U.S. panel raps how agencies handle human research

WASHINGTON (Reuters) - U.S. government agencies fund thousands of studies on human subjects, but do not have a very good handle on the basic information about that research -- possibly putting participants in harm's way, a presidential panel of reviewers has found.

The presidential bioethics commission looked into the current protections for human subjects in a review triggered by evidence of unethical behavior in a 1940s experiment that deliberately infected Guatemalan prison inmates and mental patients with sexually transmitted disease.

The commission earlier this year concluded that U.S. government researchers must have known they were violating ethical standards at the time of the experiment, shortly after World War II. They have also called for a better system to compensate medical research subjects.

Nothing like the horrors of the Guatemala study could take place under U.S. government watch now, the panel said in a report released Thursday.

But the lags in how federal agencies collect and store data about their research involving human subjects offers no assurance that all unnecessary injuries or unethical activity are prevented.

U.S. government agencies last year supported more than 55,000 projects, mostly health-related, involving human subjects. The presidential commission asked 18 agencies that do most of such research to provide basic data about it, such as location of study sites, lead investigators, number of subjects involved and amount of funding designated.

What they found is that the information does exist, but in many cases is far from well overseen or readily available.

The Pentagon, for example, took more than seven months to get the basic data ready on research by the Department of Defense, which was found to have no public information system.

Some agencies had one public system tracking research and another tracking funding, but had trouble connecting them. Examples included the Department of Education and Department of Homeland Security, which could not provide the funding data saying "it would be overly burdensome, and in many cases not feasible," according to the commission's report.

"Because of the currently limited ability of some governmental agencies to identify basic information about all of their human subjects research, the Commission cannot conclude that all federally funded research provides optimal protections against avoidable harms and unethical treatment," said the report titled "Moral Science."

The panel called the Department of Energy and the National Institutes of Health examples of best examples of transparent and centralized systems tracking research on human subjects.

"There can be significant improvement in the assurance that can be given to human research subjects and the general public, significant improvements to what happens today. First step in those improvements, would be greater transparency and accountability of the experiments that are going on," said commission chairwoman Amy Gutmann.

"The Guatemala experiments remind us never to take ethics for granted," she said.

The United States apologized last year for the Guatemalan experiment, which was meant to test the drug penicillin. The research was uncovered decades later by a college professor.

Guatemala has called the incident a crime against humanity and conducted its own investigation. Its report released earlier this month showed that 2,082 people were affected.

The United States and Guatemala will now compare reviews and investigations and determine how best to compensate the victims and their families. Several of them have sued the United States.

The subjects of the Guatemala experiment were infected with venereal diseases, more than half of them with syphilis. They included inmates exposed to infected prostitutes brought into jails and male and female patients in a mental hospital. Some subjects had bacteria poured on scrapes made on their genitals, arms or faces.

The presidential commission plowed through thousands of pages of archives to find that U.S. and Guatemalan scientists at the time deceived the participants who were members of especially vulnerable groups, kept poor notes, did not try hard to protect the subjects from risks and conducted experiments in illogical order.

"This should not be just a moment of true regret and embarrassment on the part of our country," Gutmann said. "It should be an ongoing teaching moment."

SOURCE: http://1.usa.gov/tW3DVZ The Presidential Commission for the Study of Bioethical Issues, December 15, 2011.

View the original article here

Drug Users With HIV at Much Higher Overdose Risk

FRIDAY, Dec. 16 (HealthDay News) -- HIV-infected drug users are 74 percent more likely to have an overdose than those without HIV, a new evidence review finds.

Behavioral and biological factors may be among the reasons for this increased risk, according to the Rhode Island Hospital researchers. Drug overdose is a frequent cause of non-AIDS death among people with HIV.

The link between HIV infection and drug use is well documented, but the association between HIV and overdose has received less attention and was the focus of this study, which involved a review of 24 previous studies.

"Over the past 30 years, we have made impressive strides in caring for and prolonging the lives of people with HIV. Our study found that premature death by overdose is an issue that affects people with HIV disproportionately," study leader Traci Green, a researcher with Rhode Island Hospital and the Lifespan/Tufts/Brown Center for AIDS Research, said in a hospital news release.

"It is not entirely clear why the risk is greater, and few studies have endeavored to figure out why this might be happening," she added.

Biological factors may include clinical status, weakened immune systems, opportunistic infections and poorer physical health among HIV-infected drug users. Some research has suggested that hepatitis C infection and other conditions that affect metabolic ability may also increase the risk of overdose, according to the release.

Behavioral factors -- such as high-risk lifestyles and an increased rate of psychiatric conditions -- may also contribute to the higher risk of overdose among HIV-infected drug users, Green said.

Other possible factors could include homelessness and poverty, and poor access to medications and therapy used to treat opioid dependence, she suggested. Many HIV patients take opioid painkiller drugs as part of their treatment, while others use illegal opioids.

The study appears online in advance of print in the journal AIDS.

"Bringing overdose awareness and prevention into the HIV care setting is critical to reducing overdose deaths," Green said.

"Health care providers who treat HIV-infected patients with a history of substance abuse or who are taking opioid medications should consider counseling patients on how to reduce their risk of overdose. They may also consider prescribing naloxone (Narcan) to patients, or offering a referral to MAT (medication-assisted therapy) to reduce the risk of overdose," she advised.

Naloxone is a prescription medication that reverses an opioid overdose and has no abuse potential.

More information

The New Mexico AIDS Education and Training Center has more about recreational drugs and HIV.

View the original article here

HPV Test Spots Cervical Cancer Earlier Than Pap Smear: Study

THURSDAY, Dec. 15 (HealthDay News) - To catch cervical cancer or the lesions that can lead to it, a human papillomavirus (HPV) test is the best option for women over 30, Dutch researchers report.

Using it in conjunction with the more traditional Pap smear resulted in earlier detection of precancerous lesions and prevented more cervical cancers from developing, said study author Dr. Chris Meijer, a professor of pathology at VU University Medical Centre in Amsterdam.

The study is published online Dec. 15 in The Lancet Oncology.

Nearly all cervical cancers are caused by HPV, a virus spread through sexual intercourse. Some HPV strains are more strongly linked with the cancer than others.

The superiority of HPV testing over traditional Paps at finding precancerous cervical lesions is established, Meijer noted. However, his team wanted to see if HPV testing also offered better protection and detection long-term -- in two screenings done over a five-year period.

They found it did.

While five years may sound like a long lag time between screenings, it is not, he said. "The Netherlands already has a screening interval of five years, starting from 30 years of age until 60 years," he said. The program is inexpensive and effective, he added.

In the study, Meijer's team evaluated nearly 45,000 women, aged 29 to 56. Women in one group got a traditional Pap smear and an HPV DNA test. The women in the other group got just the Pap test.

Five years later, all women got both tests.

The researchers looked to see whether HPV tests resulted in fewer high-grade cervical lesions and cervical cancer in the second screening, due to earlier detection and treatment.

In the first screen, the HPV tests found more of the early changes that can precede cervical cancer than the Pap smear alone did.

Five years later, far fewer women in the HPV group had more advanced lesions or cervical cancer than did the Pap-only women.

Four women in the HPV/Pap group were diagnosed with cervical cancer, while 14 in the Pap-only group were.

When they looked at cervical cancer or advanced lesions, 88 in the HPV arm of the study were diagnosed with one or the other compared to 122 in the Pap-alone arm.

The improved protection against advanced lesions, the researchers said, is due to the earlier detection of the precursor lesions. When they were treated, it helped prevent them from progressing.

In an accompanying commentary, scientists from the U.S. National Cancer Institute wrote that the Dutch trial does show the five-year screening interval is safe. But they added that it is unclear if the same results would hold true in a different population with different testing guidelines.

The HPV test can be done using the same specimen collected for the Pap test, Meijer said.

Costs of the tests differ. Meijer said Pap smears are about $38 in the Netherlands, while an HPV test costs about $64. However, the Dutch Minister of Health recently recommended lowering the cost of an HPV test to below that of the traditional Pap.

The new study is "further defining how we can incorporate HPV testing into our screening program," said Dr. Elizabeth Poynor, a gynecologic oncologist and pelvic surgeon at Lenox Hill Hospital, in New York City.

She noted that she doesn't think the HPV screen will replace the Pap test completely. "It may turn out to be a first-line screen. Stay tuned for more," she said. "Certainly ask your physician if you've had HPV."

In October, three U.S. cancer groups proposed new guidelines for cervical cancer testing, extending intervals between screenings and making other changes. These guidelines, issued by the American Cancer Society and others, call for combination HPV/Pap smear testing for women aged 30 and older.

After three normal Paps, women over 30 can have the test ever two to three years, according to the American Cancer Society.

However, the U.S. Preventive Services Task Force remains cautious about the use of the HPV test, standing by the Pap as the best bet for now.

The Dutch study was funded by Zorg Onderzoek Nederland (the Netherlands Organization for Health Research and Development).

More information

To learn more about cervical cancer, visit the U.S. National Institutes of Health.

View the original article here

Headaches May Plague Many With HIV/AIDS

WEDNESDAY, Dec. 14 (HealthDay News) -- Headache affects 50 percent of HIV/AIDS patients in the United States, and many of those headaches are severe, a new study says.

About 27.5 percent of the 200 HIV/AIDS patients in the study suffered "chronic migraine," a rare condition in which a person has migraine symptoms (with or without other headaches) for 15 or more days a month. This condition occurs in only 2 percent of the general population.

"This translates into a 13-fold increased risk of chronic migraine among patients with HIV disease," study author Todd Smitherman, an assistant professor of psychology at the University of Mississippi, said in a university news release.

"The strongest predictor of headache was the severity of HIV disease, such that patients with more advanced disease had more frequent, more severe and more disabling migraines," he added.

For the study, the researchers interviewed Montgomery, Ala., clinic patients who have HIV or AIDs and reviewed their medical records to look for any other cause of headache.

The findings, recently published online in the journal Headache, could help lead to improved treatment and reduced medical costs for HIV patients who suffer headaches, the researchers said.

"This research is of interest to clinicians and physicians for several reasons," Smitherman said. "Recent research from the U.S. Centers for Disease Control and Prevention shows that, despite the availability of medications that effectively slow disease progression, most Americans with HIV do not have the disease under control. Our study shows that patients with poorly controlled HIV/AIDS are most prone to suffer also from frequent, severe migraines at rates that far exceed those of the general population."

The authors said theirs is the first study since highly active antiretroviral therapy (HAART) became widely available to find that having HIV/AIDS is associated with a very high risk of headache, particularly migraines.

Doctors need to regularly monitor immune system functioning in HIV/AIDS patients and pay close attention to headache symptoms in those with more advanced disease, the researchers said.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about headache.

View the original article here

Study endorses HPV testing for all women over 30

Cigarette and alcohol use by US teenagers are at their lowest point since the mid-1970s, but marijuana use remains steady, according to the findings of a national survey released Wednesday.

View the original article here

You might not need that pelvic exam, says study

NEW YORK (Reuters Health) - Many doctors give women pelvic exams when they're not called for by guidelines, for example to screen for ovarian cancer or before prescribing birth control pills, according to a new study.

That's worrisome, researchers said, not only because the exams are invasive, but because they come with a risk of false positives that can lead to more unnecessary tests and procedures.

"Women should know that screening tests come with both harms and benefits, and the pelvic exam is not an exception to that," said Analia Stormo, from the Centers for Disease Control and Prevention in Atlanta, who led the study.

"We need to provide physicians with more of a clear message of when it's appropriate to use pelvic exams," she told Reuters Health.

The screening exams involve looking at the vagina and cervix and doing a manual exam with one hand inside the vagina and one outside to feel the uterus and ovaries.

Women have gotten in the habit of getting a pelvic exam every year, the researchers said, and doctors are accustomed to giving them -- but it's unclear if they serve any real purpose in women without any pelvic pain or signs of infection.

Stormo and her colleagues surveyed 1,250 doctors, including obstetricians and gynecologists, family doctors and internists on how often they performed pelvic exams to screen for cancer or sexually transmitted infections (STIs), as a requirement before prescribing birth control pills or as part of a typical physical or "well-woman" visit.

OB/GYNs were the most likely to say they routinely performed pelvic exams in each of those cases, but the majority of family and general doctors also did pelvic exams for every indication in question.

While the most doctors said they used the exams as part of a general well-woman visit, 95 percent of OB/GYNs and 55 percent of general doctors also screened for ovarian cancer using pelvic exams, and between 68 and 92 percent of those doctors used them to screen for STIs or as a requirement before prescribing birth control.

Internists were the least likely to perform pelvic exams for each scenario.

Dr. Mona Saraiya, who also worked on the study, said there's no need to do a full pelvic exam to screen for STIs -- taking a swab or doing a urine test is enough. The researchers also said there isn't any evidence that screening for ovarian cancer with a pelvic exam prevents women from dying of the disease, or that it's needed before women go on birth control.

As part of a well-woman exam, its usefulness isn't clear one way or the other.

No matter how it's used, a pelvic exam can lead to so-called false alarms and overdiagnosis, when doctors find disease that would never have caused any symptoms but is treated nonetheless.

It's also a very personal procedure. "It's not like palpating your stomach," Saraiya said.

"If a pelvic exam is considered so sensitive that it deters women from actually coming in for hormonal contraceptives or STI testing, that's a harm," she told Reuters Health.

PELVIC EXAMS TAKEN FOR GRANTED

Dr. George Sawaya, from the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California, San Francisco, said there simply hasn't been much attention paid to the possible benefits and harms of pelvic exams, and that more research and thought is needed to better determine and balance those.

"Any woman would say that certainly a major component of her visit to the gynecologist includes...a pelvic examination. This is something they just take from granted in many ways," said Sawaya, who wrote a commentary accompanying the study in the Archives of Internal Medicine.

Organizations including the American College of Obstetricians and Gynecologists recommended the pelvic exam as part of routine check-ups in most adult women, but other guidelines are inconsistent, adding to the confusion, according to Saraiya.

Researchers agreed that women shouldn't hesitate to have a conversation with their doctor about why they're getting a pelvic exam -- or any other screening test, for that matter.

And Saraiya emphasized that evidence-backed procedures and counseling, such as asking women about instances of domestic violence and checking their histories for specific warning signs for disease, should be top priorities during time-strapped visits.

"I think we just have to have some thoughtfulness about why we do (pelvic exams) and whether there's good evidence that the net benefit is substantial," Sawaya told Reuters Health.

When it comes to screening for ovarian cancer in particular, "that's probably a very misguided use of this examination," he said.

"I think it's important to understand that nothing is harmless," Sawaya concluded. "We're not just trying to maximize benefits, we're trying to minimize harms. It's a two-way street."

SOURCE: http://bit.ly/ueoIZG Archives of Internal Medicine, online December 12, 2011.

View the original article here

South Africa launches new drive to cut HIV infection

CAPE TOWN (Reuters) - South Africa wants to cut new HIV infection rates by at least 50 percent within five years as it seeks to build on recent successes following years of failing to tackle AIDS and increased mortality, President Jacob Zuma said on Thursday.

Former President Thabo Mbeki was widely criticized for failing to take the AIDS epidemic seriously, leaving South Africa with one of one of the world's biggest HIV infected populations.

But the country has since made strides in tackling the pandemic, with a 50 percent reduction in the transmission of HIV from mothers to children seen between 2008 and 2010 due to greater access to life-saving antiretroviral drugs.

More than 13 million people were tested for the virus since April last year in a rigorous status awareness campaign.

"Indeed, we have achieved a lot in the fight against HIV and AIDS as South Africans, and also globally," Zuma said in a World Aids Day speech, before launching the country's second AIDS masterplan to run from 2012 to 2016.

The National Strategic Plan aims, among other goals, to reducing new HIV infections by at least a half, slash the number of tuberculosis infections and related deaths by a similar margin and have at least 80 percent of eligible patients on antiretroviral treatment.

"We cannot afford to deal with HIV and TB separately," Zuma said, adding the new emphasis, missing in the first program, was necessary given the high rate of co-infection between the two diseases.

The new plan also identifies sexual violence and intimidation against women as a key factor in the spread of

HIV/AIDS.

"Recent research in South Africa shows that we could prevent HIV infections in young women if they were not subjected to violence or intimidation by their partners," Zuma said.

(Reporting by Wendell Roelf; Editing by Jon Hemming)

View the original article here

South Africa unveils plan to halve HIV infections

President Jacob Zuma on Thursday unveiled a plan to halve the number of HIV infections over the next five years, cementing South Africa's turnaround from years of deadly denialism.

The five-year plan is the first drafted since the 2008 ouster of president Thabo Mbeki and his health minister Manto Tshabalala-Msimang, known as Dr Beetroot for advocating vegetables rather medication to treat AIDS.

Despite his own gaffes -- he once said he had showered to prevent HIV infection -- Zuma has dramatically expanded South Africa's AIDS treatment programme, which is the largest in the world serving 1.3 million people.

"We are steadily overcoming fear and confusion. We have overcome divisions. We have stopped making HIV and AIDS a battlefield on which to fight one another," Zuma said in a speech in the southern city of Port Elizabeth.

The new plan calls for stepped-up prevention efforts to halve new infections of HIV and tuberculosis by 2016 and to put 80 percent of eligible patients on anti-retroviral drugs to fight AIDS.

South Africa has 5.6 million people with HIV, in a population of 50 million, and the expanded treatment has already made gains in combating the epidemic.

The number of mothers who transmit HIV to their babies during childbirth has plunged, while the rate of new infections dropped by 22 percent during the last decade, with mortality dropping at a similar pace.

In January 2010, only 495 health facilities could start patients on a drug regimen. Now the number is 2,948, Zuma said.

The number of nurses accredited to provide AIDS treatment also jumped from 290 to 10,542.

Over the last two years, South Africa has also made a greater push to offer testing services, with 13 million people taking HIV tests since April 2010, when a national testing campaign was launched.

Zuma made no mention of what the new plan will cost, but local media put the price tag at 131 billion rands ($16 billion, 12 billion euros).

AIDS activists, who were shunned by the Mbeki administration, welcomed the new plan, which was crafted after widespread consultations among civil society and health authorities.

"South Africa started the last plan with Manto Tshabalala-Msimang as the Minister of Health and Thabo Mbeki as president. Although the plan was adopted by the government, it was resisted by the minister," said the Treatment Action Campaign, which spearheaded efforts to force the government to provide to anti-retrovirals (ARVs).

"For several years the roll of ARVs was kept as slow as possible. Preventable infections and deaths continued," it said.

"Five years later, all that has changed. We have almost all the tools and policies to fight HIV and TB. What we need now is accountability for implementation."

View the original article here

Scientists ID Gene That Predicts Chances of Cold Sores

FRIDAY, Dec. 2 (HealthDay News) -- Scientists have identified the first gene associated with frequent herpes-related cold sores.

The herpes simplex virus type 1 (HSV-1) affects more than 70 percent of the U.S. population. Once the virus infects the body it is never removed by the immune system. It's transported to nerve cell bodies, where it remains dormant until reactivated.

A cold sore on or around the mouth is the most common visible symptom of HSV-1 reactivation.

"Researchers believe that three factors contribute to HSV-1 reactivation -- the virus itself, exposure to environmental factors and genetic susceptibility," study first author Dr. John Kriesel, a research associate professor of infectious diseases at the University of Utah School of Medicine, said in a university news release. "The goal of our investigation was to define genes linked to cold sore frequency."

He and his team conducted genetic analyses of 355 people infected with HSV-1 and 263 uninfected people and discovered that a gene called C21orf91 was associated with susceptibility to frequent cold sore outbreaks.

Two variants of the gene seemed to protect against HSV-1 reactivation while two other variants seemed to increase the risk of frequent cold sore outbreaks, according to the report published in the Dec. 1 issue of the Journal of Infectious Diseases.

"There is no cure for HSV-1 and, at this time, there is no way for us to predict or prevent cold sore outbreaks," Kriesel said in the news release. "The C21orf91 gene seems to play a role in cold sore susceptibility, and if this data is confirmed among a larger, unrelated population, this discovery could have important implications for the development of drugs that affect cold sore frequency."

More information

The American Academy of Dermatology has more about cold sores and other mouth and lip conditions.

View the original article here

S.Africa ponders sex education for 10-year-olds

One is a healthy first-grader, the other an honors college student majoring in psychology. Once the tiniest babies ever born, both girls are thriving, despite long odds when they entered the world weighing less than a pound.

View the original article here

AIDS Research Holds Promise for Reducing HIV Transmission Rates

THURSDAY, Dec. 1 (HealthDay News) -- The data may at first seem dire: More people are living with HIV/AIDS than ever before in the United States, according to the U.S. Centers for Disease Control and Prevention.

But researchers say that's actually good news because people are living with the disease through effective medical treatment, rather than dying from its relentless progress.

But even better news comes in the form of potential new treatments that could keep people from acquiring HIV in the first place -- progress that will be noted Dec. 1 as countries around the world mark World AIDS Day.

"AIDS research has brought us some extraordinary advances over the past couple of years," said Kevin Robert Frost, chief executive of amfAR, the Foundation for AIDS Research. "When you take all that and combine it with the other preventive measures we know of, we have this phenomenal toolbox at our disposal for radically reducing transmission."

These advances include new ways to prevent transmission, as well as growing evidence that early and effective treatment of HIV in those already infected actually prevents the virus from spreading to others.

Some researchers are even beginning to become excited about the prospects of finding the holy grail of AIDS research -- an actual cure for the dread disease.

"Every day . . . I hear growing enthusiasm [that] we can cure this disease," Frost said. "We think it's possible. We think we could get there."

According to the CDC's most recent tally, more than 1 million adults and children in the United States were living with HIV in 2008. That's an increase of about 7 percent from the agency's previous estimate, made in 2006. Experts at the CDC say the increase is a good sign that disease management is working, but they also point out that more people are becoming infected with HIV than are dying from HIV or AIDS.

Another sign of progress involves the transmission rate of HIV. The CDC estimates that for every 100 people living with HIV, just five end up transmitting the disease to someone else. That's an 89 percent decline in the estimated rate of HIV transmission since the epidemic's peak in the mid-1980s.

The new research that promises to reduce HIV transmission even further includes:

Evidence that effective treatment prevents transmission. In a government study, called HPTN 052, "it became very clear that people who received early treatment [with antiretroviral medications] had a 96 percent decline in the likelihood they would infect their uninfected partners," said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases.Development of medication that prevents acquisition of HIV. Another series of studies focused on the use of medications to make a person less likely to acquire HIV, known as PrEP, or pre-exposure prophylaxis. The studies found that non-infected gay or bisexual men who take antiretroviral medications daily are much less likely to become infected. "Basically, it's a pill that could prevent HIV acquisition in gay men if taken once a day," said Frost, noting that one combination drug therapy called Truvada appears to cut HIV transmission by 44 percent.Topical prevention for women. Experts say that a woman's chances of acquiring HIV can be reduced through the use of a topical microbicide. One study at Columbia University identified a gel containing a small amount of tenofovir, an antiretroviral medication, that reduced women's risk for HIV infection by 39 percent and risk for genital herpes by 51 percent.Male circumcision. Research also has found that circumcised males are as much as 60 percent less likely to acquire HIV, Fauci said. This has led world health leaders to consider promoting circumcision as prevention, particularly in third-world countries.Vaccine research. A long-standing quest of AIDS researchers, the development of a potential HIV vaccine, has continued, Fauci said. The largest-ever HIV vaccine trial, conducted in Thailand, reported in 2009 that people who received the vaccine were 31 percent less likely to acquire the virus. "It certainly is not ready for prime time, but it is evidence that we can protect through vaccination," Fauci said.

All of this progress has led researchers to dare to dream of what was once unthinkable -- discovering an actual cure for HIV/AIDS.

"New interest is growing around the concept of trying to cure HIV and AIDS," Fauci said. "Ultimately, get these patients off therapy so they can lead normal lives again."

However, he cautioned that talk of a cure should not be taken as a sign that doctors are near the goal. "This is an aspirational hope," he said. "We don't yet have exciting results."

Frost is concerned that the pace of these advances could flag in coming years as medical research reels from the impact of the global recession.

"The challenge is, it's all happening against the backdrop of the worst financial crisis since the Great Depression," Frost said. "We really need people to support these efforts if we're going to make a difference. Unfortunately, we're victims of our own success. As AIDS becomes more and more a chronic but manageable disease, a lot of the urgency is lost."

More information

The U.S. National Institute of Allergy and Infectious Diseases has more about HIV/AIDS.

A companion article offers more on the emotional toll of living with HIV/AIDS.

View the original article here

Children with HIV in Asia resistant to AIDS drugs

HONG KONG (Reuters) - Teenagers in Asia receiving treatment for HIV are showing early signs of osteoporosis and children as young as five are becoming resistant to AIDS drugs, an anti-AIDS group said on Thursday, urging more attention be given to young HIV patients.

The finding, made available on World AIDS Day, is a reminder that while more people in Asia now have access to basic AIDS drugs, improved medicines remain out of reach and patients -- both adults and children -- still suffer from inadequate care.

In Asia, some 160,000 children are infected with the human immunodeficiency virus (HIV), which causes AIDS. Of these, 57,000 require treatment but only 30,000 were receiving it as of the end of 2008, according to UNICEF.

Researchers at TREAT Asia found children as young as five were developing resistance to AIDS drugs and may soon require improved, more expensive medicines, which are not available for them yet.

"In our cohort, about 14 percent of the children have failed first-line drugs ... Some of the children who are already on second-line are under the age of five," Annette Sohn, director of TREAT Asia, told Reuters in a phone interview.

Poor adherence to the timing or frequency of taking AIDS drugs can result in resistance. But in Asia, resistance is also due to the lack of drug formulations for children.

"We all made some mistakes on how we managed patients with HIV in the beginning of the epidemic," Sohn said. "We used adult tablets. We had no pediatric formulations in our countries."

Sohn said health experts and drug providers need to find ways to make third-line, more powerful drugs available for children in poor countries. Such medications are available or subsidized in rich nations but very expensive and sometimes unavailable in developing countries.

"Unless we develop access to third-line drugs, we are going to find ourselves in a clinic room with a patient that there is nothing left and we have no other drug to give them."

A long-term study of 4,000 HIV patients under the age of 23 in Asia by TREAT Asia also showed that a high percentage of teenagers had low bone mineral density, a precursor of osteoporosis.

"We did a special X-ray on these teenagers who are about 16 years old and found that 15 percent of them had low bone mass," Sohn said.

"That is not normal. Kids are not supposed to have low bone mass when they're 16 years old and that's because of the effect of HIV on their bodies ... brain, bone, immune system."

Sohn, a pediatric specialist for children with HIV/AIDS, said this may also be due to toxic effects that some AIDS drugs, such as tenofovir, have on bones.

"It is not so much about avoiding one drug or another but being aware of these side effects, studying what drug doses will suppress the virus while not being toxic, having the resources to monitor the side effects, and having access to alternate drugs if they do arise."

The study covers Thailand, Vietnam, Malaysia, Cambodia, Indonesia and India. TREAT Asia is a network of clinics, hospitals and research institutions working together to improve treatment access.

View the original article here

Glenmark seeks arbitration after U.S. co breaches pact

REUTERS - Glenmark Pharmaceuticals said on Tuesday it has sought an arbitration in the U.S. as Napo Pharmaceuticals has no basis for terminating a collaboration agreement with it to develop and market an HIV-associated diarrhoea drug.

Napo Pharma had terminated the pact on November 10, according to a press release posted the U.S.-based firm's website.

The move is a fresh hurdle to Glenmark's ambitious plans to exclusively market the drug, Crofelemer, in 140 countries.

Reacting to the news, shares of Glenmark declined more than 6 percent in early trade in a volatile Mumbai market. At 11:31 a.m. (0601 GMT), the stock was down 5.2 percent at 291 rupees.

Glenmark, along with U.S.-based partners Napo and Salix Pharmaceuticals has developed Crofelemer, the first ever drug developed by an Indian firm.

According to the licensing agreement, Glenmark holds the exclusive rights to distribute Crofelemer in 140 countries while Salix would sell it in regulated markets such as North America, Japan and Europe.

Napo Pharma was the initial developer of the molecule who licensed it out to Glenmark and Salix.

Glenmark, in a press release on Tuesday, vehemently denied Napo had any basis to terminate the agreement and that it was seeking a declaration from an arbitration panel that Napo's claims of breach were unfounded.

The Mumbai-based firm, in August, had filed for arbitration claims against Napo Pharma to prevent the latter from distributing Crofelemer in Glenmark's territories through relief agencies.

"We believe that the licensing fees and other payments received by Glenmark need not be paid back in case the development process for Crofelemer is terminated," Nomura said in a note.

Glenmark in July received $15 million from Salix Pharma towards upgrading the manufacturing facility for Crofelemer and is expected to get $6.6 million in five equal instalment.

(Reporting by Kaustubh Kulkarni and Manoj Dharra in MUMBAI; Editing by Rajesh Pandathil)

View the original article here

African leaders must boost AIDS programmes: Bush

African leaders must ensure that programmes to fight HIV/AIDS on the ravaged continent are successfully carried out, former US president George W. Bush said Sunday.

Bush said at the opening ceremony of the International Conference on AIDS and STIs (ICASA) in Africa that funding from foreign donors such as the US President’s Emergency Plan for Aids Relief (PEPFAR) alone was not enough.

"PEPFAR also relies on African leaders to take responsibility for the success of programs," he said.

"The developing world must set priorities and there is no greater priority than saving a human life," he added.

PEPFAR has contributed $1.4 billion to HIV/AIDS programs in Ethiopia since it was launched by Bush in 2003.

Bush also encouraged the US to remain committed to saving lives in the developing world by promoting fighting disease. "Isolationism is always shortsighted," he said.

HIV/AIDS funding has diminished in recent years due to the global economic recession.

Last week, the Global Fund for HIV/AIDS, malaria and tuberculosis, the leading funding agency for the diseases, said it would not renew funding this year.

"It’s the wrong thing to do from my personal view, it will create a serious problem in terms of putting people on treatment," the executive director of the UN agency for AIDS Michel Sidibe told AFP.

An estimated 22.9 million people are infected with HIV in sub-Saharan Africa, with the majority of cases in eastern and southern Africa, according to the UN.

The ICASA conference is being held in the Ethiopian capital until December 8 and is expected to attract some 10,000 delegates.

View the original article here

Human rights key in combating AIDS among gay men: WHO

Vast improvements in human rights and access to treatment are needed to protect gay men against HIV/AIDS, the World Health Organisation (WHO) said Monday.

"If you want to achieve zero new infections, you have to address the human rights issues," WHO official Ying-Ru Lo said after a meeting about infection rates among gay men at the International Conference for AIDS and sexually transmitted infections in Africa (ICASA).

She said stigmatisation and high levels of discrimination blocked access to AIDS treatment, boosting infection rates among gay men in developing countries.

"We must ensure the well-being of the most marginalised groups," she added.

Men who have sex with men are 19 times more likely to contract HIV/AIDS in lower income countries, according to a 2011 WHO report.

Africa is the region hardest hit by epidemic.

Homosexuality is illegal in more than 75 countries of the world, and is widely considered taboo in Africa.

The director general of the African Medical and Research Foundation, Teguest Guerma, said it would take time to create laws protecting gay rights, but speaking openly about homosexuality was a crucial first step.

"In the past they were really underground, at least now they are coming to the surface," she said.

The ICASA conference in the Ethiopian capital has scheduled three sessions concerning the rights of homosexuals affected by HIV/AIDS, before closing on Thursday.

View the original article here

FDA to Review Safety Issues Surrounding Leading Birth Control Pill Yaz

View the original article here

FDA Advisory Panel Wrong to Advocate Sale of Birth Control Patch

OAKLAND, Calif (Reuters) - Anti-Wall Street demonstrators, confronted by police in riot gear, marched on several West Coast ports on Monday seeking to disrupt cargo traffic and re-energize their faltering protest movement. By singling out port operations from California to Alaska, organizers hoped to call attention again …

View the original article here

Study finds impotence risk higher in men taking several drugs

NEW YORK (Reuters Health) - Men taking multiple medications for different health conditions may have a higher risk of erectile dysfunction -- a link that doesn't seem to be explained by the health problems themselves, a new study finds.

It's known that men with chronic health problems like high blood pressure, diabetes and high cholesterol are more likely to develop erectile dysfunction, or ED, than healthier men their age.

But in the new study, researchers found a link between medication use and ED independently of those medical conditions.

Of 37,700 men in a large California health plan, researchers found that those on three or more medications had higher rates of ED.

Overall, 16 percent of men on no more than two drugs reported moderate ED -- meaning they "sometimes" had trouble getting or maintaining an erection. That compared with 20 percent of men on three to five medications, a quarter of men on six to nine drugs and 31 percent of those on at least 10 drugs.

Not surprisingly, ED was more common in men who were older, heavier, smoked or had health problems like diabetes or high blood pressure. But even when the researchers accounted for that, being on multiple medications was still tied to an increased ED risk.

Men on three to five medications were 15 percent more likely to report ED than those on fewer drugs. And the odds were more than doubled among men on 10 or more medications.

The findings do not prove that the drugs themselves are to blame, said senior researcher Dr. Steven J. Jacobsen, of Kaiser Permanente Southern California's Department of Research and Evaluation.

"We did try to control for the underlying conditions," he told Reuters Health in an email, "but we may not have completely accounted for aspects such as severity."

Still, he added, "the data suggest that some characteristic of men on multiple medications may predispose them to ED."

The findings, reported in the British Journal of Urology International, are based on questionnaires given to 37,712 men ages 45 to 69. Overall, 29 percent reported moderate or severe.

More than half of the men -- 57 percent -- were on more than three medications in the past year. And as expected, men with high cholesterol, high blood pressure, diabetes or depression tended to be on more medications.

Jacobsen said that it's possible the drugs themselves could contribute to or worsen ED -- via drug interactions, for instance. But there's no way to tell for sure from these findings.

What is clear, he stressed, is that men with erectile problems should not simply stop taking their prescriptions.

"Men should certainly not stop taking their medications without consulting their provider," he said.

But, Jacobsen added, men with ED who are on multiple drugs could ask their doctor if the problem might be related to the medication. It might be possible to lower a drug dose, or try an alternative treatment.

SOURCE: http://bit.ly/vdgVLd BJU International, online November 15, 2011.

View the original article here

Taxes could fill AIDS funding crunch: U.N.

ADDIS ABABA (Reuters) - The fight against AIDS risks being set back years by a global financial crisis, the head of the United Nations campaign against the disease warned Wednesday.

About 34 million people worldwide are infected with the Human Immunodeficiency Virus (HIV) that causes AIDS, just over two-thirds of them in sub-Saharan Africa. Incidence rates are falling and access to treatment is expanding.

However, a decline in donor contributions has caused a funding crisis within the Global Fund to Fight AIDS, Tuberculosis and Malaria, the largest body for HIV funding, and is dampening optimism about an eventual end to the disease, UNAIDS director Michel Sidibe told Reuters in an interview.

"It is not the time to stop, to reverse all this achievement. The financial crisis is there ... but when we have a financial crisis we need to be innovative," Sidibe said.

Annual funding for HIV/AIDS programs fell to $15 billion in 2010 from $15.9 billion in 2009, well below the $22-24 billion the U.N. agency says is needed annually by 2015 to pay for a comprehensive, effective global response.

Speaking on the sidelines of an international AIDS conference in the Ethiopian capital, Addis Ababa, Sidibe said donors could raise funds through taxes.

"If we have a global financial transaction tax, say of 0.5 percent, we will have $226 billion. Ten percent of that resource is enough for financing the fight against HIV/AIDS, stopping the epidemic, because we can reduce by 96 percent the number of new infections by putting people early on treatment," Sidibe said.

"We can have taxation on cigarettes and alcohol. We can find different ways to mobilize new resources."

With many large international donor countries struggling with looming recession and debt crises, public health experts say it is crucial for countries affected by HIV/AIDS to increase their own funding, especially developing countries.

"Sustainability and particularly reducing dependency, making sure that African leaders are taking responsibility to initiate a new discussion around treatment and (the) AIDS financing crisis in Africa, those for me will be the most important messages to come out from Addis Ababa," Sidibe said.

The Global Fund is already cutting new grants for countries battling HIV. The public-private fund contributes about 70 percent of the money spent on life-saving antiretroviral drugs in developing nations.

Former President George W. Bush, whose President's Emergency Plan for AIDS Relief (PEPFAR) program committed $15 billion dollars for a five-year period in 2003, urged Americans to contribute despite their own economic woes.

"It's essential our country not retreat from the world, it's essential that we continue to show our compassion by funding programs that work," Bush told reporters ahead of the meeting, which opened Sunday.

The U.S. government provided the Global Fund with its founding contribution and has been its largest single donor since its inception in 2001.

(Editing by Richard Lough and Alessandra Rizzo)

View the original article here

FDA eyes stronger warning on popular birth control

WASHINGTON (Reuters) - Health officials are weighing stricter labels on the widely used new generation of birth control pills, based on data showing they may put women at a higher risk of dangerous blood clots.

U.S. Food and Drug Administration staff reviewed studies comparing an older generation of birth control with newer pills that contain the compound drospirenone, such as Bayer AG's popular Yaz and Yasmin.

In a report released on Tuesday, the reviewers said the body of evidence shows conflicting data on a link between pills containing drospirenone and blood clots, but the link could not be ruled out either and that fact may warrant a new label.

"Because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility," they said. A panel of outside experts advising the FDA is due to vote on the labels on Thursday.

Most common contraceptive pills combine the hormones estrogen and progestin, which help block ovulation and sperm. They can also increase the chance of a woman getting blood clots than if she didn't take birth control pills, particularly as she ages.

"While it's rare, it's heartbreaking when this happens. When there are safer options available, we can't let this continue," said Cynthia Pearson, executive director of the National Women's Health Network, one of several consumer advocacy groups that argue the drugs should be taken off the market entirely.

Drawing a definitive conclusion that adding drospirenone elevates the risk has been also complicated by the fact that risk of blood clots also goes up if a woman smokes, has clogged arteries, a family history or other health problems.

HIGHER RISK OF DANGEROUS CLOTS

An FDA study earlier this year found a higher risk of venous thromboembolisms (VTEs) in women, especially those younger than 35, who were taking Yasmin. A similar conclusion was drawn about Johnson & Johnson's Ortho Evra contraceptive patch, which does not contain drospirenone. FDA advisers will discuss Ortho Evra on Friday.

With VTEs, a blood clot occurs in one of the deep veins in the body, such as the leg or pelvis, and then travels to the lungs. The study also reported a higher risk of arterial thrombotic events, or ATEs, in older women on Yasmin. VTEs and ATEs can significantly increase the risk of strokes or death.

Court documents unsealed on Monday allege that Bayer failed to inform the FDA or the public about adverse VTE events linked to Yasmin before the drug was approved in May 2001. Former FDA Commissioner David Kessler is expected to testify in upcoming trials against Bayer that the company, Germany's largest drugmaker, withheld reports of dangerous blood clots.

Yaz, a reformulated version of Yasmin, remains one of the top-selling contraceptives in the United States. Bayer raked in $374 million in Yaz sales last year and twice as much at the peak of Yaz's popularity in 2009, according to data from IMS Health.

The number of prescriptions filled for Yaz also dropped more than by half to 5 million in 2010 from 11 million in 2009, according to IMS.

The company makes newer Beyaz and Safyral pills, versions of Yaz and Yasmin that add levomefolate to raise levels of folate, which is thought to help fertility.

Apart from preventing pregnancy, Yaz and Beyaz also have a secondary indication to treat moderate acne and symptoms of premenstrual dysphoric disorder, a severe mood problem.

In briefing documents for the FDA advisers, Bayer maintains that when used according to the label, benefits of using Yaz and its other drospirenone-containing pill outweigh the risks.

Labels now include a boxed warning that smoking increases the risk of serious cardiovascular problems, especially in women over 35. Warnings also highlight higher risk of blood clots associated with birth control pills.

(Additional reporting by Anna Yukhananov in Washington; Editing by Michele Gershberg and Steve Orlofsky)

View the original article here

US revisits safety of newer birth control drugs

WASHINGTON (AP) — Birth control drugs that were heavily promoted as having fewer side effects and the ability to clear up acne and other hormonal bothers are under new scrutiny from U.S. safety regulators.

Research suggesting that newer birth control formulations are more likely to cause blood clots than older drugs has prompted the Food and Drug Administration to consider new safety measures in meetings later this week. The increased risk is slight, but significant because blood clots can cause heart attacks, strokes and blockages in lungs or blood vessels, which can be fatal.

Regulators could order new warning labels on several contraceptives that gained popularity in the last decade, including Bayer's pill Yaz, which was the best-selling birth control pill in the U.S. for 2008 and 2009.

Yaz, its Bayer precursor Yasmin, and similar drugs use a version of a female hormone that appears to reduce side effects found in older drugs, including bloating and mood swings.

On Tuesday, a judge unsealed several court documents suggesting Bayer may have withheld data from the FDA about the blood clot risks of its drugs. The documents stem from expert opinion gathered by personal injury lawyers suing Bayer on behalf of patients.

A Bayer spokeswoman said the company had no comment on the material in the documents, noting the issues would be addressed at trial.

Bayer AG spent more than $270 million on TV and magazine advertisements for Yaz between 2007 and 2010, according TNS Media Intelligence. Such big-budget campaigns are rare for birth control products. One advertisement featured young women singing the Twisted Sister anthem, "We're Not Gonna Take It," while popping balloons labeled "moodiness," ''bloating" and "acne."

Sales of Yaz have fallen since regulators forced Bayer to correct advertisements that overstated Yaz's benefits and as safety questions drew scrutiny in both the U.S. and Europe.

FDA also is reviewing research on clot risks associated with Johnson & Johnson's weekly Ortho Evra patch, which is marketed as an "option for busy women who are looking to simplify life." The drug uses a different version of the female hormone progestin.

Millions of women have used the products since they launched a decade ago, but recent studies comparing the medical histories of women taking the newer drugs to older ones suggest a slightly higher risk of blood clots in the legs and lungs. Last year, the U.S. market for female contraceptive drugs totaled $3.4 billion, according to IMS Health.

Sorting out the blood clot risk of birth control drugs is especially difficult because all hormone-based drugs increase the risk of clotting. Further complicating the matter is that clots can be caused by factors such as smoking, obesity or family history.

Yaz, Yasmin and other pills containing a synthetic hormone called drospirenone are the focus of a discussion Thursday. The next day's meeting focuses on the Ortho Evra patch, which uses the hormone norelgestromin.

Bayer says its studies have shown no difference in blood clot risk between its drugs and the older birth control drugs. But several large, independent studies suggest the risk with Yaz and similar medications is slightly higher. The latest analysis by the FDA estimates the risk of a blood clot with drospirenone-containing pills is 1.5-fold higher than other hormone-based contraceptives. That translates into an estimated 10 in 10,000 women on the newer drugs experiencing a blood clot, compared with 6 in 10,000 women on older contraceptives, according to the FDA.

"It's a very small percentage of patients that develop these, but it's such a serious side effect that I think doctors have to use a lot of caution," said Dr. Jennifer Wu, of Lenox Hill Hospital in New York.

Even if Yaz and other newer drugs get additional warning labels some doctors say they don't expect to stop prescribing them. They point out that the risk of blood clots with any birth control pill is still far lower than that associated with pregnancy and birth, when hormone levels and reduced blood flow increase clotting risk.

"At the end of the day I tell my patients the absolute risk is still very, very low compared to pregnancy and post-partum risk," said Dr. Rebecca Starck, of Cleveland Clinic's Fairview Hospital. "There are still many benefits to combination birth control pills."

The Ortho Evra patch already carries warning labels about an increased risk of blood clots compared with pills. Some, but not all, studies suggest patch users have twice the risk of clots. The FDA will try to further define that risk using the latest data.

Most birth control drugs use a combination of two female hormones, estrogen and progestin, to stop ovulation and help block sperm. But for decades many women have reported bloating and mood swings as side effects.

Introduced in 2001, Yasmin was the first birth control pill to use a new form of progestin called drospirenone, which appeared to have fewer side effects. The reformulated version of the drug, Yaz, was approved in 2006 with approval to claim on the label that it decreased acne and a severe type of mood disorder.

Yaz quickly grew into the best-selling birth control pill in the U.S. Sales plummeted more than 50 percent in 2010, after the company was forced to run corrective TV and magazine advertisements. Among other problems, the FDA said the company's commercials suggested Yaz could treat premenstrual syndrome when it has only been shown to decrease incidence of premenstrual dysphoric disorder, a severe mood disorder associated with major depression. Yaz currently ranks fourth in sales among contraceptive pills in the U.S.

Newer drugs like Yaz are no more effective than older pills, generally allowing one unplanned pregnancy per year for every 100 women.

"Many women will do fine on the older generation drugs, but some women will not," said Dr. Petra Casey, of the Mayo Clinic. "I think the newer drugs help many women in terms of mood and the water retention."

About 4,000 lawsuits against Bayer argue that any additional risk with the newer drugs should have been detected and emphasized to the public.

View the original article here

FDA adviser: revise popular birth control labels

One is a healthy first-grader, the other an honors college student majoring in psychology. Once the tiniest babies ever born, both girls are thriving, despite long odds when they entered the world weighing less than a pound.

View the original article here

US health official says no to young teens on pill

WASHINGTON (AP) — The U.S. health secretary stopped the Plan B morning-after pill from moving onto drugstore shelves next to the condoms, deciding in a surprise move Wednesday that young girls should not be able to buy it on their own.

The Food and Drug Administration was preparing to lift a controversial age limit and make Plan B One-Step the U.S.'s first over-the-counter emergency contraceptive, available for purchase by people of any age without a prescription.

But Health and Human Services Secretary Kathleen Sebelius intervened at the eleventh hour and overruled her own experts.

Plan B instead will remain behind the pharmacy counter, as it is sold today — available without a prescription only for those 17 and older who show an ID proving their age.

Sebelius' reason: Some girls as young as 11 are physically capable of bearing children, and Plan B's Jerusalem-based maker did not prove that younger girls could properly understand how to use this product without guidance from an adult.

"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said in a statement. "I do not believe enough data were presented to support the application to make Plan B One-Step available over-the-counter for all girls of reproductive age."

It was the latest twist in a nearly decade-long push for over-the-counter sales of pills that can prevent pregnancy if taken soon enough after unprotected sex. Major doctors' groups and women's health advocates say easier, quicker access to those pills could cut the nation's high number of unplanned pregnancies.

The decision shocked maker Teva Pharmaceuticals, which had been gearing up for over-the-counter sales to begin by month's end, and women's health groups.

"We are outraged that this administration has let politics trump science," said Kirsten Moore of the Reproductive Health Technologies Project, an advocacy group. "There is no rationale for this move."

"What else can this be but politics?" said Cynthia Pearson, executive director of the National Women's Health Network, an advocacy group that supports making Plan B available to all ages. "It's not science. It's not medicine. It's not women's health."

Indeed, FDA Commissioner Dr. Margaret Hamburg made clear in her own statement that the decision is highly unusual. She said her agency's drug-safety experts had carefully considered the question of young girls and that she had agreed that Plan B's age limit should be lifted.

"There is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," Hamburg wrote.

But, she added, she had followed her boss' order to deny Teva's application.

"We commend the FDA for making the recommendation ... and we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion," said a statement Teva issued Wednesday.

The company said it would review the decision before determining next steps.

Already, the FDA's age limits have gone to court. In 2009, a federal judge said the agency had set them initially based on politics, not science, and ordered the agency to reconsider. A hearing already was scheduled for next week to consider whether the FDA should be held in contempt of court for not doing so earlier.

View the original article here

HHS says no to over-the-counter morning-after pill

WASHINGTON (AP) — In a surprise move, the nation's health secretary stopped the Plan B morning-after pill from moving onto drugstore shelves next to the condoms, deciding Wednesday that young girls shouldn't be able to buy it on their own.

The Food and Drug Administration was preparing to lift a controversial age limit and make Plan B One-Step the nation's first over-the-counter emergency contraceptive, available for purchase by people of any age without a prescription.

But Health and Human Services Secretary Kathleen Sebelius intervened at the eleventh hour and overruled her own experts.

Plan B instead will remain behind the pharmacy counter, as it is sold today — available without a prescription only for those 17 and older who show an ID proving their age.

Sebelius' reason: Some girls as young as 11 are physically capable of bearing children, and Plan B's maker didn't prove that younger girls could properly understand how to use this product without guidance from an adult.

"It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age," Sebelius said in a statement. "I do not believe enough data were presented to support the application to make Plan B One-Step available over-the-counter for all girls of reproductive age."

It was the latest twist in a nearly decade-long push for over-the-counter sales of pills that can prevent pregnancy if taken soon enough after unprotected sex. Major doctors' groups and women's health advocates say easier, quicker access to those pills could cut the nation's high number of unplanned pregnancies.

The decision shocked maker Teva Pharmaceuticals, which had been gearing up for over-the-counter sales to begin by month's end, and women's health groups.

"We are outraged that this administration has let politics trump science," said Kirsten Moore of the Reproductive Health Technologies Project, an advocacy group. "There is no rationale for this move."

"What else can this be but politics?" said Cynthia Pearson, executive director of the National Women's Health Network, an advocacy group that supports making Plan B available to all ages. "It's not science. It's not medicine. It's not women's health."

Indeed, FDA Commissioner Dr. Margaret Hamburg made clear in her own statement that the decision is highly unusual. She said her agency's drug-safety experts had carefully considered the question of young girls and that she had agreed that Plan B's age limit should be lifted.

"There is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," Hamburg wrote.

But, she added, she had followed her boss' order to deny Teva's application.

"We commend the FDA for making the recommendation ... and we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion," said a statement Teva issued Wednesday.

The company said it would review the decision before determining next steps.

Already, the FDA's age limits have gone to court. In 2009, a federal judge said the agency had set them initially based on politics, not science, and ordered the agency to reconsider. A hearing already was scheduled for next week to consider whether the FDA should be held in contempt of court for not doing so earlier.

View the original article here

Sebelius Blocks FDA Decision on 'Morning After' Pill

View the original article here

FDA advisers: Ortho Evra patch needs clearer label

ADELPHI, Maryland (Reuters) - U.S. drug advisers recommended that the label for Johnson and Johnson's Ortho Evra birth control patch be simplified to better explain the risk of blood clots.

In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. It is the only contraceptive patch sold in the United States.

The panel voted 19 to 5 that the patch's risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.

All commonly used birth control pills increase women's chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of hormone estrogen than a pill.

The current label, which has undergone numerous revisions over the past decade, has a boxed warning of a higher risk compared to older birth control pills. But a new FDA study earlier this year again showed that women using the patch were about 60 percent more likely to get dangerous blood clots.

The same group of advisers on Thursday recommended a more detailed description of blood clot risks and studies for a popular new generation of contraceptive pills, such as Bayer AG's Yaz and Yasmin.

Those pills contain the compound drospirenone, which has been linked to higher risk of venous and arterial thrombotic events, when a blood clot forms in a leg and can travel to the lung to cause stroke or even death. Ortho Evra does not contain that compound.

The FDA usually follows its advisers' recommendations.

J&J shares closed 1.2 percent higher at $64.53 on the New York Stock Exchange on Friday.

(Reporting by Alina Selyukh; editing by Andre Grenon)

View the original article here

US panel urges stronger labels on Yaz birth control

A panel of experts that advises the US Food and Drug Administration has urged stronger labeling on birth control pills such as Bayer's Yaz that have a shown a higher risk of blot clots.

Results of the 21-5 vote released late Thursday showed that most panel members found the current labels did not adequately reflect the risks and benefits.

The panel was divided on the question of whether the benefits of such pills outweigh the risks, with 15 saying "yes" and 11 saying "no."

At issue were pills that contain drospirenone, which studies have found carry a higher risk of blood clots than another type of progestin known as levonorgestrel.

Some brand names include Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah.

Many have been marketed on the basis they help alleviate premenstrual symptoms, reduce acne and cause less weight gain than competitors.

The pills have been the focus of numerous lawsuits, including one lodged earlier this year on behalf of a teenager who died from a blood clot allegedly linked to the German chemical and pharmaceutical company Bayer's Yaz contraceptive.

Two studies out this year in the British Medical Journal found that drugs like Yaz and Yasmin increase the risk of serious blood clots three-fold or two-fold compared to earlier-generation oral contraceptives.

The official Yaz website says the drug is associated with "increased risks of several serious side effects, including blood clots, stroke, and heart attack."

The European Medicines Agency concluded on May 27 that such birth control pills carry a higher risk of venous thromboembolism and that warning labels should be updated accordingly.

However, it noted the overall risk of blood clot from any birth control method remains small and stopped short of advising women to stop taking pills containing drospirenone.

Yaz is the second biggest selling product made by the German pharmaceutical giant Bayer, with $1.56 billion in global sales.

The FDA does not have to follow the advice of the advisory panel but it usually does.

View the original article here

FDA advisers: revise popular birth control labels

ADELPHI, Maryland (Reuters) - U.S. health advisers recommended a revision of labels for the widely used new generation of birth control pills, based on data showing they may put women at a higher risk of dangerous blood clots.

Although all common birth control pills increase women's chances of getting blood clots, concerns have recently been mounting about an even higher risk linked to a newer generation of pills that contain the compound drospirenone, such as Bayer AG's popular Yaz and Yasmin.

Outside experts advising the Food and Drug Administration on Thursday, in a 21-5 vote, agreed that the current, rather complex label does not adequately help women and doctors understand the risks and benefits of such pills.

"(The label) is incredibly hard for physicians to read and if we think that patients are reading these and understanding these before making their decisions, we're delusional," said panel member Dr. Peter Kaboli, associate professor of internal medicine at the University of Iowa Caver College of Medicine.

Nonetheless, in a very close vote of 15 to 11, the panel concluded that benefits of preventing unwanted pregnancies did outweigh the risks.

A number of studies have been conducted on Bayer's Yasmin, the first drospirenone-containing contraceptive to be approved in the United States in 2001. And overall, the evidence is conflicting whether the compound indeed raises the chances of developing potentially fatal blood clots - something that made some panelists reluctant to seek drastic changes to the label.

However, several panel members pointed out that only Bayer-sponsored studies seemed to find Yasmin equally safe as other birth control pills.

"I found that disturbing," said Dr. Maria Suarez-Almazor, a professor at the University of Texas MD Anderson Cancer Center, to applause from numerous women's advocates and patients.

Many of them earlier tearfully recounted sudden deaths and life-changing disabilities they or their loved ones suffered from blood clots they believe were caused by Yaz or Yasmin.

"Most people only see the watered-down label ... We know that labels just don't change behavior," said Cynthia Pearson, executive director of the National Women's Health Network, one of several consumer advocacy groups that argue the drugs should be taken off the market entirely.

FDA REVIEW

FDA's own study earlier this year found that women taking Yasmin were about twice as likely to develop venous or arterial thrombotic events (VTEs and ATEs) than women on older birth control. The risk of VTEs was especially higher in women under 35 while risk of ATEs was higher in women older than 35.

With VTEs, blood clots occur in one of the deep veins in the body, such as the leg or pelvis, and then may travel to the lungs, which could lead to stroke or death.

The FDA study also estimated that 10 in 10,000 women taking the newer drug would get a blood clot per year, compared with about six in 10,000 women taking older contraceptives.

Drawing a definitive conclusion that drospirenone elevates the blood clot risk has been complicated by the fact that the risk also increases if a woman smokes, has extra weight, clogged arteries, a family history or other health problems.

FDA's scientists in their review released on Tuesday suggested that, despite conflicting data, the pills' labels should better reflect all the evidence. The FDA usually follows the advice of its advisory panels.

The FDA study raised a similar concern of a blood clot risk about Johnson & Johnson's Ortho Evra contraceptive patch, which does not contain drospirenone. FDA advisers will discuss Ortho Evra on Friday.

POPULAR PILL

Yaz, a reformulated version of Yasmin, remains one of the U.S. top-selling contraceptives. Bayer raked in $374 million in Yaz sales last year, according to data from IMS Health.

However, that's only about half of what Bayer made off Yaz at the peak of its popularity in 2009. The number of prescriptions filled for the pill also dropped more than by half to 5 million in 2010 from 2009, according to IMS.

Apart from preventing pregnancy, Yaz and Beyaz also have a secondary indication to treat moderate acne and symptoms of premenstrual dysphoric disorder, a severe mood problem.

The company also makes newer Beyaz and Safyral pills, versions of Yaz and Yasmin that add levomefolate to raise levels of folate, which is thought to help fertility.

The current labels for Bayer's family of pills now include a boxed warning that all birth control pills carry, that smoking increases the risk of serious cardiovascular problems, especially in women over 35.

Warnings also highlight higher risk of blood clots associated with birth control pills and present an overview of studies looking at that risk.

"This language goes heavily toward the positive side and is dismissive of conflicting results," said Jacqueline Gardner, a University of Washington professor. "I think that needs to be corrected."

(Editing by Gary Hill and Andre Grenon)

View the original article here

FDA favors more risk info on birth control pills

WASHINGTON (AP) — Federal health regulators are leaning toward adding new information about the risk of blood clots to the labels of widely prescribed birth control pills such as Yaz, in light of growing evidence that the newer contraceptive drugs may be riskier than older drugs.

In documents released Tuesday, the Food and Drug Administration said there is conflicting evidence about the risk, but that the information should appear in labeling used by doctors and patients.

"We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility," state the briefing documents from FDA scientists.

On Thursday, the FDA will ask a panel of outside experts to weigh in on the issue and to consider whether some women should not take the drugs. The agency is not required to follow the panel's advice, though it often does.

Yaz and several other pills contain a manmade hormone called drospirenone which was heavily marketed as carrying fewer side effects than earlier drugs.

But over the last two years several large, independent studies have suggested the rate of blood clots with drospirenone-containing drugs is slightly higher than with other hormone-based contraceptives. The most recent analysis by FDA estimates that 10 in 10,000 women on the newer drugs will experience a blood clot per year, compared with 6 in 10,000 women on older contraceptives.

Studies conducted by German drugmaker Bayer, which markets Yaz and related pill Yasmin, found no increased risk of blood clots. Sorting out the blood clot risk of birth control drugs is especially difficult because all hormone-based drugs increase the risk of clotting. Further complicating the issue is that clots can be caused by lifestyle factors such as smoking, obesity and family history.

FDA scientists say none of the existing studies provide a definitive answer and that new studies are needed.

"The entire body of studies provides conflicting evidence that cannot be easily reconciled by any single difference among studies," states the agency's review.

Looking across the half-dozen studies available, FDA scientists say the risk of blood clots appears most likely in the first 3 to 6 months taking a drug, and increases among older women.

Most birth control drugs use a combination of two female hormones, estrogen and progestin, to stop ovulation and thicken cervical mucus, which helps block sperm. For decades many women have reported bloating and mood swings as side effects.

Introduced in 2001, Yasmin was the first birth control pill to use a new form of progestin called drospirenone, which appeared to have fewer side effects. The reformulated version of the drug, Yaz, was approved in 2006 with new claims on the label that it decreased acne and a severe type of mood disorder. With the slogan, "beyond birth control," Bayer's advertisements pitched Yaz to women in their 20's as an alternative to older generations of contraceptives. One advertisements featured young women singing the Twisted Sister anthem, "We're Not Gonna Take It," while popping balloons labeled "moodiness," ''bloating" and "acne."

Within two years, Yaz had grown into the best-selling birth control pill in the U.S. with peak sales of $781 million in 2009, according to data from IMS Health. But sales plummeted more than 50 percent the following year after the company was forced to run corrective TV and magazine advertisements. The FDA said the company's commercials suggested Yaz could treat premenstrual syndrome. In fact, the drug has only been shown to decrease incidence of a much more serious mood disorder called premenstrual dysphoric disorder. Additionally, the FDA said Bayer's commercials used distracting music and visuals to downplay the drug's list of side effects.

In the first half of this year, Yaz ranked fourth among contraceptive pills sold in the U.S., behind Warner Chilcott's Loestren, Johnson & Johnson's Ortho Tri-Cyclen and a generic version of Yaz marketed by Teva Pharmaceuticals, according to IMS Health.

Newer drugs like Yaz are no more effective than older pills, generally allowing one unplanned pregnancy per year for every 100 women.

View the original article here

Obama: Morning-after pill decision 'common sense'

WASHINGTON (AP) — President Barack Obama on Thursday defended his health secretary's decision to stop the Plan B morning-after pill from moving onto drugstore shelves next to the condoms.

"As the father of two daughters," he said, "I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine." The president spoke the morning after his administration stunned major doctors' groups and women's health advocates with the decision.

Plan B is a pill that can prevent pregnancy if taken soon enough after unprotected sex. Health and Human Services Secretary Kathleen Sebelius overruled scientists at the Food and Drug Administration who were preparing to let Plan B sell without a prescription to people of any age. Sebelius decided that young girls shouldn't be able to buy the pill on their own, saying she was worried about whether 11-year-olds would know how to use it properly.

Obama said Sebelius made that decision on her own. But he said he thought she was worried about young girls experiencing harmful side effects, saying "I think most parents would probably feel the same way.

For now, Plan B will stay behind pharmacy counters, available without a prescription only to those 17 and older who can prove their age.

Sebelius' decision is "medically inexplicable," said Dr. Robert Block of the American Academy of Pediatrics, one of a number of major medical groups that contends over-the-counter access to emergency contraception would lower the nation's high number of unplanned pregnancies.

Pediatricians say the morning-after pill is safe — containing a high dose of the same female hormone that's in regular birth control pills — especially compared to some existing over-the-counter medicines.

"I don't think 11-year-olds go into Rite Aid and buy anything," much less a single pill that costs about $50, added fellow AAP member Dr. Cora Breuner, a professor of pediatric and adolescent medicine at the University of Washington.

Instead, putting the morning-after pill next to the condoms and spermicides would increase access for those of more sexually active ages "who have made a serious error in having unprotected sex and should be able to respond to that kind of lack of judgment in a way that is timely as opposed to having to suffer permanent consequences," she said.

The move has election-year implications and angered many Democrats. Sen. Patty Murray of Washington, a member of the Senate leadership, already was asking Sebelius to explain her decision. But it also could serve to illustrate to independents, whose support will be critical in next fall's presidential election, that Obama is not the liberal ideologue Republicans claim.

Nor will this end the emergency contraception saga. In 2009, a federal judge said the FDA had let politics, not science, drive its initial behind-the-counter age restrictions and said it should reconsider. At a hearing scheduled in federal court in New York next Tuesday, the Center for Reproductive Rights will argue the FDA should be held in contempt.

Sebelius' decision pleased conservative critics.

"Take the politics out of it and it's a decision that reflect the concerns that many parents in America have," said Wendy Wright, an evangelical activist who helped lead the opposition to Plan B.

"This is the right decision based on a lack of scientific evidence that it's safe to allow minors access to this drug, much less over-the-counter," said Sen. Chuck Grassley, R-Iowa.

FDA Commissioner Dr. Margaret Hamburg made clear that the decision is highly unusual. She said her agency's drug-safety experts had carefully considered the question of young girls and she had agreed that Plan B's age limit should be lifted.

"There is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential," Hamburg wrote.

But Sebelius said maker Teva Pharmaceuticals hadn't proved that the very youngest girls who might try Plan B would understand how to use it properly.

A Teva-funded study tracked 11- to 17-year-olds who came to clinics seeking emergency contraception. Nearly 90 percent of them used Plan B safely and correctly without professional guidance, said Teva Vice President Amy Niemann. But Teva wouldn't say how many of the youngest girls were part of the study.

The company was determining its next steps.

Taking Plan B within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent. But it works best within the first 24 hours. There are two other emergency contraception pills: a two-pill generic version named Next Choice that also is sold behind the counter, and a prescription-only pill named ella.

If a woman already is pregnant, the morning-after pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn't begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus.

___

Associated Press writer Ricardo Alonso-Zaldivar contributed to this report.

View the original article here

FDA Panel Cites Clot Risk From Contraceptive Patch

MONDAY, Dec. 12 (HealthDay News) -- An advisory panel to the U.S. Food and Drug Administration on Friday said that the Ortho Evra birth control patch carries a higher risk of blood clots for women compared to older methods, but should not be taken off drug store shelves.

The panel, which based its decision on the results of a new review of the data, voted 19 to 5 that the benefits of Johnson & Johnson's Ortho Evra patch exceed its risks, which included a higher risk for blood clots lodging in the legs or lungs.

The panelists felt that the patch, first approved in 2001, remains a valuable option for those younger women who find it tough to stick to a daily regimen of the 'Pill,' the Associated Press reported.

"I have many teenagers and it's the only method they'll use -- for them it's the perfect method," Dr. Melissa Gilliam of the University of Chicago, told the AP.

The panel did vote 20 to 3 (with one abstention) that the patch's labeling requires updating to better inform women of the higher risk for clots.

Studies on risks associated with the patch have had conflicting results. The most recent study by the FDA found a 50 percent higher risk for clots for women on the Ortho Evra patch versus those on various forms of the 'Pill.' But FDA scientists stressed that the data was not conclusive, the AP said.

The news agency said that prescriptions for Ortho Evra have waned over the past five years, from 5 million in 2006 to around 1.3 million in 2010.

Friday's announcement followed on the heels of a decision by the same FDA-appointed panel on Thursday that several newer forms of oral contraceptives carry revised labels warning about an increased risk of potentially fatal blood clots.

The U.S. Food and Drug Administration advisers voted 21-5 in favor of the new labels for oral contraceptives such as Bayer's Yaz or Yasmin. Both contain a newer type of man-made progestin hormone called drospirenone, which could increase the chances of dangerous clots in the legs or lungs, compared to older forms of oral contraceptives. The newer contraceptives have been successfully marketed on the premise that they have fewer of the unwanted side effects of older hormone pills such as bloating, mood swings and acne.

Speaking ahead of the decision, Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York City, said that the risk of clotting with the newer pills is "a low risk but the risk exists. The idea of the FDA looking at this and potentially increasing the warning has no downside. If anything, it increases awareness and that can only be a good thing."

Earlier Thursday, the panel members voted 15 to 11 that the newer contraceptives, which gained initial FDA approval in 2001, are a viable method of birth control, and that the benefits of preventing pregnancy outweigh the health risks.

While the FDA isn't obligated to follow the recommendations of its advisory panels, it usually does so.

More information

The U.S. Department of Health and Human Services has more about birth control at womenshealth.gov.

View the original article here

Analysis: U.S. focus on birth control may raise new concerns

WASHINGTON (Reuters) - A ruling last week on the morning-after pill, as well as government recommendations on new forms of birth control, could have long-lasting effects on women's perceptions of its safety, health experts say.

Last Wednesday, the health secretary for the first time overruled government scientists, refusing to make the morning--after pill available to users of all ages without a prescription.

In the days that followed, advisers to the Food and Drug Administration recommended revised labels on the best-selling class of birth control pills, as well as for a contraceptive patch, to better convey their higher risk of blood clots.

Some women's advocacy groups worried the negative attention on the blood clot risk of a new generation of pills that contain drospirenone -- including Bayer AG's popular Yaz and Yasmin -- would create concerns about birth control in general.

An FDA study estimated that 10 in 10,000 women taking the drospirenone-containing drugs would get a blood clot per year, compared with about six in 10,000 women taking older contraceptives.

A clot in the blood vessels can prove fatal if it breaks loose and travels to the lungs, heart or brain.

"If you've seen on TV somebody crying that their daughter died taking birth control pills, and you're a mom, you may not remember the (particular) birth control pill," said Diana Zuckerman, president of the National Research Center for Women & Families. "You'll just say you can't be on it to your daughter."

While Zuckerman and others called for the drospirenone-containing pills to be removed from the market because women have safer options available, Planned Parenthood said the pills should remain on sale.

Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America, said that when the issue of blood clots first arose in 1995 with a new generation of pills in Britain, many women abandoned birth control altogether, leading to higher rates of unwanted pregnancies or abortions.

"What we know is that a focus by the media on meetings such as this carries the risk of creating panic among everyday women and also healthcare providers who may not be knowledgeable about why the meetings are being held and the data that is conveyed during the actual meetings," Cullins told Reuters.

MORE CONVERSATIONS

The better outcome of a new focus on birth control may be to encourage women to question their doctors more thoroughly about the best kind of contraception for them, others said.

Dr. Valerie Montgomery Rice chaired the FDA panel on Friday, which recommended that the label for Johnson and Johnson's Ortho Evra birth control patch be simplified to better explain the risk of blood clots.

The attention "is going to raise concerns but I hope that it does more than just that, (that it) raises awareness and pushes women to have more thorough conversations with their providers," said Rice, dean and executive vice president of the Morehouse School of Medicine.

A study from the non-profit Guttmacher Institute that drew on government data showed 47 percent of sexually-active teenagers were using hormonal contraceptives in 2008-10, compared to 37 percent in 2006-08.

Joyce Brink, 80, said she would still advise her daughters, both mothers in their 50s, and her 12- and 13-year-old granddaughters to take the pill if advised by their doctors.

"There are all sorts of side effects of almost any medication," said Brink, who was visiting Washington on Friday from Nevada. "Women have to protect themselves."

But for some, the week's events simply reinforce just how far what happens in Washington is removed from the daily lives of women.

Dr. Michele Curtis, an obstetrician and gynecologist at the University of Texas-Houston Medical School, said this week's moves would not change her opinion on birth control or what she prescribes to her patients.

"I don't think any of the stories this week should change somebody's opinion of the risk that combined contraceptives pose," she said, pointing out that the blood clot risks of the new generation of pills was known before the FDA's meetings.

"You can label it differently to try to protect yourself from the attorneys. But I'm not sure that's going to make a difference to physicians.

"All I want to know is whether it'll do more harm than good," Curtis said.

Some advocates said the morning-after pill decision by Health Secretary Kathleen Sebelius would dominate headlines, erasing any broader message from the FDA meetings about the safety of all birth control pills.

Sebelius' decision also sounded a contrary note to her other policies, including a decision in August to mandate insurance coverage of birth control, including the morning-after pill.

They said Sebelius's ruling to limit the morning-after pill to women 17 and older goes against President Barack Obama's pledge to reassert the power of science in his administration's decisions. Obama said a day later that he supported the decision.

Critics say the morning-after-pill -- meant to be taken up to 72 hours after unprotected sexual intercourse to prevent a pregnancy -- could lead to promiscuity, sexual abuse and fewer visits to the doctor if it is readily available for purchase.

"The scientific review that happened at the FDA is completely overshadowed in the larger message that birth control gets politicized all the time," said Kirsten Moore, president and CEO of the Reproductive Health Technologies Project, an advocacy group in favor of giving women more contraceptive options.

"The majority of the news that's going to break through is about contraception being political, rather than whether it's safe or not."

(Reporting By Anna Yukhananov and Alina Selyukh, additional reporting by Lily Kuo; editing by Michele Gershberg and Bill Trott)

View the original article here

FDA advisers: Ortho Evra patch needs clearer label

ADELPHI, Maryland (Reuters) - U.S. drug advisers recommended that the label for Johnson and Johnson's Ortho Evra birth control patch be simplified to better explain the risk of blood clots.

In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. It is the only contraceptive patch sold in the United States.

The panel voted 19 to 5 that the patch's risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.

All commonly used birth control pills increase women's chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of hormone estrogen than a pill.

The current label, which has undergone numerous revisions over the past decade, has a boxed warning of a higher risk compared to older birth control pills. But a new FDA study earlier this year again showed that women using the patch were about 60 percent more likely to get dangerous blood clots.

The same group of advisers on Thursday recommended a more detailed description of blood clot risks and studies for a popular new generation of contraceptive pills, such as Bayer AG's Yaz and Yasmin.

Those pills contain the compound drospirenone, which has been linked to higher risk of venous and arterial thrombotic events, when a blood clot forms in a leg and can travel to the lung to cause stroke or even death. Ortho Evra does not contain that compound.

The FDA usually follows its advisers' recommendations.

J&J shares closed 1.2 percent higher at $64.53 on the New York Stock Exchange on Friday.

(Reporting by Alina Selyukh; editing by Andre Grenon)

View the original article here

FDA advisers stand behind Ortho Evra patch

One is a healthy first-grader, the other an honors college student majoring in psychology. Once the tiniest babies ever born, both girls are thriving, despite long odds when they entered the world weighing less than a pound.

View the original article here