Covid-19 vaccinations – British Medical Journal article

‘Primary Care can do it, but needs extra support to do it fast, safely and effectively’ say Professor Azeem Majeed and Mariam Molokhia writing in the bmj 30 November 2020.

For anyone wanting to know more about the Covid-19 vaccine being offered to the UK public, the Rapid Responses to this article (currently numbering 29 and, like the article, all with free access to the public) offer interesting information and flag up several concerns, not least openness, patient/person safety and informed consent.

Vaccinating the UK against Covid-19. Majeed A, Molokhia M. BMJ 2020;371:m4654

https://www.bmj.com/content/371/bmj.m4654?utm_source=etoc&utm_medium=email&utm_campaign=tbmj&utm_content=weekly&utm_term=20201211

Government Advisers’ Conflicts of Interest hidden

‘…the government has faced mounting questions about procurement decisions, from personal protective equipment to testing kits, from vaccine deals to the services of logistics companies.’

Conflicts of interest among the UK government’s covid-19 advisers. Paul D Thacker

(Published 09 December 2020) BMJ 2020;371:m4716

https://www.bmj.com/content/371/bmj.m4716

Reducing bias and improving transparency in medical research; a critical overview of the problems, progress and suggested next steps

A review in the Journal of the Royal Society of Medicine by Bradley et al around problems that have undermined trust in medical research in recent years outlines some of the most important issues: research culture, reporting biases, and statistical and methodological issues. It examines the success and limitations of measures that have been instituted to address these problems and suggests ways of achieving significant improvement which include a public campaign about which it invites readers’ feedback and participation.

Reducing bias and improving transparency in medical research; a critical overview of the problems, progress and suggested next steps. Bradley S H, de Vito N J, Lloyd K E, Richards G C, Rombey T, Wayant C, and Gill P J. JRSM; 2020, Vol 113(11) 433-443

From the Bad and Sad Came Forth Sweetness and Humour

Covid is not all doom and gloom. The School House Gallery, York, started a project

IDEAS OF HOME

‘asking people to share their ideas of ‘home’ during the global pandemic.’

IDEAS OF HOME

I was amazed when they accepted the verses I sent in and delighted to see them posted in the online gallery.

IDEAS OF HOME

This is the gallery of contributions mainly paintings, photos, sculpture and ceramics– it’s continuously evolving so keep checking back – and keep scrolling, as there’s lots here. I don’t know how long they will be accepting contributions.

Breast cancer, screening, health checks and fake disease

So you think screening saves lives? This video is so good perhaps I should be posting it once a month – or once a week – or every day! For anyone who wants to know more about screening, health checks, overdiagnosis, lead time bias, with how and why what seems like a good idea can actually cause more harm than benefit – from the horse’s mouth –

This video is so good, perhaps I should be posting it every month, or every week, or even every day. It’s what we all need to know about screening and health checks – from breast screening and DCIS to having your life ‘saved’.

The epidemic of Fake Disease:

Breast cancer: Blatant disregard to proper consent continues in screening programmes

‘The healthcare system is disjointed, siloed, unresponsive, and defensive.’

‘Cumberlege review exposes stubborn and dangerous flaws in healthcare’ writes Helen Haskell (BMJ 2020; 370:3099). The Independent Medicines and Medical Devices Safety Review (IMMDSR) was carried out by Baroness Cumberlege and looked into patients’ reports of harm from two drugs and one medical device: Primodos, sodium valproate and pelvic mesh. Serious shortcomings were found in the marketing and oversight of the three treatments as well as the patients who raised concerns.

Hazel Thornton’s rapid response (7 August, 2020) picks up on the review’s point of informed consent: ‘Perhaps most striking was the testimony from hundreds of patients reporting lack of informed consent for their initial treatment, followed by years of dismissal by clinicians and regulators who did not want to associate life-altering symptoms or injured children with their medical interventions’ and highlights that it is not only patients, but (asymptomatic) citizens who are targets of health professionals in preventative medicine, ie breast screening and the (known harms of the) AgeX Trial. – My parentheses.

Emma Friedmann’s blistering response questions the BMJ’s role regarding concerns raised by the review.

It is to be hoped that the 9 recommendations of the IMMDSR will be swiftly implemented.

https://www.immdsreview.org.uk/Report.html

Second reading of Medicines & Medical Devices Bill

Second reading of Medicines and Medical Devices Bill in the House of Lords –

See esp Lord Blencathra at 6pm https://hansard.parliament.uk/lords/2020-09-02/debates/C647246B-5166-4FF1-AD1F-7449B60B248C/MedicinesAndMedicalDevicesBill.

I begin by paying a warm tribute to my noble friend the Minister. He is one of the finest Ministers I have encountered in this House: intelligent, knowledgeable, on top of his brief, courteous and very hard-working. I am delighted that he is going to listen to the criticisms on delegated powers today. Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation. I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power…. etc

Breast screening -Age X trial recruitment ends, but questions still unanswered

The vast AgeX breast screening trial ended, ever so quietly. What did it cost and who approved the spend?

Published: 27 August 2020 by HealthWatch-UK, the charity.

https://www.healthwatch-uk.org/news/208-agex-ends.html

HealthWatch News:

‘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….’

But HealthWatch would still like answers to questions they have been asking for almost a decade…  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”?

………………………………………………

Full article with relevant links to today’s BMJ News; Healthwatch’s BMJ paper on harms and ethical flaws of AgeX full text; and ‘See for Yourself, the full story with 100+ pages of documents obtained via freedom of information requests can be found here:

https://www.healthwatch-uk.org/news/208-agex-ends.html

 

 

Breast Screening: Age X trial

BMJ: News Exclusive re AgeX Trial

Trial to extend breast screening won’t resume after pandemic.

‘Emeritus Professor of Obstetrics and Women’s Health, Susan Bewley told The BMJ, “Although covid will be credited with ending AgeX, this trial would not have stopped prematurely with no fanfare were it actually answering a necessary research question that had been through proper channels of peer review and funding.

“This largest randomised controlled trial in history has been criticised for having no statistical plan or oversight at onset, and repeatedly changing protocol, numbers, and endpoints. Four million women have already taken part in this unethical human experiment, without having had their understanding checked and giving their explicit informed consent.”

Bewley has called for an independent inquiry “to learn the lessons of this government funded research, sponsored by the University of Oxford, and approved by the Human Research Authority that rode roughshod over women’s rights for a decade … We need to ask the question: who approved this, and how much did it cost?”’

Elizabeth Mahase

BMJ 2020;370:m3337

https://www.bmj.com/content/370/bmj.m3337

…………………………………………………………………………………………………………………………………………….

• NB: Sadly, the breast screening programme has been shown to harm more women than it benefits (Marmot, Independent Review). The harms include overdiagnosis and overtreatment.

See also BMJ – Observations:  THE ART OF RISK COMMUNICATION Breast cancer screening pamphlets mislead women All women and women’s organisations should tear up the pink ribbons and campaign for honest information Gerd Gigerenzer director Harding Centerfor Risk Literacy and Centre for Adaptive Behaviour and Cognition, Max Planck Institutefor Human Development, Berlin, Germany.

BMJ2014;348:g2636doi: 10.1136/bmj.g2636(Published25 April 2014) and

Breast Cancer Early Detection by Mammography Screening – Harding Center for Risk Literacy.

Fact Box Images at

https://www.google.com/search?source=univ&tbm=isch&q=gerd+gigerenzer+risk+literacy+fact+box&client=firefox-b-d&sa=X&ved=2ahUKEwjQ2LjTibvrAhUFZMAKHfZQBI4QsAR6BAgLEAE&biw=1920&bih=938

Numbers for 1000 women aged 50 years or over who participated in breast screening for 10 years:

Benefits

Without screening: 5 died of breast cancer              – With screening: 4 died of breast cancer

Without screening: 21 died from all types of cancer – With screening: 21 dies from all types of cancer

Harms

Without screening: false alarms or biopsies – Without screening: none

With screening: false alarms or biopsies      –  100

Numbers with non- progressive cancer who experienced unnecessary partial or complete breast removal

Without screening                                       – None

With screening                                             – 5

Breast screening – misleading claims

Misleading statistical claims including breast screening ‘saving lives’/all-cause mortality

this morning’s BBC Radio 4 More or Less programme.

Now online at:  https://www.bbc.co.uk/sounds/play/m000lzgy