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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

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

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 ©

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

How Good Are the Treatments for Osteoporosis?

Posted by medconsumers on August 1, 2005

The osteoporosis drug Fosamax has been on the market for ten years now. Merck promoted it heavily for the last decade by selling women the fear of a disabling hip fracture and the necessity of regular bone-density measurement tests. Merck’s initial ad campaign directed at physicians featured a slender woman in her 40s, thus conveying the erroneous idea that testing was appropriate for this age group.

Estrogen used to be an option for fracture prevention—that is, until the Women’s Health Initiative trial found, in 2002, that it posed more risks than benefits. Now Fosamax is the dominant drug for low bone density. Along with two newer osteoporosis medicines Actonel and Didronel, Fosamax is in a drug class known as bisphosphonates. These drugs improve bone density, but where it concerns the more important issue of fracture prevention, their benefit is modest—in fact, very modest.

Some osteoporosis researchers are concerned that this drug, when taken for more than ten years, will make the bones more brittle and more susceptible to fracture. One such researcher is Susan M. Ott, MD, of the University of Washington. In a 2004 letter to Annals of Internal Medicine, she wrote, “Many people believe that these drugs are ‘bone builders,’ but the evidence shows they are actually bone hardeners.”

An expert in bone physiology, Dr. Ott offered this caution, “The drugs deposit in the skeleton for many years, depressing the bone resorption rate as well as the bone formation rate. The bisphosphonates seem safe enough for the first 10 years, but there are theoretical reasons why these drugs might not prevent fractures 20 years into the future: the bones could become brittle with long-term accumulation.” These unknowns are one reason why most osteoporosis guidelines committees do not recommend bone-density measurement prior to the age of 60. Also, a woman’s risk of a hip fracture under the age of 65 years is low—1%.

Anyone taking a drug for 10 to 20 years should know how effective it is in reducing the fracture rate. While hip fracture is the most serious consequence of osteoporosis,  this risk is small and so is the protective effect of Fosamax.  In a three-year study of older women with osteoporosis and at least one previous fracture, 2% of the women taking a placebo had a subsequent hip fracture, as compared to 1% of the women on Fosamax. There is no information about the benefit of Fosamax to postmenopausal women who have never experienced a fracture. And not much is known about its effect on men because few studies have included them.

Safe (So Far) But Not Very Effective

An extension of the above-mentioned three-year trial was published last year in the New England Journal of Medicine. The study participants who had been taking a placebo went on Fosamax. For the rest of this ten-year study, all participants were on varying doses of Fosamax. The research team led by Henry Bone, MD, concluded that the drug is safe. Results showed that discontinuation of Fosamax resulted in a gradual loss of bone density. The number of participants was too small, however, to determine Fosamax’s effect on the ultimate goal—reducing the fracture rate. The study was financed by Merck with two Merck researchers listed as co-authors.

In the editorial that accompanied this study, Gordon J. Strewler, MD, raised a long list of questions remaining about Fosamax. Among them are: What is the optimal dose and optimal duration of treatment? Is there an eventual point at which the benefit of treatment with regard to protection from fractures will diminish? How rapidly does the risk of fracture increase after Fosamax is discontinued? Could Fosamax be stopped after 10 or more years with continued protection against fractures?

Fosamax is frequently prescribed to people whose bone loss was caused by long-term use of prescribed steroids, such as prednisone. This is a major concern to people with auto-immune diseases, such as asthma, rheumatoid arthritis, and lupus, who are frequently treated with steroids. In their best-selling book, Worse Pills, Best Pills, the authors from Public Citizen’s Health Research Group warn against the use of bisphosphonates for people with steroid-induced osteoporosis. Fosamax increases bone mineral density, they wrote, but it also increases fractures of the foot, pelvis, ankle, and hip.

What else is there?

Another osteoporosis drug, Evista, has been proven only to reduce the rate of the less-serious spinal, or vertebral, fractures that often do not produce symptoms. The studies of this drug have lasted eight years. Evista is a selective estrogen receptor modulator. As with estrogen, Evista increases the risk of blood clots.

Calcitonin nasal spray is the safest bone drug, according to Dr. Ott, who cites studies that showed some reduction in vertebral fractures—though less so than the other drugs. Worst Pills, Best Pills strongly disagree, “After 30 years of clinical experience, there is no clear evidence that calcitonin reduces the risk of fracture. In the absence of such evidence, calcitonin should no longer be prescribed for the treatment of patients with osteoporosis.”

Weight-bearing exercises are widely regarded as the best way to prevent osteoporosis, and as a result, walking is the most popular form of regular exercise among older women. But it might not provide the preventive benefit we’ve been led to believe, according to a study published recently in The Lancet. The research team led by Paul M. Mayhew found that walking does not sufficiently load the portion of the bone implicated in a sideways fall—the most likely way older women break their hips.

The researchers concentrated on the top of the thigh bone where it joins the hip socket. Using scanning machines and X-rays, they studied 77 thigh bones from people, aged 20-95 years, who had died suddenly. The researchers zeroed in on the importance of elasticity of the bone tissue in this small portion of the upper femur. “In many societies in which sitting near ground level is usual, hip fracture is rare, even when most women older than 65 years have osteoporosis, as in Gambia. This paradox might be due to the beneficial loading effect on the upper femur of regular standing up from squatting or of subsistence farming,” wrote Dr. Mayhew and colleagues.

Based on their findings Dr. Mayhew and colleagues identified sculling, cycling, gymnastics and weights as exercises that should be investigated further for hip fracture prevention because they involve extension of the flexed femur. In the meantime, get rid of the scatter rugs and watch out for certain prescription drugs implicated in falling. Worst Pills, Best Pills contains a long list of prescription drugs that can cause falls and hip fracture.

Daily supplements of 1000 mg calcium and 800 IU vitamin D3 decrease the likelihood of a first hip fracture, according to an analysis of relevant trials conducted by Heike A. Bischoff-Ferrari, MD, and colleagues. This is a lower amount of calcium and a higher amount of vitamin D than the longstanding recommendations. The analysis, published May 11, 2005 issue of the Journal of the American Medical Association (JAMA), raised questions about the importance of calcium. Dr. Bischoff-Ferrari and colleagues reported that in all but one of the studies that make up their analysis, the participants taking higher doses of vitamin D were also taking calcium. They suspect that calcium may not be critical to the reduction of non-spinal fractures once 700-800 IU vitamin D is taken daily.

Something to think about

Merck’s ads directed to women sell the idea of bone-density measurement (“Ask your doctor”). The pharmaceutical industry has long been aware that screening itself creates customers for its drugs. Years ago, Merck entered a financial arrangement with a company that makes bone-density measuring equipment in order to get these machines in as many doctors’ offices as possible. Since the drugs for preventing hip fracture are only marginally effective, give careful thought to undergoing this test. As consumer advocate Barbara Mintzes once put it in the British medical journal, BMJ, “Bone mineral density testing is a poor predictor of future fractures, but an excellent predictor of the start of drug use.”

And, finally, a little history

In the not-so-distant past, one would not have been diagnosed with osteoporosis until a fracture occurred. In 1992, the World Health Organization held a conference to see if osteoporosis could be diagnosed before this happened, thus preventing fractures. Co-sponsored with pharmaceutical and medical equipment companies, the WHO committee constructed a new definition of osteoporosis. First, normal was identified as the bone density of a 30-year-old woman, the age at which bone mass peaks. Anyone with a spinal fracture or a -2.5 T-score or worse now had osteoporosis. The -2.5 T score means that the bones are about 32% less dense than those of the average 30-year-old woman.

In time another diagnosis was created called osteopenia, or low bone mass—a T score of less than -2.5. One prominent osteoporosis researcher Steven Cummings, MD, University of California School Of Medicine, San Francisco, has stated that there is no medical basis for using that number. In the May 3, 2005 Annals of Internal Medicine, Michael R. McClung, MD, Oregon Osteoporosis Center, wrote, “It is time to abandon the diagnosis of osteopenia based on bone mineral density values and give the term back to radiologists to describe decreased bone mineralization on radiographs.” Some osteoporosis researchers have stated that osteopenia rarely requires drug therapy, especially in women under age 65.

For more information

Dr. Susan Ott has an excellent Web site called “Osteoporosis and Bone Physiology.” http://courses.washington.edu/bonephys/ It is aimed at physicians and the general public. She deals with everything from the importance of good nutrition to providing a risk chart so women can put their odds of having a hip fracture in perspective. For example, a 70-year-old woman with osteoporosis and a vertebral fracture has a 3% chance of having a hip fracture in the next five years.

Maryann Napoli, Center for Medical Consumers ©
August 2005

Posted in Diet & Exercise, osteoporosis, Women's Health | Tagged: , , , | Comments Off

Spiral CT Lung Scans for Smokers and Former Smokers

Posted by medconsumers on May 1, 2005

The introduction in the 1990s of a high-tech procedure for scanning the lungs of smokers and former smokers raised hopes that it would spare many of them a lung cancer death. A new study reported in the journal Radiology, however, confirmed the fears of a few physicians who have publicly questioned the premature promotion of this test. Its potential for harm has been verified in the study conducted by researchers at the Mayo Clinic in Rochester, Minnesota.

The spiral computed tomography, or CT, lung scan provides three-dimensional images that allow doctors to find many more tiny lung nodules than would be apparent on the standard chest x-ray. And that is the problem. The high number of nodules and other lung abnormalities found in this new study required extensive investigation and, in many instances, risky surgery before most of them could be classified as benign. This high rate of false alarms can be justified only by a screening test that offers a substantial reduction in lung cancer deaths. And the jury is still out on this important point.

Too Many False Alarms

Funded by the U. S. National Cancer Institute, the study included over 1500 men and women who were given annual CT lung scans. 61% of them were current smokers and the rest were former smokers. After five years, the research team led by Stephen J. Swensen , MD, at the Mayo Clinic in Rochester, Minnesota , found that the false-positive (false-alarm) rate was extremely high. Nodules—749 altogether—that proved to be benign were found in 69% of the participants. In some cases, the lung abnormalities proved to be cancer, but they were a type that would never produce symptoms or become life-threatening.

“Intervention for benign nodules is common and has substantive financial, mortality, morbidity, and quality of life costs,” wrote Dr. Swensen and colleagues. A lung biopsy, for example, is a potentially risky procedure that is typically ordered to rule out lung cancer. A small amount of lung tissue is removed through a telescope-like tube that is inserted down the windpipe (a bronchoscopy) or via a needle inserted through the chest wall. Occasionally, a larger amount of lung tissue must be biopsied which requires major surgery (thoracotomy or thoracic surgery), with the potential for severe complications in people with ailments common to smokers, such as heart or lung diseases.

Lifesaving Benefit Unproven

Here are the Mayo Clinic study’s conclusions: “Screening for lung cancer offers the possibility of reducing mortality from lung cancer. Our preliminary results do not support this possibility and may raise concerns that false-positive results and overdiagnosis could actually result in more harm than good.” They explained overdiagnosis as the detection of slow-growing lung cancers that “a patient dies with and not from,” a phenomenon that is not limited to the lungs. The breast, prostate, thyroid and other organs also contain cancers that would never become symptomatic or deadly if they went undiscovered.

Researchers suspect overdiagnosis whenever a study like this one finds a high number of early-stage would-be cancers but no reduction in the number of people diagnosed with more advanced disease. This strongly suggests that the overwhelming majority of these suspicious abnormalities would never have progressed to fatal lung cancer.

The study was not designed to come to a conclusion regarding the ability of the CT scan to reduce the rate of lung cancer deaths because there were no unscreened participants to serve as a comparison to the people given lung scans. There were only nine lung cancer deaths but 40 deaths from other causes. The investigators, however, point out that the lung cancer death rate was similar to that of an earlier study called the Mayo Lung Project.

The definitive answer regarding the spiral CT scan’s potential contribution to reducing the lung cancer death rate is expected from another National Cancer Institute- financed project called The National Lung Screening Trial. This is the first trial to compare the new technology with the old. 50,000 current or former smokers have already been enrolled. They have been randomly assigned to receive either a chest x-ray or a CT lung scan. After one or two years, each group will have the same screening procedure again. Results will not be published before 2010.

Trial Sponsor Issues Warning

The National Cancer Institute warns about the risks of screening on its Web site:

“Conventional wisdom suggests that the smaller the tumor, the more likely the chance of survival. But no scientific evidence to date has shown that screening or early detection of lung cancer actually saves lives. The National Lung Screening Trial, because of the large number of individuals participating and because it is a randomized, controlled trial, will be able to provide the evidence needed to determine whether spiral CT scans are better than chest X-rays at reducing a person’s chances of dying from lung cancer.”

Maryann Napoli, Center for Medical Consumers ©

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

Prenatal Ultrasound—Safe, So Far

Posted by medconsumers on March 1, 2005

The prenatal ultrasound examination is an example of a medical test widely accepted before it was proven safe for the developing embryo or fetus. Ultrasound imaging has been standard prenatal care for 30 years. Acknowledging that the evidence supporting its acceptance is “far from comprehensive,” Australian researchers set out to fill some major information gaps. Their results, published recently in the British journal The Lancet (12/4/04), were reassuring.

John P. Newnham, MD, and colleagues at the University of Western Australia specifically wanted to know whether there were any adverse effects on the growth and development of the fetus. The Australian researchers had already conducted a clinical trial that found multiple ultrasound examinations produced an “unexplained and significant increase in the proportion of growth-restricted newborns.” Now the researchers wanted to know what happens to these babies as they grow up. Assessments were done on children whose mothers had participated in five studies of ultrasound imaging. The children were tested nearly every year between the ages of one and eight. The mothers had been randomly assigned to receive either a single ultrasound or two ultrasounds plus another test called umbilical artery Doppler flow velocity waveform.

At one year of age and thereafter, the size of the children was similar whether their mothers had received just the one ultrasound or multiple testing. There were no differences between the two groups in terms of speech, language, behavior, and neurological development. “Our studies have provided strong reassurance that the intensity of ultrasound used in traditional imaging studies appears to be safe,” wrote Dr. Newnham in an e-mail. He stressed that he is referring to the ultrasound intensity used between 1989 and 1992 when the five studies were conducted. “But newer machines have higher outputs and continuing research is required,” he cautioned. “The greatest danger to a pregnant woman and her unborn child is an unskilled operator who may make an incorrect diagnosis, not the machine itself. That is why our two countries [ Australia and the U.S. ] have worked so hard to have high standards and credentialing of sonographers.”

Maryann Napoli, Center for Medical Consumers ©
March 2005

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

C-Reactive Protein Testing Not For Everyone

Posted by medconsumers on February 1, 2005

The upbeat cardiac news last month involved a protein in the blood called C-reactive protein, or CRP. High levels are a sign of inflammation within the artery walls, which some researchers see as an important predictor of heart disease. All they lacked was the proof that reducing a high CRP level would also reduce the risk. As the story played out in the media, two studies that appeared in the same issue of The New England Journal of Medicine have produced the strongest evidence to date. They purportedly showed that lowering CRP levels with statin-drug therapy can lower the rate of heart attacks in people with severe heart disease.

The findings are likely to encourage widespread use of the CRP test. And this, in turn, will greatly expand the market for statins, a drug class that includes Lipitor, Mevacor, Zocor, Pravachol and Crestor. Both studies deserve scrutiny because they are destined to lead to a broader use of statins by people for whom the drugs may cause more harm than good. Both were funded by companies that make statin drugs, and the lead authors of each study, like most cardiovascular research physicians, have strong financial ties to the cardiac drug industry.

First of all, the participants in both studies had severe heart disease. And the CRP test has yet to be proven useful to people in the early stages of heart disease or to healthy people who are at risk for developing heart disease. The lead author of one study, Paul Ridker, MD, of Brigham and Women’s Hospital in Boston , was quoted extensively in the media with variations on his comment to The New York Times: “What we now have is hard clinical evidence that reducing CRP is as least as important as lowering cholesterol.” Keep in mind that half of all heart attacks occur in people with normal cholesterol levels.

In both studies the participants had been randomly assigned to take either daily high-dose Lipitor (80 mg) or a lower dose of Pravachol (40 mg). Both measured the effect of reducing CRP levels. In the study headed by Dr. Ridker, there was a higher reduction in heart attacks and strokes among people taking high-dose Lipitor. In the other study led by Steven Nissen, MD, of the Cleveland Clinic, the participants on high-dose Lipitor showed (on ultrasound) greater reductions in the rate of atherosclerosis progression.

There are several reasons to be skeptical about Dr. Ridker’s study, according to John Abramson, MD, author of Overdosed America and a clinical instructor at Harvard Medical School . After careful review of this study, Dr. Abramson said that he remains unconvinced that the researchers proved that reduced CRP levels account for the reduced incidence of heart attack and stroke.

High CRP levels may merely be an indicator that a person is at higher risk for another heart attack or stroke, he explained in a telephone interview. What’s more, Dr. Abramson drew attention to the high percentage of the study participants who smoked. “36% of these people were smokers—if the goal is really to reduce heart disease, then it doesn’t make sense to focus attention exclusively on CRP without addressing smoking cessation and other lifestyle modifications like exercise that are at least as effective as statin therapy,” he said. “Not only does current smoking raise the CRP levels, but the risk remains elevated for 10 to 14 years after people stop smoking.” The Ridker study did not identify how many of the participants were former smokers. Ironically, the relationship between high CRP levels and smoking had already been established in an earlier study conducted by the same research team, according to Dr. Abramson, who added, “CRP might simply be a measure of smoking status.”

Statin drugs work when given appropriately, explained Dr. Abramson, referring to the fact that all the study participants had recently been hospitalized either for a heart attack or unstable angina. “After these people had been treated with statins for a month, however, those whose CRP levels remained high appeared to be at higher risk of having another heart attack or stroke, but we don’t have evidence that additional treatment—with even more drugs—will further reduce their risk.”

Whether it is appropriate to prescribe statins to women is another unknown. Heart disease trials now include women, but they are underrepresented, reaching no more than one-third of all participants (the new studies are no exception). What’s more, most clinical trials have not separated the findings that apply to women. This makes it difficult to know one way or another whether statins are safe and effective for half the human race. At least one researcher is paying attention, Beatrice Golomb, MD, PhD, assistant professor of medicine, University of California at San Diego . “No study that has released gender-specific information has shown a survival benefit to statin use in women,” said Dr. Golomb in a telephone interview, making it clear that she was referring to all the major statin trials that included women with and without heart disease. And there is no conclusive evidence that statins spare women without heart disease a non-fatal heart attack or stroke.

“Another group that should also be careful about taking high-dose Lipitor on the basis of the new findings includes everyone over the age of 65 years,” observed Dr. Abramson. “It is important to remember that the earlier version of this study [published last year] showed no difference — whether the participants in this age group took high-dose Lipitor or lower dose Pravachol.”

High doses of statins used in the new studies should be a concern for everyone, according to Dr. Golomb, who has been documenting the serious adverse reactions to this drug class. “There is reason to be concerned about 80 mg. because the benefit of statins is dose dependent, and so are the harms,” she said, “There is more potential for serious adverse reactions.” Dr. Golomb is also the principal investigator of the University of California San Diego Statin Study . People typically take statins for life; yet the statin trials lasted no more than five years.

“What matters is not just whether the person has a heart attack or not,” she continued, “What matters is the over-all complications and over-all mortality, yet in most cases, the drug companies have not released the non-cardiac data.” Dr. Golomb explained that the few statin trials that have done so, either showed the benefits and harms of the drug were even or there was “a trend toward harm”—that is, more women died in the statin group then in the placebo group, but this was not statistically significant.

All government-funded trials, Dr. Golomb continued, are obligated to make their serious adverse events data available to the public. This includes hospitalizations, prolonged hospitalizations and deaths from all causes. “But the reality is that all the major statin trials are funded by drug companies, and there is no obligation to release this critical information,” Dr. Golomb said, adding that she wrote each drug company that has failed to release its data and was turned down. “They [the drug companies] claim it’s irrelevant.”

To Dr. Abramson, lifestyle changes are the forgotten element in the rush to drug therapy: “We know that people over 65, who don’t smoke, eat a Mediterranean-style diet, exercise regularly, drink moderately, have a death rate reduced by two-thirds that of people the same age who don’t maintain these healthy habits.”

Maryann Napoli, Center for Medical Consumers ©
February 2005

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Early Promoters Of PSA Screening For Prostate Cancer Do A Turnabout

Posted by medconsumers on February 1, 2005

At first, it appeared to be heresy. A paper published last October in the Journal of Urology indicates that the PSA screening test for prostate cancer has lead to widespread cancer diagnoses in men who did not need to be treated. The paper entitled, “The prostate specific antigen [PSA] era in the U.S. is over for prostate cancer: what happened in the last 20 years?” received surprisingly little publicity. What made it so remarkable was the fact that the lead author, Thomas A Stamey, MD., and colleagues at Stanford University are credited with early promotion of PSA screening in a paper published in 1987. Now, their recent data present a powerful argument against this use in symptomless men.

The paper describes a study that shows the presence of cancer in the prostate increases with age. Autopsies conducted on 525 men, equally divided between white and black men, killed accidentally on the streets of Detroit , showed that 8% of those in their 20s had prostate cancer. There was a linear increase in prostate cancer with each increasing decade of life. About 80% of the men (of both races) who were in their 70s had invasive prostate cancer.

The fact that most prostate cancers will remain dormant is demonstrated aptly by another statistic in this paper: “[Prostate cancer] has an extraordinarily small death rate of 226 per 100,000 men older than 65 years,” wrote Stamey and colleagues. Deaths from prostate cancer are rarer yet in men under age 65, according to the National Cancer Institute. Yet despite these statistics that make a case for not screening symptomless men for prostate cancer, the PSA blood test began to go into widespread use in the late 1980s. There is still no test that can accurately distinguish slow-growing or latent prostate cancer from the type that is moderately rapid and fatal.

Over the course of two decades, Dr. Stamey and colleagues assessed 1,317 consecutive prostates that had been removed surgically between 1983 and 2003—what they called the “PSA era.” The idea was to see how well the PSA test given before surgery accurately reflected the size of the largest cancers. Here’s what they found: “In the first ten years after PSA screening was introduced, there was a reasonably good, although not great, correlation between serum PSA and prostate cancer volume.”

But, as the years went by, things changed completely. When the researchers assessed the prostates removed most recently, that is, between 1998 and 2003, they found that the PSA tests were detecting benign enlargement of the prostate, rather than cancer. Benign prostatic hyperplasia, or enlarged prostate, is a common condition in men over age 60.

Dr. Stamey and colleagues explained their findings in this way: American men between 50 and 80 years have been screened so intensely over the last 20 years that the most significant of the prostate cancers had already been detected. However, they glossed over the substantial harm done to men in the PSA era in terms of unnecessary prostatectomies and unnecessary radiation therapy. The issue was alluded to in only one sentence, using one word— overtreatment.

In a telephone interview, Dr. Stamey said he had no hope that the huge industry that has now built around PSA screening will disappear with his findings. So he stressed the importance of informed consent where it concerns the use of the PSA test in symptomless men. “It is immoral for surgeons not to tell patients that we [men] all get prostate cancer as we age,” said Dr. Stamey, after describing himself as a 76-year-old surgeon who hasn’t had a screening PSA test in several years.

“Patients should be told that there’s a high chance of having prostate cancer that rises with age, but a very low chance of dying of it. Do we really want to screen 100,000 men to save 226 from dying of prostate cancer? In fact, it’s about the same chance of my not driving home safely tonight.” What’s more, he continued, 20 years ago, the prostate was biopsied in only six places, now it’s 36.

What about the PSA test’s possible role in the slight dip in the U.S. prostate cancer death rate? Dr. Stamey gave no credit to PSA screening.

“The death rates from several other common cancers have fallen, too, but we have no idea why.”

Maryann Napoli, Center for Medical Consumers ©
February 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

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

Survey Of Patient Education Materials About Prostate Cancer Treatment

Posted by medconsumers on June 1, 2004

One-Sided Information Common

Our office often receives calls asking for a source of balanced information about the treatment options for early prostate cancer. It has always been a stumper. Our usual recommendation is the National Cancer Institute’s treatment summaries (www.cancer.gov), but this is a disappointing source of information where it concerns prostate cancer. Unlike other cancers, this one might be just as well left undetected and untreated (more on that later), and it is hard to find anything that gives a balanced view of all options, including no treatment. In fact, we have yet to find one.

That’s why we were interested in a new survey of “Patient Education Materials about the Treatment of Early Prostate Cancer,” published last month in Annals of Internal Medicine. 546 consumer pamphlets and Web sites were surveyed and given scores based on these two crucial questions: Are all the options presented? Are the potential harms as well as potential benefits presented? Professional organizations, medical centers, and drug companies were among the publishers of the educational materials in this survey.

What makes early-stage prostate cancer such a good test of an information source’s honesty is the fact that no head-to-head comparison study of all three treatment options has ever been conducted, though radical prostatectomy has long been the common treatment. For what other cancer would a prospective patient face the choice of having an organ removed, irradiated, or left alone unless symptoms develop (watchful waiting)—all of which are equal in terms of survival?

So when this patient education materials survey was published last month, we were ready to champion the top choices in this newsletter and add a link within our Web site to those with the high scores. The first stop was the Web site of the medical division of the University of Toronto (www.library.utoronto.ca/medicine/prostate).

After multiple failed attempts to get through and no response from the site’s Web master, it was on to the next high scorer, the Web site of Memorial Sloan-Kettering Cancer Center, which describes itself on the local public radio station as providing, “The best cancer care anywhere.”

This Web site’s information amounts to a sales pitch for certain radiation and surgical techniques pioneered by doctors at Memorial Sloan-Kettering Cancer Center. Don’t expect a full explanation for why watchful waiting might be worth considering. This option merits only five sentences. The American Cancer Society wasn’t any more forthcoming on watchful waiting, providing exactly the same minimal amount of space.

How did these Web sites score so high? That question merited a return to the statements written by Angela Fagerlin, PhD, of the University of Michigan, and colleagues after completing their survey:

All sites reviewed were accurate, but some erred by omission, most typically de-emphasizing side effects of therapy. Several sites presented so little of the key content that they generated somewhat misleading impressions.

And this about the printed materials:

No print education materials we evaluated had clinically significant misstatements, although some references were out of date because of the publication date. We found only one case of clinical significant imbalance in the treatment descriptions. However, a general bias was toward active treatment that minimized the role of watchful waiting. In addition, the likelihood and impact of side effects were minimized [emphasis ours].

What is really needed here is not just a balanced view of treatments, but an honest view of prostate cancer. Men die of prostate cancer. A small percentage of all prostate cancers are aggressive, and rapidly fatal no matter how early they are detected and treated. The majority, however, are so slow growing that they will never become life threatening or produce symptoms. In between, there may be a small proportion of men with a type of prostate cancer that could benefit from early detection and immediate treatment. An ongoing clinical trial is pursuing the question of whether early detection of prostate cancer is lifesaving. Though men will be told their PSA and Gleason scores, no test can determine accurately which prostate cancers will become aggressive and which will remain dormant.

As this survey shows, treatment-related harms are usually left out of the information given to patients. Since the choice of watchful waiting is counterintuitive to most people, it deserves a clear and lengthy explanation. After all, hasn’t the early-detection-saves-lives message been drummed into the public’s consciousness for years?

There is a reasonable amount of preliminary research to suggest that men should give serious thought to avoiding a PSA test for prostate cancer because it is unclear whether early treatment is lifesaving. For example, a Swedish study, which had randomly assigned men to watchful waiting or radical prostate surgery, showed that the men who underwent surgery did not live longer than those who did not. After six years, there were 4% fewer prostate cancer deaths among the surgically treated men. That benefit, however, was canceled by the fact that their quality of life was worse (incontinence and impotence are treatment complications) and their 4% higher rate of deaths from other causes.

Several studies monitored untreated men with favorable results, for example, one followed Swedish men who were not treated unless symptoms developed. At 15 years, those whose cancers appeared to be confined to the prostate at diagnosis had a prostate cancer death rate of 11%. In the U.S., men treated with a radical prostatectomy for early-stage disease have a similar mortality rate. Don’t expect to hear about these studies from your average urologic surgeon. And there is no financial incentive for a medical center’s Web site to provide a balanced description of watchful waiting.

What you can do:

  • Send for the free pamphlet that got the best score in the print material category by calling the National Cancer Institute (NCI) hotline, 1(800) 4-CANCER. Ask for “Understanding Treatment Choices for Prostate Cancer.” The same pamphlet can be read at the NCI Web site (www.cancer.gov/prostate). It includes a survey of prostate cancer patients’ experiences with treatment-related complications, such as incontinence and impotence.
  • Talk over the options with a knowledgeable primary care physician. When getting a second opinion about treatment, recommendations will correspond to the bias of the specialist. Not surprisingly, urologic surgeons advise surgery and radiation oncologists recommend radiation therapy. As with the information sources in this survey, a test of a primary care doctor’s knowledge would be his or her opinion of watchful waiting.
  • Do not have a PSA screening blood test for prostate cancer without informing yourself beforehand. Read the new book entitled Should I be Tested for Cancer? Maybe not and here’s why (Berkeley: University of California Press) by H. Gilbert Welch, MD.

Maryann Napoli
June 2004

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2004 Update on Summary of the Evidence

Posted by medconsumers on January 26, 2004

It is not clear whether the benefits of mammography outweigh the risks for women in their 40s. Not all of the clinical trials have consistently shown that mammography screening reduces your chances of dying of breast cancer. Of the seven large trials in which women were randomly assigned to have periodic mammograms or not, five trials showed a lower breast cancer death rate among all mammography-screened women, ages 40 to 69 years. But two found no lifesaving benefit to mammograms for women of any age. Pool the results of all seven trials for women ages 50 and older, and the breast cancer mortality for those having mammograms drops by 22% in relation to the unscreened women. Pool the results for women in their 40s, and their breast cancer mortality drops by 15% in comparison to their counterparts not given mammograms. Here’s what that means to you as an individual: If you are in your early 40s, your risk of dying of breast cancer in the next ten years is 0.3%. If you start mammograms and continue having them for the next ten years, you will, at best, reduce that risk of dying of breast cancer by one-tenth of 1%.

This modest benefit should be weighed against mammography’s potential for causing some women to undergo unnecessary treatment with radiation therapy or mastectomy. Clinical trials have documented mammography’s ability to find cancers that will never produce symptoms or become life threatening. One of the two trials that found no mortality reduction benefit for mammography was conducted in Canada . It is the only one specifically designed to answer the long-standing question of mammography’s value to women in their 40s. All the women in this trial were given skilled professional breast exams, but only half of them had regular mammograms.

There were 40 more cases of nonpalpable invasive breast cancer and 42 more cases of ductal carcinoma in situ (a non-invasive cancer that some experts believe is just a risk factor for breast cancer) detected in those screened with mammography than in those given solely a professional breast exam. Contrary to expectations, their rate of breast cancer deaths after 13 years was no different from that of the women not given regular mammograms. This not only shows that the technology leads to the unnecessary treatment of some cancers that would have remained dormant, but it also detects a type of breast cancer so slow-growing that women will be successfully treated regardless of when tumors are found.

An in-depth review of all seven mammography-screening trials, conducted in 2001 by the Nordic Cochrane Centre, concluded that the two showing no breast cancer mortality-reduction benefit to mammography were of a higher quality than the five trials that did. This review also looked at the question of whether mammography saves lives when deaths from all causes are taken into account. This is an important consideration because some women die of breast cancer treatment-related causes. For example, some trials showed an increase in cardiovascular deaths after radiation therapy among younger mammography-screened women. The Nordic Cochrane Centre concluded that mammography screening does not reduce the overall death rate. This conclusion has been widely challenged by other researchers; it is important for women to know about it nonetheless. Although mammography screening is thought to lead to less drastic treatment, the Nordic analysis of all seven trials found 20% more mastectomies among the women given mammograms.

Unnecessary breast biopsies are another well-known consequence of mammography screening. The rate of false alarms, causing emotional trauma, is particularly high among women under the age of 50. If 10,000 women under the age of 50 have a mammogram, 640 will have an abnormal mammogram and 1,280 extra tests will be performed on them. 150 will go on to have a surgical biopsy, of which 17 turn out to have invasive breast cancer. However, only one death, at best, will have been prevented.

Keep in mind that the statistics quoted here come from clinical trials in which high-quality mammography screening is done under the best of circumstances, and results may differ where it concerns mammography as it is performed and interpreted in the day-to-day practice of medicine. While your health practitioner may strongly recommend them, the decision whether to undergo regular mammograms is entirely up to you.

Maryann Napoli
January 26, 2004

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

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