Tag: carcinogenic

In February of this year Pfizer announced their intention to seek U.S. regulatory approval for the combined menopausal-osteoporosis drug Aprela®, a combination of Premarin® and bazedoxifene. Bazedoxifene is a Selective Estrogen Receptor Modulator or SERM also known as Viviant® specifically developed to help prevent postmenopausal osteoporosis.

Viviant® has failed to receive approval from the FDA as a result of increased risks of stroke and thromboembolic events although it has been approved for use in other countries (i.e. EU and Japan) under different trade names.

If and when approved, Aprela® will be offered as an alternative to Pfizer’s controversial hormone-replacement therapies – Prempro® and Premarin® – both associated with increased cancer and cardiovascular risks among countless other maladies. Aprela® is predicted to restore the HRT market with peak sales of approximately $1 billion if approved in 2013. Some speculate that approval in North America will be not be sanctioned given the delays in developmental stages and inherent risks associated with both components that comprise the new drug.

On February 17, 2012, just shortly before the Premarin® patent expired, Pfizer and Zhejiang Hisun Pharmaceutical, a leading pharmaceutical company in China, signed a framework agreement pursuant to an earlier announcement which would establish a joint venture to develop, manufacture and commercialize off-patent pharmaceuticals in China and global markets.

Ostensibly this was a direct consequence of Premarin’s patent expiration with the potential to drive brand sales over the long term and substantially boost overall sales give China’s large population.

Nearing the end of March the Int’l Fund for Horses revealed, via information procured from an inside source at a bulk powder conjugated estrogen manufacturing company in China, that PMU farms have been in operation in Northern China for the last 8 years with the company’s manufacturing site also in the same location.

This more or less coincides with the release of the WHI study citing the horrors associated with CEE-derived HRT. Well aware of the risks involved, Wyeth had probably begun to move their PMU facilities prior to or just after the damning results of the WHI were released to the public.

On April 1, 2012 a large study was presented at a cancer conference in Chicago. The research involved roughly 60,000 nurses who participated in The Nurses’ Health Study. Data was analyzed from 1980 through 2008. Women who took both estrogen and progesterone (Prempro for example) had an 88 percent higher risk of breast cancer after 10 years on the treatment.

Those who took estrogen alone for at least a decade had a 22 percent increased risk of developing breast cancer. Those women who were exposed to just estrogen for more than 15 years had a 43 percent greater chance of being diagnosed with breast cancer.

Despite the continuing efforts of the medical profession and Big Pharma to reassure women that taking estrogen by itself, short term, to relieve symptoms will decrease the risk of breast cancer, the data continues to roll in against this reasoning. There’s a continued increase in risk with longer durations of use and there does not appear to be a plateau.

In May results of a study conducted at Massachusetts General Hospital in Boston revealed that hormone replacement therapy taken by some women after menopause is linked with ulcerative colitis. It is a disease of the colon (large intestine) or rectum causing diarrhea, abdominal cramping and rectal bleeding. Data from nearly 109,000 women past menopause enrolled in the Nurses’ Health Study that began in 1976 indicate that those on hormone therapy had a 1.7 times higher risk of ulcerative colitis, compared to never-users.

Also in May Pfizer announced a restructuring of its estrogen extraction plant at Brandon, Manitoba calling for about 40 per cent fewer employees by the end of next year. Pfizer stated that it plans to cut about 50 of 130 positions at the plant “gradually through to the end of 2013. Apparently this layoff will not affect the PMU ranchers “for now”. Time will tell.

On the heels of the announcement that Pfizer would be downsizing their Brandon Manitoba estrogen extraction plant, in June the Int’l Fund for Horses learned, through direct correspondence, that certain companies seeking to get into the generic Premarin® market are looking to enter into contracts with PMU ranchers for the collection of pregnant mare’s urine ostensibly as Pfizer vacates them.

As much as the patent stifled the competition for such a long time, there is no doubt that during these years the technology for manufacture has been developed by other pharmaceutical companies awaiting the loss of patent protection.

Of course the lawsuits continue. Also in June the price tag Pfizer’s Prempro® settlements was estimated.

The drugmaker has paid $896 million to wrap up about 60% of the patient lawsuits representing about 6,000 cases Pfizer has also set aside more money–$330 million–to cover the rest of its Prempro® liability for about 4,000 suits still outstanding. Total: $1.226 billion for 10,000 cases. The company also noted that the extra $330 million is just an estimate and may not cover all of the remaining 4,000 claims.

In July more deception by the medical profession surfaced. A coalition of leading medical groups has concluded that hormone-replacement therapy can be useful and safe for many women suffering from the symptoms of menopause.

The coalition includes 15 medical groups, including the North American Menopause Society, the American Society for Reproductive Medicine, the Endocrine Society and the American Academy of Family Physicians. The goal of the statement, released Monday, is to reassure women and doctors that hormone-replacement therapy (HRT) is acceptable and relatively safe for healthy, symptomatic, recently postmenopausal women.

With concerns about risks associated with conventional hormone replacement therapy manufactured from the urine of pregnant mares (i.e. Premarin®, Prempro®) Depomed Inc., a specialty pharmaceutical company headquartered in Newark, CA submitted a New Drug Application (NDA) to the U.S. FDA on July 31, 2012 for Serada™ – an extended time release formulation designed to provide women with prolonged relief of menopausal “hot flashes” with potential for reduced side effects.

Approximately one month later on August 29, 2012, Noven Pharmaceuticals announced that it had submitted a NDA for low-dose mesylate salt of paroxetine (LDMP) to the FDA also seeking approval for the treatment of vasomotor symptoms associated with menopause. LDMP is an investigational oral non-hormonal therapy specifically developed for the treatment of vasomotor symptoms due to menopause.

The FDA formally accepted the application for Serada™ on October 15, 2012 and established a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. Similarly, the application for LDMP was also accepted with an assigned PDUFA action date of June 28, 2013. These dates represent the goal date for the completion of the FDA NDA review.

Hormone replacement therapy (HRT) manufactured from pregnant mare’s urine is currently the only FDA-approved single-agent therapy for the treatment of menopausal hot flashes. Such non-hormonal drugs as these would be a welcome reprieve for women and horses alike.

In October Martha Rosenberg long-time writer about the issues surrounding the Premarin® family of drugs penned another excellent article: “Will Women Have Short Memories About Hormone Replacement Therapy?”

The question arises as to whether a new generation of women approaching menopause will lose sight of the HRT lessons of the 1970’s and 2000’s. No doubt Big Pharma’s slick marketing tactics will try to sway this generation in favor of these carcinogenic drugs despite the risk. It has never stopped them before and the FDA still condones their sales.

THE HORSES

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

by JANE ALLIN

Further studies indicate higher risks of asthma, lung cancer, malignant melanoma, and reduced insulin resistance associated with HRT.

Since 1976, Wyeth (now a Division of Pfizer) have been fighting on-going lawsuits related to the use of their Premarin® family of drugs. This number is estimated to be as many as 5000 cases primarily related to the incidence of breast cancer.

Pfizer’s/Wyeth’s estimated sales figures suggest that Aprela will be available on the market in 2011.

Pfizer Q4 2009 earnings from Biopharmaceutical were $14.6 billion, an increase of 30% compared with $11.2 billion in the year-ago quarter.

Operationally, revenues increased $2.9 billion, or 26%, of which $2.5 billion, or 22%, was attributable to legacy Wyeth products, primarily Premarin® in the Primary Care unit.

Pfizer/Wyeth’s projected sales for their HRT therapies (Premarin®, Aprela®) to exceed one billion USD by 2015.

Pfizer Inc. re-affirms confidence in its (Wyeth) hormone therapy medicines (Premarin®) as important treatment options for symptoms of menopause and osteoporosis.

Hormone replacement therapy makes a comeback in New York Times magazine article called “The Estrogen Dilemma”. One of the authors, Cynthia Gorney, spins a poignant tale about a psycho-socio-hormonal-spiritual breakdown that led her to hormone discipleship in midlife. Turns out that Gorney’s “sources” are (1) the Wyeth funded Roberta Diaz Brinton, (2) Thomas Clarkson-who worked with the Wyeth ghostwriting firm, DesignWrite-and Louann Brizendine and (3) Claudio N. Soares, who have served as actual paid Wyeth speakers.

Pfizer Inc. announces closure of eight manufacturing plants, decreased production at six others and 6,000 job cuts since acquiring rival drug maker Wyeth.

Plans are to cease operations at several plants in Ireland, Puerto Rico, Germany, Britain and the United States by late 2015.

Pfizer manufactures three former Wyeth hormone-based medications in Rouses Point: Premarin®, Premarin® Vaginal Cream and Prempro® which will close in 2011. Manufacturing responsibility for these products is expected to be mostly shifted to other Pfizer sites once the company permanently pulls out.

Due to increased risks of stroke and thromboembolic events, the FDA delays the approval of Bazedoxifene (Viviant®), the osteoporosis component of Aprela®. Once slated for release in 2011, Aprela is now subject to delay as well (possibly 2012 or later).

Giant drug manufacturer Wyeth, a division of Pfizer, announces their intention to downsize the PMU industry through the cancellation of ranch contracts that will see their numbers dwindle from the current 64 to as few as 25. Herein lies a conundrum based on their projected sales for Premarin® and Aprela® of more than 1 billion USD by 2015.

Pfizer, the world’s largest drug maker, announces the withdrawal of its new drug application (NDA) for Fablyn® a selective estrogen receptor modulator (“SERM”) for the treatment of both osteoporosis and selected consequences of menopause. As with other SERMs, Fablyn® has been shown to have significant side-effects which contraindicate widespread use. Of note is that Viviant®, the osteoporosis component of Aprela® , is also a SERM.

The apparent ambiguity of the relationship of the decrease in North American PMU industry and projected sales of Premarin® and Aprela® is solved.

According to an article in The Western Producer; “Wyeth plans to ramp up production of PMU facilities in China, Kazakhstan and Poland, out of the scrutiny of North American values. The byproduct of meat foals has a lucrative market, while Wyeth can continue to make statements relating to supply and demand to justify price of HRT”.

THE HORSES

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

by JANE ALLIN

2001: First results of the WHI study are released spreading bad news to not only doctor’s offices but also Wall Street. Although physicians remained ambiguous about the results of increased cancer risk and heart attacks, shares of Wyeth fell 19%. The company responded by emphasizing it was the combination therapy of estrogen-progestin Prempro® and not Premarin® that was at fault.

2002: Barr Laboratories suffers at the hands of Wyeth. A Minnesota Federal judge finds that Barr misappropriated trade secrets thereby protecting Wyeth’s lucrative monopoly of Premarin®.

Government scientists abruptly end the WHI HRT study – the nation’s largest – which states that long-term use of estrogen and progestin significantly increases women’s risk of breast cancer, strokes and heart attacks.

After the government’s announcement, millions of women discontinue the use of HRT – down from about 6 million users for Prempro® to 3.3 million.

FDA announces it will more thoroughly evaluate HRT use – the first official response from the government.

Prempro®’s sales plummet 32% for 2002.

2003: Further studies indicate there were increased incidences of cardiovascular events, and breast cancer in women taking the combination therapy drug Prempro®.

FDA orders that both medications – Premarin® and Prempro® – carry warning labels advising users of the increased risk of heart disease, stroke, breast cancer, pulmonary embolisms and blood clots.

Additional results from the NIH study indicate that HRT contributes to dementia.

Media reports escalate the public awareness of the sequestered pregnant mares and slaughtered foals – the “byproducts” of the PMU industry.

2004: As a result of falling sales of Premarin® and Prempro®, Wyeth introduces a lower dosage estrogen-progestin drug claiming it is safe.

The estrogen-only (Premarin®) division of the WHI study continues to 2004 but it also is terminated prematurely due to indications of increased risk of stroke, deep vein thrombosis and without benefit in terms of coronary heart disease.

Sales of Premarin® and Prempro® freefall from $1.3 billion in 2002 to $880 million in 2004.

2005: Wyeth closes a manufacturing plant and eliminates 15% of its sales force as sales of Prempro® falls 76% and Premarin® 47%.

Wyeth asks the FDA to investigate independent pharmacies producing bio-identical hormone replacement therapy (BHRT) claiming there are potential risks to women’s health and possible violations of manufacturing practices. In October of 2005, Wyeth files a “Citizen’s Petition” demanding the ban of bio-identical hormones which coincidentally compete with their synthetic hormones.

2007: Numerous cancellations of contracts for the Premarin® family of drugs results in herd reductions on PMU farms.

A report in The Lancet found that HRT increases the risk of ovarian cancer by 20%.

FDA declines to approve Pristiq – a non-hormonal drug for menopausal symptoms produced by Wyeth – without further testing due to some indications that the drug causes serous heart and liver complications.

After years of research, analysis, and debate, the International Agency for Research on Cancer, the U.N.’s cancer research agency, has reclassified HRT from “possibly carcinogenic” to “carcinogenic.”

2008: Wyeth announces that it plans to meet with the FDA in February to discuss product formulation, bioequivalence and clinical study efforts to support the planned NDA filing of Aprela – a new drug containing CEEs for menopausal symptoms and a selective estrogen receptor modulator, for the prevention of postmenopausal osteoporosis.

2009: Another report is published by WHI investigators regarding the “timing hypothesis” of HRT. Advocates suggest that if HRT is started within six years of the menopause transition, the favorable estrogen environment of pre-menopause can be sustained and may improve cardiovascular status. The results of the study and the WHI data clearly refute this hypothesis.

Pfizer acquires Wyeth to become the largest pharmaceutical company in the world.

Court documents reveal that Wyeth paid ghostwriters to produce 26 papers backing the use and safety of HRT suggesting that the hidden agenda of Big Pharma and its manipulation of medical literature and promotion of questionable medications are more wide-spread than once believed.

Despite the controversy and factual evidence of the risks of HRT, Pfizer affirms confidence in its HRT drugs and maintains the coverage of these drugs is misleading and heavily weighted in favor of selective literature that condemns their use.

The Horses or PMU’s.

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019