Category Archives: bioidentical hormones

Seven Things To Know About Hormones – My Take

The Wall Street Journal gives a nice response to Oprah’s recent HRT hype with an article entitled “Seven Things You Should Know about Hormones. This, of course, is not to be confused with George Carlin’s Seven Words You Can’t Say on TV, which is really funny but won’t help you decide whether or not to take estrogen…

Here’s my take on the seven things –

1. ‘Bio-identical’ hormones are available in FDA-approved forms
I agree. The stuff Suzanne Somers and Oprah are getting compounded is exactly the same chemical ( probably purchased from the same supplier) as Big Pharma uses to make their estradiol patches and creams and progesterone pills.

2. Hormones from compounding pharmacies aren’t safer than conventional HRT.
I completely agree. Any compounding pharmacist or doctor who sells HRT without warning patients about the risks should be put out of business. We don’t stand for this behavior from Big Pharma, and we shouldn’t accept it from these folks. They are couching their sales pitch around women’s wellness and selling women a purported fountain of youth, while trashing Wyeth for doing the same thing with Prempro. FDA – Get on it. And if you don’t have the authority, Congress needs to give it to you. Women’s Rights Groups should be all over this one, but they are unfortunately being duped by these shysters into thinking they are all on the same side.

3. Don’t trust saliva tests.
Ditto. Most of the folks doing saliva testing make money on the testing. Be wary of any doc who has a financial interest in what test he/she orders. Or what vitamins you take.

4. There’s a critical window of time for starting HRT.
Not so fast. It’s a hopeful hypothesis, but it’s just not proven yet. A lot of the docs pushing the hypothesis are also consultants and speakers for pharmaceutical companies who sell HRT. In my heart of hearts I think and hope that they are right, but I’m not willing to tell a patient to count on it. We need studies to prove it.

5. The increased risk of breast cancer appears related to progesterone rather than estrogen.
The key words here are “appears to be”. It’s not written in stone yet, so don’t count on it. And don’t go taking estrogen without progesterone if you still have your uterus – that’s a recipe for uterine cancer. I’m not about to trade one risk for another with my patients.

6. Estrogen applied to the skin, in patch, cream or gel form, may have a lower risk of blood clots and strokes than in pill form.
Agree. This is the one piece of new data that makes the most sense to me and that I am willing to put out there. I prescribe transdermal estrogen preferentially over oral whenever I can. We know clot risk is related to dose and there are well-done studies showing the lesser impact of transdermals on serum clotting factors. There’s no reason to think this won’t translate this to lower incidence of blood clots. Stroke incidence is a little more tricky, since strokes are multifactoral, but if clotting times are closer to normal, that’s one less factor to worry about.

7. Stay tuned.
This, of course, is the hardest part about HRT. It’s not like your menopause is going to wait for the next big randomized, placebo controlled trial. You have to make a decision with imperfect information and uncertainty. And that’s difficult for some women to understand and accept.

Easier to do what Oprah and Suzanne have done and latch onto the compounding pharmacy crowd, who sell certainty and security along with their drugs. But it’s a false security and very dangerous. I find it so sad that these two intelligent women are letting themselves be taken in this way. And even sadder that they are bringing other women along with them into their fantasy of hormonal certainty.

If you’re interested
Here are TBTAM’s Ten Rules for Prescribing HRT.

Now if you’ll excuse me, I have to get back to You Tube…

Oprah’s Talking Hormones

I should have expected it. Today, while counseling a patient about hormone replacement, I heard those three little words that I predict will haunt me from this day forward – “But Oprah says..”

Yes folks, Oprah’s in menopause.

“You feel flat and you feel tired, you haven’t had a good night’s sleep in two years [and you’re] just going through the motions, trying to get through the day,” Oprah says. “You feel like your life force is being sucked out of you.”

Now Oprah’s taking hormone replacement, which of course means that America’s women are heading back on the HRT roller-coaster, wondering if they should be forgetting everything they heard in 2002 and doing the same thing as Oprah.To get the conversation going, Oprah’s doing a two-part series on her TV show and running special issue on the topic in her magazine next month. (Thanks, Linda, for the heads up.) I figured I’d better head over to Oprah’s web site and see what ‘s going on.

So what exactly is Oprah saying?

To her credit, Oprah seems to be trying to frame the HRT issue as a debate – “Should you replace your hormones?” she asks. A reasonable question, I’d say.

Her magazine features a well-written article that frames the issues nicely and is medically up to date and fairly well-balanced. Everything you need to know is in there, albeit with a little too much paragraph space given to the theories that support HRT use and not enough to the facts that recommend against it. Still, it’s a good start.

But Oprah’s blowing it with her show.

She gets points for working with Christiane Northrup, the author of the book The Wisdom of Menopause, and the leading medical guru to the public on HRT. While Northrup’s book is a bit too long and a bit woo-woo for most of my patients, it is medically correct, and I really liked her Public TV Special last year.

Oprah also featured a short segment with Dr Wolf Utian from the North American Menopause Society, who faced off against Suzanne Somers on Larry King last year. Utian warned about the risks of HRT – and both he and Northrup recommended that women work in close partnership with their doctor in managing their menopause.
Unfortunately, Northrup’s measured wisdom and Utian’s warnings were no match in grabbing the audience’s attention compared to the anectodal testimonies of Robin McGraw and others about bioidentical hormones.It’s the “HRT changed my life and you should take it too” school of menopause management by girlfriend.
HRT is touted as the cure for everything from weight gain to depression, and as long as its bioidentical, there are no risks. These folks have free rein to spout whatever theories and beliefs they have, unchallenged by Oprah, Northrup or Oprah’s own medical guru, Dr Oz.

Dr Oz dropped the ball

To my disappointment, Dr Oz failed to question the unsubstantiated statements made by Dr Prudence Hall, a practitioner he interviews who prescribes ridiculously high doses of estrogen and progesterone to her patient without once mentioning their potential risks.

This is not informed choice – it’s pure salesmanship, and both the patient and Oz fall for it hook, line and sinker. Oz even puts Hall’s crazy regimen up on the screen as if it were gospel – 2 mg of estradiol and 150 mg of progesterone twice a day – 8 times the starting doses I use in my practice, and much more than most women need even at the start of treatment.

DR OZ – Who should take hormone replacement?
DR HALL – Anyone who has a low hormone should have that hormone replaced.

Huh????? I though we got away from this craziness with the WHI.

Oprah, I’m disappointed.

You had such good intentions, but you’re giving way to the hype, and taking your viewers along with you. Like poor Michelle, who you promise to take to Dr Hall for her “Oprah Hormone Makover”-

OPRAH:…It’s ultimately up to you to make the choice for what’s right for your body. We just want women to start to feel better and to be in charge of your own health. Because you don’t have to feel this bad. Look at Michelle. Michelle, there is hope for you.

MICHELLE: I’m going to get myself some of these hormones.

OPRAH: Yeah. Yeah.

MICHELLE: Sign me up!

This is not letting Michelle make her own decisions, Oprah. This is pulling her into your club. HRT is not a makover that you offer your viewers for free. It’s a medical treatment, with risks and benefits about which every woman deserves to be properly informed. Your show, unfortunately, is not informing. It’s hyping.

Things are no doubt going to get even worse when Oprah gives the stage over to Suzanne Sommers later this week for part 2 of her HRT series. (Northrup will be airing a Webcast Thursday evening that will be worth listening to, but I don’t think is going to be on the show again.).

Disclaimer

I take HRT, and I prescribe it to my patients who want to use it for treatment of menopausal symptoms. Every one of my patients who takes HRT is informed of the potential risks, and their decision to use it or not is made in light of their own risk factors, symptoms and concerns.

In the end, most of my menopausal patients don’t need HRT or don’t want the risks, and we either find them non-hormonal alternatives or they find other ways to handle their symptoms. It’s called informed choice.

I prescribe FDA-approved regimens, mostly bioidentical but not always, and sometimes custom-made formulations for women who can’t find the right regimen among the approved products. I recommend the lowest dose for the shortest time, and prefer transdermal estrogen over oral forms if possible.

I also offer alternatives to HRT, including SSRI’s and neurontin for hot flashes, low dose vaginal estrogen for dryness (along with over the counter non-hormonal remedies for the same), and encourage all my patients to eat well, exercise, avoid dietary and stress triggers for hot flashes and take care of themselves.

If you want to learn about HRT

Check out the readings listed at the bottom of this post. Or my series on HRT. Or talk to your doctor.

And remember, just because Oprah’s doing it, does not mean it’s right for you. Use her show to start the conversation, but take the responsibility to inform yourself and do what’s best for your menopause.
Not Oprah’s.
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Menopause Reading list
-The Menopause Guidebook by North American Menopause Society – The Cliff Notes of menopause management. Everything you need to know without the hype.
–Is It Hot in Here, or Is It Me? by Barbara Kantrowitz and Pat Wigert Kelly – The What to Expect while you’re in Menopause book. Q&A format, easy to read in short segments.
–The Wisdom of Menopause by Christiane Northrup. The Torah of Menopause – Everything’s there, along with the book of Job. Read it and believe.
–Our Bodies, Ourselves for the New Century. If you liked the original, you’ll love this version.
–Medicine Net answers FAQ’s about bio-identical HRT and Oprah.
–TBTAM on HRT – my four part series. Everything I needed to say.

Suzanne Somers Back on Larry King Live

This post refers to Somers 2008 appearance on Larry King Live. There is a more recent post about Somer’s 10/23/09 appearance here.

Well, I called that one, didn’t I? After being cited by the FDA for making unsubstantiated claims, the compounding hormone industry hit back with a one-two punch aimed straight at Wyeth, delivered of course by Suzanne Somers on Larry King Live. As I predicted, they’re framing the fight as the little guy (them) against the rich pharmaceutical companies, forgetting of course that it is the informed choice of American women which is at stake here.

Once again, the American public is distracted from the real issue, which is that these anti-aging folks don’t have a scientific leg to stand on when it comes to the health claims they are making for their billion dollar compounded hormone industry. Since these charlatans can’t find a legitimate doctor to tout their medical blasphemy, they have to rely on poor Suzie, who, God bless her, doesn’t know a steroid backbone from a botox molecule (which, by the way looks suspiciously like the Thigh Master).

Larry King should be ashamed of himself. The only voice he gives to the side of science is to give out the FDA’s website. Because when it comes to the health of American women, the only expert he wants us to hear is an actress with a book to sell. (Suzanne’s book, Ageless, just came out in paperback)

In fairness to Suzanne, you should know that I prescribe HRT, almost exclusively bio-identical hormones. I’ve even given these hormones to women who have had breast cancer and were unable to find a non-estrogen alternative to treat their symptoms. But every one of these women was informed about the risks of HRT as we best know them today, and not as the compounding industry would like them to be.

Some of the claims Suzanne and her friends are making could someday prove true – but until they have the data to support these claims, they are not allowed to make them. If you want to sell drugs, you’ve got to play by the rules. And you can’t point fingers at the big bad pharmaceutical industry and then pretend that the rules don’t apply to you.

If you want to claim that estriol prevents against breast cancer, go out and prove it. At this point, there is not enough data, either in the European or American scientific literature, to support that claim. Estriol looks better than estradiol in some studies simply because it is a weaker estrogen. But when given at the higher doses prescribed by many anti-aging docs, that advantage is gone. Suzanne should know this – she herself had a hysterectomy for endometrial hyperplasia – a precancerous condition of the uterine lining known to be caused by her hormone replacement.

I’ve said it before, and I’ll say it again – Estrogen is estrogen, whether it comes from mare’s urine or the moon. Until you prove otherwise, women who take HRT must be given the information they need to make an informed choice. The FDA is absolutely right on this one.

Now if you’ll excuse me, I’m heading over to Home Shopping Network to buy a Thigh Master.
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Read my Four Part Series on Hormone Replacement

The FDA Takes on the Compounded Hormone Industry

The FDA has finally taken on the compounding pharmacy industy for misleading and unsubstantiated claims made in marketing so-called “bioidentical” or natural hormone therapy.

In warning letters to seven such pharmacies, the FDA cited them for making unsubstantiated claims that their hormonal formulations are safer than FDA-approved formulations. They’ve also challenging the use of estriol, an estrogen formulation never approved for use by the FDA for hormone replacement.

Estriol is a form of estrogen found in the body, along with estrone and estradiol. Estriol is a weaker estrogen than estradiol, leading its proponents to claim it is safer than estradiol, the most commonly used bioidentical estrogen, and the one found in many FDA approved products such as patches, creams and pills. There is no data to prove that claim. Estriol binds to estrogen receptors, can stimulate both uterine lining and breast cancer cells, and if used in high enough doses, probably has the same risks as conventional estrogen replacement.

I am disappointed that the FDA stopped short of assuming regulatory power over these pharmacies and is not requiring them to include standard patient information and warnings for estrogens when these drugs are compounded.

What still upsets me is that it took a so-called “citizen’s petition” from Wyeth Pharmaceuticals to get the FDA to take action. Wyeth manufactures Prempro, the HRT formulation studies in the Women’s Health Intitiative, the study that put the nail in the coffin for HRT’s use for heart disease prevention.

I’ve said it before and I’ll say it again – Wyeth’s involvement in the battle allows the multi-billion dollar anti-aging industry to frame the battle as the little guy (them) against Big Pharma. This is not a battle for Wyeth – it is about informing women.

The seven companies targeted by the FDA are –

Panorama Compounding Pharmacy
Saint John’s Medical Plaza Pharmacy
Murray Avenue Apothecary
Village Compounding Pharmacy
Pharmacy Compounding Specialties
Reed’s Compounding Pharmacy
Pacifica Pharmacy

These pharmacies appear to be taking the warning seriously – When I checked their websites tonight, all but one was either offline or had taken down their information on hormone replacement.
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FDA information on compounded hormones

Suzanne Somers on Larry King Live

Suzanne Somers appeard on Larry King last night, supposedly to take on her critics in the medical establishment who, like me, are concerned about the misleading medical information contained in her best selling books. (See my recent post on suzanne and the bio-identical hormone hype.)

What could have been an informative debate ended up being a cat fight that did nothing to inform American women about the real issue. That issue is the unfettered promotion of bio identical hormones as a risk-free cure-all for everything from depression to cancer to getting old.

Neither Suzie nor her critics got to say more than a few uninterrupted words at a time, and Larry seemed unable to control his guests or to frame the debate. When he did attempt to give some context, he focused on the personal battle between two of the guests, a physician and an unlicenced practitioner of anti-aging medicine. (You could read the transcript here, but don’t waste your time.)

Wolf Utian, the head of the North American Menopause Society, and probably the most objective of the guests, was unfortunately placed at a distinct disadvantage given his consultant work for Wyeth and his society’s Big Pharma support. (One more argument for disentangling the medical profession from Big Pharma.)

The fact that Wyeth appears to be leading the charge against Suzie and her anti-aging consituents is unfortunate. Wyeth’s involvement only serves as a lightening rod that distracts from the real issues and hurts the credibility of those in the medical establishment who want to see the FDA regulate the multi-billion dollar anti-aging and compounding pharmaceutical industries. These folks love to play themselves as the little guy against Big Pharma, and as long as Wyeth stays in the fight, that’s how they get to frame it.

This is not about protecting Big Pharma or defending Prempro. It is about informing women. Wyeth needs to step out of the fray.

Category: Second Opinions