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Posts Tagged ‘Women’s Health’

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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Walk-in clinics good choice for minor ills

Posted by medconsumers on September 29, 2009

Big chain stores like Wal-Mart and CVS have opened on-site medical clinics for customers seeking care for minor problems like sore throats. Though these retail clinics have been targets of disapproval from medical organizations, a Rand Corp. study showed that the quality of the care they provide is comparable to and less expensive than the care provided at physician offices and urgent care centers. The study was led by Ateev Mehrotra, MD, University of Pittsburgh, and published this month in Annals of Internal Medicine.

Store-based walk-in clinics have become popular for a variety of reasons. No appointments are required; they are open seven days a week and some evenings; less time is usually spent in the waiting room; and an increasing number of Americans do not have a primary care physician. Many of these clinics are manned by nurse practitioners or physician assistants, which raises the possibility of inferior care in the minds of some people, primarily physicians. The most high-profile criticism, however, came from the AMA, which saw a potential conflict of interest in retail clinics where health workers may be overprescribing drugs sold in their stores. (It’s hard to keep a straight face about this complaint from the AMA, not known to have the same concerns about surgeons recommending surgery.)

The Rand Corp. study is based on information from the claims made by 2,100 enrollees in a large Minnesota health plan that has allowed its enrollees to use retail clinics for the last five years. Dr. Mehrotra and colleagues looked at the claims made for three common illnesses—sore throat, urinary tract infection and ear infection. The claims for these three illnesses treated at retail clinics were compared with claims for the same illnesses treated at physician offices, urgent care centers, and emergency rooms (ERs).

The prescription drug costs were the same at retail clinics, physician offices, and urgent care centers. The exception was the ER where the average prescription costs were higher and the quality of care was significantly lower than in the other three settings. The overall cost of the visit to a walk-in retail clinic was $110, compared to $166 for physician offices, $156 for urgent care centers, and $570 for the ERs.

A related study published in the same issue of Annals of Internal Medicine explored the general question of whether these clinics provide access to care for “underserved populations.” Using data from the U.S. Census and 2008 Health Resources and Services Administration, the study found that retail clinics are currently located in more advantaged neighborhoods and concluded that this makes the clinics inaccessible to those most in need.

Both studies were funded by California HealthCare Foundation.

Maryann Napoli, Center for Medical Consumers©

Posted in Children's Health, Chronic Conditions, Drugs, Women's Health | Tagged: , , , , , , , | 1 Comment »

The Marketing of Osteoporosis

Posted by medconsumers on May 19, 2009

How a risk factor (bone loss) became a disease (osteoporosis) by Maryann Napoli. American Journal of Nursing. For PDF version, go to “article tools” at top right.

Posted in Drug ads, Drugs, Scans and X-rays, Screening, Women's Health, osteoporosis | Tagged: , , , , , | Comments Off

Healthy Ovaries Should Not Be Removed

Posted by medconsumers on May 5, 2009

For about 50 years, gynecologists have been recommending the surgical removal of healthy ovaries in women who undergo a hysterectomy for reasons unrelated to cancer. The advice is based on the fact that ovarian cancer is difficult to diagnose until it is advanced, as well as a blatant disregard for the usefulness of the ovaries once a woman has all the children she wants.

A new study shows that this longstanding practice causes two health improvements (fewer cases of ovarian and breast cancers), but more harms (an increased risk of death from all causes, fatal and non-fatal heart disease, and lung cancer). In other words, the women who kept their ovaries lived longer.

The findings are based on data from nearly 30,000 participants of the famed Nurses’ Health Study who had a hysterectomy for benign disease. More than half had a hysterectomy with bilateral oophorectomy (removal of both ovaries); and 44% had a hysterectomy with ovarian conservation. The participants periodically filled out an extensive questionnaire about their health status and were followed over a 24-year period. Results were published this month in the journal Obstetrics & Gynecology.

The women who fared the worst were those who had a bilateral oophorectomy before the age of 50 years and did not go on estrogen replacement therapy. They had an increased risk of all-cause mortality, heart disease, and stroke. “With an approximate 35-year life span after surgery,” estimated the authors, “one additional death would be expected for every nine oophorectomies performed. In no age group was oophorectomy associated with increased survival,”

The authors noted that ovarian cancer is rare. About 1% of American women will die of ovarian cancer.

Maryann Napoli, Center for Medical Consumers© May 2009

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

A Critical Evaluation of the Pap Test and Its Role in Reducing Cervical Cancer Deaths

Posted by medconsumers on March 1, 2007

Widespread use of the Pap test has successfully reduced cervical cancer incidence and mortality. This bit of medical wisdom has largely gone unchallenged with one noteworthy exception in 1978, when Anne-Marie Foltz and Jennifer L. Kelsey co-authored “The Annual Pap Test: A Dubious Policy Success” in the Milbank Memorial Fund Quarterly. This critique has resonance today, now that the test is an integral part of the discussion surrounding the merits of the new HPV vaccine. Many consumer advocates who are against mass HPV vaccinations see Pap testing as the safer alternative.

Would that things could be that simple.

The Pap test’s role in the much-heralded “dramatic” decline in the cervical cancer death rate is overstated, according to Foltz and Kelsey, because the rate began to drop well before the Pap test became widely used. Moreover, they report that estimates of the effect of hysterectomy on this decline vary from 10% to 25%. (Hysterectomy involves the removal of the cervix which is the neck of the uterus.)Foltz and Kelsey estimated that one in five American women are without a uterus. After their paper was published, the U.S. hysterectomy rate eventually rose to one in three women. At very least, this would explain why the incidence of cervical cancer has declined in the last 50 years.

Whatever the reasons, the decline in cervical cancer deaths can hardly be described as dramatic. In 1968, there were 7,108 cervical cancer deaths in the U.S. (by 1973, nearly 50% of women reported having had one Pap test during the previous year). In 1976, there were 5,525 deaths. [In 2006, it was 3,700 deaths. For the role of the Pap test in half these deaths in 2006, see below.]

Cervical cancer is not a major cause of death in the U.S. or other Western countries, wrote Foltz and Kelsey, who pointed out that screening people for a disease of low prevalence flies in the face of the medical research standards set by leading thinkers of the time. “The lower the prevalence, the less likely it is that a positive test will correctly identify a woman who really has cancer. This means that many women with positive test results but without disease will be referred unnecessarily for further diagnostic tests and treatment, with concomitant costs and worry,” explained Foltz and Kelsey, respectively, of the Graduate School of Public Administration, New York University; and the Department of Epidemiology and Public Health, Yale School of Medicine.

Wrong Women are Getting Pap Test
Making a point that is relevant today in the promotion of Gardasil, a 1976 editorial in The New England Journal of Medicine raised the issue of whether the wrong women were being screened, “since it was the middle-class low-risk women who were coming in for Pap tests, while the low-income high-risk women were not being seen in clinics.”

If low-risk women are the major customers for the Pap test, their odds of false alarm test results will be unacceptably high, but that was never a major concern to the promoters of cervical cancer screening, chief among them, the American Cancer Society. “The accuracy and reliability of the Pap test have not been established despite its use for over 30 years,” wrote Foltz and Kelsey in 1978.

In other words, no clinical trial has ever been conducted to determine the value of the Pap test because its promotion predated the introduction of the “gold standard” of medical research. Had a large trial randomly assigned women to a Pap test or no Pap test, its efficacy and harms would have been established. And the harms are many, especially in the early days of the Pap screening, according to Foltz and Kelsey. The primary purpose of the Pap test was to detect cancer or tiny lesions that may be pre-cancerous. But by 1978, it was known that these so-called “early,” pre-cancers, carcinoma in situ detected so frequently on a Pap test do not always progress to become deadly, if left untreated.

According to Foltz and Kelsey, this was acknowledged by pathologists, but it took time for the word to get out to the surgeons (i.e., gynecologists). The unnecessary hysterectomies, oophorectomies (surgical removal of the ovaries), and biopsies for “cancers” that would have spontaneously regressed went uncounted. The focus was entirely on the decline in cervical cancer deaths.

Today, a hysterectomy following a Pap test-discovered pre-cancerous lesion or a carcinoma in situ (Latin for cancer in place) is no longer as common. But then again, who’s counting? What were cancers or precancers in another era have long since been renamed as LSIL (see the quote below) or ASCUS, which stands for atypical squamous cells of uncertain significance. The latter nicely describes the unknowns that continue to surround most of what is currently detected on a Pap test.

Today, other harms are acknowledged to result from mass Pap screening. The following quote is from the National Cancer Institute’s Web site www.cancer.gov. “Based on solid evidence, regular screening with the Pap test leads to additional diagnostic procedures (e.g., colposcopy) and treatment for low-grade squamous intraepithelial lesions (LSIL), with uncertain long-term consequences on fertility and pregnancy. These harms are greatest for younger women, who have a higher prevalence of LSIL, lesions that often regress without treatment.”

Maryann Napoli, Center for Medical Consumers© March 2007

Half of the 9,710 U.S. women who develop cervical cancer have not had a Pap test. The other half of all cervical cancers occur in women who have had one. Imperfect testing is estimated to be responsible for 30% of all cervical cancers in women who have had Pap test and improper follow-up of abnormal test results for another 10%. Even under the best screening circumstances, an incidence rate of two to three per 100,000 women can be expected. Some risk factors for not having a Pap test are lack of insurance, poverty, geographic isolation, and lack of provider.

From the American Cancer Society Guidelines for Human Papilloma Virus (HPV) Use to Prevent Cervical Cancer and Its Precursors reported in CA: A Journal for Clinicians, January 23, 2007.

CDC: HPV Prevalent, But Not Cancer-Causing Types

Could it be a coincidence? Just as the media was losing interest in Gardasil, the Centers for Disease Control and Prevention (federal promoters of all vaccines) published a study in the Journal of the American Medical Association entitled, “Prevalence of HPV Infection Among Females in the U.S.” (Why no study of prevalence in males?)

The short of it is this: HPV is much more common than previously thought. In fact the prevalence is highest among those aged 20 to 24 years. The overall prevalence is 26.8%, but the overall prevalence of the high-risk HPV types was only 2.6%. Though this study also noted previous research showing that “approximately 90% of infections clear within two years,” the new findings have already begun to play out in the media as: HPV is prevalent, get your Gardasil shots.

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How Vaccine Policy is Made: The Story of Merck and Gardasil

Posted by medconsumers on February 1, 2007

Much has happened since the November HealthFacts took the position that the new cervical cancer vaccine should not be mandated. By now, most of the U.S. is probably aware that donations from Merck, maker of the Gardasil vaccine, influenced Governor Rick Perry’s decision to make Texas the first state to mandate Gardasil vaccinations for all girls entering the sixth grade.

Behind the scenes, Merck was found to be bankrolling similar mandates under consideration in at least 20 other states. In doing so, the company moved from the usual pharmaceutical industry hucksterism (hype the disease, hype the new drug) to blatantly purchasing a public policy that is clearly a windfall for the one and only company that sells a cervical cancer vaccine.

The prolonged nationwide publicity given Merck’s actions frequently overlooked a key element to the question of whether mass cervical cancer vaccinations make sense whether they are mandated or voluntary. Cervical cancer is, by any measure, a rare disease in the U.S., afflicting fewer than 10,000 women and causing about 3,700 deaths each year.

And then there’s the proverbial elephant in the room that no one seems to want to address. It has been known for over three decades who is most likely to get cervical cancer. In fact, it is known by geographical region. So why not save taxpayers’ money, especially at a time when the states are running out of health dollars for children, and provide the vaccine for the girls most in need?

All medical decisions made by and for healthy people boil down to probabilities. What are the odds of dying of the disease that the vaccine protects against? (There are three cervical cancer deaths for every 100,000 women in the U.S.) How protective is the vaccine? (70%, according to Merck) What are the odds of serious harm from the vaccine itself?

The last question is not answerable because the vaccine has only been available for eight months, and several hundred thousand girls must be vaccinated and followed for many years before any rare or even uncommon serious adverse reactions can be documented. The longest follow-up is 4 ½ years, so how long the protection lasts is another unknown.

What makes this vaccine different from virtually all others currently given to babies and young children is the fact that cervical cancer is a sexually transmitted disease. (The hepatitis B vaccine given to newborns since 1991 is the other exception.) There are more than 100 different types of human papilloma virus (HPV), but only 23 are considered high risk. “Rarely can an infection with high-risk HPV develop into precancer or cancer. The majority of HPV infections go away on their own and do not cause any abnormal cell growth,” according to the National Cancer Institute’s Edward L. Trimble, MD. Gardasil protects against two of the cancer-causing strains that account for about 70% of all cases of cervical cancer
Typically, a new vaccine goes into use gradually, and a mandate comes only after several years. The haste with which Gardasil became mandatory in Texas is challenged. “This [cervical cancer] is not a public health emergency, so the government has no right tell parents or kids to have the vaccine or even to opt out,” said Michael Policar, MD, associate clinical professor of Obstetrics, Gynecology and Reproductive Science at the University of California, San Francisco. “You can’t get this disease from someone sitting next to you on a bus. If you have TB, a judge can tell you to take your drugs because you can give the disease to other people and if you don’t take the drugs, the judge can have you confined,” Dr. Policar said in a telephone interview.

Physicians and public health experts quoted in the media were unanimous in their recommendation of the vaccine, though some, like Dr. Policar, do not like the mandate. And all insist that strong evidence supports its safety and efficacy. Physicians seem untroubled by the fact that no published HPV vaccine trial had participants under the age of 15. The CDC recommends the HPV vaccine for 11- and 12-year-old girls, and the American Cancer Society sees the vaccine as appropriate for girls as young as nine years of age. The girls must receive the vaccination before they become sexually active or else it will not be effective.

Why is there so little public discussion among doctors about the wisdom of vaccinating all young girls for a rare disease? “Great question,” responded Dr. Policar. “Certain people are very tied into vaccines—pediatricians, infectious disease doctors, public health doctors—these people have never seen a vaccine they didn’t like. The pressure to vaccinate comes not only from them, but also from industry.”

The rush to make a new vaccine compulsory appears to be all about Merck making as much money as possible before Cervarix, GlaxoSmithKline’s version of the HPV vaccine, comes on the market. “Merck started three to four years ago convincing us that HPV is a dangerous infection,” said Dr. Policar, noting that the company has been overdoing it. “HPV is a marker for sexual activity. The majority of us are infected with it and that doesn’t mean we’ll all get cancer. This is another industry-created disease,” he explained, stressing that all HPV-vaccinated women should have regular Pap tests. (For a critique of the Pap test, see page 4.) Dr. Policar is favorably inclined toward the vaccine, but has reservations about the excessive cost and possible need for booster shots (“it took 30 years to learn that the pertussis vaccine needs a booster”). Dr. Policar said he has been “a paid lecturer on occasion for Merck regarding Gardasil.”

More and more parents worry about the growing number of vaccines now given to babies and young children, according to Barbara Loe Fisher of the National Vaccine Information Center, who notes that 40 vaccine doses are already mandated for babies and young children. Fisher, an advocate for vaccine safety, is concerned that doctors are not giving enough attention to possible harmful effects of Gardasil when combined with other vaccines.

She advises parents to inform themselves. But this is difficult when the trials are funded by the vaccine companies and the last place parents will get an unbiased evaluation of any vaccine are the U.S. Centers for Disease Control and Prevention (federal promoters of vaccines in general) or the American Academy of Pediatrics (represents the specialty that sees all vaccines as a medical triumph). In fact, Fisher’s Web site www.909shot.com is the only evidence-based independent Web site on this topic.

Science seemed to take a back seat in the prolonged media coverage last month. The one trial that proved “sustained efficacy up to 4.5 years” was funded by GlaxoSmithKline, and published last year in The Lancet. This is the longest follow-up. The majority of the participants were over 18. About half of these 776 study participants were randomly assigned to receive the HPV vaccine, thus the longest follow-up involves less than 400 women.

And now for the elephant in the room. Cervical cancer is largely a disease associated with extreme poverty, smoking, lack of education, and less than sanitary living conditions. According to a 2005 National Cancer Institute report, most cervical cancer deaths occur in black women in the rural South, Hispanic women living along the Texas-Mexico border, white women in Appalachia, American Indians in the Northern Plains, Vietnamese-American women and Alaskan Natives. These groups are also more likely than other U.S. women to be diagnosed with other diseases like breast cancer, colorectal cancer and heart disease.

Wouldn’t it make sense to aim the Gardasil vaccine recommendation at these women? Or better yet, given the limited federal health dollars, why not spend some money to improve their health in general? The answer, of course, is that this would not suit Merck, who appears to be setting the national agenda on cervical cancer. Nor does it suit the federal government and the special interests—so aptly represented in Congress—who want to do everything to keep companies from shunning the vaccine business as risky and unprofitable. Merck needs to make as much money as quickly as possible from Gardasil before Cervarix goes on the market. Each year in the U.S., about a million girls turn 11. Mandating a $360* series of three injections means an estimated $360 million-a-year market.

It didn’t take long for Merck to experience a well-deserved backlash. Within three weeks of Governor Perry’s announced mandate at the end of January, Merck revealed that it would stop lobbying state legislatures to mandate Gardasil. (Texas legislators are reportedly at work undoing the mandate.) But Merck is not the only company to provide “unrestricted educational grants” to Women in Government, a Washington, DC based advocacy organization of female state legislators. This group, the conduit for Merck donations, has also received funding from Glaxo, as well as Digene, a company that makes a test that detects HPV.

The funding paid off as female state legislators were highly visible in the media coverage given Gardasil last month. The legislators were presenting themselves as champions of women’s health and spreading the word about the dangers of HPV, often quoting worldwide cervical cancer statistics (500,000 deaths annually!! Second leading cause of cancer deaths!!) as if these numbers pertained to U.S. women. The Merck people probably knew that a vaccine company presenting itself as champions of women’s health wouldn’t fly with the public. Much better to send in the female legislators to shill for them.

*This is the most widely quoted price, but a random survey by the National Vaccine Information Center found the price varies considerably and can be as high as $825 plus office visit charges.

Maryann Napoli, Center for Medical Consumers© March 2007

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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

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