It’s tempting to cast the role of women in STEM (Science, Technology, Engineering, and Math) as one of struggles and battles because of their sex, rather than as one of contributions because of their minds. But for Women’s History Month and this Diversity in Science Carnival #14, our focus is the role of women in the enterprise of STEM. There’s more to a woman than her sex and her struggles in science–there is, after all, the enormous body of work women have contributed to science.
Our history is ongoing, but we can start with a look back. Thanks to the efforts of the Smithsonian Institution Archives, we can put faces to the names of some of the female STEMmers of history. In a presentation of photographs in an 8 by 9 space, we can see the images of 72 women who contributed to the enterprise of STEM, many of them involved with the Smithsonian in some capacity. As their clothes and the dates on the photos tell us, these women were doing their work in a time when most women didn’t even wear pants.
Some are Big Names–you’ve probably heard of Marie Curie. But others are like many of us, women working in the trenches of science, contributing to the enterprise of STEM in ways big and small. Women like Arlene Frances Fung, whose bio tells us she was born in Trinidad, went to medical school in Ireland, and by 1968 was engaged in chromosome research at a cancer institute in Philadelphia. From Trinidad to cancer research, her story is one of the millions we could tell about women’s historical contributions to science, if only we could find them all. But here there are 72, and we encourage you to click on each image, look at their direct gazes, ponder how their interest in science and knowledge trumped the heavy pressures of social mores, and discover the contributions these 72 women made, each on her own “little two inches wide of ivory.”
For more on historical and current women in science, you can also see Double X Science’s “Notable Women in Science” series, curated by Adrienne Roehrich.
And then there are the women STEMmers of today, who likely are, according to blogger Emma Leedham writing at her blog Pipettes and Paintbrushes, still underpaid. Leedham also mulls here what constitutes a role model for women–does it require being both a woman and a scientist, or one or the other?
Laurel L. James
Laurel L. James, writing at the University of Washington blog for the school’s SACNAS student chapter, answers with her post, “To identify my role as a woman in science: I must first honor my mother, my family and my past.” Her mother was the first “Miss Indian America,” and Laurel is a self-described non-traditional student at the school, where she is a graduate student in forest resources. She traces her journey to science, one that involved role models who were not scientists but who, as she writes, showed her “how to hang onto the things that are important with the expectation of getting something in return all the while, persevering and knowing who you are; while walking with grace and dignity.” I’d hazard that these words describe many a woman who has moved against the currents of her society to contribute something to the sciences.
A great site, Steminist.com, which features the “voices of women in science, tech, engineering, and math,” runs a series of interviews with modern-day STEMmers, including Double X Science’s own Jeanne Garbarino, and Naadiya Moosajee, an engineer and cofounder of South African Women in Engineering. You can follow Naadiya on Twitter here. Steminist is also running their version of March Madness, except that in honor of Women’s History Month, we can choose “Which historical women in STEM rock (our) world.” The 64 historical STEMinists in the tourney are listed here and include Emily Warren Robling (left), who took over completion of the Brooklyn Bridge when her husband’s health prevented his doing so; she is known as the first woman field engineer. Double X Science also has a series about today’s women in science, Double Xpression, which you can find here.
Today, you can find a woman–or many women–in STEM just about anywhere you look, whether it is as a government scientist at NOAA like Melanie Harrison, PhD, or at NASA. It hasn’t always been that way, and it can still be better. But women have always been a presence in STEM. In the 18thand 19th centuries, astronomer Caroline Herschellabored away through the dark hours of just about every night of her adult life, tracking the night sky. Today, women continue these labors, and STEM wouldn’t be what it is today without women like Herschel willing to stay up all night with the skies or spend days on end in the field or lean over a microscope for hours just to add a tiny bit more to what we know about our world and our universe.
For women in science, we’re there–at night, in the lab, in the field–because we love science. But as the non-science role models seem to tell us, we stick to it–and can stick with it–because we had role models in and out of science who showed us that regardless of our goals, our attitudes and willingness to move forward in spite of obstacles are really what drive us to success in STEM careers. Among the links I received for this carnival was one to Science Club for Girls, which is sponsoring a “Letter to My Young Self” roundup for Women’s History Month. The letters I’ve read invariably have that “stick with it” message, but one stood out for me, and I close with a quote from it.
It’s a letter by Chitra Thakur-Mahadik, who earned her PhD in biochemistry and hemoglobinopathy from the University of Mumbai and served as staff scientist a Mumbai children’s hospital for 25 years. She wrote to her younger, “partially sighted” self that, “The future is ahead and it is not bad!” She goes on to say, “Be fearless but be compassionate to yourself and others… be brave, keep your eyes and ears open and face the world happily. What if there are limitations? Work through them with awareness. —Yours, Chitra”
Links and resources for women in STEM, courtesy of D.N. Lee
Stay tuned for the April Diversity in Science Carnival #15: Confronting the Imposter Syndrome. This topic promises to resonate for many groups in science. I’m pretty sure we’ve all felt at least of twinge of imposter syndrome at some point in our education and careers. Your editor for this carnival will be the inimitable Scicurious, who blogs at Scientific American and Scientopia.
UPDATE: Carnival #15 is now available! Go read about imposter syndrome, why it happens, who has it, and what you can do about it.
It is no mystery that there are few women who work in the construction industry. For years the sector has been overwhelmingly male dominated, with women making only 9.6% of the construction industry workforce. The industry, while remaining male dominated, has been increasingly facing a crisis due to the lack of available qualified workers. As the demand for labor surpasses the supply, construction companies expand their recruitment efforts, including a formerly untapped labor source, women. Construction jobs allow for upward mobility directly linked to years of experience and ability to do the work well, making it a desirable career choice for many. However, while sex discrimination is illegal, many construction sites have anti-women attitudes, making construction jobs less desirable and/or torturous for women.
The United States Department of Labor Advisory Committee on Construction Safety and Health reported in 1999 that 88% of women construction workers surveyed had experienced sexual harassment at work. I searched high and low for more current data, but no extensive study has been done since then. Most recent information I found would just claim that things are “getting better” for women in construction, and while I don’t deny that there are more women in construction fields, I am not convinced that sexual harassment and bullying is a thing of the past. Progress is great, but a hostile environment affects a person’s ability to do their job correctly. I know first hand because it happened to me.
I studied Civil Engineering, and most Engineering students know that in order to improve one’s chances of getting hired when you graduate you should have at least one internship or apprenticeship during your undergraduate studies. Internships give you some real life experiences that are just impossible to get from a classroom. During my sophomore year of Engineering school I applied and was hired for an internship as a Construction Manager Assistant for a major construction management company in New York City. My work consisted of being in a construction site and maintaining the project schedule by monitoring project progress, coordinating activities among the different trades, and resolving problems. The finished product was to be a high-rise residential building overlooking Central Park. To this day I am grateful for all that I learned while in a construction site. That experience has helped me along in my professional career in more ways than I can imagine, from dealing with a team, to learning how to schedule major projects. However, being one female out of a total of about 10 women in a site with hundreds of men, was quite alienating and frustrating, at times.
The first day of my internship I arrived with three other interns, two young men and one other female. After being briefed on job site safety we were asked to visit the project’s head foreman, who called in two of his construction managers who would become our mentors. The first manager that arrived looked at all of us and immediately stated “I’ll take the two boys” and feeling a need to apologize, looked at me and the other female intern and said “sorry ladies, I don’t deal with women on this job.” Shortly after another manager arrived, upon seeing us two waiting he said “arethese the interns? I was expecting a couple of guys.” Since we were all that was left he had no choice. He led us to a Field Engineer, a recent college graduate and the only other woman on site that day, and told her to “take care of us.” Apparently, he could not be bothered with being our mentor.
Throughout the summer the two male interns were given jobs overseeing major tasks relating to mechanical equipment, electrical work, and concrete pouring, while the other female intern and I were asked to check if the finished apartments were painted, the marble was installed in the bathrooms, and the light fixtures were properly centered. It was easy to see that as females, we were given the tasks that required the least amount of effort and intelligence. After all, who goes to Engineering school to learn how to watch paint dry? It was aggravating to be doing such boring work; we wanted to be involved in actual construction tasks so as to truly learn engineering techniques applied in the field. After a few weeks of unsuccessfully trying to ask our mentor to give us more interesting work, we decide to seek help from the only female construction manager on site. She was a 50 year old Puerto Rican woman named Milly, who used to be a secretary for the company and fell in love with construction. She paid her way through night school and earned a degree in Mechanical Engineering. After finishing her degree she was hired as a Construction Manager overseeing all the mechanical trades.
Milly became our mentor and made sure that we were always learning something from the tasks we were assigned. She also encouraged us to work separately because, as she would say “you’ll probably be the only woman on any site, better get used to it.” As expected, the work that we were given required us to constantly be around the tradesmen working, as opposed to before when we were mainly in empty finished apartments. I can only speak for myself, because I never asked the other female female intern how she felt or what kind of treatment she received, but it was at this point that I became the target of a lot of sexist, rude, and inappropriate remarks from some of the men. Many times as I walked on by, working men who would stop their work to stare and wolf whistle. Several times a day I had to say “no thank you” to men asking for my number or requesting to take me out on a date. On a few occasions I got called a bitch for refusing to reply to inappropriate remarks. Some men felt the need to give me “get fit” advice and make comments about my body, often pointing at my lack of physical strength as a sign of why I did not belong on a construction site: never mind that technological advances and strict safety codes has made the use of physical strength obsolete in most jobs. Once, I found myself in the middle of a storage room with one construction worker (whom I had never seen before that day) blocking the doorway and refusing to let me leave unless I accepted his request for a date.
I worked on the site for a year, after which I decided the stress of a workplace where I constantly felt harassed, belittled, and intimidated was not worth the effort. The constant fear that someone would make me feel uncomfortable or make a rude remark was making me lose my concentration, and on an active construction site, that is an actual safety hazard. I requested to work with the Project Managers who dealt with the Engineering consultants from the main office and only went on site for field meetings. Today, I am better equipped to deal with everyday sexism, but at 18 years old I was not. I never did report any of the many incidents of sexism and harassment that I endured. I was reluctant to do so for fear of being tagged as a complainer who could not handle the job.
Writing this was one of the hardest things I’ve had to do. I still love the construction industry and promote it as a great career choice for men and women who enjoy being active on their jobs. For every man that demeaned me, there were dozens who uplifted me. For every man that made a sexist comment, there were scores who respected me and valued my work. For every man that harassed me, there were hundreds more who protected me as their coworker. The issue is not that all men refuse to work with women, the issue is that a few men who do not, make the working environment hostile and dangerous for women. Those few that harassed me had the power to ruin my day, alter my mind, and destroy my self confidence. We need to increase the number of women in the construction industry so that we are not a rarity. We must also encourage labor unions and construction employers to include sexual harassment training as part of their health and safety plans. Women deserve to have access to skilled trades, and they deserve to be respected as a fellow colleague.
[Patricia Valoy is a Civil Engineer and an Assistant Project Manager at STV, an architectural, engineering, planning, environmental and construction management firm based in New York City. She is a graduate of the Columbia University School of Engineering in Applied Science, where she majored in Civil Engineering with a concentration in Construction Management. Patricia also is a co-host of a weekly radio show called, “Let Your Voice Be Heard.” The show’s mission is to spread awareness of social and political issues. In addition, she writes a blog about feminist issues and mentors high school and college students interested in pursuing careers in STEM fields. You can follow Patricia on Twitter at @besito86 and read her blog at www.patriciavaloy.blogspot.com.]
When I take a look around my office I see a lot of men, mostly older White men. There are also women, mostly administrative assistants, accountants, and marketing personnel, but few like me. I am an engineer, and I am young, female, Ivy League educated, and Hispanic. I took the same science and mathematics classes all my male peers took. I was given the same tests, the same homework assignments, and the same projects. Yet, every day I have to battle stereotypes of what some think women should be.
Courtesy of Indiana University.
Engineering, and most science fields, have long been male-dominated professions. Yet, in spite of traditional gender roles pigeonholing women to domestic duties, women haven’t necessarily settled into domesticity without first making many great advances in the science fields. We cannot forget Merit-Ptah, an ancient Egyptian physician, and also the first woman to be known by name in the history of the field of Medicine. Or the ancient Greek philosopher Hypatia, also the first historically noted woman in Mathematics. These women were not given positions in Science to fill a status quo, they earned it, just like women today.
Stereotypes are part of my daily life. In high school I was discouraged by a school teacher to apply to Engineering school, because she claimed it was “harder than I was imagining it to be.” She told me that I wanted to pursue a degree in Engineering because of the money I would earn, but it was clear to her that I did not have a passion for it. Never mind that I outperformed all my classmates, including all my male peers, and that I was about to graduate at the top of my class. As a professional adult, I still face these misconceptions about women in science fields. I get my bosses’ mail delivered to me every day because the delivery man, after four years, still thinks that I am a secretary. I politely remind him every day that I am in fact, also an engineer, like my boss, but it seems to fall on deaf ears. So I find myself not only doing my work, but also delivering mail. A week ago I was asked by a new employee which department I belonged in, and the conversation went like this:
Me: “Hi, are you new to our office?”
New Employee: “Yes, I work in the Marketing department. Do you work with Corporate?”
Me: “No, I work in the Transportation and Infrastructure department.”
New Employee: “Are you an administrative assistant?”
Me: “No, an Engineer.”
New Employee: “Oh, you’re an Accountant.”
Me: “Noooo, an Engineer, a Civil Engineer!”
New Employee: “Oh, wow! I would have never guessed…you don’t look like one.”
While I admit to becoming irritated, it was more disconcerting that this co-worker was also a young woman like myself. She reacted in a way that was natural and all too common, because there really aren’t enough women being positively represented in the fields of Science, Technology, Engineering, and Mathematics (STEM). I quite enjoy shaking up perceived ideas of what society assumes I should be, as a woman, a woman of color, and a woman in a male-dominated field, but when will all this shock and awe over women in science fields end? Nonetheless, I love the work I do and the feeling of accomplishment I get when I finish a project. And contrary to 18th century views of the female brain, we have shown that when given the same curriculum as men, we can equally excel.
According to a research study done by the University of Washington, the main culprit for girls not becoming enthusiastic about careers in mathematics and science is gender-stereotyping. The study speaks of the widespread cultural belief in the “girls don’t do math” stereotype. In the study, 247 school-age children (126 girls and 121 boys) were asked to sort four kinds of words: boy names, girl names, math words and reading words, into categories, with the use of an adapted keyboard on a laptop. The lead author of the study, Dario Cvencek, concluded that: “Not only do girls identify the stereotype that math is for boys, but they apply that to themselves. That’s the concerning part. Girls are translating that to mean, ‘Math is not for me.’”
While the study found that both genders equate mathematics with boys, it is unclear why this stereotype is so pronounced at such a young age, though there seems to be a connection with the way in which we speak to young children about mathematics. Dario Cvencek explains: “When a girl does poorly on a math test, often she’s told, ‘That’s fine. You did your best.’ When a boy does poorly, he is more likely to be told, ‘You can do better. Try harder next time.’”
Stereotypes are hurtful, and I believe that stereotype threat, the notion that we experience anxiety in a situation where we have the potential to confirm a negative stereotype, is all too real. We cannot expect young girls to be interested in pursuing careers in science, technology, engineering, and mathematics, if we continue to associate them with one gender. Stereotyping career choices is not in our best interest as we cannot achieve success if we believe that half of our population is not capable of contributing to the betterment of our society. I challenge every educator and parent to reevaluate the way they educate their children. Think about the toys we give them. Building blocks and other shape-sorting toys are equally entertaining for girls as they are for boys, and they help develop cognitive skills, something Barbie and Easy-Bake Ovens will never achieve. Teaching is powerful, and encouraging children to challenge themselves should not depend on the child’s gender.
I am passionate about increasing the number of women represented in STEM fields, not merely because I believe we should be equally represented in all career fields, but because I know we can positively contribute to the advancement of our society. Having both sexes equally represented opens the door for a more diverse range of ideas, which in turn can result in a more robust range of services and products. Additionally, having more women in STEM fields ensures that women’s health and well-being become common practice, and not women’s issues.
Careers in STEM fields require high-level skills and earn higher wages, they are also always in high demand, and experts predicts an even stronger demand for professionals in STEM fields in the future. Our economy is in crisis and 60% of women are the breadwinners or co-breadwinners in their families. If we continue to believe that these high paying careers are only for men, we are not cashing in on the earning power of women. Ultimately, it is not about filling a status quo, it is about using our population, men and women, to the best of their abilities.
Patricia Valoy is a Civil Engineer and an Assistant Project Manager at STV, an architectural, engineering, planning, environmental and construction management firm based in New York City. She is a graduate of the Columbia University School of Engineering in Applied Science, where she majored in Civil Engineering with a concentration in Construction Management. Patricia also is a co-host of a weekly radio show called, “Let Your Voice Be Heard.” The show’s mission is to spread awareness of social and political issues. In addition, she writes a blog about feminist issues and mentors high school and college students interested in pursuing careers in STEM fields. You can follow Patricia on Twitter at @besito86 and read her blog at www.patriciavaloy.blogspot.com.
In a victory for the dense-breast patient movement, Governor Jerry Brown (D-CA) signed legislation last week requiring that doctors who discover that women have dense breasts on mammography must inform women that: §dense breasts are a risk factor for breast cancer; §mammography sees cancer less well in dense breasts than in normal breasts; and §women may benefit from additional breast cancer screening. The California law goes into effect on April 1, 2013. It follows four states (Connecticut, Texas, Virginia, and New York) with similar statutes. All have enjoyed solid bipartisan support. Rarely do naysayers or skeptics speak up.
Young women who are leading the charge often bring lawmakers the story of a young constituent, diagnosed with a very aggressive, lethal cancer that was not shown on film-screen mammography. The Are You Dense? patient advocacy group engages patients on Facebook, where women share their experiences with breast cancer, organize events, and lobby for legislation. Individual radiologists work with the advocacy groups, but many radiology groups and breast surgeons do not endorse these laws.
A Closer Look at Breast Cancer Data
Living in an age when information is viewed as an entitlement, knowledge, and power, many physicians find it hard to argue against a patient’s right to know. Can sharing information be a mistake? Some epidemiologists think so. Otis W. Brawley, MD, FACP, Chief Medical & Scientific Officer, American Cancer Society, says: “I really worry when we legislate things that no one understands. People can get harmed.” Numerous issues have to be worked out, according to Brawley. For one, he explains: “There is no standard way to define density.” Additionally, “even though studies suggest that density increases the risk of cancer, these cancers tend to be the less serious kind, but even that is open to question,” Brawley says. “We in medicine do not know what to do for women who have increased density.”
A study of more than 9,000 women in the Journal of the National Cancer Institute revealed that women with very dense breasts were no more likely to die than similar patients whose breasts were not as dense. “When tumors are found later in more dense breasts, they are no more aggressive or difficult to treat,” says Karla Kerlikowske, MD, study coauthor, and professor of medicine and epidemiologist at the University of California San Francisco. In fact, an increased risk of death was only found in women with the least dense breasts.
The trouble is what is known about dense breasts is murky. Asked whether he backs advising women that dense breasts are a risk factor for breast cancer, Anthony B. Miller, MD, Co-Chair of the Cancer Risk Management Initiative and a member of the Action Council, Canadian Partnership Against Cancer, and lead investigator of the Canadian National Breast Cancer Screening Study, says: “I would be very cautious. The trouble is people want certainty and chances are whatever we find, all we can do is explain.”
Women in their forties, who are most likely to have dense breasts (density declines with age) may want to seek out digital mammography. In studies comparing digital mammography to film-screen mammography in the same women, digital mammography has been shown to improve breast cancer detection in women with dense breasts. Findingsfrom the Digital Mammographic Imaging Screening Study, showed better breast cancer detection with digital mammography. But digital mammography is not available in many areas. Moreover, Miller explains: “We do not know if this will benefit women at all. It is very probable that removal of the additional small lesions will simply increase anxiety and health costs, including the overdiagnosis of breast cancer, and have no impact upon mortality from breast cancer.”
Additional imaging studies sound attractive to people convinced that there is something clinically significant to find. But as I pointed out in my last post, many radiologists and breast physicians contend that there is no evidence that magnetic resonance imaging or any other imaging study aids breast cancer screening in women with dense breasts. Brawley notes: “These laws will certainly lead to more referral for MRI and ultrasound without clear evidence that women will benefit (lives will be saved.) It’s clear that radiologists will make more money offering more tests.” Miller adds: “A number of doctors are trying to capitalize on this and some of them should know a lot better.”
Many Advocates Question More Tests, Statutes
Even though the “Are You Dense?” campaign has been instrumental in getting legislation on the books across the county, other advocacy groups and patient advocates want research, enhanced patient literacy about risks and benefits of procedures. Many recall mistakes made that led women down the path of aggressive procedures. In that group is the radical Halsted mastectomy, used widely before systematic study, but once studied, found no better than breast-conserving surgery for many cancers, and bone marrow transplants, also found to be ineffective, wearing, and costly.
Jody Schoger, a breast cancer social media activist at @jodymswho engages women weekly on twitter at #bcsm, had this to say on my blog about the onslaught of additional screening tests:
“What is needed is not another expensive modality… but concentrated focus for a biomarker to indicate the women who WILL benefit from additional screening. Because what’s happening now is an avalanche of screening, and its subsequent emotional and financial costs, that is often far out of proportion to both the relative and absolute risk for invasive cancer. I simply don’t think more “external” technology is the answer but one that evolves from the biology of cancer.”
Eve Harris @harriseve, a proponent of patient navigation and patient literacy, challenged Peter Ubel, MD, professor of business administration and medicine, at Duke University, on his view of the value of patient empowerment on the breast density issue. In a post on Forbes, replicated in Psychology Today, Ubel argued that in cases where the pros and cons of a patient’s alternatives are well known, for example, considering mastectomy or lumpectomy, patient empowerment play an important role. “But we are mistaken to turn to patient empowerment to solve dilemmas about how best to screen for cancer in women with dense breasts,” he writes.
Harris disagrees, making a compelling case for patient engagement:
“I think that we can agree that legislative interference with medical practice is not warranted when it cannot provide true consumer protection. But the context is the biggest culprit in this situation. American women’s fear of breast cancer is out of proportion with its incidence and its mortality rate. Truly empowering people—patients would mean improving health literacy and understanding of risk…”
But evidence and literacy take time, don’t make for snappy reading or headlines, and don’t shore up political points. Can we stop the train towards right-to-inform laws and make real headway in women’s health? Can we reallocate healthcare dollars towards effective treatments that serve patients and engage them in their care? You have to wonder.
[Today’s post is from Patient POV, the blog of Laura Newman, a science writer who has worked in health care for most of her adult life, first as a health policy analyst, and as a medical journalist for the last two decades. She was a proud member of the women’s health movement. She has a longstanding interest in what matters to patients and thinks that patients should play a major role in planning and operational discussions about healthcare. Laura’s news stories have appeared in Scientific American blogs, WebMD Medical News, Medscape, Drug Topics, Applied Neurology, Neurology Today, the Journal of the National Cancer Institute, The Lancet, and BMJ, and numerous other outlets. You can find her on Twitter @lauranewmanny.]
The opinions in this article do not necessarily conflict with or reflect those of the DXS editorial team.
The stormy landscape of the breast, as seen on ultrasound. At top center (dark circle) is a small cyst. Source: Wikimedia Commons. Credit: Nevit Dilmen.
By Laura Newman, contributor
In a unanimous decision, FDA has approved the first breast ultrasound imaging system for dense breast tissue “for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.” Patients should not interpret FDA’s approval of the somo-v Automated Breast Ultrasound System as an endorsement of the device as necessarily beneficial for this indication and this will be a thorny concept for many patients to appreciate.
If the approval did not take place in the setting of intense pressure to both inform women that they have dense breasts and lobbying to roll out all sorts of imaging studies quickly, no matter how well they have been studied, it would not be worth posting.
Dense breasts are worrisome to women, especially young women (in their 40s particularly) because they have proved a risk factor for developing breast cancer. Doing ultrasound on every woman with dense breasts, though, who has no symptoms, and a normal mammogram potentially encompasses as many as 40% of women undergoing screening mammography who also have dense breasts, according to the FDA’s press release. Dense breast tissue is most common in young women, specifically women in their forties, and breast density declines with age.
The limitations of mammography in seeing through dense breast tissue have been well known for decades and the search has been on for better imaging studies. Government appointed panels have reviewed the issue and mammography for women in their forties has been controversial. What’s new is the “Are You Dense?” patient movement and legislation to inform women that they have dense breasts.
Merits and pitfalls of device approval
The approval of breast ultrasound hinges on a study of 200 women with dense breast evaluated retrospectively at 13 sites across the United States with mammography and ultrasound. The study showed a statistically significant increase in breast cancer detection when ultrasound was used with mammography.
Approval of a device of this nature (noninvasive, already approved in general, but not for this indication) does not require the company to demonstrate that use of the device reduces morbidity or mortality, or that health benefits outweigh risks.
Eitan Amir, MD, PhD, medical oncologist at Princess Margaret Hospital, Toronto, Canada, said: “It’s really not a policy decision. All this is, is notice that if you want to buy the technology, you can.”
That’s clearly an important point, but not one that patients in the US understand. Patients hear “FDA approval” and assume that means a technology most certainly is for them and a necessary add-on. This disconnect in the FDA medical device approval process and in what patients think it means warrants an overhaul or at the minimum, a clarification for the public.
Materials for FDA submission are available on the FDA website, including the study filed with FDA and a PowerPoint presentation, but lots of luck, finding them quickly. “In the submission by Sunnyvale CA uSystems to FDA, the company stated that screening reduces lymph node positive breast cancer,” noted Amir. “There are few data to support this comment.”
Is cancer detection a sufficient goal?
In the FDA study, more cancers were identified with ultrasound. However, one has to question whether breast cancer detection alone is meaningful in driving use of a technology. In the past year, prostate cancer detection through PSA screening has been attacked because several studies and epidemiologists have found that screening is a poor predictor of who will die from prostate cancer or be bothered by it during their lifetime. We seem to be picking up findings that don’t lead to much to worry about, according to some researchers. Could new imaging studies for breast cancer suffer the same limitation? It is possible.
Another question is whether or not the detected cancers on ultrasound in the FDA study would have been identified shortly thereafter on a routine mammogram. It’s a question that is unclear from the FDA submission, according to Amir.
One of the problems that arises from excess screening is overdiagnosis, overtreatment, and high-cost, unaffordable care. An outcomes analysis of 9,232 women in the US Breast Cancer Surveillance Consortium led by Gretchen L. Gierach, PhD, MPH, at the National Institutes of Health MD, and published online in the August 21 Journal of the National Cancer Institute, revealed: “High mammographic breast density was not associated with risk of death from breast cancer or death from any cause after accounting for other patient and tumor characteristics.” –Gierach et al., 2012
Proposed breast cancer screening tests
Meanwhile, numerous imaging modalities have been proposed as an adjunct to mammography and as potential replacements for mammography. In 2002, proponents of positron emission tomography (PET) asked Medicare to approve pet scans for imaging dense breast tissue, especially in Asian women. The Medicare Coverage Advisory Commission heard testimony, but in the end, Medicare did not approve it for the dense-breast indication.
PET scans are far less popular today, while magnetic resonance imaging (AKA MR, MRI) and imaging have emerged as as adjuncts to mammography for women with certain risk factors. Like ultrasound, the outcomes data is not in the bag for screening with it.
In an interview with Monica Morrow, MD, Chief of Breast Surgery at Memorial Sloan-Kettering Cancer Center, New York, several months ago concerning the rise in legislation to inform women about dense breasts, which frequently leads to additional imaging studies, she said: “There is no good data that women with dense breasts benefit from additional MR screening.” She is not the only investigator to question potentially deleterious use of MR ahead of data collection and analysis. Many breast researchers have expressed fear that women will opt for double mastectomies, based on MR, that in the end, may have been absolutely unnecessary.
“There is one clear indication for MR screening,” stressed Morrow, explaining that women with BRCA mutations should be screened with MRI. “Outside of that group, there was no evidence that screening women with MR was beneficial.”
At just about every breast cancer meeting in the past two years, the benefits and harms of MR and other proposed screening modalities come up, and there is no consensus in the field. It should be noted, though, that plenty of breast physicians are skeptical about broad use of MR– not just generalists outside of the field. In other words, it is not breast and radiology specialists versus the US Preventive Services Task Force – a very important message for patients to understand.
One thing is clear: as these new technologies gain FDA approval, it will be a windfall for industry. If industry is successful and doctors are biased to promoting these tests, many may offer them on the estimated 40% of women with dense breasts who undergo routine mammograms, as well as other women evaluated as having a high lifetime risk. The tests will be offered in a setting of unclear value and uncertain harms. Even though FDA has not approved breast MRI for screening dense breasts, breast MR is being used off label and it is far more costly than mammography.
When patients raise concerns about the unaffordability of medical care, they should be counseled about the uncertain benefit and potential harms of such a test. That may be a tall bill for most Americans to consider: it’s clear that the more is better philosophy is alive and well. Early detection of something, anything, even something dormant, going nowhere, is preferable to skipping a test, and risking who-knows-what, and that is something, most of us cannot imagine at the outset.
[Today’s post is from Patient POV, the blog of Laura Newman, a science writer who has worked in health care for most of her adult life, first as a health policy analyst, and as a medical journalist for the last two decades. She was a proud member of the women’s health movement. She has a longstanding interest in what matters to patients and thinks that patients should play a major role in planning and operational discussions about healthcare. Laura’s news stories have appeared in Scientific American blogs, WebMD Medical News, Medscape, Drug Topics, Applied Neurology, Neurology Today, the Journal of the National Cancer Institute, The Lancet, and BMJ, and numerous other outlets. You can find her on Twitter @lauranewmanny.] Ed note: The original version of this post contains a posted correction that is incorporated into the version you’ve read here.
The opinions in this article do not necessarily conflict with or reflect those of the DXS editorial team.