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As pictures and videos surface showing young American soldiers humiliating and dehumanizing Iraqi prisoners, we, as a society, recoil in disgust and disbelie

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

f. Friends and family of those charged with such crimes, shake their heads in bewilderment and assure the world that the perpetrators are normal, caring, lov

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

Examples of combination products may in

ing individuals without any prior sadistic or bullying traits.

As the picture of prisoner degradation develops, the only surprise is that we are surprised.

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

Where have the American people, the Military, the Security Agencies, the Administration, and the Media been hiding for the past 30 years?

Research in Socia

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

l Psychology is rampant with experiments clearly demonstrating the impact of situational influence on behavior. From Zimbardo’s famous prison experiments at

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

Combination pro

Stanford University (1971) and Milgram’s extensive body of work on obedience (the administration of electrical shock torture by non-pathological students (19

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

74 and following), the dangers of placing untrained, well-meaning but na?ve individuals into a system where the cues of social acceptability have been perver

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

ted, has been shown to lead to exactly that behavior which the world has been watching over the past few months.

The killer children of Golding’s Lord of th

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

e Flies, the torturers of the Inquisition, the Jew killers of Reserve Battalion 101 (Browning, 1993), are not inherently evil people, somehow different from

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

you and I. They ARE us – placed into an intolerable, stress-laden pressure cooker where daily norms no longer apply. Systematically, they are praised and rew

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

arded for aberrant behaviors, pushed on the road to doom with a small first step, taught to dehumanize their victims in an atmosphere where responsibility is

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

Following aspects would a

diffused, anonymity guaranteed, and the absolute need for obedience to gain the goal (information, safety of other soldiers, National Security) is demanded.

dd to the challenges in developing combination products:

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

Under such extreme conditions, the behaviors exhibited by the Abu Ghraib MPs should have been completely expected. The Military and Governmental agencies i

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

nvolved have behavioral experts and 30 years of research at their fingertips. To anticipate what might occur, and to plan accordingly – ensuring that supervi

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

sion was relentless, prohibitions against improper behaviors were clear and unambiguous, training provided, and readily-accessed mechanisms provided for repo

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

rts of questionable activity – was the job of the Army, the Government, and the Administration, listening to their own psychological experts.

Courts-Martial

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

Professional from academic institutions, pharmaceutical industries, health care indust

of individual guards for their unacceptable and abhorrent behaviors are warranted to the extent that the individual always bears ultimate responsibility for

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

their personal actions. However, the primary responsibility must fall on those who directed and developed a system almost guaranteed to produce those action

.

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

s which have recently appalled all Americans and degraded our National image.

Not knowing the research, not reading long reports, not having the time to foc

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

Companies that provide selfless information through particip

us on a small area of an enormous task, does not excuse nor absolve of guilt. The top commanders are where the buck stops and where accountability truly lies

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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