Posts Tagged ‘breast cancer’

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Breast biopsy: One type is much safer

Posted by medconsumers on January 22, 2010

When a woman needs a biopsy to determine whether a breast abnormality is benign or malignant, she is usually directed to one of two procedures. Which one is best in terms of accuracy and complications is unlikely to be discussed during the usual doctor/patient encounter. It is, however, the subject of a new review that concluded in favor of the core-needle biopsy because results “seem to be almost as accurate as open surgical biopsy, with lower complication rates.” The indefinite choice of words (“seem to be”) can be attributed to the fact that the 84 studies included in this review were judged to be of low quality (though the best of what has been done so far).

A core-needle biopsy can be done with equal success with either stereotactic- or ultrasonography-guidance. The review’s finding was based on studies that compared the diagnoses of women given the minimally invasive core-needle biopsy with the diagnoses of the same women subsequently given either an open surgical biopsy or a radiologic follow-up.

Complications can be: bleeding severe enough to require treatment; pain severe enough to require pain medication; and a hematoma that requires treatment. The complication rate for core-needle biopsy was extremely low—less than 1%; whereas the complication rate for the surgical open biopsy was in the range of 2% to 10%.

This review was led by Wendy Bruening, PhD, ECRI Institute in Plymouth Meeting, PA, and published online first at the Web site of Annals of Internal Medicine. It was funded by the U.S. Agency for Healthcare Research & Quality.

More information
The findings of this review support the outrage expressed one year ago in an editorial by surgeon Melvin J. Silverstein, MD. He was commenting on a new study showing that nearly 40% of the breast biopsies done at one prestigious academic medical center were open surgical biopsies. He estimated that well over 90% of women with suspicious breast abnormalities are appropriate candidates for a needle biopsy and described the circumstances that indicate an open surgical biopsy is appropriate. To read our 2009 interview with Dr. Silverstein, click here.

Maryann Napoli, Center for Medical Consumers©

Posted in Cancer, Pain, Women's Health, breast cancer, surgery | Tagged: , , | 1 Comment »

Mammogram uproar

Posted by medconsumers on November 18, 2009

Ten years ago I opened my driver’s license renewal notice and out dropped a pink slip reminding me to have an annual mammogram. While it was touching to know that the New York State Department of Motor Vehicles cared about my breast health, I saw the pink slip as yet another example of over-the-top mammography promotion. (My husband has yet to receive any health instructions from the DMV.) When a test’s lifesaving benefit has been oversold to the public for over three decades—and the harms downplayed—any cutback in recommendations will be met with a firestorm of anger.

That’s exactly what happened yesterday when a highly respected organization recently broke ranks with others that issue screening guidelines and advised women at average risk for breast cancer to begin having regular mammograms at age 50, not age 40. The U.S. Preventive Services Task Force also changed two longstanding recommendations: women age 50 to 74 should have a mammogram every two years rather than annually (cuts down on the biopsies without altering the number of lives saved), and doctors should stop teaching women how to do breast self-examination (no benefit, more biopsies). Shock, horror, and condemnations followed the announcement in the media on Monday. Not a surprising reaction considering the advice to the public preceded the science.

The recommendation to start mammography screening at age 40 was premature to begin with, dating back to the early 1970s. Incredibly, it was based on one clinical trial conducted in the 1960s that found a 30% reduction in breast cancer deaths in the women over age 50 but no benefit for women in their forties. That clinical trial, known as the Health Insurance Plan of Greater New York study, had followed the participants for three to five years. Not unreasonably, public health officials at the time thought that the younger women in this study would eventually show a reduction in breast cancer mortality with longer followup. They didn’t bother to wait and the aggressive promotion of mammography took off after President Nixon declared the “war on cancer.” Thus began a nationwide campaign, sponsored by the American Cancer Society and the National Cancer Institute, urging women over the age of 35 to seek yearly mammograms complete with the overly optimistic message that early detection will save their lives.

Radiation exposure was the only acknowledged harm in this era, and it was usually dismissed as unimportant in comparison to the benefit of finding breast cancer early. By the 1980s, mammographic techniques had improved and the radiation exposure greatly reduced. A modest reduction in breast cancer deaths in younger women was found in some, but not all, clinical trials done in other countries. The largest trial intended to answer the question of mammography’s value to women in their forties found no lifesaving benefit. Basing its estimate on the trials that did find a benefit, the U.S Preventive Services Task Force concluded that one in every 1,900 women who undergo an annual mammography over a ten-year period will avoid a breast cancer death.

In 2001 the Lancet published the first evidence indicating that mammography screening leads to overtreatment without reducing mortality. The authors, both researchers at the Nordic Cochrane Centre, did an in-depth assessment of the data generated by all the randomized mammography screening trials. To this day the Cochrane researchers continue to reassess the research (read a 2009 update of their findings). What they have found is entirely counterintuitive and not confined to women in the forties. Mammograms can detect tiny cancers, but not all of them would become deadly or even produce symptoms if left untreated. Yet virtually all are treated aggressively because no test can accurately sort out the potentially lethal cancers from those that do not progress. Overdiagnosis and overtreatment are the terms for this problem, which was quantified in a study published recently in the British Medical Journal, showing that one in three cancers found on a mammogram would not become life-threatening. This should have been the major reason for the change in recommendations, but the media coverage frequently presented mammography’s major harm as the anxiety from false alarms and breast biopsies. As for the other major harm—radiation exposure—the USPSTF cites this estimate, “annual mammography of 100,000 women for 10 consecutive years would result in up to 8 radiation-induced breast cancer deaths.”

The USPSTF based its revised recommendations on the findings of a panel of experts made up of research physicians and most crucially, biostatisticians who quantified some of the harms as well as the benefit. Their task was to assess the evidence generated by the world’s gold standard trials, as well as observational studies. While we all hope that our physicians are familiar with the evidence supporting their advice, the sad reality is that many are not. Most simply follow the advice of organizations like the American Cancer Society and the American College of Obstetricians and Gynecologists. What’s more, it’s as hard for them to change their thinking as it is for us. Here’s just one example. From the professional advice given my daughter and her friends, I know that the long-discredited American Cancer Society recommendation for women to have a baseline mammogram in their late thirties continues to live on. (The ACS quietly withdrew this recommendation in 1992, but it takes time for the word to get out.)

Other sources of information:
If you want to make an informed decision about mammography, go directly to the scientific evidence instead of your doctor. Here’s a timeline for the key studies and previous failed attempts to raise the starting age for mammography which was published recently in the New York Times. This is a “summary of the evidence” from the randomized trials and observational or population studies (i.e., mammography done in the real world), which formed the basis for the USPSTF’s revised recommendations. And this is the National Cancer Institute’s summary of pretty much the same clinical trials (note that the first trial that justified the advice to start mammography at age 40 is described as being of “poor quality”), as well as population studies. The NCI summary is difficult to read, but this sentence from the summary is easy to understand, “Screening for breast cancer does not affect overall mortality, and the absolute benefit for breast cancer mortality appears to be small.” This applies to women who start mammgraphy at age 50 as well as those who started at 40.

Using the same data, researchers at the Nordic Cochrane Centre have produced a more understandable summary for women that is available on the Web (see link within this article). To increase your chances of having a mammography performed skillfully, read How to Select a Mammography Facility . And to reduce your chances of an inaccurate diagnosis, read “When to get a 2nd pathology opinion.”

Maryann Napoli, Center for Medical Consumers(c)

Postscript
Two days after the USPSTF issued its recommendations, HHS Secretary Kathleen Sebelius issued a statement distancing the Obama Administration from the new guidelines. In short, she told women to ignore them and claimed disingenuously that more research is needed. This is very disappointing to those of us who had high hopes that health care reform would mean that medical treatment and screening decisions, as well as cost-cutting measures, would be evidence-based. Once again, mammography’s evidence is clouded by politics. This time around, however, the politics make sense. No doubt, Secretary Sebelius did not want to derail the current health care reform efforts.

Posted in Cancer, Screening, Women's Health | Tagged: , , , , , , , , | 17 Comments »

When to get a 2nd pathology opinion

Posted by medconsumers on September 10, 2009

News Flash: American Cancer Society will warn of screening’s harms.

If I had my way, there would be a moratorium on mammography screening until doctors fully understand the natural history of what they’re looking for in the breasts of women without symptoms. The term natural history is medical jargon for knowing what would happen if breast abnormalities that look cancerous under the microscope were left untreated. At least one in every three breast cancers diagnosed via mammography screening would not progress; yet virtually all are treated aggressively as if they will. From the mammography screening clinical trials, we know that this includes not only ductal carcinoma in situ but also invasive breast cancers. Until about 40 years ago, it was thought that all cancers become lifethreatening if left untreated.

There are two breast pathologists in the U.S. who have spent their professional lives distinguishing the lethal from the nonlethal. Both have published widely on this topic. Both head second pathology opinion services that deal directly with women, who send in their tissue slides, mammograms…and their payments. In the usual situation, the pathologist and the patient do not interact. Dr. David L. Page, Vanderbilt University Medical Center, Nashville, TN, and Dr. Michael Lagios, St. Mary’s Hospital, San Francisco, CA, have, no doubt, spared many a woman the overtreatment that follows in the wake of any and all mammography screening activities. The overtreatment can involve unnecessary radiation therapy, unnecessary breast removal, and a lifetime of worrying about the recurrence of a cancer that would have been better off left undetected.

Every five or so years, I write about these two second opinion services. I decided to do it again when I heard recently from a long-time reader who was diagnosed with “ductal carcinoma in situ [DCIS] with scattered calcifications and atypical cells” at one of the top cancer centers in the U.S. She was told that a total mastectomy is necessary. Instead of following the advice, she paid for a second pathology opinion from each of the above experts who both assured her that she did not have DCIS and required only periodic follow-ups. When calling me about the revised diagnosis, she said, “My joy in learning that I didn’t need a mastectomy was overshadowed by the thought of so many women who are overtreated because of mammography screening.”

Each breast pathologist describes his service below:

David L. Page, MD Breast Consultants

“Our experienced professionals have reviewed over 50,000 consultative requests for pathologists, clinicians, and patients…. Our group has had a major interest in defining and diagnosing special breast conditions that are not truly malignant, but can recognize an increased risk of later breast cancer development, as well as minimally or low malignant lesions that may be successfully treated with local therapy alone.”

Michael D. Lagios, MD The Breast Cancer Consultation Service

“The Breast Consultation Service is designed to help self-referred women with newly diagnosed breast carcinoma or atypia with formal written review of their pathology slides, mammograms and other imaging studies. No physician referral or permission is needed to access this service.”

Disclosure: When writing this article I was surprised to see that Dr. Page has a 2004 article from our newsletter HealthFacts on his home page. It addressed the latest study about overdiagnosis and overtreatment, as well as the above second opinion services. I am flattered that Dr. Page thought enough of my article to post it. I am discouraged that it’s not out of date.

Maryann Napoli Center for Medical Consumers©

Posted in Cancer, Screening, Women's Health, surgery | Tagged: , , , , , , | 1 Comment »

Reduce your risk of breast cancer: Avoid mammograms

Posted by medconsumers on July 14, 2009

Want to know the best way to cut your chances of developing breast cancer? Stop having screening mammograms. Sure, the researchers who recently published a five-country study in the British Medical Journal would never express their findings in this manner. But read their results and decide for yourself. And keep in mind, many breast cancers detected by mammography will not become deadly or even produce symptoms if left untreated. Now it is known, one in three breast cancers fit that description.

Two Danish researchers conducted a systematic review of the breast cancer incidence in the seven years before a mammography screening program was introduced and the seven years after the screening program had been in full swing. The women in this review began having mammograms at the age of 50 years in the United Kingdom, Manitoba, Canada, New South Wales, Australia, Sweden and parts of Norway. The researchers were looking specifically at the number of women diagnosed with breast cancer after mass screening began. Although they expected a lower breast cancer incidence among the women as they grew older, this was not the case.

Here is what the researchers concluded, based on women who began screening at age 50 years. For every 2,000 women who undergo regular mammography screening over the next ten years, one will avoid a breast cancer death; 10 women will be diagnosed with a non-lethal breast cancer and treated unnecessarily; 10 to 15 women will be told they have breast cancer earlier than they would otherwise have been told, though this will have no affect on their prognosis (i.e., whether a woman’s breast cancer is found on a mammogram at age 55 or she finds it herself at age 65, her destiny is unchanged); and 100 to 500 women will have at least one “false alarm” that in about half the cases leads to a biopsy.

This review was conducted by Karsten Juhl Jorgensen and Peter C. Gotzsche, MD, of the Nordic Cochrane Centre in Copenhagen. Both have written extensively on the topic of overdiagnosis, which they define as “the detection of cancers that will not cause death or symptoms.” There is no foolproof way to determine which mammography-detected cancers do not progress from those that will. Virtually all are treated as if they will.

The lead author, Dr. Jorgensen, was asked by e-mail whether it is reasonable for a woman to decide not to have screening mammograms as a means of reducing her chance of having breast cancer. “In the light of our estimates of overdiagnosis, I would say that we now have to consider mammography screening as a major risk factor for getting a breast cancer diagnosis. And a preventable one, too,” he responded. “Of course, the breast cancers overdiagnosed through screening differ from the symptomatic ones by being non-lethal, but the individual woman cannot know this and the remaining consequences are the same (the surgery, radiotherapy and psychological stress).”

This is not the first time mammography screening was shown to cause more harm than good. Overdiagnosis and overtreatment were first identified in a 2000 systematic review of all seven trials worldwide that had randomly assigned women to receive mammograms or not. That review, which originally appeared in the British journal Lancet, has been updated as a Cochrane review.

Safest course of action? Seek medical attention at the first sign of a breast symptom.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in Cancer, Screening, surgery | Tagged: , , , , , , | 2 Comments »

Oral vs. Standard Chemotherapy To Prevent Recurrent Breast Cancer

Posted by medconsumers on June 1, 2009

Older people are underrepresented in clinical trials, a problem that is particularly acute where it concerns breast cancer. This is a disease that strikes women who are average age 63 years at diagnosis; and the overwhelming majority of deaths occur over the age of 65 years. A new study fills an important information gap about adjuvant drug treatment for older women with breast cancer. It also clears up lingering questions about oral vs. intravenous (IV) chemotherapy.

In 1998, Xeloda (capecitabine) became the first oral chemotherapy drug to be approved by the FDA for metastatic breast, i.e., late-stage cancer that has spread beyond the breast. Xeloda is produced by Roche Laboratories, which partly funded this study, published last month in The New England Journal of Medicine.

Two Questions Asked

Can Xeloda benefit women at earlier stages of breast cancer? How does it compare with standard chemotherapy? These questions were answered by the new study, led by Hyman B. Muss, MD, University of Vermont, Burlington, and conducted at many academic medical centers in the U.S. and Canada.

After their initial treatment for breast cancer, the 600 study participants were randomly assigned to Xeloda or one of two standard IV chemotherapy regimens (One known by the acronym, CMF—cyclophosphamide, methotrexate, and fluorouracil, or another regimen that combines cyclophosphamide and doxorubicin). The participants had been diagnosed with breast cancers that ranged from stage I through stage IIIB.

First, the researchers looked at the number of participants who were recurrence-free at 3 years. It was 68% of the women in the Xeloda group and 85% of the women in the IV chemotherapy group.
When the researchers looked at overall survival, IV chemotherapy again proved better than Xeloda. The survival rate at three years was 86% for the women in the Xeloda group versus 91% for those in the IV chemotherapy group. Two women in the Xeloda group died of treatment-related complications.

Although IV chemotherapy came out on top regarding recurrence and survival, it was worse when it came to side effects. Twice as many women in the chemotherapy group suffered moderate to severe toxic effects, such as nausea and vomiting (64% vs. 33%). More women on IV chemotherapy (38%) could not complete the six cycles of treatment because of severe toxic side effects, compared with 20% who could not finish the six planned cycles of Xeloda.

The greatest benefit to taking Xeloda was shown for the women in this trial who had hormone-receptor negative tumors. This is consistent with the results from earlier research conducted at Oxford University.
The new study provides more fodder for the contentious issue of drug costs. Both private and public health plans in the U.S. are requiring patients to pay more out of pocket for cancer drugs. Many plans, including Medicare, will reimburse for IV drugs, but not for oral drugs. This leads some cancer patients to suspect that they are being steered away from the newer and better oral drugs for cost-saving reasons.

News Flash:
A cancer patient on Xeloda was detained by U.S. immigration officials because his fingerprints had mysteriously disappeared, according to May 26, 2009 Annals of Oncology online. The drug can cause chronic inflammation of the palms or soles that can over time eradicate finger prints.

Maryann Napoli, Center for Medical Consumers(c) June 2009

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Alternatives to Open Breast Biopsies

Posted by medconsumers on February 1, 2009

Excessive Use of Open Breast Biopsies: An Interview

Too many U.S. women are having the more drastic, more expensive open biopsy once a mammogram detects an abnormality, according to a new study conducted at one academic medical center. This is diagnostic overkill given the facts that 80% of all such breast abnormalities eventually prove to be benign and that minimally invasive needle biopsy techniques have been available for years.

Overuse of the open biopsy means that women’s health is unnecessarily compromised because the procedure can have serious complications. The development of scar tissue, for example, may inhibit the diagnosis of a future breast cancer. Incredibly, 1.6 million breast biopsies are performed yearly in the U.S. If this study is representative of the rest of the country, nearly 40% are open biopsies.

“Where’s the Outrage?” asked surgeon Melvin J. Silverstein, MD. In the editorial that accompanied the new study, he reminded readers that the women’s movement of the mid-1970s eventually put an end to the drastic one-step diagnosis/treatment procedure. Up to that era, women with a breast lump had to sign a consent form before going under anesthesia, allowing their surgeons to determine malignancy on the basis of a quick frozen biopsy and to do an immediate radical mastectomy when results showed cancer. (Years later, the frozen-section biopsy was acknowledged to be unreliable.)

Now there’s another pressing need for advocacy, says Dr. Silverstein, Director of the Breast Program at Hoag Memorial Hospital Presbyterian, Newport Beach, California, and professor of surgery at the Keck School of Medicine, University of Southern California. He is interviewed by Maryann Napoli, Center for Medical Consumers.

MN: A shockingly high 40% of the breast biopsies done at one Manhattan teaching hospital were open (excisional) biopsies, according to the new study, conducted by Emily M. Clarke-Pearson, MD, and colleagues at Beth Israel Medical Center and Columbia University Medical Center (January 2009, Journal of the American College of Surgeons). How can a woman tell whether she truly requires an open biopsy?

MJS: She needs to know that well over 90% of all breast abnormalities can be biopsied with a needle. Very few people need an open biopsy. For example, if the abnormality is in an extremely difficult place, such as right on the chest wall, a needle biopsy may not be possible. Another possibility is that the patient may not be able to lie on her abdomen thereby making stereotactic biopsy nearly impossible. More and more, needle biopsies are being done with ultrasound guidance and they’re much easier.

MN: You were appalled to learn that so many women in this study with palpable or mammography-detected abnormalities were going straight to the operating room for diagnostic open surgical breast biopsy. What is the typical scenario?

MJS: If the radiologist has control of the patient and the radiologist is an interventionalist—that is, one who knows how to put needles in, then he or she will do a needle biopsy*. But the radiologists often do not control the patients in the U.S. The patients “belong” to the referring doctor. Many breast centers won’t do a mammogram without a doctor’s prescription. In general, a patient goes to a radiologist with a doctor’s prescription that says “bilateral mammography”. If an abnormality is found, the radiologist typically calls the referring doctor, and most of the time, he or she will say, “go ahead and do the biopsy.” But often that referring doctor is a surgeon, and he or she will do an open surgical biopsy because they do not know how to do a needle biopsy.

MN: Breast biopsies are so lucrative., I assume there’s a turf war between the radiologists and the surgeons.

MJS: Yes, when the needle biopsy came along in the early 1990s, the radiologists captured the market, and the surgeons didn’t care. But as time went on, the surgeons said, “I used to do 280 biopsies a year, but now I’m not doing any because the radiologists do them all. I’d better learn.” So the American Society of Breast Surgeons formed, mainly to teach surgeons how to do ultrasound-guided biopsies and stereotactic biopsies. Now there are probably 3,000-4,000 surgeons in U.S. who are competent to do needle biopsies, but there also [another] 30,000 surgeons who do open breast biopsies because they don’t know how to do needle biopsies. It comes down to this: If I don’t know how to do a needle biopsy, then I either have to send the patient to someone who does or do an open biopsy myself.

MN: And the cost differences?

MJS: I used to do 225 open biopsies a year for diagnosis and now I do only two or three a year. An open biopsy in New York City is probably $2,000 to $3,000 [just the surgeon’s fee]. If I lived there, I would have given up $600,000 in billing fees**. So you can understand the motivation. A lot of surgeons now know how to do needle biopsies and those who know how will do it. Open biopsy costs rise to $5,000 to $7,000 once you include the operating room fee and the anesthesia, which can be either local or general. A needle biopsy in New York City is about $2,000. In a smaller city, it will probably be between $1,000 and $1,500.

MN: There are plenty of downsides to the open biopsy besides the expense.

MJS: I’m a professor of surgery. I get a lot of referred patients and half have already had open surgical biopsies. Many times the incision was done in wrong place, and it compromises what I’m going to do, or the margins are not done well because the biopsy was done simply as a diagnostic procedure, not as a therapeutic procedure.. On the other hand, when I get a patient who has had a needle biopsy, nothing has been compromised. Studies have shown that in competent hands, the needle biopsy is just as accurate as the open biopsy.

MN: And many inconveniences are avoided.

MJS: Yes, when a woman has a needle biopsy, she is in and out in one or two hours. She doesn’t need someone to drive her home; she can go to work; she can lift things. When she has an open biopsy, the wound has to heal. She has to be careful of what she does for a few days or a week.

MN: You seemed to be counting on consumer advocacy to change doctors’ practices.

MJS: Yes, the study was done at Beth Israel Hospital, an academic medical center where the work should be top of the line and it’s in New York City, which has some of the most demanding consumers of medicine in the world. And yet nearly 40% were getting open biopsies [in 2007]—that’s outrageous. Once women all over America know about this, that number will drop precipitously.

MN: Your editorial and the study are circulating on the Internet among breast cancer advocates.

MJS: Remember about 10 or 15 years ago, there was a new procedure called sentinel node biopsy. Instead of doing a full axillary node dissection [removal of 20 or so nodes near the armpit], the surgeon could remove only one or two lymph nodes. And surgeons said, “We don’t know if it works.” And you know what happened? Women heard about it and they demanded it. And if the surgeon didn’t offer it, she came down the street to me. The surgeons were losing their patients so they learned how to do it. Now everyone does it.

*Dr. Silverstein said that the term needle biopsy refers to several different minimally invasive techniques including core biopsy, vacuum-assisted biopsy, ultrasound-assisted biopsy (most common and easiest to perform) and the MRI-assisted biopsy (most difficult and least common).

** Billing fee is different from what the physician actually receives. According to one New York City breast surgeon, Medicare and many insurance companies will reimburse only 20% of the billing fee.

Maryann Napoli, Center for Medical Consumers© February 2009

More on Breast Biopsy
One co-author of the breast biopsy study is Susan K. Boolbol, MD, Chief, Appel-Venet Comprehensive Breast Service and Director, Breast Surgery Fellowship, Beth Israel Medical Center, New York City. In a telephone interview Dr. Boolbol was asked whether her study is representative of care in the rest of the country.

SKB: Yes, I do think so. First, keep in mind that the overwhelming majority of breast abnormalities are benign and the introduction of new needle biopsy techniques means that women do not have to go the operating room for diagnosis any more.

MN: But your study was done at one teaching hospital. Do we know how women are treated in the real world?

SKB: When you look at our study, you will see that we have three separate sets of physicians. First, the academic breast surgeons like me; second, the breast surgeons in private practice who don’t work for the hospital, but perform surgery there; and third, the general surgeons who do all types of surgery, including breast surgery.

MN: It does provide a window into what’s going on in the real world. During the seven-month study period, the academic breast surgeons did only 10% of their breast biopsies as open biopsies; compared with the breast surgeons in private practice (35%) and general surgeons (37%).

SKB: Another study showed that the majority of women with breast cancer in New York State are not operated on by breast surgeons. That could be true of the rest of the country. Educating women is the whole issue raised by our study. [If told they should have an open biopsy] they need to ask the question: Is there another way to do the biopsy? Women should know that the operating room is for treatment, not diagnosis.

Maryann Napoli, Center for Medical Consumers©

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Breast Cancer Incidence Drops in U.S.

Posted by medconsumers on January 15, 2009

The incidence of breast cancer in postmenopausal women has been decreasing since 2002, probably because so many women have given up hormone therapy, say researchers who assessed the follow-up data from the Women’s Health Initiative. This is the landmark trial that was that stopped early in 2002 because the women taking the combination estrogen plus progestin showed a higher incidence of heart disease, stroke, and breast cancer than the women taking placebos. Many of them stopped taking hormones immediately, and all were followed up until 2005.

The authors of this report said they are fairly confident that the falling breast cancer incidence was caused by the decreased use of hormones, not by the other opt-proposed possibility—the drop in the number of American women going for screening mammograms. One question remains: Why did the decline in breast cancer incidence occur so rapidly after the trial was stopped? The authors speculate that some of the tiny “pre-clinical cancers” found during mammography spontaneously regressed once women stop taking hormones.

N Engl J Med 2009;360:573-87

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On Exposure to Light at Night

Posted by medconsumers on September 1, 2008

On Exposure to Light at Night, Cancer…and Rethinking Normal Sleep

There is no scientific consensus about the cause of breast cancer, according to Richard G. Stevens, PhD, Professor and Cancer Epidemiologist at the University of Connecticut Health Center, Farmington. That’s as true today as it was in 1987 when Dr. Stevens began to publish a new theory about exposure to electric light at night and how it may trigger disruptions in the body’s circadian rhythm—that is, the cyclical changes that recur regularly over a 24-hour period.

These disruptions, in turn, can cause hormonal disturbances implicated in the development of breast cancer. Central to this theory is melatonin, a hormone that helps regulate the sleeping/waking cycles. Melatonin is primarily produced by the pineal gland at night and is suppressed by exposure to light.
Since his theory was first proposed, Dr. Stevens has co-authored studies showing an increased risk of breast cancer among women who work the graveyard shift. And he has co-authored another study showing a decreased risk among women who sleep nine hours or more each night. He also challenges the prevailing medical wisdom about normal sleep in the following interview conducted by Maryann Napoli, Center for Medical Consumers.

MN: In just 20 years, you went from proposing what might have seemed like a crackpot idea at the time to having it validated by the International Agency for Research on Cancer, based in Lyon, France. In 2007, that agency, which is part of the World Health Organization, declared shift work to be a “probable human carcinogen.” What made you initially suspect the link between breast cancer and exposure to electric lighting at night?

RGS: I’ve been interested in breast cancer for a very long time. It’s a mystery why it is so common in industrialized countries and why it becomes common as countries become industrialized. Up until the mid-1980s, we [researchers] thought it had to be due to the Western diet that is high in fat, but the really good, big cohort studies of diet that followed hundreds of thousands of women for 10-30 years – all came up negative. There is no relationship between fat consumption in adulthood and the risk of breast cancer.

MN: So you began thinking of other possible causes.

RGS: Yes, I was lying in bed awake in the middle of the night with the light from the street lamp coming into my room—and I’m not suggesting that streetlights alone are the problem. [It was so bright] I could almost read in my bedroom, and I thought this is something that has changed since society has become industrialized. I wondered if that had anything to do with cancer. Then I found out about what light can do and the hormones and the melatonin connection. Then I started publishing on the topic.

MN: You took off from the idea that we humans have evolved over the course of three billion years, but we have dramatically changed the environment only in the last 130 years with the introduction of electricity. How did you start to prove your theory?

RGS: The way we gather evidence is to make predictions. For example, if shift workers get lots of light at night and their circadian rhythms are disrupted, then, according to the theory, they should be at higher risk of breast cancer. Another prediction was that blind women would be at a lower risk [because their melatonin is not suppressed by exposure to light]. Another is the association between long sleep duration and a lower risk of breast cancer.

MN: You co-authored a study of shift workers that was published in the Journal of the National Cancer Institute in 2001. It showed an increased risk of breast cancer among women who worked long hours and many years in the graveyard shift, compared with those who didn’t do shift work. But it was only a modest increase in risk, wasn’t it?

RGS: That’s correct. But keep in mind that the comparison group, though it was comprised of women who didn’t do shift work, was getting plenty of the usual exposure to electric light at night. The strongest evidence is for the shift workers, but we don’t have a lock on it yet. There are also the four or five studies of breast cancer in blind women, and they all reported a lower risk of breast cancer as predicted. There are three good studies of sleep duration, two of which found that women who sleep a long time have a lower risk of breast cancer. So you get the idea—it looks as though the more time you spend in darkness, the lower the risk of breast cancer, although there is no scientific consensus on this. We need more studies consistent with those we have if we are to get to that point.

MN: What other ill effects might be associated with circadian disruption?

RGS: Three studies about prostate cancer were published in the last few years. Two showed that shift-working men were at a higher risk of prostate cancer. And another, just published in the British Journal of Cancer, was about sleep duration—the longer the sleep, the lower the risk of prostate cancer.

MN: What about interrupted sleep? People who wake up in the middle of the night will read or watch TV. Or they turn on the light briefly just to go to the bathroom.

RGS: There is evidence that those vanity lights in the bathroom [with light bulbs all around the mirror] are bright enough to start lowering the melatonin almost immediately.

MN: Is it OK to keep a night light in the bathroom?

RGS: We don’t know yet whether this is relevant to breast cancer, but just in terms of circadian health, the best thing to install in the bathroom is a night light with a red bulb.

MN: Why red?

RGS: The wavelength with the maximum ability to affect melatonin is blue. Red is much less efficient. You need a lot of red light to affect melatonin. So a dim red bulb will almost surely have no effect on your melatonin.

MN: My husband has a very bright digital alarm clock on his side of the bed. It’s irritating to me when he’s not in the bed to block the light.

RGS: What color is it?

MN: Green.

RGS: Throw it away and get a red one. We don’t know whether that green light is bright enough [to cause a problem], but if it irritates you, throw it away.

MN: So the point is to keep the bedroom as dark as possible.

RGS: You don’t have to be asleep for melatonin rhythm to be fine, but you do have to be in the dark.

MN: So, if you can’t sleep, you’re better off just staying in bed in the dark, perhaps listening to your radio or iPod?

RGS: I don’t think there are experts on this anymore. What we have been told by the sleep doctors for some time now is that you’re supposed to be getting eight straight hours of sleep. And if you wake up in the middle of the night, you should leave the bedroom and read or watch television. But that view runs counter to our evolution and is being seriously questioned by many sleep researchers.

MN: Why?

RGS: We have evolved in 12 hours of dark—a biphasic sleep—a first sleep and a second sleep. There’s an historian who points out that there are many references to the first sleep and the second sleep in medieval literature, in Shakespeare and in Chaucer. What it means is that it was normal—up to the invention of electricity—to go to sleep fairly close after the sunset, sleep for a few hours and then wake up and be awake for maybe an hour or two in the dark. (See Recommended Reading).

MN: But isn’t this is a form of insomnia?

RGS: There is a growing group of sleep researchers who are challenging that idea. I think it’s fine to be awake in the middle of the night. Enjoy the period of quiet wakefulness. But if you do get up and turn on the lights, you are suppressing melatonin, you are disrupting circadian rhythms and that, to me, may be increasing your risk of breast cancer and perhaps other maladies.

MN: What about taking melatonin supplements?

RGS: People often say to me, “Melatonin is good for you because it fights cancer, so I’m going to take a melatonin tablet every day.” I would certainly not do that. It has become clear with experiments in people taking melatonin tablets in the evening that this will actually change circadian rhythm and that can’t be good.

MN: So in summary: If you have insomnia, you shouldn’t take melatonin supplements or get up to watch TV or read. You should just lie there in your bedroom that is as dark as possible. How do you think that advice will go over with the millions of pill-popping insomniacs out there?

RGS: Change your attitude. That period of quiet wakefulness in the middle of the night is a time to wander peacefully in your mind and spirit.

Recommended Reading:

“Acknowledging Preindustrial Pattern of Sleep May Revolutionize Approach to Sleep Dysfunction” by Walter A. Brown, MD, May 26, 2006, Applied Neurology. This article is accessible at www.psychiatrictimes.com/display/article/10168/56881

Maryann Napoli, Center for Medical Consumers ©
September 2008

Posted in Alternative Medicine, Cancer, Women's Health | Tagged: , , , , | Comments Off

MRI Scans and Mastectomies

Posted by medconsumers on September 1, 2008

Preoperative MRI Linked to Increase in Mastectomies at Mayo Clinic

Magnetic resonance imaging, or MRI, made news last spring at a meeting of cancer doctors when a Mayo Clinic oncologist reported that the use of this diagnostic technology appears to increase the number of women who are choosing mastectomy over breast-conserving surgery. The finding is based on a study of early-stage breast cancer patients treated at the Mayo Clinic in Rochester, MN.
The rate of mastectomy in the U.S. had been declining steadily since the mid-1980s when a landmark national trial proved it to be no more lifesaving than breast-conserving surgery. For example, 36% of the women treated at the Mayo Clinic had a mastectomy in 2002, down from 45% in 1997.

Matthew Goetz, MD, the medical oncologist who presented these findings at the meeting of the American Society of Clinical Oncologist, called attention to the change that began to occur once preoperative MRI was introduced. The rate of women given this imaging procedure preoperatively went from 11% to 22% between 2003 and 2006. During the same period, the mastectomy rate rose from 30% to 43%.

MRI is sometimes recommended in addition to a mammogram, especially for women with dense breasts and/or a genetic predisposition to breast cancer. The newer technology has several advantages over mammography, such as no radiation exposure, no compression of the breast, and a sharper imaging that identifies more abnormalities. The downsides of MRI include high cost and sharp imaging that causes a high rate of false alarms (19% in first year and 9% in the second, according to one study).

The Mayo Clinic findings do not prove that MRI directly caused the increase in the number of women choosing mastectomy. Nor were women or doctors asked about their decision-making process. Referring to MRI’s ability to find tiny lesions that may or may not be cancer, Dr. Goetz said, “What we don’t know from this study is whether the higher rate of mastectomy observed in our patients undergoing MRI leads to greater anxiety for the patient and physician, thus leading patients and physicians to choose mastectomy over lumpectomy.”

In a recent issue of the Journal of the National Cancer Institute, Dr. Goetz elaborated on this theme, “I wonder whether patients reach a threshold where they are unwilling to deal with the uncertainty of future imaging and biopsies,” he said. “They are tired of a physician saying, ‘We’re not sure, follow up in six months with a repeat test,’ and so those patients may say, ‘Thank you very much, but let’s just proceed with a mastectomy.’”

For More Information About MRI and Other Cancer Tests:

Go to www.cancer.gov, the Web site of the U.S. National Cancer Institute (type: MRI in the search box at the top of home page).

This Web site is also a good source of information about all cancers and their respective ltreatment options by stage. There is a patient’s version for each cancer, which is billed as “less technical,” but it only describes the treatments options. To find out how good the supporting scientific evidence is for these treatment options, go to the “health professional” version. You can click into the abstracts of the clinical trials that produced the supporting evidence. The health professional version also ranks the quality or strength of the evidence. Or, call 1(800) 4-CANCER.

Maryann Napoli, Center for Medical Consumers ©
September 2008

Posted in Cancer, Scans and X-rays, Screening, Women's Health, surgery | Tagged: , , , | Comments Off

Women-in-Towels Evista Ad Critiqued

Posted by medconsumers on July 1, 2008

The women in Eli Lilly’s new ad campaign are attractive, healthy-looking and wearing nothing but towels. “Cut two risks with Evista. The only agent indicated to treat osteoporosis and reduce the risk for invasive breast cancer.”

That two-for-one claim for Evista makes it different from other drugs taken by symptom-free people. Studies showed that the harm related to each disease drops a percentage point or two in those who took Evista, compared to those who did not. The drug is better than a placebo (or it would not get FDA approval), but not much better. This is a recurring theme in Center for Medical Consumers articles because it’s a recurring theme in many drug trials. And often the small risk of a serious adverse reaction to the drug equals that small chance of benefit.

Evista (generic name: raloxifene) has been on the market since 1997 as an osteoporosis drug. It produces a 2%-3% increase in bone density; reduces the rate of vertebral (spinal) fractures; but does not prevent the most serious type of fracture (hip). Vertebral fractures can cause pain and a dowager’s hump in advanced age, but many are symptomless. The studies did not last long enough for Lilly to make claims regarding prevention of a dowager’s hump or loss of height.
Breast Cancer “Risk Reduction”

Last year Lilly received FDA approval to promote Evista as a drug that can “reduce the risk of invasive breast cancer.” This careful wording from the Evista ads is important. Lilly cannot claim its drug prevents breast cancer because the disease can take anywhere from 8 to 17 years to develop. There were, in fact, fewer breast cancers diagnosed in the women taking Evista, compared to those taking placebos. But the trials didn’t last long enough to determine whether the drug prevents breast cancer or simply delays its onset. In Evista trials that lasted up to eight years—breast cancer was diagnosed in 2.5% of the women taking a placebo and 1% of the women taking Evista.

The other claim for Evista is based on the fact that the women in the studies already had osteoporosis (bone loss). One way bone drug companies can inflate the benefit of their product is to count symptomless vertebral fractures that can be detected only on x-ray. (In other words, the women are unaware of them.) At the start of the Evista trial about half the women had painful vertebral fractures and the other half had “fractures diagnosed radiographically.” After four years, things looked better for Lilly when results for all women were combined, but less impressive when women with painful fractures were singled out. In the latter group, only about 1% fewer Evista-treated women had new painful vertebral fractures than the women taking placebos.

Thus far serious adverse reactions to Evista include deep vein thrombosis, pulmonary embolism, retinol vein thrombosis and an increased risk of fatal stroke. (See boxed warning of the FDA-approved label). Separately, each is classified as rare, which, according to FDA standards, describes any drug reaction that occurs in less than 2% of study participants. Collectively, though, these potentially fatal adverse reactions could reach 1-2% which comes close to the percentage of women who benefited from Evista in the FDA-required clinical trials.

And lastly, the visual message conveyed by the women-in-towels ad is misleading. Most of the women look to be in their fifties. At the start of the Evista trials, however, most participants were over age 65 years, a time of life when vertebral fractures are far more likely to occur.

Maryann Napoli, Center for Medical Consumers ©
July 2008

Posted in Women's Health | Tagged: , , , , , , | Comments Off

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