Expert resigns over HRT warning
pharmafile | December 8, 2003 | News story | |Â Â Â
New guidance advising doctors not to use hormone replacement therapy to treat osteoporosis has prompted the resignation of a senior MHRA adviser.
The UK Committee on the Safety of Medicines has now adopted new EU-wide guidance which included the recommendation that women over 50 should look for alternative treatment to prevent osteoporosis.
In August, a study of one million women found current and recent use of HRT significantly increases the chance of breast cancer.
The study backed up findings from a similar large-scale US study which was halted early in 2002 when the link between combination HRT and increased risk of breast cancer and coronary heart disease and stroke became clear.
In response to the study, the CSM issued guidance that short-term HRT treatment remained beneficial, but that any women taking treatment for over a year should consult their doctor about the risks. This general guidance has now been taken one step further with three main conclusions:
- The risk-benefit of HRT is favourable for treatment of menopausal symptoms.The minimum effective dose should be used for the shortest duration.
- The risk-benefit of HRT is unfavourable for the prevention of osteoporosis as first-line use.
- In healthy women without symptoms, the risk-benefit of HRT is generally unfavourable.
But Professor David Purdie of the Centre for Metabolic Bone Disease at York Medical School strongly opposed the conclusion on osteoporosis and has resigned in protest.
"I'm afraid I don't agree with it," Professor Purdie told the BBC. "I think that HRT has a major role to play in the prevention of bone loss, and the prevention of osteoporosis, particularly in younger women in their fifties, just after the menopause," he said.
The advice recommends HRT should be used to treat osteoporosis in women aged
over 50 only where other treatments have failed because of the link to breast cancer.
Professor Purdie conceded there was a small association with breast cancer – about two or three cases per thousand but maintained that the "jury was still out" on HRT, with other research producing contradictory results about the likely threat to a woman's health.
He said: "HRT still has a role to play in preventing bone loss and fractures. Women need to be told what the absolute risk is for them, rather than the relative increase in risk for all women."
Fellow committee member Dr Rosemary Leonard said the agency was trying to give general direction to GPs and reminded them that alternative treatments like biphosphonates did not carry the additional risk of cancer.
A Department of Health spokesman confirmed Professor Purdie's resignation saying he should have aired any concerns prior to the publication of the advice.
"All the evidence points to the decision the committee has come to on HRT – there are no plans to withdraw the advice," she said.
The committee says HRT remains an effective treatment for short-term relief of menopausal symptoms and that for younger women, HRT may be used to treat menopausal symptoms and to prevent osteoporosis until the age of 50 years.
An estimated 1.5 million UK women were taking HRT at the start of 2003, but this figure has already dropped off significantly in the past few months in response to the new studies.
Women already using HRT to treat osteoporosis are advised to have their treatment reviewed at their next appointment.
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