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The U.S. Food and Drug Administration (FDA) is alerting the public to counterfeit blood glucose test strips being sold in the United States for use with various models of LifeScan, Inc., One Touch Brand Blood Glucose Monitors used by people with diabetes to measure their blood glucose.

The counterfeit test strips potentially could give incorrect blood glucose values–either too high or too low–which might result in a patient taking either too much or too little insulin and lead to serious injury or death. No injuries have been reported to FDA to date.

The counterfeit test strips are:

* One Touch Basic®/Profile® (lot #272894A, 2619932 or 2606340) test strips; and,
* One Touch Ultra® (lot #2691191) test strips.

Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician. Consumers with questions may contact the company at 1-866-621-4855.

The counterfeit test strips were distributed to pharmacies and stores nationwide–but primarily in Ohio, New York, Florida, Maryland and Missouri–by Medical Plastic Devices, Inc., Quebec, Canada and Champion Sales, Inc., Brooklyn, N.Y.

The counterfeit test strips can be identified by the following characteristics:

Counterfeit One Touch Basic/Profile Test Strips

* Lot Numbers 272894A, 2619932 or 2606340
* Multiple Languages- English, Greek and Portuguese text on the outer carton
* Limited to 50-Count One Touch (Basic/Profile) Test Strip packages

Counterfeit One Touch Ultra Test Strips

* Lot Number 2691191
* Multiple Languages- English and French text on the outer carton
* Limited to 50-Count One Touch Ultra Test Strip packages

LifeScan alerted FDA of the counterfeit test strips. The agency is investigating the matter.

LifeScan is alerting the public via a press release and is notifying pharmacists, distributors, and wholesalers through a letter. In its letter, the company is advising customers to contact their original source of supply for restitution. For more information, visit: www.GenuineOneTouch.com.

FDA is alerting its Counterfeit Alert Network partners, a coalition of healthcare professional, consumer and trade associations, who have agreed to further disseminate this important information in a timely and effective manner.

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 through the MedWatch Web site at www.fda.gov/medwatch.

Posted under Customer Service, Products

The Direct Marketing Association announced this month that the American Diabetes Association is its 2006 Nonprofit Organization of the Year.

Each year, the association recognizes a nonprofit organization that demonstrates excellence in using direct marketing techniques to help generate support, is known for high ethical standards within the nonprofit community, and above all, is making a difference through successful programs

“The American Diabetes Association demonstrates how well-planned fundraising and outreach efforts can help meet a national health challenge,” said DMANF Executive Director Senny Boone. “We are pleased to recognize them as a model for how nonprofit organizations can successfully use direct marketing tools and techniques to reach out to donors, motivate volunteers and educate the public.”

The American Diabetes Association is committed not only to helping find a cure for diabetes, but providing broad support for the prevention, detection and treatment for people affected by diabetes. For more than 65 years, the American Diabetes Association has supported diabetes research, information and advocacy efforts that help the nearly 21 million children and adults in the US with diabetes, as well as the estimated 54 million Americans with pre-diabetes. This year marks the 22nd consecutive year that the organization has reported a net surplus income. Innovative fundraising efforts have helped the organization increase its direct response income from $12 million in FY 1996 to $31 million FY 2006. Of the money raised, 78 percent goes directly to programs and services for people with diabetes.

“The support we receive from our donors and volunteers drives our success, so connecting with them effectively is critical,” says American Diabetes Association CEO Lynn Nicholas, FACHE. “But is equally important that we make that connection efficiently, so that we can use the maximum available resources on programs that help stem the tide of this devastating disease.”

This is the 19th year that the DMA Nonprofit Federation (and its precursor, the DMA Nonprofit Council) has recognized a nonprofit organization for its outstanding work. Previous award recipients have included CARE, Mothers Against Drunk Driving, the Marine Toys for Tots Foundation, Easter Seals, Special Olympics and Catholic Relief Services.

Posted under Customer Service

An operation selling Chinese herbal supplements is banned from claiming its products treat or cure diseases, to settle Federal Trade Commission charges it violated a previous court order. The FTC alleged the sellers of Dia-Cope, a pill claimed to prevent, treat, and cure diabetes, violated the order by misrepresenting the health benefits of their product and misrepresenting that clinical trials proved their claims. The defendants will give up their ill-gotten gains – all of the assets they received from the sale of Dia-Cope.

The defendants originally sold “Sagee,” a Chinese herbal supplement that they claimed could improve memory and concentration, repair damaged brain cells, slow the aging of the brain, increase the learning ability of people with mental handicaps, and treat various diseases and conditions related to brain function, including Alzheimer’s disease, senile dementia, schizophrenia, autism, cerebral hemorrhage, stroke, epilepsy, and Parkinson’s disease. They advertised Sagee mainly in Chinese-language media; some ads also appeared in Vietnamese and English. The supplements were sold by distributors on the Internet and in some stores.

The FTC charged that the claims about Sagee were false and unsubstantiated and an order entered in January 2005 prohibited the defendants from making unsubstantiated health benefit, performance, or efficacy claims for any dietary supplement, food, drug, device, or service. The order also barred them from misrepresenting the existence, results, validity or conclusions of any scientific study.

According to the FTC, the defendants then began advertising Dia-Cope on Web sites available in seven languages: English, Chinese, Japanese, Korean, Indonesian, Spanish, and Russian. The defendants claimed Dia-Cope could prevent, treat, and cure diabetes and claimed that thousands of human clinical trials proved it. Their Web sites, www.sagee.com and www.dia-cope.com, stated that the FDA had approved the product. Bottles of Dia-Cope with 90 capsules sold for $60 – enough with the suggested dosage to last one or two weeks.

According to the FTC, the defendants violated their court order by misrepresenting the health benefits of Dia-Cope, falsely claiming that the FDA had approved the product, and misrepresenting that there was clinical support for their claims. A US District Court entered a temporary restraining order against the California-based defendants, Sagee U.S.A. Group, Inc. and Xiao Hua Li, on July 5, 2006, stopping their deceptive claims.

The modified order against the defendants bans them from claiming that any foods, drugs, devices, services, or dietary supplements can prevent, mitigate, treat, or cure any disease. Under the order, the defendants will give up all of the assets derived from the sale of Dia-Cope, $10,396. The order extends the original order’s monitoring and record-keeping provisions and retains the strict provisions requiring the corporate defendant, Sagee, to monitor the activities of its distributors.

Posted under Health

Today is a special day where Consumer Help Web joins with the American Diabetes Association and others to ask for your help.

Posted under Health

AARP, the American Cancer Society Cancer Action NetworkSM (ACS CAN) and the American Diabetes Association are working together to defeat a proposal expected to be voted on in the US Senate SOON that could make health care coverage more expensive for sicker or older workers and eliminate coverage protections for important health screenings and treatments for cancer, diabetes and other life-threatening or chronic illnesses.

These leading health and consumer organizations previewed a joint national advertising effort that will help educate voters about negative effects of the Health Insurance Marketplace Modernization and Affordability Act of 2006 (S. 1955). Sponsored by Senators Mike Enzi (R-WY) and Ben Nelson (D-NE) the bill could make it harder for workers age 50 and older to get a job that provides health insurance, among other things.

In addition, health advocates worry about the long-term effects this bill will have on citizens nationwide, as it would preempt state guarantees of coverage for health benefits such as mammography, cancer screenings, emergency care, mental health services, and diabetes supplies and education.

The bill would allow any insurer to sell health policies that bypass state consumer protections requiring coverage for cancer screenings and treatments, diabetes supplies and education, well-child care and immunizations, maternity care, emergency services, and mental health care.

By doing so, Congress would partly undercut the states’ traditional role of regulating the business of insurance, such as setting requirements for what benefits should be covered and how insurance should be priced. The bill would let insurance companies sell health policies that do not meet state requirements, such as fairness in pricing for those who are older and those who are sicker.

AARP CEO Bill Novelli explains, “While it is a laudable goal to make health insurance more accessible and affordable for small businesses, the ‘Health Insurance Marketplace Modernization and Affordability Act’ does so by giving these businesses an incentive to avoid hiring or retaining sicker or older workers.”

“Ensuring access to cancer screenings and treatments is critical in the nation’s effort to reduce cancer deaths,” said John R. Seffrin, PhD, CEO for the American Cancer Society. “This bill would do more harm than good by undermining the critical work our volunteers and state legislators have done to ensure coverage for lifesaving mammograms, off-label prescription drugs and other benefits that help detect and treat cancer.”

American Diabetes Association CEO Lynn Nicholas said, “Forty-six states currently require state-regulated insurers to cover diabetes supplies, medication and treatment. S.1955, however, would allow small business health plans to bypass these vital coverage regulations. This would be devastating to millions of Americans with diabetes to whom this assurance of coverage has been a lifeline, not a luxury.”

The groups report calls pouring into lawmakers but urge consumers to continue calling. “We are a small business,” said Consumer Help Web President Joan Bounacos “but our first responsibility is to people, not an economic theory.” Bounacos’ consumer advocacy organization joined the others in calling for consumers to contact their Senators. “If you don’t know the number,” she advised, “you can always be connected directly. Just reference the Senate’s telephone directory, find your two Senators and call.”

Bounacos also urged that callers write to the American Diabetes Association at makingnoise@diabetes.org to tell them you made the call to help consumers.

Consumer Help Web acknowledges the work done by the American Diabetes Association in making us aware of this issue and providing much of the detail. All involved organizations are to be commended for their efforts in helping Americans stay healthier, not helping American financial statements grow.

Posted under Health

According to a recent survey conducted by Kelton Research, an estimated nine out of 10 people with Type 2 diabetes know that weight loss would help them to better control their diabetes and recognize the importance of a personalized weight management plan, but more than half mention expenses more than any other factor as a challenge to their daily diabetes management.

In response to the need for a personalized, affordable diabetes management plan, Abbott’s Glucerna® Brand Shakes and Bars has launched the Diabetes Control for Life™ Program, a free 24-week Web-based program for people with diabetes who want to lose weight and better control their blood sugar levels. The program was designed specifically for people with Type 2 diabetes by a team of health care professionals to encourage healthier nutrition, activity, and lifestyle changes.

“Affordable, customized care is essential to successful weight loss among the millions of Americans with Type 2 diabetes,” said Lorena Drago, Registered Dietitian and Certified Diabetes Educator at The New York Weil Cornell Medical Center. “For those living with the condition, a weight management plan tailored to their personal needs and goals is equally as important as general education about the complexities of diabetes care.”
Weight management has a profound impact on the long-term cost and complications related to diabetes. Studies have shown that even a 5 percent weight loss in people with Type 2 diabetes can improve health by lowering blood sugar levels.

The Diabetes Control for Life™ Program is a 24-week program that encourages participants to eat healthy, live an active life and address lifestyle habits that have made previous attempts at weight loss unsuccessful. The free Web-based program includes:

• Personal assessment report to determine levels of readiness to change eating habits and lifestyle
• Customizable meal plans and fitness plans
• Helpful, motivating articles about healthy eating, exercise, and lifestyle
• Weekly e-mail communication to encourage, educate and motivate participants
• Access to live, one-on-one instant messaging with registered dietitians

Among those with Type 2 diabetes, four out of five people surveyed said they would be willing to participate in a free, Web-based weight management program that was tailored to their needs, such as the Diabetes Control for Life Program (Kelton).

“Comprehensive, readily accessible lifestyle improvement programs for people with diabetes are not always affordable or easy to find,” explains Carolyn Alish, Senior Nutrition Scientist, Abbott’s Ross Products Division. “In response, our health care professional team developed the Diabetes Control for Life Program with personalized meal and fitness plans and a unique instant messaging function that allows participants to communicate online with a registered dietitian at no expense, in the comfort of their own home or anywhere they have Internet access.”

To enroll in the Diabetes Control for Life Program or for more information, visit www.DiabetesHealthConnection.com. For people with diabetes who do not have access to the Internet, a free guide to weight management and meal planning is available by calling 1-877-7GLUCERNA.

As with any weight loss program, participants should talk to their health care professional before starting the program.

Posted under Health

A letter from Barbara J. Cassens, a District Director with the US Food and Drug Administration, has warned LifeScan, Inc., of deficiencies within its OneTouch Ultra and OneTouch UItraSmart Blood Glucose Meters manufacture and distribution.

Citing five different complaints that did not receive a response or complete investigation, Cassens’ December 7 letter to LifeScan’s Chairman Eric P. Milledge said that “…our investigators determined that you are manufacturing the OneTouch Ultra and the OneTouch UltraSmart Blood Glucose Meters in violation of the Federal Food, Drug, and Cosmetic Act (the Act).” Cassens’ letter also gave the company 15 “working” days to respond to the allegations. It was unclear how the Christmas holiday would impact that date, if at all. Regardless, the deadline for any such response is imminent if not already passed.

Neither the FDA nor (shockingly) LifeScan has any information following-up this issue on their web sites.

This is not the first time that LifeScan has run afoul of the FDA. According to a March 2001 issue of IVD Technology, the company was “ordered to pay a criminal fine of $29.4 million and an additional $30.6 million in civil penalties, damages, attorneys’ fees, and restitution to the U.S. government.” LifeScan was also reportedly placed on probation for three years.

MedicineNet.com says that LifeScan estimates that 4.7 milion diabetics use the company’s devices to monitor their blood sugar — the key measurement that almost every medical person agrees is critical to reducing long-term health risks and complications associated with diabetes.

Posted under Health

The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia. Hyperglycemia can be a serious and even life-threatening condition and several cases of hyperglycemia have been reported to FDA.

The meters are designed to report blood glucose levels in two different measurements - the U.S. standard, milligrams per deciliter or mg/dL, and the foreign standard, millimoles per liter or mmol/L-and can be accidentally switched from one measurement to the other. The switch may occur when a user is setting the time and date for the meter. There also have been reports of the measurement being switched after a meter was dropped or after replacement of the battery. Abbott has not confirmed these additional causes of failure.

Abbott is not instructing users to return their blood glucose meters. The firm issued a press release on October 14, 2005, and has undertaken a worldwide correction and notification to all healthcare professionals and users, when known, about the measurement switching problem. All Abbott glucose meters currently being shipped for distribution are locked with the correct unit of measurement.

For information on how to change the meter reading back to mg/dl, users should refer to their Owner’s Manual or contact Abbott Diabetes Care at 1-800-553-4105 (open 24 hrs. per day). Consumers who think they may have been using the wrong read-out on their meters for a long period of time and are now worried about their health should contact their doctors.

The affected glucose meters made by Abbott that are sold in the United States are:

FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, and private label brands ReliOn Ultima, Rite Aid, and Kroger blood glucose meters. Precision Sof-Tact meters, which were inadvertently omitted from Abbott’s press release, also are subject to this action. These products are distributed primarily through retail and mail order pharmacies and physicians’ offices.

Affected glucose meters sold outside of the United States are: Xceed, Liberty, Boots, Xtra Classic, Easy, and SofTrac.

Physicians and consumers who have experienced a problem with any of the affected glucose meters should report to FDA’s MedWatch program at 1-800-FDA-1088 (1-800-332-1088)and to Abbott Diabetes Care.

Posted under Health