Advice Pool - Health and Fitness

An article entitled “Drunk Driving” was featured on the “Insurance Information Institute” website in February of 2007. Pardon the pun, but the following three statistical facts that were discussed in this article are quite “sobering.”

Alcohol-Related Fatalities

First, in spite of i

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

ncreasing the number of anti-drunk driving laws and campaigns, the number of people who died in alcohol-related accidents went down by only .2% from 2004 to 2005 (16,919 in 2004 versus 16,885 in 2005). While every life saved is important, this decrease, from a statistical standpoint, however, was not

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

Examples of combination products may in

significant. In other words, the fact that 34 fewer people died in alcohol-related accidents in 2005 than in 2004 could have happened totally by chance rather than because of stricter drunk driving laws or because of the influence of citizen activist groups such as Mothers Against Drunk Drivers (MADD

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

).

Repeat DUI Offenders

Second, even with the passing of stricter DUI laws and consequences, over 50% of US drivers arrested for drunk driving are repeat offenders. This statistic is disturbing when viewed on its own merits. What has also become “newsworthy,” however, is the numbe

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

of repeat offenders who have received an outrageous number of DUIs.

For instance in early 2006, an Ohio man who received 12 DUIs within a ten-year period of time killed two Hiram college students in an alcohol-related accident. Not surprisingly, many people in the local community were outraged with

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

Combination pro

the driver who accidentally killed the two college students.

What was perhaps more revealing in this case, however, was the number of phone calls made to the radio talk shows by people asking who the judges and prosecutors were and what the consequences were for this driver after he received his 3rd

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

his 8th, and his 11th DUIs. In other words, people starting asking the "tough questions" regarding the accountability of those who received multiple DUIs as well as the accountability of the judges and prosecutors who were involved in the repeat offenders’ legal proceedings.

Many Drivers wi

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

th Suspended Licenses Still Drive

Third, 67% of US drivers with suspended licenses still drive. From a logical standpoint, many people must be asking themselves how this is possible in an age of technological advancement that features capabilities such as “real-time” computer access to driv

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

r registration information that is available to the law enforcement community.

Drunk Driving Countermeasures

According to the authors of “Drunk Driving,” a number of countermeasures have been undertaken that have targeted alcohol-related fatalities on the US roads. For instance, exi

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

sting drunk driving laws have become stricter, new laws have been passed, drunk driving task forces have been established by many states, and citizen activist groups such as MADD have influenced some of the attitudes toward drinking and driving in our society.

As noteworthy as these anti-drunk drivin

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

laws and campaigns have been, however, the fact remains that only 34 fewer people died in alcohol-related accidents in 2005 than in 2004. Obviously, other measures must be undertaken in order to significantly reduce the number of US people who die in alcohol-related traffic accidents.

Addit

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

Following aspects would a

onal Anti-Drunk Driving Initiatives

In response to the need for more ammunition in the "war" on alcohol-related traffic accidents, I propose two additional anti-drunk driving initiatives. First, those who are incarcerated due to alcohol-related offenses need to receive mandatory alcoholism

dd to the challenges in developing combination products:

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

treatment while they are in jail or in prison. True, other drivers are safer when the offending persons are “off the streets” and incarcerated. When the jail or prison sentence is completed, however, the vast majority of alcohol-related offenders will return to the "real world." Acknowledging this r

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

ality, I submit that alcohol-related offenders who have received alcoholism treatment while incarcerated are more likely to become responsible people who refrain from drinking while driving and less likely to become repeat DUI offenders once they return to society.

Second, significant and observable

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

changes in our attitudes about drinking alcohol need to take place in our society. Due to the fact that drinking alcohol is so accessible, acceptable, and intimately ingrained in our society, however, it has been extremely difficult for many individuals, especially the youth, to truly understand the

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

estructive, unhealthy, and fatal aspects of alcohol abuse and alcoholism. This needs to change.

Our Enlightened and Aware Society

Our society has become more enlightened and more aware of the health hazards, fatalities, and destructive consequences of alcohol abuse and alcoholism.

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

Professional from academic institutions, pharmaceutical industries, health care indust

It is therefore time for us to balance the prevailing marketing “message” with a more realistic and healthy perspective regarding alcohol consumption. Stated differently, drinking alcohol needs to be less advertised, less glamorized, and seen as less “cool” while the commercials, advertisements, and

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

public service messages that emphasize healthy, safe, and alcohol-free activities and lifestyles need to be increased.

Conclusion

Obviously, something besides our current anti-drunk driving laws and campaigns needs to be done in order to significantly decrease the alcohol-related fa

.

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

talities on our highways. I assert that mandatory alcoholism treatment for people who are incarcerated for alcohol-related offenses and noticeable and significant changes in our attitudes toward drinking alcohol are important factors that will help contribute to the significant reduction in the numbe

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

Companies that provide selfless information through particip

of people in our society who die in alcohol-related traffic accidents every year.

Copyright 2007 - Denny Soinski. All Rights Reserved Worldwide. Reprint Rights: You may reprint this article as long as you leave all of the links active, do not edit the article in any way, and give the author credit

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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