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Have you ever had a friend hit you with the classic word trap, "Have you stopped beating your wife?" Answer yes or answer no, and you incriminate yourself. This joke is based on the

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

technique of using an implicit premise. While it may get a laugh, it is also used by politicians as more than a joke.

Political manipulation is most effectively accomplished when

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

Examples of combination products may in

ou control the framework in which others can argue and, ultimately, think. For example, if you want to get your viewpoint accepted without openly debating it, you make it an assumpt

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

on, a premise for any other debates. Not only will you win the public over to your view, but you will effectively exclude the possibility of any serious opposition.

Suppose many ye

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

rs ago a government wanted to expand it's power to by having control over what people put in their bodies. There may have been real debate among the populace as to whether this is a

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

Combination pro

n appropriate function of law or government. Many may not have wanted such a "war" on drugs, which, after all, is just a war on people who ingest certain plants or chemicals.

How,

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

hen, does the government get the public to accept such control? By simply presuming that all people want to see drug use controlled, and arguing only on the basis of the best way t

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

do that. The politicians and the public can argue all they want about whether more treatment or stricter laws are needed. In fact, such argument only strengthens the underlying pre

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

ise.

Soon anyone who questions whether there should be any government involvement in this area is on the "fringe." They are not allowed in the "serious" debates, because they don't

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

share this now "obvious" premise. The control of government over what goes into a person's body is assured, and it's power to regulate peoples lives in other similar ways is easily

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

expanded.

As I write this the U.S. government has held people in prisons for years without charges or access to attorneys. They claim this is okay because these prisoners are not c

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

Following aspects would a

tizens. The public accepts this, because the premise has been firmly established in their minds that "rights" are granted by governments.

The founders of this country explicitly st

dd to the challenges in developing combination products:

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

ted that rights are inherent in all humans. They fought against the idea that rights are mere "privileges" bestowed by governments. However, this second idea has become the basis fo

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

r all argument now, and so even the opposition is unable to make logical arguments against these current violations of human rights. Implicit premises are a powerful method of contr

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

l. We should get in the habit of recognizing the premises hidden in political debate.

Rule Their Language - Rule Their Thoughts

Another way to politically manipulate is 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

arefully choose the labels or words used. For example, social security is referred to as a "fund" or even a "retirement fund." Of course, not a penny was ever actually invested in a

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

Professional from academic institutions, pharmaceutical industries, health care indust

y "fund." The payments are taken from current tax revenues, so it is a welfare program, to be more precise.

Welfare, of course, is less acceptable to the public, so the truth of th

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

is pyramid scheme (a much more accurate label) is hidden behind better labels. You can see how the words used control the debate. If you are for this kind of "welfare program," you

.

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

et get more mileage out of "social security retirement fund."

Words matter greatly. It might be politically difficult to get millions of dollars to spend on bombs designed to cut p

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

Companies that provide selfless information through particip

ople to pieces, right? Perhaps that's why they are called "daisy cutters." Start paying attention, and you'll see how words are being used to influence and politically influence you

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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