Duavive —The Yellow Trail of Horse Pee Drugs Crosses the Pond to Europe

by VIVIAN FARRELL and JANE ALLIN

PMU foal
PMU foal

The alleged duel-acting horse pee/bazedoxifene drug DUAVIVE—also known as DUAVEE in North America—has now made its way to the EU.

Its foundation drug Premarin, which alone and in combination, has been responsible for countless cancer deaths, has now crossed international boundaries.

How did this happen? Follow the trail.

APRELA

Wyeth—gobbled up by, and now a Division of, pharmaceutical giant Pfizer—started working on Aprela in 1999 as a sister, or follow-up drug, to Premarin and its family of drugs that include Prempro and Premphase.

These drugs are produced with the estrogen rich urine of pregnant horses to treat the effects of menopause. The drugs also have osteoporosis treatment properties.

What’s the difference between Premarin and Aprela? A subtle one.

Pfizer began working with Ligand in 1991 as a research and development collaboration to develop better therapies for osteoporosis which eventually yielding the formulation of the drug Aprela.

Aprela is a single-pill formulation of conjugated [equine] estrogen and selective estrogen receptor modulator bazedoxifene.

Bazedoxifene is used instead of a progestin to help protect the uterine lining against hyperplasia that may result from estrogen alone treatment.

Wyeth had originally planned to file for FDA approval of Aprela in 2007, but the submission was repeatedly delayed. After the merger Pfizer eventually submitted Aprela on behalf of themselves and its partner Ligand to the FDA in 2012.

DUAVEE

Aprela was finally approved under the name DUAVEE during the last U.S. federal government “shutdown”.

DUAVEE (conjugated [equine] estrogens/bazedoxifene), formerly known as APRELA, is a progesterone-free treatment for moderate-to-severe vasomotor symptoms (hot flashes) associated menopausal and the prevention of postmenopausal osteoporosis.

DUAVEE combines the selective estrogen receptor modulator (SERM) bazedoxifene with PREMARIN®.

In October, 2013, DUAVEE was approved by the U.S. FDA.

Additionally, in July 2012, Pfizer announced that the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for bazedoxifene/conjugated estrogens. (see http://www.ligand.com/pfizer)

If you think DUAVEE is not as dangerous to patients as the Premarin family of drugs, look at this:

    In the United States, Duavee is marketed with a black box warning. The warning points out that women taking Duavee should not take additional estrogens. The warning also notes that Duavee brings with it an increased risk for endometrial cancer in women with a uterus who use unopposed estrogens.

    Also included in the black box warning is a reminder that estrogen therapy should not be used to prevent cardiovascular disease or dementia. In addition, the prescription insert warns that the Women’s Health Initiative estrogen-alone study reported an increased risk for stroke as well as an increased risk for deep vein thrombosis. (see http://www.medscape.com/viewarticle/833909)

DUAVIVE

DUAVIVE is the European marketing name for DUAVEE.

Ligand issued a News Release that states:

    Pfizer received EU marketing authorization for DUAVIVE® (conjugated estrogens/bazedoxifene (BZA/CE)) from the European Commission.

    In the EU, DUAVIVE™ is indicated for the treatment of estrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.

    Ligand will be entitled to a milestone payment following Pfizer obtaining pricing of DUAVIVE® in a major European market.(see http://goo.gl/STgib0)

This is tragic news for women and horses.

The Ligand News Release also states in its Forward Looking Statements section:

    This news release contains forward looking statements by Ligand that involve risks and uncertainties and reflect Ligand’s judgment as of the date of this release. Actual events or results may differ from Ligand’s expectations. For example, there can be no assurance that conjugated estrogens/bazedoxifene or any product in the Ligand pipelines will be successfully developed, that any of the milestone triggers will be achieved, that regulatory approvals will be granted, that acceptable pricing will be achieved in a timely manner, that patient and physician acceptance of these products will be achieved, that final results of human clinical trials will be consistent with any interim results, that final results will be supportive of regulatory approvals required to market products or that any revenue will be achieved from this partnered program. (see link above)

Jane Allin, Research Analyst for The Horse Fund, who has unparalleled specialist knowledge on this issue states:

    In other words, take at your own risk. The Pfizer Ph-amily of carcinogens rules.

    Don’t believe the FDA approval process or the EU’s. Don’t believe that this drug is safe and most of all, these are simply conjugated estrogens.

    And what happened to the “equine” part of them? That they are made with pregnant mare’s urine?

In our opinion this clearly indicates that even more women are at risk to suffer and die. We know for certain from the decades long history of these drugs that the horses used to make them certainly will, and by numbers and in locations that will be close to impossible to discover.

Allin warns:

    Will the slick deceptive marketing ploy convince countries outside of the US to accept this as the panacea to age-related menopausal symptoms and osteoporosis?

    Until now, 92% of the sales of the Pfizer/Wyeth Premarin family of drugs has been apportioned to the United States.

    How convenient to market the synergistic effects of a known carcinogen and a risky SERM in a pretty little propaganda package that combats the woes of being female—both here and abroad.

    Unfortunately many will buy into it.

    Horse urine kills—don’t be a statistic.

END
© The Horse Fund (Int’l Fund for Horses)

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2 thoughts on “Duavive —The Yellow Trail of Horse Pee Drugs Crosses the Pond to Europe”

  1. I doubt that many women even bother to read what is printed in the black box. They believe anything their doctors tell them and never question it or bother to look up any information on this family of drugs. I have a good idea that a large number of breast cancers in older women is caused by taking one of these drugs. Watch in a few years the number of breast cancer cases in the EU starts to climb.

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    1. Surgery patients don’t get the chance to read the black box or have a say, it appears. Premarin is injected to decrease postoperative blood loss.

      LOOK what drugs.com says about it. Sorry this is so long.

      Premarin should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens may increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Premarin. Talk with your doctor if you have questions about the benefits and risks of using Premarin.

      Premarin should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects.

      AND

      Some medical conditions may interact with Premarin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

      – if you are pregnant, planning to become pregnant, or are breast-feeding
      – if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
      – if you have allergies to medicines, foods, or other substances
      – if you have a condition called hereditary angioedema
      – if you have a history of breast lumps, breast disease, or an abnormal mammogram, or if a member of your family has had breast cancer
      – if you have a vaginal infection or a history of uterus problems (eg fibroids, endometriosis, abnormal vaginal bleeding, cancer), or you have had your uterus removed (hysterectomy)
      – if you have a history of asthma, depression, diabetes, memory problems, seizures, gallbladder disease, pancreatitis, heart problems, high blood cholesterol or triglyceride levels, high blood calcium levels, high blood pressure, low blood levels of parathyroid hormone, or porphyria
      – if you have a history of kidney or liver problems, yellowing of the skin or eyes, cancer, lupus, migraines, thyroid problems, or chorea (jerky, involuntary movements of the face, arms, or legs)
      – if you smoke, use tobacco, are very overweight, will be having surgery, or will be confined to a bed or chair for a period of time
      – if a member of your family has had high cholesterol or triglyceride levels, blood clots (eg, in the leg or lung), or lupus, or has been very overweight

      Some MEDICINES MAY INTERACT with Premarin. Tell your health care provider if you are taking any other medicines, especially any of the following:

      – Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), or protease inhibitors (eg, ritonavir) because they may increase the risk of Premarin’s side effects
      – Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifamycins (eg, rifampin), or St. John’s wort because they may decrease Premarin’s effectiveness
      – Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Premarin

      There’s lots more at link below, such a side effects. The number are mind boggling.

      http://www.drugs.com/cdi/premarin.html

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