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Monday, December 31, 2007

Happy New Year!

May the 2008 be a healthy year for all of you.
Meddesktop
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Sunday, December 30, 2007

Not to Eat Raw Oysters Harvested from the West Karako Bay

FOR IMMEDIATE RELEASE
December 29, 2007

Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Warns Consumers Not to Eat Raw Oysters Harvested from the West Karako Bay Section of Growing Area 3 in Louisiana
POSSIBLE CONTAMINATION WITH NOROVIRUS

The U.S. Food and Drug Administration (FDA) is warning consumers not to eat raw oysters harvested from West Karako Bay, a section of Growing Area 3 in Louisiana. These oysters, harvested from Dec. 3 through Dec. 21, may be contaminated with norovirus.

Symptoms of norovirus infection include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches, and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus, with the illness lasting one to two days. However, the illness can become serious for the very young, the elderly and people with weakened immune systems.

Consumers who ate raw oysters on or after Dec. 3 and experienced these symptoms are encouraged to contact their health care providers and local health departments. Consumers concerned about the origin of oysters they have recently purchased should contact the place of purchase to determine if the oysters were harvested from the identified area during the Dec. 3-21 period.

FDA has received reports of norovirus infection in seven individuals who ate raw oysters on Dec. 13 at a restaurant in Chattanooga, Tenn. The Tennessee Department of Health's test results from two of the ill patients were positive for norovirus. FDA confirmed the presence of norovirus in shell oysters harvested from the West Karako Bay section of Growing Area 3 and were served at the restaurant. Louisiana Department of Health and Hospitals closed the affected growing area on Dec. 21. FDA is working with the states involved to determine if any additional actions may be necessary to ensure public health protection.

The original shipper of the oysters is Prestige Oyster Company of Theriot, La. The company shipped the oysters to Bon Secour Fisheries in Bon Secour, Ala. Bon Secour Fisheries, in turn, shipped the oysters to the restaurant in Chattanooga. Considering the shelf-life of the product, it is possible that suspect oysters from the designated area are still available in other retail and food service settings.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

Cooking destroys the virus, eliminating the risk of illness for both healthy and immunocompromised individuals. FDA advises that it's always best to cook seafood thoroughly to minimize the risk of foodborne illness. Consumers can continue to enjoy oysters in many cooked preparations by following this advice:

At Restaurants and other Foodservice Establishments:

  • Order oysters fully cooked.

In the Shell:

  • Purchase oysters with the shells closed. Throw away any oysters with shells already opened.

To prepare oysters for eating, choose one of the following methods:

  • Boil oysters until the shells open. Once open, boil for an additional 3-5 minutes.
  • Steamer - add oysters to water that are already steaming and cook live oysters until the shells open; once open steam for another 4-9 minutes.
  • Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to not get fully cooked.
  • Discard any oysters that do not open during cooking.

Shucked Oysters:

To prepare oysters for eating, choose one of the following methods:

  • Boil or simmer shucked oysters for at least 3 minutes or until the edges curl.
  • Fry at 375 degrees for at least 3 minutes.
  • Broil 3 inches from heat for 3 minutes.
  • Bake at 450 degrees for 10 minutes.

For further information contact:

FDA Food Safety Hotline: 1-888-SAFEFOOD
FDA website: www.cfsan.fda.gov


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Truck With Possible E. Coli Tainted Beef Stolen

American Fresh Foods has announced that a truck loaded with 14,800 pounds of ground beef, some of it possibly infected with E. coli O157:H7, was stolen last Thursday. People have been advised to refrain from buying ground beef from dubious vendors. The refrigerated truck had been parked in the company's car park when it was stolen.

The company stressed that its regular meat products that are sold through normal retail outlets are safe. A company spokesman said there is concern for public safety regarding the stolen truck, because apart from their being possibly tainted produce inside, the truck was carrying a limited supply of refrigeration fuel, raising the chances that the produce could go rotten very quickly.

The company added that it is working closely with the USDA (US Department of Agriculture) and local authorities.

Below is a description of the products to look out for, they form part of this alert:

-- 73/27 Ground Beef
2 lbs approx weight packages
sell-by date 12.30.07
production times 14:27 - 15:28

-- 80/20 Ground Beef Chuck
2 lbs approx weight packages
sell-by date12.31.07
production times between 13:40 - 14:27

-- 85/15 Ground Beef Round
1 lb approx weight packages
sell-by date of 12.31.07
production times between 13:51 - 17:01

-- 90/10 Ground Beef Sirloin
1 lb approx weight packages
sell-by date of 12.31.07
production times between 13:49 - 15:35

-- 96/04 Extra Lean Ground Beef 4% Fat
1 lb approx weight packages
sell-by date of 12.31.07
production times 14:25 - 17:22

-- 73/27 100% Ground Beef; Rework Map
40 lbs net wt. box

-- Chuck 100% Ground Beef; Rework Map
260 lbs net wt. combo bin

-- Sirloin 100% Ground Beef; Rework
370 lbs net wt. combo bin

All the produce listed above was produced on 19th December.

About E. coli O157:H7 (Escherichia coli O157:H7)

E. coli O157:H7 is a strain (enterohemorrhagic) of Escherichia coli, a bacterium. It is a cause of foodborne illness. About 73,000 people are infected and 61 people die each year in the USA.

Infected young children and elderly people are the most susceptible to complications, such as bloody diarrhea, occasionally kidney failure, and hemolytic uremic syndrome (red blood cells are destroyed).

In most cases, however, the infected person will just experience abdominal pains, usually no fever, and diarrhea - the illness resolves within a week or so. In some cases the infected person will have no symptoms at all and never knew he/she had been infected.

The most common cause of human infection is the consumption of undercooked, contaminated ground beef, unpasteurized milk, swimming in contaminated water, drinking contaminated water, and eating contaminated vegetables.

Cooking any contaminated foods thoroughly will destroy the E. coli.

Preparing ground beef for safe consumption
(USDA)

-- Before and after you handle it wash your hands with warm soapy water for at least 20 seconds.

-- Wash cutting boards, utensils and dishes with hot soapy water.

-- Do not use the same cutting board for raw meat and other foods you are going to eat.

-- Clean spills immediately.

-- Do not let the raw meat near any foods that you are not going to cook.

-- Make sure ground meat patties have been cooked to a safe internal temperature of 160 F.

-- Do not rely on the meat's color to tell you whether it has been cooked to a high enough temperature. Color is not a reliable indicator.

-- The only way you can be really sure your meat has been cooked well enough to kill the bacteria is to use a thermometer to measure the internal temperature.

-- On a hot day (over 90 F) refrigerate the meat within one hour of purchasing it. On non-hot days do this within two hours of purchasing it.

-- Any meat you do not consume after cooking has to be refrigerated within two hours after cooking.
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Saturday, December 29, 2007

President George W. Bush signed into law a temporary extension of child health program

CRAWFORD, Texas (Reuters) - President George W. Bush on Saturday signed into law a temporary extension of a popular health insurance program for children after months of deadlock with the Democratic-led Congress.

The legislation extends the program that covers about 6.6 million poor children through March 31, 2009, leaving decisions about renewal to the next president and Congress.

The legislation also provides a 0.5 percent increase for Medicare doctors for six months, delaying a scheduled 10 percent pay cut.

Bush twice vetoed more ambitious earlier bills that would have expanded the children's health program to cover about 10 million children in low and moderate income families, despite bipartisan support.

Bush and Democrats have been locked in a fight over budget and spending and the president said the previous bills were too costly and would push more children into government-run health care instead of private plans.

Bush also objected to raising tobacco taxes to pay for the proposed expansion of the State Children's Health Insurance Program known as SCHIP.

Democrats had hoped for a short-term extension so they could reopen the battle before the November 2008 presidential and congressional elections, but Republicans forced them to extend it through March 2009.

In his weekly radio address, Bush vowed to push for spending restraint and low taxes in his last year in office.

"My resolution for the New Year is this: to work with Congress to keep our economy growing, to keep your tax burden low, and to ensure that the money you send to Washington is spent wisely -- or not at all," Bush said.

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Restricted Distribution Of Methadone Hydrochloride Tablets USP 40mg

As of January 1, 2008, manufacturers of methadone hydrochloride tablets 40 mg (dispersible) have voluntarily agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and maintenance treatment of opioid addiction, and hospitals. Manufacturers will instruct their wholesale distributors to discontinue supplying this formulation to any facility not meeting the above criteria.

Methadone is a long-lasting opioid medication used in the treatment of pain and narcotic addiction. The 5mg and 10 mg formulations indicated for the treatment of pain will continue to be available to all authorized registrants, including retail pharmacies. The 40 mg methadone formulation is indicated for the detoxification and maintenance treatment of opioid addiction. The 40 mg strength is not FDA approved for use in the management of pain. Thus, the distribution and availability of the 40 mg formulation will be limited to registrants in only those settings using the 40 mg formulation for the appropriate indication.

The DEA and pharmaceutical industry agree that the reported increase in methadone-related adverse events merits action and further agree to a united effort to assure that methadone is properly distributed, consistent with its approved uses. Industry and the federal entities involved commit to monitor the progress of this initiative.

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American Airlines Flight 293 Passengers Tracked Down For Possible Infection By Dangerous Strain of Tuberculosis.

The U.S. Centers for Disease Control and Prevention says a California woman boarded an American Airlines flight in New Delhi, India, on December 13th. The flight stopped at Chicago's O'Hare International Airport before continuing on to San Francisco. Santa Clara County Public Health Department and CDC officials are working on tracking down 44 people who sat within two rows of the woman on the flight 293. She is being treated in isolation at a California hospital.
A person typically needs prolonged exposure to a person with active TB to become infected, so only plane rides of eight hours or more are of primary concern to health officials, said Shelly Diaz, a CDC spokesperson.

The woman was admitted to the emergency room at Stanford Hospital on Dec. 19. She is currently in stable condition and receiving treatment in an isolation unit, said Dr. Marty Fenstersheib, the Santa Clara County health officer. The patient will remain in isolation until she is no longer infectious, which could take weeks. MDR-TB is not more infectious but it is difficult to treat, he said, possibly requiring treatment for two years.

World Health Organization guidelines call for people who have MDR-TB to avoid all commercial air travel until a physician advises they are no longer infectious.
Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30333, U.S.A.
Public Inquiries: (404) 498-1515 / (800) 311-3435

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Nutrition Information Poster For Fruits, Display Or Give Away To Your Patrons


First in a series of nutrition information posters, for Fruits, Vegetables, and Fish, here is a poster that could be printed and posted. See the print sizes below. You can print small as 8.5 x 11 inches or as larges as 29.75 x 38.5 inches. Today is the day for Fruits!

Nutrition Facts for Raw Fruits

Fruits - small PDF (463kb) (8.5 x 11 inches)
Fruits - medium PDF (481kb) (10.75 x 14 inches)
Fruits - large PDF (510kb) (18.75 x 24.25 inches)
Fruits - x-large PDF (564kb) (29.75 x 38.5 inches)

Fruits - text version/accessible version

FDA has created these in order to encourage retail stores that sell raw fruits, vegetables, and fish to participate in the voluntary point-of-purchase nutrition information program (21 CFR 101.42 through 101.45). These posters show nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. Retail stores are welcome to download the posters, print, display and/or distribute them to consumers in close proximity to the relevant foods in the stores. The list of food items with nutrition information reflects the updates published in the Federal Register of August 17, 2006 (71 FR 47439).

FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular

FOR IMMEDIATE RELEASE
December 28, 2007

Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA


These products are illegal drugs and contain undeclared active ingredients in prescription erectile dysfunction drugs

The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.

These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.

"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."

FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.

FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. FDA recommends that consumers should talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.

The products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.

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Friday, December 28, 2007

Voluven Approved By FDA To Treat Serious Blood Volume Loss following Surgery

FOR IMMEDIATE RELEASE
December 27, 2007

Media Inquiries:
Peper Long, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Approves Voluven to Treat Serious Blood Volume Loss following Surgery

This press release contains a revision posted Dec. 28, 2007, to correct the name of the manufacturer of the product Hespan.

The U.S. Food and Drug Administration today approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery.

Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues.

Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch molecules together and combining them with a salt solution, similar to the salt concentration typically found in blood. Voluven expands the volume of blood plasma – the liquid portion of the blood – and thus draws fluid into small blood vessels known as capillaries.

"Massive blood loss is a life-threatening problem. Approval of Voluven provides clinicians with an alternative blood volume product that is safe and effective in a wide range of age groups," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.

In clinical trials, Voluven was compared to other approved blood volume expanders. During orthopedic surgery, Voluven was as safe and effective in expanding blood volume as Hespan, an approved starch solution.

In newborns and infants undergoing major surgery, Voluven was as safe and effective as an equivalent volume of another expander containing albumin, a protein found in the blood. In other trials conducted overseas, Voluven was as safe as other blood volume expanders used in those countries in patients ranging in age from less than two years to 75 years who were undergoing a variety of surgical procedures.

The most common side effects from Voluven were nausea and itching.

Voluven is not recommended for the following:

  • patients with known abnormal sensitivity to the synthetic starch used in the product,
  • patients experiencing fluid overload
  • patients with kidney failure not related to low blood volume
  • patients on dialysis
  • patients with severe increases in blood levels of sodium or chloride
  • patients with bleeding inside the head

Voluven was not studied in patients with sepsis, an infection of the blood. A post-market clinical trial involving patients with sepsis is planned.

Voluven (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is manufactured by Fresenius Kabi, Bad Homburg, Germany. Hespan is manufactured by B. Braun Medical Inc. of Bethlehem, Penn.
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Thursday, December 27, 2007

CPSC Recalls For 27th December 2007


bullet Shopping Channel HSN Agrees to Pay $875,000 Civil Penalty
The U.S. Consumer Product Safety Commission (CPSC) announced today that HSN LP (previously known as Home Shopping Network), of St. Petersburg, Fla., has agreed to pay a civil penalty of $875,000. The civil penalty settles allegations that HSN LP failed to report in a timely manner, as required by federal law, serious injuries and hazards with the Welbilt Electronic Pressure Cookers.
bullet Gap Outlet Recalls Boys’ Jackets; Drawstring at Waist Poses Entrapment Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Gap Outlet, operated by Gap Inc., of San Francisco, Calif., is voluntarily recalling about 16,200 “Warmest Jacket” Boys’ Jackets. The jackets have a waist drawstring with a toggle that could become snagged or caught in small spaces or doorways, which can pose an entrapment hazard to children.
bullet North American Breaker Co. Recalls Counterfeit Circuit Breakers Due to Fire Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), North American Breaker Co. Inc. (NABCO), of Burbank, Calif., is voluntarily recalling about 50,000 Counterfeit Circuit Breakers. The recalled circuit breakers labeled “Square D” have been determined by Square D to be counterfeit and can fail to trip when they are overloaded, posing a fire hazard to consumers.
bullet Tot Tower Blocks Recalled by eeBoo Corp.; Children’s Toy Can Pose Choking Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), eeBoo Corp., of New York, N.Y., is voluntarily recalling about 170,000 Tot Tower toy blocks. The plastic covering on the toy blocks can detach, posing a choking hazard to children.
bullet World Dryer Recalls to Repair Hand and Hair Dryers Due to Electric Shock Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), World Dryer Corp., of Berkeley Ill., is voluntarily recalling about 25,000 World Dryer and Bradley Brand Hand and Hair Dryers. Some of the nozzles on these dryers are not grounded. If an electrical component comes into contact with an ungrounded nozzle, it can pose a shock hazard to consumers.

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Wednesday, December 26, 2007

California State court puts limits on health insurers' policy cancellations

San Francisco Chronicle;

Health insurers can't wait until a policyholder is sick or injured to investigate the person's medical history and then abruptly cancel the policy on the grounds that important information was left out of the original application, a state appeals court has ruled.

On Monday, the Fourth District Court of Appeal in Santa Ana called a halt to a practice that lawyers for policyholders claim is widespread. Known as "post-claims underwriting," it has led to numerous lawsuits - mostly unsuccessful so far - and state enforcement actions against insurers.

The court stopped short of a strict pro-consumer standard advocated by state regulators and plaintiffs' lawyers. But the justices said health insurers can rescind policies after the fact, because of misinformation on the application, only by showing that they conducted a reasonable investigation before issuing the policy, or that the applicant deliberately lied.

California law requires insurers to verify applicants' health information before issuing a policy, rather than waiting until they file a claim, the court said. The purpose is "to prevent the unexpected cancellation of health care coverage at a time coverage is needed most," said Justice Richard Aronson in the 3-0 ruling.

The ruling, the first by an appellate court on the issue, sets a precedent for other cases around the state. It applies only to health plans and insurance policies issued to individuals and their families and not to employer-based coverage, which does not require individual applications.

Tuesday, December 25, 2007

Does That WII Burn Calories?

If you got that WII for your youngster (or yourself) thinking that it will help him/her to burn calories, don't bet on it. According to some researchers, Playing new generation active computer games like WII uses significantly more energy than playing sedentary computer games but not as much energy as playing the sport itself. The energy used when playing active Wii Sports games was not of high enough intensity to contribute towards the recommended daily amount of exercise in children.
So get them or yourself outside and get that exercise and cool down after with that game console.
The technical report is available here at British Medical Journal.

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The Maramont Corporation, is recalling beef patty product due to possible contamination with Listeria monocytogenes

Recall Release CLASS I RECALL
FSIS-RC-058-2007 HEALTH RISK: HIGH

Congressional and Public Affairs
(202) 720-9113
Amanda Eamich

WASHINGTON, Dec. 25, 2007 - The Maramont Corporation, a Brooklyn, N.Y, firm, is voluntarily recalling approximately 88 pounds of a beef patty product that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.
The following product is subject to recall:
  • 2-oz packages of "BROILED BEEF PATTY (MICROWAVE)." The products were individually packaged and delivered from 17.25-pound cases. Each case label bears a lot code of "07352" and product number "2801." Each case label also bears the establishment number "EST. 5370" inside the USDA mark of inspection.

The beef patty products were produced on Dec. 18 and distributed on Dec. 19 to schools in the Jersey City, N.J., area.

Media and consumers with questions about the recall should contact company representative Paul Altobelli (718) 439-8900.

The problem was discovered through routine FSIS testing at the establishment. FSIS has received no reports of illnesses associated with consumption of this product.

Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease. Healthy people rarely contract listeriosis. However, listeriosis can cause high fever, severe headache, neck stiffness and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as serious and sometimes fatal infections in those with weakened immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.
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Monday, December 24, 2007

Merry XMas and Track Santa

Have a Merry Xmas and and Good New Year Break!
Track Santa OnLine As NORAD Follows Santa,!
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Are Plastic Bottles harming You?

Some researchers fear that a chemical found in plastic products we use every day could be harming the development of children and triggering a wide array of maladies from cancer to diabetes.

There is a roaring battle these days over whether a chemical called Bisphenol A is dangerous to humans. The chemical is ubiquitous - used to harden plastic in consumer products including baby bottles, food containers, cling wrap, toys, CDs, sunglasses, and thousands of other products.

A number of independent researchers say tests on animals and other research indicates that Bisphenol A can be toxic at very low doses.

But a review committee created by the National Institutes of Health's National Toxicology Program has yet to find significant danger from the drug. Last month the panel released a preliminary report finding that Bisphenol A is of some concern for fetuses and small children. But it found that adults have "almost" nothing to worry about.
I wonder?
Read the complete article at Baltimore Sun
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Saturday, December 22, 2007

FDA Develops New Self-assessment Tools to Help Improve the Security of Food and Cosmetics

Effort part of Food Protection Plan for ensuring the safety of domestic and imported foods eaten by American consumers

As part of the FDA’s comprehensive Food Protection Plan initiative, the agency today released self-assessment tools for industry to minimize the risk of intentional contamination of food and cosmetics. The tools are companion pieces designed to make previously issued industry guidance documents more user-friendly and practical.

Food protection is one of FDA’s top priorities and that means guarding against both intentional and unintentional contamination of foods. “The tools FDA is providing will help members of the food and cosmetic industry identify opportunities to better guard against intentional contamination of their products,” said CFSAN Acting Center Director David Acheson.

In 2003, FDA issued a set of Food and Cosmetic Security Preventive Measures Guidance documents. These documents are aimed at operators of food and cosmetic establishments, as well as businesses that produce, process, store, repack, relabel, distribute, sell or transport foods, food ingredients, and cosmetics to help them minimize the risk of malicious, criminal, or terrorist actions involving products under their control.

The guidance documents are:

  • Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance
  • Importers and Filers: Food Security Preventive Measures Guidance
  • Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance
  • Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures Guidance
  • Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors Food Security Preventive Measures Guidance

Using feedback from industry, the FDA repackaged the information found in the guidance documents and created a corresponding self-assessment tool for each document. By using the tools, industry members can get a quick and detailed assessment of the measures they currently have in place to protect against intentional contamination of their products. With this consolidated information, it will be easy for them to see where meaningful improvements to their current practices can be made.

The self-assessment tool asks the participant to mark the presence of a variety of food protection measures with a Y (Yes), N (No), N/A (Not Applicable), or Don't Know for each item. Examples of measures addressed by the self-assessment tools include the possibility of product tampering; identification of security procedures and responsibilities; and evaluation of response strategies in the event of product tampering or other intentional contamination.

For more information

The Food and Cosmetic Security Preventive Measures Guidance documents and self assessment tools http://www.cfsan.fda.gov/~dms/defguids.html

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FDA Issues Second Safety Warning on Fentanyl Skin Patch


Deaths and serious injuries from improper Use

The Food and Drug Administration today issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, the agency issued a similar warning to the public and to health care providers, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose. FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients.

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The skin patch was approved by FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant – meaning that they have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. The skin patch is most commonly prescribed for patients with cancer.

Recent reports to FDA describe deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant. In other cases, patients used the patch incorrectly: The patients replaced it more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch – all resulting in dangerously high fentanyl levels in the blood.

“There is an unmet need to provide patients suffering from chronic pain with safe and effective products that will not only alleviate their pain, but that will also be tolerable when used chronically,” said Bob Rappaport, M.D., FDA’s director of the Division of Anesthesia, Analgesia and Rheumatology Products. "While these products fill an important need, improper use and misuse can be life-threatening. Therefore, it is crucial that doctors prescribe these products appropriately and that patients use them correctly."

In its Public Health Advisory and Health Care Professional Sheet published today, FDA stressed the following safety information:

  • Fentanyl patches are only for patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines. The patches are not to be used to treat sudden, occasional or mild pain, or pain after surgery.
  • Health care professionals who prescribe the fentanyl patch, and patients who use it, should be aware of the signs of fentanyl overdose: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients should get medical attention right away.
  • Patients prescribed the fentanyl patch should tell their doctor, pharmacist and other health care professionals about all the medicines that they take. Some medicines may interact with fentanyl, causing dangerously high fentanyl levels in the blood and life-threatening breathing problems.
  • Patients and their caregivers should be told how to use fentanyl patches. This important information, including instructions on how often to apply the patch, reapplying a patch that has fallen off, replacing a patch, and disposing of the patch, is provided in the patient information that comes with the fentanyl patch.
  • Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death. Patients should not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds or take hot baths or sunbathe while wearing a patch. A patient or caregiver should call the patient’s doctor right away if the patient has a temperature higher than 102 degrees while wearing a patch.

This information will be reflected in the updated product information new medication guides for patients that manufacturers are being asked by FDA to develop.

The fentanyl skin patch is marketed under the brand name Duragesic by Johnson and Johnson, and generic versions of the product are sold by other manufacturers.

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FDA Approves Kuvan for Treatment of Phenylketonuria (PKU)

Orphan drug becomes first of its kind to treat this genetic disorder

The U.S. Food and Drug Administration today approved Kuvan (sapropterin dihydrochloride), the first drug of its kind approved to slow the effects of a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems. Tetrahydrobiopterin (BH4)-responsive phenylketonuria or PKU disease occurs in one out of every 12,000 to 15,000 live births in the United States.

PKU is a genetic disorder in which the enzyme phenylalanine hydroxylase (PAH), which helps our bodies break down phenylalanine (Phe), an amino acid found in foods, does not function properly. The result is high levels of phenylalanine in the blood. High levels of Phe are toxic to the brain and can lead to mental retardation, behavioral abnormalities, seizures, an inability to focus and organize information, and other neurologic complications.

“This new drug therapy represents hope for patients and families dealing with this difficult disease,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. “Now, for the first time, there is a medical intervention to help patients and their families slow the devastating neurological effects of this disease.”

Kuvan was first granted orphan drug designation by the FDA in January 2004. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. A drug is also eligible for orphan drug designation if it is intended to treat a disease of condition that affects more than 200,000 and there is no reasonable expectation that the cost of developing and making available a drug for the disease or condition will be recovered from sales of the drug.

In January, 2006 Kuvan was granted a fast track designation by FDA based on its potential to offer a significant advantage to patients over current treatment options. The Kuvan new drug application (NDA) also received a priority review by FDA.

Kuvan works by increasing PAH enzyme activity in PKU patients with some residual PAH enzyme function. This then leads to an increased breakdown (metabolism) of phenylalanine (Phe), resulting in lower levels of Phe in the blood.

Kuvan must be used in combination with a phenylalanine-restricted diet. A patient can override the effects of Kuvan by not following a Phe-restricted diet. Phenylalanine is present in foods that contain proteins such as meats, dairy and egg products.

Patients being treated with Kuvan must have their blood phenylalanine levels monitored frequently by their physicians or other health care professional to ensure their Phe levels are in the normal range. FDA also recommends patients work closely with a dietitian to manage their diets. In addition, the manufacturer will establish general disease registries for PKU to help FDA and physicians track how patients are doing on the medication around the world in order to monitor its safety, efficacy and any adverse events.
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The safety and efficacy of Kuvan was demonstrated in four short-term (up to 30 weeks) clinical studies with 579 patients with the disease. The data from these studies supported the clinical effectiveness of Kuvan in the treatment of BH4-responsive PKU. The most common adverse events reported included headache, diarrhea, abdominal pain, upper respiratory tract infection and throat pain.

Kuvan was developed by BioMarin Pharmaceutical Inc. based in Novato, Calif. in partnership with Merck Serono, a division of Merck KGaA, Darmstadt, Germany.

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Whole Foods Market Expands Allergy Alert on 365 Organic Everyday Value Swiss Chocolate Bars to All Varieties and Lots

Contact information

Ashley Hawkins
512-542-0381

FOR IMMEDIATE RELEASE --Austin, TX -- December 21, 2007 --- Whole Foods Market® is expanding the recall of the 365 Organic Everyday Value™ Swiss Milk Chocolate Bars with Rice Crisps with a Best If Used By date of 11/21/07, to include all varieties and all lots of chocolate bars with a Best If Used By date prior to 11/08/09. The products may contain undeclared milk and tree nuts. People, who have an allergy or severe sensitivity to tree nuts or milk, run the risk of serious or life-threatening allergic reaction if they consume these products.

Products affected by the recall are all lots with Best If Used by date prior to 11/08/09 as follows:

365 Organic Everyday Value Swiss Milk Chocolate with Rice Crisps UPC: 9948241730
365 Organic Everyday Value Swiss Dark Chocolate with Coconut Flakes UPC: 9948241731
365 Organic Everyday Value Swiss Dark Chocolate with Mint Crisps UPC: 9948241729
365 Organic Everyday Value Swiss Milk Chocolate UPC: 9948240805
365 Organic Everyday Value Milk Chocolate with Hazelnuts UPC: 9948240806
365 Organic Everyday Value Milk Chocolate with Almonds UPC: 9948240807
365 Organic Everyday Value Dark Chocolate UPC: 9948240808
365 Organic Everyday Value Dark Chocolate with Almonds UPC: 9948240809

The product was distributed to and sold at Whole Foods Market stores nationwide. 365 Organic Everyday Value™ Swiss Chocolate Bars are sold in 3 ounce sizes are in blue and white or maroon and white wrappers with a picture of chocolate pieces and the Swiss countryside on the front. The recalled chocolate bars have a Best If Used By date prior to 11/08/09, which is found on the back of the wrapper in a white box.

Consumers who have 365 Organic Everyday Value™ Swiss Chocolate Bars can return them to Whole Foods Market for a full refund. Consumers with questions may contact the company at (512) 542-0656 or PrivateLabel.CustomerService@WholeFoods.com.

The recall was expanded after subsequent testing of additional products indicated that the presence of undeclared allergens may be possible in additional lots.

"We have an extensive quality assurance process that works to insure the safety of our products. When we do find an issue, our course of action is to always put customer safety first,” said Bruce Silverman, Global Vice President of Private Label for Whole Foods Market. “Hence our decision last week to immediately remove potentially affected chocolate bar skus from the shelves until this further investigation was complete."

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New Era Canning Company Recalls Canned GFS Fancy Blue Lake Cut Green Beans


Contact:
Linda Miller
1-800-282-9007 Ext 111

FOR IMMEDIATE RELEASE --New Era, MI -- December 21, 2007 --- New Era Canning Company of New Era, Michigan is voluntarily recalling 171 cases/ 6 cans per case of 6 lbs. 5 oz. GFS Fancy Blue Lake Cut Green Beans, 4 Sieve, lot code 19H7FL , because they may be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death from botulism. Consumers are warned not to use the product even if it does not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these symptoms should seek immediate medical attention. The incubation period can be 2 hours to 2 weeks; in most cases the symptoms appear after 12 to 24 hours.

The canned green beans were distributed to foodservice customers in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Mississippi, Missouri, North Carolina, Tennessee, and Virginia and sold through GFS Marketplace stores in Indiana, Kentucky, and Tennessee.

The canned green beans are packaged in 6 lbs. 5 oz. cans under the GFS brand (GFS reorder #118737; UPC 93901 11873) with lot code 19H7FL printed on the end of the can. No other reorder numbers or lots are included in this recall.

No illnesses have been reported to date in connection with this problem.

The potential contamination of the product was found through testing by the Food and Drug Administration. New Era Canning in conjunction with the US Food and Drug Administration and the Michigan Department of Agriculture is thoroughly evaluating all processes and procedures to determine the cause of the problem.

Any food that may be contaminated should be disposed of carefully. Even tiny amounts of toxins ingested, inhaled, or absorbed through the eye or a break in the skin can cause serious illness. Skin contact should be avoided as much as possible, and the hands should be washed immediately after handling the food. Customers should not be encouraged to return product to Gordon Food Service. Customers who have the product or any foods made with these products should throw them away immediately. Double bag the cans in plastic bags that are tightly closed then place in a trash receptacle for non-recyclable trash outside of the home. Restaurants and institutions are encouraged to assure that such products are only placed in locked receptacles which are not accessible to the public. Additional instructions for safe disposal can be found at www.cdc.gov/botulism/botulism_faq.htm.

Anyone with questions can call FDA at 1-888-SAFEFOOD.

Customers with questions may contact New Era Canning at 1-800-282-9007 Ext. 111
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Cardinal Health Recalls Alaris Pump Module

Contact: Jim Mazzola (614) 757-3690

FOR IMMEDIATE RELEASE --DUBLIN, OH -- December 20, 2007 --- Cardinal Health today issued the following update to the company’s worldwide voluntary recall for its Alaris® Pump module:

On Nov. 5, 2007, Cardinal Health notified customers of a voluntary recall for all Alaris® Pump modules, model 8100 (formerly known as Medley™ Pump module), shipped prior to Sept. 27, 2007. Serial numbers for affected devices can be found at www.cardinalhealth.com/alaris/indexmodulealert.asp.

The reason for this recall is that the units may contain misassembled occluder springs (bent, broken, nested or missing). These conditions have occurred due to misassembly during manufacturing. Misassembled springs could lead to overinfusion that could result in serious adverse health consequences or death. Overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there is no warning or notification of an overinfusion.

The company became aware of the issue from a review of customer complaints and service data. Cardinal Health has received one report of an injury and two reports of patient deaths associated with the use of this device. The deaths could not be confirmed by the respective hospitals or Cardinal Health as definitively caused by this issue.

Instructions to Customers

Any customer inquiries related to this action should be addressed to Cardinal Health’s customer service center at 1-800-625-6627, with representatives available 24 hours a day, seven days a week. Additional information about the voluntary recall can also be found at www.cardinalhealth.com/alaris/indexmodulealert.asp.

Cardinal Health will work with customers to minimize disruption while completing an inspection of the devices as quickly as possible at the company’s service facility and repairing those units with misassembled springs. This includes dispatching field teams to customer sites and using a loaner pool of temporary substitute Alaris pump modules with hospitals while their pumps are being inspected at Cardinal Health's facility. Any devices found with misassembled springs will be repaired and then returned to the customer, along with their other devices that have passed inspection.

In the interim, the company has developed an occluder pressure test to provide customers a method to potentially identify affected devices prior to Cardinal Health’s inspection. The occluder pressure testmay not be effective in detecting all misassembled occluder springs, and a further inspection by the company is required. This test method was posted as an updated service bulletin 528A at www.cardinalhealth.com/alaris/indexmodulealert.asp. Follow hospital protocol related to monitoring that your infusion pumps are functioning correctly during use.

Cardinal Health notified customers by registered letter, posted the customer letter on the Cardinal Health web site and set up a dedicated call center for customer support. The Food and Drug Administration (FDA) has also been apprised of this action. The voluntary recall covers Alaris® Pump modules that were distributed to 46 states, the District of Columbia, Canada, Guam, Puerto Rico and Saudi Arabia. There have been approximately 201,000 Alaris® Pump modules distributed worldwide that are affected by this recall. All units shipped after Sept. 27, 2007 have undergone a new inspection process to confirm correct assembly of the occluder springs, and therefore the company has not included these units as part of this recall. The company is working on product improvements to the pump to minimize the possibility for future misassembly of the springs.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch web site at www.fda.gov/medwatch.

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AM2 PAT, Inc. Recalls Pre-Filled Heparin Lock Flush Solution

AM2 PAT, Inc. Issues Nationwide Recall of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes)

Contact:
AM2PAT, INC.
919-552-9689

FOR IMMEDIATE RELEASE --ANGIER, NC -- December 20, 2007 --- AM2 PAT, Inc., Angier, North Carolina, is initiating a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. The heparin IV flush syringes have been found to be contaminated with Serratia marcescens, which have resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Consumers and user facilities who have these recalled pre-filled syringes, Heparin Lock Flush Solution USP, should stop using the product immediately. Please quarantine the affected product in your inventory and return it to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, 100 units/ml, 5ml in pre-filled syringes.

LOT# NDC# CATALOG #
070926H 64054-1003-02 1003-02

The firm voluntarily recalled this product after confirming bacterial contamination in some end user samples.

This product was distributed nationwide including the following states: Florida, Texas, Illinois, Colorado, and Pennsylvania.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.
The firm is continuing to work with FDA and CDC on monitoring this situation and FDA will provide continuing updates.

Consumers with questions may contact the company at 1-919-552-9689 or 847-691-6500 { MONDAY THROUGH FRIDAY 9AM EASTERN TILL 5PM EASTERN}

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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CPSC Recalls For 22ndDecember 2007


bullet Super Magnet Toys Recalled by MTC Due to Aspiration and Intestinal Hazards
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Man’s Trading Company, of Brisbane, Calif., is voluntarily recalling about 2,800 Super Magnet Toys. The magnet attached to the bottom of a small toy panda can detach. If swallowed or aspirated by young children, the magnets can attract each other internally and cause intestinal perforations or blockages, which can be fatal.
bullet Teething Rings Recalled by Empire Silver Due to Choking Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Empire Silver Company, of Brooklyn, N.Y., is voluntarily recalling about 1,000 Sterling Silver Teething Rings. The silver ball that holds the ring in place can separate and release the beads inside. This poses a choking and aspiration hazard to infants.
bullet Pressure Cookers Recalled By Manttra Inc. Due to Burn Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Manttra Inc., of Virginia Beach, Va., is voluntarily recalling about 38,250 Pressure Cookers. If the pressure cookers are not closed properly, the lid can separate and allow hot contents to spill out. This poses a risk of burns to consumers.
bullet Girls’ Hooded Sweatshirts with Drawstrings Recalled by Liberty Apparel Due to Strangulation Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Liberty Apparel Co. Inc., of New York, N.Y., is voluntarily recalling about 12,000 Jewel brand girls’ hooded sweatshirts. The garments have a drawstring through the hood, which can pose a strangulation hazard to children.
bullet Lenox Recalls Covered Warmer Dishes Due to Fire and Burn Hazards
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Lenox Group Inc., of Bristol, Pa., is voluntarily recalling about 43,000 Covered Warmer Dishes with Racks. Flames from the tea candle can extend up the sides of the dish. In addition, a label on the bottom of the dish causes excessive smoke when exposed to the flame. This poses fire and burn hazards to consumers.

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Friday, December 21, 2007

CIGNA May Get Sued Over The Death Of A 17-Year-Old Girl

Time to stop insurance companies and clerks acting like doctors.
ANGELES (AP) A California family is planning to sue a health insurance company after the death of a 17-year-old girl.

The girl had been suffering from leukemia. Doctors determined that she/ needed a liver transplant after developing complications.

Cigna HealthCare initially refused to pay for the transplant, saying the procedure was experimental and outside the scope of coverage.

That decision was reversed yesterday as about 150 teenagers and nurses rallied outside the company's office. But the girl died just hours later.

Now the family's attorney wants prosecutors to press murder or manslaughter charges against the health insurer, saying the company "maliciously killed" the girl by refusing to pay for the transplant.

In a statement made before the girl died, Cigna said it sympathized with the family and would provide coverage, but that there was a lack of medical evidence showing the procedure would work.
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'CIGNA Should Have Listened to Her Doctors And Approved the Transplant a Week Ago'

GLENDALE, Calif.--(BUSINESS WIRE)--The California Nurses Association/National Nurses Organizing Committee today blasted insurance giant CIGNA for failing to approve a liver transplant one week earlier for listen to 17-year-old Nataline Sarkisyan, who tragically died last night just hours after CIGNA relented and agreed to the procedure following a massive national outcry.

On Dec. 11, four leading physicians, including the surgical director of the Pediatric Liver Transplant Program at UCLA, wrote to CIGNA urging the company to reverse its denial. The physicians said that Nataline currently meets criteria to be listed as Status 1A for a transplant. They also challenged CIGNAs denial which the company said occurred because their benefit plan does not cover experimental, investigational and unproven services, to which the doctors replied, Natalines case is in fact none of the above.

So what happened between December 11, when CIGNA denied the transplant, and December 19 when they approved? A huge outpouring of protest and CIGNAs public humiliation. Why didnt they just listen to the medical professionals at the bedside in the first place? asked Geri Jenkins, RN, a member of the CNA/NNOC Council of Presidents who works in a transplant unit at the University of California San Diego Medical Center.

On Thursday, CIGNA was bombarded with phone calls to its offices across the country while a rally sponsored by CNA/NNOC, with the substantial help of the local Armenian community, drew 150 people to the Glendale offices of CIGNA all of which produced the turnaround by CIGNA to finally reverse its prior denial of care.

CNA/NNOC Executive Director Rose Ann DeMoro called the final outcome a horrific tragedy that demonstrates what is so fundamentally wrong with our health care system today. Insurance companies have a stranglehold on our health. Their first priority is to make profits for their shareholders and the way they do that is by denying care.

It is simply not possible to organize major protests every time a multi-billion corporation like CIGNA denies care that has been recommended by a physician, DeMoro said. Having insurance is not the same as receiving needed care. We need a fundamental change in our healthcare system that takes control away from the insurance giants and places it where it belongs in the hands of the medical professionals, the patients, and their families.

Contacts

For California Nurses Association
Charles Idelson, 510-273-2246
Liz Jacobs, RN, 510-435-7674
Shum Preston, 510-273-2276

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Thursday, December 20, 2007

Woman Who Claimed to Cure 'Lou Gehrig's Disease' Sent To Prison

FDA Investigation Leads to Prison Sentence for Woman Who Claimed to Cure 'Lou Gehrig's Disease'

The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), commonly called “Lou Gehrig’s Disease.”

Elizabeth Lerner, a.k.a. "Elizabeth Cooperman," 38, of Egg Harbor City, N.J., was sentenced on Dec. 12, 2007, in the U.S. District Court of New Jersey for defrauding two ALS patients and their families. She also was ordered to pay $35,390 in restitution to the victims of the scheme and a criminal fine of $7,500.

"The FDA's Office of Criminal Investigations aggressively pursues those that provide false hope to patients by making unproven medical claims to unsuspecting patients — many with serious or life-threatening conditions who are desperate for a medical cure," said Terry Vermillion, director of FDA's Office of Criminal Investigations.

Lerner and her co-conspirator Charlene C. DeMarco, 55, a former doctor of osteopathy in Egg Harbor City, were convicted in December 2006 of all charges contained in an 11-count federal indictment. The indictment included one count of conspiracy to commit mail and wire fraud, three counts of mail fraud, six counts of wire fraud, and one count of money laundering.

DeMarco was sentenced on September 2007 to 57 months in prison, ordered to pay $32,190 in restitution to victims of the scam, and to pay a criminal fine of $7,500.

Evidence showed that from October 2002 until November 2004, DeMarco and Lerner agreed to defraud ALS patients and their families by claiming they could treat ALS patients with stem cell therapy, even though they knew they could not. The defendants falsely told their patients and their families that DeMarco had previously received FDA approval to treat ALS.

Jurors heard testimony from 24 government witnesses and viewed hundreds of pieces of evidence regarding the defendants' scheme.

Prosecutors said that Lerner and DeMarco also attempted to defraud two patients and their families in Louisiana of more than $140,000 and successfully obtained more than $40,000 from the scheme. Witnesses described how Learner and DeMarco illegally laundered money they received and used the proceeds for personal expenses.

This case was prosecuted by the United States Attorney's Office for the District of New Jersey in Camden and was investigated by the FDA's Office of Criminal Investigations’ Metro Washington Field Office.

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Royal Seafood Baza Inc. Recalls Dried Roach (Fish)

Royal Seafood Baza Inc. Recalls Dried Roach (Fish) Due to Possible Health Risk

Contact:
Royal Seafood Baza Inc.
718-318-1888

FOR IMMEDIATE RELEASE -- December 19, 2007 -- Royal Seafood Baza Inc, located at 50-01 Rockaway Beach Blvd, Far Rockaway, New York is recalling packages of "Dried Roach" (Fish) because the product may be contaminated with Clostridium Botulinum, which can cause botulism, a serious and potentially fatal food borne illness.

The sale of this type of fish is prohibited under New York State Department of Agriculture and Markets regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than in any other portion of fish. Uneviscerated fish has been linked to outbreaks of botulism poisoning. Symptoms of botulism include blurred or double vision, general weakness, and poor reflexes, difficulty swallowing and respiratory paralysis.

The recalled "Dried Roach" (Fish) was distributed to Net Cost Market stores located in Brooklyn and Staten Island, New York and Philadelphia, Pennsylvania. The product comes in clear plastic pouches of various weights with a product code 20.03.08. It is product of Latvia.

No illnesses have been reported to date in connection with this problem. Consumers who have "Dried Roach" (Fish) are urged to return it to the place of purchase for full refund. Consumers with questions should contact the company at 1-888-776-3958.

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Top Line Specialty Produce of Los Angeles Ca, Recalls "Green Paradise" Basil

Top Line Specialty Produce Recalls "Green Paradise" Basil Because of Possible Health Risk

Contact:
Alberto Martinez
(213) 747-9200

FOR IMMEDIATE RELEASE -- December 19, 2007 -- Top Line Specialty Produce of Los Angeles Ca, is voluntary recalling its 12 x 1 pound boxes of "Green Paradise label" Fresh Italian basil, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with this organism often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with "Salmonella" can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), Endocarditis and arthritis.

The recalled "Green Paradise Basil" was distributed to Food Service Distributors through direct shipping on 12/06/2007 in Southern California, Illinois and Texas.

The product comes in a 12 x 1 lb box marked with lot # 1219 on the side of the box.

No illnesses have been reported to date in connection with this problem.

The potential for contamination was noted after routine testing revealing evidence of Salmonella in some 1lb units of the basil. Imports of this label ("Green Paradise") have been suspended while FDA and the company continue their investigation as to the source of the problem.

Consumers who have purchased the affected boxes of "Green Paradise Italian Basil" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-213-747-9200.

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CPSC Recalls For 20th December 2007

bullet Christmas Candle Sets Recalled By Specialty Merchandise Corp. Due to Fire Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Specialty Merchandise Corporation (SMC), of Simi Valley, Calif., is voluntarily recalling about 13,000 Christmas Candle Sets. The snowman candle could tip over and the exterior coating on both candles can ignite, posing a fire hazard.
bullet DeWALT Recalls Cordless Drills due to Fire Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), DEWALT Industrial Tool Company, of Towson, Md., is voluntarily recalling about 346,000 DEWALT Cordless Drills. The trigger switch of the cordless drill can overheat, posing a fire hazard to consumers.
bullet McQuay Recalls Air Conditioners/Heat Pumps Following Fires
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), McQuay International, of Minneapolis, Minn., is voluntarily recalling about 8,800 Remington and McQuay “ComfortPac” Air Conditioners and Heat Pumps. Wires in the heater element can overheat and spark, posing a smoke and fire hazard to consumers.
bullet US Consumer Product Safety Commission Acting Chairman Nancy Nord Applauds House Vote on Landmark Consumer Product Safety Legislation
The Acting Chairman thanks the U.S. House of Representatives for passing landmark legislation today that finally gives the CPSC the additional tools and resources to address the growing issue of imports and other important product safety issues.
bullet AAFES Recalls “Soldier Bear” Toys Due to Violation of Lead Paint Standard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), AAFES (Army & Air Force Exchange Service), of Dallas, TX, is voluntarily recalling about 11,400 Soldier Bear Toys. The surface paint on the toys contains excessive levels of lead, violating the federal lead paint standard.
bullet American Honda Motor Corp. Recalls Lawn Mowers Due to Laceration Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), American Honda Motor Corp., of Torrance, Calif., is voluntarily recalling about 167,000 Honda Walk-Behind Lawn Mowers. The cutting blades could rotate under power when the control lever is released. The lawn mowers do not comply with mandatory federal safety standards for lawn mowers. The spinning blade poses a serious laceration hazard to consumers.
bullet Stuffer Bear Recalled Due to Choking Hazard; Sold Exclusively at Victoria’s Secret Internet site
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Victoria’s Secret, of Columbus, Ohio, is voluntarily recalling about 80 Holiday Cosmetics Stuffer Bears. The neck medallion zipper pull can detach, posing a choking hazard to young children.
bullet Discount School Supply Recalls Measuring Chart Due to Violation of Lead Paint Standard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Discount School Supply, of Monterey, Calif., is voluntarily recalling about 13,000 Giant Measuring Charts. The paint on the grow chart contains excess levels of lead, violating the federal lead paint standard.
bullet Bombardier Recreational Products Recalls Snowmobiles Due to Crash Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Bombardier Recreational Products Inc. (BRP), of Quebec, Canada, is voluntarily recalling about 480 Ski-Doo® Model Year 2008 MXZ X 600 RS Snowmobiles. A defect in the carburetor can prevent the throttle from freely returning to the idle position. This can result in an unexpected loss of control leading to a collision and cause serious injuries or death.


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Wednesday, December 19, 2007

Good Health News and a Hospital That Cares About Everyone

(PRWEB via PRWebDirect) December 19, 2007 -- When so much of the news we hear about the US health care system is what’s breaking or broken, it’s inspiring to hear the story of a hospital that is transforming stress and transforming lives. Delnor-Community Hospital in Geneva, Illinois recently received two awards from HeartMath®, an innovative research, technology and training organization which is helping hospitals across the US create healthy environments for both staff and patients.
Delnor is the first hospital in the US to receive the HeartMath Hospital designation, the highest recognition awarded by HeartMath to honor those hospitals that meet or exceed standards of quality, staff well-being and patient care. The award also honors the leaders who appreciate and recognize the importance of employee well-being. Since implementing the HeartMath program, Delnor has seen increased employee satisfaction, reduced staff turnover, improved communications at all levels, and high levels of patient satisfaction. The second award Delnor received, HeartMath’s Continuity of Care Award, recognizes a hospital’s long-term commitment to integrating HeartMath practices into the culture of the hospital for staff and patients, as well as to the community. These awards were presented by Bruce Cryer, HeartMath’s CEO, on December 5, 2007 at Delnor’s Quarterly Leadership Conference in Geneva, Illinois.

It was in 2000 that Delnor’s senior management team passionately committed to a hospital-wide initiative to address issues such as reducing employee turnover rates, vacancy rates and costs. They also wanted to become a national leader in patient satisfaction as well as becoming the hospital of choice in their primary market. To meet these objectives Delnor embarked on a multi-faceted strategic initiative, which included HeartMath’s programs and supportive tactics in service excellence to achieve these goals. Delnor has advanced to the top by demonstrating how the real meaning of care can create an exemplary work environment.

Delnor’s Chief Operating Officer, Tom Wright, says, “The HeartMath programs have enabled our leaders to sustain peak performance, to manage more efficiently in a changing environment and to maintain work life balance. For our staff, it has made the difference between required courtesy and genuine care.”

The results to date: Delnor has ranked number one nationally in employee satisfaction for the last four years. Delnor has also consistently exceeded the 90th percentile in patient satisfaction, after being at 73% prior to HeartMath. Delnor’s turnover has significantly improved, dropping from 27% to an average 6% turnover rate with their HeartMath-trained staff, whereas the industry standard is 11-12% and the national average hovers around 25%. Diane Ball, a certified HeartMath trainer at Delnor, says, “Our employees know that Delnor truly cares about their well-being on all levels and that makes all the difference. Our staff is happy, they enjoy working here and truly want to be here, and that’s felt by our patients when it comes to their care.”

This is not the first award Delnor has received in its ongoing transformation. In 2002 Delnor was honored with the Corporate Health and Productivity Management Award. In 2005 Delnor won the Management Innovations Award -- with HeartMath -- from the American College of Healthcare Executives and has been named to the Honor Roll of the Center for Companies that Care for the past three years.

HeartMath’s CEO Bruce Cryer remarked, “This is a time of unequalled stress in health care. The nursing shortage has reached unprecedented proportions, and high turnover rates, sick leave, medical errors, and shrinking reimbursement are adding even greater stress. With these compounding pressures, personal and organizational effectiveness suffer. Delnor is an inspiring example of a hospital which is putting care at the top of the priority list, creating a culture of care for their workforce as well as for the patients and their community. And they’re proving they can build a strong, viable hospital in the process,” says Cryer. “We’re extremely proud of their commitment to this process. Working with Delnor to facilitate their goals and watching their progress unfold has been very rewarding.”

Delnor has also outreached to their community with HeartMath programs for students grades 7 to 12 to help them learn how to transform test anxiety and improve test performance. They’re also offering HeartMath programs for cardiac and diabetes patients to help them learn how to reduce the stress and anxiety of their diseases.

To learn more about Delnor-Community Hospital and their community programs see http://www.delnor.com. To learn more about HeartMath’s programs for health care, see http://www.heartmath.com/health/hospital/index.html.

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CPSC Recalls For Dec 19th 2007


bullet Full Body Safety Harnesses Recalled by Gorilla Due to Fall Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Gorilla Inc., of Flushing, Mich., is voluntarily recalling about 60,000 Full Body Safety Harnesses. The harnesses could fail during use, resulting in a hunter falling from the tree stand and suffering serious injuries or death.
bullet Bicycle Helmets Recalled by Specialized Due to Failing Helmet Standard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Specialized Bicycles, of Morgan Hill, Calif., is voluntarily recalling about 3,000 Specialized Bicycle Helmets. The helmets fail testing required under CPSC's safety standard for bicycle helmets. This can pose a head injury hazard to riders in a fall.
bullet Deadly Danger: CPSC Urges Parents To Not Place Infants on Air Mattresses
The U. S. Consumer Product Safety Commission (CPSC) is warning families nationwide that air mattresses are too soft for use with sleeping infants. Never place infants to sleep on air mattresses or other soft surfaces (such as water beds and adult beds), which are not specifically designed or safe for infant use.

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