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Non-traditional alcoholism treatment methods have always recognized that 12 Step models work for some individuals but not for most, at least not for very long. The problem is tha

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

t nothing else seems to either. Designing effective treatment for individuals turns out to be a complicated business that must take into account many variables in ways that don’t

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

Examples of combination products may in

easily lend themselves to any particular model. As a result most programs offer little beyond "don’t drink, go to meetings, work your program, and repeat – forever."

It's also d

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

ifficult to remember that people have been quitting drinking for as long as alcohol has existed. Some individuals quit when their doctor suggests it's time; others when spouses t

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

reaten to leave; a few when they collect their first DUI with all of the attendant costs and embarrassment; and still more just because they decide to. They quit with or without

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

Combination pro

help or programs or meetings.

So, what happened?

Historically, most current treatment methods grew out of the experiences of two intractable alcoholics, Bill W. and Dr. Bob. Th

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

y discovered a way that worked when nothing else had for them, thus giving birth to AA and the 12 Steps. And that way was generalized by treatment providers to individuals whose

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

personal characteristics are far different from Bill and Bob, two white, male, middleclass, middle-aged, drunks.

Despite marketing to the contrary, alcoholism is not an equal op

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

ortunity disease. Its prevalence varies drastically depending on age, ethnicity, geography, income, education, religion, and many other factors. Treatment which fails to take the

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

se factors into account is far less likely to be successful than methods which do. As a result, 12 Step success tends to correlate to how closely the client matches the original

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

ill W./Dr. Bob profile.

Additionally, treatment programs which fail to address differences in how individuals process information will also suffer. In the 1960’s and 1970’s Dr.

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

Following aspects would a

Jane Loevinger, at Washington University in St. Louis, developed a model of adult development. Working with Dr. Loevinger’s test protocol in Minnesota and Alaska in the 1990’s, D

dd to the challenges in developing combination products:

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

. Ed Wilson referenced developmental levels to 12 Step success, along with identification of those clients for whom traditional treatment was apt to be ineffective as well as tho

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

se for whom it is frequently counter-productive.

As noted, the development of comprehensive and effective treatment stratagies for individuals is challenging and multi-faceted.

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

aradoxically, including developmental levels as another variable actually makes things simpler – if not easy. It allows the clinician to rapidly determine the client’s suitabilit

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

y for 12 Step programs; calculates the initial effective proportions of the cognitive/behavioral therapeutic mix; indicates the proper "half-stage" of distance to maintain so tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

the client feels neither patronized nor mystified; and the likeliest methods of avoiding relapse.

Developmental considerations do not, of course, offer any miracles. Effective

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

treatment will still require conscientious therapists who are neither wedded to any particular model nor hampered by their own history. Additionally, with time and trust, clients

.

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

are apt to reveal higher cognitive levels that necessitate continuous adjustment to the treatment plan. But that is, after all, the definition of "professional," isn’t it?

Good

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

Companies that provide selfless information through particip

therapeutic services are not static and neither are people. To suggest as much, as in never ending "recovery," is to do a disservice to conscientious clinicians and clients alike

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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