Last week, a survey on the attitudes about health and sexuality in women between the ages of 35 and 49 was released by the National Association of Nurse Practitioners in Women’s Health and Teva Women’s Health, Inc.  As you know I’ve written extensively about women’s health after 40, usually with the goal of encouraging women in this age group to redefine their wellness and medical care. Maybe someone was listening!

The survey showed that women in their late 30′s, though their 40′s, reject the idea that they are an age group in “crisis” (a word probably better suited to the economy). They don’t even like the word “midlife”. (It is rather insulting; after all we live longer and feel threatened by a prophecy that implies we’re half way out the door!) Instead, most of the women felt that they were in an age of reinvention or better yet…the age of “it’s time to be a grown up and make healthy choices.” So when I was asked by Teva Women’s Health to review the survey and discuss it via a satellite tour last week, I was delighted. Here are the main points:

The survey included 503 women between the ages of 35 and 49 who were invited through Synovate’s Consumer Opinion Panel to complete a 20 minute online questionnaire. These women matched the US Census data on age, income and region. The study was completed in June 2010.

Two thirds viewed their age as a time of transition and reinvention and 77% felt that the best years were ahead of them!

Four in five women declared they were taking steps to maintain a healthier life style. They were trying to eat right, become more conscious of food ingredients, eat more fruits and vegetables and even increased their intake of supplements. (I would have told them to take calcium, Vitamin D and folic acid…but my advice was not sought prior to the survey.)

Half the women had reduced or stopped alcohol consumption and were sleeping 6 to 8 hours regularly. (They must have become aware of the consequences of sleep deprivation…. hypertension, obesity, diabetes, not to mention auto accidents!)

Thirty six percent had reduced the medications they were taking (including hormonal medications).

Thirty six percent reduced or stopped smoking. (Yeah!)

Now some of the fun stuff…

65% were interested in keeping up a healthy sex life. And one third of sexually active women initiated sex with their partner (this was not a sexually reticent group!)

If indeed they wanted a healthy sex life, the next logical question would be (at least from me)…what did they do for contraception?

While most of the women (75%) had taken birth control pills in the past, just a quarter of women over 35 were still on the Pill. Half the women stated that they were reluctant to take hormonal birth control and 57% felt that “their bodies need a break from hormones” or that they were worried about side effects. All understandable….but of grave concern (at least for me, the gynecologist) was the fact that 24% of these women reported using NO contraception whatsoever! This percentage is truly alarming; unplanned pregnancies occur to over 50% of all women in the US and women in this age group (especially over 40) are second only to teenagers in their incidence of unplanned pregnancies!

This is where non-hormonal contraception comes to fore…Many of the women, especially in this age of “redefinition”  would be ideal candidates for long-term contraception that is both hormone-free and indeed “hands-free” (no pre sex insertion and no daily need to use or take a contraceptive). A non hormonal intrauterine contraceptive (IUC) would be most appropriate. I know the term IUC seems new…but in modern, medical parlance it replaces the old term IUD. Somehow, IUC does sound better, perhaps because decades ago (before you ever contemplated contraception) the infamous Dalkon Shield IUD caused problems. The current non-hormonal IUC is called Para Gard and has been totally redesigned. This type of IUC has been used by over 160 million women worldwide over the last 20 years and studies have shown that it is safe, extraordinarily reliable (with a 99.4% efficacy), inexpensive and once inserted can last for 10 years! (I love these stats!). And if a woman wants to remove it, her fertility returns to what it would have been without contraception… immediately. Over 1/3 of women of reproductive age throughout the world have used it. Somehow the rest of the world seems more IUC wiser than the US.

Bottom line: Based on this survey, and the fact that most women between 35 and 49 plan to maintain their sex lives and their health, I hope that they will now have a “what will help me accomplish this goal” talk with their doctor. Contraceptive planning is certainly part of crisis reduction. It’s clear that women in this age group do not accept the moniker “midlife crisis”. In their more appropriately titled age of “redefinition” women should define and ensure the reliability of their contraception.

I’m sure most of you saw the news reports that came out subsequent to the publication of the ongoing Women’s Health Initiative study (the WHI) that was published in the October 20 issue of JAMA. The “reviews” varied from (and I paraphrase): “this shows that hormone therapy is a disaster” to “maybe hormone therapy should be limited” to “well, this study was a follow-up of women who had taken Prempro and it may not be relevant to other forms of hormone therapy”. I think that the conclusion should be somewhere in between all of these statements.

First, let’s look at the statistics: The original study included 16,608 women who ranged in age between 50 and 79. Unfortunately the age range skewed high; the average age of the women was 63. (Remember that they needed to include women who did not have horrific menopausal symptoms, otherwise if their severe hot flashes, night sweats and sleep disturbances were not relieved by the placebo pills the women as well as their doctors, would know that they were not taking “true” hormones and this would “unblind” the study. So many of the women were 10 or 15 years post- menopausal.)  To continue….basically the study group was given Premarin and a synthetic progestin (Provera) in the form of Prempro and the control women were given a placebo. The study was stopped after a mean of 5.6 years because the researchers found that the women on the hormone therapy did not receive health benefits that exceeded the risks, including the risk of invasive breast cancer.

This new JAMA article reported on the follow-up of most of the original women in the study for a total of 11 years. (Remember, the group of women on Prempro were instructed to stop taking it after 5.6 years.) After obtaining consent from most of the women to continue the follow-up, the researchers looked at whether the cancers the women had at diagnosis were advanced (ie had spread to the lymph nodes) and whether those who had taken Prempro and developed breast cancer were more likely to die of the disease or indeed die from any cause. They found that, indeed, the mortality from breast cancer was higher in the women who had taken Prempro. Here, however is where numbers do matter: The risk of death from breast cancer in women who had taken Prempro, when extrapolated to 10,000 women per year was calculated to be 2.6 (ie 2.6 women out of 10,000 women who took Prempro would ultimately die from their breast cancer.) This was compared to the risk of death from breast cancer in women who did not take Prempro. That number was 1.3 deaths per 10,000. Death after diagnosis with breast cancer from other causes (not from the actual cancer) was also higher in women who took Prempro. This was extrapolated to 5.3 deaths vs 3.4 deaths in women not on this hormone per 10,000 women per year.

Here is the summary in the official response from the American Congress of Obstetricians and Gynecologists (ACOG):  The study reported 25 deaths [0.03% per year] vs 12 deaths [0.01% per year], with a Hazard ratio of 1.96; 95% CI, 1.00-4.04; P=.049). This represents an absolute risk of 2.6 deaths from breast cancer (in the combined hormone group) vs 1.3 deaths (in the placebo group) per 10,000 women per year.

  • There were more deaths from all causes occurring after a breast cancer diagnosis (51 deaths [0.05% per year] vs 31 deaths [0.03% per year]; HR, 1.57; 95% CI, 1.01-2.48; P=.045) in women taking combined estrogen and progestin compared with placebo.  This represents 5.3 vs 3.4 deaths per 10,000 women per year, respectively.

Summary:

  • The recent report from follow-up to the WHI study demonstrates the risk of breast cancer for women taking combined estrogen plus progestin.  There is an increased risk of invasive breast cancer, breast cancers presenting with positive lymph nodes, and breast cancer mortality.  While the absolute risk of breast cancer mortality is small, it is significantly increased for women taking combined estrogen plus daily progestin.
  • A 2004 report published in JAMA on the estrogen-alone component of the WHI found no increase in breast cancer risk among women with hysterectomy over an average of 7 years of randomized treatment.
  • Women considering hormone therapy for relief of menopausal symptoms should continue to be counseled that they should use the lowest effective dose, for the shortest period of time.

Now I just want to add my take…We know that progestins can increase the growth and proliferation of blood vessels (angiogenesis). It’s possible that the women on Prempro (versus those on estrogen only) had small vessel growth in their breast tissue that led to spread of the cancer cells, hence they were more likely to have a somewhat more advanced disease at diagnosis. Moreover, hormone therapy with estrogen and progestin can increase breast tissue density, making it more difficult to detect an early cancer in mammogram….leading to a delay in diagnosis. Finally, it’s possible that this type of estrogen (Premarin) with the addition of this type of synthetic progestin (Provera) together have a greater impact on breast cancer mortality as well as other causes of disease (inflammation, atherosclerosis and coronary heart disease) that are unique. The WHI was not conducted on other forms of estrogen (estradiol) or more natural progesterone… the hormones our ovaries produce during our reproductive years.  When many physicians prescribe hormone therapy, they take this into account and try to limit doses of both as well as considering the type of estrogen and progesterone they prescribe.

In the end the decision to take hormone therapy depends on a woman’s menopausal symptoms. The risk of any medication should always be calculated and weighed against its benefits. There are myriad studies that show that early hormone use in menopause has a positive impact on heart disease and symptom control for the appropriate women. There is no other therapy as effective when it comes to treating severe menopausal symptoms.

The decision to begin hormone therapy has to be made on an individual basis and should be discussed with your physician. (If you are my patient, I hope we have had this discussion.) The absolute risk for breast cancer as a result of hormone therapy remains small but real. I echo the recommendations of ACOG and the FDA. Use the smallest dose for the shortest time to reach your treatment goals.

A few weeks ago, I went for my yearly eye check-up. I was delighted to be told that I showed no signs of age related macular degeneration (AMD). Once reassured about this common cause of age-related blindness, I, of course, wanted to get more information about what I didn’t have. (Call it academic smugness.)  Then, lo and behold (the emphasis being on behold), there was an article in the October issue of JAMA titled “Genetic Research Provides Insights (even they play on words) Into Age-Related Macular Degeneration”.

There are two types of AMD. Eighty-five percent of those who suffer from AMD, have the dry form. It develops  when light-sensitive cells in the area of the retina called the macula slowly break down and cause a gradual blur to vision in the center of the eye. Wet form of AMD occurs more commonly in individuals with advanced disease. The abnormal blood vessels grow under the macula and ultimately leak blood and proteins causing severe vision loss. Unfortunately, dry AMD can progress to the wet form.

The researchers have now found two genetic pathways that are associated with AMD. These are correlated with gene variants in an inflammatory pathway (called the complement pathway) which control response to various triggers (infection or immune) and subsequent inflammation. The other genetic change that can lead to AMD involves genes that control cholesterol metabolism in the eye which, apparently, is different from cholesterol metabolism in the rest of the body. (Having a high blood level of cholesterol is not consistently linked to AMD). In the “faulty cholesterol metabolism in the eye” scenario, local lipoproteins create a substance called drusen, which is composed of proteins, cholesterol and other fats. The drusen is then deposited under the retinal pigment cells in AMD causing the damage associated with AMD.

So what does all this mean? Certainly if you have a family history of AMD, you’re at risk of developing this disease. But since scientists now know more about the genes that make you susceptible, it will soon be possible to target these genetic changes with therapy. Pharmaceutical companies are studying complement-based therapies that basically inhibit certain steps in the inflammatory reactions that occur in the eye. They are also studying the effects of cholesterol-lowering agents that target pathways in the eye.

But the good news is that you don’t have to wait for these discoveries to act on your genetic susceptibility. There are steps that you can take to reduce your risk. Eat foods that are rich in vitamins C, D and E as well as omega-fatty acids, lutein, beta-carotene, xeanthin and zinc that have been shown to lower risk of AMD. Also (and I know I always add this, but it’s true) maintain a healthy weight and don’t smoke. Tobacco smoke has been known to trigger the complement inflammatory pathway… smoke not only gets in your eye …it blinds you!

If you are at risk for AMD or have already developed this disease, ophthalmologists suggest that you take high-dose formulations of antioxidants and zinc. There are specific supplements that have been formulated with these….among them, Preservision and Optivite. Some are also specifically subtitled AREDS (from the Age-Related Eye Disease Study). Current treatments for wet AMD include laser surgery, special photo therapy (called photodynamic therapy) and injections into the eye of agents that target blood vessel formation and growth.

Bottom line…especially if you have trouble reading this as you look straight ahead at your screen…get your eyes checked on a regular basis. Make sure you relay family history of sight problems to your doctor, eat the right foods ( if you look at the vitamins and minerals listed above, these foods should include lots of fruits, vegetables and those eye saving carrots)…and don’t smoke!

The majority of women are at risk for an osteoporotic fracture in their lifetimes. A quick review: We reach “peak” bone density by the age of 30 and from then on, from a bone point of view, it is downhill (or shortening)…We lose 0.5% of our bone mass yearly, and to compound that loss, in the absence of estrogen, we may lose 2% of our bone density yearly in the first 5 to 7 years of menopause. The current national recommendations are that every woman over the age of 65 should undergo a bone density test as part of her standard health screening. But many doctors order bone density screening at a much earlier age, especially if there are reasons to suspect bone loss from previous bouts of amenorrhea, smoking, steroid use, lack of calcium intake, malabsorption, rheumatoid arthritis, and/or menopause. Bone loss is silent; the first wake up call to this loss may be a painful and debilitating fracture.

As a result of this active surveillance, many women are diagnosed with low bone density (osteopenia) in their 40’s and 50’s and a majority of women are told that they have some bone loss in their 60’s. If that loss is more than 25% from the ideal (given as a T score that is less than -2.5 standard deviations from the bone mass of a “perfect” 30 year old), a diagnosis of osteoporosis is made. Both “penia” and “porosis” sound scary (as do many Latin medical suffixes.) In the beginning….well at least more than a decade ago, the prevailing advice was to “work those bones, take that pill and prevent those fractures!” So in addition to calling for weight bearing exercise (which we still do), physicians were prescribing medications called bisphosphonates such as Fosomax to prevent osteopenia from becoming osteoporosis, especially for postmenopausal woman not on estrogen therapy. (Remember, estrogen helps prevent bone loss and fracture). New bisphosphonates soon became available and actively marketed. These included Actonel, and Boniva, as well as various forms of intravenous and intramuscular injections. They all work on the same principal; they decrease the activity of bone eating cells (osteoclasts) which are creating micro cavities and then “allow” the bone filling cells (osteoblasts) to fill these cavities up. These bisphosphonate agents were prescribed to 4.7 million individuals in the US in 2005.

But somewhere in our enthusiasm to prevent a disease that causes severe morbidity (pain, deformation and inability to walk unaided or at all!) as well as mortality (up to 20 % of those who have a hip fracture die within a year of the fracture) several underlying issues may have been overlooked. Bone is a living tissue and is always undergoing remodeling. This consists of bone breakdown by the osteoclasts and build-back by the osteoblasts. So when the former is stopped, the entire remodeling process may be changed and even though the bone may “look better” on bone density scans there is a concern that it may not have the right supportive structure. There are a plethora of studies that show that fracture rates decrease with these medications. So the question is whether the concern about abnormal architecture has clinical implications.

A recent article in the October issue of JAMA looked at this issue. It was titled “Atypical Fractures as a Potential Complication of Long-term Bisphosphonate Therapy”. The atypical fractures the article refers to are those that occur in the long bone of the leg (the femur). They occur with little or no trauma, are often preceded by deep thigh pain and when viewed with x-rays are shown to traverse laterally from one outer surface of the bone to the other. They are indeed scary. The $24,000 question (actually more if one calculates the expense of hospitalization, surgery and the long recovery necessitated for treating this type of fracture) is whether long-term use of the bisphosphonate therapy is responsible for this type of fracture. The answer, at least by the author of the article, is that we are not sure!

What seems certain is that physicians are over-treating women. The current recommendation is to “save” this therapy for the appropriate patient…who should be defined not just by her bone density but by a group of factors that increase her risk. These factors are grouped under the heading of FRAX. This is a World Health Organization multivariate model that uses bone density and risk factors such as age, previous fractures, underlying disease, medication, etc. to calculate the 10-year probability of any major osteoporotic fracture and, specifically, of hip fracture. (You can download this at http:www.sheffield.ac.uk/FRAX/). The guidelines suggest treating any patient who has a 10-year major risk of any osteoporotic fracture that is greater than 20% or a greater than 3% risk of hip fracture.

This means that many of the women we have been treating don’t need bisphosphonates. Indeed when I check my patient’s bone densities and find that the T scores are not in the osteoporotic range or that even when they are low but the FRAX index is not low enough to warrant therapy, I suggest that the patient stop the medication and simply continue sufficient doses of Vitamin D, calcium and weight bearing exercise. I then follow these women with bone densities every 2 years and put the results into the FRAX equation for therapy decisions.

How atypical are these atypical fractures? Well, so far they seem pretty rare. In reports published since 2005 on patients on long term therapy (3 to 10 years), the individual reports include fewer than 20 patients with atypical fractures. These types of fractures have also been seen in patients that were never treated with bisphosphonates. So although the press coverage has, to date, been somewhat hysterical, this is a rare complication.

The recommendation given in the JAMA article is to target bisphosphonate therapy to individuals who are at increased risk of fracture (remember, there is no question that this therapy is successful in reducing fracture risk) and to consider a 12 month interruption in therapy after 5 years in patients who are clinically stable. Stability basically means that the patient has had no more fractures and her bone densities have not continued to be dangerously low subsequent to therapy.

I know this all seems complicated. The issue is not to take a single rare complication and to consider this the reason to stop or avoid appropriate treatment. Concerns as well as indications should always be discussed with your physician.  The stability of our bones cannot be set with cookie cutter therapies.

I know I have written numerous articles in my books and this website about the horrific health consequences of smoking. But I thought I would share with you a recent positive California statistic that puts us way ahead of other states in the US. (We know we are ahead of most of the country when it comes to weather, although last week’s historic heat wave seemed to defy this statement….but now that we are back to more temperate temperatures, we can, perhaps, forget that aberration.)

The Centers for Disease Control just released a report that smoking prevalence in the US has not gone down since 2005. One in five adults in the US still smokes. As a result, 40% of Americans are exposed to second hand smoke and regrettably, 98% of children aged  3 to 11 who live with smoking parents have detectable toxins in their body. (Apparently trying to blow smoke out a window doesn’t work.)

But here is where we give ourselves a pat on the back or better yet, take a deep smoke-free breath. California’s statewide anti smoking campaign has reduced smoking prevalence by 40% between 1998 and 2006. It is now at a national low of 13%. Our state’s lung cancer rate has fallen four times faster than the national average. Apparently we are using our cigarette taxes much more wisely than other states and these taxes are working! So, at least in this regard, I can offer congratulations to those of us who live in California. And let’s hope that the rest of the nation follows our anti-smoking example. Take that (but don’t put it in your pipe) the South, Midwest and East Coast!

I know I have written numerous articles in my books and this website about the horrific health consequences of smoking. But I thought I would share with you a recent positive California statistic that puts us way ahead of other states in the US. (We know we are ahead of most of the country when it comes to weather, although last week’s historic heat wave seemed to defy this statement….but now that we are back to more temperate temperatures, we can, perhaps, forget that aberration.)

The Centers for Disease Control just released a report that smoking prevalence in the US has not gone down since 2005. One in five adults in the US still smokes. As a result, 40% of Americans are exposed to second hand smoke and regrettably, 98% of children aged  3 to 11 who live with smoking parents have detectable toxins in their body. (Apparently trying to blow smoke out a window doesn’t work.)

But here is where we give ourselves a pat on the back or better yet, take a deep smoke-free breath. California’s statewide anti smoking campaign has reduced smoking prevalence by 40% between 1998 and 2006. It is now at a national low of 13%. Our state’s lung cancer rate has fallen four times faster than the national average. Apparently we are using our cigarette taxes much more wisely than other states and these taxes are working! So, at least in this regard, I can offer congratulations to those of us who live in California. And let’s hope that the rest of the nation follows our anti-smoking example. Take that (but don’t put it in your pipe) the South, Midwest and East Coast!

Do Mammograms Make a Difference?

I routinely ask my patients who are over the age of 40 “when was your last mammogram?” If the answer is “at least a year ago”, I fill out a referral form for a radiography facility in the LA area. I have always been personally sensitive to our “need” for yearly mammograms. My mother was diagnosed with early breast cancer through a mammogram done 40 years ago at a time when screening was not routine. (I come from a long line of health concerned individuals; my father requested or actually demanded every available diagnostic test for members of his family, and this included a mammogram for my mother)…. She was 46 years old. I too had precancerous breast changes (but thankfully not cancer) diagnosed by mammogram over a decade ago, and this allowed me to make decisions that I feel prevented my ultimately receiving a cancer diagnosis.

Over the years, I have had to tell many women that their mammogram was abnormal and that further investigation was necessary. Some did indeed have breast cancer and I then referred them for the definitive surgery, radiation or chemotherapy that probably saved their lives. Others were followed with additional tests and even biopsies that were (thankfully) negative. There were certainly instances in which a screening mammogram was fine but my patient or I found a lump and follow-up ultrasound and/or MRI and biopsy showed a “missed” breast cancer.

But getting that yearly mammogram has been instilled in our women’s health psyche for the last 3 decades. Most randomized trials that have been published in the US (the latest being the US Preventive Services task Force) have shown that routine mammogram screening reduces mortality by15 to 23%. So it was with great interest and yes, concern, that I read the widely reported article in the September 23 New England Journal of Medicine which was titled “Effect of Mammography Screening on Breast – Cancer Mortality in Norway”. The study was conducted through the cancer registry of Norway. Since the entire country’s population is only 4.8 million and the health care is national, statistics from Norway are easily compiled and felt to be highly reliable.

The Norwegian breast-cancer screening program was initiated in 1996 and expanded county by county over the next 9 years. Before women were invited to enroll in the program, each county was required to establish a multidisciplinary breast cancer management team consisting of radiologists, radiologic technicians (who performed the mammograms), pathologists (to review the biopsies), surgeons, oncologists and nurses who helped manage the care of all the patients. All women between the ages of 50 and 69 years were offered screening mammography every 2 years and 77% of them did so. The statisticians then compared the death rates (from breast cancer only) in 4 groups: two groups of women who from 1996 through 2005 were either living in counties with screening (the screening group) or without screening (the non-screening group) and two “past-comparison” groups from 1986 through 1995 who were similar in age, place and general background as the women in the first two “current” groups.  A total of 40,075 women in these 4 groups had breast cancer.

There was a 10% reduction in breast-cancer mortality in the screened group of women after a maximum follow up of 8.9 years. But here is the crux of the article….when they calculated mortality rates of the women who were not screened but who had the multidisciplinary care that had been instituted and compared them to the women who did not have this care available (between 1986 and 1995) the mortality rates were improved by 8%. Adding screening mammograms improved mortality rates by only 2%!  In other words, they found that only about one third of the reduction in mortality could be attributed to breast-cancer screening with mammograms every other year. The authors ended their discussion with the statement…”the apparent benefit conveyed by optimized patient care may be missed unless breast-cancer screening is integrated into a well-functioning health care system that is available to the entire population.” My take from this study: We can’t simply rely on mammograms to prevent breast cancer deaths in women…. we need the right health care system (universal payment and availability of the appropriate experts) to improve our survival.

For now, I will continue to recommend mammograms, knowing that I can guide my patients through the care that optimizes their survival. Hopefully in the future, the multidisciplinary care that was used in the Norwegian study will be available to all women in the US.

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