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Prostate cancer treatment misused

Posted by medconsumers on December 14, 2009

Androgen deprivation therapy (ADT) is prescribed inappropriately for many men in the early stages of prostate cancer and is associated with an increased risk of cardiovascular disease and diabetes. This was shown in a new study of over 37,000 men treated at the early stages of prostate cancer in the Veterans Healthcare Administration between 2001 and 2005. Published in a recent issue of the Journal of the National Cancer Institute, the study raises questions about informed consent and how much information men are given about ADT beforehand. There is no proof that it can prolong life or help men with low-risk, early-stage disease, yet ADT can cause severe adverse effects because it is drug-induced castration.

The research team led by Nancy L. Keating, MD, Brigham and Women’s Hospital, Boston, found that the high risks of diabetes (25%) and cardiovascular disease (20%) were associated with the gonadotropin-releasing hormone (GnRH) agonists. The drugs, sold under the brand names of Lupron and Zoladex, are injected by a physician or implanted under the skin every few months. No increased risk of diabetes and cardiovascular disease was associated with oral anti-androgen drugs like Euflex and Casodex, which are usuallly given in conjunction with GnRH agonists or, rarely, by themselves.

The increased use of ADT was linked to widespread screening with the PSA (prostate-specific antigen) blood test in a hard-hitting editorial that accompanied the VA study. The author, Peter C. Albertsen, MD, Department of Surgery, University of Connecticut Health Center, Farmington, states that the VA study offers a rare glimpse into the extent of ADT usage. He went on to note that PSA screening has dramatically changed the type of patient newly diagnosed with prostate cancer. “Before the advent of PSA screening, physicians used ADT to relieve symptoms of advanced prostate cancer. Now we use ADT primarily to treat patients with a rising level of PSA.” And most tellingly, Dr. Petersen writes, “We do not know whether these treatments [ADT] have prolonged survival, but [this study] confirms that this approach has the potential for substantial unintended side effects.”

Hot flashes, weakness, fatigue, cognitive impairment, and depression are the “substantial unintended side effects” of ADT, aka chemical castration. The VA study is not the first to link ADT to an increased risk of diabetes and cardiovascular disease, but it shines a light on unproven uses of this drastic therapy. The study shows that ADT is often given as the primary treatment for men with local and regional prostate cancer who have no symptoms of the disease, as well as symptomless men whose post-treatment PSA test show rising levels. The increased use of ADT can be chalked up to the fact that the PSA screening test was introduced in the late 1980s. This is well before the benefit of finding prostate cancer before symptoms appear was proven to reduce a man’s chances of dying from prostate cancer. See results of two recent clinical trials that explored this important question.

Dr. Keating, the lead author of the VA study, was asked to identify the men with prostate cancer for whom the proven benefits of ADT outweigh its considerable risks. “There are proven benefits to ADT for men with symptomatic metastatic prostate cancer in terms of controlling the spread of the disease which causes symptoms such as bone pain and fractures,” answered Dr. Keating in an e-mail, “and [there is] also a survival benefit to ADT when used as adjuvant [additional] therapy for men with high-grade disease, which is localized disease with high-risk features that make it more likely to return after primary treatment [with surgery or radiation therapy].”

And for whom is ADT most likely to be questionable? “The concern is that many men are treated with ADT for indications where there have never been studies showing benefit (e.g., as a primary treatment of prostate cancer and as a preventive against recurrence in those whose PSA levels rise after primary treatment). In these settings, the risks may outweigh any benefits,” answered Dr. Keating. “I think this has become a popular treatment because patients and doctors like the idea of doing something to treat the cancer. But the problem is, it has never been studied, and may have substantial adverse effects.”

So has the PSA screening test saved at least some lives? Apparently not, according to editorialist Dr. Petersen, who compared the current prostate cancer death rate with that of the era when men were not diagnosed with prostate cancer until they noticed symptoms. “Before the widespread use of PSA screening, an American man had an 8.7% lifetime risk of being diagnosed with prostate cancer and 2.5% risk of dying from this disease. By 2005, the lifetime risk of being diagnosed had increased to 17%, whereas the lifetime risk of dying from prostate cancer remained virtually unchanged.”

Maryann Napoli, Center for Medical Consumers(c)

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New Pap test guidelines

Posted by medconsumers on November 21, 2009

It’s about time. That was my first thought yesterday when I read that the American College of Obstetricians and Gynecologists had changed its screening guidelines for cervical cancer. ACOG made it clear that reducing harm is the main reason for raising the starting age for Pap tests to 21 and widening the intervals between tests. The harm is the multiple, often painful, biopsies that become necessary once abnormalities are found on the cervix. Most of these abnormalities will go away on their own, but the damage to the cervix can lead to problems when women get pregnant. Two examples are an inability to carry a baby full term and an increased risk of needing a caesarean.

What infuriates me is information about Pap-related harm was available decades ago. Yes decades. It was 1980 when I first read about the Pap test as a contributing factor to the high rate of hysterectomy in the U.S. Many women in that era went directly from an abnormal Pap test to the operating room for a total hysterectomy, even though some researchers knew that many of the so-called precancers found on the cervix regress spontaneously. This was noted in a review of all studies about cancer screening tests, which was commissioned by the American Cancer Society in the late 1970s and conducted by David Eddy, MD. This review was published in the July/August 1980 issue CA–a Cancer Journal for Clinicians, the ACS’s own journal. Why, you might ask, did the ACS continue to unequivocally promote Pap testing? Why not warn women so they can make an informed decision about accepting this test?

Fast forward about ten years, when I read about a study conducted in Sweden, showing that precancers of the cervix regressed spontaneously in nine out of ten women who were left untreated. A study like this had to be done in another country because U.S. gynecologists were quicker to do a hysterectomy than their counterparts in Europe. This study was published in the Journal of the National Cancer Institute, which at the time was the federal government’s official medical journal.

Here’s another sobering thought: 15 million Pap tests are done annually in the U.S. to detect cervical cancer in women who have had a hysterectomy. The absurdity (and danger) of trying to detect cervical cancer in women who do not have a cervix hit home about 20 years ago in a call to our office. The woman on the line sounded extremely emotional. And for good reason. She had been given a Pap test that indicated precancer even though she had no cervix. The reason her doctor gave for doing a Pap test anyway was evidence-free, but fairly common: “we’ll check you for vaginal cancer.” Her life was turned upside down for two weeks while her doctor sent her for multiple invasive, painful tests to search for an extremely rare cancer. She was relieved but furious to learn that the Pap test has no proven value in detecting vaginal cancer and therefore no proof that finding it early (i.e., before symptoms develop) would alter the course of the disease.

The Pap test is the first of the cancer screening tests, introduced in the early 1960s without benefit of a clinical trial to prove it was a good idea. Pap test results did not even become standardized until 1988. Up to then, one pathologist’s precancer was another pathologist’s benign abnormality.

I doubt many women have had the pros and cons of the Pap test explained to them by their doctors. Nor are they told how rare cervical cancer is. We have been led to believe that Pap testing is the reason cervical cancer is rare, but in fact the cervical cancer death rate was going down a good decade before the Pap test was given to a significant portion of the female population (see my 2007 article on the topic). And here’s the National Cancer Institute’s cautions about the Pap test that have been on its Web site for several years. I think women deserve an apology from the ACS and ACOG. It’s unethical to give a screening test without explaining both the harm and benefit.

Maryann Napoli, Center for Medical Consumers©

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Mammogram uproar

Posted by medconsumers on November 18, 2009

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

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

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

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

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

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

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

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

Maryann Napoli, Center for Medical Consumers(c)

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

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When to get a 2nd pathology opinion

Posted by medconsumers on September 10, 2009

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

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

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

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

Each breast pathologist describes his service below:

David L. Page, MD Breast Consultants

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

Michael D. Lagios, MD The Breast Cancer Consultation Service

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

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

Maryann Napoli Center for Medical Consumers©

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Reduce your risk of breast cancer: Avoid mammograms

Posted by medconsumers on July 14, 2009

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

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

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

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

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

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

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

ADDENDUM: A 2010 study published in the New England Journal of Medicine lends support to this suggestion. See this New York Times report about the study, entitled “Mammograms’ value in cancer fight at issue.”

Note: after this article was written, a federal committee set new mammography screening guidelines for women under 50, read Mammogram Uproar.

Maryann Napoli, Center for Medical Consumers(c)

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The Marketing of Osteoporosis

Posted by medconsumers on May 19, 2009

How a risk factor (bone loss) became a disease (osteoporosis) by Maryann Napoli. Originally published in American Journal of Nursing, May 2009

Nurses probably get the same question I often get as a consumer advocate.  Should I be on this drug? You’re asked because you’re seen as the expert or simply a knowledgeable friend.  In fact, it’s a valid question not only to ask but also to look beyond the prescribing health care provider for answers.

In the name of prevention, millions of Americans have accepted the idea that it is reasonable to treat a risk factor (e.g., high cholesterol, bone loss) as if it were a disease. Think back to the 1990s when virtually all menopausal women were advised—pressured, according to accounts that came my way—by their gynecologists to go on hormone therapy to prevent heart disease and hip fractures.

More people should question the wisdom of going on long-term drug therapy. Often the magnitude of the risk factor has been overestimated; or the danger of the disease itself may be exaggerated by people trying to sell us something—like a drug you must take for the rest of your life.

Osteoporosis provides an excellent example of how the pharmaceutical industry begins creating a market for a new prevention drug years before it is approved.  The disease has become a major health concern for older women, though it was unknown to the general public until the early 1980s when the drug industry-led awareness campaign began.  It used to be that osteoporosis was not diagnosed until a fragility fracture had occurred.[1]

But a new definition, one based on bone mineral density, was established in 1993 at a World Health Organization meeting of osteoporosis researchers.  Its ostensible purpose was to determine the global prevalence of osteoporosis, but this meeting is where the definition of osteoporosis was radically changed.  What had been simply a risk factor (bone loss) became a disease (osteoporosis), complete with an arbitrary cutoff (bone density more than 2.5 standard deviations below the normal bone mass in young women).[2]

Overnight, the market for bone drugs had been expanded. Years after that WHO meeting, I would learn that it was sponsored by several pharmaceutical companies.2 Hormone drugs were the standard preventive treatment at the time of the meeting, but three years later the first non-hormonal drug for bone loss—alendronate (Fosamax)—was launched.

Getting symptom-free women to accept drug therapy requires scarey statistics that imply the danger period starts right after menopause, leaving the impression that hip fractures, the most disabling consequence of osteoporosis, often occur soon after the hot flashes are over.  Here’s one stat you would see often: 24% women, aged 50 and over, die within a year of a hip fracture.[3]  And here’s one you don’t see often: over 90% of the hip fractures occur in people over 70 and the average age is 80.[4]  Elderly men have hip fractures, too, but the early marketing of alendronate was all about the ladies.

How Predictive are Bone Scans?

In the initial phase of the industry-funded osteoporosis awareness campaign, the scan known by the acronym DEXA was advised for women at the time of menopause. Scanning caught on in a big way, especially after Merck, the maker of alendronate, began financing the installation of DEXA machines in doctors’ offices.[5]  Nothing creates drug customers faster than getting people to be routinely scanned.

Unfortunately, scanning is not good at predicting which women in their early 50s will have a hip fracture at age 80. This was known in 1997 thanks to a report from the British Columbia Office for Health Technology Assessment, which—to my knowledge—is the first to reveal industry sponsorship of that 1993 WHO meeting where osteoporosis was redefined.[6]

Unfortunately, the report had no effect on U.S.testing guidelines, but consumer advocate Barbara Mintzes, Universityof British Columbia, summed up the situation nicely, “Bone mineral density testing is a poor predictor of future fractures, but an excellent predictor of start of drug use.”[7] Merck’s ads aimed at women did not even mention alendronate, they simply said, “Ask your doctor whether a bone density test is right for you.”  Sure, low calcium/vitamin D intake, scatter rugs, poor muscle strength, certain medications, impaired vision were given lip service as contributing factors to osteoporotic fractures, but loss of bone density always seemed front and center.

How Good is the Drug?

In the initial phase of DEXA promotion, many women in early middle-age, with low bone density but no history of fracture, were put on alendronate, despite the fact that the drug was tested only in elderly women with vertebral fractures. The results, even for this supposedly high-risk elderly group, were not impressive. In the Merck-sponsored three-year trial that received Food and Drug Administration approval, hip fractures occurred in 1% of those on alendronate, compared with 2% of those on a placebo. [8] (A “50% reduction in hip fracture” is the accurate, though misleading, way these results were often portrayed.)

Here is where the nurse/advocate can serve as a sounding board for patients deciding whether to go on drug therapy, helping them consider questions like:  Are you similar in age and fracture history to the women in this trial? What does that 1% fewer hip fractures mean to you? Let’s compare that 1% benefit with the 1.5% risk for a alendronate-induced esophageal ulcer found in this trial? Consider what happened to the study participants who did not take alendronate (98% of the untreated women—i.e., the placebo group—did not have a hip fracture).  The “script” for this discussion is the drug’s official FDA-approved label and the Physicians’ Desk Reference where the trials that won FDA approval are described.

When alendronate was put to the test for elderly women with bone loss but no vertebral fractures, the four-year trial showed that the hip fracture rate was no different for the drug-treated participants than it was for the women taking a placebo.In short, the drug is good at improving bone density but not so good at reducing hip fractures. This did not stop other drug companies from introducing their own alendronate knockoffs—risedronate, ibandronate, pamidronate, etidronate and zoledronic acid.  All are in the same drug class called bisphosphonates.  In an example of how long a drug has to be on the market before the full picture of harm is known, the FDA reported early this year that all bisphosphonates carry the risk of severe and sometimes incapacitating musculoskeletal pain.[9]

Drug Ad Campaign Misled Doctors

Why younger rather than elderly women became the likely recipients of a bisphosphonate prescription is no mystery.  Merck’s initial ads aimed at physicians encouraged it.  A multi-page glossy ad campaign that ran frequently in Annals of Internal Medicine featured a thin fortysomething white woman with a crumbling ancient stone column in the background.  “Don’t wait for a fracture… No matter what her degree of osteoporotic bone loss…” [10]  I wrote to the editor-in-chief of Annals, pointing out that alendronate had no proven benefit for women in early middle age.  Never got a reply, but Annals stopped running the ad about six months later.  Still, the message had already gone out, there and elsewhere—early middle age is the appropriate time to start fracture prevention with alendronate.  From the drug industry’s point of view, the younger customer is far more desirable than, say, the  elderly nursing home resident with a limited remaining lifespan in which to take drugs.

Today, women in the osteoporosis drug ads are usually in their early sixties.  The guidelines for bone density measurement currently recommend bone mineral testing not begin before age 65 (or 60 in some high-risk cases)[11], but now there’s a bigger problem.   Researchers have known, at least since 2000, that bone strength or bone quality are better predictors of hip fracture than bone density.  In 2001, the National Institutes of Health redefined osteoporosis as a combination of bone mineral density and bone quality. But there is no test for bone  quality or bone strength. 1

It’s going to take time for the word to get out.

How relevant is this story to other drugs people take to treat a risk factor?  In a word: very.  Three-fourths of all Americans on cholesterol-lowering statins, the country’s top-selling drugs, do not have heart disease and are thus far less likely to benefit than people who do. [12]  (Statins are terrific at lowering cholesterol, but much less impressive at reducing the risk for heart attack[13]—sound familiar?)  The thresholds for high cholesterol[14] and high blood pressure were lowered several times over the years, each time making millions more people eligible for drug therapy.

Drug ads and industry-sponsored “education” programs are no longer the only major sources of biased information. Industry funding compromises the directives of non-profits like the American Heart Association and the American Cancer Society, as well as the experts who write treatment guidelines. [15]  One example of the latter: eight of the nine doctors who served on the 2004 government committee that expanded the guidelines for cholesterol-lowering drug therapy had financial ties to statin companies.[16]

More than ever, nurses must be knowledgeable advocates for their patients. You may be the last of the independent health professionals.

For More Information:

Added May 19, 2012: New take on bone density retesting.  and  Warning on bone drugs:  Stop after 5 years.

http://courses.washington.edu.bonephys    Web site of bone physiologist and osteoporosis researcher Susan Ott, MD, Associate Professor, Department of
Medicine, University of Washington.  Mostinteresting section: “When [drug] studies don’t give clear answers.”  Definitely take the quiz. (Accessed June 12, 2008.)

 


[1] Cheung, AM and Detsky, AS. “Osteoporosis and Fractures: Missing the
Bridge?” JAMA. 2008;299(12):1468-1470.

2 Kazanjian A, et al. Normal bone mass, aging
bodies, marketing of fear: bone mineral density screening of well women. University of British Columbia Centre for Health
Services and Policy Research. British Columbia Office of Health Technology Assessment BCOHTA  98:10C Sept 1998. http://www.chspr.ubc.ca/files/publications/1998/bco98-10C.pdf  (AccessedJune 13, 2008.)

[3]
National Osteoporosis Foundation. www.nof.org
(Accessed June 5,
2008)

[4]
Love S.M. with Lindsey, K.  Dr. Susan
Love’s Menopause & Hormone Book.  New York: Three Rivers
Press, 2003.  P.109

[5]
Moynihan R and Cassels A. Selling
Sickness: How the world’s biggest pharmaceutical companies are turning us all
into patients. New York: Nation Books, 2005 page 142.

[6]  Kazanjian A, et al.  Bone Mineral Density Testing: Does the
Evidence Support Its Selective Use in Well Women? 1997 British Columbia Office for Health Technology
Assessment, University of British Columbia.  http://www.chspr.ubc.ca/files/publications/1998/bco98-07C.pdf   (AccessedJune 5, 2008)

[7] Mintzes, B. Direct to consumer advertising is medicalising normal human experience. BMJ 2002;324:908-911.

[8]Physicians’ Desk Reference, 59th edition 2005, page 2051.

[9] FDA Alert: Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Alendronate, Alendronate+D, Reclast,
Skelid, and Zometa).
Posted Jan 7, 2008. http://www.fda.gov/medwAtch/safety/2008/safety08.htm#  (AccessedJune 12, 2008.)

[10] Napoli M. Alendronate: A new drug with an ad campaign that encourages misuse.   HealthFacts. July 1996.

[11] Agency for Healthcare Research and Quality. U.S. Preventive Services Task Force. Sept 2002. http://www.ahrq.gov/clinic/uspstf/uspsoste.htm
(Accessed June 13, 2008.)

[12]
Abramson J, et al. Are Lipid-Lowering Guidelines Evidence-Based? Lancet. 2007
Jan 20;369 (9557):168-9.

[13]
Carey J. Do cholesterol drugs do any good? Business Week, Jan 17,2008.
(Accessed onlineJune 16, 2008.)

[14]
Center for Science in the Public Interest. http://www.cspinet.org/integrity/press/200409231.html
(Accessed June 6, 2008).

[15]
Lenzer
J. Education and debate:  Alteplase for
stroke: money and optimistic claims buttress the “brain attack”
campaign.  BMJ 2002;324:723-729.  http://bmj.bmjjournals.com/cgi/content/full/324/7339/723#B14
(Accessed June
13, 2008.)

[16] National Cholesterol Education Program. Third Report of the Panel on Detection, Evaluation, and Treatment of high blood cholesterol in adults (Adult treatment panel III) 2004. http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm                    (Accessed June 6, 2008).

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CT Scans—Lots of Radiation, Little Research

Posted by medconsumers on May 18, 2009

“The increase in CT [scan] use and in the CT-derived radiation dose in the population is occurring just as our understanding of the carcinogenic potential of low doses of x-ray radiation has improved substantially, particularly for children.”

The low-dose in this quote is relative to the amount of radiation absorbed by atom-bomb survivors—long the only yardstick available to radiation-safety researchers. It appeared in a 2007 report in The New England Journal of Medicine which states that, contrary to conventional medical wisdom, the doses received by a CT scan carry a small but definitive risk of cancer. The lead author is David J. Brenner, PhD, Center for Radiological Research, Columbia University Medical Center, New York.

The radiation dose from a CT scan is far larger than that of a conventional x-ray because it typically involves 64 “slices” of radiation exposure, compared to one or two views of a standard x-ray. The American Heart Association, not known for warning the public about the negative aspects of medical care, acknowledged recently that the amount of radiation from a heart scan is equivalent to 600 chest x-rays.

Each scan creates an additional lifetime risk of cancer that is somewhere between 1 in 200 and 1 in 5,000, according to Dr. Brenner. Unfortunately, consumers who try to get information about radiation exposure from their doctors are unlikely to get an accurate answer. In a 2004 survey of radiologists and emergency room physicians, 75% of the entire group significantly underestimated the radiation dose from a CT scan. Worse, 53% of radiologists and 91% of the E.R. doctors did not believe that CT scans increased the lifetime risk of cancer.

Massive Increase in Scans
The large amount of radiation that concerns researchers like Dr. Brenner is due to the technology itself, as well as the alarming increase in usage. An estimated 62 million CT scans are now done annually in the U.S., up from 3 million in 1980. Lately, heart scans have become a source of alarm. The installation of cardiac scanning equipment has tripled in the U.S. in the past two years.

A recent international study in the Journal of the American Medical Association is the first to look at the radiation dose from a heart scan, aka cardiac CT angiography, as it is performed in the real world. The 50 study sites included in this research project were 21 university hospitals and 29 community hospitals. The research team led by Jorg Hausleiter, MD, found doses varied widely according to the equipment and the study site. Worst of all, the available strategies for reducing doses were not being used.

One of the obvious recommendations to emerge from this study is: “Low voltage scanning should be considered, especially for patients who are non-obese and at higher risk of radiation-associated cancer, such as children and young women.”

No one would deny that CT scans are an excellent diagnostic tool that may well have saved many lives. The problem is the complete lack of information. As often happens in the U.S., enthusiastic reception of a new technology—by doctors and consumers alike—precedes the science that would identify those people for whom the benefits outweighs the risks.

In many cases, the purportedly new, improved scan has never been proven in a large clinical trial to be better than the older, less expensive tests. Our profit-driven medical care “system” encourages the premature introduction and widespread acceptance of a new, costlier procedure. Add to the mix, entrepreneurial physicians who co-own the scanning equipment and have a financial incentive to overuse it.

Screening Uses Questioned
The first place to start questioning CT scans, according to Dr. Brenner, is their use for symptomless people. Healthy people are the ones most likely to harmed because they would incur the risks of a high radiation dose and overdiagnosis to receive an uncertain benefit. None of the following screening scans has been proven to be life-saving.

CT colonography, or “virtual colonoscopy,” is often regarded as a less-invasive alternative to the standard colonoscopy. It’s unlikely that many people who choose this method of colon cancer screening are informed of the high radiation dose or its penchant for finding abnormalities in nearby organs that lead to other investigations, some quite risky, that often prove to be benign (i.e., overdiagnosis).

CT lung screening for smokers and former smokers: This relatively new technology has become popular, despite the lung scan’s ability to find non-lethal cancers that are usually treated. A large ongoing government-sponsored clinical trial that has randomly assigned smokers and former smokers to a spiral CT lung scan or no scan will provide answers to two questions for this select group of individuals: Will regular scanning reduce their death rate? Will it cause more harm than good?   Added 2011: Lung screening scans for heavy smokers reduce lung cancer deaths.

CT whole-body screening: This is a truly awful idea promoted by Oprah Winfrey and advertised directly to the public on the radio, the Internet, and in newspapers. A whole-body scan will extend all the radiation and overdiagnosis problems cited above to the rest of the body.

Heart Scans may make sense for people with symptoms like shortness of breath and chest pain. They are not useful, however, for predicting a heart attack or stroke in people without symptoms. Constrictions in the coronary arteries that show up in the heart scans of symptom-free people are not where a future heart attack will occur (though interventional cardiologists have been opening these constrictions for years on the now-discredited belief that they are saving the patient’s life). A heart attack occurs when bits of plaque break away from the arterial wall and blocks the blood flow to the heart. Scans cannot identify which blockages will rupture.

Maryann Napoli, Center for Medical Consumers© May 2009

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Just Say No to the PSA Prostate Cancer Test

Posted by medconsumers on April 16, 2009

“Studies Fail to Settle Prostate Screening Debate” (Boston Globe);
“Prostate Screening Saves Lives” (BBC). 
“Prostate Cancer Screening May Not Reduce Deaths”
(Washington Post).

These are just some of the headlines for the big health story last month about the PSA (prostate-specific antigen) screening blood test.  The results from two long awaited clinical trials were released early and simultaneously by The New England Journal of Medicine on March 18.  Despite the seemingly conflicting messages of these sample headlines, it is now clear that symptomless men should consider refusing this test.

The larger of the two trials was conducted in several European countries.  It found that the lifesaving benefit of PSA screening is far more modest than previously thought…and the risk of harm is very high.  For every 1,400 men who regularly had a PSA screening test over the ten-year period of the European trial, one man avoided death from prostate cancer and 47 men were treated unnecessarily for a cancer that did not progress.  The risks of treatment include urinary incontinence, bowel problems, and impotence.  Otis W. Brawley, MD, chief medical officer of the American Cancer Society, summed up the findings this way: “The test is about 50 times more likely to ruin your life than it is to save your life.”  (Click here for Treatment for Early Prostate Cancer.)

The other trial was U.S. government-funded and, unlike the European trial, it showed no reduction in prostate cancer deaths. The predictable and disturbing finding from both trials is this—many more prostate cancers were diagnosed in the men who were screened with the PSA test than in those who were not.  Few men opt for the “wait and see” approach once a PSA test, biopsy and other tests indicate the presence of cancer.

The debate over the PSA test is expected to continue, largely because flaws can be found in virtually all trials.  For example, the U.S. trial had less than half the number of participants of the European trial (162,000), which some believe may account for the absence of a lifesaving benefit.  In the U.S. trial, men were randomly assigned to annual PSA tests plus a digital rectal examination (screened group) OR what is known as usual care.

Given the fact that the PSA test has been aggressively marketed as a lifesaving test to doctors and the general public for the last 20 years, usual care in the U.S. involves a doctor recommending a PSA test. It is considered unethical to ask men in the unscreened control group not to have a PSA, and a large portion of them in the U.S. trial—38% to 52%—had the test.  Western European countries put up barriers to the marketing of an unproven test to the public.  In the U.S., most men over age 50 have regular PSA tests; in the U.K., where the National Health Service does not recommend PSA testing, only about 6% of men have had a PSA test because they requested one.

Treatment-Related Deaths?
There was a troubling finding from the U.S. trial that did not get media attention last month—it involves the deaths from the prostate cancer treatment itself.  When the authors of this trial looked solely at the participants who had been diagnosed with prostate cancer in the 10-year period of the trial, there were 312 men in the PSA screening group and 225 men in the unscreened control group who had died from causes other than prostate cancer.  The unexpectedly higher number of deaths in the screened group, say the authors, is “possibly” related to treatment of non-progressive cancer.

The question that no one seems to be asking at this time is: Why was the PSA screening test allowed to become so widespread when it cannot identify which prostate cancers are aggressive and lethal?  And no test currently exists that can make that distinction accurately.

Cancer screening tests are approved by the FDA on the basis of an outdated understanding of cancer, i.e. all cancers are deadly; finding cancer early is always good.; treatments are more effective with early diagnosis. All a company has to do is prove its product can find symptomless cancers.  The success of any screening test, however, should based on how many deaths can be avoided.  And most important, the chance of avoiding death should be far greater than the chance of serious harm as a result of the test itself.  The PSA screening test fails on both counts.

What to do:

  • Inform yourself. Try to get as much information about prostate cancer, early detection, and the PSA test from sources other than hospitals and doctors who treat prostate cancer.  The National Cancer Institute is one place to start (www.cancer.gov).
  • Be aware of the fact that some men are given the PSA test without their knowledge.  It is often automatically added in with the standard blood test for cholesterol, etc.  If you decide to forego a PSA test, make your wishes known before you are given a blood test.
  • Recognize that fear-mongering with statistics is essential to cancer screening promotion.  Prostate cancer may in fact be the second leading cause of cancer death in men, but it accounts for only 3% of all deaths.  No prostate screening campaign is likely to flip that statistic around to tell men that 97% of them will not die of prostate cancer.  And the 20% reduction in prostate cancer deaths shown in the PSA screened group in the European study.  Here’s what it means: The man who regularly has a PSA test over the course of the next ten years will reduce his risk of dying of prostate cancer from 3% to 2.4%.

Maryann Napoli, Center for Medical Consumers© April 2009

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Radiation dose of cardiac CT scans

Posted by medconsumers on April 15, 2009

A CT scan of the coronary arteries is a good diagnostic tool, but it involves a large dose of radiation. To determine how much radiation is involved in cardiac CT scans (also known as computed tomography angiograms), researchers accessed data from 1,965 CT scans of the coronary arteries performed in 50 hospitals around the world. The average estimated dose was 12 mSv, which is the equivalent of 600 chest x-rays, although estimated exposures varied widely from place to place (5 mSv to 30 mSv).

The sixfold difference was caused by variations in CT scan protocols, hardware, and use of established strategies to minimize radiation exposure. One of them, called electrocardiographically controlled tube current modulation, or ECTCM, is well supported by evidence and is associated with a 25% reduction in radiation dose. Sequential scanning and low voltage scanning were mentioned as other effective options for limiting exposure. Only a minority of patients in this study, however, were scanned using either strategy.

Protecting patients from radiation is one of the basic principles of radiology, say the authors of this study, “Effective strategies to reduce radiation dose are available but some strategies are not frequently used.”

JAMA 2009;301:500– 7

For more information about radiation exposure from CT scans, click into our 2009 article, “CT scans—lots of radiation, little research.”

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Make an Informed Decision about Mammography

Posted by medconsumers on March 1, 2009

A Rare Honest Explanation of the Pros and Cons of Mammography Screening

Printed materials designed to inform women about the need for regular screening mammograms are notorious for not mentioning the harms as well as the benefits of early breast cancer detection. A ground-breaking exception has just been made freely available at the Web site of the Nordic Cochrane Centre of Denmark (click here to view leaflet updated 2012).

The “leaflet” comes from a research team led by Peter C. Gøtzsche, DrMedSci, director of the Nordic Cochrane Centre, Copenhagen, which found that the major risk to screening mammograms is overdiagnosis—that is, unnecessary treatment for a cancer that would never progress. As the new leaflet puts it, “If 2,000 women are screened regularly for 10 years, one will benefit from the screening, as she will avoid dying from breast cancer. At the same time, 10 healthy women will, as a consequence, become cancer patients and will be treated unnecessarily.” No test can accurately distinguish the cancers that will become aggressive from those that will remain dormant or develop very slowly.

This project has a history that dates back to 1999 when Dr. Gøtzsche was asked by a Danish government agency to conduct a systematic review of all mammography screening trials worldwide. The agency wanted to know what the research had actually proven because doubts had been raised about the benefit of screening. This review was eventually published in The Lancet and in the Cochrane Library in 2001, and according to the requirement of the Cochrane Collaboration, it was updated in 2006 and is currently being updated again. The conclusion of the Cochrane review is: “It is not clear whether screening does more good than harm.”

Two of the seven trials in this Cochrane review, one conducted in Sweden and the other in Canada, found no decrease in breast cancer mortality among women given regular mammograms. The other five trials found small reductions in breast cancer mortality among those who had received mammograms. The seven trials had a combined total of about 500,000 women in North America and Europe who had been randomly assigned to receive regular mammograms or not.

The new leaflet’s benefit/harm calculations are based on the combined results of these trials—for every 2,000 women who undergo mammography screening over the course of ten years, one will avoid a breast cancer death and ten more will be treated unnecessarily for a nonprogressive cancer due to overdiagnosis.

The Cochrane review was not well received in this country because it contradicts the prevailing medical wisdom about mammography screening and dared to calculate harms.

In time, Dr. Gøtzsche and colleagues went on to assess the quality of the printed information given to women in six countries with publicly funded screening programs. Such countries inform women of the need for mammograms via “letters of invitations” to be screened. “The major harm of screening, which is overdiagnosis and subsequent overtreatment of healthy women, was not mentioned in any of 31 invitations. Ten invitations argued that screening either leads to less invasive surgery or simpler treatment, although it actually results in 30% more surgery, 20% more mastectomies, and more use of radiotherapy because of overdiagnosis,” wrote Gøtzsche and colleagues in a recent issue of the British Medical Journal.

No such survey of U.S. mammography information sources has been conducted, though a 2000 survey of American women’s attitudes toward this screening test showed 94% doubt the possibility of cancers that do not progress.

To read what is arguably the first honest mammography information for women written by health professionals, go to the Web site of the Nordic Cochrane Centre (www.cochrane.dk), which also provides free access to the Cochrane review. The information is currently being translated into Spanish, Portuguese, Polish, Norwegian, Swedish, Finnish and Icelandic, and there are also plans for German and French translations.

Maryann Napoli, Center for Medical Consumers© March 2009

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