Healthcare Industry News: osteoporosis
News Release - April 18, 2007
Wyeth Responds to Special Report Published in New England Journal of MedicineCOLLEGEVILLE, Pa., April 18 (HSMN NewsFeed) -- A report of data from the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) database published today in the New England Journal of Medicine, suggests that a decline in breast cancer incidence may be caused by a drop in hormone therapy use during the same time period. Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), cautions against drawing this conclusion for the following reasons:
-- The SEER data and prescription data for 2004 cast doubt on the authors' hypothesis. In their initial presentation in December 2006, the authors reported that the incidence of breast cancer in the United States declined seven percent between 2002 and 2003, and hypothesized that this decrease was attributable to a decline in hormone therapy use during the same time period. The 2004 SEER data show a leveling off in breast cancer incidence, yet the prescription database shows hormone therapy prescriptions continued to drop by more than 20% during the same time period.
-- The SEER data showed a decline in numerous cancers, and there may be a broader explanation for this trend. For example, breast cancer tumors that do not respond to estrogen also declined in 2003. There have also been declines in other tumor types, such as colon cancer.
-- SEER is an epidemiological database that collects cancer data. It does not collect other important information such as medicine use, lifestyle or other essential factors. As such, the database cannot be used to conclude a cause-and-effect relationship between invasive breast cancer rates and hormone therapy usage.
"Reports such as this cause confusion," says Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs for Wyeth Pharmaceuticals. "The hypothesis put forth in this report does not change what we know about hormone therapy, which is based on data from numerous, more rigorous studies including the Women's Health Initiative. These randomized trials provide a higher level of evidence on the risk/benefit profile of hormone therapy."
One possible factor contributing to the decrease in breast cancer incidence reported in 2003 could be a decline in mammography screening during the same time period. If this decline represents a decrease in early cancer detection, it may only become apparent in the coming years as these cancers manifest and are detected at a later more aggressive stage.
"Hormone therapy remains a good health care choice for the appropriate woman seeking the relief of moderate to severe menopausal symptoms, including hot flashes, night sweats and vaginal atrophy, and the prevention of postmenopausal osteoporosis," adds Dr. Camardo.
Wyeth continues to support the appropriate use of hormone therapy and recommends that it be used at the lowest dose for the appropriate duration consistent with treatment goals and risks for the individual woman. Women experiencing menopausal symptoms are encouraged to speak with a health care professional to determine whether it might be the right treatment option for them. Wyeth urges women to continue to have routine mammography exams as recommended by the American Cancer Society and as advised in product information provided to patients using hormone therapy.
What is the most important information you should know about PREMARIN (estrogens) or PREMPRO (a combination of estrogens and a progestin)?
-- Estrogens increase the chances of getting cancer of the uterus.
-- Report any unusual vaginal bleeding right away while you are taking these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.
-- Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia.
Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women aged 65 years or older. You and your health care provider should talk regularly about whether you still need treatment with estrogens.
PREMARIN® (conjugated estrogens tablets, USP) is used after menopause to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching and burning in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) is used after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching and burning in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones).
PREMARIN and PREMPRO should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. If using PREMARIN or PREMPRO only to treat your symptoms of vaginal dryness, consider topical therapies first. If you do not have symptoms, non-estrogen treatments should be carefully considered before taking PREMARIN or PREMPRO solely for the prevention of postmenopausal osteoporosis.
In a clinical trial, the most commonly reported (greater than or equal to 5%) side effects that occurred more frequently with PREMARIN than with placebo were vaginitis due to yeast or other causes, vaginal bleeding, painful menstruation and leg cramps.
In a clinical trial, the most commonly reported (greater than or equal to 5%) side effects that occurred more frequently with PREMPRO 0.45 mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg than with placebo were breast pain/enlargement, vaginitis due to yeast or other causes, leg cramps, vaginal spotting/bleeding and painful menstruation. In a clinical trial, there was no difference in the commonly reported (greater than or equal to 5%) side effects for women taking PREMPRO 0.3 mg/1.5 mg compared with those taking placebo.
PREMARIN and PREMPRO should not be used if you have unusual vaginal bleeding, have or had cancer of the breast or uterus, had a stroke or heart attack in the past year, have or had blood clots, have liver problems, are allergic to any of the ingredients in PREMARIN or PREMPRO, or think you may be pregnant. In general, the addition of a progestin is recommended for women with a uterus to reduce the chance of getting cancer of the uterus.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; data generated on our products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Source: Wyeth Pharmaceuticals
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