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.
2010: 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 the Wyeth funded Roberta Diaz Brinton, Thomas Clarkson-who worked with the Wyeth ghostwriting firm, DesignWrite-and Louann Brizendine and 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”.
2011: Pfizer/Wyeth continues to promote the use of their controversial Premarin® family of drugs.
According to the new theory developed as a result of Wyeth-linked research, women shouldn’t take less hormones but rather more and start taking them at an earlier age. Unfortunately for Pfizer past research found that women with the greatest risk of breast cancer from hormones are those who took them the earliest — before or soon after menopause. In other words, women who observed the timing theory. Oops.
Pfizer Pharmaceuticals sponsors a teleconference on solutions to the “unwanted horse” problem featuring Tom Lenz following the release of the GAO slaughter report. Lenz is the Senior Director, Equine Veterinary Services, at Pfizer Animal Health and acknowledged pro-horse slaughter advocate. Pfizer’s affiliation with the most powerful equine organizations in North America leverages their position in terms of horse slaughter and the “unwanted horse’ – a “humane” alternative by their standards.
Pfizer continues to be at the centre of the slaughter debate through its on-going sponsorship of pro-slaughter organizations such as the AQHA, AAEP, AVMA, UHC, UOH, NAERIC and AHC to name a few.
An extended WHI study carried out at the University of Buffalo shows that conjugated equine estrogen based HRT interferes with the detection of breast cancer leading to cancers being diagnosed at a more advanced stage and tended to have more involvement with the lymph nodes which generally indicates a poorer prognosis. Not only were the women taking the combination of estrogen and progestin more likely to die from breast cancer, but they were also more likely to die from other causes than women who did not take the hormones.
The Buffalo study also found that estrogen therapy is associated with a significant increase in risk of kidney stones regardless of age, ethnicity, body mass index, prior hormone therapy use, or use of coffee or thiazide diuretics.
As of December 31, 2011, Pfizer and its affiliated companies had settled, or entered into definitive agreements or agreements−in−principle to settle, approximately 52% of the hormone−replacement therapy actions pending against them and affiliated companies.
Recorded aggregate charges with respect to these actions were $336 million in 2011 and $300 million in prior years. In addition, Pfizer recorded a charge of $359 million in 2011 that provides for the minimum expected costs to resolve all remaining hormone−replacement therapy actions.
- January: A Puerto Rican jury has awarded $1.5 million in compensation to a woman who claimed that she developed breast cancer from Prempro® HRT.
- February: A Pennsylvania appeals court has upheld a jury award of more than $10 million in a Prempro® breast cancer lawsuit, reversing a lower court’s ruling that overturned the award of compensatory and punitive damages in the case.
- June: Pfizer will have to pay $58 million to three women who previously won a Prempro® breast cancer lawsuit against the company’s Wyeth unit, after the U.S. Supreme Court refused to entertain an appeal by the company.
- October: About 150 HRT lawsuits pending in New Jersey state court may be in jeopardy after an appeals court upheld the dismissal of claims that the manufacturers of Prempro®, Provera® and Premarin® failed to adequately warn consumers about the risk of breast cancer and misled federal regulators
- December: A Philadelphia jury hit Pfizer with a $72.6 million verdict in a Prempro® lawsuit brought by three women who alleged that they developed breast cancer after taking hormone replacement therapy (HRT) drugs. In addition to the compensatory damages award, Pfizer could face punitive damages of many times that amount depending on the further deliberations of the jury.
The FDA has yet to approve Aprela® or Viviant® (i.e. bazedoxifene) although the approval and sales of bazedoxifene under different trade names is advancing rapidly in other parts of the world.
There is still speculation as to the downsizing of the PMU farms in North America and Pfizer/Wyeth’s ability to produce adequate quantities of pregnant mare’s urine necessary for current and projected sales of the Premarin® family of drugs. Relocation of these facilities to other parts of the world such as China for example seems a plausible and valid assumption.
Compiled by Jane Allin
© Int’l Fund for Horses