New Menopause/Osteoporosis Medicine Coming 2014. Horsing Around With Your Hormones

Good Morning Blog Circle!

I wanted to make good on my promise to present the facts about a FDA approved therapy coming to the shelves of your local pharmacy and soon to be highlighted on your physician's script pads in the Spring of 2014.  I'm just sharing what I'm reading on the healthcare professionals side of the scene so that you can do your own homework, and make an educated decision about treatment if you are struggling with the issues of menopause.  

Pfizer recently announced that the FDA gave it's 'APPROVED' stamp on a new treatment (Brand Name-Duavee) for moderate-to-severe symptoms associated with menopause and for prevention of osteoporosis in post-menopausal women.  

http://press.pfizer.com/press-release/pfizer-inc-announces-fda-approval-duavee-conjugated-estrogens-bazedoxifene-treatment

The magazine article that I read and will talk about in this blog today, states that the manufacturer anticipates the treatment will be available in the first quarter of 2014.  Sounds fantastic right?!?!  Eliminate the hot flashes and build bone all at the same time.  WOW!  It certainly must be a win-win and physicians will be seeing pharmaceutical representatives in their offices soon (I would imagine) to bring attention to this novel therapy.  I must share that I was impressed……at first….but thankfully, I did my own homework.

Yes, I was intrigued by a new therapy for menopause since I basically practice in the realm of hormonal balance 85% of my time in customizing therapies for patients.  It's no wonder that men and women are coming in to seek bio-identical hormones as a treatment option for their Andropause and Menopause problems.  The headline in an endocrine magazine caught my attention first and then I began to read certain words in the article that stood out as bright as a neon sign in my mind.  I'll explain in a minute, but let me first share some of the details of the article that physicians and prescribers are gaining their information from.  Much of those practicing medicine in any form, and if honest, would tell you that a majority of their prescribing trends and habits come from pharmaceutical representatives and from short articles in magazines such as what I am highlighting today in this blog.  That's not just an opinion, but it has been studied if you want to rabbit trail on that for awhile.  Example: 

Pharmaceutical representatives do influence physician behaviour

It is a not a truth universally acknowledged that pharmaceutical representatives influence physician behaviour. However, the pharmaceutical industry clearly believes they do. In fact so sure are they of this that in 2000, $4.8 billion dollars were spent in the USA on ‘detailing’, the one-on-one promotion of drugs by a representative of the company1

I read a lot of articles such as this endocrinology magazine to stay current on research, products, and medical industry news, but I truly realize that the nuts and bolts of the information is not always presented on the front lines of the reference material.  

Quoted from the article I was reading: 

"The agency (FDA) based its approval on the phase 3 clinical trails in the Selective Estrogens, Menopause, and Response to Therapy (SMART) program evaluating the safety and efficacy of the drug in healthy, postmenopausal women with a uterus for the approved indications.  In one (just one?) trial, the number of moderate to severe hot flashes was reduced by 74% after 12 weeks of treatment vs. 47% with placebo."  Data from other trials also demonstrated a significant increase from baseline in bone mineral density in the total hip and lumbar spine."  ~Again, sounds great right? 

Here's why the hair on my neck stood up when reading about this new therapy because I make my living treating patients with hot flashes, night sweats, osteoporosis, etc.  I just hate when patients don't know the details of what they are taking.  If you know what you're taking, ok.  If you don't, not ok. 

So here you go, and now you know...  

"It combines "conjugated estrogens" with a selective estrogen receptor modulator in a once-daily tablet designed to be taken orally." (as stated in the article)  Bingo!!!  I found the magic words I was looking for.  Conjugated estrogens?  Just like Premarin (pregnant-mares-urine) maybe? 

I then went to the manufacturers website and to the section for healthcare professionals.  I simply wanted to know what the source of the estrogens was in this hot flash busting, bone building, once daily,  magical menopausal medicine.   I thought, please tell me no, but could it possibly be...???  And there it was like a NEON sign.  ( I told you I would get to this point.  It's the most important of all...The meat and potatoes….The brass tacks….The read between the lines…..The need-to-know infO'!)

From the drug package insert:  "Conjugated estrogens are purified from PREGNANT MARES' URINE and consist of the sodium salts of water-soluble estrogen sulfates blinded to represent the average composition of material derived from pregnant mares' urine."  Eeeesh….Huh?   Horse urine? Really?   Found it!!!   Thumbs down!!!!    Didn't the FDA learn anything from the WHI study?  (BTW, I wrote a blog on this if you want to educate yourself more).  Why didn't they highlight that in this article to the physicians and practitioners?  Do all prescribers know what 'conjugated estrogens' means?  I'm not sure they do especially if the pharmaceutical reps are not highlighting this little known fact in their marketing moments with prescribers as they capture those 4.8 billion dollars at stake in the pharmaceutical industry business. The article I was reading certainly didn't come right out and state that.  Sad!

So, that's enough information for me to not want to take it, but what about the adverse reactions associated with Duavee?  

 Nausea, Diarrhea, Dyspepsia Abdominal Pain, Muscle Spasms, Neck Pain, Dizziness, Oropharyngeal pain.  (stated in the news release and package insert)

  I simply don't understand how taking hormones from horse urine and putting them into humans is considered a safe thing to do.  Some have even gone so far as to think it's a 'natural' source of hormones.  Horse urine is natural I suppose, but not when we're talking about making it into a medicine? From patient interviews throughout the years, and from clinical studies, it's not a good thing at all.  The adverse effects of those using horse urine derived estrogens tend not to sit well with patients and after reading the above, I think anyone could understand why.  How many of the side effects are due to taking a non-human hormone and putting it into humans?  Want to venture a guess?    

 Please, if you are struggling with hot flashes, night sweats, foggy thinking, anxiety, fatigue, loss of hair, poor mood, etc. then do your own research on the available treatment options out there.  I, and my team, are more than happy to send you a packet of information and some things to read about before making your choice in hormone therapy.  You do have options and I think knowing certain information is important in making your decision.  Some of the options are very good for you and for your health and longevity.  We are here to help. 

To your good hormone health,

Dr. Sonja

Prepare Now For the New Year's Resolution to Lose Weight

Hormonal imbalance is tied to more than just hot flashes, night sweats, and the other tsunami of symptoms that come with aging.   Did you know that weight problems are very much associated with hormonal imbalance as well?  Today, I'll share just a few things that you might want to get checked out before you make that New Years Resolution.  Why set yourself up for failure, when you could start now on the road to success, once and for all.  If I were wanting to lose weight, I would have these things evaluated so that I could be completely ready to put my feet in the starting blocks come January 1st.

Sex hormones:  Estradiol, Progesterone, and Testosterone

Too much estrogen and you will tend to pack the Holiday turkey and dressing on the side of your hips and in your butt.   Also, normal estrogen, but too little progesterone, and the fat distribution elves will send the fruit cake to the wrong storage areas of the body.  Ya know, the places you don't want them to be, right?  It's the same for men too.  Guys, I'm not letting you off the hook.  In overweight men, testosterone levels drop and estrogen levels rise leading to, you guessed it, weight gain in the hips, thighs, and even breasts.  Progesterone can help balance that estrogen, but also provides support to the thyroid in helping to eliminate fats, and rid the body of excess fluid.  Low Testosterone is associated with decreased lean muscle, low metabolic rate, and belly fat.  Not only that, but men and women who have low T usually aren't the first to sign up for exercise or strength training because of lost vitality and stamina.  On the other side of the spectrum are those with high testosterone.  This group of people tends to have insulin resistance and weight gain in the belly as well.  Do you see why it's important to know your hormone levels?

Adrenal Hormones:  Cortisol and DHEA
Imbalances of these two hormones can cause poor blood sugar control, poor sleep, increased appetite, food cravings, and poor exercise tolerance.  If you are super stressed, your cortisol levels will skyrocket causing fat to be sent to areas around your internal organs (visceral fat) and to your hiney. Not good!  If your adrenals are exhausted from juggling too much for too long, then you will feel it.  Exhaustion, fatigue, achy joints, poor immunity, and pitiful endurance usually are associated with low cortisol.

Vitamin D (D2,D3):
Those who are overweight tend to have low vitamin D levels.  I personally take a vitamin D supplement daily because I just don't get enough sunlight and because it has such great benefits to the body.  I'm trapped in an office like nearly everyone else in America and a boost of vitamin D is a part of my daily 'healthcare' regimen.

Insulin: If your insulin is high, and consistently high, then other problems can arise.  (i.e. polycystic ovaries, type 2 diabetes, belly fat, increased inflammation throughout the body,  increased heart disease risks, thyroid gland problems, ovulation problems, etc.)

HgA1c:  This important blood test value indicates what your blood sugar has been running over the previous 3 months.  If the number is above 6%, it can be predictive of diabetes and heart disease risk. Often, correlating a high insulin with a high Hemoglobin A1c show signs of problems in the future.  It's worth knowing and addressing.

Thyroid:  A high TSH and a low T3 and T4 will likely contribute to sluggish metabolism, weight gain, and fatigue.  I will interject here that transdermal (through skin) hormone therapy is better than oral therapy because oral estrogens can reduce thyroid hormone bioavailability.  When asked what form of hormone therapy I recommend in patients, I will probably say transdermal >90% of the time and this is one reason why.

So, what do you do with all of this information?  Well, I have an all-in-one/DIY kit that can be shipped to you.  Just call  and we'll get one in the mail ($20 kit/packet fee).  This is a great value because 12 different profile parameters can be tested right from your very own home (cost $295 to lab for analysis of sample).  That's a great discount off of the testing for each individual lab parameter (normally $45 each).  If there's diabetes, thyroid disease, cardiovascular disease, female/menstrual problems, weight gain, or anything else, then this is the test to do.  Your health is your wealth so invest in yourself, starting today!  

Creative Medicine for Your Individual Needs!  That's what I'm all about.  Get tested! Get treated!

To your good health,
Dr. Sonja

From The Experts: Could Balancing Hormones Help Save Your Life? Call & Get Tested ASAP!!

Could Balancing Your Hormones Help Save Your Life?

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During National Breast Cancer Awareness month, we should all take a pause to consider our health.
When was the last time you thought about your risk for breast cancer? Is there anything you can do about lowering those risks?
Yes. Absolutely. You can start by losing weight and balancing your hormones.
As it turns out, these may be two of the most important actions we can take to reduce breast cancer risks in our lifetime. And the science is on our side here. There are numerous studies in the medical literature linking hormones and lifestyle to cancers.
A recent study published in Cancer, a peer-reviewed journal of the American Cancer Society (Dec 2012, vol. 118) found that extra pounds - even within the overweight but not obese range - are linked to a 30 percent higher risk of breast cancer recurrence and a nearly 50 percent higher risk of death despite optimal treatment. Given that the most common type of breast tumors are fueled by excess estrogen, and that fat cells (via aromatase conversion) are mini estrogen-producing factories, pinpointing the hormonal links to weight gain is a key to preventing breast cancers.
Dr. John Lee and David Zava, PhD, reiterate that point in their groundbreaking book, What Your Doctor May Not Tell You About Breast Cancer: How Hormone Balance Can Help Save Your Life: "Experts agree that environmental risk factors, such as diet and exposure to toxins, account for about 80% of breast cancers, and genetic factors account for about 20 percent. Even those who happen to have a genetic predisposition can improve their chances of dodging a breast cancer diagnosis with hormone balance and a healthy diet."
So, let's talk about best ways to improve your odds of dodging a breast cancer diagnosis in the first place:
1. First test your hormone levels to detect hidden imbalances. Examples such as estrogen dominance or high cortisol stress hormones are associated with weight gain, as well as higher risks for breast cancer. In case you haven't heard, ZRT Laboratory just launched a Weight Management Profile that can detect and help correct such imbalances.
2. If estrogen dominance is identified through testing, take steps to correct it ASAP. An estimated 97% of breast cancers are linked with excess estrogens unbalanced by adequate progesterone. If hormone therapy is indicated, bioidentical hormone approaches are preferable with a better safety profile and fewer side effects than synthetic hormone replacement (HRT).
3. Fill up on high fiber, cruciferous vegetables like cabbage, broccoli, cauliflower and brussel sprouts that help promote proper estrogen metabolism.
4. Get your "good fats" in avocados, olive/coconut oils, nuts and seeds to help inhibit tumor growth, boost immunities, and reduce inflammation.
5. A daily dose of 64 oz of water can flush out free radicals and toxins that invite cancers.
6. Avoid bad "xeno" hormones with hormone-free meat/dairy/poultry. Also make sure to microwave in glass or ceramic versus plastic containers, drink from non-plastic water bottles, and choose "green" household, garden, and personal care products.
7. Minimize stress to stabilize cortisol, blood sugars and insulin levels. When those levels are elevated, they provide raw fuel for tumors. Prioritizing time to de-stress, eat right and exercise can boost your immunities against cancer.
Those are ZRT's top suggestions for balancing your hormones to reduce your breast cancer risk - and ultimately help save your life.

 

The "M" word!

"M"??  Ya know……(strike up the fan), Menopause!  Years ago women didn't talk about it openly.   Today, women are flooding the offices of physicians and practitioners to find help in combatting their symptoms, in turning back the hands of the ticking biological clock, and in transitioning through those years as gracefully as possible.

So what is Menopause all about?  What can be expected?  What is normal?


Menopause is the time of life when menstruation ceases.  It's a process and transition that usually occurs over several years and the average age in the U.S. is 51 years old.  This gradual change (sometimes 10 years) can be fairly unnoticeable for some, but can cause others significant disruptions. Did I mention10 years???  Absolutely!  If you start paying attention, you will notice slight changes from how you felt in years gone by, and if left untreated, WHAM!, the mirror will make you aware,…. if the scale doesn't rat you out first.



Menopause can happen these ways.
1) Natural: normal cessation of menstrual cycles often between 45-55 years old.
2) Surgical: total hysterectomy or hysterectomy but leaving the ovaries intact
3) Premature: (chemotherapy, stress, trauma, functional disorders, ovarian failure, unknown etiology)

Indications of Possible Menopause:
Irregular periods (shorter or longer cycles, lighter or heavier flow, intermittent starts and stops)
Hot flashes and feeling hot inside
Atrophy of genital tissue, dryness, painful intercourse
Being more forgetful
Mood changes
Breast tenderness
Being emotional
Loss of libido
Poor sleep
Weight gain

Now, before you just rush out to the health food store and get your friends favorite hormone remedy, STOP just one second, and realize this!  Hormonal Balancing is a science and that guesswork approach is not the best medicine.  Here's why!

Stress and weak adrenals can also contribute to Menopausal symptoms.  Hot flashes, night sweats, insomnia, mood swings, anxiety, sugar cravings, and more, can be connected to adrenal fatigue as much as to sex hormone imbalances.  It often takes a professional to help in determining whether hormones, or adrenal support products are the best approach for an individual.  This can easily be tested!  And it won't break the bank!

Now if you're 'right there' in dealing with problems or symptoms that you are connecting to menopause, please ask for help!!!  We can mail an @ home hormone/saliva testing kit, informational packet, and answer all of your questions over the phone.  Our professional staff has been providing this specialty care for nearly 15 years and we have had a positive impact in the lives of countless patients.   This is what we do all day, everyday.  So, don't go through "M" alone!  We are the professionals that can help guide your decisions based on your individual hormonal values, needs, and medical history.

***I can also read your hormone values through serum assays.  If your doctor or practitioner prefers to draw blood lab work, then call ahead to determine what hormones need to be evaluated while you are in your providers office.  Or, I can send them a lab requisition request by fax or email.  Partnering with your personal provider is an excellent approach to your care and health.

We look forward to your call.

Dr. Sonja