• Alzheimer's drug was too good to be true, studies find

    It sounded too good to be true and unfortunately it was.  Three research studies out Thursday severely diminish the hope that a cancer drug already on the market could be an Alzheimer’s treatment.

    In February 2012 scientists at Case Western University Medical Center reported that a drug approved to treat skin cancer cured a mouse of a form of Alzheimer’s.  They reported the drug eliminated the plaque that is the hallmark of Alzheimer’s from the brains of the mice and that the mice seemed to recover from their memory and other cognitive problems.

    The study, published in the journal Science, got doctors and patients alike excited.

    If this were true it would have been a gigantic step.  Since the drug, Targretin, was already approved as a cancer treatment, doctors knew its safety profile and were free to prescribe it “off label” to treat any condition, including Alzheimer’s. 

    Researchers quickly set up trials of the drug in people with Alzheimer’s. But some patients’ families did not want to wait for the human experiments.  They asked their doctors for prescriptions and in many cases, according to anecdotal reports, they got them.

    But in this week’s edition of Science, three other teams of highly respected Alzheimer’s experts report they could not repeat the mouse results.

    "It was hot stuff. It was the new miracle drug for Alzheimer's,’ said Sangram Sisodia, a professor of neuroscience at the University of Chicago.

    Sisodia said he and fellow Alzheimer's colleagues, who included Dr. Rudolph Tanzi of Massachusetts General Hospital in Boston and Dr. David Holtzman of Washington University School of Medicine, wanted to see if they could replicate the stunning results in their own labs. Scientists don’t usually accept results as valid until they’ve been repeated several times.

    It’s one of the main reasons researchers publish their findings – so that others can try them out and validate them.

    The three labs failed to see any effects on Alzheimer's plaques in three strains of mice that were treated with Targretin.

    "There is absolutely no reduction in amyloid levels in the brains of mice treated with this compound," Sisodia wrote in a technical comment in the journal Science. Teams at the University of Florida and researchers at the University of Leuven in Belgium published similar findings in the same journal.

    "I was a fan of the original study," said Dr. Samuel Gandy, associate director of the Mount Sinai Alzheimer's Disease Research Center in New York, who was not involved in any of the studies.

    "It was very dramatic. It cut plaque loads by three-quarters over less than a week. No one had ever seen anything like it before."

    Gandy has had several patients asking for the treatment, but he said the drug can damage the liver and requires very careful monitoring.

    "I have universally declined and advised others to decline,” he told Reuters.

    (Reuters contributed to this story)

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  • H7N9 bird flu spreads much like ordinary flu

    The H7N9 bird flu can spread from one mammal to another – meaning it could also spread person to person, an international team of researchers reported Thursday.

    Researchers haven’t been exactly sure how H7N9 is spreading. They know it can infect people – it’s infected more than 130 people and killed more than 30 of them – but they have suspected most of the victims had some sort of contact with infected poultry.

    The research team, led by Yi Guan of the University of Hong Kong, tried infecting ferrets – the animals closest to humans when it comes to catching flu.

    The animals could infect one another by direct contact in cages. And one ferret kept in a separate cage was infected as well, they report in this week’s issue of the journal Science.

    “Under appropriate conditions human-to-human transmission of the H7N9 virus may be possible,” they wrote.

    Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, says he is not too worried by the findings. “We already know you can infect mammals,” said Fauci, who was not involved in the research.

    “That is what influenza does. We know that. You are talking about a handful of ferrets. You can’t make major extrapolations.”

    Officials are keeping a close eye on H7N9 because it has the potential to cause a human pandemic. So far, it doesn’t seem to infect people easily and people who are infected do not seem to spread it to others much, if at all. But influenza viruses change quickly and unpredictably and if one starts passing easily from one person to another, it could spread.

    The experiment also showed that the ferrets could pass the infection before they started showing symptoms. Human flu does this too – that’s why it spreads so quickly and easily every year, because people are out and about, touching others, before they know they are sick.

    “If this virus acquires the ability to efficiently transmit from human-to-human, extensive spread of this virus may be inevitable, as quarantine measures will lag behind its spread,” the researchers wrote in Science.

    “Assuming that poultry is the source of the H7N9 virus, continued prevalence of this virus could lead to it becoming endemic in poultry as has occurred with the Asian highly pathogenic H5N1 and H9N2 virus lineages," they added. Endemic viruses are established and cause constant outbreaks.

    "If so, the opportunities for the H7N9 virus to evolve to acquire human-to-human transmissibility, or to be introduced to pigs, would greatly increase. To prevent this happening, it may be advisable to reconsider the management of live poultry markets, especially in the urban areas.”

    New H7N9 infections appear to have trailed off in China. World Health Organization officials say it might be because officials are closing poultry markets and cleaning them. Or it could be because it’s spring and influenza tends to die down in the spring.

    Marc-Alain Widdowson of the U.S. Centers for Disease Control and Prevention says the virus doesn’t make poultry sick, so it could spread quietly and easily.

    “One thing that we are particularly worried about is there is a tremendous amount of poultry that goes from China into Vietnam,” said Widdowson, who visited China with a CDC team to investigate the outbreak.

    “One of the things we are looking at is ramping up surveillance in bird markers and in the population.”

    People who buy an infected chicken won’t know, because H7N9 doesn’t make the birds sick they way H5N1 does, Widdowson says. “It worries me substantially,” he said.

    “There’s absolutely no doubt it has got some very concerning mutations which suggest it may be adapting to human receptors. These make it closer to what we are all fearing, which is a virus that can spread sustainably humans to human and cause severe disease.”

    Related:

    Mystery illness in Alabama mostly colds and flu

    H7N9 has cost billions

    US safe so far from two new viruses

  • 'Mystery' illness in Alabama mostly cold and flu, tests show

    A cluster of mysterious respiratory illnesses that alarmed southeast Alabama turned out to be nothing more sinister than ordinary cold and seasonal flu, health officials said Thursday.

    Lab tests by state and federal officials ruled out avian influenza and a novel coronavirus, now known as MERS, that has killed 22 people in the Middle East.

    “There is no evidence of any new or unexpected virus circulating,” said Dr. Don Williamson, the Alabama state health officer, who said he wanted to put "closure to this cluster."

    Seven people fell ill and two died earier this month in southeast Alabama after coming down with symptoms that included shortness of fever, shortness of breath and cough. All of the patients were adults ages 32 to 87. The people who died were 34 and 55, Williamson said.

    Of the seven patients whose specimens were tested, six were found positive for influenza A or rhinovirus or a combination of the two and three patients were found to have bacterial pneumonia. 

    “There wasn’t anything unusual or strange,” Williamson noted. He added that flu often continues to circulate in the spring and summer in his state.

    Increased worries over the spread of two bird deadly flu viruses -- H5N3 and H7N9 -- and the identification of the new coronavirus likely contributed to the concerns about this cluster, he added.

    “Because everybody is really worried about the possibility of either this novel coronavirus or the H7N9 flu from China, there was heightened awareness,” he said.”

    He praised doctors and clinicians who raised questions about unusual respiratory illnesses because next time, it might be a new and deadly germ.

    “If people aren’t attentive, we’re going to miss it,” Williamson said.

    Related: 

  • Birth control requirement in health law up for appeal

    In the most prominent challenge of its kind, Hobby Lobby Stores Inc. is asking a federal appeals court Thursday for an exemption from part of the federal health care law that requires it to offer employees health coverage that includes access to the morning-after pill.

    The Oklahoma City-based arts-and-crafts chain argues that businesses — not just the currently exempted religious groups — should be allowed to seek exception from that part of the health law if it violates their religious beliefs.

    "They ought to be able — just like a church, just like a charity — to have the right to opt out of a provision that infringes on their religious beliefs," said Kyle Duncan, who will argue before the 10th Circuit Court of Appeals on behalf of the Green family, the founders of Hobby Lobby Stores Inc. and a sister company, Christian booksellers Mardel Inc.

    The Greens contend that emergency contraception is tantamount to abortion because it can prevent a fertilized egg from implanting in the womb. They also object to providing coverage for certain kinds of intrauterine devices.

    Lower courts have rejected Hobby Lobby's claim, saying that for-profit businesses aren't covered by an exemption added to the law for religious organizations. That exemption applies to churches themselves, but not to affiliated nonprofit corporations, like hospitals, that do not rely primarily on members of the faith as employees.

    In a decision issued late last year, a federal judge concluded simply, "Hobby Lobby and Mardel are not religious organizations."

    But U.S. District Judge Joe Heaton in Oklahoma City also wrote that "the court is not unsympathetic" to Hobby Lobby's dilemma and that the question of compelling employer health coverage for certain procedures "involves largely uncharted waters."

    Other businesses in multiple states are challenging the contraception mandate, too. Hobby Lobby is the most prominent company making the claim, and it is the first to be heard by a federal appeals court. The U.S. Justice Department will argue for the government that the contraception mandate should stay.

    The 10th Circuit opted to hear the case before all nine judges, not the typical three-judge panel, indicating the case's importance.

    In December, the 10th Circuit denied Hobby Lobby's request for an injunction to prevent it being subject to fines while its argument was on appeal. The U.S. Supreme Court also denied an injunction, with Justice Sonia Sotomayor writing that it was not "indisputably clear" that Hobby Lobby needed immediate protection.

    In response, the company restructured its health insurance, Duncan said. But Hobby Lobby, which is self-insured, will face fines by July 1 if it does not provide the coverage, he said.

    Hobby Lobby calls itself a "biblically founded business" and is closed on Sundays. Founded in 1972, the company now operates more than 500 stores in 41 states and employs more than 13,000 full-time employees who are eligible for health insurance.

    The Hobby Lobby case has attracted broad interest from health groups and religious groups. A panel including reproductive rights organizations and the American Public Health Association banded together last year to ask the court to reject Hobby Lobby's claim. The groups argued it would be dangerous precedent to allow for-profit private businesses to use religious beliefs to deny coverage.

    In a brief to the court filed last year, the health groups argued that allowing businesses not to cover some contraceptives would be like allowing businesses to tell employees they can't use wages to buy morning-after pills or other products that offend the employer's religious belief.

    "Of course, no one would argue that (Hobby Lobby owners) could seek, on religious grounds, to preclude their employees from spending their wages on contraception. This same rationale requires rejecting employers' demands to impose their religious views on employees through restrictions on the use of health insurance benefits," the health groups argued.

    Susan Polan, associate executive director of the American Public Health Association, said the Hobby Lobby case is an important test of how far businesses can go in seeking to exempt coverage of health procedures they don't like.

    "We're talking about women's access to reproductive health. That should be a decision between a patient and her health care provider, not a patient and her employer," Polan said this week.

  • WHO warns countries not to hoard secrets of coronavirus

     

    By Tom Miles and Stephanie Nebehay 
    Reuters

    The World Health Organization (WHO) warned countries with possible cases of the SARS-like novel coronavirus on Thursday that they must share information and not allow commercial labs to profit from the virus, which has killed 22 people worldwide.

    Saudi Arabia, where the first case occurred, has said the development of diagnostic tests for the disease has been delayed by a foreign laboratory's patent rights on the SARS-like virus.

    "Making deals between scientists because they want to take IP (intellectual property), because they want to be the world's first to publish in scientific journals, these are issues we need to address," WHO Director General Margaret Chan told health ministers attending the WHO's annual conference in Geneva.

    "No IP will stand in the way of public health actions."

    The virus was identified in September last year, three months after a scientist took a sample from Saudi Arabia to the Erasmus Medical Center in the Netherlands.

    "There was a lag of three months where we were not aware of the discovery of the virus," Saudi Arabia's Deputy Health Minister Ziad Memish told the Geneva meeting.

    He said it was taken out of the country without permission and Saudi Arabia only learned of its discovery from ProMED, a U.S.-based internet-based reporting system.

    The Rotterdam-based Erasmus lab then patented the process for synthesising the virus, meaning that anyone else who wanted to use their method to study it would have to pay the lab.

    The patenting had delayed the development of diagnostic kits and serologic tests for the disease, Memish said.

    "The virus was sent out of the country and it was patented, contracts were signed with vaccine companies and anti-viral drug companies and that's why they have a MTA (Material Transfer Agreement) to be signed by anybody who can utilise that virus and that should not happen."

    Earlier on Thursday, Saudi Arabia announced another death from the virus in its central al-Qassim region, bringing the total number of deaths in the kingdom to 17.

    Jordan, Qatar, Tunisia, the United Arab Emirates, France and Britain have all had cases of the the virus.

    "Burning House"  

    Chan told the health ministers "you are the boss" and urged them to ensure scientists shared their specimens with WHO's network of collaborating laboratories.

    The patent does not break WHO rules on sharing such information on a possible pandemic, which only apply to flu viruses, but there is a legal requirement for countries to notify WHO of any outbreak of disease of international concern.

    Keiji Fukuda, WHO's assistant director-general for health security, said there was still a "huge amount" unknown about the virus and great concern about its potential to spread.

    Among the gaps in the knowledge of the virus was information about its geographical spread, and many countries may only have minimal surveillance for the disease, he said.

    The only test for the disease is the widely-available PCR (Polymerase Chain Reaction), but that is only useful while the patient has the virus. Once they beat the disease a serology test would be needed, but none has yet been developed to detect infection in communities.

    "We think contact isolation needs to be applied, because some patients present with diarrhoea or vomiting, which we think could be the source of the transmission," Memish said.

    Asked if he thought Erasmus had acted wrongly, Fukuda told reporters the WHO was completely focused on detecting the disease and preventing it from spreading further.

    "When you have a house burning, you look at how you put the fire out, what do you do, where do you get the water from," he said. "That's what we're worried about right now. Then later on you might look at the neighbourhood and the other issues." (Reporting by Tom Miles and Stephanie Nebehay; editing by Andrew Roche) 

     

  • Teen birth rate drops, especially among Hispanics

    Across the nation fewer and fewer teens are giving birth, especially Hispanic girls, according to a new government report.

    Researchers from the Centers for Disease Control and Prevention found that from 2007 to 2011, the overall rate of teen births plummeted a full 30 percent. The biggest decline was among Hispanic teens, whose birth rate dropped 34 percent. Among non-Hispanic black teens there was a decline of 24 percent. Among white, non-Hispanic teens, the rate decreased by 20 percent.

    “The thing that surprised me most was the big decline in rates for Hispanics: at least 40 percent in 22 states and the District of Columbia,” said Brady Hamilton, a report co-author and a statistician at the CDC’s National Center for Health Statistics. “That was pretty impressive. It really caught my eye.”

    Hamilton suspects that public service messages are starting to resonate with teens. “Teen births are the focus of many public policies,” he said. “I think this shows the message is getting out.”

    That makes sense to Dr. Carlos Lerner, medical director of the Children’s Health Center at the University of California, Los Angeles. “In settings like ours, we make sure we provide information in a culturally sensitive way in the patient’s own language,” he explained. “As we’ve learned to do that better, I think the message has been becoming more and more effective.”

    The most important part of counseling teens may be finding a way to give the information in a non-judgmental way, Lerner said.

    Higher rates of secondary and college education might also play a role in the declining birth rates in Hispanics, experts said.

    Based on U.S. Census data, “it does look like both high school and college graduation rates are going up more quickly for Latina women in the 2007-2010 period than for the general population,” said Stefanie Mollborn, an associate professor of sociology at the University of Colorado Boulder. “That would be really interesting potential explanation, since education tends to be strongly related to postponing childbearing.”

    The decline could also be related to the growing number of second generation Hispanics in the U.S., said Rogelio Sáenz, a sociologist and demographer and dean of the College of Public Policy at the University of Texas at San Antonio.

    “From a separate analysis based on the American Community Survey (2007-2011), the drop in [births] among Latinos is slightly higher among native-born Latinas compared to foreign-born Latinas,” Sáenz said.

    Another factor, Sáenz suggested, could be the increasing numbers of young Latino women who choose to remain single. That demographic change may also affect the long range birth rate among these women, he said.

    As for the overall decline in the teen birth rate, that might be related to the economy, Mollborn said.

    “The drop in the teen birth rate mirrors a fairly large drop in the overall U.S. birth rate - to women of all ages - during the same period,” she explained. “This coincides with the Great Recession. Many people are less likely to have children when they're experiencing economic troubles. Since most teen mothers are in or near poverty and come from disadvantaged backgrounds, it's not surprising that they would be especially likely to have fewer births during these difficult economic times.”

    Related stories:

    One in five teen births are repeats, CDC says

    Teen birth rates plummet to record low

      

     

     

  • Tornado birth: Mom endures labor as twister destroys hospital

    Shayla Taylor tells the story of being in active labor as her hospital room crumbles around her during the deadly Moore, Okla.,tornado.

    When a devastating tornado touched down in Moore, Okla., on Monday afternoon, Shayla Taylor was on the upper floor of the local hospital, in active labor with her second child.

    As the floor shook “like an earthquake” beneath her and ceiling tiles and insulation fell overhead, the 25-year-old huddled with four nurses, braving both the peak contractions of childbirth and the wrath of the worst twister the veteran Oklahoman had ever endured.

    “We were all just sitting there holding each other’s hands and praying,” Taylor told NBC News.

    Norman Regional Health System

    Jerome Taylor, left, Shayla Taylor, center, and Shaiden Taylor, right, welcomed baby Braeden Immanuel at the height of Monday's killer tornado in Moore, Okla.

    Moore Medical Center, a 46-bed acute care hospital at 700 S. Telephone Road, took a direct hit from the F-5 tornado, with wind speeds that topped 200 miles per hour.

    The blow devastated the hospital, as news photos plainly show, ripping away the roof and walls.

    After the chaos, Taylor said she heard not the freight train sound described by so many witnesses, but the absolute silence of the storm’s center. Then she opened her eyes.

    “All of a sudden I could see daylight and the wall was gone,” she said. “I look out and I see I-35 and part of the Warren theater,” which later became the triage center for victims of the tornado that killed 24 and injured more than 230 people.

    Rick Wilking / Reuters

    An aerial view of damage at the Moore Medical Center is shown in Moore, Okla., on May 21, after a tornado ravaged the suburb of Oklahoma City.

    She had been dilated to 9 centimeters, nearly ready to deliver the baby, when nurses gave her a quick shot to slow labor during the height of the storm. 

    Taylor was quickly reunited with her husband, Jerome Taylor, 29, who had taken their 4-year-old son, Shaiden, to wait out the tornado with others in the hospital cafeteria. With the help of hospital workers, she was carefully carried through the destroyed building and out to a waiting ambulance, which whisked her 5 miles to another hospital in the Norman Regional Health System.

    Three hours later, after doctors determined that the petite Taylor would need a cesarean section due to the baby's size, she delivered Braeden Immanuel, a healthy 8-pound, 3-ounce boy.

    “His middle name means ‘God is with us,’” said Taylor. “The name had been picked out for months. Now I know why.”

    Taylor is among 30 patients and staffers at Moore Medical Center who survived the tornado, which destroyed the hospital, said Kelly Wells, a health system spokeswoman. No decision has been made yet about whether to rebuild or simply raze the site.

    Two days after the storm, Taylor and her family are recovering from the trauma of the chaotic birth. The family can’t locate their car, a Toyota Camry, which had been parked in the hospital lot and is now nowhere to be found.

    Sossy Dombourian / NBC News

    Newborn Braeden Immanuel Taylor is fine after his harrowing birth, his mother says.

    “I don’t know if it ended up inside the hospital or down the street,” she said.

    Their home is safe, however, and Jerome Taylor, who works for The Hartford insurance company, has been overwhelmed trying to help his neighbors cope.

    Oklahomans are used to tornado warnings and Taylor said she wasn’t particularly alarmed before Monday’s storm.

    “I’m used to sirens,” she said. “If you panicked, you’d be in a constant panic.”

    Now, however, she’s thinking twice about living in Tornado Alley.

    “The tornadoes always track through here,” she said. “It’s not to say everybody’s going to pack and leave tomorrow, but they start to reconsider things.”

    Related: 

     

     

     

     

     

     

     

  • Post-tornado peril: Victims could face deadly fungal infections

    CDC

    The Mucor fungus was responsible for infections that sickened 13 patients, including five who died, after a 2011 tornado in Joplin, Mo. Health officials are urging Oklahoma doctors to be on the alert for similar infections after Monday's twister.

    Doctors treating victims hurt badly in Monday’s devastating Moore, Okla., tornado should be alert for a rare but deadly complication of wind-whipped debris: fungal infections like those that killed five people after the Joplin, Mo., twister in 2011.

    That’s the word from government experts in fungal infections, who documented 13 serious cases of necrotizing cutaneous mucormycosis -- terrible soft tissue infections -- after the Joplin tornado, including instances when visible mold started growing from the patients’ wounds.

    “We want to encourage clinicians to be aware that these infections can happen,” said Dr. Benjamin Park, chief epidemiologist with the mycotic diseases branch at the Centers for Disease Control and Prevention.

    It's not yet clear whether any fungal infections are suspected in the victims of this week's disaster. In Joplin, it took five days for the first infections to show up; within 10 days, 10 patients had been identified. 

    "In the chaos of everything, it's very hard," said Dr. Gary Wells, medical director for the Norman Regional Health System emergency department, who was at the initial triage site during Monday's storm. "It is something you keep in the back of your mind."

    Early detection and diagnosis are key to treating the infections, which occur when molds usually found in dirt, decaying wood and other matter become airborne during a heavy storm.  

    “When they are picked up out of their natural environment and injected into the skin, we’re always concerned about infection,” Park said.

    The molds can contaminate the wounds that occur after the blunt trauma, fractures and penetrating injuries common in tornadoes. The resulting infections can lead to serious illness and death. “The case fatality rate can be very high -- 50 percent,” Park noted.

    The Joplin tornado struck at 5:34 p.m. on May 22, 2011, a monster of a storm rated EF-5, with winds exceeding 200 miles per hour on the Enhanced Fujita Scale used to measure tornadoes. More than 1,000 people were hurt and 162 died.

    The Moore tornado was upgraded to an EF-5 late Tuesday. At least 24 deaths and 237 injuries have been reported. The injuries are typical of tornadoes: crush injuries, impalements and major cuts, according to NBC’s Dr. Nancy Snyderman, who spoke to trauma officials in Oklahoma.

    Doctors and other health workers have been swamped caring for the victims, so it’s not clear what steps they’re taking to detect or treat potential fungal infections.

    “I’m not sure that they’ve gotten that far yet,” said Pamela Williams, spokeswoman for the Oklahoma Department of Health.

    The need for vigilance is clear, according to a 2012 review of the Joplin infections published in the New England Journal of Medicine. Skin-related Mucormycosis infections have been reported after other natural disasters, including a 1985 volcanic eruption in Colombia and after the 2004 Indian Ocean tsunami.

    “The risk of complex wounds with foreign-body contamination during natural disasters is high, and wound management can pose considerable clinical challenge in post-disaster settings, especially when the local health care infrastructure has been damaged,” wrote authors from the CDC.

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  • Dirty dogs: Homes with pooches loaded with bacteria

    A dog may not only fill a home with joy, it fills a home with a whole lot of bacteria, new research suggests.  But that doesn't mean you have to kick your pooch out of the bed.

    featurepics.com

    This adorable puppy is loaded with bacteria, but those germs may actually be beneficial.

    Research from North Carolina State University published Wednesday in the journal PLoS ONE found homes with dogs have both a greater number of bacteria and more types of bacteria than homes without dogs. 

    The findings were part of a larger study that analyzed the types of microbes living in 40 homes in the Raleigh-Durham area of N.C.  Participants swabbed nine areas of their homes and informed researchers about aspects that could influence bacterial life, such as whether there were dogs or cats and how many people lived in the home. 

    “The project was a first step toward making an atlas of microbes found in the entire home and how they may affect our health and well-being” said Holly Menninger, a co-author and director of public science at NC State’s Your Wild Life program.

    Of the places where household bacteria were found, pillowcases and television screens had the most detectable dog-related microbes.

    “Some of the microbes we know come from dogs themselves,” said Menninger. “Some of these bacteria come from the outdoor environment, such as dogs bringing bacteria from the soil and into homes.” 

    The researchers were able to identify a few classes of bacteria linked to dogs, and certain microbial classes that may cause disease in humans, such as gingivitis and pneumonia.  However, genetic testing of the bacteria was not specific enough to determine whether any harmful strains were there.

    All those germs tracked in on dirty paws don’t mean dog-free homes are necessarily healthier, though. While the researchers did not identify the specific species of bacteria living in each household, they were able to say that most of the organisms they found are not disease-causing – and may actually provide some benefits.

    “We co-exist with bacteria and healthy, small exposures to bacteria do not pose any risk and might, on the other hand, be beneficial, as long as we keep a good hygienic environment,” said Dr. Rani Gereige, director of medical education at Miami Children's Hospital.  Gereige was not involved in the research.

    A recent study found that exposure to a microorganisms from a pet during a child’s first year of life of life may help ramp up the immune system, lowering the risk of developing allergies later. 

    “Research has actually shown that mothers who live with dogs while pregnant are less likely to have children with conditions like atopic dermatitis or to develop allergies,” said veterinarian Dr. Andy Roark of Greenville, S.C. 

    Certain bacteria from dogs – such as salmonella and listeria -- can cause infections in humans, however, so it is important to be vigilant, he cautions.

    “It is always a good idea for both adults and children to wash hands after playing with pets, especially before eating,” said Roark.

    The study did not control for certain factors that could affect bacterial growth, such as household climate and cleanliness, and there were not enough homes with cats to accurately analyze the feline contribution to residential bacteria.  The researchers did not analyze whether certain dog breeds harbor more bacteria than others.

    The microbes found throughout the different homes fell into three general groups: those that come from skin and live on surfaces we touch, such as door knobs and toilet seats; bacteria linked to food found in kitchens; and organisms found in places where dust gathers, such as television screens and moldings.

    Menninger added that the research team is in the process of analyzing samples and other data from a total of 1,300 homes across the United States. 

    “We know we have all these bacteria in our home,” said Menninger.  “Let’s learn to live with them.” 

     Related

    Your skin microbes prove you're a 'dog person'

     

     

  • New insomnia drug is effective, FDA finds

    By Matthew Perrone
    Associated Press

    A federal panel of medical experts said that an experimental insomnia drug from Merck & Co. Inc. appears safe and effective, despite evidence from company trials that the pill can cause daytime sleepiness and difficulty driving. 

    A majority of Food and Drug Administration panelists voted Wednesday that Merck's sleeping aid, suvorexant, helped patients get to sleep and stay asleep. In a separate set of votes, the panel voted that the drug appears safe at the starting doses proposed by the company.

    The FDA is not required to follow the recommendations of its experts, though it often does.

    The panel opinion was somewhat at odds with the agency's own scientists, who issued a negative review of the drug earlier in the day. FDA staff pointed out that suvorexant was associated with daytime drowsiness, driving difficulties and suicidal thinking in trials conducted by Merck.

    "How much is it worth to try and make the drug safer? How many people are you willing to risk versus how much effort are you willing to make?" said Dr. Ronald Farkas, who presented the FDA's findings.

    The FDA drew attention to five women, or roughly 5 percent of patients, who had to stop a supervised driving test because they were too sleepy to continue. In another case, a 59-year-old man reportedly fell asleep at a traffic light and later veered off the road while taking the drug.

    The FDA suggested that a lower dose of 10 milligrams might be safer for patients than the higher doses proposed by Merck.

    But a majority of panelists endorsed the safety of initial doses proposed by Merck: 15 milligrams or 20 milligrams a day for elderly patients or non-elderly patients, respectively. The panel backed their safety in a vote of 13-3, with one abstention.

    "Start low and go slow is likely to be effective," said Dr. Matthew Rizzo of the University of Iowa. "I also think the safety profile of this drug is not any worse and likely better than the drugs we are already using."

    Much the meeting's discussion focused on the shortcomings of sleeping pills already on the market, most of which are also associated with lingering drowsiness.

    In January, the FDA required drugmakers of Ambien and similar sleeping pills to lower the doses of their medications, based on studies showing that the drugs remain in the bloodstream at levels high enough to interfere with driving.

    The panel narrowly voted 8-7, with one abstention, against doses as high as 30 milligrams and 40 milligrams, saying they could exacerbate problems with drowsiness and narcolepsy.

    "I think the risks are substantial and it seemed to go up with the higher dose," said Natalie Portis, the panel's patient representative.

    Merck has suggested raising patients' prescriptions to the higher levels if they do not respond to lower doses.

    If the FDA ultimately approves suvorexant, it will be the first in a new group of drugs that aid sleep by blocking chemical messengers that keep people awake.

    A Merck spokeswoman said Wednesday the FDA is expected to issue a decision on suvorexant by mid-year. If approved the drug will have to be scheduled as a controlled substance by the Drug Enforcement Administration.

    Shares of the Whitehouse Station, N.J., company fell 62 cents to close at $46.71. 

  • Doctors print up a splint for baby's blocked throat

    Family photo via University of Michican

    Kaiba Gionfriddo of Youngstown, Ohio, has a bioprinted splint holding his airways open. Without it, he wouldn't be able to breathe.

    The Youngstown, Ohio, baby turned blue again and again as his little airways collapsed and kept air from reaching his lungs. But doctors used a 3-D bioprinter to custom-make a splint that is holding his airway open and helping him breathe.

    Now 19-month-old Kaiba Gionfriddo is “into everything”,  says his mother, April Gionfriddo.

    "Quite a few doctors said he had a good chance of not leaving the hospital alive," she adds.

    Kaiba’s life was saved by a brand-new field of regenerative medicine based on plastics and inkjet printers. Doctors at the University of Michigan used CT scans of Kaiba’s little airways to custom-design a scaffolding to pull open the passages and hold them open until they could grow strong and healthy on their own.

    Kaiba was born with a rare condition called tracheobronchomalacia. This deformity affects about one in 2,200 babies and causes the airways to be weak and prone to collapse. In tiny babies, it can look like asthma and it can take a while to diagnose.

    University of Michigan.

    Doctors at the University of Michigan bioprinted this splint, custom designed for Kaiba Giofriddo's trachea. It fits around the outside and supports the windpipe.

    Kaiba showed early symptoms. “At 6 weeks of age, he had chest-wall retractions and difficulty feeding,” the researchers wrote in this week’s issue of the New England Journal of Medicine. April Gionfriddo says it wasn’t immediately clear what was wrong, until one morning the family was eating out when Kaiba was 2 months old.

    “We went to the Waffle House,” she said in a telephone interview. “He ended up turning blue and stopped breathing on us.” They rushed to the emergency room, where doctors said the baby had just aspirated something, and sent him home.

    “Two days later, he ended up turning blue on us again,” says Gionfriddo, a 32-year-old mail room worker in Youngstown, Ohio. “He ended up spending four months in the hospital.”

    Kaiba needed a ventilator to breathe, and wasn’t going to be able to survive without it. Worse, he struggled and had to be sedated to tolerate the breathing tube.

    “Some of the arteries, especially those coming off the aorta, are malformed,” said Scott Hollister, a professor of biomedical engineering at Michigan. “They almost form a ring around the trachea. If it’s too tight, they actually compress the airway, which happened in Kaiba’s case.”

    Again and again, Kaiba’s floppy airways collapsed.

    "Even with the best treatments available, he continued to have these episodes. He was imminently going to die,” said Dr. Glenn Green, a pediatric ear, nose and throat specialist at the University of Michigan “The physician treating him in Ohio knew there was no other option, other than our device in development here.”

    Green had been working with Hollister to develop exactly what Kaiba needed – support for his growing bronchial tubes.

    “Our laboratory has been working on this area for a long time,” Hollister said in a telephone interview. “It was a little bit intimidating as well. We had been developing the prototype and gearing it toward this application.”

    Family photo/ Via University of Michigan

    Kaiba Gionfriddo can't walk yet, but he can scoot around, his mom says.

    Replacing the entire trachea is complex. “We felt the simplest solution was to build a device that would go around the trachea,” says Hollister.

    They developed a program that would design the horseshoe-shaped device, complete with small holes to allow a surgeon to suture it into place. “Then we made a model of his trachea,” says Hollister. “Just to be sure, we made it in a range of sizes.”

    Hollister’s team used a bioplastic powder called polycaprolactone.  “It’s a polymer that is approved by the Food and Drug Administration to fill small holes in the skull,” Hollister says. The bioprinting machine melts the powder, and builds the desired shape layer by layer.

    The University of Michigan team got special permission from the school’s advisory board and the FDA to go ahead. “I was a little scared at first because the doctor said he wasn’t sure it was going to work at first,” Gionfriddo says.

    “But we decided to go ahead and try it. It gave him a chance. We were pretty happy they had at least something. It kind of seemed kind of cool and the other part was science fiction.”

    In February of 2012, a surgical team re-arranged Kaiba’s twisted heart arteries and trachea, and then carefully placed the splint.

    "It was amazing. As soon as the splint was put in, the lungs started going up and down for the first time and we knew he was going to be OK," says Green. In three years, they expect the material will be completely reabsorbed and excreted by the body. By then, his own airways will be able to function on their own, doctors say. 

    "Severe tracheobronchomalacia has been a condition that has bothered me for years," he added. "I've seen children die from it. To see this device work, it's a major accomplishment and offers hope for these children."

    Three weeks after surgery, the ventilator was taken out and Kaiba was sent home. "He’s not walking yet, but he’s starting to learn how to scoot backwards on his little butt,” Gionfriddo says.

    Now, Kaiba’s 6-year-old brother and 11-year-old sister spoil him, Gionfriddo says. “They sit there and laugh at him. They end up getting in trouble with them.”

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    Girl gets artificial trachea

    Toddler is youngest to get new windpipe

    Regenerative medicine - a 'growing' field

  • New, stripped-down flu vaccine might work better, study finds

    National Institute of Allergy and Infectious Diseases

    A new flu vaccine is made out of self-assembling nanoparticles. This images shows what the particle looks like - to the immune system, it looks like a flu virus.

    Researchers have developed a “stripped down” synthetic flu vaccine that they believe will not only work better than current vaccines, but might last longer, too -- saving people from having to get a fresh flu shot every year.

    They say it’s the first step toward a new generation of influenza vaccines, designed entirely in the lab, using nanoparticles instead of the decades-old approach that uses chicken eggs. The nanoparticles assemble themselves into an imposter of the flu virus -- one that seems to excite the immune system far more than the real thing.

    “This is, I believe, an important advance,” says Dr. Tony Fauci, head of the National Institute of Allergy and Infectious Diseases, where the research was done.

    Current flu vaccines are clunky at best. Most are still grown in eggs, an uncertain technology that takes months. Entire factories full of vaccine can be shut down because of contamination. Researchers have figured out how to make synthetic versions of the flu virus to use as a basis for the vaccine, but many still use real viruses, either killed or weakened so they don’t make people sick.

    And it’s never certain from one year to the next how well the vaccine will work. No one is precisely sure why, but the virus mutates every year, and a variety of strains circulate at any given time. The result is that some years the vaccine protects people well, and in others, it doesn’t.

    For instance, this past season’s influenza vaccine reduced the chances of illness by just 9 percent in people older than 65, the Centers for Disease Control and Prevention says, and reduced illness for the population as a whole by 56 percent.

    And then every few years, a new strain pops up to infect people. Health officials are currently keeping a wary eye on two strains of bird flu, H5N1 and H7N9, either of which could mutate just a bit more to cause a pandemic.

    The new vaccine uses a key part of the flu virus, called hemagglutinin, which gives flu the “H” in its name.  Dr. Gary Nabel, who was at NIAID at the time, fused a bit of hemagglutinin to a piece of a compound called ferritin. Ferritin naturally makes itself into little nanoparticles, and the result was a nano-sized spiky ball that looked a lot like a natural bit of hemagglutinin.

    Nabel says it’s a stripped-down version of flu virus that the immune system recognizes even better than it does real flu. Tests on animals showed the nanoparticles caused the body to produce 10 times as many virus-fighting antibodies as the current seasonal flu vaccine, Nabel’s team reports in the journal Nature.

    “They look like flu. They react with antibodies like flu,” Nabel, who now works for vaccine maker Sanofi, said in a telephone interview.

    The vaccine protected ferrets against H1N1 flu viruses, an H3 flu virus and an influenza B virus, too. Ferrets are the animals that react most like humans to flu.

    Now researchers are working to make a version that can be tested in people.

    Nabel thinks the vaccine will provide broader immunity than current vaccines, as well as a stronger immune response. But humans have unique immune systems and it’s not yet clear how it will work in people.

    It may also speed up the convoluted process for making vaccines, which starts with growing the virus in the lab, something that can take months. “We don’t need the virus to replicate. We just put the gene into a cell and make the particle. It is rather an amazing process,” Nabel says.

    “In theory it could be very fast.” If it takes three months now to make a “seed” virus for a vaccine, the new process would only take a week or two, he estimates.

    It took months to make and roll out vaccine against H1N1 swine flu when it first broke out in 2009 and thousands of people died during the delay. CDC doesn’t count how many adults die from flu each year, because it’s so variable -- anywhere from 4,000 to 49,000 a year.

    The new technology might not just work against flu. “This is a platform that could be used for other viruses,” Nabel said. That could include the AIDS virus or herpes, or even coronaviruses like the new MERS virus that has killed more than 20 people in Saudi Arabia and other middle east countries.

    Fauci said in theory, a vaccine made from this new technology could last longer than the current seasonal flu vaccine. “To me, this is an important step toward the development of a universal flu vaccine,” Fauci said. “The definition of a universal flu vaccine is it covers wide range (of virus strains) and you wouldn’t necessarily need to get a new one each year.”

    Dr. John Treanor, a flu vaccine researcher at the University of Rochester Medical Center, said the approach resembled some newer-generation vaccines that use synthetic technology and that have been shown to work in people.  “It certainly is a very technically advanced approach,” said Treanor, who was not involved in the research.

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