E-Articles - Health and Fitness

They wanted me to submit to a 'root scaling and planing' procedure. They said it would not hurt because they would numb my gums before proceeding. Did I want to get started

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

today?

NO! I don't want to start today. I wondered why I needed this procedure all of a sudden!

As I looked further into the situation, a larger picture began to reveal

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

Examples of combination products may in

itself. It became apparent that I was the victim of gum disease, the silent epidemic that stalks most people who don't usually realize it until it is time for a costly and

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

potentially painful treatment and recovery.

What I think is disturbing is that a condition doesn't get this bad between office visits. Why did I suddenly need this treatme

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

nt? Why wasn't this mentioned before? How come I wasn't told how to prevent it? In fact, gum disease often develops slowly over a period of years. More importantly, it is

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

Combination pro

preventable.

Gum recession and tissue that is lost won't normally return on it's own. The gum recession remains permanent unless you go to a Periodontist, who can rebuil

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

that tissue by inserting bone matrix or by utilizing other similar procedures. This is also an expensive proposition.

As I mentioned before, I declined the root scaling

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

and planing. The response from the hygienist was that she wanted me to sign a paper that it wasn't their fault if I lost my teeth. My satisfaction came six months later wh

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

en the hygienist looked at my mouth and said that I didn't need that root scaling and planing any longer.

My frustration, however, lingers. I've visited the same dentist'

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

office for about 8 years now. This didn't happen overnight. Why wasn't I ever told how to stop gum disease from getting worse? Going back even further why was I not tol

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

d how to prevent it? The gum recession doesn't reverse by itself. The gums may be healthy again, but the tissue loss remains.

Here is a quote from the Mayo Clinic website,

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

Following aspects would a

"nearly 80 percent of American adults have some form of gum (periodontal) disease." Therefore, dentistry must know that people either have or are developing the disease.

dd to the challenges in developing combination products:

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

he question begs to be answered, "how do I prevent this in the first place?"

Unfortunately, you may get an answer suggesting that brushing and flossing are important. I a

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

gree they are important, but you can not tell me that 80% of Americans are not brushing and flossing. Just thinking about the numbers leads to the conclusion that brushing

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

and flossing are NOT enough to prevent gum disease for most people.

I found a combination of materials that I could use to stop gum disease from getting worse. It was a

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

reat discovery for me personally. The last time I visited the dentist, there was no bleeding. My gums are a healthy pink now. Unfortunately, getting the lost tissue back w

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould involve some expensive treatment and potentially painful recovery time.

Fortunately, I can prevent further problems. I wish that I had an article like this one in my

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

hands 15 years ago. That way, I could have kept the gum tissue that I had. My teeth and gums look fine, even when I smile. It's when I look closely that I notice just ho

.

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

much tissue was lost. It didn't have to be that way. If things had gotten worse, I could have lost teeth over this disease. Don't lose yours.

The Gingivitis Killer site

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

Companies that provide selfless information through particip

tells the story of how I stopped the progression of the disease. Special Note: If you have gum disease or suspect you might, visit your dentist for diagnosis and treatment

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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