Many women and doctors now avoid breast screening because it has no impact on all-cause death”.

Here is a list of just some of the media coverage that resulted:

Other publications home and abroad took apart the Department of Health’s wobbly maths.

HealthWatch has been raising concerns about breast cancer screening and its shaky evidence base since 2001, and continues to work to raise awareness of the risks and promote correct information to doctors and the public to enable informed choice.

15 AprilBristol, North Somerset and South Gloucestershire Clinical Commissioning Groups (CCGs) are consulting on proposals for homeopathy for a second time.

We reported on their first consultation last year. This overlapped with a consultation by NHS England and we understand some homeopaths had complained to the CCGs about the way their consultation had been run. This second consultation should finally decide the fate of homeopathy in the area.

After the Bristol Homeopathic Hospital closed in January 2013, homeopathy continued to be provided by a small clinic at the South Bristol Community Hospital. Just three years later, in October 2015, this too closed to be replaced by a private clinic, the Portland Centre for Integrative Medicine. That is not part of the NHS but is contracted by the CCGs to provide homeopathy services.

At the end of November 2017, NHS England announced recommendations that GPs should no longer prescribe homeopathic treatments or herbal remedies.

The CCGs give further details here and have published a summary document.

The aim of their proposal is to review the commissioning of homeopathy services and treatments and includes three options.

  • The homeopathy service should continue under the current policy where funding is granted if the patient meets the published criteria
  • The current policy should be amended to reduce access either by reducing the number of appointments routinely funded or by restricting the access criteria so the fewer patients will qualify for treatment
  • NHS funded homeopathy is only available in rare and exceptional circumstances and would need to be approved by the Individual Funding Request Panel (IFR)

The consultation closes on Sunday 15 April 2018 so plenty of time to submit your response online. This is little more than indicating how strongly you agree or disagree with each of the three proposed options, but you have the opportunity to provide further information if you so wish.

We encourage members to take a minute to submit their response.

The 2018 HealthWatch student prize competition for critical appraisal of clinical research protocols is now open.

There are two first prizes of £500 each, one for medical and dental students and one for students of nursing, midwifery and professions allied to medicine. Up to five runner-up prizes of £100 will be awarded in each class. Prize winners will be invited to attend the HealthWatch Annual General Meeting in October to receive their prizes.

The competition consists of four hypothetical research protocols: your task is to rank the protocols in order from that most likely to provide a reliable answer to the stated aims of the trial to that least likely to do so. You then have to explain your ranking in no more than 600 words.

Please pass on to any students, organisations, colleges, universities, etc you think might be interested.

Your entry must be submitted before midnight BST on Monday 30 April 2018. Entries received after that time will not be considered.

The terms and conditions can be read here.

Find out more here.

Free student membership

Whether you enter the competition or not, if you are a full-time student, please consider taking advantage of our offer of free Student Membership of HealthWatch.

The Autumn 2017 issue of the HealthWatch Newsletter is now online here!

The HealthWatch Newsletter is now free to read and download. HealthWatch members will shortly receive their personal printed copy of the newsletter if they have opted to do so.

Featured in this issue:

  • NEWS FEATURE British universities are not sharing the results of their research, resulting in wasted public money and danger to patients.
  • NEWS Consultations, awards, a new book, and how patience with homeopathy is running out.
  • TREATMENTS How a routine practice during childbirth could be putting newborn's lives at risk.
  • NUTRITION Can this best-selling "healthy" 21-day diet plan live up to its promises?
  • MEETING REPORT Worlds collide: an on-the-spot-report from an NHS Public Consultation event.
  • LETTER TO THE EDITOR "Regulatory agencies are like a car with only two speeds - too fast and too slow".
  • LAST WORD Another hair-raising story about cancer hits the headlines, but the truth will surprise you.

Join us by becoming a member of HealthWatch and a supporter of science and integrity in healthcare.

The Department of Health is seeking views on the regulation of medical associate professions (MAPs) in the UK.

Deadline for submissions

Friday 22 December 2017

Consultation description

Full details of the consultation can be found here.

Rising demands for medical treatment and advances in clinical care requires a co-ordinated approach and greater skill mix within NHS healthcare teams.

In recent years the health service has seen the emergence and increased use of new professional roles within multi-disciplinary teams as part of a continuing drive to provide safe, accessible and high-quality care for patients.

Four of these roles are:

  • physician associate (PA)
  • physicians’ assistant (anaesthesia) (PA(A))
  • surgical care practitioner (SCP)
  • advanced critical care practitioner (ACCP)
  • As these professionals become more widely employed, it is necessary to explore the options for professional regulation.

This consultation seeks your views on the following proposals:

  • To introduce statutory regulation for PAs
  • To seek further evidence on the most proportionate level of regulation for PA(A)s
  • To seek views on the position that statutory regulation of the SCP and ACCP roles is not proportionate, and whether alternative options for professional assurance should be considered

A consultation document and a risk assessment profile from Health Education England (HEE) are published alongside this consultation.

Responses

We will be considering whether to submit a formal HealthWatch response and we encourage our members to think about their own personal response.

Responses can be submitted here.

Questions

Do you feel that HealthWatch should respond to this consultation?

Do you have any suggestions about what we should say in our response?

Could you help us coordinate or write our response, particularly if you have expertise in this area?

If you submit your own personal response, could you send us a copy to help us formulate our response?

Contact

If you are able to help us, or require any further information, please contact our consultations coordinator, Roger Fisken.

HealthWatch has responded to the Government's consultation on research integrity with a practical proposal to address the issue of incomplete and inaccurate reporting of clinical trials.

The proposal, submitted jointly with Universities Allied for Essential Medicines UK, TranspariMED, and Dr Simon Kolstoe, calls for a national clinical trial audit system that would substantially strengthen research integrity by monitoring the registration, summary results posting and academic publication of every trial conducted in the UK. It refers to a pilot trial of such a scheme that was conducted over 2010–11 at the University of Portsmouth by Simon Kolstoe, senior lecturer in research design and ethics there. The pilot used documents already held by research ethics committees to monitor retrospectively whether trials have been registered, post summary results within 12 months, and publish accurate results. It found that such an audit was effective and could be implemented at minimal cost.

The House of Commons' Science and Technology Committee's Inquiry into Research Integrity was launched initially in January this year to look at trends and developments in fraud, misconduct and mistakes in research and the publication of research results, and the so-called 'crisis in reproducibility' of research. It had begun to take evidence but was closed on trhe dissolution of parliament for the general election, and there were fears that valuable evidence already submitted might not be heard (see Spring/Summer 2017 issue of the HealthWatch Newsletter, p3). The inquiry was re-opened on 13th September and closed on 5th October with nearly 100 submissions received from experts and concerned groups.

Written submissions from HealthWatch and by other parties will soon be accessible online at the House of Commons' Science and Technology Committee's webpage for the Research Integrity Inquiry.

The submission of which HealthWatch was a joint signatory was prepared by Dr Till Bruckner, of TranspariMED, a UK-based initiative that develops and promotes policy solutions to the problem of evidence distortion in medical research.