Skeptic: Examining Extraordinary Claims and Promoting Science Skeptic: Examining Extraordinary Claims and Promoting Science

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Wednesday, August 15th, 2007 | ISSN 1556-5696

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In this week’s eSkeptic we present Dr. Harriet Hall’s most recent column in Skeptic magazine (vol 13. no. 2) on bioidentical hormone treatment which has been touted by Suzanne Somers on Larry King Live but looked at skeptically by the mainstream medical community. In this column Dr. Hall, Skeptic’s resident expert on all matters medical, examines the evidence carefully.


Bioidentical Hormones
Estrogen is Good. No, It’s Bad. No, It’s Good

by Harriet Hall, M.D. (a.k.a. The SkepDoc)

Menopausal women used to have no escape from the sufferings of the dreaded “Change.” In the mid-20th century, they were offered a reprieve. They could take a pill to replace their missing hormones, and feel back to normal. That was good in itself, but then they found that replacing estrogens could prevent osteoporosis and hip fractures. We knew there were some risks, but we thought the benefits outweighed the risks. Some doctors recommended all menopausal women take estrogens to “stay young.” Then there was more good news: evidence seemed to show that hormone replacement therapy (HRT) could reduce the risk of heart attack, stroke, and cancer in postmenopausal women.

The optimism came to a screeching halt in 2002, when the Women’s Health Initiative (WHI) study said, “OOPS! It looks like hormones do more harm than good.” Thousands of women were scared into going off their hormones. Sales of Premarin dropped from $2 billion to $880 million. Some of these women tried other remedies and then went back to Premarin because it was the only thing that worked for them. Doctors learned to prescribe more selectively, and sales are rising again.

Now all of a sudden hormones are being touted as a miracle cure for whatever ails you. Suzanne Somers has a new book, Ageless: The Naked Truth about Bioidentical Hormones, recommending everyone take supplemental hormones, even men. My local newspaper has been advertising seminars by an MD on hormones for menopause, weight control, and romance: “Skinny Hormones, Happy Hormones, Youthful Hormones and Sexy Hormones.” Anti-aging clinics and longevity doctors are promoting bioidentical estrogen and progesterone along with testosterone, thyroid, and human growth hormone to prevent aging. What’s going on?

book cover

The claim is that Premarin and Provera, the drugs studied in the WHI study, are artificial and harmful, while bioidentical hormones are natural and harmless. Some also claim that bioidenticals prevent aging and the diseases associated with aging and make people feel better than they ever did before. What is the evidence behind these claims?

First we need to understand what the WHI study really said. It has been misrepresented and misinterpreted. Media reports gave the impression that HRT was killing women. Not so. Over 10,000 person-years, women on estrogen plus progestin had 7 more coronary events, 8 more strokes, 8 more pulmonary emboli, and 8 more invasive breast cancers than women who didn’t take hormones; but they also had 6 fewer colorectal cancers and 5 fewer hip fractures, and the same number of deaths overall.

So women weren’t dying because of HRT, but they were increasing their risk of some diseases while reducing their risk of others. Overall the risks exceeded the benefits. Current recommendations are to use HRT for a limited time only to control menopausal symptoms, and not to use it for disease prevention. Most of us think these recommendations will be altered in the future as we learn more about risk factors and genetic susceptibility. Meanwhile, we try to individualize advice: your doctor is more likely to recommend HRT if you are at very low risk of cardiovascular disease and at high risk of osteoporosis or colorectal cancer.

Evil Big Pharma Plot?

The bioidentical folks tell us that Premarin and Provera are unnatural and harmful substances cynically foisted on us by Big Pharma to make profits. They don’t seem to realize that all doctors are either women, married to women, or sons of women, who presumably are more concerned about women’s health than about Big Pharma profits, and that doctors have read all the same information they have. They recommend estrogens and progesterone from natural plant sources. Premarin comes from pregnant mare’s urine: that seems more natural to me, since we’re much more closely related to a horse, another mammal, than we are to a plant. And the plant isn’t used in a natural form; it’s used as the basis of laboratory synthesis. And there is a reason that we started giving women progestins like Provera instead of natural progesterone: natural progesterone is not absorbed well. Progestins were reliably absorbed and dosage easily controlled.

“Bioidentical” is not standard medical terminology. It’s their way of saying it is the same exact chemical compound found in the human body. But there are lots of different estrogenic compounds found in the body, including estriol, estradiol and estrone. Nothing we do is likely to replace all the estrogenic compounds in exactly the way they occur in the body. There are around 30 different estrogens in Premarin. One, equilin, is present in horses but not in women. Curiously, that “unnatural” element appears to be neuroprotective and is being studied as a possible treatment for Alzheimer’s disease. There’s no solid evidence that any supplemental mixture of hormones is ideal. Anything that has hormonal effects may have hormonal side effects, and for all we know good old Premarin and Provera may be less harmful than some other mixtures.

Compounding pharmacists make up the bioidentical remedies, often in the form of a cream. Advocates themselves recognize that there is inconsistency between pharmacies, and they may have tried two or three different compounders before they hit on one that seems to work consistently for them. In one survey, about a third of the compounded samples tested had substandard amounts of drugs. The FDA is concerned about the growing popularity of compounding and the need for better regulation.

There are hypothetical reasons to think “bioidentical” hormones should be superior to Premarin and Provera. But there are also hypothetical reasons to think that they may be no more effective and no safer. The only way to know for sure is to test them in a properly designed placebo-controlled trial. Until this is done, most of us feel more comfortable with the devil we know than the devil we don’t know.

What other options are there for hot flashes? Several other prescription drugs have been tried, including antidepressants, but they don’t work as well as estrogen and they all have side effects. A number of alternative natural remedies have been tried, from chasteberry to wild yam. According to The Natural Medicines Database there is insufficient evidence to support any of these but black cohosh, soy, and flaxseed; and these are only rated “possibly effective” and “possibly safe.” Black cohosh was the most promising — until a recent well-designed study found black cohosh no better than placebo.

Bioidentical Insanity

Suzanne Somers and others keep harping about “balancing” your hormones. I have difficulty understanding this concept. Hormones are complicated. There are lots of different estrogens; estrogen levels are higher early in the monthly cycle and progesterone peaks later in the cycle: if you graph them, you see that each follows a curve, and the ratio between estrogens and progesterone is constantly changing from day to day and hour to hour. So what can the bioidentical advocates mean when they say they are “balancing” your hormones?

I finally realized that they don’t have any idea what they’re “balancing.” When they do lab tests, they use salivary levels, which they think are more reliable (most endocrinologists disagree). Since they know the test only reflects one instant in time, they feel free to disregard it except as a rough starting point. Instead, they have the patient report any symptoms such as insomnia, dry skin, or lack of energy, interpret those symptoms as signs of unbalanced hormones, and adjust the dosage.

It would be bad enough if they stuck to menopause, but Somers recommends hormone regimens for every age group, including adolescents, and for both men and women.

This creates a scenario where wishful thinking and testimonials take precedence over science, where quackery can go hog wild. Patients get to obsess about every little ache and sniffle, doctors get to tweak their prescriptions, and if patients don’t improve, they just say the balance isn’t quite right yet and they try again. Lots of personal attention and caring. Certainty that they have the answer to all their problems. Enthusiasm over a new method. Oh, and they combine the hormone therapy with all sorts of diet and exercise advice, and with handfuls of supplement pills, detoxifications, homeopathic remedies, and of course the FaceMaster machine that Suzanne sells and uses regularly for electrical facelifts. If you’re still not feeling perfect, you can try going to sleep at 9 PM. And sleeping in total darkness. Or add some testosterone just for the heck of it. There’s always something more to try; there’s always a satisfying explanation for everything.

The doctors who support these true believers are creating an elite following of self-absorbed, self-deluded, obsessive-compulsive health nuts. I suppose it’s nice for these people to have a hobby.

Can Hormones Prevent Aging?

Women produce estrogen until menopause, then they get old. Men produce less testosterone as they age. Maybe a lack of estrogen and testosterone is what makes them age. Maybe if we give them estrogen and testosterone, they will stay young. Maybe not.

Children drink milk and they are young. Adults don’t drink much milk, and they get old. Maybe a lack of milk is what makes them age. Maybe if we give them milk, they will stay young. Maybe not.

The adult body is not the same as a child’s body. Milk gives some adults bloating and diarrhea because their body no longer makes the lactase it did in childhood. A 70-year old body is not the same as a 30-year old body: maybe hormones good for the 30-year old body are not so good for the 70-year old body.

In 1889, Brown Sequard injected himself with the crushed testicles of young dogs and guinea pigs. Early 20th century doctors transplanted goat glands. Patients in both treatments got wonderful results … which were later shown to be placebo effects. Anti-aging medicine remains a will o’ the wisp. I wish Suzanne Somers were right. I wish hormones were the answer. But the evidence just isn’t there.

Follow-up & articles of interest

Aetna will stop paying for dubious hormone treatments.

Aetna, a US diversified health care benefits company, has announced that as of October 1, 2007, it will no longer cover about 25 types of “bioidentical hormones” and compounded thyroid drugs. [Coverage policy changing for hormone, thyroid compounds. Aetna Office Link Updates 4(3):6, 2007]

Bioidentical hormones are often prescribed unnecessarily by practitioners who rely upon salivary hormone testing, which Aetna also criticizes. [Salivary hormone tests. Aetna Clinical Policy Bulletin 0606, Oct 17, 2006]


screenshot from YouTube video

Michael Shermer
Tests Acupuncture

One of the oldest forms of so-called alternative or complementary medicine is the ancient Chinese art of acupuncture, now claimed by many to be a science. Michael Shermer goes in search of what is behind acupuncture through interviews and getting himself poked! WATCH the video >

10 Comments »

10 Comments

  1. Gil says:

    What is your highest intention? To get people better or spend all your time looking to disprove true healing modalities. Yeah sure, hormones are complicated, so what, it doesn’t mean that we should dismiss the possibility of discovering ways to naturally parallel compounds with the body. Afterall, there’s no such thing as “vitamin birth control pill” or “vitamin statin drug.” Get real and look to the future of wellness of the flesh, not wellness of the plastic brain.

  2. Everett Willams says:

    If I had a tenth of a penny on the dollar spent for every drug that the pharmaceutical companies got to final human tests and then had it fail to work the way they thought it would, I would be a rich man. Somers is from my generation, the ones who used their bodies as experimental drug laboratories in the 60′s and 70′s, so she is comfortable in doing so again. the previous commenter who talks about wellness seems not to understand that wellness, statistically, comes from eating a proper diet, getting proper rest, not exposing oneself to an excess of toxins, and living conservatively on a personal basis. Even then, we are subject to our genetics and the various exposures that we cannot control and that we may not even be aware of. Then, there are the random mutations that occur in every body over time, most of which are intercepted by the protective measures in our bodies, but not all. Suzanne Somers is likely to suffer more problems than the rest of us, because she has exposed herself to more things that might cause trouble. In any case, she isn’t going to live forever, and it would be interesting to run a really full autopsy on her body when she dies. Unfortunately, we won’t be able to recover the lost years in the lives of those who follow her brilliant medical advice.

  3. Bagehi says:

    Take a step back and rethink this situation.

    1. The chemical structure of Premarin and Provera are different than any human estrogens. So it is safe to say that something different would require new studies to determine efficacy and the associated risks.

    2. The debate is not really between Premarin and “bioidentical” hormones. The real debate here is the increasing competition between pharmaceuticals and pharmacies for the profit margin on medications. This is why this issue has been so hotly debated. We aren’t just talking the billion made in this niche market of estrogen replacement. We are talking about the nearly trillion dollar market for all medications.

    Pharmacies have long been able to compound medications. As medication prices went up and competition from larger pharmacies increased, they began actively promoting that they could provide patients with compounded medications that did the same at a lower price. In the 1990s, pharmaceuticals began pushing back. Estrogen replacement simply makes for the best battleground as there are secondary issues that both sides can use to obfuscate the reasons behind the conflict.

  4. Walt says:

    “But there are lots of different estrogenic compounds found in the body, including estriol, estradiol and estrone.” Those three are the main ones and much *is* known about them. The idea is to use these known human hormones, not guess that the thirty non-human hormones in Premarin would be equally advantageous.

  5. healthjunkie says:

    I am not in perimenopause yet, but I believe I was always estrogene dominant (according to the symptomes in my youth, and now recently confirmed by a legitimate blood test prescribed by my new open-minded MD who, by the way, does not benefit from the compaunding meds he prescribes). I started on a low dose cycling of the bioidentical progesterone, and added a bit of testosterone as well, at my request after some research I’ve done, to slow down ‘the expedenture’ of my eggs and delay menopause. It took me 3 months to adjust the cycling doses according to my symptomes, and I never felt as good as I feel now. I wish it was known/available when I was in my teens and early 20ies and suffered horrible PMSes and painful periods. And the loss of monthly bloating, water retention, and rages are not a placibo effect- or just my ‘subjective’ opinion about the way I feel- these changes are confirmed by all those close to me.

  6. healthjunkie says:

    And I tried other things before, oh, how I tried… And the docs would just prescribe some pharmaceuticals that didn’t work and caused their own problems, and then told me to just learn to leave with it. As they told me to live with a debilitating shoulder/neck pain because ‘you are getting older’- when I was only 26(!) and advised to stop lifting weights. A regular high quality Glucosamine/chondroiton and cranberries supplements fixed that problem- and now, 10 year later, I am preparing for my first natural bodybuilding competition.
    Sorry, I don’t believe docs much- most of them. By the way, coming from the Eastern European medical family, many of the herbal remedies touted now were well known to my parents and prescribed by them to their patients.

  7. fellowskeptic says:

    You gotta be kidding yourself if you think your doctor does not benefit from prescribing bioidenticals. Does s/he not charge the 400 bucks per visit, which you pay entirely in cash since s/he doesn’t take insurance? If you drank the koolaid and are happy with what you’re getting, great! Hope your doctor also treats breast cancer and blood clots that might develop with long term hormone therapy.

  8. Phyllis Gensler says:

    My husband chose to end his own life 3 weeks after evaluation at the Amen Clinic. This was a little over 2 years ago. I would be very happy to share my story with your readers. I do apologize but this was the only area where I could find a place to write a comment to you. I wish my husband read your articles before he decided to go there. I really feel his death was due to the taking of Amen’s supplements and his anti depressant.

  9. Brucy says:

    The first comment posted by Gil about healing modalities, vitamin birth control pills and the plastic brain (Huh, what language is she speaking?) says it all. Ain’t no cure for ignorance.

  10. jj says:

    interesting article, thanks. However before you decide pharmaceutical companies are not intent on making big profits off HRT at the possible expense of patients, look at the history of DES (diethylstibestrol; developed by Eli Lilly). It was advertised long after they knew it was neither effective *nor safe*. Not just for preventing miscarriages, but also merely for “bigger, healthier babies”. Was even added to prenatal vitamins so many women don’t even know they were exposed.

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