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Read the latest HealthWatch newsletter:  Issue 106, Autumn 2017

Dr Mark Porter MBE, GP and presenter of BBC Radio 4 flagship medical series “Inside Health”, is to receive the 23rd HealthWatch Annual Award. Mark will be in conversation with HealthWatch president, the journalist and broadcaster Nick Ross, on the subject of “EBM for the people – the importance of spreading the word”, at the 2015 HealthWatch open meeting and Annual General Meeting on 20th October at the Medical Society of London. The meeting will also include presentations of cheques for up to £500 each to the winners in the UK-wide HealthWatch Student Prize competition in which students of medicine and allied professions show their skills in assessing research protocols. Awards will be presented by Nick Ross.
Attendance at the meeting is free and open to all, but the presentation will be followed by an optional buffet dinner with wine at 8.45 p.m. at a cost of £45, apply by clicking here for AGM notice 2015 and submitting completed form as soon as possible to reserve your place. Contact point for dinner reservations is David Bender, HealthWatch Secretary.

What: HealthWatch's annual Open Meeting and Annual General Meeting

Where: The Medical Society of London, 11 Chandos Street, Cavendish Square, London W1M 0EB (nearest Underground Bond St or Oxford Circus)

When: Tuesday 20th October 2015 
18:30 Reception
19:00 AGM
19:30 Presentation of Student Prize
19:40 Presentation of 23rd annual HealthWatch Award, followed by Mark Porter in conversation with Nick Ross: “EBM for the people – the importance of spreading the word”

All are welcome at the meeting, but only members may vote at the Annual General Meeting.

 

THE SUMMER issue of the HealthWatch Newsletter is in the mail to members. Non-members can now read the highlights online here, including the full-length news feature about recent coverage of Public Health England's controversial Age Extension Trial of breast cancer screening. Also in the news is the shocking story of a brilliant neurologist who has been sued by his own hospital after he turned whistleblower in an effort to improve services for his patients. Read details of your opportunity to take part in ongoing research and get published. As always you can also read teaser intros of our latest articles, which are enjoyed by our subscribing members. If you'd like to read these in full, join us by becoming a member of HealthWatch and a supporter of science and integrity in medicine.

Susan Bewley, professor of complex obstetrics at KCL, and HealthWatch Committee member, has written in The Conversation about the dangers of celebrities making pronouncements about getting screened for cancer: Celebrity campaigns are a distraction from the real risks of cancer screening

While they make compelling media stories, this kind of media coverage of screening is often incomplete and misleading.

She writes:

It has helped to create unrealistic expectations of what screening programmes are and what they can deliver. On the one hand, there is a mistaken belief that screening only offers benefits. On the other, there is the myth that screening is only offered to certain age groups due to financial restrictions.

Sense About Science have launched a new free “Making Sense of Screening” guide that explains misconceptions about how screening works, its limitations and possible harms.

We believe women are put in harm’s way as they continue to be deceived about the nature of breast screening, especially whilst staff are not trained nor obliged to discuss and obtain formal, written consent for this unscientific and unethical randomised clinical trial.

Read our letter in the BMJ in full.

Related articles

Information for prospective patients in the trial has been updated at www.cancerresearchuk.org. After long term pressure from HealthWatch and others, it is good to see that the trial is now being described more openly. It is clearly stated that the policy on screening the extended age ranges will depend on the outcome of this trial, although that won't be known until 2022.

We were dissatisfied that the Research Ethics Committee (REC) did not appear to take our previous concerns seriously, so we sent an appeal letter on 29th December 2014. This letter is here. We itemised 20 issues that needed to be addressed by the REC. After regular prompting, we eventually received a reply dated 20th March 2015, Oversight of REC decisions is provided by the National Research Ethics Advisors’ Panel (NREAP). In summary, this body dismissed most of our concerns, and allowed the study to proceed unconditionally.

Read more ...

Date Wednesday 4 March 2015
Time 19:00
Venue

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

Accessibility information

Details

Lord Saatchi's Medical Innovation Bill: Emancipating doctors and patients — or striking at the heart of evidence-based medicine?

For: Professor Sir Mike Rawlins, seconded by Daniel Greenberg

Against: Nick Ross, seconded by Nigel Poole QC

Chairman: Sir Peter Bazalgette

Doors open at 18:30

Debate 19:00 to 20:15

Drinks reception at 20:15

Admission is free but places are limited. Registration is essential.

Latest

The motion was resoundingly defeated by 130 votes, with only three voting for the motion and 13 abstaining.

Watch the debate:

Related articles

Our intensive lobbying has achieved substantial results, albeit still incomplete. Main points:

  1. The proposed new patient information sheet will now actually tell women that they are entering a clinical trial.
  2. The Harrow Research Ethics Committee approved* a substantial amendment to the protocol, on 14th October 2014 This amendment is incorporated in the new protocol, version 3.
  3. The protocol now runs to 11 pages, instead of eight originally. It still falls far short of Good Clinical Practice (GCP) compliance; for example there is nothing about quality assurance or publication policy, and in general it doesn’t come close to following the ICH format. There is now a little detail on data processing, and there is a statistical power calculation (although based on contentious assumptions). The sponsor has refused permission for HealthWatch to publish this version of the protocol. This is strange in view of the current moves towards transparency of commercially sponsored trials.
  4. At the REC meeting, the investigators stated that full roll-out of the age extension will be dependent on the results of this trial. However the trial website still states that “The age extension will proceed regardless of whether this study goes ahead or not, and therefore regardless of whether the phasing-in is randomised or not.”

* We are using the informal terms `approved’ and `approval’ for clarity and brevity. The official term is `favourable opinion’.

Read more ...

Related articles

Update August-October 2014

It has emerged that two protocol amendments were submitted to the ethics committee, and rejected. The first rejection letter is dated 14th February 2013. The objections are uncannily similar to the ones raised by HealthWatch members who did not have the benefit of seeing the requested amendments. It reads as follows (our bold):

The members of the Committee taking part in the review decided that they could not give a favourable ethical opinion of the amendment, for the following reasons:

This amendment seeks to shift the emphasis from a pragmatic opportunity (while resources were being expanded) to compare women who were or were not invited for breast screening in the extended age range, almost a service evaluation, to a randomised trial. The name of the study has changed from evaluation to randomised to reflect this intention.

Read more ...

29 October 2014

Media contact: Media

HealthWatch commentator: Susan Bewley, Honorary Professor of Complex Obstetrics, Kings College London

HealthWatch welcomes the publication of this report and congratulates the members of the committee for their efforts and patience in the process of hearing evidence, and for publishing a full and considered report.

In particular we would like to comment on the following recommendations, many of which reflect calls that HealthWatch has been making for some time now:

 

From the report:

We agree that there should be clarification regarding the Government’s position regarding the extension of the breast screening programme, and the evidential basis for the Government’s position on this programme to be detailed.

 

HealthWatch comment:

There is no evidence to support extension of the programme. The age extension trial protocol is flawed and women are expected to give ‘implied’ consent based on false information. The NHS Breast Screening Programme has repeatedly been unwilling to engage in discussion of the shortcomings. Further, while we praise the work of Ann Mackie and the National Screening Committee, it is high time the trial management was called into question: the chief investigator is not medically or scientifically qualified, runs the national screening programme and also chairs the trial steering committee, and by obfuscation has perpetuated a dangerous lack of transparency in this trial. 1-5

Read more ...

The 22nd winner of the annual HealthWatch Award is to be Simon Singh, the author, journalist and mathematician. As well as being an accomplished communicator of science, his award recognizes his courage in fighting a libel suit, at considerable personal cost, and in doing so inspiring the movement which has resulted in a new law: the 2013 Defamation Act.

Simon will address the audience at the 2014 HealthWatch open meeting and Annual General Meeting. The meeting will also include presentations of cheques for up to £500 each to the winners in the UK-wide HealthWatch Student Prize competition in which students of medicine and allied professions show their skills in assessing research protocols. Awards will be presented by journalist and broadcaster Nick Ross.

The 2014 HealthWatch AGM and awards will take place Thursday 30th October 2014 at The Medical Society of London, Lettsom House, 11 Chandos Street, London W1G 9EB (nearest underground station Oxford Street). The evening will begin with a reception at 6.30pm, with awards presentation at approximately 7.30pm.

Attendance at the meeting is free and open to all, but the presentation will be followed by an optional buffet dinner with wine at 8.45 p.m. at a cost of £45, apply by clicking here and submitting completed form.

Related articles

Breast Cancer Screening Age Extension Randomised Controlled Trial

Key Issues

Background

Currently women between 50 and 70 years are invited to present for mammography screening. The overall benefit of this is increasingly doubtful, as better research is published, but the information women are given does not reflect this. The present policy is based on quite old randomised controlled trials, more recent data being from observational studies which are less robust.

Successive governments have been committed to extending the age range for a long time. In 2010 the Department of Health committed to extending the age range at either end, so that women over 47 and up to 73 years would also be invited. The Cancer Epidemiology Unit in Oxford (headed by Sir Richard Peto) has for years argued for randomisation of the age extension roll-out in order to collect data on effectiveness. This converted the roll-out into a randomised controlled clinical trial, which is how it is described by the government.

The controversy over mammography screening centres on the possible harms. For any screening test that is not 100% specific or accurate, and if the disease concerned only affects a small percentage of people, there will usually be far more false positive results than real positives. That is very clearly the case for mammography screening. Hence more women have unnecessary surgery than have real cancers treated. The question is whether on balance this is worth the effort, cost, and harms of screening.

Read more ...

HealthWatch members were at a party, organised by Sense About Science, which was held in the Penderel’s Oak pub in Holborn, London, on 16th May 2013.

This is the pub where, on 18th May 2009, a group of well-known scientists, comedians and writers were assembled on the initiative of the lawyer David Allen Green, to object to a libel action against the science writer Simon Singh. This meeting led to a protest against the suppression of scientific debate, which grew into a wider campaign to reform the repressive, centuries-old libel laws. After a four-year campaign, involving thousands of people and hundreds of organisations, the old laws were overturned. The new Defamation Act became law on 25th April 2013.

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