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The other night I was watching an episode of the show 20/20, in which John Stossell was exposing the dreadful situation of education in the American schools. In this episode, the host made a comparison between our schools and those in Belgium. For this comparison a test was ad

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

ministered to both American and Belgian students of the same age. To wit, the Belgian students clocked the Americans on this test. What stung even more for the American cause was that the American kids were from a rather decent school. Wow! How dreadful. Yet this state with

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

Examples of combination products may in

in American schools is something I witnessed firsthand.

You see, I was a substitute teacher for several years in several different American schools and I was also a full-time high school teacher of mathematics for two years. This experience gave me a real hard inside look at t

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

e American school system. In fact, I was an award winning teacher, former teacher of college mathematics, published author, and yet I didn’t make the high school cut for the third year. In short, I didn’t make tenure. Why? Gee, I still don’t know the answer to that. The on

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

ly thing I can think of was that I tried to do things a little differently: I tried to teach in novel ways so that students might have a chance to understand mathematics; I tried to keep the endless administrative tasks of discipline, meetings, paperwork, etc. from interfering w

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

Combination pro

ith my basic approach to teaching; and I tried to give love and understanding to all my students regardless of such issues as race, behavior, or intelligence. In essence, I tried to bring an approach toward learning that might effect student progress rivaled by the situation i

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

the Belgian school system. I wanted my students to be as competent as those in other European countries.

As a result of this approach, I was extremely popular with practically the entire student body. Students from other classes would come to me for extra help and often I w

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

ould get greeted in the hall by students who were not in my class, but who knew me because of positive things said to them by others. I was acknowledged as an expert in my field and was even lauded for my diverse knowledge in other areas as well. I showed eclectic interests an

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

d tried to make such contagious to my students. As much as I tried to keep a low profile, I could not stem the flow of love and praise that I got from the students. Knowing how politics within an organization can work, I was a bit concerned about all the positive press I was g

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

tting in such a short time. During the end of the second year, my concerns proved well founded. Even though I did everything I could to be a dedicated teacher, in the end I still came up short, and only have the dozens of letters, cards, and well wishes to ease the pain of hav

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

ing been cut.

So is this the basis of the American tenure system? I was never in favor of such a system and I was willing to work on my merits from year to year. So where did I go wrong, or should I say, where did the school system go wrong? Furthermore, is mediocrity—or wo

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

Following aspects would a

rse—sub par performance the standard of excellence in the American school system? Well the episode of 20/20 sort of gave me an answer to that question. From the episode it appears that this is the best case scenario. From my experience, I know this to be true. In Belgium, ex

dd to the challenges in developing combination products:

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

ellence is expected both from teachers and from students. Here we settle on mediocrity all the time. Heaven forfend should an outstanding teacher come along! All of a sudden, many tenured pros or administrators feel threatened. This is much like the situation in corporate Am

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

erica.

As business writer and speaker Harvey MacKay put it in his book, Beware of the Naked Man Who Offers You His Shirt, “It pays to be good but sometimes it pays a lot more to be bad.” In other countries, excellence is sought after. In Belgium students learn to speak four of

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

five languages. I always tried to be competent in at least four or five as well. As humans, we rise to the level of our expectations; therefore, in Belgium, the kids are brought up expected to speak several languages. If you go there and tell a local that you speak five lang

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

ages, you receive no special acknowledgment. Do that here, and an American will look at you like you have two heads or something.

During another part of the show, the host takes us through several areas of the country where the educational standards are let us say, less than g

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

Professional from academic institutions, pharmaceutical industries, health care indust

ood. One emphasis of the show is to stress that where there is no competition in the school system, there is no excellence—just mediocrity. Charter schools don’t have this problem because they sink or swim according to how well the students do and how well the students achieve

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

. Why should public schools not be held to the same standards and be more accountable for the results they put forth? Why should great teachers be axed because they dared to be exceptional?

There are great teachers out there—both tenured and non-tenured. We need to give more

.

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

praise to the great ones and see that competition weeds out the bad ones. We need to see that the non-tenured great ones are protected so that they can stay within the system...otherwise mediocrity will be the standard and excellence that rare gem you find only once in awhile.

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

Companies that provide selfless information through particip

After all, when excellence becomes the standard then neither teachers nor students have anything to feel insecure about, for both are assured their proper place.

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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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Just Articles - 20/20 Speaks Out on Education in America

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