To ask the Scottish Executive what research is being undertaken to establish whether women are at risk from synthetic progestins; what guidance is being issued by the Chief Medical Officer to medical practitioners about using products containing such progestins, and what public information is being made available in order to enable members of the public to make informed choices about pharmaceutical products containing synthetic progestins.
The safety of medicines is reserved and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has advised that research into the risks associated with synthetic progestins is conducted in the UK and worldwide on a continuous basis by a variety of research bodies, including pharmaceutical companies, hospitals, universities and other independent researchers.The National Research Register (NRR), a UK wide database of all publicly funded research of relevance to the NHS, records that there are currently seven projects on-going in the UK on the effects of synthetic progestins.Details of these projects are available from the NRR, a copy of which is in the Parliament's Reference Centre (Bib. number 17404).In the UK, a study (The Million Women Study) involving around one million UK women aged 50 and over is on-going and aims to answer many outstanding questions about the factors affecting womens' health in this age group. In particular, the study is looking at how hormone replacement therapy (HRT) affects a woman's health. This study was set up in 1996 by Cancer Research UK, the National Health Service Breast Screening Programme and the Medical Research Council. Over one in four women in the UK in the target age group are now participating in the study which means that the Million Women Study is the largest study of its kind in the world.In 2001, a European-wide review of all the available evidence regarding HRT use was initiated in order to produce consistent information for health professionals and women throughout Europe. The UK has had significant involvement in these discussions and has provided advice from the Committee on Safety of Medicines (CSM) Expert Working Group (EWG) on HRT. In July 2002, the combined (oestrogen and progestogen) HRT arm of the Women's Health Initiative (WHI) trial, a study that was set up to investigate the long-term effects of HRT in healthy post-menopausal women in the USA, was prematurely stopped because a pre-defined threshold of harm was reached. In the UK, the WISDOM trial, which was similarly designed to assess the balance of risks and benefits of long term HRT, was subsequently stopped as it was considered unlikely to provide substantial evidence to influence clinical practice in the next ten years. When the findings of the WHI trial were published, they were immediately considered by the CSM. Preliminary urgent advice was issued to all UK health professionals later that same day, together with a fact-sheet to help advise women who may have been concerned about the implications of these findings.The EWG on HRT has met three times since July 2002 to examine in detail these trial findings together with other recent data on the long-term risks associated with HRT and their implications for the safety of HRT in the UK. Their conclusion was that these data confirm what is already known about the small increase in risk of breast cancer and venous thromboembolism (VTE) and the lack of protection from coronary heart disease. Importantly, they also confirm protection against hip fracture and reduced incidence of colorectal cancer but provide new evidence for a small increase in the risk of stroke and ovarian cancer.In light of these data, the CSM advises that the benefits of taking HRT in the short-term outweigh the risks for the majority of women who use it. However, the risks of HRT increase with long-term use and so treatment should only continue as long as the benefit in alleviating symptoms continue to outweigh the possible risk. For women with osteoporosis, the risks and benefits of HRT should be considered alongside those of alternative treatment options and each patient's treatment should be reviewed at least yearly.The CSM advises that HRT continues to have a useful role in alleviating menopausal symptoms and helping prevent osteoporosis. However, in an effort to maximise the safe and judicious use of HRT, women are encouraged to make the decision to take HRT jointly with their doctor, taking into consideration her personal and family history, their general health, concomitant medication and personal preferences and, importantly, to review the need for continuing therapy at least annually.The new advice has recently been published in the MHRA's safety bulletin, "Current Problems in Pharmacovigilance", which is distributed to all GPs, pharmacists, dentists and coroners in the UK. This information, together with an article specifically for women, has been posted on the MHRA/CSM website (
www.mhra.gov.uk).These important messages have also been included in the British National Formulary (BNF) and are being added to the information for prescribers and the patient information leaflet that should be included with each pack of HRT.