The past 18 months have witnessed one of the most stunning reversals of fortune ever seen in the pharmaceutical industry. Hormone replacement therapy (HRT), once one of the most widely prescribed drug regimes in the world, has been virtually assigned to the scrap heap following procession of damming revelations from rigorously designed clinical trials.
HRT has been phenomenal marketing success. Wyeth, manufacturers of the widely prescribed Prempro and Premarin, boasted annual sales of US$3 billion year with projected doubling of sales in the next five years. From 1992 to 1999 the oestrogen drug Premarin was the most widely prescribed drug in America. New Zealand women were offered HRT in droves, with over 100,000 menopausal women using the drug last year. To the struggling midlife woman, HRT appeared to be the perfect panacea. Popular media promoted the idea that it would restore aging women to their former glory, complete with sharper minds, stronger sex drives, healthier hearts, and stronger bones, not to mention devoid of annoying flushes, sweats, mood swings and wrinkling skin.
Then in June 2002 the federally funded Woman’s Health Initiative (WHI) trial of HRT was prematurely aborted when data revealed women who use ‘combined HRT’ (combined oestrogen-progestagen treatment) for more than five years faced 26 percent increase in breast cancer, and 29 percent increased risk of heart attacks or other coronary events. Equally alarming was the realisation that the greatest risk of coronary events occurred in the first year of HRT use. The magic pill, which had been prescribed to millions of women around the world on the premise that it would prevent heart disease, was actually increasing their risk of dying from cardiac-linked causes.
While the WHI study generated shock and media attention, the dramatic results should not have come as revelation. As far back as 1998 the Journal of the American Medical Association published the results of four-year trial involving menopausal women with established risk factors for heart disease. The study failed to show benefit from HRT use, revealing instead significantly higher incidence of fatal heart attacks in the first year of use, along with increased deep vein thrombosis, pulmonary embolism and gallbladder disease.
For HRT users the bad news keeps on coming. Three reports in the May 28 issue of the prestigious Journal of the American Medical Association show that older women (over 65) taking HRT had twice the rate of dementia (including Alzheimer’s Disease) compared with women not using the drug. The evidence of increased risk in the HRT group appeared as early as one year after the start of the study, and persisted over the five-year follow up. It is still not known if women under 65 are exposed to the same increased risk of dementia.
A year after the WHI trial’s pronouncement on HRT and breast cancer risk, British study involving more than one million women delivered an equally alarming verdict. The study by scientists at Britain’s leading cancer charity Cancer Research UK found that using combined HRT caused four times as many extra breast cancer cases as oestrogen-only HRT. In Western countries in women aged 50 to 60 there are about 20 cases of breast cancer diagnosed per 1000 women. For the same number of women using oestrogen-only HRT for 10 years there will be an additional five cases of breast cancer, while combined HRT adds another 19 cases per 1000 women. Says professor Valerie Beral, head of research at Cancer Research UK, “the risks go up with the duration of use and are apparent within one to two years”. Once woman stops using HRT the breast cancer risks quickly recede.
Combined HRT is always used for women who still have an intact uterus, as oestrogen-only HRT is associated with massive increase in cancer of the endometrium (lining of the uterus). The June edition of the Journal of the American Medical Association published studies indicating that combined HRT appears to cause an increase in the incidence of an especially aggressive form of breast cancer. The drug also makes it harder to find tumours until they have reached later, less curable stage.
It’s not difficult to see the sad irony of the HRT debacle. Next month New Zealanders will again be urged to donate to the annual pink ribbon breast cancer appeal. The media will be full of stories about the importance of mammograms and early detection. Will anyone dare question how many New Zealand breast cancer victims have died as result of using the very medication promoted as beneficial to their mid-life health? M
Lynda Wharton is Management’s health columnist.
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