by JANE ALLIN
News of the FDA’s approval of Pfizer’s new combination drug – DUAVEE® – for the treatment of menopausal symptoms and prevention of osteoarthritis has traveled fast around the globe as have the myths surrounding it.
An online article originating in the UK is riddled with untruths and outright lies claiming that DUAVEE® is the panacea that all women have been waiting for – a drug that will “PREVENT” breast cancer. Nothing could be further from the truth.
What is appalling is that this clever marketing ploy may put thousands of credulous women at risk, even young women who need not expose themselves to the unknown risks of this novel and potentially lethal drug derived from Pregnant Mare’s Urine.
“A menopause treatment which could prevent breast cancer, rather than causing it, may soon be available for British women. Evidence shows the new hormone replacement therapy pill is even more effective at combating menopause symptoms, such as hot flushes, than the standard treatment. But crucially, early trials show it may prevent growth of breast cancer tumors. Existing forms of HRT, by contrast, are thought to cause the disease. Researchers say it could be given to millions of women worldwide who are too afraid to take menopause treatment due to the risk of breast cancer. And they also believe it could be given to younger women with a strong family history of the disease to prevent it occurring.”
MYTHS AND FACTS
|Myth:||DUAVEE® prevents breast cancer.|
|Fact:||DUAVEE® comes with the same boxed warning as well as other warnings and precautions that appear on the labels of previously approved estrogen products (i.e. Premarin®, Prempro®) including increased risk of breast, endometrial and ovarian cancer. The effect of DUAVEE® on the risk of breast, endometrial and ovarian cancers is “UNKNOWN”.|
|Myth:||DUAVEE® is more effective at combating menopausal symptoms than standard HRT|
|Fact:||DUAVEE® is more effective than a placebo, yet conventional HRT (i.e. Premarin®, Prempro®) reduces the incidence of these symptoms to a much greater extent.|
|Myth:||DUAVEE® can be given to millions of women world-wide as well as younger women with a strong history of breast cancer.|
|Fact:||DUAVEE® is only intended for postmenopausal women with an intact uterus, should not be used in women with undiagnosed abnormal uterine bleeding; known, suspected, or past history of breast cancer or estrogen-dependent neoplasia; active or past history of venous or arterial thromboembolism; hypersensitivity to estrogens, bazedoxifene, or any ingredients; known hepatic impairment or disease; known thrombophilic disorders. Women who are or may become pregnant and nursing mothers should not use DUAVEE®.
Repeat — The effect of DUAVEE® on the risk of breast, endometrial and ovarian cancers is “UNKNOWN”.
|Myth:||DUAVEE® is safe.|
|Fact:||DUAVEE®’s safety profile is tenuous at best. Bazedoxifene, the osteo- component, (currently not approved by the FDA) is proven to increase the incidence of stroke, deep vein thrombosis, retinal thrombosis and hot flushes while conjugated equine estrogens (CEEs) extracted from pregnant mare’s urine increase the risk of many cancers and other life-threatening diseases. Boxed warnings clearly outline the seriousness and potentially life-changing side effects of DUAVEE®.|
BEWARE BIG PHARMA
There is a deep conflict of interest when pharmaceutical companies sponsor trials on their own drugs; recall that the clinical studies for DUAVEE® (formerly Aprela®) were funded by Pfizer.
What is most unsettling about the approval of DUAVEE® is that Pfizer is notoriously known for their participation in so-called “ghost management” of research and publication – corporate science so to say. See http://goo.gl/Waon4x.
Sadly “ghost writing” and failing to publish negative and unfavorable results from clinical trials is commonplace for unscrupulous Big Pharma and medical researchers. This precise conspiracy was used by Wyeth, now a division of Pfizer, where ghostwriters were hired to prepare over 40 medical journal articles promoting the benefits of its hormone-replacement drug Premarin® while downplaying the risks. See http://goo.gl/3K1bBn.
Did DUAVEE® gain FDA-approval using the same tactics? We will never know.
SAFER NON-HORMONAL PRESCRIPTION ALTERNATIVE NOW AVAILABLE
While the FDA’s approval of DUAVEE® is indeed disappointing, one can only hope that due to the established serious risks of each individual component of this drug, physicians will be cautious in prescribing it.
Of particular interest is the recent FDA approval of the first non-hormonal therapy proven to treat severe vasomotor symptoms (VMS). Despite the fact that any drug carries with it some level of risk, Brisdelle™, manufactured by Noven Pharmaceuticals is, undoubtedly, a safer alternative to the unknown effects of DUAVEE® over the longer term.
Keep in mind that the boxed warnings for DUAVEE® are identical to those for Premarin® and Prempro® – all three of these drugs contain CEEs and when assimilated in the body form equine metabolites that have toxic properties with carcinogenic risk factors. See http://goo.gl/7lO5i9
Brisdelle™ is a low-dose (7.5 mg/day) version of paroxetine (paroxetine mesylate). This is in the same group of drugs such as Paxil (paroxetine hydrochloride) and Pexeva (paroxetine mesylate) – serotonin reuptake inhibitors (SSRIs) used to treat a number of psychiatric disorders but in higher doses than Brisdell™ (www.brisdelle.com). Noven also manufactures Pexeva™.
Two randomized, double-blind, placebo-controlled studies with a total population of 1,175 menopausal women experiencing moderate to severe hot flashes were used to evaluate the efficacy and safety of Brisdell™. See http://goo.gl/04xsPn.
Results from two Phase 3 clinical studies, published in Menopause, the peer-reviewed, scientific journal of The North American Menopause Society, show that Brisdell™ reduced both the frequency and severity of hot flashes compared to a placebo. See http://goo.gl/771fTH.
The mechanism by which hot flashes are reduced is complex and thought to differ from those involved in the treatment of psychiatric disorders.
Brisdell™ carries with it the same risks and side effects as higher-dosage SSRI anti-depressants but is well tolerated for the vast majority of people. See http://goo.gl/04xsPn.
Furthermore the adverse effects and withdrawal symptoms associated with higher paroxetine doses appear to be avoided with the lower 7.5 mg dose. See http://goo.gl/771fTH.
“The approval of Brisdelle™ is significant because it meaningfully expands the therapeutic options for the 24 million women in the U.S. affected by moderate to severe VMS, two-thirds of whom are not currently treating these often debilitating symptoms,” said Joel Lippman, M.D., FACOG, Noven’s Executive Vice President – Product Development and Chief Medical Officer. “Noven has long focused on developing and offering therapies to address women’s menopausal health concerns, and we are pleased to address the diverse needs of this population.”
Some may ask – why recommend yet another prescription drug manufactured by a pharmaceutical company? First and foremost is that Brisdelle™ (paroxetine 7.5 mg) is free from pregnant mare’s urine together with the fact that cancer and other dire health risks are not side effects – killing two birds with one stone so to speak.
It has long been known that certain antidepressants are effective in reducing hot flashes in menopausal women. Selective serotonin reuptake inhibitors (SSRIs) affect the brain’s use of the neurotransmitter chemical serotonin which is thought to have a role in regulating body heat. Moreover, increased serotonin can also improve menopausal perimenopausal irritability, depression and moodiness. Paroxetine is one such drug belonging to the family of SSRIs.
When evaluating potential medications for treatment of a particular condition, prescription or otherwise, there is a need to consider the benefit-risk balance of any or all recommended drugs/therapies. In some cases the decision is a difficult one to make. One factor of relevance is how long a drug has been on the market and its long-term safety profile.
Paroxetine was first marketed in 1992 by the pharmaceutical company Smithkline Beecham, now GlaxoSmithKline and is sold under the trademark Paxil. Generic versions have been available since 2003 when the patent ran out. See http://goo.gl/4Oia1A. As with any drug there are side effects associated with Brisdelle™ (low dose paroxetine 7.5 mg) but none of them include the insidious cancers and other life-threatening risks associated with CEEs and SERMs.
Encouragingly several studies of higher dose (20 mg) paroxetine for the treatment of depression and depression-associated anxiety have shown that it is effective, well-tolerated and safe with nausea being the commonest adverse event reported. See http://goo.gl/j6AfcI.
What’s more, side effects tend to occur early during therapy and are usually temporary with no new adverse events emerging over the long term. See http://goo.gl/j6AfcI.
Despite the fact that Brisdelle™ is a new drug in the paroxetine family of SSRIs the history of paroxetine derivatives is well established. A full description of possible side effects of Brisdelle™ can be found here.
Keep in mind that the boxed warnings for DUAVEE® are identical to those for Premarin® and Prempro® – all three of these drugs contain CEEs and when assimilated in the body form equine metabolites that have toxic properties with carcinogenic risk factors.
As with any prescription drug there are warnings and precautions to be aware of, some of them serious; those listed for Brisdelle™ are taken from the safety profiles of other SSRIs at higher doses. For the most part, common side effects are mild and decrease in frequency with continued therapy (headaches, fatigue, malaise, lethargy, nausea, vomiting).
Although no drug is 100% safe, the bottom line is that apart from patients 24 and younger (possibility of a small increased of suicide risk during the first few months of medication (http://goo.gl/E92LP1) paroxetine has a favorable risk-benefit profile for the greater majority of people.
Given that Brisdelle™ will be prescribed to women suffering from the symptoms of perimenopause or menopause the risk of suicide in this cohort is significantly diminished. In fact some studies show that there is no increase in suicidality in older people while others conclude that a greater suicide risk is not associated with any type/class of antidepressants including SSRIs. See http://goo.gl/1MbGYZ; http://goo.gl/gpxklG.
In contrast DUAVEE® contains Premarin® – a known carcinogen, and bazedoxifene – a selective estrogen receptor modulator (SERM) not yet approved by the FDA due to increased risks of stroke and deep vein thrombosis. See http://goo.gl/84qdBw.
Nothing more to say there – two drugs, both with serious life-threatening risks associated with them. One drug a demonstrated killer the other not even approved by the FDA.
In no way is this intended to promote the use of prescription drugs for the treatment of menopausal symptoms. Not all drugs are suitable for everyone nor are they without some risk – this is simply a comparison of the perceived risk/benefit profiles of Brisdelle™ and DUAVEE®. While there are risks associated with both drugs, the boxed warnings are especially disconcerting for DUAVEE® given the track record of HRT medications containing conjugated equine estrogens (CCEs).
There is a long ugly history for these drugs – adulterated with deception, conspiratorial marketing campaigns, fraud and most importantly death – while the emotional and physical scars of the survivors and their families live on. Together with an unapproved drug known to increase the risk of stroke and deep vein blood clots – clots that may break loose into the bloodstream and migrate to the lungs causing pulmonary embolism and potentially death – the safety profile of DUAVEE® seems ill-omened.
In fact Premarin® itself is a precursor of deep vein thrombosis and pulmonary emboli. According to a recent joint University of Washington (UW) – Group Health study in JAMA Internal Medicine, women who were prescribed estradiol – a bio-equivalent estrogen – experienced fewer vascular events than did those prescribed Premarin®. See http://goo.gl/KXTaiD.
Furthermore, compared to estradiol users, Premarin® users had levels of blood clotting (coagulation) factors that made them more apt to form blood clots, demonstrating that conjugated equine estrogens contribute directly to these thrombotic events. See http://goo.gl/KXTaiD.
Seriously, is DUAVEE® worth the risk?
Menopause is a natural transition in every woman’s life, not an illness. Often the symptoms can be alleviated through safe, humane alternatives rather than relying on drugs derived from conjugated equine estrogens extracted from pregnant mare’s urine.
Brisdelle™ is the first approved prescription non-hormonal drug shown to be effective in the treatment of menopausal symptoms but there are other options that may be equally effective. Please refer to our compilation of alternative treatments on the International Horse Fund website at http://www.horsefund.org/pmu-alternatives-to-cee-drugs.php.
LEST WE FORGET THE HORSES
When God created the horse, he said to the magnificent creature:
I have made thee as no other.
All the treasures of the earth shall lie between thy eyes.
Thou shalt cast thy enemies between thy hooves,
but thou shalt carry my friends upon they back.
Thy saddle shall be the seat of prayers to me.
And thou fly without any wings, and conquer without any sword. ~ The Koran
© Int’l Fund for Horses
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