Archive for the ‘Breast Cancer’ Category

December 20, 2010

Avastin Follow-Up: Info from the FDA

On Friday, Christine posted, FDA Moves to Revoke Approval of Popular Breast Cancer Drug, with the news of and reactions to the FDA’s recent decision that Avastin (bevacizumab) should no longer be approved for use for breast cancer because “the agency has determined that the risks of the drug outweigh the benefits for this use.”

The FDA has posted a site with additional details about the recommendation, including their decision memo explaining the agency’s rationale, press release, questions and answers, and letter to the breast cancer community.

December 17, 2010

FDA Moves to Revoke Approval of Popular Breast Cancer Drug

The FDA has begun the extraordinary process to revoke approval of the use of the popular drug Avastin to treat advanced breast cancer.

Avastin had received accelerated approval in 2008, but further studies have not shown that the drug improves either overall survival rate or quality of life.

Andrew Pollack of The New York Times notes that the approval is not without some controvery — as “various breast cancer patients and some patient advocacy groups have urged the F.D.A. to keep the drug approved and not deny patients a chance at what they say could be a life-saving therapy.”

Pollack also notes the financial stake the drugmaker Roche has in the drug: “Avastin is the world’s best-selling cancer drug, with annual sales of about $6 billion. Analysts have estimated that revocation of the breast cancer approval could cost Roche $500 million a year or more in lost sales.”

Some Republicans in Congress, moreover, have tried to portray the potential revocation as “an attempt at cost control, the beginning of rationing under the new health care law,” even though the FDA’s actions are part of the system set up in the 1990s to evaluate drugs that have received accelerated approval.

Breast Cancer Action, whose opinion we trust more than Republicans’ when it comes to advocating for the best interests of women, opposed Avastin’s original approval of the drug and sent a letter to the FDA this past July recommending approval be revoked. As BCA Program Manager Kimberly Irish noted in an e-mail concerning the latest news, the FDA’s decision is a matter of medical justice:

In 2007, BCA was the only breast cancer organization to actively oppose the use of Avastin for metastatic breast cancer patients because of its failure to improve overall survival or quality of life, its side effects and its high price tag. We applaud the FDA for recommending that Roche’s request for full approval of Avastin for advanced breast cancer treatment be denied.

The interests of patients must come before the profits of companies manufacturing the treatments. We need to continue to demand better drugs for people with metastatic disease. We have a long way to go to end this epidemic but the FDA’s decision to put patient needs before drug company profits is at least a step in the right direction.

November 3, 2010

NPR Takes on Pink Ribbon Fatigue: Views from Komen, Breast Cancer Action

We’ve written multiple times about pink ribbon-type breast cancer awareness campaigns — with good reason.

Concerns abound over whether the explosion of pink products for purchase promotes a false sense of doing something about breast cancer; whether the dollars collected by these pink campaigns are directed effectively; the gender stereotypes perpetuated by both the color focus and many of the product campaigns; and whether some of those pinked-out products may actually be harmful to women’s health.

Noted author Barbara Ehrenreich explores the issue more thoroughly in this still incredibly relevant 2001 Harper’s piece, and discussions of “pinkwashing” can be readily found online.

NPR dove into the debate recently with two interviews: one with Barbara Brenner of Breast Cancer Action, which has raised the concerns above for some time, and the other with Katrina McGee of Susan G. Komen for the Cure, which signs off on the majority of those pink ribbon product campaigns.

Brenner argues:

“Awareness we have, the question is, what are we doing about it? And when companies can just slap a pink ribbon on any product, then we’re in trouble, because many of those products don’t do anything for breast cancer. And many of them are actually harmful to our health.”

The stand-out line: “If shopping could cure breast cancer, it would be cured by now.”

KFC’s “Buckets for the Cure” campaign, says Brenner, sends the wrong message: “You can’t sell pink bucketed chicken that’s bad for your health to raise money to help breast cancer.” BCA has more info on its website concerning the implications.

McGee, in a separate interview, seems to argue that branding unhealthy products (such as fried chicken from KFC) with pink ribbons is OK, because the organization believes “in reaching people where they live, work and play.” She continues:

“KFC helps us do that in very small communities where they may be the only fast food restaurant in town, and in many large communities where the franchisees, and those are really the people who made the contribution, sent their commitment to breast cancer to race for the cure. They did education in their restaurants and a host of other things to support the partnership.”

When asked whether there is a certain amount of pink ribbon fatigue, and whether people are somewhat jaded about these campaigns, McGee answered:

No, I really don’t. I mean, first of all, you know, nearly 40,000 women die of breast cancer each year. And until we get to the point where less women are dying, we will never have enough pink. And as long as there are still myths and misperceptions in the market, we need Breast Cancer Awareness Month. We hear all kinds of things from underwire bras cause breast cancer, to promiscuous sex causes breast cancer, to, you know, if I use a hair relaxer, it will cause breast cancer. [...] It’s the reminder, the repetitive messaging that gets women to act.

Critics of the campaign would probably ask how much of those purchase-related donations actually contributes to education about such issues.

For further guidance on evaluating pink ribbon campaigns, see Breast Cancer Action’s list of questions for consumers to ask in order to “Think Before You Pink.”

October 12, 2010

The Explosion of Pink

It’s October, so the explosion of pink products at the grocery and other stores shouldn’t surprise us: it’s National Breast Cancer Awareness Month, the time of the year when we’re asked to eradicate breast cancer by buying pink-ribboned  products.

Over the years, many women’s health activists have criticized the pink ribbon campaigns, protesting that these efforts do little to fund prevention, are less useful than direct donations, and promote a false sense of doing something to cure breast cancer. The New York Times Well Blog yesterday included a piece on “Pink Ribbon Fatigue,” which nicely summarizes some of the objections to the overwhelming pinkification of October and breast cancer campaigns.

Breast Cancer Action, of course, has run a “Think Before You Pink” campaign for several years, encouraging consumers to ask how much their pink purchases actually contribute and whether any of those products may actually contribute to cancer risk.

New to the conversation is a recently published book by Gayle Sulik, Pink Ribbon Blues: How Breast Cancer Culture Undermines Women’s Health. I haven’t read it yet, but Sulik is interviewed in the Times piece linked above, where she talks about the kind of forced optimism associated with these campaigns, the associated gender roles and expectations, and potential financial conflicts “that keep the war on breast cancer profitable.” Sulik also  blogs on the issue.

If you’re a Facebook user, you may have seen recent “I like it on…” posts and wondered what they’re about. It turns out they’re an even less useful version of the earlier bra color meme, ostensibly intended to raise awareness about breast cancer through status posts. I think it’s clear enough that while social media tools may be useful for organizing and awareness-raising, mysterious status updates with faux titillation and no actual mention of breast cancer do little to promote real action on women’s health. As the blogger at Voxygen responded, “I like it without pinkwashing.”

August 19, 2010

Committee to Shape Federal Research Agenda on Breast Cancer Genetics, Environmental Factors

Earlier this summer, we wrote about the President’s Cancer Panel report on environmental causes of cancer. Relatedly, the National Institutes of Health announced this week the formation of a committee to focus in part on environmental factors related specifically to breast cancer.

The committee will “develop and coordinate a strategic federal research agenda on environmental and genetic factors related to breast cancer.” It will apparently review current federal breast cancer research activities and make recommendations for improving these programs.

The committee is composed of representatives from the EPA, CDC, National Cancer Institute, the National Institute of Environmental Health Sciences, and other federal agencies, along with several physicians and scientists, and representatives from the advocacy groups Zero Breast Cancer, Breast Cancer Options, Academy for Cancer Wellness, Huntington Breast Cancer Action Coalition, National Breast Cancer Coalition, and the Breast Cancer Fund.

For more information, the National Institute of Environmental Health Sciences provides some (rather technical) resources on breast cancer and the environment, and has produced a report (most recently in 2008) on the State of the Evidence: The Connection Between Breast Cancer and the Environment [PDF]. The National Cancer Institute provides an online “understanding cancer” series which includes a set of slides and information on cancer and the environment.

July 23, 2010

Breast Cancer: Early Detection Methods Prone to Error; Plus News on Avastin, New Study on Risks

When the U.S. Preventive Services Task Force (USPSTF) released new recommendations in 2009 calling for less frequent screening mammograms for women under age 50, the news caused quite a ruckus.

Many women’s health organizations, such as Our Bodies Ourselves, National Women’s Health Network and Breast Cancer Action, applauded the new guidelines — and had, in fact, been recommending the same approach for pre-menopausal women for many years. But understanding the science behind the logical, if somewhat counter-intuitive, recommendations requires a nuanced analysis.

Now, a New York Times examination of breast cancer cases explains, in very personal terms, the problems with diagnosing breast cancer — especially early detection methods, which are “prone to both outright error and case-by-case disagreement over whether a cluster of cells is benign or malignant.”

As a result, pathologists are over-diagnosing and doctors are over-treating small growths in the breasts that are often benign.

While the initial reaction might be, “Wait, isn’t it better to treat all potential signs of cancer than leave them untreated?” the NYT does a good job explaining the very real dangers that can result. Moreover, the root problem is that we still don’t have a truly accurate diagnostic tool, and diagnosis can vary depending on one person’s reading of a tiny speck.

As the Times explains, ductal carcinoma in situ, or DCIS (also called Stage 0 or non-invasive cancer) was a rare diagnosis before the 1980s, but today more than 50,000 women per year in the United States alone are told they have DCIS. Typically the abnormal cells in the breast ducts are removed via surgery — which can result in disfiguration of the breast — along with drugs and radiation. DCIS may progress to a more invasive cancer about 30 percent of the time, according to estimates in the Times article, but in some women it can take decades to do so.

Stephanie Saul’s reporting chiefly concerns pathologists, who are responsible for determining whether cells from a biopsy are malignant:

Advances in mammography and other imaging technology over the past 30 years have meant that pathologists must render opinions on ever smaller breast lesions, some the size of a few grains of salt. Discerning the difference between some benign lesions and early stage breast cancer is a particularly challenging area of pathology, according to medical records and interviews with doctors and patients.

Diagnosing D.C.I.S. “is a 30-year history of confusion, differences of opinion and under- and overtreatment,” said Dr. Shahla Masood, the head of pathology at the University of Florida College of Medicine in Jacksonville. “There are studies that show that diagnosing these borderline breast lesions occasionally comes down to the flip of a coin.”

There is an increasing recognition of the problems, and the federal government is now financing a nationwide study of variations in breast pathology, based on concerns that 17 percent of D.C.I.S. cases identified by a commonly used needle biopsy may be misdiagnosed. Despite this, there are no mandated diagnostic standards or requirements that pathologists performing the work have any specialized expertise, meaning that the chances of getting an accurate diagnosis vary from hospital to hospital.

In the face of studies that have shown the high risk of misdiagnosis (in anywhere from 7.8 to 20 percent of cases, depending on the study), the College of American Pathologists is vowing to start a voluntary certification program for pathologists who read breast tissue. But as Saul notes, “Some pathologists have found the response to these types of studies slow and inadequate” — especially since studies going back as far as 2002 have revealed the problem.

The physical and psychological scarring that ensues is, in many cases, unnecessary — along with the potential long-term effects of radiation therapy.

Where you live and what kind of insurance coverage you have can also affect the accuracy of the diagnosis. Rural, community hospitals are more likely to have less experienced pathologists on staff. And insurers have not encouraged second opinions.

“Some insurance plans pay as little as $10 to pathologists who are performing second opinions on DCIS,” Saul notes in response to a comment left by “MK,” who made an excellent point: “If insurers had a requirement that any slides in which cancer was suspected were automatically sent to a board-certified pathologist, it would save patients having to search for a second opinion and save the insurers the cost of unnecessary treatment.”

It should be noted that percentages of misdiagnosis, as Saul reminds “MK,” includes both false negatives and false positives. Under-diagnosis and under-treatment is also an issue. The danger of a positive diagnosis, however, goes beyond whether it is false:

Fear compounds the confusion, and even though D.C.I.S. is 90 percent curable, there is growing concern that women and their doctors opt for more aggressive surgery, radiation and drug therapy than is needed.

A mastectomy is sometimes offered as an option for D.C.I.S., although experts say it is usually not advisable unless the D.C.I.S. is large or appears in several sites in the breast.

Yet more women who are faced with the diagnosis of D.C.I.S. become so fearful that they elect to have both breasts removed, often against their doctor’s recommendations.

“The patient gets paralyzed with a fear of cancer,” Dr. Masood said. “They want the breast off.”

Among women who had surgery for D.C.I.S., the rate of double mastectomy rose to 5 percent in 2005, from 2 percent in 1998, according to a study last year.

Dr. Ira J. Bleiweiss, chief of surgical pathology at Mount Sinai Medical Center in New York, said that ideally, all breast cancer diagnoses would be referred for a second opinion. He warns patients and their doctors: “Don’t rush to the operating room.”

In related news …

New Study Links Breast Cancer Risk, Household Products: Speaking of caution and prevention, a new study in Environmental Health found a higher breast cancer risk among women with higher use of household cleaning products.

The study by Silent Spring Institute was based on telephone interviews with 787 women diagnosed with breast cancer and 721 comparison women. Many of the products contain endocrine disrupting chemicals or mammary gland carcinogens, making them suspect as contributors.

There are, of course, limitations inherent to this type of study, including the potential for recall bias. Researchers recommend further study.

Julia Brody, executive director of the Silent Spring Institute, said, “When women are diagnosed with breast cancer, they often think about what happened in the past that might have contributed to the disease. As a result, it may be that women with breast cancer more accurately recall their past product use or even over-estimate it. Or, it could also be that experience with breast cancer influences beliefs about its causes. For example, women diagnosed with breast cancer are less likely to believe heredity contributes ‘a lot’, because most are the first in their family to get the disease.”

Plus: Interested in taking action — personally and politically? The Silent Spring Institute offers a number of action kits full of helpful information, including how to reduce risks in your home.

Recommendation to Revoke Avastin: An FDA advisory committee has recommended revoking approval of the drug Avastin, for which the FDA had given conditional approval in 2008 to treat breast cancer (part of an accelerated process for drugs that treat life-threatening diseases but have less than complete evidence of effectiveness).

If the FDA, which usually follows these recommendations, takes the very unusual step of revoking approval of a drug, Avastin will still be available, since it is approved for a variety of other cancers. This would leave it open to “off-label” use for breast cancer, but insurers would be reluctant to pay for it and it would no longer be part of a program that caps its annual cost to patients.

Breast Cancer Action program manager Kimberly Irish responds to the decision: “We agree with the committee’s recommendation, and we’re saddened that after all this time there’s still no good option to offer patients when current treatments have failed.” Read the written comments BCA sent to the committee here (PDF).

April 20, 2010

Social Justice Activist: Rita Arditti

View all Women’s Health Heroes. Voting closes May 14. Background info here.

Entrant: Emma McGuinnes
Nominee: Rita Arditti

As a women’s studies major, I have learned the importance of examining and understanding connections when fighting for social justice. Rita Arditti, a feminist, a human rights activist, an environmentalist and a biologist, spent her life exposing these intersections and advocating for the need to develop a consciousness about such links that contribute to oppression.

Rita was born in 1934 in Argentina and studied biology in Italy before settling in the United States. She co-founded the Science for the People movement in the 1970s, which pushed to show the connections between science, the Vietnam War and politics. The movement, which was anti-war in spirit, was to raise awareness about how science can be manipulated to support certain political agendas.

In 1974, Rita was one of four founders of the New Words Bookstore in Cambridge, Mass., a women’s bookstore that offered a space for words and voices of those who had been silenced to be showcased and heard. The bookstore also hosted several activism events bridging the gap between academia and the community.

Later in life, Rita also helped to found the Women’s Community Cancer Project, whose mission was to raise awareness about environmental exposures that contribute to women’s cancers. Rita herself lived with breast cancer for decades, and she was dedicated to showing the links between chemicals and the rise in cancer in women. Intersecting her feminist, environmentalist and biology background, Rita critiqued the medical world for being male-dominated and influenced by major chemical producers. She was not satisfied with the treatment-oriented approach to cancer research and advocated for looking at how to prevent women from getting cancer in the first place.

Rita Arditti passed away on December 25, 2009. She will be greatly missed and always be remembered. She raised a critical awareness about how fields traditionally taken as fact, such as science and medicine, can be misused to support certain political ideologies and to perpetuate oppression. Rita worked endlessly for social justice and for providing the space for those who have been marginalized to be heard.

April 5, 2010

Breast Cancer Gene Patents Invalidated

Last summer, we shared that OBOS had joined an ACLU lawsuit challenging breast and ovarian cancer gene patents.

Briefly, the ACLU and the Public Patent Foundation (with plaintiffs including OBOS, pathology associations, and individuals) filed a lawsuit against the U.S Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, “charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.” The suit focused on the BRCA1 and BRCA2 genes, mutations of which are related to increased risk of breast and/or ovarian cancers, and for which Myriad Genetics controlled the patents (effectively controlling the available testing for important mutations).

As Breast Cancer Action explained, “When one company controls all the testing, less information and resources are available to both patients and researchers.” The New York Times story on the ruling also explains that “Some doctors and researchers contend that this monopoly has long held up not only competing, cheaper tests but has also hindered gene-based research.”

Last Monday, a U.S. judge ruling in the case invalidated the patents, arguing that “the company deserved praise for what is ‘unquestionably a valuable scientific achievement,’ but not a patent because the ‘isolated DNA is not markedly different from native DNA as it exists in nature.’” Essentially, the relevant genes are found in nature and thus aren’t novel enough to qualify for patent protection.

The judge dismissed the claim that the U.S. Patent and Trademark Office’s issuing of the patents was unconstitutional. The complete ruling can be found here [PDF]. The ruling has the potential to make the study of and testing for important genetic variations cheaper and more readily available.

Genomics Law Report has a good overview of the ruling, and several ScienceBlogs authors are also talking about the case, with one calling the ruling “a monumental step towards bringing sanity to biotech patents.”

This Sunday, CBS aired an episode of 60 Minutes that prominently featured the case. As OBOS was a plaintiff to the suit, we also got a chuckle out of the title of this editorial at the NYDailyTimes: Our bodies, ourselves: Judge rightly rules that no one can patent human genes

The ACLU itself also has commentary on the ruling, calling it “a huge victory for women’s health and scientific freedom,” and NPR’s Richard Knox has an interview with an attorney who explains the ruling and its implications.

February 9, 2010

Quick Hit: Panel Discussion on Mammography and Breast Self-Examination Recommendations

For our Wellesley, Mass.-area readers, an upcoming panel discussion on new recommendations for mammography and breast self-examination may be of interest.

Panelists will include Cindy Pearson of the National Women’s Health Network and Ngina Lythcott of the Black Women’s Health Imperative, with moderator Susan Reverby from Wellesley College’s Women and Gender Studies department.

The discussion will take place on Thursday, Feb. 25, in PNW 212 (Pendleton West 212 Amphitheater Classroom) from 5 – 6:15 p.m.

Questions can be directed to ctaylor1 at wellesley dot edu.

November 25, 2009

Courts Find in Favor of Women Claiming Prempro Caused Breast Cancer

Courts in Philadephia recently ruled in favor of two plaintiffs who sued Pfizer because they believed their breast cancer was caused by taking Prempro, an estrogen plus progestin combined hormone replacement therapy (formerly sold by Wyeth).

More than $100 million was awarded by juries between those two cases, although news reports indicate that Pfizer will appeal and damages awarded are likely to be reduced; a Pfizer spokesperson said the company does not believe the verdicts “were supported by the evidence or the law.” About 10,000 similar cases are apparently pending at this time.

In 2002, the Women’s Health Initiative study was released results indicating that women taking estrogen plus progestin hormone replacement (such as Prempro) were more likely to develop breast cancer than women taking placebo, and their cancers were more likely to be more advanced. The trial was stopped early that year after it became clear to investigators that the risks of combination hormone therapy outweighed the reported benefits.

As a result of WHI findings, in 2003 the FDA required the addition of a black box warning to the drug’s label to state that estrogen and estrogen plus progestin therapies should not be used for the prevention of cardiovascular disease, and to warn of increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women taking the estrogen/progestin combo.

November 18, 2009

New Mammogram Guidelines Are Causing Confusion, But Here’s Why They Make Sense

New government guidelines recommending that women start screening for breast cancer at age 50 instead of 40 set off a round of criticism this week and caused much confusion for women who for years have been told that early detection saves lives.

But a number of women’s health organizations, including Our Bodies Ourselves, the National Women’s Health Network and Breast Cancer Action, for years have warned that regular mammograms do not necessarily decrease a women’s risk of death. Premenopausal women in particular are urged to consider the risks and benefits.

In fact, the NWHN issued a position paper in 1993 recommending against screening mammography for pre-menopausal women. It was a very controversial position at the time — even more so than now. The breast cancer advocacy movement was in its infancy and efforts were focused on getting Medicare and insurance companies to cover mammograms. What the NWHN found — and other groups have since concurred — is that the potential harm from screening can outweigh the benefits for premenopausal women.

That statement is tricky, and based on the poor explanations I’ve seen that fail to specifically address the potential dangers, it’s no wonder women are frustrated. Some are even questioning whether the guidelines were unveiled as a cost-cutting measure — a sign of the “rationing” to come under health care reform. In addition to delaying routine screening until age 50, the guidelines recommend screening women between the age of 50 and 74 every two years. It’s important to keep in mind this is intended for women with no known risk factors; women in high-risk groups should start earlier, and it may be prudent to schedule more frequent mammograms.

Adding to the confusion, cancer groups are split. The American Cancer Society came out strongly against the new guidelines. The National Cancer Institute, meanwhile, said it would reconsider its own recommendations in light of new studies. Some doctors said they would proceed cautiously before revising screening advice for patients.

I don’t believe the new guidelines are politically motivated, nor are they “patronizing” to women simply because they call into question the stress related to biopsies and false positive results. Rather, the guidelines provide a useful framework for helping each of us to decide when is the best time to begin screenings and the intervals at which they should be repeated.

The guidelines are in sync with international recommendations; the World Health Organization recommends starting screening at age 50, and in Europe, mammograms are given to post-menopausal women every other year and detection rates are similar to the United States. During an interview on MSNBC on Tuesday, breast cancer expert Dr. Susan Love said the government’s guidelines bring us into line with the rest of the world and with current research. (Read more at her blog.)

You might be thinking: Wait a moment, isn’t earlier better? Why would delaying detection be in my best interest? I’m going to explain why, but let’s first take a closer look at the guidelines, which were released by the U.S. Preventative Services Task Force (USPSTF), an independent panel of experts in prevention and primary care. (The task force operates under the Agency for Healthcare Research and Quality, the research arm of the U.S. Department of Health and Human Services.)

The guidelines are an update of the 2002 USPSTF recommendation statement, which called for mammograms every one to two years, starting at age 40. Dr. Alfred Berg of the University of Washington, who chaired the task force in 2002, told The New York Times this week, “We pointed out that the benefit will be quite small.” He added that while older women experience the most benefits from the screening, mammograms still prevent only a small percentage of breast cancer deaths.

Breast cancer is the second-leading cause of cancer-related deaths in women (lung cancer is number one). According to the National Cancer Institute, about 192,370 women will be diagnosed with breast cancer in 2009, and 40,170 women will die of the disease this year. A woman who is now 40 years old has a 1.44 percent chance of being diagnosed with breast cancer over the next 10 years.

For the 2009 update, the panel, now with different members, examined the role of five screening methods in reducing breast cancer mortality rates: film mammography, clinical breast examination, breast self-examination, digital mammography, and magnetic resonance imaging. It also commissioned two studies:

1.) A targeted systematic evidence review of six selected questions relating to benefits and harms of screening.

2.) A decision analysis that used population modeling techniques to compare the expected health outcomes and resource requirements of starting and ending mammography screening at different ages and using annual versus biennial screening intervals.

Here is the summary of the task force’s findings, published in the Annals of Internal Medicine. The grades are explained here; A is the highest recommendation (meaning there’s a high certainty the benefits are substantial), and D is the lowest. A rating of I indicates evidence is insufficient or conflicting.

The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms. This is a C recommendation.

The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. This is a B recommendation.

The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. This is an I statement.

The USPSTF recommends against teaching breast self-examination (BSE). This is a D recommendation.

The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. This is an I statement.

The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer. This is an I statement.

Dr. Diana Petitti, a professor of biomedical informatics at Arizona State University and vice chair of the current task force, told The New York Times the panel knew the recommendations would surprise many women, but, she said, “We have to say what we see based on the science and the data.”

Frankly, I was surprised by the conclusion that self breast exams are not considered useful. News stories this week have included many anecdotes from women who found a lump that turned out to be cancerous, and every doctor I heard interviewed said that women should definitely contact their physician if they notice any changes in their breast. But what we’re learning is that feeling our own breasts for lumps is not statistically effective, and women who do self breast exams get twice as many biopsies.

The World Health Organization concurs: “There is no evidence on the effect of screening through breast self-examination (BSE). However, the practice of BSE has been seen to empower women, taking responsibility for their own health. Therefore, BSE is recommended for raising awareness among women at risk rather than as a screening method.”

Around 37 million mammograms are done each year. So what’s the problem there? For starters, mammograms use low-dose X-rays to examine the breast, and exposure to radiation can have a cumulative effect on the body. And they’re imperfect. About half of all premenopausal women, and one-third of postmenopausal women, have dense breasts, which makes their mammograms more difficult to read.

Mammograms produce false-positive results in about 10 percent of cases, leading to anxiety that can last for years, unnecessary and sometimes-disfiguring biopsies, and unneeded treatment, including surgery, radiation and chemotherapy — each of which present their own complications and health risks, including an increased risk of other cancers and heart disease.

According to the National Breast Cancer Coalition, U.S. estimates show a woman’s cumulative risk for a false-positive result after 10 mammograms is almost 50 percent. The risk for undergoing an unnecessary biopsy is almost 20 percent. Barbara Brenner, executive director of Breast Cancer Action, told me last year that research indicates that having more biopsies increases the risk of breast cancer, though the reason is unclear (read my post here).

Women are constantly being told “early detection saves lives,” but in reality we know some breast cancers, by the time they’re found, cannot be treated. Other cancers will never be life-threatening, and some will respond to currently available treatments. Unfortunately, the type of cancer cannot be determined at the time of diagnosis, which means we don’t know for sure whether the treatment will cause more harm than the cancer.

If you’re reading this and thinking you still want to keep that scheduled mammogram, you should certainly do so.

“No one is saying that women should not be screened in their 40s,” said Petitti, the task force vice chair. “We’re saying there needs to be a discussion between women and their doctors.”

Dr. Amy Abernethy of the Duke Comprehensive Cancer Center said she agrees with updated recommendations.

“Overall, I think it really took courage for them to do this,” she said. “It does ask us as doctors to change what we do and how we communicate with patients. That’s no small undertaking.”

Finally, I want to address the insurance question. At this point, insurance companies and Medicare administrators are saying that they will continue to pay for mammograms. Here’s what may change in the future, according to The New York Times:

The guidelines are not expected to have an immediate effect on insurance coverage but should make health plans less likely to aggressively prompt women in their 40s to have mammograms and older women to have the test annually.

Congress requires Medicare to pay for annual mammograms. Medicare can change its rules to pay for less frequent tests if federal officials direct it to. Private insurers are required by law in every state except Utah to pay for mammograms for women in their 40s.

But the new guidelines are expected to alter the grading system for health plans, which are used as a marketing tool. Grades are issued by the National Committee for Quality Assurance, a private nonprofit organization, and one measure is the percentage of patients getting mammograms every one to two years starting at age 40.

That will change, said Margaret E. O’Kane, the group’s president, who said it would start grading plans on the number of women over 50 getting mammograms every two years.

For more information, here are some good stories and links:

NPR: All Things Considered looks at the research.

Washington Post: A good overview of the guidelines and cost controversy.

ScienceBlogs: “From my perspective, these new recommendations are a classic example of what happens when the shades of gray that make up the messy, difficult world of clinical research meet public health policy, where simple messages are needed in order to motivate public acceptance of a screening test,” writes Orac. “It’s also an example where reasonable researchers and physicians can look at exactly the same evidence for and against screening at different ages and come to different conclusions based on a balancing of the potential benefit versus the cost.”

November 11, 2009

Breast Cancer Survivors May Experience Ongoing Pain After Surgery

The current issue of JAMA has an article and editorial on the chronic pain experienced by some women following breast cancer surgery. This is not a topic I’ve personally read or heard much, so I was interested and surprised to read the editorial’s opening statement that “Chronic pain after breast cancer surgery occurs in approximately 50% of patients.”

The associated study paper in the journal provides more detail.  The research looked at 3,253 women in Denmark who had undergone unilateral (one-sided) breast cancer surgery in 2005-2006. The women were surveyed 2-3 years after surgery. Clinical data on the surgeries and follow-up was extracted from Danish registries, and women were surveyed about the presence or absence of pain and its location, severity, and frequency.

The authors found that 47% of the surveyed women reported pain. Of these women, 13%  reported severe pain; 39% reported moderate pain; and 48% reported light pain.

Among the 13% of women with severe pain, 77% experienced pain every day. Many of the women experiencing ongoing pain (28%) had additional contact with a physician to try to address the issue, or were taking analgesics or receiving other therapy in attempts to relieve the pain.

Younger women were more likely to report pain. There was no difference in rates of ongoing pain for mastectomy vs. breast conserving surgery, but women who had mastectomy had a higher risk of moderate to severe pain as opposed to lighter pain. Women who received adjuvant radiotherapy also had a higher risk of reporting pain. Additional women reported sensory disturbances or discomfort.

With nearly 50% of women experiencing chronic pain 2 to 3 years after surgery, it’s clear that more research on effective ways of controlling or preventing the pain needs to happen.

October 26, 2009

Revisiting Breast Cancer Screening Guidelines

A commentary in the current issue of the journal JAMA addresses breast and prostate cancer screening and the complexities and limitations of current screening approaches. The authors explain that while screening for the two diseases has increased, “the absolute numbers of more advanced disease have not decreased nearly as much as hoped for either cancer,” and that mortality has not decreased as much as expected.

It’s a complicated topic, even without getting into issues of access to screening and racial disparities in screening and treatment (which the JAMA piece does not). Essentially, the key limitations of screening are that widespread screening with current methods may sometimes detect slow-growing or inconsequential tumors, resulting in unnecessary treatment (because it’s not yet possible to predict which tumors present little risk), while in other cases, early detection doesn’t decrease mortality rates, because certain aggressive cancers, even when caught early, will not respond to treatment.

These messages are not easy message to convey or understand, and some worry that the related headlines may lead people to think screening is unwarranted. In a New York Times article on the commentary one biostatistician expressed concern that “the complex view of a changing landscape will be distilled by the public into yet another ‘screening does not work’ headline. The fact that population screening is no panacea does not mean that it is useless.”

The authors of the JAMA commentary don’t propose abandonment of breast and prostate cancer screening, however – they propose an improved approach consisting of determining validation tools that can identify and differentiate high and low risk cancers, reduction of treatment for minimal-risk disease,  improved clinical and patient support tools to help guide decision-making, and identification of the the highest-risk patients for prevention initiatives. They suggest that there should be investment of significant funds – perhaps 10-20% of the $20 billion spent each year on screening – in these four areas “to improve screening, accelerate prevention research, and reduce harm from breast cancer and prostate cancer deaths.”

The New York Times article on the commentary also generated some controversy when it characterized the American Cancer’s Society’s response to the commentary as “saying that the benefits of detecting many cancers, especially breast and prostate, have been overstated” and that the organization was as a result “reconsider[in] its message about the risks as well as potential benefits of screening.”

The American Cancer Society has issued multiple responses to this characterization, explaining that it is standing by its screening guidelines. Organization representatives stated that they have long acknowledged that cancer screening isn’t perfect, but that “The bottom line is that mammography has helped avert deaths from breast cancer, and we can make more progress against the disease if more women age 40 and older get an annual mammogram.”

However, this research adds more fodder to the question of whether and how effective mammograms are. The Cochrane Collaboration, which creates meta-analysis of high quality systematic reviews, states in its review Screening for breast cancer with mammography that while screening likely reduces breast cancer mortality, ” it is not clear whether screening does more good than harm.”

For more on this topic, see our online content, Mammography Screening Controversy.

August 27, 2009

Politics Interfere with Breast Health Program Funding in California

As noted in a recent article for the LA Times, Planned Parenthood for Orange and San Bernadino Counties is in a dispute with the Orange County (California) government over money from tobacco settlement revenue (TSR) that would have funded a breast health program for uninsured/low-income women under age 40 at high risk for breast cancer.

The County claims that the organization was denied funding for the program due to a missed deadline, while PPOSBC argues that the County set an unreasonable deadline and created restrictions not applied to other clinics receiving the funds.

According to the LA Time Times, Planned Parenthood and 17 other community clinics have received tobacco settlement revenue from the county for the last eight years, but PP’s contract was suspended in March after someone questioned taxpayer money going to a group that performs abortions.

Planned Parenthood for Orange and San Bernadino Counties has information about the situation on its website, including a description of the breast health program and a copy of the letter [PDF] sent to the County of Orange Health Care Agency on July 29th addressing the deadline issue, the county’s refusal to fund or treat Planned Parenthood in the same manner as other clinics, and the perception that barriers to implementing the breast health program are being created because of the abortion services provided by Planned Parenthood.

PPOSBC President & CEO Jon Dunn writes:

The real reason behind this parade of barriers, unreasonable deadlines and refusals to negotiate has nothing to do with providing vital health care to the uninsured women of Orange County. It is because Planned Parenthood offers abortion-related services, wholly independent from any services funded through TSR either in the past or contemplated. The County obviously wants to use any excuse imaginable to preclude Planned Parenthood from participating in the TSR program due to its opposition to abortion. The real losers in this attack on Planned Parenthood, of course, are the medically underserved men, women, and children who live in Orange County.

[Hat tip to the Daily Women's Health Policy Report]

June 4, 2009

OBOS Joins ACLU Lawsuit Challenging Breast and Ovarian Cancer Gene Patents

We’ve written previously about the ACLU’s concern about gene patents, especially regarding the possibility that “high licensing and diagnostic testing fees that some biotech companies charge for use of ‘their’ genes are inhibiting biomedical research and interfering with patient care.”

On May 12, the ACLU and the Public Patent Foundation filed a lawsuit against the U.S Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, “charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.” The suit focuses on the BRCA1 and BRCA2 genes, mutations of which are related to increased risk of breast and/or ovarian cancers.

In explaining the rationale for the lawsuit, ACLU Executive Director Anthony D. Romero wrote:

Knowledge about our own bodies and the ability to make decisions about our health care are some of our most personal and fundamental rights. The government should not be granting private entities control over something as personal and basic to who we are as our genes. Moreover, granting patents that limit scientific research, learning and the free flow of information violates the First Amendment.

The following video provides an excellent overview of concerns about BRCA gene patenting, with additional commentary from ACLU representatives and women concerned about how the patents affect their own health:

Our Bodies Ourselves has joined the suit as a plaintiff, along with the Association for Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, and the College of American Pathologists, several prominent individuals in genetics and pathology, genetic counselors, and individual women patients who have been affected by the patents.

Breast Cancer Action has also joined the suit as a plaintiff, explaining that:

When one company controls all the testing, less information and resources are available to both patients and researchers. Women unable to afford the $3,500 fee are prevented from access to the test; women seeking second opinions on any results they might receive have nowhere to go; and women of African, Hispanic, or Asian descent are at a significant disadvantage because they disproportionately receive ambiguous results when tested by Myriad.

BCA Executive Director Barbara Brenner notes the importance of the landmark case:

There are so many injustices and inequities in breast cancer. The time has come to address them in all their forms—as they affect genetic risk, as well as social, political, and economic realities. This case is an important first step.

OBOS Executive Director Judy Norsigian will appear in a segment on the issue produced by Ivanhoe Broadcast News’s “Smart Woman” team — we’ll post an update when the piece airs.

The suit itself, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York in Manhattan and can be accessed online via this ACLU webpage.

The ACLU is also providing answers to frequently asked questions about the issue, and a number of background resources and fact sheets. Individuals may also sign a statement of support for the plaintiffs.