Women have been oversold HRT for decades

On my desk I keep a copy of Feminine
Forever, a book promoting hormone
replacement therapy (HRT), published in
1966, by Robert A Wilson. On the front, it
proclaims that it is “a fully documented
discussion of one of medicine’s most
revolutionary breakthroughs – the
discovery that the menopause is a hormone
deficiency disease, curable and totally
preventable and that every woman, no
matter what her age, can safely live a fully
sexed life for her entire life”.
I keep this book to remind me of a few
things. One, that it is possible to be very,
dramatically wrong in medicine –
especially when you are very sure of
yourself. Two, that when you make big
promises, you should have robust,
unbiased and powerful data to support
them. Three, that when medicine tries to
suggest that a new large section of the
population – on this occasion, that all
women over menopausal age – are
“diseased”, one had better look to see who
is behind that claim, and why. And last,
hype around new medical products are,
sadly, nothing new.
As a junior doctor more than two decades
ago, I attended meetings (which had
sandwiches, pens and soft drinks supplied
by drug companies, I am sorry to say)
where HRT was promoted as not just the
dream solution to all menopausal
symptoms – but the way to prevent
cardiovascular disease, dementia, stress
incontinence, hair loss, the need for
dentures, and osteoporosis. There were
even claims made that it could prevent
depression and supposedly restore a sex
life back to ecstatic peaks. Wilson
suggested that women should start
hormone replacement in their mid-30s,
claimed that “the myth that oestrogen is a
causative factor in cancer has been proven
to be entirely false” and that it would
generate “youthful appearance and
vigorous energy”, else poor ladies would
simply “crumble in ruin”. It took until 2002
for it to emerge that Wilson was being
funded by Wyeth, a major manufacturer of
HRT – a fact not disclosed in the book.
HRT is still widely recommended for
treatment of menopausal symptoms –
particularly hot flushes and night sweats –
but with the mantra of “informed choice”.
Properly informed choice needs accurate
information . The initial promises made
that HRT could reduce future
cardiovascular disease were based on
observational studies. Observational
studies, though, are highly prone to bias,
wrong conclusions, and thus bad
information. High-quality, reliable,
clinical data is best generated by double-
blind, randomised controlled trials that
compare groups, with the only difference
being the drug under test, and careful
attention to monitoring benefits and
harms. One such trial, the Hers study,
published in 1998, found that recurrent
cardiovascular disease wasn’t prevented
by HRT. Then – to shock, surprise and
dismay – the Women’s Health Initiative
Study, published in 2002, found that the
risk of cardiovascular disease was in fact
increased with HRT, not decreased. For
10,000 people-years of taking HRT, there
were 15 more heart attacks or strokes, eight
more pulmonary emboli – blood clots to
the lungs – and eight more breast cancers.
Last week, an analysis published in the
Lancet found that for every 1,000 women
using HRT for five years, there is one extra
case of ovarian cancer – a slightly higher
risk than seen in previous studies.
This pattern in medicine is recurrent and
depressing: low-quality studies are used to
drive the creation of a new diagnostic label
– according to Feminine Forever that’s all
women over the age of 30 who didn’t want
to “crumble”. Then, having told millions of
people that they are diseased, a treatment
is offered – even if inadequately studied,
especially in the long-term, and without
powerful enough studies capable of
finding unanticipated harms. This is
followed by widespread use of said newly
popular product, often driven by
overblown pharmaceutical or media hype.
It is only much later that high-enough-
quality studies are done which call into
question the original hypothesis – and
which find out that the premise was either
false, or actively harmful.
This week another study was also
published which found that, of women
who have frequent hot flushes and sweats
due to the menopause, the average
duration of symptoms was just over seven
years. It seems that the length of time that
symptoms go on for has been
underestimated by doctors (but not
women, if anyone had listened) – thanks to
a historical lack of quality studies on such
basic knowledge. And isn’t it the basics
that we need to get right first, so that we
can advise women properly?
In the past few years there has been a
widening of non-hormonal treatments for
menopausal symptoms – including the SSRI
group of antidepressants, which provide
modest improvement only, and with the
typical antidepressant side-effects.
But here’s the thing. There is increasing
evidence that group and guided cognitive
behavioural therapy – both for women who
have had a menopause due to breast
cancer treatment, and women who had
typically problematic hot flushes and night
sweats – improves mood and quality of life,
and decreases the frequency of night
sweats. So it’s not just drugs that can work
– women can be helped to control their
own symptoms. But there is no big
publicity campaign for CBT.
Clearly the menopause is disabling for
some women, and inconvenient or
minimally disruptive for others. We need
high-quality information about our
choices, and honesty about what we don’t
know and aren’t sure of. The menopause
has been made a disease and opened a
marketing opportunity, and the resulting
misinformation has served us all badly.