Buyer Beware: "Bioidentical" Hormone Myths

by Lauren Streicher, MD

Frequently, patients ask if I prescribe “bioidentical” hormones. It’s a good question, but unfortunately, the answer is not a quick one. Like many  phrases, “bioidentical” means different things to different people. Generally, however, most women inquiring about bioidentical hormones are referring to compounded hormones that are advertised as being safer and better than FDA-approved estrogen and progestogens distributed by commercial pharmaceutical companies.

The North  American Menopause Society (NAMS) recently conducted a survey of 3725 hormone users  to determine the extent and differences between commercial compounded hormone therapy and compounded hormone therapy. Roughly one of four women who use hormone therapy are using compounded hormone therapy however  most are unaware that compounded hormones have not been evaluated or approved by the FDA .  Most are unaware that compounded hormones have risks in addition to benefits. 

Many promoters of compounded hormones claim that their products reverse aging, enhance sex, prevent cancer and, unlike FDA-approved commercial hormones, have no risks or side effects. It all sounds pretty good. But like most things that sound too good to be true, it’s important to separate fact from the myths propagated by clever marketing. 

 

 

Myth #1: “Bioidentical Hormones Are Natural.”

The only thing that is natural is to drink the horse urine or eat the soy plant (both are used in the manufacturing of hormones). All plant-derived hormone preparations, whether they come from a compounding pharmacy or a large commercial pharmacy, require a chemical process to synthesize the final product, which can then be put into a cream, a spray, a patch or a pill.

Promoters of compounded plant-derived hormones use the terms “natural” and “bioidentical” because it is appealing to consumers and implies that it is not synthetic.

Myth #2: “Compounded Bioidentical Hormones Are Identical to the Hormones in Our Bodies.”

Plant-derived estrogen from soybeans is molecularly very similar, but not identical to human hormones. That’s why I prefer the term “bio-mimetic” to “bioidentical.”

Furthermore, what you get from the compounding pharmacy (where a compounding pharmacist custom mixes drugs to fit the unique needs of a patient) is not “more human-like” than what you get in an FDA-approved product. In fact, you are actually getting the IDENTICAL estradiol molecule whether you get your hormones from a compounding pharmacy or your mega-pharmacy.

How can that be? This is the interesting part. Compounding pharmacies don’t manufacture hormones – they just mix them. Manufacturing factories are the ones that extract estrogen from plants, synthesize it to a useable form, and then sell the same active ingredients to both commercial pharmaceutical companies and compounding pharmacies. It is then that the active ingredient is used to make lotions, pills, sprays or patches.

It’s basically all the same stuff. In fact, many compounding pharmacies mass produce hormone preparations that are copies of those produced commercially.

Myth #3: “Since Compounded Bioidentical Hormones Are Natural, They are Safer Than Other Hormones.”

First of all, “natural” does not equal “safer.” We can all name many things that are natural, but hardly safe. Arsenic comes to mind. But, in any case, I’ve already dispelled the “natural myth” (see Myth #1).

Let’s forget the word natural and ask if compounded hormones are safer than FDA-approved commercial hormones.

Since compounded alternatives to FDA-approved estrogen and progestogen formulations have the same active ingredient (see Myth #2), they obviously are going to have the same benefits, and the same safety concerns. But unlike commercial hormones, the distributors and promoters of compounded hormones deny these risks. And that’s really misleading. So, how do they get away with it?

Since the FDA does not regulate compounding pharmacies, they can make whatever claims they want. So, they tell women what they want to hear – namely that compounded bioidentical hormones have fewer risks, fewer side effects, and are more effective than standard hormones even though there is no scientific evidence to prove that claim.

While women generally distrust the pharmaceutical industry – which is legally obligated to back up their claims, does testing, and reports all safety risks and negative findings – the general population seems to have little problem placing their trust in companies that have no such efficacy or safety standards. This combined with aggressive advertising and marketing has resulted in women believing that compounded products are safer than standard products.

It’s pretty scary to think that millions of women are using prescription drugs that have never gone through a new drug approval process to substantiate safety, prove efficacy, and ensure quality.

Since it is the same active ingredient, what’s the problem? 

It’s the dosages and protocols, which are commonly recommended, that have never been shown to be safe, much less safer or more effective than conventional prescription hormone products. I just saw a woman who was essentially going bald because of sky high levels of testosterone in a pellet that was injected into her hip. Transdermal progestogens from a compounding pharmacy are particularly  dangerous since there is no evidence that they prevent the lining of the uterus from developing pre-cancerous or cancerous cells. And in fact, the survey  recently published by NAMS  showed  there were 4 cases of endometrial cancer in the group using compounded hormone therapy compared to zero cases of endometrial cancer in the group using commercial products.  No surprise since only oral progestogens have been proven to offer that protection.

So, back to the original question: Do I prescribe bioidentical hormones? I prescribe FDA-approved “bio-mimetic” plant-derived estrogen, produced and distributed by companies that are obligated to tell you not only the benefits, but potential risks as well.  I prescribe products made by companies that adhere to strict protocols to assure purity of the product  and consistency of dosage.   I  do use compounding pharmacies when I need a product that is not available commercially but   I then inform my patient  of all known risks and benefits.

 One last thing...an added bonus to commercially available products is that your insurance company will likely cover your prescription.. The non-FDA approved compounded versions will require you to open not only your trust, but also your checkbook. 

Edited Oct 22, 2015  Originally posted  on doctoroz.com 11/09/2011

Must Know Information About Angelina Jolie's Decision

Most of the media comments about Angelina Jolie’s decision to remove her ovaries have been along the lines of, “What a difficult decision!” or “Was it too radical?”

I’ve got news for you: Every day I see women who are BRCA positive. Knowing they have a gene mutation that guarantees almost a 50 percent chance of developing ovarian cancer does not make for a difficult decision. Most of them can’t get on my surgery schedule fast enough.

The decisions that BRCA-positive women must make once they opt for ovary removal are far more complex, including whether to go on hormone therapy.

When Should I Have My Ovaries Removed?

The most appropriate time to remove ovaries to prevent cancer is when pregnancy is no longer desired, but before cancer can occur. Hereditary cancers occur at a younger age than sporadic ovarian cancer. Statistically, age 35 is the point at which the most ovarian cancers can be prevented by surgical intervention. Many women, Angelina Jolie for one, prefer to hold off.

The Tubes Too?

Yes! We now know that the majority of ovarian cancers originate from the fallopian tubes. Removal of the tubes reduces ovarian cancer risk not only in BRCA-positive women, but also in every woman. In fact, women who are at risk but  not ready or willing to remove their ovaries should consider tubal removal.

What About My Uterus?

The advantage of keeping the uterus is that there is still the ability to carry a pregnancy, albeit with someone else’s egg. The disadvantage of keeping the uterus is that there is always the possibility of uterine cancer.

Now just to be clear, women who have a BRCA mutation are NOT at increased risk of developing uterine cancer. However, if someone does not undergo mastectomy, they are often advised to take tamoxifen to protect their breasts. And tamoxifen increases the risk of uterine cancer. In addition, women who have post-menopause estrogen therapy must also use a progestin to protect the lining of their uterus, and that often creates problems.

Most experts believe the greater good is to undergo a prophylactic hysterectomy at the time of ovary removal. The additional surgery requires only an extra 20 to 30 minutes. And since the uterus is also removed laparoscopically, recovery time is no greater than if just the ovaries are removed.

Will Hormone Therapy Affect My Cancer Risk?

You may be thinking that it would be better to face the risk of ovarian cancer than go through early surgical menopause. However, when ovaries are removed at a young age, hormone therapy is not a problem because it’s not the hormones that create the risk for cancer but the ovarian tissue. Just as it is fine for a young woman with a BRCA mutation to take birth control pills if she still has her ovaries, it is fine to use hormone therapy to alleviate menopause symptoms. The real decision is determining which hormone therapy is best.

First, consider estrogen.

Despite the media hysteria, estrogen is not poison and estrogen does NOT increase the risk of breast cancer. You read that right. In the Women’s Health Initiative (WHI) study, in the estrogen-only group of women who had a hysterectomy, there was an 18 percent decrease in breast cancer. It is now clear that the modest increase that is sometimes seen in breast cancer in women who take hormone therapy is due to the progestin, not the estrogen. In addition, many women who undergo prophylactic removal of their tubes and ovaries also have a prophylactic mastectomy, essentially eliminating any concerns about breast cancer.

As far as the choice of estrogen, an FDA-approved, commercially produced plant-derived transdermal product (patch, spray, or gel) estrogen like Jolie chose has advantages over oral estrogens or compounded hormones. Further details regarding the specifics of estrogen choices are in my book, Sex Rx.

The Progestin Problem

If a woman is taking estrogen and still has her uterus, it is well established that she needs a progestin as well, because there is an increased risk of uterine cancer if you take estrogen only.

Because breast cancer risk increases if a progestin is taken along with estrogen, this presents a real dilemma for those women who, unlike Angelina Jolie, have not had a mastectomy but still need to protect their uterus.

In addition, many women don’t tolerate progestins and experience bloating, depression, and irregular bleeding.

One non-progestin alternative is to take the oral estrogen pill that is combined with a unique selective estrogen receptor modulator (SERM), bazedoxefene (Duavee), which blocks estrogen pathways in the uterine lining.

Another other option is to do what Jolie did, and that is to place a progestin IUD in your uterus. While standard in Europe, this is not yet FDA-approved here and is therefore an “off-label” practice. It is still a good idea and one I recommend to my patients as well. The disadvantage is that the IUD must be replaced every five to seven years as long as estrogen therapy is continued. For those women on a more limited budget than Jolie, cost is a consideration because an IUD is not covered by insurance after menopause.

If your  uterus has been removed, there is no reason to take a progestin.

Breast and Ovarian Cancer in the Spotlight

Each year 22,000 American women are diagnosed with ovarian cancer. Of those, 5 percent to 10 percent are carriers of a BRCA mutation that is responsible for their cancer. Half a million women in the United States have this gene mutation, but more than 90 percent of women who are at very high risk for developing breast or ovarian cancer don’t even know it.

So kudos to Angelina Jolie for increasing awareness and  going public with the other tough decisions she made.

Lauren Streicher, MD is the author of Sex Rx: Hormones, Health and Your Best Sex Ever and the definitive consumer publication on hysterectomy and alternatives, The Essential Guide to Hysterectomy. Connect with her on Twitter and Facebook.

Photo Credit:  FameFlynet

Cold Facts About Hot Flashes

By Lauren Streicher, MD

Published May 27, 2014, Everyday Health

The number one reason most women start systemic estrogen is to treat hot flashes once they realize that yoga, carrying a portable fan, and dressing in layers are not real solutions. Hot flashes occur in 75 percent of menopausal women and typically begin as a sudden sensation of heat on the face and upper chest that becomes generalized. A severe flash can be pretty intense (I call it the furnace inside you) lasting between two and four minutes with profuse sweating, followed by chills and shivering. Physiologically, a hot flash happens for the same reason that you sweat in a sauna… the body is trying to cool down. The difference is, you don’t really need to cool down, but your menopausal brain thinks you do. While most last 2-4 years, some women will experience flashes for up to 10 years. About 10 percent…forever.

Toughing it out works out for some women, but other’s who have severe hot flashes though out the day and nights are totally blind sided by just how debilitating hot flashes can be. Estrogen therapy will eliminate or dramatically reduce flashes, but many women choose not to take estrogen, or have been advised by their doctors to steer clear. In fact only 7 percent of women with hot flashes ultimately accept a prescription for estrogen. As an estrogen alternative, menopause experts, including myself, often prescribe one of the antidepressants which years ago were serendipitiously found to reduce hot flashes in menopausal women. This of course is the rationale for Brisdelle; the FDA approved option of low dose paroxetine, one of the selective serotonin reuptake inhibitor (SSRI) antidepressants.

While numerous scientific studies have shown that many antidepressants are effective at reducing hot flashes, no studies have compared antidepressants, estrogen and placebo in the same study.

In the May 27 issue of JAMA, a new research study is published looking specifically at this issue. 339 peri and postmenopausal women in the study took estrogen, venlafaxine (an antidepressant), or a placebo for 8 weeks. Women that took the venlafaxine had a reduction in hot flashes that was essentially as good as women that took low dose estrogen.

In addition to flash frequency, this study also looked at “treatment satisfaction” and interference of symptoms with daily life and found that treatment satisfaction was highest for estradiol, intermediate for venlafaxine, and lowest for placebo.

The study is somewhat limited in that it was short (only 2 months) and did not evaluate libido or weight gain, both of which have been shown to be affected by antidepressants used in typical doses used to treat depression. That evaluation would require a longer study and more women. But, be that as it may, this is still important information and confirms that venlafaxine, like other SSRI’s and SNRI’s, at least in the short term, not only reduces hot flashes, but does it almost as well as estrogen.

Every once in awhile someone will say, my grandmother didn’t take anything for hot flashes, why should I? Well grandma was more likely to be home baking cookies than doing a job that required a good night’s sleep and the ability to think clearly. Grandma may have been having occasional sex with Grampa, (there’s a visual I didn’t need to give you!) but was unlikely to be starting a second marriage or a new relationship in her 50’s. Grandma likely did not live nearly as long as you will. So whether you chose to take hormone therapy or an alternative, if your flashes are getting in the way of your sleep, your sexual health or your quality of life, know that you have options.