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Dispute flares within FDA over safety of popular blood pressure drugs

The top-selling class of blood-pressure drugs is under attack from an unusual source: a senior regulator at the Food and Drug Administration. Bucking his bosses, Thomas A. Marciniak is seeking stronger warnings about the drugs known as angiotensin receptor blockers, or ARBs, according to internal documents reviewed by The Wall Street Journal. The drugs, which are taken by millions of people and generated $7.6 billion in U.S. sales in 2012, may be linked to higher cancer rates, Dr. Marciniak argues, a view shared by some outside doctors. Top FDA officials say evidence doesn't support a link. The debate over ARBs highlights the question of whether the U.S. drug-safety agency devotes enough effort to examining the safety of long-marketed blockbusters as it focuses on new drugs. In a rare rebellion by an FDA reviewer, Dr. Marciniak has clashed with his bosses over his desire to spend time on ARB safety, instead of just on new-drug applications. Ellis Unger, chief of the drug-evaluation division that includes Dr. Marciniak, called the complaints a “diversion,” and said in an interview, “We have no reason to tell the public anything new.” ARBs on the market in the U.S. include Novartis AG's Diovan, Daiichi Sankyo Co.'s Benicar, Merck & Co.'s Cozaar, Boehringer Ingelheim GmbH's Micardis; Avapro, from Sanofi SA and Bristol-Myers Squibb Co.; and AstraZeneca PLC's Atacand. Patients take these medicines daily to avoid heart attack, stroke and heart failure. In a 2010 study published in Lancet Oncology, Ilke Sipahi and colleagues at University Hospitals in Cleveland looked at five studies involving 68,402 patients and found that people taking ARBs had an 11 percent greater risk of new cancer overall and a 25 percent greater risk of new lung cancer, compared with patients who didn't get the drugs. But within a year, the FDA gave the all-clear signal, saying its own analysis found “no increase in risk” from taking ARBs. Europe's drug regulator also dismissed the cancer concerns. Dr. Marciniak wasn't persuaded. In its analysis, the FDA combined different studies to look at more patients, multiplying its statistical power to find possible side effects from the drugs, a technique called meta-analysis. If the original studies have flaws, however, meta-analyses can simply compound the problem, researchers say. That is what happened to the FDA, says Dr. Marciniak, who warned others in the agency that taking results tabulated by companies was likely to produce unreliable results: “Garbage in, garbage out,” he wrote. Among other things, Dr. Marciniak said in an internal analysis viewed by the Journal that the FDA meta-analysis didn't count cases of “lung carcinomas” as lung cancers, which they are. Click for more from The Wall Street Journal.source : http://www.foxnews.com/health/2013/05/31/dispute-flares-within-fda-over-safety-popular-blood-pressure-drugs/

For veterans, mental health care often fragmented

For veterans with mental health conditions, prompt and continuous access to mental health care can be lifesaving. However, research shows that after deployment, veterans often go years without obtaining mental health care, and when they do, their care is often fragmented. A recent study found that, among veterans with mental health conditions such as post-traumatic stress disorder (PTSD) and depression, the average time between return from deployment and initiation of mental health care was two years. The study, which looked at veterans of the Iraq and Afghanistan wars who visited Veterans Affairs (VA) medical centers between 2001 and 2011, also found that an average of seven and a half years lapsed between the first mental health visit, and the start of treatment that would be considered “minimally adequate” for these conditions which would be eight treatment sessions within a year. By the end of the study, 75 percent of veterans had not received minimally adequate care. The findings were published in the December 2012 issue of the journal Psychiatric Services. Prompt care is important because mental illness can impair people's lives and interfere with their relationships and jobs, said study researcher Shira Maguen, a psychologist at the San Francisco Veterans Affairs Medical Center who treats patients with PTSD. “If we can get them into care sooner, thats less time that they have to live with some of those challenges after they return from deployment,” Maguen said. Many factors can interfere with veterans getting mental health care, including the stigma associated with mental illnesses (such as the belief that seeking care is a sign of weakness), concern that seeking care may jeopardize their careers, trouble finding transport to VA centers, and trouble getting appointments. (Last year, a report from the VA inspector general found that about half of veterans seeking a mental health evaluation waited an average of 50 days for an evaluation.) To broaden access to mental health care, the VA says it has taken steps to increase staffing and to partner with community health care centers. In a report released last week, the VA said it has made agreements with 15 local clinics in seven states to allow veterans to be treated at those clinics. Maguen said it is also important to identify the factors that keep veterans coming back for care. Her study found that most veterans who receive minimally adequate care do so within one year of their first visit. Follow-up appointments are critical for patients at risk for suicide studies show that one of the highest risk periods for suicide is the month following discharge from a hospital or emergency room for a suicidal episode. But a report from the VA inspector general released last month found that about one-third of veterans at high risk for suicide did not receive the required four mental health follow-up visits within a month after their discharge. What's more, for about a third of these at-risk veterans, there was no documented attempt to contact them to remind them of their appointments. “That kind of a clinical response is not acceptable,” said M. David Rudd, provost of the University of Memphis who has studied suicide risk among veterans. “You dont have control over whether or not somebody will keep and appointment. You do have control of whether you attempt to track them.” The inspector general report said the VA needs to improve its effort to reach out to patients who do not show up for mental health appointments. Rudd said the VA may want to consider conducting home visits for psychiatric patients who have trouble getting to VA centers. The inspector general report said the VA should consider expanding the use of telemental health services, such as videoconferencing. The VA also said this week it has increased capacity of its Veterans Crisis Line to connect veterans in crisis with trained mental health providers. Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.source : http://www.foxnews.com/health/2013/05/31/for-veterans-mental-health-care-often-fragmented/

France to ban electronic cigarettes in public

France will ban electronic cigarette smoking in public places by imposing the same curbs enforced since 2007 to combat tobacco smoking, Health Minister Marisol Touraine said on Friday. Amid mounting global concern over the public health implications of so-called e-cigarettes, Touraine said they faced the same fate as traditional ones: a ban on smoking in public spaces and sales to minors and a blackout on media advertising. In a country where the pungent waft of Gaulloises and Gitanes once seemed an unassailable part of cafe culture, smokers have long been banished to outdoor terrace seats. The near-odorless electronic alternative - battery-driven devices that allow users inhale odorless nicotine-laced vapor rather than smoke - are gaining ground in no-go zones such as bars, cafes, trains, waiting rooms and offices. A government-commissioned report said this week that around 500,000 people in France had turned to e-cigarettes, which are designed to look like cigarettes although some come in different colors, and recommended a crackdown on public use. Health officials in many countries say the impact of electronic cigarettes on health needs further study. Another worry they cite is that the electronic alternative will increase the general temptation to smoke, including enticing those who have quit to start again, or that smokers may use them alongside rather than instead of regular cigarettes. “This is no ordinary product because it encourages mimicking and could promote taking up smoking,” said Touraine, who announced her plans at a news conference. In the United States, the number of smokers who have tried out e-cigarettes doubled to one in five in 2011 and the number of all adults trying it doubled too, to 6 percent, according to the U.S. Centers for Disease Control and Prevention. In France, a country of 66 million, the government says tobacco smoking kills some 66,000 people a year and another 5,000 are killed through passive exposure to smoke. The expert in charge of the French report advised against an outright ban on e-cigarettes, however, saying they still seemed safer than tar-laden tobacco. Electronic cigarettes, whose invention is widely credited to a Chinese pharmacist a decade ago, usually comprise disposable cartridges of liquid such as propylene glycol that is easily turned to vapor and can contain artificial flavors alongside concentrated liquid nicotine.source : http://www.foxnews.com/health/2013/05/31/france-to-ban-electronic-cigarettes-in-public/

Quit-smoking treatments safe, effective, review says

Popular smoking cessation treatments - such as nicotine replacements and antidepressants - improve people's chances of kicking the habit without much risk, according to a review of past research. “It seems very clear that medications can help. They're not the magic bullet but you do improve your chances of quitting - generally - if you try them. And as far as we can tell, they're safe to use,” said Kate Cahill, who led the study. Several reviews have looked at the effectiveness of smoking cessation treatments, but the researchers wanted to put those results into a single large review to help people who want to use medical treatments to stop smoking, Cahill, a senior researcher for the Cochrane Tobacco Addiction Group at the University of Oxford, UK, said. About one fifth of the U.S. and UK populations are current smokers, according to the researchers. Previous studies have found between 70 percent and 75 percent want to quit, but only about 3 percent accomplish that every year. For the new study, the researchers pulled data from 12 reviews published by the Cochrane Collaboration, an international research organization that evaluates medical evidence. Those analyses, which were conducted between 2008 and 2012, included data from 267 studies of more than 101,000 smokers. The studies typically compared smokers trying to quit without the help of a smoking cessation treatment to smokers using nicotine replacement therapies, such as nicotine gum and patches, or prescription drugs. The medications include varenicline (marketed by Pfizer as Chantix or Champix) and bupropion (marketed by GlaxoSmithKline as Zyban or Wellbutrin, but available as a generic). The researchers found that the nicotine replacement therapies and the antidepressant bupropion led about eighteen people to successfully give up smoking for every 10 people who quit without treatments. Varenicline performed even better and led to about 28 people quitting for every 10 who did so without medication. What's more, Cahill and her colleagues found that lesser-known smoking cessation treatments were also effective. Those include the antidepressant nortriptyline and cytisine, a plant-derived supplement available in Eastern Europe. All of the treatments also appeared to be reasonably safe, according to the researchers who published their results on Thursday in The Cochrane Library. Previous reports have found that about 1 in every 1,000 people taking bupropion has a seizure, but the researchers found a lower rate of 1 in 1,500. Also, despite conflicting reports over the safety of varenicline, the researchers didn't find evidence that the drug increased the risk of neuropsychiatric or heart problems. Judith Prochaska, who researches tobacco treatment but was not involved in the new study, said not all smokers will use smoking cessation tools but it's important for them to know they're available. Nicotine replacement therapy is available over the counter in the U.S. and varenicline and bupropion are available with a prescription for about $4 per day - less than a pack of cigarettes, said Prochaska, associate professor of medicine at the Stanford Prevention Research Center in California. “They have been shown to pretty much double the likelihood that somebody will quit,” she added. Cahill cautioned, however, that smoking cessation tools won't work for everyone, but “they certainly help some people.”source : http://www.foxnews.com/health/2013/05/31/quit-smoking-treatments-safe-effective-review-says/

New weapon in fight against cervical cancer

The E7 protein is produced early in the lifecycle of the human papillomavirus (HPV) and blocks the body’s natural defences against the uncontrolled division of cells that can lead to cancer. Researchers at the University of Leeds’ School of Molecular and Cellular Biology have synthesised a molecule, called an RNA aptamer, that latches onto the carcinogenic protein and targets it for destruction, significantly reducing its presence in cells in the laboratory derived from cervical cancers…

Brain capable of making its own version of Valium, researchers find

The oral drug Valium – also known by its generic name, diazepam – was once popular with doctors in the 1970s as a treatment for seizures brought on by epilepsy.  However, the drug, also used to treat anxiety, has fallen out of favor in recent years as it is prone to abuse and often dangerous if taken in high doses. Now, in light of a recent study, the need for Valium to treat epilepsy may be even further diminished.  Researchers from Stanford University School of Medicine have discovered a naturally occurring protein in the brains of mammals that acts like Valium, stopping certain types of seizures from occurring. Researchers hope that if they are able to discover a way to boost this protein naturally, doctors would no longer have a need to prescribe Valium. The protein, identified as diazepam binding inhibitor (DBI), essentially acts like the brain’s very own brake system, sensing when a seizure is about to occur and arresting the process before it can spiral out of control. “Our thinking on brain circuits and epilepsy has been that our brains have their own ways to control seizures, and this is why most of us aren’t having seizures every day,” study author John Huguenard, professor of neurology and neurological sciences at Stanford, told FoxNews.com.  “But what happens as a seizure starts, a few cells in the brain may get too active, and you get an avalanche of activity that eventually can take up most of the brain circuitry.  The brain’s own ‘Valium’ is acting as an anti-avalanche method, checking things when they’re first starting.” According to Huguenard, the brain has two main groups of nerve cells.  The first type of cells – excitatory cells – are responsible for stimulating other cells and sending messages from one area of the brain to another.   This messaging process, known as excitation, is responsible for communicating what we see, what we smell, what we do, etc. The other key type of cells are known as inhibitory cells, which are responsible for keeping the brain circuitry under control.  If one area of the brain gets too excited and starts to receive too many signals at once, the inhibitory cells kick into gear and slow the process in order to restore balance. “In terms of this form of epilepsy we’ve been studying, if a certain group of brain cells can’t communicate well through this inhibitory process, then (the animals) have seizures,” Huguenard said. The protein DBI is a crucial component of the inhibitory process, as it boosts the actions of an important neurotransmitter called gamma-aminobutyric acid (GABA).  Roughly one-fifth of the inhibitory nerve cells in the brain operate by secreting GABA, which binds to receptors located on excitatory cells, rendering them temporarily unable to fire any more electrical signals.   Without DBI, GABA cannot be enhanced, and the excitatory cells ultimately don’t get the message telling them to calm down.  However, up until now, this function of DBI was not well understood by researchers. To determine exactly how DBI operates in the brains of mammals, Huguenard and his team analyzed a group of bioengineered mice with the DBI gene mutation, meaning their brains were incapable of producing DBI. “When we tested seizures in these animals and tested communication, we found that (the inhibitory process) was ineffective and that the animals had more seizures,” Huguenard said.  “It told us that this gene is producing a product in the brain that is controlling the seizures.” When they re-introduced the DBI-gene back into the brains of these mice, GABA-induced inhibition was restored and the mice suffered from fewer seizures. Benzodiazepine drugs, like Valium, work in a very similar way to DBI by also enhancing GABA-induced inhibition. But they often come at a high cost.  Many who take these medications long-term develop a physical dependence on the drug, experiencing serious withdrawal symptoms if they cease taking it.  Some studies have also found Valium to have an adverse effect on both short-term and long-term cognition. While the researchers only examined the brains of mice, they are optimistic DBI exists similarly in the brains of humans as well.   If the results end up translating to the human mind, Huguenard hopes to find a way to naturally boost DBI in the brain, negating the need for Valium to help control seizures. “The ultimate goal would be to develop new lines of therapy that would take this general approach – taking the brain’s mechanism for dealing with seizures and making them even more effective,” Huguenard said. The research was published May 30 in the journal Neuron.source : http://www.foxnews.com/health/2013/05/30/brain-capable-making-own-version-valium-researchers-find/

Caffeine withdrawal: A made-up condition included in the DSM-5

Disorders called caffeine intoxication and caffeine withdrawal join the likes of heroin and alcohol dependence in the fifth edition of the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM)—the organization’s official list of mental disorders. According to the DSM-5, too much coffee, cola or caffeine-laced gum can cause restlessness, nervousness, a red face and rambling speech.  And stopping caffeine suddenly can cause sleepiness and depressed mood. Is that really news?  No, it isn’t.  What is news is that the DSM-5, by overreaching so dramatically to pathologize every American and make all of us ripe for psychiatric medications covered by insurance, has finally helped all of us see the disservice the American Psychiatric Association (APA) is doing to America. Medicare and Medicaid, beware.  Both insurers should refuse payment for any psychiatric service supposedly delivered for caffeine intoxication and caffeine withdrawal – and other insurers should, too. What else could we expect, though, from an organization that also just created a disorder called binge eating disorder, a scourge defined as overeating a dozen times in three months?  Now, if you also have too much coffee at the end of those meals, you can have two disorders!   Caffeine is a common dietary ingredient in sodas.  It is found in coffee and tea, and it is consumed without ill effects by, perhaps, one hundred million Americans each day.  Focusing on caffeine as a drug, like heroin, is just a land grab for more patients.  Will sugar excitement syndrome be next?  How about post-food fatigue syndrome…

Most travelers survive in-flight medical emergencies, study shows

Is there a doctor on board? Surprisingly often, there is - in half of in-flight medical emergencies - and sick airline passengers almost always survive, a new study finds. The research is the largest look yet at what happens to people who develop a medical problem on a commercial flight - about 44,000 of the 2.75 billion passengers worldwide each year, researchers estimate. Most cases don't require diverting a plane as the study's leader, Dr. Christian Martin-Gill, advised a pilot to do two years. He works for MD-STAT, a service at the University of Pittsburgh Medical Center that advises about 20 major airlines on how to handle in-flight emergencies. Another large service is based in Phoenix. Martin-Gill handled a call when a passenger seemed to be having a heart attack on a flight from Europe to the U.S. The man's implanted defibrillator had shocked his heart five times to try to restore normal rhythm. “The aircraft was in the middle of its destination, flying over the Atlantic,” so he recommended landing at Newfoundland off the Canadian coast to get the man to the nearest hospital, Martin-Gill said. The federally funded study reviewed about 12,000 cases handled by the Pittsburgh center over nearly three years. Results are in Thursday's New England Journal of Medicine. Researchers found: -The odds of a medical emergency are 1 per 604 flights, or 16 per 1 million passengers. -Planes had to be diverted for emergency help in only 7 percent of cases. -Doctors were on board and volunteered to help in 48 percent of cases; nurses and other health workers were available in another 28 percent. Only one-third of cases had to be handled by flight attendants alone. -The most common problems: Dizziness or passing out (37 percent of cases); trouble breathing (12 percent) and nausea or vomiting (10 percent). -About one-fourth of passengers were evaluated at a hospital after landing and 9 percent were admitted, usually with stroke, respiratory or cardiac symptoms. -Out of nearly 12,000 cases, a defibrillator was applied 137 times, including in 24 cases of cardiac arrest, where the heart had stopped. (Sometimes defibrillators are used to analyze an irregular heart rhythm to help doctors figure out what to do, not necessarily to deliver a shock.) -Of the cases in this study, only 36 deaths occurred, 30 of them during the flight and the others after landing. -Pregnancy-related problems were generally rare - 61 cases, in this study - and two-thirds of them involved women less than 24 weeks along with possible miscarriages. Air travel is considered safe up to the 36th week, or the last month, of pregnancy. Only three cases of women in labor beyond 24 weeks of pregnancy led to a plane being diverted. Dr. Lisa Rosenbaum, a University of Pennsylvania cardiologist, helped in a case like that in 2007, on a flight from Boston to Portland, Ore. The passenger was three months from her due date but was having contractions every minute - something that can often be stopped with drugs and treatment at a hospital but not in midair. “It was clear to me that labor was imminent and that we needed to land the plane,” so, on her advice, the pilot diverted to upstate New York, Rosenbaum said. “It was one of the scariest experiences of my life. It's not like taking care of a patient in the hospital.” Dr. David Rogers, a pediatric surgeon at the University of Alabama at Birmingham School of Medicine, felt that fear five years ago when an elderly woman had trouble breathing during a flight to Atlanta from Toledo, Ohio. Being a specialist at treating children rather than adults, “my first reaction was to look around and hope there would be somebody else” more qualified to help, he said. Luckily, a flight attendant had already given the woman an oxygen mask and she seemed to be improving, so he felt the plane could continue to Atlanta, the woman's home. Trying to determine whether to divert a plane was a tough call, he said. “I'm making a decision that's going to affect a plane full of people,” not just the patient, Rogers said. Some passengers may fear liability if they help in such situations, but a Good Samaritan law protects those who do so, the study notes. And although health workers are not legally obliged to help, they have a moral obligation to do so, the authors write. And you never know what kind of help will be requested. Martin-Gill said a partner once was consulted when a dog suffered a cardiac arrest during a flight. He didn't know how things turned out.source : http://www.foxnews.com/health/2013/05/30/most-travelers-survive-in-flight-medical-emergencies-study-shows/

The best way to scorch fat and lean up for the summer

With less than a month left until summer, you've got to tone up fast. It's time to learn about Tabata, a Japanese method of training with sessions that's based on timing instead of counting reps and is absolutely perfect for scorching fat and getting toned up for the summer. Tabata is known for improving performance and muscle tone. In fact, a study in the Journal of Physiology found that short, intense interval workouts like Tabata can be a more time-efficient way to get in shape than longer, steadier paced workouts. RELATED: Last-Minute Beach Shape-Up Routine Try these four Tabata moves two to three times a week; it should take 20 minutes to complete. Each move should start with 20 seconds of flat-out effort on each move, 10 seconds of rest, and repeat eight times. Take a full minute to rest before moving on to the next exercise. You will also need weights that are about half the weight of your normal level so you can last through the time sets. Lastly, since this is a high-intensity exercise, you should try wearing a heart rate monitor to make sure that you're working out at 80 percent of your maximum heart rate, your optimal fat-burning zone. Let's get started! 1. Press-up Row. In a pushup position, grip the handles of two weights. Instead of lowering yourself down, bring one arm up to your armpit while holding yourself tight. Lower and repeat. RELATED: 24 Fat-Burning Ab Exercises (No Crunches!) 2. Leapfrog Plank.  Leave your weights to the side, get in the pushup position, with your shoulders and hands in line and your back straight. “Leap” your feet forward towards your hands, and then jump back to plank position. Do this back and forth as fast as you can. 3. Front Squat. Rest your weights on your shoulders, palms facing out, standing with feet hip-width apart. Slowly squat (remember to keep your butt tucked in and your back straight!) as far down as you can, making sure that your knees are aligned with your toes. then return to start. 4. Clean and Press. Stand with your weights at your toes. Squat down and grab your weights overhand. Stand up and lift the weights up and over your head, then lower them down to the floor. Repeat. RELATED: Fastest Fat Burners Ever! Jennifer Cohen is a leading fitness authority, TV personality, best-selling author, and entrepreneur.  With her signature, straight-talking approach to wellness, Jennifer was the featured trainer on The CW's Shedding for the Wedding, mentoring the contestants' to lose hundreds of pounds before their big day, and she appears regularly on NBC's Today Show, Extra, The Doctors and Good Morning America. This article originally appeared on Health.com.source : http://www.foxnews.com/health/2013/05/30/best-way-to-scorch-fat-and-lean-up-for-summer/