Consumer Warning on Serrano Peppers from Mexico

FDA has extended it's warning on Serrano peppers from Mexico.
Recallr: Consumer Warning on Serrano Peppers from Mexico Extended By FDA.

Tags: FDA Warning, food poison, Serrano Peppers from Mexico, Salmonella Saintpaul

California Bans Trans Fats, State Wide.

Governor Arnold Schwarzenegger today signed AB 97 by Assemblymember Tony Mendoza (D-Norwalk), which will phase out the use of trans fats in all California restaurants beginning in 2010 and from all baked goods by 2011.

"California is a leader in promoting health and nutrition, and I am pleased to continue that tradition by being the first state in the nation to phase out trans fats," Governor Schwarzenegger said. "Consuming trans fat is linked to coronary heart disease, and today we are taking a strong step toward creating a healthier future for California."

Scientific evidence demonstrates a strong association between the consumption of artificial trans fat and the development of coronary heart disease and stroke, as well as other chronic conditions such as diabetes. According to the New England Journal of Medicine, eliminating artificial trans fats from the food supply could prevent between six and 19 percent of heart attacks and related deaths each year. Coronary heart disease is California's leading cause of death, and AB 97 will be a strong step toward removing this harmful substance from the foods that Californians purchase and consume.

The Governor's leadership has put in place some of the nation's most innovative and successful strategies to promote health and nutrition. The Governor has:

• Established the toughest school nutrition reforms in the nation, taking junk food and sugary sodas off our campuses.
• Banned trans fat and food fried in unhealthy oils in school meals.
• Invested millions of dollars in fresh fruits and vegetables in school meals.
• Adopted the first-ever physical education standards.
• Convened a Summit on Health, Nutrition and Obesity where leaders of public and private sector organizations made significant commitments to change core business practices to help achieve a healthier California.
• Reinvigorated the Governor's Council on Physical Fitness and Sports, which focuses on rewarding positive leadership in implementing healthy living in youth.
• Proposed a comprehensive health care reform plan that emphasizes prevention and wellness.

Trans fat is linked to the following health issues:

• Trans fat increases the risk of developing coronary heart disease - the leading cause of death in the U.S. "Like saturated fat, trans fat also raises the low density lipoprotein (LDL or "bad") cholesterol in the blood. But, unlike saturated fat, trans fat lowers high density lipoprotein (HDL or "good") cholesterol in the blood. An elevated LDL cholesterol increases the risk of developing coronary heart disease." (U.S. FDA: Center for Food Safety and Applied Nutrition, "Questions and Answers about Trans Fat Nutrition Labeling," Press Release, 1/1/06)
• University of Maryland research suggests that kids who consume trans fats early on will develop heart disease sooner. "Children who start at age three or four eating a steady diet of fast food, pop tarts, commercially prepared fish sticks, stick margarine, cake, candy, cookies and microwave popcorn can be expected to get heart disease earlier than kids who are eating foods without trans fats... Some of our research here at the University of Maryland has shown that kids as young as eight, nine and 10 already have the high cholesterol and blood fats that clog arteries. By starting healthy eating habits early, parents can help their children avoid heart attacks and stroke." (Mary Beth Sodus, "Trans Fats 101," University of Maryland Medical Center)
• According to the American Heart Association, trans fat should make up less than one percent of calories for Americans over two. "Another major change in the dietary recommendations is a lower goal for saturated fat - from less than 10 percent to less than seven percent - and establishing a goal for trans fatty acids of less than one percent of total calories." (American Heart Association, "Association releases new diet and lifestyle recommendations," Press Release, 6/19/06)

Tags: california healthcare, Trans Fat Ban, California restaurants

Are You Storing Food Correctly?

Are you storing food correctly? Just by following simple directions, you can keep you and your family healthy.
The document below contains;

• Storage Basics
• Refrigeration Tips
• Freezer Facts
• If You Lose Electricity
• Tips for Non-Refrigerated Items

Whether putting food in the refrigerator, the freezer, or the cupboard, you have plenty of opportunities to prevent foodborne illnesses.

The goal is to keep yourself and others from being sickened by microorganisms such as Salmonella, E. coli O157:H7, and C. botulinum, which causes botulism. Keeping foods chilled at proper temperatures is one of the best ways to prevent or slow the growth of these bacteria.

These food storage tips can help you steer clear of foodborne illnesses.

Download the PDF document by clicking on the image below!.

Tags: Salmonella, E. coli O157:H7, C. botulinum, botulism, Food Facts, Food Safety, Food Storage

Xiadafil VIP Tablets Seized By Federal Authorities After SEI Pharmaceuticals Refuses to Recall The Product.

FOR IMMEDIATE RELEASE July 24, 2008

Media Inquiries: Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
Product contains undeclared ingredient that could harm consumers

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

Today's action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.

The FDA's chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.

"Today's seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers," said Margaret O'K Glavin, associate commissioner of the FDA's Office of Regulatory Affairs. "FDA will not tolerate a company's failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so," she added.

On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA's findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.

On May 13, 2008, Florida state officials issued a "stop sale" action at SEI's distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.

ED is a common problem in men who have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Furthermore, because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.

Consumers should discontinue the use of Xiadafil VIP tablets immediately and consult their health care professional if they have experienced adverse events that they believe may be related to the use of this product.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Tags: SEI Pharmaceuticals Recall, Xiadafil VIP Tablets Recall, FDA Action, FDA Seizure, erectile dysfunction

Boost Weight Loss By Limiting Fructose

DALLAS – July 24, 2008 – One of the reasons people on low-carbohydrate diets may lose weight is that they reduce their intake of fructose, a type of sugar that can be made into body fat quickly, according to a researcher at UT Southwestern Medical Center.

Dr. Elizabeth Parks, associate professor of clinical nutrition and lead author of a study appearing in a current issue of the Journal of Nutrition, said her team's findings suggest that the right type of carbohydrates a person eats may be just as important in weight control as the number of calories a person eats.

Current health guidelines suggest that limiting processed carbohydrates, many of which contain high-fructose corn syrup, may help prevent weight gain, and the new data on fructose clearly support this recommendation.

"Our study shows for the first time the surprising speed with which humans make body fat from fructose," Dr. Parks said. Fructose, glucose and sucrose, which is a mixture of fructose and glucose, are all forms of sugar but are metabolized differently.

"All three can be made into triglycerides, a form of body fat; however, once you start the process of fat synthesis from fructose, it's hard to slow it down," she said.

In humans, triglycerides are predominantly formed in the liver, which acts like a traffic cop to coordinate the use of dietary sugars. It is the liver's job, when it encounters glucose, to decide whether the body needs to store the glucose as glycogen, burn it for energy or turn the glucose into triglycerides. When there's a lot of glucose to process, it is put aside to process later.

Fructose, on the other hand, enters this metabolic pathway downstream, bypassing the traffic cop and flooding the metabolic pathway.

"It's basically sneaking into the rock concert through the fence," Dr. Parks said. "It's a less-controlled movement of fructose through these pathways that causes it to contribute to greater triglyceride synthesis. The bottom line of this study is that fructose very quickly gets made into fat in the body."

Though fructose, a monosaccharide, or simple sugar, is naturally found in high levels in fruit, it is also added to many processed foods. Fructose is perhaps best known for its presence in the sweetener called high-fructose corn syrup or HFCS, which is typically 55 percent fructose and 45 percent glucose, similar to the mix that can be found in fruits. It has become the preferred sweetener for many food manufacturers because it is generally cheaper, sweeter and easier to blend into beverages than table sugar.

For the study, six healthy individuals performed three different tests in which they had to consume a fruit drink formulation. In one test, the breakfast drink was 100 percent glucose, similar to the liquid doctors give patients to test for diabetes – the oral glucose tolerance test. In the second test, they drank half glucose and half fructose, and in the third, they drank 25 percent glucose and 75 percent fructose. The tests were random and blinded, and the subjects ate a regular lunch about four hours later.

The researchers found that lipogenesis, the process by which sugars are turned into body fat, increased significantly when as little as half the glucose was replaced with fructose. Fructose given at breakfast also changed the way the body handled the food eaten at lunch. After fructose consumption, the liver increased the storage of lunch fats that might have been used for other purposes.

"The message from this study is powerful because body fat synthesis was measured immediately after the sweet drinks were consumed," Dr. Parks said. "The carbohydrates came into the body as sugars, the liver took the molecules apart like tinker toys, and put them back together to build fats. All this happened within four hours after the fructose drink. As a result, when the next meal was eaten, the lunch fat was more likely to be stored than burned.

"This is an underestimate of the effect of fructose because these individuals consumed the drinks while fasting and because the subjects were healthy, lean and could presumably process the fructose pretty quickly. Fat synthesis from sugars may be worse in people who are overweight or obese because this process may be already revved up."

Dr. Parks said that people trying to lose weight shouldn't eliminate fruit from their diets but that limiting processed foods containing the sugar may help.

"There are lots of people out there who want to demonize fructose as the cause of the obesity epidemic," she said. "I think it may be a contributor, but it's not the only problem. Americans are eating too many calories for their activity level. We're overeating fat, we're overeating protein; and we're overeating all sugars."

Contact: Kristen Holland Shear
kristen.hollandshear@utsouthwestern.edu
214-648-3404
UT Southwestern Medical Center

Tags: Weight Control, weight loss, fructose in body weight, clinical nutrition, fat synthesis from fructose, fat synthesis, glycogen, lipogenesis

Virtual Patients And Student Dentists In Second Life.

A virtual toothache helps student dentists

Masha is a dental patient. Her oral health problems continue to change as she meets new Case Western Reserve University student dentists in Second Life's virtual dental office.

The middle-aged avatar is an integral part of a new research project of the Case Western Reserve University School of Dental Medicine and the College of Arts and Sciences department of communication sciences to teach and give students practice time to communicate with mock patients.

Not only do findings from the study have potential to revolutionize dental education but also to change the way national testing is done for patient-side communication skills.

Kristin Z. Victoroff from the dental medicine's department of community dentistry will direct the three-year Innovative Dental Assessment Research and Development (IDEA) Grant project from the American Dental Association's Joint Commission on National Dental Examinations. She will develop patient communication scenarios for simulated education and test their effectiveness in preclinical training for students.

"More dental schools are experimenting with simulation as a way to teach," said Victoroff. She is joined in the research project by Roma Jasinevicius and Catherine Demko from the dental school faculty in testing and implementing simulations in dental education at the university.

Since 2001, the Case Western Reserve dental school has been on the forefront in using simulations in teaching the physical dexterity skills by using a technology called DentSim (http://www.denx.com/). DentSim is a simulated and computerized training system that uses a simulated dental patient. The school's use of the technology in dental education was spearheaded by Jasinevicius.

From that technology, the attention turned to developing what Victoroff's describes simulated experiences for the "softer" skills of dental medicine—communicating with patients.

Victoroff enlisted virtual reality experts and Art and Sciences' communication disorder scientists Stacy Williams, who directs the Virtual Immersion Center for Simulation Research (VICSR), and Kyra Rothenberg, director of the health communications minor.

They will take three approaches to simulated communications training—live actors, the immersion theater where students interact with a virtual patient in a 180-degree surround theater and with avatars, like Masha, in Second Life.

Of the three simulation methods, Victoroff is interested in using the immersion theater and Second Life. She noted that paper-based, live actors and real patients present limitations from ethical issues to logistical challenges. Meanwhile, the interactive theater and Second Life have capabilities to assess competencies in a convenient, standardized and cost-effective situation.

According to Victoroff, if successful, the virtual scenarios in an immersion theater setting or the online Second Life community might provide a potentially better way of assessing a student's abilities to communicate with patients than the current multiple-choice questions on the national examinations required for practicing professionally.

During spring semester, 70 students in the third-year dental class participated in a pilot study to develop their communication skills with live actors and virtual patients during communication skills training at the Mt. Sinai Skills and Simulation Center at the Veterans Administration Hospital.

The research project focuses on developing scenarios that aid and test students in taking patient histories, providing oral health education like tobacco cessation counseling for smokers, explaining procedures, talking about healthcare options and obtaining informed consent, and working through situations that present ethical dilemmas. These are among the competencies outlined by the American Dental Education Association.

Along with communication sciences students, the use of the virtual reality theater by dental students will advance the researchers understanding in how this technology can be applied to teaching and assessing students in different disciplines. The dental students will use a portable 50-inch LCD panel instead of the larger fixed 180-degree theater. In real time, the students interact and communicate with Masha.

"Ideally it is not that we are out to prove that virtual worlds or the VICSR system is better than standard instruction, but that they are of equal value," said Williams, adding that students should be able to walk away learning the same types of knowledge they can learn from working with live patients.

Students are very accepting of the VICR environment and put a lot of reflection in their voices when they are talking to the animated characters, said Williams.

Rothenberg will piece together students' motivations and perceptions when using this technology for their education.

According to Rothenberg who works in health communications, VICSR is already showing positive results from communication science students and patients using the virtual theater for their education and speech therapy.

"Virtual patients have much to offer in training healthcare providers, and it is equally important to explore how interactive virtual reality technology can enhance assessment of competency," said Victoroff.

Case Western Reserve University is among the nation's leading research institutions. Founded in 1826 and shaped by the unique merger of the Case Institute of Technology and Western Reserve University, Case is distinguished by its strengths in education, research, service, and experiential learning. Located in Cleveland, Case offers nationally recognized programs in the Arts and Sciences, Dental Medicine, Engineering, Law, Management, Medicine, Nursing, and Social Work. http://www.case.edu.

Contact: Susan Griffith
susan.griffith@case.edu
216-368-1004
Case Western Reserve University

Tags: Medical Training, Virtual Medicine, Second Life, Dental Assessment Research and Development, dental education

Cranberry Juice Keeps Bacteria Away From Cells By Creating An Energy Barrier.

Results help explain how cranberry juice can prevent urinary tract infections

WORCESTER, Mass. – For generations, people have consumed cranberry juice, convinced of its power to ward off urinary tract infections, though the exact mechanism of its action has not been well understood. A new study by researchers at Worcester Polytechnic Institute (WPI) reveals that the juice changes the thermodynamic properties of bacteria in the urinary tract, creating an energy barrier that prevents the microorganisms from getting close enough to latch onto cells and initiate an infection.

The study, published in the journal Colloids and Surfaces: B, was conducted by Terri Camesano, associate professor of chemical engineering at WPI, and a team of graduate students, including PhD candidate Yatao Liu. They exposed two varieties of E. coli bacteria, one with hair-like projections known as fimbriae and one without, to different concentrations of cranberry juice. Fimbriae are present on a number of virulent bacteria, including those that cause urinary tract infections, and are believed to be used by bacteria to form strong bonds with cells.

For the fimbriaed bacteria, they found that even at low concentrations, cranberry juice altered two properties that serve as indicators of the ability of bacteria to attach to cells. The first factor is called Gibbs free energy of attachment, which is a measure of the amount of energy that must be expended before a bacterium can attach to a cell. Without cranberry juice, this value was a negative number, indicating that energy would be released and attachment was highly likely. With cranberry juice the number was positive and it grew steadily as the concentration of juice increased, making attachment to urinary tract cells increasingly unlikely.

Surface free energy also rose, suggesting that the presence of cranberry juice creates an energy barrier that repels the bacteria. The researchers also placed the bacteria and urinary tract cells together in solution. Without cranberry juice, the fimbriaed bacteria attached readily to the cells. As increasing concentrations of cranberry juice were added to the solution, fewer and fewer attachments were observed.

Cranberry juice had no discernible effect on E. coli bacteria without fimbriae, suggesting that compounds in the juice may act directly on the molecular structure of the fimbriae themselves. This reinforces previous work by the WPI team that showed that exposure to cranberry juice alters the shape of the fimbriae, causing them to become compressed. Using an atomic force microscope as a minute strain gauge, the team also showed that the adhesive force exerted by bacteria on urinary tract cells declined in direct proportion to the concentration of cranberry juice in the solution.

"Our results show that, at least for urinary tract infections, cranberry juice targets the right bacteria—those that cause disease—but has no effect on non-pathogenic organisms, suggesting that cranberry juice will not disrupt bacteria that are part of the normal flora in the gut," Camesano says. "We have also shown that this effect occurs at concentrations of cranberry juice that are comparable to levels we would expect to find in the urinary tract."

Camesano notes that unpublished work has shown that while cranberry juice has potent effects on disease-causing bacteria, those effects are transitory. "When we takes E. coli. bacteria that have been treated with cranberry juice and place them in normal growth media, they regain the ability to adhere to urinary tract cells," she says. "This suggests that to realize the antibacterial benefits of cranberry, one must consume cranberry juice regularly—perhaps daily."

For those watching calories, Camesano says other recent work in her lab has shown that the effects of regular cranberry juice cocktail and diet (sugar-free) cranberry juice are identical. "That's good news for people who do not like to consume a lot of sugary juice," she says.

###

About Worcester Polytechnic Institute

Founded in 1865 in Worcester, Mass., WPI was one of the nation's first engineering and technology universities. WPI's 18 academic departments offer more than 50 undergraduate and graduate degree programs in science, engineering, technology, management, the social sciences, and the humanities and arts, leading to the BA, BS, MS, ME, MBA and PhD. WPI's world-class faculty work with students in a number of cutting-edge research areas, leading to breakthroughs and innovations in such fields as biotechnology, fuel cells, and information security, materials processing, and nanotechnology. Students also have the opportunity to make a difference to communities and organizations around the world through the university's innovative Global Perspective Program. There are more than 20 WPI project centers throughout North America and Central America, Africa, Australia, Asia, and Europe.

Contact: Michael Dorsey
mwdorsey@wpi.edu
508-831-5609
Worcester Polytechnic Institute

Tags: Medical Research, urinary tract infections, cranberry juice, Worcester Polytechnic Institute, Gibbs free energy

"Circulation: Cardiovascular Quality and Outcomes" Fifth New Journal By American Heart Association Will Launch In September, 2008

American Heart Association Set To Launch Fifth New Journal
DALLAS, July 17 - Reflecting the growing emphasis on evidence-based cardiology practice, the American Heart Association has announced a September premier for Circulation: Cardiovascular Quality and Outcomes. The journal -- the fifth in a series of six new titles to appear under the banner of Circulation: Journal of the American Heart Association -- will be published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.
"Our journal will be a catalyst for turning outstanding science into actions that will improve health and healthcare," said Harlan M. Krumholz, M.D., S.M., who has been named editor of the new journal. Krumholz is Harold H. Hines, Jr. professor of medicine and epidemiology and public health at Yale University and director of the Center for Outcomes Research and Evaluation at Yale-New Haven Hospital.
Circulation: Cardiovascular Quality and Outcomes arrives at a time when cardiologists are increasingly challenged to translate new scientific knowledge into meaningful advances in patient care and clinical outcomes, according to Krumholz.
"As a profession we are manifesting remarkable advances in our ability to prevent and treat cardiovascular disease and yet we see marked gaps in our ability to provide safe, effective, efficient, equitable, timely and patient-centered care," Krumholz said. "There is a need for scholarship to promote improvements in cardiovascular health and healthcare, focusing on the end results of our efforts."
The core of Circulation: Cardiovascular Quality and Outcomes will be original research studies that span the spectrum of cardiovascular outcomes research. The journal will also present papers focusing on methodology, including new measurement tools and analytic approaches. "Our journal will be multidisciplinary in its orientation and will welcome contributions that bring into focus the methods of a wide range of fields as they apply to outcomes research," Krumholz said.
Other features will include case reports focusing on local innovations from practitioners, commentaries on clinical practice and policy, "primers" on statistical interpretation or methods, and "MMWR-style" rapid data reports. Online extras will include special data supplements, as well as the opportunity for readers to submit "E-Letters" in response to published articles.
"I am very pleased with the release of the latest in our new line of subspecialty journals, and with its new editor, Dr. Harlan Krumholz," said Joseph Loscalzo, M.D., Editor-in-Chief of Circulation and the Circulation portfolio of journals. "With his leadership, this journal is poised to become a leading voice in the cardiovascular outcomes community."
The editors are actively seeking new research studies and other manuscripts for consideration for Circulation: Cardiovascular Quality and Outcomes. "Quantitative, qualitative, mixed methods, economic and health policy research, among others, will be welcome," Krumholz said. "To be competitive for publication, the research questions must be strong and consequential and the methods and writing should be outstanding."
Information on submitting a manuscript can be found at http://circ.ahajournals.org/misc/ifora_outcomes.shtml.
Like the previous titles in the Circulation portfolio of journals, Circulation: Cardiovascular Quality and Outcomes addresses the need for tightly focused information at the cutting edge of cardiology. Four journals have previously launched: Circulation: Arrhythmia and Electrophysiology, Circulation: Heart Failure, Circulation: Cardiovascular Imaging, and Circulation: Cardiovascular Interventions. The final title -- Circulation: Cardiovascular Genetics -- will premier in October.
Circulation: Cardiovascular Quality and Outcomes and all of the Circulation portfolio journals will be available in both print and online formats. The journal Web site, http://circoutcomes.ahajournals.org/, will launch when the first issue is posted in September and will also present "Publish Ahead of Print" articles and other online features.
American Heart Association/American Stroke Association Premium Professional members will have free, full-text access to journal articles through December 31, 2008. The first issue of each of the six new journals will be available to the public for free as sample issues.
About the American Heart Association
Founded in 1924, the American Heart Association is the nation's oldest and largest voluntary health organization dedicated to building healthier lives, free of heart disease and stroke. These diseases, America's No. 1 and No. 3 killers, claim more than 870,000 lives a year. In fiscal year 2006-07 the association invested more than $554 million in research, professional and public education, advocacy and community service programs to help all Americans live longer, healthier lives. To learn more, call 1-800-AHA-USA1 or visit americanheart.org.

CONTACT: Cathy Lewis of the American Heart Association, (214) 706-1324.

iTunes in Hospitals

iTunes allows radiologists to save, sort and search personal learning files

iTunes has the ability to manage and organize PDF files just as easy as music files, allowing radiologists to better organize their personal files of articles and images, according to a recent study conducted by researchers at Renji Hospital and Shanghai Jiaotong University School of Medicine in Shanghai, China.
"Most published medical papers are available on the internet in a PDF format now," said Li Jun Qian, MD, lead author of the study. "For radiologists, these electronic papers provide richer information (e.g. various cases, reviews and abundant, valuable images) than conventional textbooks and can be easily found and downloaded for further reading via online databases. However, managing PDF files is troublesome and it is difficult to find software designed for organizing them," said Dr. Qian.
Generally speaking, most people sort PDF files in folders on their PC by topic. However, using this approach does not solve the issue of how to file multi-subject articles, said Dr. Qian The study authors found that iTunes can address this issue due to its powerful search and sort functions, its ability to remember a user's favorite articles and its capability to support customized shortcuts for different topics and/or categories.
"One day I just happened to drag and drop a PDF into iTunes and was surprised to find that it was supported by iTunes. This means that you can search, describe, and rate PDFs just like you do the music files," said Dr. Qian. "We no longer need to keep PDF files in redundant folders."


Contact: Necoya Tyson
necoya@arrs.org
703-858-4304
American Roentgen Ray Society 

Are You Prepared for Hurricanes and Floods?

Click on the image to download a printer friendly PDF version of this document

Prepare for Hurricanes and Floods: Advice From FDA

Here are resources from the Food and Drug Administration on how to keep food, medical products, and pets safe during an emergency such as Hurricanes and Floods.

FOOD

Food that has been exposed to flood waters or that hasn't been properly refrigerated can cause illness.

• When in doubt, throw it out. Don't eat food that may have been exposed to flood water.


• Use bottled water if it is available. Don't drink water that may have been exposed to flood water. If you don't have bottled water, boil water at a rolling boil for one minute to make it safe.
  
  
  • Follow these steps if you can't boil water.
    
    
    • If the water is cloudy, filter it through clean cloths or allow it to settle, and draw off the clear water for disinfection.
    
    
    • Add 1/8 teaspoon (or 8 drops) of regular, unscented, liquid household bleach per each gallon of water. Stir it well and let it stand for at least 30 minutes before you use it.
    
    
    • Store disinfected water in clean containers with covers.
    
    
  
  


• Keep refrigerator and freezer doors closed. If the power goes out, keep refrigerator and freezer doors closed as much as possible. Your refrigerator will keep food cold for about 4 hours if it's unopened. A full freezer will keep an adequate temperature for about 48 hours if the door remains closed.


• Use appliance thermometers. Thermometers should be in your refrigerator and freezer. When power is restored, check your freezer thermometer. If it reads 40°Fahrenheit, the food is safe and may be refrozen. Refrigerated food should be safe as long as the power was out no more than 4 hours and the door has remained closed.


• Be prepared - have coolers and ice or frozen gel packs. Coolers can help keep refrigerator food cold. If the power will be out for more than 4 hours, store foods that require refrigeration so they are in contact with ice or frozen gel packs. Purchase or make ice cubes and store in the freezer for use in the refrigerator or in a cooler. Freeze gel packs ahead of time for use in coolers.


• Throw out spoiled food. Discard any perishable foods—such as meat, poultry, seafood, eggs, or leftovers—that have been above 40°Fahrenheit for 2 hours or more.

Returning Home After a Hurricane or Flood

www.cfsan.fda.gov/~dms/fsdisas5.html

Food and Water Safety

www.cfsan.fda.gov/~dms/fsdisas.html

MEDICINE

If you are in an area that may flood …

• Keep your medication containers in zippered plastic bags. Store them in your home in a place less likely to flood.


• Keep a list of your medications. Be sure to include:
  
  
  • the name of the medicine
  
  
  • the dose of the medicine
  
  
  • how frequently you take the medicine
  
  
  • your doctor's name and phone number
  
  


• Take the bags and medications with you if you must evacuate.

If a medication container falls into flood water …

• Replace the medication. That's the safest approach.

But during an emergency, replacing your medicines may not be easy.

• If the container gets wet but it appears that flood water did not touch the medicine, then use the medication, but only until a replacement can be obtained.


• Do not use the medication if any pills were touched by flood water.


• Save the original containers.


• Contact your physician or local public health provider for guidance.

Safe Drug Use After a Natural Disaster

www.fda.gov/cder/emergency/water-refrig.htm

INSULIN

If a hurricane strikes, people with diabetes may not be able to refrigerate their insulin.

• Replace the medication with a new supply. Temperature sensitive drugs, like insulin, lose potency if not refrigerated, so they should be replaced with a new supply as soon as possible.


• Insulin products may be left unrefrigerated (between 59 and 86°F) for up to 28 days and still maintain potency.


• Contact a hospital or other health care provider for guidance.

Insulin Storage and Switching Between Products in an Emergency

www.fda.gov/cder/emergency/insulin.htm

MEDICAL DEVICES

In an emergency, follow these tips for safe use of medical devices and equipment.

• Keep your medical device and supplies clean and dry.


• Seek emergency services immediately if you depend on your device to keep you alive.


• Request evacuation. If possible, notify your local public health authority to request evacuation before bad weather occurs.


• Use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use. This lowers the risk of fire.


• Contact your distributor or device manufacturer if your device appears to be damaged or you need a back-up device.


• Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power at the main breaker.


• Never run a generator inside your home or garage unless the equipment has been professionally installed and vented.

Medical Devices and Hurricanes

www.fda.gov/cdrh/emergency/hurricane.html

Medical Devices Requiring Refrigeration

www.fda.gov/cdrh/emergency/refrigeration.html

VACCINES AND OTHER BIOLOGICS

Most biological products, including bacterial and viral vaccines, allergenic extracts (e.g. for allergy shots and tests), and blood products, require specific storage conditions to maintain their safety, purity, and potency. This type of information is indicated in the product labeling.

These products may often be found in health clinics, physicians' offices and patients' homes where emergency back up power may not be available.

Here are some suggested actions to preserve cold or frozen storage conditions during a power outage:

Vaccines and Non-Blood Biologicals

• Note the time of the power outage and do not open freezers and refrigerators until power is restored. This will help conserve the cold mass of the products.


• Do not open units to check temperatures during a power outage, as many products will maintain their potency for a few days in a closed refrigerator.


• For vaccines requiring freezer storage, you may consider removing them from the freezer after one day (if the power outage continues) and packing them in dry ice. But if the vaccines are not cold to the touch upon removal from the freezer, you may wish to consider not using them.

Blood Products and Plasma Derivatives

Blood banks and plasma centers typically have back up generators and emergency procedures in place for storing products in the event of a power outage. For those facilities and in-home users that may not have emergency back up power, the following may be helpful:

• There is some evidence that lyophilized coagulation products such as Factor VIII and Factor IX may be stored at room temperature for a fairly long period of time without loss of factor potency. If you are concerned about the exposure or efficacy of a particular product, please contact the supplier or the manufacturer.


• Many immune globulin products are licensed for storage at 36 to 46 degrees Fahrenheit, and some products may be stored at room temperature for all or part of the time before expiration. Because storage temperatures and times are specific to each product, you should follow the package insert recommendations for Immune Globulin Intravenous (IGIV), intramuscular IG (IG), and subcutaneous IG (IGSC) products. Products requiring lower temperatures can be stored on wet ice. All of these products should not be frozen.

Severe Weather Conditions and Biological Products

www.fda.gov/cber/weatherimpact.htm

TAKING CARE OF PETS

When a hurricane strikes, it's a dangerous situation for people AND pets.

• Try to take your pets with you if you leave home during an emergency.


• Plan in advance. Find out which motels or hotels accept pets in an emergency. Or, plan to go to the home of a friend or relative who will allow you to bring your pet.


• Prepare a disaster kit that you can grab as you leave home. The kit should include pet food, medicines, vaccination records, and pet insurance information.


• Make arrangements for a neighbor or nearby friend to take care of your pets in case you get trapped away from home.


• Make sure your pets have identification tags (including rabies and license tags, if applicable.) This may help reunite you with your pets if you get separated. Identification tags should provide your name, home address, a phone number where you can be reached, and an out-of-state phone number of someone with whom you will be in contact during or soon after the disaster/evacuation.


• Have a leash, collar or harness for your pets (cats and dogs) and pet carriers or transport kennels/cages for each pet.

Taking Care of Pets

www.fda.gov/cvm/disaster.htm

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer)

Tags: INSULIN, MEDICINE, FOOD, Hurricanes, Floods, medical products, FDA Advisory, FDA Guidance, Disaster preparedness

'Dragon' Protein May Lead To A Cure For The Most Common Strain Of Avian Influenza, (bird flu)

ARGONNE, Ill. (July 15, 2008)—Scientists and researchers have taken a big step closer to a cure for the most common strain of avian influenza, or "bird flu," the potential pandemic that has claimed more than 200 lives and infected nearly 400 people in 14 countries since it was identified in 2003.

Researchers at the U.S. Department of Energy's (DOE) Argonne National Laboratory, in conjunction with scientists from China and Singapore, have crystallized and characterized the structure of one of the most important protein complexes of the H5N1 virus, the most common strain of bird flu.

All viruses, including H5N1, contain only a small number of proteins that govern all of the viruses' functions. In H5N1, perhaps the most important of these proteins is RNA polymerase, which contains the instructions that allows the virus to copy itself along with all of its genetic material. The Argonne study focused on H5N1's RNA polymerase protein, which contains three subunits: PA, PB1 and PB2.

After performing X-ray crystallography on the protein crystals at Argonne's Structural Biology Center at the Advanced Photon Source, the researchers saw a surprising resemblance in the protein structure's image. "When we mapped out the PA subunit, it looked very much like the head of a dragon," said Argonne biophysicist Andrzej Joachimiak. "One domain looked like the dragon's brains, and the other looked like its mouth."

During RNA replication – the phase during which the virus "reproduces" – all three of the subunits of the protein assemble themselves in a particular configuration. In order for this congregation to take place, the researchers determined the end of the PB1 subunit has to insert itself and bind to the "dragon's mouth" part of the PA subunit.

This unexpected relationship between the two subunits could inspire a number of different therapies or vaccines for H5N1 that rely on muzzling the "dragon's" jaws with another molecule or chemical compound that would block the PB1 subunit's access to the PA site, according to Joachimiak. "If we can put a bit in the dragon's mouth, we can slow or even potentially someday stop the spread of avian flu," he said. "Since we are talking about a relatively small protein surface area, finding a way to inhibit RNA replication in H5N1 seems very feasible."

Joachimiak hopes to more precisely identify the types of compounds that could inhibit RNA replication in H5N1 by looking at the atomic-level grooves and pockets within the PA "mouth" region. According to Joachimiak, scientists must gain a more thorough understanding of the geometry of that small region in order to effectively synthesize drugs that could prevent the further spread of bird flu.

Argonne researchers Joachimiak and Rongguang Zhang collaborated with Zihe Rao and Yingfang Liu, both members of the Institute of Biophysics of Chinese Academy of Sciences. Rao is one of the most influential Chinese crystallographers and biophysicists, Joachimiak said. The protein samples were manufactured in China and crystals were shipped to Argonne for data collection and structural analysis.

The results of the study will be reported in an upcoming issue of Nature and can be found online at http://dx.doi.org/10.1038/nature07120. The work was funded by the National Natural Science Foundation of China as well as the Chinese Ministry of Science and Technology and the U.S. Department of Energy's Office of Biological and Environmental Research.

Argonne National Laboratory brings the world's brightest scientists and engineers together to find exciting and creative new solutions to pressing national problems in science and technology. The nation's first national laboratory, Argonne conducts leading-edge basic and applied scientific research in virtually every scientific discipline. Argonne researchers work closely with researchers from hundreds of companies, universities, and federal, state and municipal agencies to help them solve their specific problems, advance America 's scientific leadership and prepare the nation for a better future. With employees from more than 60 nations, Argonne is managed by UChicago Argonne, LLC for the U.S. Department of Energy's Office of Science.

This research was funded by the National Natural Science Foundation of China as well as the Chinese Ministry of Science and Technology and the U.S. Department of Energy's Office of Biological and Environmental Research.

By Jared Sagoff.

For more information, please contact Steve McGregor (630/252-5580 or media@anl.gov) at Argonne.

Tags: H5N1 virus, Cure For H5N1 virus, UChicago Argonne, U.S. Department of Energy's Office of Science, National Natural Science Foundation of China, U.S. Department of Energy, bird flu, Avian Influenza

What is an FDA advisory committee?

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As technology changes, so do the tools we use to combat disease in the United States. Many companies use new technologies and scientific innovations to develop new generations of drugs, medical devices, and biological products such as vaccines. Some of these new medical products hold great promise. But some pose great risk.

Part of the Food and Drug Administration’s (FDA) mission is to evaluate new therapies and determine which are safe and effective for their intended use. This is a complex job, often involving many areas of expertise, and sometimes FDA turns to outside experts for counsel.

FDA's advisory committees provide independent, expert advice to the agency on a range of complex scientific, technical, and policy issues. This includes questions related to the development and evaluation of products regulated by FDA. The agency currently has 49 technical and scientific advisory committees and panels. They are a valuable resource and make an important contribution to the agency’s decision-making processes. Although advisory committees provide recommendations to the agency, FDA makes the final decisions.

What is an FDA advisory committee?

An advisory committee lends credibility to the product review process and provides a forum for public discussion of certain controversial issues. The process helps air issues that do not have simple answers. For specific products, advisory committees consider the available evidence and provide scientific and medical advice on safety, effectiveness, and appropriate use. Committees might also advise the agency on broader regulatory and scientific issues.

Who serves on advisory committees and panels?

In general, each committee includes a chairperson, several members, a consumer representative, an industry representative, and often a patient representative. Additional experts may be added for specific meetings, as needed.

Committee membership typically includes ethnic, gender, and geographic diversity. Members have recognized expertise and judgment in a specific field. Typical members include

• Physician-scientists
• Statisticians
• Epidemiologists
• Pharmacologists
• Nutritionists
• Nurses
• Experts in animal (preclinical) studies

Representatives for industry, patients, and consumers add different perspectives and expertise that give balance to the discussions and final recommendations.

What does a consumer representative do?

Consumer representatives are technically qualified professionals who have specific links with consumer advocacy groups or community based organizations.

Consumer representatives

• facilitate dialogue with the committees on scientific issues that affect consumers
• must be able to analyze scientific data
• must understand research design
• must discuss benefits and risks
• must evaluate the safety and effectiveness of products under review

How often do advisory committee meetings occur?

Advisory committee meetings can occur during any stage of a product's review process, or if appropriate, once a product is marketed. Typically, an individual committee may convene on average one to four times per year. The decision to involve an advisory committee is usually at the discretion of the Division Director of one of FDA's five product centers.

How does a person become a member of an advisory committee?

Nominations for scientific members and consumer, industry, and patient representatives typically come from professional societies, industry, consumer and patient advocacy groups, the interested individual, or from other interested people. Candidates must be willing to provide detailed information about financial holdings, employment, research grants and contracts, and other potential conflicts of interest. FDA is committed to finding qualified individuals who represent a variety of points of view to serve on advisory committees. Applications are now available on line.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer)

Tags: FDA Guidance, FDA News, FDA advisory committees

The Food and Drug Administration (FDA) Requests Stronger Warnings On Fluoroquinolones Drug's Label.

Stronger Warnings Requested for Fluoroquinolones

The Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. A boxed warning on a drug's label calls attention to serious or life-threatening risks.

The agency has also determined that manufacturers should provide patients with a Medication Guide about possible side effects. Medication Guides are paper handouts that come with certain prescription medications.

What are fluoroquinolones?

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

Which drugs are involved in this action?

These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

What should patients know?

• The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in people taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients.
• Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should stop taking their fluoroquinolone medication and contact their health care professional promptly about changing their antimicrobial therapy.
• Patients should also avoid exercising and using the affected area at the first sign of tendon pain, swelling, or inflammation.

This article appears on FDA's Consumer Health Information Web page.

Meddesktop

Tags: FDA Action, Fluoroquinolones, tendinitis, tendon rupture, bacterial infections.antibacterial drugs, ophthalmic Use, otic use, Cipro, generic ciprofloxacin, Cipro XR, Proquin XR, Factive, Levaquin, Avelox, Noroxin, Floxin, generic ofloxacin

Recallr: Nestlé Recalls Lean Pockets Frozen Stuffed Chicken Sandwiches

Recallr: Nestlé Recalls Lean Pockets Frozen Stuffed Chicken Sandwiches

Tags: Nestlé Prepared Foods Company Recall, Nestlé Recall, Nestlé Prepared Foods Company, Lean Pockets Recall

Resveratrol Improve Health, But Not Longevity, A Study Finds.

Resveratrol found to improve health, but not longevity in aging mice on standard diet

Scientists have found that the compound resveratrol slows age-related deterioration and functional decline of mice on a standard diet, but does not increase longevity when started at middle age. This study, conducted and supported in part by the National Institute on Aging (NIA), part of the National Institutes of Health, is a follow-up to 2006 findings that resveratrol improves health and longevity of overweight, aged mice. The report confirms previous results suggesting the compound, found naturally in foods like grapes and nuts, may mimic, in mice, some of the effects of dietary or calorie restriction, the most effective and reproducible way found to date to alleviate age-associated disease in mammals.

The findings, published July 3, 2008, in Cell Metabolism, may increase interest in resveratrol as a possible intervention for age-related declines, said NIA scientists. The authors emphasized, however, that their findings are based on research in mice, not in humans, and have no immediate and direct application to people, whose health is influenced by a variety of factors beyond those which may be represented in the animal models.

The study is a collaborative effort between the laboratories of Rafael de Cabo, Ph.D., of the Laboratory of Experimental Gerontology at the NIA; David A. Sinclair, Ph.D., of the Glenn Laboratories for Molecular Biology of Aging at Harvard Medical School; and an international group of researchers. The investigators compared mice fed a standard diet, a high-calorie diet, or an every-other-day feeding regimen with or without high- or low-dose resveratrol to study the impact of resveratrol on aging and health. In previous studies, different forms of dietary restriction, including every-other-day feeding, have been shown to improve markers of health.

"Research is attempting to understand the process of aging and to determine how interventions can influence this process. Dietary restriction has well-documented health benefits in mammals, and the study of possible mimetics of it, such as resveratrol, are of great interest," said NIA Director Richard J. Hodes, M.D. "Resveratrol has produced significant effects in animal models, now including mice, where it mimics some, but not all, consequences of caloric restriction. Its effects in humans remain to be studied."

A major finding of the study reported today is that resveratrol prevented age-related and obesity-related cardiovascular functional decline in the mice as determined by several parameters. Total cholesterol was significantly reduced in 22-month-old non-obese mice after 10 months of resveratrol treatment, although triglyceride levels had only a slight, non-significant trend toward a decrease. Further, the aortas of 18-month-old obese and non-obese mice treated with resveratrol functioned significantly better than untreated mice. Resveratrol also moderated inflammation in the heart.

In addition to cardiovascular function, the scientists found resveratrol to have a variety of positive effects on other age-related problems in mice:

• Treated mice tended to have better bone health, as measured by thickness, volume, mineral content and density, and bending stiffness compared to the non-treated control group.

• At 30 months of age, resveratrol-treated mice were found to have reduced cataract formation, a condition found to increase with age in control-group mice.

• Resveratrol enhanced balance and motor coordination in aged animals. Scientists found significant improvement in performance at 21 and 24 months versus 15 months in the resveratrol-treated mice but not in the untreated mice.

• Resveratrol partially mimicked the effects of dietary restriction on the gene expression profiles of liver, skeletal muscle and adipose (fatty) tissue in mice.

Along with determining the effect of resveratrol on the health of mice, scientists also studied the effect of resveratrol on longevity.

"We found that while quality of life improved with resveratrol, the compound did not significantly affect overall survival or maximum lifespan for mice on a standard diet, compared to mice on the same diet without resveratrol," said de Cabo.

Resveratrol did not have a significant effect on lifespan in animals fed standard chow, suggesting that the intervention did not affect all aspects of the basic aging process. Mice on a high-calorie diet without resveratrol lived the shortest length of time and mice on an every-other-day regimen lived the longest, regardless of resveratrol treatment. However, for mice on a high-calorie diet, mean and maximum lifespan increased for mice on resveratrol when compared with the control mice. Researchers found that resveratrol's effects on longevity could be completely uncoupled from changes in body weight, meaning that mice on a high-calorie diet with resveratrol did not necessarily lose weight but did experience a longer (and healthier) life than mice on the same high-calorie diet not taking resveratrol. They speculate that improved cardiovascular health and reduced fatty changes in the liver may have contributed to the increased lifespan of resveratrol-treated mice.

Researchers still have much to learn before resveratrol can be recommended for human use. Basic questions of safety and biological effect in humans remain to be studied experimentally.

"We are learning a great deal about how resveratrol affects the health and survival of mammals," said Sinclair. "Continued study of calorie restriction mimetics such as resveratrol may eventually point the way to new medicines to treat diseases of aging."

Contact: Megan Homer
nianews3@mail.nih.gov
301-496-1752
NIH/National Institute on Aging

Tags: Resveratrol, improve health, standard diet, age-related deterioration, Cell Metabolism, National Institute on Aging

Cost Of Raising Children With Special Needs Based On State They Live.

July 10, 2008 -- Therapies, rehabilitation and specialty medical care are just a few of the extra costs that parents face when raising children with special needs. In a new study that will be published in current issue of Pediatrics, Paul T. Shattuck, Ph.D., professor of social work at Washington University in St. Louis, found that families with similar demographics and nature of their children's special needs have different out-of-pocket health expenditures depending on the state in which they live.
The complete list of all 51 states could be found at Washington University in St. Louis.

Tags: children with special needs, health expenditures, health care, Children's Health

FDA issues alert on Raw Jalapeno and Serrano Peppers.

Read the article to find out more information on Tomato Salmonella outbreak and newly included Raw Jalapeno and Serrano Peppers.
Recallr: FDA Updates Salmonella Outbreak Beyond Tomatoes, Raw Jalapeno And Serrano Peppers May Be Linked.

Tags: Raw Jalapeno, Serrano Peppers, Salmonella serotype Saintpaul, Salmonella Outbreak, FDA Advisory, FDA

FDA Revises Communication Process For Drug Applications

FOR IMMEDIATE RELEASE July 9, 2008

Media Inquiries: Christopher DiFrancesco, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Revises Process for Responding to Drug Applications

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.

"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."

Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.

Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.

"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.

The revision should not affect the overall time it takes the FDA to review new or generic drug applications or biologic license applications. These changes, which will become effective on Aug. 11, 2008, are not expected to directly affect consumers.

In July 2004, the FDA issued a proposed rule on these topics. At that time the agency asked for comments on the proposal. Today's final rule addresses comments submitted to the agency.

For more information, see:

Link to the Complete Response Final Rule
http://www.fda.gov/cder/regulatory/complete_response_FR/default.htm

Link to the drug approval process page
http://www.fda.gov/fdac/special/testtubetopatient/default.htm

Tags: Center for Drug Evaluation and Research, CDER, FDA, FDA Action

Update On Recalled Heparin By FDA

Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recommendations on this continuing issue. Heparin is an anticoagulant commonly used subcutaneously and intravenously in patients undergoing kidney dialysis, certain types of cardiac surgery and other procedures. It is also used in lock flush solutions to maintain the patency of IV catheters, and as a coating or ingredient in certain medical devices and diagnostic products. Towards the end of 2007, FDA started receiving an increasing number of reports of adverse events associated with injectable heparin products, especially when the heparin was administered as a bolus dose. Many of these events were consistent with either an anaphylactic-type reaction or acute hypotension. A small number of similar events have also been reported for heparin flush solutions. FDA has identified a contaminant in the heparin, an oversulfated chondroitin sulfate, that may have led to the adverse events. This contaminant mimics heparin activity so closely that routine testing did not uncover it. Special test methods are needed to detect this contaminant, and the major U.S. heparin manufacturers and suppliers have agreed to perform these tests to screen all heparin active ingredient that they receive. FDA has also asked medical device companies to identify any product they market that contains heparin or uses heparin in processing. A number of companies have recalled heparin or products containing heparin. They did this based either on reports of adverse events or as a precaution after the special testing revealed that the company had been supplied with contaminated lots of heparin. FDA is asking healthcare professionals and facilities to take the following steps: • Report adverse reactions associated with any drug or device that contains heparin. FDA is continuing to actively monitor this situation and it is essential that new events are reported as soon as possible. FDA is focusing on events involving injectable heparin, heparin lock flush solutions or medical devices that contain heparin. That could include certain blood collection tubes, intravascular catheters, vascular stents and grafts, and other devices used during cardiac procedures, such as oxygenators, pumps, filters and blood reservoirs. • Pay attention to recalls of heparin or heparin-containing products, including those by Baxter Healthcare, American Health Packaging, B. Braun, Covidien, Medtronic and Atrium Medical. • Check all drug and device storage areas, including emergency kits, crash carts, dialysis units and automated drug storage cabinets, to make sure that all recalled heparin products have been removed and are no longer available for use. The investigation of contaminated heparin is still underway. The links (see "Additional Information" below) will be updated with the latest information as it becomes available. Additional Information: FDA. Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products. http://www.fda.gov/cder/drug/infopage/heparin/default.htm#healthcare FDA. Information on Heparin Sodium Injection. April 25, 2008. http://www.fda.gov/cder/drug/infopage/heparin/default.htm FDA MedWatch Safety Alert. Heparin Sodium Injection. May 15, 2008. http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2

Tags: FDA News, Heparin, HEPARIN RECALL

Fluoroquinolone Antimicrobial Drugs Carry Risk Of Developing Tendinitis And Tendon Rupture In Patients Taking Fluoroquinolones For Systemic Use.

[Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria. [July 08, 2008 - Drug Information Page - FDA] [July 08, 2008 - Information for Healthcare Professionals - FDA] [July 08, 2008 - News Release - FDA]

Tags: FDA Alert, Fluoroquinolones, tendinitis, tendon rupture

Happy 4th Of July America!

Happy 4th Of July America!

Tags: 4th of July, America People We See, Independence day

Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

Audience: Orthopedic surgeons, neurosurgeons, hospital risk managers, surgical service staff
[Posted 07/02/2008] FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.

[July 01, 2008 - Public Health Notification - FDA]

Tags: fda warning, recombinant human Bone Morphogenetic Protein, rhBMP, cervical spine fusion

Products Marketed as Dietary Supplements, Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Recalled By Jack Distribution, LLC.

ack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that these lots of Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Recallr: Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Recalled By Jack Distribution, LLC.

Tags: Rize 2 The Occasion Capsules recall, Rose 4 Her Capsules recall, Dietary Supplements Recall, FDA Recall, Jack Distribution LLC recall

Get Smart Or Stay Smart By Selecting Right Food.

Get smart about what you eat and you might actually improve your intelligence

MIT researchers offer tantalizing evidence on how to make people smarter, naturally

New research findings published online in The FASEB Journal provide more evidence that if we get smart about what we eat, our intelligence can improve. According to MIT scientists, dietary nutrients found in a wide range of foods from infant formula to eggs increase brain synapses and improve cognitive abilities.
"I hope human brains will, like those of experimental animals, respond to this kind of treatment by making more brain synapses and thus restoring cognitive abilities," said Richard Wurtman, MD, senior researcher on the project.
In the study, gerbils were given various combinations of three compounds needed for healthy brain membranes: choline, found in eggs; uridine monophosphate (UMP) found in beets; and docosahexaenoic acid (DHA), found in fish oils. Other gerbils were given none of these to serve as a baseline. Then they were checked for cognitive changes four weeks later. The scientists found that the gerbils given choline with UMP and/or DHA showed cognitive improvements in tasks thought to be relevant to gerbils, such as navigating mazes. After these tests were concluded, the researchers dissected the mouse brains for a biological cause for the improvement. They found biochemical evidence that there was more than the usual amount of brain synapse activity, which was consistent with behaviors indicating higher intelligence.
"Now that we know how to make gerbils smarter," said Gerald Weissmann, MD, Editor-in-Chief of The FASEB Journal, "it's not too far a stretch to hope that people's intelligence can also be improved. Quite frankly, this can't happen soon enough, as every environmentalist, advocate of evolution and war opponent will attest."

This article is scheduled for final publication in the November 2008 issue of The FASEB Journal (http://www.fasebj.org), which is published by the Federation of American Societies for Experimental Biology (FASEB) and is the most cited biology journal worldwide according to the Institute for Scientific Information. FASEB comprises 21 nonprofit societies with more than 80,000 members, making it the largest coalition of biomedical research associations in the United States. FASEB advances biological science through collaborative advocacy for research policies that promote scientific progress and education and lead to improvements in human health.

Contact: Cody Mooneyhan
cmooneyhan@faseb.org
301-634-7104
Federation of American Societies for Experimental Biology 

Employer-Based Weight Loss Programs Are Helpful

CINCINNATI—A new review of studies from UC shows that a little shove from the workplace may actually be the ticket to dropping weight.

According to Michael Benedict, MD, and colleagues at UC, employer-based programs for weight loss are modestly effective at helping workers take off extra pounds.

“Worksite-based programs do tend to result in weight loss for the people that participate in them,” says Benedict, co-author of the study and researcher in the department of internal medicine.

The review appears in the July-August issue of the American Journal of Health Promotion.

Benedict and colleagues looked at 11 studies published since 1994 to determine their results.

Most of the programs involved education and counseling designed to improve diet and increase physical activity and lasted anywhere from two to 18 months. Forty-six percent of the studies involved low-intensity interventions, 18 percent were moderate intensity and 36 percent were high intensity.

Benedict says that intensity may be an important factor when it comes to weight loss. He added that programs incorporating face-to-face contact with subjects more than once a month appeared to be more effective than other programs.

In comparison, participants in higher intensity programs lost an average of 2.2 pounds to almost 14 pounds, while non-participants ranged from a loss of 1.5 pounds to a gain of 1.1 pounds.

“Most employed adults in the U.S. spend nearly half of their waking hours at their place of employment,” Benedict says. “Worksite based programs have great potential to positively impact our current obesity epidemic.

However, Benedict says it was difficult to draw conclusions about weight-loss maintenance.

“Participants in these programs may lose weight, but it is unclear what happens after the fact, as weight maintenance has not been studied,” he says.

There is also minimal data to show how much money employers could save if they start worksite weight-loss programs. Benedict says many employers want to know that implementing these programs will lead to a positive return on investment.

Studies have shown that other worksite health interventions targeting high risk employees, like smokers and people with hypertension, may benefit employers financially within only a few years.

“These programs have the potential to have a tremendous public health impact,” he says. “However, more high quality research is needed.”

Michael Benedict, MD,

Media Contact: Katie Pence, (513) 558-4561

Tags: weight loss, Weight Control, American Journal of Health Promotion