• The Women’s Health Initiative Study, the largest government-financed study of women’s health that linked hormone use with health problems, was deeply flawed. As one doctor put it, they tested “the wrong drugs” on the “wrong population.”  The study used estrogens made from the urine of a pregnant mare (sold as Premarin and Prempro by Wyeth) and enrolled women whose average age was 63 – a good ten years after their final menstrual period.  In short, the study wasn’t designed to answer the question of hormone safety in women just entering menopause.

• The estrogen used in transdermal patches (e.g. Vivelle-dot, Climara) is different from the estrogen used in the WHI study. As the author explains, “pharmaceutical estradiol comes from plants whose molecules have been “tweaked”  in labs until they are atom for atom identical to human estradiol, the most prominent of the estrogens pre-menopausal women produce naturally on their own.”  As Gorney further clarified online; “although there’s nothing that proves Premarin carries more risk, estradiol was the form preferred by all the researchers I talked to who either use estrogen or said (esp if they were men) that they’d have no problem using it.”

• The author reports that researchers are focusing on what they refer to as the “timing hypothesis – the proposition that estrogen could bring great benefit to a woman who start it in her 50s while having the reverse effect on a woman 10 years older.” Gorney writes that though this “timing hypothesis” is still experimental, scientists know there are ways estrogen improves and protects the brain when it is added to healthy tissue.  But the converse is true too. If estrogen is given to brain cells that are aged or otherwise damaged, it appears useless and can even be harmful. That is why the WHI also reported that hormones increase the risk for aging-related dementia. (remember, many of the test participants were aged 65 when they started the hormones).

• There is such a thing as “perimenopausal depression,” that can be set off by “ricocheting hormones.” Doctors seem quick to prescribe anti-depressants when often estrogen replacement will correct the hormone fluctuations that are causing the sudden onset of depression.

If you are considering whether or when to take hormones to alleviate perimenopausal symptoms including depression, sleep disorders, hot flashes and lack of focus or concentration, be sure to read this article for an explanation of HRT today.  You’ll be more informed and able to make a decision based on facts and unbiased thinking thanks to the reporting of Cynthia Gorney.  Tara Parker-Pope also writes about this article in her most recent blogpost, The Mental Chaos of Menopause, in the New York Times.  The comments left by readers are just as interesting.

The appeals court said “the evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct.”  According to the news report, Pfizer’s lawyers argued that the plaintiff received ample warning about the cancer risks tied to the company’s Prempro and Premarin drugs and chose to continue using them.

Editor’s note:  Earlier this month, I wrote about a webinar on Bioidentical Hormone Therapy,  that was “supported” by Ascend Therapeutics, makers of an FDA-approved topical estrogen gel that competes with compounded hormone products.  There’s a companion magazine, “The Buzz on Bioidenticals,”  that is available free online and in doctors’ offices and it, too, is “supported”  by Ascend. The publication repeatedly cautions women against using compounding pharmacies and, in an article called “Why You Should Avoid Compounded Hormone Therapy” the writers suggest that doing so poses a risk to our health.

In the interest of fairness and to contribute to a balanced discussion that will help you make an informed decision about using compounded, bio-identical hormones, I contacted Christine Givant (pictured below), a pharmacist and founder of La Vita Compounding Pharmacy, in San Diego, to ask her to respond to some statements made in the “Buzz on Bioidenticals” publication.

Wendy:  First, explain what a compounding pharmacy does and why a woman on hormone therapy would choose to have her hormones “compounded.”  What does that mean exactly?

Christine:  A compounding pharmacy serves many vital purposes. To begin with, it allows the physician the opportunity to customize therapy to a patient’s individual needs. For example, Ascend Therapeutics offers a hormone product that comes in one strength, one dosage form, and one delivery device. Well, that will work for some women, but not all. A compounding pharmacy would be able to make it in the exact strength your physician determines you need and put it in a variety of dosage forms depending on your lifestyle (i.e gel, cream, suppository, lozenge, capsule, sub-lingual drop). A compounding pharmacy could also combine a daily hormone regimen into one cream, which could result in increased compliance and a lower cost to the patient.

Wendy:  In the Buzz on Bioidenticals article, “Why You should Avoid Compounded Hormone Therapy,” the writers state that “the FDA is concerned that patients may be in danger since the agency does not have oversight over compounding pharmacies and that it won’t approve compounded products because they’re not standardized.”  How are compounding pharmacies regulated, if not by the FDA?

Christine:  No pharmacy, not even the ones you find at WalMart or Walgreens, is regulated by the FDA. Its jurisdiction lies instead with commercial medications. All pharmacies, including those that offer compounding services are, in fact, highly regulated by the State Board of Pharmacy. We undergo regular inspections by the Board of Pharmacy and are required to have independent certification companies inspect and certify our clean rooms every six months.

Wendy: The article suggests that pharmacy oversight on a state-by-state level can result in problems since each state has different laws and different methods of oversight.

Christine: The Boards of Pharmacy have been regulating pharmacies since the beginning. All have stringent regulations regarding compounding. State regulations are often more stringent than the FDA regulation would be if applicable.

Wendy:  Another concern expressed in the article pertains to the possible inconsistency of compounded hormone products since “each compounding pharmacy makes hormones with various different ingredients and doses” and “batches can vary in potency.” Can you explain the compounding process?  Are you using the same FDA-approved, bio-identical Estradiol in your pharmacy that Ascend Therapeutics is using in their EstroGel product?

Christine:  The compounding process is pretty straight forward.  If a prescription calls for Estradiol 1 mg/gm cream for example, a formula is created and entered into the computer by a pharmacist and a log of the formula with a unique lot number is printed out. The log reflects the exact amount of each ingredient in the cream that needs to be weighed or measured along with detailed instructions on the proper compounding techniques.  Our scales are connected to printers that record the weight of each ingredient and we attach this printed document to the log.  This allows for a “checks and balances” system to ensure that the exact weights are weighed correctly.

The final compound and the log are checked by another pharmacist for accuracy and quality assurance. Once determined that the process used to make the compound and the weights of ingredients are accurate, the second pharmacist initials the log for approval to release to the patient.  We only utilize chemicals that are obtained from FDA approved chemical houses. We also randomly batch test our compounds and send samples into an independent lab for either potency and/or stability testing.

Of course, it is important to check out the compounding pharmacy you work with or ask your physician if they have done some investigation to ensure they are following similar practices.

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Note from Wendy: If you want to listen to the on-demand web cast of the “Buzz on Bioidenticals” presentation and read the accompanying magazine, click here.

If you’re considering Bio-identical hormone therapy and Oprah’s shows on the topic left you more confused than ever,  tune into a free, live webinar, “The Buzz on Bioidenticals,” scheduled next week, on August 4th.  It will feature Dr. Elizabeth Lee Vliet, author of Women, Weight and Hormones: A Weight-Loss Plan for Women Over 35 and Karen Giblin, founder of Red Hot Mamas, a menopause education organization. There’s also a free companion magazine that you can download from their website.

You should be aware that both the webinar and the magazine are supported “by an educational grant” from Ascend Therapeutics, which makes EstroGel, an FDA appproved estrogen gel that competes with the Vivelle-Dot estrogen patch  as well as hormone products formulated by compounding pharmacies.  That explains the repetitive advice you’ll find throughout the magazine against using compounded hormone products (i.e. “you don’t need to go to a compounding pharmacy to obtain bioidentical hormone therapy” and  “there is no need to risk using a compounding pharmacy.”)

As I’ve written here before, the debate continues over the safety of bio-identical hormones, the reliability of saliva tests and the safety and consistency of compounding pharmacies.  It’s hard to evaluate claims when the information we receive is “sponsored” by an interested party.  All I can say is read and listen to everything, ask questions and know the source.

Some women are just plain lucky. They sail through Menopause without a minute of discomfort.  I put them in the same category as super-models.  They’re freaks of nature.  The fact is that most menopausal women experience hot flashes and/or night sweats and they can range from mildly disruptive to downright debilitating.   Hormone therapy will help with the hot flashes (vasomotor symptoms as they are called), but current guidelines recommend that it be taken at the lowest effective dose for the shortest period of time.   So,  in making the decision to take HT, wouldn’t it be a lot easier if women knew how long their hot flashes would last?

Current guidelines state that vasomotor symptoms last anywhere from 6 months to 2 years.  Another report claims that hot flashes resolve in most women within 4 to 5 years.  So, to find an estimate based on real data, researchers at the Melbourne Women’s Midlife Health Project tracked more than 400 Australian women, ages 45-55, from pre-menopause through the menopausal transition.  After thirteen years, they recently reported that hot flashes, for these women, averaged nearly SIX YEARS (!!!) in hormone users and just over FIVE YEARS (!!!) for nonusers.

Two other noteworthy findings:  There was a connection between high exercise levels and shorter hot flash duration;  and the longer women experienced hot flashes, the lower the average positive mood score.  That’s certainly not a surprise.

Researchers wrote last year in the Archives of Internal Medicine (9/8/08)  that hormone use was associated with 37% to 66% higher risk for Gerd symptoms, depending on the preparation used.  They concluded that “physicians prescribing hormone therapies should inform patients about possible Gerd symptoms, and those evaluating patients with new Gerd symptoms should ask about hormone therapy use as a possible contributing factor.”  Characteristics of Gerd include:

• Heartburn
• Acid regurgitation
• Chest pain
• Dysphagia (difficulty swallowing)
• Indigestion
• Estraesophageal symptoms (chronic cough, wheeze, laryngitis)

If any of these symptoms look familiar, and you’re using hormone therapies, you should discuss this possible linkage with your physician.

Your claims of brain fog, senior moments, or whatever you want to call the small but frequent memory lapses you experience during the menopause transition are real, according to the findings of a new study just published in Neurology journal.

Researchers spent four years investigating the effects of the menopause transition and hormone use on three areas of cognitive function; processing speed, verbal memory and working memory.  They concluded that mid-life women, particularly those in the late-perimenopause stage (they haven’t have a period in three to 11 months) were not able to learn as well as they had during pre-menopause.  The good news is that their test scores eventually improved and rebounded to pre-menopause levels once they hit post-menopause (no period for 12 months), indicating that “menopause related cognitive difficulties may be time-limited.”

The impact of hormone treatments on cognitive function were also evaluated. They found that if you started taking hormones before your final menstrual period, the hormones had a “beneficial effect” on cognitive function. The opposite was true for women who began hormone therapy during the post-menopause transition. In those cases, cognitive performance was worse!

So, if you’re a mid-life woman (mid 40s to early 50s) who is struggling to learn new computer skills, or returning to school for a degree, cut yourselves some slack and know that your body’s hormones, which have always been in control, will take a temporary performance break as you approach menopause.

Be sure to read (Bay area physician) Doc Gurley’s humorous take on this study:  “Are You Moron-o-pausal? which appears in her City Brights online column for the San Francisco Chronicle.

Wendy:   What do you recommend to your patients who complain of feeling debilitated by the classic menopausal symptoms, such as hot flashes, insomnia or anxiety?

Dr. Low Dog:  I first ask her what’s she looking for, what she has tried and what she wants. Some women don’t want any kind of hormone due to a family history of breast cancer. Others ask for it.

I would probably do a blended approach. For example, I’d use Hops instead of Valerian to help her sleep at night.  I’d probably put her on fermented soy – not just soy, but fermented soy products to see if that helps.  If she’s having a lot of anxiety, then I might use Kava. But there is not one, simple answer.

Natural products just don’t work as well as hormones. They don’t have the same degree of adverse effects, but they also don’t have the same degree of benefits. I tend to think that women who have more severe menopausal symptoms should use hormones and you can taper them down over time, unless she has a real risk.  If you have mild symptoms, I don’t know why you’d pull out the heavy artillery. For many women, products like Black Cohosh will take the edge off and that’s all they will need.  It’s a misperception that herbs will be as strong as hormones.

Wendy:  You were commissioned by the NIH to review all the supplements for the State of the Science Conference. What’s the bottom line on Black Cohosh for hot flashes?  

Dr. Low Dog:  It helps in some women, but not in others.  I like the combination of St. John’s Wort and Black Cohosh better and I recommend it for women who are not taking a lot of other medications.  This approach is much more popular in Europe.

St. Johns Wort is undergoing a phase two trial at the National Cancer Institute,  for women who’ve had breast cancer, who have hot flashes and symptoms, but can’t take hormone therapy.  For many women, St. John’s Wort can be effective for hot flashes in the same way we’re using Effexor and Paxil and other anti-depressants.

Wendy: In addition to hot flashes – and often because of hot flashes, insomnia is a major problem for women beginning in their mid to late 40s.  Is there a natural remedy that helps?

Dr. Low Dog: With insomnia, it’s not just about sleep – it’s about the quality of the sleep and there are many herbs that can help.   If you have trouble falling asleep, then I’d suggest trying melatonin, where the best evidence is.  If the problem is staying asleep, then I’d probably suggest a combination of valerian and hops for at least 2-3 weeks to see how you do.  Sometimes inositol can be useful or L-theanine.

Sometimes people do really well with Kava.  It was associated with some rare liver problems but in otherwise healthy people and good quality Kava products, I still use them and think they can be very effective for people with anxiety, irritability and difficulty sleeping.

I strongly suggest that any one with insomnia cut out caffeine in the daytime, eat lighter and not drink alcohol with dinner. Alcohol is one of the worst offenders for people who wake up in the middle of the night.  A lot of people drink wine to help them fall asleep, but that’s the stuff that will disrupt your sleep.

Dr. Brody’s time slot coincided with another, equally compelling presentation on “Chocolate and Tea: A Scientific Overview and Tasting Demonstration.”  It was a tough call, I admit, yet he drew a full house of mostly female physicians and nurses.  And when the hour was up, no one would let him go. His discussion continued outside the presentation room, as a sea of women, notebooks in hand, peppered him with more questions.  He was still holding court at lunch the next day as more conference attendees (perhaps the ones who chose chocolate over his presentation) pulled up their chairs to join him at his table. Despite all the research, articles, FDA actions, dueling press releases and Oprah shows, there is still a lot of confusion about bio-identical hormones, and an urgent need for unbiased information.

In Dr. Brody’s opinion, conjugated hormones – namely Premarin, which consists of about six different conjugated estrogens derived from the urine of pregnant mares, is “one of the worst offenders for woman’s health in the last 50-100 years.  It’s natural for horses, not for women,” he said.

Dr. Brody was trained at Yale and Stanford Universities, where he said he was taught the “party line” about hormones.  Like other gynecologists of this time, he too prescribed synthetic hormones as a cure-all for hot flashes, heart diseases, osteoporosis and memory loss.  “It was said to be free of serious side effects,” he explained.

In a conversation with Dr. Brody the following day, he described to me his own “moment of “revelation” about conjugated hormones around 1990, when he gave a lecture in Europe to a group of accomplished clinicians.  Prior to 2002, over 20 million menopausal women had been treated with traditional HRT in the U.S.  At the same time, different approaches were being used by doctors in Europe, South America and Asia.  “I learned what their impressions, attitudes and experiences were with conjugated estrogens and I was absolutely flabbergasted!  We were saying they were helpful, safe and good for women.  They thought it was ‘insane and dangerous’ for doctors to be prescribing these drugs. It wasn’t even a close call.”

Since then Dr. Brody has been recommending instead bio-identical hormone therapy for his patients who need relief from menopausal symptoms.  However, he points out that “like any compound, if you use it improperly, you can harm someone. If used properly, there are a myriad of benefits.” Such as?

• Eliminates hot flashes
• Improves mood and concentration
• Improves vitality
• Decreases wrinkles
• Maintains skin collagen
• Improves fine motor skills
• Increases sexual interest
• Decreases memory lapses
• Reduces heart risks
• Reduces painful intercourse
• Reduces night sweats

Add bone health to this list as well. “Estrogen is for the prevention – not treatment- of osteoporosis in early post-menopausal women,” he explained.

Dr. Brody’s presentation also covered bio-identical progesterone, “which should always be used if the uterus is intact. Natural progesterone improves sleep, breathing, blood pressure, mood and fat metabolism,” he explained.  He recommended using natural, micronized progesterone or transdermally with a topical gel or cream.

On the topic of bio-identical testosterone, Dr. Brody told the audience that it “may improve well being,  increase sexual interest, and should be used topically, either added to the estrogen gel or used separately.”

Finally, Dr Brody said that many women will experience benefits from taking bio-identical DHEA, an adrenal androgen, which declines with age and is a precursor to estrogen and testosterone.  “It can enhance immune function, improve sleep and well being, and increase lean body mass.”

Have bio-identical hormones helped you? I’d love to hear your stories.

* Lower photo by Bob Ross for Scripps Center for Integrative Medicine

Update (2/16) :

In Dr. Randolph’s Hormone Well newsletter this week, Genie James, Executive Director of The Natural Hormone Institute of America and co-author of From Hormone Hell to Hormone Well, explains why, in her view, synthetic hormones continue to be actively marketed by the pharmaceutical companies.

“Sales of synthetic hormones is a multi-billion dollar business for pharmaceutical companies. Despite the fact that the 2002 Women’s Health Initiative (WHI) study established beyond a shadow of a doubt the harmful and sometimes lethal side effects linked to synthetic hormone use, the Rx industry is financially vested in continuing to brainwash doctors that there is no medically-proven option for treating women desperate for relief from hot flashes, night sweats and hormone-related weight gain, migraines and low libido. This is dead wrong thinking and it continues to put women’s lives at risk.”

Ms. James also explains why she thinks bio-identical hormones are a safer alternative:

“In order to be patented, the molecular structure of synthetic hormone drugs has to be different from the molecular structure of the hormones produced by the ovaries or testes. At a cellular level, that difference causes a chain reaction that can lead to side effects from weight gain and depression to cancer and heart attack. In contrast, bio-identical hormones have EXACTLY THE SAME molecular structure as the hormones produced by the human body. They do not trigger side effects because the body recognizes and receives them without hesitation.”

You can read the entire Hormone Well newsletter by visiting their website.

Melinda Beck’s “Health Journal” column in today’s Wall Street Journal focuses on “The 7 Things You Should Know About Hormones.“  She tries to clarify the debate over bio-identical hormone replacement therapy by offering 7 facts about bio-identicals, some of which are, well, debatable such as: don’t trust saliva tests, and hormones from compounding pharmacies aren’t safer than conventional HRT.  I don’t know if those statements are true, but I do know that there is still principled debate on both sides.

Melinda Beck quotes a physician-spokeswoman representing the Endocrine Society who weighs in against bio-identicals: “women may be putting themselves at much higher levels of risk.”  I wish Ms. Beck would have pointed out that Wyeth Pharmaceuticals, the maker of Premarin and Prempro,  (the most widely prescribed hormones until the WHI study was prematurely stopped), is a Corporate Liaison Board member of The Endocrine Society and was a “Leadership Donor” in 2002, according to Compounding Facts.Org (written by an organization of compounding pharmacists).

That doesn’t negate the spokesperson’s statement.  A connection with Wyeth just colors the debate and makes us wonder, don’t you think?