by JANE ALLIN
2013 was a tumultuous year for the plight of horses.
What with the precarious and unnerving threat of horse slaughter resuming in the U.S., the adulterated horsemeat scandal in the EU and the continuing issues with the BLM’s incompetent range management of the wild horses, slaughter risk for these American icons and the shameless abuse during roundups and within holding facilities there was no dearth of trepidation for horse advocates around the globe.
As much as the PMU mares and their foals are not on the radar at all times, the exploitation and sad fate of these trusting creatures is nonetheless equally as important.
Despite the dwindling presence of PMU farms in North America and the subsequent relocation to China and other foreign lands, sales of the Premarin family of drugs derived from the urine of pregnant mares remain strong in North America and Pfizer continues to reap in vast rewards at the expense of these innocent mares and their foals. Jump to How You Can Help.
TWO NEW NON-HORMONAL THERAPIES FOR MENOPAUSAL SYMPTOMS DENIED APPROVAL
In mid-2012, New Drug Applications (NDAs) for two new promising drugs which would potentially serve as alternatives or replacements for the carcinogenic Premarin family of drugs were filed and later accepted by the FDA with Prescription Drug User Fee Act (PDUFA) action dates assigned mid-2013.
Each of these drugs was developed due to the concern about risks associated with conventional hormone replacement therapy (HRT) manufactured from the urine of pregnant mares (i.e. Premarin, Prempro).
At this time hormone replacement therapy manufactured from pregnant mare’s urine was the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes. In the United States alone there is an estimated 32 million women who experience menopausal hot flashes, of whom 13 million seek medical treatment.
The two drugs under review were both non-hormonal therapies and specifically designed to alleviate vasomotor symptoms associated with menopause.
Serada, manufactured by Depomed Inc., is an investigational formulation of another drug – Gabapentin (Neurontin), an FDA-approved immediate release pharmaceutical – originally developed for the treatment of epilepsy and currently also used to relieve neuropathic pain and vasomotor symptoms (hot flashes) associated with menopause and in women with breast cancer.
Noven Pharmaceuticals low-dose mesylate salt of paroxetine (LDMP) is a selective serotonin reuptake inhibitor (SSRI) with a chemical structure related to paroxetine hydrochloride (brand name Paxil). The use of off-label anti-depressants – for example, paroxitine (Paxil), venlafaxine (Effexor), fluoxetine (Prozac) and sertraline (Zoloft) – to offer some relief of vasomotor symptoms associated with menopause is not new.
Both of these drugs would serve the market well given that vasomotor symptoms – hot flashes and night sweats – are the most common medical complaint of peri-menopausal and post-menopausal women affecting upwards of 80% of women experiencing menopause. In fact, there is evidence that sleep disturbances due to moderate to severe hot flashes is the leading driver of women seeking prescription HRT products.
But this was not to be.
On March 4, 2013, the US Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee voted that the overall risk/benefit profiles of both Serada and LDMP were not acceptable to support approval. The FDA committee, based on their own analysis, suggested that clinical data looking at the drugs’ effectiveness in reducing the frequency and severity of hot flashes were mixed and didn’t meet all required efficacy endpoint goals.
What was particularly disappointing about this verdict is that both of the parent drugs – gabapentin and paroxetine – despite being unapproved products for VMS are indeed prescribed for these very symptoms and have proven to be safe and effective in doing so.
HRT PREVENTS BREAST CANCER?
There was also no shortage of diehard Premarin advocates attempting to promote the benefits of conjugated equine estrogen (CEE) derived HRT; evidently more propaganda to distance the facts from the clever marketing strategies to further muddle the minds of middle-aged women.
Not surprisingly these incidences involve physicians blindly and doggedly promoting Big Pharma’s misinformation. In this case a Dr. Timothy Bilash specializing in women’s health issues was encouraging women of all ages to attend an informational talk regarding a study claiming that there is a reduced incidence of breast cancer while taking estrogen.
Time and again estrogen has been shown to play a major role in promoting the proliferation of breast cancer cells. The association between estrogen and cancer is nothing new. In fact In December 2002, the hormone estrogen was declared a known human carcinogen by the National Toxicology Program.
Yet every year a study surfaces that tries to dispel this.
The study Dr. Bilash was referring to appeared online in the journal Lancet Oncology in March of 2012 and was authored by Garnet L. Anderson PhD., “Conjugated equine oestrogen and breast cancer incidence and mortality in postmenopausal women with hysterectomy: extended follow-up of the Women’s Health Initiative randomized placebo-controlled trial.”
However the question arises as to the validity of this study and any politics behind it if in fact any exist. There is nothing new about Big Pharma’s conspiracies and their ability to insert distorted information into so-called “scientific” medical journals and use them as marketing tools.
On closer examination of the robustness of this study it seems sadly lacking – much of it indicates a total lack of control on the researcher’s part – more of a “soft science” area of statistics rather than a rigorous study with defined formal phases. Without all the women taking either the estrogen-HRT or placebos for the full length of the study or in lower dosages, particularly the HRT group, the study seems inherently flawed.
Fortunately there are those in the medical community that recognize these rogue studies. Valerie Beral, director of the cancer epidemiology unit at Oxford University was not convinced citing that the conclusion of the study was inconsistent with the totality of evidence that finds estrogen increases breast cancer risk.
FDA APPROVES FIRST NON-HORMONAL DRUG FOR TREATMENT OF “HOT FLASHES”
In early June 2013 the U.S. Food and Drug Administration approved the drug “Brisdelle” (paroxetine) for the treatment of hot flashes due to menopause.
Brisdelle, manufactured by Noven Pharmaceuticals, is the first non-hormonal treatment to be approved by the FDA for hot flashes associated with menopause.
Brisdelle contains the selective serotonin reuptake inhibitor paroxetine mesylate, making it unique from all other FDA-approved treatment for hot flashes which contain the hormones estrogen or progestin. In fact Brisdelle is the same drug, formerly known low-dose mesylate salt of paroxetine (LDMP) that was rejected by the US Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee in March of 2013 citing that the drug’s effectiveness in reducing the frequency and severity of hot flashes were mixed and didn’t meet all required efficacy endpoint goals.
The good news is that the FDA is not bound by the recommendations of its advisory committees, such that ongoing reviews of the New Drug Applications (NDA) for LDMP continued until the scheduled Prescription Drug User Fee Act (PDUFA) action dates. Evidently Noven diligently worked with the FDA as it completed its ongoing evaluation to prove that their trial data supported LDMP as a safe, effective non-hormonal treatment option offering clinical benefit to menopausal women.
The approval of Brisdelle is a significant milestone since 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.
NORM LUBA, KING OF THE HORSE PEE INDUSTRY, CRIES FOUL
There will always be those that continue to promote and defend the atrocities associated with the PMU industry — those who profit from the exploitation of both women and horses alike.
In a letter addressed to the Concord Monitor (Concord NH) Norm Luba, Executive Director of NAERIC (North American Equine Ranching Council) a non-profit association involved in the collection of pregnant mare’s urine (PMU), carried on about “Unfair charges against mare urine industry”.
In this diatribe he pointed out that experts from American Association of Equine Practitioners (AAEP), Canadian Veterinary Medical Association (CVMA), and International League for the Protection of Horses (ILPH) (now operating under the name World Horse Welfare) reviewed PMU ranches during the collection season to observe the horses’ health and welfare. According to their consensus report, they proclaimed that the allegations of inhumane treatment of horses involved in PMU ranching are unfounded.
Nothing unusual there given that all three of these organizations are pro-slaughter. Enough said.
Do not be tricked with Luba’s insipid drivel into believing this industry is above board in its treatment of the horses – mares tethered to urine collection bags for much of their 11 month pregnancy, confined to tiny stalls unable to turn around and re-impregnated year after year until they are spent and sent to the slaughterhouse. And then there are the foals – the innocent by-products, many of which see the same fate as the spent mares.
Besides, there is a lot more to the PMU industry than Luba alludes to. With its ties to Big Pharma and the slaughter industry – the hidden agenda – how can anyone condone such a statement that dismisses the allegations of inhumane treatment of the PMU horses? It’s not just the dreadful conditions the mares are subject to, none of which is remotely “normal” for a horse of any kind, it’s the fact that these innocent mares and their foals are considered disposable items routinely sent to slaughter when their usefulness subsides.
Just more propaganda to champion a cruel and merciless industry – one that serves no benefit to the horses or the women who continue to foolishly, or naively, gamble with their lives.
APRELA’S APPROVAL DATE LOOMS CLOSER
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October 3, 2013 is the day that the U.S. Food and Drug Administration (FDA) will make a decision whether or not to approve Ligand Pharmaceutical’s dual-acting drug Aprela for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone a hysterectomy.
Aprela is a combination of Premarin, which lost patent protection in February 2012, and bazedoxifene, a selective estrogen receptor modulator or SERM also known as Viviant specifically developed to help prevent postmenopausal osteoporosis. Of particular note is that Viviant has failed to receive approval from the FDA as a result of increased risks of stroke and thromboembolic events.
Many in the industry are of the opinion that there will be impediments to the approval – at least from an ethical perspective if nothing else. Pfizer has essentially taken two drugs with significant safety concerns and packaged them together – bazedoxifene and its tromboembolic effects and the established risks of CEE-derived HRT which include a plethora of insidious diseases, most notably cancers and cardiac events.
The consensus is that even if Aprela is approved it will have a minimal impact on the osteoporosis market as a result of other more efficacious therapies that are currently available. Moreover even with Pfizer’s marketing expertise, Aprela may not be able to surpass the mounting wave of mediocre efficacy data and a suspect safety profile.
In any case, in essence it is not the efficacy that is of concern but more so the safety aspect and the continued abuse of the pregnant mares and their foals. Pfizer claims that preliminary, and very limited (1-year), studies of Aprela have not shown to prove deleterious to the overall health of women in terms of carcinogenic effects.
That said these studies are insufficient in evaluating longer-term safety effects of the combination drug. Specifically, the studies did not evaluate adverse events (AEs) such as cancers that occur relatively infrequently which are considered primary risk factors with conventional HT. Consequently, in addition to reduced efficacy compared to Premarin, there is no guarantee that Aprela provides a better long-term safety profile than standard HT.
A WORD FROM A BREAST CANCER SURVIVOR
Blind trust – nations of menopausal women follow their physicians’ recommendation to employ the use of HRT derived from Pregnant Mares Urine for the relief of menopausal symptoms. Unfortunately the inauspicious effects of using these drugs have adversely affected thousands upon thousands of unsuspecting women.
The reality is that there is nothing more poignant than the words of those whose lives have been forever altered due to the devastating effects of these drugs unscrupulously peddled by the indifferent pharmaceutical industry and yes, doctors – the pawns of their marketing schemes.
“I took these hormones [Prempro] for my change of life and had my first breast cancer in 2002 & my other one in 2007. Both breasts were removed. My lawyer threw us women under the bus and settled with Pfizer. The lawyers made out like a fat rat while we all ended up with very little. In the meantime the animals are the ones who have to suffer because of the pharmaceutical companies. It’s downright cruel.”
Oft time it has been stated that doctors and the pharmaceutical industry are drug dealers and that the guidelines relating to the collaboration between healthcare professionals and the pharmaceutical industry are self-regulated and detrimental to the welfare of the patient. With a wealth of information regarding the potentially devastating effects of HRT doctors are still loathe the prescribe anything else.
It’s called “Bad Pharma” – the ability of drug companies to mislead doctors and harm patients. Why and how these seemingly intelligent individuals succumb to the whims of Big Pharma is perplexing yet explicable. Impressionable medical students are indoctrinated into the drug-based model of disease care and brainwashed in medical school to favor the drug paradigm.
Don’t fall prey to the brainwashing game.
It’s up to you to protect yourself. Rather than just accepting whatever prescription your doctor gives you discuss all the options available. It could save your life.
BIG PHARMA WINS AGAIN: FDA APPROVES APRELA UNDER NEW NAME
FDA Manages to defeat the mares, their foals and menopausal women yet again.
Despite government shutdown, on October 3, 2013 the FDA approved the dual-acting drug DUAVEE, formerly known as Aprela, for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis in women who have not undergone a hysterectomy. 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 – a drug that has yet to gain approval in North America due to increased risk of stroke and venous thromboembolic events.
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.
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; cancer, cancer and more cancer, blood clots, high blood pressure, heart attack, stroke, dementia, the list goes on.
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.
Has the FDA yet again been bullied by Big Pharma into approving a potentially dangerous drug that could negatively affect the lives of thousands of unsuspecting women? It wouldn’t be the first time, nor will it be the last.
Last, but in no way least, is the plight of the horses now confined to PMU ranches in China and other foreign lands. A video report from BONTV – Horse urine a profitable industry in China – sadly recounts the thriving industry abroad.
Regrettably the suffering will continue at its worst; the new beginning in China bodes a critical end for the innocent mares and their foals.
Distance – the great separator. Who will be there for them in their new homeland?
Perhaps there is a glint of hope.
While the horrors of animal abuse in China have painted an ugly picture for many around the globe, over the past several years there have been major developments in support of the plight of animals at the hands of these abhorrent and unforgiving industries and practices.
Raising awareness and educating those who now preside over the welfare of the PMU mares and foals will be paramount in transferring our efforts to a distant land unaccustomed to the realities of the negative implications of these drugs from both a human and equine perspective.
It does not matter where one hails from; it is the goodness in each of us that promotes welfare and justice.
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
HOW YOU CAN HELP
Please print and send our Dear Physician Letter (3 pp) to OB/GYNs where you live. The letter was researched and prepared by the author of this post, Jane Allin.
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