Once again, a respected standard-promulgator of a large medical specialty - in this case the American College of Cardiology - has been persuaded to recommend blanket prescribing of an expensive [or not - see comments] daily medication, with a risk of harmful side effects that requires regular monitoring, despite the acknowledged fact that 92.5% of the target group will derive no benefit.
Yes. The change in guidelines for statin "therapy" recently issued jointly by the ACC and the American Heart Association includes prescribing statins for anyone between the ages of 40 and 75 whose estimated ten-year risk of cardiovascular disease exceeds 7.5 percent In other words, they want to treat every male over the age of 65 for at least ten years.
Like my highly accomplished executive uncle with his free executive physicals: for years he took niacin, which damaged his liver, and then statins, for spuriously elevated cholesterol levels (spuriously, because in our family we make big cholesterol particles incapable of causing atherosclerosis, so our high levels actually reflect low particle counts; we might be harmed by reducing them). My uncle died of pancreatic cancer, while suffering from rapidly progressive dementia; his autopsy detected not a speck of atherosclerotic plaque. My aunt, his wife, a faithful statin user (in her case, for actual heart disease) also died of pancreatic cancer, but without the dementia.
Happily, the critical op eds by prominent physicians have been quick to hit the media after the announced revision of statin guidelines. They make the valid point that statins prevent disease less reliably than claimed, perhaps not at all in people with no history of overt cardiovascular disease. But I have yet to see anyone suggest that statins might have harmful side effects with a long latency undetected in clinical trials - side effects we have thus far failed to appreciate. The incidence of pancreatic cancer in the US has been ticking up slowly for the past two decades. I can think of possible reasons besides statins, but what if? Is anybody looking at this? Not the manufacturers, it's safe to bet.
My expertise was in gynecology. This strikes me as a ripe moment to remind the vulnerable public that the American College of Obstetrics and Gynecology, under the influence of Big Pharma, once convinced itself that breast cancer was an unlikely side effect of hormone replacement "therapy"; at worst, HRT might "just" cause a latent breast cancer to show up sooner. Leading experts went so far as to recommend that every woman over fifty should ideally be on HRT if she hadn't been diagnosed with an estrogen-dependent malignancy. The great majority of board-certified ACOG fellows bought into it, as did our colleagues in Internal Medicine.
I didn't, thanks to my background in statistics and anthropology, plus considerable personal and professional experience with unanticipated side effects of medical treatment. Below the fold is the unpublished op ed I submitted to Newsweek in 1996, during National Menopause Awareness Month. (Note that I didn't dismiss the putative cardiovascular benefit of HRT, later shown to be more a risk than a benefit.) But it was either bend to the "compliance" monitors and keep my insurance rankings, or get out. Within a year, feeling like a lone voice crying in the wilderness, I got out.
Barbara B. Harrell, M.D.
Women’s Medical Specialists, P.C.
1229 Madison, Suite 1450
Seattle, WA 98104
(206) 467-1450
May 8, 1996
My Turn Editor NEWSWEEK
251 West 57th Street
New York, NY 10019-1894
To the editor:
I just saw another one—a spunky 83-year-old whose well-educated, devoted daughter, the sort of person who gets regular Pap smears and mammograms and visits her dental hygienist every six months, had dragooned her into starting estrogen about five years ago. Now she’s bleeding for the first time in over thirty years, and she has a potato-sized tumor in her uterus; it’s probably a reactivated, benign fibroid, latent all these years, but a little surgery will be required to sort things out. Try convincing this lady that her quality of life has been improved by her hormone supplements.
National Menopause Awareness Month. NEW TREATMENTS FOR MENOPAUSE MEAN WOMEN CAN ENJOY MANY MORE YEARS OF LIFE, screams a full-page ad in The New York Times Magazine by (you guessed it) America’s Pharmaceutical Research Companies. “Thanks to these drugs, women can continue living active and healthy lives after menopause.” What is my mother, hiking happily in the Sierras when not campaigning for the politician of her choice—a turnip? Even Gail Sheehy, like most in the menopause industry, would have us believe that women before our time didn’t live past fifty. This is absurd! Look at your own family tree, if you need proof. While it is true that average life expectancy in the undeveloped world was under fifty, that is because a third of the population died before the age of two. There have always been old women—more old women than old men.
Besides, hormone replacement therapy does not significantly extend longevity, as estrogen-promoting drug reps concede over the lavish lunches they provide for my entire office. If you take estrogen for thirty years after menopause, you increase your lifespan by an average of eleven months. “It’s quality of life,” they say. “Quality of life. And you know the other thing, Doctor? If you get your patients on estrogen, you’ll keep them. We’ve got studies showing that women stop seeing their gynecologist regularly after menopause, unless they’re on estrogen. If they’re not on HRT, you’ll lose them.” Indeed, there are marketable quality issues here—bones, heart, sex—and the Baby Boom is a hugely enticing market for the purveyors of addicting menopause therapies.
Addicting? You bet. Estrogen has a recognized withdrawal syndrome, consisting of hot flashes, insomnia, and emotional lability, just like natural menopause; this is true for FDA-approved pharmaceuticals, as well as for the untested herbal estrogens which many women seem to prefer. Yes estrogen makes some people sick, and takes some getting used to when you’re 70 years old, but so do narcotics, and we know how addicting they are.
And then there’s progesterone, the crabby, downer hormone essential to keep estrogen from causing uterine cancer in women who still possess their original equipment. How is this vexing little obstacle being handled by the drug companies? Combinations, of course. How convenient! “And one big advantage, Doctor, is that now they can’t take their estrogen without getting the progesterone, which, as you know, a lot of them don’t like. In fact, we have compliance studies showing that a lot of women on conventional HRT don’t take the progesterone as prescribed, or at all, for that matter.”
My practice includes a handful of menopausal patients whose primary care providers have refused to continue seeing them if they won’t take hormone replacement therapy. These are not women with stunning risk factors for osteoporosis or heart disease; in fact, several of them have excellent grounds for avoiding HRT, such as a history of hormone-related migraine headaches or a history of troublesome, biopsy- requiring fibrocystic breast problems. Of course, there is ample precedent for this sort of well-intentioned medical browbeating, arrogant in the extreme: recall how women who wanted to breast-feed were treated in the 1950’s by a profession that recommended supplementing infant cereal with egg yolk—raw egg yolk—for the “essential” iron. Back then, doctors served as handmaidens to the dairy industry, including manufacturers of infant formula, whose products captured us Boomers in the Newborn Nursery. Now we know better. Or do we?
These days it’s difficult to imagine what was so compelling about cow’s milk that it managed to displace practically a whole generation from the breasts of mothers who were, overwhelmingly, home with their babies. Obviously, proper formula was crucial to the survival of a few, and a great step forward for women who worked outside the home; for them, there were definite advantages. In hormone replacement therapy we have a similar situation: for some, there are definite advantages. But when a prudent consumer hears that estrogen lowers a woman’s risk of heart disease, she should ask, “compared to what?” Compared to having never smoked a cigarette? No. Compared to having no family history of heart attack or stroke? No. To taking a baby aspirin a day? Maybe. A glass of red wine a day? Probably not. How does daily estrogen, at fifty cents a pill, compare to a small dab of mayonnaise, twice a week? According to the latest voodoo from our diet professionals, vitamin E-rich mayonnaise appears to trump estrogen, hands down—but those results remain to be confirmed.
While it is possible that the above-noted cardiovascular health factors are additive in their effects, even synergistic, it seems unlikely that immortality would actually be achieved by combining them, much as we might like to believe otherwise. If estrogen reduces death from heart disease, it must increase death by something else, since we all have a one hundred percent chance of dying at some point. I believe it is this intuitive fact that scares people, rightly or not, about a possible association between estrogen replacement therapy and cancer, particularly breast cancer. Most people of my acquaintance would rather deal with heart disease than cancer, if they had the choice. Of course, for the generation currently approaching menopause, all of this is mere extrapolation, as nobody actually knows whether our baseline risk of atherosclerosis or breast cancer will be the same as our mothers’ by the time we reach 70.
Hormone replacement therapy is being touted to health professionals almost as an obligation; we are so sure of the “obvious benefits” that we must force women to “improve compliance” by any means available. Yes, osteoporosis is a major public health problem that can be ameliorated by estrogen replacement, and yes, many women require supplemental estrogen in order to enjoy sexual intercourse after menopause. But does any of this truly justify foisting an unwelcome medication on an otherwise healthy, informed individual, pleased with her own lifestyle? I think not. And I can guarantee you, if there weren’t big money in menopause, we wouldn’t be hearing so much about it.
Sincerely,
Barbara B. Harrell, M.D.