P R E M S T O P P E R S
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.
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