Industry News and Innovations

Sensible Solutions Program Shows Nutrition Criteria on Packaging

Kraft Foods Inc (Glenview, Ill) is now labeling some of its products with a flag that contains nutritional product information.

This flag, which is a symbol of Kraft’s new Sensible Solution program, makes it easy for consumers to locate healthier products that are “better-for-you,” according to the company. The program uses nutritional criteria from 2005 USDA guidelines and other sources like the FDA and National Academy of Sciences to identify products that meet specific nutritional guidelines. Such products include Kraft 2% Milk Shredded Reduced Fat cheese, Post Shredded Wheat cereal, Minute Rice Instant whole grain brown rice, Triscuit Original baked whole grain wheat crackers and Crystal Light beverages.

Products labeled with the Sensible Solution flag qualify as “better-for-you” in one of the following ways: if the product has nutritionally-meaningful levels of beneficial nutrients like protein, calcium or fiber/whole grain; if the product delivers a functional benefit like heart health or hydration, and does not exceed limitations on caloric, fat, sodium and sugar levels; or if the product meets “reduced,” “low” or “free” caloric, fat, saturated fat, sugar or sodium specifications.

For more information on Kraft Foods Inc, visit www.kraftfoods.com/kf.

Weight Loss Struggle Continues

A survey by Medifast (Owing Mills, Md) found that most Americans are unable to lose weight and keep it off. While most Americans understand the dangers of obesity, nearly half of respondents said they were “not concerned at all” about their weight affecting their health.

A total of 61% of surveyed Americans would like to lose weight. Half (49%) find it “difficult or impossible.” According to results, 49% of people who managed to lose weight saw it return.

“Most Americans are desperate to lose weight, but traditional food diets and weight-loss plans are often ineffective at helping keep weight off in the long run,” said Wayne Andersen, MD, medical director of Medifast, in a news release.

While there is no standard solution to the US weight epidemic, clinically developed meals are a convenient and proven alternative to diets and exercise plans. Medifast’s portion controlled meal plan adheres to governmental dietary guidelines. These high-protein, low-fat meals were created with a carefully balanced formula of high-quality soy protein, carbohydrates, vitamins and minerals.

A 2-year study conducted by researchers from Johns Hopkins Bloomberg School of Public Health demonstrated that patients who participated in the Medifast program lost twice as much weight compared to those following basic nutrition recommendations from the American Diabetes Association (ADA).

The same study showed that those on the Medifast program lost an average of 16 lbs versus the 8 lbs that ADA diet group lost. Two-thirds of patients on the Medifast program lost ≥5% of their weight versus 25% of those on the ADA diet. For more information, visit www.medifastdiet.com/.

Trans Fat Eliminated from Retail and School Products

Tyson Foods (Springdale, Ark) has removed trans fat from its fully-cooked, breaded poultry retail and child nutrition school foodservice products.

There are no trans fats in Tyson’s breaded chicken products including nuggets, patties and tenders. Chicken, beef and pork products are naturally low in trans fat. The company changed its recipes to offer a healthier choice without sacrificing taste and quality.

Tyson ZERO trans fat products are available on supermarket shelves nationally. Recipes are available on the back of packages as well as online at www.tyson.com.

All retail poultry packaging now have the “zero grams of trans fat” message. Additionally, the nutrition panel includes detailed information on polyunsaturated and monounsaturated fat. Tyson is the first national processor and marketer of meat protein to accomplish this goal. The removal of trans fat from consumer products comes 1 year ahead of FDA labeling regulations.

Committee Advises Against OTC Statin Sales

According to an FDA advisory panel, Mevacor (lovastatin, Merck and Co, Whitehouse Station, NJ) should not be sold over-the-counter (OTC).

The decision from the advisory committee is an outside recommendation and does not constitute as a final ruling of the FDA. According to the panel, which voted 20-3 against approving the drug that is used as a treatment to lower cholesterol, there was not enough research that suggested patients could use the product safely before speaking to a physician. The recommended dosage of Mevacor is 20 mg.

Gaps Found in Private Health Insurance for Diabetes Patients

The American Diabetes Association, in conjunction with the Georgetown University Health Policy Institute, announced the results of a 14-month study examining barriers to accessible, affordable and adequate health insurance for Americans with diabetes.

“Falling Through the Cracks: Stories of How Health Insurance can Fail People with Diabetes,” is funded by the Commonwealth Fund, Robert Wood Johnson Foundation and WK Kellogg Foundation. The study of 851 people from the United States identifies barriers in all components of the private health insurance system that may prevent diabetes patients from properly managing the disease.

Common problems highlighted in the report document flaws in the private- and publicly-financed health insurance system including health insurance policies that did not cover basic diabetes needs; high risk pools with preexisting condition exclusions that deterred people from enrolling; health insurance premium surcharges for diabetes that drove premiums above what individuals and small businesses could afford; medical underwriting practices that designated diabetes as uninsurable; Medicaid eligibility limits that left many low income people unable to access this safety net; cumbersome insurance processes that fail to help people navigate complex rules and deadlines; and application procedures that drove many to give up on seeking coverage altogether.

To obtain copies of the report, visit www.diabetes.org/insurancereport or www.healthinsuranceinfo.net.

Pharma Treatment for DME

Alimera Sciences Inc (Atlanta) and Control Delivery Systems Inc (Watertown, Mass), entered an agreement to codevelop and market a pharmacologic treatment indicated for diabetic macular edema (DME).

Alimera Sciences and Control Delivery Systems are in discussions with the FDA to initiate clinical trials that are aimed at determining the effectiveness of injecting an implantable form into the vitreous of the eye via a 25-ga needle. It is expected to provide drug delivery to the back of the eye for up to 3 years.

“The prospect of offering patients with diabetes, their caregivers and ophthalmology professionals the convenience of an outpatient injection with the potential for 3-year drug delivery is truly exciting,” said Dan Myers, CEO of Alimera Sciences. “We are confident that our collaboration and joint expertise will successfully deliver this invaluable option to diabetic patients.”

The only approved DME treatment is laser photocoagulation therapy, which can leave irreversible blind spots.

For more information, visit www.alimerasciences.com or www.controldelivery.com.

Lilly Announces Individual Bar Coding on All Insulin Vials

As part of its long-standing commitment to patient safety, Eli Lilly and Company (Indianapolis) announced that individual vials of its insulin products including Humulin and Humalog will now have bar codes.

The bar codes have been included on Lilly’s insulin product outer packaging in the past, but this marks the first time the bar codes are being included on the vial labels. This is part of a larger effort within the health care industry to decrease medication errors. Individual bar codes now appear on vials for nine insulin products.

Bar code labeling on prescription drugs is projected to reduce error by 500,000 instances over the next 20 years, with an estimated savings of $93 billion in additional health care costs, patient pain and suffering and lost wages, according to the FDA. Studies in 2003 indicate insulin products have the highest rates of errors in a hospital setting.

“Insulin is a life-saving medication for so many patients, so it’s disheartening to see that it can be involved in errors,” said Scott J. Jacober, DO, medical advisor at Lilly. “Much of this can be attributed to the high volume of insulin used in a hospital setting and the complexity of hospital medication orders for insulin. With the new bar coded vials, doctors can have greater confidence that the drug they are prescribing is being given to the correct patient and at the correct time.”

OmniPod Insulin Management System Receives FDA Clearance

Insulet Corporation (Bedford, Ma) announced that the OmniPod Insulin Management System has received 510(k) clearance from the FDA.

This innovative two-part system combines health care benefits of continuous subcutaneous insulin delivery and blood glucose monitoring technology and eliminates the need for daily insulin injections. The system will be available by prescription later this year.

The OmniPod Insulin Management System features fully programmable continuous subcutaneous insulin delivery with multiple basal rates and bolus options, suggested bolus calculations, safety checks and alarm features. It also incorporates blood glucose monitoring technology. It’s fully-integrated design has two components: the OmniPod and the Personal Diabetes Manager (PDM). The OmniPod is a small, lightweight device that combines an integrated infusion set, automatic inserter and insulin reservoir.  The pod is worn discretely on the skin and delivers insulin according to preprogrammed instructions from the wireless, handheld PDM.  Once the OmniPod is programmed, the PDM is used to check blood glucose levels, give bolus dosages and adjust basal rates.  The PDM can be carried separately in a backpack, briefcase or purse.  Each OmniPod may be worn ≤3 days. For more information, visit www.MyOmniPod.com

Ocular Network Creates Total Diabetes Care Platform

MedSys Corp (Hasbrouck Heights, NJ) has added PMC Ocular Network to its total health care delivery platform for diabetic patients.

PMC Ocular Network lists 1,100 ophthalmologists in 14 states. It anticipates that additional ophthalmologists and centers will be added throughout the year. This network is complementary to the company’s PMC/Foot Care Network for the treatments of diabetic patients requiring foot and ocular side treatments.

With the PMC Ocular Network addition, MedSys Corp has rounded out its offerings in foot, eye, wound care, diabetic supply and orthotics/diabetic shoes for health care payers concerned with the increasing numbers of diabetic patients across the United States.

The company has contracted with Wills Eye Surgical Network to facilitate participation from all facilities controlled directly or indirectly by the company. Wills Eye will also assist MedSys Corp in executing provider agreements with physicians who use its facilities.  

African-American Health Project Targets Disparities

An African American Family Health Project focusing on the health concerns of African-Americans will suggest preventive health strategies and encourage African-Americans to take charge of their health.

Kaiser Permanente’s (Oakland, Calif) project stresses two vital concepts:

• Know your history – Investigate what medical conditions exist in your family; and

• Know your numbers – Learn what is healthy blood pressure, cholesterol, blood sugar and body mass index and what your personal numbers are in each category.

Sections teaching about high blood pressure, diabetes, weight management, managing high cholesterol and heart disease are highlighted. Individuals are encouraged to make healthy food choices and find time for regular exercise.

The project was produced in partnership with the American Academy of Family Practice Physicians and the Institute of Church Administration and Management (formerly known as the Congress of National Black Churches). Kaiser Permanente will work with its two partners to distribute the materials to African-American church leaders and physicians to help empower the community to act as its own best health advocate.

For more information, or to download the companion guidebook, visit www.kaiserpermanente.org.