Thanks to Butterworths.co.uk
Doctors' dilemma over HRT treatment
The Committee on Safety of Medicines recently issued a guidance putting the
onus on doctors on how and when to treat women with HRT after serious health
risks were reported to be associated with the treatment. Paul McNeil, a clinical
negligence partner with Field Fisher Waterhouse talks to Veronica Cowan about
doctors' duties in these cases...
The health pages of the press,
and research papers published in medical journals often feature the latest
thinking on the use of hormone replacement therapy (HRT), and put a gloss on
what has gone before. So are busy doctors, awash in a sea of paper, obliged to
trawl their list of patients on HRT, and call women in to discuss the latest
quantification of the risk? "Of course doctors should keep up to date, but
it really depends on what the risk is", comments Paul McNeil, a clinical
negligence partner with Field Fisher Waterhouse, and editor and contributor to
The Medical Accidents Handbook.
He says: "A line has to be drawn between what is a fad and what is a
serious concern. Doctors are inundated with research findings, and it can be a
difficult judgment for them to make. He adds: "One cannot expect general
practitioners to act on everything that appears in the Lancet or the British
Medical Journal". He made the point that if doctors were appraised of a
serious health risk by the Government, and did nothing that would be potentially
negligent: "They would be expected to act on guidance about drugs, such as
HRT, issued by the Department of Health."
This kind of advice is given by the Medicines and Healthcare Products Regulatory
Agency, formed from a merger of the Medicines Control Agency and the Medical
Devices Agency on 1 April 2003. It is the Executive Agency of the Department of
Health protecting and promoting public health and patient safety by ensuring
that medicines, healthcare products and medical equipment meet appropriate
standards of safety, quality, performance and effectiveness, and are used
safely. The Committee on Safety of Medicines (CSM) provides the Agency with
information to ensure medicines meet the standards of quality, efficacy and
safety the public and health professions would expect. Last year, it sent GPs
and other health professionals guidance on the risks, following the announcement
that an American study on HRT had been halted prematurely.
More recently, it issued guidance to doctors and women. after a large research
project, the "Million Women Study", provided important new information
on the risk of breast cancer in association with using HRT, which confirmed
oestrogen-only products were associated with a small increase, while with
combined oestrogen-progestagen HRT, the increase was substantially higher. With
each product, the risk increased the longer it was taken and started to become
apparent within 1-2 years of initiating treatment.
The CSM advised that for short-term use of HRT for the relief of menopausal
symptoms, the benefits outweighed the risks for many women. But it specifically
advised that each decision to start HRT should be made on an individual basis,
and that treatment should be regularly reappraised, at least once a year, which
seems to put the onus on doctors to call patients in. "This kind of advice
is influential, and doctors would be expected to act on it", observes
McNeil. He adds: "If a claimant came to me and said there was an article in
the BMJ about the risks of HRT, I would wonder how far that took us, given the
amount of research there is, of varying quality, and different views emanating
from various academics. But where statements are issued by governmental and
other respected bodies that makes a difference. The bottom line is, what would a
reasonable doctor do in these circumstances?"
The CSM states: "'We realise that these findings may present women and
their doctors with a dilemma about long-term HRT treatment. However, what this
study clearly shows is that, in all cases, the additional risk of breast cancer
begins to decline when HRT is stopped and by five years reaches the same level
as in women who have never taken HRT". It added: "Women who are
concerned by these new findings should make a routine appointment to discuss
these matters with their doctor.' But can there ever be a duty on patients to
alert their doctors? McNeil replies: "In a situation, such as with cervical
smears, if they know they are in the group where the system got it wrong, it is
possible there could be a duty. But with HRT, it might be different".
(10/11/03)