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Monday, January 31, 2011

2010 Dietary Guidelines For Americans, Joint USDA and HHS Effort To Keep Americans Healthy.

USDA and HHS Announce New Dietary Guidelines to Help Americans Make Healthier Food Choices and Confront Obesity Epidemic

WASHINGTON, Jan. 31, 2011 — Agriculture Secretary TomVilsack and Secretary of the Department of Health and Human Services (HHS) Kathleen Sebelius today announced the release of the 2010 Dietary Guidelines for Americans, the federal government's evidence-based nutritional guidance to promote health, reduce the risk of chronic diseases, and reduce the prevalence of overweight and obesity through improved nutrition and physical activity.
Because more than one-third of children and more than two-thirds of adults in the United States are overweight or obese, the 7th edition of Dietary Guidelines for Americans places stronger emphasis on reducing calorie consumption and increasing physical activity.
“The 2010 Dietary Guidelines are being released at a time when the majority of adults and one in three children is overweight or obese and this is a crisis that we can no longer ignore,” said Secretary Vilsack.  “These new and improved dietary recommendations give individuals the information to make thoughtful choices of healthier foods in the right portions and to complement those choices with physical activity.  The bottom line is that most Americans need to trim our waistlines to reduce the risk of developing diet-related chronic disease. Improving our eating habits is not only good for every individual and family, but also for our country.”
The new 2010 Dietary Guidelines for Americans focus on balancing calories with physical activity, and encourage Americans to consume more healthy foods like vegetables, fruits, whole grains, fat-free and low-fat dairy products, and seafood, and to consume less sodium, saturated and trans fats, added sugars, and refined grains.
“Helping Americans incorporate these guidelines into their everyday lives is important to improving the overall health of the American people,” said HHS Secretary Sebelius. “The new Dietary Guidelines provide concrete action steps to help people live healthier, more physically active and longer lives.”
The 2010 Dietary Guidelines for Americans include 23 Key Recommendations for the general population and six additional Key Recommendations for specific population groups, such as women who are pregnant. Key Recommendations are the most important messages within the Guidelines in terms of their implications for improving public health.  The recommendations are intended as an integrated set of advice to achieve an overall healthy eating pattern.  To get the full benefit, all Americans should carry out the Dietary Guidelines recommendations in their entirety.
More consumer-friendly advice and tools, including a next generation Food Pyramid, will be released by USDA and HHS in the coming months. Below is a preview of some of the tips that will be provided to help consumers translate the Dietary Guidelines into their everyday lives:
  • Enjoy your food, but eat less.
  • Avoid oversized portions.
  • Make half your plate fruits and vegetables.
  • Switch to fat-free or low-fat (1%) milk.
  • Compare sodium in foods like soup, bread, and frozen meals – and choose the foods with lower numbers.
  • Drink water instead of sugary drinks.
This edition of the Dietary Guidelines comes at a critical juncture for America’s health and prosperity.   By adopting the recommendations in the Dietary Guidelines, Americans can live healthier lives and contribute to a lowering of health-care costs, helping to strengthen America’s long-term economic competitiveness and overall productivity.
USDA and HHS have conducted this latest review of the scientific literature, and have developed and issued the 7thedition of the Dietary Guidelines for Americans in a joint effort that is mandated by Congress. The Guidelines form the basis of nutrition education programs, Federal nutrition assistance programs such as school meals programs and Meals on Wheels programs for seniors, and dietary advice provided by health professionals.
The Dietary Guidelines, based on the most sound scientific information, provide authoritative advice for people 2 years and older about how proper dietary habits can promote health and reduce risk for major chronic diseases.
The Dietary Guidelines aid policymakers in designing and implementing nutrition-related programs. They also provide education and health professionals, such as nutritionists, dietitians, and health educators with a compilation of the latest science-based recommendations. A table with key consumer behaviors and potential strategies for professionals to use in implementing the Dietary Guidelines is included in the appendix.
The 2010 Dietary Guidelines is available at www.dietaryguidelines.gov.
For more information on dietary guidelines, see www.health.gov/dietaryguidelines  andwww.healthfinder.gov/prevention

A Self-Help Intervention for African American Smokers

African American adults have one of the highest smoking rates and one of the lowest quit rates in the US, with disproportionately high rates of morbidity and mortality from tobacco-caused disease.  African American smokers are no less likely to make serious quit attempts, but are more likely to quit "on their own", without the benefit of evidence-based treatments that could double their quit rates. Two decades of research have shown favorable results with treatments that combine self-help materials with brief telephone cessation counseling. At the time of this study, the Cancer Information Service (CIS), sponsored by the National Cancer Institute, offered an effective population-based strategy for assisting smokers in diverse socio-demographic groups to acquire the motivation, skills, and support needed to quit smoking and remain nonsmokers.  Similar services are now provided through a national network of state quitlines accessible through a single portal: 1-800-QUIT-NOW.  However, African American smokers tend to underutilize these evidence-based quit-smoking help lines. African Americans' distinctive smoking patterns (e.g., daily smoking rate, menthol, high tar/nicotine cigarettes), and the unique quitting motives and barriers and cultural values in the African American community (e.g., lack of information about how smoking harms health, stronger smoking norms, pervasive targeted advertising, higher life stress) can be effectively addressed through tailored, culturally-appropriate quitline promotions, materials and evidence-based counseling.

ATTENTION: Program materials used in this research project may be downloaded and saved from this site. The material may be used "as is" or may be modified and adapted for your context.
Adaptation Guidelines

Program Adaptation Guidelines: provides tips on how to ensure your program's optimal success in your community's setting when adapting materials that were designed and tested within a controlled research study. Before adapting programs, users should review current literature, guidelines, and other evidence reviews to update the program materials. 

Using What Works: a train-the-trainer course that teaches users how to adapt a research-tested intervention program to the local community context.
You may review each item individually by selecting the links provided or, unless indicated otherwise, you may order a copy of the program's product materials by using the Order link to the right: 

The program CD-ROM is not copyrighted, please feel free to duplicate the program CD-ROM as needed.

Order Free CD-ROM

Implementation Guide
Program delivery protocol. 

The Implementation Guide is a resource for implementing this program. It provides important information about the staffing and functions necessary for administering this program in the user's setting. Additionally, the steps needed to carry out the research-tested program, relevant program materials, and information for evaluating the program are included. 

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Pathways to Freedom - Winning the Fight Against Tobacco
Participant's manual 

Average Readability Score: Grade 7.5
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Quitting Barriers Manual
Counselor's manual 

Average Readability Score: Grade 8.5

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Tailored Counseling Checklist
Suggested counseling dialogue 
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NCI RTIPs

Friday, January 28, 2011

Pfizer Inc. and Progenics Pharmaceuticals, Inc Alerts About Recalled Triad Alcohol Prep Pads Packaged With RELISTOR® Injection.

Pfizer and Progenics advise patients using the RELISTOR kit not to use the Triad alcohol prep pads included in the RELISTOR packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their RELISTOR injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.
Recallr: Do Not Use Triad Alcohol Prep Pads Packaged With Pfizer Inc. and Progenics Pharmaceuticals, Inc RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection.

Food Safety : Refrigiration And Power Outages, Keeping Food And Your Family Safe During an Emergency

Government  Food safety site has published a chart, adapted from "Keeping Food Safe During an Emergency",  USDA,.(United States Department of Agriculture).
I am sure you have asked yourself a few times "Is food in the refrigerator safe during a power outage?"
It depends on the length of the outage and the ambient temperature.
Usually refrigerated food safe as long as power is out no more than 4 hours. Keep the Fridge / Refrigerator doors closed as much as possible. Discard any perishable food (such as meat, poultry, fish, eggs, and leftovers) that have been above 40 °F for over 2 hours. Following chard has some information.

Simply, never judge the safety of by the looks and never taste food to see if it is safe. As a rule, Always discard any items in the refrigerator that have come into contact with raw meat juices.

Be healthy, a few dollars you save may not worth it and evaluate each food item individually.


Food CategoriesSpecific FoodsHeld above 40 °F for over 2 hours
MEAT, POULTRY, SEAFOODRaw or leftover cooked meat, poultry, fish, or seafood; soy meat substitutesDiscard
Thawing meat or poultryDiscard
Salads: Meat, tuna, shrimp, chicken, or egg saladDiscard
Gravy, stuffing, brothDiscard
Lunchmeats, hot dogs, bacon, sausage, dried beefDiscard
Pizza – with any toppingDiscard
Canned hams labeled "Keep Refrigerated"Discard
Canned meats and fish, openedDiscard
Casseroles, soups, stewsDiscard
CHEESESoft Cheeses: blue/bleu, Roquefort, Brie, Camembert, cottage, cream, Edam, Monterey Jack, ricotta, mozzarella, Muenster, Neufchatel, queso blanco, queso frescoDiscard
Hard Cheeses: Cheddar, Colby, Swiss, Parmesan, provolone, RomanoSafe
Processed CheesesSafe
Shredded CheesesDiscard
Low-fat CheesesDiscard
Grated Parmesan, Romano, or combination (in can or jar)Safe
DAIRYMilk, cream, sour cream, buttermilk, evaporated milk, yogurt, eggnog, soy milkDiscard
Butter, margarineSafe
Baby formula, openedDiscard
EGGSFresh eggs, hard-cooked in shell, egg dishes, egg productsDiscard
Custards and puddings, quicheDiscard
FRUITSFresh fruits, cutDiscard
Fruit juices, openedSafe
Canned fruits, openedSafe
Fresh fruits, coconut, raisins, dried fruits, candied fruits, datesSafe
SAUCES, SPREADS, JAMSOpened mayonnaise, tartar sauce, horseradishDiscard if above 50 °F for over 8 hrs.
Peanut butterSafe
Jelly, relish, taco sauce, mustard, catsup, olives, picklesSafe
Worcestershire, soy, barbecue, hoisin saucesSafe
Fish sauces, oyster sauceDiscard
Opened vinegar-based dressingsSafe
Opened creamy-based dressingsDiscard
Spaghetti sauce, opened jarDiscard
BREAD, CAKES, COOKIES, PASTA, GRAINSBread, rolls, cakes, muffins, quick breads, tortillasSafe
Refrigerator biscuits, rolls, cookie doughDiscard
Cooked pasta, rice, potatoesDiscard
Pasta salads with mayonnaise or vinaigretteDiscard
Fresh pastaDiscard
CheesecakeDiscard
Breakfast foods –waffles, pancakes, bagelsSafe
PIES, PASTRYPastries, cream filledDiscard
Pies – custard, cheese filled, or chiffon; quicheDiscard
Pies, fruitSafe
VEGETABLESFresh mushrooms, herbs, spicesSafe
Greens, pre-cut, pre-washed, packagedDiscard
Vegetables, rawSafe
Vegetables, cooked; tofuDiscard
Vegetable juice, openedDiscard
Baked potatoesDiscard
Commercial garlic in oilDiscard
Potato saladDiscard
Casseroles, soups, stewsDiscard

Foodsafety.gov

Tuesday, January 25, 2011

Patients Oppose Prescription Mandate for OTC Medicines (Cold, Flu, Asthma Allergy) Containing Pseudoephedrine

(Washington, DC – January 24, 2011) More than 300 million Americans get the common cold, and up to 70 million get the flu annually. But for the 60 million people who also have asthma and allergies, a cold or flu can pose even greater risks. Together, these respiratory diseases take a devastating toll on public health, costing billions of dollars in direct medical expenses, reducing quality of life, lowering workplace and school performance, and can even be life-threatening to high-risk populations, such as asthma patients.
While over 16 million children and adults in the U.S. depend on over-the-counter (OTC) medicines containing pseudoephedrine (PSE) for relief and care, direct and immediate access to these medications is being threatened by some states looking at requiring prescriptions for them. Although alternatives exist for some, OTC medicines containing PSE are the only oral decongestants available for 12- and 24- hour relief, and for many, these medicines are the only oral decongestants that work for them. Without timely access to these OTC options, negative health consequences could result for many patients.
Regrettably, some criminals divert PSE-containing medicines to illegally manufacture methamphetamine. In response, a small number of states and cities have suggested these OTC medications be made “prescription only,” but patients and doctors are beginning to speak up to let policy makers know that this is not the right solution.
Strong Opposition to “Prescription-Only” Measures
In a recent survey by the Asthma and Allergy Foundation of America (AAFA) (www.aafa.org/pse), researchers found that seven in ten asthma, allergy, cold, cough and flu sufferers who purchased non-prescription medicine for their condition (71%) oppose “prescription-only” laws.
“Taking away patient freedom by requiring prescriptions for important over-the-counter medications is not a solution to the meth problem,” says Mike Tringale, Vice President of External Affairs at AAFA. “Based on our recent survey of allergy, asthma, cold, cough and flu patients, we recognize that timely access to these medicines is critical for people. In fact, prescription medication abuse itself is a bigger problem than ever, and continues to rise, which proves that we need to find better law-enforcement strategies for this.”
AAFA’s study, conducted online among more than 2,006 asthma, allergy, cold, cough, and flu sufferers who purchased non-prescription medicine for their condition by Harris Interactive and supported by a grant from the Consumer Healthcare Products Association (CHPA), provides a major indication that patients would like to see lawmakers consider alternate measures that don’t force a prescription mandate on the millions of law-abiding patients who rely on these OTC medicines.
E-Tracking Succeeds Where Log Books Fail
Since 2006, consumers purchasing OTC medicines with PSE have been asked to sign log books at pharmacies, but enforcement of this policy, monitoring of logs, and manually tracking purchases has been inconsistent and unreliable with deadly consequences: the meth problem continues to rise in many states. The challenge: everyone wants to end the illegal drug problem, so how can we stop meth without limiting patient access to the critical medications they need?
According to the findings in AAFA’s survey, patients feel strongly that there are smarter, more effective solutions to controlling the manufacture of meth than moving common OTC medications to prescription status. In fact, another key finding showed that two-thirds of respondents (66%) would support a law for nationwide electronic tracking (e-tracking) of medication purchases, and 64% would prefer an e-tracking law, rather than requiring a doctor’s prescription, to track and block sales of pseudoephedrine that go over the legal limit – a system that is already working in more than a dozen states.
When faced with the choice, 63% of asthma, allergy, cold, cough and flu sufferers said they agree the implementation of e-tracking would be the most effective way of preventing medication sales for illegal uses without penalizing those who truly need them. Only 18% say they agree that a doctor’s prescription would be the most effective way.
New, smart technology is the best way to fight illegal methamphetamines,” according to Chris Ward, a lifetime asthma patient, Past-President of AAFA’s national Board of Directors and a career professional in the technology and life-science industry. “Using a multi-state electronic blocking technology can be an effective tool to catch criminals while still preserving access to these medicines, and not over-burdening physicians with more prescribing decisions,” says Ward.
Among the chief reasons patients in the survey prefer e-tracking include:
• It is more effective and less burdensome than requiring prescriptions (66% support);
• It doesn’t infringe on law-abiding citizens who want easy and immediate access to the OTC meds they need (49% oppose a prescription requirement for this reason);
• E-tracking builds on the existing framework and law enforcement in states and regions (65% support);
• It can be updated in real-time (59% support); and,
• Health records remain private and protected (65% support).
AAFA has posted the survey report online for the public and policymakers at www.aafa.org/pse so people can learn what to do in their own states to fight meth while also preserving access to OTC medications.
“Patients are really concerned about extreme local laws that limit their freedom to access meds,” says Tringale, “and AAFA is working with patients nationwide to teach lawmakers about solutions like e-tracking. We want to ensure that any policy decision to prevent the illegal sale of these medicines takes into account the voices of patients.” 
About the Survey
AAFA’s National Pseudoephedrine (PSE) Awareness Study was conducted online in July 2010 among more than 2,000 U.S. adults age 18+ who personally suffered from asthma, allergies, cold, cough or flu in the preceding 12 months and purchased non-prescription medications for at least one condition during that time. Survey participants were asked more than 40 questions each. Nearly two-thirds (62%) of respondents are employed, more than half (57%) are female, nearly half (42%) are married and one-quarter (24%) have a child in the household. The study was conducted online and used Harris Interactive’s proprietary propensity weighting to ensure the online sample reflects general population trends. For a full copy of the survey report, and to learn what you can do in your state to fight meth and preserve access to OTC medications, visit www.aafa.org/pse.
About AAFA
The Asthma and Allergy Foundation of America (AAFA), a not-for-profit organization founded in 1953, is the leading patient organization for people with asthma, allergies and related conditions. AAFA is dedicated to improving the quality of life for patients through education, advocacy and research. AAFA provides practical information, community based services and support through a network of regional chapters, support groups and other local partners around the United States. For more information, visit www.aafa.org.

Monday, January 24, 2011

Viibryd Approved To Treat Major Depressive Disorder

Clinical Data, Inc. (NASDAQ: CLDA), and FDA announced today that  Viibryd has been approved for treating major depressive disorder (MDD). The Food And Drug Administration, FDA has approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder (MDD) in adults. Major Depression, the other term for Major Depressive Disorder, interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities.
“Major depressive disorder is disabling and prevents a person from functioning normally, Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.” according to Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
"When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient, Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile." said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego.

Viibryd was demonstrated to be safe in clinical studies. In the placebo-controlled, Phase III studies, the most commonly observed adverse reactions in Viibryd-treated patients were diarrhea, nausea, vomiting and insomnia. No single adverse event led to discontinuation of treatment in greater than 1% of patients. Overall, 7.1% of the patients who received Viibryd discontinued treatment due to an adverse reaction, compared to 3.2% of placebo-treated patients. Viibryd has not been associated with any clinically important changes in laboratory test parameters including liver function tests, ECG including QT interval, or vital signs. In addition, Viibryd had no effect on body weight as measured by mean change from baseline in the 8-week studies. Among the common adverse reactions (≥2%) related to sexual function with Viibryd compared to placebo were decreased libido (4% vs. <1%), abnormal orgasm (3% vs. 0%), delayed ejaculation (2% vs. 0%, males only), and erectile dysfunction (2% vs. 1%, males only).1


Viibryd (vilazodone hydrochloride) is manufactured by PGxHealth, New Haven, Conn.
Clinical Data, Inc. (NASDAQ: CLDA),


For Immediate Release: Jan. 21, 2011
Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Viibryd to treat major depressive disorder
The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.
Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.
Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.
“Major depressive disorder is disabling and prevents a person from functioning normally,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression.”
The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.
The drug will be available in 10, 20 and 40 milligram tablets.
Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.
The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.
Viibryd is manufactured by PGxHealth, New Haven, Conn.
For more information:
FDA: Antidepressant Use in Children, Adolescents, and Adults1
National Institute of Mental Health: Depression2

Saturday, January 22, 2011

What Is Chronic Obstructive Pulmonary Disease (COPD)?

Chronic Obstructive Pulmonary Disease (COPD) is a desease of the lungs that makes it hard for one to breathe. It is also a progressive disease, "Progressive" means the disease gets worse as time passes. 
Coughing up mucus is often the first sign of COPD. Chronic bronchitis and emphysema are common COPDs. The signs of wheezing, shortness of breath, chest tightness, and other symptoms. are indications od COPD or beginig of the disease.
Cigarette smoking is the most common cause of COPD. Breathing in other kinds of irritants, like pollution, dust or chemicals, may also cause or contribute to COPD.Quitting smoking is the best way to avoid developing COPD.
Air get in to lungs through small tubes called bronchial tubes or airways. Your airways branch out inside your lungs like an upside-down tree. Within the lungs, your bronchial tubes branch into thousands of smaller, thinner tubes called bronchioles. These tubes end in bunches of tiny round air sacs called alveoli (al-VEE-uhl-eye). In healthy people, both the airways and air sacs are springy and elastic. When you breathe in, each air sac fills with air like a small balloon. The balloon deflates when you exhale. Small blood vessels called capillaries run through the walls of the air sacs. When air reaches the air sacs, the oxygen in the air passes through the air sac walls into the blood in the capillaries. At the same time, carbon dioxide (a waste gas) moves from the capillaries into the air sacs. This process is called gas exchange.
If you have COPD, your airways and air sacs lose their shape and become floppy, like a stretched-out rubber band. The gas exchange become less and less as the disease progresses.
In COPD, less air flows in and out of the airways because of one or more of the following:
  • The airways and air sacs lose their elastic quality.
  • The walls between many of the air sacs are destroyed.
  • The walls of the airways become thick and inflamed.
  • The airways make more mucus than usual, which tends to clog them.
COPD is a major cause of disability, and it's the fourth leading cause of death in the United States. More than 12 million people are currently diagnosed with COPD. Many more people may have the disease and not even know it.
Treatment can make you more comfortable, but there is no cure. However, treatments and lifestyle changes can help you feel better, stay more active, and slow the progress of the disease.
NIH NHLBI: National Heart, Lung, and Blood Institute

Do Not Use Triad Alcohol Prep Pads Packaged With Bayer HealthCare Pharmaceuticals Betaseron.

Important Information for Betaseron® (interferon beta 1-b) Consumers 
Regarding Triad Group’s Alcohol Prep Products


Contact:
Rose Talarico, Bayer HealthCare, rose.talarico@bayer.com, (973) 305-5302
Rosemarie Yancosek, Bayer HealthCare, rosemarie.yancosek@bayer.com, (973) 305-5213
FOR IMMEDIATE RELEASE - Wayne, NJ, January 8, 2011 - Bayer HealthCare Pharmaceuticals has become aware of a broad United States market recall of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names.  In the interest of patient safety, Bayer wants to ensure that U.S. patients and physicians using Bayer’s Betaseron are aware of the Triad recall.   

The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria, Bacillus cereus, that could lead to life-threatening infections. 

Triad alcohol prep pads packaged for use in the U.S. with Betaseron should not be used by patients.  There is NO involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging.   This issue is confined to the actual Triad alcohol prep products.  Triad alcohol prep products are not used in Betaseron packaging outside of the United States.

Bayer instructs patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash.  When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol.  

Bayer is currently in the process of gathering additional information from both Triad and the U.S. Food and Drug Administration.  In the interim, Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad.  Bayer has posted this important information on its websites.    

Further information on this Triad recall can be found on the FDA website athttp://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm.  If you have additional questions, please consult with your pharmacist or healthcare provider or contact BETAPLUS at 1-800-788-1467 option 1 to speak to a BETA Nurse.  Or call Bayer at 1-888-84-BAYER, where operators will be available 24 hours a day to respond to questions from consumers or medical professionals.  Members of the media should call Rosemarie Yancosek at 973/305-5213 or Rose Talarico at 973/305-5302.

Bayer will provide additional information when it becomes available. 

BETASERON® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

IMPORTANT SAFETY INFORMATION
      • BETASERON should be used with caution in patients with depression.
      • Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites.
      • Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON.
      • BETASERON should be used with caution in patients with seizure disorders or cardiac disease.
      • Female patients should be warned about the potential risk to pregnancy.
      • Cases of anaphylaxis have been reported rarely.
      • The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), injection-site reaction, asthenia (general weakness), flu-like symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms.
    See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information available at www.betaseron.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.  For important risk and use information please see the full Prescribing Information available at www.betaseron.com.
    About Bayer HealthCare Pharmaceuticals Inc.  Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry.  Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Monday, January 10, 2011

University of Rhode Island Engineers Develop Lab-on-a-chip For Fast, Inexpensive Blood Tests That Also Might Come To Smartphones Soon

KINGSTON, R.I. – January 10, 2011 -- While most blood tests require shipping a vial of blood to a laboratory for analysis and waiting several days for the results, a new device invented by a team of engineers and students at the University of Rhode Island uses just a pinprick of blood in a portable device that provides results in less than 30 minutes.
"This development is a big step in point-of-care diagnostics, where testing can be performed in a clinic, in a doctor's office, or right at home," said Mohammad Faghri, URI professor of mechanical engineering and the lead researcher on the project. "No longer will patients have to wait anxiously for several days for their test results. They can have their blood tested when they walk into the doctor's office and the results will be ready before they leave."
With the new lab-on-a-chip technology, a drop of blood is placed on a plastic polymer cartridge smaller than a credit card and inserted into a shoebox-sized biosensor containing a miniature spectrometer and piezoelectric micro-pump. The blood travels through the cartridge in tiny channels 500 microns wide to a detection site where it reacts with preloaded reagents enabling the sensor to detect certain biomarkers of disease.
Several patents are pending on the invention.
Compared to similar devices in development elsewhere, the URI system is much smaller, more portable, requires a smaller blood sample, and is less expensive. While the sensor costs about $3,200, each test costs just $1.50, which is the cost for the plastic cartridge and reagents.
The first cartridges the researchers developed focus on the detection of C-reactive proteins (CRP) in the blood, a preferred method for helping doctors assess the risk of cardiovascular and peripheral vascular diseases. From 2002 to 2004 (the only years for which data are available), the number of CRP tests paid for by Medicare tripled from 145,000 to 454,000, and it is estimated that those numbers have quadrupled since then.
Faghri said that additional cartridges can be designed to detect biomarkers of other diseases. The researchers are already working to engineer the device to detect levels of the beta amyloid protein that can be used as a predictor of Alzheimer's disease. The device can also be engineered to detect virulent pathogens, including HIV, hepatitis B and H1N1 (swine) flu.
The next generation of the device will incorporate a hand-held sensor that will reduce manufacturing costs. Faghri also envisions a further miniaturization of the invention that can be adapted as a smartphone application. By embedding the biosensor in the cartridge and using the computer power of the phone, as well as its wireless communication capabilities, Faghri believes that patients may be able to conduct the tests themselves and have the results transmitted immediately to their doctor's office via their phone. Among many other benefits, this should help to significantly reduce health care costs.
"We are already making progress on many of the steps toward the next generation of the system, and it won't be long before we can begin to commercialize it," Faghri said.
###
In addition to Faghri, the research team includes URI Adjunct Professor Constantine Anagnostopoulos, Postdoctoral Associate Assem Abolmaaty, graduate students Peng Li, Kelly Cook, Jeremy Cogswell, John Jones, Michael Godfrin, Alex Pytka, Assad Akinfolarin, Hong Chen and Toru Yamada, and undergraduate students Admir Monteiro and Nick DiFillipo, as well as Research Associate Stefanie Demming from the Technical Institute of Braunschweig, Germany.
Primary funding for the project was provided by the National Science Foundation through its Partnership for International Research and Education Program.

Thursday, January 06, 2011

Does Vaccines Cause Autism?

Yes and no. I am not convinced of either but if I had a child, I think I will let him or her take the risk and give the vaccines. My parents gave me all the vaccines and I am functional, at least I hope.
But I enjoyed reading an article on Harvard Health by Ann MacDonald, Editor, Harvard Mental Health Letter. You can read it too and form your own opinion. The article focuses on what British journalist Brian Deer uncovered. The arguments continue on the subject.
Harvard Health

Wednesday, January 05, 2011

Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation Submitted To FDA For Approval

Johnson and Johnson Pharmaceuticals and Development LLC has filed a new drug application for  Rivaroxaban which is aiming to Prevent Stroke in Patients with Atrial Fibrillation.

RARITAN, N.J.--(BUSINESS WIRE)--Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).

The submission is supported by data from the pivotal, global Phase 3 ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial.

AF is the most common sustained cardiac rhythm disorder, affecting more than 2.3 million people in the U.S. In patients with AF, the heart’s irregular beat makes them vulnerable to the formation of blood clots in the atria, which can travel to the brain, potentially resulting in a stroke. Strokes can lead to major physical and behavioral impairments, or even death. People living with AF are at a five-fold increased risk for stroke compared with the general population, and almost one-third will suffer from a stroke in their lifetimes.

J&JPRD also announced today that it has submitted its complete response to the FDA seeking approval to use rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total hip or total knee replacement surgery. The submission includes specific information requested by the FDA in a complete response letter issued to J&JPRD on May 28, 2009, and is primarily supported by data from the pivotal, global Phase 3 RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program.

More information about the rivaroxaban clinical development program, and the diseases for which it is being developed, may be accessed at http://www.jnjpharmarnd.com/jnjpharmarnd/rivaroxaban.html.

About Rivaroxaban

Rivaroxaban is a novel oral anticoagulant being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. In clinical studies, the compound has shown no requirement for routine laboratory coagulation monitoring, and limited risk for food and drug interactions. The extensive program of clinical trials evaluating this compound makes rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which is part of the Johnson & Johnson Family of Companies, and Bayer HealthCare AG.

Tuesday, January 04, 2011

Treatment For Dry Age-Related Macular Degeneration Using Embryonic Stem Cells Cleared By FDA To Begin Phase I/II Clinical Trials.

Advanced Cell Technology, Inc. announced today the company’s Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) has been approved by FDA. Advanced Cell Technology, Inc now has permission  to begin a Phase I/II multicenter clinical trial to treat patients with Dry Age-Related Macular Degeneration. AMD is the most common form of macular degeneration, afflicting between 10-15 million Americans alone and currently no treatments available for this prevalent disease among the aging. As well as providing a medical solution for patients, economically treatment of Dry Age-Related Macular Degeneration, represents a substantial global market opportunity.

Following is the press release;

MARLBOROUGH, MA – January 3, 2011. Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). ACT is now permitted to initiate a Phase I/II multicenter clinical trial to treat patients with Dry AMD, the most common form of macular degeneration in the world. There are currently no treatments available for this prevalent disease of an aging global population. Dry AMD, representing a substantial global market opportunity and afflicts between 10-15 million Americans.

Age-Related Macular Degeneration has two predominant forms, wet and dry. Dry AMD is the most common form, accounting for almost 90% of all cases. The progress of Dry AMD includes a breakdown or thinning of the layer of RPE cells in the patient’s macula, the region at the center of the retina responsible for high acuity vision. Over time, the progressive loss of RPE cells and accompanying loss of photoreceptors can cause severe vision loss and even blindness.

“ACT is now the first company to receive FDA clearance for two hESC trials, and is now a true translational leader in the field of regenerative medicine,” said Gary Rabin, Interim Chairman and CEO of ACT. “It marks a major step forward, not just within the stem cell sector, but, potentially for modern healthcare techniques. We plan to proceed into the clinic with both of our hESC-based programs as quickly as possible. .”

The Phase I/II trial will be a prospective, open-label study that is designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with Dry AMD. Twelve patients will be enrolled in the study at multiple clinical sites. Sites currently under consideration are the Jules Stein Eye Institute at UCLA, and the Ophthalmology Department at Stanford University School of Medicine. Additional sites may be considered.

“Dry AMD is the leading cause of blindness in individuals over the age of 55,” stated Robert Lanza, MD, ACT’s Chief Scientific Officer. “As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need. Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells. Because only a small number of cells (50-200K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well. Based on our animal model studies, we are very excited about the opportunity to treat patients. In a rat model of macular degeneration, we have seen a remarkable improvement in visual performance over untreated animals, without any adverse effects. We have also maintained near-normal function in a mouse model of Stargardt’s Disease, a form of juvenile macular degeneration. In addition to this trial, we plan to concurrently use our RPE cells in our Phase I/II Clinical Trial for Stargardt’s Disease, which received the green light from the FDA in November. We hope to see a similar benefit in both Stargardt’s Disease and Dry AMD patients.”

ACT’s Dry AMD therapeutic program uses RPE cells derived from hESCs to replace the lost RPE cells in the patient’s eyes. ACT’s proprietary RPE cell manufacturing process is protected by a number of broad patents, as is the use of hESC-derived RPE cells for treating macular degeneration. While the initial portion of the clinical trial will focus on safety, in subsequent clinical trials the Company hopes to demonstrate that the RPE cells injected into the retinal space will be capable of slowing or halting progression of the disease, and potentially even restoring some visual acuity to patients.

“It is estimated that over ten million Europeans suffer from Age-Related Macular Degeneration, representing a vast unmet need and a significant market opportunity,” commented Edmund Mickunas, ACT’s Vice President of Regulatory Affairs. “We are moving ahead aggressively to seek regulatory clearance from the European Medicines Agency to conduct clinical trials in Europe.”

Specific inclusion and exclusion requirements and Investigator contact information will be posted shortly at clinicaltrials.gov. Patients and their caregivers should refer to this source rather than contacting ACT or its representatives.

Monday, January 03, 2011

Recallr: FDA posts Warning Letter To vanderveercenter.com For False Or Misleading Claims Of Lipodissolve Products.

Recallr: FDA posts Warning Letter To vanderveercenter.com For False Or Misleading Claims Of Lipodissolve Products.

Absolute Humidity Governs Seasonal Flu Patterns In Winter!

With all the theories about why flu spread widely in winter, from weak immune systems to cooping up together in chilly weather, a scientific answer seem to be emerging.
It has been long known that the Flu Survival and Flu Transmission is related to humidity. It seems now that the lesser the humidity, absolute humidity, leading to lesser water vapors in the air, flu thrives. The relative humidity is a ever changing number which depends on the temperature has been an unreliable indicator for providing data for the study of flu.
National Institute of Health, NIH, supported disease modeling research team analyzed 30 years of flu and weather data and built a computer model that showed the patterns of how the seasonal flu spread.
Using absolute humidity, "we found that we could reproduce the seasonal cycle of influenza very nicely in basically the whole country. The flu virus survived longer and transmitted more easily from person to person in the low absolute humidity typical of U.S. winters. It didn't live as long and had more trouble transmitting in the high absolute humidity typical of summers " says Oregon State University climatologist Jeffrey Shaman one of the people who led the research team.
But just using humidifiers will not prevent people from getting flu, unless there is a humidifier large enough to humidify the whole continent, but then it might turn into a giant snow machine.
So the best prevention against flu is vaccination!

Novartis Invests $500 Million In Russian Pharmaceutical Manufacturing And Other Related Fields.

While a $500 million infusion to facebook has driven facebook to have a $50 Billion valuation, Novartis seem to be quietly approaching Russia with a similar amount of investment but the valuation has not jumped that much, if at all.
On the other hand Novartis investment is spread over five years and the first part of the investment project, Novartis has signed an agreement to build a pharmaceutical manufacturing facility in St. Petersburg, Russia. Other parts include infrastructure, health care initiatives, and R&D in Russia over the next five years. The  facility to be constructed this year will house technology for both generic and innovative pharmaceuticals. 
“This collaboration shows our commitment to contributing to the ambitious health care goals of the Russian government,” Novartis CEO Joseph Jimenez says.
Novartis says it will also invest in research collaborations  and may license Novartis compounds to qualifying Russian companies and license compounds from Russian scientists and universities which have developed compounds and solutions. Novartis aims to double its investment in drug development and clinical trials in Russia, joining Russian Prime Minister Vladimir Putin in pharmaceutical development in Russia. The Prime Minister pledged a $4 billion in federal funding for pharmaceutical industry development over the next 10 years. The Russian government wants 90% of Russia’s “essential medicines”, to be produced locally by 2020.

Saturday, January 01, 2011

Happy and Healthy 2011 For All Of You!

Thank you everyone and I wish you all to be happy and and to be in excellent health. Finally this year the Meddesktop.com seem like coming alive, we will be focusing on Oncology (Cancer) related matters first as we expand the horizon with projects such as Oncowikia and OncoSemantic.
May all you be awesome this year.

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