Editor’s Note: You may have seen Karuna’s article back in April of this year when it was published in The Guardian. The piece generated a lot of discussion – over 1,000 people shared it on their Facebook page and over 150 people commented on the article itself. Many of you who have been through several iterations of these debates are used to the controversy that arises from publicly challenging routine mammography screening. What’s new this time around is the growing agreement that the benefits of routine mammography screening have long been overstated, and the harms long underestimated. Ten years ago, our challenge to the conventional position that “early detection saves lives” and “early detection is your best protection” was highly unpopular. Our independent position was a hard truth for many to hear even though it was grounded in evidence because it went against the grain of pretty much every mainstream breast cancer organization—many of which were and still are heavily invested (both in terms of funders and core values) in the “early detection saves lives” philosophy. We’ve reached a tipping point recently and now increasingly we hear more discussion about this issue and less unquestioned acceptance of the earlier screening messages.
By Karuna Jaggar, Executive Director
How will we ever hope to make desperately needed progress in the breast cancer epidemic when the mainstream breast cancer movement continues to push an outdated and scientifically debunked agenda? The evidence has been mounting that the time has come to radically re-think the tenets of the breast cancer awareness movement because it is clear that the fundamental philosophy behind “early detection” is flawed. [Read More…]
Doctors at the World Congress on the Menopause in Cancun, Mexico, have called for any decision to participate in mammography to be a based on an informed choice and consideration of all factors, rather than just be an automatic process.
A major session at the World Congress on the Menopause has debated the benefits and risks associated with regular mammography. The potential benefit of mammography is earlier detection of breast cancer, but increasing evidence has shown that mammography also uncovers some cancers which would not go onto cause any problem, and many doctors believe that this over diagnosis can cause real harm through unnecessary treatment. The debate in the scientific press has led to confusion in the minds of many women, who hope for a definitive answer on whether or not they should undergo regular mammography.
Now two prominent doctors from opposing sides of the debate have agreed that women need to be more involved in making decisions on whether or not mammography is right for them.
Dr Eugenio Paci presented work from the EUROSCREEN working group, showing that over diagnosis is at the lower end of the estimates, indicating that mammography saves lives. This work indicates that screening 1000 women saves up to 7 lives, with only 4 over diagnosis. Professor Robin Bell presented an analysis showing that up to 40% of invasive breast cancer cases identified in women invited for mammography may be over diagnosed, and says that the total number of deaths in screened patients does not drop when measured against non-screened patients, indicating that screening has few benefits. [Read More…]
Nikola Biller-Andorno, M.D., Ph.D., and Peter Jüni, M.D.
April 16, 2014DOI: 10.1056/NEJMp1401875
In January 2013, the Swiss Medical Board, an independent health technology assessment initiative under the auspices of the Conference of Health Ministers of the Swiss Cantons, the Swiss Medical Association, and the Swiss Academy of Medical Sciences, was mandated to prepare a review of mammography screening. The two of us, a medical ethicist and a clinical epidemiologist, were members of the expert panel that appraised the evidence and its implications. The other members were a clinical pharmacologist, an oncologic surgeon, a nurse scientist, a lawyer, and a health economist. As we embarked on the project, we were aware of the controversies that have surrounded mammography screening for the past 10 to 15 years. When we reviewed the available evidence and contemplated its implications in detail, however, we became increasingly concerned.
First, we noticed that the ongoing debate was based on a series of reanalyses of the same, predominantly outdated trials. The first trial started more than 50 years ago in New York City and the last trial in 1991 in the United Kingdom. None of these trials were initiated in the era of modern breast-cancer treatment, which has dramatically improved the prognosis of women with breast cancer. Could the modest benefit of mammography screening in terms of breast-cancer mortality that was shown in trials initiated between 1963 and 1991 still be detected in a trial conducted today? [Read More…]
More controversy has emerged surrounding mammograms ever since a new report in JAMA recommended that the test be performed based on a woman’s risk and preferences.
Dr. Lydia Pace and Dr. Nancy Keating both of Brigham and Women’s Hospital in Boston, conducted a systematic review of data spanning 50 years. They examined about 450 studies from 1960 through the present to look for evidence on the benefits and harms of the diagnostic test.
According to their report, annual mammograms lower mortality from breast cancer by about 19 percent, though the benefits vary based on a woman’s risk and age. Approximately 1,904 women in their 40s would have to undergo a mammogram to prevent one death, while the same would be true for 377 women in their 60s. The disease is more common as a woman ages. At 40, the risk for breast cancer in the next 10 years is 1.5 percent, but that rises to 2.3 percent by age 50, and 3.5 percent by age 60. [Read More…]
Nearly 20% of breast cancers diagnosed by mammogram would never cause problems if left alone, according to a new report. Melinda Beck and the study’s lead author Dr. Nancy Keating join the News Hub. Photo: AP.
A large study published Tuesday adds to the growing body of research concluding that screening mammograms save relatively few lives from breast cancer while discovering many cancers that wouldn’t have caused problems if left alone.
“The more we screen for cancer, the more we find it. But we could have saved some of these women the angst of being told they have cancer,” said Nancy Keating, a researcher at Harvard Medical School and senior author of the study, which examined decades of screening data.
Other recent studies also have found that mammograms often lead to unnecessary treatment, including a British Medical Journal study in February that followed 90,000 Canadian women over 25 years. But to date, that message hasn’t resulted in fewer mammograms or changes in treatment—largely because scientists still can’t tell which breast cancers can be safely left alone.
“The challenge is, we can’t tell which are the aggressive cancers,” said Dr. Keating.
Growing doubts about the benefits of mammograms prompted the U.S. Preventive Services Task Force to change its recommendations in 2009. Since then, it has urged women to get mammograms every other year starting at age 50, rather than annually at 40. The American Cancer Society and other cancer advocacy groups continue to recommend annual screenings starting at 40.
Many health-care policies encourage more screening. Several states now require doctors to tell women if they have dense breasts, which can make mammograms less accurate, and to discuss more high-tech options. A growing number of doctors are rated—and compensated—on the percentage of their patients who are up to date on screenings. And the Affordable Care Act requires insurers to make mammograms free to women without copays or deductibles.
About 225,000 cases of breast cancer are diagnosed in the U.S. each year, and about 40,000 people die of it, according to the American Cancer Society.
The latest study, published in the Journal of the American Medical Association, took an especially long view of the data, examining randomized trials and observational studies on mammograms back to the 1960s to calculate the benefits and harms for women at various ages. Researchers concluded that annual mammograms reduced the overall death rate from breast cancer by about 19%. But they also discovered that about 19% of the breast cancers found when women undergo 10 years of annual mammograms are “over-diagnosed”—that is, they never would have caused problems if left alone.
Younger women had the least benefit, researchers found. They estimate that for every 10,000 women in their 40s who undergo annual mammograms for 10 years, 190 will be diagnosed with breast cancer. But only five of those women would avoid dying of breast cancer as a result of the screening. Of the remainder, about 25 would die despite being treated, and 36 would be treated unnecessarily because the cancer wouldn’t have become life-threatening.
For women in their 50s, 10 breast-cancerdeaths would be averted for every 10,000 women screened annually for 10 years. For women in their 60s, 42 breast-cancer deaths would be averted. But as many as 137 women in their 50s, and 194 in their 60s would be diagnosed and treated unnecessarily.
The conclusion that some cancers are overtreated is controversial, and critics note that it is based on statistical estimates alone. Scientists can’t ethically watch to see whether some breast cancers progress and some don’t. Even precancerous changes, known as ductal carcinoma in situ, can become invasive cancers, so those are almost always treated aggressively.
Treatment typically involves a combination of surgery, radiation, chemotherapy and hormone therapy, with side effects that can last for years.
Still, many breast-cancer survivors say they are simply grateful that their cancer was treatable. And some experts stress that even if screening spurs some unnecessary treatments, it saves lives. “Over a decade or so, we prevent between 10,000 and 11,000 deaths,” said Richard Wender, chief cancer control officer at the American Cancer Society. “The overwhelming odds for any one women to benefit are quite low, but overall, from a population perspective, it’s one of our best tools in the war on cancer.”
Scientists are working on ways to distinguish between breast cancers that are slow-growing and those that are fast-moving and lethal, and to better predict which women are at high risk for aggressive cancers so that screening and treatment can be more targeted.
In the meantime, many cancer experts urge women and their doctors to weigh their individual risks and preferences.
“There isn’t a one-size-fits-all on mammograms,” said Dr. Keating, who said she discusses all the pros and cons with her primary-care patients at Brigham and Women’s Hospital.
“I have a lot of patients who say, ‘I’m comfortable waiting,’ ” she said.
There are already more than enough reasons for ‘pink’ to make you see red, not the least of which is the notion that exposing the healthy breasts of asymptomatic women to breast-cancer causing x-ray radiation for ‘early detection’ is the best form of ‘prevention.’ But now, adding to the growing awareness that mammograms don’t make sense, a groundbreaking new study published in the British Medical Journal reveals regular mammogram screenings do not reduce breast cancer death rates – the only true measure of whether they benefit women who undergo them.
Moreover, the study found that women in the mammography arm were more likely to be ‘overdiagnosed’ (a euphemism for misdiagnosed) with breast cancer that wasn’t there.
The 25-year follow up study, involving almost 90,000 Canadian women, compared breast cancer incidence and mortality up to 25 years in women aged 40-59 who did or did not undergo mammography screening.
The results were reported as follows:
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)
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), i.e. there was a 5% increased risk of death in the mammography arm
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, revealing a similar cumulative mortality from breast cancer between groups.
After 15 years of follow-up a residual excess of 106 cancers was observed in the mammography arm, attributable to over-diagnosis.
The study concluded:
“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.”
As we have reported on extensively in the past, x-ray mammography is far more dangerous than the general public is being let on to. For starters, we have spent considerable time indexing research from the National Library of Medicine on the unintended adverse effects of this diagnostic intervention, including evidence for its lack of effectiveness, which can be viewed here: X-Ray Mammography Harms. We encourage our readers to familiarize themselves with the primary literature on these topics, instead of relying exclusively on mainstream news reporting, or simply the authority of ‘experts’ whose interpretations and recommendations are usually policy-driven and not evidence-based.
There are a wide range of problems with conventional breast screenings that we believe everyone should be made aware of, especially considering it is a medico-ethical obligation as a necessary part of informed consent:
They Contribute to Radiation-Induced Breast Cancer: In our previous article, “How X-Ray Mammograpy Is Accelerating The Epidemic of Cancer,” we addressed the radiobiological hazards of mammography radiation, which is far more carcinogenic than previously believed. Essentially, the radiation risk model used to determine whether the benefit of breast screenings in asymptomatic women outweighs their harm, underestimates the risk of mammography-induced breast and related cancers by between 4-600%. [Note: even the “therapeutic” use of radiation (radiotherapy) to treat breast cancer has been shown to make the cancer cells up to 30x more malignant: “Study: Radation Therapy Makes Cancers 30x More Malignant“]
They Cause Psychological Trauma: Beyond the obvious fact that a multi-billion dollar “pink” cause marketing agenda has converted women’s breasts into being perceiving first and foremost as ‘cancer time-bombs,’ the omnipresent psychological threat of being diagnosed with breast cancer, along with the statistical inevitability – at least 1 in 2 women undergoing regular screening will have a false-positive recall or biopsy recommendation after 12 years[i] – of being ‘overdiagnosed,’ i.e. misdiagnosed and [mis-]treated for cancers that weren’t there, or were intrinsically benign/indolent, there is the reality that millions of women will suffer harm from screening that will never be accounted for in studies like the one featured in the beginning of this article. In a previous exploration on the topic, “‘Hidden Dangers’ of Mammograms Every Woman Should Know About,” we reported on a 2013 study from the Annals of Family Medicine, which found that women with false-positive diagnoses of breast cancer, even three years after being declared free of cancer, “consistently reported greater negative psychosocial consequences compared with women who had normal findings in all 12 psychosocial outcomes.” What is even more concerning is that “[S]ix months after final diagnosis, women with false-positive findings reported changes in existential values and inner calmness as great as those reported by women with a diagnosis of breast cancer.” Overdiagnosis can no longer be written off as ‘collateral,’ or ‘the cost of doing business.’ These ‘psychological’ traumas have real physiological consequences, and can directly lead to increased mortality, both through adrenaline’s role in activating malignancy associated genetic pathways within cancer, as well as the recent discovery that the clinical ritual of cancer diagnosis itself can accelerate heart-related deaths up to 26.9 fold within 1 week post-diagnosis. Read: “Research: Some Cancer Diagnoses Kill Quicker Than The Cancer.”
They Aren’t Evidence-Based/Scientific: On the most fundamental level, exposing the presumably healthy breasts of asymptomatic populations to breast cancer-causing radiation (the equivalent of 300 chest x-rays each screen), makes little sense. This is all the more true now that we know most of the early stage “breast cancers” that have been diagnosed in the quarter century old push for ‘early detection’ via x-ray mammography screenings, were benign lesions, some of which (including so-called “invasive breast tumors”) have been reported to spontaneously regress when left untreated. Given the accumulating evidence against x-ray based screening, and the availability of non-ionizing radiation-based methods such as thermography, why take the well-documented risks? For further research, read our contributor Rolf Hefti’s excellent mini-review: “Why Mammography Is Unscientific and Harmful.”
One of the largest and most meticulous studies of mammography ever done, involving 90,000 women and lasting a quarter-century, has added powerful new doubts about the value of the screening test for women of any age.
It found that the death rates from breast cancer and from all causes were the same in women who got mammograms and those who did not. And the screening had harms: One in five cancers found with mammography and treated was not a threat to the woman’s health and did not need treatment such as chemotherapy, surgery or radiation.
The study, published Tuesday in The British Medical Journal, is one of the few rigorous evaluations of mammograms conducted in the modern era of more effective breast cancer treatments. It randomly assigned Canadian women to have regular mammograms and breast exams by trained nurses or to have breast exams alone.
Researchers sought to determine whether there was any advantage to finding breast cancers when they were too small to feel. The answer is no, the researchers report.
The study seems likely to lead to an even deeper polarization between those who believe that regular mammography saves lives, including many breast cancer patients and advocates for them, and a growing number of researchers who say the evidence is lacking or, at the very least, murky.
“It will make women uncomfortable, and they should be uncomfortable,” said Dr. Russell P. Harris, a screening expert and professor of medicine at the University of North Carolina, Chapel Hill, who was not involved in the study. “The decision to have a mammogram should not be a slam dunk.”
The findings will not lead to any immediate change in guidelines for mammography, and many advocates and experts will almost certainly dispute the idea that mammograms are on balance useless, or even harmful.
Dr. Richard C. Wender, chief of cancer control for the American Cancer Society, said the society had convened an expert panel that was reviewing all studies on mammography, including the Canadian one, and would issue revised guidelines later this year. He added that combined data from clinical trials of mammography showed it reduces the death rate from breast cancer by at least 15 percent for women in their 40s and by at least 20 percent for older women.
That means that one woman in 1,000 who starts screening in her 40s, two who start in their 50s and three who start in their 60s will avoid a breast cancer death, Dr. Harris said.
Dr. Wender added that while improved treatments clearly helped lower the breast cancer death rate, so did mammography, by catching cancers early
But an editorial accompanying the new study said that earlier studies that found mammograms helped women were done before the routine use of drugs like tamoxifen that sharply reduced the breast cancer death rate. In addition, many studies did not use the gold-standard methods of the clinical trial, randomly assigning women to be screened or not, noted the editorial’s author, Dr. Mette Kalager, and other experts.
Dr. Kalager, an epidemiologist and screening researcher at the University of Oslo and the Harvard School of Public Health, said there was a reason the results were unlike those of earlier studies. With better treatments, like tamoxifen, it was less important to find cancers early. Also, she said, women in the Canadian study were aware of breast cancer and its dangers, unlike women in earlier studies who were more likely to ignore lumps.
“It might be possible that mammography screening would work if you don’t have any awareness of the disease,” she said.
The Canadian study reached the same conclusion about the lack of a benefit from mammograms after 11 to 16 years of follow-up, but some experts predicted that as time went on the advantages would emerge.
That did not happen, but with more time the researchers could, for the first time, calculate the extent of overdiagnosis, finding cancers that would never have killed the women but that led to treatments that included surgery, chemotherapy and radiation.
Many cancers, researchers now recognize, grow slowly, or not at all, and do not require treatment. Some cancers even shrink or disappear on their own. But once cancer is detected, it is impossible to know if it is dangerous, so doctors treat them all.
If the researchers also included a precancerous condition called ductal carcinoma in situ, the overdiagnosis rate would be closer to one in three cancers, said Dr. Anthony B. Miller of the University of Toronto, the lead author of the paper. Ductal carcinoma in situ, or D.C.I.S., is found only with mammography, is confined to the milk duct and may or may not break out into the breast. But it is usually treated with surgery, including mastectomy, or removal of the breast.
Mammography’s benefits have long been debated, but no nations except Switzerland have suggested the screening be halted. In a recent report, the Swiss Medical Board, an expert panel established by regional ministers of public health, advised that no new mammography programs be started in that country and that those in existence have a limited, though unspecified, duration. Ten of 26 Swiss cantons, or districts, have regular mammography screening programs.
Dr. Peter Juni, a member of the Swiss Medical Board until recently, said one concern was that mammography was not reducing the overall death rate from the disease, but increasing overdiagnosis and leading to false positives and needless biopsies.
“The mammography story is just not such an easy story,” said Dr. Juni, a clinical epidemiologist at the University of Bern.
Even experts like Dr. H. Gilbert Welch, a professor of medicine at Dartmouth, who have questioned mammography’s benefits were surprised by Switzerland’s steps to reconsider its widespread use.
“Wow, times they are a-changin’,” Dr. Welch said.
In the United States, about 37 million mammograms are performed annually at a cost of about $100 per mammogram. Nearly three-quarters of women age 40 and over say they had a mammogram in the past year. More than 90 percent of women ages 50 to 69 in several European countries have had at least one mammogram.
Dr. Kalager, whose editorial accompanying the study was titled “Too Much Mammography,” compared mammography to prostate-specific antigen screening for prostate cancer, using data from pooled analyses of clinical trials. It turned out that the two screening tests were almost identical in their overdiagnosis rate and had almost the same slight reduction in breast or prostate deaths.
“I was very surprised,” Dr. Kalager said. She had assumed that the evidence for mammography must be stronger since most countries support mammography screening and most discourage PSA screening.
For women who dutifully keep their mammogram appointments year after year, the latest results from a long-term trial in Canada, which found no difference in death rates from breast cancer among women who had regular mammograms and those who did not, are bound to sow confusion, perhaps even anger.
For decades now, the annual mammogram has been promoted vociferously and continuously as an essential way to protect oneself from breast cancer. Many women feel they are being irresponsible if they do not get a regular scan, said Dr. Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice.
“For so long, we have been trying to convince people that you’re irresponsible or not taking care of yourself if you don’t do this,” Dr. Schwartz said. “People were hit over the head with that message.”
But attitudes have been changing as evidence accumulates of the hazards of intensive cancer screening. The American Urological Association has loosened its prostate cancer screening guidelines for men, for instance, because of the potential for unnecessary, invasive treatment that often leads to incontinence and impotence.
In light of the accumulating data that the benefits of regular mammography may be negligible for women, and that the practice has led to false positives and overtreatment, “it’s important for women to realize there is a genuine decision to be made here,” Dr. Schwartz said.
It is not a decision that medical groups are making any easier. In 2009, the United States Preventive Services Task Force, an influential group that makes recommendations to the federal government, concluded that women over age 50 should have mammograms every two years instead of annually and that the evidence of benefit was only moderate. The group did not recommend the screening test for younger women.
The American Cancer Society refrained from following the task force’s lead and continues to recommend annual mammograms beginning at age 40, as do the National Cancer Institute and the American College of Radiology.
In 2011, the American Congress of Obstetricians and Gynecologists urged more screening, recommending that women 40 and over receive a mammogram annually; previously, the group had recommended that women start yearly mammograms at age 50.
But the days of one-size-fits-all screening may be ending. Now patients and their doctors will face much more nuanced choices, based on each woman’s risk for breast cancer and her feelings about the prospect of unnecessary treatment.
“The balance between benefits and harms is more and more up in the air,” said Dr. Russell P. Harris, a professor of medicine at the University of North Carolina, Chapel Hill. “Reasonable people will disagree.”
A new study shows that slow-growing breast lesions classified as “probably benign” commonly found with ultrasound screenings can be safely re-evaluated in 12 months instead of being immediately followed up with unnecessary biopsies and exams.
Current guidelines suggest that such lesions should be followed up either with a biopsy or with a short-term follow-up, but some doctors now say this might be unnecessary.
A growing body of evidence suggests that ultrasound is an effective supplemental tool to find cancers that mammography can’t.
“We’re finding additional lesions on ultrasound that we wouldn’t find on mammo, and vice versa. The numbers somewhat overlap,” Dr. Richard Barr, lead study researcher and professor of radiology at the Northeast Ohio Medical University, told DOTmed News.
However, ultrasound screenings have a downside: a high number of cancers detected by the modality are lesions at low-risk for turning into cancer — what doctors classify as BI-RADS 3.
Study researchers analyzed the screening of ultrasound exams and follow-up data of 2,662 women recruited between 2004 and 2006 in the American College of Radiology Imaging Network (ACRIN) trial.
Of all the trial participants, 745 low-risk lesions were detected by the screening, representing 25 percent of all ultrasound-detected lesions in the study.
However, of those 745 cases, only six were considered malignant — averaging a 0.8 percent malignancy rate overall.
Furthermore, of those six cases, suspicious changes in the cancer detected at the 12-month mark had not spread beyond the breast, meaning that the odds of these already-rare cases developing suspicious changes at the half-year mark were very low.
“Even though we waited a year to follow up, it didn’t change the prognosis,” said Barr.
Barr also cautions that because these lesions have always been automatically removed in the past, researchers still have incomplete data on these lesions and their long-term likelihood of developing into cancer.
“Though this study involved 2662 participants, we ended up with a very small number of cancers. We need larger studies that try this technique instead of short term follow-up to see if this is true,” he said.
In recent years, cancer screening programs such as mammography have come under fire from critics who say that their high rate of false positives, unnecessary biopsies and over-treatment do more harm than good.
The conversation around over-diagnosis applies to more than just screenings: earlier this month a panel affiliated with the National Cancer Institute also came out with a recommendation to redefine cancer to rein in over-treatment and over-diagnosis for certain low-risk lesions — acknowledged by a growing chorus of doctors to be a real medical problem.
And with health care cost reduction dominating the conversation within the industry, ideas around curbing over-treatment are becoming more popular. “We can also make a significant impact on the cost of follow-up,” said Barr.
This first appeared in the July 2013 issue of DOTmed Business News
It’s no secret that getting a mammogram is a nerve-wracking experience for many women. Although some studies suggest women at higher risk for breast cancer are more likely to get regular screens, others show that the most fearful women are the least likely to be screened.
To that end, many imaging centers are working to try to put women at ease by making their mammography screening more than just a test. “We want to make sure they’re the most important person at that given moment,” explains Barbara Marshall of Battlefield Imaging.
The facility, based in Ringgold Georgia, is designed to convey a spa-like feeling, complete with oversized furniture, flat screen TVs and a nutrition café. Even the center’s mammography machines supplied by Siemens contribute to the atmosphere, coming in different colors like pink and green, and equipped with mood lighting designed to soothe the patient. “It’s been the talk of the community,” says Marshall. “The patients are surprised when they see it, they say, this is beautiful.”
But even as doctors are trying to encourage more of the population to get screened regularly, others are questioning whether routine annual screenings for certain women are necessary at all. [Read More…]