11 August 2014 The current SA Menopause Society newsletter says:
Benefits of mammography
||“the benefits of screening mammography are modest at best” (Elmore & Harris BMJ 2014;348:g3824). This is the conclusion after the latest research to come out of Norway where the introduction of screening has been gradually introduced over the last 2 decades (Weedon-Fekjaer et al BMJ 2014;348:g3701).
The Norwegian authorities invited women between 50 and 70 years old to attend for screening every second year and looked at before and after death rates from breast cancer. They found RELATIVE risk reduction of 28% in those invited compared with those not invited to be screened. Without knowing the ACTUAL risk reduction or the harms of screening this sounds like a “good deal”. However it is an observational study not a randomised trial and therefore susceptible to various biases.
For women to make up their own minds about screening, actual figures of benefits and harms need to be given because without accuracy perceived dangers and benefits are very far from reality. For example in the US or UK asking women about their estimates of breast cancer deaths – taking 1000 women aged 50 and following them for 20 years – gave the following results:
||Of 1000, number
alive after 20 years
Women believe that breast cancer is a far greater threat than it really is. They also believe that screening halves such risk.
If actual death reductions from breast cancer are taken into account, screening benefits are modest at best and if all cause deaths are taken into account the benefits all but disappear.
20 July 2014 Two new papers from Scandinavia highlight the harms of screening mammography.:
15/3/ 2014 update: Great Mammography Debate : Dr. Patrick Borgen, Chairman of Surgery at Maimonides Medical Center in Brooklyn, New York, talks about the role of screening mammography, a topic bracketed by strong opinions. It has been a particular focus of discussion at the 31st Annual Miami Breast Cancer Conference, held March 6 through March 9, 2014, in Miami, Florida.
Commentary The mammography debate is one of the facets of the Miami Breast Cancer Conference this year. It seems as though the field of breast cancer has always been controversial, going back half a century, and breast cancer is a disease that, more than most others, is very polarizing. This disease engenders great passion—and great debate, which has been ongoing about the role of screening mammography.
A few weeks ago, The New York Times covered an article that was published in the British Medical Journal 1 about the Canadian National Breast Screening Study. On the surface, this study failed to show any benefit from mammography. That was the story that the writer, Gina Kolata, picked up and ran with. Ms. Kolata had written about her own experience with breast cancer a number of years ago; her breast cancer had not been picked up on a mammogram, and so she is somewhat biased.
In short, the Canadian study evaluated mammograms from more than 90,000 women who had very primitive mammograms between 1980 and 1984, and that is really the first problem with this study: the technology and the equipment then was incredibly limited, such that the mammograms only showed 30% of breast cancers; whereas, today, mammography detects 70% to 80% of breast cancers. Thus, taking results generated by technology from 34 years ago and making a conclusion about them in today’s world is a stretch.
One of the fundamental flaws of the Canadian study, besides the dated technology on which the conclusions were based, was that it was not randomized. Nurses, and, in some provinces in Canada, doctors, did a clinical breast exam, and, if they felt a mass or a lump, they preferentially put the patient into the mammography arm. That is what I would have done in their place; if I felt a lump, I would not be willing to send someone home.
By the end of the study, there were more than 100 extra breast cancers in the mammography arm and more breast cancers that had spread to lymph nodes in the mammography arm. And, in fact, the chance of dying of breast cancer was higher in the mammography arm.
All of the authorities with whom I have ever spoken or read who have reviewed this study dismiss it as very flawed. A number of the doctors who were involved with the study resigned their positions in protest. Despite all of that, The New York Times ran an article headlined, “Vast Study Casts Doubts on Value of Mammograms” (February 11, 2014).
Well, it is a vastly flawed study, and, in fact, there are six other, much larger and much better controlled studies, all of which showed a reduction in breast cancer mortality from 20% up to 40% in women who have mammograms—and that is certainly what we observe clinically.
We felt that it was important to really highlight this at the Miami Breast Cancer Conference this year. My guess is that our audience already knows this; but, what we would like to give them is the science about why the Canadian study was flawed so that they can talk to their patients and talk to their colleagues who may not be in the breast cancer field. That is really what I think our mission is for part of this year’s conference.
We think that this is dangerous information. We think that women will unnecessarily lose their lives to breast cancer if they forego mammography, which this study frankly says one should. I have a busy practice in Brooklyn, New York, and, at least once or twice a week, I see someone, without any question, whose life was saved by a mammogram.
I think that we all agree we need something better than mammography. We all agree that mammography can lead to over-diagnosis of breast cancers, and over-diagnosis happens, of course, when we screen for diseases in other areas of the body. We all accept this limitation.
But, for a major media outlet to take a single study that was deeply flawed and not even mention the existence of other studies, even as a point–counterpoint, I think was a bit outrageous!
12 March 2014 this publication on the Huffington Post website today under screening mammography is as appropriate as when it was published in 2010:
BREAST CANCER UNAWARENESS MONTH: Rethinking Mammograms
The NBCAM has assured women that “early (mammography) detection results in a cure nearly 100 percent of the time.” More specifically, the NBCAM is directed to claims for reducing the incidence and mortality of breast cancer through early detection by annual mammography starting at age 40. Moreover, mammograms can miss cancers in premenopausal women due to the density of their breasts, and also fail to detect cancers smaller than half an inch.
Still denied by the ACS is clear evidence that premenopausal mammography poses significant risks of breast cancer. The routine practice of taking two films annually for each breast results in approximately 0.5 rad (radiation absorbed dose) exposure. This is about 500 times the dose from a single chest X-ray and is broadly focused on the entire chest rather than narrowly on the breast. This is also 25 times higher than is allowed by the Environmental Protection Agency for whole-body radiation from local nuclear industries (0.02 rad). Moreover, the breast is the most sensitive organ to ionizing radiation.
As warned by the prestigious National Academy of Sciences in 1972 but still ignored by the ACS, the premenopausal breast is highly sensitive to the risks of cancer from mammography, as each rad exposure increases the risks of breast cancer by 1 percent. This results in a cumulative 10 percent increased risk for each breast following a decade of routine screening. This can also accounts for the 19-percent increased incidence of breast cancer since 1975. Not surprisingly, the prestigious U.S. Preventive Task Force, supported by the National Breast Cancer Coalition, warned last year against routine premenopausal mammography. Also, not surprisingly, routine premenopausal mammography is practiced by no nation other than the U.S.
Risks of premenopausal mammography are some four-fold greater for the 2 percent of women who are carriers of the A-T gene (ataxia telangiectasia) and are highly sensitive to the carcinogenic effects of radiation. By some estimates, this accounts for up to 20 percent of all breast cancers diagnosed annually. Compounding these problems, missed cancers are common in premenopausal women due to the density of their breasts.
That most breast cancers are first recognized by women was admitted by the ACS in 1985. “We must keep in mind that at least 90 percent of the women who develop breast cancer discover the tumors themselves.” Furthermore, an analysis of several 1993 studies showed that women who regularly performed breast self-examination (BSE) detected their cancers much earlier than women failing to examine themselves. The effectiveness of BSE, however, depends on training by skilled professionals, enhanced by an annual clinical breast examination. Nevertheless, in spite of such evidence, the ACS dismisses BSE, and claims that “no studies have clearly shown [its] benefit.”
As reported in our 1999 publication in the International Journal of Health Services, an article in a leading Massachusetts newspaper featured a photograph of two women in their twenties. The article promised that early detection by mammography results in a cure “nearly 100 percent of the time.” Questioned by journalist Kate Dempsey, an ACS communications director responded: “The ad isn’t based on a study. When you make an advertisement, you just say what you can to get women in the door. You exaggerate a point — Mammography today is a lucrative [and] highly competitive business.”
If all 20 million U.S. premenopausal women submitted to annual mammograms, the minimal annual costs would be $2.5 billion. Such costs would be increased some fourfold if the industry, supported by radiologists, succeeds in its efforts to replace film machines, costing about $100,000, with high-tech digital machines, costing over $400,000, even in the absence of any evidence for their improved effectiveness.
With this background, it is hardly surprising that the National Breast Cancer Awareness Month neglects to inform women how they can reduce their risks of breast cancer. In fact, we know a great deal about its avoidable causes which remain ignored by the ACS. These include:
- Prolonged use of the Pill, and estrogen replacement therapy.
- Prolonged consumption of milk from cows injected with a genetically engineered growth hormone to increase milk production. This milk is contaminated with high levels of a natural growth factor, which increases risks of breast cancer by up to seven-fold.
- High consumption of meat, as it is contaminated with potent natural or synthetic estrogens. These are routinely implanted in cattle before entry into feedlots, about 100 days prior to slaughter, to increase muscle mass and profits for the meat industry.
- Prolonged exposure to a wide range of hormonal ingredients in conventional cosmetics and personal care products.
- Living near hazardous waste sites, petrochemical plants, power lines, and nuclear plants.
The enthusiastic and continuing support of premenopausal mammography by the ACS is hardly surprising in view of its major conflicts of interest that still remain unrecognized. Five radiologists have served as ACS presidents. In its every move, the ACS promotes the interests of the major manufacturers of mammogram machines and films, including Siemens, DuPont, General Electric, Eastman Kodak and Piker. The mammography industry also conducts research for the ACS, serves on its advisory boards, and donates considerable funds. DuPont is also a substantial backer of the ACS Breast Health Awareness Program. It sponsors television shows touting mammography; produces advertising, promotional materials and literature for hospitals and doctor; and lobbies Congress for legislation promoting the availability of mammography. The ACS has been and remains strongly linked with the mammography industry, while ignoring or criticizing the value of breast self-examination, even following training by a qualified nurse or clinician.
The ACS conflicts of interest extend well beyond the mammography industry. The ACS has received contributions in excess of $100,000 from a wide range of “Excalibur (industry) Donors,” who manufacture carcinogenic products. These include petrochemical companies (DuPont, BP and Pennzoil), Big Pharma (AstraZenceca, Bristol Myers Squibb, GlaxoSmithKline, Merck & Company and Novartis), and cosmetic companies (Christian Dior, Avon, Revlon and Elizabeth Arden).
Samuel S. Epstein, M.D. is professor emeritus of Environmental and Occupational Medicine at the University of Illinois at Chicago School of Public Health; Chairman of the Cancer Prevention Coalition; and a former President of the Rachel Carson Trust. His awards include the 1998 Right Livelihood Award and the 2005 Albert Schweitzer Golden Grand Medal for International Contributions to Cancer Prevention. Dr. Epstein has authored 270 scientific articles and 20 books on cancer prevention, including the groundbreaking “The Politics of Cancer” (1979), and most recently “Toxic Beauty” (2009, Benbella Books: www.benbellabooks.com) about carcinogens, besides other toxic ingredients, in cosmetics and personal care products. Email: email@example.com. Web: www.preventcancer.com.
update 6 March 2014 Switzerland debates dismantling its breast cancer screening programme BMJ 2014;348:g1625 “A row has erupted in Switzerland after the Swiss Medical Board recommended that the country’s mammography screening programme for breast cancer be suspended because it leads to too many unnecessary interventions.
In a report made public on 2 February, the board said that while systematic mammography screening for breast cancer saved 1-2 women’s lives for every 1000 screened, it led to unnecessary investigations and treatment for around 100 women in every 1000.1 “The desirable effect is offset by the undesirable effects,” said the report, which was based on study data from 1963 to 1991 comparing 1000 women who were screened with 1000 women who were not. The report also concluded that screening was not cost effective.…”
update 1 Mar 2014 Supporting informed decision making when clinical evidence and conventional wisdom, clash. The nub of the screening mammography war – and all hard-sell marketing hype- is elegantly analyzed by a USA multiUniversity Communications team in Against conventional wisdom: when the public, the media, and medical practice collide. Jakob Jensen ea argue that “the screening mammography controversy was driven by the systematic removal of uncertainty from science communication. To increase comprehension and adherence, health information communicators remove caveats, limitations, and hedging so science appears simple and more certain. This streamlining process is, in many instances, initiated by researchers as they engage in dissemination of their findings, and is facilitated by public relations professionals, journalists, public health practitioners, and others whose tasks involve using the results from research for specific purposes. Uncertainty is removed from public communication because many communicators believe that it is difficult for people to process and/or that it is something the audience wants to avoid. Uncertainty management theory posits that people can find meaning and value in uncertainty. CONCLUSIONS: Science is routinely simplified as it is prepared for public consumption. In line with the model of information overload, this practice may increase short-term adherence to recommendations at the expense of long-term message consistency and trust in science”.
The Mammography Saves Lives screening campaign was and is to recruit all older women to regular screening; it was progressively oversold by removing, ignoring the science uncertainty. “Science is routinely simplified as it is prepared for public consumption. In line with the model of information overload, this practice may increase short-term adherence to recommendations at the expense of long-term message consistency and trust in science”.
We see the same collusion between corporate marketeers and government regulators in so many high-profit industries:
* on Pubmed, screening mammography features for 50 years, and continued to expand exponentially without hindrance until enough epidemiologists – led by the Cochrane Group- collectively rang enough alarm bells the past decade. The zealous huge-profit USA radiology-oncology industry simply shouted down the negative result of the massive Canadian Screening Mammography trial outcome 30 years ago in 90 000 women, and continue to do so with the 25year results now reported. The huge Breast Industry retaliates by threatening whistle blowers.
*at the same time around 50years ago, as many of us were starting medical studies, Keys and Stamler et al in USA did bad epidemiological studies that subverted the facts of healthy indigenous diets around Europe, Africa and Asia, and the healthy traditional English-speaking (USA and the British Empire) working population’s mainly fresh meat/fish fat and farm produce diet,
to claim that the reverse be promoted- factory-produced low fat low cholesterol high carbohydrate (cereals, potato, white flour and white rice) – and worse, quadrupling of fructose and sucrose intake, with increasing obesity; and then noxious statins- for-all for the resultant carbs-inducedlipidemia “epidemic”; and the dangerous hypoglycemic drugs for mushrooming type 2 diabetes, and NSAIDs for arthritis; and numerous wannabe antiobesity drugs; and finally the new industry of bariatric surgery!.
see the classic expose books: John Gofman’s Preventing Breast Cancer 1996; James le Fanu ‘s The Rise and Fall of Modern Medicine 1999 ; Gary Taubes’ The Diet Delusion (2007); Ben Goldacre’s Bad Pharma 2012 and Peter Gotzsche’s Mammography Screening: Truth, Lies and Controversy 2013
*and as a result, the past 30years,- against all rational food science and biology – Montsanto’s Government- approved rape of healthy food agriculture by genetically modified crops laced with toxic environmentally persistent glyphosate C3H8NO5P- Roundup.
It is no irony that one of the leading medical scientists of the 20th century Dr John Gofman took part in the Manhattan nuclear Project, was a pioneer of VLDL lipidology, and then an activist for protecting women against the accumulating harm of mammography – “there is no safe dose of radiation”.
| at Exam.
|| Resulting Risk of Mammogram-Induced Breast Cancer. 1998
|Any age in
||1 chance in about 1,100.
||5 chances/1100, or 1 chance in 220.
|Any age in
||1 chance in about 1,900.
||10 chances/1900, or 1 chance in 190.
|Any age in
||1 chance in about 2,000.
||15 chances/2,000, or 1 chance in 133.
Dr Emily Transue MD eloquently describes her personal disillusionment with screening mammography.
and Dr Charles Wright in the Toronto Globe and Mail says “It’s time for a new approach to mammograms
The New York Times review this week turns the report of the Canadian trial to focus on the importance of breast self-examination
; their other review
agrees that Vast Study Casts Doubts on Value of Mammograms.
It is damning that Cochrane studies
(which date from about 1994) -for mammography
published only since year 2000 – have consistently found that screening mammography imaging has no material longterm survival benefit for women with apparently normal breasts, with numerous potential harms.
The question remains, should people without suspicious cancer symptoms or bad family history have any invasive screening (of breast and prostate) beyond regular appropriate physical examination? when all of us should follow sensible lifestyle, diet and appropriate supplements to minimize both acute and chronic diseases, and thus die well in old age.
If women without apparent high risk will not be satisfied by clinical reassurance, prescreening image recording without compression irradiation will depend on what is locally available.
The USA National Cancer Institute at the NIH
, while dutifully promoting regular screening mammography, negates their promotion by listing precisely 7 lines, one benefit : Early detection of breast cancer with screening mammography means that treatment can be started earlier in the course of the disease, possibly before it has spread. Results from randomized clinical trials and other studies show that screening mammography may reduce the number of deaths from breast cancer among women ages 40 to 70, especially for those over age 50..
But it lists 46 lines of potential harms:” What are some of the potential harms of screening mammograms?
1. “Finding cancer early doesnt reduce a woman’s chance of dying from breast cancer or any cause. Even though mammograms can detect malignant tumors that cannot be felt, treating a small tumor does not always mean that the woman will not die from the cancer. A fast-growing or aggressive cancer may have already spread to other parts of the body before it is detected.
2. Fear: “Women with such detected early tumors live a longer period of time fearing that they likely have a fatal disease… screening mammograms dont help prolong the life of a woman who is suffering from other, more life-threatening health conditions. Depression anxiety let alone suicide are increased .
3. “False-negative results occur when mammograms appear normal even though breast cancer is present. Overall, screening mammos miss about 20% of breast cancers that are present at the time of screening.. from high breast density i.e., glandular tissue and connective tissue, together known as fibroglandular tissue) and fatty tissue. Because fibroglandular tissue and tumors have similar density, tumors can be harder to detect in women with denser breasts more often among younger women than among older women because younger women are more likely to have dense breasts. As a woman ages, her breasts usually become more fatty, and false-negative results become less likely. False-negative results can lead to delays in treatment and a false sense of security for affected women.
4. “False-positive results occur when radiologists decide mammograms are abnormal but no cancer is actually present. All abnormal mammograms should be followed up with additional testing (diagnostic mammograms, ultrasound, and/or biopsy) to determine whether cancer is present… more common for younger women, women who have had previous breast biopsies, women with a family history of breast cancer, and women who are taking estrogen (for example, menopausal hormone therapy). False-positive mammogram results can lead to anxiety and other forms of psychological distress in affected women. The additional testing required to rule out cancer can also be costly and time consuming and can cause physical discomfort. .
5. “Overdiagnosis and overtreatment. Screening mammograms can find cancers and cases of ductal carcinoma in situ (DCIS, noninvasive tumor cells that may become cancerous build up in the lining of breast ducts) that need to be treated. However, they can also find cancers and cases of DCIS that will never cause symptoms or threaten a woman’s life, leading to “overdiagnosis” of breast cancer. Treatment of these latter cancers and cases of DCIS is not needed leads to “overtreatment.” Overtreatment exposes women unnecessarily to the adverse effects associated with cancer therapy. Because doctors often cannot distinguish cancers and cases of DCIS that need to be treated from those that do not, they overtreat .
6. “Radiation exposure. Mammograms require very small doses of radiation. The risk of harm from this radiation exposure is extremely low, but repeated x-rays have the potential to cause cancer.
They fail to list other adverse effects: 7. Pain and bruising of crush mammography- sometimes prolonged; 8. spreading early and likely dormant cancer. 9. Increased incidence of breast cancer and thus more irradiation, mastectomy and all-cause mortality, and 10. complications of surgery, radiotherapy and chemotherapy. ………………………..
Prof Michael Baum
as a former UK Screening Mammography leader again trenchantly quotes reality to protect women from terrorism by screening mammography and mastectomy, in particular urging the same policy of watchful waiting
to see the natural course of early cancer- that has saved so many men from harmful diagnostic and therapeutic invasion of asymptomatic prostate cancer.
We must stress that, if the patient refuses or is denied conventional oncotherapy, Watchful Waiting should always be supported including by all possible improvements in multibeneficial diet, lifestyle and supplements, and avoidance of cancer-promoting estrogenics .
Women who choose not to have mammography and oncotherapy for highly suspicious lumps or even advancing cancers, or have been classified by cancer clinics as too advanced for oncotherapy- told they have very short life expectancy- illustrate the lesson of watchful waiting with active intervention. We see surprising regression in breast lumps, breast cancer and quality life extension in those who refuse to accept the oncologists’ death predictions and who apply strong faith and some of the many evidence-based changes and preventative natural supplement remedies we have collated,
before or even after the gamut / gauntlet of crush mammography, biopsy, surgery and radio-chemotherapy.
update 21 Feb 2014 The Oncologist
publishes epidemiologist Archie Bleyer’s “Were Our Estimates of Overdiagnosis With Mammography Screening in the United States Based on Faulty Science”?
rebuttal of radiologist Prof Daniel Kopans’ denial of the overdiagnosis of breast cancer.
The point Bleyer again makes is that women have the choice provided they are fully informed of the pros and cons, and the options to screening mammography and biopsy.
16 Feb 2014 update: a slew of new papers reinforces the futility and hazards of mammography screening for early breast cancer- and the divide between the vested interests of mammographers/ oncologists – those who make their living from finding every possible cancer- and the welfare of women:
in NEJM 13 Feb , 2014,
Lisa Rosenbaum MD , Univ Pensylvania: sums up the dilemma of real but unprofitable evidence vs profiteering, culture and feeling : “Misfearing” — Culture, Identity, and Our Perceptions of Health Risks Despite knowing that heart disease kills more women each year than all cancers combined, most women fear breast cancer far more — and their health-related behavior reflects this difference. If our sense of risk is less about fact than about feeling, how do we adjust it?
BMJ Feb 11, 2014: 25year Breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial
Anthony Miller, Cornelia Baines, Steven Nar ea, compared breast cancer incidence and mortality up to 25 years later in 89 835 volunteer women aged 40-59 randomly assigned to mammography (five annual mammography screens) or control (no mammography) in 15 screening centres in six Canadian provinces, 1980-85 . . Women aged 40-49 in the mammography arm and all women aged 50-59 in both arms received annual physical breast examinations. Women aged 40-49 in the control arm received a single examination followed by usual care in the community. Main outcome measure Deaths from breast cancer. Results During the five year screening period, 666 invasive breast cancers were diagnosed in the mammography arm (n=44 925 participants) and 524 in the controls (n=44 910), and of these, 180 women in the mammography arm and 171 women in the control arm died of breast cancer during the 25 year follow-up period. The overall hazard ratio for death from breast cancer diagnosed during the screening period associated with mammography was 1.05 (95% confidence interval 0.85 to 1.30). in those aged 40-49 and 50-59 . During the entire study period, 3250 women in the mammography arm and 3133 in the control arm had a diagnosis of breast cancer, and 500 and 505, respectively, died of breast cancer. Thus the cumulative mortality from breast cancer was similar between women in the mammography arm and in the control arm (hazard ratio 0.99, 95% confidence interval 0.88 to 1.12). After 15 years of follow-up a residual excess of 106 cancers was observed in the mammography arm, attributable to over-diagnosis. Conclusion Annual mammography in women aged 40-59 does not reduce mortality from breast cancer beyond that of physical examination or usual care when adjuvant therapy for breast cancer is freely available. Overall, 22% (106/484) of screen detected invasive breast cancers were over-diagnosed, representing one over-diagnosed breast cancer for every 424 women who received mammography screening in the trial.
Editorial Too much mammography
11 February 2014 BMJ 2014;348:g1403 http://dx.doi.org/10.1136/bmj.g1403
Mette Kalager,Hans-Olov Adami, Michael Bretthauer, Norway. Long term follow-up does not support screening women under 60. Before being widely implemented, mammography screening was tested in randomised controlled trials in the 1960s to 80s. Meta-analyses of these trials showed a relative reduction in deaths from breast cancer of between 15% and 25% among women aged 50 to 69.1 2 3 Only the Canadian National Breast Screening Study showed no reduction in breast cancer mortality.1 2 3 This large randomised controlled trial compared physical breast examination with combined physical breast examination and annual mammography in women aged 40 to 59.1 2 3 In a linked paper (doi:10.1136/bmj.g366), Miller and colleagues present the results for up to 25 years of follow-up in the Canadian study.4 No difference in breast cancer mortality was observed between the mammography and control arms, whereas a significant excess incidence of invasive breast cancer was observed in the mammography arm, resulting in 22% overdiagnosis. This means that 22% of screen detected invasive cancers would not have reduced a woman’s life expectancy if left undetected. The major strengths of this study include its randomised design, intense intervention with five annual mammography screenings, high compliance, and complete, long term follow-up. The lack of mortality benefit is also biologically plausible because the mean tumour size was 19 mm in the screening group and 21 mm in the control group. This 2 mm difference—which might be even smaller if overdiagnosed cancers could be excluded from the screening group—represents a minimal proportion of the entire clinical course for breast tumours. But the trial also has some potential limitations. No quantitative data are available on the degree of contamination in the control arm or possible confounding by screening mammography after the trial. It seems unlikely, however, that such potential limitations would conceal a clinically important benefit. The rate of overdiagnosis did not include ductal carcinoma in situ, and the trial provides no data for women older than 60.
The Canadian study, launched in 1980, is the only trial to enroll participants in the modern era of routine adjuvant systemic treatment for breast cancer, and the women were educated in physical breast examination as advocated today.4 These important features may make this study more informative for a modern setting, compared with other randomised trials. The results of the study are strikingly similar—for both lack of efficacy and extent of overdiagnosis—to recent studies evaluating today’s screening programmes.5 6 7 The real amount of overdiagnosis in current screening programmes might be even higher than that reported in the Canadian study,4 because ductal carcinoma in situ, which accounts for one in four breast cancers detected in screening programmes,8 was not included in the analyses.
Other studies also indicate that improved treatment rather than screening is the reason for the decline in breast cancer mortality during the past four or five years.5 7 Even though different studies arrive at different reductions in breast cancer mortality (from 10% to 25%), these benefits translate to only marginal differences in absolute effects. Much larger variation is seen in the estimates of overdiagnosis.6 In studies based on statistical modelling, overdiagnosis was less than 5%.6 By contrast, most observational studies report higher estimates of overdiagnosis, ranging from 22% to 54%,6 depending on denominator used.9 When the number of breast cancers detected at screening is used as the denominator (as in the Canadian study), the amount of overdiagnosis observed in the previous randomised controlled trials is strikingly similar (22-24%).4 10
How do the data on mammography screening compare with data on prostate cancer screening by prostate specific antigen, which is currently not encouraged in the United Kingdom and other countries owing to its small effect on mortality and large risk of overdiagnosis (www.screening.nhs.uk/prostatecancer)? The figure on bmj.com shows that the absolute harms (overdiagnosis) and benefits (mortality reduction) are not very different between the screening types. The 20 year risk of breast cancer for a 50 year old woman is 6.1% with screening (including 22% overdiagnosis 4),11 and 5.0% without screening; and the corresponding numbers for prostate cancer in a 50 year old man are 3.9% with screening (including 45% overdiagnosis 12) and 2.7% without screening.11 The 20 year risk of death from cancer for a 55 year old woman is 1.5% with screening (assuming a 20% reduction in mortality2)11 and 1.9% without screening; and the corresponding numbers for prostate cancer in a 55 year old man are 1.0% with (assuming a 20% reduction in mortality12) and 1.3% without screening.11
Nevertheless, the UK National Screening Committee does recommend mammography screening for breast cancer but not prostate specific antigen screening for prostate cancer, stating that the “aim is to only implement programs that do more good than harm and that the informed choice is a guided principle of screening” (www.screening.nhs.uk/screening). Because the scientific rationale to recommend screening or not does not differ noticeably between breast and prostate cancer, political pressure and beliefs might have a role.
We agree with Miller and colleagues that “the rationale for screening by mammography be urgently reassessed by policy makers.” As time goes by we do indeed need more efficient mechanisms to reconsider priorities and recommendations for mammography screening and other medical interventions. This is not an easy task, because governments, research funders, scientists, and medical practitioners may have vested interests in continuing activities that are well established.
RESPONSES: 12 February 2014 BMJ 2014;348:g366 : 1. rebuttal by USA radiologists : Daniel B. Kopans, Professor of Radiology Harvard Medical School. Having been one of the experts called on in 1990 to review the quality of their mammograms I can personally attest to the fact that the quality was poor (1). To save money they used second hand mammography machines. The images were compromised by scatter since they did not employ grids for much of the trial. They failed to fully position the breasts in the machines so that cancers were missed because the technologists were not taught proper positioning, and their radiologists had no specific training in mammographic interpretation.
The CNBSS’s own reference physicist wrote:“..in my work as reference physicist to the NBSS, [I] identified many concerns regarding the quality of mammography carried out in some of the NBSS screening centers. That quality [in the NBSS] was far below state of the art, even for that time (early 1980’s). ” (2)
In this latest paper (3) the authors gloss over the fact that only 32% of the cancers were detected by mammography alone. This extremely low number is consistent with the poor quality of the mammography. At least two thirds of the cancers should be detected by mammography alone (4). In their accompanying editorial (5) Kalager and Adami admit that ” The lack of mortality benefit is also biologically plausible because the mean tumour size was 19 mm in the screening group and 21 mm in the control group….a 2 mm difference.” Poor quality mammography does not find breast cancers at a smaller size and earlier stage and would not be expected to reduce deaths.
The documented poor quality of the CNBSS mammography is sufficient to explain their results and all of the above disqualifies the CNBSS as a scientific study of mammography screening, but it was even worse than that. In order to be valid, randomized, controlled trials (RCT) require that assignment of the women to the screening group or the unscreened control group is totally random. A fundamental rule for an RCT is that nothing can be known about the participants until they have been randomly assigned so that there is no risk of compromising the random allocation. Furthermore, a system needs to be employed so that the assignment is truly random and cannot be compromised. The CNBSS violated these fundamental rules (6). Every woman first had a clinical breast examination by a trained nurse (or doctor) so that they knew the women who had breast lumps, many of which were cancers, and they knew the women who had large lymph nodes in their axillae indicating advanced cancer. Before assigning the women to be in the group offered screening or the control women they knew who had large incurable cancers. This was a major violation, but it went beyond that. Instead of a random system of assigning the women they used open lists. The study coordinators who were supposed to randomly assign the volunteers, probably with good, but misguided, intentions, could simply skip a line to be certain that the women with lumps and even advanced cancers got assigned to the screening arm to be sure they would get a mammogram. It is indisputable that this happened since there was a statistically significant excess of women with advanced breast cancers who were assigned to the screening arm compared to those assigned to the control arm (7). This guaranteed that there would be more early deaths among the screened women than the control women and this is what occurred in the NBSS. Shifting women from the control arm to the screening arm would increase the cancers in the screening arm and reduce the cancers in the control arm which would also account for what they claim is “overdiagnosis”. The analysis of the results from the CNBSS have been suspect from the beginning. The principle investigator ignored the allocation failure in his trial and blamed the early excess of cancer deaths among screened women on his, completely unsupportable, theory that cancer cells were being squeezed into the blood leading to early deaths. This had no scientific basis and was just another example of irresponsibility in the analysis of the data from this compromised trial and he finally retracted the nonsense after making front page headlines (6).
The compromise of the CNBSS trial is indisputable. The 5 year survival from breast cancer among women ages 40-49 in Canada in the 1980’s was only 75%, yet the control women in the CNBSS, who were supposed to represent the Canadian population at the time, had a greater than 90% five year survival. This could only happen if cancers were shifted from the control arm to the screening arm. The CNBSS is an excellent example of how to corrupt a randomized, controlled trial. Coupling the fundamental compromise of the allocation process with the documented poor quality of the mammography should, long ago, have disqualified the CNBSS as a legitimate trial of screening mammography. Anyone who suggests that it was properly done and its results are valid and should be used to reduce access to screening either does not understand the fundamentals, or has other motives for using its corrupted results.
2. confirmation: http://www.bmj.com/content/348/bmj.g366?tab=responses Per-Henrik Zahl, MD & statistician Norwegian Institute of Public Health. In this 30-year old study, the authors report no mortality reduction when screening with mammography and 22% overdiagnosis (1). The sensitivity of the mammography technique has improved tremendously in the last three decades. Ten years ago we got digital mammography and recently we have got tomosynthesis (2). The detection rate at mammography in the Canadian study was about 3 per 1000 in the second and later screening rounds (3). In digital mammography, the corresponding detection rate is 6 per 1000 screened woman and in tomosynthesis, the detection rate is 8 per 1000 (2). It could even have been higher if the pathologists had time to perform more biopsies (personal communications). In tomosynthesis a large number of stellate lesions appear, many more than in traditional mammography, and they are probably representing a reservoir of overdiagnosed breast cancers. In the last 15 years, the rate of interval cancer has been constant and is at the same level as in Canada 30 years ago (4). Thus, the level of overdiagnosis is far much bigger today than in Canada 30 years ago.
update 6 Feb 2014 This column has noted that in the 2012 report of the the giant ATLAS (and aTTom) trials in 37 countries the past decade (discussed in detail below), despite the claimed 80% cure rate of early silent breast cancer (diagnosed by mammography screening at around 55yrs), by 15 years after repeated screening mammography- surgery-radiotherapy, tamoxifen for 5 or 10 years and annual screening mammography followup, of the women who had died by age 70yrs and had autopsy, some 43% had (silent) recurrence of breast cancer- although this had been detected in far fewer living women. The 15 year ATLAS results overall were depressing- in those originally early silent estrogen-receptor positive breast cancers, although only about 20% had clinical recurrence by a mean age of 70yrs, of the 22% who had died by then, almost half ie 43% had recurrence of breast cancer at autopsy.
How successful was tamoxifen versus placebo?
Why was the Atlas trial felt not to justify a no-tamoxifen control group?
Sir Richard Peto’s earlier Oxford review (Horm Res 1989;32:165) Effects of Adjuvant Tamoxifen and of Cytotoxic Therapy on Mortality in Early Breast Cancer. An Overview of 61 Randomised Trials Among 28,896 Women sought information worldwide on mortality according to assigned treatment in all randomised trials that began before 1985 of adjuvant tamoxifen or cytotoxic therapy for early breast cancer (with or without regional lymph node involvement). Coverage was reasonably complete for most countries. In 28 trials of tamoxifen nearly 4,000 of 16,513 women had died, reductions in mortality due to treatment were significant when tamoxifen was compared with no tamoxifen (p < 0.0001), any chemotherapy with no chemotherapy (p=0.003), and polychemotherapy with single-agent chemotherapy (p=0.001). In tamoxifen trials, there was a clear reduction in mortality only among women aged 50 or older, for whom assignment to tamoxifen reduced the annual odds of death during the first 5 years by about one fifth. In chemotherapy trials there was a clear reduction only among women under 50, for whom assignment to polychemotherapy reduced the annual odds of death during the first 5 years by about one quarter. Direct comparisons showed that combination chemotherapy was significantly more effective than single-agent therapy. Because it involved several thousand women, this overview was able to demonstrate particularly clearly that both tamoxifen and cytotoxic therapy can reduce five-year mortality.
A decade later the 1998 Tamoxifen for early breast cancer: overview of the randomised trials:
Oxford Early Breast Cancer Trialists’ Collaborative Group
(The Lancet, 1998: 351,:
1451 – 1467) confirmed Peto’s review: In 1995, information was sought on each woman in any randomised trial that began before 1990 of adjuvant tamoxifen versus no tamoxifen before recurrence on 37 000 women in 55 such trials, comprising about 87% of the worldwide evidence. Compared with the previous such overview, this approximately doubles the amount of evidence from trials of about 5 years of tamoxifen and, taking all trials together, on events occurring more than 5 years after randomisation.
Nearly 8000 of the women had a low, or zero, level of the oestrogen-receptor protein (ER) measured in their primary tumour. Among them, the overall effects of tamoxifen appeared to be small, and subsequent analyses of recurrence and total mortality are restricted to the remaining women (18 000 with ER-positive tumours, plus nearly 12 000 more with untested tumours, of which an estimated 8000 would have been ER-positive). For trials of 1 year, 2 years, and about 5 years of adjuvant tamoxifen, the proportional recurrence reductions produced among these 30 000 women during about 10 years of follow-up were 21% (SD 3), 29% (SD 2), and 47% (SD 3), respectively, with a highly significant trend towards greater effect with longer treatment (χ21=52·0, 2p<0·00001). The corresponding proportional mortality reductions were 12% (SD 3), 17% (SD 3), and 26% (SD 4), respectively, and again the test for trend was significant (χ21= 8·8, 2p=0·003). The absolute improvement in recurrence was greater during the first 5 years, whereas the improvement in survival grew steadily larger throughout the first 10 years. The proportional mortality reductions were similar for women with node-positive and node-negative disease, but the absolute mortality reductions were greater in node-positive women. In the trials of about 5 years of adjuvant tamoxifen the absolute improvements in 10-year survival were 10·9% (SD 2·5) for node-positive (61·4% vs 50·5% survival, 2p<0·00001) and 5·6% (SD 1·3) for node-negative (78·9% vs 73·3% survival, 2p<0·00001). These benefits appeared to be largely irrespective of age, menopausal status, daily tamoxifen dose (which was generally 20 mg), and of whether chemotherapy had been given to both groups. In terms of other outcomes among all women studied (ie, including those with “ER-poor” tumours), the proportional reductions in contralateral breast cancer were 13% (SD 13), 26% (SD 9), and 47% (SD 9) in the trials of 1, 2, or about 5 years of adjuvant tamoxifen. The incidence of endometrial cancer was approximately doubled in trials of 1 or 2 years of tamoxifen and approximately quadrupled in trials of 5 years of tamoxifen (although the number of cases was small and these ratios were not significantly different from each other). The absolute decrease in contralateral breast cancer was about twice as large as the absolute increase in the incidence of endometrial cancer. Tamoxifen had no apparent effect on the incidence of colorectal cancer or, after exclusion of deaths from breast or endometrial cancer, on any of the other main categories of cause of death (total nearly 2000 such deaths; overall relative risk 0·99 [SD 0·05]).
So, for corroboration we need the autopsy results of the women in the earlier tamoxifen vs placebo studies; and the 20 year results of the Atlas study. The ATLAS study reports clearly that silent breast cancer was more than twice as high in autopsied cases as in screening mammography during life. The conundrum remains whether early cancer detection by regular repeated screening mammography, and early treatment by biopsy, surgery, radiotherapy and tamoxifen, is more beneficial or more harmful to women long term?
24 Jan 2014 Overdiagnosis Overtreatment of Breast Cancer
.Am Soc Clin Oncol Educ Book.
2012;32:e40-e45. doi: Alvarado M
, Ozanne E
, Esserman L
. meetinglibrary.asco.org/sites/meetinglibrary.asco.org/files/Educational Book/PDF Files/2012/zds00112000e40.pdf
Dept Surgery Univ Calif San Francisco. write: “Breast cancer is the most common cancer in women. Through greater awareness, mammographic screening, and aggressive biopsy of calcifications, the proportion of low-grade, early stage cancers and in situ lesions among all breast cancers has risen substantially. The introduction of molecular testing has increased the recognition of lower risk subtypes, and less aggressive treatments are more commonly recommended for these subtypes. Mammographically detected breast cancers are much more likely to have low-risk biology than symptomatic tumors found between screenings (interval cancers) or that present as clinical masses.
Recognizing the lower risk associated with these lesions and the ability to confirm the risk with molecular tests should safely enable the use of less aggressive treatments. Importantly, ductal carcinoma in situ (DCIS) lesions, or what have been called stage I cancers, in and of themselves are not life-threatening. In situ lesions have been treated in a manner similar to that of invasive cancer, but there is little evidence to support that this practice has improved mortality. It is also being recognized that DCIS lesions are heterogeneous, and a substantial proportion of them may in fact be precursors of more indolent invasive cancers. Increasing evidence suggests that these lesions are being overtreated. The introduction of molecular tests should be able to help usher in a change in approach to these lesions. Reclassifying these lesions as part of the spectrum of high-risk lesions enables the use of a prevention approach. Learning from the experience with active surveillance in prostate cancer should empower the introduction of new approaches, with a focus on preventing invasive cancer, especially given that there are effective, United States Food and Drug Administration (FDA)-approved breast cancer preventive interventions
.” 5 January 2014: Quantifying the Benefits and Harms of Screening Mammography. H Gilbert Welch & Honor Passow , Dartmouth Geisel school of medicine, NewHampshire write: JAMA Intern Med.
2013 Dec 30. Like all early detection strategies, screening mammography involves trade-offs. If women are to truly participate in the decision of whether or not to be screened, they need quantification of its benefits and harms. Providing such information is challenging, however, given the uncertainty-and underlying professional disagreement-about the data. In this article, we attempt to bound this uncertainty by providing a range of estimates-optimistic and pessimistic-on the absolute frequency of 3 outcomes important to the mammography decision: breast cancer deaths avoided, false alarms, and overdiagnosis. Among 1000 US women aged 50 years who are screened annually for a decade, 0.3 to 3.2 ie ~0.17% will avoid a breast cancer death 490 to 670 ie ~58% will have at least 1 false alarm recall, and 3 to 14 ie 0.85% will be overdiagnosed and treated needlessly. We hope that these ranges help women to make a decision: either to feel comfortable about their decision to pursue screening or to feel equally comfortable about their decision not to pursue screening. For the remainder, we hope it helps start a conversation about where additional precision is most needed
A recent review of a new book by journalist Rolf Hefti- The Mammogram Myth
- consolidating the controversy for and against screening mammography is reviewed by Cape Ray
. The book relies heavily on Dr John Gofman (1919-2007), a distinguished medical scientist, a key member of the Manhattan Project that developed the first atomic bomb used on Nagasaki. In 1996 Gofman published a book entitled Preventing Breast Cancer: The Story of a Major, Proven, Preventable Cause of This Disease, in which he made the astonishing claim that 75% of all breast cancers were caused by women being exposed to ionising radiation from X-rays. As highlighted in a review in JAMA, Gofman’s claim — based on an extensive literature review and certain critical assumptions — was at variance with every other authority, including the National Academy of Sciences and the National Council on Radiation Protection. Martin Yaffe of Toronto has recently shown that the risk of radiation-induced breast cancer from mammographic screening is not negligible, but this risk is small when compared to the expected reduction in mortality achieved through screening.
So the dilemma for health professionals, and for the target of the zealous Cancer Screening Industry- healthy women in their prime-of-life middle years- remains: why have xray mammography screening when the independent evidence from expert epidemiologists is that screening mammograpy to find preclinical ie precancer does not in fact meaningfully save lives, entend health or reduce breast surgery and cancer therapy, it actually increases all these risks compared to waiting till cancer presents clinically. Zahl Jorgensen and Gotzsche in their latest review show that Overestimated lead times in cancer screening has led to substantial underestimation of overdiagnosis.
20 July 2013 HUMAN PROGESTERONE BREASTCANCER RISK REVISITED:
Its 3 years since this column last reviewed progesterone, in the context of osteoporosis, bone building
. While the first Pubmed report on progesterone implants is apparently sixty years ago (probably in veterinary reproductive use), Drs John Lee and Kathy Dalton promoted use of solo human progesterone P4 for (post)menopausal protection, also against cancer including breast cancer; which l’Hermite
2013 from France, and eg David Sturdee
from UK, have recently favourably summarized in respect of balanced transdermal estrogen and oral micronized progesterone P4. The evidence for P4 as almost global protection as HRT has largely been confirmed provided progesterone is used in moderation – ideally transdermally/ transvaginally like estrogen (Genazzani ea);
some believe in the basal physiological bloodlevel of about 1 to 2 nmol/L, in balance with basal levels of human estrogen and androgens. Vanadin Seiffert-Klauss ea in Munich have recently (2012) confirmed that “women in the (~10year) menopause transition lose trabecular bone at a rapid rate despite intermittently high and usually normal estrogen levels – especially the lean women (BMI<20kg), and those with family fracture history”.
And in their PEKNO study
, “Decreasing rates of ovulation, hormonal changes, and increasing bone loss pre-date menopause by several years.; in addition to estradiol, progesterone may play a significant role in the interrelationship between the ovaries and the skeleton in women. differentiation of human osteoblasts from perimenopausal women has been shown to be dose-dependent on progesterone at physiological concentrations. Higher progesterone levels, as seen in the luteal phase of ovulatory cycles, may be associated with more bone formation and with slightly less bone resorption than anovulatory cycles in which progesterone levels are low (< 5.8 ng/ml)”. These data led to the initiation in perimenopausal women of a large, prospective, 2-year observational PEKNO study – from which interim data indicate that a decrease in ovulation correlated with an increase in the loss of bone mineral density (BMD). A meta-analysis in women *with normal ovulation estimated a BMD increase of 0.5% per year, vs *with ovulatory disturbances (anovulation or short luteal phase) a BMD decrease of 0.7% per year in young women ; but * in postmenopausal women a 1.3% increase per year in BMD when receiving hormone replacement therapy with unopposed estrogens, and a further 0.4% increase in BMD in women receiving estrogens plus progestogens. The role of progesterone in bone metabolism in perimenopausal women who are estrogen-replete requires further study.”
Thus they show that postmenopausally, addition of progestin may boost BMD by 31% more than ERT alone
. But currently some experts eg Kuhl and Schneider
and David Zava
feel that evidence warrants caution, that oral human progesterone P4 may have a role in breast cancer promotion; although it has protective benefit against estrogen dominance in most circumstances eg against endometrial cancer. As this column has previously reviewed, longterm experience of experts like Greenblatt & Gambrell, Gelfand, Lee Vliet in N America; Schleyer-Saunders, Whitehead & Studd (London) , Burger & Davis (Australia) ; and Davies ea (Cape Town) showed no increase but reduction in all postmenopausal morbidity including cancer with non-oral
eg implants of BIDHRT (estradiol balanced with human antiestrogen eg testosterone and/or progesterone).
Now Stephenson ea
at the Tyler Women’s Wellness Center, Texas publish a 3 year
study showing multiple benefits and no adverse effects of balanced compounded bioidentical transdermal hormone therapy BIDHRT on hemostatic, inflammatory, immune factors; cardiovascular biomarkers; quality-of-life measures in peri- and postmenopausal women. Conventional nonhuman hormone therapy HT eg CEE and medroxyprogesterone results in increased thrombotic events, and an increased risk of breast cancer and dementia in large prospective clinical trials including the HERS and the Women’s Health Initiative studies. Physiologic human sex steroid therapy with transdermal delivery for peri/postmenopausal women may offer a different risk/benefit profile, yet long-term studies of this treatment model are lacking. In a prospective, approved closed-label study, 75 women who met strict inclusion/exclusion criteria were enrolled; following baseline hormone evaluation, women received compounded transdermal bioidentical hormone therapy of BiEst (80%Estriol/20%Estradiol), and/or Progesterone to meet established physiologic reference ranges for the luteal phase. Subjects receiving BIDHRT in doses targeted to physiologic reference ranges administered in a daily dose showed significant favorable changes in menopausal symptoms, cardiovascular biomarkers, inflammatory factors, immune signaling factors, and health outcomes, despite very high life stress, and home and work strain in study subjects. There were no associated adverse events. This model of care warrants consideration as an effective and safe clinical therapy for peri/postmenopausal women especially in populations with high perceived stress and a history of stressful life events prior to, or during the menopausal transition.
This Texas study supports the 2009 metanalysis by Holtorf: The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy? Patients report greater satisfaction with HRTs that contain progesterone compared with those that contain a synthetic progestin. Bioidentical hormones have some distinctly different, potentially opposite, physiological effects compared with their synthetic counterparts, which have different chemical structures. Both physiological and clinical data have indicated that progesterone is associated with a diminished risk for breast cancer, compared with the increased risk associated with synthetic progestins. Estriol has some unique physiological effects, which differentiate it from estradiol, estrone, and CEE. Estriol would be expected to carry less risk for breast cancer, although no randomized controlled trials have been documented. Synthetic progestins have a variety of negative cardiovascular effects, which may be avoided with progesterone. Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts. Until evidence is found to the contrary, bioidentical hormones remain the preferred method of HRT.
And of course the recent 4year Kronos KEEPS study by Harman ea 2012
confirms that in early postmenopausal woemen, parenteral physiological-dose estradiol has subtle benefits over oral premarin, with or without parenteral progesterone, with no significant adverse effect.. 17 June 2013 SHOULD WE EVER TELL A PATIENT WITH A BREAST LUMP THAT IT’S CANCER?
or THAT IT MAYBE PRECANCER?
This was and is a major dilemma in medicine. One of the big lessons arising out of the high technology in living memory ie the past >century-our grandparents’ time- is that before modern laboratory, imaging and surgical diagnostics, all we could do was wait and see, the trial of observation and therapy, prayer, meditation. Now we have gone to the other extreme in the aging, bullying them to have risky invasive screening on the crass assumption that screening and early radical – invasive ie potentially harmful- treatment of silent ie precancer saves lives- when the evidence has become progressively clearer that unselective invasive screening of asymptomatic prostates and breasts simply creates worried well, overdiagnoses silent disease which may never cause illness or death , and may hasten misery; whereas combining natural preventative remedies may benefit all systems including regress cancer.
Silent hypertension and unrealised overweight/ metabolic syndrome are radically different from cancer. With simple measurement of asymptomatic arterial hypertension, visceral obesity and eg glycosuria, the earlier that risk factors are defined and addressed, and the earlier the adiposity/glycosuria/ hypertension corrected with lifestyle, abolishing smoking and boozing, and diet improvements, supplements and if necessary the safest prescription drugs- initially fish oil, lowdose amiloretic and reserpine, metformin, and the basket of vitamins and minerals especially magnesium, zinc, vits C and D3 – the sooner is the progressive risk reversed to the heart, brain, mind, vision, lungs, digestive and excretory system, joints and legs, let alone to fertility, carcinogenesis and other immunoendocrine functions So instead of driving well aging women witless with disease-mongering- forced regular invasive xray screening mammography- we should instead respect the power of the mind over disease, and use simple careful history, and physiological biometrics including behaviometrics
to persuade and condition those at risk to take sensible precautions including if necessary supplements, exercise and corrective diet/psycho/hypnotherapy. The lesson of screening breasts and prostates for silent cancer the past 20 years is that so many cases of silent dormant cancer regress spontaneously if left well alone, especially if they are left undiagnosed and instead just the score of common risk factors for all common diseases addressed as this column keeps exploring. So when asymptomatic changes and lumps in breasts are detected by noninvasive means eg clinical or Sure Touch or thermal exam, there is no need to alarm the woman by labelling her a patient with breast disease – it is more than healing for her to show her that within a month, these changes can be reversed with all the appropriate natural steps as described in Combatting Breast Cancer
, including the Magic Oils
. If there were indeed (pre)malignant changes present, they too regress as normally happens in so many – so leave well alone. As reviewed below, up to 45% of apparently well adults who are killed have silent cancers; and in the giant ATLAS and aTTom trials in 37 countries the past decade (discussed in detail below), despite the claimed 80% cure rate of early silent breast cancer (diagnosed at around 55yrs) by 5 and 15 years after repeated screening mammography- surgery- and radiochemotherapy, and annual screening mammography followup, of the women who had died by age 70yrs and had autopsy, the similar 43% had (silent) recurrence of breast cancer.
So like men, asymptomatic women should be discouraged from invasive screening; but the higher their risk score, the more readily they should be offered simple noninvasive
breast screening, and thereby encouraged to optimize diet, habits, lifestyle, body build-fitness, including with the battery of multibenefit preventative supplements . Like millions of partisans have sung in bitter wars and holocausts, Hirsh Glik’s “Never Say that You Are Trodding the Final Path
“- remains the hope-givimg mantra that all patients and caregivers must hold to – the power of positive thought and action if not prayer. Both mistakes and miracles happen. upate June 14 2013:
a new review from Oxford University Breast cancer mortality trends in England (1979-2009) and the assessment of the effectiveness of mammography screening
concludes: In the Oxford region, For all ages combined, mortality rates peaked for both underlying cause and mentions in 1985 and then started to decline, prior to the introduction of the NHSBSP in 1988. There was no evidence that declines in mortality rates were consistently greater in women in age groups and cohorts that had been screened at all, or screened several times, than in other (unscreened) women, in the same time periods. Conclusions Mortality statistics do not show an effect of mammographic screening on population-based breast cancer mortality in England. update June 10 2013
a review published today by Coldman and Phillips on Incidence of breast cancer and estimates of overdiagnosis after the initiation of a population-based mammography screening program
in Canada over 40years showed that ” the extent of overdiagnosis of invasive cancer was modest and primarily occurred among women over the age of 60 years. However, overdiagnosis of ductal carcinoma in situ was elevated for all age groups.” update 9 June 2013: THE HARMFUL COERSIVE PRESSURE APPLIED ON WOMEN, AND ON THEIR BREASTS, WITH SCREENING XRAY MAMMOGRAPHY: W
omens’ wishes must be respected when they prefer no-xray no-squeeze prescreening, choose not to have xray mammography. Breast discomfort and breast trauma from xray mammography -breast sandwiching – vary greatly between women and especially in young more hormonally-driven breasts.. The pressure is manyfold: not just in crushing the breasts, but in PTSD- post-traumatic stress disorder
: Breast cancer: PTSD—prevalent and persistent: Receiving a diagnosis of breast cancer is likely to have aconsiderable impact on the psychological wellbeing of the patient. In a recent observational study, Vin-Raviv et al.1 reported that 23% of 1,139 women with newly diagnosed localized breast cancer experienced post-traumatic stress disorder (PTSD) symptoms.
This is not to deny that many women experience post-traumatic character growth, as a recent Greek study
discusses. Posttraumatic stress disorder and posttraumatic growth in breast cancer patients.
But Elklit and Blum
and O’Connor ea
in Denmark a year earlier highlight PTSD
as being highly relevant in oncology settings after early breast cancer.. This awareness has been reviewed on Pubmed from before 1997. A recent report
says the physical crushing force applied in such breast compression – snackwiching – is briefly up to about 130 Newtons, ie 13 kg or 25 pounds force. This compares to the gentle 1.5 to 2kg force applied briefly when having a mechanical tactile Sure Touch surface breast anatomical mapping, or professional clinical breast exam; or zero force with a no-touch infrared thermomammogram. Hence some women report breast pain, bruising and discomfort for weeks after a compression xray mammogram. And because oncologists insist on followup regular xray mammography after cancer therapy with breast-conserving surgery & radiochemotherapy, women increasingly ignore breast lumps let alone any screening breast exams at all. It is common cause that stress, anxiety increase cortisol, insulin and thus estrogenic stimulation, and thus cancer risk to breasts. It is still unknown how much the longterm risk of breast problems and cancer is increased from rupturing breast cells (let alone spreading cancer cells) with repeated successive compression xray mammography and the cumulative xray dose used – especially when perhaps 1 in 10 women screened is recalled by radiologists for more compression views, to find (by biopsy of perhaps 10 to 20 women per 1000) the 2 to 4 clinically undetected tiny breast (pre)cancers in each 1000 women so screened preventatively
… And it is obvious that with denser more active breasts in young women- monthly high-turnover glandular cells (especially in those on cyclic synthetic estrogen-progestin contraception) – both breast fragility and sensitivity are higher the earlier that xray mammography is commenced as radiologists insist.
Hence Regulators in most countries have reduced recommendations for routine screening mammography to starting at age >50yrs and stopping by 70-75years (ie 10-12 times on average through midlife); whereas Radiology Associations ignore the risks and still advise screening annually from age 40 years, for life – ie at least THREE times as many times from age 40years. So women are doubly exposed to harmful pressure both in being bullied that they need screening xray mammography – the lie that ” screening mammography saves lives” when the benefit of this is unproven, and in being forced to undergo breast crushing repeatedly. A woman who recently attended for Sure Touch in Port Elizabeth objected to having her breasts snackwiched again by compression mammography. The flippant analogy is eerie when one considers how such women are expected to attend annually to have their breasts both flattened and irradiated – and more so with cumulative frying after therapeutic radiotherapy. No wonder some end up with a hard breast. . So while the young at heart may love nudging breasts-, and massage heals, (and Bissell and Fletcher at the Berkley lab show that gentle nudging with about 50 gm pressure knocks errant breast ductal cells back into healthy behaviour) – crushing force and coersion do women harm, not good; in contrast to men where forceful digital massage may (also with putative risk) relieve the infected painful prostate.. .
And Gøtzsche and Jørgensen in
.Cochrane Database Syst Rev.
have Jun 4 published update stats against Screening for breast cancer with mammography
“from PubMed and the WHO ‘s International Clinical Trials Registry (to November 2012). Eight eligible trials included 600,000 women in the age range 39 to 74 years. Three trials with adequate randomisation did not show a statistically significant reduction in breast cancer mortality at 13 years (relative risk (RR) 0.90); four trials with suboptimal randomisation showed a significant reduction in breast cancer mortality with an RR of 0.75 (95% CI 0.67 to 0.83). The RR for all seven trials combined was 0.81 (95% CI 0.74 to 0.87). We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly from differential misclassification of cause of death. The trials with adequate randomisation did not find an effect of screening on total cancer mortality, including breast cancer, after 10 years (RR 1.02, 95% CI 0.95 to 1.10) or on all-cause mortality after 13 years (RR 0.99, 95% CI 0.95 to 1.03). Surgeries – Lumpectomies and mastectomies (RR 1.20-1.31, 95% CI 1.08 to 1.42) were significantly more in the screened groups . The use of radiotherapy was similarly increased whereas there was no difference in the use of chemotherapy. AUTHORS’ CONCLUSIONS: If we assume that screening reduces breast cancer mortality by 15% and that overdiagnosis and overtreatment is at 30%, it means that for every 2000 women invited for screening through 10 years, one will avoid dying of breast cancer and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. Furthermore, more than 10% will experience important psychological distress including anxiety and uncertainty for years because of false positive findings. To help ensure that the women are fully informed before they decide whether or not to attend screening, we have an evidence-based lay leaflet http://www.cochrane.dk. Because of substantial advances in treatment and greater breast cancer awareness since the trials, it is likely that the absolute effect of screening today is smaller than in the trials. Recent observational studies show more overdiagnosis than in the trials and very little or no reduction in the incidence of advanced cancers with screening”.
update 26 May 2013 Apart from the strident promotion of preventative mastectomy by a film star, reports the past week prompt review of : why and whether aggressive breast cancer may have doubled in young women 25-39years old; and it’s prevention by natural steps.
update 22 May 2013
: WHY DO SO MANY WOMEN HAVE RELAPSE OF BREAST CANCER BY 25 YEARS AFTER DIAGNOSIS AND APPARENTLY CURATIVE TREATMENT OF EARLY SILENT BREAST CANCER?: three landmark new papers
shine more light on why 43% of women who died by 15 years after aggressive treatment of initial silent preclinical breast cancer had relapse/recurrence of breast cancer at autopsy – the depressing result of the monumental 180 000 women-year ATLAS trial
Lisa Willis, Karen Page, Trevor Graham, Tomás Alarcón, Malcolm Alison & Ian Tomlinson from Universities of London, Oxford, Cambridge, and Barcelona this month dissect “What Can Be Learnt about Disease Progression in Breast Cancer Dormancy from Relapse Data? why Breast cancer patients have an anomalously high rate of relapse up to 25 years after apparently curative surgery removed the primary tumour. Disease progression during the intervening years between resection and relapse is poorly understood. There is evidence that the disease persists as dangerous, tiny metastases that remain at a growth restricted, clinically undetectable size until a transforming event restarts growth. This suggests a natural question and a surprising answer: why are interesting trends in long-term relapse data not more commonly observed?” But they are observed: another recent 15 year followup study, from Denmark (Grantzau ea), furthermore shows that DXRT after early breast cancer almost doubles the risk of radiotherapy-associated second cancer to 1:200 of women so treated..
Thus at least dangerous dormant micrometastases, and the enormous cumulative radiation exposure from both screening mammography over decades, and DXRT itself, will explain much of the 43% recurrence rate of breast cancer by 15 years (at autopsy in those who had died by then, at a mean of only 70 years) seen in the ATLAS trial.
These reports raise yet further doubts about the wisdom of regular mass xrayscreening of well breasts from age 50 years let alone 40years, and worse- zealous major surgery and DXRT for preclinical disease, and then even worse, ongoing xray mammographic surveillance into old age.
They point in the opposite direction: that xray screening of well breasts should be avoided; DXRT avoided in localized early breast cancer; and surveillance for breast cancer limited to the many available non-xray methods;
and that women must be encouraged instead to maintain prevention with combination of safe natural (and multisystem-protecting) means as discussed repeatedly in this column – lifestyle, diet, exercise, and massage and oral use of safe natural preventative supplements. Anticancer antiangiogenesis factors from our diet are legion, include cannabis, mushrooms, resveratrol, green tea, black rasberry and Royal jelly. One would not recommend soya against breast cancr because of its phytoestrogen potential.
Xradiation has been known for decades eg 1978 1990 to be both an angiogenic and an antiangiogenic factor in tumour growth angiogenesis (Judah Folkman 1971) . so it is obviously a double-edged sword that should certainly not be used in the witchhunt for silent and usually irrelevant precancer in well breasts.
So we have the ludicrous situation reported today in JAMA that despite all the evidence for 20 years now to stop or at least halve mass xray screening and thus (over)treatment of silent early breast cancer, “Physicians, Patients Not Following Advice From USPSTF on Mammography Screening: In 2009, the US Preventive Services Task Force (USPSTF) recommended against routine screening mammography for women under 50 years and advised biennial rather than annual screening for women aged over 49yrs. But women and physicians ignored these recommendations. A new study from Harvard found that in 2005 to 2011, the percentage of women aged 40 to 49 years reporting that they had undergone mammography screening in the previous year was the same, about 47%. As for women aged 50 to 74 years, the percentage reporting mammography screening in the previous 12 months for each year analyzed also remained essentially the same, in the upper 50% range.”
Update 21 April 2013: FIFTEEN YEAR FOLLOWUP STUDIES OF BREAST CANCER AND ALLCAUSE MORTALITY FROM MENOPAUSE ONWARDS: Overall, long-term studies do not favour invasive breast screening or adjuvant therapy of early breast cancer, but actually argue against early diagnosis and treatment of both silent breast and prostate cancer. Rather, the focus must be on safe natural prevention to reduce the occurrence of all common degenerative diseases of aging.
It is instructive to juxtapose the diverse 15 year followup studies in 14 countries (Nordic Cochrane- Gotzsche, Jorgensen ea
) of women routinely xray- mammography screened or not, with the 15 year ATLAS study (that ended in 2010) reviewed below in 36 countries, of women zealously xray- screened for early breast cancer, prompt biopsies and surgical/ radiotherapy treatment- the majority mastectomy- and then randomized to tamoxifen for up to 10 years.
and it is reported by the ATLAS authors that there was a major breach of protocol - The protocol stated that 20 000 patients would need to be randomised in ATLAS and the other trials of tamoxifen duration to detect reliably an absolute difference of 2–3% in mortality. Entry to ATLAS was halted in 2005 (with 12 894 patients, including 6846 with ER-positive disease) because the MA.17 trial showed benefit from continued endocrine treatment after 5 years of tamoxifen.. Yet the MA17 trial was with a different drug- letrozole;
the trial conclusion was that “the results from the analyses based on the Cox model with time-dependent covariates were similar for letrozole and placebo.” ie that letrozole was no better than placebo.
. Thus, like the Womens’ Health Initiative misguided early termination, it is unclear why MA17 was used as reason to terminate the ATLAS trial.
The 15 year ATLAS results overall were depressing- in those originally early silent estrogen-receptor positive breast cancers, although only about 20% had clinical recurrence by a mean age of 70yrs, of the 22% who had died by then, almost half ie 43% had recurrence of breast cancer at autopsy. Many new such trials
are under way.
The aTTom trial the UK arm of the ATLAS trial similarly “followed women with early breast cancer after initial treatment for about 15 years: it randomly assigned 6934 women (39% ER-positive, 61% ER-untested) at the completion of 4 or more years of tamoxifen therapy to either 5 additional years of tamoxifen or cessation of tamoxifen therapy. With a median follow-up of 4.2 years, there was a slight, non-significant advantage for the 10-year tamoxifen arm (RR, 0.94; 95% CI, 0.81–1.09; P = .4). Thus, the optimal duration of therapy is not known, but it is at least 5 years”.
For undisclosed reasons this trial has apparently never been published in full although it was first reported in 2008- this raises the usual question by eg Booth and Tannock 2008
of bias against negative results, whether there was suppression by sponsors…
And the aTTom trial design was heavily criticised
at the outset in 1996.
published the past week by Heidi Nelson ea for the USPSTF confirms the ATLAS study, showed that tamoxifen/ raloxifen for 5 years reduced absolute mortality from breast cancer by about 0.16% per year. Neither reduced breast cancer-specific or all-cause mortality rates. Both reduced the incidence of fractures, but tamoxifen increased the incidence of thromboembolic events more than raloxifene by 4 cases in 1000 women. Tamoxifen increased the incidence of endometrial cancer and cataracts compared with placebo and raloxifene. Trials provided limited and heterogeneous data on medication adherence and persistence. Many women do not take tamoxifen because of associated harms.
It then becomes apparent that having early breast cancer detected – without the adverse risk factors of xray mammography of repeated breast crushing, radiation, biopsies and overtreatement, but with better application of safe preventative measures including vitamin D3, melatonin, metformin, iodine, DMSO, coconut oil, fish oil, sutherlandia, I3C/DIM, vitamins and minerals – while women will live healthy longer, few women (perhaps <5% of all deaths) will die of breast cancer. The common risk factors (for all common premature disease and deaths) are m anaged with the same basket of safe natural effective preventatives including supplements like appropriate balanced hormone replacement -that this column addresses.
Dr. Northrup says “[Gilbert Welch] pointed to a study [from] way back, of women who died in car accidents in their 40s. They sectioned their breast tissues and found that 40 percent of them – this is normal healthy women dying in car accidents – had evidence of ductal carcinoma in situ that was never going to go anywhere. This is the big dilemma,”
. Welch and Black 1997 reported Among seven autopsy series of women not known to have had breast cancer during life, the median prevalence of invasive breast cancer was 1.3% (range, 0% to 1.8%) and the median prevalence of DCIS was 8.9% (range, 0% to 14.7%). Prevalences were higher among women likely to have been screened (that is, women 40 to 70 years of age).
Erbas ea at Univ Melbourne studied all sources for the prevalence of ductal carcinoma in situ. “The reported prevalence of undiagnosed DCIS in autopsy studies, of approximately 9%, has been used to suggest a larger reservoir of DCIS may exist in the population”.
Update 18 April 2013: a new study from Italy graphically illustrates the lower sensitivity of xray screening – U/S ie ultrasound picked up ‘significantly’ more tiny asymptomatic breast cancers missed in 22,131 women with negative mammography. “The overall U/S detection was 0.185%, but 0.55% with previous cancer vs 0.145% in women without cancer history (p = 0.0004), 0.22% in dense breasts (p = 0.17) vs .156% in fatty breasts. The U/S- generated invasive assessment was 0.19% The benign to malignant open surgical biopsy ratio was thus 0.17.” This is likely more overdiagnosis unless the women simply apply the preventative measures recommended below.
But while no screening method can diagnose cancer (only invasive biopsy can), and none can guarantee there arnt cancer cells busy germinating especially if stirred up by severe anxiety, radiation, crushing, biopsy etc, Sure Touch mapping is more accurate than even U/S for reassuring while reducing referral rate for U/S.
UPDATE 14 APRIL 2013: Because of the evidence the past score years set out below that xray screening actually does more harm than good, integrative medical clinics world wide do not promote xray screening mammography. But such clinics including in Cape Town generally offer regular safe and lower-cost anatomical eg Sure Touch mechanical tactile if not ultrasound or MRI, and physiological no-touch eg thermography ie bloodflow studies, – for those who need peace of mind. Some women choose to alternate Sure Touch and thermomammography.
While only 1 in 200 women have the familial gene risk, the majority of older women have the common multiple risk factors eg longevity, estrogenic and heavy metal pollution, stress, overweight density, smoking, alcohol; and there are many simple remedies described in these columns that can reverse most of the risk factors – not just of even genetic breast cancer and increasing overweight, but of all the major diseases of aging.
The problem remains the stubbornness of third party payers including governments to listen to both the evidence and to womens’ wishes, and pay for such safe, cheaper and arguably more accurate prscreening than crush xray mammography, if any is desired or desirable .
Dr Johnnie Ham MD MSc MBA Californian ObGyn discusses why xray screening mammography and aggressive medical assault on well breasts- the witchhunt for the pot of hidden gold, silent preclinical breast cancer – is a giant con by the for-profit high-tech medical goliath industry terrorizing and mutilating naive women.
Governments -WHO silence on harms of screening mammography : What is tragicomedy is that worldwide, government Regulators seem to be standing silently firm, not saying a word about the harm likely exceeding the medical benefit- the screening and cancer industry is far too profitable in jobs, taxes and votes. Search on the internet for Government warnings on harms of screening mammography does not yield a word of warning. Regulators and Medical Schemes piously promote quality screening, but say nothing about the harms versus benefits. The FDA still promotes annual screening mammography on line without a word about the risks and harms of mammography; others like the UK NHS promote it every 2 to 3 years. Yet the US Senate is actually considering a Republican Act to promote more xray breast imaging.
UPDATE 12 April 2013 The Wiki entry on breast cancer prognosis says now: “One result of media hype- breast cancer’s high visibility -(compared to other cancers in eg men, and other common major diseases) is that statistics may be misinterpreted, such as the claim that breast cancer will be diagnosed in one in eight women during their lives—a claim that depends on the unrealistic assumption that no woman will die of any other disease before the age of 95. This obscures reality that about ten more women will die from heart disease or stroke than from breast cancer.The emphasis on breast cancer screening may be harming women by subjecting them to unnecessary radiation, biopsies, and surgery. One-third of diagnosed breast cancers might recede on their own. Screening mammography efficiently finds non-life-threatening, asymptomatic breast cancers and pre-cancers, even while overlooking serious cancers. According to Prof Gilbert Welch of Dartmouth Institute, research on screening mammography has taken the “brain-dead approach that says the best test is the one that finds the most cancers” rather than the one that finds dangerous cancers.
The latest report Lancet 2011) on the Relevance of breast cancer hormone receptors and other factors to efficacy of Tamoxifen protection after breast cancer looked at 20 trials (n=21,457) in early breast cancer . In oestrogen receptor (ER)-positive disease, about 5 years of tamoxifen halved recurrence rates throughout the first 10 years but no further gain or loss after year 10; risk was approximately independent of progesterone receptor status (or level), age, nodal status, or use of chemotherapy. Breast cancer mortality was reduced by about a third throughout the first 15 years. Overall non-breast-cancer mortality was little affected, despite small absolute increases in thromboembolic and uterine cancer mortality (both only in women older than 55 years), so all-cause mortality was substantially reduced. In ER-negative disease, tamoxifen had little or no effect on breast cancer recurrence or mortality.
This is not surprising as tamoxifen like all synthetic sex hormones /blockers has a long list of adverse effects on bone, brain, cardiovascular, bladder, mood, immunity, body weight and metabolism, womb etc.
But the Oxford UK-led (Davies ea) landmark monumental ATLAS trial (2012) from 1996 -2010 in 36 countries and 180 000 women-years (mean presentation age mid 50s, ER+ breast cancer about 1 cm size, 2/3 had mastectomy – which is now known to increase mortality) showed that after 6846 women taking tamoxifen for up to 10 years, at about 15 years from diagnosis, tamoxifen in absolute terms was only marginal benefit- marginally reduced the risk for breast cancer recurrence, compared with stopping tamoxifen (617 vs 711; P = .002), reduced breast cancer mortality relatively by 8% (331 vs 397 deaths; P = .01) but that’s only about 1% in absolute terms, and reduced overall mortality by 10% (639 vs 722 deaths; P = .01). Over all, approximately 1/5 clinically relapsed, 1/7 deaths were from breast cancer; but of those who died, webfigures 4a and 4b of the supplementary appendix of the main ATLAS report showed that at autopsy almost half (43%) indeed had recurrent breast cancer. This gives the lie to early screening and treatment- 15 years later, even with tamoxifen for 10 years, early xray mammography detection and conventional surgical-radio-chemotherapy treatment does not cure much more than half of women with preclinical ER+ breast cancer that screening detects.The risk for recurrence by year 15 was 21.4% in the continuers group and 25.1% in the control group. ie only 3.7% absolute reduction. In addition, breast cancer mortality by year 15 was significantly reduced by nearly 3%; it was 12.2% in the continuers group and 15.0% in the control group. ie only 2.8% absolute reduction. Thus even in these women with early breast cancer, the cure rate even with tamoxifen was poor- slight reduction in the 25% recurrence and 15% breast cancer mortality rates. But almost half of the women who died had recurrence. Once again, the actual results published 4 months ago in the final Lancet report were much less impressive than the media release published 5 days later. Of these >6000 women allocated after initial surgery/ radio/chemotherapy to the tamoxifen or placebo trial, 85% did not die of breast cancer. But the cure rate was at best still only about 75%, and only half of those who died -by a mean of age 70 years – of any causes were free of breast cancer.
11 April 2013 the SA Menopause Society Menopause Matters today also features The Great Mammography Debate- concluding “The point being that the treatments of breast cancer are not benign and need to be drawn into the calculations when assessing the harms of screening mammography. If these treatments are carried out on a significant number of people who are not in danger of being harmed by their breast cancer in the first place (those over-diagnosed) then the scales of benefit versus harm from routine mammography may well tip in favour of harm. If so it may be unwise or even unethical to recommend screening by mammography.”
9 April 2013 Robert Stern at University of Arizona writes that “xray mammography alone is not a very good screening modality and has strikingly variable false positive, false negative, specificity, and efficacy rates, depending on what you read and who you believe.
Worldwide, the days of simple repetitive yearly/ biannual mammograms for every living woman over some arbitrary age may be over soon.. breast cancer screening is about to evolve into a personalized, patient-centered program. It means you can’t just order a mammogram when a flag pops up saying it’s time. It means understanding fairly complex risk stratification, the indications for these new technologies, and the clinical context for various imaging strategies”,
mostly still based on irradiation; as detailed in the American Medical Journal by Drukteinis ea at
the Florida Mofitt Cancer Centre ..
8 April 2013: UPDATE: see vitamin D3 and Breast Cancer.
JAMA publishes on line from University Basel Switzerland, Shaw and Elger’s viewpoint on Evidence-Based Persuasion, often an ethical imperative to forcefully guide a hesitant patient into what seems to be the best decision, using arguments from Removal of Bias to Recommending Options and occasionally even Creating New Biases. The eternal problem remains, what is truly right? Is mass flu vaccine right? Is screening xray mammography truly lifesaving? especially if one quotes impressive but misleading relative risk reduction rather than in fact the crucial trivial absolute reduction? Is Directive Counselling however well-meant exercising undue influence? They conclude that it is an essential part of modern medical practice, without which it may be impossible to respect patients’ autonomy. Such necessary persuasion needs to meet 6 criteria.
A month ago BCAction held a webinar reported by Manie Clark
updating the risks and futility of screening xray mammography.
24 Mar 2013
. THE COVERUP OF HARMS AND FUTILITY OF XRAY BREAST SCREENING CONTINUES IN USA
: Many opinions
from around the world in recent NEJMs say it all about screening mammography: most are subjective, emotive. There is no impartial objective evidence to support the gold standard xray mammography at all (except arguably in cases of obvious cancer- when biopsy, and MRI scan is better and safer). When there are acceptable prescreenings that do no harm and when combined, give good sensitivity and specificity eg any two of mechanical tactile imaging, thermomammography, breast ultrasound and (if affordable) MRI.
Karla Kerlikowske ea co-author already four peer-reviewed Pubmed-listed studies on xray mammography this year.. the latest
on screening well women from the Breast Cancer Surveillance Consortium asks: Screening Outcomes in Older US Women Undergoing Multiple Mammograms in Community Practice: Does Interval, Age, or Comorbidity Score Affect Tumor Characteristics or False Positive Rates?Uncertainty exists about appropriate use of screening mammography among older women because comorbid illnesses may diminish the benefit of screening. We examined the risks from 1999 to 2006 on 140000 women aged 66 to 89 years at study entry undergoing mammo . About 7% had breast cancer, in a data linkage between the Breast Cancer Surveillance Consortium and Medicare claims. Cumulative probability of a false-positive mammo result was higher among annual screeners than biennial screeners irrespective of comorbidity: 48% of annual screeners aged 66 to 74 years had a false-positive result compared with 29% of biennial screeners. These women who undergo biennial screening mammo had similar risk of advanced-stage disease and lower cumulative risk of a false-positive recommendation than annual screeners, regardless of comorbidity.
But their abstract abysmally fails to ask and answer the obviously far more important question: – did screening mammo give any significantly lower mortality, surgery or radiotherapy at 15 or 20year followup compared to a matched randomly selected cohort not screened over the same period, or compared to women who were screened only once at the outset??
All independent studies show that women regularly screened by xray mammogram do no better and sustain far more harms, in fact may die sooner than those not screened. Why did they not say this in their abstract, that xray mammo screening is unethical abusive harmful exploitation of women?
The BCSC website
registers over 8million screening mammograms done there 1996-2009 – 24% of women had 5 or more xray screens- ` yet similarly fails to mention the crucial harms and mortality data in screened versus unscreened women. The reason is obvious: admitting the truth, that xray screening mammo is not only futile but harmful, would kill what must now be a $10billion a year industry in USA for xray manufacturers, radiologists, breast surgeons, hospitals, medical schemes, oncologists and Big Pharma in the Find a Hidden Breast Cancer Conspiracy against older women. . Indeed, the endgame would be that lawyers will swarm to call on women to sue the Breast Cancer Industry for wrongful assault.
23 Mar 2013 Dr Enza Ferreri
is a London-based Italian journalist philosopher of science, christian human and animal rights activist, including saving Britain from an Islamist President Charles Windsor.. She yesterday wrote a devastating critique of screening xray mammography, its profiteering oversell
by Scandinavian and English-speaking governments’ propaganda that omit to explain all the risks and lack of benefits. “On one side you have the stories about women whose ” life was saved” by breast screening, on the other women whose life was made hell by discovery of a possibly benign DCIS, and those who endure a nightmare of false positives believing that she has breast cancer when she hasn’t. “
22 Mar 2013
Even this month’s European Radiology Congress
, and the South African Menopause Society SAMS newsletter Menopause Matters, and the Annals of Family Medicine -
a new Copenhagen study- now question screening xray mammography, including cumulative radiation damage to heart and lungs; and chronic psychological trauma from false positive reports.
the SAMS author says: ” the fundamental question is “Does screening for cancer improve length or quality of life?” The latest arguments from the UK ask if screening saves lives, if you take all causes of death into account (Baum BMJ 2013;346:f385). Firstly, the author accepts that screening saves lives. If 10 000 women are screened for a decade then 4 deaths will be avoided. As treatments improve as they are doing all the time, then deaths avoided become lower, maybe 2 per 10 000 in the near future and thus screening becomes less valuable… current data about survival need to be used when making calculations about prolonging life.
Secondly, overdiagnosis is important because if some women who do not have life-threatening disease are treated, they may die from the treatment. Mastectomy, radiation, chemo- or endocrine therapy are not trivial treatments. Surgery carries anaesthetic and sepsis possibilities, especially in obese patients. Radiation is not without its risks, raising the incidence of ischaemic heart disease 27% and of lung cancer 78%. These risks would be worth taking if there were no cases of overdiagnosis – but there are – somewhere between 10% and 50% -so any lives saved may be cancelled out by deaths caused. So with all-cause mortality no longer showing benefit, it devolves to other factors such as the positive peace of mind screening provides or the negative over-investigation of false positives to sway decisions for or against screening. No wonder the editor of the BMJ (26th January 2013) asks “At what stage must we seriously consider whether this screening is a good use of £96m of NHS budget?” So how should we advise our patients? The statistics show the “lives saved” argument is neutralized. The cost of screening, time involved and morbidity from false positive tests are all non-fatal harms so these have to be weighed against peace of mind of a negative result and these calculations are in the mind of the beholder. The parallels with prostate specific antigen screening are uncanny and PSA testing is rapidly falling into disfavour or even disrepute. It seems those with vested interests are those promoting mammography screening. The moral position of doctors is becoming increasingly complex – can it be correct to say mammography screening in low-risk women is “the right thing to do”?
16 Mar 2013 Recently Bateman
in Cape Town suggests “PinkDrive intervention ‘over-rated’ : Breast health professionals are questioning the life-saving impact of the high profile non-profit breast cancer organisation PinkDrive.
The Pink Drive
website opens with some fallacies eg that: xray mammo 23kg breast compression causes no pain or damage –
that It is a tool to diagnose breast cancer
“- wrong-only histology does; and that diagnostic breast irradiation is no risk after age 40years
; wrong- this column has quoted authoritative opinion
and research eg Lemay, Sherbrooke Univ 2011 to the contrary, the linear no-threshold model
, although Mina Bissell’s Berkley Lab 2011 research paper perhaps
contradicts this – the jury is still out . .
It is significant that of the seven Platinum Pink Drive sponsors
, two are private Hospital chains with major vested interest in the Breast Cancer Surgery and Reconstruction Industry.
Contrary to the Pink Drive website stating that mammograms diagnose breast cancer, a major new study
from Japan on xray mammography of almost 120000 women found histological cancer in 0.22% of those who underwent mammography alone, 0.37% of those who underwent ultrasonography alone, and 0.5% of the 974 participants who underwent both mammography and ultrasonography. Recall rate due to mammographic abnormalities was 4.9% for women screened only with mammography and 2.6% for those screened with both modalities. The cancer detection rate was 0.22% for women screened only with mammography and 0.31% for those screened with both modalities.
Their conclusion that It is possible to reduce the recall rate in screening mammography by combining mammography and ultrasonography for breast screening
is precisely the point, that hazardous xray mammography screening with its immediate and longterm risks is not needed when any two of the three well-tested lowcost zero-risk portable facilities are available eg Sure Touch Mechanical Tactile imaging, thermomammgraphy
, and ultrasound, and two combined give high sensitivity and specificity.
Neither of the above new abstracts raised the issue of overdiagnosis or longterm hazards.. In fact the NCI Nat Cancer Institute Journal itself published a study this month from San Fran University California
showing that in 140 000 women from 66years upward screened between 1999 and 2006, Cumulative probability of a false-positive mammography result was higher among annual screeners than biennial screeners irrespective of comorbidity: 48% of annual screeners aged 66 to 74 years had a false-positive result compared with 29% of biennial screeners. Women aged 66 to 89 years who undergo biennial screening mammography have similar risk of advanced-stage disease and lower cumulative risk of a false-positive recommendation than annual screeners, regardless of comorbidity.
Thus even cancer comes and go. Reducing xray screening in USA to every second year reduced the frequency of false positive recall – overdiagnosis – from almost half – 48% – by above one third, without increase in advanced cancer.
A Comparative Table
shows the many methods, procedures for objective breast imaging (mammography) available. Of the established procedures it lacks only comparison with the gold standard- the oldest ie manual clinical examination- and with forty year old Infrared Thermography
. As this column has stressed previously, mammography is not a patented word for xray breast imaging, it is simply a generic description of breast (mammo-) and image (-gram) . Any image of the breast is thus a mammo-gram, and the process is mammo-graphy.SCREENING METHODS COMPARATIVE TABLE: this table shows
the relative merits of some different methods of breast imaging. Mechanical Tactile Sure Touch Imaging leads the field for combined sensitivity and specificity, portability, all-age utility without problems of breast density interference, cost, risks and reproducible mapping. Like a photograph, a plaster or other cast of the bust would thus also be a mammogram image- and unlike plastic surgeons, dermatologists and thermographers, other health professionals and patients alike too often forget to record a photograph to compare changes in the skin and breast serially. .
NEJM 28 Feb
from Harvard, Adler and Colbert’s “Mammography Screening Poll Results”
is a sobering commentary on the health professionals’ wrong perceptions about routine X-ray mammography screening of all well breasts from midlife. What do readers say about the indisputable overwhelming independent evidence against routine X-ray screening mammography?
One has to question the rationality of most NEJM readers – surprisingly few in total – who responded to the poll after Bleyer and Welch’s
, Mette Kalager’s
publications last year, that the majority of NEJM readers polled still promote X-ray screening despite the hard evidence, the absence of benefit from screening irradiation of well breasts- significant reduction in mortality in such women – in the face of multiple hazards of such screening.
The risks, the list of hazards – in five broad categories – is so great that as pointed out below last month, not even the NCI National Cancer Institute itself any longer clearly promotes routine X-ray mammography screening. As Colbert and Adler and the 2nd Canadian mammography trial 20 yrs ago noted (Miller and Baines) , the evidence for presymptomatic screening X-ray mammo is no better than clinical digital exam. Early diagnosis of silent breast precancer by xray screening and biopsy does not save lives, it is a vast waste of money except for the career Breast Industry, that has been characterized as terrorizing and damaging gullible submissive women (Winifred Cutler, Athena Inst).
There are certainly many safe natural ways we reviewed recently of reversing the risks of breast proliferation and cancer, thus justifying periodic safe low cost breast screening – mammo-imaging – by independent eg digital, mechanical tactile ” Sure Touch ” , ultrasound and/ or thermo- means.26 Feb 2013. There is a flood of new progress against breast disease , breast cancer and xray screening mammography: Contrary to the for-profit Breast industry, like all independent authorities including the Cancer Association of South Africa CANSA , the National Cancer Institute of America in 2013 no longer recommends routine xray mammography screening- it rates the EVIDENCE on X-ray screening mammography as FAIR evidence for its sole and arguable benefit – Decrease in total and breast cancer mortality – -*Consistency of studies is only Fair. External Validity: Good. Internal Validity: Variable,. But as GOOD evidence for the FIVE major HARMS of xray screening -* both consistency, internal & external validity -are good -
- Discomfort if not cellular rupture and bruising from violent 23 kg 50 lb crushing,
- Overdiagnosis and Resulting Treatment – including mastectomy or radiochemotherapy- of Insignificant Cancers:
- False-Positives with Additional Testing and Anxiety.
- False-Negatives with False senseof Security and Potential Delay in Cancer Diagnosis.
- Radiation-Induced Breast Cancer.
Winifred Cutler’s Athena Institute team warns again that screening X-ray mammography on well women is dangerous , inflicts terror, it does not reduce but may worsen the occurrence of invasive breast cancer. The Berkeley Institute’s Dr Venugopalan under profs Mina Bissell and Daniel Fletcher show that simply gentle massage helps – Compressing Breast Cancer Cells Can Stop Out-of-Control Growth Shelley Hwang ea show that in California simple lumpectomy for early breast cancer reduced deaths (up to 2009) by 28% compared to mastectomy. Belinski & Boyages at the Westmead Centre in Australia show again that common very low vitamin D levels more than double the risk of breast cancer let alone colon and all other cancers. A Harvard team (Liu ea) has just shown that the carnage of legalized poisoning (smoking – lungcancer, vascular; alcohol -liver disease, violence; adulteration with refined sugar/fructose - diabetes, vascular disease, cancer) aside, breast cancer far outstrips the other common cancers (colon, prostate cancer) in preventible life years lost. Willaims ea show again the major benefit of metformin against lethal breast cancer. Amadou ea in France confirm again the strong link between abdominal obesity and breast cancer from childhood throughout life. This again highlights the criminal stupidity of delaying metformin use till obesity let alone infertility or diabetes are established. Metformin can safely be introduced at any stage of life provided it is started at very low dose eg below 250mg/day and cautiously titrated to the maximum well-tolerated dose to avoid nausea and diarrhoea- and temporarily halved or stopped in case of intercurrent gastrointestinal upset. . Grani et al from Rome, Italy and many others remind us that both thyroid and breast malfunction are common by middle age and need to be sought and managed together. We know that in most aging populations, deleterious deficiency of especially magnesium, iodine, selenium, sulphur, and vits B, C, D and K , and melatonin and sex hormones is very common along with crippling multitoxic carcinogenic overload. So it is logical to use multisupplements, and massage anti- inflammatory anti-cancer antioxidant chelating antiestrogenic deep – penetrating iodine, coconut oil and DMSO – into the breasts as multidisease prevention and part of treatment. Oz ea in Turkey show that DMSO is more effective against breast cancer than thalidomide. But more importantly, DMSO enhances transport of any anticancer agents into cancer cells. Already in 2008 Frederick ea showed that Lugol’s Iodine is an important antiestrogen adjuvant against breast cancer. Hence we advise the harmless combination of natural multisystem micronutrients- especially fish oil, coconut oil, DMSO, vitamin C, D, K, melatonin, metformin, selenium, Lugol’s iodine and appropriate progesterone/ testosterone/ DHEA – as nutrient supplements against all chronic aging diseases especially in women at risk of breast cancer. . At Univ Newcastle on Tyne, Dr Dorota Overbeck-Zubrzycka’s landmark PhD thesis just published on FOXP3 regulates metastatic spread of breast cancer via control of expression of CXCR4 chemokine receptor promises new gene therapy in future. and her parallel study with Harvey, A. Griffiths & C. Griffith, Randomised control trial of Breast Tactile Imaging as an assessment tool for diagnosis of breast lumps in 2009/10 is now being published in full in a leading UK journal, validating this ( Sure Touch) bedside and outpatient clinic procedure as an established no-risk screening procedure, objective breast mapping record for anxious women as shown in USA, Indian and Chinese studies. Thus increasingly Authorities are accepting that screening X-ray mammography harms far outweigh trivial if any improvement in survival. But screening – by eg regular clinical exam and mechanical tactile mapping – for early signs of breast degeneration allows gentle safe self – treatment of all multisystem diseases that reverses both the breast degeneration and multisystem risk factors.
4 Feb 2013 UPDATE: BREAST SCREENING: Time lag to benefit after screening for common internal problems: routine high-tech mass screening is inappropriate insurance.
a lot of the prestigious British Medical Journal last issue of 23 January 2013
is dedicated to the Breast Screening controversy; with a number of critics questioning the November 2012 Government (Marmot) whitewash of the gigantically costly- and risky- NHS screening mammography program. Professor Michael Baum
of London University in particular has argued against this process for the past decade, after being the lead UK breast surgeon to set up this program in the 1990s and realizing it’s folly and risks.
Editorial: Breast cancer screening: what does the future hold?
The role of national breast screening programs and the quality and transparency of information given to participating women are increasingly the subject of heated debate. In the past 12 months alone, the BMJ, the Lancet, and the New England Journal of Medicine have published 24 articles debating the value of breast cancer screening. After calls for an impartial review of the value of breast screening in the United Kingdom, the findings of an independent panel of experts, led by Professor Marmot, were published in November 2012.1 Currently in the UK, women aged 50-70 years are invited for screening every three years; 2.3 million women were invited during 2010-11. The rate of uptake currently stands at 73.4%, having steadily increased in the past decade.2 The primary aim of screening is to reduce mortality from breast cancer. Reduced breast cancer related mortality is balanced against the cost of screening in terms of physical and psychological harm to women and the financial impact on health services. Much recent debate has concerned overdiagnosis—that is, diagnosis of a condition that would never cause symptoms or death during a patient’s lifetime. Although over-investigation can cause harm (pain and anxiety from mammography and biopsies), this is usually …”
Personal View Harms from breast cancer screening outweigh benefits if death caused by treatment is included : Prof Michael Baum
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f385 (Published 23 January 2013) Cite this as: BMJ 2013;346:f385
13 Jan 2013 As this column
has long noted, routine high-tech mass screening is inappropriate insurance/prevention. Contrary to the gospel of the American Radiology, Breast and endoscopy costly screening industry, and Curves International, no human survives for > 10 000 years to benefit from routine hightech screening to avoid premature disease and death ie ‘save a life’ . . There is still grave doubt about the risk:benefit of routine prostate screening
in the well.
A new January 2013 BMJ paper by a California University team Lee et al
looks at ‘noninvasive’ cancer screening of breast (xray mammography) and colon (testing stool for occult blood) in Europe and USA. It found that at least 1000 patients must be screened for at least 10 years – ie >10 000 patient-years of screening- before screening for either cancer could be claimed to save a life. The corollary is that such screening of the well has a very low chance – below 1:10 000 in any year, ie 0.01% – of finding a silent killer cancer that will save/ extend a life.
Thus they advise against screening people with an expected lifespan of below about 10 years. But who would undergo such bothersome risky screening even over 10 years for a proposed benefit (in death risk reduction) of 0.1% a decade ? They found the reasons against routine screening of those not at high risk ( ie no suspicious personal symptoms or familial history) are as usual those of the ensuing anxiety, the procedures – radiation and colonoscopy and biopsies – and overdiagnosis. The worst is of course the cumulative risk of breast irradiation, and perforation death from colonoscopy: “For cancer screening, about one in 10 patients who are screened (with xray mammography , or with fecal occult blood testing) will have a false positive result, leading to recall worry and likely biopsy/ colonoscopy. Serious complications (such as perforation, major bleeding, and death) occur in 3.1 colonoscopies per 1000 screened. One in 100 routinely mammography-screened women will be biopsied, and one in 1000 will be subject to overdiagnosis (that is, diagnosed with a breast cancer that was unlikely to have been clinically evident during their lifetime) and possibly unnecessary treatment.”
The same arguments apply strongly against routine screening of men for prostate cancer, or smokers for lung cancer, in the absence of symptoms. . It should be noted that even the Wikipedia Mammography review now strongly highlights the arguments against mass screening mammography. The introduction sums it up bluntly: “task force reports point out that in addition to unnecessary surgery and anxiety, the risks of more frequent mammograms include a small but significant increase in breast cancer induced by radiation. The Cochrane Collaboration (2011) concluded that mammograms reduce mortality from breast cancer by an absolute amount of 0.05% or a relative amount of 15%, but also result in unnecessary surgery and anxiety, resulting in their view that it is not clear whether mammography screening does more good or harm. They thus state that universal screening may not be reasonable. Mammography has a false-negative (missed cancer) rate of at least 10 percent. This is partly due to dense tissues obscuring the cancer and the fact that the appearance of cancer on mammograms has a large overlap with the appearance of normal tissues. A meta-analysis review of programs in countries with organized screening found 52% over-diagnosis.“
It can be argued that noninvasive screeing that finds suspicious premalignant signs can then motivate prevention by natural means- lifestyle diet and appropriate supplements. But since these preventative steps (including blood-pressure and waist/breast girth measurements and monthly self-exam for breast changes) hugely reduce the risks of all serious acute and chronic diseases, accidents and premature disability and death, routine mass screening for common ‘silent’ internal cancers eg breast, prostate colon lung womb and ovary , is irrelevant, risky and huge waste of resources for no benefit. Not applying sensible diet, lifestyle, blood-pressure checks and supplements is like failing to maintain your car, house, computers and electrical appliances etc , until these crucial assets break down. The evidence against hightech screening of the well of course does not stop the anxious well from worrying. As a heavy cigarette-smoking prof of lung medicine said 30 years ago, if an anxious patient demands a scope despite reassurance that the risk:benefit doesnt justify it, it is wise to do it. Or someone else will. At least in the context of the younger adult who will thereby be more motivated to apply prevention, non-xray non-invasive screening by eg Sure Touch breast mapping- from onset of menopause, or younger in eg diabetics and others more prone to cancer eg in AIDS, – and ultrasound quantitative bone-density risk measurement from toddlers upwards , in exercising ie sportspeople, and in any serious chronic disease especially with hormone overtones eg thyroid, diabetes, COPD/ asthma, cancer, arthritis, paralysis, AIDS,TB, cardiacs, renal, liver disease – are relatively low cost and safe compared to the traditional xray screening procedures. The brilliant new French movie The Intouchables is all about choices of lifestyle and the risks entailed. Thats what screening, and voluntary prevention, are about. No adult should be pressurized – by vested interests – into having hightech eg xray (breast, bone) or more invasive (eg scope, biopsy) screening without understandable explanation of the possible although infrequent immediate and distant risks, and remote if any benefits. Only the frequent incidental unexpected screening discovery of hypertension, increased breast lumpiness/density, and low bone density, and initiation of simple lifestyle diet changes and safe supplement therapy- the below- listed scores of supplements against all common degenerative diseases (and if needed the best primary antihypertensive – lowdose reserpine and co-amilozide – costs perhaps $1 a month to control most; and simple (breasts, arthritis, wound or elsewhere) antiinflammatory self massage if indicated with Lugol’s iodine, and analgesic antioxidant coconut oil and DMSO), gives huge early and permanent preventative pain and inflammatory benefits without risks. There are also promising studies on Pubmed between 1989 and 2011 of the benefits of DMSO in management of prostate problems in rats, and humans for transrectal procedures and intravenously as cancer adjuvant palliation. DMSO-MSM is cheaply and safely available . It comes back to basics that are anathema to politicians, Government, profiteers, Big Business Pharma and the Disease Industry. Motivating and enforcing better lifestyle and natural diet (minimizing sugar , aspartame, alcohol, processed food especially cornstarch) , and healthgiving realistic doses of supplements – vits (all – especially B, C, D3 and K), minerals (especially Mg, Zn, I2, Se, P, Bo,) and biological (plant and sealife – not land animal) extracts, (including fish oil, metformin, bioidentical human hormones, tryptophan, MSM, DMSO, chondroglucosamine, coconut oil, cinnamon, pepper, curcumin, arginine, carnitine, carnosine, ribose, coQ10, proline, rauwolfia) – reduces the occurrence of serious disease drastically with decades of health extension. This vastly reduces profit to the Disease Hospital-Drug and processed food- alcohol – tobacco industry in delayed disease till very old age, and thus loss of skilled workers’ jobs – that need to be taken up elsewhere. That’s called reinvention, recycling…