E-Articles - Health and Fitness

In the movie Super Size Me, the star eats at a major fast-food chain for about 30 consecutive days. Within that brief time frame, he picks up over 24.5 pounds and is advised by his doctor to end the documentary immediately or risk his life

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

. He experienced liver damage, sexual dysfunction, and mood swings. It took him 14 months to lose the weight. It is frightening to imagine there are millions of human beings consuming diets that are largely the functional equivalent of w

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

hat the star of Super Size Me ate during the movie.

The Centers for Disease Control recently ranked obesity second only to smoking as the leading cause of preventable death. The growth in obesity can be tied to the upward trend in the con

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

sumption of high-fat foods, sugary foods, candies, and soft drinks. More than 10% of the worlds children are overweight with this figure rising to over 30% in many industrialized countries. For every $1 spent by the World Health Organizat

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ion (WHO), the food industry spends $500 on promoting processed foods.

The food industry is approaching one trillion dollars in the U.S. With a world advertising budget of over $40 billion dollars, this figure is larger than the gross dom

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

estic product of over 70 percent of the world’s countries. Children are the most susceptible to this pervasive flow of imagery designed to influence them. The World Health Organization (WHO) reports increases in chronic diseases such as h

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

eart disease, cancer, and diabetes amongst the global population. The organization further notes a “probable” or “convincing” link between many of these diseases and the patterns of food consumed.

The WHO cites the negative effects of the

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

following three points: 1) the adverse effects of high intake of energy (calorie) dense, low-nutrient foods; the adverse effects of high-intake of sugar-sweetened beverages; and 3) the adverse effect of heavy marketing of energy-dense foo

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ds and fast-food outlets.

These “non-communicable” diseases such as heart disease, diabetes, and obesity are considered to be communicated through cultural transmission from parents to children, from corporations to consumers, and from dev

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

eloped to less developed countries. The organization is calling for policies that will protect the world’s children from developing dietary habits that may result in disease and premature death.

There is a greater awareness of obesity, ty

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e 2 diabetes, cardiovascular disease, and diet-related cancers than ever before. A greater adoption of the “western” style diet high in fats, sugars, and salt threatens to undermine the health gains of the past century. With mature and de

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

veloped markets around the world becoming saturated, multinationals are looking to less developed markets such as Eastern Europe, Latin America, and Africa as ripe opportunities to sell their products.

According to the United Nations Food

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

and Agriculture Organization the shift from subsistence farming to importation of foods from the industrialized world has led to a shift from diets dominated by grains and vegetables to ones dominated by high fat and sugar in developing cou

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ntries. Japan presents a case-study for a progressive approach to dealing responsibly with the nutritional needs of school children.

In Japan, school children are prohibited from purchasing food or beverage while traveling either to or fr

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

om school. The School Lunch Law sets nutritional standards for school lunches. Each school follows a well-balanced, low-fat (fat is limited to 25 to 30% of total calories), low-salt lunch of rice or bread and soup, 2 to 3 side dishes, mil

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

k, and desert. Families are provided with a menu each month providing caloric and nutritional breakdown.

Around the world there are aggressive community-based efforts to combat the enormous marketing pressures of multinational food corpor

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ations. For example, the Save Harry program has sent almost 30,000 letters to the author of the Harry Potter series attempting to persuade her to abandon her advertising agreement with Coca Cola.

Fight the Obesity Epidemic was established

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

in New Zealand to address the growing challenge there. In New York City, school menus feature low-fat and low-salt menus, and sugary drinks have been replaced by fruit juice and water. The Naked Chef, Jamie Oliver, has forced changes in

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

the entire U.K. public school lunch system.

There are efforts to make better choices for our children around the world, but there must be a sustained counter to an industry that is approaching a trillion dollars in annual revenue. It is a

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

huge task, but what’s in the balance is our children’s long-term health prospects. It is worth the fight in my opinion. The star of Super Size Me stopped his experiment, but for millions of poor children this choice simply does not exist

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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