Wyeth Pharmaceuticals has launched Premarin*0.3mg (conjugated
estrogens), the first low dose estrogen-only HRT, which contains less than
half the estrogen i.e. 0.3mg of standard Premarin* 0.625mg (conjugated
estrogens).1 This will give healthcare professionals a new option in
treating the menopausal symptoms of 1 in 5 women who undergo hysterectomy in
the UK before the age of 52.2 Until now, only unhysterectomised women
treated with combined progestogen/estrogen HRT, have had a low dose option.
HRT has been shown to be effective in relieving debilitating menopausal
symptoms such as hot flushes and night sweats.3 Current guidelines4
recommend that all women going through the menopause who are seeking
treatment should be offered a choice of HRT. Treatment with HRT should aim
to use the lowest effective dose for the shortest duration and should be
reviewed on an annual basis in light of any new knowledge and changes in
women's risk factors. Because every woman is different, treatment should be
tailored to an individual's need.
"For the hysterectomised woman the availability of new low dose
Premarin 0.3mg is a welcome addition. This new low dose option gives
practitioners more flexibility in treating these women and allows us to
tailor treatment to their individual needs," said Dr John Stevenson,
Consultant Physician, Imperial College London.
When the ovaries are removed during a hysterectomy, women will experience an
immediate menopause regardless of age. If the ovaries are left intact,
there is a 50% chance of the ovaries failing within five years of a
hysterectomy resulting in menopause.1
About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), has leading products
in the areas of women's health care, central nervous system, inflammation,
transplantation, haemophilia, oncology, vaccines and nutritional products.
Wyeth has a diverse portfolio of biopharmaceutical products. Wyeth is one of
the world's largest research-driven pharmaceutical and healthcare products
companies. It is a leader in the discovery, development, manufacturing, and
marketing of pharmaceuticals, vaccines, biotechnology products and
nonprescription 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.
*Premarin is a Wyeth Trademark
References
1 Premarin 0.3mg. Summary of Product Characteristics. November 2006
2 Management of the Menopause: The Handbook. 4th edition. Rees M, Purdie DW.
BMS Publications Ltd and RSM Press Ltd 2006
3 Utian H, Shoupe D, et al. Relief of vasomotor symptoms and vaginal
atrophy with lower doses of conjugated equine estrogens and
medroxyprogesterone acetate. Fertil Steril 2001;75:1065-1079
4 Consensus Conference on Hormone Replacement Therapy. Royal College of
Physicians of Edinburgh. October 2003
wyeth
View drug information on Premarin.
суббота, 26 ноября 2011 г.
суббота, 19 ноября 2011 г.
Neb. Bill To Ban Abortion After 20 Weeks Could Start Legal Battle
A Nebraska bill (LB 1103) that would ban abortion after 20 weeks' gestation in nearly all cases could prompt a legal battle regarding its constitutionality, the Omaha World-Herald reports. The bill, introduced by Speaker of the Legislature Mike Flood (R), would allow abortion past 20 weeks only to save the woman's life or to "avert serious risk or substantial and irreversible physical impairment of a major bodily function." Current Nebraska law bans abortion after viability except to preserve the life or health of the woman.
Flood's bill claims there is "substantial evidence" that fetuses feel pain at 20 weeks and proposes to use the fetus' ability to feel pain, rather than viability, as the dividing line between legal and illegal abortion, the World-Herald reports. Flood said he introduced the measure to stop abortion provider LeRoy Carhart from performing procedures late in pregnancy. Carhart has said that he plans to offer late abortions at his Bellevue, Neb., clinic as a way to continue the work of George Tiller, a Kansas abortion provider who was killed last May (Stoddard, Omaha World-Herald, 1/22). Flood claims that the 2007 Supreme Court decision Gonzales v. Carhart, which upheld the federal Partial-Birth Abortion Ban Act of 2003, "clearly affirmed that the state has a legitimate and substantial interest in preserving fetal life and promoting respect for human life at all stages of pregnancy."
Lawmakers in several states have cited the 2007 decision to support legislation requiring women to receive certain information before abortion procedures. Janet Crepps of the Center for Reproductive Rights said the Nebraska bill goes much further and has several constitutional flaws. "The Supreme Court has drawn a clear line between requiring women to receive certain information and telling them they can't have abortions before viability," Crepps said. She added, "The Supreme Court has made clear there's no state interest that trumps a woman's interest in having an abortion before viability."
Carhart and other abortion-rights supporters also dispute Flood's assertions regarding fetal pain (Jenkins, AP/Columbus Telegram, 1/22). Carhart said he is prepared to fight Flood's bill in court, adding, "We've been to the Supreme Court twice. I have no problem going again" (Omaha World-Herald, 1/22).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
суббота, 12 ноября 2011 г.
Concentrations Of Certain Toxins In Breast Milk Are Low, Study Finds
Nursing mothers worried about passing harmful chemicals to their infants through breast milk should be aware that the air inside their home may pose a greater health risk.
Researchers from Ohio State and Johns Hopkins universities measured the levels of harmful gases called "volatile organic compounds" (VOCs) in human milk and in the air inside the homes of three lactating mothers in inner-city Baltimore.
A nursing infant's exposure to VOCs from indoor air was 25- to 135-fold higher than what that infant ingested through breast milk. In fact, levels found in milk were far below the U.S. EPA's maximum contaminant levels for drinking water.
"I was worried that we were going to see a much larger contribution from milk, so I am tremendously relieved by these findings," said Timothy Buckley, the study's senior author and an associate professor of public health at Ohio State.
Although the study is small and provides just a preliminary assessment of VOC levels in human milk, it is one of the first studies of its kind in the United States in which researchers are able to quantify levels of these compounds in human milk.
"We ought to focus our efforts on reducing indoor air sources of these compounds," said Sungroul Kim, the study's lead author and a postdoctoral fellow with the Johns Hopkins Bloomberg School of Public Health.
Both Buckley and Kim stress that despite human milk's vulnerability to chemical contamination, the health benefits of nursing far outweigh the risks, and that breast milk is the best source of nutrition for a growing infant.
The findings currently appear online at the website for the journal Environmental Science & Technology. Buckley and Kim conducted the study with Rolf Halden, an assistant professor of public health at Johns Hopkins.
The researchers analyzed eight milk samples from three lactating mothers living in inner-city Baltimore. From May through July 2005, the mothers provided a milk sample each morning for three consecutive mornings. The women were asked to manually express milk into a glass jar and then seal the jar with a provided cap. The researchers also placed air samplers in the living rooms of the women's homes - each woman lived in a two-story row home on a busy street. Air samples were collected over the three days that coincided with milk collection.
The researchers analyzed the milk and indoor air samples for four VOCs - benzene, MTBE (methyl tertiary butyl ether), toluene and chloroform. Automobile exhaust is the primary source for benzene and MTBE, while toluene comes from car exhaust as well as consumer products such as glue, shoe polish, and paint thinner. Treated drinking water is the biggest source of chloroform inside most homes.
In the laboratory, the researchers transferred the milk samples to vials. They then inserted a syringe through the cap on the vial and into the air space between the cap and the milk. The VOCs in breast milk samples disperse into this air space, and the gases were collected with a needle coated with absorbent material. The researchers collected indoor air samples by passing air through a material that specifically absorbed the VOCs of interest.
Once they collected the VOCs, the researchers used gas chromatography-mass spectrometry to analyze the levels of each compound in the milk and indoor air samples. This analysis technique differentiates between various substances in a given sample.
The milk samples had higher concentrations of chloroform than any other of the three VOCs. Next came toluene, followed by benzene and MTBE. The researchers had also acquired five additional human milk samples from a milk bank in Raleigh, N.C., provided by anonymous donors. They ran these samples through the same tests, and found that the VOC levels in this milk were comparable to those of the Baltimore samples.
As there are no health-based guidelines or standards for chemicals in human milk, the researchers compared the concentrations in the milk samples to the U.S. EPA's safe drinking water standards. The levels of chloroform, benzene and toluene in milk were well below the EPA's maximum contaminant level for drinking water, by factors of 180, 40 and 2170, respectively. MTBE isn't specifically regulated in drinking water by the EPA.
"We were pleasantly surprised to see these relatively low concentrations of VOCs in human milk," said Buckley, who also chairs the Division of Environmental Health Sciences in Ohio State's College of Public Health. "Especially for inner-city settings, which is where VOC levels tend to be the highest."
The rank of VOC concentrations in indoor air differed from that in milk, with toluene levels ranking the highest followed by MTBE, chloroform and benzene. After comparing the level of VOCs in milk to the concentrations in the air, the researchers found that higher levels of toluene, benzene and MTBE in indoor air meant greater concentrations of the contaminants in breast milk. This suggests that the indoor air was the likely source for the VOCs that eventually get into the mother's breast milk.
However, the researchers did not see this relationship with chloroform.
"Chloroform exposure occurs not only through inhalation, but also through water ingestion and absorption through the skin while showering or bathing," Buckley said. "So in this case, exposure was probably poorly captured by the air samplers set up in the living rooms."
The indoor VOC levels measured in the current study are comparable to what has been reported in inner cities across the United States, the researchers say.
"Therefore, it's also likely that the levels of VOCs in human milk that we found are typical for lactating women living in urban areas," Buckley said.
VOCs are a fact of modern life - nearly every human on the planet has at least a trace of these compounds in their body. The focus should be on minimizing our exposure to their sources, Buckley said.
"With respect to automobile sources of air toxics, the level of traffic and your distance from that traffic both affect what you breathe," Buckley said. "The homes in our study were within five or six feet of busy roadways. Many inner-city residents may not have the choice to reside very far from these heavily used roads."
Grants from the Johns Hopkins NIEHS Center in Urban Environmental Health, the Johns Hopkins Center for a Livable Future and the U.S. EPA funded this work.
Contact: Timothy Buckley
Ohio State University
Researchers from Ohio State and Johns Hopkins universities measured the levels of harmful gases called "volatile organic compounds" (VOCs) in human milk and in the air inside the homes of three lactating mothers in inner-city Baltimore.
A nursing infant's exposure to VOCs from indoor air was 25- to 135-fold higher than what that infant ingested through breast milk. In fact, levels found in milk were far below the U.S. EPA's maximum contaminant levels for drinking water.
"I was worried that we were going to see a much larger contribution from milk, so I am tremendously relieved by these findings," said Timothy Buckley, the study's senior author and an associate professor of public health at Ohio State.
Although the study is small and provides just a preliminary assessment of VOC levels in human milk, it is one of the first studies of its kind in the United States in which researchers are able to quantify levels of these compounds in human milk.
"We ought to focus our efforts on reducing indoor air sources of these compounds," said Sungroul Kim, the study's lead author and a postdoctoral fellow with the Johns Hopkins Bloomberg School of Public Health.
Both Buckley and Kim stress that despite human milk's vulnerability to chemical contamination, the health benefits of nursing far outweigh the risks, and that breast milk is the best source of nutrition for a growing infant.
The findings currently appear online at the website for the journal Environmental Science & Technology. Buckley and Kim conducted the study with Rolf Halden, an assistant professor of public health at Johns Hopkins.
The researchers analyzed eight milk samples from three lactating mothers living in inner-city Baltimore. From May through July 2005, the mothers provided a milk sample each morning for three consecutive mornings. The women were asked to manually express milk into a glass jar and then seal the jar with a provided cap. The researchers also placed air samplers in the living rooms of the women's homes - each woman lived in a two-story row home on a busy street. Air samples were collected over the three days that coincided with milk collection.
The researchers analyzed the milk and indoor air samples for four VOCs - benzene, MTBE (methyl tertiary butyl ether), toluene and chloroform. Automobile exhaust is the primary source for benzene and MTBE, while toluene comes from car exhaust as well as consumer products such as glue, shoe polish, and paint thinner. Treated drinking water is the biggest source of chloroform inside most homes.
In the laboratory, the researchers transferred the milk samples to vials. They then inserted a syringe through the cap on the vial and into the air space between the cap and the milk. The VOCs in breast milk samples disperse into this air space, and the gases were collected with a needle coated with absorbent material. The researchers collected indoor air samples by passing air through a material that specifically absorbed the VOCs of interest.
Once they collected the VOCs, the researchers used gas chromatography-mass spectrometry to analyze the levels of each compound in the milk and indoor air samples. This analysis technique differentiates between various substances in a given sample.
The milk samples had higher concentrations of chloroform than any other of the three VOCs. Next came toluene, followed by benzene and MTBE. The researchers had also acquired five additional human milk samples from a milk bank in Raleigh, N.C., provided by anonymous donors. They ran these samples through the same tests, and found that the VOC levels in this milk were comparable to those of the Baltimore samples.
As there are no health-based guidelines or standards for chemicals in human milk, the researchers compared the concentrations in the milk samples to the U.S. EPA's safe drinking water standards. The levels of chloroform, benzene and toluene in milk were well below the EPA's maximum contaminant level for drinking water, by factors of 180, 40 and 2170, respectively. MTBE isn't specifically regulated in drinking water by the EPA.
"We were pleasantly surprised to see these relatively low concentrations of VOCs in human milk," said Buckley, who also chairs the Division of Environmental Health Sciences in Ohio State's College of Public Health. "Especially for inner-city settings, which is where VOC levels tend to be the highest."
The rank of VOC concentrations in indoor air differed from that in milk, with toluene levels ranking the highest followed by MTBE, chloroform and benzene. After comparing the level of VOCs in milk to the concentrations in the air, the researchers found that higher levels of toluene, benzene and MTBE in indoor air meant greater concentrations of the contaminants in breast milk. This suggests that the indoor air was the likely source for the VOCs that eventually get into the mother's breast milk.
However, the researchers did not see this relationship with chloroform.
"Chloroform exposure occurs not only through inhalation, but also through water ingestion and absorption through the skin while showering or bathing," Buckley said. "So in this case, exposure was probably poorly captured by the air samplers set up in the living rooms."
The indoor VOC levels measured in the current study are comparable to what has been reported in inner cities across the United States, the researchers say.
"Therefore, it's also likely that the levels of VOCs in human milk that we found are typical for lactating women living in urban areas," Buckley said.
VOCs are a fact of modern life - nearly every human on the planet has at least a trace of these compounds in their body. The focus should be on minimizing our exposure to their sources, Buckley said.
"With respect to automobile sources of air toxics, the level of traffic and your distance from that traffic both affect what you breathe," Buckley said. "The homes in our study were within five or six feet of busy roadways. Many inner-city residents may not have the choice to reside very far from these heavily used roads."
Grants from the Johns Hopkins NIEHS Center in Urban Environmental Health, the Johns Hopkins Center for a Livable Future and the U.S. EPA funded this work.
Contact: Timothy Buckley
Ohio State University
суббота, 5 ноября 2011 г.
Study Shows Carraguard Microbicidal Gel Fails To Protect Women From HIV Infection
The candidate vaginal microbicide gel Carraguard does not protect women from HIV infection, reports an Article in this week's edition of The Lancet, Stephanie Skoler-Karpoff and Barbara Friedland, Population Council, New York, USA, and colleagues.
Around 33.2 million people worldwide are living with HIV, of whom 68% live in sub-Saharan Africa; and in that region, women and girls are disproportionately affected, accounting for 61% of infections. Furthermore, in 15-24-year-olds, 90% of new HIV infections occur in girls and women. As a result, female-initiated HIV-prevention options, such as microbicides, are urgently need. In this randomised, placebo-controlled trial, the authors assessed Carraguard, a carrageenan-based compound developed by the Population Council.
The trial took place at three sites in South Africa, and involved 6,202 sexually active, HIV-negative women, who were assigned to receive Carraguard (3103 women) or a placebo gel of methylcelluose (3099). The women were instructed to use one applicator of gel plus a condom for each vaginal sex act. Participants were followed up for up to two years. The women visited a clinic every three months, which included testing for HIV presence and pregnancy, pelvic examinations, risk reduction counseling, and treatment for curable sexually transmitted infections and symptomatic vaginal infections. The primary outcome of the trial was time to seroconversion (HIV infection).
The researchers found that HIV incidence was 3.3 per 100-woman years in the Carraguard group (134 infections) and 3.8 per 100 woman-years in the placebo group (151 infections), with no significant difference in the time to serocoversion. Rates of self-reported gel use (96.2% Carraguard, 95.9% placebo) and condom use (64.1% both groups) at last sex acts were similar in both groups. On the basis of applicator testing, however, gel was estimated to have been used in only 42.1 % of sex acts on average (41.1% Carraguard, 43.1% placebo). Adverse events were similar in both groups; adverse events related to gel use and serious adverse events were similar in both groups.
The authors conclude: "This study did not show Carraguard's efficacy in prevention of male-to-female transmission of HIV, although no safety concerns were recorded. Low levels of gel use could have compromised the potential to detect a significant protective effect. Although the results from this and other completed microbicides efficacy trials have been disappointing, the search for female-controlled HIV-prevention methods must continue."
In an accompanying Comment, Dr Willard Cates and Dr Paul Feldblum, Family Health International, North Carolina, USA, say: "Whenever we develop effective new tools for HIV prevention, no single approach to prevention will suffice. Rather a combination of partly effective prevention approaches will be bundled into packages targeted to specific populations. This bundling will involve behavioural, biomedical, and structural interventions, each designed to reinforce the effect of the other. The cumulative influence of combination prevention is our hope for thwarting the spread of HIV."
Click here to see SUMMARY of ARTICLE online.
Source
Tony Kirby
Press Officer
The Lancet
32 Jamestown Road
Camden
London
NW1 7BY
thelancet
Around 33.2 million people worldwide are living with HIV, of whom 68% live in sub-Saharan Africa; and in that region, women and girls are disproportionately affected, accounting for 61% of infections. Furthermore, in 15-24-year-olds, 90% of new HIV infections occur in girls and women. As a result, female-initiated HIV-prevention options, such as microbicides, are urgently need. In this randomised, placebo-controlled trial, the authors assessed Carraguard, a carrageenan-based compound developed by the Population Council.
The trial took place at three sites in South Africa, and involved 6,202 sexually active, HIV-negative women, who were assigned to receive Carraguard (3103 women) or a placebo gel of methylcelluose (3099). The women were instructed to use one applicator of gel plus a condom for each vaginal sex act. Participants were followed up for up to two years. The women visited a clinic every three months, which included testing for HIV presence and pregnancy, pelvic examinations, risk reduction counseling, and treatment for curable sexually transmitted infections and symptomatic vaginal infections. The primary outcome of the trial was time to seroconversion (HIV infection).
The researchers found that HIV incidence was 3.3 per 100-woman years in the Carraguard group (134 infections) and 3.8 per 100 woman-years in the placebo group (151 infections), with no significant difference in the time to serocoversion. Rates of self-reported gel use (96.2% Carraguard, 95.9% placebo) and condom use (64.1% both groups) at last sex acts were similar in both groups. On the basis of applicator testing, however, gel was estimated to have been used in only 42.1 % of sex acts on average (41.1% Carraguard, 43.1% placebo). Adverse events were similar in both groups; adverse events related to gel use and serious adverse events were similar in both groups.
The authors conclude: "This study did not show Carraguard's efficacy in prevention of male-to-female transmission of HIV, although no safety concerns were recorded. Low levels of gel use could have compromised the potential to detect a significant protective effect. Although the results from this and other completed microbicides efficacy trials have been disappointing, the search for female-controlled HIV-prevention methods must continue."
In an accompanying Comment, Dr Willard Cates and Dr Paul Feldblum, Family Health International, North Carolina, USA, say: "Whenever we develop effective new tools for HIV prevention, no single approach to prevention will suffice. Rather a combination of partly effective prevention approaches will be bundled into packages targeted to specific populations. This bundling will involve behavioural, biomedical, and structural interventions, each designed to reinforce the effect of the other. The cumulative influence of combination prevention is our hope for thwarting the spread of HIV."
Click here to see SUMMARY of ARTICLE online.
Source
Tony Kirby
Press Officer
The Lancet
32 Jamestown Road
Camden
London
NW1 7BY
thelancet
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