Advice Pool - Health and Fitness

As parents who’ve had gastric bypass we face many challenges raising a family. Perhaps an unexpected challenge is when

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

a child develops an eating disorder that may be exacerbated by the parents dieting habits. It turns out as our children

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

Examples of combination products may in

observe us diet and fail (repeatedly) before having gastric bypass, then they watch us lose weight in an almost obsess

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

ive excitement after weight loss surgery (WLS), some panic and vow “this will not happen to me.” A descent into an eati

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

ng disorder may follow.

According to AnorexiaBulimaHelp “Dieting or restriction of certain foods, or excessive dieting

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

Combination pro

from parents” is a contributing factor in teen and pre-teen eating disorders. In addition “The appearance obsessed soci

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

ety most people live in can contribute to eating disorders . . . When combined with a low self-esteem, feelings of depr

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

ession or anxiety or isolation, the effects can be devastating. Eating disorders commonly erupt as a coping mechanism,

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

as a way for people to feel more “normal” and in control in a society that isn’t really normal to begin with.”

Wow. Ar

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

e you worried? Growing up I watched my mother work her way up and down the scale many times. No need to name the diets

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

he tried: we all tried them. I believe I learned from her that diet equals failure. It seems like every time she’d get

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

Following aspects would a

to the benchmark, “this is the lowest weight I’ve been since having my first child” suddenly her weight loss would stop

dd to the challenges in developing combination products:

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

and back up the scale she’d climb at a rapid rate. She is morbidly obese today and no longer attempts dieting. Who can

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

blame her?

Did she know that was the lesson she was teaching me? That eventually I’d "diet" myself into morbid obesit

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

y? I don’t think so, and I don’t blame her. She didn’t know any better.

We know better today. It is our stewardship to

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

our children to do the best we can to protect them, raise them healthy, and teach them healthy habits of nutrition and

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

Professional from academic institutions, pharmaceutical industries, health care indust

exercise. We owe it to our children to keep them off the operating table and out of eating disorder treatment centers.

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

But how to do that? By example and by being informed.

AnorexiaBulimaHelp.com is a comprehensive resource on eating d

.

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

isorders – if you fear someone in your family is suffering from an eating disorder please visit this site. The site inc

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

Companies that provide selfless information through particip

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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