Archive for the ‘Breast Cancer’ Category

February 14, 2014

New Study Raises More Questions About the Value of Mammograms

This chart, published in British Medical Journal, shows that the breast cancer mortality of patients who underwent mammogram screening vs. those who did not is practically equal.

new, long-term study in BMJ provides perhaps the most compelling argument to date that screening mammograms may not be effective in reducing the death rate from cancer and may in fact cause harm from overtreatment in some women.

The study is based on results from the Canadian National Breast Screening Study. For this research, 89,835 women ages 40 to 59 were randomly assigned to receive either annual mammograms for five years, or no mammograms during the study period. All of the women received breast exams by trained nurses. The women were followed for up to 25 years to see which of them died of breast cancer.

Based on the data, the authors report that there was no difference between those who had screening mammography and those who didn’t in terms of their likelihood of dying from breast cancer. The authors conclude:

Annual mammography in women aged 40-59 does not reduce mortality from breast cancer beyond that of physical examination or usual care when adjuvant therapy for breast cancer is freely available. Overall, 22% (106/484) of screen detected invasive breast cancers were over-diagnosed, representing one over-diagnosed breast cancer for every 424 women who received mammography screening in the trial.

Put simply, this means that one in five cancers do not pose a deadly threat, yet these women may still undergo treatment, including surgery, chemotherapy and radiation.

A New York Times article this week summarizes the research, and provides some commentary from doctors. Among them, Dr. Russell P. Harris, a screening expert and professor of medicine at the University of North Carolina, Chapel Hill, commented that the results “will make women uncomfortable, and they should be uncomfortable.”

“The decision to have a mammogram,” he added, “should not be a slam dunk.”

New York Times reporter Gina Kolata explains that the number of cancers treated unnecessarily would be even higher if a precancerous condition had been included in the study:

Many cancers, researchers now recognize, grow slowly, or not at all, and do not require treatment. Some cancers even shrink or disappear on their own. But once cancer is detected, it is impossible to know if it is dangerous, so doctors treat them all.

If the researchers also included a precancerous condition called ductal carcinoma in situ, the overdiagnosis rate would be closer to one in three cancers, said Dr. Anthony B. Miller of the University of Toronto, the lead author of the paper. Ductal carcinoma in situ, or D.C.I.S., is found only with mammography, is confined to the milk duct and may or may not break out into the breast. But it is usually treated with surgery, including mastectomy, or removal of the breast.

These findings are unlikely to result in any immediate change in what doctors recommend to women, and are likely to cause controversy among experts.

An accompanying editorial in BMJ, “Too Much Mammography,” explains the strengths and limitations of the study, and notes that it is difficult to make changes around screening mammography practices “because governments, research funders, scientists, and medical practitioners may have vested interests in continuing activities that are well established.”

Indeed, the American College of Radiology — which represents radiologists who perform and interpret mammograms — has issued a statement criticizing the study. This organization also objected to the 2009 recommendations on routine mammography, put forth by the U.S. Preventive Services Task Force, which we discussed here.

The National Partnership for Women and Families also provides a summary of the research, and Breast Cancer Action has issued a response as well, noting that the findings may not apply equally to all women:

The information that we have seen from this study does not let us draw conclusions for specific communities, many of which are most affected by higher morbidity rates. Given the unequal burden that women of color bear when it comes to breast cancer morbidity and mortality, questions remain as to whether there are different findings for difference communities. Absent this evidence, there are no clear answers for women of color. The growing body of evidence, of which this study is part, continues challenge long-standing and commonplace assertions that mammograms are a driving factor in reducing death rates.

What this research makes clear, however, is that we need more effective methods for detecting breast cancer, and new ways of determining which cancers need treatment.

Previous posts on the evidence about mammograms include:


January 8, 2014

False Alarms Remain a Huge Problem with Mammograms Used for Breast Cancer Screening

Breast cancer detection has become a more controversial subject over the past several years, with routine screening mammograms — the kind many women are encouraged to undergo starting in their 40s — drawing more scrutiny.

More and more, researchers and clinicians are acknowledging that screening mammography has a high rate of false alarms, causing worry along with sometimes unnecessary treatment.

annual mammogram benefit harm tradeoff chartH. Gilbert Welch, a professor at the Dartmouth Institute for Health Policy and Clinical Practice, recently wrote an excellent New York Times op-ed exploring the difficult science around breast cancer screening. Explaining the findings of a study on the benefits and harms of screening mammography that he and Honor J. Passow, also of the Dartmouth Institute, published last month in JAMA Internal Medicine, Welch asks how much overdiagnosis we’re willing to tolerate compared to the possibility of reducing deaths from breast cancer.

Using data from radiologists who perform mammograms, Welch and Passow concluded that among 1,000 40-year-old American women screened annually over the course of a decade, between 0.1 and 1.6 women will avoid dying from breast cancer. (See chart at left; click to view full size.) A staggeringly high number — between 510 and 690 women — will have at least one false alarm (60-80 of whom will undergo a biopsy), and up to 11 women will be overdiagnosed and treated needlessly with chemotherapy or radiation therapy, or surgeries such as lumpectomy or mastectomy.

For 50-year-old women screened annually for 10 years, the numbers are as follows:
* 0.3-3.2 women will avoid dying from breast cancer.
* 490-670 women will have at least one false alarm (70-100 will undergo a biopsy).
* 3-14 women will be overdiagnosed and treated needlessly.

And for 60-year-old women screened annually for 10 years:
* 0.5-4.9 women will avoid dying from breast cancer.
* 390-540 women will have at least one false alarm (50-70 will undergo a biopsy).
* 6-20 women will be overdiagnosed and treated needlessly.

“Overtreatment” sometimes occurs when women receive treatments for cancers that would never have gone on to grow, spread, or cause health problems. In those cases, surgery, chemotherapy, and other treatments don’t provide any health benefit, but there are clear harms. Unfortunately, there is no way to know which cancers would go on to be deadly.

Meanwhile, there is little public awareness that routine screening can lead to both false alarms and overtreatment. A recent online survey of middle-aged Americans, notes Welch, suggests that acceptance of routine screening would diminish if the facts were more readily available.

Welch argues that more research is needed, especially on whether older findings showing that early detection might save lives still matter, now that treatment for breast cancer has changed and improved. He is, however, pessimistic about whether trials will happen that would help answer these questions, or explore outcomes when women choose more or less screening:

Two randomized trials could begin to answer the central question of mammography interpretation: How hard should the radiologist look? Women who view mammography favorably might be willing to be screened under either the current approach or a high-threshold approach — meaning their radiologist would ignore small, likely harmless abnormalities found on a mammogram.Those who view it less favorably might choose that high-threshold approach (knowing that the harms of false alarms and overdiagnosis would be minimized) or forgo mammography completely.

Putting the two trials together, we could finally learn what level of screening minimizes false alarms and overdiagnosis while saving the most lives. Most experts would say that it’s never going to happen. It would cost too much, take too long and need too many subjects.

Maybe they are right. But maybe not. Sure, it would cost millions of dollars. But that’s chicken feed compared with the billions of dollars we spend on breast cancer screening every year. Sure, it would take 10 to 15 years. But it would help our daughters know more. Sure, it would take tens of thousands of women to participate. But maybe they would want to be part of the effort to help sort out the morass surrounding what is one of the most common medical interventions done to American women.

We agree with Welch that more needs to be done — both in terms of research and educating the public about the real risks and benefits of their routine screening decisions.

“A screening program that falsely alarms about half the population is outrageous,” writes Welch, adding:

To be sure, many women are quickly reassured by a second test that their breast is normal. But others — while told they don’t have cancer — are told that their breast is somehow abnormal, that they have dysplasia or atypia, that they are at ‘high risk.’ Whether you blame the doctors or the system or the malpractice lawyers, it’s a problem that needs to be fixed.

Plus: For more information, read our previous posts on breast cancer, including several on what is known about the benefits and risks of routine mammography. Good starting points are: “New Mammogram Guidelines Are Causing Confusion, But Here’s Why They Make Sense,” “Do Screening Mammograms Do More Harm Than Good?“, and “The Benefits and Harms of Routine Mammograms.”


December 13, 2013

Digital Mammography: Is Newer Always Better?

Mammogram machineYou may have noticed last time you got a mammogram that the facility used digital imaging rather than traditional X-ray film.

Why is that? And, are there any benefits to the newer techniques?

In 2009, when the U.S. Preventive Services Task Force (USPSTF) reviewed the evidence and updated its recommendations on breast cancer screening, it concluded there was not enough evidence to assess the benefits and harms of digital vs. film mammography, due to a lack of studies on the effectiveness of the two methods. (To re-cap, the USPSTF recommends that for women with no increased risk of breast cancer, the decision to start screening before age 50 should be an individual one, rather than a general recommendation. After age 50, the USPSTF recommends screening every two years, up to age 74. There has been some controversy about the guidelines due to concerns about harms of routine mammograms – for for more information, see our related posts, The Benefits and Harms of Routine Mammograms and Do Screening Mammograms Do More Harm Than Good?)

The USPSTF noted that both screening methods may detect some cancers that are not identified by the other, but that overall detection is similar for many women. It found that the chance of false-positives (indication of cancer where it doesn’t exist) is similar in both types.

The Digital Mammographic Imaging Screening Trial (DMIST), published in 2005, is the most important trial of digital vs. film mammography for breast cancer screening to date. The study compared the accuracy of both methods in almost 50,000 women and concluded they’re similar in their effectiveness — neither technology was able to detect 100 percent of the cancers examined.

That said, researchers found digital to be the better tool for women under age 50, or who have very dense breast tissue, or are still menstruating. But it showed no benefit in terms of accuracy for women with all three criteria. And there was no difference in accuracy by race, breast cancer risk, or type of digital machine used.

The DMIST trial was not designed to compare differences in mortality rates among women who underwent different imaging — so it can’t answer the all-important question of whether digital mammography could save more lives than film.

Still, as the National Cancer Institute notes, some health care providers recommend women with a very high risk of breast cancer — women with BRCA1 or 2 genetic mutations, for example, or extremely dense breasts — get digital rather than conventional mammograms, even though no studies have shown that digital is better at reducing these women’s risk of death.

When examining a new medical technology, one consideration is how much the technology costs compared with how many years of quality life may be gained by using it. At least one trial has indicated that screening all women with digital mammograms was not cost-effective, because digital costs more and doesn’t improve health outcomes when used so broadly. Targeting women for digital mammography based on age (i.e., using digital for women under 50) appears to be more cost-effective than using film or digital for all women. The study concluded that a shift to all-digital mammography “has the potential to result in health gains for younger women (especially those with dense breasts) possibly at the expense of older women (especially those with non-dense breasts).”

Unfortunately, providers may not give women a choice. Some health care systems have simply switched over to digital, and individual providers may refer women for a mammography without indicating which type they will receive. In some cases, referrals for digital mammography may be linked to a provider’s investment in the machines, since evidence suggests that doctors are more likely to recommend expensive medical technologies when they have a financial stake in them, even if the procedure isn’t supported by medical evidence.

Medicare also reimburses more for digital screening exams than for film, creating a financial incentive for clinics and hospitals to conduct digital scans instead of film ones.

Digital mammography does have other benefits over film: digital files can be enhanced and manipulated in ways film cannot, and electronic images can be readily shared with clinicians at other locations, which may particularly benefit rural and underserved communities using telemedicine for reading and interpreting mammograms. Finally, digital mammograms may have a slightly lower radiation dose than film (although this may not be meaningful in terms of radiation-related risks, since the radiation dose with either type is very low).

These potential benefits may not justify a switch to digital mammography for all women. The USPSTF notes: “Consumer expectations that new technology is better than old may obscure potential adverse effects, such as higher false-positive results and expense. No screening trials incorporating newer technology have been published.”

So, when your doctor refers you for a mammogram, ask:

  • Are you referring me for a digital or a film mammogram?
  • If you are under 50 years of age: Why do you believe I need a mammogram at this time? Am I in a higher risk group? (This is important if you don’t know that you have any factors that may put you at increased risk).
  • Do you have a financial stake in the mammography facility?

You can also ask your insurer if a film mammogram would cost you less. Many women’s screening mammograms are completely covered by insurance, but costs can vary widely, so it’s good to confirm what the charges will be in advance.

A version of this article originally appeared in the November/December issue of The Women’s Health Activist, the newsletter of the National Women’s Health Network.

Photo: themozhi’s pixel display


October 10, 2013

All Pinked Out in October? There’s a Cure for That! Join the Think Before You Pink Campaign

by Annie Sartor
Policy and Campaigns Coordinator, Breast Cancer Action

Why is the breast cancer epidemic still raging after 30 years of “awareness” and pink ribbon products?

Each year, corporations pack the shelves with pink ribbon products, surrounding us with “breast cancer awareness” messages. These products help to raise billions of dollars in the name of breast cancer, and yet more than 40,000 women in the United States still die of the disease every year.

And many corporations sell pink ribbon products in the name of breast cancer that actually contain chemicals linked to an increased risk of the disease. At Breast Cancer Action, we call this blatant hypocrisy “pinkwashing.”

For 12 years, Breast Cancer Action’s Think Before You Pink campaign has held corporations accountable for their toxic pink ribbon products. This year, it’s time to say we’ve had enough. Instead of targeting pinkwashers one at a time, it’s time to go straight to the source — the chemicals in these products that are making us sick in the first place.

Do you have any idea how many toxic chemicals are in the average pink ribbon product? Nope? Neither do we. Nor does anyone!

Toxic Time is UpAll anyone knows for certain is that only a small handful — about 200 of the over 80,000 chemicals in use in the United States — have been tested for human safety. And that’s a serious problem for all of us.

These chemicals are found in everyday consumer products such as plastics, paint, clothing, and cleaning supplies, including an unknown number of pink ribbon products being sold in the name of breast cancer.

Evidence of the links between environmental toxins and cancer continues to mount. In 2010, the President’s Cancer Panel reported that “the true burden of environmentally induced cancer has been grossly underestimated [and] … the American people — even before they are born — are bombarded continually with myriad combinations of these dangerous exposures.”

And just this week, yet another study came out showing an even stronger link between BPA and breast cancer than we’d previously thought.

Why is pinkwashing so prevalent, and even possible in the first place? Our current chemical policy, the Toxic Substances Control Act, is extremely outdated and woefully inadequate to protect public health from hazardous chemicals in our daily lives.

Thanks to a large coalition of health activists, environmentalists, scientists, and thousands of others, pressure has continued to mount for reform of this outdated and toothless law. If strong TSCA reform legislation moves forward this fall, we will have a real opportunity to enact a bill that could make history and be the biggest win for cancer prevention we’ve ever seen.

We refuse to waste another October watching corporations make money off pink ribbon products that contain toxins linked to breast cancer.

Please join us in taking a stand to protect all of us from toxic chemicals that are making us sick, because the manufacturers of pink ribbon products certainly won’t. Sign our petition to end pinkwashing once and for all via strong chemical regulations. It’s time to turn our outrage over pinkwashing into action and ban the toxins that make us sick in the first place.


August 20, 2013

Breast Cancer, Mastectomy and Breast Implants: A 20-Year History of Images and Attitudes

CBS Sunday Morning this week aired a segment looking at breast cancer and body image, especially women’s choices around reconstructive surgery and implants.

Artist and former fashion model Matuschka, whose self-portrait on The New York Times Magazine cover 20 years ago (Aug. 15, 1993) created a shock because it displayed her mastectomy scar where her right breast had been removed, describes her reasons for creating the image — wanting to start a conversation about breast cancer — and the backlash she received from readers who thought she brought shame to women.

The moment was compared to the reaction to Angelina Jolie’s recent decision to undergo prophylactic mastectomy, and current public attitudes about women’s breasts.

OBOS Executive Director Judy Norsigian notes how moneyed interests guide what is seen as narrow beauty ideals for women, and how that affects women’s choices about reconstruction after breast cancer surgery.

“We live in a culture in which large breasts are almost universally idealized,” said Norsigian. “We’ve had at the same time a huge industry that has burgeoned to promote the idea that women must have implants.”

(It was great to hear veteran reporter Martha Teichner, in her introduction to the segment, call the ninth edition of “Our Bodies, Ourselves” “the now iconic guide on women’s sexual and reproductive matters, and a gauge of social attitudes.” )

The segment also includes a clip of  7-year-old girls who are interviewed in “Absolutely Safe,” a documentary that examines the popularity of breast implants among ongoing controversies about implant safety. It’s disturbing to see how thoroughly these young girls have already received the message that bigger breasts are better and attract more attention.

Another resource mentioned is The Scar Project, a series of photographs displaying the bodies and scars of breast cancer survivors. The project generated some controversy earlier this year when Facebook began removing and banning some of the photos for allegedly violating Facebook’s policies on nudity; more details are provided in these posts at the Scar Project blog.


August 2, 2013

Racism, Mistrust in Medical System May Affect Black Women’s Use of Genetic Testing for Breast and Ovarian Cancers

Black women in the United States face many health disparities. The CDC recently provided data showing the average life expectancy for black women (at birth in 2010) is 78 — 3.3 years shorter than that for white women.

One of the many diseases for which there are unequal outcomes is breast cancer. Black women are less likely than white women to develop breast cancer, but are much more likely to die of the disease. One hypothesis to explain at least some of the disparity is that black women may be more likely to carry forms of the BRCA1/2 genes that increase their risk for breast and ovarian cancer.

Genetics alone, though, is probably not enough to explain the difference. A recently published study looks at how racism and mistrust in the medical system may also affect black women’s use of genetic testing to inform the monitoring and care they receive.

The authors studied 100 black women at high risk for breast cancer. They looked at whether the women knew how to get, pay for, and what to do with the results of BRCA gene testing, their knowledge of a U.S. law forbidding discrimination based on genetic findings, and their level of mistrust in the medical system, alongside whether the women knew about or had received genetic counseling and testing.

While it’s a small study, the researchers found that the more women knew about how to get and pay for the tests, and the more trust they had in the medical system, the more likely they were to have had BRCA testing.

It should come as no surprise that the more mistrust the women had in the medical system, the less likely they were to undergo genetic testing and counseling. In fact, some of the researchers on this study are affiliated with Johns Hopkins, which back in the 1950s oversaw the (now) widely publicized experiments using the cells of Henrietta Lacks for research.

There’s a long history of abuse — and resulting mistrust — between the medical and scientific establishment and the black community in the United States. Books such as “Bad Blood: The Tuskegee Syphilis Experiment” and “Killing the Black Body” review this history and are crucial to understanding how past injustices may contribute to ongoing disparities.

The study authors acknowledge this likelihood, and comment on how the era of “personalized medicine” may not benefit all patients equally due to this history of racism:

If minority communities have distrust of the medical system and have not benefited from traditional technologies, it is possible that disparities will persist or even widen in the pharmacogenomics era.

Despite being considered high risk, fewer than 1/3 of the women in the study had ever been referred for BRCA genetic testing by their healthcare provider.

Although the researchers didn’t measure it, the women in the study may have been more likely than many black women to have been referred for BRCA testing in general, as they were largely college-educated women and almost all of them had health insurance.

“Black women who are uninsured or those who have lower levels of education may have less genetic testing and counseling awareness and engagement than we found in our sample,” the study’s authors wrote.

The authors also note that women who are underinsured or uninsured may have trouble accessing these tests, which are expensive. Our Bodies Ourselves was a co-plaintiff in the recent lawsuit against Myriad Genetics, opposing the patenting of BRCA1/2 genes. We hope that the recent Supreme Court decision on those patents will lead to more available, affordable gene testing options for all women.

As an action item for potentially reducing disparities, the authors urge physicians and genetic counselors to “improve medical care by ensuring that risk assessment and risk reduction strategies include a clear presentation of the benefits, not just the risks of testing, and by addressing patient trust and concerns about the medical system.”

Read the full study, “Medical Mistrust and Self-efficacy Influence Black Women’s Level of Engagement in BRCA1/2 Genetic Counseling and Testing,” which is available online for free.


May 17, 2013

Angelina Jolie, Breast Cancer, and You: How to Make the Right Decisions for YOUR Health

Angelina Jolie on the cover of Time magazineAngelina Jolie certainly has good intentions in sharing her experience with breast cancer genetic testing and her decision to have a prophylactic mastectomy, and her announcement marks another welcomed example of well-known women coming forward about personal health issues.

But it is now up to women’s health advocates to ensure that the media coverage and public debate that follows does not offer false information or false hope — which I fear it will, if women are not fully informed about all the issues involved before imagining that Jolie’s decisions would be the right ones for them.

Already, women in the United States undergo a higher rate of mastectomies than women in other countries. “Breast cancer experts believe that many women undergoing mastectomies don’t need them and are getting them out of fear, not because of the real risks,” Diana Zuckerman, president of both the National Research Center for Women and Families and the Cancer Prevention and Treatment Fund, wrote this week.

First, women need to remember that BRCA1 and BRCA2 mutations occur in less than 1 percent of the population. To decide whether testing for breast cancer genetic mutations makes sense for them, it is important to speak with a knowledgeable health care provider. According to the National Cancer Institute:

The likelihood that a breast and/or ovarian cancer is associated with a harmful mutation in BRCA1 or BRCA2 is highest in families with a history of multiple cases of breast cancer, cases of both breast and ovarian cancer, one or more family members with two primary cancers (original tumors that develop at different sites in the body), or an Ashkenazi (Central and Eastern European) Jewish background. However, not every woman in such families carries a harmful BRCA1 or BRCA2 mutation, and not every cancer in such families is linked to a harmful mutation in one of these genes. Furthermore, not every woman who has a harmful BRCA1 or BRCA2 mutation will develop breast and/or ovarian cancer.

The steep price tag of testing, around $3,300, is of concern, though some women considered appropriate candidates for testing may be covered, all or in part, through their insurance. Under the Affordable Care Act, genetic counseling and BRCA testing, if appropriate, are considered preventive services and are covered without cost-sharing.

If a woman does seek testing, she needs to consider the pros and cons of all possible approaches to positive test results. While a bilateral mastectomy reduces the risk of getting the disease by 90 percent, about 10 out of 100 women who have their breasts removed will still get breast cancer in the underlying tissue. And there are numerous potential problems with such surgery that need to be fully discussed, such as infection and mobility impairment.

For those who choose this radical surgery, there is also the decision about whether to pursue breast reconstruction and, if so, what kind. Despite widespread assumptions to the contrary, there are major unresolved safety issues, especially for silicone breast implants.

Some women choose to forgo reconstruction entirely, though most media fail to mention this. The truth is, some women have no problems with their “breastless” bodies, nor do their sexual/intimate partners. Some women also find that modern prostheses are comfortable and offer a satisfying appearance.

Moreover, not all choices — even what might be ideal in a given circumstance — will be possible given financial constraints and lack of adequate medical coverage or support. As Cheryl Lemus, managing editor of Nursing Clio, a blog on gender and medicine, writes:

In order for all women to have the right to red carpet healthcare [...] then all women don’t just need money and insurance, but also the other resources Jolie highlighted in her op-ed, which include the supportive partner/spouse, family, an understanding employer, reliable transportation and childcare, and “time” in general.

Sadly, we know this is often not the case.

We also need to be honest about what we know and don’t know about breast cancer and risk. According to the NCI, women who have inherited a harmful mutation in BRCA1 or BRCA2 gene are approximately five times more likely to develop breast cancer than women who do not carry the mutation.

The way the numbers break down, about 12 percent of the general population — or about 120 women out of 1,000 — will develop breast cancer at some point during their lives, compared with about 60 percent — 600 out of 1,000 — who have inherited a harmful BRCA1 or BRCA2 gene mutation.

Yet there are other factors, such as environmental exposure, that influence breast cancer risk. Some women living in communities with high levels of toxic exposure may have elevated breast cancer risk for a non-heritable reason.

The NCI also notes that the risk factor for those carrying the mutated gene is based on research on large families in which many individuals have been affected by cancer. We still have many questions to answer about genetic and environmental influence:

Because family members share a proportion of their genes and, often, their environment, it is possible that the large number of cancer cases seen in these families may be due in part to other genetic or environmental factors. Therefore, risk estimates that are based on families with many affected members may not accurately reflect the levels of risk for BRCA1 and BRCA2 mutation carriers in the general population. In addition, no data are available from long-term studies of the general population comparing cancer risk in women who have harmful BRCA1 or BRCA2 mutations with women who do not have such mutations. Therefore, the percentages given above are estimates that may change as more data become available.

This heightened interest in breast cancer genetic testing caused an uptick in the stock of Myriad Genetics, which has a monopoly on BRCA1 and 2 testing. OBOS is a co-plaintiff in the lawsuit challenging Myriad Genetic’s patenting of human genes, along with the ACLUBreast Cancer Action, a number of scientific organizations and researchers, and Lisbeth Ceriani, a single mother whose circumstances led her to seek breast cancer genetic testing and who felt stymied by Myriad’s monopoly.

The Supreme Court heard arguments in the case last month and is expected to issue a ruling this summer. Its decision will have a major impact on whether or not scientists will be able to improve upon the current test as well as the future price tag for such testing. In the meantime, let’s hope that thousands of women don’t make hasty decisions about testing and treatment without careful consideration of all the issues involved.

As Zuckerman writes:

As an actress whose appeal has focused on her beauty, surgically removing both her breasts when she didn’t have cancer was a very gutsy thing to do. But if we care about women’s health, we need to stop thinking of mastectomy as the “brave” choice and understand that the risks and benefits of mastectomy are different for every woman with cancer or the risk of cancer. In breast cancer, any reasonable treatment choice is the brave choice.


April 18, 2013

Supreme Court Hears Case Against Myriad Genetics: Why Patents Hurt Women’s Health

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On Monday, the Supreme Court heard oral arguments in the lawsuit against Myriad Genetics, challenging the company’s right to hold patents on  two genes linked to increased risk of breast and ovarian cancer: BRCA1 an BRCA2.

The primary concern — which Our Bodies Ourselves, a co-plaintiff in the case, shares – is that human genes shouldn’t be patentable because they occur in nature. Allowing the patents restricts access to testing and research on these genes, and negatively affects women’s health.

Nina Totenberg, in her coverage for NPR, highlights the significance of the Court’s decision, expected later this year: “There is no way to overstate the importance of this case to the future of science and medicine.”

The oral arguments boiled down to two key opposing points. The attorney for the Association for Molecular Pathology and other plaintiffs in the case argued that the genes cannot be patented because they are found in nature. The attorney for Myriad Genetics essentially argued that because the company found and isolated the gene, it should be able to patent it. There was a great deal of discussion about this point, with analogies such as whether finding and removing a plant from the Amazon should entitle someone to patent that plant as an “invention.”

Major medical organizations have argued that the patents force people in the United States to “undergo tests that are inferior to and more costly than those available in other countries,” with the consequence that “no woman in America can get an independent second opinion about her condition before deciding to have her healthy breasts or ovaries removed in order to avoid cancer.”

In explaining the consequences of allowing the patents, the ACLU has written:

The patents on BRCA1 and BRCA2 are harmful to patients and create barriers to medical and scientific advancement. Myriad has a monopoly on BRCA genetic testing in the U.S. and therefore controls the type and price of testing. Thus, while genetic testing technologies have advanced to the point where all 23,000 human genes can be sequenced for $1000, Myriad has raised its price for BRCA genetic testing to over $4000 in the last few years and still does not capture all known BRCA mutations. Other laboratories cannot provide second opinions, and they cannot include the BRCA genes when offering testing of the multiple genes that are now associated with breast and ovarian cancer risk. Gene patents also have a chilling effect on research. Researchers must either obtain permission from the patentholder, or run the risk of being sued. And by virtue of its patents, Myriad controls most of the data about the BRCA genes and has refused to share that information with the scientific community.

Reporting from the courtroom, Breast Cancer Action praised those who made their voices heard in opposition to the patents:

It was a thrill to meet so many wonderful people working hard for women’s health, and it was incredibly moving to hear from the powerful women who stood up to tell their personal stories. We know that Myriad’s patents on our genes are wrong, and we hope that the Supreme Court will take this opportunity to come down on the right side of women’s health.

More coverage of the case:

For further information and resources, see OBOS’s previous posts:


March 21, 2013

Are Right-to-Know Breast Density Laws Good for Women’s Health?

There’s been much discussion lately about routine mammogram screening for breast cancer, including, according a new study, the very real psychological harm connected to false positive readings.

Complicating this information further is the issue of breast density. Dense breasts have less fat and more glandular and connective tissue. While some women’s breasts become less dense and more fatty as they age, other women’s breasts remain relatively dense.

Why does this matter? Having dense breast tissue makes it harder to obtain an accurate reading of mammograms. It also increases a woman’s risk of developing breast cancer.

However, questions remain about what women should do with that information. In fact, recent research suggests that actual risk of death from breast cancer is not increased for women with denser breast tissue.

Despite a lack of certainty about how dense breast tissue affects health outcomes, a handful of states have mandated that providers discuss breast density with women. On April 1, California will become the fifth state with a breast density notification law in place. Similar bills have been introduced in other states.

At the federal level, the Breast Density and Mammography Reporting Act was introduced in Congress in 2011, but never made it out of committee. It, too, would require that women be told about breast density, the correlation with cancer, and that they might benefit from supplemental screening tests.

It’s not clear, however, if additional tests would even help.

The authors of a recent commentary in the medical journal Radiology note that while explaining the increased risk of cancer to women with dense breasts “seems ethical, reasonable, and appropriate,” there is little known about what additional follow-up might help those women.

They conclude that “the advocacy push to legislate mandatory reporting of breast density and possible adjunct screening for all women with heterogeneously or extremely dense breasts is far outpacing the reporting of evidence that supplemental screening may provide better outcomes for these patients.”

They also raise concerns about invasive procedures: “Because some cancers detected at screening may not go on to cause symptoms or death, additional interventions performed on these excess cancers would only increase morbidity for these patients.”

These concerns are similar to those raised about routine mammography in younger women — that more testing may increase harm to women from extra procedures, while not actually increasing survival rates.

Breast Cancer Action addressed mandatory notification laws in late 2012, coming down against such legislation:

Unfortunately, the importance of breast density is still not well understood and as a result there is no clear action for women who receive this information. Breast Cancer Action believes that medical practitioners should discuss all aspects of a woman’s health with her and we do not believe legislation is the appropriate way to address the issue of breast density. We believe resources and energy are better spent on working for better medical care and understanding the ways to prevent breast cancer in the first place.

Laura Newman, a medical journalist, has also looked at this issue. Her Patient POV blog has a couple of clear, useful posts, including “Are Dense-Breast, Right-to-Know Laws Helpful?” and “Is the Bar High Enough for Screening Breast Ultrasounds for Dense Breasts?

Where does this leave women, especially those who may be told they have dense breast tissue as a result of one of these new laws? Unfortunately, there is no clear answer right now.


March 15, 2013

Rally at the Supreme Court – Breast Cancer Gene Case to be Heard Next Month

Arguments are scheduled to be heard by the Supreme Court on April 15 on the Myriad Genetics case, which will challenge patents held on human genes, especially the BRCA1 and BRCA2 genes known to increase breast cancer risk.

The suit charges that leaving human genes in the hands of corporations limits diagnostic testing and research that could lead to cures, and limit women’s options for medical care.

Breast Cancer Action is holding a rally on April 15, the day the case is heard, to stand up for women’s health and against corporate control of our genes. It begins at 9:30a.m and will take place on the steps of the Supreme Court. To find out more, follow @BCAction on Twitter.

Our Bodies Ourselves is a co-plaintiff in the lawsuit challenging these gene patents. For further information and resources, see these previous posts:


December 12, 2012

The Benefits and Harms of Routine Mammograms

The topic of routine screening mammography has become extremely controversial in recent years, especially following publication of a 2009 evidence review and subsequent U.S. Preventive Services Task Force recommendation that mammography be considered on an individual basis for women in their 40s, rather than automatically recommending mammograms for all women in that age group.

A new study published in the New England Journal of Medicine adds to the questioning of routine mammograms, concluding that “whatever the mortality benefit, breast-cancer screening involved a substantial harm of excess detection of additional early-stage cancers that was not matched by a reduction in late-stage cancers.”

The authors looked at data on how many women age 40 or older had screening mammograms and the incidence of early and late stage breast cancers. The assumption is that if widespread mammography is really helping to catch cancers at earlier, presumably more treatable stages, we’ll see fewer of those late stage breast cancers.

What they actually found was a large increase in detection of early cases (122 per 100,000 women), but a much smaller decrease (8 per 100,000 women) in late cases.

If mammograms were simply shifting diagnosis earlier, they should have seen about the same number for the increase in early cases and decrease in later cases. Instead, it resulted in diagnosis of numerous extra early cases that might not have progressed to more serious disease and would be considered over-diagnosis (with the corresponding over-treatment).

The researchers conclude that “the excess detection attributable to mammography in the United States involved more than 1.3 million women in the past 30 years.”

The authors did find that the death rate attributable to breast cancer had decreased over the last three decades, but they suggest that improvements in treatment over the last few decades may be primarily responsible.

As Dr. Diana Petiti, former vice chair of the USPSTF, explained in an email exchange:

Not all breast cancers detected by mammography would have caused a lump. Some breast cancers detected by mammography (we don’t know how many) revert to normal. Some breast cancers detected by mammography (we don’t know how many) don’t grow to the size of a lump. Some breast cancers detected by mammography (we don’t know how many) grow so slowly, they would not cause a lump in the forseeable lifespan of a woman.

Further not all lumps found by a woman (without mammography) would have caused death from breast cancer. Some breast cancers found as lumps (without mammography) are cured by treatment. Some breast cancers found as lumps (without mammography) grow so slowly that they never cause death due to breast cancer (which occurs because the cancer spreads). Some breast cancers found as lumps (with or without mammography) occur so late in life that something else causes death before the breast cancer spreads and causes death.

The newest data suggests that a not-small percentage of the breast cancers detected by mammography (without a lump) would not have killed the woman from breast cancer had it not been found.

While this is a complicated topic, this New York Times op-ed by Dr. H. Gilbert Welch, one of the authors of study published in NEJM, does a reasonable job of explaining it clearly. Welch, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and an author of “Overdiagnosed: Making People Sick in the Pursuit of Health,” includes this call for change:

What should be done? First and foremost, tell the truth: woman really do have a choice. While no one can dismiss the possibility that screening may help a tiny number of women, there’s no doubt that it leads many, many more to be treated for breast cancer unnecessarily. Women have to decide for themselves about the benefit and harms.

But health care providers can also do better. They can look less hard for tiny cancers and precancers and put more effort into differentiating between consequential and inconsequential cancers. We must redesign screening protocols to reduce overdiagnosis or stop population-wide screening completely.

Dr. David Newman, an emergency room physician in New York City and author of the book “Hippocrates Shadow: Secrets from the House of Medicine,” tackles the controversy head-on in a column titled ”Ignoring the Science on Mammograms“:

For years now, doctors like myself have known that screening mammography doesn’t save lives, or else saves so few that the harms far outweigh the benefits. Neither I nor my colleagues have a crystal ball, and we are not smarter than others who have looked at this issue. We simply read the results of the many mammography trials that have been conducted over the years. But the trial results were unpopular and did not fit with a broadly accepted ideology—early detection—which has, ironically, failed (ovarian, prostate cancer) as often as it has succeeded (cervical cancer, perhaps colon cancer).

More bluntly, the trial results threatened a mammogram economy, a marketplace sustained by invasive therapies to vanquish microscopic clumps of questionable threat, and by an endless parade of procedures and pictures to investigate the falsely positive results that more than half of women endure. And inexplicably, since the publication of these trial results challenging the value of screening mammograms, hundreds of millions of public dollars have been dedicated to ensuring mammogram access, and the test has become a war cry for cancer advocacy. Why? Because experience deludes: radiologists diagnose, surgeons cut, pathologists examine, oncologists treat, and women survive.

Newman also notes that mammography is not the only area of medicine ripe for questioning:

It is normally troubling to see an observational study posing questions asked and answered by higher science. But in this case the research may help society to emerge from a fog that has clouded not just the approach to data on screening mammography, but also the approach to health care in the United States. In a system drowning in costs, and at enormous expense, we have systematically ignored virtually identical data challenging the effectiveness of cardiac stents, robot surgeries, prostate cancer screening, back operations, countless prescription medicines, and more.

To further explore this topic, listen to this WBUR Boston (NPR) segment with Dr. Welch, Judy Norsigian, OBOS founder and executive director, and Dr. Otis Brawley, chief medical officer at the American Cancer Society. Norsigian also wrote a column for WBUR’s Cognoscenti section, “Do Screening Mammograms Do More Harm Than Good?


December 12, 2012

Do Screening Mammograms Do More Harm Than Good?

A sweeping U.S. study published on Nov. 22, 2012 in the New England Journal of Medicine shows that mammograms have done surprisingly little to catch deadly cancers before they spread. At the same time, they have led more than a million women to be treated for growths that never would have threatened their lives. 

Women over 40 are routinely advised to have yearly mammograms, and it’s widely believed that having one is key to protecting a woman’s health.

Although experts agree that diagnostic mammograms are beneficial (cases where there is a breast lump or other symptoms), there is much controversy about screening mammograms, which are performed on women with no signs of cancer. Mammograms detect breast cancer, although many people believe mistakenly that they prevent breast cancer. We now know that the mortality benefits remain quite small.

Eight trials performed in the United States, Canada and Europe have evaluated the ability of screening mammograms to decrease the death rate from breast cancer, as well as overall mortality. Looking at the overall death rate, not just death from breast cancer, is essential, because this approach also evaluates whether the screening test and any subsequent treatment may be causing other harms.

Overall, the early studies showed a 30 percent reduction in the risk of dying from breast cancer in women who were screened by mammography. In 2001, a critical review of all eight trials by the Cochrane Collaboration found that six of them were sufficiently flawed to invalidate their results. The Cochrane Collaboration then pooled the results of the two remaining studies and found no evidence to support the use of screening mammography.

The U.S. Preventive Services Task Force (USPSTF) evaluated the trials also. Although recognizing many of the same flaws, the USPSTF felt only one trial was sufficiently flawed to be invalidated. They pooled the results of the remaining trials and found a 16 percent reduction in the risk of dying of breast cancer in the women in the screened group.

The meta-analysis published in 2006 by the Cochrane Collaboration confirmed that screening does slightly reduce breast cancer mortality, but that it also leads to over-diagnosis and overtreatment of breast cancer. They concluded:

(F)or 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.

In a recent issue of the New England Journal of Medicine, Dr. Archie Bleyer and Dr. Gilbert Welch summarized the latest analyses as follows:

Despite substantial increases in the number of cases of early-stage breast cancer detected, screening mammography has only marginally reduced the rate at which women present with advanced cancer.

And this is the key to meaningful breast cancer screening — that we reduce the rate at which women have to be treated for late stage cancer.

When the data for women under 40 were studied (these are women who generally don’t get regular mammograms), Dr. Welch and Bleyer wrote:

There was a larger relative reduction in mortality among women who were not exposed to screening mammography than among those who were exposed. We are left to conclude, as others have, that the good news in breast cancer — decreasing mortality — must largely be the result of improved treatment, not screening.

Dr. Susan Love, a long time clinician and researcher, would like to see less emphasis on screening and more focus on cancer prevention and treatment for the most aggressive cancers. (Roughly 15 percent to 20 percent of breast cancers are deadly.)

“There are still 40,000 women dying every year,” Dr. Love notes. “Even with screening, the bad cancers are still bad.”

As Donald Berry, a biostatistician at M.D. Anderson Cancer Center in Houston, has pointed out:

Most breast cancers are not lethal, however found. Screening mammograms preferentially find cancers that are slowly growing, and those are the ones that are seldom deadly. Getting something noxious out of the body as soon as possible leads women to think screening saved their lives. That is most unlikely.

The challenge now is to make more widespread the use of techniques that help clinicians identify biological markers that will distinguish between the lethal and benign types of tumors. This appears to be the next big advance in reducing mortality from breast cancer.

Mammography, like other detection tools, is imperfect (it misses about 20 percent of lumps due to dense breasts and other factors). Some would consider it a very weak detection tool, and given the harms of overtreatment (for example, unnecessary chemotherapy and radiation treatments), it is not surprising that some women will want to forego screening mammography.

Women need to carefully consider these factors and decide for themselves what would be best, although friends, caregivers, and even commercial interests may tell them that having routine mammograms is the only rational choice. What really helps is knowledgeable and supportive counseling.

This article was originally posted at Cognoscenti, WBUR Boston’s ideas and opinions section, and is re-posted with permission.


July 31, 2012

The Women’s Health Initiative Studies, Ten Years Later

Although the Women’s Health Initiative trials, which studied different aspects of postmenopausal women’s health, began in 1991, the real game-changing results from the trials happened 10 years ago, in 2002, when the trial of estrogen plus progestin hormone therapy was stopped early. The trial was stopped because those responsible for monitoring trial safety found an increased risk of breast cancer, along with risks for heart attacks, strokes and blood clots to the lungs and legs.

This was major news at the time, because many, many women had been prescribed this combination hormone therapy under the assumption that it might actually protect them from heart disease, cancer, and stroke.

Today, both consumer advocate organizations like the National Women’s Health Network and the federal U.S. Preventive Services Task Force seem to agree that hormone therapy should not be used for the prevention of these diseases.

Earlier this month, in honor of the 10 year anniversary of the halting of the trials, the National Women’s Health Network hosted a blog carnival about hormone therapy. Among the posts:

  • Dr. Sharima Rasanayagam of the Breast Cancer Fund writes about hormone therapy, chemical exposures, and breast cancer risk. (full post here)
  • Karuna Jaggar of Breast Cancer Action on the importance of independently funded research, including the WHI (full post here)
  • Cindy Pearson, Executive Director of the National Women’s Health Network, on the importance of the WHI and the need for ongoing research and “protections against misleading promotion of unproven and unsafe drugs.”
  • Amy Allina, also of NWHN, writes about “challenging unproven medicine and saving lives.”
  • Also, an interview with Dr. Vivian Pinn, former Director of the NIH’s Office of Research on Women’s Health, NIH, on the importance and impact of the WHI trials.

You can find these and other posts on NWHN’s blog.

The NWHN is also collecting stories from women took or were offered hormone therapy before the WHI; who refused it because of the study’s findings; were involved in the study as researchers or participants; and other health care providers, advocates, and individuals affected by the WHI.


June 5, 2012

Hormone Therapy and Chronic Disease Prevention

This month, the U.S. Preventive Services Task Force released a new report which is informing their updated recommendations on hormone therapy for chronic disease prevention in menopausal women. Bone fractures, dementia, stroke, and urinary incontinence were among the chronic conditions they examined.

In the 2005 recommendations, USPSTF recommended against routine use of combined estrogen and progestin for the prevention of chronic conditions in postmenopausal women, and against estrogen alone for the prevention of chronic conditions in postmenopausal women who have had a hysterectomy. The new research looked at 9 newer studies – mostly from the Women’s Health Initiative – in order to review and update those recommendations.

Based on their review of the evidence, the authors concluded that both regimens – estrogen plus progestin, and estrogen alone – decrease risk of bone fracture but increase risk for stroke, thromboembolic events (blood clots in the legs or lungs), gallbladder disease, and urinary incontinence. Estrogen plus progestin was found to increase risk for breast cancer and probably dementia, while estrogen alone may slightly decrease risk for breast cancer.

The draft new recommendations are very similar to the 2005 ones. The USPSTF “concludes with high certainty that there is zero to negative net benefit for the use of combined estrogen and progestin therapy for the prevention of chronic conditions, and concludes with moderate certainty that there is no net benefit for the use of estrogen alone.” They also explain that the recommendations do not apply to women younger than age 50 who have undergone surgical menopause, and they don’t address use of hormone therapy for the management of menopausal symptoms like hot flashes or vaginal dryness.

There were some limitations of this research described by the authors, like the small number of new studies, variations in the studies that make it hard to combine their findings, and lots of study participants who dropped out before the trials were finished. In addition, most of the women in the studies were 60 to 69 years old. Additional research is needed that looks at women who are transitioning through menopause or immediately postmenopausal.

A Washington Post article puts the findings in context, explaining:

One form of hormone replacement therapy — estrogen alone — did appear to slightly reduce the incidence of breast cancer. Invasive breast cancer looms large as a concern to many women, but affects just 11 percent of them past menopause.

That possible protective effect became less consequential when weighed against hormone therapy’s impact on far more likely risks to women’s health…It fails to reduce the risk of heart disease, which will affect 30 percent of women who live past menopause. It slightly increased the likelihood of dementia, which will affect 22 percent of all post-menopausal women. It was linked to a higher likelihood of stroke, affecting 21 percent of these women.

 


May 24, 2012

Breast Cancer Action Webinar: Inequities in Breast Cancer

Last week, Breast Cancer Action hosted a webinar, Inequities in Breast Cancer: Race and Place Matter, presented by Sahru Keiser of BCA and Irene Yen of UCSF. They discussed disparities in deaths and especially survival 5 years past diagnosis among Black, Latina, Asian and Pacific Islander, Native Hawaiian, and Native American and Alaska Native women. For example, Keiser noted that Latinas are 20% more likely to die than white women, even when diagnosed at a similar age and cancer stage.

The presenters also discussed how these disparities persist even if the women have equal access to health care. One factor they considered was exposure to toxic chemicals at work at home, for which there are also disparities between races/ethnicities, and access to neighborhoods and communities that promote physical activity, which reduces cancer risk. The presenters wanted participants to understand the role of place in disparities as well as the role of race, and to consider how communities could plan places in a way that reduces those disparities.

If you’d like to view the recording of the webinar, it’s now online.