E-Articles - Health and Fitness

It was bad enough hearing almost daily that obesity in adults is a growing problem, now our children are the focal point. Yes, moms and dads, the research is in. In a study conducted by Weight Wat

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

chers International Inc., and the American Health Foundation, 25% of American children are now officially overweight, and the youngest are especially at risk. The American Dietetic Association (AD

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

Examples of combination products may in

) found that 14% of six to 11 year olds weighed more than they should, as did 12% of 12-17 year olds. In addition, another ADA study suggests the half of obese adolescents will become fat adults.

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

This is not a passing phase, obesity in children is increasing daily and with the increase comes a slew of health issues – the prevalent ones being diabetes and breathing difficulties.

Karen Mill

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

r-Kovach, R.D., chief scientist for Weight Watchers states “lack of exercise accounts for more than 50% of the problem, just 30% of the problem is due to overeating or choosing the wrong types of

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

Combination pro

oods.” Instead, experts point to the same things I have been saying for the past 10 years, cuts in school physical education programs, less time spent outdoors and more time playing video games o

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

sitting in front of the computer or television. Not riding bikes around the neighborhood due to safety issues.

As I mention in Keep Kids Fit, with the cuts in physical education, after school pr

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

grams and just the general lack of activity by our children you need to be creative about getting your family more active. One way is get the whole family out and about is to take walks after dinn

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

r, and if you have a pet, bring him/her along, because sad to say along with obesity in humans, so also go our “furkids”. Have your children do chores, like vacuum, mow the lawn, rake leaves, pick

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

up their room. Have a dance night. Let the kids pick the music (I know you don’t like their music, but think of it this way, our parents didn’t like ours either). Play more physical games, like ch

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

rades, twister, kick ball, soft ball. I love bowling, have a bowling night with the family or get your children interested in a league. Not only will they be more active, they will make some new f

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

Following aspects would a

iends in the process and learn how to become part of a team effort!

Also, don’t forget, while activity is important so is healthy eating. I know the study said activity was important, but you sti

dd to the challenges in developing combination products:

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

l have to eat healthy. Fast foods once in a while is one thing, however, making them a habit can be disastrous. Drop the sugar filled fruit juices, and give them water or caffeine free, diet soda

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

for older children). Have them take their daily vitamin along with a glass of OJ. One thing too many parents tend to do is to fill their kids up with fruit juices that are way too high in sugar.

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

rew your own ice tea and limit the sugar (use a sugar substitute, like Splenda). Same thing with lemonade, make your own. Get them used to water, it is good for them and fills them up in the proce

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

s. “The American Academy of Pediatrics recommends limiting 100% fruit juice to 4 to 6 ounces a day for 1 to 6 year olds and to 7 to 12 ounces a day for those ages 7 to 18.

A study reported in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

January 2005 issue of Prevention, by Barry M. Popkin, PhD., a professor of nutrition at the University of North Carolina found “Liquid sugar from soda, juice and fruit drinks is the biggest source

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

of sugar consumption”. His study of more than 73,000 children and adults found that between ages 2 and 18, kids drink 135% more calories in sweetened beverages than you probably did as a child.”

.

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

Most important is that you don’t make your children uncomfortable. Don’t talk in terms of weight, but in terms of a healthy lifestyle and having more energy. Realize it is going to take time for y

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

Companies that provide selfless information through particip

ur children and family to adjust to the new healthy lifestyle you want to put in place. Foremost, if you want to be a good role model, practice what you preach!

Copyright 2005, DeFiore Enterprise

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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