Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury Comments Open.

Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.


The Food and Drug Administration (FDA) is reopening for 90 days, the comment period for the proposed rule, published in the Federal Register of February 20, 2002 (67 FR 7620), on the classification of encapsulated amalgam alloy and dental mercury, the reclassification of dental mercury, and the issuance of special controls for amalgam alloy. In the Federal Register of July 17, 2002 (67 FR 46941), the initial comment period was reopened for 60 days. The agency is taking this action to provide the public with an additional opportunity to comment and to request data and information that may have become available since publication of the proposed rule. DATES: Submit written or electronic comments by July 28, 2008. ADDRESSES: You may submit comments, identified by Docket No. FDA-2008- N-0163 (formerly Docket No. 2001N-0067), by any of the following methods: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: FAX: 301-827-6870. Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in the ADDRESSES portion of this document under Electronic Submissions. Instructions: All submissions received must include the agency name and Docket No(s). and Regulatory Information Number (RIN) (if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ``How to Submit Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Michael E. Adjodha, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276- 3688.
tag: FDA Proposed Rule, Dental Devices, HHS, Amalgam Alloy, Dental Mercury, Reclassification of Dental Mercury

Lymphazurin 1% injection (isosulfan blue) Shortage Resolved.

Lymphazurin 1% injection (isosulfan blue) Shortage has been resolved and Covidien now has Lymphazurin 1% injection available.
Covidien (formerly U.S. Surgical)
1-203-845-1000
tag: FDA, Drug Shortage, Covidien, Lymphazurin, isosulfan blue

Safeguards for Consumers of Beef Strengthened By FDA

FDA Strengthens Safeguards for Consumers of Beef
Issues Regulation on Animal Feeds with Added Safeguards Against BSE

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease").

"This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE," said Dr. Bernadette Dunham, Director of FDA's Center for Veterinary Medicine. "The new rule strengthens existing safeguards."

The new measure builds on FDA's 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed.

The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE. These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older. The entire carcass of cattle not inspected and passed for human consumption is also prohibited, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed. The risk of BSE in cattle less than 30 months of age is considered to be exceedingly low.

The removal of high-risk materials from all animal feed will further protect against inadvertent transmission of the agent thought to cause BSE, which could occur through cross-contamination of ruminant feed (intended for animals with four-chambered stomachs, such as cattle) with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm. The added measure of excluding high-risk materials from all animal feeds prevents any accidental feeding of such ingredients to cattle.

Today's regulation finalizes a proposed rule that the FDA issued for public comment in October 2005. The final rule is effective 12 months from today to allow the livestock, meat, rendering, and feed industries time to adapt their practices to comply with the new regulation. Under the new requirements of the final rule, renderers that process cattle not inspected and passed for human consumption must make available for FDA inspection their written protocols for determining the age of cattle and demonstrating that the brain and spinal cords of cattle have been effectively removed.

Scientific studies have linked BSE to cases of variant Creutzfeldt-Jakob Disease (vCJD) in humans, an invariably fatal disease that most likely results from human consumption of infectious material from cattle with BSE. Rules issued in 2004 prohibited specified risk materials from use in the human food supply. There have been no vCJD cases linked to consumption of U.S. beef and the risk of BSE among U.S. cattle is low.

FDA regulates animal feed and drugs. The U.S. Department of Agriculture (USDA) and FDA promulgate and enforce the regulations that ensure the exclusion of specific risk materials from the human food supply.

For more information about the FDA's work on BSE, go to www.fda.gov/oc/opacom/hottopics/bse.html.
tag: FDA Regulations, Beef Safeguards, BSE, animal feed, Creutzfeldt-Jakob Disease,

FDA Approves Coronary Artery Plaque Imaging Device.

Coronary Artery Plaque Imaging Device Cleared by FDA

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

Plaque is a deposit made up of cholesterol-rich fat, calcium, and other substances found in the blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots which can lead to a heart attack.

Nearly one million Americans suffer a heart attack every year and about half die. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots. Pathologic studies of patients who died from heart attack have identified a large lipid (fatty) core among features of coronary artery disease that were associated with plaque rupture and thrombosis (blood clots). Research is currently underway to determine how plaques that are prone to rupture can best be identified before they cause a heart attack.

“This is the first device that can help assess the chemical make-up of coronary artery plaques and help physicians identify those plaques with lipid cores, which may be of particular concern,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health.

The InfraReDx LipiScan NIR Catheter Imaging System uses infrared imaging to detect lipid core-containing plaques of interest and assess a patient's coronary artery lipid core burden index. The device works by placing a catheter equipped with a fiber-optic laser light into the artery. The device shines the near infrared light delivered through the blood to the artery wall, and measures the light reflected back from the artery wall, a technique called spectroscopy. The reflected wavelengths vary depending on how much fat and other substances are in the plaque in the illuminated portion of the wall.

LipiScan is manufactured by InfraReDx Inc. of Burlington, Mass. The device is cleared for use by physicians who are evaluating patients with symptoms of coronary heart disease during a heart test known as cardiac angiography, to help in detection of plaques that have lipid (fatty) cores.

tag: FDA Approval, Medical Devices, InfraReDx LipiScan NIR Catheter Imaging System, blood clots,

Health Related Recalls For Today, From Recallr

Recallr has a bunch of recalls listed for today and here are some that are directly related to health. But please visit Recallr and register so that you get notified of all recalls, daily. Newsletter is free!

Lifetime Brands Recalls Pfaltzgraff® Villa della Luna® pattern and Nautica J Class® pattern (Red Only) Stoneware Dinnerware Product Lines.

Actavis Totowa recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP).

Nintendo Recalls Lapel Pins Due To Lead Paint

tag: recallr, health related recalls, food recalls

NURSING HOME COMPARE WEB SITE UPDATED

CRITICAL NEW INFORMATION ADDED TO NURSING HOME COMPARE WEB SITE
MULTI-YEAR PLAN FOR IMPROVED NURSING HOME QUALITY ALSO RELEASED

Medicaid beneficiaries and families searching for top quality long-term care services can find critical new information added today to the Centers for Medicare & Medicaid Services’ (CMS) Web site “Nursing Home Compare.”

For the first time, information about nursing homes on the Compare Web site will list whether a home is or has been on CMS’ special focus facility (SFF) list. The agency’s SFF initiative gives heightened scrutiny to nursing homes that have a history of poor performance or repeated violations of state and federal health and safety rules.

“Today’s expansion of information on Nursing Home Compare will give beneficiaries a more complete picture of a nursing home’s history of providing quality care,” CMS Acting Administrator Kerry Weems said.

The SFF initiative was created because a number of facilities were consistently providing poor quality of care, yet were periodically instituting enough improvement that they would pass one survey only to fail the next (for many of the same problems as before). Such facilities with a “yo-yo” compliance history rarely addressed underlying systemic problems that were giving rise to repeated cycles of serious deficiencies.

In November 2007, the agency began publishing a list of Medicare and Medicaid participating nursing homes that have a history of serious quality of care problems and had failed to show significant improvement. In February 2008, CMS took the next step and published an updated, expanded list of nursing homes in the SFF initiative and included the category they fell within such as new additions, not improved, improving, recently graduated or no longer in the Medicare and Medicaid programs.

As of April 2008, there are 134 SFFs, out of about 16,000 active nursing homes. CMS works closely with states to select participants and as homes improve their quality of care and “graduate” from the program, or fail to improve and are terminated from Medicare and Medicaid, new homes are added to the list. This movement of homes off the list allows more facilities with problems to be added as the program continues.

Once a facility is selected as an SFF, the state survey agency conducts twice the number of standard surveys and will apply progressive enforcement until the nursing home either (a) significantly improves and graduates from the SFF initiative, (b) is granted additional time due to promising developments, or (c) is terminated from Medicare and/or Medicaid. CMS and the state can more quickly terminate a facility that is placing residents in immediate jeopardy.

Nursing homes that have the SFF designation, including information about that designation, will now be noted on Nursing Home Compare, which can be accessed at www.medicare.gov. The site helps families find nursing homes in their area. Information about the homes includes performance scores on quality measures, staffing information and a three-year history of the home’s health, safety and fire inspection reports. The Web site will be updated with new information quarterly.

“Today’s action is the next step in our commitment to bring transparency and accountability to the process families must go through to find the care that is best for them and their family member,” Weems said.

tag: CMS, Medicare, NURSING HOME COMPARE,

National Infant Immunization Week, Protect Your Children Against Vaccine-Preventable Disease.

More Than Twenty Percent of Children Not Fully Protected Against Vaccine-Preventable Disease

The U. S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) will launch National Infant Immunization Week (NIIW) with events beginning April 19 and continuing through April 26, 2008.

Parents, caregivers and healthcare providers will be reminded during NIIW of the benefits of vaccination and the importance of routine childhood vaccination. One focus will be encouraging parents to become informed medical consumers by talking to their healthcare providers and asking them questions about vaccines.

“Immunization has been cited as one of the ten great public health achievements of the 20th century. We can now protect children from more vaccine-preventable diseases than ever before,” said Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases. “More than four million children are born each year in the U.S. and each one will need to be vaccinated. We prevent millions of cases of disease and thousands of deaths when we vaccinate them.”

There are now vaccines to protect children against 15 diseases before age two. Despite recent gains in infant immunization coverage, more than 20 percent of the nation’s two-year-olds are not fully immunized against infectious diseases to which they are especially vulnerable.

“A substantial number of children in the United States still aren't adequately protected from vaccine-preventable diseases," said Dr. Schuchat. "The suffering or death of even one child from a vaccine-preventable disease is an unnecessary human tragedy. Let us renew our efforts to ensure that no child, adolescent, or adult will have to needlessly suffer from a vaccine-preventable disease."

The number of cases of most vaccine-preventable diseases and deaths is at an all time low. Vaccination programs in the United States have contributed to the elimination of many vaccine-preventable diseases and have greatly reduced the incidence of most other vaccine-preventable diseases.

“Infants are more vulnerable to many diseases than older children and adults,” said Dr. Schuchat. “Yet it’s important for adults to also be vaccinated to keep themselves healthy and to keep from spreading infections to vulnerable people, including children.

Although vaccines have drastically reduced vaccine-preventable diseases, they are still circulating in many parts of the world and the United States can see a return of these diseases if we don’t maintain high vaccine coverage levels. Diligent efforts are required to ensure our immunization programs remain strong to protect our children.

Events throughout the United States and the entire Western Hemisphere will reach out to parents, caregivers, health care providers, and communities to highlight the benefits of vaccination and the need for routine vaccinations.

Education and media events in Washington, Rhode Island, and Connecticut will kick off this year’s celebration. Hundreds of communities across the United States are also expected to participate. Events will promote vaccinations, reminding parents and other caregivers how important it is to protect babies against vaccine-preventable diseases starting at birth.

For the fifth year, NIIW takes place at the same time as Vaccination Week in the Americas, a partnership among CDC, the Pan American Health Organization (PAHO), and the United States-Mexico Border Health Commission. Border kick-off events will be in El Paso, TX and Sundland Park, NM, and in Mexico.

For more information please visit www.cdc.gov/vaccines or call 1- 800-CDC-INFO (800-232-4636).

tag: HHS, CDC, National Infant Immunization Week,

Relistor for Opioid-Induced Constipation Approved By FDA

FOR IMMEDIATE RELEASE April 24, 2008

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

FDA Approves Relistor for Opioid-Induced Constipation
Drug will help reduce effects of drugs like morphine on bowel function

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients with a diagnosis of incurable cancer, end-stage Chronic Obstructive Pulmonary Disease (COPD) from emphysema, heart failure, Alzheimer’s disease with dementia, HIV/AIDS or other advanced illnesses.

Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally.

“This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advanced illness.” said Joyce Korvick, M.D., deputy director of the Division of Gastroenterology Products, FDA.

Relistor is an injectable medication. It can be administered as needed, but not to exceed one dose in a 24 hour period. The recommended starting schedule is one dose every other day as needed for patients with late-stage advanced illness. Relistor is not recommended for patients with known or suspected intestinal obstructions.

Common side effects include abdominal pain, gas, nausea, dizziness and diarrhea. If severe diarrhea, vomiting, nausea or abdominal pain occurs while taking Relistor, patients should discontinue use of the medication in consultation with their health care professional.

The safety and effectiveness of the drug was demonstrated in clinical studies conducted by the sponsors. The two randomized, double-blind placebo-controlled studies involving a total of 287 participants were conducted over a four month period. The median age of the study participants was 68 years, and 51 percent of the participants were women. In both studies, all patients had advanced late-stage illnesses with a life expectancy of less than 6 months. Prior to treatment with Relistor, participants had either less than three bowel movements in the week prior to treatment or no bowel movement for more than 2 days. Patients who were treated with Relistor had a significantly higher rate of elimination than those receiving placebo. The safety and effectiveness of Relistor have not been studied in pediatric populations.

Relistor is manufactured by Wyeth Pharmaceuticals Inc., Philadelphia, PA., and Progenics Pharmaceuticals, Tarrytown, NY.

tag: FDA News, Drug Approvals, Relistor, Opioid-Induced Constipation, morphine, methylnaltrexone bromide, Gastroenterology, Wyeth Pharmaceuticals, Progenics Pharmaceuticals,

Fight Drug-Resistant Tuberculosis, NIAID's Research Agenda.

The World Health Organization (WHO) estimates that 500,000 people worldwide have rug-resistant TB-multidrug, MDR TB, while the frequently fatal XDR TB, extensively drug-resistant TB has been detected in 46 countries. Factors contributing to the rising tide of drug-resistant TB include

• Lack of routine testing to determine TB drug-sensitivity
• Incomplete treatment of people infected with TB-causing bacteria
• The epidemic of TB in HIV-infected people
• Limited TB research by pharmaceutical companies, resulting in few new anti-TB drugs or other interventions.

The National Institute of Allergy and Infectious Diseases, NIAID research agenda complements domestic and international efforts to prevent and control the spread of MDR and XDR TB. Whereas the WHO's STOP TB Partnership plan emphasizes increased surveillance and control and treatment efforts, the NIAID agenda focuses on biomedical research. The Institute also collaborates with the Centers for Disease Control and Prevention and other NIH Institutes and Centers on TB research efforts in the United States.

To prevent the further emergence and spread of MDR and XDR TB, the NIAID agenda identifies areas of biomedical research that are likely to contribute substantially to a global public health response. Building on existing efforts within the international network of TB research, NIAID's priorities include efforts to

• Develop and test reliable technologies to rapidly diagnose TB and to identify drug resistance
• Define the most effective use of existing TB therapies and other antibiotics available to treat drug-resistant TB and develop new drugs, particularly to treat MDR and XDR TB
• Better understand the basic biology of TB-causing bacteria and their interaction with the human host that underlie the development of drug-resistant TB
• Understand the epidemiology of drug-resistant TB
• Investigate the various manifestations of TB in adults, children and those with co-infections, including HIV/AIDS
• Conduct research to develop new vaccines and other preventive strategies.

The full NIAID research agenda for MDR and XDR TB is available at: http://www3.niaid.nih.gov/topics/tuberculosis/default.htm
tag: WHO, NIAID, MDR TB, XDR TB

Digital Poison Awareness and Prevention Initiative By HRSA

Campaign Features New Web site with Online Ads, Bilingual Radio Jingles, Resources for Parents, Older Americans and Health Professionals

The Health Resources and Services Administration (HRSA) has announced a new poison prevention campaign in conjunction with National Poison Prevention Week, March 16-22.

The Poison Help Campaign addresses the alarming statistics on poisonings in the United States. This past year, more than 2.4 million poison exposures were reported to the nation's network of Poison Control Centers (PCCs). Unintentional poisoning deaths are the second leading cause of injury death for U.S. adults.

The campaign features a new Web site, PoisonHelp.hrsa.gov, with downloadable resources to inform and educate the public on poison prevention, and the national Poison Help toll-free number (1-800-222-1222) that callers can use to reach a PCC. The Campaign also serves as a resource for health professionals, PCC staff, and injury prevention organizations.

“Poisonings are preventable,” noted HRSA Administrator Elizabeth M. Duke. “This campaign will give the public valuable tools to prevent poison exposures and life-saving information about our national poison control centers.”

HRSA collaborated with PCCs and other national partners in developing the site, which highlights the real dangers associated with items used daily, from medications to cleaning products to plants or other items at home or at work.

HRSA administers the national Poison Control Program that supports the work of PCCs serving all states, Puerto Rico, the District of Columbia, Guam, the Federated States of Micronesia, and American Samoa. HRSA also funds the national Poison Help toll-free number that provides universal access to PCCs and immediate, 24-hour access to a nurse, pharmacist or other poison expert as well as bilingual services.

Campaign advertisements will appear on Web sites and radio stations that reach families and older Americans. The spots are also suitable for distribution in schools and local communities. Other resources available on the Web site include a bilingual radio jingle, a campaign brochure, seasonal tip sheets, Frequently Asked Questions, and a list of “Myths vs. Realities.”

For more information, visit PoisonHelp.hrsa.gov.

tag: Health Resources, HRSA, Poison Help Campaign, PoisonHelp.hrsa.gov,

Cimzia to Treat Crohn's Disease Get Approval From FDA

FOR IMMEDIATE RELEASE April 22, 2008

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

FDA Approves Cimzia to Treat Crohn's Disease

A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide.

Crohn's disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.

"Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn's, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

The most common side effects of Cimzia are headache, upper respiratory infections, abdominal pain, injection site reactions and nausea.

Patients taking Cimzia are at increased risk for serious adverse effects, including serious infections that can lead to hospitalization or death. Because Cimzia affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic infections. Cimzia is a blocker of TNF (tumor necrosis factor) and may cause lymphomas (a form of cancer) and other malignancies. Although an increased risk of tumors was not seen in studies of Cimzia, the modest size and relatively short duration of the controlled studies prevents any firm conclusion. Post-marketing studies and clinical trials will be required to obtain long-term safety data.

Patients taking Cimzia should be educated about how to identify an infection and be instructed to contact their health care professional at the first sign of infection while on Cimzia. In cases of serious infections, the drug should be discontinued immediately.

Cimzia is manufactured by UCB, Inc., Smyrna, GA.

For more information on Crohn's disease, visit:
Crohn's Disease–National Institute of Diabetes and Digestive and Kidney Diseases
www.digestive.niddk.nih.gov/ddiseases/pubs/crohns/index.htm

tag: Drug Approvals, FDA Approval, Crohn's disease, Cimzia, certolizumab pegol, tumor necrosis factor, lymphomas, UCB Inc.,

First Compact Heart Assist Device, Thoratec HeartMate II Approved By FDA.

FOR IMMEDIATE RELEASE April 21, 2008

Media Inquiries: Karen Riley, 301-827-6244 Consumer Inquiries: 888-INFO-FDA

FDA Approves First Compact Heart Assist Device

Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle do its work of pumping blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men. But the Thoratec HeartMate II Left Ventricular Assist System employs a first-of-a-kind design. Instead of the standard pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor. This allows the device to be slimmed down to a mere three inches in length and a weight of approximately one pound.

"The HeartMate II is an important advance in mechanical heart technology,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. "Until now, some heart transplant candidates have been underserved due to the large size of previously approved heart assist devices."

An electrical cable that powers the blood pump passes through the patient's skin to an external controller that the patient wears on his or her waist. The controller is powered either by batteries or connected to an electrical power outlet. Blood flow is set through the pump based on the patient's need, and the controller monitors pump performance, sounding alarms if it detects dangerous conditions or a possible malfunction. The system can operate on two external batteries, allowing the patient to move freely for up to three hours.

In a clinical study of 126 patients at 26 transplant centers, 57 percent of patients with the HeartMate II survived to heart transplant, which is comparable to the survival of patients treated with currently approved heart assist devices.

The product's manufacturer, Thoratec Corporation of Pleasanton, Calif., is required to conduct a post-approval study to further evaluate the HeartMate II's performance during commercialization.

#

tag: FDA Approval, Thoratec HeartMate II, Compact Heart Assist Device,

Bayer Schering Pharma AG files a patent infringement lawsuit against Watson Pharmaceuticals, Inc., and Sandoz, Inc. Over Contraceptive Yasmin

Leverkusen, April 21, 2008 – Bayer confirmed that Bayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals Inc. filed a patent infringement lawsuit in U.S. Federal Court in the Southern District of New York (New York) against Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Sandoz, Inc. Bayer Schering Pharma’s suit concerns Watson’s and Sandoz’s respective applications to the FDA for approval to market a generic form of Bayer Schering Pharma’s oral contraceptive Yasmin®. The patent at issue in the suit is Bayer Schering Pharma’s U.S. Patent No. 5,569,652.
Health Law, Drug Patents, Bayer Schering Pharma,Watson Laboratories, Sandoz,Watson Pharmaceuticals,yasmin

Real Men Wear Gowns, (A public service campaign designed to raise awareness among men about the importance of preventive medical testing by AHRQ)

Press Release Date: April 21, 2008

The U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality (AHRQ) joined with The Advertising Council today to launch a national public service campaign designed to raise awareness among middle-aged men about the importance of preventive medical testing.

Men are 25 percent less likely than women to have visited the doctor within the past year and are 38 percent more likely than women to have neglected their cholesterol tests (Source: AHRQ Medical Expenditure Panel Survey, 2005). Furthermore, men are 1.5 times more likely than women to die from heart disease, cancer and chronic lower respiratory diseases (Source: Centers for Disease Control and Prevention, 2005).

The new campaign encourages men over 40 to learn which preventive screening tests they need to get and when they need to get them. This campaign complements AHRQ's existing efforts toward improving the safety and quality of health care and promoting patient involvement in their own health care, including the "Questions are the Answer" campaign launched with the Ad Council in March 2007 and the "Superheroes" Spanish-language campaign launched in March 2008.

"We hope this campaign will inform men about the importance of prevention and show them that they should work with their health care providers to find out what they should do to stay healthy," said AHRQ Director Carolyn M. Clancy, M.D.

The campaign highlights the work of the AHRQ-sponsored U.S. Preventive Services Task Force, which is an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services. "By taking steps to prevent disease and stay healthy, men can live longer and more productive lives," said Task Force Chair Ned Calonge, M.D., M.P.H. "Prevention is a decision that includes participating in regular physical activity, eating a healthy diet and finding out which preventive medical tests are right for you."

Created pro bono for the Ad Council by McCann Erickson Detroit, the public service advertising campaign includes new television, radio, print and Web advertising featuring the theme "Real Men Wear Gowns." The lighthearted ads incorporate family as a key motivating factor for men to take a more active role in preventive health. They show the target audience that being a real man means taking care of themselves (and their health) in order to be there for their families and in the future. Ad Council research showed this was a strong motivating factor for men. To view the PSAs, visit www.ahrq.gov/realmen.

"Our research conducted during the development of this campaign found that despite their increased health risks men aren't taking preventive steps and are often only visiting their doctors when they experience symptoms," said Peggy Conlon, President & CEO of the Ad Council. "We are proud to continue our initiative with AHRQ with this wonderful series of PSAs designed to motivate men to take a more active role in their preventive health care.

The campaign encourages men to visit a comprehensive Web site, www.ahrq.gov/realmen. The site provides the recommended ages for preventive testing (as well as a list of tests), a quiz designed to test your knowledge of preventive health care, tips for talking with your doctor, a glossary of consumer health terms, and links to online resources where you can find more medical information.

Public service advertisements are being distributed to approximately 33,000 media stations nationwide this week. Per the Ad Council's donated media model, all of the new public service advertisements will air and run in advertising time and space donated by the media.

AHRQ

The Agency for Healthcare Research and Quality (www.ahrq.gov) is part of the U.S. Department of Health and Human Services. AHRQ's mission is to improve the quality, safety, efficiency and effectiveness of health care for all Americans. AHRQ's research helps people make more informed decisions and improve the quality of health care services.

The Advertising Council

The Ad Council (www.adcouncil.org) is a private, non-profit organization that marshals talent from the advertising and communications industries, the facilities of the media, and the resources of the business and non-profit communities to produce, distribute and promote public service campaigns on behalf of non-profit organizations and government agencies in issue areas such as improving the quality of life for children, preventive health, education, community well-being, environmental preservation and strengthening families.

tag: health, AHRQ, Real Men Wear Gowns, Real Men, Agency for Healthcare Research and Quality, The Advertising Council

Eye Cosmetics Safety

Click On The Image Or Here To Download a PDF Version Of The Document.

The volunteer organization Prevent Blindness America has designated April as Women's Eye Health and Safety Month—a good time to brush up on safe and hygienic ways to store, apply, wear, and remove eye cosmetics.

The Food and Drug Administration (FDA)regulates all cosmetics marketed in the United States, including mascara, eye shadows, eye liner, concealers, and eyebrow pencils.

Safety experts within the Office of Cosmetics and Colors in FDA's Center for Food Safety and Applied Nutrition (CFSAN) offer consumers the following advice:

Keep everything clean. Dangerous bacteria or fungi can grow in some cosmetic products, as well as their containers. Cleanliness can help prevent eye infections.

Always wash your hands before applying eye cosmetics, and be sure that any instrument you place near your eyes is clean. Be especially careful not to contaminate cosmetics by introducing microorganisms. For example, don't lay an eyelash wand on a countertop where it can pick up bacteria. Keep containers clean, since these may also be a source of contamination.

Don't moisten cosmetic products. Don't add saliva or water to moisten eye cosmetics. Doing so can introduce bacteria. Problems can arise if you overpower a product's preservative capability.

Don't share or swap. People can be harmed by others' germs when they share eye makeup. Keep this in mind when you come across "testers" at retail stores. If you do sample cosmetics at a store, be sure to use single-use applicators, such as clean cotton swabs.

Don't apply or remove eye makeup in a moving vehicle. Any bump or sudden stop can cause injury to your eye with a mascara wand or other applicator.

Check ingredients, including color additives. As with any cosmetic product sold to consumers, eye cosmetics are required to have an ingredient declaration on the label. If they don't, they are considered misbranded and illegal.

In the United States, the use of color additives is strictly regulated. Some color additives approved for cosmetic use in general are not approved for areas near the eyes.

If the product is properly labeled, you can check to see whether the color additives declared on the label are in FDA's List of Color Additives Approved for Use in Cosmetics. (Under "For More Information" below, see "Color Additives Approved for Use in Cosmetics" and "FDA's Import Alert for Cosmetics Containing Illegal Colors.")

Use only cosmetics intended for the eyes on the eyes. Don't use a lip liner as an eye liner, for example. You may expose eyes either to contamination from your mouth or to color additives that are not approved for use near the eyes.

Say "no" to kohl! Also known as al-kahl, kajal, or surma, kohl is used in some parts of the world for enhancing the appearance of the eyes. But kohl is unapproved for cosmetic use in the United States.

Kohl contains salts of heavy metals such as antimony and lead. Reports have linked the use of kohl to lead poisoning in children.

Some eye cosmetics may be labeled with the word "kohl" only to indicate the shade, not because they contain true kohl.

A product's "ingredient statement" should not list kohl—this is not an FDA-approved color additive. Check the ingredient statement to make sure that kohl is not present.

Don't dye eyelashes and eyebrows. No color additives are approved by FDA for permanent dyeing or tinting of eyelashes and eyebrows. Permanent eyelash and eyebrow tints and dyes have been known to cause serious eye injuries.

Use care with false eyelashes or extensions. False eyelashes and extensions, as well as their adhesives, must meet the safety and labeling requirements for cosmetics. Since the eyelids are delicate, an allergic reaction, irritation, or injury in the eye area can occur. Check the ingredients to make sure you are not allergic to the adhesives.

Don't use eye cosmetics that cause irritation. Stop using a product immediately if irritation occurs. See a doctor if irritation persists.

Avoid using eye cosmetics if you have an eye infection. Discard any eye cosmetics you were using when you got the infection. Also, don't use eye cosmetics if the skin around the eye is inflamed.

Don't use old eye cosmetics. Manufacturers usually recommend discarding mascara two to four months after purchase. Discard dried-up mascara.

Don't store cosmetics at temperatures above 85° F. Preservatives that keep bacteria or fungi from growing can lose their effectiveness, for example, in cosmetics kept for long periods in hot cars.

Report Problems

If you need to contact FDA concerning an eye cosmetic product problem, go to the "How to Report" page on FDA's MedWatch Web site at www.fda.gov/medwatch and use form FDA 3500. You can also find contact information for an FDA office near you at www.cfsan.fda.gov/~dms/district.html

tag: FDA Advisory, Cosmetics, Prevent Blindness America, Women's Eye Health and Safety Month, mascara, Say "no" to kohl!, eye shadows, eye liner, concealers, eyebrow pencils, CFSAN, kohl,

KFC Recalls Double Chocolate Chip Cakes

Check this article and then your fridge! Be aware of allergy issues.
Recallr: KFC Corporation Recalls Double Chocolate Chip Cakes
tag: FDA Recall, Food Recall, KFC Recall, Double Chocolate Chip Cakes Recall,

Celebrate National Playground Safety Week With Public Playground Safety Handbook

CPSC Promotes the Building of Safer Playgrounds to Help Reduce 200,000 Annual Injuries
Agency Releases Updated Public Playground Safety Handbook

WASHINGTON, D.C. – Children and playgrounds go together like chocolate and milk. Drop by any playground this spring and summer and you are bound to find dozens of active kids swinging, sliding, climbing and having a good time.

Yet a good time on the community or school playground can be ruined by a fall, entrapment, cut or another type of injury. Each year, about 200,000 children are treated in hospital emergency rooms for injuries related to playground equipment.

During National Playground Safety Week (April 21-25), CPSC staff is releasing an update to the popular Handbook for Public Playground Safety (PDF), which contains guidance for childcare personnel, school officials, designers, inspectors, parents and school groups on building safer playgrounds. Considered by many to be the model handbook of playground safety, the agency’s guidelines for public playgrounds have been incorporated by many municipalities into local and state building codes. The handbook provides specifications for creating safer play zones and avoiding hazards with equipment such as sharp points, entrapments, and entanglements. The updated Handbook for Public Playground Safety contains new guidelines from CPSC staff for playground equipment for children as young as six months old, track and log rolls for older children, and playground surfacing, as well as suggestions on protecting children from sun exposure on playgrounds. CPSC offers the following tips to help prevent injuries and other hazards on public and home playgrounds: The Commission provides these important life-saving tips:

• Always supervise children on play equipment to make sure they are safe.
• Purchase playground equipment that meets the latest safety standards.
• Maintain at least 9 inches of protective surfacing, including shredded/recycled rubber, wood chips, wood mulch (non-CCA treated), sand or pea gravel under and around playground equipment to cushion children from falls.
• Check that protective surfacing extends at least 6 feet in all directions from play equipment. For swings, extend protective surfacing in front and back of the swing, twice the height of the suspending bar.
• Repair sharp points or edges on equipment. Replace missing hardware and close “S” hooks that can cause injuries.
• Never attach ropes, jump ropes, clotheslines, pet leashes or cords of any kind to play equipment due to the strangulation hazard.

To order free copies of the CPSC staff’s updated Handbook for Public Playground Safety (CPSC-325), CPSC’s Outdoor Home Playground Handbook (CPSC-324), Home Playground Safety Checklist (CPSC-323), or any CPSC publication, email us at info@cpsc.gov. CPSC publications can also be downloaded at www.cpsc.gov

You can find more information about National Playground Safety Week at www.playgroundsafety.org the Web site for the National Program for Playground Safety.

tag: Playground Safety, National Playground Safety Week, CPSC News,

HHS Appeals the "Consumers Checkbook, Center for the Study of Services v. U.S. Department of Health and Human Services." Decision

FOR IMMEDIATE RELEASE Wednesday, April 16, 2008

Contact: HHS Press Office (202) 690-6343

Statement of the Department of Health and Human Services Regarding Appeal of Consumers Checkbook Decision

Consumers should have access to a health care marketplace that provides information on the quality and cost of health care – such transparency empowers them to make better health care choices. As a provider of health insurance to more than 44 million Americans, the Medicare program is a considerable resource for such information. In fact, broader use and release of Medicare data holds the potential not only to transform Medicare from a purchaser of services to a purchaser of value, but also to transform the private marketplace as well. HHS is continually working to ensure the availability of information from Medicare through such means as expanding Medicare’s Compare Web sites, collaborating with organizations outside of the Department, and proposing legislative changes to expand HHS’ authority to use and release this data.

The Department of Justice, on behalf of HHS, today submitted an appeal in the case of Consumers Checkbook, Center for the Study of Services v. U.S. Department of Health and Human Services. In 2006, the Consumers Checkbook organization sought raw Medicare claims data under the Freedom of Information Act (FOIA) that would reveal all procedures performed by physicians who treat Medicare beneficiaries in Washington, D.C., Maryland, Virginia, Illinois and Washington during 2004. HHS denied this request, based on existing law, and Consumer Checkbook brought suit. In August 2007, a federal court in the District of Columbia ordered HHS to release the data.

HHS is appealing this decision because of two conflicting court opinions that control HHS’ release of data. Release of certain Medicare claims data is currently governed, in part, under an existing order issued by a federal court in Florida in 1979. That order, which is still in effect, prohibits Medicare from releasing physician reimbursement data in a manner that would enable the user of that data to identify individual physicians. The court order states that this information is protected by the Privacy Act of 1974. The data sought by Consumers Checkbook, when combined with other publicly-available data on Medicare fees, could lead to the disclosure of annual Medicare reimbursement amounts for individual physicians. Release of the data would, therefore, result in a violation of the existing Florida court order. On the other hand, HHS faces the decision rendered last year by the District of Columbia court ordering the release of the data. HHS argues in its appeal that the recent decision is based on an erroneous application of the Florida court order and of the Freedom of Information Act’s exemption that protects privacy. The Department seeks resolution of this conflict from the Court of Appeals.

Beyond the legal issues that must be resolved, HHS recognizes and shares the goals of Consumers Checkbook. Like Consumers Checkbook, HHS seeks to support consumers and providers with quality performance and cost information for a variety of providers and plans. For many years, HHS has worked closely with providers and other stakeholders in developing and reporting quality information, including the use of national consensus-based quality performance measures. While Consumers Checkbook seeks to post the number of times a provider has performed a specific service, the quality measures used by HHS generate more valid, specific, and comprehensive information on the quality of care delivered.

Recent legislation proposed by the Administration to modernize and transform Medicare, as required following the 2007 funding warning, would also support HHS’ efforts to share data. Under the plan, Medicare spending would be reduced through the application of value-based principles and HHS would have enhanced authority to use and release Medicare claims data for quality improvement, performance measurement, public reporting, and treatment purposes.

Currently, HHS makes significant quality performance and cost information available on its Compare Web sites for hospitals, nursing homes, home health agencies, and other providers as well as Medicare Advantage and Part D prescription drug plans. Efforts are underway to expand the information available on these Web sites as well. For example, on March 28, 2008, HHS announced the addition of patient satisfaction measures to the Hospital Compare Web site.

The availability of this information supports the shared goals of HHS and Consumers Checkbook to help consumers make the best choices for their health care. It can likewise help providers themselves in continually improving the care they deliver. HHS encourages Consumers Checkbook and all consumers, providers, health plans, employers, and other stakeholders to use and direct others to this information on the Medicare Web site (http://www.medicare.gov/).

HHS continues to explore additional opportunities to ensure that Medicare data is available to support consumer and provider decision-making as well as the efforts of other stakeholders, while ensuring the privacy and security of individually-identifiable information as required by law.

Additional information on the following subjects can be found online:

Compare Web sites: http://www.medicare.gov/
Hospital Compare: http://www.hospitalcompare.hhs.gov/
Value-Driven Health Care: http://www.hhs.gov/valuedriven
Medicare Funding Warning Response Act of 2008: http://www.hhs.gov/asl/
Consumers Checkbook organization

tag: health law, HHS, Consumers Checkbook, Privacy Act of 1974,

Premature Infant Survival, A NIH Study

This report was published by NIH News
NIH Study Reveals Factors That Influence Premature Infant Survival, Disability

Based on observations of more than 4,000 infants, researchers in an NIH newborn research network have identified several factors that influence an extremely low birth weight infant's chances for survival and disability. The findings offer new information to physicians and families considering the most appropriate treatment options for this category of infants.

Every day, physicians and new parents must struggle with the type of care to provide to extremely low birth weight infants, the smallest, most frail category of preterm infants. These infants are born in the 22^nd through the 25^th week of pregnancy — far earlier than the 40 weeks of a full term pregnancy. Many die soon after birth, despite the best attempts to save them, including the most sophisticated newborn intensive care available. Some survive and reach adulthood, relatively unaffected. The rest will experience some degree of life long disability, ranging from minor hearing loss to blindness, to cerebral palsy, to profound intellectual disability.

The study authors referred to the issue of providing intensive care for extremely low birth weight infants. For example, physicians and family members may be reluctant to expose an infant to painful life support procedures if the infant is unlikely to survive. In such cases, they may opt for "comfort care," which provides for an infant's basic needs, but foregoes painful medical procedures. In deciding the kind of care to provide, specialists at intensive care facilities traditionally have relied heavily on an infant's gestational age — the week of pregnancy a premature infant is born. Gestational age is known to play a large role in the infant's survival. For this reason, in many facilities, intensive care is likely to be routinely given to infants born in the 25^th week of pregnancy, whereas infants born in the 22^nd week may be more likely to receive comfort care.

The study authors noted, however, that it is often difficult to assess gestational age. Moreover, an estimate that is inaccurate by only a week could result in an infant receiving care that was not appropriate for his or her individual case. To identify other factors that influenced survival and disability risk, the study authors observed more than 4,000 extremely low birth weight infants in their network.

The researchers published their findings in the April 17 New England Journal of Medicine. In addition to gestational age, factors influencing survival and risk of disability consisted of: whether the baby is male or female (sex); birthweight; whether the baby was a single baby, or one of two or more infants born; and whether the baby's mother was given medication during pregnancy to prompt the development of the baby's lungs. Known as antenatal steroids, these drugs are typically given to women in premature labor, or who are at known risk for giving birth prematurely.

Physicians and parents may access an online tool that generates statistics, based on the factors the researchers listed in their article, at http://www.nichd.nih.gov/about/org/cdbpm/pp/prog_epbo/. By specifying the baby's sex, weight, and information related to each of the variables listed above, physicians and family members can generate composite statistics on infant outcomes, based on the experiences of extremely low birthweight infants in the NICHD Neonatal Research Network study. The Web tool is not a substitute for a physician's careful assessment, but physicians and families may find the statistics it generates useful when considering the most appropriate care to provide an infant.

"Every individual is different, and no single tool can precisely predict a given baby's chances of survival or disability," said Duane Alexander, M.D., director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NIH Institute that supports the Neonatal Research Network. "However, the researchers' findings, and the tool they developed, provide important information that physicians and family members can consult to help them make the most informed treatment decisions possible."

Additional funding for the study was provided by NIH's National Center for Research Resources.

The researchers were led by Jon E. Tyson, M.D., of the University of Texas Medical School at Houston. Other authors of the study were Nehal A. Parikh, D.O., and Charles Green, Ph.D., also of the University of Texas Medical School at Houston; John Langer, M.S., of the Research Triangle Institute, Research Triangle Park, NC, and Rosemary Higgins, M.D., the program scientist for the NICHD Neonatal Research Network.

The study involved only infants born at level III neonatal intensive care facilities. For this reason, the study findings may not apply to infants born at level I and level II facilities.

Level III facilities are the most advanced of neonatal care facilities. They offer the highly specialized medical care that extremely low birth weight infants need to survive. Most extremely low birth weight infants are born in level III facilities, as it is routine practice to rush women likely to give birth prematurely to level III facilities. However, in some cases, a woman may give birth before she can be brought to a level III facility. These infants are typically cared for at level I and II facilities until they are stable enough to transport to a level III facility.

To conduct their analysis, researchers in the NICHD Neonatal Research Network observed 4,446 infants born at 22-25 weeks' gestational age at hospitals around the United States, explained the NICHD co-author of the study, Rosemary Higgins, M.D.. Dr. Higgins said that extremely low birthweight infants (those weighing less than 1,000 grams, or 2.2 pounds) make up about 1 percent of babies born in the United States each year, or roughly 40,000 babies a year.

Using standardized measures of mental development, vision, and hearing, the researchers assessed the health status of surviving infants when the infants were from 18 to 22 months corrected age — the age they would have been, had they been born full term. Dr. Higgins said that 49 percent of the infants in the study had died, 21 percent lived and did not have a disability, while the remainder experienced some degree of disability.

After conducting mathematical analyses of all the infants' cases, the researchers determined that infants were more likely to survive — and more likely to survive without disability — if they were of older gestational age, their mothers had been given corticosteroids, if they were female, were single born rather than part of a multiple birth, and been of a higher birthweight.

"Many neonatal intensive care units base treatment decisions mainly on gestational age," said Dr. Higgins. "We found that it's much more accurate if the assessment is based on the combination of 5 factors, rather than just on gestational age."

Dr. Higgins added that it is often difficult to accurately estimate gestational age, and a preterm infant may be as much as a week or two younger, or older, than believed.

She noted that the researchers found that race appeared to play no role in subsequent survival or chances of disability.

She stressed that the study data could not be used to predict with certainty the outcome of individual cases.

"A lot of medicine is a judgment call," Dr. Higgins said. "We provided our data in the hope that it would be helpful for making the best judgments for a particular situation."

A video interview with Dr. Higgins in which she provides additional information about the study and the online tool is available at http://www.nichd.nih.gov/news/resources/links/neonatal/.

The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute's Web site at http://www.nichd.nih.gov/.

tag: NIH News, Premature Infant Survival, Premature Infantl, National Institute of Child Health and Human Development

To Keep Our Children Heatlthy, We Can! (Ways to Enhance Children's Activity and Nutrition), Joins Turnoff Week

We Can! Joins National Call for Reducing Screen Time During Turnoff Week

Children and teens who spend more than a couple of hours a day on average in front of a TV, video, or computer screen, are more likely to be overweight than their peers who limit their screen time. We Can! (Ways to Enhance Children's Activity and Nutrition), a science-based national education program from the National Institutes of Health (NIH) to help children ages 8-13 stay at a healthy weight, is working with the Center for Screen Time Awareness (CSTA) and other national and community organizations to raise public awareness about the negative impact of excessive screen time. CSTA is a leading nonprofit organization focused on the impact of electronic media on society, health, education, family and community.

Turnoff Week, April 21-27, is an excellent time to start limiting recreational screen time and boosting physical activity and healthier living.

"We know that the more time a child spends in front of the TV or computer, the more likely he or she is to be overweight," said Acting U.S. Surgeon General Steven K. Galson, M.D., M.P.H. "Kids are spending more time sitting in front of screens every day than they do anything else except perhaps sleeping. For Turnoff Week, we are asking parents to turn off the screens and get active with their kids."

Although the Turnoff Week awareness campaign formally lasts only seven days each year, Galson added, "We encourage parents to regularly limit recreational screen time to fewer than two hours a day."

More than 12.5 million American children and adolescents are overweight, putting them at increased risk for chronic conditions such as high blood pressure, high blood cholesterol, type 2 diabetes, and asthma. Recognizing the prevention of childhood overweight as a national health priority, Galson leads the "Healthy Youth for a Healthy Future" childhood overweight and obesity prevention initiative and the U.S. Department of Health and Human Services' Childhood Overweight and Obesity Coordinating Council. The council is working with federal agencies and community stakeholders as they develop and foster programs such as We Can! that share the goal of providing options for community-based interventions.

To help families make important lifestyle changes to prevent childhood overweight, the We Can! program offers sensible, evidence-based guidance and tips for parents to help them not only reduce screen time, but also to encourage physical activity and better nutrition choices. "Today more than ever, parents need help to keep their kids at a healthy weight," said Karen A. Donato, S.M., program coordinator of We Can! and of the Obesity Education Initiative of NIH's National Heart, Lung, and Blood Institute (NHLBI). "By doing simple things like keeping TVs out of our kids’ rooms or logging screen time to get an accurate picture of daily habits, parents can begin to address this very real problem in a productive, positive way."

At the national launch of 2008 Turnoff Week, held at the University of the District of Columbia, Robert Kesten, CSTA executive director, pointed out some stark realities: "Many kids are spending more than six hours every day in front of screens, when they really should be spending less than two. As parents, we play a large role in changing this reality, and Turnoff Week is a great opportunity to start." CSTA is the leading nonprofit organization focused on the impact of electronic media on society, health, education, family and community. The organization provides information so people can make intelligent decisions leading to healthier lives, functional families and vibrant communities.

Consider the facts:

• Every day, children ages eight to 18 spend more than six hours watching TV, playing video games or using the computer for recreational purposes.
• The more time youth spend in front of the screen, the more likely they are to be overweight.
• Overweight is highest among children watching four or more hours a day.
• Research has shown that children who reduced their screen time showed decreases in body mass index (BMI), which measures body fat related to height, and decreases in unhealthy weight gain.

We Can! offers the following tips for parents:

• Agree to limit screen time to no more than 2 hours a day.
• Don’t put a TV in your child’s bedroom.
• Make screen time, active time by doing simple exercises during commercial breaks.
• Take a family walk after dinner instead of turning on the TV.
• Turn off the TV and play ball at the park.

Parents and others can download a free screen time log to help assess the amount of time children and other family members spend watching TV, playing video games, or using the computer for recreational purposes. The log sheets and other strategies to limit family screen time are part of the We Can! curriculum for parents, "We Can! Energize Our Families," which is offered by hundreds of community sites nationwide.

In addition to ideas for parents to turn screen time into active time, We Can! offers lessons for youth to adapt healthier lifestyles, including the Student Media Awareness to Reduce Television (SMART) curriculum and Media Smart Youth: Eat, Think, and Be Active! A Curriculum for Youth. Four NIH Institutes have combined their unique resources and activities to create We Can!: the National Heart, Lung, and Blood Institute; the National Institute of Diabetes and Digestive and Kidney Diseases; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; and the National Cancer Institute. We Can! is unique among existing youth obesity-prevention initiatives in its focus on reaching parents and families as a primary group for influencing young people. The program offers flexible, turnkey resources complete with partnership ideas and outreach opportunities to unite community organizations.

For more information, on We Can!, visit http://wecan.nhlbi.nih.gov or call toll-free 866-35-WE CAN (866-359-3226).

To arrange an interview with Ms. Donato, contact the NHLBI Communications Office at (301) 496-4236 or email nhlbi_news@nhlbi.nih.gov. To interview Dr. Galson, call (202) 205-0143. To speak with Mr. Kesten or for more information about CSTA, call 202-333-9220 or email rkesten@screentime.org.

tag: Children's Health, We Can!, National Institutes of Health, NIH, Center for Screen Time Awareness, CSTA, Turnoff Week, Child Obacity

Job Vacancies At Center for Biologics Evaluation and Research CBER, FDA

Chemist
GS-1320-14/14
Laboratory of Method Development
Division of Viral Products
Office of Vaccine Research and Review
Center for Biologics Evaluation and Research
Closes: April 25, 2008

Administrative Support Assistant (AO)
GS-0303-05/05
Office of Management
Center for Biologics Evaluation and Research
Closes: April 28, 2008

Mathematical Statistician (General) (Biomedical)
GS-1529-11/13
Closes: April 30, 2008

Chemist
GS-1320-11/13
Closes: April 30, 2008

Consumer Safety Officer
GS-0696-09/13
Closes: April 30, 2008

Pharmacologist
GS-0405-11/13
Closes: April 30, 2008

Microbiologist
GS-0403-09/13
Closes: April 30, 2008

Biologist
GS-0401-09/13
Closes: April 30, 2008

Tenure-Track or Tenured Research/Review Scientist, Immunology
Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Closes: April 30, 2008

Interdisciplinary Scientist
GS-13
Gene Therapies Branch
Division of Cellular and Gene Therapies
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
Closes: May 30, 2008

Mathematical Statistician
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research
Closes: May 30, 2008

Multiple Positions
GS-13
Division of Epidemiology
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research
Closes: May 30, 2008

Postdoctoral Fellowship
Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research
Closes: May 30, 2008

Engineer
Cellular Therapies Branch
Division of Cellular and Gene Therapies (DCGT)
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation & Research
Closes: June 1, 2008

Medical Officer
Clinical Review Branch
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Closes: June 1, 2008

tag: FDA News, FDA Jobs, Job Vacancies, Center for Biologics Evaluation and Research, CBER,

VBLOC Weight-loss Therapy, A Clinical Research Study By Stanford

Stanford researchers are conducting a national study to test a new weight-loss therapy,VBLOC that interfere with the nerves that tell people when they're hungry and in control how the body stores fat.Carrying extra weight is a real cause for concern. Overweight and obesity are risk factors for a number of diseases, including Type 2 diabetes (diabetes mellitus), high cholesterol, hypertension, osteoarthritis, obesity-related cardiomyopathy and perhaps even some forms of cancer (breast, colorectal, endometrial and kidney).

Although successful, long-term weight loss still requires a commitment to modifying lifestyle behaviors, there may be more you can do to empower healthy weight loss.

Unlike other types of bariatric surgery (laparoscopic banding or gastric bypass,) that alter the stomach’s anatomy, VBLOC Therapy is delivered by an implantable, investigational device intended to block signals carried on the vagus nerve between the brain and the digestive system that control sensations of hunger, satisfaction and fullness.

The device itself uses laparoscopically-implanted electrodes that deliver high-frequency, low-energy electrical impulses to block the signals conveyed through the vagal nerves. By being able to reversibly control these signals, VBLOC Therapy may aid in weight loss.

VBLOC Therapy includes both external and implanted components. VBLOC Therapy may be turned off and is designed to be reversible, programmable and non-invasively adjustable.

The EMPOWER clinical research study is now enrolling patients to evaluate the safety and effectiveness of the investigational device that delivers VBLOC Therapy.

Who Is a Candidate for Clinical Trials of VBLOC Therapy?

Individuals may be considered for participation in Clinical Trials of VBLOC Therapy if they:

• Have a Body Mass Index (BMI) of 40 to 45, or of 35 or greater and also suffer from at least one obesity related condition or co-morbidity such as diabetes, high blood pressure, high cholesterol or sleep apnea.
• Have completed at least six months of a supervised weight loss program and have failed to lose weight or to maintain weight loss.

For more information about VBLOC Therapy and the EMPOWER clinical research study, please call the nurse-staffed information line at 1-866-291-9146 Monday–Thursday, 7 a.m.–7 p.m. and Friday, 7 a.m.–6 p.m., CST.

CAUTION: Investigational device. Limited by Federal law to investigational use.

tag: Weight-loss, Weight Control, VBLOC Therapy, EMPOWER clinical research study, Body Mass Index, laparoscopic banding, gastric bypass, bariatric surgery

Marijuana Smokers Were Poisoned With Lead.

Marijuana smokers were poisoned with lead by cheating drug sellers trying to make more money. Illegal trades conducting more illegal methods of making profits. New England Journal of Medicine has a descriptive report with data tables and slides.

But the following, a portion of an easy more readable report from Wall Street Journal;

The poisoning was widely reported by German newspapers and television, and an anonymous lead-screening program was set up for marijuana users. Among 145 people who showed up for testing, 95 more cases were found.

The authorities do not know where the tainted marijuana came from or why the lead was added, but the German police suspect that it was done to make money. The samples tested contained 10 percent lead by weight, which translates into an increased profit of about $682 per pound of marijuana.

The patients are recovering and taking medicines called chelating agents to help remove the lead from their bodies. But it could take years to clear it completely, particularly from bones. And some were quite disillusioned to learn that poison was added to what they thought was a pure, all-natural product, said their doctor, Prof. Michael Stumvoll of University Hospital in Leipzig, who commented, “How naïve!”

tag: Lead Poisoning, lead tainted marijuana, marijuana

FDA offices in China Ready To Open Doors.

We reported about the FDA's inspection units potential move to China in March 14th;

FDA offices in China. Now the mass media is also getting the story with interviews etc. Here is an excerpt from Wall Street Journal.

SINGAPORE -- U.S. food and drug regulators will start working in China next month once Beijing gives its final approval, the top U.S. health official said Tuesday.

U.S. Health and Human Services Secretary Mike Leavitt said the U.S. Food and Drug Administration is planning to open an office in China as part of a change in strategy following product safety problems in Chinese imports that prompted several health scares and have been linked to some deaths.

"In the past, the United States and many other countries have employed a strategy of standing at the border trying to catch things that aren't safe," Mr. Leavitt said in an Associated Press interview during a visit to Singapore. However, he said it is impossible to inspect all of the massive amounts of goods that enter the country.

"So we're changing our strategy from one of trying to catch unsafe products to building safety into the products," Mr. Leavitt said. "Our purpose is not just inspection, it's building capacity and maintaining relationships between regulators."

The FDA's China office will be headed by Christopher Hickey, currently director of the Asia and the Pacific office at the U.S. Department of Health and Human Services, Mr. Leavitt said. Mr. Hickey, who was with Mr. Leavitt in Singapore, said Washington is still awaiting final approval from the Chinese government on the opening of the U.S. FDA's office there, but that the agency expected to begin work in May before the official opening of the office in October.

tag: FDA, FDA Regulations, FDA in China