HC Deb 07 November 2002 vol 392 cc510-1W
Lynne Jones

To ask the Secretary of State for Health what assessment he has made of the effect of taking HRT long term on(a) the incidence of (i) breast cancer and (ii) osteoporosis and (b) the quality of life of women. [78570]

Ms Blears

The Committee on Safety of Medicines (CSM) and its Expert Working Group on Hormone Replacement Therapy (HRT) have reviewed the long-term safety of HRT as new information has become available. In 2001, the United Kingdom was actively involved in a European-wide review of all available evidence relating to HRT use in order to provide consistent core product information throughout Europe. Following the publication of further studies relating to the long-term effects of HRT earlier this year, the CSM re-convened its Expert Working Group (EWG) on HRT to examine in detail all the latest evidence. In light of the findings of its EWG, CSM has made further recommendations for product information to ensure that the advice for women and doctors accurately reflects current knowledge.

A very small increase in the risk of developing breast cancer in women on long-term HRT was first recognised in 1997. Women and health professionals were warned of this risk through an article in the drug safety bulletin "Current Problems in Pharmacovigilance" and product information was updated. Among women aged 50 who do not use HRT, approximately 45 in every 1000 will develop breast cancer by the age of 70. Recently published studies have confirmed that this number will increase to about 47 per 1000 women who take HRT for 5 years, about 51 per 1000 women who take HRT for 10 years, and about 57 per 1000 women who take HRT for 15 years.

In the UK, HRT products are indicated for the treatment of menopausal symptoms, and some products are also licensed for the prevention of osteoporosis. Data relating to the effectiveness of HRT in preventing bone fractures were reviewed by CSM at the time of licensing and were judged to support "the prevention of osteoporosis" as an indication for HRT. Further evidence was provided in studies published earlier this year for a significant reduction in the number of hip fractures with long-term HRT use.

A recent trial in women with pre-existing heart disease examined cardiovascular effects of long-term HRT and also considered "quality of life" indicators. Although the findings of this trial were mixed, the women suffering from post-menopausal symptoms experienced an overall improvement in "quality of life". Based on all currently available evidence, the benefits of short-term use of HRT for the relief of menopausal symptoms are judged to outweigh the risks. The decision to use HRT should be discussed by a woman with her doctor on an individual basis and the risks and benefits regularly reappraised with continued HRT use.