The Women’s Health Initiative (WHI) (a long-term national health study in the US)…It is hard for me to say these words without uttering a curse, much as Maimonides stated that the word Jesus should only be spoken when uttered with a curse - no love lost there...
In 2002, in typical American “larger than life” fanfare, this “landmark” study was announced to the world by the first female director of the National Institutes of Health (NIH), Dr Bernadine Healy, and her team…and women promptly abandoned their Hormone Replacement Therapy (HRT) in droves, terrified of the promised breast cancer or stroke they were certain to suffer should they continue this man-crafted medical abomination. Hmmm… Prior to the announcement of the study’s findings, 40% of American women were using HRT in one form or another. Those numbers fell precipitously, both in America and worldwide, after the announcement of the study’s findings, and the Pharma industry supporting HRT suffered a calamitous downturn in business. I guess they would have been expecting a bankrupting class action from all those women who had suffered as a result of this injurious therapy. They didn’t have to wait long, with large class action firms leading the charge world-wide to take these greedy institutions to task for recklessly foisting such dangerous therapy on ill-informed, vulnerable, middle-aged women.
And yet, even early on, there were rumblings…
For one, why did women consider taking HRT in the first place? Well, from my perspective, it arose because a great many women suffered debilitating oestrogen deficiency symptoms: hot flushes; drenching night sweats; depression; mood swings; poor libido; vaginal dryness and painful intercourse; skin, hair, and breast changes; urinary incontinence; urgency and frequent UTIs; escalation of migraine; bone and muscle atrophy…sounds appealing, doesn’t it!? Now, not all women suffer intractable symptoms, but a substantial proportion do, and continue to do so as they are too afraid to consider HRT as an option to address their symptoms. And was it this cohort of women who were studied in the WHI? Those younger, newly-menopausal and perimenopausal women who are more likely to suffer from menopausal oestrogen deficiency. Well, er, no, actually. In fact, the selection criteria for the WHI actively excluded symptomatic post-menopausal women! If you had symptoms of menopause, you did not meet the WHI selection criteria!
Only 3.5% of the WHI cohort were aged 50 to 54. The age range of the study’s participants ranged from 50 to 79, with the range skewed towards older women. But, hey, wouldn’t older women be more prone to things like breast cancer and stroke, among other things, virtue of their more advanced age? I think the answer is “yes”. And, were a wide range of HRT regimens assessed? Er, no. In fact, the regimens studied were quite narrow, the target cohort was heavily biased towards overweight, Caucasian ex-smokers with a median age of 63! Sound representative of the average newly menopausal or perimenopausal woman? No, not even close! And, was the study designed to address menopause-related conditions? No! The study was designed to address disease prevention. Menopausal conditions just happened to be an accompaniment of the target population. The dropout rate was so substantial, and the conclusions drawn in terms of menopause management risks so distantly related to the aims of the study, that criticisms of the study began almost immediately, and the groundswell of opinion has risen to a deafening roar. But what of the validity of the conclusions of nearly 1,800 follow-up studies conducted on the WHI data?…draw your own conclusions!
From my perspective, I can see an enormous disservice done to women in the name of empire building and grandstanding. At the risk of “yank-bashing” and “fake news” statements, it strikes me that those behind the WHI study far-overreached their scientific boundaries in announcing conclusions based on the most tenuous of associations, and based on the flimsiest of evidence. Subsequent well-constructed and targeted studies have demonstrated no increase in all-cause mortality, for women taking a range of HRT regimens. In such a wide field of study with diverse regimens and population groups, blanket statements such as those made by the WHI authors must be viewed with great scepticism, rather than accepted at face value, because they arise from such an austere institution as the NIH.
As a scientist at heart, it pains me to see the scientific method ravaged in such a manner.
It also demonstrates the ease with which erroneous conclusions can be perpetuated as dogma, when cloaked in pseudoscientific jargon, and espoused from a position of authority. In recent times, a number of scientific studies in a range of fields have been exposed as fraudulent, dishonest, call it what you like. Those calling themselves scientists are not immune from human frailty, and I advise all to study the fine print underlying any grandiose statement, and keep your sceptic radar trained on the target. Remember, if it smells faecal, looks faecal, tastes faecal…you guessed it.
Above all, I am most pained by the suffering of those women whose quality of life, and the quality of their relationships, may have been so impacted by a condition so eminently treatable. Isn’t the aim of medicine to ease human suffering and promote wellness?! For not the first time, I fear we have failed in our endeavours.
Dr Alan Underwood