Big Pharma wins again: FDA approves Aprela under new name

BY JANE ALLIN

Despite government shutdown, on October 3, 2013 the FDA approved the dual-acting drug formerly known as Aprela for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone a hysterectomy.[1]

Aprela, approved under the new name Duavee.

It’s new name is fittingly ugly — DUAVEE® — for an ugly vile drug that robs life from the pregnant mares, their foals and unsuspecting women who have faith in Big Pharma and the propaganda they continue to spew regarding the purported benefits of hormone replacement therapy (HRT) derived from pregnant mare’s urine. Pfizer anticipates that DUAVEE® will be available in the U.S. in the first quarter of 2014. This is the first approval of DUAVEE® in any country worldwide.

DUAVEE® is a combination of Premarin® and bazedoxifene, a selective estrogen receptor modulator or SERM known as Viviant® specifically developed to help prevent postmenopausal osteoporosis. Amid speculation regarding its safety profile and Pfizer/Wyeth’s lengthy struggle to gain approval, Big Pharma has yet again overridden barriers seemingly insurmountable.

Given the tainted history of the Premarin® family of drugs and their contribution to a plethora of cancers and other maladies attributed to the use of conjugated equine estrogens (CEEs) it is inconceivable how another such drug containing a known carcinogen can possibly make its way into the Doctor’s office and onto the shelves of pharmacies across the nation.

While studies have confirmed that DUAVEE® is effective in relieving moderate to severe vasomotor symptoms (VMS), vulvar and vaginal atrophy (VVA) associated with menopause as well as the prevention of postmenopausal osteoporosis, the jury is still out on the safety aspect. Most alarming is the fact that Viviant® has failed to receive approval from the FDA and is itself not without issues. Clinical trials have indicated an increased risk of stroke in addition to higher incidences of deep vein thrombosis, retinal thrombosis, hot flushes and leg cramps compared to placebo-treated subjects. These are well-known side effects of SERMs which can also include increased risk of endometrial cancer. [2]

This together with limited safety data on DUAVEE® does not bode well — cancer is an insidious disease and can take years to develop. This is exactly what happened with the Premarin® family of drugs — not just the combination Prempro® therapy.

As far back as the 1970’s there was damaging evidence about the risk of cancers and cardio vascular disorders using CEEs, long before the arrival of Prempro® in 1995 and finally the WHI which undisputedly linked HRT with increased cancer and cardio risks among others. Yet Big Pharma continues to peddle its dangerous wares with the blessing of the FDA.

But true to the manipulative and contemptible reputation of Pfizer there is a seemingly logical scientific explanation as to why two wrongs make a right.

DUAVEE® is categorized as a tissue-selective estrogen complex (TSEC) with dosages of 0.45 mg CEEs and 20 mg bazedoxifene. The overall strategy for the combination drug is that a SERM functions to selectively stimulate or inhibit estrogen receptors in various target tissues (e.g. breast tissue) — either stimulating cell proliferation (i.e. estrogen active) or inhibiting it (i.e. estrogen inactive). In short a SERM that blocks the effect of estrogen in breast tissue, for example, does so by taking up residence in the breast cell estrogen receptors. However other tissue cells in the body also have estrogen receptors which have different chemical structures dependent on the type of cell and as their name implies they are “selective”. Consequently a SERM that blocks the activity of estrogen in breast cells can potentially activate estrogen’s activity in other cells (e.g. bone, liver, uterine).

According to Pfizer:

“Bazedoxifene was specifically selected to be studied as the SERM in DUAVEE because of its unique pharmacologic profile and mechanism of action, as demonstrated by pre-clinical studies that looked at a number of different SERMs. The pairing of CE with bazedoxifene enables DUAVEE to work selectively in different tissues to activate estrogen receptors in some while inhibiting estrogen activity in others (the uterus). This pairing allows DUAVEE to offer estrogen efficacy in treating moderate-to-severe hot flashes and preventing postmenopausal osteoporosis while providing an alternative way to help protect the uterine lining from hyperplasia.”

See Pfizer News Release at http://goo.gl/yjb2qq >>

As it happens this is not necessarily a good thing.

Tamoxifin was the first SERM to be studied for its capacity to block the action of estrogen in breast cells effectively inhibiting cell proliferation and therefore useful in treating breast cancer. However Tamoxifin has the serious side effect of increasing the risk of uterine cancer as it mimics the actions of estrogen and stimulates cell proliferation in the uterus.[3]

This concept was further explored with the combination estrogen-progestin therapies Prempro® and Premphase®. Studies in the 1980s suggested that the progesterone hormone tended to counteract the increased risk of uterine cancer. As the public well knows, this combined HRT resulted in increased risks of breast cancer, strokes, heart attacks and blood clots.[4]

Theoretically isn’t this the same premise as DUAVEE®? Instead of progestin DUAVEE® uses bazedoxifene – a drug not approved by the FDA here in NA – to help protect the uterine lining against hyperplasia that may result from estrogen-alone treatment according to Pfizer. Moreover if bazedoxifene is inhibiting estrogens in the uterus what tissues is it activating estrogen in?

No one ever imagined the nightmare Prempro® became, or Premarin for that matter; it’s like a game of Russian Roulette — taking chances without knowing or understanding the odds — risk at its worst. Will DUAVEE® be any different?

Time and again SERMs have proven to be unsafe with much controversy in the scientific community purely from a safety aspect. Together with the established risks of CEEs it’s anyone’s guess as to the ramifications over the longer-term.

Pfizer has taken two questionable drugs with well-established serious side effects and re-labeled this combination formula as innovative, new and improved and safer than conventional HRT anticipating that the public will buy into their marketing ruse. But wait, the packaging reveals a different story — it carries with it the same boxed warnings as Premarin® and Prempro® and more[5]:

  • blood clots
  • stroke
  • heart attack
  • cancer of the lining of the uterus (endometrial cancer)
  • breast cancer
  • ovarian cancer
  • dementia
  • gallbladder problems
  • loss of vision
  • high blood pressure
  • increased fats in your blood
  • liver problems
  • thyroid problems
  • fluid retention
  • low calcium
  • swelling of the mouth or tongue
  • worsening of other medical problems such as asthma, diabetes, epilepsy, migraines, a genetic problem called porphyria, lupus and liver problems

Who are they kidding?

Unfortunately, with the FDA as the central driving force of its depravity and deception, the corruption and addiction to fraud by Big Pharma continues to poison consumers. Pfizer has a proven track record of promoting drugs in ways not necessarily backed up by medical science. The usual tactic employed is one in which insufficient details of clinical trials are published, frequently authored by individuals who will benefit financially from the companies whose drugs they are writing about – often these articles are deficient to the point of being misleading.

Publication bias, or selectively publishing results of trials, is nothing new. Years ago in the 1990s and early 2000s concern arose over the practice of “cherry-picking” Pharma-funded positive-sounding clinical trial results while negative results were never reported.

Sadly this is deliberate, widespread and prolific — there are no watchdogs when it comes to Big Pharma, only lapdogs. Big Pharma simply hides its failures and the FDA looks the other way. And in their wake, the innocent suffer — money and power at the dire detriment of all creatures on earth.

“Corruption in the pharmaceutical sector occurs throughout all stages of the medicine chain, from research and development to dispensing and promotion”

~ World Health Organization (WHO) fact sheet. See http://www.naturalnews.com/028686_Big_Pharma_corruption.html

© Int’l Fund for Horses

To learn more about Premarin Horses, please read our Fact Sheet. Note: DUAVEE is a sister drug to Premarin and Prempro, all of which are produced using the estrogen rich urine of pregnant mares.

 

14 thoughts on “Big Pharma wins again: FDA approves Aprela under new name”

  1. How is this allowed? After all the suffering that has been caused on boths sides (humans and animals) because of this invention, it is still allowed to be used. What is wrong with the synthetic version? Why the hell do we need to use this crap just because some women have a few hot flashes. Get OVER yourselves. I will NEVER EVER use this stuff no matter what. I am writting to both companies, in fact I think I will start a petition…

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    1. It’s allowed because it is a drug and our senators and congress are highly vested in drug stocks! Hence, they would loose money!

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    2. When I asked my gynnie about the synthetic version, he told me that it “doesn’t work as well” as the one from mares’ urine. These docs are a trip. They get “paid” plenty of “perks” from Pfizer to push the medication and they think we’re stupid. No thank you, doc, I’m not going to have horses treated cruelly and even die for the sake of avoiding some hot flashes.

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  2. Good article! We need more people to warn us of the dangers of these drugs. Doctors don’t seem to feel the need and continue to prescribe these dangerous drugs. My mother took Premarin for over 30 years! I finally got her off of it. Her asthma has improved to the point that she doesn’t need to take as much medication for it.

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  3. Thank You Jane, for Providing this article, So Many Women Do Not Make The Connection Between the PMU industry and HRT’S, and many that do, have no idea of what the Mare urine industry truly is and what happens to these Mares and the Foals they produce..on top of that..Many are told the risks of HRT’s are out weighed by the benefits, many Women are not told that several Safer options exist, For Both Themselves and Horses!

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    1. Thanks Kathy. You are so right about many women being in the dark about these drugs. In fact, believe it or not there are some doctors who are unaware as well. Pharmaceutical companies can have very slick advertising and marketing campaigns that dupe the public and the medical profession. It is criminal.

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  4. This must be one of the quotes of the year on TH: “There are no watchdogs when it comes to Big Pharma, only lapdogs.” Thank you Jane for a terrific article. I hope everyone is sharing this far and wide, to men as well as women. Most men have a woman or two in their lives they care about.

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    1. Thanks Vivian. Agree, we all need to spread the word.

      And we can’t forget about the tragic fact that the majority of these mares and their foals are now being exploited in foreign countries where we here in NA have far less influence. We cannot give up the fight.

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  5. I never take a drug ….just because my doctor said so. Separating the wheat from the chafe is my responsibility. As I become older I not only become more responsible for myself but for others, the environment, animals ect. Even if it is reaching out to just one person at a time or one animal at a time…that in its self is making a difference especially to the one I have reached. You have to start somewhere. Thank you for a great article …sharing, twittering & pin.

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  6. We cannot defend and be kind to animals until we stop exploiting them. Exploiting them in the name of science, exploiting them in the name of sport, exploiting them in the name of fashion, and yes, exploiting them in the name of food.

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  7. No matter what the dangers using any of these drugs are there are millions of women all over the planet that will ignore the warnings and take them anyway. If their doctor prescribes it they think its safe. None of them would ever think about the cruelty involved producing it. Since the mares that produce the drug have been moved to China there is no one that can check to see just what is happening to the horses. We know where they and the foals they produce will go and are going. But what can any of us do about it? It sure wasn’t stopped here for 60 years. This government knew all about the cruelty that went on and the dangers of the drugs produced but chose to ignore it.

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    1. Thank you Barbara. But there are many things women (people) can do. We cannot expect the ones committing the crimes to wake up and change their evil ways, especially when they are raking in millions year after year by them, simply because we are sitting around talking and complaining about them!

      It takes people who care about the horses used and killed to make these vicious drugs and to people who know about them, to get active and stay active. The drug companies and the feds are not going to do it for us.

      Where have all the activists gone? We miss them and we need them. More importantly, the horses need them.

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