- "Results of the largest study... calculated that
HRT had caused 20,000 cases of breast cancer over the past decade in Britain."
-
- The dangers of hormone replacement therapy (HRT), the
treatment for the menopause, have been likened to those caused by thalidomide
40 years ago by the head of a European drug regulatory agency.
-
- Professor Bruno Muller-Oerlinghausen, chairman of the
German Commission on the Safety of Medicines, described HRT as a "national
and international tragedy" after evidence emerged that it had caused
thousands of deaths.
-
- Comparing it to thalidomide, the drug prescribed for
morning sickness that caused hundreds of babies to be born with birth defects
in the late 1950s and early 1960s, he said: "There is similarity.
We are talking about a therapy for women that is used to treat disturbances
in well being. And we are talking about ... a naÔve and careless
use of a medication that is perceived as natural and optimal and more or
less harmless."
-
- He added: "More women have probably died from the
... hormone therapy than damaged children were born in the wake of the
thalidomide scandal." A series of studies over the past two years
has shown that HRT, which is taken by an estimated 1.5 million women in
Britain, doubles the risks of breast cancer and increases the risk of blood
clots, strokes and heart attacks. Results of the largest study, published
in The Lancet in August, calculated that HRT had caused 20,000 cases of
breast cancer over the past decade in Britain.
-
- Called the "million women" study, it studied
more than one million women aged 50-64 from 1996 to 2001. It was conducted
by the Medical Research Council and Cancer Research UK.
-
- When the findings were released, regulatory agencies
in Europe moved quickly to revise their advice on HRT. The European Medicines
Evaluation Agency launched a review of the treatment after requests from
France, Belgium and the Netherlands. It is due to report by the end of
the year. If the agency decides that HRT presents a "public health
risk" it can recommend a formal investigation. The agency can also
place restrictions on the use of drugs throughout the EU and in extreme
cases remove them from the shelves.
-
- A spokesman said: "We felt this was something we
could not ignore even though no one has formally referred it to us."
-
- In Germany, the country's Commission on Safety of Medicines
said in its first guidelines to doctors that the international evidence
now clearly showed that the risks of HRT outweighed the benefits. It said
that doctors should restrict the treatment to women with particularly severe
symptoms and prescribe it in the lowest doses for as short a time as possible.
-
- The German commission also attacked the pharmaceutical
industry, suggesting it had turned "a natural phase of life"
into a hormonal sickness that needed treatment.
-
- An estimated 43 per cent of women aged 50-70 in Germany
took HRT before the latest scare but prescriptions have fallen sharply
since, according to a report in the British Medical Journal. In the UK,
the average length of use of HRT is between two and three years. But some
women have taken it for as long as 10 years after its youth-restoring properties
were extolled by celebrities including the Tory MP Teresa Gorman and the
broadcaster Dr Miriam Stoppard. Specialists have defended it for its role
in preventing osteoporosis.
-
- Professor Gordon Duff, chairman of the UK Committee on
Safety of Medicines (CSM), rejected the comparison with thalidomide yesterday.
He said of his German counterpart: "He is obviously expressing a strongly
held personal view. I would say that does not reflect the majority medical
opinion in Europe."
-
- Last month, the CSM in Britain began monitoring the evidence
on HRT in response to the million-women study. It said doctors should make
a judgement for each patient and ensure that women were fully informed.
-
- Professor Duff said: "There are benefits [from HRT]
in preventing osteoporosis and possible benefits in reducing other cancers,
in particular colon cancer, but they are not fully evaluated yet.
-
- "That is why at the moment it is still a clinical
judgement by the prescriber in conjunction with a fully informed patient."
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- © 2003 Independent Digital (UK) Ltd
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- http://news.independent.co.uk/uk/health/story.jsp?story=449861
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