HISTORY and CLINICAL STUDIES

• History of Jason Pharmaceuticals, Inc. and Medifast
• Clinical Studies
  

History of Jason Pharmaceuticals, Inc. and Medifast
William Vitale, M.D., founded Jason Pharmaceuticals, Inc. in 1980.

Jason Pharmaceuticals is proud of the Medifast brand, which has been recommended by over 15,000 physicians nationwide and used by more than 750,000 overweight customers.

Medifast's primary focus is the development, manufacture and distribution of the Medifast® program and Medifast® products. Medifast is a medically supervised weight loss program, which specializes in multidisciplinary patient education programs and uses the highest quality meal replacement supplements.

Medifast offers a wide spectrum of weight management options depending on the amount of weight you have to lose. The Medifast philosophy is meal replacement. The more meals you replace, the more you lose weight.

Unlike other diets, Medifast provides life changing behavior modification programs and products that support you through weight loss and weight maintenance. The Medifast program teaches you how to lose weight and keep it off for life.

Medifast offers more than 50 years combined knowledge and experience with world-class customer service, technical and medical support. Medifast Products are manufactured to exacting specifications in our state-of-the-art production facility in Owings Mills, Maryland.

Product labeling, quality, control, manufacturing processes and equipment are subject to regulations and inspections mandated by the Food & Drug Administration (FDA), Maryland State Department of Health and Hygiene and Baltimore County Department of Health.

Medifast's plant strictly adheres to all cGMP practices and has proudly maintained its status as an "OU" (Orthodox Union) Kosher-approved facility since 1982.

Medifast Is Clinically Proven
Medifast has been clinically proven in studies conducted by the Johns Hopkins University School of Medicine and the National Institutes of Health.

In the study conducted by Dr. Cheskin and Dr. Crowell at the Johns Hopkins University School of Medicine, males lost an average of 67.41 pounds and females lost an average of 47.5 pounds over a sixteen-week period.

Medifast Has Been Chosen by premier Medical/Research Institutions including:
Johns Hopkins Weight Management Center. For over 8 years, the Johns Hopkins Weight Management Center in Baltimore, Maryland has chosen Medifast Products for their very-low-calorie program patients. Dr. Cheskin has been quite satisfied with the Medifast and Take Shape products (shakes, bars, creamy soups, hot cocoa, crackers) used at the Center.

The University of Vermont at Burlington selected Medifast Products for its NIH-commissioned Obesity Study entitled "Energy Metabolism in the Post-Obese State" underway at The University of Vermont.

This 4-year study will help define the metabolic consequences of the mutation in the B3AR gene in the regulation of daily energy expenditure and fat metabolism in older women.

Researchers at the University of Vermont chose to use Medifast and Take Shape products in the study based on the recommendation of Dr. Lawrence Cheskin, Director of the Weight Management Center at Johns Hopkins University.

Maine State Prison. Prison physician with prior experience using the Medifast Program has begun treating obese inmates with Medifast. Reports indicate that the improved health of these individuals directly translates to significant cost savings in medical care in a short period of time. With the initial weight losses achieved with Medifast, many patients have already reduced or discontinued medications needed to treat associated health conditions including hypertension, diabetes and hypercholesterolemia, among others.

Shands Teaching Hospital. Affiliated with The University of Florida, Shands Teaching Hospital selected Medifast Products as part of their adolescent obesity treatment program. Medifast Products consistently provide high biological value protein from soy and/or milk, essential vitamins/minerals, trace elements and are rich in dietary fiber - nutritional factors important to researchers.

Medifast Medical Practitioners and Voluntary Advisors
Wayne Andersen, M.D.
Dr. Andersen is the Chairman of the Medical Advisory board for Medifast, Inc.

Lawrence J. Cheskin, M.D.
Dr. Cheskin is a board-certified gastroenterologist, weight management expert, and author of the top-selling book Losing Weight For Good: Developing Your Personal Plan of Action. He is director of the Johns Hopkins School of Medicine and the Johns Hopkins School of Hygiene and Public Health. The Johns Hopkins Weight Management Center conducts a very extensive program in which they use the Medifast Products exclusively with patients who are indicated for a modified fasting program.

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The Johns Hopkins University - Abstract
During a multi-center evaluation of health benefits and weight loss on the Medifast Weight Management Program, doctors M.D. Crowell and L.J. Cheskin and the Johns Hopkins University School of Medicine conducted a 16-week analysis of 185 people using the Medifast program.

Findings: Males lost an average of 67.41 lbs. (as much as 121 lbs.) and females lost an average of 47.5 lbs. during fasting. 91% percent of males and 72% of females lost more than 40 lbs. on the program.

Significant reductions were seen in systolic and diastolic blood pressure, total cholesterol and triglycerides. Blood pressures were normalized in 90% of hypertensive patients. Only minor, transient side effects were seen during the modified fast. The most common complaints were headaches, fatigue, lightheadedness, and cold intolerance.

Conclusion: Medically-supervised, protein-sparing modified fasts (the Medifast program) offer a safe, effective means of weight reduction and are accompanied by significant improvements in coexisting health problems.

Medifast® Products Part of National Institute of Health Obesity Study
Medifast weight management products were used by patients enrolled in a National Institute of Health (NIH) Obesity Research Study being conducted by the University of Vermont in Burlington, VT in collaboration with Johns Hopkins University in Baltimore, Maryland.

The products were used as part of the study's 1,100-1,300 calorie weight loss program used by obese patients. This program helps patients get to their ideal body weight.

The end of the four-year study was in the beginning of February 1998. Preliminary results showed that of the 15 or so patients who completed the study, the average weight loss was approximately 45 lbs. with some individuals losing as much as 65-80 lbs. Ms. Amy Turner, RD, the registered dietitian who is in charge of the dietary component of the study states that, "The patients love the taste of both the Medifast and Take Shape shakes and I've had no complaints."

Researchers at the University of Vermont chose to use Medifast products in the study based on the recommendation of Dr. Lawrence Cheskin, Director of the Weight Management Center at Johns Hopkins University. Dr. Cheskin has used Medifast products (shakes, bars, creamy soups, hot cocoa, crackers) at the Weight Management Center for over 8 years and has been very happy with them.

Brad MacDonald, CEO of Medifast says, "Medifast offers consumers 'clinically tested' weight management products that work."

Medifast Products Quality to Make the Health Claim for Soy: "May Reduce the Risk of Heart Disease" As Approved by the FDA
Coronary heart disease (CHD), one of the most common and serious forms of cardiovascular disease, is a major public health concern because it causes more deaths in the U.S. than any other disease.

Risk factors for CHD include high total cholesterol levels and high levels of low-density lipoprotein (LDL) cholesterol.

This new health claim is based on evidence that including soy protein in a diet low in saturated fat and cholesterol may also help to reduce the risk of CHD. Recent clinical trials have shown that consumption of soy protein compared to other proteins such as those from milk or meat, can lower total and LDL-cholesterol 'bad cholesterol' levels, without affecting HDL-cholesterol 'good cholesterol' levels.

The Medifast weight management product-line consists of delicious shakes, satisfying bars, creamy soups, oatmeal and chili that incorporates healthy meal replacements and snacks as part of the overall dietary plan included in every box. The Medifast brand has been clinically tested to get results. Lactose-free and Kosher-certified Medifast Take Shape Shakes provide over 10 grams of soy protein per serving (the most in its category).

On October 20, 1999, the Food and Drug Administration authorized Medifast®, as a manufacturer, to make the following health claim pertaining to its Medifast® Products:

"25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease." Great-tasting Medifast Products contain clinically-significant amounts of soy protein, making it easy for you to take control of your health!

Other Promising Health Benefits of Soy. Studies have suggested that soy protein may:

• Protect against coronary heart disease by lowering LDL-cholesterol levels
• Protect against some cancers
• Protect against breast cancer - the estrogen-like compounds found in soy protein compete with "naturally-occurring" estrogen
• Protect against prostate cancer - genistein from soy is a potent inhibitor of cancer cell growth
• Protect against osteoporosis - decreases calcium excretion, prevents bone breakdown
• Reduce menopausal symptoms - estrogen-like compounds provide an "estrogen lift" during menopause (reduces hot flashes, etc.)