• Search Archives

  • Categories





  • We are one of a few medical consumer advocacy organizations in the U.S. that takes no funding from the pharmaceutical and device industries.




Posts Tagged ‘osteoporosis’

Next Entries »

Reduce Risk of Breast Cancer

Posted by medconsumers on May 1, 2006

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

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

The study is yet to be published and therefore has not been peer-reviewed.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

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

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

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

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

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

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

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

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

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

Maryann Napoli, Center for Medical Consumers ©May 2006

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

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

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

Women’s Health Advice Falls Short

Posted by medconsumers on March 1, 2006

Prevention Advice to Women Doesn’t Hold Up

This is not the first time we’re seen medical dogma upended. Remember breast self-examination? It was proven to have no life-saving benefit and an increased risk of unnecessary breast biopsies. Now it is calcium supplements and a low-fat diet that will not save your life.

February 2006 was a banner month for disproving medical dogma. First, the public learned that the low-fat diet does not prevent heart disease. The next week, another study found that calcium does not protect against fractures or colon cancer. And in between, yet another study provided the surprising news that estrogen might lower the risk of heart disease in some women. (This last one actually reconstituted a previously disproved medical belief. For over ten years, women had been told that estrogen will save them from heart disease, but a major clinical trial was stopped early several years ago when it found that this hormone caused heart-related problems.) In each case, the findings were strongly contested.

Women’s Health Initiative

All these newsworthy announcements came from the same landmark clinical trial called the Women’s Health Initiative (WHI), an $18 million government-funded project, which involves thousands of healthy women over age 50. It is designed to test the prevailing health advice about how to prevent the chief causes of death and disability in older women.

Medical research is constantly evolving and we should expect health advice to change as more studies are published. But how is it that so many recommendations based on uncertain evidence can become orthodoxy? Recall how women were made to feel negligent by their doctors for not doing breast self-exams. A similar guilt was laid on those who refused to take postmenopausal hormones or were doubtful about high-dose calcium.

Surrogate Endpoints

Physician acceptance of the preventive measures was nearly universal, though they were based on a less reliable type of study called population, or observational studies. In this type of study, for example, the women who chose to take estrogen (as opposed to being randomly assigned to take it in a clinical trial) tended to have lower rates of heart disease. A closer look at these less reliable studies showed that women in the higher income brackets were more likely to take estrogen, and a high income is known to be associated with better health and a longer life.

Often, health recommendations are based on what researchers call surrogate endpoints—plus a heavy dose of assumptions. Estrogen lowers cholesterol in women; therefore it must save them from heart disease. Calcium improves bone density; therefore it must cut the risk of hip fracture. Long-term  trials that follow participants until they have a heart attack or a hip fracture are expensive and take many years to produce answers, which is why so much health advice is based on surrogate endpoints.

The WHI is a massive research effort that involves multiple clinical trials. As researchers continue to sift through the data generated by the WHI, they will be publishing results for years to come. What follows is a summary of the evidence (or gaps in the research) that led the WHI to study the low-fat diet, high-dose calcium, and estrogen in younger women; the doubts that long surrounded each preventive measure; and the questions that remain unanswered.

LOW-FAT DIET AND HEART DISEASE

The supporting evidence:

No long-term trial had ever been conducted to support the idea that a low-fat diet (below 20% of total calories) reduces the risk of heart attack in healthy older people. While the WHI was still underway, a 2001 Cochrane review on this topic was published in the British medical journal, BMJ. Lee Hooper, PhD, and colleagues assessed all clinical trials in which healthy older men and women had been randomly assigned to continue on their normal diet or go on a low-fat or a reduced-fat diet.

This review exposed the difficulty in finding definitive answers as heart disease takes years to develop and few of the trials lasted more than six months. Results were predictably unimpressive: There was no reduction in heart attacks or cardiac deaths, but the few trials that lasted two years hinted at a lower risk of heart  disease.

Flaws in the WHI:

The most valid criticism of the WHI/diet trial centers on the fact that it made no distinctions in the types of fat, as in: olive oil is good; trans-fatty acids (partially hydrogenated vegetable oils) are bad. Participants were simply instructed to keep their total fat intake below 20%. Because the WHI was designed 15 years ago, it reflects the general thinking among nutrition scientists at the time, said nutrition scientist Sharon Akabas, PhD, in a telephone interview. “As recently as 12 to 15 years ago, you still had people [in the nutrition field] who thought trans-fatty acids were OK and omega-3 fatty acids were seen as fringe—olive oil and other monosaturated oils were thought to be neutral.”

The Mediterranean-type diet is favored by many nutritionists today and that is a glaring omission of the WHI, according to Dr. Akabas, who is associate director of education at the Institute of Human Nutrition, Columbia University in New York City. “If I could design the WHI now, I would have had a group whose fat intake was 40% of calories with a significant contribution from olive oil. The Mediterranean diet also puts more emphasis on omega-3 fatty acids; it is high in plant food; low in animal foods; has more whole food; and less processed foods,” she said, adding that there is more to healthful living than dietary choices. Referring to the numerous population studies that showed the Mediterranean diet to be one of the most healthful in the world, Dr. Akabas continued, “People eating the Mediterranean diet at the time of these studies were taking a nap in the afternoon, they didn’t snack all day; they were physically active. And they are on the diet by choice, as opposed to have it imposed on them during a study.”

Doubters Have Reason to Remain Doubtful:

Even the highly motivated women who volunteered for the WHI could not get their fat intake under 20% of calories. (Many critics of the WHI saw this as a sign that a low-fat diet is impossible for Americans.) The best the WHI participants could do was 24% in the first year and 29% in the subsequent years. Since that narrowed the difference between them and the other women who had been assigned to remain on their usual diet, the WHI results were seen by some critics as not proving anything one way or another about the value of the low-fat diet.

The most steadfast proponent of the low-fat diet is Dean Ornish, MD, president of Preventive Medicine Research Institute and clinical professor of medicine at the University of California, San Francisco. The author of several books about reversing heart disease, Dr. Ornish has also co-authored a study that showed regression of severe coronary atherosclerosis after only one year, without the use of cholesterol-lowering drugs. In addition to a low-fat vegetarian diet, the study participants took part in a program of comprehensive lifestyle changes that included smoking cessation, stress management training, and moderate exercise. As yet, Dr. Ornish has not published a clinical trial that proves his program results in lower rates of heart attack or cardiac death.

Other Potential Benefits to Low-Fat Diet

The WHI produced a hint that even small reductions in dietary fat might reduce the risk of developing breast cancer. There was a 9% reduced rate of breast cancer in the women who attempted a low-fat diet, but this was not regarded as statistically significant, though it came close. Dr. Jacques Rossouw, the project officer for the WHI has stated that this finding might have become statistically significant had the trial lasted longer.

CALCIUM AND HIP FRACTURES

Supporting Evidence:

The body needs calcium for strong teeth and bones. That’s a fact. A controversy, however, surrounds the question whether anyone (including children) has to get it from milk or other dairy foods. It was also unclear whether massive increases in calcium intake in middle  age will make any difference in fracture reduction.

Many population or observational studies show an increase in calcium intake in middle age improves bone density, but others show that women with high intake of calcium from diet or supplements actually have higher rates of fractures. Until, the WHI published its results last month, no well-designed clinical trial followed women long enough to prove increased calcium intake in middle age will reduce the rate of hip fractures.

The WHI Findings:

The WHI/calcium plus vitamin D trial involved 36,282 women. The hip fracture rate in those taking calcium plus vitamin D was the same as that of the women taking inactive placebos. One benefit shown in the calcium/vitamin D3 group was a 1% increase in bone density at the hip. Another is a slightly lower risk of hip fracture in one subgroup—women over the age of 60 years at the start of the trial.

Only 70% of the women in the calcium/vitamin D group took their assigned supplements regularly. When the investigators looked solely at this group, they found that these women had 29% fewer hip fractures than those taking placebo. In other words, there were 10 compared to 14 hip fractures per 10,000 women each year.

Furthermore, the supplements did not prevent colon cancer as originally thought, but they slightly raised the risk of developing kidney stones. There were an additional five cases of kidney stones per 10,000 women per year among those on supplements.

Doubts That Remain:

Since the WHI was planned, researchers have begun to view the recommended dose of vitamin D3 (400 international units) as inadequate and the recommended dose of calcium (1200 milligrams) as excessive. The WHI chose to use a daily dose of 1,000 milligrams of calcium and 400 international units of vitamin D3 (cholecalciferol). Last year, an analysis of all clinical trials that looked at the relationship between fractures and vitamin D was published in the Journal of the American Medical Association. It concluded: “Oral vitamin D supplementation between 700 to 800 IU a day appears to reduce the risk of hip and any non-spinal fractures in ambulatory or institutionalized elderly persons. An oral vitamin D dose of 400 IU/day is not sufficient for fracture prevention.”

Doubters Proven Correct (so far):

The two high-profile doubters about the relevance of calcium intake to hip fracture are Walter Willett, MD, Harvard School of Public Health, and T. Colin Campbell, PhD, professor emeritus of nutritional biochemistry at Cornell, who have, respectively, conducted numerous studies on the topic. Both argue that there is too much focus on calcium and too little focus on exercise and vitamin D. Both cite the excessive protein intake in the American diet, primarily from meat as a probable cause of hip fracture (though this was not factored into the WHI).

For the last 25 years, Dr. Willett has been one of the principle investigators of the Nurses’ Health Study, which has spawned scores of nutrition and health related studies including one that found the highest rates of hip fracture among women with the highest calcium intake.

Dr. Campbell directed the Cornell-China-Oxford Project, the most comprehensive project on diet and disease ever conducted. He has observed: “Most of the world’s peoples do not consume cow’s milk, and yet most of the world does not experience the high rates of osteoporosis found in the West. In Asian countries, for example, where consumption of dairy foods is low (and where women tend to be thin and small-boned, universally accepted risk factors for osteoporosis), fracture rates are much lower than they are in the United States and in Scandinavian countries, where consumption of dairy products is considerably higher.”

ESTROGEN AND HEART DISEASE

New Evidence for Women Without a Uterus:

One component of the WHI was designed to test several assumptions about the health effects of hormone therapy by comparing it to a placebo. This trial made international headlines in 2002 because it had to be stopped early. There was a higher rate of heart disease, breast cancer, blood clots, and stroke among the participants who had been taking combination hormones, estrogen and progestin (the latter hormone is necessary only for women with an intact uterus due to estrogen’s ability to increase the risk of uterine cancer). Though the hormone combination was also associated with decreased risk of colon cancer and hip fracture, it is no longer universally recommended as a preventive measure because the risks clearly outweigh the benefits.

Another “arm” of the WHI/hormone study continued to follow the 10,739 participants who had undergone a hysterectomy. All had been randomly assigned to take daily doses of estrogen (0.625 milligrams) or a placebo. Their mean age at entry into the WHI was 63 years. In February 2003, this arm of the WHI was also stopped early due to a higher stroke rate among women on estrogen.

The WHI Findings:

A study that looked at the heart-related WHI findings for the hysterectomy group was published last month in the Archives of Internal Medicine. After about seven years, the rate of heart attack and cardiac death was exactly the same for both the estrogen and the placebo groups. But there was “a suggestion” of a lower heart disease risk only among the women who had started taking estrogen while in their fifties. There was no suggestion of benefit in women who were 60 years or older when they started taking estrogen. Stroke was not taken into account in this particular study.

Doubts that Remain:

Whenever researchers use the word suggestion to describe their results, as in “a suggestion of lower heart disease risk,” they are saying that the findings aren’t clearly established. Despite the breathless headlines that went out across the country heralding the results of this study (“Estrogen May Help Heart”), they could be due to chance, which is how the WHI Web site (see below) describes them. A co-author of this study, quoted frequently in the media, saw the lack of an increased risk of heart disease as reassuring to women who want to take hormones on a short-term basis to alleviate hot flashes.

For More Information:

The WHI is a 15-year project that includes 161,000 women. It is paid for by taxpayer money, and as such, the WHI has been entirely open—via its Web site (www.whi.org)—about its findings both good and bad. The WHI has two major components: a randomized clinical trial (RCT) and an observational study. The RCT section is divided into three additional components: hormones, dietary modification and calcium/vitamin D.

Maryann Napoli, Center for Medical Consumers ©
March 2006

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

Dueling Osteoporosis Drug Ads

Posted by medconsumers on February 1, 2006

The goal of osteoporosis drug therapy is not to stop bone loss or improve bone density. Rather it is to reduce the chance of having a serious fracture. Over the years, osteoporosis researchers have found that improving bone density does not always lead to fracture reduction. The drug class called bisphosphonates has dominated the osteoporosis drug market ever since Fosamax became available in 1994. Actonel, another bisphosphonate soon followed. Boniva is the latest drug in this class.

How good are these drugs at reducing the rate of hip fracture, the most serious consequence of osteoporosis? Not very. The first clinical trial proving Fosamax’s benefit showed that at three years, 1% of the drug-treated women had had a hip fracture, compared with 2% of the women on the placebo. Significantly, the elderly women in this trial all had evidence of a previous fracture; whereas many younger women are inappropriately put on long-term Fosamax purely because a bone-mineral density test showed bone loss.

As Fosamax nears the end of its patent life, its competitors, Actonel and Boniva, are promoted in ads that emphasize the fact that they do not have to be taken daily. For example, the TV and print ads for Boniva feature its once-a-month dose convenience, but the ads for once-a-week Actonel also mention its proven fracture-prevention. These two different promotional approaches merit scrutiny.

What did the clinical trials prove?

In a three-year trial, Boniva was no better than a placebo in reducing non-spinal fractures (hence the Boniva ads’ focus on once-a-month dosing). As for Actonel, its advertised claims are correct but misleading: “Actonel is clinically proven to help protect many bones where a woman is most vulnerable to fractures caused by osteoporosis: The spine and a combination [emphasis added] of wrist, hip, collarbone, upper arm, leg and pelvis.”

Clustering the non-spinal fractures together clearly makes the clinical trial results look more impressive. 11% rate of the women on a placebo had a non-spinal fracture, compared to 7% for the women on Actonel.  However, where it concerns hip fracture, the same trials showed Actonel to be much less impressive. The rate of hip fracture of the women on Actonel was identical (2%) to that of the women on the placebo. (These findings appear in Actonel’s “label,” known as the packet insert which provides prescribing information for doctors.)

Who were the study participants?

In both the Boniva and the Actonel clinical trials, the participants were postmenopausal women with documented osteoporosis—that is, spinal fractures shown on x-ray—but only some had symptoms. In many cases, women are unaware of their spinal fractures.

Cautions

The bisphosphonates, particularly Fosamax and Actonel, are usually prescribed for five years or more. In her excellent Web site, Susan Ott, MD, one of the country’s leading osteoporosis researchers, explains why five years is enough. “The bisphosphonates get deposited in the bone and will accumulate for years. It is possible that many years of continuous medicine would make bone more brittle or impair the ability to repair damage. Bisphosphonates do reduce fractures and improve measurements of bone strength for the first five years in both animal studies and in women who have osteoporosis. After five years, the fracture rates are as high in the women who keep taking alendronate [Fosamax] as in the women who quit.” (http://courses.washington.edu/bonephys)

Alternatives:

Reduce the chances of falling by eliminating scatter rugs from the home and by avoiding certain prescription drugs like tranquilizers and barbiturates. Regular exercise will also reduce the risk of 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 clinical trials published last year in the Journal of the American Medical Association. This is a lower amount of calcium and a higher amount of vitamin D than the longstanding recommendations.

For updates on this topic, read our more recent articles: Prevent falls with vitamin D3, “The Marketing of Osteoporosis—How a risk factor became a disease,” (April 2009 issue of the American Journal of Nursing), “Fosamax-induced osteonecrosis of the jaw—more common than previously thought,” and “Osteoporosis drug: New adverse effects.”

Maryann Napoli, Center for Medical Consumers ©

Share This Article

Posted in Chronic Conditions, osteoporosis, Women's Health | Tagged: , , , | Comments Off

How Good Are the Treatments for Osteoporosis?

Posted by medconsumers on August 1, 2005

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

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

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

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

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

Safe (So Far) But Not Very Effective

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

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

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

What else is there?

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

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

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

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

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

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

Something to think about

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

And, finally, a little history

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

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

For more information

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

Maryann Napoli, Center for Medical Consumers ©
August 2005

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

Vitamin D Deficiency: Cause Of Many Ailments

Posted by medconsumers on January 1, 2005

The Institute of Medicine brought experts together recently to explore the question of whether the RDA or recommended daily allowance, of vitamin D has been set too low. The impetus for the occasion was the mounting evidence for this vitamin’s role in preventing common cancers, autoimmune diseases, type 1 diabetes, heart disease, and osteoporosis. Furthermore, studies have shown that vitamin D deficiency is common in the U.S. Because the typical symptoms are aching bones and muscle discomfort, vitamin D deficiency is often misdiagnosed as fibromyalgia or chronic fatigue syndrome, according to Michael F. Holick, MD, PhD, of the Boston University School of Medicine.

Dr. Holick has conducted a review of all vitamin D studies, which was published in the December 2004 issue of the American Journal of Clinical Nutrition. Vitamin D has become the vitamin of the moment, possibly because researchers in this field want to raise the RDA again. And Dr. Holick’s review, which was funded by the U.S. National Institutes of Health, certainly supports the move.

For most Americans, sunlight provides the lion’s share of our vitamin D requirements because we eat few foods that naturally contain vitamin D, such as cod liver oil and oily fish (salmon, sardines, and mackerel). But many Americans do not meet the minimum requirement of sun exposure. What’s more, vitamin D deficiency is more pronounced among people living at higher latitudes, such as the New England States, especially in winter.

Dr. Holick and colleagues conducted a 2002 study at the Boston Medical Center , which found that, by the end of the winter, 32% of students and doctors, aged 18 to 29 years, were vitamin D deficient. Winter isn’t the only problem because, year-round, many people spend a lot of time indoors or slather themselves with sunscreen when they do go outside. So it was not too surprising that another study conducted in Boston found a high degree of D deficiency in white (30%), Hispanic (42%) and black (84%) elderly people at the end of August. Another study found that 38% of nursing home residents were vitamin D deficient.

Much of the sun avoidance and excessive sunscreen use is attributed to public education campaigns by dermatologists warning about skin cancers. It should be noted, however, that the most deadly form of skin cancer, melanoma, is not entirely related to sun exposure. In fact, Dr. Holick describes the sunlight-melanoma link as baffling because the disease rarely occurs on the face and hands. Instead, melanoma is more likely to appear on areas of the body that are not as exposed to the sun.

Obesity is yet another cause of vitamin D deficiency, according to Dr. Holick, who found that even when dietary vitamin D intake and sun exposure are adequate, the vitamin becomes unavailable because it becomes stored in the large amount of body fat. Aging skin requires more sun exposure. A 70-year-old exposed to the same amount of sunlight as a 20-year-old will only make 25% of the vitamin D that the young person can make. Breastfed infants are deficient in vitamin D because human milk is deficient in vitamin D. Dr. Holick offered this explanation for why deficiencies are widely overlooked: During the standard blood work-up, doctors tend to focus on the blood calcium levels, and if they are normal, doctors incorrectly assume their patients are getting enough D.

Why the seemingly sudden interest in vitamin D when intriguing research goes back over a half century? In 1949, a researcher published his observation that people who live at higher latitudes, such as New Hampshire , Vermont , and Massachusetts , had a higher incidence of cancer deaths, compared with people living in southern states, such as Texas , Georgia , and Alabama.

In a telephone interview, Dr. Holick was asked why other researchers didn’t pick up on this study and look further. “It was an interesting observation, but people didn’t take epidemiology seriously,” he answered. “Little attention was paid to it until the 1980s when other researchers reported that colon and breast cancer rates were higher for those living at higher latitudes in the U.S. ” Even then, the finding was not taken seriously until researchers understood the mechanism for how the breast, colon, and prostate activate vitamin D and use it to regulate cell growth, which Dr. Holick explained as a process that is, “keeping cell growth in check and possibly preventing the cell from becoming autonomous and developing into an unregulated cancer cell.”

After the paper explaining the mechanism was published in the British journal The Lancet, much more research attention began to be paid to vitamin D. And after 1999, many more observational studies were published showing a link between vitamin D deficiency and several chronic diseases. For example, there are higher rates of multiple sclerosis in people who live at higher latitudes; and another study showed vitamin D intake is inversely associated with rheumatoid arthritis.

In a 2001 study published in The Lancet, children treated with 2,000 IU daily of vitamin D from their first birthday onward had an 80% decreased risk of developing type 1 diabetes throughout the next 20 years. And in the last few years, several studies have been published indicating a link between schizophrenia and decreased exposure to sunlight. Dr. Holick’s review states that animal studies have successfully shown that type 1 diabetes, rheumatoid arthritis, and multiple sclerosis can be prevented using mice prone to these diseases.

To Dr. Holick, who is an endocrinologist, it is clear from studies like these (and many more that go unmentioned in this article for lack of space) that vitamin D should no longer be thought of only as the nutrient necessary for the prevention of rickets in young children. He said that his work has been instrumental in the vitamin D fortification of several common foods, including milk products, bread, and orange juice.

In the telephone interview, Dr. Holick was asked whether an increase in the RDA for vitamin D was imminent, given the fact that the Institute of Medicine , a division of the National Academy of Science, recently held a meeting on the topic. “No, it usually takes 10 to 15 years to change an RDA,” he answered. “A huge bureaucratic system is involved.” In the meantime, he and other vitamin D researchers recommend a minimum of 1,000 IU vitamin D daily. This increase, he explained, will maximize the absorption of calcium.

As for the risk of overdose, Dr Holick said, “You’d have to take 10,000 to 20,000 IU daily to approach toxicity.” Is the type of vitamin D important? “Multivitamins usually have D 2 which comes from yeast, but it’s probably only 20-40% as effective as D 3 ,” which, he believes is better and longer lasting.

Then there’s the question of what constitutes an adequate amount of sunlight: “Five to ten minutes of exposure of the arms and legs or the hands, arms and face two or three times a week,” stated Dr. Holick, adding a way of determining the right timing, “25% of the time that it would take to cause a light pinkness to the skin.”

For More Information:
Read Dr. Holick’s book, co-authored with Mark Jenkins and written for the general public, The UV Advantage ( New York : Simon & Schuster/ibooks , 2003).

Maryann Napoli, Center for Medical Consumers ©
January 2005

Posted in Cancer, Chronic Conditions, Diet & Exercise, Heart | Tagged: , , , , | Comments Off

Osteoporosis: How Effective is Prevention?

Posted by medconsumers on December 1, 2003

by Maryann Napoli

When osteoporosis emerged as a major health problem in the 1980s, experts in the field believed that the devastating fractures suffered by some women in old age could be prevented. Most of the diet and exercise advice was aimed at mid-life women who were warned that they would be rapidly losing bone right after menopause. The bone loss, they were told, was largely due to the body’s declining level of estrogen. In time, bone density testing became a rite of passage for many menopausal women.

The increased awareness of osteoporosis plus the overemphasis on estrogen’s role in bone loss had the unfortunate consequence of making mid-life women believe that an inevitable hip fracture loomed in the near future. Once bone density testing continued to show bone loss, something had to be done. And that something often turned out to be a lifelong prescription for estrogen. This hormone drug proved itself many times over to be good at stopping bone loss. However, estrogen had never been proven to reduce the fracture rate.

That proof arrived in 2002 with the results from the Women’s Health Initiative (WHI) trial. Estrogen, in combination with progestin, slightly reduced the rate of hip fractures in the WHI. Unfortunately, this hormone combination is too risky for lifelong use because the WHI showed that it raised the risk of developing blood clots, stroke, breast cancer and Alzheimer’s disease. (Progestin was added to the regimen to protect the uterus from estrogen’s cancer-causing effect.)

Now, the tide of expert opinion is slowly changing its focus away from mid-life women to those of advanced age. As Dr. Susan Love said in her Menopause & Hormone Book, “The usual line is that prevention is always better than treatment, and this has certainly driven the use of HRT [hormone replacement therapy] in postmenopausal women. This may not actually be the case.”

Dr. Love sees the newer osteoporosis medication–from a drug class known as the bisphosphonates (brand names: Fosamax, Actonel, Didronel)–as safer alternatives to 30 years on estrogen.

Bisphosphonates will modestly reduce the hip and spinal fracture rate, but the published evidence for this benefit is primarily confined to elderly women with low bone mineral density and at least one other major risk, such as a previous spinal fracture.

An osteoporosis-related hip fracture is rare in women younger than 70 (the average age at which it occurs in women is 79), and only 18% of all white women will ever have a fracture. One reason to reserve treatment for high-risk older women is the lack of long-term information–beyond seven years–about bisphosphonate’s safety and continued effectiveness.

The shift in thinking about osteoporosis prevention is reflected in the revised recommendations about when to start bone density testing. Several medical organizations, such as the National Osteoporosis Foundation, now suggest that women not start until age 65, unless they are at extremely high risk. Some osteoporosis researchers have made a case for the quality of bone strength as the more important indicator of a future fracture than bone density. There is no available test for bone strength.

How Good are the Best Drugs?
The bisphosphonates cannot improve bone strength, but they are the only drugs proven to reduce the rate of hip and spinal fractures. Actonel, for example, modestly reduced the fracture rate in a study of 10,000 high-risk elderly women with low bone density or osteoporosis and at least one risk factor for hip fracture, such as an unsteady gait. At three years, there was a 1% lower rate of hip and spinal fractures among the women taking Actonel than those taking the placebo. Interestingly, the three-year fracture rate was low in these supposedly high-risk women, even among those not taking the drug. Overall, the fracture rate was 4% among those taking a placebo versus 3% among those on Actonel (New England Journal of Medicine, 2/1/01).

The fracture prevention value of bisphosphonates in younger women is yet to be demonstrated. In another trial, 1,609 postmenopausal participants, aged 45 to 59 years, were chosen because they did not have osteoporosis. Short-term treatment with Fosamax (5 mg/daily or 2.5 mg/daily) was compared with estrogen plus progestin. The idea was to see whether Fosamax had a sustained effect once the drug was discontinued. The study was paid for in part by a grant from Merck, maker of Fosamax. Some of the women in the Fosamax group took the drug for two years and were than switched to a placebo; others remained on the drug for the four-year duration of the study.

At the end of this study, bone loss had been prevented in those taking Fosamax and in those on estrogen/progestin. Continuous Fosamax treatment, however, was more effective in preventing bone loss than the shorter two-year regimen. The fracture rate is low in this age group, and the study lasted only four years; therefore, this trial could not show that Fosamax reduced fractures (Annals of Internal Medicine, 12/21/99).

What about Diet and Exercise?
Osteoporosis research has clearly shown that increased calcium intake and certain exercises will stop bone loss and/or improve bone density, but few studies have lasted long enough to prove the ultimate goal of fracture reduction. In 2002, the Cochrane Library published an updated review of all studies that assessed the value of exercise in preventing osteoporosis. The reviewers conclusions favored aerobics, weight bearing and resistance exercises as the most effective in increasing bone mineral density of the spine. And walking was effective for the hip. Of the few studies that showed fracture reduction, two found walking to be the best for older men and women. In fact, a moderate amount of walking (2-4 hours a week), and even standing, reduced the hip fracture rate. Interestingly, one study showed that the people who spent more time walking did not have a lower rate of fractures than those did just the 2-4 hours a week.

Where diet is concerned, emphasis has been almost entirely—-and perhaps, inappropriately—-placed on calcium. For over 20 years, women have been advised to increase their daily calcium intake with diet and/or supplements to 1,000 mg daily, and then raise it to 1,500 mg after age 50.

Studies show that calcium supplements will stop bone loss, but they typically did not last long enough to provide information about fractures. As for any fracture-reduction benefit from high dietary calcium intake, the famed Nurses’ Health Study produced some bad news. About 77,000 of the participants were singled out because they did not take calcium supplements. All were between the ages of 30 and 55 years in 1980 when they began filling out extensive questionnaires biannually about their health habits. After 18 years, there was a modest but significantly increased incidence of fracture among the women who reported the highest dietary intake of calcium, primarily from milk and other dairy foods (American Journal of Public Health, 6/97).

To determine whether this study was an aberration, Diane Feskanich, D.Sc., and colleagues at Harvard Medical School, looked at all the trials in which calcium supplementation was compared to a placebo, as well as the longer studies, such as the Nurses’ Health Study, in which women were asked about their diet, calcium supplement usage and other health habits while being followed for many years. The Harvard researchers concluded that the first category of trials, those that lasted only a few years, typically showed that calcium supplements reduced bone loss. But “the longer observational studies did not generally find a lower risk of hip fracture with higher-calcium diets” (American Journal of Clinical Nutrition, 2/03).

In a telephone interview, Dr. Feskanich was asked why women continue to be told to increase their calcium intake. “Calcium’s importance is overrated––we have a strong milk industry [in this country], and the U.S. Department of Agriculture was started with the mission to promote the idea that certain foods, especially dairy foods, must be consumed,” she answered, adding the importance of the Dairy Council, which has had a major influence on doctors as well as the general public. Contradictions abound. “We know from worldwide population studies that the high-calcium intake is associated with high hip fracture rates–Scandinavian countries, for example,” Dr. Feskanich continued, noting that Asian and Mediterranean countries with very low calcium intake have low fracture rates.

Vitamin A
The emphasis on the importance of calcium has led many women to drink low-fat or non-fat milk to prevent osteoporosis, a practice that is counterproductive, according to Dr. Feskanich. Drawing, once again, from 18-year data provided by the Nurses’ Health Study, Dr. Feskanich and her colleagues found that a certain type of vitamin A, is associated with an increase in hip fractures (JAMA, 1/2/02). They identified the fortification of dairy products as the chief culprit. “Because the fat has been removed, the vitamin A has to be put back,” explained Dr. Feskanich, adding that people typically take a one-a-day vitamin supplement and eat a fortified breakfast cereal, and they might eat a power bar–all of which are fortified with vitamin A.

The fortification is usually done with the cheaper form of the vitamin called retinol, the type that is not good for bones in the long term, according to Dr. Feskanich. You can get beta carotene [the other form of vitamin A] from orange and yellow vegetables and fruits, she added, “and you can get plenty without eating animal products or taking a supplement.” Consumption of just one multivitamin often provides an excessive amount of vitamin A if the label says 5,000 IU with retinol as the major source. But some vitamin manufacturers have begun to reduce or eliminate retinol from their products.

To Dr. Feskanich and other nutrition researchers, the current RDA of 5,000 IU daily of vitamin A is too high, a point made in the editorial that accompanied her study. The editorial cites, approvingly, the Institute of Medicine’s new recommendations for vitamin A intake as 800 IU daily for men and 700 IU daily for women.

Vitamin D
At the end of the telephone interview, Dr. Feskanich said, “I can’t say that there is no benefit to calcium, but I think there’s a bigger benefit from vitamin D.” Unfortunately, Dr. Feskanich and colleagues found that only a few studies focused on this vitamin as a way to prevent fractures. One of them, published in 2003 in the British Medical Journal, had over 2,600 participants, aged 65 to 85 years at the onset. All were living in the community (as opposed to a nursing home) and had been randomly assigned to take a placebo or vitamin D.

The study was conducted entirely by mail. The participants were sent one capsule containing 100,000 IU of vitamin D3 (cholecalciferol) or a placebo every four months for five years. The total fracture incidence was reduced by 22%. The research team led by Daksha P. Trivedi cautioned that the fracture incidence was extremely low even in those who had been taking the placebo, possibly due to the fact that most of the participants were men.

This was a small pilot study, and as such cannot be considered the last word on the role of vitamin D and fracture prevention. Dr. Trivedi and colleagues wrote, “The results, nonetheless, indicate that isolated vitamin D supplementation prevents fractures.” In discussing their findings, Dr. Trivedi and colleagues wrote that the every-four-month dose of 100,000 IU averages out to be a daily equivalent of 800 IU of vitamin D. And this might explain why their results were different from those of earlier trials, which used a lower dose (400 IU) and found no fracture-reduction benefit due to vitamin D.

The rapid responses to this article, or letters to the editor, can be read at no charge on the British Medical Journal’s Web site (www.bmj.com, see March 1,2003). Several raised the concern about the potential toxicity of high doses of vitamin D. This was answered by one of the study’s co-authors, Kay Tee Shaw, who wrote that several earlier trials showed that extremely high doses of vitamin D are safe. In one Scandinavian trial, nursing home residents were safely given single-dose injections of 300,000 IU of vitamin D annually for four to five years.

Dr. Feskanich’s response to the same concern was that vitamin D is fat-soluble so people don’t need to take a little bit every day. What’s more, “vitamin D is stored in the liver, and this is good,” she explained, because elderly people don’t metabolize vitamins well as they age, and the body’s capacity to produce vitamin D when exposed to sunlight also declines with age. Her studies found that women typically consume less than the recommended intake of vitamin D. Therefore, they should consider supplement use or dark fish consumption.

Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.
December 2003

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

Two New Books about Hormones

Posted by medconsumers on July 1, 2003

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

When To Start Bone Density Testing

Posted by medconsumers on March 1, 2003

Bone Density Testing: New Recommendations for When to Start

“Bone mineral density testing is a poor predictor of future fractures, but an excellent predictor of start of drug use.”
Barbara Mintzes, University of British Columbia
British Medical Journal, 4/13/02

The selling of bone density tests to younger women took off, not incidentally, once a fracture-prevention drug became available. In 1997, Merck received approval from the U.S. Food and Drug Administration to promote its new osteoporosis drug Fosamax (alendronate) as a preventive. Initially, Merck’s ads directed to physicians featured a fit-looking woman in her early forties, but now older women are portrayed in the ads directed to the public. (“See how beautiful 60 can look, see how invisible osteoporosis can be?….Ask your doctor if a bone density test if right for you.”)

The change might have been initiated by the 1998 guidelines set by the Osteoporosis Foundation and nine other professional organizations that recommend 65 as the age at which to begin routine bone density measurement. The older age makes sense because there is no point in having your bone density tested unless you are willing to go on drug therapy for years once bone loss is detected. Hip fractures related to bone loss are uncommon before the age of 70; they occur on average at age 79. Moreover, drug therapy is best initiated at an older age because the long-term (more than five years) adverse effects of osteoporosis drugs are unknown.

Fosamax belongs to the only drug class (bisphosphonates) proven to reduce hip fractures. And its efficacy is modest. For example, a major clinical trial that compared Fosamax-treated women for three years showed that 1% (11 women) suffered a hip fracture, as compared to 2% (22 women) taking a placebo, or inert pill.

Another reason for delaying the start of bone density testing was provided last year when the U.S. Preventive Services Task Force announced its new recommendations. Current tests for bone density cannot accurately predict far into the future–that is, identify whether a 55-year-old is likely to fracture at age 79. But the 2002 Task Force report did find that bone density measurement could accurately predict the risk for fractures in the short-term. This is a clear refutation of the screening advice women got in the late 1990s when Merck ads aimed at doctors promoted the idea that screening should begin just before menopause.

Canadian Report

Bone density measurement’s poor long-range predictive ability was the central point in a 1998 report from the British Columbia Office of Health Technology Assessment. After a review of the research, the report concluded that a woman could have low bone mass at age 48 and not suffer a hip fracture in old age. Conversely, a woman can have good bone density at age 48 and have a hip fracture at age 79.

The British Columbia report warned, “The greatest concern is that bone density measurement will mislabel most women. More than half of the women who will eventually suffer fractures will be classified as normal.” The U.S. Preventive Services Task Force also concluded that potential harms “may arise from inaccuracies and misinterpretations of bone density tests.” Of the different tests used to measure bone density, the dual-energy X-ray absorptiometry (DXA) was identified as the best at predicting hip fracture.

The Task Force did not find strong or consistent evidence to back up the typical laundry list of risk factors used to encourage women to seek testing. The list includes “white or Asian ethnicity, history of fracture, family history of osteoporotic fracture, history of falls, low levels of physical activity, smoking, excessive alcohol or caffeine use, low calcium or vitamin D intake, and the use of various medications.” Not surprisingly, the strongest risk factor was advanced age and to a lesser degree, a slight build and low body weight (under 150 pounds). Low body weight, however, is enough of a risk factor for the Task Force to recommend that women who fit this description start bone density testing at age 60 years.

Long-term drug therapy is the usual recommendation once severe bone loss has been detected in elderly women and men*. Fosamax and another bisphosphonate called Actonel are the drugs of choice once low bone mass is diagnosed, which is defined as at least 2 standard deviations below the mean for a healthy young woman, or the presence of a fracture.

Estrogen has often been prescribed to women who are diagnosed with osteopenia, which is defined as moderately low bone mass, or one standard deviation below the norm for a healthy young woman. Another drug often prescribed for osteoporosis prevention is Evista. No head-to-head comparison, however, has ever been done with these drugs and the bisphosphonates.

Estrogen clearly preserves bone density, but, unfortunately, the first trial to prove that it could also reduce the rate of hip fractures also showed that the risks far outweighed this benefit. The Women’s Health Initiative trial, which made headlines last summer, found a higher rate of breast cancer, heart attacks, clots, and strokes among women who took estrogen in combination with another hormone progestin. The trial showed no such ill effects for women taking estrogen alone (i.e., those who had had a hysterectomy and did not need progestin); consequently, the Task Force determined that they could delay the start of bone density testing to age 65.

The other osteoporosis drug Evista can increase bone density, but its fracture reduction capabilities are confined to the spine. All trials combined showed that nearly 2% of the Evista-treated women had painful vertebral fractures, as compared with 3% in the placebo group. As noted, only the bisphosphonate drugs have been shown to reduce fractures of the hip which are the most likely to cause disability and death. No osteoporosis drug has been proven to reduce the rate of death.

For More Information

For summary of the scientific evidence from the U.S. Preventive Services Task Force, visit its Web site (www.preventiveservices.ahrq.gov) or call AHRQ Publications Clearinghouse at 1(800) 358-9295.
—
*Men are usually at a more advanced age than women once severe osteoporosis is diagnosed. And many have drug-induced bone loss from the standard drug therapy for prostate cancer. The clinical trials proving that Fosamax can reduce the rate of hip fracture did not have male participants.

Maryann Napoli, Center for Medical Consumers(c)

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

Next Entries »
 
Follow

Get every new post delivered to your Inbox.

Join 49 other followers