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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

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

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

Posted in Book Reviews, Cancer, Screening | Tagged: , , , | Comments Off

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.

Posted in Cancer, Scans and X-rays, Screening | Tagged: , , , , | Comments Off

Second Pathology Opinion for Early Breast Cancer

Posted by medconsumers on August 1, 2003

Why You Should Consider a Second Pathology Opinion for Ductal Carcinoma in Situ
By Maryann Napoli
(August 2003)

Ductal carcinoma in situ now represents one out of every five new cases of mammography-detected breast cancer diagnosed in the U.S. Despite its ominous name, which means cancer within the milk duct of the breast, DCIS is not always destined to become deadly. Only an estimated one-third of all cases will progress to invasive breast cancer, even if left untreated. The massive rise in DCIS is due to the increased acceptance of mammography screening. But the ability to diagnose DCIS has outpaced the knowledge of how to treat it without causing too much harm. A new study conducted in the UK, New Zealand, and Australia provides some partial answers (The Lancet, 7/12/03).

No cancer agency keeps track of how DCIS is treated in the U.S, but uncertainty is clearly reflected in the range of possibilities. This microscopic lesion can be treated with excision plus six weeks of radiation therapy, breast removal, or excision alone. There is also a great deal of uncertainty about the use of the anti-breast cancer hormonal drug tamoxifen following the initial treatment.

The new study conducted by the UK Coordinating Committee on Cancer Research set out to determine which treatment or treatment combination results in a lower rate of recurrence. All of the 1,694 participants had an excisional biopsy and were then given either no further treatment, radiation therapy, or tamoxifen, or both. The recurrence rate was lower in the women given radiation therapy, as compared to women treated with surgical excision alone. But the difference between the two groups was small:TInvasive breast cancer occurred in the affected breast of 2.5% of the women given radiation therapy, compared with 5.3% in the excision alone group.

The median follow-up for this study was only four years–too short a time to know whether radiation therapy actually extends life, or if the adverse effects of radiation itself outweigh the reduced chance of recurrence. (Earlier research showed a slight increase in cardiovascular deaths among younger women given radiation therapy.) This study will have the unfortunate effect of reinforcing the current “treat all to decrease recurrences in a tiny minority” approach to radiation. As for tamoxifen, the new study found little evidence to support its use.

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

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

Two New Books about Hormones

Posted by medconsumers on July 1, 2003

Two New Books that take a Critical Look at Hormone Therapy
By Maryann Napoli
(July 2003)

The bad news about postmenopausal hormones came in increments. In July 2002, the Women’s Health Initiative trial was stopped prematurely because the estrogen/progestin combination drug called Prempro was-over a five-year period-causing more diseases than it was preventing. Then eight months later, the WHI produced another unexpected finding: hormone drugs aren’t all that helpful to women taking them to alleviate hot flashes.

In time, widely advertised hopes that estrogen could prevent Alzheimer’s disease were dashed when the WHI showed that the women taking Prempro had a higher rate of this much-feared disorder. And if that weren’t bad enough, last month a study involving one million British women found a substantially higher rate of breast cancer deaths among those had taken combination hormones than those who did not or those who took estrogen alone (The Lancet, 8/9/03).

So many questions remain. Why were gynecologists unanimously convinced that long-term hormone “replacement” therapy would prevent heart disease? Why were the adverse effects shown only for combination hormones and not estrogen alone? Are there any safe and effective alternatives for women who were taking hormones to alleviate menopausal symptoms? Two new books provide some answers.

For Susan M. Love, MD, the much admired breast surgeon, the underlying question that the WHI raises for her is why women need to replace hormones in the long term. Women require high levels of hormones to reproduce, she says, then they shift down to lower levels for the second half of life. In her latest book, Dr. Susan Love’s Menopause & Hormone Book, written with Karen Lindsey (New York: Three Rivers Press, 2003), Dr. Love notes that the marketing of hormone “replacement” therapy went hand in hand with the idea that once menopause begins, a heart attack or hip fracture will soon follow. Diseases of aging, like heart disease and osteoporosis, were reclassified as diseases caused by menopause. Both were portrayed as estrogen-deficiency diseases.

In The Greatest Experiment Every Performed on Women: Exploding the Estrogen Myth (NewYork: Hyperion, 2003), journalist Barbara Seaman writes that many women injured by hormones were bullied by their doctors into taking estrogen that they didn’t want or need; now many of them are being bullied by lawyers who also may not know what they are doing. In her 1969 ground-breaking book The Doctors’ Case Against the Pill, Seaman almost single-handedly started the women’s health movement when she brought public attention to the serious, sometimes fatal, health risks associated with oral contraceptives because the products sold in the 1960s had more than ten times the amount of hormones needed to prevent pregnancy.

The Greatest Experiment starts 65 years ago when a British biochemist published his formula for a cheap and powerful oral estrogen. Within months, writes Seaman, thousands of doctors and scores of drug companies around the world were working with this formula, prescribing it to slow and prevent aging, to stop hot flashes, to avoid pregnancy or miscarriage, and as a morning-after contraceptive. The risks of these drugs were known and documented from the start, according to Seaman, whose research shows that the British doctor who published his estrogen formula in 1938 spent many years warning that, though these drugs had great promise, they also put women at serious peril. He would become the first of several doctors to warn about giving hormones to healthy women.

Seaman, whose aunt died of estrogen drug-induced endometrial cancer, takes us through the subsequent decades of early failed attempts to study estrogen’s safety and efficacy as a contraceptive; the widespread prescription of the synthetic estrogen called DES to prevent miscarriage (it couldn’t, but that didn’t stop its use); the marketing of estrogen as an anti-aging panacea; and then brings the reader right up to recent years when healthy women were told to take estrogen to prevent heart disease and hip fractures. The injuries and deaths that occurred along the way did not seem to deter doctors and drug companies, nor did the lack of evidence to support the broad range of health claims. (Research has proven estrogen to be safe and effective only for alleviating symptoms of natural and surgical menopause.)

Seaman provides a behind-the-scenes view of the effectiveness of the women’s health activists who can be credited for-among many other things-getting written information about side effects, warnings, etc. mandated for all hormone drugs. When Wyeth-Ayerst asked the FDA to approve its estrogen drug Premarin for the prevention of heart disease, no professional medical society objected to the request. It was Cindy Pearson of the National Women’s Health Network who was the most vigorous dissenter. She successfully pressured the FDA to have the written information include the fact that estrogen has never been proven to prevent heart disease.

At a 1996 FDA meeting about the perennial fight to have written information with all prescription drugs, Seaman managed to get the then head of the AMA to admit publicly why his organization has been so adamantly against the idea. Dr. Roy Schwartz conceded Seaman’s points-that the provision of written information for hormone drugs had saved lives and reduced malpractice suits. Almost half of all prescriptions are written for conditions that are unproven, he explained. Doctors don’t want their patients to know they are getting a drug for [what is called] an off-label use, continued Dr. Schwartz, adding that people might sue their doctors for an injury incurred by a drug prescribed off-label.

While Seaman’s book provides the historical perspective that should make any reader into an educated skeptic once the next “miracle” drug comes along, Love’s book takes on the question of what menopausal women can do now that the all-purpose menopausal drug has been knocked from its pedestal. There are lots of options for women who want to prevent diseases of aging without resorting to estrogen, she writes, offering five chapters on non-drug approaches to symptom relief, as well as lifestyle changes. Some women suffer so severely from night sweats and hot flashes that they are willing to risk taking the drug for a year or so. Love provides easy-to-understand ways of weighing risks, not only of taking the combination hormones but also of developing the diseases of aging. In the WHI, taking estrogen alone, a choice available only to women without a uterus, appears to be safe-for now. This is the only group of participants allowed to continue to the trial’s originally intended end in 2006. As new research becomes available, Love advises women to be prepared to reevaluate their decisions.

One way for drug companies to sell mid-life women on the idea of lifelong hormone therapy was to sell fear of a potentially fatal hip fracture. Never mind that the odds of this occurring before age 70 are pretty slim. (Ironically, the WHI provided the first scientific evidence that combination hormones actually can reduce the rate of hip fracture.) Osteoporosis moved into the female collective consciousness in the 1980s. The chief culprit was purportedly loss of estrogen. What was once a risk factor (bone loss) has been turned into a disease, writes Love. Not so long ago, a woman did not have osteoporosis unless she had a fracture. A panel of international experts redefined osteoporosis as “a disease characterized by low bone mass and microarchitectural deterioration of bone tissue, which lead to increased bone fragility and a consequent increase in fracture risk.”

This greatly expands the number of people who now have a disease, writes Love, who observed that doctors and drug companies have focused women solely on the first half of that definition-low bone density. However, some researchers have found that bone architecture, or bone strength, is a far better determinant of who will suffer a hip fracture. No test can accurately measure bone strength so doctors test what they can-bone density-and continue to rely on dual-energy X-ray absorptiometry (DEXA). This test, suggested for all women over age 60 in osteoporosis ads by Merck, the maker of an osteoporosis drug, has caused many women to be diagnosed with what Love thinks is a made up condition. Osteopenia (reduced bone mass) is not a disease and not even a risk factor, she writes, and should not be treated. However, a DEXA-produced diagnosis of osteopenia led many a woman to an estrogen prescription.

Both books are written by women who have been at the vortex of the estrogen controversy for many years. Both authors are high-profile activists long known to have women’s best interests at heart.

Posted in Book Reviews, Cancer, Drugs, Heart, Women's Health | Tagged: , , , , , , , , , , , , , | Comments Off

Mammography: Should you have one?

Posted by medconsumers on October 1, 2002

Read This Before You Have A Mammogram
In 2001, yet another mammography controversy was triggered by two Danish researchers who, after an in-depth assessment of all mammography-screening clinical trials, found the test leads to more aggressive treatment; increases the detection of cancers that do not progress; and might not save lives.  In this review, conducted by Ole Olsen and Peter Gotzsche of the Nordic Cochrane Centre, mammography-screened women showed a slight increase in heart-related deaths. The deaths are believed to be related to radiation therapy, a standard treatment for early breast cancer. (Read a 2009 update of this review.) Another controversy is brewing among researchers over the cause of the slight increase in breast cancer deaths among women in their forties shown in all mammography screening trials. This topic was addressed in two interviews conducted in 2002 by Maryann Napoli.

Mammography’s Risk to Younger Women

Last month, the Canadian National Breast Screening Study published follow-up results showing, once again, that mammography screening did not reduce the breast cancer death rate for women in their 40s (Annals of Internal Medicine, 9/3/02). The Study’s findings have challenged the prevailing belief that early breast cancer detection saves lives. Worse, they show that mammography screening leads many more women to be treated unnecessarily with mastectomy or radiation therapy. Though 40 more cases of non-palpable invasive breast cancer were detected in the mammography-screened women, their breast cancer death rate was no different from that of the women who did not get mammograms. Similarly, there were 42 more cases of ductal carcinoma in situ, a non-invasive cancer, detected in the mammography-screened women. This shows that mammography screening causes a significant number of younger women to suffer treatment-related harm without reducing their odds of dying of breast cancer.

Mammography proponents have criticized the Canadian Study ever since it first published results more than a decade ago. The Study now has 11 to 16 years worth of follow-up for women in their 40s. Its deputy director, Cornelia J. Baines, MD, was interviewed about the fact that—in the early years of this trial—there were more breast cancer deaths among women given mammograms. This was initially thought to be a statistical fluke when it first showed up. Now some researchers are having second thoughts.

MN: When you published your seven-year results, there were more breast cancer deaths (38) in the mammography-screened women, compared with those in the control group who had no mammograms (28). Were there any surprises now that you have 11-16 year results?

Dr. Baines: No, I knew by 1983 that more breast cancer deaths were occurring in the mammography-screened group rather than the control group. Of course, that’s not what we expected. When we started out, we were sure that we were going to show a major benefit. After all, the HIP Study [the first mammography trial conducted in the 1960s] had shown a benefit to women ages 50-69, and we assumed that the only reason a benefit wasn’t shown for younger women was that the mammography was archaic by today’s standards.

MN: When I interviewed you at the time you published the seven-year results, you said that the excess of ten breast cancer deaths was not statistically significant. I thought that meant it could be ignored.

Dr. Baines: You are quite right it’s not statistically significant, but what is disturbing is that this excess has happened in all screening trials in three different countries. 1985 was a landmark year for mammography screening trials. A Swedish study headed by Laszlo Tabar was published in The Lancet (4/13/85). When you read the abstract [summary] of that study, it says that women ages 40-74 showed a 31% reduction in breast cancer deaths. But if you look in the text of the article, you see that the number of deaths in the [small subset of] women in their 40s given mammograms was higher than in the control group. Similar results were observed in the Stockholm and HIP trials. The consistency of this trend demands further evaluation.

MN: Is anyone looking into it?

Dr. Baines: When we published our first results in 1992, it never entered my head that the people who have been promoting mammography would try to completely destroy the credibility of our study and ignore this phenomenon which had been clearly shown in Tabar’s study and which had also been shown in the HIP study. I started out saying that this needs investigating at the basic science level and believing that screening researchers would pay attention to these trends. Well, was I ever out to lunch. People, when they strongly believe in something, don’t waste time looking at evidence that challenges their beliefs. That’s just not human nature.

MN: Dr. Tabar is a recipient of an American Cancer Society award for his promotion of mammography screening and a teacher of Continuing Medical Education courses for American radiologists. He and the other mammography researchers might not want to look at the “why” behind the increase in breast cancer deaths, but haven’t some researchers begun to investigate a possible underlying biological mechanism for the deaths?

Dr. Baines: Yes, Michael Retsky, PhD, at Harvard Medical School, and Romano Demicheli and William Hrushesky. They studied the relapse patterns of 251 premenopausal women with node-positive breast cancer who had been treated only with surgery only and followed for 16-20 years. Retsky and colleagues found that the breast cancer mortality rates show two peaks: one occurs three years after diagnosis, the other at nine years, and after that, women seem to survive quite well. This, of course, corresponds with what we have been observing in mammography screening trials. Increasingly, researchers like Michael Retsky and Michael Baum speculate that something associated with the biopsy or surgery stimulates growth factors. In some women with micrometastases [undetectable spread of cancer outside the breast], these growth factors may stimulate the micrometastases, and the woman goes on to die. This is consistent with the suggestion made along time ago by Bernard Fisher [America's leading breast cancer researcher]—that micrometastases has already occurred in 90% of all breast cancers before clinical or radiological detection.

MN: Are you talking only about women in their 40s?

Dr. Baines: The finding was more prominent in younger women, but Tabar’s study showed a breast cancer mortality increase in older women as well.

SECOND INTERVIEW ABOUT MAMMOGRAPHY SCREENING

The following interview relates to the same topic. Michael Baum, MD, emeritus professor of surgery at University College in London, U.K., has been a breast cancer surgeon for 30 years. After leaving the Breast Screening Programme for the National Health Service in the southeast of England, Dr. Baum became an outspoken critic of mammography screening, particularly for women in their 40s.

In this interview, Dr. Baum is asked to comment on the new Canadian Study results. In doing so, he argues for a new paradigm for how and why breast cancer spreads. Dr. Baum champions the ideas of the famed Boston-based researcher Judah Folkman whose work is associated with angiogenesis. This is a natural process controlled by certain chemicals produced in the body, leads to the formation of new blood vessels. In adults, angiogenesis is involved in wound healing and menstruation. Angiogenesis can also have negative effects. Tumor growth is dependent on blood and oxygen supplied by these newly formed blood vessels, which also provide a means by which cancer cells can travel to distant organs and form new tumors.

MN: What do you make of the increase in breast cancer deaths shown in the women given mammograms in the early years of the Canadian Study?

Dr. Baum: I believe that it is a real phenomenon and not simply an artifact of this study. It appears in all the studies

MN: In all the studies, not just three?

Dr.Baum: Yes, to a lesser extent in all the other trials.

MN: There were more than twice as many cases of ductal carcinoma in situ [Latin for cancer in place] in the mammogram group. What do you make of that?

Dr. Baum: I’m very influenced by Judah Folkman’s work. He believes that in situ is probably not a good word, and we should call it latent cancer. These latent cancers, particularly in premenopausal women, are grossly overrepresented [in women given mammograms]–something like five times more, compared to what you would expect. That suggests if left to their own devices, these latent cancers might never trouble a woman. If you identify these latent cancers and biopsy them, you have traumatized the area. You immediately trigger the natural healing mechanisms, and natural healing mechanisms involve angiogenesis. So, effectively, the biopsy could be considered an angiogenic switch. You take a latent cancer that would never hurt a woman, biopsy it, turn on the angiogenic switch, and it ceases to be latent. A latent disease can become an aggressive disease.

MN: Is this true only for premenopausal breast cancer?

MB: You see this in other cancers. The most notorious is renal cell cancer. If you find a symptomless renal tumor by chance, and operate, [then] in no time the patient is riddled with metastasis. This happened to a dear friend of mine. I think that “angiogenic switch” might be an explanation. It’s really scary.

MN: Is that what you suspect is happening to some women with premenopausal breast cancer?

Dr. Baum: My explanation sounds a bit farfetched, but it is strongly supported by basic science that is coming out of the work on angiogenesis. There are profound cyclical changes going on in the premenopausal breast, and these changes can also be seen in a premenopausal cancer. So just by happenstance, you might get a surgical insult at a time in the menstrual cycle that favors the cancer cells. It’s all quite alarming.

MN: In the Canadian Study there were 71 cases of DCIS diagnosed in the women given mammograms, compared to 29 in the women not given mammograms.

MB: That tells you two things: 1) It emphasizes the quality of the study. If they were not detecting DCIS, then the screening zealots would say that the screening techniques in the Canadian Study were bad; 2) It demonstrates, yet again, that all screening programs will show an excess of cancers. And the excess is mostly DCIS. In women given a manual breast exam, only about 3% of cancers are DCIS; whereas in mammography-screened women, 20% of the cancers are DCIS.

MN: The breast cancer death rate was the same for both groups in the Canadian Study. Doesn’t that indicate that early detection is of no benefit to women with DCIS?

Dr.Baum: Yes, I think so. I don’t know if any lives are saved by screening, frankly. But the one argument about which I cannot be shaken is that women invited to screening should know these things. I was one of the people given the job of setting up a screening program in the 1987-88 in the U. K. Then it gradually dawned on me that this was state interference with public health, and it was coercion. I resigned in disgust from the National Screening Committee because they were intentionally deceiving women [about the harms]. They went on record saying, “We mustn’t let women know this because it might deter them from coming to screen.” So I decided to work outside the system to inform women about the truth of screening. I can see how some women, fully informed, would accept screening over the age of 50, but to promote mammography to women under the age of 50 is absolutely unethical.

MN: The American Cancer Society has been promoting mammography starting at age 40 for many years now.

Dr. Baum: Either the ACS is funded by the screening industry, or they’ve backed themselves into a corner and can’t admit they’ve been wrong all this time. The message is so seductive: “The secret to cancer is catching it early.” That’s rubbish. It’s so naive. The only thing that influences cancer mortality is better treatment, as far as I’m concerned. The word “early” has no meaning to a scientist. MN: Do you have an equivalent to the ACS in your country overselling the early detection message?

Dr. Baum: No, but we have “Black October,” which is what I call Breast Cancer Awareness Month, when lots of fine young women have these campaigns with catwalk models advising breast self- examination every month. And that gets across two false messages: 1) that self-examination is of any value; and 2) that the role model for breast cancer patients is a skinny girl of 23.

MN: Any parting thoughts about mammography research?

Dr. Baum: It ceases to be medical science now–it’s egos. A proper scientist should learn that you go through life being humiliated again and again. You have prepare yourself to admit you were wrong. That’s the very mechanism of science. Scientific truths are only temporary expressions of reality that serve us for the time being. There’s no such thing as scientific truth. It’s all an approximation to reality. A true scientist has to accept that his version of reality will be overturned in the fullness of time. If you can’t accept that, you’re not a scientist.

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A Critical Review Of All Clinical Trials Shows That Mammography-Screening Could Cause More Harm Than Good

Posted by medconsumers on December 1, 2001

Mammography improves your chances for a longer life. Find a cancer early–that is, before any symptoms appear–and you are far more likely to survive the disease and to require less-drastic treatment.

This conventional medical wisdom has been turned upside down by a reassessment of the world’s best mammography-screening trials. After a thorough analysis of each trial, two Danish researchers concluded that the trials do not provide reliable evidence that regular mammograms will reduce mortality. What’s more, mammography screening actually causes more harm than good. The findings, summarized last year in The Lancet (10/20/01), are an update of a review the same authors published nearly two years ago, also in The Lancet.

Ole Olsen and Peter C. Gotzsche, MD, of the Nordic Cochrane Centre in Copenhagen, Denmark, have explored something traditionally ignored in studies of screening tests. Mammography screening trials emphasize the number of breast cancer deaths among the participants. But Olsen and Gotzsche contend that that is not enough; you must also look at deaths from other causes as well. They found that many more women given regular mammograms are treated for breast cancer, and the treatment itself can cause fatalities.

A review like this, one that reverses so much accepted wisdom, will meet a lot of resistance. While there is disagreement over the value of mammography screening for women in their 40s, there has long been a consensus among medical organizations in the U.S. and Canada that regular mammograms can prevent some breast cancer deaths in women, aged 50-69 years. The widely quoted 30% breast cancer mortality reduction shown for this age group comes from the combined results of the same seven trials that were reviewed by Olsen and Gotzsche. (Since two of the seven trials found no benefit to mammography, pooled results are a way of resolving contradictory findings.) The seven trials, initiated in North America and Europe between 1963 and 1980, are regarded as the “gold standard” of medical research because they randomly assigned women to receive regular mammograms, or not. How can the Danish reviewers come to such opposing conclusions when drawing from the same clinical trials that so firmly established mammography screening as lifesaving? Naturally, the reviewers and their methods should be scrutinized.

Olsen and Gotzsche went well beyond what other reviewers would normally do. They analyzed the design and methods of each trial, and they found biases that favored mammography. Specifically, there were flaws in the randomization process and how the causes of death were determined. Here’s an example of the latter. Trial records show that it is not unusual for elderly women to have more than one cancer; and trial investigators might be less likely to attribute the cause of death to breast cancer in a study participant known to have had her tumor found early on a mammogram. Mistakes in identifying cause of death, even if they occur in a minority of cases, can skew results in a trial showing a 30% benefit to screening.

After looking at all the important elements of a good clinical trial, Olsen and Gotzsche concluded that five of these trials had so many flaws that their breast cancer mortality reduction conclusions could not be substantiated. None of the seven were judged to be perfect, but the two given the highest methodological ratings were conducted in Malmö, Sweden and in Canada. These two are the only trials that did not find a lower breast cancer death rate among mammography-screened women. The Canadian trial has been criticized repeatedly in the U.S. media, ever since it announced this unpopular finding in 1992. Still, Olsen and Gotzsche found it to be of much higher quality than the five that purportedly proved mammography’s life-saving benefit.

Should we trust this new review? The peer review process, which is employed by the top medical journals, is intended as a guard against the publication of substandard work. Two or three peers, or experts in the same field, are asked to critique a review or a study to see if it should be accepted for publication. The authors must, in turn, defend their work and correct any errors.

The peer-review process that Olsen and Gotzsche underwent is arguably more rigorous than that of the leading medical journals. They belong to a highly respected international non-profit organization called the Cochrane Collaboration. It started in 1992 with a mission to review all relevant randomized controlled clinical trials to determine whether a treatment, or a screening procedure, is effective. Today, the Cochrane Collaboration includes over 6,000 researchers, physicians, statisticians, consumer advocates, and epidemiologists in over 60 countries. Most are based at universities and medical schools.

What makes the new review different from all others is the philosophy of the Cochrane Collaboration. It encourages reviewers to look at results other than those intended by the people who designed the trials. When Olsen and Gotzsche compared the number of treatments in the screened and the unscreened groups, they found many more treatments were given to the mammography-screened women. They had, for example, about 20% more mastectomies. Many of these treatments, including radiation therapy, were unnecessary, as Olsen and Gotzsche observed that screening identifies some slow-growing tumors that would never develop into a lethal cancer in a woman’s remaining lifetime. Even the microscopic mammography-detected lesions called ductal carcinoma in situ are treated with lumpectomy plus radiation, or a mastectomy, though the majority would never become life threatening had they gone undetected.

The higher number of treatments among mammography-screened women would be acceptable if it led to many more lives saved. But this isn’t what Olsen and Gotzsche found. Some trials actually showed an increase in deaths in the women, aged 40-49, who had received mammography screening. Olsen and Gotzsche suspect that the deaths could be treatment related, for example, heart damage as a result of radiation therapy. To support their hypothesis, they cite an overview of 40 clinical trials involving women who had been treated for early breast cancer 10-20 years earlier (Lancet 2000; 355:1757-70). The overview, conducted by the Early Breast Cancer Trialists’ Collaborative Group, showed that radiation therapy reduced the annual death rate for early breast cancer by 13%, but increased the death rate from other causes by 21%. Much of the latter death rate was attributed to cardiovascular and cerebrovascular causes.

The new review by Olsen and Gotzsche has ramifications for all other screening tests, since none are as thoroughly studied as mammography. It raises the most obvious question about the standard cancer-screening advice to the public: Are we better off not subjecting ourselves to screening tests and, instead, promptly seeking treatment once a symptom appears?

Maryann Napoli, Center for Medical Consumers

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Breast Self-Exam Leads To Unnecessary Breast Biopsies

Posted by medconsumers on November 5, 2001

As of last year, several cancer organizations, once the biggest promoters of breast self-examination (BSE), decided to tone down the recommendation. After decades of telling women that this monthly ritual will save their lives, the National Cancer Institute, for example, acknowledged that no study has been able to verify this widespread assertion (News Section, Journal of the National Cancer Institute, 7/19/00). Last month, a Canadian policy-setting organization went one step further. After reviewing all the BSE studies, the group advised against teaching this practice because it causes harm.

The Canadian Task Force on Preventive Health Care identified eight studies in which healthy women who performed BSE were compared with those who did not. The two best-designed clinical trials were conduced in Russia and China, where women have no access to mammography and, therefore, could not “cloud” the results. Both trials had randomly assigned women to either a BSE training group or a control group (no BSE). The BSE group in each trial had exactly the same breast cancer death rate as the control group. Worse, both trials showed higher rates of benign biopsy in the BSE groups than in the control groups.

Promoters of BSE have been criticized over the years for creating an unhealthy disease-focus, particularly in young women whose odds of getting breast cancer are extremely low. The American Cancer Society used to recommend that every woman practice BSE from the time her breasts develop, though acknowledging that breast cancer is rare in teenagers. The “earlier in life the BSE habit is established, the more likely it will be used monthly–and knowledgeably–for life,” wrote ACS spokesman Arthur I. Holleb, MD, in a 1977 book, he co-authored called You Can Fight Cancer and Win.

Surveys show that most women are aware of BSE, but most do not examine their breasts. Still, the practice is seen by many as empowering, a way of taking control in the face of a widely feared disease. But there is a cost beyond the anxiety and pain of undergoing an unnecessary biopsy; scar tissue from the biopsies can obscure detection of a future cancer. Furthermore, an enormous amount of funding has been directed to the promotion of BSE that could have been spent more productively on finding the causes of breast cancer.
BSE promotion may have outlived its usefulness for other reasons. The idea of teaching women BSE was spawned in the mid-20th century, an era when women were still showing up at the doctor’s office with tumors far larger than those found today. It was also a time when women were raised to avoid touching their breasts. Today, women have been educated to see a doctor more promptly, and they tend to be more comfortable with their bodies. Most non-mammography-detected breast tumors are found by women themselves in the course of normal everyday practices, showering, dressing, making love, and so forth.
The new recommendation from the Canadian Task Force is an update of its 1994 recommendation which concluded that there was insufficient evidence to recommend for or against BSE. The update should be acknowledged for what it is: a public policy recommendation. Women are not being advised to stop performing BSE. The Task Force is addressing doctors and nurses, advising them to stop teaching BSE as part of the usual health examination for women “…because there is fair evidence of no benefit, and good evidence of harm.” Noting that some women will ask to be taught BSE, the Task Force advised they be instructed to perform BSE in a proficient manner and informed of the rate of unnecessary biopsies associated with the practice. The recommendations were published in last month’s issue of the Canadian Medical Association Journal.

American Cancer Society reaction to the new Canadian recommendation was swift and negative. ACS spokespeople were quoted in the media, saying that BSE was too useful to drop. None cited evidence to support the contention. The ACS people seem to have missed the fact that the Canadian Task Force did not say that the practice should be stopped. It advised professionals to stop teaching BSE and to warn women of the risk, if they insist upon being taught. In other words, stop selling women the idea that BSE is an entirely safe, lifesaving practice until you can come up with some good, trustworthy evidence that the claim is true.

Maryann Napoli, Center for Medical Consumers(c)

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Links: Cancer

Posted by medconsumers on January 1, 2000

Adjuvant therapy decision aid for breast cancer patients.
Read our take on this free service   PREDICT

www.BrainMetsBC.org
Fills an enormous gap in treatment information needed by women whose breast cancer has spread (metastasized) to the brain.

Annie Appleseed Project
Information about complimentary, alternative, natural therapies for people with cancer.

Breast Cancer Action
A critical take on breast cancer treatment and policy decisions.

Cancer Treament
For summaries of the latest treatments for cancer complied by the National Cancer Institute. this Web Site also has a wide variety of other information, such as a registry of cancer-related trials and a directory of physicians, geneticists and genetic counselors.

Mammography Pamphlet for Informed Decision-Making
Excellent 2009 pamphlet from the Nordic Cochrane Centre is the first to provide women with balanced information about mammography screening.

YourmesotheliomaWeb
Mesothelioma Web
Two comprehensive sites on asbestos and mesothelioma, providing information and support to those who have been exposed to asbestos.

National Breast Cancer Coalition
A coalition of grassroots advocacy groups working to eradicate breast cancer. See advocacy training conferences, legislative accomplishments, free breast cancer information, and position statements.

PleuralMesothelioma.com
Pleural mesothelioma is a rare cancer that develops in the lungs. It is almost solely caused by exposure to asbestos, which was used in everything in children’s toys, house-hold insulation, and naval carriers. This Web site has information about symptoms, treatment options, and steps to take after a diagnosis.

www.susanlovemd.com
Susan Love, MD, American women’s favorite breast surgeon, provides a wealth of information about breast cancer.

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