Yes, Bioidentical Hormones are Safe and Effective, and Let’s Apply Caution and Common Sense

Dear Oprah,

Ever since your shows on bioidentical hormones aired, my newsletter readers have showered me with emails requesting that I respond. Being a discriminating group, they realize that while your shows were wonderful and will help millions of women, there are a few points to be made that can help women use hormones with even greater wisdom and safety.

Once again you’ve shown amazing courage in speaking out on a touchy but important subject. Bioidentical hormones are on Big Pharma’s blacklist, and we know how many millions of advertising dollars they bring to television. I also applaud your choice of Dr. Christiane Northrup as an intelligent, rational, informed voice in bioidentical hormone replacement. She has been an articulate spokesperson for bioidenticals for many years.

Although I am a medical writer, not an M.D., I have been dedicated to educating women and health care professionals about bioidentical hormones for well over a decade. I co-authored four books, two of them best-sellers, about bioidentical hormones with the late, great Dr. John Lee, and continue our work with a website and newsletter, the Virginia Hopkins Health Watch. I stay in touch with physicians who use bioidentical hormones in their practices, and keep up on the research. As such, I would like to address a few concerns I have about the information on your show, and on your website.

Identifying Conflicts of Interest
I realize that it’s important to present both sides of an issue, but Dr. Wulf Utian and his North American Menopause Society (NAMS) are funded by the drug industry, and in particular by those whose bottom line is most threatened by bioidentical hormones. Dr. Utian’s extreme conflict of interest should be made clear to your audience.

I was disappointed to hear Dr. Lauren Streicher also speaking like a mouthpiece for Big Pharma, with sly half-truth answers and bashing of compounding pharmacies. Sure, she can provide her patients with the exact same hormones from FDA-approved products by giving them estradiol patches and progesterone pills, both bioidentical hormones. It’s a matter of semantics, not molecules. In fact, estrogen patches are by far the best way to deliver estrogen to the body—they work even better than creams. But progesterone doesn’t come in a patch, which means that, without a compounding pharmacy, Dr. Streicher can only offer her patients progesterone pills, suppositories, or injections, none of which work well. Progesterone cream is by far the superior method of delivering progesterone at this time. Creams made by compounding pharmacies can be made according to the individual needs of each woman. There are also high quality progesterone creams available over-the-counter.

Undoubtedly the bottom line of certain large (and recently acquired) drug companies is being eroded by the migration of millions of women away from conventional HRT and towards bioidenticals. Now if Big Pharma would turn its attention to creating a progesterone patch instead of trying to squash bioidenticals, they could create their own billion-dollar industry! In fact, if they had jumped on the bioidentical bandwagon a decade ago instead of trying to defend their dangerous synthetic hormones, they would be reaping the rewards of the bioidentical revolution right now.

You have a link on your website to the FDA page on bioidenticals, but that organization is almost exclusively an arm of the drug industry these days, and has little to do with protecting consumers. Their information is merely an echo of Big Pharma anti-bioidenticals propaganda.

Just in case you think this is a fringe point of view, here's a quote from an article in the January 2009 New York Review of Books titled, Drug Companies & Doctors: A Story of Corruption by Marcia Angell:

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of TheNew England Journal of Medicine.”

One of the mantras of Big Pharma and their spokespeople (e.g. Utian, Streicher, FDA) is that there is no published clinical evidence of the safety and efficacy of bioidenticals. In fact, there are several large and excellent studies published in reputable European medical journals. The majority of French women on HRT have been using bioidenticals for many years, in the form of estradiol gel and progesterone pills. French research, done with tens of thousands of women, shows that this combination is well tolerated by the majority of women and does not increase the risk of breast cancer, stroke or heart disease, as the synthetics do.

Evidence of Bioidentical Hormone Safety and Efficacy
Below are listed some articles that will provide evidence-based medical research on the safety and efficacy of bioidentical hormones:

Breast Cancer Research for Your Doubting Doctor

Bioidentical Hormones and Heart Disease

Bioidentical Hormones and Breast Cancer Risk

A Comprehensive Review of the Safety and Efficacy of Bioidentical Hormones for the Management of Menopause and Related Health Risks
This review article cites some of the studies done in the U.S., many of which are small due to lack of funding from Big Pharma!

Hormone Mega-Doses are Dangerous
I’m concerned about the hormone dosages flashed on the screen during the piece with Dr. Prudence Hall. Those are extremely high doses of hormones, far beyond anything our bodies make naturally when we are younger. For example, a woman in the middle of her menstrual cycle will typically produce 10 to 20 mg of progesterone a day. The dose recommended by Dr. Hall was 150 mg twice a day, or 300 mg per day. She is prescribing 4 mg of estrogen a day (2 mg twice a day). The ovaries produce 0.1 to 0.2 mg daily. The goal of hormone replacement should be to mimic physiologic levels, which simply means, “what the body makes.” Dr. Hall’s doses are hundreds of times higher than what the body would make. These are not natural doses, they are mega-doses. Hormone balance is an intricate dance that affects every system in the body, and over time mega-doses will have negative effects on health.

Let’s Clarify Hormone Testing Issues
This type of overdosing has been created by a misunderstanding of hormone testing. A blood, urine or saliva test will accurately measure hormones made by the ovaries, but this is not the same as measuring hormones applied with a cream or patch. Although it is a somewhat complex subject, the bottom line is that when hormones are delivered through the skin, as with a hormone cream, they show up little to not at all in conventional blood tests. They simply aren’t in the part of the blood that is measured in conventional testing, which is taken from a vein and measured in plasma, the watery part of the blood. Doctors give higher and higher doses of hormones, trying to get “normal” results with a blood test, without understanding that it’s never going to show up there with that delivery system!

On the other hand, a saliva test will show higher levels than are actually in the blood and tissues, so saliva tests need to be calibrated accordingly; only a few testing labs make these types of recalibrations.

Capillary blood spot hormone testing, which requires only a finger stick and can be done at home, is a newer form of hormone testing that accurately measures hormones delivered with a cream. Were Dr. Hall to test her patients’ hormone levels with this method she would find that they are grossly overdosed.

If Mega-Doses are Bad, Why do I Feel so Good!
If Dr. Hall’s patients are so overdosed, why are they feeling so good? At the risk of sounding flip, cocaine and heroin make people feel really good too, so that’s not a good criteria for making medical dosage decisions. To stay with the drug analogy, estrogen is an upper. It excites and stimulates the brain. A whopping 4 mg dose per day really excites and stimulates the brain. When you’ve been hormone deficient and feeling tired, foggy and irritable, it’s thrilling to have the brain wake up again. Estrogen also very effectively makes hot flashes, night sweats and vaginal dryness go away. The good news is, for most women, an estradiol patch of just 0.025 mg or 0.05 mg will bring back brain function and solve other estrogen deficiency symptoms, without over-excitation.

A woman who is taking too much estrogen is fairly easy to spot. Her cheeks are flushed, she’s a bit puffy (which does help the wrinkles go away), a bit twitchy, she’s having trouble sleeping, she’s gaining weight in her hips and thighs, and once she starts talking she has trouble stopping. Estrogen is definitely the chatty hormone. Because it’s such a powerful and effective upper, there’s an addictive quality to excess estrogen.

Extremely high doses of progesterone are needed to counteract mega-doses of estrogen. Progesterone is a calming hormone, helps with sleep, and balances the dangerous side of estrogen, which tells cells to grow and can cause uterine and breast cancer. High doses of progesterone, without estrogen, can cause sleepiness, bloating and indigestion.

Mega-doses of progesterone and estrogen will eventually start to shut down the body’s ability to use the hormones. When the body starts getting “overload!” messages, it shuts down the parts of the cells that let the hormones in. So now you have a terribly overdosed woman who’s starting to feel bad again, and the tendency is to start using even higher doses, or adding other types of natural uppers to the supplement and diet regimen (e.g. caffeine, amino acids, acai).

As for testosterone, levels in women are not well studied, but it’s generally accepted that they make between 0.25 and 1 mg a day. Dr. Hall is recommending 2.5 mg per day. Excess testosterone can cause “testiness,” aggressiveness, excessive sex drive, excessive hair growth on the face and hair loss on the head, acne, and ovarian cysts. Furthermore, excess testosterone may be converted by the body to estrogen.

Hormone Delivery Systems: Pill, Patch or Pellet?
There are other important issues about how hormones are delivered. They can be given in a pill, as a troche/sublingual (held in the cheek or under the tongue), injected under the skin in time-release pellets, with vaginal suppositories, with injections, and through the skin (transdermal) with a cream or patch.

A hormone pill has to travel through the digestive system and liver before being delivered to the blood, so as much as 80 to 90 percent of it is lost in this process. Thus, a 100 mg progesterone pill may deliver 10 to 20 mg of progesterone to the blood and tissues. The other 80 to 90 mg may be excreted or turned into byproducts that can have a wide variety of (often negative) effects on the body.

Troche or sublingual hormone delivery causes a steep rise in hormones, followed by a steep fall, creating a roller coaster effect that does not promote hormone balance. Testosterone delivered this way can cause local effects such as hair growth on the face.

Pellets can be a convenient delivery system, but the downside is that once they’re injected under the skin they don’t come out, so a woman is stuck with those hormone dosages for months. If she’s getting too much estrogen or testosterone in particular, she may suffer months of unwanted side effects such as bloating, breakthrough bleeding, insomnia, weight gain and so forth. We also do not know the long term consequences of having pellets put under the skin over many years.

Vaginal suppositories are messy and drippy. Need I say more? Some people claim that vaginal hormone suppositories only have local effects on the vagina and uterus. No so. This is essentially transdermal delivery, so once again the hormones are not showing up in the part of the blood that is being tested, so it’s assumed that they aren’t there! Hormones delivered vaginally have effects throughout the body.

Hormone injections are unnecessarily invasive, and tend to leave painful bumps at the injection site. This is a primitive way to deliver hormones.

Hormone creams and patches are presently the most effective hormone delivery system, because hormones enter the bloodstream directly and gradually. Virtually all of the hormone in the cream or patch gets into the bloodstream if it is put on thin areas of the skin such as the inner arms. If put on fatty areas such as the buttocks, the hormones may sit in the fat cells.

Is Having Periods Again an Anti-Aging Strategy?
Another important issue is giving hormone doses so high that a menopausal woman starts having periods again, or bleeds intermittently. This is playing with fire, or more specifically cancer. Mother nature shuts down the uterus in middle age for good reasons. As we age, our cells repair damage less effectively which puts us at a  higher risk for cancers of all kinds. During menstrual cycles the uterus is stimulated by estrogen to grow tissue, stimulated by progesterone to develop the tissue, and then stimulated by a drop in hormones to shed the tissue. This type of activity on an aging uterus has the potential to cause uterine (endometrial) cancer. The lower physiologic doses of hormones mentioned above are more than adequate to alleviate menopausal symptoms such as hot flashes, improve skin quality, perk up the brain, increase overall energy, stabilize mood, improve heart and stroke risk factors, promote good sleep and stabilize weight, for example.

DHEA is Not the Mother Hormone
Dr. Christiane Northrup’s webcast was a wonderful clarification of many questions that could not fit into the show, but she made one seemingly small but potentially troublesome error when she stated that DHEA is the mother hormone, and all other hormones are made from it. In fact, testosterone and estrogen can be made from DHEA, but progesterone cannot. This misunderstanding is important because women might take DHEA thinking they are getting progesterone’s protective effects.

The other problem with DHEA is that it’s impossible to predict what it will convert to, if anything. In women seeking support for tired adrenal glands, it may convert to estrogen and make the adrenal problems worse.

If you’re interested in research-based information on how DHEA affects women's hormone levels, here’s an article I wrote a few months ago, DHEA Supplements and Hormone Levels.

Thank you again Oprah, for all that you do for women worldwide. You are a Hormone Heroine!

With Admiration and Sincerity,
Virginia Hopkins