Thursday, February 28, 2013
Special program increases birth control use in at-risk teens
(Reuters) - Long after completing an 18-month program designed to teach them about contraception and healthy relationships, U.S. teens at high risk for pregnancy were still using contraceptives more often, among other safe sexual practices, a U.S. study said.
The teen pregnancy rate in the United States is the highest in the developed world, researchers writing in JAMA Pediatrics said. According to the U.S. Centers for Disease Control and Prevention, in 2011 31 out of every 1,000 U.S. teenage girls between the ages of 15 and 19 gave birth to a baby.
But researchers in Minnesota developed and tested an approach to teen pregnancies based on providing access to birth control methods and information as well as building the girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
For the study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' youth development program.
At the study's outset, just over half of all the girls in both groups, around 56 percent, were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention, other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Each girl in the program got a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family. Those teens also went through training to educate others about what they were learning.
Six months after the 18-month program ended, the teens were asked about their sexual behavior.
Girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier. But the girls who went through the program did 50 percent better at using a condom every time they had sex than they had when the study began.
The use of other contraceptives increased in both groups, but especially the group that went through the special program.
Those girls were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, they were also more likely to go to college or technical school, Sieving said.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute! So it's really cool to see that shift in how they see themselves.' SOURCE: http://bit.ly/V9WKBO
(Reporting from New York by Andrew Seaman at Reuters Health; editing by Elaine Lies)
The teen pregnancy rate in the United States is the highest in the developed world, researchers writing in JAMA Pediatrics said. According to the U.S. Centers for Disease Control and Prevention, in 2011 31 out of every 1,000 U.S. teenage girls between the ages of 15 and 19 gave birth to a baby.
But researchers in Minnesota developed and tested an approach to teen pregnancies based on providing access to birth control methods and information as well as building the girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
For the study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' youth development program.
At the study's outset, just over half of all the girls in both groups, around 56 percent, were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention, other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Each girl in the program got a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family. Those teens also went through training to educate others about what they were learning.
Six months after the 18-month program ended, the teens were asked about their sexual behavior.
Girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier. But the girls who went through the program did 50 percent better at using a condom every time they had sex than they had when the study began.
The use of other contraceptives increased in both groups, but especially the group that went through the special program.
Those girls were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, they were also more likely to go to college or technical school, Sieving said.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute! So it's really cool to see that shift in how they see themselves.' SOURCE: http://bit.ly/V9WKBO
(Reporting from New York by Andrew Seaman at Reuters Health; editing by Elaine Lies)
Wednesday, February 27, 2013
Program increases contraceptive use in at-risk teens
NEW YORK (Reuters Health) - Long after completing an 18-month program designed to teach about contraception and healthy relationships, teenage girls at high risk for unwanted pregnancy were using contraceptives more often and maintaining other safer sexual practices, according to a new study.
Researchers in Minnesota tested an approach to preventing teen pregnancies that is based on providing access to birth control methods and information as well as building girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
According to the U.S. Centers for Disease Control and Prevention, 31 out of every 1,000 teenage girls between 15 and 19 years old gave birth to a baby in 2011.
That is a record low, but still the highest teen pregnancy rate in the developed world, Sieving and her colleagues point out in the journal JAMA Pediatrics. They add that black and Hispanic teens bear most of the burden of these teen pregnancies.
For the new study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' 'Prime Time' youth development program.
At the study's outset, just over half of all the girls in both groups (around 56 percent) were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention - other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Prime Time assigned each girl participating in that program a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family.
The Prime Time teens also went through training to become leaders and teachers who could educate others about what they were learning.
The program took 18 months to complete, and the teens were then asked about their behaviors six months after it the program's end.
The researchers found that the girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier.
Girls who went through the program, however, ended up doing about 50 percent better at using a condom every time they had sex than at the beginning of the study.
The use of other contraceptives also increased in both groups, but more in the group who went through the Prime Time program.
The girls who went through the program were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, the Prime Time teens were also more likely to go to college or technical school, according to Sieving.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute!' So it's really cool to see that shift in how they see in themselves,' she added.
Amy Bleakley, who studies teen sexual behavior and reproductive health at the University of Pennsylvania in Philadelphia, said the results are promising.
'I think that investment in youth development programs such as this could yield positive results for high-risk adolescent girls,' said Bleakley, who was not involved with the new study.
Sieving told Reuters Health that compared to the approximately $10.9 billion teen pregnancy cost U.S. taxpayers in 2008, investing in this type of program also makes financial sense. The Prime Time program costs about $2,800 per teen, she said.
'I just think when you invest in ways that help kids to thrive, it's good for our next generation and there is some cost saving involved,' she added.
SOURCE: http://bit.ly/V9WKBO JAMA Pediatrics, online February 26, 2012.
Researchers in Minnesota tested an approach to preventing teen pregnancies that is based on providing access to birth control methods and information as well as building girls' sense of connectedness to family and society.
'Our study shows that when we invest in young people through ongoing one-on-one relationships, through opportunities to lead and access to sex and health services, we really support the next generation of citizens,' said Renee Sieving, the study's lead author from the University of Minnesota in Minneapolis.
According to the U.S. Centers for Disease Control and Prevention, 31 out of every 1,000 teenage girls between 15 and 19 years old gave birth to a baby in 2011.
That is a record low, but still the highest teen pregnancy rate in the developed world, Sieving and her colleagues point out in the journal JAMA Pediatrics. They add that black and Hispanic teens bear most of the burden of these teen pregnancies.
For the new study, Sieving's team recruited 253 sexually active girls between 13 and 17 years old from clinics in St. Paul and Minneapolis, to be randomly placed in one of two groups.
All would get standard care at the clinic, but half would also be enrolled in the researchers' 'Prime Time' youth development program.
At the study's outset, just over half of all the girls in both groups (around 56 percent) were using condoms on more than half of the occasions that they had sex. More than 40 percent said they used condoms less than half of the time.
Just 2 percent of girls in each group were also on some other type of birth control, such as the Pill.
One group of 127 girls did not receive any special attention - other than the clinic's standard care and guidance. The other 126 girls were assigned to the new program.
Prime Time assigned each girl participating in that program a case manager who taught about healthy relationships, contraceptive use and how to become more involved with school and family.
The Prime Time teens also went through training to become leaders and teachers who could educate others about what they were learning.
The program took 18 months to complete, and the teens were then asked about their behaviors six months after it the program's end.
The researchers found that the girls who did not go through the program ended up using a condom during sex less consistently than they had two years earlier.
Girls who went through the program, however, ended up doing about 50 percent better at using a condom every time they had sex than at the beginning of the study.
The use of other contraceptives also increased in both groups, but more in the group who went through the Prime Time program.
The girls who went through the program were also more likely to say they were close with their family, and were more confident in turning down unwanted sex. In addition, the Prime Time teens were also more likely to go to college or technical school, according to Sieving.
'The kids we're working with are oftentimes struggling in school - the kid in the back of the room you don't often hear from, and we give them tools,' Sieving said.
'You watch them move from 'I don't really have anything that's of any use to anybody,' to 'Wow, I have stuff to contribute!' So it's really cool to see that shift in how they see in themselves,' she added.
Amy Bleakley, who studies teen sexual behavior and reproductive health at the University of Pennsylvania in Philadelphia, said the results are promising.
'I think that investment in youth development programs such as this could yield positive results for high-risk adolescent girls,' said Bleakley, who was not involved with the new study.
Sieving told Reuters Health that compared to the approximately $10.9 billion teen pregnancy cost U.S. taxpayers in 2008, investing in this type of program also makes financial sense. The Prime Time program costs about $2,800 per teen, she said.
'I just think when you invest in ways that help kids to thrive, it's good for our next generation and there is some cost saving involved,' she added.
SOURCE: http://bit.ly/V9WKBO JAMA Pediatrics, online February 26, 2012.
GlaxoSmithKline unit joins patent pool for AIDS drugs
LONDON (Reuters) - GlaxoSmithKline's HIV/AIDS drugs business is to share intellectual property rights on children's medicine in a patent pool designed to make treatments more widely available in poor countries.
ViiV Healthcare, majority-owned by GSK, is the second research-based pharmaceutical business to sign up to the new Medicines Patent Pool, following a lead set in 2011 by Gilead Sciences.
Although more than half of people living with the human immunodeficiency virus (HIV) that causes AIDS now get the drugs they need - thanks to a major roll-out of treatment in Africa - an estimated 6.8 million still go without, according to UNAIDS.
The Medicines Patent Pool (MPP), launched in 2010 by the UNITAID health financing system that is funded by a levy on airline tickets, aims to address the remaining gap by getting patent holders to share know-how with makers of cheap generic drugs.
In the case of ViiV, a key pediatric medicine known as abacavir will be made available to generic manufacturers which will be able to take a license to make and sell it in 118 poor countries, the patent pool said on Wednesday.
ViiV and the patent pool have also agreed to negotiate further licenses that will allow generics firms to manufacture low-cost versions of an experimental drug, dolutegravir, that is currently awaiting regulatory approval in Western markets.
There are 3.4 million children living with HIV worldwide but only 562,000 have access to medicines. Treating them is challenging because many drugs are not adapted for use in children.
Abacavir and dolutegravir are both seen as priority products for fighting HIV in poor countries. ViiV also sells other older drugs, some of which are already off patent and available as cheaper generics.
ViiV - which is owned 76.5 percent by GSK, 13.5 percent by Pfizer and 10 percent by Shionogi - only signed up to the patent pool after lengthy negotiations.
Some other major drugmakers have yet to join.
Bristol-Myers Squibb, Roche and privately owned Boehringer-Ingelheim are currently discussing plans to join the scheme, but Abbott, Johnson & Johnson and Merck have so far remained outside.
J&J decided in November to take unilateral action by not enforcing its patents on HIV drug Prezista in a limited number of poor countries, in a move that disappointed campaigners who argued joining the pool would have been more effective.
(Reporting by Ben Hirschler, Editing by Kate Kelland and Mark Potter)
ViiV Healthcare, majority-owned by GSK, is the second research-based pharmaceutical business to sign up to the new Medicines Patent Pool, following a lead set in 2011 by Gilead Sciences.
Although more than half of people living with the human immunodeficiency virus (HIV) that causes AIDS now get the drugs they need - thanks to a major roll-out of treatment in Africa - an estimated 6.8 million still go without, according to UNAIDS.
The Medicines Patent Pool (MPP), launched in 2010 by the UNITAID health financing system that is funded by a levy on airline tickets, aims to address the remaining gap by getting patent holders to share know-how with makers of cheap generic drugs.
In the case of ViiV, a key pediatric medicine known as abacavir will be made available to generic manufacturers which will be able to take a license to make and sell it in 118 poor countries, the patent pool said on Wednesday.
ViiV and the patent pool have also agreed to negotiate further licenses that will allow generics firms to manufacture low-cost versions of an experimental drug, dolutegravir, that is currently awaiting regulatory approval in Western markets.
There are 3.4 million children living with HIV worldwide but only 562,000 have access to medicines. Treating them is challenging because many drugs are not adapted for use in children.
Abacavir and dolutegravir are both seen as priority products for fighting HIV in poor countries. ViiV also sells other older drugs, some of which are already off patent and available as cheaper generics.
ViiV - which is owned 76.5 percent by GSK, 13.5 percent by Pfizer and 10 percent by Shionogi - only signed up to the patent pool after lengthy negotiations.
Some other major drugmakers have yet to join.
Bristol-Myers Squibb, Roche and privately owned Boehringer-Ingelheim are currently discussing plans to join the scheme, but Abbott, Johnson & Johnson and Merck have so far remained outside.
J&J decided in November to take unilateral action by not enforcing its patents on HIV drug Prezista in a limited number of poor countries, in a move that disappointed campaigners who argued joining the pool would have been more effective.
(Reporting by Ben Hirschler, Editing by Kate Kelland and Mark Potter)
Thursday, February 21, 2013
Most women misunderstand IUD birth control
NEW YORK (Reuters Health) - In a new survey, most women had inaccurate perceptions about the safety and effectiveness of intrauterine devices (IUDs) in preventing pregnancy, say U.S. researchers, who urge doctors to talk more about the benefits of the devices.
In particular, many of the study participants didn't know that IUDs are more effective contraceptives than the birth control pill and that the devices don't increase the risk of getting a sexually transmitted disease.
'It's not clear whether women have an overly optimistic view of the effectiveness of the birth control pill or an overly pessimistic view of the IUD,' said Dr. Lisa Callegari, the study's lead author and a clinical assistant professor at the University of Washington.
Whatever their source, these misperceptions lead to underuse of 'one of the most safe and effective methods' of birth control, said Dr. Jeffrey Peipert, an obstetrics and gynecology professor at Washington University, who was not part of the study.
IUDs, which include the brand name products ParaGard and Mirena, are small plastic or copper-and-plastic objects inserted into the uterus. They can be left implanted for years, and are more than 99 percent effective at preventing pregnancy.
In contrast, the birth control pill has been found in real-world practice to be about 95 percent effective.
Callegari said that earlier studies have highlighted some of the mistaken beliefs women have about IUDs, and she and her colleagues wanted to get a better sense of how common they are among average women visiting primary care clinics.
They surveyed more than 1,600 women between the ages of 18 and 50 who had visited one of four clinics in Pennsylvania.
Five percent of the women were currently using an IUD, and another 5.8 percent had used one previously.
Only about one in five of the women correctly stated that IUDs are more effective at preventing pregnancy than the Pill.
And just 28 percent knew that an IUD is more cost effective than the Pill when it is used for more than three years, the researchers report in the medical journal Contraception.
According to Planned Parenthood, the upfront costs of an IUD are between $500 and $1,000, whereas birth control pills can cost between $15 and $50 a month - so they become more expensive over time.
The women in the study were considerably more knowledgeable about the risk of disease related to an IUD, with 57 percent answering correctly that there is no greater risk of contracting a sexually transmitted disease with an IUD compared to the Pill.
Still, Peipert said he's not surprised that women might view IUDs less favorably.
'There's been a LOT of bad press about IUDs in the past,' Peipert wrote in an email to Reuters Health.
For instance, thousands of women have sued the makers of the Dalkon Shield, an IUD sold in the 1970s, because of injuries sustained from infections.
'It's not surprising, because of the history of the IUD in the United States, that people still have inaccurate perceptions of the device,' said Dr. Rebecca Allen, an assistant professor of obstetrics and gynecology at Brown University, who was not involved in the study.
Currently available devices are considered to be much safer, said Allen.
Indeed, women over age 36 tended to have more misperceptions than younger women who took the survey, the researchers note in their report.
It's likely, too, that many women are simply not as familiar with the devices as they are with the Pill, said Callegari.
According to a 2012 study by the Centers for Disease Control and Prevention (CDC), 28 percent of women of reproductive age use oral contraception, making the Pill the most common form of birth control, followed closely by sterilization methods like getting the fallopian tubes 'tied,' used by 27 percent of women.
The same CDC study found that IUD use had risen from 0.8 percent of reproductive-age women in 1995 to 5.6 percent in 2010.
To correct widespread misconceptions about IUDs, Allen said, health care providers should be encouraged to talk to their patients about the devices.
Among women who have never used an IUD, Callagari's study found that those who had been counseled about the device by a health care provider were more knowledgeable than women who hadn't discussed it.
'I think it helps to give more evidence that providers should be talking with patients about IUDs,' she told Reuters Health. 'Women hear it and it affects their perceptions.'
Providers themselves might need to be educated too, however.
One recent survey of physicians found that 30 percent had outdated ideas about IUDs, including thinking they are unsafe for women who had never had a baby or being unsure about their safety (see Reuters Health story of March 28, 2012 here: http://reut.rs/HhJ0dH).
'We need to educate more primary care providers about the facts about IUDs so that they can counsel their patients,' said Allen.
SOURCE: http://bit.ly/XP6lK8 Contraception, online February 18, 2013.
In particular, many of the study participants didn't know that IUDs are more effective contraceptives than the birth control pill and that the devices don't increase the risk of getting a sexually transmitted disease.
'It's not clear whether women have an overly optimistic view of the effectiveness of the birth control pill or an overly pessimistic view of the IUD,' said Dr. Lisa Callegari, the study's lead author and a clinical assistant professor at the University of Washington.
Whatever their source, these misperceptions lead to underuse of 'one of the most safe and effective methods' of birth control, said Dr. Jeffrey Peipert, an obstetrics and gynecology professor at Washington University, who was not part of the study.
IUDs, which include the brand name products ParaGard and Mirena, are small plastic or copper-and-plastic objects inserted into the uterus. They can be left implanted for years, and are more than 99 percent effective at preventing pregnancy.
In contrast, the birth control pill has been found in real-world practice to be about 95 percent effective.
Callegari said that earlier studies have highlighted some of the mistaken beliefs women have about IUDs, and she and her colleagues wanted to get a better sense of how common they are among average women visiting primary care clinics.
They surveyed more than 1,600 women between the ages of 18 and 50 who had visited one of four clinics in Pennsylvania.
Five percent of the women were currently using an IUD, and another 5.8 percent had used one previously.
Only about one in five of the women correctly stated that IUDs are more effective at preventing pregnancy than the Pill.
And just 28 percent knew that an IUD is more cost effective than the Pill when it is used for more than three years, the researchers report in the medical journal Contraception.
According to Planned Parenthood, the upfront costs of an IUD are between $500 and $1,000, whereas birth control pills can cost between $15 and $50 a month - so they become more expensive over time.
The women in the study were considerably more knowledgeable about the risk of disease related to an IUD, with 57 percent answering correctly that there is no greater risk of contracting a sexually transmitted disease with an IUD compared to the Pill.
Still, Peipert said he's not surprised that women might view IUDs less favorably.
'There's been a LOT of bad press about IUDs in the past,' Peipert wrote in an email to Reuters Health.
For instance, thousands of women have sued the makers of the Dalkon Shield, an IUD sold in the 1970s, because of injuries sustained from infections.
'It's not surprising, because of the history of the IUD in the United States, that people still have inaccurate perceptions of the device,' said Dr. Rebecca Allen, an assistant professor of obstetrics and gynecology at Brown University, who was not involved in the study.
Currently available devices are considered to be much safer, said Allen.
Indeed, women over age 36 tended to have more misperceptions than younger women who took the survey, the researchers note in their report.
It's likely, too, that many women are simply not as familiar with the devices as they are with the Pill, said Callegari.
According to a 2012 study by the Centers for Disease Control and Prevention (CDC), 28 percent of women of reproductive age use oral contraception, making the Pill the most common form of birth control, followed closely by sterilization methods like getting the fallopian tubes 'tied,' used by 27 percent of women.
The same CDC study found that IUD use had risen from 0.8 percent of reproductive-age women in 1995 to 5.6 percent in 2010.
To correct widespread misconceptions about IUDs, Allen said, health care providers should be encouraged to talk to their patients about the devices.
Among women who have never used an IUD, Callagari's study found that those who had been counseled about the device by a health care provider were more knowledgeable than women who hadn't discussed it.
'I think it helps to give more evidence that providers should be talking with patients about IUDs,' she told Reuters Health. 'Women hear it and it affects their perceptions.'
Providers themselves might need to be educated too, however.
One recent survey of physicians found that 30 percent had outdated ideas about IUDs, including thinking they are unsafe for women who had never had a baby or being unsure about their safety (see Reuters Health story of March 28, 2012 here: http://reut.rs/HhJ0dH).
'We need to educate more primary care providers about the facts about IUDs so that they can counsel their patients,' said Allen.
SOURCE: http://bit.ly/XP6lK8 Contraception, online February 18, 2013.
Wednesday, February 20, 2013
Gilead, Teva reach settlement in Viread patent lawsuit
(Reuters) - Gilead Sciences Inc said it has agreed with Israel's Teva Pharmaceuticals Industries Ltd to settle a lawsuit relating to patents protecting Viread, a treatment for HIV infection and chronic hepatitis B.
As per the agreement, Gilead said Teva will be allowed to launch a generic version of Viread on December 15, 2017.
'This settlement removes some uncertainty and minimizes further distraction and investment of human and financial resources associated with this litigation,' Gilead's chief operating officer, John Milligan, said in a statement late on Tuesday.
Gilead, based in California, is the world's largest maker of branded drugs to treat the human immunodeficiency virus, the cause of AIDS.
The trial in the lawsuit, which was scheduled to begin on February 20 in a Manhattan court, has been adjourned to finalize the settlement, Gilead said.
(Reporting by Sakthi Prasad in Bangalore; Editing by Matt Driskill)
This article is sponsored by real estate news.
As per the agreement, Gilead said Teva will be allowed to launch a generic version of Viread on December 15, 2017.
'This settlement removes some uncertainty and minimizes further distraction and investment of human and financial resources associated with this litigation,' Gilead's chief operating officer, John Milligan, said in a statement late on Tuesday.
Gilead, based in California, is the world's largest maker of branded drugs to treat the human immunodeficiency virus, the cause of AIDS.
The trial in the lawsuit, which was scheduled to begin on February 20 in a Manhattan court, has been adjourned to finalize the settlement, Gilead said.
(Reporting by Sakthi Prasad in Bangalore; Editing by Matt Driskill)
This article is sponsored by real estate news.
Monday, February 18, 2013
GSK wins priority status for new HIV drug in U.S
LONDON (Reuters) - U.S. regulators gave priority review status to an experimental GlaxoSmithKline drug for HIV/AIDS, which industry analysts view as a possible multibillion-dollar-a-year seller.
The U.S. Food and Drug Administration awards certain drugs priority status when they have the potential to offer significant improvement over existing treatments.
The agency is due to give its verdict on whether to approve dolutegravir by August 17, Britain's biggest drugmaker said on Friday.
The once-daily drug, which belongs to a novel class known as integrase inhibitors that block the virus causing AIDS from entering cells, is owned by ViiV Healthcare, a joint venture focused on HIV in which GSK is the largest shareholder.
The new medicine has already performed strongly in clinical trials, prompting GSK to raise its bet on the product last October by redrawing a deal with Japan's Shionogi.
Under that agreement Shionogi agreed to take a 10 percent stake in Viiv - which was set up in 2009 between GSK and Pfizer - in exchange for its shared rights to dolutegravir.
The agreement left GSK holding 76.5 percent of ViiV, with Pfizer controlling 13.5 percent and Shionogi the remainder.
Analysts see dolutegravir as a strong competitor to HIV treatments from market leader Gilead Sciences.
(Reporting by Ben Hirschler. Editing by Jane Merriman)
This article is sponsored by free dating site.
The U.S. Food and Drug Administration awards certain drugs priority status when they have the potential to offer significant improvement over existing treatments.
The agency is due to give its verdict on whether to approve dolutegravir by August 17, Britain's biggest drugmaker said on Friday.
The once-daily drug, which belongs to a novel class known as integrase inhibitors that block the virus causing AIDS from entering cells, is owned by ViiV Healthcare, a joint venture focused on HIV in which GSK is the largest shareholder.
The new medicine has already performed strongly in clinical trials, prompting GSK to raise its bet on the product last October by redrawing a deal with Japan's Shionogi.
Under that agreement Shionogi agreed to take a 10 percent stake in Viiv - which was set up in 2009 between GSK and Pfizer - in exchange for its shared rights to dolutegravir.
The agreement left GSK holding 76.5 percent of ViiV, with Pfizer controlling 13.5 percent and Shionogi the remainder.
Analysts see dolutegravir as a strong competitor to HIV treatments from market leader Gilead Sciences.
(Reporting by Ben Hirschler. Editing by Jane Merriman)
This article is sponsored by free dating site.
Thursday, February 14, 2013
Male circumcision tied to less sexual pleasure
NEW YORK (Reuters Health) - Men circumcised either as children or adults report less intense sexual pleasure and orgasm than their uncircumcised counterparts, according to a new study from Belgium.
'We're not saying less sexual activity or satisfaction, but sensitivity,' said the study's senior researcher Dr. Piet Hoebeke, from Ghent University Hospital.
The new study surveyed 1,369 men over the age of 18, who responded to leaflets handed out in train stations across Belgium.
The men were asked whether they were circumcised, and were then asked to rate how sensitive their penis was, how intense their orgasms were and whether they experience any pain or numbness when they are aroused.
Overall, 310 men who took the survey were circumcised, and 1,059 were not. Each rated how sensitive their penis was on a scale from 0 to 5, with higher numbers being the most sensitive.
Overall, uncircumcised men reported between 0.2 points and 0.4 points higher sensitivity and sexual pleasure when their penis's head - known as the glans - was stroked during arousal, compared to circumcised men.
For example, uncircumcised men reported an average sensitivity score of 3.72 when they or their partner stroked the top part of their penis's glans, compared to 3.31 amongst circumcised men.
Uncircumcised men also reported more intense orgasms.
'It's not a very big difference in sensitivity, but it's a significant difference,' Hoebeke said.
Currently, about half of U.S. baby boys have their foreskin surgically removed at birth, and about 30 percent of men around the world are circumcised.
Some religions, such as Judaism and Islam, consider circumcision part of religious practice, while other people choose circumcision for possible health benefits - including a reduced risk of urinary tract infections (see Reuters Health article of December 7, 2012 here:).
Hoebeke and his colleagues write in BJU International that there are few studies researching whether foreskin plays a role in sexual pleasure. But Dr. Aaron Tobian, who studies circumcision but was not part of the new study, said that previous randomized controlled trials - considered the gold standard of medical research - looked at sexual performance and satisfaction. Those studies, he said, did not find a difference.
One possible explanation for any potential difference in sensitivity is that a man's foreskin may protect his penis's head from rubbing against underwear and clothing. It's possible, the researchers write, that friction makes the head of the penis thicker, drier and ultimately less sensitive.
The researchers also found circumcised men were more likely to report more pain and numbness during arousal than uncircumcised men, which Hoebeke said is likely due to scar tissue.
'I'm amazed that people report pain during sexual pleasure. That's very amazing and that was unexpected,' he said.
'ABUNDANTLY CLEAR' EVIDENCE
Tobian, from Johns Hopkins University in Baltimore, said the findings are missing important context.
'The medical evidence and the benefits of male circumcision are abundantly clear,' Tobian told Reuters Health.
'If there was a vaccine out there that reduces the risk of HIV by 60 percent, herpes by 30 percent and the penile cancer causing HPV by 35 percent, the medical community would rally behind it,' said Tobian.
The American Academy of Pediatrics says the benefits of male circumcision outweigh the risks, but stops short of recommending universal circumcision (see Reuters story of August 27, 2012 here:).
SOURCE: http://bit.ly/X7j39D BJU International, online February 4, 2013.
This article is sponsored by technology.
'We're not saying less sexual activity or satisfaction, but sensitivity,' said the study's senior researcher Dr. Piet Hoebeke, from Ghent University Hospital.
The new study surveyed 1,369 men over the age of 18, who responded to leaflets handed out in train stations across Belgium.
The men were asked whether they were circumcised, and were then asked to rate how sensitive their penis was, how intense their orgasms were and whether they experience any pain or numbness when they are aroused.
Overall, 310 men who took the survey were circumcised, and 1,059 were not. Each rated how sensitive their penis was on a scale from 0 to 5, with higher numbers being the most sensitive.
Overall, uncircumcised men reported between 0.2 points and 0.4 points higher sensitivity and sexual pleasure when their penis's head - known as the glans - was stroked during arousal, compared to circumcised men.
For example, uncircumcised men reported an average sensitivity score of 3.72 when they or their partner stroked the top part of their penis's glans, compared to 3.31 amongst circumcised men.
Uncircumcised men also reported more intense orgasms.
'It's not a very big difference in sensitivity, but it's a significant difference,' Hoebeke said.
Currently, about half of U.S. baby boys have their foreskin surgically removed at birth, and about 30 percent of men around the world are circumcised.
Some religions, such as Judaism and Islam, consider circumcision part of religious practice, while other people choose circumcision for possible health benefits - including a reduced risk of urinary tract infections (see Reuters Health article of December 7, 2012 here:).
Hoebeke and his colleagues write in BJU International that there are few studies researching whether foreskin plays a role in sexual pleasure. But Dr. Aaron Tobian, who studies circumcision but was not part of the new study, said that previous randomized controlled trials - considered the gold standard of medical research - looked at sexual performance and satisfaction. Those studies, he said, did not find a difference.
One possible explanation for any potential difference in sensitivity is that a man's foreskin may protect his penis's head from rubbing against underwear and clothing. It's possible, the researchers write, that friction makes the head of the penis thicker, drier and ultimately less sensitive.
The researchers also found circumcised men were more likely to report more pain and numbness during arousal than uncircumcised men, which Hoebeke said is likely due to scar tissue.
'I'm amazed that people report pain during sexual pleasure. That's very amazing and that was unexpected,' he said.
'ABUNDANTLY CLEAR' EVIDENCE
Tobian, from Johns Hopkins University in Baltimore, said the findings are missing important context.
'The medical evidence and the benefits of male circumcision are abundantly clear,' Tobian told Reuters Health.
'If there was a vaccine out there that reduces the risk of HIV by 60 percent, herpes by 30 percent and the penile cancer causing HPV by 35 percent, the medical community would rally behind it,' said Tobian.
The American Academy of Pediatrics says the benefits of male circumcision outweigh the risks, but stops short of recommending universal circumcision (see Reuters story of August 27, 2012 here:).
SOURCE: http://bit.ly/X7j39D BJU International, online February 4, 2013.
This article is sponsored by technology.
Tuesday, February 12, 2013
Court grants Indiana employer relief from contraceptives mandate
(Reuters) - An Indiana company has won temporary court relief from having to provide its employees with coverage for contraceptives and other birth-control procedures, as mandated under the 2010 healthcare overhaul.
By a 2-1 vote, a panel of the 7th U.S. Circuit Court of Appeals in Chicago issued an injunction pending appeal in favor of the Grote family, whose Grote Industries makes vehicle safety systems and has more than 1,100 full-time workers.
Members of the Grote family are Catholic, and opposed including coverage for various contraception and sterilization procedures in a group health insurance plan for their privately-held company, which is based in Madison, Indiana.
(Reporting by Jonathan Stempel in New York; Editing by Alden Bentley)
By a 2-1 vote, a panel of the 7th U.S. Circuit Court of Appeals in Chicago issued an injunction pending appeal in favor of the Grote family, whose Grote Industries makes vehicle safety systems and has more than 1,100 full-time workers.
Members of the Grote family are Catholic, and opposed including coverage for various contraception and sterilization procedures in a group health insurance plan for their privately-held company, which is based in Madison, Indiana.
(Reporting by Jonathan Stempel in New York; Editing by Alden Bentley)
Monday, February 4, 2013
German Catholic Church may back some "morning-after pills"
PARIS (Reuters) - Germany's Catholic Church may approve some so-called morning-after pills for rape victims after a leading cardinal unexpectedly announced they did not induce abortions and could be used in Catholic hospitals.
Cardinal Joachim Meisner of Cologne, an ally of German-born Pope Benedict, changed his policy after two Catholic hospitals refused to treat a rape victim because they could not prescribe the pill, which is taken after sex to avoid pregnancy.
The Catholic Church firmly opposes abortion and artificial birth control. Many Catholics see all emergency contraceptives as abortion-inducing drugs banned by this policy, but Meisner said some prevent fertilization and could be used in rape cases.
'The German Bishops' Conference is holding a regular meeting in two weeks and the issue will certainly be on the agenda,' Cologne archdiocese spokeswoman Nele Harbeke said on Monday.
'The bishops' conference must in principle agree on a common line.'
Meisner, 79, has in the past rejected emergency contraceptives as producing a 'just-in-case abortion'.
The pills have become a hot issue in the United States as many Catholics oppose President Barack Obama's health reform in part because it mandates Catholic hospitals to provide birth control for female employees.
One pill, marketed as 'Plan B' in the United States and based on the synthetic hormone levonorgestrel, is rejected by these critics as an abortifacient, but might meet Meisner's criteria.
The Cologne incident sparked uproar in Germany last month and the cardinal apologized publicly, saying it 'shames us deeply because it contradicts our Christian mission and our purpose'.
CONSERVATIVE VIEWS
Meisner's change of mind made headlines because he is known for his outspoken conservative views. The surprise was compounded when another conservative, Berlin Archbishop Rainer Woelki, urged the Church to debate the issue.
Meisner said he had changed his view after learning from scientists that some newer pills did not abort fertilized eggs but rather prevented fertilization altogether.
'If a medication that hinders conception is used after a rape with the purpose of avoiding fertilization, then this is acceptable in my view,' he said.
His office stressed in an accompanying statement that this exception was valid only in rape cases and not within Catholic marriage, where artificial contraception is banned.
It also said there was no change to the ban on the so-called abortion pill, based on the drug mifepristone or RU-486, and marketed as Mifegyne or Mifeprex.
Harbeke said Meisner had consulted the Vatican as well as a 2009 directive for Catholic hospitals in the United States that says a rape victim 'may be treated with medications that would prevent ovulation, sperm capacitation or fertilization'.
That directive by the U.S. bishops' conference does not name the Plan B pill - marketed elsewhere as Levonelle, NorLevo, Postinor-2 or Optinor - which some U.S. Catholic hospitals use and others do not, depending on their reading of Church teaching.
The German Catholic Hospitals' Association hailed Meisner's statement for spelling out what they can do for rape victims.
'We are still against the abortion pill,' association official Thomas Vortkamp told Cologne's Catholic broadcaster Domradio. 'But it helps to know we can give a 'morning-after pill' in cases of raped women who must be helped urgently.'
(Reporting By Tom Heneghan; Editing by Kevin Liffey)
Cardinal Joachim Meisner of Cologne, an ally of German-born Pope Benedict, changed his policy after two Catholic hospitals refused to treat a rape victim because they could not prescribe the pill, which is taken after sex to avoid pregnancy.
The Catholic Church firmly opposes abortion and artificial birth control. Many Catholics see all emergency contraceptives as abortion-inducing drugs banned by this policy, but Meisner said some prevent fertilization and could be used in rape cases.
'The German Bishops' Conference is holding a regular meeting in two weeks and the issue will certainly be on the agenda,' Cologne archdiocese spokeswoman Nele Harbeke said on Monday.
'The bishops' conference must in principle agree on a common line.'
Meisner, 79, has in the past rejected emergency contraceptives as producing a 'just-in-case abortion'.
The pills have become a hot issue in the United States as many Catholics oppose President Barack Obama's health reform in part because it mandates Catholic hospitals to provide birth control for female employees.
One pill, marketed as 'Plan B' in the United States and based on the synthetic hormone levonorgestrel, is rejected by these critics as an abortifacient, but might meet Meisner's criteria.
The Cologne incident sparked uproar in Germany last month and the cardinal apologized publicly, saying it 'shames us deeply because it contradicts our Christian mission and our purpose'.
CONSERVATIVE VIEWS
Meisner's change of mind made headlines because he is known for his outspoken conservative views. The surprise was compounded when another conservative, Berlin Archbishop Rainer Woelki, urged the Church to debate the issue.
Meisner said he had changed his view after learning from scientists that some newer pills did not abort fertilized eggs but rather prevented fertilization altogether.
'If a medication that hinders conception is used after a rape with the purpose of avoiding fertilization, then this is acceptable in my view,' he said.
His office stressed in an accompanying statement that this exception was valid only in rape cases and not within Catholic marriage, where artificial contraception is banned.
It also said there was no change to the ban on the so-called abortion pill, based on the drug mifepristone or RU-486, and marketed as Mifegyne or Mifeprex.
Harbeke said Meisner had consulted the Vatican as well as a 2009 directive for Catholic hospitals in the United States that says a rape victim 'may be treated with medications that would prevent ovulation, sperm capacitation or fertilization'.
That directive by the U.S. bishops' conference does not name the Plan B pill - marketed elsewhere as Levonelle, NorLevo, Postinor-2 or Optinor - which some U.S. Catholic hospitals use and others do not, depending on their reading of Church teaching.
The German Catholic Hospitals' Association hailed Meisner's statement for spelling out what they can do for rape victims.
'We are still against the abortion pill,' association official Thomas Vortkamp told Cologne's Catholic broadcaster Domradio. 'But it helps to know we can give a 'morning-after pill' in cases of raped women who must be helped urgently.'
(Reporting By Tom Heneghan; Editing by Kevin Liffey)
Friday, February 1, 2013
Obama offers compromise on birth control health coverage
WASHINGTON (Reuters) - The Obama administration on Friday sought to settle a dispute with some religious leaders over the inclusion of contraceptives in employees' health insurance plans by proposing to separate birth control from other benefits.
The approach offers religious employers a way to avoid paying for women's contraceptives through employer-provided health insurance, while still guaranteeing their workers access to birth control coverage with no out-of-pocket costs as called for in President Barack Obama's healthcare reform law.
It follows months of protest and legal action by groups representing Roman Catholics, Protestant evangelicals and private employers, who argued that the 2010 healthcare law forced them to violate their religious tenets against contraception.
For more than a year, the Obama administration has grappled with how to balance its desire to guarantee universal, free contraceptive coverage with religious freedoms provided in the U.S. Constitution.
Faced with the ire of religious leaders and social conservatives in the midst of a heated presidential campaign, Obama said last February that he would create some sort of accommodation for religious employers.
The new rules, which would largely leave contraceptive coverage to outside insurers, consolidate many of the ideas administration officials voiced a year ago, but in greater detail.
'Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns,' Health and Human Services Secretary Kathleen Sebelius said in a statement.
'We will continue to work with faith-based organizations, women's organizations, insurers and others to achieve these goals.'
Cardinal Timothy Dolan of New York and other leading voices in the Roman Catholic community said they would study the proposal but offered no immediate response. However, other groups expressed disappointment over the rule, including the exclusion of for-profit businesses from its terms.
'This proposal does nothing to change the scope of religious employer exemption,' said Kyle Duncan, general counsel for the Becket Fund for Religious Liberty, which is assisting in the legal challenges to the policy. He called it 'very disappointing.'
'The proposal has nothing to do with millions of family businesses and owners who are having their rights violated by the mandate and are currently in litigation,' he said.
Meanwhile, Catholics United, a group with a history of supporting liberal causes, applauded the move. 'This is a victory not only for the Obama Administration, but for the Catholic Church,' said James Salt, executive director of Catholics United.
GUARANTEES ACCESS
The mandate contained in Obama's Patient Protection and Affordable Care Act requires most employers to provide coverage for contraceptives and sterilization procedures approved by the U.S. Food and Drug Administration, including the so-called morning-after pill.
The new rule makes clear that churches and other places of worship remain exempt even when they operate parochial schools and social services such as soup kitchens that benefit or employ people of different religious faiths.
But the change did not alter the administration's position that employees and students at religiously affiliated nonprofit groups should have access to contraceptive coverage even if their institutions object.
The rule, which requires the institutions to self-certify their status as religious nonprofits, calls on private insurers to cover contraceptives through separate individual plans with the insurer covering the cost. Officials said insurers would be compensated by lower healthcare expenses due to fewer births.
People who work for religious affiliates that self-insure would receive coverage through a private insurer arranged by a third-party administrator. Those insurers would be compensated by lower user fees for participation in state-based healthcare exchanges, which are scheduled to begin operating on January 1, 2014.
The proposed rules, published in the Federal Register, are open for public comment through April 8.
(Additional reporting by Atossa Abrahamian in New York; Editing by Karey Wutkowski and Jackie Frank)
The approach offers religious employers a way to avoid paying for women's contraceptives through employer-provided health insurance, while still guaranteeing their workers access to birth control coverage with no out-of-pocket costs as called for in President Barack Obama's healthcare reform law.
It follows months of protest and legal action by groups representing Roman Catholics, Protestant evangelicals and private employers, who argued that the 2010 healthcare law forced them to violate their religious tenets against contraception.
For more than a year, the Obama administration has grappled with how to balance its desire to guarantee universal, free contraceptive coverage with religious freedoms provided in the U.S. Constitution.
Faced with the ire of religious leaders and social conservatives in the midst of a heated presidential campaign, Obama said last February that he would create some sort of accommodation for religious employers.
The new rules, which would largely leave contraceptive coverage to outside insurers, consolidate many of the ideas administration officials voiced a year ago, but in greater detail.
'Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns,' Health and Human Services Secretary Kathleen Sebelius said in a statement.
'We will continue to work with faith-based organizations, women's organizations, insurers and others to achieve these goals.'
Cardinal Timothy Dolan of New York and other leading voices in the Roman Catholic community said they would study the proposal but offered no immediate response. However, other groups expressed disappointment over the rule, including the exclusion of for-profit businesses from its terms.
'This proposal does nothing to change the scope of religious employer exemption,' said Kyle Duncan, general counsel for the Becket Fund for Religious Liberty, which is assisting in the legal challenges to the policy. He called it 'very disappointing.'
'The proposal has nothing to do with millions of family businesses and owners who are having their rights violated by the mandate and are currently in litigation,' he said.
Meanwhile, Catholics United, a group with a history of supporting liberal causes, applauded the move. 'This is a victory not only for the Obama Administration, but for the Catholic Church,' said James Salt, executive director of Catholics United.
GUARANTEES ACCESS
The mandate contained in Obama's Patient Protection and Affordable Care Act requires most employers to provide coverage for contraceptives and sterilization procedures approved by the U.S. Food and Drug Administration, including the so-called morning-after pill.
The new rule makes clear that churches and other places of worship remain exempt even when they operate parochial schools and social services such as soup kitchens that benefit or employ people of different religious faiths.
But the change did not alter the administration's position that employees and students at religiously affiliated nonprofit groups should have access to contraceptive coverage even if their institutions object.
The rule, which requires the institutions to self-certify their status as religious nonprofits, calls on private insurers to cover contraceptives through separate individual plans with the insurer covering the cost. Officials said insurers would be compensated by lower healthcare expenses due to fewer births.
People who work for religious affiliates that self-insure would receive coverage through a private insurer arranged by a third-party administrator. Those insurers would be compensated by lower user fees for participation in state-based healthcare exchanges, which are scheduled to begin operating on January 1, 2014.
The proposed rules, published in the Federal Register, are open for public comment through April 8.
(Additional reporting by Atossa Abrahamian in New York; Editing by Karey Wutkowski and Jackie Frank)
Obama offers faith groups new birth control rule
WASHINGTON (AP) - The Obama administration on Friday proposed a work-around for religious nonprofits that object to providing health insurance that covers birth control.
The government's new regulation attempts to create a barrier between religious groups and contraception coverage, through insurers or a third party, that would still give women free access to contraception. It wasn't immediately clear whether religious leaders would accept the new approach, or whether it would stem the tide of lawsuits by Roman Catholic charities and other faith-affiliated nonprofits nationwide challenging the requirement to provide such coverage.
The Catholic Health Association, a trade group for hospitals, and the U.S. Conference of Catholic Bishops separately had no immediate reaction, saying they were studying the regulations. Policy analyst Sarah Lipton-Lubet of the American Civil Liberties Union said the rule appeared to meet the ACLU's goal of providing 'seamless coverage' of birth control for the affected women.
Health and Human Services Secretary Kathleen Sebelius said in a statement the compromise would provide 'women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns.'
The regulation is part of President Barack Obama's health care overhaul, known as the Affordable Care Act. The birth-control rule, first introduced a year ago, became an election issue, with advocates for women praising the mandate as a victory and religious leaders decrying it as an attack on faith groups.
The new health care law requires most employers, including faith-affiliated hospitals and nonprofits, to provide health insurance that includes artificial contraception, including sterilization, as a free preventive service. The goal, in part, is to help women space out pregnancies to promote health.
Under the original rule, only those religious groups which primarily employ and serve people of their own faith - such as churches - were exempt. But other religiously affiliated groups, such as church-affiliated universities, Catholic Charities and hospitals, were told they had to comply.
Roman Catholic bishops, evangelicals and some religious leaders who have generally been supportive of Obama's policies lobbied fiercely for a broader exemption. The Catholic Church prohibits the use of artificial contraception. Evangelicals generally permit the use of birth control, but some object to specific methods such as the morning-after contraceptive pill, which they argue is tantamount to abortion.
Obama had promised to change the birth control requirement so insurance companies - and not faith-affiliated employers - would pay for the coverage, but religious leaders said more changes were needed to make the plan work.
Since then, more than 40 lawsuits have been filed by religious nonprofits and secular for-profit businesses claiming the mandate violates their religious beliefs. As expected, this latest regulation does not provide any accommodation for individual business owners who have religious objections to the rule.
In the latest version of the rule, houses of worship remain exempt, including those that offer social services such as a food pantry directly from their buildings.
At the same time, a mechanism would be set up to provide contraception coverage for women employees of religious employers that is outside of the employer's health insurance plan. It would allow those employees to be covered without their employer 'contracting, arranging, paying, or referring for such coverage.'
If a nonprofit identifies itself as religious and has private insurance, the private insurer will work directly with women employees to provide coverage for contraception. Many religious nonprofits, however, are self-insured. In those cases, a third party, not the religious employer, would handle the coverage.
Questions remained about how the services ultimately would be funded, but the Health and Human Services department said any additional cost would be covered by a deduction in federal user fees for whoever issues the policy. The federal agency has not tallied an overall cost of the plan, according to Chiquita Brooks-LaSure, an HHS deputy policy director.
In its new version of the rule, the department argued that the change wouldn't impose new costs on insurers because it would save them money 'from improvements in women's health and fewer child births.'
John Gehring, Catholic program director at Faith in Public Life, a liberal advocacy group based in Washington, called the compromise 'a strong signal that the administration is responsive to the concerns of Catholic institutions.'
The Alliance Defending Freedom, a conservative religious liberty group which is representing several for-profit businesses in lawsuits over the regulation, said it would continue to press for exemptions for business owners in court. So far, about 10 businesses have obtained temporary injunctions against the regulation while their cases move through the courts.
The latest version of the mandate is now subject to a 60-day public comment period. The mandate takes effect for religious nonprofits in August.
____
Associated Press writer David Crary contributed from New York.
The government's new regulation attempts to create a barrier between religious groups and contraception coverage, through insurers or a third party, that would still give women free access to contraception. It wasn't immediately clear whether religious leaders would accept the new approach, or whether it would stem the tide of lawsuits by Roman Catholic charities and other faith-affiliated nonprofits nationwide challenging the requirement to provide such coverage.
The Catholic Health Association, a trade group for hospitals, and the U.S. Conference of Catholic Bishops separately had no immediate reaction, saying they were studying the regulations. Policy analyst Sarah Lipton-Lubet of the American Civil Liberties Union said the rule appeared to meet the ACLU's goal of providing 'seamless coverage' of birth control for the affected women.
Health and Human Services Secretary Kathleen Sebelius said in a statement the compromise would provide 'women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns.'
The regulation is part of President Barack Obama's health care overhaul, known as the Affordable Care Act. The birth-control rule, first introduced a year ago, became an election issue, with advocates for women praising the mandate as a victory and religious leaders decrying it as an attack on faith groups.
The new health care law requires most employers, including faith-affiliated hospitals and nonprofits, to provide health insurance that includes artificial contraception, including sterilization, as a free preventive service. The goal, in part, is to help women space out pregnancies to promote health.
Under the original rule, only those religious groups which primarily employ and serve people of their own faith - such as churches - were exempt. But other religiously affiliated groups, such as church-affiliated universities, Catholic Charities and hospitals, were told they had to comply.
Roman Catholic bishops, evangelicals and some religious leaders who have generally been supportive of Obama's policies lobbied fiercely for a broader exemption. The Catholic Church prohibits the use of artificial contraception. Evangelicals generally permit the use of birth control, but some object to specific methods such as the morning-after contraceptive pill, which they argue is tantamount to abortion.
Obama had promised to change the birth control requirement so insurance companies - and not faith-affiliated employers - would pay for the coverage, but religious leaders said more changes were needed to make the plan work.
Since then, more than 40 lawsuits have been filed by religious nonprofits and secular for-profit businesses claiming the mandate violates their religious beliefs. As expected, this latest regulation does not provide any accommodation for individual business owners who have religious objections to the rule.
In the latest version of the rule, houses of worship remain exempt, including those that offer social services such as a food pantry directly from their buildings.
At the same time, a mechanism would be set up to provide contraception coverage for women employees of religious employers that is outside of the employer's health insurance plan. It would allow those employees to be covered without their employer 'contracting, arranging, paying, or referring for such coverage.'
If a nonprofit identifies itself as religious and has private insurance, the private insurer will work directly with women employees to provide coverage for contraception. Many religious nonprofits, however, are self-insured. In those cases, a third party, not the religious employer, would handle the coverage.
Questions remained about how the services ultimately would be funded, but the Health and Human Services department said any additional cost would be covered by a deduction in federal user fees for whoever issues the policy. The federal agency has not tallied an overall cost of the plan, according to Chiquita Brooks-LaSure, an HHS deputy policy director.
In its new version of the rule, the department argued that the change wouldn't impose new costs on insurers because it would save them money 'from improvements in women's health and fewer child births.'
John Gehring, Catholic program director at Faith in Public Life, a liberal advocacy group based in Washington, called the compromise 'a strong signal that the administration is responsive to the concerns of Catholic institutions.'
The Alliance Defending Freedom, a conservative religious liberty group which is representing several for-profit businesses in lawsuits over the regulation, said it would continue to press for exemptions for business owners in court. So far, about 10 businesses have obtained temporary injunctions against the regulation while their cases move through the courts.
The latest version of the mandate is now subject to a 60-day public comment period. The mandate takes effect for religious nonprofits in August.
____
Associated Press writer David Crary contributed from New York.
White House offers compromise on birth control coverage
WASHINGTON (Reuters) - The Obama administration on Friday offered a compromise on controversial new health care rules that would allow religious employers to exclude contraceptives from health insurance for their employees, but would still guarantee those employees access to free coverage for birth control.
The proposed compromise follows months of protest and legal action by the Roman Catholic Church, Protestant evangelicals and others groups who argued that the President Barack Obama's health care reform law forced them to violate religious tenets against contraception.
For more than a year, the Obama administration has been grappling with how to balance its desire to guarantee universal, free contraceptive coverage with religious freedoms provided in the U.S. Constitution. Obama in February said he would create some sort of exemption for religious employers.
Catholics United, a group with a history of supporting liberal causes, applauded the move.
'This is a victory not only for the Obama Administration, but for the Catholic Church,' said James Salt, executive director of Catholics United.
The U.S. Department of Health and Human Services said in a statement that the rules offer religiously affiliated hospitals, universities and charities opposed to contraceptives coverage 'an accommodation.' Employees and students could enroll in separate contraceptive coverage plans without co-pays and without cost to the employer.
Self-insured employers would provide notice to a third-party administrator that would then work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies, HHS said.
The proposed rules, published in the Federal Register, are open for public comment through April 8.
(Reporting by David Morgan; Editing by Jackie Frank)
The proposed compromise follows months of protest and legal action by the Roman Catholic Church, Protestant evangelicals and others groups who argued that the President Barack Obama's health care reform law forced them to violate religious tenets against contraception.
For more than a year, the Obama administration has been grappling with how to balance its desire to guarantee universal, free contraceptive coverage with religious freedoms provided in the U.S. Constitution. Obama in February said he would create some sort of exemption for religious employers.
Catholics United, a group with a history of supporting liberal causes, applauded the move.
'This is a victory not only for the Obama Administration, but for the Catholic Church,' said James Salt, executive director of Catholics United.
The U.S. Department of Health and Human Services said in a statement that the rules offer religiously affiliated hospitals, universities and charities opposed to contraceptives coverage 'an accommodation.' Employees and students could enroll in separate contraceptive coverage plans without co-pays and without cost to the employer.
Self-insured employers would provide notice to a third-party administrator that would then work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies, HHS said.
The proposed rules, published in the Federal Register, are open for public comment through April 8.
(Reporting by David Morgan; Editing by Jackie Frank)
Subscribe to:
Posts (Atom)