Before we look at an update on hormone replacement therapy (HRT), let’s look at the facts about menopause. Generally, 51 is the average age for menopause to kick in. However, it does affect one in 100 women under the age of 40. It occurs when a woman’s endocrine system (principally the ovaries) begin to produce less oestrogen, progesterone and testosterone.
Eighty per cent of women experiencing menopause suffer from the various symptoms associated with it. Four years is the typical duration of menopause, which technically begins when there is no menstruation for 12 months. However, 10 per cent of women suffer symptoms for up to 12 years, the most common being hot flushes and night sweats.
There is much confusion about the use of HRT. For more than 50 years women have been taking a synthetic hormone to replace oestrogen and ease them through the menopause. However, in 2002, a major study – the Women’s Health Initiative – announced that HRT increased the risk of cancer. At the end of 2015, another study claimed that the dangers have been overstated and that women should consider using HRT again.
The UK’s National Institute for Health and Care Excellence says that the latest evidence puts HRT back on the table; suddenly it is a therapy women can start considering with their doctors once again.
The question is: why has the advice been so conflicting? It’s mainly because the manufacturers of HRT have deliberately created false trails and red herrings for the past 60 years. We need to look at the history and the money trail to understand it. The first brand of HRT was Premarin, made up of conjugated equine oestrogen, or horse urine, in more simple terms. This was approved in 1942. However, as early as the 1950s, doctors were seeing an increase in uterine cancer cases in women taking the hormone. Wyeth, the manufacturer, quietly introduced a new treatment, Prempro, which added progesterone (or its synthetic form progestin) – another hormone – to the oestrogen. This was approved in 1994.
The new therapy was marketed with the message that it kept women youthful, sexy and helped to build strong bones, thereby countering brittle bones and osteoporosis, other symptoms associated with the loss of hormones following menopause.
Using oestrogen/progesterone HRT doubled the chances of breast cancer
American doctors even faced malpractice claims if they didn’t prescribe it and conservative British doctors were encouraged to write out more prescriptions for it. Wyeth advised them to search through their patient records to identify all the women aged over 45 who could be offered HRT. At its peak, in the US alone, doctors were writing 126 million prescriptions for HRT every year. This generated sales of $3 billion for Wyeth, the main manufacturer of the therapy.
However, in 1997, researchers discovered that HRT increased the risk of breast cancer by 2.3 per cent for every year it was used; on average women were taking it for 11 years. The risk persisted for five years after halting the treatment (Lancet, 1997). Other studies found that HRT quadrupled the risk of breast cancer (N. Eng. J. Med., 1989). Wyeth and other manufacturers countered that the researchers were looking at the wrong type of HRT. Instead of oestrogen-only remedies, they should be exploring oestrogen/progesterone combinations which, they said, were safer. A US Congress hearing in 2008 discovered that Wyeth and other HRT manufacturers were using PR companies to write articles to submit to journals that leading academics were paid to put their names to.
The WHI trial was a game changer. Its discoveries were so alarming that researchers stopped the study prematurely, as they feared they were jeopardising the lives of the participants. It was designed to be a 15-year survey of HRT starting in 1991, but 10 years into the study, the researchers discovered that oestrogen/progesterone HRT increased the chances of a heart attack by 29 per cent, stroke by 41 per cent and breast cancer by 26 per cent, among the 161,000 post-menopausal participants.
Sales of HRT dropped precipitously. By 2003, Wyeth’s annual revenues from HRT had fallen from £2 billion to £880 million, sending its PR machine into overdrive, in an effort to convince doctors of the safety of HRT. It wasn’t only the WHI study that offered the alarming findings. The Oxford-based Radcliffe Infirmary’s Million Women Study was coming up with similarly disturbing findings.
This study recruited more than one million women aged 50 years or older. The primary remit was to explore the safety of HRT, which was being used by half of the participants. Its first report concluded that using oestrogen/progesterone HRT doubled the chances of breast cancer. Other findings related to endometrial cancer; oestrogen increased the risk, but oestrogen/progesterone had a protective effect. It was decided that the risk of developing breast cancer was too great to offset any protective effects of endometrial cancer.
Next week we will look further at studies and also at the alternatives to HRT.
kathryn@maltanet.net