By Maggie Fox, Senior Writer, NBC News on Vitals

  • New SARS cousin finally has a name : MERS

    Cynthia Goldsmith / Maureen Metc / CDC

    Novel MERS coronavirus particles as seen by negative stain electron microscopy.

    Every virus needs a catchy name, and now the new coronavirus linked to the Middle East that has infected 40 people and killed half of them has one: Middle East Respiratory Syndrome Coronavirus or (MERS-CoV).

    Various scientists have been calling it MERS, but the Coronavirus Study Group, which groups experts from around the world, made it official on Thursday.

    “This name is endorsed by the discoverers of the virus and other researchers that pioneered MERS-CoV studies, by the World Health Organization and by the Saudi Ministry of Health. We strongly recommend the use of this name in scientific and other communications,” the group, led by Raoul de Groot of Utrecht University in the Netherlands, wrote in the Journal of Virology.

    The issue of naming viruses can be touchy. Usually, countries don’t want their names associated with diseases, and often geographical regions don’t either. That’s why names such as the “Hong Kong flu” aren’t used any more -- now influenza viruses carry genetic names such as H1N1 or H7N9.

    The MERS coronavirus is clearly linked to the Middle East, however. All patients have either been in, or have traveled to, Jordan, Qatar or Saudi Arabia -- or they have been infected by travelers from those countries. Cases have been seen in France, Germany and Britain.

    Researchers worried about what to name SARS when it broke out in 2003. It was first seen in China, but the World Health Organization finally settled on the name severe acute respiratory syndrome, or SARS. At the time it was named, expert had not yet figured out precisely what type of virus it was.

    The new MERS virus is a distant cousin of SARS. Coronaviruses are a big family and they usually cause common cold-like symptoms in people. MERS appears to have come from bats, de Groot’s group reports.

    “The novel coronavirus seems most closely related to as yet unclassified viruses from insectivorous European and African bats in the Vespertilionidae and Nycteridae families, respectively,” they write.  It’s unlikely most patients were directly infected by bats, however, the Coronavirus Study Group said.  Bats have probably infected some other animal, which in turn is infecting humans, they said.

    But the virus can transmit from person to person, especially in hospitals, and that worries health officials. SARS spread easily in hospitals when it flashed around the world, infecting close to 8,000 people and killing 775 of them, before it was stopped.

    There’s no vaccine against MERS and antiviral drugs don’t appear to be of much use against it, either. The Centers for Disease Control and Prevention has told U.S. hospitals to take strict precautions if someone shows up with symptoms and has recently traveled to the Middle East. Health care workers in contact with such patients should wear special face masks, gloves and gowns and follow other protocols to protect themselves and other patients.

    The World Health Organization says there are more questions than answers about MERS. “We know this virus has infected people since 2012, but we don't know where this virus lives,” WHO says in a statement on its website.

    “We know that when people get infected, many of them develop severe pneumonia. What we don't know is how often people might develop mild disease. We also know that most of the persons who have been infected so far have been older men, often with other medical conditions. We are not sure why we are seeing this pattern and if it will change over time,” WHO added.

    “The greatest global concern, however, is about the potential for this new virus to spread.”

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  • Attention deficit leads US kids' mental health problems, CDC reports

    Getty Images via CDC

    CDC's most comprehensive look yet at mental health shows ADHD affects close to 7 percent of US kids.

    The most comprehensive report on specific mental disorders in children shows attention deficit hyperactivity disorder (ADHD) is the most commonly diagnosed problem in kids aged 3-17, with close to 7 percent of kids having a diagnosis.

    Another 3.5 percent have behavioral problems, 3 percent have anxiety and 1.1 percent have autism. For teenagers, addiction to drugs, alcohol and tobacco are the most common issues, the Centers for Disease Control and Prevention reported on Thursday.

    These percentages translate into millions of children, said CDC’s Ruth Perou, who put the study together. She found that 6.8 percent of U.S. children have ADHD. “That’s about 4.18 million children,” Perou told NBC News.

    “This first report of its kind documents that millions of children are living with depression, substance use disorders, ADHD and other mental health conditions,” CDC director Dr. Tom Frieden said in a statement.

    “No parent, grandparent, teacher or friend wants to see a child struggle with these issues. It concerns us all. We are working to both increase our understanding of these disorders and help scale up programs and strategies to prevent mental illness so that our children grow to lead productive, healthy lives.”

    It adds up to a lot of kids. “It is estimated that 13 –20 percent of children living in the United States (up to 1 out of 5 children) experience a mental disorder in a given year and an estimated $247 billion is spent each year on childhood mental disorders,” the report reads.

    The report takes data from many other surveys. The estimates on autism spectrum disorder might not be quite up to date. In March, CDC published a survey showing 2 percent of U.S. schoolkids – or about a million children – have been diagnosed with some sort of autism.

    Thursday’s report was finished before that latest data came out, Perou said.

    Behavioral disorders affect 2.1 million children, Perou says. “We are not looking at whether kids misbehave or are having a bad day,” she said. “What we are talking about is a child incapable of behaving well or playing well with others.”

    Children with a diagnosed behavioral disorder, such as oppositional defiance disorder, have constant conflicts with authority that affect their ability to attend school. “They are having such challenges in how they are dealing with emotions or behavior that it impairs their ability to lead their day-to-day lives,” Perou said.

    The survey confirms a lot of what experts already knew: autism, conduct disorders and ADHD are more common among boys; depression is more common among girls. More children were diagnosed as they got older.

    The data on adolescents aged 12 to 17 show a million teenagers are drug or alcohol abusers, and more than 695,000 are addicted to tobacco. This doesn’t mean casual use or experimentation, but serious addiction, Perou said. “You are looking at something that is debilitating and really impairs their ability to function day to day,” she said.

    The good news is that there are treatments for all the disorders, Perou said, and CDC is working to help come up with more approaches that work. “We can make a difference in their lives,” she said.

    CDC has information for teachers and parents on spotting mental illness in kids.

    The definitions for all the disorders come from the DSM-IV, the guide used by mental health professionals to diagnose and classify disease. A new version, the DSM-V, comes out Friday, and many of the changes have been widely leaked.

    Thursday’s report will set a baseline, so that changes in classifying mental health issues that come from changes in the DSM-V can be tracked, Perou said.

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  • No. 1 swimming pool problem? It's number two!

    Mario Tama / Getty Images

    A lifeguard keeps watch on opening day of the McCarren Park Pool, June, 2012 in Brooklyn. CDC researchers found evidence of feces in many US pools.

    People always worry about pee in the pool, but number two is the No. 1 problem, government health experts say. They found plenty of evidence that someone’s pooping in the pool.

    It’s not only disgusting, but it’s evidence that people are not following basic hygiene rules, says Michele Hlavsa, chief of the Centers for Disease Control and Prevention’s Healthy Swimming Program.

    “It is time to stop treating the swimming pool as a toilet,” Hlavsa told NBC News. “Nowhere else except for the pool is it acceptable to poop in public or pee in public. In other places if we did this in public, we’d be arrested.”

    CDC and county health officials tested the pools in four Georgia counties last summer for the study. They got water out of the pool filters and ran tests for microbes – especially E. coli, which lives inside the bodies of animals and which is carried in feces. If E. coli is somewhere, it likely got there via feces.

    Escherichia coli, a fecal indicator, was detected in 93 (58 percent) samples; detection signifies that swim­mers introduced fecal material into pool water,” Hlavsa’s team wrote in CDC’s weekly report on disease and death.

    “We don’t know how it got in there. It either washed off somebody’s body or somebody had a bowel movement in the pool,” Hlavsa said.

    Regular bowel movements – what CDC delicately refers to as a “formed fecal incident” – isn’t so much a worry. But diarrhea is. Diarrhea carries the germs that caused the illness right into the water, and the chlorine doesn’t kill it instantly.

    The good news is that there were no reports of sickness outbreaks at any of the pools tested last summer – or anywhere else in Georgia last summer, for that matter, Hlavsa says. But every year there are between 20 and 80 disease outbreaks associated with public pools – and those are just the ones that get reported, Hlavsa says.

    The other piece of good news is that there weren’t too many other pathogens in the pools. Only one sample of Cryptosporidium, a common cause of diarrhea, showed up. Two samples of a parasite called Giardia were found – that one can cause a very uncomfortable stomach upset. Viruses such as adenovirus, which causes colds, and norovirus, which causes "stomach flu," can survive in swimming pools.

    The E. coli in the pool didn’t necessarily come from a bowel movement, Hlavsa said -- and this is why it’s important to actually obey the signs that virtually everyone ignores about showering before going into the pool.

    “The average person has about .14 grams of feces on their rear end,” Hlavsa said. “If that rinses off into the water, the amount from one person might not be that much. But as more and more swimmers introduce it that much, it does become an issue.”

    She’s actually done the math.

    “Let’s imagine 1,000 kids go to a water park. They have as much as 10 grams of feces on their rear ends,” she said.  “We are now talking about 10,000 grams or 10 kg. That translates to 24 pounds of poop in the water.”

    So one important rule – never swallow the water from a swimming pool. “Basically, these pools are big bathtubs we all share together,” Hlavsa said.

    She doesn’t want to scare anyone away from swimming, which is, after all, a great way to exercise. “As soon as the weather gets warm enough here in Atlanta, I plan to swim,” Hlavsa said.

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  • Doctors doubt nurses skills, survey finds

    Nurse practitioners are staffing retail health clinics, diagnosing and treating ills from strep throat to conjunctivitis. They’re giving flu shots and prescribing drugs. And the influential Institute of Medicine says they should not only work side by side with physicians, but replace them in some cases.

    But a survey published on Wednesday shows a huge gap between what nurse practitioners think they can and should do, and what doctors think. And that’s bad news for patients, Karen Donelan of the Mongan Institute for Health Policy at Massachusetts General Hospital says.

    “We were surprised by the level of disagreement reported between these two groups of professionals," says Donelan, who led the survey published in the New England Journal of Medicine.

    Her team’s survey of 467 nurse practitioners and 505 physicians found both groups agree that nurse practitioners should practice “to the full extent of their education and training.” Where the disconnect comes is just what this training should allow them to do, and how much they should get paid for it.

    Only 17 percent pf physicians agreed that nurse practitioners should coordinate a patient’s care as a leader of a “medical home”, versus more than 82 percent of the nurse practioners, the survey found. And only 3.8 percent of doctors felt that a nurse practitioner should be paid the same for providing the same service as a physician, compared to 64 percent of the nurse-practitioners.

    “At the core of the controversy is whether nurse practitioners have the education and experience to provide high-quality services and lead clinical practices without supervision by a physician,” Donelan’s team wrote.

    The Institute of Medicine tried to settle that question in a 2010 report, saying that nurses can handle much of the strain on the health care system and should be given both the education and the authority to take on more medical duties.

    But the American Medical Association, which represents about 120,000 practicing physicians and students, rejected the idea immediately.

    "Nurses are critical to the health care team, but there is no substitute for education and training," the AMA said at the time.

    The Association of American Medical Colleges estimates that by 2015, the United States will be short about 62,100 physicians. Many experts are looking to the 180,000 nurse practitioners now in the field to help cover the gaps.

    When the Robert Wood Johnson Foundation set up a series of meetings among doctors’ and nurses’ guilds to try to smooth out the disagreements in 2011, things looked up until the organizers issued a report urging less hierarchy, says John Iglehart of the journal Health Affairs in a separate commentary in the New England Journal. “The `captain of the ship' notion  … needs to be eliminated, focusing on the patient as the driver of care,” the report read. “A physician, nurse, social worker or other provider may take the lead in a given situation.’

    The American Academy of Family Physicians,  American Osteopathic Association and the American Academy of Pediatrics pulled out and the whole attempt collapsed, Iglehart says.

    Dr. David Blumenthal and Melinda Abrams of the Commonwealth Fund said the survey confirmed that doctors and nurse practitioners often “inhabit different universes”.  And clearly they have different training and skills. Nurse practitioners, often referred to as advanced practice registered nurses, usually have a four-year bachelor's degree with at least a master's degree and sometimes a doctorate beyond that, depending on the requirements of their state.

    But nurse practitioners can fill the growing gap in the supply of health care prviders for the U.S., they argued. “The existing literature shows that nurse practitioners provide care similar to that of physicians with respect to health outcomes, resource utilization, and cost, and the same studies show that nurse practitioners get higher grades than physicians with respect to communication with patients seeking urgent care,” they wrote.

    Jan Towers, policy director for the American Association of Nurse Practitioners, saw it coming. “There is nothing surprising there,” she said in a telephone interview. “The disconnect has been there a long time.”

    She thinks relationships will improve as doctors and nurse practitioners work together more. A bigger issue, Towers says, is the way the U.S. healthcare system pays for care. “How do we institute value-based purchasing so that we look at outcomes rather than who is performing the task?” she asked.

    Once the medical system evolves toward taking care of a patient’s health, instead of the current system of paying for each individual test, treatment or consultation, the differences should even out, she predicts.

    Donelan isn’t so hopeful. “Our findings suggest that a substantial number of primary care physicians are unlikely to embrace policy recommendations aimed at further expansion of the roles and supply of nurse practitioners,” her team wrote.

    “In particular, physicians' concerns about the likely effect of an expanded workforce of nurse practitioners on several aspects of health care quality need to be addressed in discussions of strategy for the development of the U.S. health care workforce.”

    Peter Buerhaus, director of the Center for Interdisciplinary Health Workforce Studies at Vanderbilt University and a registered nurse with a Ph.D who worked on the survey team, agreed.

    "It is unsettling that primary care physicians and nurse practitioners, who have been practicing together for several decades, seem so far apart in their perceptions of each other's contributions. I am concerned that these large gaps in perceptions will inhibit efforts to redesign care delivery and to improve the productivity and configuration of the primary care workforce,” Buerhaus said in a statement.

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  • Cloning technique produces human stem cells for the first time

    Oregon Health&Science University

    Donor egg held by pipette prior to nuclear extraction.

    Researchers say they have finally managed to use cloning technology to make human embryos and grow stem cells from them in the hopes of making perfectly matched grow-your-own tissue transplants.

    They used a human egg cell and parts of a human skin cell to grow a very early human embryo, then transformed cells from this ball of cells into beating heart cells and skin cells. The process may eventually help treat a range of diseases, from Parkinson’s to rare inherited conditions, they reported Wednesday in the journal Cell.

    The researchers, at Oregon Health & Science University, say their embryos almost certainly could not grow into living human babies or even start a pregnancy – they’re deficient in a key way. But they admit also that they haven’t quite overcome ethical qualms about working with human embryos.

    However, the work opens another route to treatments using human embryonic stem cells, the body’s master cells. “These stem cells are kind of very early unprogrammed cells but they have the capacity to become any other cell type,” says Shoukhrat Mitalipov, who led the research.

    These cells are very different from so-called adult stem cells, like those taken from bone marrow. Adult stem cells cannot give rise to cells of other tissue types -- blood cells cannot be used to make brain cells, for instance.

    Dr. George Daley, a stem cell expert at Harvard Medical School, called it a "beautiful piece of work".

    When human embryonic stem cells were first discovered in 1998, scientists immediately dreamed of using cloning technology to help people grow their own organ and tissue transplants, and to use them to study disease. They’d be perfect genetic matches for each patient, meaning an end to a lifetime of taking dangerous immune-suppressing drugs after an organ transplant.

    But in the many years since, no lab’s been able to do the work easily. It seems it is much harder to clone a human being than it is to clone a sheep, a frog or a mouse. And then there are the ethical concerns, not only concerns about cloning human beings but over working with human embryos. A federal court has only just ruled in the past year that government funds may be used in the research.

    Scientists have found several other routes to harnessing the power of these master cells, which can give rise to any tissue type in the body, from nerve cells to muscle, bone and skin. There are cells taken from embryos left over at fertility clinics – currently being tested as treatments for blindness by a company, Advanced Cell Technology of Massachusetts.

    Oregon Health & Science University

    Researchers at Oregon Health & Science University have successfully developed a method for converting human skin cells into embryonic stem cells.

    Other groups have learned how to “trick” ordinary skin cells into re-modeling themselves into different tissues. These so-called induced pluripotent stem cells, iPS cells for short, might also some day be used to grow transplants perfectly matched to a patient. But again, the technique isn’t easy and there have been many stumbling blocks.

    Several other scientists said the science was sound, but said the field had mostly moved on from the pursuit of cloning technology. "IPS cells are easier to produce and have wide applications in research and regenerative medicine, and it remains to be shown whether (cloned embryonic stem cells) have advantages over iPS cells," Daley said by e-mail.

    Cloning almost got left in the dust with the work on the other techniques. But the team at OHSU had been perfecting the technique in monkeys, and now they’ve managed to make it work with human cells. The advantage, they say, is that the donated human egg provides fresh and rejuvenating DNA.

    The technique they use is called somatic cell nuclear transfer – the same method used to make Dolly, the sheep who was the first mammal cloned from the cell of another adult mammal, in 1996. Scientists remove the nucleus from a normal cell, usually a type of skin cell. They do the same with a human egg cell, then inject the nucleus from the skin cell into the egg.

    Various chemical or electrical tricks can be used to start the egg growing as if it had been fertilized by sperm. The method’s been used to make sheep, dogs, horses, and mice – but never human beings.

    None of these clones are precise copies because the egg contains an important source of DNA, called mitochondrial DNA. And defects in this DNA cause many diseases, including diabetes and a condition called Leigh syndrome, which causes seizures and dementia.

    Mitalipov hopes that replacing the mitochondrial DNA as part of the cloning process might help make tissue that could correct these diseases. His team tested cells taken from a patient with Leigh syndrome, a neurological disorder, and made stem cells using the technique.

    “It allows you to produce genetically corrected cells,” he said. “There are a variety of age-related diseases that we believe are caused by acquired mitochondrial mutations.”

    Lots of testing lies ahead and because of laws banning the use of federal money to directly make human embryos, Mitalipov’s lab uses private funds instead. But he believes the method cannot be used to make human babies.

    “We have been doing it for years in primates and the embryos never implant,” he said. The blastocysts appear to lack a key layer of cells, he said, that give rise to the placenta and that are needed for a normal pregnancy.

    Nonetheless, he admits that is unlikely to reassure people who object to experimenting on human embryos. “They’ll say ‘oh, you are just creating a disabled embryo’,” he said.

    O. Carter Snead, a bioethicist and professor of law at the University of Notre Dame, called it sad news. “The use and destruction of living human beings – at any stage of biological development – for scientific research is a terrible injustice.  Human cloning for biomedical research is a particularly aggravated form of this harm," Snead said in a statement.

    Another barrier --- human eggs are not easy to come by and there are also ethical questions about whether women should be paid to donate their eggs for this kind of research.

    The work will almost certainly be used to study diseases in lab dishes at first. But Daley, who heads the bone marrow transplant program at Boston Children's Hospital, said using a patient's own cells offers potentially huge advantages. "A lot of patients don't have an optimal donor," he said. So bone marrow transplants are done only for the patients in the most dire need.

    "If we could make every patient their own donor ... we would bypass the transplant barrier," he said. "Everyone could be a donor for themselves."

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  • Report questioning salt guidelines riles heart experts

    An unusual medical brawl erupted on Tuesday when the influential Institute of Medicine issued a report questioning the basis of years of advice for Americans to cut their salt intake in half.

    The Institute, which advises the federal government on medical issues, concluded that the studies have answered the question poorly.  A panel of experts looked at studies showing the medical effects of eating too much salt, as well as at studies that have been used to suggest that some people may suffer form eating too little salt.

    Its finding: There’s enough evidence to support advising Americans to keep sodium to 2,300 milligrams a day or less, but there’s not enough to support the current, lower target of 1,500 milligrams a day.

    “There is evidence to lower excessive salt intake,” Dr. Brian Strom, a professor of medicine, epidemiology and biostatistics at the University of Pennsylvania, who chaired the panel, told reporters.

    There is also good evidence that lowering intake to around 2,300 milligrams a day decreased the risk of heart disease,” Strom said. But he said that the evidence was absent to support recommendations of taking it as low as 1,500 milligrams a day. And, he said, there were some studies suggesting this could harm some people -- although those studies are also flawed.

    This infuriated the American Heart Association.

    “While the American Heart Association commends the IOM for taking on the challenging topic of sodium consumption, we disagree with key conclusions,” Heart Association CEO Nancy Brown said in a statement.

    “The report is missing a critical component -- a comprehensive review of well-established evidence which links too much sodium to high blood pressure and heart disease.”

    The Institute agrees that Americans eat far too much salt -- more than 3,400 milligrams a day on average. Most is “hidden” salt, in processed foods such as bread and cereal, restaurant meals and especially fast food.

    And studies clearly show that salt raises blood pressure and that cutting salt can lower blood pressure. High blood pressure damages blood vessels and can lead to stroke, kidney failure and heart failure.

    “We knew about all this data and it didn’t change our thinking,” said Dr. Elliott Antman of Brigham and Women’s Hospital and Harvard  Medical School . “We have to take the evidence that we have -- which is strong,” added Antman, a spokesman for the American Heart Association.

    Several studies have suggested that about a quarter of Americans are salt-sensitive -- that their blood pressure is directly and immediately affected by how much salt they eat. But this doesn’t mean that the other 75 percent can pile on the salt with impunity, Antman said.

    “About 90 percent of the population will ultimately develop hypertension as they age,” he said. “Part of this is almost certainly from years of eating too much salt, he added. Eating too much salt can also affect kidney function, he said.

    An aggressive reduction in sodium is the way to go,” he said.

    Strom would not be drawn into an argument. “What we are saying is the available data is not consistent on outcomes,” he said. “We are not saying that one shouldn’t be lowering excessive salt intake in the general population,” he added.  “There is simply a lack of data showing it is beneficial.”

    And, he said, it is not up to the panel to set a target. “It’s not that we are against (a target intake of) 1,500 milligrams,” he said. “The data are not consistent.”

    The trouble with trying to measure salt intake is that it’s very hard to separate out salt from the rest of the  ingredients in food, said Antman.

    A truly scientifically rigorous study would randomly assign people to eat diffferent amounts of salt daily and watch to see what kind of diseases they develop -- something that would be difficult to set up, police and also difficult to defend, ethically.

    Antman says most Americans get their salt from prepared foods and from restaurants, not from at-home, scratch cooking. What’s needed, he said, is more encouragement for restaurants and food companies to lower sodium content of food.

    The food industry argues that Americans have a taste for salt and they won’t buy products that are salt-free.  Antman agrees that it’s hard.  “We are used to a high sodium content in our food,” he said.

    “But the data say that in just two to three weeks you can train person’s taste buds to become accustomed to a lower sodium content in food.”

    The Center for Science in the Public Interest piled on, too.

    "What the committee failed to emphasize is that most Americans are deep in the red zone, consuming 3,500 to 4,000 milligrams of sodium a day,' the group, which publicizes calorie counts and other food risks, said in a statement.

    "It's clear that those excessive levels increase the risk of high blood pressure, heart attacks, and strokes. Whether we aim for 2,300 or 1,500 milligrams a day is irrelevant until we move down out of the red zone. At restaurants, you can get roughly 2,000 milligrams of sodium from just one burrito, a single-serve pizza, or an order of kung pao chicken, and at least 1,000 milligrams from a typical sandwich or burger."

    The Centers for Disease Control and Prevention has a widget on salt intake here.

     

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  • Government appeals 'morning-after pill' ruling

    The Obama administration filed its expected appeal on Monday of a judge's order to make the so-called "morning-after pill" available to anyone, without a prescription.

    The federal government asked the 2nd U.S. Circuit Court of Appeals in New York to postpone federal judge Edward Korman’s ruling against the Health and Human Services Department’s requirement that anyone under 17 get a prescription for the emergency contraception.

    Korman refused on Friday to stay his ruling while the appeals court considered the appeal, calling the government’s legal attempts “frivolous” and saying they were done in bad faith.

    Women’s health groups had sued against the HHS decision, which had overruled the Food and Drug Administration’s original approval of Plan B birth control pills for women and girls of all ages. HHS Secretary Kathleen Sebelius had said she wasn’t comfortable seeing the pills freely available to girls as young as 11.

    The FDA, which had protected against Sebelius’s decision, last month approved another drug application to make one brand available over the counter to girls as young as 15, but still requiring proof of age.

    Korman railed against both decisions and has accused the government of simply trying to delay the inevitable.

    For now, things are a bit confusing. The appeal, technically filed by the Food and Drug Administration, asks the appeals court to stop Korman's ruling from taking effect until the case is settled.

    Teva Pharmaceutical’s single-pill option, called Plan B One-Step, is available with ID to anyone 15 and older. Anyone younger needs a prescription to get it.

    Other versions of the medication are available to anyone 17 and older with proof of age, and to anyone younger with a prescription.

    "You have to show an ID either way," said Judy Waxman of the National Women's Law Center. Waxman  predicts the appeals court will stay Korman's decision until a hearing can be scheduled on the appeal. "This could take months again until we get the Second Circuit decision," Waxman said in a telephone interview.

    Related:

    Judge refuses to delay Plan B ruling, has choice words for HHS

    Judge: Make 'morning-after pill' available to all girls without prescription

  • 2012 was deadliest year for West Nile in US, CDC says

    West Nile virus killed 286 people in the United States last year, making it the deadliest year yet for the virus, the federal government reported on Monday.

    Texas was especially hard hit by the virus, which is carried by mosquitoes and which only arrived in the United States in 1999, the Centers for Disease Control and Prevention reports.

    “A total of 5,674 cases of West Nile virus disease in people, including 286 deaths, were reported to CDC from 48 states (excluding Alaska and Hawaii),” the CDC said in a statement.

    West Nile virus is widespread in Africa, Asia and parts of Europe. It causes fever and aches and usually isn’t serious.  But in some people it can spread to the brain or spinal cord, killing them or causing paralysis.

    No one’s sure precisely how West Nile arrived in North America, but it was first reported in New York in 1999. It’s now been reported in all 48 contiguous states, as well as parts of Canada and Mexico and all the way to Argentina.

    The CDC's Dr. Lyle Petersen says it's impossible to know what West Nile will do this summer. "It is very hard to predict," he said in a telephone interview. "I can't tell you what the weather is going to be like this summer, for example." The virus is driven by weather; it's worse during hot, wet summers in temperate climates.

    "What last summer's outbreak tells us is that West Nile is not going to go away," Petersen said. "Most places in the United States are at risk of having outbreaks."

    The virus has a life cycle that takes it from mosquitoes to birds and back into mosquitoes that bite people. Its severity varies from year to year. In some years, only a few cases are reported, and in others, like 2012, it infects many people.

    In 2011, CDC reported 712 cases of West Nile virus, and 43 deaths. The worst previous year was 2003, when 9,862 cases were reported with 264 deaths. Only severe cases are reported to CDC -- health experts say most people who are infected don’t even know it. People over 50 and people with underlying illnesses are the most vulnerable.

    “Last summer’s outbreak likely resulted from many factors, including higher-than-normal temperatures that influenced mosquito and bird abundance, the replication of the virus in its host mosquitoes, and interactions of birds and mosquitoes in hard-hit areas,” the CDC said in a statement.

    “Because the factors that lead to West Nile virus disease outbreaks are complex, CDC cannot predict where and when they will occur."

    There’s no vaccine against West Nile virus for people, but there is one for horses. There’s also no specific antiviral drug that can help infected people -- those who are seriously ill get what’s called supportive treatment in the hospital.

    The CDC recommends that people avoid being bitten by mosquitoes, which can carry other diseases, also, from Eastern equine encephalitis to, in very rare cases, dengue fever. Standing water, even in extremely small containers, can breed mosquitoes. People should wear long sleeves and use insect repellent that contains DEET, picaridin, IR3535, and para-menthane-diol (PMD), CDC advises.

    Petersen says scientists don't quite understand why, but West Nile tends to cause more human outbreaks in temperate climates than in tropical zones. Female mosquitoes carry the infection over from one summer to another, he said. "Infected female mosquitoes find a warm place to live and they just hang out all winter," he said. They often overwinter in sewers or basements, he said.

    "These infected mosquitoes come out in the spring and then they look for a blood meal and they bite birds and infect birds. During spring and summer you get more and more infected mosquitoes and birds," Petersen added.

    "By the middle of summer there are so many infected mosquitoes that it starts to present a human infection risk."

    And because the virus can live in both mosquitoes and birds, it would be much more difficult to eradicate than malaria, which mostly infects people, Petersen said. The CDC helped eradicate malaria in the United States in 1951.

     

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  • Pediatricians take on gun lobby – carefully

    To pediatricians, gun control is a public health issue, not a political one. But they're treading a fine line, and they know it.

    The American Academy of Pediatrics has begun a renewed push to try to get Congress to pass gun control measures, sending more than 100 pediatricians to Capitol Hill earlier this month. But others who have taken on the issue over the past decade have a warning for them: they can run afoul of the National Rifle Association and other pro-gun groups that are quick to paint anyone who advocates for gun control as a political extremist.

    What the doctors want is an assault weapon ban, mandatory background checks and waiting periods before all firearm purchases, a ban on high-capacity magazines, handgun regulations and requirements for safe firearm storage under federal law.

    “I think we can be honest brokers,” says Dr. Lolita McDavid, medical director for child advocacy and protection at University Hospitals, part of Case Western Reserve University’s school of medicine in Cleveland.

    Johnny Hanson / AP file

    With a little help, a child shoots an Airsoft gun at a target during NRA Youth Day events at the National Rifle Association's 142 Annual Meetings and Exhibits in Houston on Sunday, May 5, 2013..

    “We have to have a collectively louder voice,” Dr. Danielle Laraque, who chairs the pediatrics department at Maimonides Infants and Children’s Hospital in Brooklyn, told a meeting of the Pediatric Academic Societies in Washington, D.C., earlier this month. “What we need is a call to action, to really look at how we can change public policy that is not often affected by data.”

    They don't always get a friendly reception. Just two weeks before the doctors arrived, Congress had scuttled what gun-control advocates had considered a modest bill to expand background checks for gun sales.

    Congress had already dropped a wider measure pushed by President Barack Obama and Vice President Joe Biden after the December shootings of 20 schoolchildren and six adults in Newtown, Conn.

    Obama has been trying to roll back some of the restrictions placed on gun research by Congress. He’s issued an executive order specifically directing the Centers for Disease Control and Prevention to conduct research into gun injuries. While the CDC was never banned from doing so, Congress had specifically cut precisely the amount CDC spent on firearms violence research, sending a clear message.

    “If you think that Congress has sort of been asleep…you are wrong,” said Dr. Daniel Webster of Johns Hopkins University, one of the few academic experts who has continued research on gun violence despite efforts to divert funding. “They have been doing a very good job of weakening the laws to make it easier for gun dealers to have the least amount of responsibility. They have made it harder to sue dealers and made it harder to access data on … which dealers are pumping out guns to criminals. They’ve made it almost impossible to prosecute a gun dealer.”

    Pediatricians are puzzled that the statistics aren’t speaking for themselves.

    “Where there are more guns in the United States, there are more people dying,” Dr. Matthew Miller of the Harvard Injury Control Research Center told the meeting in Washington, D.C. “There are more women dying, there are more men dying, and there are more children dying. We are talking about a lot of people who are dying when they live in places with a lot of guns and homes with guns.”

    Miller’s done research on gun deaths using what CDC data he could get -- dating from before Congress cut its funding.

    He divided the U.S. population in half, classifying half as living in high-gun-ownership states and half in low-gun-ownership states. In the “high gun states,” 21,148 people were murdered between 1988 and 1997, compared with 7,266 in the “low gun states”.  He found 369 kids up to 14 of age who were murdered using guns in states with high rates of gun ownership; 97 were killed deliberately with guns in low-ownership states.

    And there were more murders overall, even using weapons other than guns in the high-gun-ownership states, Miller found. Other research finds kids and adults alike are more likely to commit suicide if they have access to a gun.

    Miller hopes that pediatricians can change the tone of the argument, making it about safety.

    “Here we are talking about children. We can’t gun-proof a child. We have to childproof our homes,” he said. “It is a leading argument that hopefully will change the way people think about guns generally.”

    “Can we reframe the conversation so that it is about data, not about political beliefs?” Dr. Barbara Stoll of Emory University asked the meeting.

    That might not be easy.  

    “I am widely known as the ‘widely discredited Dr. Arthur Kellermann’,” Dr. Arthur Kellermann of the RAND Corporation, a think-tank, told the pediatrics meeting in D.C. Kellermann, who established the Emory Center for Injury Control, has spoken out about gun-injury and death rates that are almost 20 times higher in the U.S. than those in other high-income nations with populations of more than 1 million.

    He’s also done research showing that people are 2.7 times more likely to be murdered if they have firearms in their homes – research challenged by guns-rights advocates. Kellermann says he’s not an advocate for gun control and cautioned the pediatricians to pursue changes that gun owners are comfortable with. 

    Gun advocacy groups have moved to discredit the AAP, which represents 60,000 doctors who have voted overwhelmingly to support some gun measures. One was set up specifically to do this – the Doctors for Responsible Gun Ownership (DRGO).  “DRGO is a nationwide network of 1,400 medical doctors, other health care professionals, scientists, and others who support the safe and lawful use of firearms for any legitimate purpose,” the group says on its website.

    Founded by the pro-gun-ownership Second Amendment Foundation, DRGO says the the AAP and the American Medical Association are “motivated by deep-seated prejudice against gun owners.” “DRGO’s mission is to expose the poor medical scholarship -- and the anti-gun bias behind it -- held out as truth by organized medicine and medical journalism,” the group says.

    The NRA has sponsored legislation to stop pediatricians from asking parents about guns in the home -- something that really puzzles doctors who routinely ask about other safety issues, such as using car seats and wearing helmets while riding bikes.

    A federal judge struck down Florida’s 2011 law that forbade doctors to ask about guns in the home, but the NRA has sponsored similar legislation in Alabama, North Carolina, West Virginia, Minnesota, and Oklahoma.

    “The chilling effect persists,” Miller said.

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  • Judge refuses to delay ruling on Plan B

    A federal judge who's been battling the Obama administration over “Plan B” emergency contraception took another swipe at the federal government on Friday, denying a request to delay his ruling ordering the government to make the pills available to everyone, without restrictions.

    Uncredited / AP

    Plan B One-Step is designed to make pregnancy unlikely if taken within three days of unprotected sex.

    Judge Edward Korman also accused the Food and Drug Administration of cooking up “a sweetheart deal” with drug maker Teva Pharmaceuticals.

    Korman said he would put his original ruling on hold until Monday as a courtesy to the Court of Appeals and to allow the government to appeal the ruling. He didn’t mince words in expressing his opinion of the government’s legal attempts, calling them “frivolous” and saying they were done “in bad faith."

    “The motion for a stay pending the appeal is denied. Indeed, in my view, the defendants’ appeal is frivolous and is taken for the purpose of delay,” Korman wrote in the ruling issued on Friday.

    In 2011, the FDA approved emergency contraception, also known as the "morning-after" pill or "Plan B", for women of all ages. But the administration stepped in immediately. “The FDA was reversed by the Secretary of Health and Human Services on the same day in a decision that was politically motivated and that, even without regard to the Secretary’s motives, was so unpersuasive as to call into question her good faith,” Korman wrote in Friday’s decision.

    Health and Human Services Secretary Kathleen Sebelius said at the time she didn’t want girls “as young as 11” buying contraceptives on their own. She limited over-the-counter sales to women 17 and older.

    Women’s health groups filed suit and on April 5, Korman ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception.

    “I did so because the Secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent,” Korman says.

     Just a few weeks later, the FDA approved an application by Teva Pharmaceutical Industries Ltd that would allow girls as young as 15 to buy Teva’s particular product without a prescription. It required that emergency contraception be labeled as not for sale to those younger than 15 and required pharmacies to demand proof of age.

    Korman called this a “sweetheart deal’ for TEVA. “Teva’s proposal would enable it to have its product, and its product alone, displayed on the shelves in the family planning area of stores with an on-site pharmacy. Thus, a consumer looking for an emergency contraceptive would only find Plan B One-Step on the shelves, and if she came in after the pharmacy counter was closed, her only option would be Plan B One-Step,” he wrote.

    “If she were under the age of 15, she would have no option, because she could only obtain levonorgestrel-based emergency contraceptives with a prescription.” Plus, Teva would get to sell its product to 15- and 16-year-olds for three years exclusively.

    “The pharmaceutical companies that sell “brand X” versions of Plan B One-Step as well as the two-pill package of the drug could not display their products on the shelf because the old marketing regime remains in effect for them, and their products can only be sold from behind the pharmacy counter. Anyone under the age of 17 needs a prescription to obtain these products, and anyone over the age of 17 can only obtain them from the pharmacy by showing proof-of-age identification,” Korman wrote.

    The government had asked for a stay of Korman’s April 5 ruling, saying it and the public would suffer “irreparable harm." Korman called this “silly” and said the appeal was “taken solely to vindicate the improper conduct of the Secretary”.

    Korman also noted that the FDA originally protested Sebelius's decision. FDA commissioner Dr. Margaret Hamburg wrote a scathing blog post, calling it government interference. Yet FDA was now joining the government's lawsuit "in something out of an alternate reality," Korman wrote.

    Plan B One-Step is designed to make pregnancy unlikely if taken within three days of unprotected intercourse. The single pill contains a high dose of the same hormone used in birth control pills to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg in the uterus. Plan B One-Step will not end a pregnancy if a woman is already pregnant and there is no medical evidence it harms a developing fetus, FDA officials have said.

    Plan B, available from generic manufacturers, uses two doses of levonorgestrel. Another emergency contraceptive, ella, or ulipristal, is a prescription-only product that prevents pregnancy when taken within five days of unprotected intercourse.

    The FDA has said that all the drugs are extraordinarily safe.

    Women’s health groups note that girls of all ages can buy far more dangerous products over the counter now, from aspirin to cold medicines, and that they also have access to condoms without a prescription or parental permission.

    Related:

    Judge criticizes FDA's move on Plan B

    FDA approves on Plan B product for girls 15 and older

    Plan B available to 15-year-olds - with ID

     

  • Bird flu: US safe from two new viruses - so far

    Centers for Disease Control and Prevention

    A CDC scientist harvests H7N9 virus that has been grown for sharing with partner laboratories for research purposes.

    More than 50 travelers just back in the United States from China who had flu-like symptoms have been tested for the H7N9 bird flu virus, federal health officials say. So far, none has tested positive.

    But the fact that they’re being tested at all shows just how worried the U.S. government is about this new strain of bird flu, which threatens at the same time as a still-mysterious coronavirus from the Middle East. The test kits had to be specially made up and distributed under an emergency provision.

    “While no cases of H7N9 have been detected at this time in the U.S., 54 people with flu-like symptoms after travel to China have been tested. All have 54 tested negative for H7N9; while six tested positive for seasonal influenza A, and three tested positive for seasonal influenza B,” the Centers for Disease Control and Prevention says in its latest update on the virus.

    Emergency operations centers are running 24/7, keeping an eye on both situations. While it's not unusual for the centers to be operating around the clock, it is rare to have two pandemic threats at once to plan for, says Edward Gabriel, who heads preparedness and response issues at the health and Human Services Department. 

    "We want the latest and best information that we can get," Gabriel told NBC News. "We also need to look and see where it is moving to. To try to isolate its motion is a pretty significant thing."

    If either virus turns into a form that spreads easily from person to person, a pandemic could follow within weeks. Both seem especially deadly in their current form: H7N9 seems to have about a 20 percent fatality rate, while the new coronavirus appears to have killed more than half its victims.

    “In the case of the two latest threats — the H7N9 influenza virus and the new coronavirus — the number of infected people is small, and the infections are occurring thousands of miles away from the United States. Yet we should be seriously concerned about both,” Mike Osterholm, an infectious disease expert at the University of Minnesota, wrote in the New York Times on Friday.

    “Our public health tools to fight these viruses are limited. We have no vaccines or effective drugs readily available to stop or treat the new coronavirus in the Middle East,” Osterholm adds. 

    CDC

    Influenza A H7N9 as viewed through an electron microscope. Both filaments and spheres are observed in this photo.

    The H7N9 flu can spread silently, as people transmit influenza before they’re sick themselves. If the flu did mutate into a pandemic form, it would probably take at least six months to make enough vaccines to protect large numbers of people.

    “It may take longer than it takes the virus to spread,” says Dr. John Treanor, a flu vaccine expert at the University of Rochester Medical Center. “The technology that we have today is such that the bulk of the pandemic disease may have already taken place before a vaccine is in place and can be used,” he added.

    “The virus can spread very, very quickly. You are in a race against time.”

    That happened in 2009, when the new strain of H1N1 swine flu broke out to cause the first pandemic of a new flu in 40 years. Companies raced to make vaccine but it was months before it was ready.

    There are drugs to fight flu – a pill called Tamiflu and an inhaled powder called Relenza. Neither is a cure, however, and both need to be given very quickly to do much good at all.

    Right now, H7N9 seems mostly confined to China and the spread has slowed. The World Health Organization reports 32 people have died out of 131 lab-confirmed cases.

    “The drop-off in newly reported H7N9 cases in China may be the result of containment measures reportedly taken by Chinese authorities, including closing live bird markets, a venue where the risk of exposure to bird flu viruses can be high," the CDC says. “However it may also be a result of changing seasons, or a combination of both.”

    Researchers in Hong Kong did a computer analysis of the outbreak and estimate that at least 200-500 more people have likely been infected with H7N9. The virus seems to cause serious illness mostly in people over 65 – doctors are not sure why yet.

    “We estimated that risk of serious illness after infection is 5.1 times higher in persons 65 years and older versus younger ages,” Ben Cowling and colleagues at Hong Kong University wrote in the journal Eurosurveillance.

    The evidence suggests that most of the patients got infected directly by birds, probably in poultry markets. So Cowling’s team took all the data and estimated how many younger people were likely to have been infected without knowing they had H7N9. "Our results suggest that many unidentified mild influenza A(H7N9) infections may have occurred, with a lower bound of 210–550 infections to date," they wrote. This would mean the virus isn’t that widespread, but which also confirms its high fatality rate. 

    The coronavirus, which some are dubbing Middle East Respiratory Syndrome Coronavirus, or MERS, is a little different story. WHO says 33 infections have been reported, with 18 deaths. Experts are watching cases in France, where one patient who traveled from Dubai was confirmed to have the virus. 

    A man who shared a hospital room with the 65-year-old man also has the virus, French officials said Sunday -- something that shows the virus and and does spread in hospitals. 

    Officials were relieved that three health care workers who cared for the 65-year-old patient and who got sick have tested negative for the virus.

    Also Sunday, WHO Assistant Director-General Keiji Fukuda could probably be passed between people in close contact, but there was no evidence of sustained "generalized transmission in communities."

    Some reports suggest an outbreak in Saudi Arabia also affected people in the same hospital.

    This worries Dr. Eric Toner of the Center for Health Security at the University of Pittsburgh Medical Center. SARS – severe acute respiratory syndrome – also spread mostly in hospitals. SARS spread to 29 countries in 2003, killing 775 people and making 8,000 sick before it was stopped.

    “These cases, whether confirmed or not, should be a wake-up call,” Toner writes in his blog.

    The good news is that SARS was stopped using good hospital hygiene. Face masks, gloves and careful disinfection prevented its spread. And SARS only spread once people were noticeably ill, unlike flu, which people can spread before they feel sick and after they feel better.

    The bad news is that hospitals may have forgotten this lesson. “SARS was stopped by healthcare workers being aware of the disease, having a high index of suspicion of anyone with fever and respiratory symptoms who had recently been in an affected region, and quickly implementing infection control measures with any suspect case,” Toner says.

    “Until now, all cases of MERS originated in the Middle East, but as the confirmed French case demonstrates, the virus is only a plane ride away from other parts of the world. In the 10 years since the SARS outbreak, many hospitals have become lax in their attention to respiratory precautions.”

    Gabriel says he’s working to make sure this isn’t the case with U.S. hospitals. “Hygiene practices are now better than they ever have been,” Gabriel said. “We send out reminders daily.”

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    This story was originally published on

  • Senate moves closer to law to prevent more pharmacy outbreaks

    At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now.

    Iowa Senator Tom Harkin says he believes the Senate is close to getting legislation that would give the FDA specific control over large pharmacies like the one behind the outbreak of fungal meningitis that’s killed 55 people so far. The hope is to prevent any more of these outbreaks.

    “We must have changes or this is going to happen again,” Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told a hearing of the Senates Health, Education, Labor and Pensions Committee Thursday. Harkin, a Democrat, chairs the committee.

    “This tragedy was only the worst in a series of incidents involving compounded products,” Woodcock added. “In retrospect, FDA should have been more aggressive… We are being more aggressive now.”

    More than 740 people have been sickened in the outbreak of disease linked to contaminated products distributed by the New England Compounding Center in Massachusetts last year. At latest count, the Centers for Disease Control and Prevention says, 55 have died from a rare form of meningitis caused by mold-contaminated steroid injections.

    The Pew Charitable Trusts ran down some recent incidents and came up with 19 other compounding pharmacy errors that led to 22 deaths since 2001. And at least 38 patients were blinded or suffered vision loss because of contaminated eye injections.

    The cases include three people killed and 11 sickened in California in 2001 from contaminated injections of a steroid called betamethasone. Five had bacterial meningitis. They also include overdoses from saline solutions that had too much sodium and bloodstream infections from various contaminated infusion products.

    "I think it's unconscionable that we have failed to regulate this industry for so long and I am committed to moving forward," Sen. Elizabeth Warren, a Massachusetts Democrat, said at the hearing. But previous efforts to give the FDA more power have fallen apart, most recently in 2007. Tennessee Sen. Lamar Alexander, a Republican, said lobbying by the compounding pharmacy pressured lawmakers into dropping the legislation.

    Inspections of NECC showed many of its products were contaminated with fungus and bacteria. The operation has been closed down and the FDA and several states have stepped up inspections of large-scale pharmacies.

    The FDA says the problem has arisen because so many compounding pharmacies have become major manufacturers of products from saline solution to chemotherapy drugs. They were originally licensed to whip up treatments on a prescription-by-prescription basis, but many now make products far in advance of their being prescribed, and ship them all over the country.

    What has not been clear is who regulates them, and the FDA says many of these operations use the lack of clear regulation as an excuse to fend off efforts to inspect them and see their records. States are supposed to regulate traditional pharmacies, including compounding pharmacies. FDA regulates large drug manufacturers.

    The Senate legislation, proposed by the FDA, would create a third category – large-scale compounders – that it would regulate.

    State pharmacy boards said they’d support the new legislation. “We agree with the FDA that the situation can and will happen again,” Carmen Catizone, executive director of the National Association of Boards of Pharmacy, told the hearing. He did question one part of the proposed law – allowing FDA to get into the records of pharmacies regulated by states, saying it could cause confusion.

    The consumer group Public Citizen opposes the new legislation, saying the FDA has all the authority it ever needed to stop rogue compounding pharmacies, but has failed to act. Woodcock says this isn’t true and says pharmacies regularly defy the agency when it tries to inspect facilities and their records.

    “We need to get into pharmacies to make sure they are not posing as traditional pharmacies,” she told the hearing. “Sometimes, if there is an outbreak, we get reports and they say, ‘no you can’t come into our pharmacy’. “ Without seeing records, Woodcock says, FDA can’t tell where a contaminated drug may have been shipped.

    This, in turn, makes it hard to track outbreaks. A person with a complication caused by a contaminated drug may not even know which product caused it.

    Pew supports prioritized oversight of sterile products, notes there are a number of areas it would miss. These include non-sterile compounded drugs, such as compounded “bioidentical” hormone replacement pills. ”Compounded oral dosage forms have the potential to cause harm by both impurities and sub- or super-potency,” Pew’s Allan Coukell told the hearing.

    It would also leave large pharmacies that don’t ship their products out of state free to operate under the FDA’s radar, Coukell noted.

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