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The belief expressed by some in the Bush administration that the troop surge will help create the conditions for a more stable society in Iraq and for greater long-term security is far-fetched. This is naive thinking and risks repeating blun

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

ders we have seen in the past.

One thing has become clear about the Iraqi position over the course of this war - the Iraqi people don't take kindly to having plans implemented on their behalf. Come what may they generally end up doing it th

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

Examples of combination products may in

ir way no matter how ugly and messy it gets in the interim.

Let's assume US forces succeed in clearing out the gangs of Sunni and Shia insurgents that have been running their operations out of neighborhoods in Baghdad. What will be achieved

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

? A society that will then proceed to develop in Bush's preordained direction?

This won't happen for the simple reason that American logic is incapable of parsing local wisdom and priorities that don't easily blend with Western style pragma

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

ism. Moreover the internecine complexities of Iraqi society won't simply "shape up", especially on the basis of a plan that is being imported, and to some extent imposed by outside agents.

This escalation by the US military would seem to be

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

Combination pro

yet more military theater. Once Baghdad districts are cleared and secured, the Americans will eventually be obliged to hand over control to Iraqi forces. Anyone who knows about the current state of the Iraqi army can be excused for being do

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

nright cynical when presented with the prospect of these forces holding ground and maintaining order under pressure from insurgents. As we know from past examples the insurgents never simply disappear, they just go to ground and resurface as

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

soon as the American "act" of the play is over. This was exactly what happened during the last surge in Baghdad involving 7,000 American troops - Operation Forward Together. Once the Americans handed control back to the Iraqi military, the

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

ontrols that had been put in place began to unravel and the insurgents moved back in.

The insurgents have time on their side. They can easily wait out this US surge, while building up strength for a later return. Meanwhile the Americans hav

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

e no such luxury. They have to be successful within a year or public support will plummet. Not a good prospect for Republicans with an election looming in 2008.

As before, we are liable to see a chimera ... a desert mirage of sorts involvin

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

an appearance of success in the short term. As was the case with earlier efforts by the US military, the appearance of order gradually gives way to chaos as ethnic rivalries resurface. So long as the Iraqi forces continue to demonstrate div

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

Following aspects would a

ded loyalties and in many instances a willingness to collude with the insurgents, there is little chance that the conditions established by this counterinsurgency strategy will show long term progress.

The Iraqi government itself is no more

dd to the challenges in developing combination products:

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

dependable than its military arm. The government of Nuri al-Maliki has been sending mixed messages on its willingness to implement the US plan. The Shi'ite operational commander for Baghdad selected by al-Maliki is a little known Lt. Genera

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

named Aboud Qanbar. There is a strategy to twin American and Iraqi officers in an operational chain-of-command. This move may well complicate an already complicated task. American forces tend to perform best under direct operational control

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

, so this strategy could well give rise to frustrations, with a potential for internal conflicts.

It remains to be seen how far al-Maliki will go on his apparent readiness to take on Shia militias. A few months ago this scenario seemed unli

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

ely since the PM owes his political rise to leaders such as Muqtada al Sadr. His willingness to target key Shia militias risks leaving him politically isolated, or worse - a target himself. On the other hand many army and police units are no

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

Professional from academic institutions, pharmaceutical industries, health care indust

w predominantly Shi'ite in composition, many with loyalties to the Mahdi Army and Badr Brigade. This make civilian militias seem increasingly like renegade elements.

I don't believe that a military escalation will "win" it for Bush. At best

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

it may help to create an appearance of work-in-progress as America heads toward the 2008 election campaign. Real stability and genuine progress can only be brokered by Iraqis themselves, and until they are ready to make that arrangement ther

.

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

e will almost certainly be more civil conflict in the future.

The larger lesson here, is that the uploading of democracy on the back of military intervention doesn't work when the targeted society operates with a mindset so different from t

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

Companies that provide selfless information through particip

e American-world-view, it almost amounts to a parallel reality.

Now that an internal power struggle has been unleashed in Iraq, it is doubtful that a time-restricted American counterinsurgency will do anything except postpone the inevitable

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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