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Maybe you’ve heard about body dysmorphia – it’s a mental image many victims of anorexia nervosa have that tells them they look fat, even when they are emaciated. Baria

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

tric patients can suffer from body dysmorphia as well.

When we were morbidly obese our emotional coping mechanisms kicked in and many of us were able to convince ours

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

Examples of combination products may in

elves we really weren’t that big. It is emotionally kinder to avoid body criticism, the whole issue seems hopeless. In fact, many morbidly obese patients will say they

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

see themselves normal sized. That is until a rude moment reminds them they are not normal sized: a skinny chair, a turnstile, a bathroom stall, a flight of stairs, a

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

photograph. This false perception is a subconscious coping strategy to protect us from the brutal truth, the truth about how big morbidly obese really is.

My sister a

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

Combination pro

nd I were clothes shopping one day with our morbidly obese mother. She tried an outfit and complained to us, “but it makes me look fat.” And gently we told her, “Mom,

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

you are fat.” Intellectually my mother knows she is morbidly obese, but the emotional issues run over reason and she doesn’t see herself fat. She is in serious denial

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

that is preventing her from getting the help she needs – bariatric surgery – to save her life.

After surgery, there is a tendency for the body dysmorphia to reverse.

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

Before surgery we denied how big we were, after surgery we judge ourselves critically – like the anorexic – and fail to see an honest reflection. One woman, down from

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

size 24 to size 10 wrote, “I feel fat daily. I never felt this at 248 pounds – I saw a thinner person in the mirror than I see now. I look at my size 10 jeans and they

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

look like tents. I don’t feel as attractive as I did when I was heavy. I don’t understand it,” she continued, “but I think it has to do with learning to accept yourse

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

Following aspects would a

lf fat so you didn’t see all the fat. Now I just have to learn to accept myself as thinner.”

Many patients report hyper-judging their figures after weight loss. It se

dd to the challenges in developing combination products:

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

ems the thinner you get the more judgmental of your body you become. To this day, the first thing I see in my reflection in my pudgy tummy – I think it’s enormous. I d

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

on’t see long slender legs or a tiny waist or trim arms. I see a Buddha belly. I’ve even apologized for my chubby tummy to others when they compliment my new figure. T

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

he apology usually goes, “Yes, but I can’t get rid of this stomach.” I say this while pointing to my "flaw".

That is wrong and brutally unfair to myself. I am working

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

daily to keep this hyper-judgment in check, reminding myself the days of belittlement and self-loathing are over. Now is the time when I love myself.

Patients report

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

Professional from academic institutions, pharmaceutical industries, health care indust

universal success when they do one thing in the face of body dysmorphia: dress to impress! Get rid of the flowing camouflage clothes and wear a smart, well fitted out

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

fit. Gentlemen, tuck in your shirts in. Ladies, wear a fitted skirt with a waistband. Small sized “fat clothes” do nothing for body image – dump that style and get som

.

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

ething that flatters your new size. Enlist the help of friends you trust to find flattering clothes. Sometimes you have to force yourself to see your body as 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

great fitting outfit will certainly do the trick.

Extreme cases of body dysmorphia after gastric bypass weight loss may be treated with counseling and psycho-therapy.

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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