By using medications packaged just like fast-food ketchup, HIV-positive mothers in developing countries can more easily provide protection to newborn babies born at home.
Biomedical engineers at Duke University have developed an inexpensive and easy-to-use system that allows mothers to give their newborns a potentially life-saving dose of an anti-HIV medication shortly after birth. This is especially important since such drugs can only be found in clinics or hospitals, which can be days away from an expectant mother.
Timing is crucial for the newborn.
In order to be effective, the drug, known as Nevirapine, must be given to the newborn within days of birth. The challenge to date has been reaching distant mothers who give birth at home. Since most mothers are not up to traveling that soon after delivery to get medication, the biomedical engineers developed a way of providing the medication in a simple manner and with a long shelf-life --- pouches made of foil and plastic that can hold a single dose of Nevirapine.
"In Africa, the World Health Organization (WHO) estimates that more than 90 percent of 430,000 new cases of AIDS in 2008 were attributable to mother-to-child transmission," said Carolina Gamache, program coordinator in senior researcher Robert Malkin's Developing World Healthcare Technology Laboratory at Duke's Pratt School of Engineering. "A single dose of Nevirapine right after birth has been shown to be effective in protecting the baby from the virus, but it has been difficult for many reasons to make this option available to women who give birth at home."
Gamache presented the results of the Duke research in London at the Appropriate Healthcare Technologies for Developing Countries conference, which is sponsored by WHO and the Institute of Engineering and Technology. Her paper describing the team's results was selected by judges as the conference's top research paper.
While healthcare workers in Africa have in the past tried packaging single doses by other means - syringes and containers - they have all suffered from evaporation during storage and loss of preservatives. This is not an issue for bulk quantities of the drug, which are common in clinic and hospital pharmacies.
Also, as Gamache explained, drug manufacturers have not shown much interest in devising single-dose systems because of development costs and limited marketing potential outside the Third World. The new pouch, which was fabricated at Duke, has been shown in tests to greatly reduce evaporation while remaining potent at various temperatures - all greatly extending its life span.
"In our system, the pharmacist can fill an individual pouch for women early in their pregnancy, and they can take it home with them," Gamache said. "When the baby is born, the mother can then easily rip off the corner of the pouch and empty the drug into the newborn's mouth. Further treatments can be given to the baby at the clinic or hospital later when travel becomes easier for the mother."
The WHO estimates that just 32 percent of infants born to HIV-positive mothers received prophylactic antiretroviral drugs like Nevirapine, compared to 45 percent of their pregnant mothers.
"If borne out in upcoming clinical trials, it would be expected that the current gap in anti-retroviral prophylaxis between mothers and their children could be reduced with the pouch," Malkin said. "This could be accomplished at little additional cost and could be a significant step in creating a generation of children free of HIV."
The team has conducted field testing the past year on the use of the pouches with nurses and pharmacists in Tanzania, and based on the encouraging results, they are planning clinical trials to determine if the new system can reduce the number of mother-to-child cases of HIV transmission.
Although the latest studies were conducted with Nevirapine, the Duke researchers also plan to test the system with other anti-HIV medications and combinations of medications.
The research was supported by Duke's Research in Practice Program and the Provost's Common Fund. Pratt undergraduates Michael Spohn, Shannon Skinner and Peter Horgan were also part of the team.
Source:
Richard Merritt
Duke University
четверг, 31 мая 2012 г.
четверг, 24 мая 2012 г.
Actions Taken On HPV Proposals Legislation In Alaska, Indiana, Washington State
The following highlights recent state news related to human papillomavirus vaccines. Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. CDC has added Gardasil to its Vaccines for Children Program, which provides no-cost immunizations to children ages nine to 18 covered by Medicaid, Alaska Native and American Indian children, and some uninsured and underinsured children (Kaiser Daily Women's Health Policy Report, 3/22). GSK last month announced that it has filed for FDA approval of Cervarix (Kaiser Daily Women's Health Policy Report, 4/5). Summaries appear below.
Alaska: The Department of Health and Social Services last week announced that by early summer it will distribute more than 20,000 doses of Gardasil to public and private health clinics in the state, the AP/Helena Independent Record reports (Quinn, AP/Helena Independent Record, 4/9). Nearly two-thirds of Alaska girls qualify to receive the vaccine at no cost, Laurel Wood, state immunization program manager said (Shinohara, Anchorage Daily News, 4/10). If all women and girls eligible to receive Gardasil at no cost through the Vaccines for Children program are vaccinated this year, the cost would total $16 million, Wood said, adding that it is unlikely all eligible females will be immunized. Wood estimates that the state program for the vaccine will cost about $5 million this year, which is enough to vaccinate more than 17,000 females (AP/Helena Independent Record, 4/9). Planned Parenthood of Alaska has been offering Gardasil at a cost of $480. Chris Simon, CEO of PPA, said the organization has vaccinated "a little under 50" people statewide (Anchorage Daily News, 4/10).
Indiana: The Senate on Monday voted 45-3 to approve an amended version of a bill (SB 327) that would require schools in the state to provide parents and guardians of girls entering the sixth grade information about Gardasil and the link between HPV and cervical cancer, the Fort Wayne Journal Gazette reports. According to the Journal Gazette, the measure would require parents and guardians to submit a written statement that says whether the student has received the vaccine, is going to receive the vaccine or will not receive the vaccine, or if the parent chooses not to answer the question. Answers in the statements, which will not affect a student's ability to attend school, would be used by the State Department of Health to track Gardasil's effectiveness at preventing cervical cancer, the Journal Gazette reports. The bill now heads to Gov. Mitch Daniels (R) (Kelly, Fort Wayne Journal Gazette, 4/17).
Washington: The House on Saturday voted 76-18 to approve an amended version of a bill (HB 1802) that would require all schools in the state to provide information about HPV and HPV vaccines but would not require private schools to distribute the information at school, the AP/Olympian reports (Byrd, AP/Olympian, 4/14). Under the original bill, sponsored by Rep. Jeannie Darneille (D), all public and private schools would have been required to give parents of children entering the sixth grade information on HPV, its symptoms and causes, and places where vaccines can be obtained (Kaiser Daily Women's Health Policy Report, 3/15). The amended version of the legislation, which passed the Senate, still requires public schools to provide parents with the information but only requires private schools to notify parents that the information is available to pick up. State lawmakers also included funding in the budget to add the HPV vaccine to the state's universal vaccine program, which would make it available to girls ages nine to 18 at almost no cost, the AP/Olympian reports. Parents and guardians only would have to pay the doctor visit fee, according to the AP/Olympian. The bill now heads to Gov. Chris Gregoire (D), who is expected to sign it into law, according to spokesperson Holly Armstrong (AP/Olympian, 4/14).
"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 Cervarix [Human Papillomavirus Bivalent; Gardasil.
Alaska: The Department of Health and Social Services last week announced that by early summer it will distribute more than 20,000 doses of Gardasil to public and private health clinics in the state, the AP/Helena Independent Record reports (Quinn, AP/Helena Independent Record, 4/9). Nearly two-thirds of Alaska girls qualify to receive the vaccine at no cost, Laurel Wood, state immunization program manager said (Shinohara, Anchorage Daily News, 4/10). If all women and girls eligible to receive Gardasil at no cost through the Vaccines for Children program are vaccinated this year, the cost would total $16 million, Wood said, adding that it is unlikely all eligible females will be immunized. Wood estimates that the state program for the vaccine will cost about $5 million this year, which is enough to vaccinate more than 17,000 females (AP/Helena Independent Record, 4/9). Planned Parenthood of Alaska has been offering Gardasil at a cost of $480. Chris Simon, CEO of PPA, said the organization has vaccinated "a little under 50" people statewide (Anchorage Daily News, 4/10).
Indiana: The Senate on Monday voted 45-3 to approve an amended version of a bill (SB 327) that would require schools in the state to provide parents and guardians of girls entering the sixth grade information about Gardasil and the link between HPV and cervical cancer, the Fort Wayne Journal Gazette reports. According to the Journal Gazette, the measure would require parents and guardians to submit a written statement that says whether the student has received the vaccine, is going to receive the vaccine or will not receive the vaccine, or if the parent chooses not to answer the question. Answers in the statements, which will not affect a student's ability to attend school, would be used by the State Department of Health to track Gardasil's effectiveness at preventing cervical cancer, the Journal Gazette reports. The bill now heads to Gov. Mitch Daniels (R) (Kelly, Fort Wayne Journal Gazette, 4/17).
Washington: The House on Saturday voted 76-18 to approve an amended version of a bill (HB 1802) that would require all schools in the state to provide information about HPV and HPV vaccines but would not require private schools to distribute the information at school, the AP/Olympian reports (Byrd, AP/Olympian, 4/14). Under the original bill, sponsored by Rep. Jeannie Darneille (D), all public and private schools would have been required to give parents of children entering the sixth grade information on HPV, its symptoms and causes, and places where vaccines can be obtained (Kaiser Daily Women's Health Policy Report, 3/15). The amended version of the legislation, which passed the Senate, still requires public schools to provide parents with the information but only requires private schools to notify parents that the information is available to pick up. State lawmakers also included funding in the budget to add the HPV vaccine to the state's universal vaccine program, which would make it available to girls ages nine to 18 at almost no cost, the AP/Olympian reports. Parents and guardians only would have to pay the doctor visit fee, according to the AP/Olympian. The bill now heads to Gov. Chris Gregoire (D), who is expected to sign it into law, according to spokesperson Holly Armstrong (AP/Olympian, 4/14).
"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 Cervarix [Human Papillomavirus Bivalent; Gardasil.
четверг, 17 мая 2012 г.
GOP Letter To Obama Urges 'Common Ground' On Health Reform, Restrictions On Abortion Funding
House Republicans on Wednesday sent President Obama a letter urging "open and constructive dialogue across party lines" on health care reform and calling on him to maintain current restrictions on federal funding of abortion services, Politico reports. The letter, signed by House Minority Leader John Boehner (Ohio), House Minority Whip Eric Cantor (Va.), House Republican Conference Chair Mike Pence (Ind.) and six other Republican House members, outlines the Republicans' positions on health care reform. It says achieving those objectives "can be accomplished through health reform that maintains current law provisions regarding restrictions on federal funding of abortion services, restricts federal funds from flowing to abortion providers and does not impose mandates either on insurance carriers or medical providers to participate in activities that violate their religious and moral beliefs."
The letter says that Republicans have several "areas for potential common ground on health care reform." In all, it mentions the phrase "common ground" four times in eight paragraphs, Politico reports (Allen, Politico, 5/13).
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.
© 2009 The Advisory Board Company. All rights reserved.
The letter says that Republicans have several "areas for potential common ground on health care reform." In all, it mentions the phrase "common ground" four times in eight paragraphs, Politico reports (Allen, Politico, 5/13).
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.
© 2009 The Advisory Board Company. All rights reserved.
четверг, 10 мая 2012 г.
60% Of People With Embryos In U.S. Fertility Clinics Would Consider Donating Them For Stem Cell Research, Survey Says
About 60% of people who have embryos stored at U.S. fertility clinics would be very or somewhat likely to donate them for stem cell research, according to a survey published Thursday in the online edition of the journal Science, Reuters reports (Dunham, Reuters, 6/20). For the survey, Anne Drapkin Lyerly, associate professor of gynecology at Duke University, and Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics, sent questionnaires to 2,000 random couples at fertility clinics around the country (AP/CBS News, 6/20). They received responses from 1,020 people who have embryos stored at nine fertility clinics in California, Colorado, Maryland, Missouri, New Jersey, North Carolina, Oregon, Pennsylvania and Washington, D.C. (Reuters, 6/20).
Federal funding for human embryonic stem cell research currently is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by President Bush on that date. Bush on Wednesday vetoed a bill (S 5) -- called the Stem Cell Research Enhancement Act of 2007 -- that would have allowed federal funding for research using stem cells derived from human embryos originally created for fertility treatments and willingly donated by patients (
Federal funding for human embryonic stem cell research currently is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by President Bush on that date. Bush on Wednesday vetoed a bill (S 5) -- called the Stem Cell Research Enhancement Act of 2007 -- that would have allowed federal funding for research using stem cells derived from human embryos originally created for fertility treatments and willingly donated by patients (
четверг, 3 мая 2012 г.
Opinion Pieces Respond To Obama's Call For 'Empathy' In Supreme Court Justice
Two newspapers recently published opinion pieces responding to President Obama's comments on the need for "empathy" in candidates to replace retiring Supreme Court Justice David Souter. Summaries appear below.
~ Ellen Goodman, Boston Globe: When discussing Souter's replacement, Obama said he will seek a nominee "'who understands that justice isn't about some abstract theory. ... It is also about how our laws affect the daily realities of people's lives,'" Globe columnist Goodman writes in an opinion piece. According to Goodman, Obama's emphasis on the need for judicial "empathy" has sparked outrage among a "phalanx of horrified conservatives" who claim that "empathy is just a code word for the sentimental liberal bias in favor of underdogs over the Constitution." However, she continues, "let us remember that empathy is not sympathy. It doesn't require that we take sides. Nor is it an emotional shortcut that upends all legal reasoning to declare a winner." According to Goodman, empathy "is rather the ability to imaginatively enter into the experience of others." She writes that the "capacity to recognize another person's reality is not just liberal," adding that empathy "doesn't trump reason, it informs reason." Goodman writes, "The truth is that we want judges who 'get it,'" adding that the "myth of justice as a matter of pure objective reasoning that could be meted out by a computer is just that, a myth" (Goodman, Boston Globe, 5/22).
~ Mike Rosen, Denver Post: Although Obama's emphasis on empathy might seem "[c]ompassionate and seductive" to some, his stance "represents a radical and dangerous departure from traditional American jurisprudence," radio host Rosen writes in a Post opinion piece. Rosen writes, "When empathetic judges rule on their feelings, they are exceeding their authority," adding that the "role of the judicial branch of our government is to rule on the Constitution as written and the law as passed by Congress and signed by the president." According to Rosen, the courts "are a co-equal branch of government, not a superior branch," and judges should not "rule on what they think the law ought to be" because that would be "government by a presumptuous, unelected judiciary." Rosen continues that "judges are referees, not rule makers" because they are "not there to empathize with the fans or the players. They represent the rule book, and they aren't authorized to … make it 'fairer.'" According to Rosen, the "dispute between conservatives and liberals on judicial activism is philosophical and irreconcilable." He concludes that Senate confirmation hearings for Obama's nominee "should make for an interesting debate on these principles" (Rosen, Denver Post, 5/22).
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.
© 2009 The Advisory Board Company. All rights reserved.
~ Ellen Goodman, Boston Globe: When discussing Souter's replacement, Obama said he will seek a nominee "'who understands that justice isn't about some abstract theory. ... It is also about how our laws affect the daily realities of people's lives,'" Globe columnist Goodman writes in an opinion piece. According to Goodman, Obama's emphasis on the need for judicial "empathy" has sparked outrage among a "phalanx of horrified conservatives" who claim that "empathy is just a code word for the sentimental liberal bias in favor of underdogs over the Constitution." However, she continues, "let us remember that empathy is not sympathy. It doesn't require that we take sides. Nor is it an emotional shortcut that upends all legal reasoning to declare a winner." According to Goodman, empathy "is rather the ability to imaginatively enter into the experience of others." She writes that the "capacity to recognize another person's reality is not just liberal," adding that empathy "doesn't trump reason, it informs reason." Goodman writes, "The truth is that we want judges who 'get it,'" adding that the "myth of justice as a matter of pure objective reasoning that could be meted out by a computer is just that, a myth" (Goodman, Boston Globe, 5/22).
~ Mike Rosen, Denver Post: Although Obama's emphasis on empathy might seem "[c]ompassionate and seductive" to some, his stance "represents a radical and dangerous departure from traditional American jurisprudence," radio host Rosen writes in a Post opinion piece. Rosen writes, "When empathetic judges rule on their feelings, they are exceeding their authority," adding that the "role of the judicial branch of our government is to rule on the Constitution as written and the law as passed by Congress and signed by the president." According to Rosen, the courts "are a co-equal branch of government, not a superior branch," and judges should not "rule on what they think the law ought to be" because that would be "government by a presumptuous, unelected judiciary." Rosen continues that "judges are referees, not rule makers" because they are "not there to empathize with the fans or the players. They represent the rule book, and they aren't authorized to … make it 'fairer.'" According to Rosen, the "dispute between conservatives and liberals on judicial activism is philosophical and irreconcilable." He concludes that Senate confirmation hearings for Obama's nominee "should make for an interesting debate on these principles" (Rosen, Denver Post, 5/22).
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.
© 2009 The Advisory Board Company. All rights reserved.
четверг, 26 апреля 2012 г.
EMILY's List Launches Campaign Against Nev. Congressional Candidate Heck
EMILY's List is launching a two-week television ad campaign in Nevada that portrays Republican House candidate Joe Heck as hostile toward women's health issues, Politico reports. EMILY's List, which supports female candidates who are in favor of abortion rights, is backing Heck's opponent, Democratic incumbent Rep. Dina Titus. The ad is produced through Women Vote!, an independent expenditure of EMILY's List.
According to Politico, the race between Titus and Heck is "one of the most competitive House contests" this election cycle, with a mid-August Mason-Dixon poll showing the two candidates in a statistical tie of 43% for Titus and 42% for Heck. A "significant offensive" against Heck could give Titus a boost in the campaign, Politico reports.
The new ad attacks a vote Heck made while serving in the Nevada state Senate against a bill that would have required health plans to cover the human papillomavirus vaccine, which prevents some forms of HPV that can cause cervical cancer. The ad states that Heck "actually voted against requiring insurance companies to cover the vaccine" and "said women wouldn't need it if they did not engage in risky behavior." The ad continues, "This from a man who graduated from medical school. ... If we can't trust Heck with our health, can we trust him with our future?"
The ad campaign is "precision-targeted" toward women ages 18 through 49, Politico reports. It will air on TV shows and websites where young Nevada women are likely to see it, including during MTV's "Teen Mom" and "Jersey Shore," on the Internet TV site Hulu, and during TV shows like "Grey's Anatomy," "30 Rock," and "Real Housewives of New Jersey." A simultaneous campaign will run on Facebook, with ads reading "What the Heck?" and "Heck: Bad for Our Health."
EMILY's List spokesperson Jen Bluestein Lamb said the group "will do everything we can to ensure voters know the truth and get out to vote" (Burns, Politico, 9/8).
Associated Press Fact Checks Anti-Health Reform Claims
Several Republican candidates and their supporters are airing campaign ads attacking the federal health reform law (PL 111-148) and the Democratic candidates who voted for it, the AP/ABC News reports in a fact check of such ads. The ads "often resor[t] to exaggeration and omission to make their points," including claims regarding abortion, the AP/ABC News reports.
For example, radio ads by AUL Action, the legislative arm of Americans United for Life, claim that three House Democrats who voted for the health reform law -- Reps. John Boccieri (Ohio), Christopher Carney (Pa.) and Baron Hill (Ind.) -- "voted for taxpayer-funded abortion." The ads also call the law "the largest expansion of taxpayer-funded abortions ever."
However, the AP/ABC News reports that an executive order signed by President Obama after the bill's passage reaffirms that the reform law prohibits the use of federal funds to pay for abortion coverage.
AUL argues that Obama's executive order could be reversed and that courts "could interpret" the law as permitting federal funding for abortion services. Such situations "are hypothetical, and the trend is in the other direction," the AP/ABC News reports. For example, HHS announced in July that the high-risk insurance pools created under the law are prohibited from covering abortion except in cases of rape, incest or to save the life of the woman (Kuhnhenn, AP/ABC News, 9/8).
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.
© 2010 National Partnership for Women & Families. All rights reserved.
четверг, 19 апреля 2012 г.
FDA Warns Bayer About Two Illegal Aspirins
The US Food and Drug Administration (FDA) has written warning letters to drug company Bayer HealthCare about two over the counter (OTC)
aspirins that contain supplements and claim to be effective not only for pain relief but against heart disease, and this constitutes a use for which the
drugs have not been given approval and therefore makes them illegal said the agency in a statement on Tuesday.
The two aspirins are: Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart
Advantage).
Bayer Women's has aspirin and calcium carbonate in a single tablet and Bayer Heart Advantage has aspirin and phytosterols in a single tablet. They
both carry labels that describe them as being a drug and a dietary supplement, but when these are together in one tablet the product is subject to FDA
regulation said the FDA.
Mike Chappell, the FDA's acting associate commissioner for regulatory affairs said in a statement that:
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process."
Chappell said the federal agency was prepared to enforce action against manufacturers who broke the law or who tried to get around the drug approval
process.
The two aspirins are labelled not only as pain relievers, but also carry claims that they reduce the risk of heart disease, said the FDA statement. Bayer's
Women's also claims to "fight" osteoporosis. Neither of these uses is approved by the FDA. Moreover, the drugs are misbranded said the agency since such uses take the products out of the OTC
category because these conditions should be diagnosed by a healthcare professional who then advises which medication to take and then supervises the
patient on the drug.
Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said she was troubled by the marketing of these unapproved
drugs.
"Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these
aspirin-containing products can put consumers at risk for internal bleeding and other adverse events."
"It is essential that companies obtain FDA approval and fully comply with FDA regulations."
The FDA said the labels also carry mixed messages about long versus short term use because the instructions for the aspirin content conflict with the
instructions for the supplement content.
It would seem that part of the problem is in the wording. Claiming to fight a disease or directly claiming to lower cholesterol is not the same as
claiming to reduce the risk of these conditions.
The label on the Bayer Heart Advantage product claims that the phytosterols are intended to lower blood cholesterol and the label on the Bayer
Women's product claims that the calcium is intended to strengthen bones to "fight" osteoporosis.
Although some dietary supplements that contain calcium are allowed to claim to "reduce the risk of osteoporosis", claims to fight or treat the
condition directly requires approval by the FDA. Similarly, some supplements containing phytosterols are allowed to claim they "reduce the risk of
coronary heart disease" and may say they do this by lowering blood cholesterol, but a direct claim to lower cholesterol is the same as saying the drug
prevents or treats coronary heart disease and hypercholesterolemia, for which FDA approval is necessary.
Not only should the company apply for new drug approval for such claims, but they would not be approved for OTC use anyway and to market them as
such is another reason that makes them illegal, said the FDA.
There are some conditions under which the FDA allows OTC drugs to be marketed without first getting FDA approval but the agency said these two drugs
do not meet the conditions because they do not comply with "set requirements for the drugs' labeling and formulation, as well as the indications (uses)
for which the drugs can be marketed".
The FDA said it was not aware of any significant adverse events arising from use of these products.
According to Reuters, a Bayer spokesperson told the press that the company stands by both products and defends its right to market them as labelled.
The drug company said advertisements tell consumers to check with their health professional before taking aspirin with supplements, and the label on
the Bayer Aspirin with Heart Advantage also says it does not replace cholesterol-lowering medication.
Sources: FDA, Reuters.
: Catharine Paddock, PhD.
aspirins that contain supplements and claim to be effective not only for pain relief but against heart disease, and this constitutes a use for which the
drugs have not been given approval and therefore makes them illegal said the agency in a statement on Tuesday.
The two aspirins are: Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart
Advantage).
Bayer Women's has aspirin and calcium carbonate in a single tablet and Bayer Heart Advantage has aspirin and phytosterols in a single tablet. They
both carry labels that describe them as being a drug and a dietary supplement, but when these are together in one tablet the product is subject to FDA
regulation said the FDA.
Mike Chappell, the FDA's acting associate commissioner for regulatory affairs said in a statement that:
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process."
Chappell said the federal agency was prepared to enforce action against manufacturers who broke the law or who tried to get around the drug approval
process.
The two aspirins are labelled not only as pain relievers, but also carry claims that they reduce the risk of heart disease, said the FDA statement. Bayer's
Women's also claims to "fight" osteoporosis. Neither of these uses is approved by the FDA. Moreover, the drugs are misbranded said the agency since such uses take the products out of the OTC
category because these conditions should be diagnosed by a healthcare professional who then advises which medication to take and then supervises the
patient on the drug.
Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said she was troubled by the marketing of these unapproved
drugs.
"Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these
aspirin-containing products can put consumers at risk for internal bleeding and other adverse events."
"It is essential that companies obtain FDA approval and fully comply with FDA regulations."
The FDA said the labels also carry mixed messages about long versus short term use because the instructions for the aspirin content conflict with the
instructions for the supplement content.
It would seem that part of the problem is in the wording. Claiming to fight a disease or directly claiming to lower cholesterol is not the same as
claiming to reduce the risk of these conditions.
The label on the Bayer Heart Advantage product claims that the phytosterols are intended to lower blood cholesterol and the label on the Bayer
Women's product claims that the calcium is intended to strengthen bones to "fight" osteoporosis.
Although some dietary supplements that contain calcium are allowed to claim to "reduce the risk of osteoporosis", claims to fight or treat the
condition directly requires approval by the FDA. Similarly, some supplements containing phytosterols are allowed to claim they "reduce the risk of
coronary heart disease" and may say they do this by lowering blood cholesterol, but a direct claim to lower cholesterol is the same as saying the drug
prevents or treats coronary heart disease and hypercholesterolemia, for which FDA approval is necessary.
Not only should the company apply for new drug approval for such claims, but they would not be approved for OTC use anyway and to market them as
such is another reason that makes them illegal, said the FDA.
There are some conditions under which the FDA allows OTC drugs to be marketed without first getting FDA approval but the agency said these two drugs
do not meet the conditions because they do not comply with "set requirements for the drugs' labeling and formulation, as well as the indications (uses)
for which the drugs can be marketed".
The FDA said it was not aware of any significant adverse events arising from use of these products.
According to Reuters, a Bayer spokesperson told the press that the company stands by both products and defends its right to market them as labelled.
The drug company said advertisements tell consumers to check with their health professional before taking aspirin with supplements, and the label on
the Bayer Aspirin with Heart Advantage also says it does not replace cholesterol-lowering medication.
Sources: FDA, Reuters.
: Catharine Paddock, PhD.
четверг, 12 апреля 2012 г.
Blogs Comment On Catholics' Support For Health Reform, Chicago 'Bubble Zone' Law, Other Topics
The following summarizes selected recent women's health-related blog entries.
"Survey of Catholics: Strong Support for Health Reform and Women's Rights," Kathleen Reeves, RH Reality Check: A recent survey by Catholics for Choice found that, "lo and behold, the Catholic hierarchy is not in line with [U.S] Catholics" on the issue of abortion coverage under health care reform, Reeves writes. While many Catholic bishops "have voiced unconditional opposition" to any health reform legislation that does not explicitly exclude coverage for abortion services, 68% of Catholics surveyed "disagree[d] with the idea that Catholics should oppose the entire health care reform plan if it includes coverage for abortions," Reeves says. The survey also found that 21% of Catholics believe abortion should be legal in all cases, half of whom said health insurance plans should cover abortion services "whenever a woman and her doctor decide it is appropriate." She continues, "This is one of the survey's most valuable findings -- that is, you don't have to be 'pro-choice' in any traditional political sense to believe in a woman's right to choose an abortion" or "that insurance should cover this medical procedure." In addition, "even if some Catholics don't believe in abortion and don't believe that any health plan should cover abortion, these Catholics don't necessarily wish to sacrifice health care reform for these beliefs," Reeves writes. She concludes, "Perhaps Catholic bishops should look to their flock for a reminder of how religion does what it does best; that is, to fight suffering, degradation and despair" (Reeves, RH Reality Check, 10/12).
"Roundup: Abortion Clinic Safety Zones in Chicago; Misreading the Pew Poll on Attitude Toward Abortion," Jodi Jacobson, RH Reality Check: In a blog entry, Jacobson highlights recent news relating to abortion rights, including Chicago Mayor Richard Daley's (D) announcement that he will sign an ordinance requiring protesters "to keep a healthy distance from women entering abortion clinics." Daley said, "Everybody has the right to demonstrate and picket," but "to use words and other things to frighten people going in to seek assistance, that is another question." Jacobson also references an American Prospect blog entry by Sarah Posner "argu[ing] that some commentators ... have misread recent polls on abortion," including the recent Pew Research Center poll on abortion attitudes. A commentary in The Politic Jonathan McCleod "suggests that U.S. health reform make room for federal funding on abortion care," Jacobson writes. McCleod wrote, "[I]t would be wrong for the government to start dictating the terms of valid insurance coverage, such that a common and basic procedure like abortion would be excluded. If the government is going to take taxpayer's money to create a subsidy, the government has no right to create disincentives to purchase that which an individual considers the optimal insurance coverage" (Jacobson, RH Reality Check, 10/12).
"Abortion: A Healthy Choice," Jacob Appel, Huffington Post blogs: Some abortion-rights opponents "have increasingly attempted to scare women away from abortion with specious claims that the procedure is unsafe," including suggesting links between abortion and breast cancer and mental health issues, writes Appel, a medical historian and bioethicist. "Even if these assertions were true -- and years of study have established categorically that they are not -- this data would obscure the larger truth regarding abortion and women's health," which is that "abortion is convincingly far safer for maternal health than bringing a fetus to term," he states. Appel notes that about 500 additional women would have died in childbirth if the 50 million abortions that have occurred since 1973 were carried to full-term deliveries. According to Appel, studies show that the risk of a woman in the U.S. dying in childbirth is approximately one in 7,500, compared with a risk of dying of one in one million for abortions in the first eight weeks of pregnancy, when the majority of procedures take place. The "shell game perpetrated by abortion opponents is quite clever" because they "focus public attention on a comparison between abortion and baseline health, rather than between abortion and pregnancy," Appel writes. He continues that although the "significant risks of childbirth may well be worth enduring for the rich joys of motherhood, ... "[w]hat is harder for me to understand is why anyone would take such risks in order to deliver a baby that they do not want." Appel adds, "That should be a woman's choice too, of course. But if you're going to put your own well-being at risk, you should certainly know all the risks" (Appel, Huffington Post blogs, 10/11).
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.
© 2009 The Advisory Board Company. All rights reserved.
четверг, 5 апреля 2012 г.
European Court Of Human Rights Upholds Ruling That Rights Of Polish Woman Allegedly Denied Abortion Were Violated
The European Court of Human Rights on Monday upheld a ruling that ordered the Polish government to award damages to a Polish woman who says that in 2000 she was denied an abortion despite warnings from physicians that she could become blind if she continued the pregnancy, the Irish Times reports (Irish Times, 9/25).
Alicja Tysiac alleges that Poland's abortion law violated her rights under Article 8 and Article 14 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, which guarantee "respect for privacy and family life" and "prohibition of discrimination," respectively. Polish law allows abortion only if a woman has been raped, if there is danger to the life of the woman or if the fetus will have birth defects. Three ophthalmologists in February 2000 told Tysiac she would go blind if she were to give birth to a third child. None of the doctors would refer her for an abortion procedure.
In April 2000, Tysiac had an appointment at a public hospital in Warsaw, Poland, where a gynecologist said there was no medical reason to have the procedure. Tysiac gave birth via caesarean section in November 2000. After her c-section, Tysiac experienced a retinal hemorrhage. Since then, "a panel of doctors concluded that her condition required treatment and daily assistance and declared her to be significantly disabled," court documents said.
Alicja Tysiac alleges that Poland's abortion law violated her rights under Article 8 and Article 14 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, which guarantee "respect for privacy and family life" and "prohibition of discrimination," respectively. Polish law allows abortion only if a woman has been raped, if there is danger to the life of the woman or if the fetus will have birth defects. Three ophthalmologists in February 2000 told Tysiac she would go blind if she were to give birth to a third child. None of the doctors would refer her for an abortion procedure.
In April 2000, Tysiac had an appointment at a public hospital in Warsaw, Poland, where a gynecologist said there was no medical reason to have the procedure. Tysiac gave birth via caesarean section in November 2000. After her c-section, Tysiac experienced a retinal hemorrhage. Since then, "a panel of doctors concluded that her condition required treatment and daily assistance and declared her to be significantly disabled," court documents said.
Ruling, Reaction
Tysiac filed a complaint with the European Court in January 2003, and the court upheld her appeal in March 2007. The ruling stated that Poland failed to guarantee access to legal abortions, that Tysiac's privacy rights had been violated and that her treatment had caused her "severe distress and anguish." In the decision, the court said that Poland has no effective legal framework for pregnant women to assert their right to abortion on medical grounds. It added that Polish law "did not contain any effective mechanism capable of determining whether the conditions for obtaining a lawful abortion had been met" (Kaiser Daily Women's Health Policy Report, 6/21).
According to the Times, the ruling "enraged" the government of Prime Minister Jaroslaw Kaczynski (Irish Times, 9/25). The governing coalition in the country has been pushing for a total ban on abortion. However, Kaczynski's conservative party has tried to keep abortion-related issues "off the political agenda" since lawmakers in April rejected proposals for tougher abortion restrictions (Kaiser Daily Women's Health Policy Report, 6/21). Under the ruling, the government will be required to pay Tysiac 39,000 euros, or about $54,900 (Irish Times, 9/25).
Reprinted with kind 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.
четверг, 29 марта 2012 г.
New Emergency Contraceptive Prevents Pregnancy Up To Five Days, Study Finds
A study published Friday in the British medical journal Lancet found that a new type of emergency contraception, ulipristal acetate, appears to be more effective for a longer time than the most widely used form of EC, levonorgestrel, the AP/USA Today reports. The new EC pill -- available by prescription in Europe under the brand name ellaOne -- prevented pregnancy for up to five days in the study. Levonorgestrel -- sold as Levonelle and Plan B in the U.S. and more than 140 other countries -- can be taken for up to three days.
Lead author Anna Glasier of the Family Planning and Well Woman Services at Dean Terrace Centre in Edinburgh, Scotland, and colleagues followed about 1,700 women ages 16 through 36 who received either ellaOne or Plan B within three to five days of having unprotected sex. The study found that there were 22 pregnancies in the group that received levonorgestrel, compared with 15 in the group that received the newer drug. Overall, women who took ulipristal acetate had a 1.8% chance of becoming pregnant, compared with a 2.6% chance among the women who took levonorgestrel. The newer pill appeared to work consistently for up to five days, whereas levonorgestrel decreases in effectiveness over time.
Glasier said that the different ingredients in the two pills might be one reason for the discrepancy. Plan B contains synthetic progesterone and mimics the effects of the natural hormone by interfering with the ovulation as the egg develops, whereas the newer EC pill delays ovulation, according to the AP/USA Today.
Glasier said that more safety data are needed before the new drug can be recommended for over-the-counter use. She estimated that ellaOne costs about three times more than Plan B. The study was designed and funded by HRA Pharma, which produced ellaOne.
Health officials said women should still act quickly to prevent an unintended pregnancy. "The message has to be always that women should act as soon as possible," Tony Kerridge, a spokesperson for Marie Stopes International, said. He added, "You may think you have a window of opportunity, but as soon as you can, go somewhere and get it sorted [out]" (AP/USA Today, 1/28).
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.
четверг, 22 марта 2012 г.
Latest US Policy In Iraq Can Lead To Human Rights Abuses Says Hebrew University Researcher
U.S. policy in Iraq courting tribal leaders may be yielding positive results in combating al-Qaida and stabilizing the country, but may also be repeating British policy of the previous century which led to severe human rights abuses, particularly against women, says a researcher at the Hebrew University of Jerusalem.
In an article being released in conjunction with Human Rights Week, now being marked around the world, Dr. Noga Efrati, head of the Iraq research group at the Hebrew University's Harry S. Truman Research Institute for the Advancement of Peace, reviews British tribal policy in Iraq from 1914-1932, during which Britain first occupied the country and then (from 1920) ruled it under mandate authority. Her article on the subject appears in a new book, Britain and the Middle East, to be published later this month
The British, who came to Iraq during the First World War in order to defend their interests in the region, sought to revive a disintegrating tribal system in order to control the vast rural areas of the country. To accomplish this, they appointed sheikhs as tribal leaders, granting them wide discretionary powers, including the settling of disputes via "tribal law." This had an adverse effect particularly on women.
"Under the British mandate, rural women - the majority of women in Iraq - were not constructed as citizens of a modern state whose rights and liberties should be protected, but as tribal possessions, abandoned and left outside state jurisdiction," Dr. Efrati writes in her article. Among other things, this meant that women could be offered in marriage to settle disputes or be forced to marry within their family. Even more serious was that the state had essentially legitimized "honor" murders.
The British maintained a "blind eye" toward these customs even though they were incompatible with both Islamic and Iraqi criminal law. "Tribal justice" could not be undermined lest it weaken the powers of the sheikhs who were serving British interests. Only in 1958, with the overthrow of the "old regime," was the tribal justice system annulled. Even so, these practices did not disappear entirely and even achieved renewed recognition under Saddam Hussein, notes Dr. Efrati.
Like the British of yesterday, the Americans today are increasingly depending on local leaders to restore order. However, in its effort to break the Sunni insurgency, stabilize the country and bring about political progress, the Bush Administration should learn from the mistakes of its predecessors, says Dr. Efrati, and be aware of the severe consequences that will arise by leaving the administration of "tribal" affairs in the hands of local leaders. If women are again to become "tribal property" this will be yet another strike against their human rights; the very rights the U.S. set out to defend when it went to war.
Source: Jerry Barach
The Hebrew University of Jerusalem
In an article being released in conjunction with Human Rights Week, now being marked around the world, Dr. Noga Efrati, head of the Iraq research group at the Hebrew University's Harry S. Truman Research Institute for the Advancement of Peace, reviews British tribal policy in Iraq from 1914-1932, during which Britain first occupied the country and then (from 1920) ruled it under mandate authority. Her article on the subject appears in a new book, Britain and the Middle East, to be published later this month
The British, who came to Iraq during the First World War in order to defend their interests in the region, sought to revive a disintegrating tribal system in order to control the vast rural areas of the country. To accomplish this, they appointed sheikhs as tribal leaders, granting them wide discretionary powers, including the settling of disputes via "tribal law." This had an adverse effect particularly on women.
"Under the British mandate, rural women - the majority of women in Iraq - were not constructed as citizens of a modern state whose rights and liberties should be protected, but as tribal possessions, abandoned and left outside state jurisdiction," Dr. Efrati writes in her article. Among other things, this meant that women could be offered in marriage to settle disputes or be forced to marry within their family. Even more serious was that the state had essentially legitimized "honor" murders.
The British maintained a "blind eye" toward these customs even though they were incompatible with both Islamic and Iraqi criminal law. "Tribal justice" could not be undermined lest it weaken the powers of the sheikhs who were serving British interests. Only in 1958, with the overthrow of the "old regime," was the tribal justice system annulled. Even so, these practices did not disappear entirely and even achieved renewed recognition under Saddam Hussein, notes Dr. Efrati.
Like the British of yesterday, the Americans today are increasingly depending on local leaders to restore order. However, in its effort to break the Sunni insurgency, stabilize the country and bring about political progress, the Bush Administration should learn from the mistakes of its predecessors, says Dr. Efrati, and be aware of the severe consequences that will arise by leaving the administration of "tribal" affairs in the hands of local leaders. If women are again to become "tribal property" this will be yet another strike against their human rights; the very rights the U.S. set out to defend when it went to war.
Source: Jerry Barach
The Hebrew University of Jerusalem
четверг, 15 марта 2012 г.
High Levels Of Testosterone Increases Appetite For Risk In Women; High Levels Connected To Choice Of Riskier Careers
The battle of the sexes rages on, this time from the trading floor. While there has long been debate about the social and biological differences between men and women, new research by the Kellogg School of Management at Northwestern University, the University of Chicago Booth School of Business and the University of Chicago's Department of Comparative Human Development explores how the hormone testosterone plays an important role in gender differences in financial risk aversion and career choice.
Prior research has shown that testosterone enhances competitiveness and dominance, reduces fear, and is associated with risky behaviors like gambling and alcohol use. However, until now, the impact of testosterone on gender differences in financial risk-taking has not been explored.
The new paper, "Gender differences in financial risk aversion and career choices are affected by testosterone," has been published in the Aug. 24, 2009 early edition of the Proceedings of the National Academy of Sciences (PNAS). The research was conducted by Paola Sapienza, Associate Professor, Kellogg School of Management at Northwestern University; Luigi Zingales, Robert McCormick Professor, University of Chicago Booth School of Business; and Dario Maestripieri, Professor in Comparative Human Development, University of Chicago.
"In general, women are more risk averse than men when it comes to making important financial decisions, which in turn can affect their career choices," said Sapienza. "For example, in our sample set, 36 percent of female MBA students chose high-risk financial careers such as investment banking or trading, compared to 57 percent of male students. We wanted to explore whether these gender differences are related to testosterone, which men have, on average, in higher concentrations than women."
The researchers, using an economic-based measure of risk aversion, found that higher levels of testosterone were associated with a greater appetite for risk in women, but not among men. However, in men and women with similar levels of testosterone, the gender difference in risk aversion disappeared. Additionally, the researchers reported that the link between risk aversion and testosterone predicted career choices after graduation: individuals who were high in testosterone and low in risk aversion chose riskier careers in finance.
"This is the first study showing that gender differences in financial risk aversion have a biological basis, and that differences in testosterone levels between individuals can affect important aspects of economic behavior and career decisions," said Maestripieri. "That the effects of testosterone on risk aversion are strongest for individuals with low or intermediate levels of this hormone is similar to what has been shown for the effects of testosterone on spatial cognition."
To investigate the relationship between testosterone and risk aversion, the authors measured testosterone levels in saliva samples (as well as markers of prenatal testosterone such as finger length) from approximately 500 MBA students at the University of Chicago Booth School of Business.
The uncharacteristically large sample which was global in demographic scope was familiar with financial risk by virtue of their education, and many pursued financial careers after business school. Also, the participants were relatively homogeneous in age, cultural and educational background, and socioeconomic status, thereby minimizing the effects of other non-biological variables.
As part of a mandatory MBA course, the students were asked to participate in a laboratory experiment to measure the relationship between risk and hormonal levels. Over two days in October 2006, the participants were asked to play a computer game that evaluated their risk aversion attitudes. They answered a series of questions that asked them to choose between accepting a guaranteed monetary award or choosing a risky lottery with a higher potential payout. Students had to choose repeatedly between the lottery and a fixed payment at increasing values. Two saliva samples were collected, once before the session and once after the test was completed, to measure hormonal changes over that time period.
As expected, more risk-prone participants chose the lottery more often, whereas more risk-averse individuals preferred the guaranteed payout. Overall, men exhibited significantly lower risk aversion than women in the study, and also had significantly higher levels of salivary testosterone than women.
"This study has significant implications for how the effects of testosterone could impact actual risk-taking in financial markets, because many of these students will go on to become major players in the financial world," said Zingales. "Furthermore, it could shed some light on gender differences in career choices. Future studies should further explore the mechanisms through which testosterone affects the brain."
Source: University of Chicago
Prior research has shown that testosterone enhances competitiveness and dominance, reduces fear, and is associated with risky behaviors like gambling and alcohol use. However, until now, the impact of testosterone on gender differences in financial risk-taking has not been explored.
The new paper, "Gender differences in financial risk aversion and career choices are affected by testosterone," has been published in the Aug. 24, 2009 early edition of the Proceedings of the National Academy of Sciences (PNAS). The research was conducted by Paola Sapienza, Associate Professor, Kellogg School of Management at Northwestern University; Luigi Zingales, Robert McCormick Professor, University of Chicago Booth School of Business; and Dario Maestripieri, Professor in Comparative Human Development, University of Chicago.
"In general, women are more risk averse than men when it comes to making important financial decisions, which in turn can affect their career choices," said Sapienza. "For example, in our sample set, 36 percent of female MBA students chose high-risk financial careers such as investment banking or trading, compared to 57 percent of male students. We wanted to explore whether these gender differences are related to testosterone, which men have, on average, in higher concentrations than women."
The researchers, using an economic-based measure of risk aversion, found that higher levels of testosterone were associated with a greater appetite for risk in women, but not among men. However, in men and women with similar levels of testosterone, the gender difference in risk aversion disappeared. Additionally, the researchers reported that the link between risk aversion and testosterone predicted career choices after graduation: individuals who were high in testosterone and low in risk aversion chose riskier careers in finance.
"This is the first study showing that gender differences in financial risk aversion have a biological basis, and that differences in testosterone levels between individuals can affect important aspects of economic behavior and career decisions," said Maestripieri. "That the effects of testosterone on risk aversion are strongest for individuals with low or intermediate levels of this hormone is similar to what has been shown for the effects of testosterone on spatial cognition."
To investigate the relationship between testosterone and risk aversion, the authors measured testosterone levels in saliva samples (as well as markers of prenatal testosterone such as finger length) from approximately 500 MBA students at the University of Chicago Booth School of Business.
The uncharacteristically large sample which was global in demographic scope was familiar with financial risk by virtue of their education, and many pursued financial careers after business school. Also, the participants were relatively homogeneous in age, cultural and educational background, and socioeconomic status, thereby minimizing the effects of other non-biological variables.
As part of a mandatory MBA course, the students were asked to participate in a laboratory experiment to measure the relationship between risk and hormonal levels. Over two days in October 2006, the participants were asked to play a computer game that evaluated their risk aversion attitudes. They answered a series of questions that asked them to choose between accepting a guaranteed monetary award or choosing a risky lottery with a higher potential payout. Students had to choose repeatedly between the lottery and a fixed payment at increasing values. Two saliva samples were collected, once before the session and once after the test was completed, to measure hormonal changes over that time period.
As expected, more risk-prone participants chose the lottery more often, whereas more risk-averse individuals preferred the guaranteed payout. Overall, men exhibited significantly lower risk aversion than women in the study, and also had significantly higher levels of salivary testosterone than women.
"This study has significant implications for how the effects of testosterone could impact actual risk-taking in financial markets, because many of these students will go on to become major players in the financial world," said Zingales. "Furthermore, it could shed some light on gender differences in career choices. Future studies should further explore the mechanisms through which testosterone affects the brain."
Source: University of Chicago
четверг, 8 марта 2012 г.
High Efficacy Of Gardasil® Leads Independent Data And Safety Monitoring Board To Recommend Urgent Vaccination Of Young Women In Placebo Group
In the light of the high efficacy of Gardasil® observed in the large clinical trials, FUTURE I and II, the independent Data and Safety Monitoring Board (DSMB) of these studies recommended that women in the placebo group should be vaccinated with Gardasil®. The DSMB recommended that the studies should be terminated as soon as feasible in order to provide the benefits of vaccination with Gardasil® to these women rapidly.
Gardasil®, Human Papillomavirus Vaccine [types 6,11,16,18] (Recombinant, adsorbed), is the only licensed vaccine for the prevention of cervical cancer and other Human Papillomavirus diseases that occur before cervical cancer and beyond the cervix.
In clinical trials, including FUTURE I and II, Gardasil® prevented up to 100% of cervical cancer, precancerous and potentially precancerous cervical lesions, precancerous vulval and vaginal lesions, and genital warts due to Human Papillomavirus virus types 6, 11, 16 and 18.1,, a), b)
It is estimated that Human Papillomavirus types 6, 11, 16 and 18 together cause 75% of cervical cancer,4 70% of precancerous5,6 and 50% of potentially precancerous cervical lesions7, a significant proportion vulval and vaginal cancers and their associated precancerous lesions8,,,91011, and 90% of genital warts in Europe.12,13
"I can more than understand that the board felt the responsibility not to leave these women unprotected. To be able to prevent Human Papillomavirus-related cervical cancer and their pre-cancerous stages as well as other Human Papillomavirus-related lower genital tract pre-cancerous lesions and infections so effectively, hardly allows any other conclusion. Young women are at the age of maximal exposure to the virus. Even though some years exist between infection and cancer development, prevention should start at this time so as to prevent later complications inherent in diagnostic and treatment procedures.", comments Albert Singer, Professor of Gynaecological Research, University of London, United Kingdom.
In Europe, vaccination of women in the placebo groups of the FUTURE I and II studies has already begun in study centres in Germany, Sweden, Denmark and Austria. In other countries, vaccination will start within the next days or weeks. In the United Kingdom, vaccination starts today. In total, approximately 4,300 women are anticipated to be vaccinated in European study centres, with the objective of completing before the end of the year 2007. In a similar way, vaccination of almost 4,500 women in many other countries around the world, including the United States, Australia and Canada, has begun or is anticipated to begin soon.
Gardasil® licence applications have been filed in 120 countries and approved in 55 countries (all under accelerated review timelines), including the European Union, the United States, Canada and Australia.
In addition to the women in the placebo group of the FUTURE I and II studies, women in the vaccine group of these studies who have either received less than three doses of Gardasil® or the monovalent precursor of Gardasil® instead of Gardasil® should also complete vaccination with Gardasil®. The monovalent precursor of Gardasil® targets only the Human Papillomavirus type 16 whereas Gardasil® targets the Human Papillomavirus types 6, 11, 16 and 18.
Current recommendation and funding of Human Papillomavirus vaccination
Just four months after gaining a licence in the European Union, Gardasil® is now available in 15 European countries. Accelerated discussions are under way in most European countries to integrate Human Papillomavirus vaccination in each country's recommendation and reimbursement programme.
As of 1 January 2007 vaccination is recommended in Austria for girls and boys aged 9 to 15 years as well as for women, preferably before the start of sexual activity.
In Germany, decisions are anticipated soon. Since early December 2006, several statutory health insurance funds in Germany, which together cover half of the population, have announced immediate and full reimbursement of Human Papillomavirus vaccination for females even before any recommendations by the authorities have been published. Other funds are anticipated to follow soon.
The French health minister has announced recommendations for March 2007 and reimbursement by the national social security system by July 2007 the latest. Since October 2006, three large private health insurance funds in France have announced immediate partial reimbursement of Human Papillomavirus vaccination also even before any recommendations by the authorities have been published.
The Italian Health Minister has recently announced that Italy will have a vaccination programme with Gardasil® next spring actively proposed of the young girls 12 years old.
In Spain, the region Navarra has recently announced the vaccination of young girls (aged 12 or 13 years) as soon as Gardasil® becomes available. The opportunity to add a catch-up vaccination programme for females >12 or 13 years and/or vaccination of boys will be investigated.
In Sweden, the first county has recently announced to offer Gardasil® girls and women even before the decision of the national health authorities.
Some Belgian health insurance funds have announced partial reimbursement of Human Papillomavirus vaccination before any recommendations by the authorities have been published.
Four Dutch health insurance funds have announced in December 2006 to completely reimburse Human Papillomavirus vaccination for females aged 9 to 26 years and males aged 9 to 15 years as of January 2007.
In the UK, the Joint Committee on Vaccinations and Immunisations (JCVI) have said they will meet to make a decision about a recommendation in early 2007.
In June 2006, the US health authorities recommended the routine vaccination of 11 and 12 year old females and the vaccination of females aged 13 to 26 who have not previously been vaccinated and that 9 and 10 year old females can be vaccinated at the discretion of their physicians. Pap and Human Papillomavirus screening prior to vaccination are not necessary according to the recommendation. The US authorities also recommended that females can receive Gardasil® regardless of whether they have or previously had an abnormal Pap test, a positive Human Papillomavirus test or genital warts. In the meantime, health insurers covering approximately 94% of privately insured lives in the US have decided to reimburse Gardasil®. In November, the authorities added Gardasil® to their Vaccines for Children (VFC) contract for girls and women aged 9 to 18 years.
In November 2006, the Australian government announced the funding of Gardasil® for girls and women aged 12 to 26 years from 2007. Gardasil® will be put on the national immunisation programme for 12 to 13 year old girls to be delivered through schools. The government will also fund a two year catch-up programme for 13 to 18 year old girls in schools and 18 to 26 year old women to be delivered through general practitioners.
As of 15th February 2007, Gardasil® is recommended in Canada for females aged 9 to 26 years. Females who had previous Pap abnormalities including cervical cancer or have had genital warts or known Human Papillomavirus infection would still benefit from Gardasil according to the recommendations of the Canadian authorities.
EU indication of Gardasil®
According to the licence in the EU, Gardasil®, Human Papillomavirus Vaccine [types 6,11,16,18] (Recombinant, adsorbed), can be given to children and adolescents 9 to15 years and adult females aged 16 to 26 years and is indicated for the prevention of cervical carcinoma (cervical cancer), high grade cervical dysplasia CIN2/3 (precancerous cervical lesions), high grade vulvar dysplastic lesions VIN 2/3 (precancerous vulvar lesions) and external genital warts (condyloma acuminata) caused by Human Papillomavirus types 6, 11, 16 and 18.
Cervical Cancer and other HPV diseases before Cervical Cancer and beyond the Cervix
Despite screening for early detection, cervical cancer remains the second most common cause of death from cancer (after breast cancer) among young women (15-44 years) in Europe.,14 In Europe, approximately 33,500 women are diagnosed with, and 15,000 women die from cervical cancer each year (40/day or nearly 2/hour).15 Hundreds of thousands of women are diagnosed with cervical, vulval or vaginal precancerous lesions. Genital warts are a growing problem.
It is estimated that Human Papillomavirus types 16 and 18 cause 25,000 new cases of cervical cancer each year in Europe4, 15and 1,900 new cases of vulval and vaginal cancer.8,9,16
It is estimated that types 16 and 18 cause 112,000 new cases of precancerous cervical lesions (CIN2/3)5,, 617and 24,000 new cases of precancerous vulval and vaginal lesions (VIN2/3 and VaIN2/3) each year in Europe.8,9,,,,, 1011161819It is estimated that types 6,11,16 and 18 cause 280,000 cases of potentially precancerous cervical lesions (CIN1) each year in Europe.7,,1718 Types 6, 11, 16 and 18 also cause 225,000 new cases of genital warts each year in Europe in women.12
More about Gardasil®
Gardasil® has been developed by Merck & Co., Inc. and Sanofi Pasteur MSD. In Europe, the vaccine is marketed by Sanofi Pasteur MSD.
Merck is actively working to accelerate the availability of Gardasil® in the developing world. Clinical trials for the development of Gardasil® have already included participants from 33 countries on 5 continents in a variety of settings. In December 2005, Merck and the Indian Council of Medical Research announced a collaboration to study Gardasil® in populations in India. Clinical trials in developing world countries are being initiated this year to assess the efficacy of Gardasil® in other environments; first studies are underway in Africa. In June 2006, PATH announced the launch of a 5-year effort to help bring HPV vaccines to those nations where cervical cancer rates are highest. PATH selected Uganda, Peru, India & Vietnam to participate in this project. Merck is committed to provide Gardasil® to support PATH in this effort. Upon completion of the study in India, the two partners will work together to assess the public health role of Gardasil® in the population of India and to identify ways of providing access to Gardasil®. Merck will make our new vaccines, including Gardasil®, available at dramatically lower prices to developing world countries. gardasil
About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.
Clinical study details
a) Gardasil® efficacy was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies. The first phase II study evaluated the Human Papillomavirus 16 component of Gardasil® (Protocol 005, N=2391) and the second evaluated all components of Gardasil® (Protocol 007, N=551). The Phase III studies evaluated Gardasil® in 5,442 (FUTURE I or Protocol 013) and 12,157 (FUTURE II or Protocol 015) subjects. Together, these 4 studies evaluated 20,541 women 16 to 26 years of age at enrolment who received in three studies 3 injections of the quadrivalent Human Papillomavirus (types 6, 11, 16, 18) vaccine at day 1, month 2 and month 6 of the study and in one study women received 3 injections of the monovalent Human Papillomavirus (type 16) at day 1, month 2 and month 6 of the study. At specific pre-determined times during the study the women were examined and tests carried out for the presence of Human Papillomavirus and cervical lesions. The median duration of follow-up was 4.0, 3.0, 2.4, and 2.0 years for Protocol 005, Protocol 007, FUTURE I, and FUTURE II, respectively.
b) 18,150 women (16-26 yrs) from the Americas, Europe and Asia were enrolled in 1 of 3 trials (protocol 007, FUTURE I, FUTURE II). Subjects were randomised to either quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine or placebo. For all trials, vaccination occurred at day 1, and months 2 and 6. Genital tract specimens were obtained at day 1 and at 6-12 month intervals thereafter for a maximum of 48 months. Colposcopy referral was algorithm-based. Biopsies were HPV-typed. Cytology, histology, and HPV detection were conducted centrally. Analyses were done per protocol (PP) (subjects received 3 doses, had no major protocol violations, were HPV 16 or 18 seronegative at day 1 and HPV 16 or 18 DNA negative day 1 through month 7, n=15,513) and modified intention to treat (MITT) (received ?‰?1 dose and were HPV 16 or 18 negative at Day 1 by serology and DNA). Endpoint counts began after Month 7 and day 30 in the PP and MITT analyses, respectively.
Gardasil® prevented 100% of precancerous cervical lesions (high grade, CIN2/3) related to Human Papillomavirus types 16 and 18.
Gardasil® prevented 100% of precancerous vulval lesions (VIN2/3) and 100% of precancerous vaginal lesions (VaIN2/3) related to Human Papillomavirus types 16 and 18.
Gardasil® prevented 100% of potentially pre-cancerous cervical lesions (low grade, CIN1) related to Human Papillomavirus types 6,11,16,18 in Future I study in which cervical lesions of all grades (CIN1 to CIN3) were a co-primary endpoint and 93.1% efficacy in the combined analysis of grouped clinical studies .
Gardasil® prevented 100% of genital warts related to Human Papillomavirus types 6,11,16,18 in Future I study where external genital lesions were a co- primary endpoint and 98.9% efficacy in the combined analysis of grouped clinical studies.
References
1 Skjeldestad FE and Koutsky L for the Merck Phase III HPV Vaccine Steering Committee (FUTURE II). Phase III trial of prophylactic quadrivalent HPV 6, 11, 16, 18 L1 virus-like particle vaccine: Prevention of cervical intraepithelial neoplasia (CIN) 2/3 including adeno- and squamous-cell carcinoma in situ (CIS). Abstract presented at the Infectious Diseases Society of America. 7 October 2005. San Francisco, USA.
2 Ferris D for FUTURE I investigators. Efficacy of a prophylactic quadrivalent Human Papillomavirus (HPV) (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine for prevention of precancerous cervical dysplasia and external genital lesions (EGL). Abtract presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). 16-19 September 2005. Washington DC, USA.
3 Joura EA et al. High sustained efficacy of a quadrivalent HPV (types 6/11/16/18) L1 virus-like particle (VLP) vaccine against vaginal and vulvar pre-cancerous lesions: a combined analysis, Oral presentation and abstract, 18th International Congress on Anti Cancer Treatment, Paris, France, 7th February 2007.
4 Clifford GM, Smith JS, Plummer M et al. Human Papillomavirus types in invasive cervical cancer worldwide: A meta-analysis. Br J Cancer 2003:88:63-73.
5 Clifford GM, Smith JS, Aguado T et al. Comparison of HPV type distribution in high-grade cervical lesions and cervical cancer: A meta-analysis. Br J Cancer 2003;89101-105.
6 Sotlar K, Diemer D, Dethleffs A et al. Detection and typing of Human Papillomavirus by E6 nested multiplex PCR. J Clin Microbiol 2004;42:3176-3184.
7 Clifford GM, Rana RK, Franceschi S et al. Human Papillomavirus genotype distribution in low-grade cervical lesions: Comparison by geographic region and with cervical cancer. Cancer Epidemiol Biomarkers Prev 2005;14:1157-1164.
8 Daling JR, Madeleine MM, Schwartz SM et al. A population-based study of squamous cell vaginal cancer: HPV and cofactors. Gynecol Oncol 2002;84:263-270.
9 Madeleine MM, Daling JR, Carter JJ et al. Cofactors with Human Papillomavirus in a population-based study of vulvar cancer. J Natl Cancer Inst 1997;89:1516-1523.
10 van Beurden M, ten Kate FJW, Smits HL et al. Multifocal intraepithelial neoplasia grade III and multicentric lower genital tract neoplasia is associated with transcriptionally active Human Papillomavirus. Cancer 1995;75:2879-2884.
11 Hording U, Junge J, Poulson H et al. Vulvar intraepithelial neoplasia III: A viral disease of undetermined progressive potential. Gynecol Oncol 1995;56:276-279.
12 Wieland U, Pfister H. papillomaviruses in human pathology: Epidemiology, pathogenesis and oncologic role.In:Gross,Barasso EDS.Human Papillomavirus Infection:A clinical atlas.Ullstein Mosby1997;p1-18.
13 Von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol 2001;11:598-603.
14 Ferlay J, Bray F, Pisani P et al, editors. Globocan 2000: Cancer incidence, mortality and prevalence worldwide. IARC Cancer Base No.5. version 1.0. IARC Press, Lyon 2001.
15 Ferlay J, Bray F, Pisani P et al, editors. Globocan 2002: Cancer incidence, mortality and prevalence worldwide. IARC Cancer Base No.5. version 2.0. IARC Press, Lyon 2004.
16 Parkin DM, Whelan SL, Ferlay J et al. Cancer incidence in five continents (GIS). Volume VIII. p606-611.
17 Insinga RP, Glass AG and Rush BB. Diagnoses and outcomes in cervical cancer screening: A population-based study. Am J Obstet Gynecol 2004;191:105-113.
18 Dodge JA, Eltabbakh GH, Mount SL et al. Clinical features and risk of recurrence among patients with vaginal intraepithelial neoplasia. Gynecol Oncol 2001;83:363-369.
19 Jones RW. Vulval intraepithelial neoplasia: Current perspectives. Eur J Gynaecol Oncol 2001;22:393-402.
20 UK Health Protection Agency. CDR Weekly 2003;3(44)
gardasil
View drug information on Gardasil.
Gardasil®, Human Papillomavirus Vaccine [types 6,11,16,18] (Recombinant, adsorbed), is the only licensed vaccine for the prevention of cervical cancer and other Human Papillomavirus diseases that occur before cervical cancer and beyond the cervix.
In clinical trials, including FUTURE I and II, Gardasil® prevented up to 100% of cervical cancer, precancerous and potentially precancerous cervical lesions, precancerous vulval and vaginal lesions, and genital warts due to Human Papillomavirus virus types 6, 11, 16 and 18.1,, a), b)
It is estimated that Human Papillomavirus types 6, 11, 16 and 18 together cause 75% of cervical cancer,4 70% of precancerous5,6 and 50% of potentially precancerous cervical lesions7, a significant proportion vulval and vaginal cancers and their associated precancerous lesions8,,,91011, and 90% of genital warts in Europe.12,13
"I can more than understand that the board felt the responsibility not to leave these women unprotected. To be able to prevent Human Papillomavirus-related cervical cancer and their pre-cancerous stages as well as other Human Papillomavirus-related lower genital tract pre-cancerous lesions and infections so effectively, hardly allows any other conclusion. Young women are at the age of maximal exposure to the virus. Even though some years exist between infection and cancer development, prevention should start at this time so as to prevent later complications inherent in diagnostic and treatment procedures.", comments Albert Singer, Professor of Gynaecological Research, University of London, United Kingdom.
In Europe, vaccination of women in the placebo groups of the FUTURE I and II studies has already begun in study centres in Germany, Sweden, Denmark and Austria. In other countries, vaccination will start within the next days or weeks. In the United Kingdom, vaccination starts today. In total, approximately 4,300 women are anticipated to be vaccinated in European study centres, with the objective of completing before the end of the year 2007. In a similar way, vaccination of almost 4,500 women in many other countries around the world, including the United States, Australia and Canada, has begun or is anticipated to begin soon.
Gardasil® licence applications have been filed in 120 countries and approved in 55 countries (all under accelerated review timelines), including the European Union, the United States, Canada and Australia.
In addition to the women in the placebo group of the FUTURE I and II studies, women in the vaccine group of these studies who have either received less than three doses of Gardasil® or the monovalent precursor of Gardasil® instead of Gardasil® should also complete vaccination with Gardasil®. The monovalent precursor of Gardasil® targets only the Human Papillomavirus type 16 whereas Gardasil® targets the Human Papillomavirus types 6, 11, 16 and 18.
Current recommendation and funding of Human Papillomavirus vaccination
Just four months after gaining a licence in the European Union, Gardasil® is now available in 15 European countries. Accelerated discussions are under way in most European countries to integrate Human Papillomavirus vaccination in each country's recommendation and reimbursement programme.
As of 1 January 2007 vaccination is recommended in Austria for girls and boys aged 9 to 15 years as well as for women, preferably before the start of sexual activity.
In Germany, decisions are anticipated soon. Since early December 2006, several statutory health insurance funds in Germany, which together cover half of the population, have announced immediate and full reimbursement of Human Papillomavirus vaccination for females even before any recommendations by the authorities have been published. Other funds are anticipated to follow soon.
The French health minister has announced recommendations for March 2007 and reimbursement by the national social security system by July 2007 the latest. Since October 2006, three large private health insurance funds in France have announced immediate partial reimbursement of Human Papillomavirus vaccination also even before any recommendations by the authorities have been published.
The Italian Health Minister has recently announced that Italy will have a vaccination programme with Gardasil® next spring actively proposed of the young girls 12 years old.
In Spain, the region Navarra has recently announced the vaccination of young girls (aged 12 or 13 years) as soon as Gardasil® becomes available. The opportunity to add a catch-up vaccination programme for females >12 or 13 years and/or vaccination of boys will be investigated.
In Sweden, the first county has recently announced to offer Gardasil® girls and women even before the decision of the national health authorities.
Some Belgian health insurance funds have announced partial reimbursement of Human Papillomavirus vaccination before any recommendations by the authorities have been published.
Four Dutch health insurance funds have announced in December 2006 to completely reimburse Human Papillomavirus vaccination for females aged 9 to 26 years and males aged 9 to 15 years as of January 2007.
In the UK, the Joint Committee on Vaccinations and Immunisations (JCVI) have said they will meet to make a decision about a recommendation in early 2007.
In June 2006, the US health authorities recommended the routine vaccination of 11 and 12 year old females and the vaccination of females aged 13 to 26 who have not previously been vaccinated and that 9 and 10 year old females can be vaccinated at the discretion of their physicians. Pap and Human Papillomavirus screening prior to vaccination are not necessary according to the recommendation. The US authorities also recommended that females can receive Gardasil® regardless of whether they have or previously had an abnormal Pap test, a positive Human Papillomavirus test or genital warts. In the meantime, health insurers covering approximately 94% of privately insured lives in the US have decided to reimburse Gardasil®. In November, the authorities added Gardasil® to their Vaccines for Children (VFC) contract for girls and women aged 9 to 18 years.
In November 2006, the Australian government announced the funding of Gardasil® for girls and women aged 12 to 26 years from 2007. Gardasil® will be put on the national immunisation programme for 12 to 13 year old girls to be delivered through schools. The government will also fund a two year catch-up programme for 13 to 18 year old girls in schools and 18 to 26 year old women to be delivered through general practitioners.
As of 15th February 2007, Gardasil® is recommended in Canada for females aged 9 to 26 years. Females who had previous Pap abnormalities including cervical cancer or have had genital warts or known Human Papillomavirus infection would still benefit from Gardasil according to the recommendations of the Canadian authorities.
EU indication of Gardasil®
According to the licence in the EU, Gardasil®, Human Papillomavirus Vaccine [types 6,11,16,18] (Recombinant, adsorbed), can be given to children and adolescents 9 to15 years and adult females aged 16 to 26 years and is indicated for the prevention of cervical carcinoma (cervical cancer), high grade cervical dysplasia CIN2/3 (precancerous cervical lesions), high grade vulvar dysplastic lesions VIN 2/3 (precancerous vulvar lesions) and external genital warts (condyloma acuminata) caused by Human Papillomavirus types 6, 11, 16 and 18.
Cervical Cancer and other HPV diseases before Cervical Cancer and beyond the Cervix
Despite screening for early detection, cervical cancer remains the second most common cause of death from cancer (after breast cancer) among young women (15-44 years) in Europe.,14 In Europe, approximately 33,500 women are diagnosed with, and 15,000 women die from cervical cancer each year (40/day or nearly 2/hour).15 Hundreds of thousands of women are diagnosed with cervical, vulval or vaginal precancerous lesions. Genital warts are a growing problem.
It is estimated that Human Papillomavirus types 16 and 18 cause 25,000 new cases of cervical cancer each year in Europe4, 15and 1,900 new cases of vulval and vaginal cancer.8,9,16
It is estimated that types 16 and 18 cause 112,000 new cases of precancerous cervical lesions (CIN2/3)5,, 617and 24,000 new cases of precancerous vulval and vaginal lesions (VIN2/3 and VaIN2/3) each year in Europe.8,9,,,,, 1011161819It is estimated that types 6,11,16 and 18 cause 280,000 cases of potentially precancerous cervical lesions (CIN1) each year in Europe.7,,1718 Types 6, 11, 16 and 18 also cause 225,000 new cases of genital warts each year in Europe in women.12
More about Gardasil®
Gardasil® has been developed by Merck & Co., Inc. and Sanofi Pasteur MSD. In Europe, the vaccine is marketed by Sanofi Pasteur MSD.
Merck is actively working to accelerate the availability of Gardasil® in the developing world. Clinical trials for the development of Gardasil® have already included participants from 33 countries on 5 continents in a variety of settings. In December 2005, Merck and the Indian Council of Medical Research announced a collaboration to study Gardasil® in populations in India. Clinical trials in developing world countries are being initiated this year to assess the efficacy of Gardasil® in other environments; first studies are underway in Africa. In June 2006, PATH announced the launch of a 5-year effort to help bring HPV vaccines to those nations where cervical cancer rates are highest. PATH selected Uganda, Peru, India & Vietnam to participate in this project. Merck is committed to provide Gardasil® to support PATH in this effort. Upon completion of the study in India, the two partners will work together to assess the public health role of Gardasil® in the population of India and to identify ways of providing access to Gardasil®. Merck will make our new vaccines, including Gardasil®, available at dramatically lower prices to developing world countries. gardasil
About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.
Clinical study details
a) Gardasil® efficacy was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies. The first phase II study evaluated the Human Papillomavirus 16 component of Gardasil® (Protocol 005, N=2391) and the second evaluated all components of Gardasil® (Protocol 007, N=551). The Phase III studies evaluated Gardasil® in 5,442 (FUTURE I or Protocol 013) and 12,157 (FUTURE II or Protocol 015) subjects. Together, these 4 studies evaluated 20,541 women 16 to 26 years of age at enrolment who received in three studies 3 injections of the quadrivalent Human Papillomavirus (types 6, 11, 16, 18) vaccine at day 1, month 2 and month 6 of the study and in one study women received 3 injections of the monovalent Human Papillomavirus (type 16) at day 1, month 2 and month 6 of the study. At specific pre-determined times during the study the women were examined and tests carried out for the presence of Human Papillomavirus and cervical lesions. The median duration of follow-up was 4.0, 3.0, 2.4, and 2.0 years for Protocol 005, Protocol 007, FUTURE I, and FUTURE II, respectively.
b) 18,150 women (16-26 yrs) from the Americas, Europe and Asia were enrolled in 1 of 3 trials (protocol 007, FUTURE I, FUTURE II). Subjects were randomised to either quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine or placebo. For all trials, vaccination occurred at day 1, and months 2 and 6. Genital tract specimens were obtained at day 1 and at 6-12 month intervals thereafter for a maximum of 48 months. Colposcopy referral was algorithm-based. Biopsies were HPV-typed. Cytology, histology, and HPV detection were conducted centrally. Analyses were done per protocol (PP) (subjects received 3 doses, had no major protocol violations, were HPV 16 or 18 seronegative at day 1 and HPV 16 or 18 DNA negative day 1 through month 7, n=15,513) and modified intention to treat (MITT) (received ?‰?1 dose and were HPV 16 or 18 negative at Day 1 by serology and DNA). Endpoint counts began after Month 7 and day 30 in the PP and MITT analyses, respectively.
Gardasil® prevented 100% of precancerous cervical lesions (high grade, CIN2/3) related to Human Papillomavirus types 16 and 18.
Gardasil® prevented 100% of precancerous vulval lesions (VIN2/3) and 100% of precancerous vaginal lesions (VaIN2/3) related to Human Papillomavirus types 16 and 18.
Gardasil® prevented 100% of potentially pre-cancerous cervical lesions (low grade, CIN1) related to Human Papillomavirus types 6,11,16,18 in Future I study in which cervical lesions of all grades (CIN1 to CIN3) were a co-primary endpoint and 93.1% efficacy in the combined analysis of grouped clinical studies .
Gardasil® prevented 100% of genital warts related to Human Papillomavirus types 6,11,16,18 in Future I study where external genital lesions were a co- primary endpoint and 98.9% efficacy in the combined analysis of grouped clinical studies.
References
1 Skjeldestad FE and Koutsky L for the Merck Phase III HPV Vaccine Steering Committee (FUTURE II). Phase III trial of prophylactic quadrivalent HPV 6, 11, 16, 18 L1 virus-like particle vaccine: Prevention of cervical intraepithelial neoplasia (CIN) 2/3 including adeno- and squamous-cell carcinoma in situ (CIS). Abstract presented at the Infectious Diseases Society of America. 7 October 2005. San Francisco, USA.
2 Ferris D for FUTURE I investigators. Efficacy of a prophylactic quadrivalent Human Papillomavirus (HPV) (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine for prevention of precancerous cervical dysplasia and external genital lesions (EGL). Abtract presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). 16-19 September 2005. Washington DC, USA.
3 Joura EA et al. High sustained efficacy of a quadrivalent HPV (types 6/11/16/18) L1 virus-like particle (VLP) vaccine against vaginal and vulvar pre-cancerous lesions: a combined analysis, Oral presentation and abstract, 18th International Congress on Anti Cancer Treatment, Paris, France, 7th February 2007.
4 Clifford GM, Smith JS, Plummer M et al. Human Papillomavirus types in invasive cervical cancer worldwide: A meta-analysis. Br J Cancer 2003:88:63-73.
5 Clifford GM, Smith JS, Aguado T et al. Comparison of HPV type distribution in high-grade cervical lesions and cervical cancer: A meta-analysis. Br J Cancer 2003;89101-105.
6 Sotlar K, Diemer D, Dethleffs A et al. Detection and typing of Human Papillomavirus by E6 nested multiplex PCR. J Clin Microbiol 2004;42:3176-3184.
7 Clifford GM, Rana RK, Franceschi S et al. Human Papillomavirus genotype distribution in low-grade cervical lesions: Comparison by geographic region and with cervical cancer. Cancer Epidemiol Biomarkers Prev 2005;14:1157-1164.
8 Daling JR, Madeleine MM, Schwartz SM et al. A population-based study of squamous cell vaginal cancer: HPV and cofactors. Gynecol Oncol 2002;84:263-270.
9 Madeleine MM, Daling JR, Carter JJ et al. Cofactors with Human Papillomavirus in a population-based study of vulvar cancer. J Natl Cancer Inst 1997;89:1516-1523.
10 van Beurden M, ten Kate FJW, Smits HL et al. Multifocal intraepithelial neoplasia grade III and multicentric lower genital tract neoplasia is associated with transcriptionally active Human Papillomavirus. Cancer 1995;75:2879-2884.
11 Hording U, Junge J, Poulson H et al. Vulvar intraepithelial neoplasia III: A viral disease of undetermined progressive potential. Gynecol Oncol 1995;56:276-279.
12 Wieland U, Pfister H. papillomaviruses in human pathology: Epidemiology, pathogenesis and oncologic role.In:Gross,Barasso EDS.Human Papillomavirus Infection:A clinical atlas.Ullstein Mosby1997;p1-18.
13 Von Krogh G. Management of anogenital warts (condylomata acuminata). Eur J Dermatol 2001;11:598-603.
14 Ferlay J, Bray F, Pisani P et al, editors. Globocan 2000: Cancer incidence, mortality and prevalence worldwide. IARC Cancer Base No.5. version 1.0. IARC Press, Lyon 2001.
15 Ferlay J, Bray F, Pisani P et al, editors. Globocan 2002: Cancer incidence, mortality and prevalence worldwide. IARC Cancer Base No.5. version 2.0. IARC Press, Lyon 2004.
16 Parkin DM, Whelan SL, Ferlay J et al. Cancer incidence in five continents (GIS). Volume VIII. p606-611.
17 Insinga RP, Glass AG and Rush BB. Diagnoses and outcomes in cervical cancer screening: A population-based study. Am J Obstet Gynecol 2004;191:105-113.
18 Dodge JA, Eltabbakh GH, Mount SL et al. Clinical features and risk of recurrence among patients with vaginal intraepithelial neoplasia. Gynecol Oncol 2001;83:363-369.
19 Jones RW. Vulval intraepithelial neoplasia: Current perspectives. Eur J Gynaecol Oncol 2001;22:393-402.
20 UK Health Protection Agency. CDR Weekly 2003;3(44)
gardasil
View drug information on Gardasil.
четверг, 1 марта 2012 г.
Fox, CBS Reject Trojan Condom-Promotion Commercial, New York Times Reports
Fox and CBS recently rejected a television commercial for Trojan condoms, the New York Times reports. According to the Times, the commercial, which premiered Monday night, features women at a bar surrounded by pigs. When one pig goes to the restroom and returns with a condom purchased at a vending machine, he is transformed into an attractive man. The end of the commercial carries the message: "Evolve: Use a condom every time."
Fox in a letter to Trojan said it rejected the ad because contraceptive "advertising must stress health-related uses rather than the prevention of pregnancy." CBS in a rejection wrote that the ad was not "appropriate" for the network "even with late-night only restrictions."
Both networks accepted Trojan's previous campaign, which promoted condom use because of the possibility that a partner could be HIV-positive. The Times cites a 2001 report about condom advertising from the Kaiser Family Foundation that found some "networks draw a strong line between messages about disease prevention -- which may be allowed -- and those about pregnancy prevention, which may be considered controversial for religious and moral reasons."
The ad will run on ABC, NBC and nine cable stations, including MTV, Comedy Central and Cartoon Network's Adult Swim. In addition, print ads will appear in 11 magazines, including Cosmopolitan and Glamour, and on seven Web sites. All of the ads highlight a Web site trojanevolve, the Times reports.
Jim Daniels, vice president for marketing at Trojan, said the ad is more expensive than any previous campaigns, but he declined to give a specific amount. Daniels said the company's goal is to "dramatically increase" condom use in the U.S. "The 'Evolve' ad does a nice job of being humorous, but it's also a serious call to action," Daniels said, adding, "The pigs are a symbol of irresponsible sexual behavior and are juxtaposed with the condom as a responsible symbol of respect for oneself and one's partner" (Newman, New York Times, 6/18).
NPR's "Morning Edition" on Monday reported on not-for-profit social marketing groups that promote and distribute condoms in Ethiopia. Andy Piller, manager the social marketing group DKT International, said annual condom distribution in Ethiopia has increased from about 250,000 when the group launched in 1991 to about 75 million to 80 million today. However, only 5% of Ethiopians say they use condoms, "Morning Edition" reports. DKT and similar groups use marketing techniques -- such as scented condoms, billboards and television ads -- to encourage condom use. Sally Cowal, senior vice president of the social marketing group Population Services International, said the organization sells condoms rather than providing them at no cost because people are more likely to use products for which they have paid (Wilson, "Morning Edition," NPR, 6/18). Audio of the segment and expanded NPR coverage are available online.
"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.
Fox in a letter to Trojan said it rejected the ad because contraceptive "advertising must stress health-related uses rather than the prevention of pregnancy." CBS in a rejection wrote that the ad was not "appropriate" for the network "even with late-night only restrictions."
Both networks accepted Trojan's previous campaign, which promoted condom use because of the possibility that a partner could be HIV-positive. The Times cites a 2001 report about condom advertising from the Kaiser Family Foundation that found some "networks draw a strong line between messages about disease prevention -- which may be allowed -- and those about pregnancy prevention, which may be considered controversial for religious and moral reasons."
The ad will run on ABC, NBC and nine cable stations, including MTV, Comedy Central and Cartoon Network's Adult Swim. In addition, print ads will appear in 11 magazines, including Cosmopolitan and Glamour, and on seven Web sites. All of the ads highlight a Web site trojanevolve, the Times reports.
Jim Daniels, vice president for marketing at Trojan, said the ad is more expensive than any previous campaigns, but he declined to give a specific amount. Daniels said the company's goal is to "dramatically increase" condom use in the U.S. "The 'Evolve' ad does a nice job of being humorous, but it's also a serious call to action," Daniels said, adding, "The pigs are a symbol of irresponsible sexual behavior and are juxtaposed with the condom as a responsible symbol of respect for oneself and one's partner" (Newman, New York Times, 6/18).
NPR's "Morning Edition" on Monday reported on not-for-profit social marketing groups that promote and distribute condoms in Ethiopia. Andy Piller, manager the social marketing group DKT International, said annual condom distribution in Ethiopia has increased from about 250,000 when the group launched in 1991 to about 75 million to 80 million today. However, only 5% of Ethiopians say they use condoms, "Morning Edition" reports. DKT and similar groups use marketing techniques -- such as scented condoms, billboards and television ads -- to encourage condom use. Sally Cowal, senior vice president of the social marketing group Population Services International, said the organization sells condoms rather than providing them at no cost because people are more likely to use products for which they have paid (Wilson, "Morning Edition," NPR, 6/18). Audio of the segment and expanded NPR coverage are available online.
"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.
четверг, 23 февраля 2012 г.
Nocturnal Sleep In Mothers May Be Improved By Bright Light Therapy
Bright light therapy may improve a mother's nocturnal sleep, decrease daytime sleepiness and be beneficial to her well-being, according to a research abstract presented on Monday at SLEEP 2008, the 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS).
The study, authored by Shih-Yu Lee, PhD, of Georgia State University, focused on 16 first-time mothers with a low birth weight infant hospitalized in the intensive care unit. The subjects were randomly assigned to two groups: the treatment group mothers received a 10,000 lux blue-green bright light therapy for four weeks and the control group mothers received a placebo dim red light therapy. Total sleep time during the day and night was measured by averaging the data obtained from two consecutive days of wrist actigraphy monitoring.
According to the results, the post-treatment average nocturnal total sleep time increased from 383 minutes (6.38 hours) at the baseline to 424 minutes (7.07 hours) for the treatment group mothers. However, the total sleep time in the control group mothers worsened from 413 minutes (6.88 hours) to 373 minutes (6.22 hours). After the four-week intervention, the treatment group mothers' daytime total sleep time decreased from 114 to 39 minutes.
"Having a low birth weight infant in the ICU can intensify sleep disturbances for mothers because of extended periods of exposure to the artificial dim light in the ICU and stress related to the infant's medical condition," said Dr. Lee. "Impaired sleep may have negative impact on the mother's well-being. In our research, we were looking for an intervention to help mothers that would be feasible for them to use even when their infant is hospitalized. The preliminary findings from our pilot study indicate that bright light therapy given through use of the special visor may improve mothers' nocturnal sleep, decrease daytime sleepiness, and be beneficial to their well-being. While our results are promising, a larger scale randomized clinical trial is needed to establish if this would be an effective therapy in this population."
Sleep plays a vital role in promoting a woman's health and well being. Getting the required amount of sleep is likely to enhance a woman's overall quality of life. Yet, women face many potential barriers - such as life events, depression, illness, bad sleep habits and medication use - that can disrupt and disturb her sleep. Overcoming these challenges can help her enjoy the daily benefits of feeling alert and well rested.
It is recommended that women get between seven and eight hours of nightly sleep.
The American Academy of Sleep Medicine (AASM) offers the following tips for women on how to get a good night's sleep:
Follow a consistent bedtime routine.
Establish a relaxing setting at bedtime.
Get a full night's sleep every night.
Avoid foods or drinks that contain caffeine, as well as any medicine that has a stimulant, prior to bedtime.
Do not bring your worries to bed with you.
Do not go to bed hungry, but don't eat a big meal before bedtime either.
Avoid any rigorous exercise within six hours of your bedtime.
Make your bedroom quiet, dark and a little bit cool.
Get up at the same time every morning.
Those who suspect that they might be suffering from a sleep disorder are encouraged to consult with their primary care physician or a sleep specialist.
More information on "women and sleep" is available from the AASM at sleepeducation/Topic.aspx?id=67.
The annual SLEEP meeting (9-12 June, 2008) brings together an international body of 5,000 leading researchers and clinicians in the field of sleep medicine to present and discuss new findings and medical developments related to sleep and sleep disorders.
More than 1,000 research abstracts will be presented at the SLEEP meeting, a joint venture of the AASM and the Sleep Research Society. The three-and-a-half-day scientific meeting will bring to light new findings that enhance the understanding of the processes of sleep and aid the diagnosis and treatment of sleep disorders such as insomnia, narcolepsy and sleep apnea.
SleepEducation, a patient education Web site created by the AASM, provides information about various sleep disorders, the forms of treatment available, recent news on the topic of sleep, sleep studies that have been conducted and a listing of sleep facilities.
Source: Kathleen McCann
American Academy of Sleep Medicine
The study, authored by Shih-Yu Lee, PhD, of Georgia State University, focused on 16 first-time mothers with a low birth weight infant hospitalized in the intensive care unit. The subjects were randomly assigned to two groups: the treatment group mothers received a 10,000 lux blue-green bright light therapy for four weeks and the control group mothers received a placebo dim red light therapy. Total sleep time during the day and night was measured by averaging the data obtained from two consecutive days of wrist actigraphy monitoring.
According to the results, the post-treatment average nocturnal total sleep time increased from 383 minutes (6.38 hours) at the baseline to 424 minutes (7.07 hours) for the treatment group mothers. However, the total sleep time in the control group mothers worsened from 413 minutes (6.88 hours) to 373 minutes (6.22 hours). After the four-week intervention, the treatment group mothers' daytime total sleep time decreased from 114 to 39 minutes.
"Having a low birth weight infant in the ICU can intensify sleep disturbances for mothers because of extended periods of exposure to the artificial dim light in the ICU and stress related to the infant's medical condition," said Dr. Lee. "Impaired sleep may have negative impact on the mother's well-being. In our research, we were looking for an intervention to help mothers that would be feasible for them to use even when their infant is hospitalized. The preliminary findings from our pilot study indicate that bright light therapy given through use of the special visor may improve mothers' nocturnal sleep, decrease daytime sleepiness, and be beneficial to their well-being. While our results are promising, a larger scale randomized clinical trial is needed to establish if this would be an effective therapy in this population."
Sleep plays a vital role in promoting a woman's health and well being. Getting the required amount of sleep is likely to enhance a woman's overall quality of life. Yet, women face many potential barriers - such as life events, depression, illness, bad sleep habits and medication use - that can disrupt and disturb her sleep. Overcoming these challenges can help her enjoy the daily benefits of feeling alert and well rested.
It is recommended that women get between seven and eight hours of nightly sleep.
The American Academy of Sleep Medicine (AASM) offers the following tips for women on how to get a good night's sleep:
Follow a consistent bedtime routine.
Establish a relaxing setting at bedtime.
Get a full night's sleep every night.
Avoid foods or drinks that contain caffeine, as well as any medicine that has a stimulant, prior to bedtime.
Do not bring your worries to bed with you.
Do not go to bed hungry, but don't eat a big meal before bedtime either.
Avoid any rigorous exercise within six hours of your bedtime.
Make your bedroom quiet, dark and a little bit cool.
Get up at the same time every morning.
Those who suspect that they might be suffering from a sleep disorder are encouraged to consult with their primary care physician or a sleep specialist.
More information on "women and sleep" is available from the AASM at sleepeducation/Topic.aspx?id=67.
The annual SLEEP meeting (9-12 June, 2008) brings together an international body of 5,000 leading researchers and clinicians in the field of sleep medicine to present and discuss new findings and medical developments related to sleep and sleep disorders.
More than 1,000 research abstracts will be presented at the SLEEP meeting, a joint venture of the AASM and the Sleep Research Society. The three-and-a-half-day scientific meeting will bring to light new findings that enhance the understanding of the processes of sleep and aid the diagnosis and treatment of sleep disorders such as insomnia, narcolepsy and sleep apnea.
SleepEducation, a patient education Web site created by the AASM, provides information about various sleep disorders, the forms of treatment available, recent news on the topic of sleep, sleep studies that have been conducted and a listing of sleep facilities.
Source: Kathleen McCann
American Academy of Sleep Medicine
четверг, 16 февраля 2012 г.
Antiabortion Advocates Criticize Kansas Sen. Brownback's Support Of Sebelius
Sen. Sam Brownback's (R-Kan.) recent support for HHS Secretary-designate Kansas Gov. Kathleen Sebelius (D) is provoking criticism from antiabortion-rights advocates, who typically have been "enthusiastic backers" of Brownback, the AP/Wichita Eagle reports. Austin Ruse, president of the Catholic Family and Human Rights Institute, said it "makes absolutely no sense" that Brownback, an opponent of abortion rights, would endorse Sebelius, who supports abortion rights. Ruse said the senator "could have remained silent" instead. Troy Newman, president of Operation Rescue, said, "There is profound disappointment within the pro-life community on [Brownback's] position. Politicians stick their fingers up in the air to see which way the wind is blowing, and it's up to the grassroots to make the wind blow."
Brian Hart, a spokesperson for Brownback, said that the senator's office has received "quite a few" phone calls and that there have been angry Internet postings in recent days regarding Brownback's support for Sebelius. Hart said the senator understands the criticism but that he "feels that despite profound policy differences, he should support a fellow Kansan who has been asked to serve by the president." In expressing his support for Sebelius earlier this week, Brownback noted that the "president won the election."
Mary Kay Culp, executive director of Kansans for Life, said Brownback's stance has drawn mixed reactions from the antiabortion-rights movement because some of its members would like to see him replace Sebelius as governor in 2010. Culp said she "disagree[s] with his decision on this, but it doesn't make me question his being pro-life." She added, "We know it doesn't serve the cause of unborn children and their mothers to beat up on" Brownback.
According to the AP/Eagle, criticism of Brownback "seems less vocal in Kansas" because he intends to run for governor, "fulfilling a promise not to run for another Senate term." Sebelius is not allowed to run for a third term under the state Constitution, and she was considered to be the Democrats' best candidate to run for Brownback's vacant Senate seat. If the Senate confirms Sebelius as head of HHS, it "all but ends any chance she'll run," the AP/Eagle reports. Newman said he suspects that Brownback's support for Sebelius is motivated by the GOP's desire to keep his Senate seat in their party. Nonetheless, abortion-rights opponents have been "vocal enough to prompt a counter-campaign" by groups that support Roman Catholic Democrats who support abortion rights, such as Sebelius, the AP/Eagle reports.
Supporters of Sebelius note that the governor has supported efforts to expand adoption and programs to help unmarried pregnant women. In addition, they said the abortion rate has declined in Kansas since she ran for office in 2002. Sebelius, who has also served as state insurance commissioner and a state legislator, said she has "worked pretty diligently for over 20 years to reduce the conditions for women to be in a situation where they feel they have no alternative." She added that she is "proud" that the abortion rate declined by 11% during her time in office. Ruse contended that Sebelius cannot take credit for the Kansas decline, saying that it has occurred all over the country.
Sebelius vetoed antiabortion bills in 2003, 2005, 2006 and 2008. She also has attracted criticism from antiabortion-rights advocates because abortion provider George Tiller attended an April 2007 reception at the governor's residence. Kansas City, Kan., Archbishop Joseph Naumann -- who in 2008 urged Sebelius to stop taking Holy Communion because of her position on abortion rights -- said her nomination is "particularly troubling." Naumann said in a recent blog posting on The Catholic Key that as HHS secretary, Sebelius would be in a position to make decisions "promoting legalized abortion and her cooperation in this intrinsic evil" (Hanna, AP/Wichita Eagle, 3/5).
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.
© 2009 The Advisory Board Company. All rights reserved.
Brian Hart, a spokesperson for Brownback, said that the senator's office has received "quite a few" phone calls and that there have been angry Internet postings in recent days regarding Brownback's support for Sebelius. Hart said the senator understands the criticism but that he "feels that despite profound policy differences, he should support a fellow Kansan who has been asked to serve by the president." In expressing his support for Sebelius earlier this week, Brownback noted that the "president won the election."
Mary Kay Culp, executive director of Kansans for Life, said Brownback's stance has drawn mixed reactions from the antiabortion-rights movement because some of its members would like to see him replace Sebelius as governor in 2010. Culp said she "disagree[s] with his decision on this, but it doesn't make me question his being pro-life." She added, "We know it doesn't serve the cause of unborn children and their mothers to beat up on" Brownback.
According to the AP/Eagle, criticism of Brownback "seems less vocal in Kansas" because he intends to run for governor, "fulfilling a promise not to run for another Senate term." Sebelius is not allowed to run for a third term under the state Constitution, and she was considered to be the Democrats' best candidate to run for Brownback's vacant Senate seat. If the Senate confirms Sebelius as head of HHS, it "all but ends any chance she'll run," the AP/Eagle reports. Newman said he suspects that Brownback's support for Sebelius is motivated by the GOP's desire to keep his Senate seat in their party. Nonetheless, abortion-rights opponents have been "vocal enough to prompt a counter-campaign" by groups that support Roman Catholic Democrats who support abortion rights, such as Sebelius, the AP/Eagle reports.
Supporters of Sebelius note that the governor has supported efforts to expand adoption and programs to help unmarried pregnant women. In addition, they said the abortion rate has declined in Kansas since she ran for office in 2002. Sebelius, who has also served as state insurance commissioner and a state legislator, said she has "worked pretty diligently for over 20 years to reduce the conditions for women to be in a situation where they feel they have no alternative." She added that she is "proud" that the abortion rate declined by 11% during her time in office. Ruse contended that Sebelius cannot take credit for the Kansas decline, saying that it has occurred all over the country.
Sebelius vetoed antiabortion bills in 2003, 2005, 2006 and 2008. She also has attracted criticism from antiabortion-rights advocates because abortion provider George Tiller attended an April 2007 reception at the governor's residence. Kansas City, Kan., Archbishop Joseph Naumann -- who in 2008 urged Sebelius to stop taking Holy Communion because of her position on abortion rights -- said her nomination is "particularly troubling." Naumann said in a recent blog posting on The Catholic Key that as HHS secretary, Sebelius would be in a position to make decisions "promoting legalized abortion and her cooperation in this intrinsic evil" (Hanna, AP/Wichita Eagle, 3/5).
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.
© 2009 The Advisory Board Company. All rights reserved.
четверг, 9 февраля 2012 г.
New Jersey Health Department Releases Records Of Investigation Into Operations Of Abortion Clinic, Reasons Behind Closure
New Jersey Department of Health and Senior Services officials on Tuesday released the records of their investigation of one of the state's largest abortion providers, Metropolitan Medical Associates in Englewood, N.J., after ordering the clinic to close last month, the Bergen Record reports (Padawer, Bergen Record, 3/14). Metropolitan Medical, which opened in the 1970s, performs more than 10,000 abortions annually and is one of the few clinics in the state that performs abortions up to 24 weeks' gestation. Rasheedah Dinkins, who had an abortion at Metropolitan Medical, earlier this month filed a lawsuit in the State Superior Court in Newark, N.J., against the clinic, charging clinic physicians Keith Gresham and Nicholas Kotopoulos with "negligent, careless and reckless care." According to Dinkins' lawyer Adam Slater, Dinkins on Jan. 27 went to Metropolitan Medical to have an abortion of a fetus at more than 15 weeks' gestation. After the procedure, she had pains and was taken to Newark Beth Israel Medical Center, where she was unconscious for more than three weeks, had two strokes and was forced to undergo a hysterectomy, according to Slater. Newark Beth Israel filed a complaint against Metropolitan Medical to the state health department (Kaiser Daily Women's Health Policy Report, 3/2). Investigators in separate records released on Tuesday concluded that Metropolitan Medical failed to notify the health department "of an event occurring within the facility that jeopardized the health and safety of a patient." The department declined to release details of the event, the Record reports (Bergen Record, 3/14).
Investigation Findings, Reaction
The health department after a licensing inspection last month ordered the clinic to stop seeing patients after finding violations that posed "immediate and serious risk of harm to patients" (Kaiser Daily Women's Health Policy Report, 3/2). According to investigation records, state health officials found "brownish blood-like residues" encrusted on forceps, rusty crochet hooks used to remove intrauterine devices, and one-quarter-inch of dark red "dirt and debris" under an examination table at the clinic. Health officials also found that the clinic could not provide evidence that it had an infection-control plan or of an infection-control specialist on staff. The clinic had a letter on file documenting the appointment of a particular employee as the infection-control professional; however, that employee was not familiar with the appointment. The employee also had not received training or certification in infection control and prevention, which is a violation of state law. The report found that packs of sterilized instruments, which are supposed to be opened just before their use, had been unsealed and left open in storage. In other areas of the clinic, investigators found open packages of sterilized speculums, scissors, forceps and clamps, and some surgical instruments were found in the same drawer as light bulbs, the Record reports. According to the records, the clinic failed to train janitorial personnel upon employment and annually about proper cleaning procedures and equipment care, as is required by law. In addition, the health department found that a clinic patient who is suing for malpractice had incomplete medical and operative records (Bergen Record, 3/14). The state is requiring the clinic to hire infection-control and administrative consultants, both of whom must be approved by the state and be at the clinic at least 40 hours per week. The consultants "shall have full authority to review, revise, if necessary, and implement all facility policies and procedures," the order said. In addition, the consultants must submit weekly written reports to the health department (Kaiser Daily Women's Health Policy Report, 3/2). Representatives of the health department and the clinic say the clinic is working to correct the problems and hoping to resume operations as soon as possible. "It is clear that facility is going through an extremely rigorous review," Frank Capece, attorney for Metropolitan Medical, said. He added, "We can debate whether that is arbitrary or necessary, but it's a moot point. It is the intention of the facility to be in full compliance with all requirements. And it's my perception that everyone's working in good faith. ... There's no doubt that we're being held to a strict standard, a tougher standard than any other facility that we know of" (Bergen Record, 3/14).
"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.
четверг, 2 февраля 2012 г.
FDA Advisory Committee To Review Genentech's Avastin For Use As Breast Cancer Treatment
Genentech on Thursday announced that an FDA advisory panel in December will review its colon and lung cancer treatment Avastin as a first-line treatment for metastatic breast cancer, Reuters reports (Baertlein, Reuters, 9/13).
Genentech in May 2006 filed for FDA priority review of its application to use Avastin as a breast cancer treatment based on data from a late-stage clinical trial. The trial -- which involved 722 patients with previously untreated, locally recurrent or metastatic breast cancer -- found that Avastin reduced the risk of disease progression or death by 52% for patients who used the treatment with chemotherapy, compared with patients who only underwent chemotherapy.
Avastin -- which costs about $50,000 annually as a treatment for colon cancer -- might cost as much as $100,000 to treat breast cancer because breast cancer patients would require a double dose of the drug. FDA in September 2006 requested that Genentech provide more thorough data than it gave in the late-stage trial -- which was organized by National Cancer Institute researchers -- as well as require radiologists not involved in the trial to determine when patients' cancer has worsened (Kaiser Daily Women's Health Policy Report, 9/12/06).
According to Reuters, FDA's Oncologic Drugs Advisory Committee in December will consider the application. FDA is expected to take action on the application by Feb. 23, 2008 (Reuters, 9/13). Avastin, which is approved as a breast cancer treatment in the European Union, increasingly is being prescribed off-label to treat breast cancer, Dow Jones reports (Gryta, Dow Jones, 9/13).
Reprinted with kind 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 Avastin.
Genentech in May 2006 filed for FDA priority review of its application to use Avastin as a breast cancer treatment based on data from a late-stage clinical trial. The trial -- which involved 722 patients with previously untreated, locally recurrent or metastatic breast cancer -- found that Avastin reduced the risk of disease progression or death by 52% for patients who used the treatment with chemotherapy, compared with patients who only underwent chemotherapy.
Avastin -- which costs about $50,000 annually as a treatment for colon cancer -- might cost as much as $100,000 to treat breast cancer because breast cancer patients would require a double dose of the drug. FDA in September 2006 requested that Genentech provide more thorough data than it gave in the late-stage trial -- which was organized by National Cancer Institute researchers -- as well as require radiologists not involved in the trial to determine when patients' cancer has worsened (Kaiser Daily Women's Health Policy Report, 9/12/06).
According to Reuters, FDA's Oncologic Drugs Advisory Committee in December will consider the application. FDA is expected to take action on the application by Feb. 23, 2008 (Reuters, 9/13). Avastin, which is approved as a breast cancer treatment in the European Union, increasingly is being prescribed off-label to treat breast cancer, Dow Jones reports (Gryta, Dow Jones, 9/13).
Reprinted with kind 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 Avastin.
четверг, 26 января 2012 г.
It Is A Tragedy So Many Newborns Die Each Year
According to Save the Children, over two million newborns die within one day of being born worldwide every year - eight million children die each before they reach the age of five. Most of these deaths could be prevented if simple provisions were available, such as trained midwives.
The charity, in a report called The State of the World's Mothers 2006 says more than 500,000 women die annually from either giving birth or complications of pregnancy. Many of them give birth at home, alone.
Save the Children estimates that 70% of these deaths could and should be prevented.
The report describes childbirth as a dance with death for many babies and their mothers in the developing world. When I read it I was reminded of those baby turtles that break out of their eggs and race to the sea, hoping to make it before being picked off by swooping seagulls.
The report paints a bleak picture for many pregnant women and newborns in the developed world. It also reveals a gigantic gap between the rich and poorest nations.
Out of 1000 babies born in Japan, 1.8 die in their first day of life. In parts of sub-Saharan Africa the number stands at 200 out of every 1000.
The charity, in a report called The State of the World's Mothers 2006 says more than 500,000 women die annually from either giving birth or complications of pregnancy. Many of them give birth at home, alone.
Save the Children estimates that 70% of these deaths could and should be prevented.
The report describes childbirth as a dance with death for many babies and their mothers in the developing world. When I read it I was reminded of those baby turtles that break out of their eggs and race to the sea, hoping to make it before being picked off by swooping seagulls.
The report paints a bleak picture for many pregnant women and newborns in the developed world. It also reveals a gigantic gap between the rich and poorest nations.
Out of 1000 babies born in Japan, 1.8 die in their first day of life. In parts of sub-Saharan Africa the number stands at 200 out of every 1000.
четверг, 19 января 2012 г.
Early Consumption Of Soda Indicator Of Unhealthy Diet
Young girls who drink soda have less healthy diets through adolescence than their peers who do not drink soda, according to a Penn State study.
The ten-year study showed that girls who drank soda at age five had diets that were less likely to meet nutritional standards for the duration of the study, which ended at age 15. Girls who did not drink soda at age five did not meet certain nutritional requirements, but their diets were healthier.
The difference between the two groups in nutrient intake is "not just because of what they are consuming, but because of what they are not consuming," said Laura Fiorito, postdoctoral fellow in Penn State's Center for Child Obesity Research.
Milk intake differed greatly between the two groups - soda drinkers drank far less milk than non-soda drinkers - and milk has all of the nutrients that differed between the groups except fiber. At age five, non-soda drinkers consumed 10 to 11 ounces of milk daily, while soda drinkers had less than seven ounces.
"Adequate nutrient intake is important for optimal health and growth," the researchers reported in a recent issue of the Journal of the American Dietetic Association.
For example, low calcium intake is associated with increased risk of bone fractures and higher added sugar is associated with dental problems and the development of several chronic diseases, such as type 2 diabetes.
The Institute of Medicine, part of the National Academy of Sciences, recommends that girls between age 14 and 18 receive at least 65 milligrams of vitamin C daily. In this study, soda drinkers fell short at just 55 milligrams daily, while non-soda drinkers exceeded the recommendation at 70.5 milligrams daily.
Although soda drinkers had less healthy diets, both groups failed to meet recommendations for certain nutrients. The Institute recommends that girls age 14 to 18 receive at least 1,300 milligrams of calcium daily. At age 15, soda drinkers in the study averaged 767 milligrams a day, while non-soda drinkers had slightly higher intakes at 851 milligrams a day, but were still deficient.
The researchers also found that both groups increased their soda consumption by age 15. However, soda drinkers were consuming nearly twice as much soda at age 15 than their counterparts - 6.6 ounces a day versus 3.4 ounces a day.
Although the study has considerable implications on how beverages impact diet, Fiorito believes children may already have developed drinking preferences and patterns by age five.
"We think that the patterns develop when they are younger. Some studies show that children already drinking soda or carbonated beverages at age two," said Fiorito.
The study followed 170 girls for 10 years, documenting meals three times every two years. Girls classified as "soda drinkers" - those who drank roughly four ounces of soda daily at age five - showed much lower intakes of fiber, protein, vitamin C, vitamin D, calcium, magnesium, phosphorous, and potassium throughout the study than "non-soda drinkers" -- those who had no soda intake at age five. Also, the soda drinkers had much higher intake of added sugars. The study did not distinguish between diet and regular soda because the "soda drinkers" drank both types, but diet soda intake was very low at age five.
Parents of soda drinkers in the study had higher body mass indexes than non-soda drinkers' parents. Fiorito believes this suggests that "parents model consumption patterns for their children," and that the parents' unhealthy eating habits not only contributed to an increased BMI, but influenced children.
There have been other studies on the effects of soda on dieting, but this is the first study to track the consumption of multiple beverages over a ten-year period. Included in the study were coffee/tea, soda, milk, 100 percent fruit juice, and fruit drinks - any fruit-flavored drinks with less than 100 percent fruit juice.
Other beverages have come under scrutiny in recent years for their possible negative health consequences. For example, the American Academy of Pediatrics issued a formal statement in 2001 that recommended limits on children's fruit juice intake. The Academy has not issued any formal statement on soda, but this study provides a clear link showing that soda can prevent people from maintaining a healthy diet.
Other researchers on the study were Leann L. Birch, distinguished professor of human development and family studies; Helen Smiciklas-Wright, professor emerita of nutritional sciences; Diane C. Mitchell, diet assessment coordinator, and Michele Marini, project assistant, all at Penn State.
The National Institutes of Health and the National Dairy Council supported this work.
Source:
A'ndrea Elyse Messer
Penn State
The ten-year study showed that girls who drank soda at age five had diets that were less likely to meet nutritional standards for the duration of the study, which ended at age 15. Girls who did not drink soda at age five did not meet certain nutritional requirements, but their diets were healthier.
The difference between the two groups in nutrient intake is "not just because of what they are consuming, but because of what they are not consuming," said Laura Fiorito, postdoctoral fellow in Penn State's Center for Child Obesity Research.
Milk intake differed greatly between the two groups - soda drinkers drank far less milk than non-soda drinkers - and milk has all of the nutrients that differed between the groups except fiber. At age five, non-soda drinkers consumed 10 to 11 ounces of milk daily, while soda drinkers had less than seven ounces.
"Adequate nutrient intake is important for optimal health and growth," the researchers reported in a recent issue of the Journal of the American Dietetic Association.
For example, low calcium intake is associated with increased risk of bone fractures and higher added sugar is associated with dental problems and the development of several chronic diseases, such as type 2 diabetes.
The Institute of Medicine, part of the National Academy of Sciences, recommends that girls between age 14 and 18 receive at least 65 milligrams of vitamin C daily. In this study, soda drinkers fell short at just 55 milligrams daily, while non-soda drinkers exceeded the recommendation at 70.5 milligrams daily.
Although soda drinkers had less healthy diets, both groups failed to meet recommendations for certain nutrients. The Institute recommends that girls age 14 to 18 receive at least 1,300 milligrams of calcium daily. At age 15, soda drinkers in the study averaged 767 milligrams a day, while non-soda drinkers had slightly higher intakes at 851 milligrams a day, but were still deficient.
The researchers also found that both groups increased their soda consumption by age 15. However, soda drinkers were consuming nearly twice as much soda at age 15 than their counterparts - 6.6 ounces a day versus 3.4 ounces a day.
Although the study has considerable implications on how beverages impact diet, Fiorito believes children may already have developed drinking preferences and patterns by age five.
"We think that the patterns develop when they are younger. Some studies show that children already drinking soda or carbonated beverages at age two," said Fiorito.
The study followed 170 girls for 10 years, documenting meals three times every two years. Girls classified as "soda drinkers" - those who drank roughly four ounces of soda daily at age five - showed much lower intakes of fiber, protein, vitamin C, vitamin D, calcium, magnesium, phosphorous, and potassium throughout the study than "non-soda drinkers" -- those who had no soda intake at age five. Also, the soda drinkers had much higher intake of added sugars. The study did not distinguish between diet and regular soda because the "soda drinkers" drank both types, but diet soda intake was very low at age five.
Parents of soda drinkers in the study had higher body mass indexes than non-soda drinkers' parents. Fiorito believes this suggests that "parents model consumption patterns for their children," and that the parents' unhealthy eating habits not only contributed to an increased BMI, but influenced children.
There have been other studies on the effects of soda on dieting, but this is the first study to track the consumption of multiple beverages over a ten-year period. Included in the study were coffee/tea, soda, milk, 100 percent fruit juice, and fruit drinks - any fruit-flavored drinks with less than 100 percent fruit juice.
Other beverages have come under scrutiny in recent years for their possible negative health consequences. For example, the American Academy of Pediatrics issued a formal statement in 2001 that recommended limits on children's fruit juice intake. The Academy has not issued any formal statement on soda, but this study provides a clear link showing that soda can prevent people from maintaining a healthy diet.
Other researchers on the study were Leann L. Birch, distinguished professor of human development and family studies; Helen Smiciklas-Wright, professor emerita of nutritional sciences; Diane C. Mitchell, diet assessment coordinator, and Michele Marini, project assistant, all at Penn State.
The National Institutes of Health and the National Dairy Council supported this work.
Source:
A'ndrea Elyse Messer
Penn State
четверг, 12 января 2012 г.
Link Between Increased Contraceptive Supply And Fewer Unintended Pregnancies
Rates of unintended pregnancies and abortions decrease significantly when women receive a one-year supply of oral contraceptives, instead of being prescribed one- or three-month supplies, a UCSF study shows.
Researchers observed a 30 percent reduction in the odds of pregnancy and a 46 percent decrease in the odds of an abortion in women given a one-year supply of birth control pills at a clinic versus women who received the standard prescriptions for one - or three-month supplies.
The researchers speculate that a larger supply of oral contraceptive pills may allow more consistent use, since women need to make fewer visits to a clinic or pharmacy for their next supply.
"Women need to have contraceptives on hand so that their use is as automatic as using safety devices in cars, " said Diana Greene Foster, PhD, lead author and associate professor in the UCSF Department of Obstetrics, Gynecology and Reproductive Sciences. "Providing one cycle of oral contraceptives at a time is similar to asking people to visit a clinic or pharmacy to renew their seatbelts each month."
Foster also is director of research for Advancing New Standards in Reproductive Health, part of the UCSF Bixby Center for Global Reproductive Health. Her study's findings appear online here.
The researchers linked 84,401 women who received oral contraceptives in January 2006 through Family PACT (Planning, Access, Care, Treatment), a California family planning program, to Medi-Cal data showing pregnancies and births in 2006. Through Family PACT, some family planning clinics are able to dispense a one-year supply of pills on-site.
Oral contraceptive pills are the most commonly used method of reversible contraception in the United States, the team states. While highly effective when used correctly (three pregnancies per 1,000 women in the first year of use), approximately half of women regularly miss one or more pills per cycle, a practice associated with a much higher pregnancy rate (80 pregnancies per 1,000 women in the first year of use), according to the team.
The findings of this study have implications for women using oral contraceptives across the country. Most oral contraceptive users in the United States get fewer than four packs at a time; nearly half need to return every month for resupply, according to a 2010 study published in Contraception.
Making oral contraceptive pills more accessible may reduce the incidence of unintended pregnancy and abortion, while saving taxpayers' dollars, the researchers state. If the 65,000 women in the analysis who received either one or three packs of pills at a time had experienced the same pregnancy and abortion rates as women who received a one-year supply, almost 1,300 publicly funded pregnancies and 300 abortions would have been averted, according to the team.
"The evidence indicates that health plans and public health programs may avoid paying for costly unintended pregnancies by increasing dispensing limits on oral contraceptives," said Foster. "Improving access to contraceptive methods reduces the need for abortion and helps women to plan their pregnancies."
Co-authors are Denis Hulett, Mary Bradsberry, Phillip Darney, MD, MSc, and Michael Policar, MD, MPH, all with the Bixby Center for Global Reproductive Health, UCSF Department of Obstetrics, Gynecology, and Reproductive Sciences, and San Francisco General Hospital.
Source:
Karin Rush-Monroe
University of California - San Francisco
Researchers observed a 30 percent reduction in the odds of pregnancy and a 46 percent decrease in the odds of an abortion in women given a one-year supply of birth control pills at a clinic versus women who received the standard prescriptions for one - or three-month supplies.
The researchers speculate that a larger supply of oral contraceptive pills may allow more consistent use, since women need to make fewer visits to a clinic or pharmacy for their next supply.
"Women need to have contraceptives on hand so that their use is as automatic as using safety devices in cars, " said Diana Greene Foster, PhD, lead author and associate professor in the UCSF Department of Obstetrics, Gynecology and Reproductive Sciences. "Providing one cycle of oral contraceptives at a time is similar to asking people to visit a clinic or pharmacy to renew their seatbelts each month."
Foster also is director of research for Advancing New Standards in Reproductive Health, part of the UCSF Bixby Center for Global Reproductive Health. Her study's findings appear online here.
The researchers linked 84,401 women who received oral contraceptives in January 2006 through Family PACT (Planning, Access, Care, Treatment), a California family planning program, to Medi-Cal data showing pregnancies and births in 2006. Through Family PACT, some family planning clinics are able to dispense a one-year supply of pills on-site.
Oral contraceptive pills are the most commonly used method of reversible contraception in the United States, the team states. While highly effective when used correctly (three pregnancies per 1,000 women in the first year of use), approximately half of women regularly miss one or more pills per cycle, a practice associated with a much higher pregnancy rate (80 pregnancies per 1,000 women in the first year of use), according to the team.
The findings of this study have implications for women using oral contraceptives across the country. Most oral contraceptive users in the United States get fewer than four packs at a time; nearly half need to return every month for resupply, according to a 2010 study published in Contraception.
Making oral contraceptive pills more accessible may reduce the incidence of unintended pregnancy and abortion, while saving taxpayers' dollars, the researchers state. If the 65,000 women in the analysis who received either one or three packs of pills at a time had experienced the same pregnancy and abortion rates as women who received a one-year supply, almost 1,300 publicly funded pregnancies and 300 abortions would have been averted, according to the team.
"The evidence indicates that health plans and public health programs may avoid paying for costly unintended pregnancies by increasing dispensing limits on oral contraceptives," said Foster. "Improving access to contraceptive methods reduces the need for abortion and helps women to plan their pregnancies."
Co-authors are Denis Hulett, Mary Bradsberry, Phillip Darney, MD, MSc, and Michael Policar, MD, MPH, all with the Bixby Center for Global Reproductive Health, UCSF Department of Obstetrics, Gynecology, and Reproductive Sciences, and San Francisco General Hospital.
Source:
Karin Rush-Monroe
University of California - San Francisco
четверг, 5 января 2012 г.
NIH Panel Releases Conclusions About Compound BPA's Effect On Reproductive Disorders
A 12-member panel from NIH's Center for the Evaluation of Risks to Human Reproduction on Wednesday said it has "minimal" or "negligible" concerns that the compound bisphenol A, which is found in plastic and is similar to estrogen, can cause human reproductive disorders, the Los Angeles Times reports. The panel also said that the compound, also known as BPA, could pose some risk to the neurological development of infants and children (Cone, Los Angeles Times, 8/9).
The journal Reproductive Toxicology last week published on its Web site a statement warning that BPA likely is causing various human reproductive disorders. The statement was accompanied by a new study from NIH that found uterine damage in animals exposed to BPA. The damage is a potential predictor of reproductive diseases among women, including fibroids, endometriosis, cystic ovaries and cancers. Several dozen scientists reviewed about 700 earlier studies and for the first time linked BPA to female reproductive disorders. They also concluded that people are exposed to higher BPA levels than those found to harm laboratory animals. Infants and fetuses are most likely to experience harm from BPA.
In the statement, 38 scientists said that BPA causes cells to turn genes on or off, which could predispose a fetus or child to a reproductive disorder. In addition, BPA levels found in lab animals are similar to those found in human fetal blood, the statement said.
According to Retha Newbold of NIH's National Institute of Environmental Health Sciences, the study found that BPA can cause reproductive damage similar to the anti-miscarriage drug diethylstilbestrol, which was given to pregnant women from the 1940s to the 1970s. Diethylstilbestrol was later found to cause infertility and reproductive cancers among children born to women who took the drug. No studies have been conducted on BPA's effects among humans, and the scientists who signed the statement are calling for human research (Kaiser Daily Women's Health Policy Report, 8/6).
The panel reviewed 500 animal studies and used five rankings -- negligible concern, minimal concern, some concern, concern and severe concern -- for its findings, the Times reports. For fetuses, pregnant women, infants and children, the panel said there is "some concern that exposure to BPA causes neural and behavioral effects." For fetuses and children, the panel said there is "minimal concern" that BPA harms the prostate gland and causes premature puberty. The panel also said that there is "negligible concern" that BPA cases birth defects. For adults, they reported "negligible concern about adverse reproductive effects." According to the Times, part of the reason the panel ranked the reproductive risks less seriously than the other group of scientists is that the panel rejected several studies in which animals were exposed to BPA through injection rather than through their diets. The panel's recommendation will be reviewed by the National Toxicology Program for a federal report that could lead to regulations restricting use of the chemical, the Times reports.
The journal Reproductive Toxicology last week published on its Web site a statement warning that BPA likely is causing various human reproductive disorders. The statement was accompanied by a new study from NIH that found uterine damage in animals exposed to BPA. The damage is a potential predictor of reproductive diseases among women, including fibroids, endometriosis, cystic ovaries and cancers. Several dozen scientists reviewed about 700 earlier studies and for the first time linked BPA to female reproductive disorders. They also concluded that people are exposed to higher BPA levels than those found to harm laboratory animals. Infants and fetuses are most likely to experience harm from BPA.
In the statement, 38 scientists said that BPA causes cells to turn genes on or off, which could predispose a fetus or child to a reproductive disorder. In addition, BPA levels found in lab animals are similar to those found in human fetal blood, the statement said.
According to Retha Newbold of NIH's National Institute of Environmental Health Sciences, the study found that BPA can cause reproductive damage similar to the anti-miscarriage drug diethylstilbestrol, which was given to pregnant women from the 1940s to the 1970s. Diethylstilbestrol was later found to cause infertility and reproductive cancers among children born to women who took the drug. No studies have been conducted on BPA's effects among humans, and the scientists who signed the statement are calling for human research (Kaiser Daily Women's Health Policy Report, 8/6).
The panel reviewed 500 animal studies and used five rankings -- negligible concern, minimal concern, some concern, concern and severe concern -- for its findings, the Times reports. For fetuses, pregnant women, infants and children, the panel said there is "some concern that exposure to BPA causes neural and behavioral effects." For fetuses and children, the panel said there is "minimal concern" that BPA harms the prostate gland and causes premature puberty. The panel also said that there is "negligible concern" that BPA cases birth defects. For adults, they reported "negligible concern about adverse reproductive effects." According to the Times, part of the reason the panel ranked the reproductive risks less seriously than the other group of scientists is that the panel rejected several studies in which animals were exposed to BPA through injection rather than through their diets. The panel's recommendation will be reviewed by the National Toxicology Program for a federal report that could lead to regulations restricting use of the chemical, the Times reports.
Comments, Reaction
John Bucher, associate director of NTP, said the panel gave the most weight to neurological effects in children, infants and fetuses because studies consistently have found those effects when newborn animals are exposed to low doses similar to what humans encounter. He added that because the science remains uncertain, it is up to individuals to decide whether to avoid products with BPA.
Steve Hentges of the American Chemistry Council's polycarbonate division said the panel's report is a "strong reassurance to consumers" that products containing BPA are safe. Frederick vom Saal, a University of Missouri-Columbia reproductive toxicologist who has conducted studies on BPA, said that it is disappointing that the panel did not rank the risk higher but that the "panel is now on record saying there are human health concerns."
Some environmental advocates "lambasted" the panel's report, saying it minimized the risks and ignored important research, according to the Times. Anila Jacob of the Environmental Working Group said, "Only the chemical industry agrees with the decision that BPA has little or no human health risks." She added, "That by itself should speak volumes about the corrupted process endorsed by the panel today" (Los Angeles Times, 8/9).
The panel's report is available online. Note: You will need Adobe Acrobat to view the report.
CNN on Thursday included a discussion with CNN medical correspondent Elizabeth Cohen about the panel's findings (Phillips, CNN, 8/9). A transcript of the segment is available online. In addition, NPR's "All Things Considered" on Thursday included a discussion with panel member Jane Adams, a neurodevelopmental toxicologist, about the findings (Seabrook, "All Things Considered," NPR, 8/9). Audio of the segment is available online.
Reprinted with kind 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.
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