Breast screening – HealthWatch AgeX trial exposure

A screening programme that causes mostly harms (to asymptomatic women) is not compassionate healthcare:

Cost of extending the NHS breast screening age range in England published today http://bmj.com/cgi/content/full/bmj.l1293

There’s more detail behind the investigation here https://www.healthwatch-uk.org/projects/breast-cancer-screening-age-extension/122-age-extension-trial-of-mammography-screening-part-5-april-2019.html including a full non paywalled version of the article

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

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Posted in bad science, biopsies, Breast Cancer, breast screening, Campaigns, cancer, citizen safety, clinical trials, cochrane, Compassion in healthcare, complaint, diagnoses, ethics, evidence-based medicine, harms, healthcare modernisation, information, informed consent, mastectomy, medicine's flaws, open access, openness, overdiagnosis, overtreatment, patient/doctor communication, psychological harm, Public safety, science, Screening, Screening Mammography, speaking out, unethical payments, unsolicited appointments, unsolicited mail | Tagged , , , , , | Leave a comment

Breast screening: BMJ article and detail behind the investigation

Cost of extending the NHS breast screening age range in England published online by BMJ today, 10 April 2019.

http://bmj.com/cgi/content/full/bmj.l1293

Detail behind the investigation here https://www.healthwatch-uk.org/projects/breast-cancer-screening-age-extension/122-age-extension-trial-of-mammography-screening-part-5-april-2019.html

Posted in bad science, Breast Cancer, breast screening, Campaigns, cancer, citizen safety, clinical trials, ethics, harms, healthcare modernisation, information, informed consent, mastectomy, medicine's flaws, open access, openness, overtreatment, patient/doctor communication, psychological harm, Public safety, science, Screening, Screening Mammography, unethical payments, unsolicited appointments, unsolicited mail | Tagged , , , , , | Leave a comment

Breast screening, ‘bad science’ and unnecessary surgeries – the six million women NHS cancer screening experiment

‘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)’ – Cost of extending the NHS breast screening age range in England. Bewley S, Blennerhassett M, Payne M. https://www.bmj.com/content/365/bmj.l1293.full

Exposed by HealthWatch: the bad science and unnecessary surgeries behind the six million women NHS cancer screening experiment. Wednesday, 10 April 2019.

https://www.healthwatch-uk.org/index.php?option=com_content&view=article&id=161:exposed-by-healthwatch&catid=9:news

Posted in bad science, biopsies, Breast Cancer, breast screening, Campaigns, cancer, citizen safety, clinical trials, evidence-based medicine, harms, healthcare modernisation, information, informed consent, mastectomy, medicine's flaws, openness, Over-medicalisation, overdiagnosis, overtreatment, patient/doctor communication, psychological harm, Public safety, Screening, Screening Mammography, unsolicited appointments | Tagged , , , , , | Leave a comment

Breast screening – GP payments for increased take-up/FIRST DO NO HARM

1 Should GPs be paid for increasing breast screening take-up when the Marmot Review found participants were 3 times more likely to be harmed than to benefit; the Parliamentary Review echoed the same findings; and neither included all cause mortality ie deaths caused by treatments/screening – etc.?

2 Excluding GP payments, is it ethical for GPs to advise women to go to breast screening when many of them do not understand the research findings – or, if they do understand the serious harms and lack of benefit, do not get screened themselves?

Writing in the BMJ (BMJ 2019;365:l1409) Helen Salisbury explains the dilemma faced by doctors.

‘… I have a problem with breast cancer screening. The evidence for its benefit is very much less clear. There are well known problems with lead time bias, overdiagnosis, and toxic treatments of screen detected “cancers” that would never have been clinically relevant.

Michael Baum, an architect of the UK screening programme, said in a letter to the Times last week that “screening seems to be a zero sum game in that for every breast cancer death avoided there is one death from overtreatment of pseudocancers.” He went on to say that it was time to de-implement screening. He is not alone in this. In 2017 the Swiss Medical Board reviewed the available evidence and concluded that no new systematic mammography programmes should be introduced in Switzerland.’

People need to be able to trust their doctors.

Helen Salisbury: Should I persuade patients to have mammograms?

BMJ 2019;365:l1409 https://www.bmj.com/content/365/bmj.l1409

 

Posted in Breast Cancer, breast screening, Campaigns, cancer, citizen safety, clinical trials, ethics, evidence-based medicine, harms, healthcare modernisation, informed consent, mastectomy, medicine's flaws, Over-medicalisation, overdiagnosis, overtreatment, patient/doctor communication, Primary care, psychological harm, Public safety, Screening, Screening Mammography, speaking out, unethical payments, unsolicited appointments | Tagged , , , , | Leave a comment

HealthWatch-UK

Just in case you haven’t come across this wonderful, independent organisation yet –

HealthWatch-uk.org is a registered charity (No.1003392) which has been promoting science and integrity in healthcare since 1991.

‘Its formal aims are: the assessment and testing of treatments, whether ‘orthodox’ or ‘alternative’ – consumer protection of all forms of healthcare…’

PLEASE NOTE: HealthWatch-UK is not connected with the (later) NHS organisation, ‘Healthwatch England’.

www.healthwatch-uk.org

newsletter@healthwatch-uk.org

Posted in alternative therapies, bad science, Breast Cancer, breast screening, Campaigns, cancer, cancer drugs, citizen safety, clinical trials, Compassion in healthcare, ethics, evidence-based medicine, harms, healthcare modernisation, information, medicine's flaws, openness, Over-medicalisation, overdiagnosis, overtreatment, palliative care, Primary care, Public safety, science, Screening, Screening Mammography, unsolicited appointments, unsolicited mail | Tagged , , , , , , | Leave a comment

Unethical unsolicited appointments

The government requires energy suppliers to offer smart meters to all small businesses and homes by 2020, so it was understandable that my electricity supplier, nPower, had contacted me about this. But Smart meters are not a legal requirement – it is not compulsory to have a smart meter installed. Nevertheless, someone had decided they would come and fit one in my home!

It was the second such unsolicited letter and, shockingly, it not only asked me to confirm the installation appointment and suggested I should get in touch with the power organisation if I wanted to change the time or date, but required me to call them within the next 5 days to do so. However, it did not mention that I could decline the offer. (And the onus should not be on me to respond about an appointment I had not requested.) A separate, coloured box nudged me to ‘Please act now – confirm or change your appointment’. To me, any unsolicited mailing of an appointment which has not been agreed to (including unsolicited breast screening appointments) is unethical; also, it could cause stress, especially to vulnerable people, regarding decision-making, the need to make contact and difficulties in declining the ‘offer’.

I tried to telephone the company but was put ‘on hold’ along with canned ‘musak’, so after a while I rang off. An attempt to decline online was similarly unsuccessful, as the list of issues I was asked to choose from before writing a message did not include a refusal. Finally, I sent an email complaint.
Such an unsolicited appointment letter was surely ‘lying by default’ (ie giving the impression Smart meters were a mandatory requirement). Intentionally misleading messages which give no opportunity to decline an ‘offer’ are as much a scam as any other which tries to hoodwink the public in order to achieve an objective.
Later that day I received an email telling me ‘the smart refusal has been added to your account, however we are unable to confirm the date that this was added to your records. This will prevent any further correspondence being issued for smart meters. Due to the level of service you have received and for the inconvenience this has caused you, I have arranged for a goodwill gesture of £10.00 to be credited to your account.’ This merely added to my frustration and distrust about the whole business. I wanted to stop what I believed to be sharp practice.

The Ofgem website informed me that it did not get involved in disputes and offered links to the Citizens Advice Bureau and the Ombudsman, but advised taking the issue to one’s energy supplier first.

Apparently, people are still having problems with Smart meters, and these include being unable to have the meter removed: ‘consumers do not currently have an automatic right to have a smart meter removed and it is up to the individual energy suppliers to decide what they want to do.’

https://www.thisismoney.co.uk/money/bills/article-6565209/The-problems-people-dont-want-smart-meters-encountering.html

The consumer organisation, Which?, has much useful information about Smart meters on its website:

https://www.which.co.uk/consumer-rights/advice/do-i-have-to-accept-a-smart-meter

 

 

Posted in breast screening, Campaigns, ethics, information, Public safety, Screening, Screening Mammography, unsolicited appointments, unsolicited mail | Tagged , , , | Leave a comment

Breast cancer (and other cancers) – can this pill save lives?

I don’t usually share information about so-called cancer ‘cures’, but the possibility that surgery, and even fine needle biopsies, could prompt cancer spread has interested me for many years. So when I came across this blog and understood the scientific reasoning behind the hope, I felt it could be important.

The story is explained on a blog by Ralph W Moss  PhD, 28 December 2018:

“About ten years ago, an anesthesiologist named Patrice Forget, MD, PhD (pronounced “For-shay”), of University Hospital, Brussels, compared the cancer recurrence rate of 327 women. All the women had received one of four different painkillers during their surgery for breast cancer. Dr. Forget found something astonishing. There was a greatly reduced risk of a distant relapse among breast cancer patients who got ketorolac. This was compared to patients who received the three other non-NSAID painkillers. They got no such benefit.

There was a good scientific reason why this would be so. As the name implies, an NSAID is an anti-inflammatory drug, not specifically a breast cancer pill. And as Dr. Forget has said: “Surgery and inflammation are closely associated, and linked to mechanisms that promote tumor growth.”

…When a surgeon removes a tumor, the resulting surgical wound causes systemic inflammation for a week or so. The body, in trying to heal that wound, release some hormone-like compounds to speed healing. But these growth and repair signals can have an unanticipated side effect. If the patients have any remaining cancer cells in their bodies, the normal wound healing can stimulate the re-growth of their cancers.”

The blog goes on to explain how the pill works by reducing systemic inflammation and so preventing the growth of new blood supplies to micro-metastases and stopping the growth of a new tumour.

Is it proven too work? Two retrospective studies have shown and a 41% and 45% reduction in the risk of distant recurrences. “These two studies show “a definite benefit of perioperative ketorolac in breast cancer,” according to Dr. Michael Retsky of the Harvard School of Public Health.

The ideas have been put forward in a medical textbook by Michael W Retsky and Romano Demicheli: Perioperative Inflammation as Triggering Origin of Metastases Development, Springer.

Please note – further clinical trials are needed before any definite benefit of ketolac as an anti-cancer drug can be proven.

https://www.mossreports.com/breast-cancer-pill-ketorolac/

Posted in Breast Cancer, cancer, cancer drugs, citizen safety, clinical trials, evidence-based medicine, healthcare modernisation, inflammation, medicine's flaws, metastases, patient safety, prostate cancer, Public safety, rarer and uncommon cancers | Tagged , , , , | Leave a comment