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  • Lumpectomy survival rates good for early breast cancer

    By Andrew Seaman at Reuters 

    A new U.S. study examining survival rates for women with early stage breast cancer found that surgery such as lumpectomy that preserves the rest of the breast may offer survival odds as good as, or even better than, mastectomies.

    Despite clinical trials showing lumpectomy, or removal of the cancer only, to be as effective as mastectomies in treating early breast cancers, the number of women choosing breast removal has been on the rise, wrote lead researcher E. Shelley Hwang in the journal Cancer.

    "It was kind of an exciting and hopeful message that women don't have to go off to get a mastectomy to do better," said Hwang, from the Duke Cancer Institute in Durham, North Carolina.

    "I think a lot of women were making that decision (for mastectomy) because they thought the lumpectomy was not enough. In that context, we wanted to know if lumpectomy works just as well as mastectomy in the modern era."

    For the study, they used data collected by the Cancer Prevention Institute of California on 112,154 women who were diagnosed with stage I or II breast cancer between 1990 and 2004.

    The majority - 55 percent - had a lumpectomy with radiation, and the rest had a mastectomy without radiation. The researchers then tracked the women's health for an average of nine years.

    Overall, 31,425 women died by the time the study ended in 2009, and 39 percent of those deaths were due to breast cancer.

    But the researchers found that the women who had a lumpectomy with radiation were more likely to survive than women who had a mastectomy, regardless of age or cancer subtype.

    The difference was most pronounced among women who were over 30 years old and diagnosed with the most common type of breast cancer, one that's fed by hormones like estrogen or progesterone. Those who chose lumpectomy had a 19 percent lower chance of dying from breast cancer than counterparts who got mastectomies.

    The survival advantage with lumpectomy held up even when researchers accounted for age, tumor stage and type, race, economic status and other factors. Among women younger than 50 with hormone-sensitive cancers, for instance, those who had lumpectomy had a 7 percent lower chance of death than those who had mastectomy.

    Hwang said the survival difference might be partly explained by the fact that women who got a mastectomy tended to be in worse health to begin with.

    The study cannot prove that lumpectomy alone is the factor responsible for the improved survival, and researchers did not have access to some specific details about the women's tumors, or whether some had genetic susceptibility to breast cancer.

    "I wouldn't overstate these results, because survival can come from other things," said Dawn Hershman, co-leader of the Breast Cancer Program at the Columbia University Medical Center in New York - though she did say the results are reassuring.

    "Sometimes patients in practice can be very different than patients in randomized trials," she added. "It's reassuring that patients who get breast-conserving therapy do at least as well as those with mastectomy." 

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  • New stroke guidelines expand use of clot-busting drugs

    By Rachael Rettner, MyHealthNewsDaily
    Some people who've had a stroke can receive a clot-busting drug up to 4.5 hours after their symptoms begin, according to new guidelines from the American Heart Association. 

    Previously, the guidelines said the drug must be delivered within three hours of the onset of symptoms.

    The drug, called tissue plasminogen activator, or tPA, breaks down blood clots in the brain, and can improve stroke symptoms and reduce the risk of disability. It is used only for strokes caused by blood clots, and not those caused by bleeding in the brain. The sooner the treatment is given, the better a patient's chances for recovery, said Dr. Edward Jauch, lead author of the guidelines and director of the Division of Emergency Medicine at the Medical University of South Carolina.

    Currently, just 3 to 5 percent of stroke patients reach the hospital in time to be considered for the treatment, the AHA says. Researchers hope the new guidelines will increase the number of patients who receive the treatment, Jauch said.

    Patients are eligible to receive tPA in the extended time window — 3 to 4.5 hours after stroke symptoms appear — if they are younger than age 80, if their stroke is mild to moderate in severity, if they are not taking anticoagulants (blood thinners), and if they do not have a history of stroke or diabetes, Jauch said.

    Another new recommendation says stroke patients eligible for tPA should receive it within one hour of arriving at the hospital.

    A 2007 European study showed the benefits of using tPA in the extended time window. In 2009, the AHA issued an advisory to doctors about the benefits of using tPA in the extended window, but this is the first time the recommendation has appeared in the organization's official stroke management guidelines. 

    The new guidelines also recommend that hospitals offering specialized stroke treatment should collaborate with facilities that don't have such specialized treatments. For instance, the hospitals might set up a network for "telemedicine," which would allow doctors at special treatment centers to assess a patient remotely via a computer monitor or TV screen. Hospitals also should set up efficient systems that allow stroke patients to be quickly transferred from one hospital to another if needed, Jauch said

    Symptoms of stroke include difficulty speaking (slurred speech) or understanding others, arm weakness or numbness, face numbness or drooping, and blurred vision. If you experience these symptoms, you should call 911 right away, the AHA says.

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  • Time to kidney transplant varies by race, insurance

    By Genevra Pittman, Reuters

    NEW YORK - Kidney disease patients who are black or lack private health insurance are less likely to get matched up with a donor organ before needing to go on dialysis, a new study suggests.

    Still, researchers said, as long as patients get a kidney transplant within a year or so of starting dialysis, any extra benefit of a pre-dialysis transplant may be low.

    "It's a possible benefit, but it's not entirely clear," said Dr. Morgan Grams, who led the new study at the Johns Hopkins University School of Medicine in Baltimore.

    She told Reuters Health the findings represent "just another disparity" for African American patients, in particular, who take longer to get on the waitlist for a donor kidney and are less likely to get one at all.

    "Studies over the last 10 to 15 years have consistently shown that minorities have poorer access to transplantation," said Dr. Douglas Scott Keith, head of the kidney transplant program at the University of Virginia Medical Center in Charlottesville.

    "This article basically shows that it's persisting, it hasn't gotten much better," Keith, who wasn't involved in the new study, told Reuters Health.

    Grams and her colleagues looked at about 122,000 first-time kidney recipients who received their organ from a deceased donor off a transplant list between 1995 and 2011.

    Nine percent of those patients had their kidney transplant before going on dialysis, and another 12 percent received a kidney within their first year on dialysis, the researchers reported Thursday in the Clinical Journal of the American Society of Nephrology.

    African Americans were 56 percent less likely to receive a kidney before dialysis than whites - possibly because there was a delay in getting them on the transplant list or fewer matching donors, researchers said.

    Typically, an available organ goes to the local patient who has been on the kidney transplant list the longest - but that person can be skipped if the organ is a direct match to the immune system of another patient high on the list.

    People in the study who had private insurance were also three times more likely to get an early kidney than others.

    Insurance is required for a transplant, so anyone with private insurance can get on the list early. Others aren't eligible for government-funded insurance until they're on dialysis.

    It's still unclear whether receiving a kidney very early on improves the long-term outlook for patients with renal disease.

    Pre-dialysis recipients and people who got their kidney within a year of starting dialysis were equally likely to survive for years after their transplant, the researchers found. Both did better than late-dialysis recipients.

    "I would certainly not advocate postponing dialysis in the hope of getting a transplant without getting dialyzed," said Dr. Titte Srinivas, the head of transplant nephrology at the Medical University of South Carolina in Charleston, who also wasn't part of the research team.

    For a patient who needs it, "A short duration of dialysis is not really detrimental to health."

    Srinivas told Reuters Health what's most important is for anyone diagnosed with renal failure to get on the kidney transplant list as quickly as possible.

    Health care reform could make that easier for some people, Grams noted, as more low-income patients will have access to insurance - and the transplant list.

    "People don't realize that insurance makes such a huge difference," she said.

    Keith said aside from the insurance issue, researchers are still grappling with how to distribute kidneys of all different qualities, from all different types of donors, to the people who need them most.

    "We should be trying to make the system as fair as possible, and to limit disparities as much as possible," he said. "The question is how to do it."

  • Diabetics can eat right after using insulin, study says

    By Andrew M. Seaman, Reuters

    NEW YORK  - People with type 2 diabetes are sometimes told to wait after using insulin for the drug to work its way into the body before they can begin eating, but a new study from Germany says that's not necessary. 

    In a group of about 100 diabetics, researchers found that blood sugar levels remained steady regardless of whether or not participants left a 20 to 30-minute gap between using insulin and eating a meal. The diabetics overwhelmingly preferred being able to eat right away, too.

    "It's a very promising result. It will lead to better adherence and satisfaction," said Dr. Aaron Cypess, a staff endocrinologist in the clinic of the Joslin Diabetes Center in Boston who was not involved in the study.

    Insulin gives glucose - or blood sugar - access to the body's cells to be used as fuel. But in type 2 diabetes cells are resistant to insulin or the body doesn't make enough of the hormone, so glucose remains in the bloodstream and can climb to dangerously high levels.

    Injectable insulin is available for diabetics in a newer fast-acting form, but it's expensive and many still use human insulin, which takes some time to become active in the body. So doctors often recommend waiting to eat after using human insulin to prevent blood sugar spikes.

    Not all experts think waiting is necessary, though, according to the researchers led by Nicolle Mueller of Universitätsklinikum Jena. To see what difference it makes, Mueller and her colleagues randomized type 2 diabetics into two groups.

    For four weeks, one group of 49 people waited 20 minutes to eat after using human insulin. Then they switched to eating immediately after injecting insulin for another four weeks. A second group of 48 diabetics did the same in reverse order, eating immediately after injection for the first four weeks, then observing a waiting period for the next four.

    Using a blood test that measures average glucose levels over time, the researchers found that all the participants had generally higher than ideal blood sugar levels - but the difference in those levels between periods when they waited or didn't wait to eat after insulin injections was a negligible 0.08 percent.

    The participants also reported about the same number of high-blood sugar episodes between the two time periods, and about 87 percent of them said they "significantly preferred" doing away with the 20-minute wait altogether.

    Cypess said people should talk with their doctors before making any sort of change to their insulin routine.

    "What would I do with a patient who is moderately adherent to what I recommend? I'd say give it a shot," he said, because it's better for people to eat closer to the time they use insulin.

    "This is really useful, because you get into a problem if people are supposed to take insulin so many minutes before. That's where adherence goes down," he said.

    These results may also allow some people to switch from the fast-acting insulin analogs to the less-expensive human insulin, said Cypess, but he added that more studies would be needed to compare the two.

    He also warned that people shouldn't assume these results apply to people with type 1 diabetes, whose bodies produce virtually no insulin.

    "Talk to your doctor," he said.

  • Novartis recalls cough syrups due to cap seal defect

    By Adam Kerlin, Reuters

    NEW YORK - Novartis AG said on Thursday it is recalling 183 lots of cough syrup after discovering the child-resistant feature on some bottle caps was not functioning correctly. 

    The Swiss drug company is recalling 142 lots of Triaminic and 41 lots of Theraflu Warming Relief Syrups manufactured in the United States before December 2011.

    The company said it received four reports of accidental ingestion of the Triaminic syrup. One patient required medical attention but recovered.

    No adverse affects were reported with the Theraflu syrup, but the product is being recalled because it has the same cap as the malfunctioning Triaminic bottles.

    The affected cough syrup bottles were produced at Novartis' Lincoln, Nebraska, manufacturing facility. A consumer complaint last November triggered an internal investigation that led the company to issue the recall.

    Julie Masow, a spokeswoman for Novartis, said 97 percent of the product in question has either been used or already returned.

    Manufacturing at the Lincoln, Nebraska, facility was suspended in December 2011 and has yet to reopen, Masow said.

  • Few may pay for skipping health insurance, new regs show

    People worried about having to pay a fine for not carrying health insurance coverage got a little more guidance this week with some new federal regulations. The bottom line: Hardly anyone will end up paying the tax when the health reform law takes full effect in 2014.

    The Urban Institute has projected that only about 2 percent of Americans would likely have to pay what the government calls the “shared responsibility payment.” The new regulations from the Internal Revenue Service and the Health and Human Services Department explain all the ways people can get out of paying it.

    “What we are talking about is a relatively small slice of the population,” says Linda Blumberg, senior fellow at the Urban Institute’s health policy center.

    The Congressional Budget Office has said that 80 percent of the non-elderly population would have some sort of health insurance even without the health reform law.

    The so-called individual mandate, one of the least popular provisions of the 2010 health reform law, is meant to make sure that people don’t wait until they are sick to buy health insurance—especially as the law makes health insurance available more easily to more people, including those who are already sick.

    The idea is that people will have many more chances to get health insurance because of the exchanges, the marketplaces where private insurance plans will offer policies for people to buy if they are not covered by an employer or by government-sponsored insurance such as Medicare, Medicaid and Tricare.

    And the federal government is subsidizing all but the wealthiest buyers. The Supreme Court ruled it constitutional and says the payment is actually a tax.

    It’s a nominal tax at first -- $95 in 2014, $325 in 2015 and $695 or 2.5 percent of household income in 2016. The IRS will make sure people pay it. Starting next year, you’ll have to declare where you get your health insurance on your income tax form.

    “If you don’t pay on your tax returns if you own an assessment, what they are going to do is take it out of possible future tax refunds,” Blumberg said in a telephone interview.

    One way the law aimed to get more people covered by health insurance was by making Medicaid more widely available. But the Supreme Court ruled last summer that states, which administer Medicaid and pay for part of it, could opt out.

    The regulations make it clear there are plenty of exemptions. For instance, people who live in a state that has decided against expanding Medicaid won’t have to pay the tax if they would have been eligible for Medicaid.

    So, if people live in a state that isn’t expanding Medicaid, they might not be on the hook to buy health insurance for themselves, although the government recommends they do.

    “That’s an important clarification,” Blumberg says.

    Also, people get one three-month slide. You can go for as long as three months, one time, without health insurance before the payment kicks in. After that, the IRS rules say people will be assessed 1/12th of the annual payment for each month they or their legal dependents lack coverage.

    “For each month during the taxable year, a nonexempt individual must have minimum essential coverage or pay the shared responsibility payment,” the regulation reads.

    People are exempt if they are in jail or prison, if they make too little money to file an income tax return ($9,500 a year for an individual), if their health insurance premium would cost them more than 8 percent of annual income, members of Indian tribes, those whose religion forbids buying health insurance, illegal immigrants, Americans living abroad, and members of a health care sharing ministry.

    The IRS has a public hearing scheduled for May 29 on the new regulations.

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  • One-hour condom delivery service launched in Dubai

    By Associated Press

    Need a condom delivered to your doorstep in an hour? Then Dubai is the place to be.

    Already the launching pad for American fast-food restaurants and a Canadian coffee shop, the glittering Gulf metropolis now features a service from Durex and Buzzman Middle East called SOS Condoms.

    Starting this week, users can have Durex products delivered within an hour to anywhere in the city from 4 p.m. to 4 a.m. Users order condoms from their smartphone or a website.

    Sandrine Girard, a spokesman for Buzzman, said Thursday that the service will expand to other cities with the next city decided by a competition on SOS Condoms' Facebook page.

    Dubai has strict laws on sex-related issues, but is more liberal than the rest of the Persian Gulf.

  • Pet hedgehogs sicken more people with salmonella

    By Rachael Rettner
    MyHealthNewsDaily

    A salmonella outbreak linked to pet hedgehogs has sickened 20 people in eight states, according to a new report from the Centers for Disease Control and Prevention (CDC).

    All the patients were infected with a strain of bacteria called Salmonella typhimurium. Fourteen of the ill people reported direct contact with hedgehogs, the CDC said.

    The outbreak began in December 2011, and has continued into 2013. So far, four people have been hospitalized, and one has died. Many of the affected have been children, the CDC said.

    Related story: Pet hedgehogs sicken 14 with salmonella, CDC says

    Washington state has reported the most cases, seven, followed by Michigan, Minnesota and Ohio, which have each reported three cases. Other states that have reported infections are Alabama, Illinois, Indiana and Oregon.

    Although the most common source of salmonella infections is food poisoning, animals can spread the disease as well. Besides hedgehogs, salmonella outbreaks have also been linked to pet turtles.

    To reduce the risk of infection, it's important to wash your hands after handling hedgehogs, or anything the animals come in contact with, the CDC said. Adults should supervise children around hedgehogs and make sure the youngsters wash their hands after touching the animal or anything the hedgehog has been in contact with.

    The report will be published this week in the CDC's Morbidity and Mortality Weekly Report.

    Follow Rachael Rettner on Twitter@RachaelRettner, or MyHealthNewsDaily@MyHealth_MHND. We're also onFacebook&Google+.

  • Hartz recalls chicken jerky pet treats, too

    The Hartz Mountain Corp. is withdrawing some 20,000 packages of chicken jerky pet treats in the U.S. after the firm's own tests found trace amounts of antibiotic residue, the same problem that led to earlier recalls by top suppliers. 

    Hartz Chicken Chews and Hartz Oinkies Pig Skin Twists Wrapped with Chicken for dogs have been pulled voluntarily from retail shelves nationwide, according to the Secaucus, N.J., firm. 

    Company officials said they conducted independent laboratory tests after New York state agriculture officials found evidence of antibiotic residue in treats produced by Nestle Purina PetCare Corp. and Del Monte Corp. Nestle withdrew Waggin' Train and Canyon Creek Ranch brand dog treats and Del Monte pulled its Milo's Kitchen Chicken Jerky and Chicken Grillers home-style dog treats from shelves nationwide.

    In addition, two more firms recalled their treats as well, including Publix stores, which recalled its private brand Chicken Tenders Dog Chew Treats and IMS Pet Industries Inc., which withdrew its Cadet Brand Chicken Jerky Treats sold in the U.S.

    Hartz officials said they found evidence of antibiotic residue in about a third of the treats they tested, but removed all the products as a precaution. They were not contacted by the New York officials, but lab tests found the same unapproved drugs including sulfaclozine, tilmicosin, trimethoprim, enrofloxacin and sulfaquinoxaline.

    Four of the antibiotics are approved in China, where most of the treats are made, and in other countries, but not in the U.S. A fifth is allowed in the U.S., but in virtually undetectable amounts in finished products. 

    There is no indication that the detection of antibiotic residue is related to an ongoing investigation into deaths and illnesses of dogs and cats linked to chicken jerky pet treats made in China, treat manufacturers and Food and Drug Administration officials agree. The trace antibiotic pose no health threat to pets or humans, FDA officials said. 

    The agency is continuing to investigate what may be behind reports of 500 deaths and more than 2,700 illnesses in dogs and cats who consumed chicken jerky pet treats made in China. 

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  • Childhood obesity may boost MS risk

    By Rachael Rettner
    MyHealthNewsDaily

    Very obese children and teens may be at risk for multiple sclerosis, a new study suggests.

    In the study, very obese girls (those who had a body mass index (BMI) of 35 or higher) were nearly four times more likely to be diagnosed with multiple sclerosis (MS) within the study period, compared with girls who were normal weight. The link was strongest among teenagers.

    No link between obesity and multiple sclerosis was found for girls in other weight classes, or for boys.

    In people with MS, the immune system attacks the nerve cells of the brain and spinal cord, producing symptoms such as numbness, loss of balance, weakness and tremors. MS is rare in children — about one to two kids out of every 100,000 will develop the condition. Symptoms are similar in children and adults, although youngsters may also experience symptoms not typical of MS, such as seizures or lethargy, according to the National Multiple Sclerosis Society.

    The findings suggest that, as the prevalence of childhood obesity increases, so will cases of multiple sclerosis, said study researcher Dr. Annette Langer-Gould, of Kaiser Permanente Southern California Department of Research & Evaluation in Pasadena, Calif.

    "Our study suggests that parents or caregivers of obese girls and teenagers should pay attention to symptoms such as tingling and numbness or limb weakness, and bring them to a doctor's attention," said Langer-Gould.

    However, the study only found an association, and cannot prove that obesity causes multiple sclerosis. It could be that an aspect of the condition itself — such as having trouble exercising before the condition is diagnosed — predisposes youngsters to obesity. But if this were the case, researchers would expect to see the same link in girls and boys, which the study did not find, Langer-Gould said.

    The researchers analyzed information from 75 children and teens ages 2 to 18 who were diagnosed with pediatric MS, and compared them with more than 913,000 children and teens who did not have MS. For those with MS, BMI was measured before the condition was diagnosed.

    Obesity is known to increase inflammation in the body, which may be involved in the development of MS, Langer-Gould said. Estrogen, a female hormone, also increases inflammation, and together with other inflammatory factors released from fat cells, could accelerate the development of MS, Langer-Gould said. The involvement of estrogen might explain why the link was only seen in girls.

    "The authors certainly have opened the door to an interesting association," said Dr. Michael Duchowny, a pediatric neurologist and director of academic affairs at Miami Children's Hospital Research Institute, who was not involved in the study. "These findings need to be repeated, expanded and clarified further" with additional research, including studies that test the estrogen hypothesis, Duchowny said.

    Previous studies in adults have suggested that obesity, or related factors, such as levels of appetite hormones, play a role in the development of MS, said Dr. Steven Mandel,  a neurologist at Lenox Hill Hospital in New York City.

    "It doesn't mean that if you're obese or overweight ,you're going to develop MS," but rather, that a link between the two conditions exists, Mandel said. The findings may be another reason to bring childhood obesity under control, he said.

    Although preliminary, some saw the findings as hopeful.

    "We're beginning to accumulate a good deal of information about some of the environmental factors that may play a role in MS, and environmental factors that are possible to be modified," such as smoking and obesity, said Dr. Nicholas LaRocca, vice president of health care delivery at the National Multiple Sclerosis Society. "That’s a very exciting possibility," LaRocca said.

    The study will be published today (Jan. 30) in the journal Neurology.

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  • Prostate cancer treatments have serious long-term side effects

    New research strongly reinforces the notion that prostate cancer is vastly overtreated with often dire results.

    A study out Wednesday in the New England Journal of Medicine focused on treatment side effects, following a group of 3,533 men for 15 years after they got either surgery (called prostatectomy) or radiation for cancer that had not spread beyond the prostate. Radiation produced fewer side effects -- especially in the first years after treatments-- but both groups experienced huge impacts.

    “This paper tells you that if you get treatment there are a lot of side effects regardless of the therapy you chose,” the senior author Dr. David Penson, professor of urologic surgery at Vanderbilt University Medical Center, said in an interview.

    Most men were in their sixties when they were first treated. Two years after treatment 60.8 percent of the men who had undergone radiation had erectile dysfunction, compared to 78.8 percent of those who chose surgery. By 15 years, the numbers became 87 percent and 93.9 percent. Many men also suffered urinary and bowel problems and those, too, grew worse with time.

    A rational argument is that such side effects are acceptable if the treatment is saving lives. But the paper raises serious doubts.

    “So many of these men have low-risk disease that probably doesn't need to be treated,” Penson said.

    Men typically undergo needle biopsies because they have elevated levels of the blood test called prostate-specific antigen (PSA). If the needle finds cancer cells, a pathologist measures their severity, resulting in what is called a combined Gleason score that ranges from 1-- the least severe-- to 10. Most prostate cancers score between 6-7. Several top urologists at university medical centers agreed that prostate cancer below a score of 6 should be watched, but not treated. Yet in this latest study, which is a reliable cross-section of how medicine is actually practiced, about 60 percent of the men who underwent treatment had scores of 2 to 4.

    The findings prove that “a staggering percentage of men with totally inconsequential prostate cancer got treated and suffered the consequences,” says oncologist Dr. Marc Garnick of Beth Israel Deaconess Medical Center and Harvard Medical School, who was not involved the study.

    Undoubtedly, prostate cancer can be deadly. Estimates are that it will kill almost 30,000 men in the United States this year, second only to lung disease as the major cause of cancer deaths in men. But the problem is, there are at least two kinds of prostate cancer.

    The common form appears in the majority of men over age 50, grows slowly, and never presents a health threat. The other form spreads rapidly and can lead to a horribly painful death, usually from malignant cells invading the bones. Doctors cannot tell the difference between the dangerous and harmless cancers. Researchers are looking for genetic markers that would make the critical distinction, but they have yet to find them.

    Meanwhile, increasing numbers of prostate cancer specialists argue that the sensible path is for men with lower combined Gleason scores to undergo active surveillance (formerly called watchful waiting), come back for future tests and forgo treatment until it is indicated. Often they will never need treatment.

    That doesn’t happen, however. Penson said recent surveys show that fewer than one in four men who are candidates gets active surveillance. The majority get surgery or radiation.

    One reason for the intervention is “incentives for the facility and for the providers” -- in other words, money for hospitals and doctors. “Also,” he adds, “patients don't like to hear 'I have cancer and I'm just going to watch it.’” But patients should demand and doctors should educate that “just watching it” is perfectly safe in many cases. 

    Learning that lesson could spare an enormous amount of misery and money.

    Related:

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    Shorter penis alarms some men after prostate treatment
    Caffeine linked to leaky bladder in men

  • EPA moves to ban D-Con rat killer from market

    By MATTHEW DALY
    AP
    The Environmental Protection Agency is moving to ban the sale of a dozen rat and mouse poisons sold under the popular D-Con brand in an effort to protect children and pets.

    The agency said Wednesday it hopes to reduce the thousands of accidental exposures that occur every year from rodent-control products. Children and pets are at risk for exposure because the products typically are placed on floors.

    The agency had targeted a handful of companies two years ago, saying they needed to develop new products that are safer for children, pets and wildlife. All but Reckitt Benckiser Inc., manufacturer of D-Con, did so.

    The company will have at least 30 days to request a hearing before an administrative law judge. If no hearing is requested, the ban will take effect.

  • Sterile drugs often contaminated, pharmacists admit

    Courtesy Minnesota Department of Health via AP

    Vials of injectable steroid drugs made by the New England Compounding Center in Framingham, Mass., have been blamed for fungal meningitis and other infections that have caused 45 deaths and nearly 700 illnesses. Now, a new survey says that 13 percent of pharmacists and others polled said they found contamination in their sterile drugs last year.

    As deaths continue to climb in the ongoing outbreak of fungal meningitis infections caused by contaminated pain shots, a new survey of hospital pharmacists shows that they believe it could happen again.

    About 13 percent of pharmacists, pharmacy technicians and others who responded to a poll from the Institute for Safe Medication Practices said that they believed contamination had occurred in the compounded sterile drugs made by their shops last year.

    Those are the same types of drugs now blamed for 45 deaths and nearly 700 infections in people who received tainted injectable steroids made by the shuttered New England Compounding Center of Framingham, Mass., according to the Centers for Disease Control and Prevention.

    Only about half of staff pharmacists in the ISMP poll were confident that contamination had not occurred at their site in the past year. And nearly three-quarters of the 412 health care practitioners who responded said that contamination certainly could occur in drugs from their sites that were supposed to be sterile.

    “We’ve known that this is a risk and a hazard for a long, long time,” said Mike Cohen, president of the ISMP, which monitors medication safety. “Consumers are still at risk. And they need to know.”

    The fungal meningitis outbreak, which has left hundreds of people facing months or years of treatment, is among the “worst public health disasters related to medication in my lifetime,” Cohen said.

    ISMP officials wanted to understand if the problems of properly managing high-risk compounded sterile preparations -- known as CSPs -- were as widespread as they thought.

    It appears that the answer is yes.

    The poll, which included mostly pharmacists, but also pharmacy techs, doctors and nurses, was conducted last November and December, at the height of the meningitis investigation, which was first detected in September.

    It focused on how hospitals are managing CSPs, which are either made on-site by trained staff, or purchased from external compounding pharmacies, which includes companies such as NECC.

    Sterile injectable drugs are particularly difficult to produce because they require mixing non-sterile drugs and other ingredients, which must be then terminally sterilized to ensure that no contamination such as bacteria, mold or fungi get into the final products.

    In the case of NECC, federal inspectors found significant contamination throughout the site, including in the company’s so-called clean room.

    But the new poll shows that problems may be present in other places, too. Eleven percent of the pharmacists and 29 percent of pharmacy techs in the study reported they believed there had been contamination of CSPs on site in the previous year. It’s not clear from the poll whether the contamination was detected before distribution, or whether the drugs made it to patients. Nor is it clear whether they reported the problems to hospital authorities or others.

    Those are important questions, said Bona Benjamin, director of medication use quality improvement at the American Society for Health-System Pharmacists. If techs responsible for enforcing sterilization requirements under the strict USP 797 guidelines detected contamination as a result of careful testing, then it's a good sign. If the drugs were dispensed, then it's not. 

    "Contamination is a well-known risk of compounding sterile products," Benjamin said. "I think the results are very interesting and I think it would bear a little bit of a deeper dive."

    The poll also showed that half of the pharmacists were confident that contamination had not occurred on their watch, but that dropped to 38 percent when the pharmacy techs were asked.

    Of the quarter of respondents who said that contamination could not occur in their facility, most noted that it was because high-risk CSPs were not prepared in their hospital pharmacies.

    Ryan Forrey, associate pharmacy director at The Ohio State University Medical Center, said the ISMP poll underscores that hospitals should use high-risk CSPs only when they're necessary -- and that they should follow strict guidelines. 

    "It highlights the need for work practices that are followed consistently and that are effective for reducing contamination," said Forrey, who is affiliated with the James Cancer Hospital and the Solove Research Institute.

    The recent poll is only one more indication of the potentially serious problems involving sterile drug contamination, Cohen said. Food and Drug Administration Commissioner Margaret Hamburg faced harsh questioning by Congress in November about the agency’s handling of the fungal outbreak. In December, FDA officials recommended changing the way compounding pharmacies are regulated, in part to keep a closer eye on high-output pharmacies like NECC.

    In the meantime, consumers should understand that sterile injectable drugs -- including back pain shots -- may be riskier than even the doctor acknowledges, Cohen said.

    “If they’re going to get an epidural injection -- or have concerns about any injection, they should ask,” he said.

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  • Erectile dysfunction may increase a man's heart woes

    By Rachael Rettner
    MyHealthNewsDaily

    The more severe a man's erectile dysfunction is, the greater his risk of being hospitalized for heart problems, a new Australian study finds.

    Among men in the study who had no history of heart disease, those with moderate erectile dysfunction (ED) were 23 percent more likely to be hospitalized for a cardiovascular problem, such as a heart attack, during a two-year period compared to men who did not have ED. And those with severe ED were 35 percent more likely to be hospitalized for cardiovascular problems than those without ED.

    Men who already had heart problems and severe erectile dysfunction at the study's start were 64 percent more likely to be hospitalized for another heart problem during the study period compared to men without ED.

    The results held even after the researchers accounted for factors that might increase the risk of heart problems, such as age, smoking, alcohol consumption and obesity.

    The findings agree with previous studies that have linked erectile dysfunction to an increased risk of cardiovascular disease. [See For Men, Sex Life Gets Better with Improved Heart Health.] But the new study is one of the first to investigate whether or not the risk of heart problems increases with the severity of ED.

    The findings suggest erectile dysfunction may be a marker that signals underlying heart disease, the researchers, from Australian National University, said. It has been hypothesized that atherosclerosis (plaque in the arteries that limits blood flow) might first manifest itself in smaller blood vessels, such as those in the penis, the researchers said.

    When a man sees the doctor for erectile dysfunction, the visit might be an opportunity to evaluate him for other problems, said Dr. Andrew Kramer, a urologist at the University of Maryland Medical Center, who was not involved in the study.

    "You can use ED to get men in the door. It might be the only thing that brings them in," Kramer said. Urologists should encourage men with moderate or severe ED to visit a primary care doctor or cardiologist for heart disease screening, he said.

    The researchers examined information from more than 95,000 Australian men ages 45 and over who filled out a health questionnaire between 2006 and 2009, and linked this information to records of hospital admissions and deaths in 2010.

    During the study period, there were 7,855 hospital admissions related to cardiovascular disease and 2,304 deaths, the researchers said.

    Men with erectile dysfunction of any severity (mild, moderate or severe) were at increased risk for hospitalization for heart failure compared to men who did not have ED.

    Those with severe ED were about twice as likely to die during the study period than men without ED, the researchers said.

    The study only found an association, not a cause-effect link. The researchers also did not have information about any medications participants were taking (some medications have ED as a side effect.)

    The study was published today (Jan. 29) in the journal PLOS Medicine.

    7 Surprising Reasons for Erectile Dysfunction

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    Beyond Vegetables and Exercise: 5 Surprising Ways to Be Heart Healthy

  • Brain test results don't mean Ariel Sharon will 'come back,' bioethicist says

    Kevin Frayer / AP, file

    Former Israeli Prime Minister Ariel Sharon in June 2005, just over six months before he suffered a massive stroke.

    Ariel Sharon, the former prime minister of Israel, has been in a permanent vegetative state since suffering a massive stroke on January 4, 2006. For the past seven years, a respirator and a feeding tube have kept him alive at Sheba Hospital in Tel Hashomer, Israel. He has never shown any reliable signs of awareness or consciousness – until last week.

    The stroke left the man once dubbed by Israelis as “the Lion of God” bedbound and technologically dependent on machines for his existence.

    In the past, some of his family felt that he was able to slightly move a finger and show some signs of responsiveness but his doctors believed that the strokes so damaged his brain that both recovery and any serious mental activity were impossible.

    But last week, a team of doctors and neuroscientists from Israel's Soroka University Medical Center subjected the 84-year-old Sharon to a series of sophisticated brain scans. They were surprised at what they saw.

    They showed him pictures of random houses, which he would not be expected to know. Then they flashed a picture of his own house before his eyes. When the images of his own home were shown, areas of his brain "lit up" with activity. Similarly his brain ”fired up” in response to hearing the voices of family members but did not when nonsensical gibberish sounds were presented to him.

    Sharon is not the first person to surprise doctors who doubted that anything could be going on in a brain located in a body that was otherwise unresponsive for years. Other patients with massive brain injuries have shown some brain activity included one case in which a 23-year-old woman, when asked to imagine different scenarios including playing tennis, showed strikingly similar patterns of brain activity to those found in scans of healthy volunteers.

    So what are we to make of this? Can doctors say with certainty that he won’t recover?  Is Sharon really “in there” unable to move but alert and awake?  Should we ever remove life-support from someone who has been severely brain injured by a stroke or traumatic injury or asphyxiation? These questions are hardly trivial since families and health care teams face them every day all over the world.

    Can Sharon come back? Many Israelis and his family fervently hope so but older patients, especially 84-year-olds who have been through two strokes and remained unresponsive for seven years, do not come back.

    Is he “in there”? Let’s hope not. Being trapped in your own body year after year unable to move anything or communicate in any way would be horrific.

    What about the brain activity? The data that the doctors and scientists see is very hard to interpret.  Something is going on in Sharon’s brain when he sees or hears familiar things. But is he really aware of what he sees or are well-worn neural pathways firing up when familiar stimuli are present without anyone home to appreciate them? No one really knows for certain, but it seems fair to say that a very damaged brain is not ”thinking” or aware or self-conscious in a manner similar to healthy human brains.

    So what is the case for keeping Sharon alive?  He is not dead—he has brain activity. Still, he may be suffering if he has any awareness of being trapped inside his own body. Prolonging his life may be causing incredible misery to him and others like him. 

    The best we can do is to let families try to decide what to do as long -- as they understand the facts and the uncertainties. And as long as they are willing to help pay the bill.  Keeping Sharon or others like him alive in a very damaged, extremely limited state with no hope of recovery is not something that the government should pay for without some support from those who want life to go on.

    The choice to keep Ariel Sharon alive is one that deserves respect but is also one that demands involvement—emotionally and fiscally. The choice to let him go also deserves respect. In this case, uncertain medical science can only give way to well-intentioned ethics.

    Arthur Caplan is the head of the Division of Medical Ethics at NYU Langone Medical Center.

     

  • Brain circuitry behind cigarette cravings revealed

    By Tanya Lewis, LiveScience 

    Addiction to cigarettes and other drugs may result from abnormal wiring in the brain's frontal cortex, an area critical for self-control, a new study finds.

    Drug cravings can be brought on by many factors, such as the sight of drugs, drug availability and lack of self-control. Now, researchers have uncovered some of the neural mechanisms involved in cigarette craving. Two brain areas, the orbitofrontal cortex and the prefrontal cortex, interact to turn cravings on or off depending on whether drugs are available, the study reports today (Jan. 28) in the journal the Proceedings of the National Academy of Sciences.

    The researchers scanned the brains of 10 moderate-to-heavy smokers using functional magnetic resonance imaging (fMRI), which measures brain activity by changes in blood flow. Researchers measured activity while the participants watched video clips of people smoking as well as neutral videos. Before viewing, some subjects were told cigarettes would be available immediately after the experiment, while others were told they would have to wait 4 hours before lighting up.

    When participants watched the smoking videos, their brains showed increased activity in the medial orbitofrontal cortex, a brain area that assigns value to a behavior. When the cigarettes were available immediately as opposed to hours later, smokers reported greater cravings and their brains showed more activity in the dorsolateral prefrontal cortex. The researchers hypothesize that this area modulates value. In other words, it can turns up or down the "value level" of cigarettes (or other rewards) in the first area, the medial orbitofrontal cortex. The results show that addiction involves a brain circuit important for self-control and decision-making.

    Prior to some of the scans, study participants were exposed to transcranial magnetic stimulation, or TMS. This non-invasive method excites or blocks neural activity by inducing weak electrical currents in a particular region of the brain. When the dorsolateral prefrontal cortex was deactivated using TMS, there was no difference in brain activity between those who watched the smoking clips and those who watched neutral videos; those two groups also reported similarly low cravings for cigarettes.

    The blocking of this brain region cut off the link between craving and awareness of cigarette availability, suggesting that suppressing the area could reduce cravings brought on by impending access to the drug.

    "This is something that we've all been working on, trying to find the target in the brain that you could hit and cause somebody to stop smoking," study researcher Antoine Bechara, a neuroscientist at the University of Southern California, told LiveScience.

    Scientists will quibble over the exact brain areas that are the most important targets, Bechara said, but he thinks transcranial magnetic stimulation is a useful approach. "It gives hope to be able, in a noninvasive manner, to help people quit smoking," Bechara added.

    More from LiveScience:

  • Too few adults get recommended shots

    By Rachael Rettner, MyHealthNewsDaily 

    More adults are getting vaccinated against human papillomavirus (HPV) and whooping cough, according to a new report from the Centers for Disease Control and Prevention (CDC). However, as a whole, adults aren't doing a good job at keeping up to date with recommended shots, the CDC said.

    Besides the flu shot, there are nearly a dozen vaccines recommended for adults, the CDC says. Coverage rates for most adult vaccines, including vaccination with the herpes zoster (shingles) vaccine, the pneumococcal vaccine, and the hepatitis A and B vaccines, are low, and have seen little to no change in recent years.

    "Far too few adults are being vaccinated against these important diseases," said Dr. Howard Koh, assistant Secretary for Health at the U.S. Department of Health and Human Services (HHS). "We're encouraging all adults to talk with their health care provider about which vaccines are appropriate for them."

    In the new report, the biggest improvements in vaccination rates were seen among young women receiving the HPV shot.

    In 2011, nearly 30 percent of women ages 19 to 26 said they had received at least one dose of the HPV vaccine, up from about 21 percent in 2010, the report said. Among men in this age group, 2.1 percent had received the shot in 2011, up from 0.6 percent in 2010. HPV vaccination is primarily recommended for girls and boys ages 11 to 12, but is also recommended for women up to age 26 and men up to age 21 who did not receive the shot when they were younger.

    Between 2010 and 2011, the percentage of adults who reported receiving the "Tdap" vaccine (which protects against tetanus, diphtheria and whooping cough, also called pertussis) increased from 8.2 percent to 12.5 percent, the report said. The CDC recommends Tdap vaccines for adults in place of a tetanus booster, especially those who expect to have close contact with infants, and pregnant women.

    But improvements in vaccination rates for other adult vaccines were limited.

    For example, in 2011, 15.8 percent of adults ages 60 and over reported ever receiving the herpes zoster vaccine to prevent shingles. That was similar to the rate in 2010 (14.4 percent). The CDC recommends the shingles vaccine for people ages 60 and over. A goal of HHS is to increase herpes zoster vaccination in adults in this age group to 30 percent by 2020.

    Also in 2011, 12.5 percent of adults ages 19 to 49 were vaccinated against hepatitis A, and 36 percent were vaccinated against hepatitis B.

    Hepatitis A vaccination is recommended for adults who are at increased risk for infection with the disease, such as those traveling to countries with high rates of hepatitis A, or those who have chronic liver disease. The agency recommends hepatitis B vaccine for adults who wish to be protected against hepatitis B, and those who have risk factors, such as sexually active people not in a monogamous relationship. (The hepatitis B vaccine is primarily recommended for children and adolescents.)

    Rates of pneumococcal vaccination were 62.3 percent among adults ages 65 years and older, and 20 percent for adults ages 19 to 64. The CDC recommends one type of vaccine pneumococcal, called PPSV23, for adults ages 65 and older, and another type, called PCV13, for adults with certain medical conditions such as HIV infection. By 2020, the HHS hopes 90 percent of older adults will be vaccinated against the disease.

    Making vaccines more widely available, such as offering them in workplaces and at pharmacies, and sending reminders to patients, may be ways to increase vaccination rates among adults, the CDC said.

    More from LiveScience:

  • The surprising foods that make people sick

    Salad greens make the most people sick, but contaminated poultry kills the most Americans, federal researchers report in the first comprehensive look at the foods that cause foodborne illnesses. And there are a few surprises -- the bug most likely to be lurking in a salad is norovirus, and it probably came from the hands of the person who made it.

    This doesn’t mean salad is more dangerous, the team at the Centers for Disease Control and Prevention stresses: It just shows what foods are most involved and may reflect how often people eat them.

    “When the average American looks at this data, they need to know that we are not trying to make estimates of the risk of illness per serving of any of the food categories,” says the CDC’s  Dr. Patricia Griffin, who heads the agency’s branch that investigates stomach bugs.

    “We are just providing information on what are the food categories that are the major sources of illness ... so regulators can take action to make food safer.”

    Food poisoning is extremely common.  The CDC estimates that 48 million Americans get some sort of foodborne illness every year, 128,000 of them are sick enough to go to the hospital and 3,000 die. Most of the time, the bacteria, virus or parasite responsible is never identified, and usually the particular food isn’t, either.

    Griffin’s team analyzed all the data they could get on every outbreak of foodborne illness reported between 1998 and 2008 in which both the food source and the microbe responsible were known. They broke the food down into 17 categories.

    “We attributed 46 percent of illnesses to produce and found that more deaths were attributed to poultry than to any other commodity,” they wrote in their report, published in the journal Emerging Infectious Diseases on Tuesday.

    “(The data ) indicate that efforts are particularly needed to prevent contamination of produce and poultry.”

    This doesn't mean people should swap out salads for, say, fries.

    “We certainly would not want people to avoid any category of food,” Griffin said. “We know that the vast majority of meals are safe. As far as fruits and vegetables in particular, CDC is well aware and promotes the fact that they are an important part of a healthy diet. They are linked to reduced risk of heart attacks, strokes and cancer. “

    Cooking food is one of the best ways to prevent illness, as proper cooking will kill most disease-causing agents. As raw meat and eggs are often contaminated, proper food handling techniques are also important.

    It’s harder to protect against germs on raw food, however. “Our data found that produce items were a common cause of illness, accounting for almost half of illnesses,” Griffin said in a telephone interview. “Most of those produce items that caused those illnesses were consumed raw.”

    And norovirus – also known as Norwalk virus, which causes gastrointestinal upset commonly known as stomach flu or winter vomiting disease – was a major cause of illness contracted from raw vegetables, the CDC finds.

    Contaminated meat and poultry accounted for 22 percent of illness but 29 percent of deaths, while dairy and eggs accounted for 20 percent of illnesses and 15 percent of deaths.

    Last week, CDC reported 1,527 foodborne disease outbreaks in 2009 and 2010. They said 29,444 people got sick and 23 died in these outbreaks. Norovirus or Salmonella -- especially in eggs, sprouts, tomatoes and peppers -- caused most, while Campylobacter in unpasteurized dairy products, Salmonella in eggs, and E. coli 0157 in beef were also very common causes of food poisoning outbreaks. And nearly half -- 48 percent -- of all outbreaks from a single place were traced to restaurants or delis.

    News reports have focused a great deal on outbreaks of diseases such as salmonella, listeria and E. coli, and the Food and Drug Administration, US Department of Agriculture and other regulators have focused on protecting food from animal contamination such as bird droppings and manure from pigs and cows, which carry these agents.

    But norovirus is carried and spread only by humans.

    “The way that you get it from food is when a food handler doesn’t wash his hands after an episode of diarrhea or vomiting and then prepares food,” Griffin said. This is an area that may require extra focus, she says.

    “Washing hands is very, very important,” she added.  Norovirus can be spread before a person feels sick and for days after he or she recovers, also.

    Adding to the risk is the issue of sick leave. Many food preparers, restaurant workers and food handlers do not get paid sick leave, and thus are encouraged to work while they are ill.  One study published in 2011 in the American Journal of Public Health projected that workers who did not get paid time off for illness helped spread 5 million cases of respiratory disease during the 2009 H1N1 swine flu pandemic.

    The Bureau of Labor Statistics says 39 percent of private sector workers have no paid sick leave, and this number rises to 70 percent for food and hotel workers.

    There’s a bill in Congress that would mandate sick leave for many employers,  supported by President Barack Obama and groups including  the National Women’s Health Network, the AFL-CIO,  Families USA and others. It was last considered in 2009.

    So besides cooking meat and making sure greens are washed well, how can people protect themselves? “I would advise people to avoid eating raw foods of animal origin, and that includes raw milk,” Griffin said.  Shellfish? “You have to make a decision about raw shellfish and how much you love them, how much risk you want to take and what your risk might be,” she said.

    Related stories:

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    Why norovirus is coming back

    New strain of norovirus on the rise

    Don’t miss the latest health news on NBCNews.com

  • 'Life's much easier': Coming out can lower stress, ease depression

    Shelley Metcalf

    Carlo Joyce, right, and Thomas Joyce share a moment on their wedding day on July 10, 2010.

    As a teenager, Carlo Joyce’s relationship with his parents was strained. He’s gay, but hid that fact from family and most of his friends. So he usually found himself lying when his folks asked where he was going and with whom.

    “After I came out at 19, things got better with my family,” he recalled. But then he joined the Marines and had to hide his sexuality all over again.

    He had to go to strip bars to fit in, and when the other guys talked about sex, or dating, he had to be sure he changed the gender in his stories. “It was very stressful to live that double life,” he explained. “I always had to watch what I said.”

    Now, in a study released today in the journal Psychosomatic Medicine, a team of psychologists and neurologists from McGill University and the University of Montreal has found that leading that double life affects physical and mental health. Gays, bisexuals and lesbians who disclosed their sexuality to family, friends and co-workers were psychologically healthier and had lower levels of a key stress-related hormone than those who were still “in the closet.”

    That finding could help explain a remarkable study published last year by a group of researchers from Columbia University in the American Journal of Public Health. They found that after Massachusetts enacted its same-sex marriage law in 2003, there was a significant drop in medical and mental health care visits -- and therefore costs – incurred by gay men.

    Lead author of the Montreal study, Robert-Paul Juster, a PhD student at the Centre for Studies on Human Stress at the University of Montreal, said “it seems to be that if you’re using more avoidance coping, and wishful thinking, then you get poorer health. If you aren’t dealing with the problem, it affects health in a negative way.”

    On the other hand, dealing with the problem by transitioning from “in” to “out” can instill a great sense of accomplishment. “A rebirth happens that makes them feel much more empowered and conscientious” for having taken what many see as a risky action. That sense of empowerment can have ripple effects benefitting overall health and well-being.

    Juster’s study was complex. It included 87 people with a mean age of about 25, 46 of whom were lesbian, gay, or bisexual, and 41 of whom were heterosexual. There were slightly more men than women.

    All the participants completed a battery of psychological testing to gauge traits like depressive symptoms, chronic stress, burnout, anxiety and conscientiousness. Blood samples were taken by the researchers, and the participants collected their own urine and saliva at five time points each day for two consecutive days. These were tested for a series of 21 biomarkers related to immune function, metabolism, inflammation, the cardiovascular system, and the endocrine system.

    When all the numbers were sifted, and differences like social and economic status were controlled for, it turned out that disclosed sexual minorities had fewer symptoms of depression.

    They also had lower cortisol levels 30 minutes after waking. That’s important because cortisol, a key stress hormone, spikes about half an hour after we wake up, like an ignition spark getting us ready to face the day. But you don’t want too much or too little. Disclosed gay men and lesbians were just right. In fact, dislcosed gay men also had lower cortsone levels than straight men.     

    Juster isn’t sure why, exactly. It could be because the gay men were in better physical shape. It could also be that because heterosexual men have never had to go through the stress of living life undercover, they’re less practiced at coping and so less resilient to life’s stress.

    Joyce, now 33, and living in San Diego, has had a lot of practice. He’s an engineer at a large corporation. When he first started that job, he again hid his sexual orientation, from co-workers and bosses.

    “It was like I was back in the closet,” he said. The hiding was self-imposed, but stressful all the same. “Once I did come out, it was much less stressful and I found great acceptance and support.” When he married his partner, many of his co-workers attended. (To clarify, the July 10, 2010, wedding was not a legal marriage as recognized by the state.)  “Life’s much easier,” he said.

    Brian Alexander (www.BrianRAlexander.com) is co-author, with Larry Young Ph.D., of "The Chemistry Between Us: Love, Sex and the Science of Attraction," (www.TheChemistryBetweenUs.com), now on sale.

     Related:

    When depression drugs don't help, talking might

  • Lungs from pack-a-day smokers safe for transplant, study finds

    featurepics.com

    About 13 percent of double-lung transplants in the U.S. came from donors who were heavy smokers, a new study finds.

    Using lung transplants from heavy smokers may sound like a cruel joke, but a new study finds that organs taken from people who puffed a pack a day for more than 20 years are likely safe.

    What’s more, the analysis of lung transplant data from the U.S. between 2005 and 2011 confirms what transplant experts say they already know: For some patients on a crowded organ waiting list, lungs from smokers are better than none.

    “I think people are grateful just to have a shot at getting lungs,” said Dr. Sharven Taghavi, a cardiovascular surgical resident at Temple University Hospital in Philadelphia, who led the new study.

    Surprisingly, however, organ recipients who do get smokers’ lungs often learn about it only afterward -- if at all, experts say.

    “If someone had a transplant and after the transplant they say, ‘What can you tell me about the donor?' there are a limited number of characteristics we can tell them,” said Dr. Ramsey Hachem, a pulmonologist at Barnes-Jewish Hospital in St. Louis. “We don’t do that routinely before.”

    About 13 percent of double-lung transplants in the U.S. came from donors with a heavy smoking history, according to Taghavi’s new study, presented Tuesday at the annual meeting of the Society of Thoracic Surgeons. He and his colleagues analyzed records of some 5,900 adult procedures in the database maintained by the United Network for Organ Sharing, or UNOS, which manages transplants in the U.S.

    Typically, that meant smoking at least a pack of cigarettes a day for more than 20 years, or two packs a day for 10 years.

    In the end, after all other variables were accounted for, people who got lungs from heavy smokers lived as long and as well as those who got lungs from the tobacco-free, Taghavi found. There was no significant difference in cancers, though the study didn’t specifically look at lung cancer.

    “General guidelines say that donors that have smoked should be excluded, but there are certain circumstances in which they can be used,” Taghavi said. “That can be when the donors are otherwise very healthy and there’s no evidence of the really bad effects of smoking, like emphysema.”

    Only about 20 percent of smokers actually develop the worst effects of smoking, noted Hachem.

    “It is certainly counterintuitive to say we’re going to use lungs from a donor with a smoking history, but the majority of people who smoke do not have lung disease,” said Hachem, who was not involved in the study.

    Some people may have smoked for a long time years ago, then stopped, vastly improving the health of the organs. Others could have been active smokers when they died. The data in the study didn’t include that history, Taghavi said.

    Freeing up smokers’ lungs could help reduce a shortage that has left more than 1,650 people on the transplant waiting list -- the “last resort” for those with end-stage lung disease, according to the National Heart Lung and Blood Institute. There were nearly 5,200 liver transplants in the U.S. in 2012, but typically only half the people on the list receive lung transplants in a given year, the NHLBI said. 

    Taghavi emphasized that transplant recipients who get lungs from heavy smokers ought to be told in advance.

    “This is a very important point,” he said. “None of this should be done without a thorough discussion with the recipient. They have to be aware that there are risks with accepting these lungs, but there are benefits.”

    But Hachem said current practice usually doesn’t include that discussion.

    Recipients decide in advance whether to take organs from high-risk donors, including those with a history of infections such as viral hepatitis or HIV. But behavior habits, such as smoking, are almost never disclosed, Hachem said.

    “I don’t know what other centers do, but at our center, we don’t get into those details,” he said.

    Instead, the organs are inspected carefully and only those found free of disease or disability are approved for transplant. “We’ve sort of screened the organ pretty well,” he said.

    Of course, problems can occur. Widespread media reports last year centered on Jennifer Wederell, a 27-year-old British woman with cystic fibrosis who died of lung cancer last year after receiving lungs from a heavy smoker. In 2007, the family of a New Jersey man, Tony Grier, sued the University of Pennsylvania Health System after they said Grier developed lung cancer a month after a 2005 lung transplant. Court records show the case was settled in 2010.

    Such cases are very sad -- but also very rare, said Hachem, who noted that all transplants carry inherent risks. And, he said, most transplant recipients are like Randy Cooke, 52, of Chatham, Ill., who received a new set of lungs in 2011.

    Cooke, who was diagnosed in 2008 with a degenerative lung disease, said that by the time he was placed on the transplant waiting list, he would have accepted lungs from a heavy smoker -- gladly.

    “If I’d have waited another three months, I don’t know if I’d be here talking to you,” he said.

    If his lungs had come from a smoker, Cooke trusted that his doctors would have screened out any potential problems.

    “You have to take a lot of times what you can get,” he said. “You don’t have a choice. Time is not on your side.”

     Related:

     

  • Pregnant women need whooping cough shot, CDC says

    By Genevra Pittman
    Reuters
    Moms-to-be should get a booster tetanus, diphtheria and pertussis (Tdap) vaccine during each pregnancy to help protect their infants from whooping cough, according to a new vaccine schedule released today by the Centers for Disease Control and Prevention (CDC).

    Babies don't get their first pertussis vaccine until two months of age - and even then, they aren't fully protected until after their third shot, at six months. In the interim, they are at especially high risk of getting very sick from the bacterial disease.

    During a 2010 whooping cough outbreak in California, for example, more than 9,000 cases were reported and 10 infants died.

    Vaccinating pregnant women serves the dual purpose of keeping moms from contracting whooping cough and passing it to their infants as well as allowing some immune cells to pass to babies through the placenta.

    "It turns out that immunity wanes pretty quickly," said Dr. H. Cody Meissner, a pediatrician from the Tufts University School of Medicine in Boston who is on the CDC's immunization committee.

    "Without boosting with each pregnancy, a mother's immunity will wane and she will have much less immunity to pass on to the baby," Meissner told Reuters Health.

    Although not part of the new immunization schedule, experts recommend immunizing a new baby's father, siblings and other caretakers. That strategy is known as cocooning.

    "It's a good time to make sure that everyone who will be caring for the child is also up to date on their vaccines," said Dr. Daniel McGee, a pediatrician with Helen DeVos Children's Hospital in Grand Rapids, Michigan, who wasn't involved in the new guidelines.

    "You need to make sure if grandma and grandpa are coming to visit, they're protected as well," he told Reuters Health.

    Along with the new guidelines for pregnant women, updates to the CDC's vaccination schedule include a routine Tdap shot for adults age 65 and older and a pneumococcal vaccine approved for adults with immune compromising conditions like kidney failure.

    Some children who are ill, such as with sickle cell disease, should get meningococcal vaccines starting at two months of age, according to the schedule. Other kids don't have to start those shots until middle school.

    The influenza vaccine is still recommended annually, but will now protect against four strains of flu rather than three, said Erin Kennedy, a medical epidemiologist at the CDC.

    Parents should educate themselves as best they can on recommended vaccines, researchers said.

    "It's quite complicated, and it does change all the time. But it's imperative for people to stay up to date and informed about which vaccines are available," Meissner said.

    "There are 16 vaccine preventable diseases that children receive immunizations against in the first 18 years of life," he added. "If vaccination rates fall, we're going to see increases in some of these diseases."

    Because the immunization program has focused on children, Kennedy said some adults don't know the schedule also calls for them to get a range of vaccinations based on their age, health or where they travel.

    "Adults need to be aware of the fact that there are vaccines that are recommended throughout the lifespan," she told Reuters Health. "Right now coverage is low for all of these vaccines."

    Updates to the CDC's vaccination schedule were published concurrently on Monday in Pediatrics and the Annals of Internal Medicine.

  • Placebo as good as drugs for kids' migraines

    By Genevra Pittman
    Reuters
    A drug-free placebo pill prevents migraines in kids and teens just as well as most headache medicines, according to a new review of past evidence.

    Researchers found only two drugs known to help migraine-plagued adults reduced the frequency of kids' headaches better than a placebo. And even in those cases, the effect was small - a difference of less than one headache per month compared to the dummy pills.

    "Parents should be aware that our medication choices aren't as good as they should be," said Dr. Jennifer Bickel, a neurologist and headache specialist at Children's Mercy Hospitals and Clinics in Kansas City, Missouri.

    Bickel, who wasn't involved in the new research, said no drugs have been rigorously tested and approved for preventing migraines in kids, so doctors have to rely on headache drugs made for adults.

    Those medicines, she added, are "not a miracle cure."

    For cases when medication may not be enough, Bickel told Reuters Health, parents may want to look into relaxation techniques - such as meditation - for kids with chronic headaches.

    According to data from the Cleveland Clinic, about 2 percent of young children and 7 to 10 percent of older kids and teenagers up to age 15 get migraines.

    In their review, Dr. Jeffrey Jackson from the Medical College of Wisconsin in Milwaukee and his colleagues looked at 21 trials comparing headache drugs to each other or to placebos. They found only topiramate (marketed as Topamax) and trazodone (Oleptro and Desyrel) significantly reduced the frequency of headaches in kids and teens who got regular migraines.

    Other adult headache prevention medicines, including flunarizine, propranolol and valproate, were of no help.

    "All the drugs in our analysis have been found effective in adults with migraine headaches, but few were beneficial among children," Jackson's team wrote.

    "This suggests there may be something different about pediatric migraines or that the response to treatment differs between children and adults."

    Bickel said there is the least research on the one percent of kids who are most severely affected by migraines - those with chronic daily headaches. For those youth, "we don't have any evidence to suggest that the medications are enough," she added.

    Power of placebo?

    In the new analysis, published Monday in JAMA Pediatrics, placebo pills alone led to a drop in kids' headache frequency from between five and six headaches per month to three per month.

    That may have to do with the effect of seeing a doctor and being reassured the pain isn't due to anything serious, Bickel said.

    According to a report from the U.S. Food and Drug Administration published in the same journal issue, two drugs - almotriptan malate (Axert) and rizatriptan benzoate (Maxalt) - are approved to treat (but not prevent) headaches in kids and teens.

    In a review of evidence provided to the FDA, Dr. William Rodriguez and his colleagues also found kids tended to get better after treatment with a placebo more often than adults - possibly related to their headaches lasting less time anyway.

    For kids who get headaches once a week or less, Bickel said the pain can be treated with over the counter painkillers, or even just waited out in a quiet place.

  • Dog treat made from bull penis may pose health risks

    By LiveScience Staff

    When dog owners toss their canine companions a bully stick to chew on, they might not be aware that the popular treat could be packed with calories and contaminated with bacteria, researchers say. And pet owners might not even know that the stick is made from an uncooked, dried bull penis.

    In a small study, researchers examined a sample of 26 bully sticks, also known as pizzle sticks, manufactured in the United States and Canada. They found that the treats contained 9 to 22 calories per inch. That means the average 6-inch bully stick potentially represents 9 percent of the recommended daily calorie count for a larger 50-pound (22-kilogram) dog and 30 percent of the requirements for a smaller 10-pound (4.5-kg) dog — a significant source of calories pet owners might not be aware of.

    "With obesity in pets on the rise, it is important for pet owners to factor in not only their dog's food, but also treats and table food," researcher Lisa Freeman, a professor of nutrition at Cummings School of Veterinary Medicine at Tufts University, said in a statement.

    Tests for bacteria showed that one of the treats contained Clostridium difficile, one was contaminated with methicillin-resistant Staphylococcus aureus ( MRSA ), and seven contained E. coli. The researchers noted that their sample was small and a more extensive study is needed to investigate the widespread contamination rate in bully sticks. But they said their results at least suggest pet owners should wash their hands after touching such treats, as they would with any raw meat.

    (This isn't the first time a pet treat has been linked with contamination. Researchers from the Centers for Disease Control and Prevention reported in 2010 in the journal Pediatrics that an outbreak of salmonella in 79 people between 2006 and 2008 was caused by contaminated dry pet food.)

    While the source of the bully sticks is no secret, many pet owners don't seem to be aware that the treats are made from the raw penises of bulls or steers, a survey by the research team showed. A 20-question online poll completed by 852 dog owners from 44 states and six countries showed that 44 percent of respondents could correctly identify the source of bully sticks as bull penises. (Twenty-three percent said they fed their dogs the treats.) And there was even some confusion among veterinarians — an unimpressive majority of vets (62 percent) polled by the researchers knew where bully sticks came from.

    "We were surprised at the clear misconceptions pet owners and veterinarians have with pet foods and many of the popular raw animal-product based pet treats currently on the market," said Freeman in a statement. "For example, 71 percent of people feeding bully sticks to their pets stated they avoid by-products in pet foods, yet bully sticks are, for all intents and purposes, an animal by-product."

    The research is detailed in this month's issue of the Canadian Veterinary Journal.

    More from LiveScience:

  • Soldier who lost 4 limbs has double-arm transplant

    Seth Wenig / AP

    In this July 4, 2012 file photo, Army Sgt. Brendan Marrocco of Staten Island, N.Y., left, Marine Cpl. Todd Love of Atlanta, Ga., center, and Marine Cpl. Juan Dominguez of Deming, N.M., pose for a picture at the 9/11 Memorial in New York.

    Seth Wenig / AP

    In this July 4, 2012 file photo, Army Sgt. Brendan Marrocco of Staten Island, N.Y., wearing a prosthetic arm, poses for a picture at the 9/11 Memorial in New York. Marrocco, 26, the first soldier to survive losing all four limbs in the Iraq war, has received a double-arm transplant in Baltimore.

    By Marilynn Marchione, AP

     

    The first soldier to survive after losing all four limbs in the Iraq war has received a double-arm transplant.

    Brendan Marrocco had the operation on Dec. 18 at Johns Hopkins Hospital in Baltimore, his father said Monday. The 26-year-old Marrocco, who is from New York City, was injured by a roadside bomb in 2009.

    He also received bone marrow from the same dead donor who supplied his new arms. That novel approach is aimed at helping his body accept the new limbs with minimal medication to prevent rejection.

    The military is sponsoring operations like these to help wounded troops. About 300 have lost arms or hands in the wars.


    "He was the first quad amputee to survive" from the wars in Iraq and Afghanistan, and there have been four others since then, said Brendan Marrocco's father, Alex Marrocco. "He was really excited to get new arms."

    The Marroccos want to thank the donor's family for "making a selfless decision ... making a difference in Brendan's life," the father said.

    Surgeons plan to discuss the transplant at a news conference with the patient on Tuesday.

    The 13-hour operation was led by Dr. W.P. Andrew Lee, plastic surgery chief at Johns Hopkins, and is the seventh double-hand or double-arm transplant done in the United States. Lee led three of those earlier operations when he previously worked at the University of Pittsburgh, including the only above-elbow transplant that had been done at the time, in 2010.

    Marrocco's "was the most complicated one" so far, Lee said in an interview Monday. It will take more than a year to know how fully Marrocco will be able to use the new arms, Lee said.

    "The maximum speed is an inch a month for nerve regeneration," he explained. "We're easily looking at a couple years" until the full extent of recovery is known.

    While at Pittsburgh, Lee pioneered the novel immune suppression approach used for Marrocco. The surgeon led hand transplant operations on five patients, giving them marrow from their donors in addition to the new limbs. All five recipients have done well and four have been able to take just one anti-rejection drug instead of combination treatments most transplant patients receive.

    Minimizing anti-rejection drugs is important because they have side effects and raise the risk of cancer over the long term. Those risks have limited the willingness of surgeons and patients to do more hand, arm and even face transplants. Unlike a life-saving heart or liver transplant, limb transplants are aimed at improving quality of life, not extending it.

    Quality of life is a key concern for people missing arms and hands — prosthetics for those limbs are not as advanced as those for feet and legs.

    Lee has received funding for his work from AFIRM, the Armed Forces Institute of Regenerative Medicine, a cooperative research network of top hospitals and universities around the country that the government formed about five years ago. With government money, he and several other plastic surgeons around the country are preparing to do more face transplants, possibly using the new minimal immune suppression approach.

    Marrocco expects to spend three to four months at Hopkins, then return to a military hospital to continue physical therapy, his father said. Before the operation, he had been living with his older brother in a handicapped-accessible home on New York's Staten Island built with the help of several charities.

    The home was heavily damaged by Superstorm Sandy last fall.

    Despite being in a lot of pain for some time after the operation, Marrocco showed a sense of humor, his father said. He had a hoarse voice from a tube in his throat during the long surgery, decided that he sounded like Al Pacino, and started doing movie lines.

    "He was making the nurses laugh," Alex Marrocco said.

  • Norovirus: Why washing your hands isn't enough

    REUTERS/Lisi Niesner

    Paramedics dressed in protective attire enter a German cruise ship quarantined in December after an outbreak suspected to be norovirus. A new strain is making people miserable around the world this year.

    It gets in your food, in your laundry, it sticks to plates and it might even float into the air when you flush your toilet. A new strain of norovirus -- often called stomach flu -- is going around and it’s going to be very hard to avoid it, experts say.

    Federal health officials say a new strain, called the Sydney strain, is now causing most of the misery across the United States and the world. The virus, sometimes known as Norwalk virus or winter vomiting disease, causes vomiting, diarrhea and that someone-just-hit-me-with-a-plank feeling.

    There’s no real treatment for it except for waiting it out, no vaccine, and recent studies show it’s one of the hardest viruses to get rid of. Simple cleaning alone doesn’t always kill it, and it takes just a few particles of virus to sicken a person.

    “It is pretty difficult to get rid of,” says Allison Aiello, who studies how viruses spread at the University of Michigan. “It is pretty stable. It lives quite some time on surfaces. It is hard to kill.”

    For instance, a few recent studies show that a quick application of hand sanitizer won’t get rid of it, Aiello says. And most people don’t wash their hands properly, either -- it takes about 30 seconds of vigorous rubbing using hot water and soap to wash away the tiny bits of virus, and that means getting under the nails, too.

    Perhaps worst of all, people start spreading norovirus before they actually feel sick, and they can spread it for as long as two weeks after they start getting better. 

    “Imagine you have a food handler who uses the bathroom and they haven’t washed their hands thoroughly,” Aiello said in a telephone interview. “They can end up preparing a salad for the diners that evening and end up infecting a lot of people because the food isn’t cooked. You can’t really do anything about that.”

    Raw shellfish is a notorious source of norovirus and other foodborne germs, but at least one recent study suggests norovirus may be even more insidious than that. In December, a team at Ohio State University found the virus stuck to plates that had been washed in restaurant-like conditions -- and they found sticky dairy products like cheese helped the virus stay there.

    Hand-washed dishes are especially likely to carry the virus, the Centers for Disease Control and Prevention says in its website -- which could be one reason norovirus causes so many outbreaks on cruise ships. “You cannot get the water hot enough if you wash by hand,” says Aiello.

    Norovirus is spread fecally -- in the poop -- and that means it can get into laundry. Studies show that fecal matter spreads even in ordinary laundry, so if someone is sick, it’s important to use very hot water and bleach to destroy virus that could be on any clothing, sheets or towels.

    And regular cleaner won’t get the virus off surfaces. CDC recommends using bleach, including chlorine bleach or hydrogen peroxide.

    Complicating the problem, most restaurant workers don’t get paid sick leave, so if they miss work, they don’t get paid. This means many workers come in sick, and they can spread the virus to hundreds of customers. Food handlers, dishwashers, even staff who bus and clear tables, all can spread the germ.

    “If they have to go back to work there has to be complete and utter vigilance about washing your hands,” Aiello says.

    In June, the Food Chain Workers Alliance issued a report showing that only 21 percent of workers surveyed could take a paid sick day off work. More than half said they come to work sick because they cannot take time off.

    The problem extends to the home, too. There, Aiello said, several factors make it hard to keep one sick family member from infecting others.

    “It could be the door handle. It could be the toilet tank cover. Some studies show it can be aerosolized. If you throw up and then flush the toilet, how much of the spray gets into the air?” she asked. One study last year showed how the virus spread on a plastic bag that had been in a bathroom where a norovirus patient threw up. 

    Norovirus is the most common cause of acute gastroenteritis -- stomach upset -- in the United States. It makes 21 million people sick every year in the United States – 70,000 on average sick enough to go to the hospital. As many as 800 people die, mostly elderly patients who become dehydrated. It’s the the most common cause of foodborne-disease outbreaks, CDC says.

    Dr. John Treanor of the University of Rochester Medical Center in New York is working on a vaccine against norovirus. But the same properties that make norovirus so hard to kill also make it hard to make a vaccine.

    For one thing, it’s simple. Like all viruses, norovirus hijacks live cells, turning them into virus factories that kick out particles called virions. “There is only one protein they use to make virions,” Treanor says. “If you have that one protein, it will self-assemble.”

    The virus is also surrounded by a case called a capsid, which makes it hard to kill. The viruses infect the epithelial cells which line the digestive tract, causing cramps, diarrhea and vomiting, but it’s not understood exactly why.

    And the virus mutates. “You typically see a specific strain, and then that strain is replaced by a new strain,” Treanor said. In this case, a strain called New Orleans has been replaced by the Sydney strain. Like with influenza, people who may have had some immunity against one strain aren’t protected agaisnt the new one.

    So until there is a vaccine, what can people do? “There really isn’t very much you can do,” says Treanor. “Clearly, washing your hands is important.”

    Related stories:

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