Dr. Handel Reynolds
Handel E. Reynolds, MD, FACR, is a breast radiologist at the Doris Shaheen Breast Health Center at Piedmont Hospital in Atlanta, Georgia.
Dr. Reynolds wrote The Big Squeeze for the millions of women who face the decision about whether to get a mammogram, for health professionals interested in the latest guidelines for cancer screening, and for public health policy makers who must balance the findings of current scientific research with the public perception of mammography as it is currently promoted in aggressive marketing campaigns.
With a deep awareness of the confusion that surrounds the uses of mammography, Dr. Reynolds revisits the pivotal decisions made during mammography’s initial launch that made it all but inevitable that the test would be contentious. He describes how, at several key points in its history, the establishment of mammography screening as a fundamental aspect of women’s preventative health care coincided with social and political developments, from the Women’s Health Movement in the early 1970s to breast cancer activism in the 1980s and ’90s.
Prior to joining Piedmont Hospital in 2002, he spent more than a decade in academic practice at Indiana University School of Medicine where he held the titles of Associate Professor of Radiology and Chief of Breast Radiology. Dr. Reynolds has made significant contributions to the field of Breast Radiology having presented over 50 lectures and workshops at national and international conferences. He has published more than 30 peer-reviewed articles in scientific journals and co-authored 3 book chapters. He is a Fellow of the American College of Radiology, a Fellow of the Society of Breast Imaging and a member of numerous other medical professional organizations.Click to print a PDF of Dr. Reynolds' biography
A Conversation with Handel Reynolds, MDClick to print a PDF of A Conversation with Handel Reynolds, MD
You are a radiologist who specializes in mammography, yet you have written a book that, some might say, is critical of mammography. Why did you choose to write this book?
The Big Squeeze is meant to be a balanced assessment of our 40-year effort to defeat breast cancer using mammography. Throughout its history, mammography has been promoted as a “magic bullet” of sorts; the single best thing a woman can do to protect herself from breast cancer. The main goal of mammography campaigns has been to increase utilization by promoting one simple, optimistic message: mammography may save your life; therefore, you should just do it.
The promotion of mammography has largely focused on highlighting its benefits, yet there are benefits and risks associated with all cancer screenings, including mammography.
However, screening for cancer is almost never such a straightforward proposition. There are always potential risks, or harms, involved. Risks of false positives, where additional testing and biopsies are done for findings that ultimately turn out to be non-cancerous and overdiagnosis, or the identification of cancers that would not otherwise have come to light in the patient’s lifetime, are inherent in all cancer screening tests, including mammography.
Thus, although I firmly believe that all women over forty should have access to mammography and should consider being screened, I believe the strategy of increasing utilization by promoting simple, but incomplete messages, is flawed. I believe the goal of the mammography community should be patient/consumer education. Women should be informed of the benefits and the risks of mammography and helped to make an informed decision. Some will choose to begin screening at forty, others may choose to wait until they are fifty, and still others may choose not to be screened at all.
Describe the process by which mammography went from being a “diagnostic test,” used on women who had suspicious findings on physical examination, to a “screening test,” advocated for all women.
Mammography was first used in a clinical setting in the 1930s. Its initial use was in the evaluation of women with suspicious findings on physical examination. In those early days, there were many technical challenges in obtaining high quality images. For this reason, mammography failed to achieve broad acceptance and it was performed only in a few institutions.
Two important events occurred in the early 1960s. First, a radiologist by the name of Robert Egan, who was in training at MD Anderson Cancer Center in Houston, developed a reliable and easily reproducible method for achieving high quality mammograms. The second was the publication of a study by a Philadelphia radiologist named Jacob Gershon-Cohen. Over a 5 year period, he had performed mammography and physical examination, every six months, on 1300 healthy women. During the course of his study, twenty-three cancers, six of which could not be felt on physical examination were found. This was one of the first demonstrations that mammography could find breast cancer that was not apparent on physical examination. Later that decade, a large scientific trial of the effectiveness of mammography as a screening test was undertaken. When the results were in, the HIP Trial, as it was known, showed that screened women 50-59 reduced their risk of dying of breast cancer by 40% compared to unscreened women.
Mammography’s gradual transformation from a test for women with suspected breast cancer to a test for healthy women culminated in the Breast Cancer Detection Demonstration Project (BCDDP). This was a massive program jointly sponsored by the American Cancer Society and the National Cancer Institute. In it, 280,000 healthy women were recruited to undergo annual screening with mammography and physical examination at 27 centers across the country. The program ran from 1973 to 1978 and was the first large-scale use of mammography as a screening test in the United States. In the years immediately following the conclusion of the BCDDP, mammography began to be aggressively promoted by means of public health campaigns and by screening guidelines promulgated by a variety of organizations.
When new guidelines were introduced in 2009 that raised the recommended age for initial mammogram screening from forty to fifty, there were some groups that believed that the decision was a cost-saving measure rather than a decision based on the best interests of women.
In the United States, mammography has never been far from controversy. On the other hand, the test has had a far more placid existence in other developed countries. This, I believe, is due to the fact that in most other countries fifty is the accepted age at which women should begin undergoing mammography. In the United States, there has never been any long-lasting consensus on the question of when women should begin screening. The issue of whether women should begin screening at forty versus fifty has been at the heart of every major mammography debate since 1976, three years after the beginning of widespread screening in the United States.
When new guidelines raised the recommended
age for initial mammogram screening from
forty to fifty, some believed it was a cost-saving measure rather than a decision based on the best interests of women.
Changes in mammography guidelines have collided with federal healthcare reform efforts on two occasions in the recent past. In both cases, the result was a particularly vitriolic public feud. In 1993, after the publication of a new mammography study from Canada that showed no benefit from mammography for women under fifty, the National Cancer Institute (NCI) dropped its previous recommendation for screening in this age group. President Bill Clinton's Health Security Act was at that time being considered in Congress. The fact that the proposed legislation only required insurance coverage for mammography in women over fifty made it “obvious” to the President's political opponents and mammography's defenders that the change at the NCI was politically motivated, designed to help bolster Health Security Act's prospects.
In 2009, in the midst of Congress' deliberations on the Obama Administration's Affordable Care Act, the US Preventive Services Task Force (USPSTF) an independent panel of government scientists dropped its seven year old recommendation for mammography in women under fifty. Predictably, opponents of the legislation as well as mammography's backers denounced the decision as a clear example of healthcare rationing by the federal government. The Affordable Care Act required insurance coverage for preventive services that received an “A” or “B” USPSTF rating and mammography in women under fifty had been given a “C” rating. In the end, the Administration chose simply to ignore the recommendation of its own expert panel. The Affordable Care Act made the former (2002) USPSTF guidelines (grade “B” recommending for screening women under fifty) the binding standard. The “new” (2009) guidelines were, in essence, given an early retirement.
Are there other examples of the influence of politics in the setting of mammography policy?
The most blatant example of political interference in the scientific process related to mammography guidelines occurred in 1997. Four years earlier, in a very controversial move, the National Cancer Institute (NCI) had dropped its recommendation for mammography in women under fifty. Congressional lawmakers tried unsuccessfully to force the NCI to reverse its decision and renew its support for screening younger women. In 1996 NCI director Richard Klausner attended a breast cancer conference in Sweden where some new research that seemed to suggest that mammography was beneficial to women under fifty was presented. When he returned to Washington, he announced plans for an NCI Consensus Development Conference. In this format, an independent panel of experts weighs the evidence for or against the question at hand and tries to arrive at a consensus. At the end of the 3-day gathering in January 1997, the panel announced that current data did not warrant a universal recommendation for screening women in their forties and that women should decide for themselves whether to undergo mammography.
Shortly thereafter, Sen. Arlen Spector of Pa, chair of the senate subcommittee overseeing NCI funding, announced that his committee would be holding hearings on the matter. In his opening statement, Spector conceded that his mind was already made up and that he firmly believed that the NCI should reinstate its pre-1993 guideline. In fact, he expressed confidence that when it was all said and done, the matter would be resolved to his satisfaction. Unsurprisingly then, about one month after the hearings the NCI announced that the pre-1993 guidelines advocating screening for women under fifty would be reinstated.
This incident is important because it (a) firmly established the primacy of politics over science in the mammography debate and (b) it defined, for the first time, a federal government position on the question of mammography in younger women. Furthermore, it is because of this precedent that the Obama Administration, 12 years later, was able to so swiftly dispense with the politically untenable guidelines proposed by another panel of government scientists.
What are the risks or harms associated with mammography?
Mammography promotion efforts over the past forty years have largely focused on highlighting its benefits. While mammography has been proven to reduce a woman's risk of dying of breast cancer, its effects are not wholly salutary. There are benefits and risks associated with all cancer screening, including mammography. The main risks of mammography include false positive and false negative readings, overdiagnosis, procedure discomfort and radiation-induced cancer.
A false positive mammogram is one where a red flag is raised over an abnormality that is ultimately found to be non-cancerous. False positive readings are significant because patients undergo additional testing, such as additional mammogram views and biopsy, in order to resolve the questionable abnormality. A woman who undergoes annual mammography from age forty to fifty has a 61% likelihood of a false positive mammogram. A false negative mammogram is one where the mammogram fails to disclose a cancer that is actually present. Mammography may miss up to 15% of cancers. This rate is much higher for women who have dense breast tissue.
Overdiagnosis refers to the identification of cancers that, in the absence of screening, would not have become evident in the individual's lifetime. The precise rate of mammography-induced overdiagnosis is unknown but some studies suggest it may be substantial. Breast cancer caused by the low dose of radiation used for the procedure has never been directly observed but is a theoretical possibility. It has been estimated that in a group of 100,000 women undergoing mammography between ages forty and seventy-four, there may be eleven deaths due to mammography-induced breast cancer. At the same time, mammography would save the lives of about five hundred of these women who develop naturally occurring breast cancer. Finally, most women consider mammography to be an uncomfortable or even painful procedure. However, this physical discomfort is rarely a barrier to future screening.
In the book you talk about overdiagnosis of DCIS. What is DCIS and why do you say it is being over diagnosed?
DCIS or ductal carcinoma in situ is regarded as the earliest stage (stage 0) of breast cancer. It is the point in the disease's evolution when the cancer cells are entirely confined to the milk duct of origin. Typically, it does not cause a lump or any other sign or symptom. Thus, prior to widespread mammography, DCIS only accounted for 1-2% of all breast cancers. Currently, it accounts for up to 25% of all new cases of breast cancer. There are 50-60,000 new cases of DCIS every year in the United States.
The reason for this dramatic increase in DCIS is simple. The condition is frequently associated with tiny crystals of calcium, referred to as microcalcifications. These microcalcifications are easily identified on mammography. DCIS poses a significant dilemma in that not all cases would progress to the next stage, known as invasive (or infiltrating) breast cancer. DCIS that never progresses is non-lethal because it remains confined to the milk duct system. While the rate of progression is not precisely known, it is believed that no more than one-third to one-half of cases would progress in the absence of treatment. In this regard, a substantial fraction of DCIS cases represent overdiagnosis, that is, disease that would not have become evident in the individual's lifetime, absent screening. Because there is currently no reliable method to predict which cases will and which will not progress, almost all patients with DCIS undergo treatment, either lumpectomy followed by radiation therapy or mastectomy. There is also an increasing trend for patients with DCIS to opt for removal of both breasts.
What can be done about this problem?
Screening for breast cancer with mammography will inevitably result in the identification of large numbers of DCIS cases. Clearly more research needs to be done to help physicians discriminate between “trivial” DCIS cases: ones that are not likely to progress and the potentially more dangerous varieties that are likely to progress to potentially lethal invasive breast cancer. This information may allow the institution of “watchful waiting” strategies, as opposed to aggressive treatment, for patients with the less dangerous forms. Radiologists also need to reevaluate their current approach to microcalcifications. Currently, radiologists are encouraged to assiduously seek out and biopsy all but the most benign-looking forms. A reduced emphasis on biopsy and an increased use of close follow-up in the management of microcalcifications could potentially go a long way in reducing the burden of DCIS overdiagnosis. Finally, the condition may need to be renamed something other than “carcinoma” in order to better convey our lack of certainty about the biological potential of this condition.
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