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Jeffrey Dach, M.D. NewsLetter
The Untold Message of Breast Cancer Awareness Month
by Jeffrey Dach MD
__________________________________________
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Dear Friend or Colleague
Breast Cancer Awareness Month Fails to Disclose Limitations of Mammography
October was Breast Cancer Awareness Month, which is an advertising campaign for national mammography screening. An eminent radiologist, Leonard Berlin MD says this message fails to disclose the limitations of screening mammography, namely that mammography will miss 30-70% of breast cancers, and leads to over diagnosis and over treatment. He also says mammography disclosures should be mandated, just like the cigarette and drug warnings that appear on their ads.
Otherwise, we create unrealistic expectations for mammography which cannot be met. The public expects every breast cancer to be detected. They are not. This translates into increased medical malpractice payouts for the missed cancer, which is now the most prevalent medical malpractice case against all physicians.
(1)
(1A)
(1B)
(2)
(3)
(4)
The fact is that mammograms are difficult to interpret, cancers can be hidden, and many are missed. This cancer miss is not from lack of training or competency on the part of the radiologist. It is inherent in the mammogram technique itself.
The American College of Radiology says that 30-70% of breast cancer are missed on the initial mammogram, and are seen in retrospect a year later by going back to the previous mammogram interpreted as normal.
(5)
(6)
With this legal environment, it is a miracle that mammography has survived at all.
Screening mammography is not prevention.
Leonard Berlin points out that 57% of the American women believe that mammograms prevent breast cancer, a misleading message from Breast Awareness Month.
(1B)
Mammograms are designed to detect cancer, not prevent it.
Thinking that a mammogram can prevent breast cancer is like thinking that checking your house annually for broken windows, prevents robberies.
Secondly. the most likely outcome of a positive mammogram is an unnecessary biopsy, causing emotional distress, breast deformity and scarring. 80% of all breast biopsies done for a positive finding on a mammogram are negative for cancer.
(5)
My own experience with mammography
When I began residency training in radiology at Rush Presbyterian Hospital in Chicago in 1971, the state of the art was Xeromammography. This was a machine made by the Xerox Company which was prone to mechanical failure, and always breaking down. It produced a blue photo on paper with blue toner powder.
(27)
(29)
Example of Xeromammogram
Example of X-ray Film Mammogram
In those days,
Franklin S Alcorn MD, was the only brave soul willing to read the Xerox images, and the book was Xeroradiography by John N. Wolfe. In 1972, the consensus in the department was that mammography was an orphan procedure and might never become acceptable. Some docs thought xeromammography was bordering on quackery, and screening mammogram had not been invented yet.
(30)
Useful to the Surgeon
In those early days the surgeons criteria for doing a breast biopsy was a palpable mass. Many women have palpable lumps and bumps called fibrocystic breast disease which is quite common, and now known to be caused by iodine deficiency. (7)
Cyst or Solid Breast Mass?
In those days, the surgeon approached a breast mass with needle aspiration to differentiate between a fluid containing cyst or a solid mass. Nowadays, ultrasound determines this easily.
Back to the needle aspiration procedure; if the lesion is a cyst, the fluid is removed and the mass disappears. If no fluid can be obtained, then the mass is solid, and surgical removal is the next step. This is where the surgeons found the xeromammogram useful, occasionally showing a second occult mass or calcification which alerts the surgeon to remove additional tissue.
Invention of Needle Localization
Sometimes the surgeon had trouble actually finding the tiny calcifications at surgery since they couldnt feel them, so needle localization was invented. The radiologist placed a needle in the breast tissue near the calcifications which guided the surgeon to the spot to be removed.
Examples of Needle Localization for calcifications
Examples of Needle Localization for spiculated mass typical for malignancy.
The Switch from Blue Paper to Gray Xray Film
Grey X-Ray film mammograms replaced the blue Xerox paper images around 1982. By that time, I had joined a radiology group in Hollywood, Florida, but they were still using the xerox machine even though the whole country had already made the switch to regular x-ray film. This inevitable switch-over to X-ray film made possible the large scale national breast screening programs, since the mammogram could be done at any hospital x-ray department.
(27)
Finally, We All Learn Mammography
My radiology group made the plunge into film mammography. None of us had prior training or experience reading mammograms, so we traveled to expensive meetings and teaching courses on mammography from leaders in the field, such as Marc Homer MD and Laszlo Tabar MD (Sweden), and then we started reading on our own. (8)
From Breast Needle Biopsy to the Creation of a New Department
Soon we were doing the needle localizations (using the Marc Homer needle) and needle biopsies in the radiology department. Initially, biopsies were done with simple supplies, a standard 20 gauge needle and 10 cc disposable syringes. A few years later, the radiology industry came out with spring loaded and vacuum assisted biopsy guns, and later invented dedicated biopsy tables using stereo tactic guidance. This machine allows the operator to take two x-rays at different angles, and uses a computer to calculate the exact position for the biopsy needle.
By 2005, the cranky unreliable blue toner xeromammogram had been replaced with a shiny new department on the third floor with all the new modalities: hi-resolution digital mammography, stereotactic biopsy, breast ultrasound, and breast MRI. There is no question that the combination of these modalities makes a powerful and useful tool for diagnosis, treatment and follow up of breast cancer cases. However, this is quite different from screening mammography which is discussed below.
Victimization of Women?, No, Merely Good Medical Care.
When we started the screening mammogram program, many of the suspicious findings were false positive meaning they looked like something, but were in fact nothing. The radiologist would send a report of suspicious requires biopsy to the doctor who would tell the patient it might be cancer and the terrorized woman would then not only submit to surgical biopsy under anesthesia, she would become hysterical and insist on the biopsy immediately. The negative biopsy would be a relief to the patient making the surgeon a hero. Feminists call this victimization of women, and healthcare professionals would call this good medical care.
Occasionally, about 10-20% of the time, a real cancer would be found at surgery. These were typically spiculated masses or branching tell-tale calcification patterns. In the early days, the punctate calcifications and the milk-of calcium (teacup) were called benign and did not require biopsy, and the branching calcifications indicated malignancy requiring biopsy and further treatment, However, nowadays, even the benign calcifications are routinely sent for biopsy, sometimes showing a controversial non-aggressive cancer called DCIS.
(9)
(10)
What's Your Track Record ?
At first, we had no idea how many of our mammogram readings of suspicious for cancer were actually found to be cancer by surgical biopsy and pathology evaluation. So, we started compiling the pathology data and attended monthly conferences to review the data and our track record. The average is one cancer every 5 biopsies, but each radiologist and hospital may have more or less. Optimally, this information should be posted on the wall of the waiting room. Unfortunately, this type of data is rarely available to the patient.
Questioning Screening Mammography
In the 1980s I believed, along with every one else in the health care industry, that mammography was capable of early detection of breast cancer, and that mass screening programs were capable of reducing breast cancer mortality. I even wrote a short editorial that appeared in the Miami Herald to this point which won the praise of my associates at the hospital.
Starting around 1995, however, I began to question the idea of screening mammography. Even from the beginning, there was a debate between proponents and critics of mammogram screening. They argued that the studies either did, or did not show reduction in breast cancer mortality. The critic, Samuel Epstein says mammograms cause harm from overtreatment with unnecessary breast biopsies, and the radiation increases breast cancer risk.
Luck of the Draw - Mammography Malpractice
One of radiologists in my group had the misfortune of being sued for malpractice. He missed a cancer on a mammogram that was visible in retrospect a year later. Remember, this happens 30-70% of the time, routinely.
This event happened early in his career, just out of training, before I joined the group. His insurance company quickly settled the case by paying the woman a settlement of a million dollars, with no attempt at defending the case. As you can imagine, this was a major event which changed how he interpreted mammograms. After that, he was gun shy, almost always did a callback for additional views, and always recommended biopsy for any vague density. The problem is that almost every mammogram has vague densities. Almost all of these biopsies were unnecessary for the patient, but they were quite necessary for the radiologist, considering the medico-legal climate.
The x-ray techs quickly learned to bring the mammograms over to my reading area for a quick negative, rather than to the other reading room, where they usually end up doing more views and send the patient for biopsy of a questionable area. This went on for years, and I was never sued for malpractice on a mammogram reading during my entire career. I consider this "the luck of the draw".
Realizing the high rate of false positive biopsies and the emotional impact on women, I did my best to call the negative mammograms negative realizing there could be a cancer hiding somewhere, and the visible cancers were sent to biopsy.
Biopsy Everything and Anything
The reality of a hostile medico-legal malpractice climate and financial pressure dictates the practice of mammography in most community hospitals. Current practice is to basically biopsy anything and everything that shows up on the mammogram, as long as the patient is compliant. Its not difficult getting compliance by telling patient that it might be cancer, we cant be sure. That usually is enough to make the woman hysterical and submit to biopsy. The radiologist is happy because he thinks he is reducing his chances of being sued for malpractice. His partners and the hospital administrators are happy because the procedures bring in more income. If cancer is found, the surgeons are happy because they have more lumpectomies and cancer operations to keep them busy.
DCIS, the Controversial Non-Aggressive Cancer
Over half of the cancers detected with mammography are DCIS (ductal carcinoma in situ). This is a non-aggressive form of cancer which has a 98% survival after 5 years even with no treatment, although when found, they are treated with surgery as any other cancer. Some consider this detection and treatment of DCIS a form of overtreatment, others consider it good medical care.
Example small calcifications representing DCIS.
Some critics have said that increased mammographic detection of DCIS has skewed the statistics, falsely reducing breast cancer mortality. This makes it look like we are reducing breast cancer mortality, and we are not.
Without mammography, most of these DCIS cases would go undetected, and probably never cause a problem.
Autopsy studies of women dying from car accidents have shown occult DCIS in up to 15% of the population. The actual incidence of cancer mortality is 0.4 per cent, not 15 per cent, suggesting that 96% of DCIS cases never go on to clinical disease. Yet, when DCIS is detected on the mammogram, these cases are treated with the same mastectomy or lumpectomy.
A third of the time, pathologists will disagree on the diagnosis of DCIS while looking at the same case. (11)
(12)
Lung Cancer Screening
Screening tests in radiology have been tried before. For example chest x-ray screening for lung cancer was tried, studied and abandoned. It was found that when you do a chest X-ray on smokers every 6 months, find the cancers and send the patient to surgery for treatment, there is no change in mortality figures. No lives are saved. In addition to make matters worse, when you go back to the earlier films 6 months before, on the film that was read as negative or normal in retrospect the lesion is visible 90% of the time. (13)
(14)
We thought these problems would be solved by moving up to CAT scans, a more advanced imaging technique. However, now we have a problem with seeing too many "suspicious" lesions and the false positive diagnosis. The net result is that lung cancer screening even with CAT scanning has not caught on.
(15)
Mammogram screening in the under 50 age group NOT recommended by all other countries.
Current guidelines recommend a screening mammogram every 2 years for the 40-50 year age group. No other western country does this, as these women have dense breast tissue difficult to image and are most prone to a false positive reading, or a diagnosis of DCIS, the controversial less aggressive form of cancer. Most European countries restrict screening to post-menopausal women, after 50, when breast tissue involutes to fat and the cancers become more conspicuous.
Efficacy of Breast Cancer Screening - Does It Reduce Mortality?
The public perception is that breast cancer screening reduces breast cancer mortality. The reality is that this is a fiercely debated question in the medical literature with no clear winner. Leonard Berlin's articles summarize this debate in the medical literature.
(3)
The debate is best exemplified by one example cited by Dr. Berlin in the Annals of Internal Medicine (2002), in which two conflicting articles appeared in the same issue, one stating that mammography has no mortality benefit, and the other saying it does.
Here are the two articles:
(1) Canadian researchers concluded that mammography screening did not reduce breast cancer mortality
(16)
(17)
(2) United States Preventive Services Task Force concluded mammography reduces breast cancer mortality among women 40-74 years old.
(18)
(19)
Another listing and review of Mammography Screening Studies is found of the National Breast Cancer Coalition (web site). (44)
Bottom line, the debate rages on with no clear winner.
One observation which might clarify the debate is this:
in two countries with socialized medicine, Canada and Sweden, careful studies of mammography screening were found to have NO Mortality Benefit compared to breast clinical exam.
Here in the US, however, with a 4 billion dollar fee-for-service screening mammogram industry, the mammography studies are interpreted to show that Yes, there is a Mortality Benefit of about 15-20% .
The influence of money and politics over medical science is pervasive, and mammography is certainly not immune. A few MD PHD's from Canada or Sweden are not about to derail a 4 billion dollar industry in the US.
Conflict of Interest in Sponsoring Breast Cancer Awareness Month?
Screening mammography critic, Samuel Epstein MD, irritates the establishment every time he points out that in 1984, the American Cancer Society created the October National Breast Cancer Awareness Month sponsored by money from the Astra-Zeneca Company, the maker of Tamoxiphen, the best selling breast cancer drug. In addition, Astra-Zeneca also manufactures industrial chemicals that cause breast cancer. Some consider this a conflict of interest.
Epstein also points out that past ACS advertisement promised early detection results in a cure nearly 100% of the time. Even more seriously, the Awareness Month advertisements avoid any reference to information on avoidable causes and prevention of breast cancer. (20)
(21)
What is breast cancer prevention?
A previous newsletter discusses Iodine supplementation as the most effective way to prevent breast cancer. Iodine tablets are safe, inexpensive and readily available. This is true prevention.(7)
Samuel Epsteins landmark book, "The Politics of Cancer" discusses carcinogenic chemicals in our food supply, home and workplace. Removing them can reduce breast cancer. This is true prevention.
(22)
(23)
The Untold Message of Breast Cancer Awareness Month:
To summarize, here is the untold message of Breast Cancer Awareness Month:
1) mammography screening is detection, not prevention and has several limitations, namely 30-70% missed cancers, and a tendency towards over diagnosis and over treatment. (5)
2) Many different carcinogenic chemicals cause breast cancer, and removing these chemicals from the workplace or home can reduce breast cancer rates.
(22)
(23)
3) Iodine deficiency causes fibrocystic disease, and Iodine supplementation prevents breast cancer.(7)
4) Synthetic hormones like Provera increase breast cancer risk. (WHI Study)(24)
5) Bio-Identical Hormone programs are safe, and do not increase risk of breast cancer. (French Cohort Study) (25)
Will mainstream medicine ever endorse Dr. Leonard Berlin's Truth-in-Mammography disclaimers ? No, this will never happen. The public's unrealistic expectation that a breast cancer nodule will be detected 100% of the time will continue, and the high cost of medical malpractice will simply be absorbed into "the cost of doing business". The screening mammogram is here to stay.
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Jeffrey Dach MD
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References
(1)
American Cancer Society Breast Cancer Prevention Page:
Yearly mammograms are recommended starting at age 40 and continuing for as long as a woman is in good health.
(1A) Leonard Berlin MD Biography
(1B)
Leonard Berlin, MD Mammography Screening Can Survive
Malpractice . . . If Radiologists Take Center Stage and Assume the Role of Educator
(2)
Berlin L. The missed breast cancer redux: time for educating the public about the limitations of mammography? AJR Am J Roentgenol 2001; 176:1131–1134.
(3)
Malpractice Issues in Radiology, Breast Cancer, Mammography, and Malpractice Litigation: The Controversies Continue Leonard Berlin,Excellent discussion of controversy of screening mammography and impact on mortality figures.
(4)
Perspective Dot Size, Lead Time, Fallibility, and Impact on Survival Continuing Controversies in Mammography Leonard Berlin MD
(5)
STATEMENT of Leonard Berlin, M.D. To the U.S. Senate Committee on Health, Education Labor and Pensions Re: Mammography Quality Standards Act Reauthorization April 8, 2003.
Leonard Berlin: Suffice it to say that research studies performed at some of the most prestigious medical institutions in the United States reveal that as many as 90% of lung cancers, and 70% of breast cancers, can at least partially be observed on previous studies read as normal.
(6)
A Manifesto for Truth-in-Mammography Advertising
by Leonard Berlin MD Imaging Economics, November 2004
From cigarettes to pharmaceuticals to financial services, all advertisements feature a disclaimer: Why not those for mammography?
Of all medical malpractice lawsuits filed in the United States that allege a delay in the diagnosis of breast cancer, radiologists are the most frequently sued specialists. Of all medical malpractice lawsuits lodged against radiologists, the most frequent cause is the allegation of a missed breast cancer on mammography. Why has "missed breast cancer" risen to first place in the medical malpractice standings? I suggest that it is because we have oversold mammography. We have marketed mammography without informing the American public all that we know about not only the benefits, but more important the limitations and potential harms of mammography.
(7) Iodine Prevents Breast Cancer by Jeffrey Dach MD
(8)
Screening mammogram studies
Swedish Study by Dr. Laszlo Tabar (1977-
1984) Population-based randomized controlled study
31% reduction in breast cancer mortality in women 50 plus
(9) INTERACTIVE MAMMOGRAPHY ANALYSIS WEB TUTORIAL Images of benign calcifications, secretory disease, milk of calcium, etc.
(10) Tutorial 2 : CALCIFICATIONS ASSOCIATED WITH A HIGH PROBABILITY OF MALIGNANCY
(11)
Ductal Carcinoma In Situ of the Breast
Elisabeth L. Dupont, MD; Ni Ni K. Ku, MD; Christa McCann, BA;
and Charles E. Cox, MD, FACS
DCIS, 60% of DCIS cases are discovered solely by mammography
Seven major autopsy studies of women not known to have had breast cancer have provided insight. Six studies found an incidence of 4% to 18%.7 The seventh and largest study showed a 0.2% incidence (1 in 519 cases).8 However, this study included a significant proportion of groups known to have a smaller than usual risk of breast cancer. Of the more than 1,000 cases comprising these seven studies, only one case of invasive cancer was detected. Further analysis with fixed criteria is needed. (DCIS) this type of cancer now accounts for nearly half of mammographically detected cases of cancer.
(12)
Using Autopsy Series To Estimate the Disease "Reservoir" for Ductal Carcinoma in Situ of the Breast: How Much More Breast Cancer Can We Find? H. Gilbert Welch, MD, MPH, and William C. Black, MD Annals of Internal Medicine December 1997 Volume 127 Issue 11 Pages 1023
(13) DOES LUNG CANCER SCREENING SAVE LIVES?
(14) Lung cancer screening
(15) Corporate Medical Policy Lung Cancer Screening, CT Scanning or Chest Radiographs
BC BS doesn’t cover Lung cancer screening with chest CAT or Xrays.
(16)
Miller AB, To T, Baines CJ, Wall C. The Canadian national breast screening study. 1. Breast cancer mortality after 11 to 16 years of follow-up. Ann Intern Med 2002;137:305 312
After 11 to 16 years of follow-up, four or five annual screenings with mammography, breast physical examination, and breast self-examination had not reduced breast cancer mortality compared with usual community care after a single breast physical examination and instruction on breast self-examination. The study data show that true effects of 20% or greater are unlikely.
Controversy will persist because other studies suggest that screening causes small reductions in breast cancer mortality.The Editors
(17)
Journal of the National Cancer Institute, Vol. 92, No. 18, 1490-1499, September 20, 2000
Canadian National Breast Screening Study-2: 13-Year Results of a Randomized Trial in Women Aged 50–59 Years
Anthony B. Miller, Teresa To, Cornelia J. Baines, Claus Wall, For the Canadian National Breast Screening Study-2
Results: Randomization achieved virtually equal distribution of demographic and breast cancer risk variables. At the first annual screen, 21% of the cancers found by mammography alone (in the mammography plus physical examination group) were 20 mm or more in size compared with 46% of those found by physical examination in the mammography plus physical examination group and 56% in the physical examination-only group. The corresponding percentages for screens were 10%, 42%, and 50%, respectively. Screening detected 267 invasive breast cancers in the mammography plus physical examination group compared with 148 in the physical examination-only group. By December 31, 1993, 622 invasive and 71 in situ breast carcinomas were ascertained in the mammography plus physical examination group, and 610 and 16 were ascertained in the physical examination-only group. At 13-year follow-up, with 107 and 105 deaths from breast cancer in the respective groups, the cumulative rate ratio was 1.02 (95% confidence interval = 0.78 ). Conclusion: In women aged 50 - 59 years, the addition of annual mammography screening to physical examination has no impact on breast cancer mortality.
(18) Humphrey LL, Helfand M, Chan BKS, Woolf SH. Breast cancer screening: a summary of the evidence for the U. S. Preventive Services Task Force. Ann Intern Med 2002;137:347 -360 The U.S. Preventive Services Task Force recommends screening mammography, with or without clinical breast examination, every 1 to 2 years for women aged 40 and older.
(19) United States Preventive Services Task Force concluded mammography reduces breast cancer mortality among women 40-74 years old.
(20) Dangers and Unreliability of Mammography: Breast Examination is a Safe, Effective, and Practical Alternative Samuel S. Epstein, Rosalie Bertell, and Barbara Seaman International Journal of Health Services, 31(3):605-615, 2001.
(21) Cancer, Inc - National Breast Cancer - Awareness Month Sierra, Sept, 1999 by Sharon Batt, Liza Gross THEY MAKE THE CHEMICALS, THEY RUN THE TREATMENT CENTERS, AND THEY'RE STILL LOOKING FOR "THE CURE"--NO WONDER THEY WON'T TELL YOU ABOUT BREAST CANCER PREVENTION Astra Zeneca Sam Epstein
(22) Cancer Prevention Coalition
(23) The Politics of Cancer, Revisited 1998 By Samuel S. Epstein, M.D. Foreword by Congressman David Obey,Introduction by Congressman John Conyers In this book, world-cancer expert Dr. Samuel Epstein indicts the National Cancer Institute and the American Cancer Society for responsibility in losing the cancer war-
(24)
Postmenopausal Hormone Replacement Therapy Scientific Review Heidi D. Nelson, MD, MPH; Linda L. Humphrey, MD, MPH; Peggy Nygren, MA; Steven M. Teutsch, MD, MPH; Janet D. Allan, PhD, RN
JAMA. 2002;288:872-881.
(25)
French Cohort Study
(26) Leonard Berlin MD biography
(27) Breast Imaging: From 1965 to the Present Edward A. Sickles, MD, Radiology. 2000;215:1-16.) Examples of xeromammograms and film mammograms, speculated lesion, needle localization.
(28) Case 41: Ductal Carcinoma in Situ, Alanna T. Harris, MD
The detection of ductal carcinoma in situ has increased markedly in recent years secondary to the widespread use of screening mammography, and it now accounts for 25 to 40% of mammographically detected breast cancers
(29) History of Breast Cancer WILLIAM L. DONEGAN
(30) History: Narratives Radiology in Illinois By Franklin Alcorn, M.D. Dr. Alcorn's history appeared in the program of the Chicago Radiological Society at the Centennial of Radiology in 1995.
(31) Miller AB, To T, Baines CJ, Wall C. The Canadian national breast screening study. 1. Breast cancer mortality after 11 to 16 years of follow-up. Ann Intern Med 2002;137:305 –312 After 11 to 16 years of follow-up, four or five annual screenings with mammography, breast physical examination, and breast self-examination had not reduced breast cancer mortality compared with usual community care after a single breast physical examination and instruction on breast self-examination. The study data show that true effects of 20% or greater are unlikely.
Controversy will persist because other studies suggest that screening causes small reductions in breast cancer mortality.The Editors
(32) Journal of the National Cancer Institute, Vol. 94, No. 20, 1546-1554, October 16, 2002
Detection of Ductal Carcinoma In Situ in Women Undergoing Screening Mammography Virginia L. Ernster
Results: A total of 3266 cases of breast cancer were identified, 591 DCIS and 2675 invasive breast cancer. The percentage of screen-detected breast cancers that were DCIS decreased with age (from 28.2% [95% confidence interval (CI) = 23.9% to 32.5%] for women aged 40 to 49 years to 16.0% [95% CI = 13.3% to 18.7%] for women aged 70 to 84 years).
However, the rate of screen-detected DCIS cases per 1000 mammograms increased with age (from 0.56 [95% CI = 0.41 to 0.70] for women aged 40 to 49 years to 1.07 [95% CI = 0.87 to 1.27] for women aged 70 to 84 years). Sensitivity of screening mammography in all age groups combined was higher for detecting DCIS (86.0% [95% CI = 83.2% to 88.8%]) than it was for detecting invasive breast cancer (75.1% [95% CI = 73.5% to 76.8%]).
Conclusions: Overall, approximately 1 in every 1300 screening mammography examinations leads to a diagnosis of DCIS. Given uncertainty about the natural history of DCIS, the clinical significance of screen-detected DCIS needs further investigation.
(33) Ductal Carcinoma In Situ of the Breast Elisabeth L. Dupont, MD; Ni Ni K. Ku, MD; Christa McCann, BA; and Charles E. Cox, MD, FACS
DCIS, 60% of DCIS cases are discovered solely by mammography Seven major autopsy studies of women not known to have had breast cancer have provided insight. Six studies found an incidence of 4% to 18%.7 The seventh and largest study showed a 0.2% incidence (1 in 519 cases).
However, this study included a significant proportion of groups known to have a smaller than usual risk of breast cancer. Of the more than 1,000 cases comprising these seven studies, only one case of invasive cancer was detected. Further analysis with fixed criteria is needed. (DCIS) this type of cancer now accounts for nearly half of mammographically detected cases of cancer.
(34) STATEMENT of Leonard Berlin, M.D. To the U.S. Senate Committee on Health, Education Labor and Pensions Re: Mammography Quality Standards Act Reauthorization April 8, 2003.
Leonard Berlin: Suffice it to say that research studies performed at some of the most prestigious medical institutions in the United States reveal that as many as 90% of lung cancers, and 70% of breast cancers, can at least partially be observed on previous studies read as normal.
(35) A Manifesto for Truth-in-Mammography Advertising by Leonard Berlin MD Imaging Economics, November 2004
From cigarettes to pharmaceuticals to financial services, all advertisements feature a disclaimer: Why not those for mammography?
Of all medical malpractice lawsuits filed in the United States that allege a delay in the diagnosis of breast cancer, radiologists are the most frequently sued specialists. Of all medical malpractice lawsuits lodged against radiologists, the most frequent cause is the allegation of a missed breast cancer on mammography. Why has "missed breast cancer" risen to first place in the medical malpractice standings? I suggest that it is because we have oversold mammography. We have marketed mammography without informing the American public all that we know about not only the benefits, but more important the limitations and potential harms of mammography.
(36) Mammography Books
(37) AJR 2001; 176:1123-1130
Perspective Dot Size, Lead Time, Fallibility, and Impact on Survival
Continuing Controversies in Mammography
Leonard Berlin
mammography had become the most prevalent procedure involved in malpractice lawsuits filed against radiologists, and that the allegation of an error in the diagnosis of breast cancer had become the most prevalent condition precipitating medical malpractice lawsuits against all physicians.
An article published in the ACR (American College of Radiology) Bulletin pointed out that 30-70% of breast cancers detected at followup mammography are visible in retrospect on initial mammograms that had been interpreted as showing normal findings
The debate as to whether screening mammography saves lives and lengthens survival rages on and will certainly not be resolved in the foreseeable future .
This article is not intended to be a comprehensive review of all available data on the subject of mammographic efficacy. Even if it were, no definitive answer to the question of whether mammography does indeed reduce mortality from breast cancer would be found.
(38) Journal of the National Cancer Institute, Vol. 92, No. 18, 1490-1499, September 20, 2000 Canadian National Breast Screening Study-2: 13-Year Results of a Randomized Trial in Women Aged 50 to 59 Years Anthony B. Miller, Teresa To, Cornelia J. Baines, Claus Wall, For the Canadian National Breast Screening Study-2
Results: Randomization achieved virtually equal distribution of demographic and breast cancer risk variables. At the first annual screen, 21% of the cancers found by mammography alone (in the mammography plus physical examination group) were 20 mm or more in size compared with 46% of those found by physical examination in the mammography plus physical examination group and 56% in the physical examination-only group. The corresponding percentages for screens were 10%, 42%, and 50%, respectively.
Screening detected 267 invasive breast cancers in the mammography plus physical examination group compared with 148 in the physical examination-only group. By December 31, 1993, 622 invasive and 71 in situ breast carcinomas were ascertained in the mammography plus physical examination group, and 610 and 16 were ascertained in the physical examination-only group.
At 13-year follow-up, with 107 and 105 deaths from breast cancer in the respective groups
Conclusion: In women aged 50 to 59 years, the addition of annual mammography screening to physical examination has no impact on breast cancer mortality.
(39) Pink Ribbon Madness: Say No to Breast Cancer Exploitation for Corporate Profit
(40) article critical of mammographhy
(41) Dangers and Unreliability of Mammography: Breast Examination is a Safe, Effective, and Practical Alternative Samuel S. Epstein, Rosalie Bertell, and Barbara Seaman International Journal of Health Services, 31(3):605-615, 2001.
(42) AJR 2001; 176:1131-1134 Malpractice Issues in Radiology
The Missed Breast Cancer Redux Time for Educating the Public About the Limitations of Mammography? Leonard Berlin
(43) Cancer, Inc - National Breast Cancer - Awareness Month Sierra, Sept, 1999 by Sharon Batt, Liza Gross
THEY MAKE THE CHEMICALS, THEY RUN THE TREATMENT CENTERS, AND THEY'RE STILL LOOKING FOR "THE CURE"--NO WONDER THEY WON'T TELL YOU ABOUT BREAST CANCER PREVENTION Astra Zeneca Sam Epstein
(44) National Breast cancer Coalition, Position Statement on Screening Mammography Updated May 2007
Excellent review of all studies up to May 2007. Overall, mammography screening has a modest effect on breast cancer mortality. When analyzed in absolute terms, the death rate is reduced by just 0.05%.
(45) Dr. Nortin Hadler is professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, and an attending rheumatologist at University of North Carolina Hospitals.
Does Screening Mammography Save Lives?
Numbers May Not Justify Practice for Routine Mammograms
OPINION By NORTIN HADLER. M.D.
In the United States, radiologists are so hesitant to read a mammogram as "normal" that false positive rates can reach 80 percent. This hedging on the readings is driven by the fact that "missing a breast cancer" on mammography is the most frequent reason for malpractice litigation in the United States.
But screening mammography is so terribly blunt that it approaches useless: It finds very few cancers that are truly treatable, it misses many of these and it is awash in false positives.
Norway, Sweden, Australia and the United Kingdom are re-examining their national experience with screening mammography because of appraisals similar to mine.
If a woman's life was saved because of early detection of an evil breast cancer, she should thank her lucky stars rather than her mammographer. I would relegate mammograms to the archives of false starts, next to radical mastectomy
(46) After 40 Years, Mammography Remains as Much Emotion as Science Judith Randal
Journal of the National Cancer Institute, Vol. 92, No. 20, 1630-1632, October 18, 2000
For the better part of a century, it would have been unthinkable to treat primary breast cancer with anything but the operation pioneered in the 1890s by William Halsted, M.D., one of the most prominent surgeons of his day. Beginning in the 1970s, the Halsted era drew gradually to a close when randomized controlled trials found that the operation generally known as radical mastectomy was no more effective than less drastic surgery (sometimes in combination with radiation). Could a similar fate await the current gold-standard status of screening mammography? Will a time come when its popularity dwindles, too?
mammography now a $4 billion a year industry in the United States alone
Absent unforeseen developments, it is probably safe to predict that mammography for screening will continue to be as much about strongly held opinions and political pressures as about science.
(47) Good News and Bad News About Breast Cancer by David Plotkin M.D. The Atlantic Monthly
Breast cancer is a major public-health concern; it kills 0.04 percent of all American women yearly.
Most of the time the news is reassuring; two thirds to four fifths of all biopsies reveal that the abnormality is not malignant. (Women in their forties are more likely than older women to have negative biopsies, because mammograms of their naturally lumpier breasts are harder to interpret.)
An official nationwide mammography program would be a huge commitment: 51.5 million American women are aged forty or above. And one must bear in mind the cost of needless medical procedures generated by the huge number of false-positive mammograms—two to four false positives for every true positive, according to some measures.
On balance, then, I reluctantly support the status quo. When my patients come in for their mammograms, I do not try to dissuade them. But I tell them that the most optimistic interpretation of the available evidence suggests that routine mammography has only a marginal effect on a woman's chances of surviving breast cancer—and that it may have no effect at all.
(48) Journal of Clinical Oncology, Vol 21, Issue 1 (January), 2003: 41-45
High Prevalence of Premalignant Lesions in Prophylactically Removed Breasts From Women at Hereditary Risk for Breast Cancer
N. Hoogerbrugge, P. Bult, L.M. de Widt-Levert, L.V. Beex, L.A. Kiemeney, M.J.L. Ligtenberg, L.F. Massuger, C. Boetes, P. Manders, H.G. Brunner
Full text
The fact that an occult carcinoma was present in only one of 67 patients in our study might indicate that surveillance is as effective as prophylactic mastectomy. However, in our study, all 10 DCIS cases were missed by surveillance, and it was recently shown by Meijers-Heijboer that surveillance is less effective than prophylactic mastectomy in preventing breast cancer deaths.
(49) Mammographic Screening for Breast Cancer Suzanne W. Fletcher, M.D., and Joann G. Elmore, M.D., M.P.H. NEJM Volume 348:1672-1680 April 24, 2003 Number 17
(50) POINT COUNTERPOINT On the efficacy of screening for breast cancer David A Freedman,1 Diana B Petitti,2 and James M Robins International Journal of Epidemiology 2004;33:4355
(51) International Journal of Epidemiology 2004;33:6973
Rejoinder David A Freedman, Diana B Petitti and James M Robins REJOINDER
(52) Screening for Breast Cancer. Joann G. Elmore, MD, MPH; Katrina Armstrong, MD; Constance D. Lehman, MD, PhD; Suzanne W. Fletcher, MD, MSc JAMA. 2005;293:1245-1256.
All major US medical organizations recommend screening mammography for women aged 40 years and older. Screening mammography reduces breast cancer mortality by about 20% to 35% in women aged 50 to 69 years and slightly less in women aged 40 to 49 years at 14 years of follow-up.
Approximately 95% of women with abnormalities on screening mammograms do not have breast cancer with variability based on such factors as age of the woman and assessment category assigned by the radiologist. Studies comparing full-field digital mammography to screen film have not shown statistically significant differences in cancer detection while the impact on recall rates (percentage of screening mammograms considered to have positive results) was unclear.
(53) Cancer Epidemiology Biomarkers & Prevention Vol. 13, 501-510, April 2004
Fear, Anxiety, Worry, and Breast Cancer Screening Behavior: A Critical Review Nathan S. Consedine, Carol Magai, Yulia S. Krivoshekova, Lynn Ryzewicz and Alfred . Neugut3
Women's fears surrounding breast cancer seem to encompass nearly "everything" but certainly include fear of a breast cancer diagnosis, fear of pain/discomfort, and more complicating, fear of embarrassment. To this list, we can add fear of the medical establishment, radiation, nonspecific "cancer worry" general anxiety, or phobia .
(54)
Cancer: When it isn’t a killer DCIS: Precancer, benign cancer or what? What Doctors Don't Tell You (Volume 13, Issue 10)
The cancer establishment was recently rocked to its core when Professor Michael Baum, an eminent and well-respected breast surgeon and researcher, claimed that screening for breast cancer should be scrapped because it caused hundreds of healthy women to undergo risky, mutilating and unnecessary treatments even when they may never develop the disease. His comments, made at a meeting of the Royal Society of Medicine, cut even more deeply because Baum was one of the physicians who helped set up the 50-million-a-year breast-screening service (Frith M, Scrap Breast Cancer Screening, Evening Standard, 10 December 2002, p 1).
Baum has stated publicly that the most dramatic consequence of the rise in the numbers of routine mammographies has been a huge increase in the incidence of small, well-contained, relatively benign breast cancers known as ductal carcinoma in situ (DCIS) (BMJ Rapid Responses at bmj.com/cgi/eletters/325/ 7361/418#24945, 24 August 2002).
(55) Michael Baum, Emeritus Prof. of Surgery University College London The Portland Hospital, 212-214 Great Portland Street, London W1W 5QN Re: Screening and Mastectomy rates
(56)
'Scrap breast cancer screening' By Maxine Frith, Health Correspondent, Evening Standard 10.12.02
The man who helped to set up the NHS breast screening programme claims today that it does more harm than good.
Professor Michael Baum, a leading expert in the field, said that screening for the disease causes hundreds of healthy women to have risky, mutilating and unnecessary treatments even when they may never develop the disease.
Fifteen years after he established one of the first screening centres in the UK, Professor Baum has now called for the £50million a year service to be shut. He believes the techniques used for screening are not accurate enough and lead to too many false alarms.
Professor Baum, who is to address the Royal Society of Medicine in London today, has been a long-standing critic of screening but has never before gone so far as to say it should be scrapped entirely,
He is one of the most eminent breast surgeons in the country and a respected researcher into the disease. His comments have sparked a furious row among experts over the benefits of the NHS breast screening programme
(57) Breast screen 'wrong care' fears, Breast screening may produce false positives. Concerns have been raised that breast cancer screening might lead to some women undergoing unnecessary treatment. Researchers looked at international studies on half a million women. They found that for every 2,000 women screened over a decade, one will have her life prolonged, but 10 will have to undergo unnecessary treatment. UK experts said women over 50 should go for their breast checks, but a screening pioneer raised doubts about the NHS programme's future. The report, published in the Cochrane Library, involved a review of breast cancer research papers from around the world.
(58) Doubts raised by the pioneer of screening By Nic Fleming, Medical Correspondent
18/10/2006
(59) Screening for breast cancer with mammography. Gotzsche PC, Nielsen M Cochrane Reviews
Main results: Seven completed and eligible trials involving half a million women were identified. We excluded a biased trial from analysis.
Two (Canada and Malmo)trials with adequate randomisation did not show a significant reduction in breast cancer mortality, relative risk (RR) 0.93 (95% confidence interval 0.80 to 1.09) at 13 years; four trials with suboptimal randomisation showed a significant reduction in breast cancer mortality, RR 0.75 (0.67 to 0.83) (P = 0.02 for difference between the two estimates). RR for all six trials combined was 0.80 (0.73 to 0.88).
The two trials with adequate randomisation did not find an effect of screening on cancer mortality, including breast cancer, RR 1.02 (0.95 to 1.10) after 10 years, or on all-cause mortality, RR 1.00 (0.96 to 1.04) after 13 years. We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death.
Numbers of lumpectomies and mastectomies were significantly larger in the screened groups, RR 1.31 (1.22 to 1.42) for the two adequately randomised trials; the use of radiotherapy was similarly increased.
Authors' conclusions: Screening likely reduces breast cancer mortality. Based on all trials, the reduction is 20%, but as the effect is lower in the highest quality trials, a more reasonable estimate is a 15% relative risk reduction. Based on the risk level of women in these trials, the absolute risk reduction was 0.05%. Screening also leads to overdiagnosis and overtreatment, with an estimated 30% increase, or an absolute risk increase of 0.5%.
This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm. Women invited to screening should be fully informed of both benefits and harms.
(60)
Should We Offer Routine Breast Cancer Screening with Mammography? SEAN P. DAVID, M.D., S.M., Brown Medical School, Pawtucket, Rhode Island July 15 2003
(61) Screening for breast cancer with mammography Gøtzsche PC, Nielsen M cochrane collaboration 2006 full text pdf
(62)
BMJ 2001;323:956 (27 October)
Row over breast cancer screening shows that scientists bring "some subjectivity into their work Susan Mayor, London
The review claimed that there was no reliable evidence to support the value of mammo-graphy screening in reducing deaths from breast cancer and alleged an association with increased rates of breast surgery.
Ole Olson and Peter Gotsche from the Nordic Cochrane Centre, Righospitalet, Copenhagen, Denmark, reassessed as part of a Cochrane review a meta-analysis of seven randomised trials of screening mammography which they had previously carried out. This confirmed their original conclusion, they said, that there was no evidence of a reduction in either total or breast cancer mortality in two of the trials that they considered to be of sufficient quality to analyse.
They added: "We have also confirmed that screening leads to more aggressive treatment, increasing the number of mastectomies by about 20% and the number of mastectomies and tumourectomies by about 30%" (Lancet 2001;358:1340-2 ).
(63) BMJ 2002;324:677 ( 16 March ) Hazel Thornton, independent advocate for quality in research and healthcare. Letters Breast screening seems driven by belief rather than evidence.
(64) BMJ 2001;323:1131 ( 10 November ) Letters. Office of NHS cancer screening programme misrepresents Nordic work in breast screening row Peter C Gotzsche, director. Nordic Cochrane Centre, Rigshospitalet, DK-2100 Copenhagen ø,
(65) List of articles in Lancet on Screening Mammography
(66) Professor of Radiology Course Director L�zlo� Tab�r, M.D. Professor of Radiology Course Director 2007 BREAST SEMINAR SERIES Covering the world of breast diagnosis
(67) Screening mammogram studies Swedish Study by Dr. Laszlo Tabar (1977-
1984) Population-based randomized controlled study
31% reduction in breast cancer mortality in women 50 plus
(68) National Breast Cancer Coalition (NBCC) The Mammography Screening Controversy:Questions and Answers February 8, 2002
(69) www.stopbreastcancer.org National Breast Cancer Coalition 1707 L Street, NW, Suite 1060 Washington, D.C. 20036 (202) 296-7477 voice (202) 265-6854 fax
Position Statement on Screening Mammography Updated May 2007
Xeromammography is not quackery done by quacks says John Wolfe MD, author of Xeromamogram interpretation. Film screen mammography replaced it shortly there-after.
Womens perception of the benefits of mammography screening: population based survey in four countries. Domenighetti G, DAvanzo B, Egger M, et al.Int J Epidemiol 2003; 32:816 821.
Enthusiasm for cancer screening in the United States. JAMA 2004; 291: 7178. Schwartz LM, Woloshin S, Fowler FJ Jr, Welch HG
Bartow SA, Pathak DR, Black WC, et al. Prevalence of benign atypical, and malignant breast lesions in populations at different risk for breast cancer: a forensic autopsy study. Cancer. 1987;60:2751-2760.
Ringberg A, Palmer B, Linell F, et al: Bilateral and multifocal breast carcinoma: A clinical and autopsy study with special emphasis on carcinoma-in-situ. Eur J Surg Cancer 17:2029, 1991
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Dach J, Patel N, Patel S, Petasnick J. Peritoneal mesothelioma: CT, sonography, and gallium-67 scan. AJR Am J Roentgenol. 1980 Sep;135(3):614
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