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How to Select a Mammography Facility

Posted by medconsumers on July 1, 2008

Can women do anything to improve their chances of receiving an accurate interpretation of a screening mammogram? A new study found that there are several important characteristics to look for when selecting a mammography facility. The finding is based on a survey of 44 U.S. mammography facilities published last month in the Journal of the National Cancer Institute.
To learn how women can act on the results of this study, Maryann Napoli, Center for Medical Consumers, interviewed one of its co-authors, Joann G. Elmore, MD, Professor of Medicine, Adjunct Professor of Epidemiology, University of Washington School of Medicine, Seattle.

MN: Doesn’t the physician usually choose the mammography facility?

JGE: Most often women see their primary doctors and that doctor will refer them to a mammography facility that is linked with the primary care office.

MN: So women don’t actually do the choosing?

JGE: Mammography screening is a unique medical test in that women can refer themselves. There are mobile vans going around the country, stopping at work sites. I don’t know the actual number of women who self refer, but I suspect many women are actively involved in choosing mammography facilities.

MN: You have co-authored dozens of mammography-related studies. I recall being shocked by your first one, published in The New England Journal of Medicine in 1994. You found that experienced board-certified radiologists interpreting the same images often come to different conclusions about the presence or absence of breast cancer.

JGE: For many years I’ve been trying to figure out why there is so much variability in the interpretation of mammograms. Then we went on to identify characteristics of the patients that put them at risk of having an inaccurate exam. Some characteristics you cannot change like having dense breasts, and some you can change. For example, menstruating women can make sure not to schedule a mammogram around the time of their periods when the breasts swell and become tender. A few studies show accuracy is lower at this time.

MN: And now you’ve taken on the characteristics of the mammography facilities in your latest study.

JGE: Yes, I have been working in this area for 15-20 years, but I had never really asked the question: Does it matter which facility women choose? We found that facilities that have breast imaging specialists on their staff had a higher degree of accuracy.

MN: Don’t all facilities have breast imaging specialists interpreting the mammograms?

JGE: No, in some facilities mammograms are interpreted by general radiologists who do not have specialty training in breast imaging. And these radiologists interpret the minimum number [of mammograms] required for accreditation, but they may also interpret chest x-rays, MRI scans, ultrasounds, etc. Mammography may be a small part of their clinical workload.

MN: So women should ask this question of the facilities on the phone, prior to making an appointment: Do you have a breast imaging specialist on the staff? I know this is an awful question but do you really think women will get an honest answer from facilities that have only general radiologists reading their mammograms?

JGE: Well yes, if women ask the question this way: Do you have a radiologist that spends more than 50% of the time working in breast imaging? That’s pretty clear-cut. That’s how we define a breast imaging specialist in our study.

MN: What else did you find that women should ask about the facility?

JGE: They should ask whether the facility conducts audit reviews two or more times a year. Our study found higher accuracy among the facilities that review their audit data with the radiologist on a regular basis. This finding makes sense to me because the radiologists are learning from the prior history and probably improving the quality of their interpretations.

MN: Audit reviews are a form of quality control. The facility should compare the mammogram interpretations with the results of the breast biopsies in order to regularly test the accuracy of the radiologists’ decisions.

JGE: If you read the fine print of the Mammography Quality Standards Act, you’ll see that the facilities don’t have to show the audit results to the individual radiologists.

MN: That’s disturbing. Why collect audit information if the facility doesn’t show it to the radiologist?

JEG: Yes, as a physician, I believe that we have the opportunity to improve when we get feedback.

MN: That changes the second question women should ask when choosing a facility. It should be: Does your facility do audit reviews at least twice a year, and is the radiologist routinely given the results of these reviews?

JEG: Yes.

MN: You did not find volume to be important to accuracy. One would think that the more images a radiologist reads, the more likely he or she will make accurate interpretations.

JGE: Many studies have evaluated whether high volume is associated with performance, and there’s an assumption that really high volume by the radiologist is good because it means that the radiologist has a lot of experience. But like all areas of life, it’s more difficult than that. It’s possible that the facility could have high volume, but the facility might not be collecting and reviewing the audits and therefore not following up on those many thousands of patients whose mammograms have been interpreted.

MN: What’s the definition of high-volume?

JGE: There have been a few studies, but many of them have contradictory results. In the U.S., radiologists must do a minimum 480 mammograms per year, as required by law.

MN: That doesn’t sound like much.

JGE: In Europe, the minimum in some countries is 5,000 cases a year. But the question is: Are some countries doing better because they have higher volume? The published studies have contradictory results. There’s an ongoing study funded by the American Cancer Society and the National Cancer Institute. It will be helpful to see if they can clarify this at all.
MN: What are you working on now? What are the other major unanswered questions about mammography that should get research attention?

JGE: I’m continuing my research efforts aimed at improving the quality of breast cancer screening and detection. I am investigating the efficacy of new technology, such as digital mammography and computer-aided detection, and how we can improve our communication related to mammography.

MN: Mammography screening has been aggressively promoted to women ever since the early 1970s. It’s interesting to see how long it takes to get some basic questions answered. You are to be congratulated for being in the forefront of mammography screening research and for continuing to ask the research questions that will lead to more improvements. See Mammography Leaflet from the Nordic Cochrane Centre.

Maryann Napoli Center for Medical Consumers ©
July 2008

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FDA Regulation of “Home Brew” Tests

Posted by medconsumers on February 8, 2007

Support for FDA Regulation of “Home Brew” Diagnostic Tests

On February 8, 2007, the FDA held a meeting to discuss the agency’s plan to regulate certain diagnostic laboratory tests for cancer and many other diseases. The central question of the day was: Should the FDA have regulatory power over “home brew” tests, which are multi-gene profiles? These tests will be used to diagnose cancer, determine the most effective treatment, as well as seeing who is at high risk of getting the disease. Traditionally, the FDA has not regulated tests, such as these, that are not done in one central lab. However, the agency has recently designated these tests, called in vitro diagnostic multivariate index assays, as devices. This opens the door to regulation.

At the public comment portion of the meeting breast cancer advocate, Helen Schiff, presented her position on behalf of the Center for Medical Consumers. Her testimony follows:

My name is Helen Schiff. I am a breast cancer survivor and a member of SHARE a breast and ovarian cancer organization in New York City. I am also a patient consultant for the FDA.

The potential for complex biomarkers known as IVDMIAs (In vitro diagnostic multivariate index assays) to change the face of breast cancer treatment is tremendous. For too long we have been plagued with a one size fits all approach to treatment. Even though many women are cured with surgery they have to suffer through radiation, chemotherapy, and 5 years of hormonal treatment because there is no way to know with certainty what treatment a woman really needs, IF ANY. While this treatment strategy has had a small impact onbreast cancer mortality, it has meant that many women have been exposed needlessly to the lethal and life altering effects of all these modalities. Just to name some of the worst ones: leukemia, cardiomyopathy, endometrial cancer, stroke, pulmonary embolism, infertility, lymphedema, “chemobrain,” and loss of libido.

So we welcome a new technology that has the potential to customize our treatments. To give us only what we need. To even tell us which chemotherapy, hormonal treatment, monoclonal antibodies, or small molecule will be optimal for our specific tumors. And we know that in the future IVDMIAs will also have the potential tofind breast cancer earlier than is now possible and to do a better job than the Gail model at determining who is really at high risk for getting breast cancer.

Nevertheless, it is very important to be aware of the pitfalls that have plagued biomarker research over the years. In almost half a century of breast cancer biomarker research only TWO biomarkers have proved to be of clinical value: ER and Her2. The significance of what PR means is still disputed. We know for a fact that problems with assays have led to erroneous assessments, less than optimal treatment, and most importantly, premature loss of many lives. Unfortunately, recent studies indicate that there are still problems, for example, with accurate ER and Her2 assays. For example the cut point for ER positivity varies from 1 to 25% of cells with estrogen receptors. A recent study showed that 20% of Her2 tests were not accurate. As many have said, a treatment is only as good as its biomarker, and hence they too need to be rigorously regulated.

One of the most important recommendations of the National Breast Cancer Coalition’s Strategic Consensus Report on Breast Cancer Biomarkers is “to incorporate the best components of drug development to guide the development and validation of biomarker assays.” This new FDA Guidance for IVDMIAs is an important first step in that direction. It will assure that IVDMIAs are: 1) examined before they are marketed; 2) that their results are reproducible by an independent body; 3) that they are tested for accuracy; and 4) that they have clinical relevance. The writing of the IVDMIA label, as with new drugs, must be over seen by the FDA to ensure that there are no false claims and that the results of an INDMIA assays are understandable to both doctors and patients. It is clear to me that neither CLIA, the Federal Trade Commission, nor any other agency in HHS has the depth of the experience, the capabilities, or the resources to undertake such a job, nor do they have the regulatory power.

One need only look to the Ova Check experience to see why this kind of regulatory power is so important. Ova Check was developed as a blood test for the early detection of ovarian cancer in high risk women by Correlogic, a private company, in partnership with scientists from the FDA and the NCI. However, the FDA said that it would not allow Ova Check to be marketed until it published clinical evidence that it WORKED in patients. Keith Baggerly, a bioinformatics specialistat MD Anderson, when trying to replicate the study, found, among other problems, that test results were influenced by the order in which the assay was run. According to an article by David Ransohof in the Journal of the National Cancer Institute Ova Check had not been properly validated its finding in an independent data set and there was a possible problem with over-fitting and bias. Three years later, it has still not been approved to be marketed, confirming its problems were serious. If it were up to CLIA or the Federal Trade Commission, Ova Check would have been marketed-because they do not have the power to stop it. And we all know how hard it is to get something off the market once it is on. Not to mention the irreparable damage it would have done to women.

To me the arguments that FDA regulation of IVDMIAs will hinder development and commercialization, or that this new regulation is unfair, are non red herrings. Don’t we want to find out which IVDMIAs work and which ones don’t, regardless of when they were developed or by whom? If anything will hold up development in this field it will be the premature marketing of more Ova Checks. As we see this is not just a matter ofj “colorful characters” or fly by night companies as suggested in a recent GAO report. Reputable scientists can make honest mistakes.

As an advocate I think we need to introduce rigor and oversight into the biomarker field and I think the FDA Guidance on IVDMIAs is an important step in that regard. I certainly don’t follow the logic that when IVDMIAs are homebrews they should not be regulated by the FDA. My logic leads in the other direction. All biomarkers, including home brews, when used in the CLINIC should be regulated by the FDA. Otherwise we leave the successful commercialization of IVDMIAs to companies who write the best press release, do the most advertising or try and court advocacy groups.

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Only One in 2000 Women Benefit from Mammography

Posted by medconsumers on December 1, 2006

Over the 31 years of publishing our newsletter, we have reported frequently about the lack of honesty in the mammography-screening information directed at women. Whether it comes from the American Cancer Society or a family physician, the information tends to be heavy on the lifesaving benefits and light on potential harms.

Here’s something a woman is unlikely to hear: For every 2000 women* who go for mammography screening throughout a ten-year period, one woman will have her life prolonged. BUT ten additional healthy women, who would not have received a breast cancer diagnosis had they avoided mammography screening, will be treated unnecessarily for a breast cancer that would never have become life-threatening. And more than 200 women will experience significant psychological distress for many months because of false-alarm findings on a mammogram.

This important information, so crucial to a woman’s informed decision-making, comes from a recent update of a 2001 Cochrane Review of the world’s major mammography screening clinical trials with a combined total of a half a million women. In all seven trials, which form the basis of the U.S. screening recommendations, women were randomly assigned to receive screening mammograms or not. These trials, conducted in North America and Europe, were published many years ago, but researchers continue to argue over their interpretation and conclusions.

* These statistics apply to women, aged 50-69 years. Odds of lifesaving benefit are even smaller for women in their forties.

Original Review in 2001
The 2001 Cochrane Review of these trials was co-authored by Peter Gotzsche, MD, of the Nordic Cochrane Centre in Copenhagen, as is the 2006 update published recently in the Cochrane Library. The original review triggered a prolonged debate in the American media in 2001-2002 after The Lancet published a summary of its results. The lifesaving benefit of mammography screening was shown to be far more modest than previously thought and the harms had been greatly underestimated.

The Cochrane Review also found that the mammography-screened women in the trials had more mastectomies, more lumpectomies, and many more cases of ductal carcinoma in situ (DCIS) than the women who were not screened. Although most cases of DCIS, a tiny non-invasive cancer within the milk duct, do not progress, they were—and in some parts of the country, still are—always treated with breast removal. Now radiation therapy is the more common treatment for DCIS.

In the two trials judged to be of the highest quality by the Cochrane reviewers, there were 30% more cancers in the mammography-screened groups than in the unscreened groups and 31% more mastectomies and lumpectomies. Yet surprisingly, in both of these trials, conducted in Canada and Malmo, Sweden, respectively, mammography screening did not reduce the rate of breast cancer deaths. The other five trials, judged to be of inferior quality by the Cochrane reviewers, did show a modest reduction in breast cancer deaths.

Old Trials, New Data
You might wonder why we are still learning new information from these seven trials, which were conducted between the 1960s and 1980s. The answer lies in the Cochrane reviewers’ thorough assessment of the enormous amount of data that was originally withheld and, in some cases, continues to be generated by these trials. The data, it should be noted, were requested by the Cochrane reviewers.

The long-term data provided by the Canadian trial are a case in point. Mammography’s ability to detect many more cases of DCIS has long been known. Not until this trial published 11- to 16-year follow-up results for women in their forties did it become evident that mammograms also detect non-palpable invasive breast cancers that do not progress. This means that some breast cancers can begin to invade the surrounding tissue, but go no further.

This was demonstrated by the Canadian trial results: There were 43 more invasive breast cancers and 42 more cases of DCIS in the women who underwent mammography screening, compared to those who did not. Yet 16 years later, the breast cancer death rate of both groups was exactly the same. (It is likely that there were just as many breast cancers of both types in the women not given mammograms, but these women benefited from being unaware of them.) Currently, doctors are not able to determine which cases of DCIS and invasive cancer will not progress to become life-threatening. All are treated as if they will be lethal.

Bottom Line: Mammography screening was introduced 35 years ago to reduce the rate of breast cancer deaths by finding and treating breast cancer before it can be felt by a woman or her doctor. even trials have produced contradictory results about the reduction in deaths. And some of these trials found that mammography can detect non-palpable breast cancers—both invasive and noninvasive—that do not progress. All are treated as if they will. For the first time, the benefit and harms have been quantified for women who want to make an informed decision. Based on the combined results of these trials, the Cochrane reviewers produced the one in 2000 women will have her life-prolonged estimate stated at the beginning of this article.

“Women, clinicians and policy makers should consider the trade-offs carefully when they decide whether or not to attend or support screening programs,” concludes the updated Cochrane Review, which was originally commissioned and funded in 1999 by the Danish Institute for Health Technology Assessment and the (Danish) National Board of Health.

 

Maryann Napoli, Center for Medical Consumers ©
December 2006

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Breast Cancer Chemotherapy: Adverse Effects Higher Than Reported in Clinical Trials

Posted by medconsumers on September 1, 2006

Breast cancer probably generates a higher than normal amount of informed decision-making on the part of consumers, largely because the disease generates a higher than normal number of clinical trials. And chemotherapy has been the topic of many, if not, most of these trials over the last two decades. A new study illustrates a major barrier to informed decision-making. It found that the incidence of serious adverse effects* is actually much higher in “the real world” than is reported in clinical trials.

The finding came from a new study that determined the prevalence of serious adverse effects by looking at the insurance claims of 12,239 women with breast cancer newly diagnosed between 1998 and 2002, aged 63 years or younger. Of these, 4,075 women were treated with chemotherapy within 12 months of their initial diagnosis. The study was led by Michael J. Hassett, MD, MPH, Center for Outcomes and Policy Research at Dana-Farber Cancer Institute, Boston, and published last month in the Journal of the National Cancer Institute.

Dr. Hassett and colleagues found that the women with breast cancer who received chemotherapy were more likely to be hospitalized or visit emergency rooms than those who had not (61% for those given chemo vs. 42% for those not given chemo). The more common types of serious adverse reactions were fever or infections, low blood counts, dehydration, nausea, vomiting, diarrhea, anemia, and deep-vein blood clots. This study was funded by a grant from the U.S. Agency for Healthcare Research and Quality.

Several explanations are offered for why this study revealed higher rates of serious adverse drug effects than are typically shown in breast cancer chemotherapy trials. For example, it has long been known that people who participate in clinical trials typically do better than people who do not. This is because they are usually healthier to begin with, and therefore less likely to experience a toxic reaction to chemotherapy. Most cancer trials would, for example, exclude people with other illnesses.

Furthermore, cancer trials are designed to determine the success of a treatment, such as disease-free survival or overall survival, rather than its toxicities. The trials do not usually have enough participants to fully explore the prevalence of adverse drug effects, wrote Hassett and colleagues. If only a few thousand people are given chemotherapy, then uncommon toxicities might be overlooked or they might be detected but inaccurately estimated to be rare.

Late Adverse Effects Go Unreported

In the editorial that accompanied the study, John K. Erban and Joseph Lau, MD, cite a 2001 study of breast cancer patients that found most would opt for chemotherapy, even when their oncologists inform them of the low odds of benefit, “…though the improvements in survival may be below 5%, women will often accept chemotherapy for as little as a 1%-2% survival advantage.” (It should be noted, however, that such women are unlikely to be informed of the treatment’s harms which might in some cases cancel the 1-2% survival advantage.)

Erban and Lau warned physicians to be vigilant about the potential for adverse effects of new drugs that might not show up until years after the treatment regimen is over. They are especially concerned about the growing use of so-called targeted drugs, such as Herceptin and Femara, which are prescribed for certain types of breast cancer to prevent recurrences. “These newer molecular drugs are increasingly effective against breast cancer and less toxic in the short term,” wrote Erban and Law.

The editorialists warn that this will encourage drug companies to “push them to market, and there will be few incentives for longer term toxicity studies.” Because clinical trials are designed to determine a drug’s benefits (e.g., prolonged survival), they suspect that there will be no incentive to track what is known as the “late adverse effects” of these newer drugs.

* The definition of a serious drug-related adverse effect is: Any untoward medical occurrence that is related to drug use and results in death or significant disability/incapacity, requires hospital admission or prolongation of existing hospital stay, or is life threatening.

Maryann Napoli, Center for Medical Consumers ©
September 2006

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Cancers That Do Not Kill

Posted by medconsumers on August 1, 2006

Prevalent and Usually Treated Aggresively

If doctors look hard enough, they will find abnormalities. The problem has escalated with improved imaging techniques like ultrasound and scans that allow them to find tiny cancers and precancerous lesions that, in another era, were not seen beyond the autopsy table. Many, if not most, are inconsequential, but no test can definitively sort out the minority that merit treatment. A lot of unnecessary aggressive treatment is the unhappy result.

Ambiguous findings are so common that they have been given the somewhat wry name of incidentalomas. The word begins with the breezy sound of something found unexpectedly and ends with an ominous ring of cancer. Incidentalomas are found in the kidney, liver, pancreas, adrenal glands, thyroid gland, lung, breast, and prostate—in other words, any organ that can be imaged.

The detection of incidentalomas has been ruining people’s lives well before there was a word for them. Ever since the introduction of the first cancer screening test—the Pap smear—50 years ago. Cancer screening (by definition, a test given to people without symptoms) frequently reveals a type of cancer or a precancer that would have regressed or remained dormant for an entire lifetime. For every person who benefits from early detection, many more are diagnosed with a cancer they did not need to know about.

Based on the combined results of the mammography screening trials, for example, it is estimated: “For every woman who has had her life prolonged [because breast cancer was found on a screening mammogram], five healthy women who would not have received a breast cancer diagnosis had there not been screening will be converted into cancer patients,” according to Jorgensen and Gotzsche (BMJ, 1/17/04). What the public needs is a medical organization that would serve as counterpoint to the American Cancer Society—one that provides a realistic understanding of cancer and all its uncertainties.

The word incidentaloma is more typically applied to a tiny mass, nodule, or lesion found by chance during a biopsy or an imaging test ordered in response to unrelated symptoms. The dilemma they pose was illustrated recently in a New England Journal of Medicine article by John H. Stone, MD, Johns Hopkins School of Medicine, Baltimore. His patient’s puzzling and diffuse symptoms were finally understood after a full-body CT scan identified a problem in the temporal artery. A biopsy specimen found giant-cell arteritis—not cancer, as he had feared. But the relief felt by doctor and patient alike was immediately overshadowed by an unexpected CT-scan finding in the patient’s abdomen: a “5-mm mass in the posterior right kidney. Cannot exclude renal-cell carcinoma.”

The next step was magnetic resonance imaging that produced a report which was not completely reassuring: “consistent with proteinaceous cyst. Recommended follow-up imaging in six months.” As Dr. Stone put it, “Thus, an incidentaloma ruined the patient’s peace of mind and diverted our focus from the otherwise clear path to health.” The most challenging question facing physicians, he wrote, “regardless of the organ in which incidentalomas are found, is what to do with the small ones—the renal mass smaller than 1.5 cm*, the adrenal lesion smaller than 4 cm, and the pituitary abnormality smaller than 1.0 cm. My patient’s 5-mm [about 1/5 of an inch] renal mass challenges the capabilities of any radiologic test ordered in the hope of definitive reassurance. With a growing number of incidentalomas, what to tell the patient remains unclear.”

Although many incidentalomas are clearly cancer, most would never have become life-threatening or symptomatic had they gone undetected and untreated. This is the take-home message from a recent study published in the Journal of the American Medical Association, entitled, “Increasing Incidence of Thyroid Cancer in the U.S., 1973-2005.” The authors, Louise Davies, MD, and H. Gilbert Welch, MD, found a nearly three-fold increase in the U.S. thyroid cancer incidence in this 32-year time period. Yet death from thyroid cancer has always been—and still is—rare, less than 1,500 deaths annually.

Davies and Welch examined other explanations, such as environmental radiation, but traced the increase instead to the widespread use of ultrasound that began in the 1980s. “While thyroid ultrasound cannot diagnose a thyroid nodule as malignant, it can detect nodules as small as 0.2 cm,” they wrote, noting that the physician’s manual examination could only detect nodules that are larger. Ultrasound examinations used to be done in hospital radiology departments, but now more and more thyroid ultrasound machines can be found in doctor’s offices.

“Fine-needle aspiration biopsy is currently our gold standard because it is more likely to produce definitive information,” said Louise Davies, MD, of the VA Outcomes Group, Department of Veterans Affairs Medical Center, White River Junction, Vermont. But, she explained in a telephone interview, fine-needle aspiration may not provide a clear diagnosis, which means undergoing an operation to get a definitive answer, where half or all of the thyroid gland is removed. The latter operation (thyroidectomy) requires life-long thyroid replacement therapy. “Surgeons may recommend removing the whole gland because of the risks associated with re-operation if the nodule turns out to be cancerous,” said Dr. Davies, a surgeon and lead author of the thyroid cancer study.

Asked what people can do to avoid unnecessary treatment, Davies suggested, “Think one step ahead about what you would do, so that you don’t find yourself down a path toward thyroid removal. Consider what you would do if an ultrasound showed a nodule—would you, for example, rather not know you had one in the first place, or would you want to have it rechecked periodically?” She advises people to consider how the thyroid nodule was found, whether it causes symptoms, or if there is a family history of thyroid cancer.

A second opinion about the decision to undergo a fine-needle aspiration is also a good idea, explained Davies. For second opinions, she had this suggestion for choosing a doctor to consult: “If, for example, an endocrinologist suggested you undergo evaluation, then another endocrinologist, a surgeon or a primary care doctor might be a good choice for a second opinion. In any case, choose a doctor at a hospital, or office different from that of the first-opinion doctor.”

Davies and Welch found that the increasing incidence of thyroid cancer is predominantly due to the increased detection of tiny papillary cancers, the most common type of thyroid cancer, usually symptomless, and the least likely to kill. “An untreated 1 cm or less papillary thyroid cancer has a virtually 100% survival rate,” said Davies. “Most worrisome are medullary and anaplastic thyroid cancers, which usually have symptoms.”

The presence of symptoms is key. “If you have a small lump that you can’t feel, but your doctor can, and yet you have no symptoms—that’s an incidentaloma. People should realize if they don’t have symptoms, they have time to wait three to six months to have it evaluated. With incidentalomas, that’s key,” said Davies. “Early detection of an incidentaloma doesn’t necessarily lead to a longer life. Instead, it may just lead to a longer period of time in which you know you have cancer.”

*2.5 cm or 25 mm = 1 inch

How Prevalent is Cancer? How Prevalent are Cancers That Kill?

The following statistics are based either on autopsy studies of people not known to have cancer during their lifetime or ultrasound examination studies of symptom-free people. They show that the prevalence of many cancers—and would-be cancers—is well in excess of cancer diagnosed in the living population. The U.S. cancer death statistics come from the American Cancer Society.

Thyroid:
An ultrasound screening study of 96,278 people found thyroid nodules present in 35% of women age 26 to 35, increasing to nearly 45% of women aged 55 and over. Thyroid nodules were present in 9% of men ages 26 to 35 and increased to 32% in men aged 55 and over.

Several autopsy studies have found that thyroid cancer is present in 36% of all people. In one of these studies, researchers examined extremely thin slices of the thyroid glands of 101 people and found many more, smaller (2-3 mm) thyroid cancers in the slices. This led them to conclude that, if sliced finely enough, virtually everyone’s thyroid would be found to have cancer.

An estimated 1,460 people will die of thyroid cancer in 2006.

Adrenal gland:
Autopsy studies found adrenal masses, 2 mm to 4 cm, in diameter to be present in approximately 10% of people.

Approximately 1 out of every 4,000 adrenal tumors is malignant. Deaths from adrenal cancer are so rare that the ACS does not provide a number.

Kidney:
An ultrasound study of the urinary tract of 729 people found the prevalence of kidney cysts was 1.7% in those aged 30-49 years, 11.5% in those aged 50-70 years, and 22% in those aged 70 years and older.

An estimated 12,480 people will die of kidney and renal pelvis cancer in 2006.

Prostate:
Autopsy studies indicate the presence of prostate cancer in men is 10-42% at age 50-59 years, 17-38% at age 60-69 years, 25-66% at age 70-79 years, and 18-100% at age 80 years and older.

There were 30, 350 prostate cancer deaths in 2005.

Breast:
Autopsy studies show the prevalence of ductal carcinoma in situ, a tiny non-invasive cancer within the milk duct, is 6-16%. Prior to the introduction of mammography screening, this diagnosis represented less than 5% of all new cases of breast cancer, now it is 20%. Since most cases of DCIS are treated with either breast removal or radiation, it is not known how many would have regressed or remained dormant without treatment. However, 78 women whose biopsied tissue was mistakenly diagnosed as benign in the pre-mammography era provided an opportunity for researchers. They did a followup study and found that only 20-25% of these untreated women went on to develop invasive cancer ten years after the biopsy. Some breast cancer researchers believe that the DCIS diagnosed today with improved imaging techniques is even more likely to be inconsequential than these 78 cases indicate.

Evidence that some invasive breast cancers found “early” on a screening mammogram do not always progress to be life-threatening comes from the National Breast Screening Study of Canada. Over 50,000 women in their 40s were randomly assigned to have mammograms or not. 82 more breast cancers were detected in the women given mammograms. (592 invasive and 71 non-invasive breast cancers in the mammography group, compared to 552 invasive and 29 noninvasive breast cancers in the control group.) One would expect a higher survival in the mammography group with its higher rate of cancer detection. But, in fact, the breast cancer death rate in both groups was exactly the same at 16 years.

There were 40,410 breast cancer deaths in 2005.

Maryann Napoli, Center for Medical Consumers©
August 2006

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Reduce Risk of Breast Cancer

Posted by medconsumers on May 1, 2006

Drugs to Reduce Breast Cancer Risk: Is It Worth It?

Initial results from a government-sponsored study indicate that the osteoporosis drug raloxifene (brand name: Evista) may protect against breast cancer. The study compared it against an older anti-breast cancer drug, tamoxifen (brand name: Nolvadex), and found both are equally good at reducing the chances of developing breast cancer. Some media reports of this study were overly enthusiastic about its finding.

The study is yet to be published and therefore has not been peer-reviewed. If the results hold up, Eli Lilly, maker of raloxifene, will be able to apply to the FDA for permission to promote raloxifene as a breast cancer preventive. Expect an overheated advertising campaign by Lilly touting raloxifene as a “two-for”—a drug that will save women from osteoporosis AND breast cancer.

Raloxifene has been on the market since 1997. It is good at increasing bone density; completely ineffective at reducing the most serious type of fracture (hip); and minimally effective in reducing spinal fractures. Spinal fractures can cause pain and a dowager’s hump in advanced age, but many are entirely symptomless. Tamoxifen has been on the market since 1972. First as an adjunctive treatment for breast cancer and more recently (1998) as a preventive drug for healthy but high-risk women. It never took off for the latter purpose because, according to one report, many doctors were uneasy about prescribing a cancer drug to healthy women every day for five years.

Both raloxifene and tamoxifen are what is called selective estrogen receptor modulators, or SERMs, which means that they protect the breast from estrogen’s cancer-causing potential but preserve estrogen’s protective effect on the bones. This is why SERMS were initially promoted as designer estrogens.

The National Cancer Institute sponsored the new study that compared the two drugs called the STAR trial, short for Study of Tamoxifen and Raloxifene, and the initial results were posted last month on its Web site (www.cancer.gov see initial results STAR). The STAR trial included postmenopausal women at high risk for breast cancer who had been randomly assigned to take one or the other drug. The NCI hailed both drugs as having reduced the incidence of breast cancer by 50%, which was uncritically picked up by most of the media.

Here’s what the NCI should have explained: Of the 9,700-plus women in each drug group, about 165 got breast cancer. This translates to 1.7%; whereas, 3.4% would be expected to develop breast cancer had they not taken a drug. (Hence the 50% reduction in breast cancer incidence.) Another way of saying the same thing is: 98.3% of high-risk women will not get cancer if they take raloxifene or tamoxifen; whereas, if they take no drug, 96.6% of women will not get cancer. Obviously, much more research is needed to determine who is at high risk for breast cancer.

If you are thinking of taking raloxifene every day for five years, consider the following:

It is premature to call raloxifene and tamoxifen preventive drugs. The STAR lasted only four years and breast cancer can take from 12 to 17 years to develop. Therefore, it is not known whether these drugs prevent breast cancer or merely delay its onset. The Tamoxifen Breast Cancer Prevention Trial lasted nearly five years.

The media reports of STAR emphasized fewer adverse reactions for raloxifene. However the 29% fewer blood clots and 36% fewer uterine cancers are not considered to be statistically significant because these conditions are rare. (Findings could have occurred by chance.) However, the finding of fewer cataracts in the raloxifene users is statistically significant. There were fewer cases of noninvasive breast cancer (e.g., ductal carcinoma in site, which does not always become life-threatening if left undetected.) in the women taking tamoxifen. [Note: When the STAR results were reported at a June meeting of the American Society of Clinical Oncology and published simultaneously online in the Journal of the American Medical Association, there was no overall difference between the two drugs in the study participants’ self-reported side effects—with some exceptions. Hot flashes, vaginal bleeding, bladder control problems were more common in women on tamoxifen. And pain during sexual intercourse and joint pain were more common in those on raloxifene.]

Raloxifene’s spinal fracture reduction benefit is small. Three-year results of a major trial showed spinal fractures in 10.1% of the women on placebos; in 6.6% of women on 60-mg/daily of raloxifene; and in 5.4% for women on 120 mg/daily of raloxifene.

Less is known about the long-term effects of raloxifene than is known about tamoxifen. It took more than 25 years of tamoxifen use before a rare life-threatening adverse effect (endometrial sarcoma) became apparent.

Maryann Napoli, Center for Medical Consumers ©May 2006

For another perspective on this study, see Breast Cancer Action’s Newsletter

http://www.bcaction.org/Pages/SearchablePages/2006Newsletters/Newsletter092A.html

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Breast Cancer Awareness Month: Read This Before You Have a Mammogram

Posted by medconsumers on September 1, 2005

Mammography Screening—Both Good and Bad News

Mammography screening seems destined to spawn controversial study results, as it has in the last few months. And its role in reducing the breast cancer death rate will remain the subject of heated debate among researchers for a good long time. The U.S. breast cancer death rate has declined 20% since 1990, as it has in other western countries. But it is not clear whether this can be credited to mammography, treatment improvements, or simply greater awareness among women that breast tumors should be promptly examined. What has become increasingly clear is this: Mammography screening harms more women than it helps.

That’s not the message that goes out to women via the media and their doctors. Of the three recently published mammography screening studies, the most media attention went to the one that seemed to equate the improvements in breast cancer survival with the increase in the proportion of women now diagnosed with small breast cancers. That was the take-home message from a CNN TV interview with Clifford Hudis, MD, a co-author of this study published last month in the journal Cancer.

With his colleagues at Memorial Sloan-Kettering Cancer Center, New York City, Dr. Hudis reviewed the early-stage breast cancers diagnosed in the U.S. over a 24-year period, from 1975 to 1999. The statistics came from the government’s database that draws from nine cancer registries across the country considered to be broadly representative of the U.S. population.  Information concerning more than ¼ million breast tumors from the same population was also available to the researchers. The upshot: Many more small breast cancers were diagnosed in 1999 than were diagnosed in 1975.

Certainly sounds like good news, and that’s how it played out in the Wall Street Journal and other media. Yet despite the messages conveyed in the CNN TV interview, Dr. Hudis’s study did not determine why the breast cancer death rate went down. It simply found a greater number of women diagnosed with breast cancer in recent years had small tumors.

It is unclear why Dr. Hudis would misrepresent his own study and leave CNN viewers with the impression that mammography and breast self-examination (BSE) are largely responsible for the decline in breast cancer deaths. Let’s put aside for the moment Dr. Hudis’s discredited belief in BSE, as two trials showed the practice leads to unnecessary biopsies with no discernible benefit.

Instead, a hard look at the nation’s increase in small cancers is long overdue. The topic is too complicated for a four-minute TV interview. The breast cancer death rate may be going down, but there has also been a steady annual increase in the number of women diagnosed with breast cancer over the last two decades. The increase is generally acknowledged to be related, at least in part, to mammography screening. This is not entirely good news. Mammography screening may prolong life for some women, but it also causes many more women to be diagnosed and treated for cancers that they would be better off not knowing about. Not all cancers are deadly even if left undetected.

“Screening mammography is great for finding small cancers. But finding small cancers is not necessarily good,” according to Donald Berry, PhD, Chair of the Department of Biostatistics and Applied Mathematics at the University of Texas M.D. Anderson Cancer Center. In an e-mail interview, Dr. Berry explained that breast cancer comes in several different forms. “Some cancers are lethal and others are not. Non-lethal cancers tend to be smaller, and they tend to grow more slowly.” Dr. Berry recently co-authored a study that showed that breast cancers detected by mammography tend to have the best prognosis (excellent chance of recovery with treatment), even when the cancer has spread to the lymph nodes. The authors advise doctors to take that into consideration when recommending treatment.

Dr. Berry and colleagues assessed the outcomes of two major mammography screening trials that together included over 150,000 women, singling out those who eventually developed breast cancer. More cancers—both invasive and noninvasive (ductal carcinoma in situ)—were detected among mammography-screened participants, as compared with those not given mammograms.

“Screening mammography finds a greater proportion of non-lethal cancers than do other methods of detection. Unfortunately, it is not possible to perfectly identify which cancers are lethal. So we treat them all. Consequently, screening leads to overdiagnosis and excessive treatment,” Dr. Berry explained, referring to surgery, radiation, hormonal therapy, and chemotherapy that some women could have avoided without risking their health.  Unfortunately, women have been led to believe the opposite—that mammography leads to less drastic treatment.

One of the trials assessed by Dr. Berry and colleagues found the breast cancer death rate among the women given mammograms was no different from that of the women not given mammograms. This is after 16 years of followup. The finding clearly suggests that mammography is not only useless but harmful to a significant number of women. There were 82 additional breast cancers* (half were invasive and half were noninvasive) in the women given mammograms. In other words, 82 of the mammography-screened women were treated for a cancer, including invasive cancer, which would not have produced symptoms or become life-threatening.

No other cancer screening test has been as well studied as mammography. Of the seven such trials conducted worldwide, two found no difference in the breast cancer death rate between the mammography-screened women and those not given mammograms. In a systematic review of the seven mammography trials conducted in 2000 by the Cochrane Collaboration, the two trials that found no life-prolonging benefit to mammography were determined to be superior in terms of quality than the five trials that showed a modest benefit to mammography. (None were without flaws.) The Cochrane Review’s conclusion: “Screening is unjustified.”

The merits and flaws of these seven major trials have dominated the controversies over the value of mammography. Little is known about the quality of mammography screening in the real world. Women who participate in clinical trials are given high-quality mammograms that are read by experienced radiologists. In other words, it is mammography under the best of circumstances. Not enough research attention has been given to the question of how women fare when given mammograms in the everyday practice of medicine. That was the point of a new study led by Joanne Elmore, MD, School of Medicine, Harborview Medical Center, University of Washington, Seattle.

With colleagues at several medical centers, Dr. Elmore looked at the medical records of women enrolled in six health plans around the country. They singled out the women who died from breast cancer between 1983 and 1998, an era that followed major improvements in mammographic techniques. 1351 women with breast cancer (aged 40 to 65 years) were matched with 2501 cancer-free women who were the same age and with the same level of risk for breast cancer.

Dr. Elmore and colleagues compared the screening practices (mammography and a physician’s breast exam) of the women who died of breast cancer with the high-risk women who were still alive. High-risk was defined as having a family history of breast cancer or a breast biopsy, as noted in the medical records. If screening reduces the rate of breast cancer death, the researchers expected to find that the women who died of breast cancer had undergone less screening then the women still alive. In fact, there was no difference between the two groups.  “Our findings suggest that breast cancer screening in the community was minimally effective in preventing death,” concluded Dr. Elmore and colleagues. Results were published in the Journal of the National Cancer Institute.

In the editorial that accompanied this study, Russell Harris, MD, University of North Carolina, Chapel Hill, gave several reasons why screening may be making “a smaller contribution” to the reduction in breast cancer deaths than the major trials have led us to believe. “Better treatment may mean that screening is less necessary than it was previously, because treatment of later stage cancers may still be effective.”  He also cites the fact that women today are more likely to have breast lumps “found accidentally” promptly examined by a health professional. Here Dr. Harris is referring to women finding tumors while in the shower, as opposed to finding them while doing BSE.

Women continue to get one-sided information about mammography (“it will save your life”) and little about its harms (unnecessary treatment). This was reflected in a survey of American women’s attitudes toward this technology in 2000. Only 6% reported that they knew about cancers that do not progress or become life-threatening.

For an international perspective on the accuracy of the mammography information dispensed to women via Web sites in eight countries, a 2003 survey was conducted by Karsten Juhl Jorgensen, MD, and Peter C. Gotzsche, MD, of the Nordic Cochrane Center in Copenhagen. They assessed 27 Web sites that were sponsored by governments, professional organizations, and consumer advocacy groups.

Jorgensen and Gotzsche, whose findings appeared last year in the British medical journal, BMJ, concluded, “The information material provided by professional advocacy groups and governmental organizations is information poor and severely biased in favor of screening…and failed to mention major harms.”  On the other hand: “Web sites of consumer groups were more balanced and comprehensive.” The three consumer advocacy groups with the balanced information are all U.S.-based: The National Breast Cancer Coalition (www.stopbreastcancer.com), Breast Cancer Action (www.bcaction.org) and the Center for Medical Consumers (www.medicalconsumers.org).

Based on the findings from seven clinical trials, Jorgensen and Gotzsche describe the cost to women in terms of unnecessary treatment. For every 1000 women who undergo mammography screening for ten years, they report, one woman will have her life prolonged; five additional women will receive an unnecessary cancer diagnosis and treatment; and three women will have a benign tumor biopsied.

“Whether this is too high a price to pay is open to debate,” wrote Jorgensen and Gotzsche, “but if women and policy makers are not informed of this balance between major benefits and major harms—which they have not been so far—then there cannot be any discussion or rational decision making.”

Bottom Line: Mammography-detected breast cancers have the best outlook. The screening test also leads to the detection and treatment of breast cancers that would never become life-threatening. Mammography’s role in the nation’s declining breast cancer death rate remains unclear. At best, it appears minimal. Women are not receiving honest information about mammography’s harms.

*There were 592 cases of invasive breast cancer and 71 noninvasive breast cancer in the approximately 25,000 women given mammograms, as compared with 552 invasive and 29 noninvasive breast cancers in the approximately 25,000 not given mammograms. The women were age 40 at the start of the trial. Only half of all noninvasive cancers, also called ductal carcinoma in situ, are likely to become invasive, but all are treated as if they will. This trial indicates that invasive cancers do not always progress and become lethal.

Maryann Napoli, Center for Medical Consumers ©

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Radiation-Induced Heart Damage on the Decline

Posted by medconsumers on May 1, 2005

Radiation therapy now has a lower risk of fatal heart damage to women with breast cancer than it did for women treated in the past. The cardiac harm, however, does not show up until ten or more years after treatment, so it remains unclear whether this adverse effect has been completely eliminated by modern improvements in radiation techniques. These findings were published last month in the JNCI (Journal of the National Cancer Institute, 3/16/05).

As of 2002, about 42% of American women newly diagnosed with breast cancer had the cancerous breast tumor surgically removed (lumpectomy) followed by six weeks of radiation therapy. This has been a valid choice ever since 1985 when a major nationwide clinical trial found that mastectomy (breast removal), lumpectomy plus radiation therapy, and lumpectomy alone all had the same survival rate. Lumpectomy alone, however, was—and still is—rarely offered to women. This is because the same large clinical trial found, in 1993, that the radiation therapy decreased the rate of breast cancer recurrence, though it did not reduce the death rate. Worse, as women treated with radiation were followed beyond ten years, they showed a higher death rate then the women whose breasts were not irradiated.

Obviously, this was not expected. Researchers began to speculate that the anticipated decrease in breast cancer mortality was being offset by an increase in treatment-related deaths. By the early 1990s, researchers knew that there were more cardiac deaths among breast cancer patients given radiation therapy than those whose breasts had not been irradiated. A 1994 analysis showed a 62% increase in heart-related deaths among women treated with radiation. Researchers also knew that women with left-sided breast cancer had higher rates of radiation exposure and higher rates of cardiovascular mortality.

To determine whether the multiple improvements in breast radiation techniques had overcome this hazard, a Texas research team assessed the data from 12 cancer registries around the country. Altogether the registries included 27,283 women with early-stage breast cancer who had been treated with radiation therapy between 1973 and 2000. (Radiation therapy after a mastectomy was the standard breast cancer treatment until the mid-1970s; and it continues to be used in certain circumstances.) Half of the women had left-sided breast cancer, and half had right-sided breast cancer. These registries are broadly representative of the way breast cancer patients are treated across the country.

The researchers, led by Sharon H. Giordano, MD, MPH, University of Texas M.D. Anderson Cancer Center, Houston , found that the risk of death from heart disease decreased over time. For the women diagnosed between 1973 and 1979, the heart disease mortality rate at 15 years was 13% for those with left-sided breast cancer and 10% for those with right-sided breast cancer. For the women diagnosed in the late 1980s, it was nearly 6% and nearly 5%.

Dr. Giordano and colleagues concluded that, due to advances in radiation techniques, the risk of cardiac death associated with radiation after breast cancer “has substantially decreased over time.” Given that radiation-induced heart damage takes many years to develop, the researchers added this caution. “Whether the risk of ischemic heart disease mortality resulting from radiotherapy has been entirely eliminated cannot be determined definitely from this study. Continued follow-up of the women diagnosed and treated in the late 1980s will be necessary to answer this question.”

Where does this leave the woman diagnosed today? If radiation therapy doesn’t prolong life, wouldn’t it be safer to forego this treatment, just have a lumpectomy, and take the small risk of recurrence? “Not quite true,” answered Jack Cuzick, PhD, author of the editorial that accompanied the study. In an e-mail interview, Dr. Cuzick explained, “Recent trials are showing a reduction in breast cancer deaths [in women given radiation therapy], and little effect on other causes of death, so for women at high risk of recurrence and breast cancer death, for example, those with node-positive breast cancer, radiotherapy is a pretty good option.” But, Dr. Cuzick cautioned that there is still uncertainty about the value of radiation therapy for women whose breast cancer death risk is low, for example, those with tumors under 1 cm or ductal carcinoma in situ.

Maryann Napoli, Center for Medical Consumers ©
May 2005

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Should I be Tested for Cancer? Maybe Not and Here’s Why

Posted by medconsumers on June 10, 2004

New Book by H. Gilbert Welch: Should I be Tested for Cancer

Americans are keen on cancer screening. In fact a recent survey showed that most would rather have a free whole-body scan than $1,000 in cash. 32% thought that an 80-year-old man who chose not to undergo a colonoscopy was irresponsible. And 74% believe that finding cancer early saves lives “most or all of the time.” Even the common occurrence of an anxiety-producing false alarm, experienced by 38% of those surveyed, did not blunt enthusiasm for cancer screening. Nearly all who had this experience acknowledged its terror-inducing aspect, but were glad they had been tested.

Cancer testing for symptom-free people is accepted as a must-do health maintenance ritual by most Americans, but are they undergoing screening with eyes wide open? How many women, for example, have ever had the pros and cons of Pap testing explained to them? How many even know there is a downside to a Pap test? But screening for any disease is a two-edged sword carrying risks as well as benefits. And sometimes the former cancels out the latter.

One of the authors of the above-mentioned survey, which was published early this year in the Journal of the American Medical Association, is H. Gilbert Welch, MD, MPH, Professor in the Departments of Medicine and Community and Family Medicine at Dartmouth Medical School. Dr. Welch’s new book entitled, Should I be Tested for Cancer? Maybe not and here’s why, serves as a counterbalance to the one-sided information the public receives from their physicians and organizations like the American Cancer Society. (“Your life will be saved.” “Your treatment will be less drastic.”) In fact, his book is downright subversive, as its title suggests consumers can make an informed decision not to be screened.

Dr. Welch writes that his book is for people who “are open to questioning the wisdom of these testing efforts.” It is not for people who need to have simple answers. “None of us likes uncertainty–but this book is full of it.” He describes cancer as a disease that is not inevitably fatal, or even inevitably invasive. Before screening, it helps to know your odds of getting the target cancer. Typically, people are told a given test reduces the odds of dying of cancer by 30%. Dr. Welch says such statistics mean nothing unless you know your odds of getting the target cancer. As an example, he provides a graph based on the mammography screening trials. In the next ten years, of 1,000 American women age 50, six will die of breast cancer without mammography; four will die of breast cancer despite having had mammograms. Therefore, only two out of 1,000 will avoid a breast cancer death because of mammography. His explanation provides not only a realistic expectation of mammography’s benefit but it also illustrates the low odds of dying of breast cancer. News flash: Most women will never get it!

The colon cancer screening trials show a puzzling finding that is rarely conveyed to the public. The people who were randomly assigned to be screened showed a modest drop in colon cancer deaths, compared to the people who were not screened. However, the same trials showed that this benefit was canceled by an inexplicable increase in deaths from other causes, chiefly heart disease.

Screening tests are good at finding something Dr. Welch calls pseudodisease, and unnecessary treatment is the usual consequence. It is the PSA-detected prostate cancer that would have remained dormant, but is usually treated with radical prostatectomy; it is the nodule found during a lung scan that demands a biopsy to rule out cancer; it is the mammography-detected ductal carcinoma of the breast that automatically means breast removal in some areas of the country.

Some high-tech screening procedures are so sensitive that they identify lumps in nearby organs. Dr. Welch relates a written account of a doctor who underwent a virtual colonoscopy, which can “see” beyond the colon. It turned up a kidney mass, a 2 cm liver mass and multiple non-calcified nodules in the lung. After several CAT scans, a liver biopsy, removal of three small sections of his lung, four days of potent painkillers, he began to feel “nearly normal” five weeks later, except for the rib pain caused by the surgical interruption of the nerves during the lung biopsies. “No cancer” was the outcome. The doctor/patient may have been relieved, observed Dr. Welch, but he was also motivated to start asking hard questions about radiologists and their remarkably sensitive imaging tests. “His story certainly makes one wonder whether they are seeing too much.”

Maryann Napoli, Center for Medical Consumers© June, 2004

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Second pathology opinion for mammography-detected breast cancer

Posted by medconsumers on April 1, 2004

“Screening causes cancer.” When British surgeon and screening critic Michael Baum, MD, once expressed this opinion during a protracted media controversy over the safety of mammograms, it, no doubt, struck many as hyperbole. A recent study of mammography screening in Norway and Sweden, however, shows the comment to have a strong element of truth.

These two Scandinavian countries provide the basis for testing out a prevailing theory about the benefit of screening. Yes, many more cancers are diagnosed once a screening program is introduced, goes the theory, but they are “tomorrow’s cancers” diagnosed today. Then there are the skeptics who look at the long-range statistics and see something quite different. The increase in “tomorrow’s cancers” found in a large group of middle-aged women given regular mammograms, they reason, should eventually result in a corresponding decrease in breast cancer diagnosed later in life.

The skeptics were validated in the Scandinavian study published recently in the British electronic journal, BMJ Online First. After mammography screening was introduced in Norway for women aged 50 to 69 years, the incidence of breast cancer had increased by 54%, according to Per-Henrik Zahl and colleagues at the Norwegian Institute of Public Health, Oslo. The increase was 45% after mammography screening began in Sweden in 1987. Contrary to expectations, there was no corresponding long-term reduction in the rate of women diagnosed with breast cancer. Dr. Zahl and colleagues wrote that the increases in breast cancer incidence were too large to be attributed to causes other than screening, such as hormone therapy.

The significance of these findings is this: Mammography causes many women to be diagnosed and treated for a type of breast cancer that would never produce symptoms or become life threatening if left undetected. Doctors call this overdiagnosis and overtreatment. Unfortunately, most women are not informed of this risk, as they should be, before they consent to mammography screening. A survey of U.S. women’s attitudes toward mammography screening in 2000 showed that only 6% had ever heard that mammograms can find cancers that do not progress.

Whenever researchers address the problems associated with overdiagnosis and overtreatment, they usually focus on the mammography-related massive increases in the diagnosis of ductal carcinoma in situ (DCIS), a type of microscopic cancerous lesion within the milk duct that, in most cases does not progress to life-threatening disease if left untreated. (At least 60% of DCIS will not go on to become invasive and life threatening.).

Dr. Zahl and colleagues, however, have confined their statistics solely to invasive breast cancers, which makes their results even more alarming. The only way women can protect themselves from overtreatment is to give serious thought to the decision whether or not to undergo mammography screening. The risks associated with overdiagnosis and overtreatment are significant enough to make avoiding mammography a reasonable choice for women without breast symptoms. After looking at their survey results, Dr. Zahl and colleagues concluded, “Without screening, one third of all invasive breast cancer in the age group 50-69 years would not have been detected in the patients’ lifetime. This level of overdiagnosis is larger than previously reported.”

Another element of the mammography-related overdiagnosis and overtreatment picture was published within a week of the Scandinavian study. It involves DCIS, which was rare before mammography screening was introduced in the U.S., and now, more than 55,000 women receive this diagnosis yearly. DCIS has been variously called a precancer, a cancer, not a cancer, a high-risk factor. A survey published in the Journal of the National Cancer Institute showed that women are still given unnecessarily aggressive treatment for DCIS (e.g., mastectomy and removal of some of the lymph nodes at the armpit). Conversely, some are undertreated with excision alone for an uncommon type of DCIS called comedocarcinoma that will become invasive and therefore should be treated more aggressively (with radiotherapy).

What you can do:

If DCIS is diagnosed, it is advisable to get a second surgical opinion and a second pathology opinion (see below). With the exception of comedocarcinoma, pathologists are unable to identify which DCIS lesion will progress to invasive cancer and how long it will take to do so.

-To help you decide whether to have regular mammograms, go to this excellent decision-making Web site at the University of California, San Francisco www. mammography.ucsf.edu/inform/index.cfm

-Two of the country’s leading breast pathologists have long been working on ways to distinguish the forms of DCIS that will become invasive from those that will remain dormant. If diagnosed with DCIS, consider a second pathology opinion from Michael Lagios, MD, St. Mary’s Hospital, San Francisco (415) 789-0965 (www.breastcancerconsultdr.com), or David Page, MD, Vanderbilt University, Tennessee (615) 343-0072 (www. breastconsults.com). Both are breast pathologists who will deal directly with breast cancer patients.

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