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Drugmakers to cooperate in safety review of diabetes drugs

Global drugmakers said on Wednesday they would cooperate with an independent review to address concerns of a potential link between widely used diabetes medicines and pancreatic cancer and other safety problems. The American Diabetes Association (ADA) this week called for a new evaluation of clinical data on drugs used to control blood sugar for patients with type 2 diabetes. They include Merck & Co's $4 billion a year Januvia franchise, Novo Nordisk's Victoza, and Byetta and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc, among others. “People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment,” Dr. Robert Ratner, ADA's chief scientific and medical officer, said in a statement. The medicines are called incretin mimetics because they mimic hormones the body produces to stimulate release of insulin, and are from classes of drugs known as GLP-1 receptor agonists and DPP-4 inhibitors. GLP-1 drugs boost insulin production by the pancreas and slow absorption of food. DPP-4 inhibitors block an enzyme the breaks down the GLP-1 peptide in the gut, thereby increasing insulin production. The U.S. Food and Drug Administration in March said it was studying unconfirmed reports that the drugs cause inflammation of the pancreas and pre-cancerous changes to cells in the pancreas. European health regulators are also studying the issue. Around the same time, new concerns arose from a small study conducted by a leading diabetes expert, Dr. Peter Butler, from the University of California, Los Angeles. Butler examined human pancreases from patients who had died of causes unrelated to pancreatic disease and found more pancreas lesions and one cancerous tumor in those who had taken Januvia or Byetta compared with nondiabetics or diabetics who had not taken those medicines. More than 370 million people are living with diabetes worldwide, with type 2 accounting for 90 percent to 95 percent of the cases, according to the International Diabetes Federation. Without significant lifestyle changes to curb obesity and other causes of diabetes, that number could balloon to as many as 552 million by 2030, the organization projected. NO FIRM EVIDENCE OF RISK Bristol-Myers and AstraZeneca issued a joint statement expressing support for the ADA initiative. Merck said it is committed to participating in the ADA effort, and is separately conducting a 14,000-patient heart safety study of Januvia. Danish drugmaker Novo Nordisk, in an emailed comment, said its studies to assess safety signals of its $1.8 billion a year Victoza do not reveal any evidence of increased risk of pancreatitis or pancreatic cancer. “As far as the ADA proposal is concerned, this is something that I do support from a conceptual basis,” said Alan Moses, Novo's global chief medical officer, in a telephone interview. “In principle, Novo Nordisk absolutely supports working with the other companies, but the final details depend on what specifically is being proposed,” Moses said, adding “it all depends on the credibility of the data that's being evaluated.” The safety concerns are being discussed on Wednesday and Thursday at a workshop conducted by the National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). A document outlining the FDA's presentation at the workshop was handed out at the meeting. Attendees quoted it as saying the agency review of trial data on the drugs did not provide enough evidence to say whether there is a link to pancreatitis, and that long-term study would be required to determine any cancer risk. A FDA spokeswoman could not immediately confirm the contents of the document. “The FDA basically appears to just be saying 'look, there just isn't enough information here to make an informed decision',” said Mark Schoenebaum, a drug industry analyst with ISI Group who was attending to two-day NIH/NIDDK workshop. “There are no conclusions at this point in time from the meeting and I doubt very much there will be because the science quite frankly is immature about the whole area of pancreatic cancer,” said Novo's Moses, who will address the workshop on Thursday. “Everybody agrees that this is an incredibly complex area.” In an interview with Reuters earlier this week Peter Stein, Merck vice president of clinical research for diabetes, expressed full confidence in the safety of Januvia. During the workshop, Merck said it will present data on the safety profile of Januvia, known chemically as sitagliptin, including an updated analysis of data from more than 14,000 patients from 25 randomized clinical trials. Merck last month reported a surprising decline in first quarter sales of Januvia, which has been the drugmaker's fastest growing medicine since its 2006 approval. It was not clear if increased competition, safety concerns or other factors led to the 4 percent slip in quarterly sales to $884 million.source : http://www.foxnews.com/health/2013/06/13/drugmakers-to-cooperate-in-safety-review-diabetes-drugs/

Experimental vaccine shows promise against TB meningitis

A report on the federally funded research is published online June 11 in the journal PLOS ONE. TB brain infections often cause serious brain damage and death even when recognized and treated promptly, researchers say. This is so because many drugs currently used to treat resistant TB strains cannot cross the so-called brain-blood barrier, which stops pathogens from entering the brain, but also keeps most medicines woefully out of the brain’s reach…

Walking after meals may reduce diabetes risk

Doctors have long recommended exercise to reduce the risk of type 2 diabetes, especially in those at high risk for the condition. But a new study found that doing a short walk right after you eat may be the simplest and most effective strategy, especially for older adults. The study,  published in Diabetes Care, found that a 15-minute walk about a half an hour after each meal was as effective at reducing blood sugar as a single 45-minute morning or late afternoon walk.  But researchers found that the quick walk after dinner was even more effective than the longer afternoon walk in lowering blood sugars (glucose) over night into the next day. “The post-meal exercise was especially efficient at lowering the 3-hour post-dinner blood sugar glucose,” said the study’s lead author Dr. Loretta DiPietro, chair of the department of exercise science at George Washington University School of Public Health and Health Services. The study also found that the most effective time to go for a post-meal walk was after the evening meal. Dinner is usually the largest meal of the day, causing the greatest rise in blood sugar, which lasts into the night and the next morning. These affects were significantly reduced by the after dinner walk.    This is an important finding for older people. As you age, your insulin response to help shuttle sugar out of the bloodstream becomes sluggish. Insulin levels also start to fall in the afternoon and into the evening, adding to the weaker response to sugars you consume. Many people end up sitting around after dinner and going to bed with very high blood sugar levels – which according to DiPietro – is the worst thing you can do. When you exercise, contracting muscles help to clear sugar from the blood and get it stored in the muscles or liver. In this study, older adults walked at a moderate pace, not a brisk walk and not a leisurely stroll. This study, though small, was one of the first to look at the timing of exercise. The general recommendations are to get 150 minutes of exercise a week or at least 30 minutes five days a week. But the study looked at what happened a half an hour after a meal, during the time when sugar begins to flood the blood stream. “When you look at the data, you can see the blood sugar started to go up after a meal, and the exercise abruptly halted that upward rise in blood sugar,” said DiPietro. Though the findings need to be confirmed in larger trials, they are important for those with prediabetes and older individuals. An estimated 79 million Americans have prediabetes but most have no idea they are even at risk. “It may be easy for older adults to take a short walk or combine walking after a meal with running errands or walking the dog,” said DiPietro. The findings may be important for others including pregnant women who are at risk of gestational diabetes.  And if you overindulged in a meal, going for a brisk walk may help your body get rid of that excess sugar more efficiently.Laurie Tarkan is an award-winning health journalist whose work appears in the New York Times, among other national magazines and websites. She has authored several health books, including “Perfect Hormone Balance for Fertility.” Follow her on Twitter and Facebook.source : http://www.foxnews.com/health/2013/06/12/walking-after-meals-may-reduce-diabetes-risk/

Bug bites causing allergies? How to avoid dangerous tick bites

As we transition into summer, it is expected that the now infamous lone star tick will continue to spread throughout the United States.  When the lone star tick bites, saliva is injected into the victim that contains a specific sugar known as “alpha gal,” according to research from the University of Virginia. In as little as a few weeks, this appears to cause an antibody surge that can precipitate a full blown allergic reaction after eating red meat, such as beef, pork and/or lamb, but not poultry.   It’s important to be aware of health issues related to tick bites, and of course to plan ahead to reduce the likelihood of giving your favorite host a warm-blooded meal.  That means following some of the suggestions by the CDC: 1. Know your neighborhood.  Find out whether deer or lone star ticks are prevalent in your area. 2. Assess the risk of your activity and the chance of exposure to ticks, i.e. hiking in woods vs. back yard picnics.   3. Know the proper way to apply both DEET and natural based insect/tick repellents, how long they protect and what concentration is appropriate for adequate protection for adults and children.   4. Consider dressing in light clothing making it easier to spot very small ticks. 5. Always due a close inspection and tick check when returning from tick endemic areas. 6. Learn the recommended techniques in removing a tick. 7. Save the recovered tick for analysis by your local department of health, and they can determine the type of tick and whether it may contain the bacteria that causes Lyme disease, for example. So be prepared - and avoid getting “ticked off” this summer!Dr. Clifford Bassett is an adult and pediatric allergy specialist, and diplomat of the American Board of Allergy and Immunology. He is the medical director of& Allergy and Asthma Care of NY.& & Bassett is a clinical assistant professor of medicine and on the teaching faculty of NYU School of Medicine and NYU Langone Medical Center and assistant clinical professor of Medicine and Otolaryngology at SUNY LICH. Follow him on& Twitter. & source : http://www.foxnews.com/health/2013/06/12/how-to-avoid-tick-bites-that-could-cause-red-meat-allergies/

Britain to regulate e-cigarettes as medicine from 2016

Britain is set to regulate electronic cigarettes as non-prescription medicines from 2016 in an attempt to improve quality, though the country's drugs watchdog said they would still be sold in convenience stores. Healthcare authorities around the world are grappling with how to deal with the battery-driven devices, which allow users to inhale nicotine-laced vapor and are increasingly popular as an apparently less harmful alternative to smoking. A few countries have banned them outright - such as Brazil, Norway and Singapore - while others are opting for varying degrees of regulation, in some cases including limits on advertising and curbs on their use in public places. Sales of e-cigarettes have boomed in recent years, prompted in part by restrictions on smoking. But their long-term effects are as yet unproven and some doctors argue their popularity could undermine anti-smoking efforts. They could also affect sales of regulated nicotine-replacement products, such as patches, sold by drugmakers like Pfizer and GlaxoSmithKline. Under the new British system, manufacturers will have to prove the quality of their products and demonstrate that they deliver the correct amount of nicotine. But they will not need to conduct clinical trials. The Medicines and Healthcare products Regulatory Agency (MHRA) said on Wednesday that existing e-cigarettes on the market were not good enough, with contaminants found in some products and nicotine levels often varying widely. However, manufacturers will have time to raise their game and apply for a license, allowing them to sell regulated devices as over-the-counter products in a wide range of retail outlets from 2016. A growing number of established tobacco companies are investing in the e-cigarette market worldwide, including Lorillard, British American Tobacco, Imperial Tobacco, Reynolds American and Altria. They are competing against a plethora of smaller private firms, all of which see a growing sales opportunity. Research indicates that around 1.3 million people currently use e-cigarettes in Britain alone, up from 700,000 a year ago. Biggest risk is smoking Jeremy Mean of the MHRA said the government had decided against banning existing poor-quality e-cigarettes, even though they did not meet desired safety and standards, since this could tip some people back into smoking. “Smoking is the riskiest thing you can do and we want to enable people to cut down and quit. We don't think a ban is proportionate to the risk, when the alternative is people continuing to smoke,” he told reporters. Britain's chief medical officer, Sally Davies, said smokers were harmed by tar and toxins in tobacco smoke, not nicotine, so it made sense to ensure e-cigarettes were properly regulated, as already happens with nicotine patches and gums. The new approach could be a boon for those companies that successfully secure a license, since licensed e-cigarettes will be able to carry smoking-cessation claims and could be prescribed by doctors to help smokers quit. Mead said there were likely to be fewer products of higher quality on the market from 2016, when pan-European regulations on e-cigarettes are also due to come into effect. Adrian Everett, chief executive of E-Lites, Britain's biggest seller of e-cigarettes, said his company was well-placed to meet the new regulatory standards but he cautioned against excessively tight rules that could reduce customer choice. “It would be a significant public health loss if electronic cigarettes were made less available to purchase or less available to use during the transition from a consumer product to a medicinal product,” he said.source : http://www.foxnews.com/health/2013/06/12/britain-to-regulate-e-cigarettes-as-medicine-from-2016/

Tick bites are making people allergic to red meat, researchers say

If Lyme disease isn't reason enough to avoid ticks, here's another: the inability to enjoy a burger. Odd as it seems, researchers say that bites from the voracious lone star tick are making some people allergic to red meat—even if they've never had a problem eating it before. The allergic reactions range from vomiting and abdominal cramps to hives to anaphylaxis, which can lead to breathing difficulties and sometimes even death. Unlike most food allergies, the symptoms typically set in three to six hours after an affected person eats beef, pork or lamb—often in the middle of the night. The bite that seems to precipitate it may occur weeks or months before, often making it difficult for people to make the link. Cases of the unusual allergy were first identified at the University of Virginia at Charlottesville in 2007, and are now being reported as far north as Nantucket, Mass., and on the east end of New York's Long Island. “It's a huge problem out here,” says Erin McGintee, a pediatric and adult allergist in East Hampton, N.Y., who says she knows of more than 70 cases and sees several more each week. “I've been trying to get the word out—but there are still a lot of people who don't believe it,” she adds. Click for more from The Wall Street Journal. source : http://www.foxnews.com/health/2013/06/12/tick-bites-are-making-people-allergic-to-red-meat-researchers-say/

Quick and simple ways to reduce risk from the most common form of cancer

"The easiest way to prevent skin cancer is to protect your skin with clothing," said board-certified dermatologist Zoe D. Draelos, MD, FAAD, consulting professor at Duke University School of Medicine, Durham, N.C. "Keep a wide-brimmed hat and sunglasses near your door so you can put them on before you go outside…

Diabetes drug points the way to overcoming drug resistance in melanoma

Their studies, conducted in cell and animal models of melanoma, demonstrate that the combined therapy could destroy a subset of drug-resistant cells within a tumor. "We have found that the individual cells within melanoma tumors are not all identical, and tumors contain a sub-population of cells that are inherently drug resistant, which accounts for the fact that advanced melanoma tumors return no matter how much the tumor is depleted," said Meenhard Herlyn, D.V.M., D.Sc., professor and director of Wistar’s Melanoma Research Center. "We found that these slow-growing, drug-resistant cells are marked by a high rate of metabolism, which makes them susceptible to diabetes therapeutics." "Our findings suggest a simple strategy to kill metastatic melanoma — regardless of cell type within the tumor — by combining anticancer drugs with diabetes drug," Herlyn said. "The diabetes drug puts the brakes on the cells that would otherwise repopulate the tumor, thus allowing the anticancer drug to be more effective." In the Cancer Cell article, the researchers describe how various anticancer drugs, including cisplatin and the targeted therapy vemurafenib, which targets melanomas with the BRAF mutation, become more effective when co-delivered with phenformin. …

Buffy star Sarah Michelle Gellar hopes to slay pertussis through vaccine awareness

While slaying vampires and saving the world may be her area of expertise, television and movie star Sarah Michelle Gellar said she was slightly overwhelmed when she had to tackle a subject she previously knew little about: children’s health care. Gellar is a mother to 3-year-old daughter Charlotte and son Rocky, who was born in September, and she said keeping them healthy has been one of the trickiest aspects of being a parent. “Someone told me when they start pre-school, they’ll be sick within the first six months,” said Gellar, who is famous for portraying Buffy the Vampire Slayer in the cult TV series of the same name.  “And sure enough, when my daughter started pre-school, she was sick for pretty much six months straight.  I thought that I would have a chair at the pediatrician’s office with my name on it, I had been there so much.” One daunting task for Gellar was delving into the world of childhood vaccinations and trying to understand the safest and most effective options for her kids.  Now having learned about the health dangers that face small children, Gellar has made it a priority to get her entire family vaccinated against pertussis – a serious illness, also known as whooping cough, that has been on the rise in the United States. While her family’s health is her chief concern, Gellar also wants others to follow her example.  Hoping to raise awareness about the importance of getting vaccinated, Gellar has teamed up with the Sounds of Pertussis Campaign, a crusade launched by Sanofi Pasteur and the March of Dimes that focuses on the dangers of pertussis and what parents can do to prevent their children from getting this potentially deadly disease. “I’m just like everyone else out there,” Gellar said.  “I’m a mom trying to keep my kids healthy, but I also have access to so much information that I can then go through it all and make it easier for people to understand.  You’re talking about an illness that doesn’t have to exist.  The only way to help fight against it is to get the vaccine, and that’s a simple way.” A serious respiratory illness, pertussis presents in infants and children like a common cold, with symptoms of a runny nose or congestion and sneezing.  But if left untreated, the disease can progress into severe coughing that forces air out of the lungs – causing pertussis sufferers to inhale with a large “whooping” sound.   According to the Centers for Disease Control and Prevention, America is experiencing one of the largest outbreaks of pertussis cases within the past 50 years, with more than 41,000 cases and 18 deaths reported in 2012.  Infants younger than 1 year of age are particularly vulnerable to the outbreak, since they do not begin receiving their own vaccinations until they are 2 months old, and they aren’t fully protected from the disease until they have received at least three doses.  This danger is compounded by the fact that infants with pertussis are often in need of hospitalization, and some can go on to develop life threatening pneumonia.   Gellar said this is why it is just as important for parents and teenagers to stay up-to-date on their vaccines in order to eliminate the possibility of passing pertussis on to small babies. “You look at the statistics, and they can track it back,” Gellar said.  “Eighty percent of the children who came down with it, they can track it back to a family member that brought it in, and 50 percent were the actual parents.  I know there’s nothing worse as a new parent than you thinking that you got your child sick…It’s a simple vaccination for an adult to get every five years, and that’s it.  It’s the only safe way to prevent the child from getting the disease.” To help families keep track of their necessary vaccinations, the Sounds of Pertussis campaign has created a Facebook application called The Breathing Room, which shows which individuals among a person’s friends and family have pledged to get vaccinated. As for the concerns that some parents have regarding the safety of vaccines, Gellar said it is important for people to do the necessary research and talk with the right people before making any judgments.  Gellar, along with many health care professionals, maintain there are minimal side effects when it comes to getting the shot. “I think there’s a lot of misinformation out there about vaccines,” Gellar said.  “People are scared, and I think that if you can bring (information) in a way that people understand the importance, and how simple it actually is, I think people will be more prone to do it.” To learn more about getting vaccinated against pertussis, visit the Sounds of Pertussis website and the campaign’s Facebook page.source : http://www.foxnews.com/health/2013/06/11/buffy-star-sarah-michelle-gellar-hopes-to-slay-pertussis-through-vaccine/

Dr. Manny: FDA loss of control on Plan B not surprising

I told you so - the government is bamboozling us about Plan B. The Obama administration announced on Monday that it will now allow girls and women of all ages to purchase the Plan B pill without a prescription. This is exactly what I have been warning the American public about. I am now totally convinced that our current federal government loves confusion. When you have a single agenda, and many ways to spin it, the American public never gets a clear answer and that is exactly what has happened with the Plan B emergency contraception controversy. Just last week, a U.S. appeals court ruled that the U.S. Food and Drug Administration (FDA) must make only certain forms of the emergency contraception pill available to children of all ages, without a prescription.  In a confusing ruling, the court stated that while the two-pill version of emergency contraception could be sold over-the-counter to women of all ages, the one-pill version would still only be sold to women age 17 or older. The court did not explain its reasoning. One has to remember that the FDA first approved this form of over-the-counter contraception for women of all ages back in 2011. When that initial FDA ruling came out, there was a loud public outcry and restrictions were quickly put in place barring women under the age of 17 from purchasing these pills. But of course, that was just one spin on the story. In April, a New York judge ruled that restricting access to Plan B was inappropriate, forcing the FDA to reconsider their initial finding that emergency contraception should be available to children of all ages. And then, we got another spin on the story, as the FDA tried to lower the age limit for access to emergency contraception to 15 last month. There was another outcry and more criticism, because we know perfectly well that a 15-year-old may not have a clear understanding of how to utilize emergency contraception. Now, we see that the FDA will get to do what they wanted to do in the first place. How convenient. So, what’s the message here?