Advice Pool - Health and Fitness

When I was a boy, girls jumping rope sang things like, "Skinny and fatty ran a race. Skinny fell down and broke his face." And, "Step on a crack. Break your mother's back." Now most of you know I have Asperger's. So can you guess how I interpreted these words?

Of course, me be

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

ing me, I took these words literally. Can you imagine? Laughing little eight year old girls singing, "break your mother's back!" Whoa! Was I confused. And try as I might, I could not, for the life of me, understand what would make them say such things. No less laugh while they

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

Examples of combination products may in

said them.

Fast forward to August 2004. I start working with a little eight year old boy. A boy who, like me, has Asperger's. And as I watched his struggles, especially with his dad, I realized why I had struggled so to understood those childhood sayings. You see, he, too, und

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

erstood only the literal meanings of peoples' words. And none of the social content.

Fortunately for this boy, his dad was the most patient father I have ever seen. Which explained why week after week, he patiently battled what I eventually came to call, his son's "fussy word

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

disease."

What the heck is "fussy word disease?" Start with that it's not exactly a disease. I call it this merely to bring to peoples' attention that having this condition is painful. Both for the parents and for the child.

What is it though? It's when a child takes every th

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

Combination pro

ing you say as if you chose your words perfectly. Straight from a dictionary. With no non verbal meaning. Which then means, if you want to say something to one of these kids, you had better say it exactly as you mean it. Otherwise, you are going to hear about it.

This in fact

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

is how this boy responded to most of his father's words. Thus if his dad said something like that they were leaving in ten minutes, at precisely ten minutes, they had better be leaving. No if's and's or but's. If not, the boy would blurt things out like, "you never do what you

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

say!" "You promised!" Or "You lied!"

Worst case he might even call him, "stupid!" Can you imagine?

Being his dad was such a patient man, whenever this happened, he would calmly try to explain how he hadn't meant exactly ten minutes, that what he said was simply a figure of sp

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

eech.

Of course, the boy would totally blow off these efforts, then rudely argue, "You're wrong! That's not what you meant!" Which would usually result in his father reluctantly getting firm with him.

At times, watching this happen made me well up with tears. This dad so obvi

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

ously loved his son. And the boy so obviously loved his father. Despite this love though, week after week, they could not find a way to understand each other. Nor to stop their ever present arguing.

Finally, one day it hit me that the problem had nothing to do with this boy's

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

social skills. Not directly, anyway. Nor was it rooted in his poor impulse control and outbursts of disrespect. What was happening was simply that when the boy said to his father, "you're wrong," he was simply trying to make him speak in a way in which he, the boy, could unders

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

Following aspects would a

tand. In the boy's own language. And when this didn't happen, his frustration overwhelmed him and he blurted out insults.

Shortly after that, I began to call the boy's language, "fussy." And his father's language, "fuzzy." At which point, I explained this idea, the idea of "tw

dd to the challenges in developing combination products:

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

o languages," to the family. Then whenever this father spoke "fuzzy," I would gently remind him that "fuzzy" language confused his son. And whenever the boy felt compelled to make his speak "fussy," I reminded the boy that "fuzzy" was his and my language, not his father's.

The

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

se reminders also helped me as well. They reminded me that in no way did the boy intend to hurt his father. In fact, whenever I managed to get him to see he had hurt his father, he'd burst into tears. Partly from this realization. And partly from the sheer frustration of having

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

to work so hard to be understood.

Here then was the opening I had been looking for. The boy's problem was that he had no sense of the personal meaning of his father's words. A meaning I was calling, the "fuzzy" meaning as in, the "warm fuzzy" meaning. And the father, while he

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

could logically grasp the words his son was saying, had no idea his son could not interpret words in other than dictionary meanings.

Today, when I think about how most of today's therapists refer to Asperger's as a social impairment, I feel sad. They're missing the point. Mor

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

Professional from academic institutions, pharmaceutical industries, health care indust

eover, treating these kids as if the main problem is a social problem only makes them worse.

The social difficulties in Asperger's are not the main problem. I say this knowing full well how disruptive kids with Asperger's can be. Even so, beneath this behavior is a far more ba

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

sic problem. The thing which actually provokes their antisocial behavior. Their inability to navigate the range of specificity within normal folks' language. The degree to which we do, and do not, include the meaning in our words.

What I'm saying is, Asperger's is first and fo

.

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

remost a language problem, not a socialization problem. And whether these kids' brains are wired differently or not simply does not matter. Whatever the case, they, and I, simply speak a different language. Fussy. And because the majority of the world speaks fuzzy, we get told

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

Companies that provide selfless information through particip

we have a disability.

[to read more on how Emergence Personality Theory sees Asperger's, visit http://theemergencesite.com/Tech/TechIssues-Autism-OCD-Aspergers-ADD.htm]

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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Advice Pool - Do You Struggle to Talk to Someone With Asperger's? The Problem is Fussy Language

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