Growth in sales of custom-compounded menopause hormones

Abstract

In 2002, the Women’s Health Initiative (WHI), a randomised control trial that studied oestrogen plus progestin in healthy postmenopausal women in the USA, linked the use of combined hormone therapy to high rates of heart disease, dementia, stroke, and some forms of cancer. The results sent shockwaves through the medical profession and prompted some women to switch from hormone therapies prescribed by their doctors to natural alternatives. More than a decade after the original WHI fi ndings, a series of reports—including further WHI data—has cast doubt about the initial conclusions. Researchers now believe the WHI data was skewed towards women aged 63 years or older who had begun using hormone therapy on average 10 years after the onset of the menopause. By contrast, the Kronos Early Estrogen Prevention Study and Danish research led by Louise Schierbeck have highlighted the benefi ts of hormone therapy for many young women, such as relieving menopausal symp toms and helping to prevent osteoporosis. Many doctors now think there might be a window of opportunity for women to benefi t from hormone therapy if they are aged less than 60 years and are within 10 years of starting the menopause. But some women are still concerned and confused about traditional hormone therapies. The number of prescriptions in the USA for traditional hormone therapies approved by the US Food & Drug Administration (FDA) has plunged by 61% from 93 million in 2002 to 36 million in 2012, according to fi gures from Symphony Health Solutions. By contrast, a rising number of prescriptions are fi lled for custom-compounded bioidentical hormones, which are mixed for patients by pharmacists but not regulated by the FDA. JoAnn Pinkerton, Professor of Obstetrics and Gynecology at the University of Virginia, USA, and her colleagues presented their fi ndings of an analysed survey (investigated during October and November 2014) on March 6, 2015 at the Endocrine Society’s 97th annual meeting. They estimated that between 26 million and 36 million prescriptions are fi lled for custom-compounded bioidentical hormones. Of the 483 pharmacies that responded to the survey, 69% believed the number of customcompounded prescriptions they fi ll will rise by 2016, with most predicting an increase of between 5% and 25%. “We think that when the WHI came out showing an increased risk in heart disease, dementia, and breast cancer—even though the relative risks were small and the absolute risks were even smaller—people became very concerned and discontinued their hormones,” Pinkerton told The Lancet Diabetes & Endocrinology. “Some of them went to bioidenticals because there was a lot of hype and myth that they were safer than FDA-approved therapies.” Pinkerton highlighted concerns about the scarcity of clinical data on the safety of bioidenticals and fears about the quality and monitoring of custom-compounded products. She pointed to an outbreak of meningitis in 2012 in the USA that was traced to compounded intrathecal steroids after issues with contamination. Pinkerton also cited an investigation by More magazine in 2012, during which 10 of 12 samples of a medicine called TriEst from diff erent compounding pharmacies were found to contain the wrong amounts of oestrogen and progesterone. The American College of Obstetricians & Gynecologists and the American Society for Reproductive Medicine have echoed her concerns; after testing 29 internet-ordered samples of bioidentical customcompounded hormones, they noted that 34% failed one or more standard quality tests, including potency testing, compared with less than 2% in FDAapproved drug therapies. However, the North American Menopause Society has claimed that custom-compounded products can benefi t some consumers who have allergies, or who need dosages or mixtures that are not available commercially. Heather Currie, Associate Specialist Gynaecologist at the Dumfries & Galloway Royal Infi rmary in Dumfries, UK, and Chairman-elect of the British Menopause Society, said bioidentical hormones are only just starting to be used in the UK. “They haven’t taken off just yet but we are concerned that they will do”, she told The Lancet Diabetes & Endocrinology. “Even though there may not be many pharmacies selling them, women can still buy them over the internet.” The UK’s National Institute for Health and Care Excellence, will launch a consultation on its fi rst menopause guidelines in May 2015, with the guidance expected to be published in October 2015. Currie hopes the publication of the guidelines will be an opportunity to dispel some of the myths surrounding hormone replacement therapy.