Monday, March 18, 2013

Parental Fear Blocks HPV Shot for Teens

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Despite evidence, parents' fears of HPV vaccine grow

By Genevra Pittman

NEW YORK (Reuters Health) - More parents of teen girls not fully vaccinated against human papillomavirus (HPV) are intending to forgo the shots altogether - a trend driven by vaccine safety concerns, new research suggests.

That's despite multiple studies showing the vaccine isn't tied to any serious side effects but does protect against the virus that causes cervical cancer, researchers said.

'There were a lot of very sensationalized anecdotal reports of (girls) having bad reactions to the vaccine,' said pediatrician and vaccine researcher Dr. Amanda Dempsey from the University of Colorado Denver.

'Safety concerns have always risen to the top of the pile, in terms of being one of the main reasons people don't get vaccinated, which is unfortunate because this is one of the most well-studied vaccines in terms of safety and is extremely safe,' Dempsey, who wasn't involved in the new research, told Reuters Health.

The U.S. Centers for Disease Control and Prevention recommends that all kids - both boys and girls - receive three HPV shots as preteens.

Researchers led by Dr. Paul Darden from the University of Oklahoma Health Sciences Center in Oklahoma City got their data from a national immunization survey that involved phone calls to almost 100,000 parents.

They found that from 2008 to 2010, the percentage of teens who were up to date on their Tdap (tetanus, diphtheria and pertussis), MCV4 (meningococcal) and HPV vaccines all increased slightly.

Still, about three-quarters of girls ages 13 to 17 were not up to date on their HPV series in 2010. And the proportion of parents of those girls who said they didn't plan to get their daughters the rest - or any - of their HPV shots rose from 40 percent to 44 percent, the research team wrote Monday in Pediatrics.

At the same time, the proportion who cited safety concerns as their reason for abstaining from getting the HPV vaccine increased from less than five percent to 16 percent.

For all three vaccines asked about in the survey, other reasons parents gave for skipping their teenagers' shots included not thinking they were necessary, not having had a specific vaccine recommended by a doctor and, for the HPV vaccine, believing their child was not sexually active.

'These are wonderful vaccines preventing severe diseases,' Darden told Reuters Health in an email. 'HPV is the first vaccine that will prevent cancer which is a tremendous health benefit.'

Dempsey said past research has suggested that although more girls are being vaccinated against HPV, vaccine rates haven't increased as quickly as for other shots, such as Tdap.

Darden reports having been a consultant for Pfizer, and one of his co-authors is on a safety monitoring board for vaccine studies funded by Merck, which makes Gardasil, one of the HPV vaccines.

Parents shouldn't rely on the media or Internet to learn about vaccines, according to Dempsey, since it's hard to tell what information is legitimate.

'If they have questions or concerns, they should trust their provider to give them accurate information about the vaccine,' she said.

SOURCE: http://bit.ly/cxXOG Pediatrics, online March 18, 2013.

Sunday, March 17, 2013

Adult HIV Patients 'Functionally Cured' Before Mississippi Baby -- What These 'Cures' Mean

On the heels of the supposed first 'functional cure' for HIV in a baby born in Mississippi, French researchers reported Friday that they'd studied 14 adult patients who'd experienced a similar remission from the virus. The patients in the French study had been off HIV medications for up to 10 years.

The French researchers followed patients who'd undergone treatment with antiretroviral drugs soon after they'd become infected with HIV. They'd stayed on the medications for several years but then stopped taking the antiretrovirals. That was 'fashionable at the time,' said Christine Rouzioux, a professor at Necker Hospital and University of Paris Descartes. They are all now in what Rouzioux calls 'HIV remission,' because the virus has not worsened and they have not shown symptoms for years.

'I know that the U.S. term is 'functional cure,'' Rouzioux told ABCNews.com. 'In France, we speak about 'remission.' . The patient controls the virus, but they still have the virus.'

RELATED: Experts Question So-Called HIV 'Cure'

The study, which was published Friday in the journal PLOS Pathogens, may show that the baby was not the first documented case of someone 'functionally cured' of HIV as researchers announced earlier this month.

Rouzioux and PLOS representatives told ABCNews.com that they did not rush their study into publication when the case of the Mississippi baby was announced.

Dr. Deborah Persaud, who works at Johns Hopkins Children's Center and studied the Mississippi baby, said there were similarities between the 14 French patients and the baby, but the baby had even lower HIV levels than the French patients.

While Rouzioux and Asier Sáez-Cirión, a senior HIV researcher at the Pasteur Institute in Paris, reported about 100 copies of HIV DNA or RNA per 1 million cells in their patients, Persaud said she found less than five copies of HIV DNA or RNA per 1 million cells in the Mississippi baby.

'I'm not sure anybody knows what that means,' said Dr. Mark Kline, a pediatric HIV and AIDS specialist at Baylor College of Medicine in Houston. 'I don't know that someone with five is necessarily going to be better off in the long term than someone with 100.'

RELATED: Hydeia Broadbent, Born With HIV, Reacts to 'Cure'

Kline said he, too, has had patients who were technically HIV-positive but have had no need for antiretroviral medication. He has also heard of patients who started antiretroviral therapy and could stop without experiencing worsening symptoms.

'This phenomenon that they're describing has been appreciated and known,' Kline said. 'I think there's a good rational for saying if you can identify these people and do treatment earlier, you can decrease the viral burden and decrease the reservoirs of infected cells in the body and probably alter the long-term course.'

But it can take anywhere from a few weeks to a few years for a person to show HIV symptoms from the time that person was infected. As such, early treatment isn't always an option, Kline said.

Rouzioux's patients all experienced symptoms very early, which is why they were able to get swift antiretroviral treatment, she said. Rouzioux and her colleagues followed their patients for about 11 years, she said.

Although these types of patients have been written about before, Kline said this particular study was important because it identified which patients had a genetic predisposition that allowed them to naturally keep HIV at bay and which did not, and therefore went into remission because of treatment.

Rouzioux's colleague, Sáez-Cirión, said about .5 percent of all HIV-positive patients were able to control the virus without medication because of a genetic predisposition, but the 14 people in the study did not have this advantage.

The researchers concluded that HIV-positive patients who undergo early treatment for at least a year have a 15 percent chance of going into HIV remission for at least two years after stopping treatment.

'The probability was 10 to15 percent, which is amazing when compared with the probability of natural (nondrug-induced) control,' Sáez-Cirión said.

Still, it's not wise for HIV-positive patients to stop taking medications because they can develop resistance to them, Kline said.

'Those are bridges you can burn that you can never rebuild,' he said. 'If you just stop treatment or take treatment intermittently, it's very likely that you'll develop a resistance to one or more medications. Once a resistance is present in an individual, it's there to stay. There may be no going back to those particular medications.'

Also Read

Friday, March 15, 2013

14 HIV Patients Have 'Functional Cure'

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Rapid HIV treatment points to "functional cure" for AIDS

By Kate Kelland

LONDON (Reuters) - Treating people with HIV rapidly after they have become infected with the virus that causes AIDS may be enough to achieve a 'functional cure' in a small proportion of patients diagnosed early, according to new research.

Scientists in France who followed 14 patients who were treated very swiftly with HIV drugs but then stopped treatment found that even when they had been off therapy for more than seven years, they still showed no signs of the virus rebounding.

The research, published in the journal PLoS Pathogens, follows news earlier this month about a baby girl in Mississippi in the United States being effectively cured of the human immunodeficiency virus (HIV) after receiving very early treatment.

Christine Rouzioux, a professor at Necker Hospital and University Paris Descartes and a member of the initial team who identified HIV 30 years ago, said the new results showed the number of infected cells circulating in the blood of these patients, known as 'post-treatment controllers', kept falling even without treatment for many years.

'Early treatment in these patients may have limited the establishment of viral reservoirs, the extent of viral mutations, and preserved immune responses. A combination of those may contribute to control infection in post-treatment controllers,' she said.

'The shrinking of viral reservoirs ... closely matches the definition of 'functional' cure,' she said.

A functional cure describes when the virus is reduced to such low levels that it is kept at bay even without continuing treatment. The virus, however, is still detectable in the body.

Most of the some 34 million people with HIV across the world will have to take anti-AIDS drugs known as antiretroviral therapy for the whole of their lives. These drugs generally keep the disease in check but also have side effects and a high cost impact on health systems.

Worldwide, the number of people newly infected with HIV, which can be transmitted via blood and by semen during sex, is falling. At 2.5 million, the number of new infections in 2011 was 20 percent lower than in 2001, according to the United National AIDS programme (UNAIDS). And deaths from AIDS fell to 1.7 million in 2011, down from a peak of 2.3 million in 2005.

Asier Saez-Cirion, a senior HIV researcher at the Institut Pasteur in Paris, said that although most patients will not be able to control HIV, these results suggest that at least some may be able to if they get treatment early enough.

'(This data) and the Mississippi study strongly support early treatment initiation and may hold important clues for the development of a strategy to cure HIV or at least induce a long-term control without the need of antiretroviral treatment,' he said.

(Editing by Ben Hirschler)

Thursday, March 14, 2013

Many poor heterosexuals in U.S. cities at risk for HIV

By Julie Steenhuysen

(Reuters) - Roughly 2 percent of 8,500 poor heterosexuals living in U.S. cities with high rates of HIV infection tested positive for the virus that causes AIDS, and nearly half of those who were infected said they had never been tested before the study, health officials said on Thursday.

The findings by the U.S. Centers for Disease Control and Prevention underscored the links between poverty and HIV infection in the United States, where up to 44 percent of new infections are clustered in 12 major cities, including Chicago, Washington, D.C., New York and Los Angeles.

'I think the main finding is that place matters,' Dr. Jonathan Mermin said in an interview. Mermin is director of the CDC's Division of HIV/AIDS Prevention.

Mermin said for many people living in urban areas where HIV is commonplace, their chance of being exposed to HIV with a new sexual partner is much higher than it would be if they were living in another part of the United States.

'Even with equivalent sexual risk behavior, their actual risk of acquiring HIV is greater,' he said.

The study, published in the CDC's Mortality and Morbidity Weekly Report, involved a sampling of nearly 8,500 heterosexuals in 21 cities.

Researchers analyzed 2010 data on heterosexuals in neighborhoods with high concentrations of AIDS patients. They focused on people with low socioeconomic status, which they defined as having an income below the federal poverty level or no more than a high school education. For an individual, the 2013 poverty level is $11.490.

More than 70 percent of participants were African American.

Of those tested, 197, or 2.3 percent, were infected with HIV, with highest rates of infection occurring among blacks, those who reported using crack cocaine and those who exchanged sex for money or drugs.

Education and income also made a difference, with higher infection rates reported among people who did not have a high school diploma or those with annual household incomes of less than $10,000. Infection rates were highest among study participants in the Northeast and South.

Overall, 25.8 percent of the study participants had never been tested for HIV. Of those surveyed who were diagnosed with HIV, 45 percent did not know they had it.

'That is much higher than the 18 percent that we estimate for the nation as a whole,' he said.

Mermin said the findings clearly showed the need for HIV prevention efforts directed at this population, as well as efforts that link infected individuals with care.

Prior studies have shown that certain groups of HIV patients - the poor, minorities, women and drug users - tended to have worse outcomes and to die earlier. Programs that help address barriers to care, such as transportation to clinics or providing housing for homeless individuals, can help people live longer and reduce HIV transmission.

Currently, the CDC recommends that doctors who treat patients in high risk communities do regular testing, but often patients report not being tested. In this survey, about two-thirds of the people with HIV who did not know they were infected had seen a healthcare provider in the prior year.

'Certainly, a proportion of those people had HIV at the time they visited the provider, but the provider did not conduct an HIV test,' Mermin said.

That may change in the next few months when the U.S. Preventive Services Task Force, an influential panel of doctors and scientists advising the government, is expected to release new guidelines calling for routine HIV screening for all Americans aged 15 to 65.

The panel released draft recommendations in November that are expected to affect the reimbursement of HIV testing, removing one of the barriers to the tests.

Under the Affordable Care Act, insurers are required to cover preventive services that are recommended by the panel.

Nearly 1.2 million people in the United States are infected with HIV, yet 20 to 25 percent of them do not know it.

(Reporting by Julie Steenhuysen; Editing by Peter Cooney, Toni Reinhold)

Many poor heterosexuals in U.S. cities at risk for HIV infection

(Reuters) - Some 2.3 percent of 8,500 poor heterosexuals living in cities with high rates of HIV infection tested positive for the virus that causes AIDS, and nearly half of those who were infected said they had never had an HIV test before the study, U.S. health officials said on Thursday.

The findings by the Centers for Disease Control and Prevention underscore the links between poverty and HIV infection in the United States, where up to 44 percent of new infections are clustered in 12 major cities, including Chicago, Washington, New York and Los Angeles.

The study, published in the CDC's Mortality and Morbidity Weekly Report, involved a sampling of nearly 8,500 heterosexuals in 21 cities.

For the study, researchers analyzed 2010 data on heterosexuals in areas with a high AIDS burden who were considered to have low-socioeconomic status, which they defined as having an income below the federal poverty level or no more than a high school education.

More than 70 percent of participants were African American.

Of those tested, 197, or 2.3 percent, were infected with HIV, with highest rates of infection occurring among blacks, those who reported using crack cocaine or those who exchanged sex for money or drugs.

Education and income made a difference as well, with higher infection rates reported among people who did not have a high school diploma or those with annual household incomes of less than $10,000. Infection rates were highest among study participants in the Northeast and South.

Overall, 25.8 percent of the study participants had never been tested for HIV.

The CDC said the findings make clear the need for HIV prevention efforts that address this population's specific needs, as well as efforts that link infected individuals to care.

Prior studies have shown that certain groups of HIV patients - the poor, minorities, women and drug users - tended to have worse outcomes and die earlier. But programs that help address barriers to care, such as transportation to clinics or providing housing to homeless individuals, can help people live longer and reduce HIV transmission.

According to the CDC, 1.2 million Americans have HIV, and 1 in 5 U.S. adults with HIV do not know they are infected.

(Reporting by Julie Steenhuysen; Editing by Vicki Allen)

Saturday, March 9, 2013

HIV 'Cure': Is It Real? Is It Safe?

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Thursday, March 7, 2013

U.S. doctor's "gutsy" move led to baby's cure from HIV

JACKSON, Mississippi/CHICAGO, Illinois (Reuters) - The doctor who cured an HIV infected baby for the first time is happier talking to children than to adults and is finding all the attention since the news came out a little overwhelming.

Dr. Hannah Gay and colleagues Dr. Katherine Luzuriaga of the University of Massachusetts and Dr. Deborah Persaud of Johns Hopkins University in Baltimore reported on the child's case at a medical meeting in Atlanta on Sunday.

'The breakthrough has been exciting and I'm very hopeful that that's going to lead to future research that will give us some answers,' said Gay, a Mississippi pediatrician and soft-spoken mother of four adult children.

But the attention is difficult for a woman 'much more comfortable talking to children than adults,' said her husband, Paul Gay. 'She didn't anticipate this kind of explosion of attention.'

Dr. Gay, a 59-year-old native of Jackson, Mississippi, likes to spend time designing needle points, singing in her church choir and reading theology or medical literature when she's not working 12-hour days treating patients, in a state with the nation's highest poverty rate.

'She is the most unlikely person in the world to be getting this kind of international attention, really,' said Jay Richardson, her former pastor at the Highland Colony Baptist Church. 'You don't ever hear her talking about herself or trying to promote herself in any way. She's a quiet, humble person. Extremely intelligent. Very committed to her faith. Very involved in her church. Very committed to teaching children the bible.'

Except for six years working in Ethiopia as a missionary, Dr. Gay has spent the bulk of her academic and professional career at the University of Mississippi, where she received her undergraduate and medical degrees and met her husband of 37 years. She has worked the better part of her career at the university's medical center serving the state's youngest victims of HIV.

During that time, Dr. Gay has published several articles about ways to keep mothers from passing HIV infection to their babies and participated in the federally sponsored Pediatric AIDS Clinical Trials Group, which studied the use of the aggressive treatment of children who are at high risk of infection.

Her daughter Ruth Gay Thomas says as an AIDS specialist her mother has had to fight the battles of her patients, overcoming access to healthcare and the stigma that comes along with being infected with HIV in the United States.

'She practices compassion and huge, unimaginable amounts of patience with her patients and their families,' Thomas said. 'She really has to embody a whole lot more than just the smart doctor that knows the right medications to give.'

To treat her own rheumatoid arthritis, Dr. Gay takes medicine that affects her immune system. 'She has that in common with her patients, but it's been a problem because with her compromised immune system, she can't have as much of a hands-on touching of her patients that was always so satisfying for her,' her husband said.

When a rural hospital in Mississippi delivered a premature baby girl in July 2010 from a mother who had just tested positive for HIV during labor, it was only natural that they would turn to Dr. Gay. The child's mother had not received any prenatal care, nor had she gotten any treatment for her HIV infection, putting the baby at high risk of becoming infected.

Dr. Gay chose to start the baby on the full treatment regimen of three potent drugs when she was just 30 hours old, even before the child's infection was confirmed.

It was a bold move. Most babies exposed to HIV in the womb or during labor would have been given a six-week course of one or two drugs intended to reduce the risk of acquiring infection until tests could confirm she was infected.

'The doctor made a judgment call that the risks for this baby were so high that they were going to assume the baby was infected,' said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, a part of the National Institutes of Health or NIH.

Some critics have questioned Dr. Gay's decision, which may have exposed the child to the risk of toxic medications without confirmation of her infection.

'This was a gutsy call that turned out to be correct,' said Fauci, adding that if it had turned out that the baby was not infected, they could have withdrawn the drugs. 'They made the right guess.'

Dr. Gay continued to treat the child until January 2012, when she was 18 months old and her mother stopped bringing the child in for appointments. Gay's team tracked her down in the fall of 2012, but the mother had not given her child any HIV medication since January.

Before restarting treatment, Gay did several tests, fully expecting that the virus had come roaring back. But none of the tests detected the virus. That's when she brought in colleagues Luzuriaga of the University of Massachusetts and Persaud of Johns Hopkins University in Baltimore, who did a series of ultrasensitive tests. They were only able to find trace amounts of genetic material from the virus, but nothing capable of rekindling the infection.

The child, now 30 months old, remains off medication and continues to fare well. 'We can't find any virus to treat at this point,' Dr. Gay said.

She said it is not clear what the child's story will mean in the wider scheme of HIV research, but she hopes it may lead to a cure for other babies infected at birth.

'I guess the message that I want to get across to the public very strongly is, we don't know yet if we can create the same outcome in other babies.' she said. 'It's far too early to draw too many conclusions. There's not a cure in sight this week.'

Dr. Gay said she is glad that this is happening in Mississippi and hopes it boosts the state's reputation.

'But it's a whole lot bigger than this one child, the University Medical Center or the state,' she said. 'It may take a long time, but I hope it will point us in the right direction to come up with a cure we can consistently apply to other babies worldwide.'

Colleagues at the medical center are planning a celebration for Dr. Gay to 'let her know how proud we are,' said Amy Smith, a nurse practitioner who works with the doctor. 'She's the type that wouldn't want a big fuss made about her, but we're going to do it anyway.'

(Reporting by Julie Steenhuysen and Emily Le Coz; Editing by Jilian Mincer and Claudia Parsons)

Wednesday, March 6, 2013

U.S. doctor's 'gutsy' move led to baby's cure from HIV

JACKSON, Mississippi/CHICAGO, Illinois (Reuters) - The doctor who cured an HIV infected baby for the first time is happier talking to children than to adults and is finding all the attention since the news came out a little overwhelming.

Dr. Hannah Gay and colleagues Dr. Katherine Luzuriaga of the University of Massachusetts and Dr. Deborah Persaud of Johns Hopkins University in Baltimore reported on the child's case at a medical meeting in Atlanta on Sunday.

'The breakthrough has been exciting and I'm very hopeful that that's going to lead to future research that will give us some answers,' said Gay, a Mississippi pediatrician and soft-spoken mother of four adult children.

But the attention is difficult for a woman 'much more comfortable talking to children than adults,' said her husband, Paul Gay. 'She didn't anticipate this kind of explosion of attention.'

Dr. Gay, a 59-year-old native of Jackson, Mississippi, likes to spend time designing needle points, singing in her church choir and reading theology or medical literature when she's not working 12-hour days treating patients, in a state with the nation's highest poverty rate.

'She is the most unlikely person in the world to be getting this kind of international attention, really,' said Jay Richardson, her former pastor at the Highland Colony Baptist Church. 'You don't ever hear her talking about herself or trying to promote herself in any way. She's a quiet, humble person. Extremely intelligent. Very committed to her faith. Very involved in her church. Very committed to teaching children the bible.'

Except for six years working in Ethiopia as a missionary, Dr. Gay has spent the bulk of her academic and professional career at the University of Mississippi, where she received her undergraduate and medical degrees and met her husband of 37 years. She has worked the better part of her career at the university's medical center serving the state's youngest victims of HIV.

During that time, Dr. Gay has published several articles about ways to keep mothers from passing HIV infection to their babies and participated in the federally sponsored Pediatric AIDS Clinical Trials Group, which studied the use of the aggressive treatment of children who are at high risk of infection.

Her daughter Ruth Gay Thomas says as an AIDS specialist her mother has had to fight the battles of her patients, overcoming access to healthcare and the stigma that comes along with being infected with HIV in the United States.

'She practices compassion and huge, unimaginable amounts of patience with her patients and their families,' Thomas said. 'She really has to embody a whole lot more than just the smart doctor that knows the right medications to give.'

To treat her own rheumatoid arthritis, Dr. Gay takes medicine that affects her immune system. 'She has that in common with her patients, but it's been a problem because with her compromised immune system, she can't have as much of a hands-on touching of her patients that was always so satisfying for her,' her husband said.

When a rural hospital in Mississippi delivered a premature baby girl in July 2010 from a mother who had just tested positive for HIV during labor, it was only natural that they would turn to Dr. Gay. The child's mother had not received any prenatal care, nor had she gotten any treatment for her HIV infection, putting the baby at high risk of becoming infected.

Dr. Gay chose to start the baby on the full treatment regimen of three potent drugs when she was just 30 hours old, even before the child's infection was confirmed.

It was a bold move. Most babies exposed to HIV in the womb or during labor would have been given a six-week course of one or two drugs intended to reduce the risk of acquiring infection until tests could confirm she was infected.

'The doctor made a judgment call that the risks for this baby were so high that they were going to assume the baby was infected,' said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, a part of the National Institutes of Health or NIH.

Some critics have questioned Dr. Gay's decision, which may have exposed the child to the risk of toxic medications without confirmation of her infection.

'This was a gutsy call that turned out to be correct,' said Fauci, adding that if it had turned out that the baby was not infected, they could have withdrawn the drugs. 'They made the right guess.'

Dr. Gay continued to treat the child until January 2012, when she was 18 months old and her mother stopped bringing the child in for appointments. Gay's team tracked her down in the fall of 2012, but the mother had not given her child any HIV medication since January.

Before restarting treatment, Gay did several tests, fully expecting that the virus had come roaring back. But none of the tests detected the virus. That's when she brought in colleagues Luzuriaga of the University of Massachusetts and Persaud of Johns Hopkins University in Baltimore, who did a series of ultrasensitive tests. They were only able to find trace amounts of genetic material from the virus, but nothing capable of rekindling the infection.

The child, now 30 months old, remains off medication and continues to fare well. 'We can't find any virus to treat at this point,' Dr. Gay said.

She said it is not clear what the child's story will mean in the wider scheme of HIV research, but she hopes it may lead to a cure for other babies infected at birth.

'I guess the message that I want to get across to the public very strongly is, we don't know yet if we can create the same outcome in other babies.' she said. 'It's far too early to draw too many conclusions. There's not a cure in sight this week.'

Dr. Gay said she is glad that this is happening in Mississippi and hopes it boosts the state's reputation.

'But it's a whole lot bigger than this one child, the University Medical Center or the state,' she said. 'It may take a long time, but I hope it will point us in the right direction to come up with a cure we can consistently apply to other babies worldwide.'

Colleagues at the medical center are planning a celebration for Dr. Gay to 'let her know how proud we are,' said Amy Smith, a nurse practitioner who works with the doctor. 'She's the type that wouldn't want a big fuss made about her, but we're going to do it anyway.'

(Reporting by Julie Steenhuysen and Emily Le Coz; Editing by Jilian Mincer and Claudia Parsons)

Tuesday, March 5, 2013

HIV linked to higher chance of heart attack

NEW YORK (Reuters Health) - People with HIV are almost 50 percent more likely to have a heart attack than those who aren't infected with the virus - even after taking into account their other health risks, according to a new study.

Researchers aren't sure what explains the higher heart attack rate in HIV-positive people, but they speculate it's a combination of the effects of HIV itself and the antiretroviral drugs used to treat it.

'It's a complicated picture,' said Dr. Matthew Freiberg, who led the new study at the University of Pittsburgh School of Medicine in Pennsylvania. 'We're still trying to understand the mechanisms.'

Just over 1.1 million people in the U.S. have HIV, according to the Centers for Disease Control and Prevention. Another 50,000 are infected each year.

Because treatment now allows HIV-infected people to live longer, researchers have started turning their attention to the other health problems those people face later in life, such as heart disease.

The new study included more than 82,000 U.S. veterans, almost all men. About one-third of them were infected with the human immunodeficiency virus.

During an average of almost six years, 871 of the study participants had a heart attack, of which 176 were fatal.

The researchers found that veterans with HIV were consistently more likely to suffer a heart attack than HIV-negative veterans in their 40s, 50s and 60s.

After Freiberg and his colleagues took into account participants' other heart risks - including high blood pressure, diabetes and drug and alcohol use - those with HIV were still 48 percent more likely to have a heart attack during the study period.

The findings suggest antiretroviral drugs accounted for at least part of the extra risk among people with HIV. But past studies have shown the virus itself also contributes to heart problems, according to Freiberg.

'It may be that HIV as it's in your body, like other infections, may be promoting an inflammatory response that is leading to these increased risks of heart attack,' he told Reuters Health - but so far, that's just a theory.

Having hepatitis C or kidney disease was also tied to a higher chance of heart attack among veterans, the research team reported Monday in JAMA Internal Medicine.

Dr. Patrick Mallon, from the University College Dublin School of Medicine and Medical Science in Ireland, said past research showed a link between HIV and cardiovascular disease.

But it's been unclear whether other differences between groups of people with and without HIV - such as smoking rates and cholesterol levels, for example - could be driving the extra risk.

The new report helps clear that up by comparing two very similar groups of people where HIV status is one of the only differences, he noted.

'There have been a lot of signals for a very long time in HIV, and we're now starting to see people constructing studies properly that really give us some very clear answers,' Mallon, who wrote a commentary accompanying the new study, told Reuters Health.

HIV has also been linked to disturbances in fat use and storage in the body.

Mallon and Freiberg agreed that people with HIV should make sure they have their blood pressure and cholesterol checked regularly and do whatever else they can to prevent heart disease - such as quitting smoking.

'There is a lot that the individual can do to mitigate their risk along the lines of lifestyle interventions,' Mallon said. 'At a personal level, that would be step number one.'

SOURCE: http://bit.ly/15vcqlf JAMA Internal Medicine, online March 4, 2013.

Monday, March 4, 2013

Anti-AIDS pill, vaginal gel unsuitable for Africa: study

JOHANNESBURG (Reuters) - Trying to prevent HIV infection through vaginal gels or daily tablets has proven ineffective in the southern African region ravaged by the disease because people did not use the medicines properly, a study released on Monday said.

A ground-breaking study issued in 2010 indicated a vaginal gel containing an HIV drug can sharply reduce infections in women who use it before and after sex.

However, a test of the gel and two types of anti-HIV pills among more than 5,000 women in South Africa, Zimbabwe and Uganda showed that, based on blood tests, more than 70 percent did not use the medication as instructed.

'We are obviously disappointed in the results. We were very hopeful that these products, which we know have been effective in other studies and clearly have a lot of promise, would work,' Jeanne Marrazzo, a researcher on the project for the University of Washington, told reporters in a teleconference.

'Women did not use consistently any of the products. Adherence was very low,' said Marrazzo, part of the project known as the Vaginal and Oral Interventions to Control the Epidemic (VOICE).

HIV/AIDS experts said the results showed how important a factor human behavior is when devising ways to prevent HIV.

'HIV prevention is never just biomedical - behavior is key. What we've learned from VOICE and other trials is that adherence to the prescribed dose - the behavioral component - is the variable that determines effectiveness,' said Mitchell Warren, director of the HIV prevention advocacy group AVAC.

East and southern Africa are the areas most heavily affected by the HIV epidemic. Out of the total number of people worldwide in 2009 living with HIV, 34 percent were in 10 countries of southern Africa, according to the U.N. Programme on HIV/AIDS.

Experts have been searching for years for inexpensive, safe and simple medications to decrease the risk of transmission among a population that is largely destitute and with little access to quality health care.

The study also found the group most likely to contract HIV - unmarried women under 25 - was also the most likely not to use any of the medicines. The results were presented at a Conference on Retroviruses and Opportunistic Infections in Atlanta.

The three-year study that started in September 2009 tested a daily tablet called Truvada, which was approved for HIV prevention in July 2012 by the U.S. Food and Drug Administration after it was shown to significantly reduce the risk of HIV infection when used as a preventative measure.

The gel with a drug called tenofovir, which a previous study showed reduced HIV infections in women by 39 percent over two and a half years, and an oral tenofovir tablet were also tested.

Researchers have been trying for years to formulate a microbicide - a gel, cream, ring or tablet inserted into the vagina or rectum before sex to prevent transmission of the human immunodeficiency virus (HIV) that causes AIDS.

'We need to rethink the design of these intervention trials ... in healthy people because it is difficult for anybody to take a pill or anything every day, particularly when you are healthy and do not feel that you need a drug,' said Marrazzo.

Truvada is made by Gilead Sciences, which also developed tenofovir. In 2006, Gilead assigned a royalty-free license for tenofovir gel to CONRAD.

Jonathan Mermin, an HIV/AIDS prevention expert at the U.S. Centers for Disease Control and Prevention (CDC) said these trial results underscored the complexities of getting healthy people to use preventative measures against HIV.

'Clinicians and public health professionals will have to further assess and better understand how to promote and support the high levels of adherence necessary,' he said.

(Additional reporting by Kate Kelland in London; Editing by Louise Ireland and Michael Roddy)

U.S. baby's cure from HIV raises hope, new questions

CHICAGO (Reuters) - The remarkable case of a baby being cured of HIV infection in the United States using readily available drugs has raised new hope for eradicating the infection in infants worldwide, but scientists say it will take a lot more research and much more sensitive diagnostics before this hope becomes a reality.

In a medical first for an infant, the Mississippi toddler was born in July 2010 infected with HIV, treated within 30 hours of delivery with aggressive HIV therapy, which continued for 18 months. She is now considered cured of her infection, a team of researchers led by Dr. Deborah Persaud, a virologist at Johns Hopkins University in Baltimore, said in a news conference at the Conference on Retroviruses and Opportunistic Infections in Atlanta on Sunday.

'From a clinical perspective, this means that if you can get an infected baby on to antiretroviral drugs immediately after delivery, it's going to be possible to prevent or reverse the infection - essentially cure the baby,' said Dr. Steven Deeks, an HIV/AIDS researcher at the University of California at San Francisco who is attending the conference, where the case was presented to researchers on Monday.

Deeks and others hailed the findings as a great advance in the search for a cure in babies born infected with HIV. But the researchers said they also suggest the need for better ways to diagnose HIV infection, a process that typically takes up to six weeks.

'This could have a profound effect on how we approach babies born to HIV-infected moms,' Deeks said.

Treatment of HIV-infected mothers before delivery is the best way to prevent HIV infection of infants, experts say, but even in resource-rich countries such as the United States, 100 to 200 babies are born each year infected with HIV, the virus that causes AIDS, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Worldwide, especially in developing countries, as many as 1,000 babies are born infected each day. For these children, the findings could have a major impact on the 'terrible burden of HIV infection throughout the world,' Fauci said.

Michel Sidibé, executive director of the Joint United Nations Programme on HIV/AIDS, known as UNAIDS, said the news 'gives us great hope that a cure for HIV in children is possible,' but it also underscores the need for research and innovation, 'especially in the area of early diagnostics.'

Fauci said the child's case was an important 'proof of concept,' but he cautioned that it was only one case and it needs to be further validated.

'The real question is will this be broadly applicable to other infants?' he said.

Fauci said there is a risk that without better diagnostics, children who were never infected in the first place could be exposed to toxic drugs with very early treatment.

In the case of the Mississippi girl, Dr. Hannah Gay, a pediatric HIV specialist at the University of Mississippi Medical Center in Jackson, made the call to treat the child with HIV drugs even before her infection was confirmed because she believed the child was at such great risk of infection. Had she been wrong, the therapy would have been stopped.

'Since the mother had really been at such high risk of transmitting to the baby, they decided to treat on square one,' said Fauci, as opposed to giving the child a lower, preventative dose of drugs until test results confirm an infection.

'The approach of treating really, really early needs to be pursued,' he said. 'When we get better diagnostics where we can tell within the first day or so whether the baby is infected, an approach like this looks like it might be a reasonable thing to pursue with the appropriate clinical trials.'

Fauci said it is not time to change treatment protocols for infants who are born infected. 'It's a single case. We've got to be careful about that.'

(Reporting by Julie Steenhuysen; Editing by Jilian Mincer and Douglas Royalty)

India board rules against Bayer in cancer drug patent case

CHENNAI (Reuters) - An Indian patent appeals board upheld on Monday a decision to allow a domestic company to sell a generic version of Bayer AG's cancer drug Nexavar, in a blow for global drugmakers' efforts to hold on to monopolies on high-price medicines.

The ruling paves the way for the issue of more so-called compulsory licenses as governments, particularly in emerging markets such as China and Thailand, battle to bring down healthcare costs and provide access to affordable drugs to treat diseases such as cancer, HIV-AIDS and hepatitis.

Bayer, Germany's largest drugmaker, said it would continue to fight to overturn the decision, which it said weakened the international patent system and endangered pharmaceutical research.

Under a global Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, countries can issue compulsory licenses on certain drugs that are deemed unaffordable to a large section of their populations.

India's $13 billion drug market is seen by drugmakers as a huge opportunity, but there are concerns about the level of protection for intellectual property in the country -- where generic medicines account for more than 90 percent of drug sales -- after a series of judicial setbacks for 'big pharma'.

COMPULSORY LICENCE CHALLENGED

Last year, the Indian patents office allowed Natco Pharma to sell generic Nexavar at 8,800 rupees ($160) for a month's dose -- a fraction of Bayer's price of 280,000 rupees.

Bayer challenged this decision to grant Natco a compulsory license at the Intellectual Property Appellate Board (IPAB) in the southern city of Chennai.

On Monday the board dismissed the petition, although it did order Natco Pharma to pay a royalty of 7 percent on sales of generic Nexavar to Bayer, an increase from the 6 percent royalty that had earlier been set.

Also, the board fined Natco Pharma 50,000 rupees for presenting incorrect facts during the legal proceedings. The amount would be donated to a cancer treatment hospital, the board ordered.

Announcing the decision, Justice Prabha Sridevan said the kidney and liver cancer drug should be available at an affordable price to everybody.

Bayer said in a statement it 'strongly disagreed' with the conclusions of the board, adding that it would seek to challenge it at the High Court in Mumbai.

'The challenges faced by the Indian healthcare system have little or nothing to do with patents on pharmaceutical products as all products on India's essential drug list are not patented,' the company said.

Natco Pharma Company Secretary M. Adinarayana told reporters the board had delivered a 'reasoned, detailed' decision that could be 'sustained in any court of law'.

LEGAL SETBACKS

In a separate case, Bayer has accused another Indian drugmaker, Cipla, of infringing its patent on Nexavar. Cipla had launched its generic version of Nexavar before Natco won the compulsory license.

Cipla undercut Natco's price in May last year and now sells the drug at 6,840 rupees for a month's dose.

Among other setbacks for Western drug companies, India has revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's hepatitis C drug Pegasys and Merck & Co's asthma treatment aerosol suspension formulation.

Another case involving drug patents is currently in front of the Supreme Court, with Novartis battling against an earlier decision refusing it a patent on cancer drug Glivec.

New Delhi has also taken other measures, such as controlling the prices of generic medicines and providing free medicines at government-run hospitals that cater to the country's poor.

Last week a government panel recommended a formula to curb prices of patented drugs to make them affordable for the world's second-most populous country.

($1 = 54.90 rupees)

(Additional reporting and writing by Kaustubh Kulkarni in MUMBAI; Editing by Alex Richardson)

Child 'Functionally Cured' of HIV

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Sunday, March 3, 2013

U.S. baby's HIV infection cured through very early treatment

CHICAGO (Reuters) - A baby girl in Mississippi who was born with HIV has been cured after very early treatment with standard drug therapy, U.S. researchers reported on Sunday, in a potentially ground-breaking case that could offer insights on how to eradicate HIV infection in its youngest victims.

The child's story is the first account of an infant achieving a so-called functional cure, a rare event in which a person achieves remission without the need for drugs and standard blood tests show no signs that the virus is making copies of itself.

More testing needs to be done to see if the treatment would have the same effect on other children, but the results could change the way high-risk babies are treated and possibly lead to a cure for children with HIV, the virus that causes AIDS.

'This is a proof of concept that HIV can be potentially curable in infants,' said Dr. Deborah Persaud, a virologist at Johns Hopkins University in Baltimore, who presented the findings at the Conference on Retroviruses and Opportunistic Infections in Atlanta.

The child's story is different from the now famous case of Timothy Ray Brown, the so-called 'Berlin patient,' whose HIV infection was completely eradicated through an elaborate treatment for leukemia in 2007 that involved the destruction of his immune system and a stem cell transplant from a donor with a rare genetic mutation that resists HIV infection.

Instead of Brown's costly treatment, the Mississippi baby's case involved the use of a cocktail of widely available drugs already used to treat HIV infection in infants.

When the baby girl was born in a rural hospital, her mother had just tested positive for HIV infection. Because her mother had not received any prenatal HIV treatment, doctors knew the child was born at high risk of being infected. So they transferred the baby to the University of Mississippi Medical Center in Jackson, where she came under the care of Dr. Hannah Gay, a pediatric HIV specialist.

Because of her high infection risk, Dr. Gay put the infant on a cocktail of three standard HIV-fighting drugs when she was just 30 hours old, even before lab tests came back confirming her infection. In more typical pregnancies when an HIV-infected mother has been given drugs to reduce the risk of transmission to her child, the baby would only have been given a single drug to reduce her infection risk.

Researchers believe this early use of antiviral treatment likely resulted in the infant's cure by keeping the virus from forming hard-to-treat pools of cells known as viral reservoirs, which lie dormant and out of the reach of standard medications. These reservoirs rekindle HIV infection in patients who stop therapy, and they are the reason most HIV-infected individuals need lifelong treatment to keep the infection at bay.

10-MONTH GAP

After starting on treatment, the baby's immune system responded and tests showed levels of the virus were diminishing until it was undetectable 29 days after birth. The baby received regular treatment for 18 months, but then stopped coming to appointments for a period of about 10 months, when her mother said she was not given any treatment. The doctors did not say why the mother stopped coming.

When the child came back under the care of Dr. Gay, she ordered standard blood tests to see how the child was faring before resuming antiviral therapy.

What she found was surprising. The first blood test did not turn up any detectible levels of HIV. Neither did the second. And tests for HIV-specific antibodies - the standard clinical indicator of HIV infection - also remained negative.

'At that point, I knew I was dealing with a very unusual case,' Dr. Gay said.

Baffled, Dr. Gay turned to her friend and longtime colleague, Dr. Katherine Luzuriaga of the University of Massachusetts, and she and Persaud did a series of sophisticated lab tests on the child's blood.

The first looked for silent reservoirs of the virus where it remains dormant but can replicate if activated. That is detected in a type of immune cell known as a CD4 T-cell. After culturing the child's cells, they found no sign of the virus.

Then, the team looked for HIV DNA, which indicates that the virus has integrated itself into the genetic material of the infected person. This test turned up such low levels that it was just above the limit of the test's ability to detect it.

The third test looked for bits of genetic material known as viral RNA. They only found a single copy of viral RNA in one of the two tests they ran.

Because there is no detectible virus in the child's blood, the team has advised that she not be given antiretroviral therapy (ART), whose goal is to block the virus from replicating in the blood. Instead, she will be monitored closely.

Dr. Rowena Johnston, vice president and director of research for the Foundation for AIDS Research, which helped fund the study, said the fact that the cure was achieved by antiretroviral therapy alone makes it 'imperative that we learn more about a newborn's immune system, how it differs from an adult's and what factors made it possible for the child to be cured.'

Because the child's treatment was stopped, the doctors were able to identify that this child had been cured, raising questions about whether other children who received early treatment and have undetectable viral loads may also be cured without knowing it.

But the doctors warned parents not to be tempted to take their children off treatment to see if the virus comes back. Normally, when patients stop taking their medications, the virus comes roaring back, and treatment interruptions increase the risk that the virus will develop drug resistance.

'We don't want that,' Dr. Gay said. 'Patients who are on successful therapy need to stay on their successful therapy until we figure out a whole lot more about what was going on with this child and what we can do for others in the future.'

The researchers are trying to find biomarkers that would offer a rationale to consider stopping therapy within the context of a clinical trial. If they can learn what caused the child to clear her virus, they hope to replicate that in other babies, and eventually learn to routinely prevent infections.

(Reporting by Julie Steenhuysen; Editing by Jilian Mincer and Sandra Maler)

Friday, March 1, 2013

Porn King Larry Flynt Has Implant

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Penile Implant Sales Rise; Porn King Larry Flynt Has One

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Thursday, February 28, 2013

Chicago Passes Sex-Ed for Kindergartners

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)

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.

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)

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.

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)



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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)



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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.



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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)