'Round and 'Round and 'Round and… You may have heard the news last week that another (yes, ANOTHER!) major hormone replacement therapy (HRT) study was shut down early to protect the health of subjects participating in the study. Or maybe you didn't hear about it. These studies are shutting down with such frequency lately that they barely rate a mention in most news reports. If it weren't so serious, it would pretty comical. But what received even less attention was a recent report in the British Medical Journal that revealed a shocking turn in the HRT saga that will not make anyone laugh. Scream with anger? That would be far more appropriate. The study that was shut down last week was just one of several Women's Health Initiative (WHI) studies on HRT. This eight-year study of 11,000 women was stopped in its 7th year when it was determined that estrogen therapy may increase the risk of stroke. Because estrogen taken alone has been shown to cause cancer of the endometrium (the glandular membrane that lines the uterus), many doctors consider estrogen therapy to be relatively safe for women who have had a hysterectomy. For women who still have their uteruses, progestin is added to the estrogen to prevent endometrial cancer. This combined HRT is the therapy that was being used in the 2002 WHI study that was abruptly halted when it became clear that the two drugs combined caused an increased risk of breast cancer and heart disease. As it now stands, the official recommendation from the National Institutes of Health (NIH, which oversees the WHI) is for menopausal women to discuss the risks and benefits of these drugs with their doctors. The NIH also recommends that all HRT therapy should be taken in the smallest effective dosage for the shortest length of time necessary. But you can be sure that many HRT advocates will continue to insist that the risks are so small that women should still strongly consider taking HRT. And it seems that no amount of bad news about HRT will shake their belief in the safety of these drugs - even though the news over the past two years has been uniformly negative. For instance: - A 2003 study showed that combined HRT increased the risk of developing Alzheimer's disease and other forms of dementia. The FDA now requires a warning about this on all HRT drug labeling.
- A University of Rochester study reported just last month that women who took HRT suffered from impaired hearing.
- Also reported last month was a study from Brigham and Women's Hospital showing a sharply increased risk of asthma for women taking either estrogen alone or combined HRT.
Arguably, none of these health problems are as significant as the 2002 revelation that HRT increases the risk of heart disease - the disease that kills more women than any other. But it turns out that this risk was known years before 2002. In previous e-Alerts I've told you how drug makers conduct trials in preparation for an FDA review and then withhold the studies that could be damaging - submitting only the research that encourages regulatory approval. This is like giving a defendant in a court trial the power to reject witnesses for the prosecution. The glaring weakness of this system is obvious: When negative results are withheld, doctors may end up prescribing a drug without knowing about some of the associated problems. And that's exactly what happened with HRT research. Early observational studies (using questionnaires and medical records) indicated that HRT might provide protection against heart disease. For several years this association was widely assumed to be a given. But when evidence to the contrary began to emerge, much of it was kept under wraps. In a recent issue of the British Medical Journal, a team of two researchers (Klim McPherson and Elina Hemminki) reported on their review of 23 HRT studies; all conducted well before 2002. A good number of these studies were mounted by drug companies in support of applications to license HRT drugs in Finland. McPherson and Hemminki successfully appealed to Finland's High Court to obtain unreleased results. (A similar appeal for study results failed in the UK.) The 23 trials included data on about 3,300 subjects. Analysis showed that HRT use actually put women at greater risk of heart disease. When their review results were initially released, McPherson and Hemminki say their findings were "ridiculed." That was in 1997 - five full years before the WHI study was shut down. For years these results were in hand! The researchers had to go to court to obtain them, while drug companies argued that the records should not be made public. Yet, they were revealed over FIVE YEARS ago. Is there any wonder why people are turning away from mainstream medicine in droves and looking for alternatives to the status quo? I'm sure that advocates of HRT will continue to put the best possible spin on the deteriorating reputation of this dangerous therapy. But statistics show that sales of HRT dropped off sharply last year. Women are finally learning that there are much safer ways to treat their menopausal symptoms. Especially when the list of side effects is getting longer and more serious practically every day. To Your Good Health, Jenny Thompson
Health Sciences Institute Sources: "NIH Asks Participants in Women's Health Initiative Estrogen- Alone Study to Stop Study Pills, Begin Follow-up Phase" National Institutes of Health Press Release, 3/2/04, nih.gov "Estrogen Study May Be Ending" Liz Szabo, USA Today, 3/1/04, usatoday.com "HRT Could Affect Ability to Hear" BBC News, 2/25/04, news.bbc.co.uk "Study: HRT Patients At Higher Risk For Asthma" WBAL TV, 2/23/04, thewbalchannel.com "Synthesising Licensing Data to Assess Drug Safety" British | Medical Journal, Vol. 328, 2/28/04, bmj.bmjjournals.com "HRT Risks 'Were Known Years Ago'" BBC News, 2/27/04, news.bbc.co.uk | 
