Elderly women: Neglected But Fast-Growing Demographic

Elderly women account for a large part of the world’s population. The number of females aged 60 and over is on course to cross one billion in 2050. This would correspond to a tripling of the level from 335 million in 2000. Older women out-number older men, and this imbalance rises with age. Indeed,  the fastest growing sub-group among ageing women consists of those over 80. Globally, there are about 125 women for every 100 men in the over-60 age group. Among the over-80s, the gap is much higher, at 190 women for 100 men.

Longer but not necessarily healthier lives
The increase in number of elderly women has been accompanied by the growth of their very specific health needs. Although women in Europe outlive men by six years, the difference in healthy life expectancy is only nine months. In effect, their extra years are severely burdened by disease and ill health.
In spite of such facts, there is a remarkable lack of data specifically focused on the health of elderly women. For instance, figures from the European statistical service, Eurostat, show standardized death rates per 100,000 inhabitants for all women, and for women under-65. Although it would be possible to determine the figure for women greater than 65 years in age, it is remarkable that this is not provided on the Eurostat site.

Data limitations
In 2005, a group called Older Women Network Europe (OWN-Europe) observed that though there was an abundance of studies on ageing, there was little gender analysis of potentially major differences in health on ageing women versus ageing men.
Ironically enough, OWN-Europe’s own website (www.own-europe.org) has been taken over by an entity dedicated to promoting anti-cellulitis stockings in the Japanese language. The organisation itself has been subsumed into AGE Platform Europe, which is a forum promoting awareness about issues affecting the aged in general, rather than differences in issues and concerns between elderly women and elderly men. As noted, this was OWN-Europe’s critique to begin with.
Another organisation, Dublin-based European Institute of Women’s Health (EIWH) has since sought to fill this gap. Though also concerned with general women’s health issues, it has an elderly-focused approach on key topics of interest – for example, providing data-based position papers on specific risks to elderly women, as compared both to men and younger women, in areas such as dementia, breast cancer, cardiovascular disease etc.

Age-related risks for women
Differences in Eurostat cause-of-death rates for women under 65 years in age versus all women yield some interesting conclusions.
Diseases of the cardiovascular system (circulatory disease and heart disease) account for the largest share of deaths in elderly women in Europe, well ahead of cancer. Lung cancer results in about
65 percent higher deaths than breast cancer, with colorectal cancer only slightly behind.
There is a steep rise in the age-related risk of dying from cardiovascular disease (CVD). This is outweighed slightly by the much smaller rate of death from respiratory disease. The age-related risk increase is also marked in dying from diseases of the nervous system.  Once again, the risk of older women dying from lung cancer as compared to younger women is significantly higher than breast cancer, while the age-related growth in risk is also high for colorectal cancer.

Lack of attention: The CVD example
Attention to specific age-related health issues in women has been inadequate.
For example, though it has been long known that CVD is a significant cause of female death, women present different symptoms than men. For example, a heart attack in a woman is often confused with indigestion—not pain in the chest. Women are also less likely to seek or to be provided with medical help and to be properly diagnosed until late in the disease process. Such factors are believed to explain why women are less likely to survive a heart attack, particularly when treated by a male doctor.

Other scourges
On the other side of the spectrum are conditions such as osteoporosis and osteoarthritis, which do not result in death, but lead to chronic pain and limit quality of life. They do not get adequate attention, since they are seen as an inevitable part of ageing – or as less serious conditions than heart disease or cancer. Both osteoporosis and osteoarthritis have a high propensity for women.

Osteoporosis: early start for women
Osteoporosis, for example, is four times more common in women aged over 50 than in men. One of the reasons is that women have a lower peak bone mass and show a younger onset of bone loss compared with men – on average, by 10 years.
For women, rapid declines in bone mass occur in the 65-69 age group as opposed to 74-79 for men. A second factor playing a role here are the hormonal changes which occur at menopause; these can alter calcium composition in a woman’s body.
Meanwhile, initiatives like hormone replacement therapy (HRT), once widely used in the wealthier countries, have become mired in controversy. Recent studies suggest that rather than prevent heart disease after menopause as was originally believed, HRT is associated with an increased risk of stroke and heart disease among some ageing women.

Osteoarthritis in one of 5 elderly women, twice rate in men

Osteoarthritis too shows the above patterns. This degenerative joint disease is associated with ageing and principally affects the articular cartilage. It impacts on joints which have been stressed over the years – such as the fingers, the knees, hips, and the lower spine region. 80% of osteoarthritis patients have limitations in movement, and 25% cannot perform their major daily activities of life.
Globally, an estimated 18 percent of women aged over 60 years have symptomatic osteoarthritis, which is almost twice a rate of 9.6 percent reported in men. Moreover, the incidence of osteoarthritis in the 60-90 age group rises 20-fold in women as compared to 10-fold in men.

Osteoarthritis and CVD
Osteoarthritis, in particular, has serious implications for another major problem, namely CVD. Meanwhile, some studies have demonstrated a high prevalence of CVD in osteoarthritis patients. One found that 54% of people with knee and hip osteoarthritis had co-existing CVD.

Need for more research on women
The above observations underwrite a need for research on diseases and health conditions of concern to women in general, and elderly women in particular.
Although CVD is one of the best known examples of differences between the sexes in symptomatic and other responses to disease, there are other cases. For instance, among men and women smoking the same number of cigarettes, women are 20 to 70 percent more likely to develop lung cancer.
One of the first areas of attention is to increase the number of clinical trials dedicated to such issues and encourage the participation of women in trials.

After thalidomide, women discouraged in clinical trials

Low female representation in clinical trials became a structural problem after the US Food and Drug Administration (FDA) issued a guideline in 1977 banning most women of ‘childbearing potential’ from participating in clinical research studies. This was the result of drugs like thalidomide, which caused severe birth defects.
Nevertheless, few denied, even then, that new drugs were metabolized differently by men and women due to factors such as body size, fat distribution and the hormonal environment.
It soon also became apparent that even new life-saving drugs might not work as well in women as they did in men. Worse still was one study in 2001, which reported that female patients have a 1.5 to 1.7-fold greater risk of developing adverse drug reactions than men, due to gender-related differences in pharmacokinetics as well as immunological and hormonal factors.
In the three years 1997-2000, eight of the 10 drugs for which the FDA withdrew approval had harmful side effects for women.

US changes approach, but gap still large

In the late 1980s, the FDA issued new guidelines to encourage inclusion of more women in studies and in 1993, formally rescinded its policy discouraging women from participating in studies.
Additional studies between 2011 and 2013 evaluated the inclusion and analysis of women in federally-funded randomized clinical trials. The researchers found that most such US studies, which were not sex-specific, had an average enrolment of 37% women. However, almost two out of three studies did not specify their results by sex and did not explain why the influence of sex in their findings was ignored.

The European case
The situation is similar in Europe. For instance, in spite of the role of CVD in female mortality, a EuroHeart report found that women comprised only a third of CVD trial participants, while one of two studies did not report the results by gender. Until the 1990s, clinical research in Europe followed the US lead and focused mainly on men. As the US began to shift stance towards encouraging women in trials, Europe followed suit, using the Inter-national Conference on Harmonisation (ICH) as a vehicle. ICH guidelines require Phase I response data be obtained for relevant sub-populations “according to gender.” However, many of the require-ments offer opt-outs with wording like “if the size of the study permits,” or recommend that demographic subgroups be “examined.”

New Regulation on Clinical Trials

EU rules on clinical trials are due to be overhauled after a new Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises clinical trial assessment and supervision via a Clinical Trials Information System (CTIS), which will be maintained by the European Medicines Agency (EMA).
The Regulation was adopted in 2014, but will enter into force after the CTIS is certified through an independent audit. This is still ongoing.
The new Regulation recommends that “gender and age groups” which would use a medicinal product should participate in its clinical trials. However, it still leaves an opt-out if exclusion is “otherwise justified in the protocol”, although “non-inclusion has to be justified”.
In other words, the jury is still out.