Advice You - Business

For those who have been following the Paul Wolfowitz scandal concerning a breach of ethics stemming from the World Bank promotion of his girlfriend, Shaha Riza, it is getting close to decision-making time for the organization's board. On Wednesday last week, U

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

nited Press International reported that the board's decision on Wolfowitz's future with the organization is expected this week.

Some background for those unfamiliar with this story: Wolfowitz, former deputy secretary of defense under President George W. Bush,

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

Examples of combination products may in

became president of the World Bank, a Washington, DC-based international institution dedicated to reducing global poverty, in June 2005. He made headlines with his pledge to curtail the high level of corruption in the governments of poor countries, calling it

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

the biggest barrier to their development.

Just prior to assuming leadership of the organization, he acknowledged his relationship with Riza, who joined the World Bank in 1997 and rose through the ranks to become senior communications officer. The organizatio

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

n's Ethics Committee pointed out that their relationship went against its rule banning personal relationships between bank employees. Wolfowitz initially suggested he recuse himself from all professional dealings with Riza, but the Ethics Committee said that w

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

Combination pro

sn't good enough, and it advised instead an "in situ promotion," according to a July 2007 memo by the committee. Wolfowitz agreed to this, but the settlement he put together included a transfer to the State Department with a tax-free six-figure salary and an a

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

utomatic annual pay raise.

In late March, The Washington Post reported that Riza's salary increased tax-exempt by more than $60,000, which spurred an avalanche of bad press for the World Bank. In late April the San Francisco Chronicle report

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

ed that the bank's employees were severely disrupted by the upheaval; in staff meetings addressing the matter, workers at various levels spoke out demanding that Wolfowitz resign.

Does an employee uprising against a public figure in a large organization sound

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

familiar? It should – a similar but in many ways very different scenario played out in April at both NBC News/MSNBC and CBS. I'm speaking, of course, of Don Imus' termination from both news organizations for his uncouth reference to the Rutgers University wom

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

en's basketball team, which we won't do the disservice of repeating here.

The most important and compelling occurrence to emerge between when Imus uttered his controversial comments on April 4 and when NBC News President Steve Capus announced a week later on

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

pril 11 that MSNBC would no longer simulcast Imus in the Morning was Capus' justification for the talk show host's termination:

These comments were deeply hurtful to many, many people. And we’ve had any number of employee conversations, d

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

Following aspects would a

iscussions, emails, phone calls. And when you listen to the passion and the people who come to the conclusion that there should not be any room for this sort of conversation and dialogue on our air, it was the only decision we could reach.

One co

dd to the challenges in developing combination products:

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

uld make the argument that the departure of key sponsors of the simulcast the same day weighed into NBC News' decision. Still, the show had a large enough following and enough revenue from the remaining sponsors to continue to air if the organization's leaders

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

hip thought that were the best course of action.

To be clear, this decision, like the one the World Bank's board is now pondering, comes down to ethical leadership and the extent to which employees will follow a company's public figures down the "wrong path."

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

In the case of NBC News, hundreds of employees made their opinions on how Imus' comments impacted the ethics and values of the business known.

Both Wolfowitz and Imus have become national media stories – one centered on politics, poverty reduction and intern

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

tional diplomacy; the other on race relations, gender issues and free speech. But we see them as more. We see them also as workplace issues – issues played out before an audience in size inconceivable to most small business owners and leaders, perhaps, but wor

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

Professional from academic institutions, pharmaceutical industries, health care indust

kplace issues nonetheless.

What can we learn? Simply, when leaders behave inconsistently with organizations' mission and values, employees react, speak out, lose confidence, become less motivated, more distracted and can't do their best work. Organizational p

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

erformance suffers. So the workplace lessons to be learned from Wolfowitz and Imus are serious red flags.

Leaders and representatives of enterprises of all sizes need to consider their actions carefully in terms of ethics and take swift action when conflicts

.

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

arise to avoid adversely affecting the attitudes of their workforce. In extreme cases, people may leave the business, believing it no longer aligns with the values they identified with when they were hired.

Given that the cost of replacing an employee can ran

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

Companies that provide selfless information through particip

ge from 50 percent to 150 percent of his or her salary, it is in leaders' best interest to do their best to hold themselves up to the ethical standards of the organization at all times in order to keep employee tenure, morale and productivity consistently high

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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