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]

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.