Read the latest issue of the HealthWatch Newsletter online now!

New for 2021: we have given the HealthWatch Newsletter an updated format, with individual articles fully readable and searchable online. This latest issue features seven original articles - including brave exclusives from new contributors - as well as news about our charity's mission to promote evidence and integrity in health care.

The HealthWatch Newsletter remains free to view, download and share. HealthWatch members will shortly receive their personal printed copy of the newsletter if they have opted to do so. Links to the full newsletter and individual articles are below, or access a printable pdf format here.

Inside Newsletter 114

Published January 2021

  • NEWS  Transparency campaign success; challenging the Charities Commission; breast cancer surgery advance; "Pseudoscience kills"; a new sponsor for the HealthWatch Student Prize; and much more
  • INVESTIGATION  The case for a register of doctors' interests: Simon Peck shares his shocking findings in the private healthcare sector
  • HEALTHWATCH AWARDWINNER 2020 Bringing stats to the masses: Jennifer Rogers explains how to make sense of data during a global pandemic
  • REPORT FROM HEALTHWATCH'S CHAIR  HealthWatch Chair Susan Bewley sums up 2020
  • PSYCHOLOGICAL TREATMENTS  Caroline Struthers' devastating commentary takes the case of ME treatments to explain why it is not only drugs and devices that can harm
  • STUDENTS How Matthew Choy scooped the top prize in last year's HealthWatch Student Prize competition, with some brilliant runner-up entries
  • NUTRITION  The trouble with nutrition research, by David Bender
  • LAST WORD  Caroline Richmond on how Lily the Pink and Dr Crippen made their secret remedies, and a century-old war on quackery

We thank the contributors of this latest issue. Find past issues here. If you'd like to write for upcoming issues of the HealthWatch Newsletter, find out more here.

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

The 2021 HealthWatch student prize competition for critical appraisal of clinical research protocols is open! Since 2002, HealthWatch has presented more than £20,000 in prizes, and this year it could be your turn to win up to £500. Starting now… you have four 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 category. Winners will be invited to attend the HealthWatch Annual General Meeting in October to receive their prizes. If for any reason large gatherings or travel are restricted, the AGM may be held virtually, in which case prize-winners will be invited to attend remotely.

Winners can also add to their CV the honour of having received a national award — which could give the edge in a competitive post-Covid jobs market.

We are extremely grateful to the Royal College of Surgeons of England for their generous sponsorship of this year's competition.

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 share with your fellow students, organisations, colleges, universities.

Your entry must be received by 23:59 BST on Friday 30 April 2021. 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.

At our AGM on 20 October, the HealthWatch Award 2020 was presented to Professor Jennifer Rogers by our President, Nick Ross.

Prof Rogers is Head of Statistical Research and Consultancy, PHASTAR and Vice President (External Affairs) at the Royal Statistical Society.

After accepting, Prof Rogers gave a fascinating talk on the statistics of Covid-19, titled Can’t see the wood for the trees? Making sense of data during a global pandemic.

Watch the presentation and her talk:

Annual General Meeting 2020 - Zoom details

20 OctoberAs previously announced, the 2020 Annual General Meeting of HealthWatch will be held by Zoom on Tuesday 20 October.

Join the Zoom meeting here from 6.30 pm (Meeting ID: 844 2483 2573, Passcode: 599388).

The AGM will start at 7.00 pm.

Presentation of Student Prize at 7.30 pm.

Presentation of HealthWatch Award to Dr Jennifer Rogers at 7.40 pm.

For further details, see the AGM announcement or contact the Secretary.

Annual General Meeting 2020

Notice is hereby given that the 2020 Annual General Meeting of HealthWatch will be held by Zoom on:

Tuesday 20 October 2020 at 19:00

The Zoom meeting will open at 18:45; log-in / joining details will be circulated nearer the time.

The 2020 HealthWatch Award will be presented to Dr Jennifer Rogers:

Prof. Jennifer Rogers is Head of Statistical Research at PHASTAR, moving in August 2019 from the University of Oxford where she was Director of Statistical Consultancy Services and an Associate Professor in the Department of Statistics. She had previously worked as a Post-Doctoral Research Fellow in the Department of Statistics funded by the National Institute of Health Research. She has a special interest in the development and application of novel statistical methodologies, particularly in medicine. Her main area of expertise is the analysis of recurrent events and her research has recently focussed on developing and implementing appropriate methodology for the analysis of repeat hospitalisations in patients with heart failure but her research has many other applications in medicine such as epilepsy and cancer, but also in retail and engineering. She works alongside other statisticians, clinicians, computer scientists, industry experts and regulators.

In her role at PHASTAR, Jennifer directs the statistical research strategy, helping the company stay at the cutting edge of new methodological advances. She is also the technical lead for the company's statistical consultancy offerings, providing guidance and direction to the group. PHASTAR work with small and large pharmaceutical, biotechnology and medical device companies to provide statistical consulting, analysis and reporting, data management and data science services.

Jennifer is a highly active member of the Royal Statistical Society, currently sitting on RSS Council and being the Society's Vice President for External Affairs. She was also previously appointed as the RSS Guy Lecturer for 2014 and was Honorary Officer for Meetings and Conferences, organising the 2015 and 2016 RSS International Conferences. In addition to her involvement with the Royal Statistical Society, Jennifer was the President of the British Science Association Mathematical Sciences Section for 2018.

Jennifer can also regularly be found giving conference presentations and talking all things statistics in schools, theatres and pubs. She is a popular statistics presenter and can often be heard on the Radio or seen on TV screens. She has made a number of appearances on BBC Radio 4's More or Less and appeared on series 42 of BBC Watchdog where she presented their "Best or Worst" segment.

Agenda

19:00 Annual General meeting of HealthWatch (only members of HealthWatch may vote).

19:30 Presentation of awards to the winners of the 2020 Student Prize competition for critical analysis of clinical research protocols.

19:40 Presentation of the 2020 HealthWatch Award to Dr Jennifer Rogers (see above).

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 / email 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 20 September.

Motions to be proposed 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 20 September.

Recruitment into the “largest randomised trial of any treatment ever conducted” has been shut down early, and so quietly that it went unnoticed … almost.

The AgeX trial, run by the UK government, had aimed to “assess the risks and benefits” of offering an extra mammogram to women aged 47-49, and additional screening to women between the ages of 70 and 79. But it has been widely criticized by experts and patient groups over its shaky ethics and poor design. Now, without any fanfare, a statement recently appeared on its website: “Following the suspension of routine breast screening in March 2020 due to COVID, and the expected overload on breast screening services when screening eventually re-starts, the AgeX investigators decided in May 2020 that randomization into AgeX should cease permanently.” The statement was spotted by the BMJ and is reported today.(1)

"Other clinical trials have been paused due to COVID, but AgeX has been stopped completely. Could this be because it is a costly and harmful juggernaut of a trial that was conceived and implemented in haste, has grown out of control, and has now become an embarrassment?" says Susan Bewley, HealthWatch's chair, and lead author of a 2019 BMJ Analysis paper that highlighted flaws in AgeX.(2)

By the time recruitment ended, some 4.4 million women had been randomly allocated to the trial. Half will have been sent an extra screening invitation. These mammograms are likely to have resulted in unnecessary surgery for thousands of women who would have been perfectly healthy but for being signed up for the trial.

Unlike regular clinical trials (which should comply with the Helsinki Agreement for the protection of human subjects in research), AgeX was designed without explicit and informed consent, to get maximum participation. HealthWatch has long argued that it will not result in trustworthy data and must be stopped before even more women are harmed.(3) We have called for women in future to be given decision aids clearly explaining the potential risks to help them decide whether to take up screening or not. 

HealthWatch welcomes the ending of recruitment into the AgeX trial. We even agree with the investigators self-penned eulogy that “the establishment of the AgeX trial has been a remarkable achievement”.  But we would still like answers to questions we have been asking for almost a decade including those on the cost and continuing approval that have not been answered by Matt Hancock, nor Jeremy Hunt before him.  Who is responsible for the science of AgeX? Who has overall responsibility for the trial?  How much has it cost the NHS and “the resource-constrained breast screening clinics throughout England”?  

Data on those women who have already been screened will be electronically linked to their health records throughout the 2020s and beyond. But who will be independent enough to be trusted to analyze the data to ensure that any resulting policy decisions will be based on best evidence?

ENDS

1) Today's BMJ news report by Elisabeth Mahase is at https://www.bmj.com/content/370/bmj.m3337.full 

2) Our paper on the harms and ethical flaws of AgeX was published in the British Medical Journal 13th April 2019 https://www.bmj.com/content/365/bmj.l1293, the full text can be read here: https://www.bmj.com/bmj/section-pdf/995203?path=/bmj/365/8195/Comment.full.pdf#page=5.

3) See for yourself. The full story with links to some of the 100+ pages of documents we obtained via freedom of information requests is here: https://www.healthsense-uk.org/2-uncategorised/122-age-extension-trial-of-mammography-screening-part-5-april-2019.html

Read the Summer issue of the HealthWatch Newsletter online now! With 11 pages of features and news about our charity's mission to promote evidence and integrity in health care.

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.

Inside our Summer 2020 issue:

NEWS  Unreported medical device trials; our take on the Cumberlege Review; and News in Brief

POPULAR HEALTH  Ethics concerns over student research activities, by Shirley Moore

NUTRITION  Adam Daly on why Nutrition needs a re-brand

UNPROVEN TREATMENTS  Bioresonance comes under fire from opposite sides of the globe

BOOK REVIEW  Sex Robots & Vegan Meat, an eye-opening review by Caroline Richmond

We thank the contributors of this latest issue. Find past issues here. If you'd like to write for upcoming issues of the HealthWatch Newsletter, find out more here.

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

On the day that the government announce a relaxation of the 2m social distancing rule in England, HealthWatch has published a new lay summary of the evidence. 

The 2 metre rule seems to have been based on the assumption that SARS-CoV-2 – the virus responsible for the disease COVID-19 – is transmitted mainly via large droplets sneezed or coughed onto other people or surfaces. Increasingly evidence is showing that the virus is also spread via tiny airborne particles that could transmit the infection at distances greater than 2m.

Social distancing alone is not a magic bullet, but is one risk-reducing factor to be used alongside good indoor ventilation, regular and effective hand washing, keeping surfaces clean, wearing face coverings where appropriate, and prompt isolation of infected individuals.

"What is the evidence to support the 2-metre social distancing rule to reduce COVID-19 transmission? – a lay summary" is based on a new evidence review by the team at the Oxford Centre for Evidence Based Medicine, who created the Oxford COVID-19 Evidence Service to conduct evidence reviews on important questions about the science of the pandemic. Volunteers at HealthWatch are working with them to produce lay summaries of their reviews. Look out for them here.

Read the Spring issue of the HealthWatch Newsletter online now! With 10 pages of features and news about our charity's mission to promote evidence and integrity in health care.

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.

Inside our Spring 2020 issue:

We thank the contributors of this latest issue. Find past issues here. If you'd like to write for upcoming issues of the HealthWatch Newsletter, find out more here.

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

In a blistering BMJ blog that has just gone online, HealthWatch's chair announces that the pandemic has resulted in the NHS' routine mammographic breast cancer screening programme being quietly suspended. Despite the misery of COVID-19, we do have one cause for celebration, she says.

“In the midst of a global pandemic, we can no longer afford the well-paid and politically popular luxury of needlessly making the general public unwell through anxiety and overdiagnosis,” says Dr Susan Bewley, obstetrician and a leading expert on women's health.

Although it is not obvious from national websites and has been largely unnoticed by the media, letters, texts and phone calls have been informing women since mid-March that all routine breast screening appointments are cancelled, while staff are being redeployed for the Herculean task of constraining coronavirus or keeping other parts of the NHS afloat.  Screening services are also suspended in parts of CanadaItalyScotland, and Australia.

“This recognition that breast cancer screening is non-necessary must be applauded, and the general public reassured,” says Bewley.  “Anyone with a lump, skin dimpling or other symptoms who might have an active cancer, should be encouraged to call their GP as usual, as the urgent pathways remain open.” 

Mammography screening aims to find breast cancer before a lump can be felt. The current UK screening programme offers mammography every three years to all women from age 50 to 70. The age range is based on evidence of when mammography is most effective at detecting tumours in the breast. But breast cancer treatments have been revolutionised since screening was introduced in 1987, to the point that treatments today for symptomatic cancer are now so good that the benefit of catching breast cancer early by screening is vanishing, and is dwarfed by the harms resulting from ‘false positives’ and the aggressive treatment of screen findings that would never have hurt a women in her lifetime.

“The good news story - that treatment for symptomatic breast cancer nowadays is excellent - has been drowned out by the thirst for searching for diseases that might never have harmed anyone,” says Bewley. “This is a golden opportunity for the National Screening Committee (NSC) to pause, reconsider serious criticisms of the breast screening programme, and evaluate whether to mothball a programme that does not impress clinically or cost-effectively.” 

By pausing breast screening, the pandemic has also called a temporary halt to the controversial AgeX trial—a vast clinical study targeting 6 million women in England, designed to generate evidence to support extending screening to women even outside the current 50-70 age group but which has attracted harsh criticism for its ethical flaws, poor science and failure to get explicit informed consent from patients. 

Most people – and even many doctors – overestimate the benefits of screening and underestimate the potential for harm. Bewley is calling on the NSC to address and correct popular myths and misunderstandings about screening generally, stand up to vested interests from private healthcare and screening service providers whose profits come with potential health damage, and to switch their focus to public health - in particular, measures such as reducing smoking, obesity and alcohol consumption are more effective at reducing cancer than screening.

She also asks for better decision aids to help patients make properly informed choices about whether or not to take up screening invitations, for example, the use of evidence-based Fact Boxes. “We need better processes and an “informed consent leaflet that makes it entirely clear that it’s a choice, and not necessarily a bad choice, to decline,” says Bewley.

Susan Bewley

HealthWatch volunteers have been helping communicate best evidence about COVID-19.

It is more important than ever that the public have access to health information based on good quality evidence. In March 2020 the Oxford Centre for Evidence Based Medicine created the Oxford COVID-19 Evidence Service to conduct evidence reviews on important questions about the science of the pandemic. HealthWatch has been working with them to produce lay summaries of their reviews. These are being updated regularly.

Go to our new COVID-19 page to see the latest list, which covers treatments, mortality rates, handwashing, social distancing, and more.

 

Groups formed by patients grievously and sometimes permanently harmed by medicines and medical devices — such as valproate-damaged babies, and women with complications of vaginal mesh and breast implants — have found a shocking lack of transparency over adverse effect data, and such low standards for device approval that serious risks to patients are inevitable. When the Independent Medicines & Medical Devices Safety Review (the “Cumberlege Report”) is finally published, HealthWatch is hoping to see action on 5 demands that will show patients are being put before profit.

The Review, chaired by Baroness Julia Cumberlege, aims to examine how the healthcare system has responded to concerns raised by patients and families about three medical interventions: the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate, and vaginal mesh. It was due to be published today, 24th March 2020, but is now delayed indefinitely as a result of COVID-19.

Surgical mesh products are among over 500,000 different medical devices and in-vitro diagnostic devices on the market in the UK, produced by over 3,500 companies turning over around £22bn, employing 120,000 people and accounting for £5bn in exports annually. “Yet there is currently no comprehensive list of devices on the market, no way of identifying and tracking them, and no clear idea of how many patients are harmed,” says Dr Susan Bewley, HealthWatch’s chair. “The government is keen to protect business, but this should not come at the expense of patient safety.” HealthWatch has also supported efforts to get more transparency into the system because commercial secrecy can harm (or even kill) people.  “Patients are entitled to know who’s paying their doctors and scientists when innovations are rushed to market without safe post-marketing monitoring systems”.

In November 2019 HealthWatch wrote a letter to Baroness Cumberlege to ask the Independent Medicines & Medical Devices Safety Review to demand that those who implant a device must know (and be able to explain to the patient):

  • what it is and what its constituents are
  • how it is identified and tracked
  • how the evidence shows that it works
  • what risks are involved
  • what to do if things go wrong.

In response, the Review team is to publish our letter and evidence on their website when the Review is published.

In June 2019 HealthWatch convened a medical symposium in central London: Evidence, Healthcare and Medical Devices & Implants which brought together scientists, patients, manufacturers and regulators to clarify the current issues facing evidence based healthcare in the field of medical devices and implants. Our 5 demands appear in a HealthWatch Strategy document resulting from those discussions.

There is more about our work on Medical Devices on the HealthWatch website here.

The Independent Medicines & Medical Devices Safety Review was announced in the House of Commons in February 2018 by Jeremy Hunt MP, the then Secretary of State for Health and Social Care, and was due to be published at 11:30am on 24 March 2020, see the IMMDS Review website.

 HTA

Now you see it, now you don’t. Survival data is clearly shown in the German and French reports, but is heavily blacked out in the UK assessments. Why so mysterious?

The author of a new HealthWatch-funded research study has called for more openness in the way new health treatments are assessed by the UK’s National Institute for Clinical Excellence (NICE).

The study, by Till Bruckner of TranspariMED, Bristol, looked at how transparently the effectiveness of a new breast cancer drug – palbociclib (brand name Ibrance) – was assessed by three different European health technology assessment agencies (HTAs).

Why is transparency in HTA assessment important?

Health technology assessment agencies evaluate all new drugs, medical devices and treatments to see if they are clinically better than other treatments currently in use for the patient group in question. New is not always better. So, if NICE decides that a new treatment adds little or no value, the NHS is unlikely to pay for patients to receive it. This is important to avoid patient harms or wasting money. Transparency over HTA decisions reduces the risk of corruption, furthers medical progress, and enables democratic debates on public health priorities and allocation of public resources.

What did the study find?

Overall, NICE does a very good job. NICE (England & Wales), IQWIG (Germany) and HAS (France) all did well at disclosing who reviewed the evidence underlying their assessments, and how possible conflicts of interest were managed. They also detailed what evidence they reviewed, and how they evaluated it. The literature suggests that many other European HTAs do not meet these high transparency standards.

However, in some places NICE used redactions to obscure efficacy data from its drug assessment reports; disclosure of similar data by HAS and IQWIG shows that such redactions are not inevitable. Bruckner calls on NICE to stop redacting clinical trial data and follow the positive example of its German counterpart. “NICE must also to follow up on its recent pledge to take into account concerns about undisclosed industry funding for patient groups in the ongoing review of its conflict of interest policies.”

Concluding, Bruckner says HTAs should raise the bar on transparency by matching or exceeding the strongest transparency policies and practices of the individual Member State that is most advanced in that area. Notably, European-level HTAs should adopt IQWIG’s approach of routinely publishing all clinical trial data used within its assessment reports.

Notes

  • The study was the work of Till Bruckner of TranspariMED. TranspariMED uses research-driven advocacy to fight distortion in the clinical evidence base, that results from failure to register and fully report clinical trials. TranspariMED develops and promotes policy ​solutions for greater transparency in health.
  • This research study, which is published Open Access (CC-BY 4.0), was made possible with a grant from HealthWatch, the UK charity the promotes science and integrity in healthcare.
  • Applications are invited for funding tranches of up to £10,000 to support further research projects that meet the aims and objectives of HealthWatch. There is no closing date. Click here to find out more and how to apply. The HealthWatch Research Fund is independent of industry and has no financial interest in any form of healthcare.
  • Reference Bruckner T. Transparency in health technology assessment: NICE, IQWIG and HAS in comparison. Published 2 March 2020 by HealthWatch, and made available under a CC-BY 4.0 International License. https://www.healthsense-uk.org/HTA.pdf

HealthWatch has joined a cross-European challenge to an EU-funded clinical trial over concerns about inevitable and avoidable harms to women.

We have been at the forefront of raising concerns about the harms of breast screening programmes and flawed clinical trials. MyPeBS (My Personal Breast Screening) is an international randomized clinical trial which will compare personalised risk-based breast screening with a control group undergoing current standard planned screening tests, age 40 to 70. The six-year trial will involve 85,000 women in France, Belgium, Italy, Israel and the UK.

Mass mammography screening for breast cancer for women aged 40 or 50 and over is currently implemented in many countries - including the UK for women aged 50-70. But evidence of efficacy is disputed, and women are expected to consent without being fully informed on the risks. In the case of MyPeBS, studying stratified screening on personal risk factors may be an interesting project, however, it starts from the assumption that mass breast screening is beneficial - best evidence says it is not - and does not take into account the risks that healthy women face by taking part, nor are they fully informed of these risks even though excellent evidence-based decision aids are available.

HealthWatch has joined with three other groups who share concerns about women's health and human rights in research: Belgium's Group de Recherche et d'Action pour la Sante (GRAS), the Italian epidemiologists and scientists of NoGrazie, and the French group Cancer Rose.

Read the letter to MyPEBS here.

Read the Winter issue of the HealthWatch Newsletter online now! With 11 pages of features and news about our charity's mission to promote evidence and integrity in health care.

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.

Inside our first issue of 2020:

We thank the contributors of this latest issue. Find past issues here. If you'd like to write for upcoming issues of the HealthWatch Newsletter, find out more here.

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

The 2020 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 Thursday 30 April 2020. 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.