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Few decisions made in Washington are more monumental than the decision to go to war with another sovereign nation. The decision to engage in hostilities where civilians will be killed and U.S. servicemen and women will be separated from their families-many never to return-is the gravest that a presiden

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 can make and a congress can approve. In the case of the Iraq War, a war predicated on the existence of weapons of mass destruction in violation of United Nations Security Council resolutions, numerous politicians are guilty of misleading the American people into a rush to war. These politicians ought

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

Examples of combination products may in

to be held to account.

Senator John F. Kerry is one such politician. He said on January 23, 2003 that, "Without question, we need to disarm Saddam Hussein. He is a brutal, murderous dictator, leading an oppressive regime . . . And now he is miscalculating America's response to his continued deceit an

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

d his consistent grasp for weapons of mass destruction . . . So the threat of Saddam Hussein with weapons of mass destruction is real" (i). Perhaps the Senator should stop blindly accepting the evidence of WMD provided by his friends in Europe. Senator Kerry had apparently held this view for some time.

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

On October 9, 2002, he said, "I believe that a deadly arsenal of weapons of mass destruction in [Saddam Hussein's] hands is a real and grave threat to our security" (ii). A Senator like Kerry, who consistently voted against every new weapons program proposed for U.S. armed forces, ought be more judici

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

Combination pro

ous in his support for U.S. military adventurism.

It was not just elected officials who beat the drum for war against Iraq; political appointees did their part in propagating lies about the Iraq regime's weapons and intentions, as well. On February 1, 1998, Secretary of State Madeline Albright said, "

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

We must stop Saddam from ever again jeopardizing the stability and security of his neighbors with weapons of mass destruction" (iii). Considering that Albright spent most of her time as Secretary of State clinking champagne glasses with the leaders of rogue states, seeing her chastise one should have w

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

arned Americans of the dishonesty behind her comment. National Security Advisor Sandy Berger chimed in a few weeks later, adding, "[Saddam Hussein] will use those weapons of mass destruction again, as he has ten times since 1983" (iv). Such blatant misuse of faulty intelligence is particularly troublin

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

g considering Berger's security clearance. Perhaps Berger thought that if he were ever called on his lies, he could always just sneak the evidence out of the National Archives in his underwear to cover his tracks.

Despite the ecological collateral damage inherent in war, leading environmentalist Al Go

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

re decided that ousting Saddam Hussein trumped environmental concerns. On September 23, 2002, the former vice president said, "We know that [Saddam Hussein] has stored secret supplies of biological and chemical weapons throughout his country" (v). Apparently, spending billions of dollars chasing non-ex

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

istent WMD was more important than combating global warming-the real world threat-according to the star of the film An Inconvenient Truth.

Few politicians are more respected, revered, and admired than Senator Ted Kennedy of Massachusetts. It is his reputation as a model senator that makes his

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

Following aspects would a

support for the Iraq war all the more repugnant. On September 27, 2002, the champion swimmer said, "There is no doubt that Saddam Hussein's regime is a serious danger, that he is a tyrant, and that his pursuit of lethal weapons of mass destruction cannot be tolerated. He must be disarmed" (vi). Appare

dd to the challenges in developing combination products:

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

ntly, the Senator knows as much about Iraqi weapons programs as he does about operating a motor vehicle under the influence of alcohol and leaving the scene of an accident.

Perhaps the two people who most eloquently-and mistakenly-made the case for war against Iraq were Hillary and Bill Clinton. On Oc

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

tober 10, 2002, the former first lady said, "In the four years since the inspectors left, intelligence reports show that Saddam Hussein has worked to rebuild his chemical and biological weapons stock, his missile delivery capability, and his nuclear program. He has also given aid, comfort, and sanctuar

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

y to terrorists, including Al Qaeda members . . . It is clear, however, that if left unchecked, Saddam Hussein will continue to increase his capacity to wage biological and chemical warfare, and will keep trying to develop nuclear weapons" (vii). The Senator's words seem quite reasonable, considering t

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

he words of her husband on February 4, 1998: "One way or the other, we are determined to deny Iraq the capacity to develop weapons of mass destruction and the missiles to deliver them. That is our bottom line" (iix). Whether it was 1998 or 2002, whether Monica Lewinsky was in the news or not, the Clint

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

Professional from academic institutions, pharmaceutical industries, health care indust

ons have always provided a united front in their dishonest justification for U.S. imperialism.

These politicians ought to be ashamed of themselves for misleading the American public. They used their provocative words and faulty intelligence to lead thousands of U.S. servicemen and an estimated 655,000

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

(ix). Iraqis to their deaths. Weapons of mass destruction were not found in Iraq, the conflict has spiraled out of control, and worse, these politicians have now absolved themselves of responsibility for the debacle by claiming they were "misled" by other politicians. Rubbish. When politicians make mo

.

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

numental mistakes that lead U.S. soldiers to their deaths over false premises and diminish U.S. standing in the international community, they should hold themselves accountable for their deceitful statements. And, we should hold them accountable, as well.

Notes:

i) John Kerry for President. 23 Januar

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

Companies that provide selfless information through particip

y 2003.

ii) John Kerry for President. 9 October 2002.

iii) CNN. 1 February 1998.

iv) USA Today. 18 February 1998.

v) Washington Post. 23 September 2002.

vi) AlterNet. 27 September 2002.

vii) U.S. Senate Floor Speech. 10 October 2002.

iix) CNN. 4 February 1998.

ix) Toronto Star. 12 October 2006.

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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