Ventana Medical Systems announced Wednesday it has received FDA approval for an antibody to aid in assessing whether breast cancer patients should be treated with Genentech's Herceptin, Reuters reports (Reuters, 1/18). FDA in 1998 approved Herceptin for treatment of advanced HER2-positive cancer that has spread beyond the breast. HER2-positive cancer is an aggressive form of the disease found in about 25% of breast cancer patients that involves extra copies of the HER2 protein. FDA in November 2006 expanded Herceptin's approval to include treatment of breast cancer when it has not spread beyond the breast or lymph nodes in patients who have undergone a lumpectomy or mastectomy (Kaiser Daily Women's Health Policy Report, 11/20/06). The Ventana antibody aims to detect presence of the HER2. FDA also approved the antibody to be used with the Ventana Image Analysis System (AP/BusinessWeek, 1/18). The system, which FDA approved in October 2006, is a breast cancer screening device used in combination with p53 -- a biomarker that suppresses tumors and is used in cancer diagnosis (Kaiser Daily Women's Health Policy Report, 10/13/06).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Herceptin.
четверг, 23 февраля 2012 г.
четверг, 16 февраля 2012 г.
Plasma From Females May Not Be As Harmful As Once Thought
As the national blood banking community considers limiting the use plasma from female donors because of a rare but potentially catastrophic lung condition, researchers from Duke University Medical Center have shown that this policy change might be premature.
In their analysis of 8,300 heart surgery patients, the researchers found no association between transfused female plasma and any adverse outcome. In fact, they found a significant decrease in complications in patients receiving only female plasma.
Plasma, which makes up about 55 percent of blood's total volume, is the liquid portion of blood that is separated from oxygen-carrying red blood cells after donation. It is pale yellow in color and is usually given to patients after surgery to help restore their blood's normal clotting ability.
Transfused plasma from female donors has been implicated as a cause of a rare condition known as transfusion-related acute lung injury (TRALI), in which the lungs fill with fluid. The incidence of TRALI is hard to determine, and it is estimated that it occurs at a rate of 1 in 1,300 transfusions to 1 in 5,000 transfusions. It is the leading cause of transfusion-related death in the United States.
"Our data showed no deleterious effect associated with female plasma transfusion, and even pointed toward the possibility of a protective effect," said Duke anesthesiologist Ian Welsby, M.D. Collaborator and co-author Marla Brumit, M.D., from the Carolinas Region of the American Red Cross, presented the results of the Duke study at the annual meeting of the American Association of Blood Bankers in Anaheim, Calif.
While red blood cells can easily be separated from whole blood, antibodies from immune cells remain in plasma products, which is the root of the problem. Pregnant women develop a specific kind of antibody in response to carrying a baby, which is genetically half mother and half father. The more children a woman has, the more of these antibodies are produced. It is thought that some recipients of transfused plasma from women react negatively to these antibodies in the plasma.
Because of this apparent risk, the United Kingdom has used only plasma from male donors since 2004.
"TRALI is important and effective preventative steps should be taken to prevent it; however, we believe that more prospective data needs to be evaluated prior to enacting a policy such as the one in the United Kingdom," Welsby continued. "By focusing on a single rare event, they may be missing the forest for the trees. The bottom line is that female donor plasma may not be as harmful as it has been made out to be and antibodies from female plasma are only one source of TRALI."
The Duke researchers scoured their extensive database of patients who underwent cardiac surgery over a ten-year period beginning in 1993, looking for any possible negative effects in patients who received female plasma. These patients were chosen because surgery and the use of the heart-lung machine during a procedure are both important risk factors for developing TRALI.
Of the sampled patients, 25.6 percent received plasma transfusions, of which 44.8 percent came from female donors.
"We found that the volume of plasma a patient received was associated with higher mortality, which makes sense, since if you can stop the bleeding sooner, the patient will do better," Welsby said. "However, there was no association between female plasma and death, respiratory complications or even delayed recovery. These results raise questions concerning the overall benefit of a broad policy that completely excludes the transfusion of female plasma."
The researchers were also intrigued by the finding that female plasma may actually reduce complications after heart surgery. They are planning future prospective studies to better understand this phenomenon.
"Theoretically, there are some plausible reasons supporting the idea that female plasma may help patients," Welsby said. "Female plasma contains estrogen and other hormones that are known to promote blood clotting and have anti-inflammatory effects."
Other Duke members of the team were Barbara Philips-Bute, Mary Lee Campbell, Joseph Mathew, Carmelo Milano and Mark Stafford-Smith. Theresa Boyd and Rebecca Ramsey from the American Red Cross were also a part of the analysis.
Source: Richard Merritt
Duke University Medical Center
In their analysis of 8,300 heart surgery patients, the researchers found no association between transfused female plasma and any adverse outcome. In fact, they found a significant decrease in complications in patients receiving only female plasma.
Plasma, which makes up about 55 percent of blood's total volume, is the liquid portion of blood that is separated from oxygen-carrying red blood cells after donation. It is pale yellow in color and is usually given to patients after surgery to help restore their blood's normal clotting ability.
Transfused plasma from female donors has been implicated as a cause of a rare condition known as transfusion-related acute lung injury (TRALI), in which the lungs fill with fluid. The incidence of TRALI is hard to determine, and it is estimated that it occurs at a rate of 1 in 1,300 transfusions to 1 in 5,000 transfusions. It is the leading cause of transfusion-related death in the United States.
"Our data showed no deleterious effect associated with female plasma transfusion, and even pointed toward the possibility of a protective effect," said Duke anesthesiologist Ian Welsby, M.D. Collaborator and co-author Marla Brumit, M.D., from the Carolinas Region of the American Red Cross, presented the results of the Duke study at the annual meeting of the American Association of Blood Bankers in Anaheim, Calif.
While red blood cells can easily be separated from whole blood, antibodies from immune cells remain in plasma products, which is the root of the problem. Pregnant women develop a specific kind of antibody in response to carrying a baby, which is genetically half mother and half father. The more children a woman has, the more of these antibodies are produced. It is thought that some recipients of transfused plasma from women react negatively to these antibodies in the plasma.
Because of this apparent risk, the United Kingdom has used only plasma from male donors since 2004.
"TRALI is important and effective preventative steps should be taken to prevent it; however, we believe that more prospective data needs to be evaluated prior to enacting a policy such as the one in the United Kingdom," Welsby continued. "By focusing on a single rare event, they may be missing the forest for the trees. The bottom line is that female donor plasma may not be as harmful as it has been made out to be and antibodies from female plasma are only one source of TRALI."
The Duke researchers scoured their extensive database of patients who underwent cardiac surgery over a ten-year period beginning in 1993, looking for any possible negative effects in patients who received female plasma. These patients were chosen because surgery and the use of the heart-lung machine during a procedure are both important risk factors for developing TRALI.
Of the sampled patients, 25.6 percent received plasma transfusions, of which 44.8 percent came from female donors.
"We found that the volume of plasma a patient received was associated with higher mortality, which makes sense, since if you can stop the bleeding sooner, the patient will do better," Welsby said. "However, there was no association between female plasma and death, respiratory complications or even delayed recovery. These results raise questions concerning the overall benefit of a broad policy that completely excludes the transfusion of female plasma."
The researchers were also intrigued by the finding that female plasma may actually reduce complications after heart surgery. They are planning future prospective studies to better understand this phenomenon.
"Theoretically, there are some plausible reasons supporting the idea that female plasma may help patients," Welsby said. "Female plasma contains estrogen and other hormones that are known to promote blood clotting and have anti-inflammatory effects."
Other Duke members of the team were Barbara Philips-Bute, Mary Lee Campbell, Joseph Mathew, Carmelo Milano and Mark Stafford-Smith. Theresa Boyd and Rebecca Ramsey from the American Red Cross were also a part of the analysis.
Source: Richard Merritt
Duke University Medical Center
четверг, 9 февраля 2012 г.
Unmarried Older Women Twice As Likely To Lack Health Insurance, Study Shows
Older women who are divorced, separated or widowed or who have never married have twice the uninsured rate of their married peers, according to a new policy brief from the UCLA Center for Health Policy Research.
The study, "Health and Health Care Access Among California Women Ages 50-64," examines a range of health issues and trends among California's approximately 3 million older women, an age group that often faces new and accelerated chronic health conditions, according to lead author Roberta Wyn, associate director of the center.
"It's a time of critical change for older women," Wyn said. "Not only are they at risk of new and complex health conditions, but as they near the age of retirement, their insurance status may change too."
Women between the ages of 50 and 64 are more prone than younger women to a wide range of health conditions, including asthma, diabetes and heart disease. Nearly four in 10 women in this age group will be diagnosed with high blood pressure, while nearly six in 10 are either obese or overweight. In both cases, the percentages are higher than for younger women.
The researchers also found that the likelihood of having health insurance was related to a woman's marital status. Using data from the 2007 California Health Interview Survey, Wyn and her co-author found that one-quarter of older women who had never married and 21 percent of divorced, separated or widowed women were uninsured - more than twice the rates of married women.
"These women have fewer coverage options, including access to family coverage, and Medicare is still several years away for many," Wyn said.
Among all women, low-income women are the most likely to be uninsured (34 percent) and the least likely to have employment-based coverage (24 percent), according to the policy brief.
Lack of insurance can result in a delay in accessing needed care. One-third (32 percent) of uninsured women aged 50 to 64 reported that they delayed or did not get needed medical care in the past year, a rate twice as high as that for women with employment-based coverage in this age group.
Uninsured women between 50 and 64 were also much more likely to report not having had a Pap test during the previous three years than women with employment-based coverage (28 percent vs. 5 percent) and were more likely to report not having had a mammogram during the previous two years (39 percent vs. 10 percent).
The data was collected in 2007, before the recession, and Wyn noted that "the economic recession and subsequent widespread job loss may have pushed uninsurance rates even higher."
Wyn stressed the need for expanded health insurance coverage and access to care to address the rising health issues and often costly health conditions associated with aging.
The study authors also stressed the need for proactive policies and programs that promote healthy behaviors and environments to help stem the rising rates of obesity in this age group.
Read the policy brief, "Health and Health Care Access Among California Women Ages 50-64."
Source:
Gwendolyn Driscoll
University of California - Los Angeles
The study, "Health and Health Care Access Among California Women Ages 50-64," examines a range of health issues and trends among California's approximately 3 million older women, an age group that often faces new and accelerated chronic health conditions, according to lead author Roberta Wyn, associate director of the center.
"It's a time of critical change for older women," Wyn said. "Not only are they at risk of new and complex health conditions, but as they near the age of retirement, their insurance status may change too."
Women between the ages of 50 and 64 are more prone than younger women to a wide range of health conditions, including asthma, diabetes and heart disease. Nearly four in 10 women in this age group will be diagnosed with high blood pressure, while nearly six in 10 are either obese or overweight. In both cases, the percentages are higher than for younger women.
The researchers also found that the likelihood of having health insurance was related to a woman's marital status. Using data from the 2007 California Health Interview Survey, Wyn and her co-author found that one-quarter of older women who had never married and 21 percent of divorced, separated or widowed women were uninsured - more than twice the rates of married women.
"These women have fewer coverage options, including access to family coverage, and Medicare is still several years away for many," Wyn said.
Among all women, low-income women are the most likely to be uninsured (34 percent) and the least likely to have employment-based coverage (24 percent), according to the policy brief.
Lack of insurance can result in a delay in accessing needed care. One-third (32 percent) of uninsured women aged 50 to 64 reported that they delayed or did not get needed medical care in the past year, a rate twice as high as that for women with employment-based coverage in this age group.
Uninsured women between 50 and 64 were also much more likely to report not having had a Pap test during the previous three years than women with employment-based coverage (28 percent vs. 5 percent) and were more likely to report not having had a mammogram during the previous two years (39 percent vs. 10 percent).
The data was collected in 2007, before the recession, and Wyn noted that "the economic recession and subsequent widespread job loss may have pushed uninsurance rates even higher."
Wyn stressed the need for expanded health insurance coverage and access to care to address the rising health issues and often costly health conditions associated with aging.
The study authors also stressed the need for proactive policies and programs that promote healthy behaviors and environments to help stem the rising rates of obesity in this age group.
Read the policy brief, "Health and Health Care Access Among California Women Ages 50-64."
Source:
Gwendolyn Driscoll
University of California - Los Angeles
четверг, 2 февраля 2012 г.
Emotional Health Risks Of Cosmetic Surgery Downplayed By Women's Magazines: UBC Study
While the emotional health implications of cosmetic surgery are still up for scientific debate, articles in women's magazines such as The Oprah Magazine and Cosmopolitan portray cosmetic surgery as a physically risky, but overall worthwhile option for enhancing physical appearance and emotional health, a UBC study has found.
The study, published in Women's Health Issues journal, is the first to examine how women's magazines portray cosmetic surgery to Canadians. It also finds that male opinions on female attractiveness are routinely used to justify cosmetic surgery and that a disproportionate amount of articles are devoted to breast implants and cosmetic surgery among women aged 19-34.
"Alongside beauty, clothing and diet advice, women's magazines present cosmetic surgery as a normal practice for enhancing or maintaining beauty, becoming more attractive to men and improving emotional health," says Andrea Polonijo, who conducted the research at UBC as an undergraduate honours thesis in the Dept. of Sociology.
Polonijo, now a graduate student at University of Toronto's Dalla Lana School of Public Health, examined how Canada's five most popular English-language women's magazines - Chatelaine, Cosmopolitan, O: The Oprah Magazine, Flare and Prevention - portray cosmetic surgery. The study focused on 35 articles published between 2002 and 2006.
"Magazines are communicating the physical risks of cosmetic surgery more than the emotional health risks," says Polonijo, noting that studies have found that emotional health issues such as anxiety and depression may arise or increase in women who undergo physically successful cosmetic surgery, regardless of their preoperative emotional state. Of the articles that mention emotional health, only 18 per cent suggest cosmetic surgery may be detrimental to emotional well-being, the study found.
Magazines routinely present two "ideal" cosmetic surgery candidates, the study found: an unhappy, insecure, lonely woman looking to boost low self-confidence and self-esteem, and a successful, attractive, confident woman with high self-esteem who seeks cosmetic surgery to maintain perfection.
"These two profiles represent extremes of a wide range of attitudes, for which many women may view themselves as being somewhere in-between," says UBC sociology professor Richard Carpiano, a co-author of the study. "This potentially allows for cosmetic surgery to be presented as an option for many women regardless of their preoperative emotional state."
Men's opinions were often considered in these cosmetic surgery articles, with 29 per cent discussing the impact that women's cosmetic surgery has on the male population.
To see the Polonijo's and Carpiano's study, entitled "Representations of Cosmetic Surgery and Emotional Health in Women's Magazines in Canada," visit: sciencedirect/science/journal/10493867.
Source: Basil Waugh, UBC Public Affairs
University of British Columbia
The study, published in Women's Health Issues journal, is the first to examine how women's magazines portray cosmetic surgery to Canadians. It also finds that male opinions on female attractiveness are routinely used to justify cosmetic surgery and that a disproportionate amount of articles are devoted to breast implants and cosmetic surgery among women aged 19-34.
"Alongside beauty, clothing and diet advice, women's magazines present cosmetic surgery as a normal practice for enhancing or maintaining beauty, becoming more attractive to men and improving emotional health," says Andrea Polonijo, who conducted the research at UBC as an undergraduate honours thesis in the Dept. of Sociology.
Polonijo, now a graduate student at University of Toronto's Dalla Lana School of Public Health, examined how Canada's five most popular English-language women's magazines - Chatelaine, Cosmopolitan, O: The Oprah Magazine, Flare and Prevention - portray cosmetic surgery. The study focused on 35 articles published between 2002 and 2006.
"Magazines are communicating the physical risks of cosmetic surgery more than the emotional health risks," says Polonijo, noting that studies have found that emotional health issues such as anxiety and depression may arise or increase in women who undergo physically successful cosmetic surgery, regardless of their preoperative emotional state. Of the articles that mention emotional health, only 18 per cent suggest cosmetic surgery may be detrimental to emotional well-being, the study found.
Magazines routinely present two "ideal" cosmetic surgery candidates, the study found: an unhappy, insecure, lonely woman looking to boost low self-confidence and self-esteem, and a successful, attractive, confident woman with high self-esteem who seeks cosmetic surgery to maintain perfection.
"These two profiles represent extremes of a wide range of attitudes, for which many women may view themselves as being somewhere in-between," says UBC sociology professor Richard Carpiano, a co-author of the study. "This potentially allows for cosmetic surgery to be presented as an option for many women regardless of their preoperative emotional state."
Men's opinions were often considered in these cosmetic surgery articles, with 29 per cent discussing the impact that women's cosmetic surgery has on the male population.
To see the Polonijo's and Carpiano's study, entitled "Representations of Cosmetic Surgery and Emotional Health in Women's Magazines in Canada," visit: sciencedirect/science/journal/10493867.
Source: Basil Waugh, UBC Public Affairs
University of British Columbia
Подписаться на:
Комментарии (Atom)