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
My doctor had me on Prempro, it helps but the side effects, do you suggest ways to ask your doctor to customize tx or suggest therapies
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