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Useful Advices - Enron's Ultimate Victim: Ethics
FROM the 'MORAL HIGH GROUND', where we imagine ourselves, the Enron fiasco should have come as no surprise. Enron is simply a quintessential example of the degradation of principles such as trust, loyalty and et
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
hical standards.
Why it happened,however,is what really needs to be understood if business is to restore its ethical foundation and survive tumultuous times.
Few will argue that business today is more challengi
Why it happened,however,is what really needs to be understood if business is to restore its ethical foundation and survive tumultuous times.
Few will argue that business today is more challengi
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ng and competitive; most everyone accepts that the marketplace is more cutthroat than ever. We live in a dog-eat-dog world where for most, corporate survival is focused on just trying to not get eaten.
Not long
Not long
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ago, things were not so ruthless, or so we’d like to think. Companies had a tacit understanding with their employees: the company will always be there for you. The expression, “I’m a company man,” once represente
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
d the unquestioned relationship between employees and employer. The company was our family, and families looked out for one another. Anything less was considered disloyal and unacceptable.
The 1990s ushered in c
The 1990s ushered in c
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
anges that still exist today. The 90’s also started us on the slippery slope that altered the ground rules for ethics and basic corporate loyalty. Call it downsizing, rightsizing or realigning, but dedicated empl
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
oyees suddenly found themselves on the outs with new, supposedly competitive, corporate initiatives that were sold as necessary to keep companies viable. Keeping viable sometimes meant severing long-serving emplo
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
yees, who were left disillusioned, betrayed and often unarmed to fend for themselves.
Pre-1990, the downsizing of corporate workforces was inconscionable. Companies had an obligation to look after their people,
Pre-1990, the downsizing of corporate workforces was inconscionable. Companies had an obligation to look after their people,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
didn’t they? Apparently, they didn’t. The targets of the realignment strategies were the suddenly “overpriced,” tenured employees. Survival strategies were designed to replace higher-income staff (in reality, tho
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 who had given the most to the company) with less experienced workers to reduce payroll expenditures.
Cuts in tenured staff were easy to justify providing you bought into the argument that older employees were
Cuts in tenured staff were easy to justify providing you bought into the argument that older employees were
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
redundant, i.e., bereft of computer skills. There was some legitimacy to this, but therein lies one of the clearest examples of expediency and cost-cutting prevailing over loyalty and ethics.
It was train existi
It was train existi
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ng staff or replace them with young techno-grads at half the price. History demonstrates the route most companies took. It also marked the beginning of the separation of trust between employees and their companie
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
s. There is little loyalty left.
Today, employees lucky enough to have outlived the 90’s occupy many of the corner offices on the executive floors. Those who write the cheques and run the companies are the survi
Today, employees lucky enough to have outlived the 90’s occupy many of the corner offices on the executive floors. Those who write the cheques and run the companies are the survi
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ving veterans of the last decade, well-trained in guerilla management now unfettered by moral obligations for traits such as loyalty or ethics.
This is not to cast aspersions upon today’s executives but to show
This is not to cast aspersions upon today’s executives but to show
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
how “Enronesque” outcomes can result when industries abandon components essential to sustaining moral values.
Ethics and morality have taken a backseat in business, and there is no greater example than the outgo
Ethics and morality have taken a backseat in business, and there is no greater example than the outgo
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
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
ng settlement cheques being issued to Enron execs. At the same time, 20- and 30-year Enron employees are losing their entire retirement portfolios.
Executives cannot be held totally to blame. They are victims th
Executives cannot be held totally to blame. They are victims th
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
emselves, the byproduct of those well-trained in the new business religion. Most new executive contracts include a Parachute Clause, insurance against the executive or company who wants to part ways. The practice
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
is ethical but, in my opinion, another example of a breakdown in loyalty. It all but promotes failure.
Parachute Planning is analogous to a prenuptial. The purpose and logic is understood. The facts speak for t
Parachute Planning is analogous to a prenuptial. The purpose and logic is understood. The facts speak for t
.
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
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
hemselves. I read recently that reported 98.9 per cent of prenup-weddings in North America fail within three years. From another perspective, it appears there are now tangible rewards for failure or disloyalty.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
The Bottom Line:
Ethics, trust and loyalty are still there. Fundamental values have not changed. Companies who buck the “all-for-me” trend to garner respect and trust will benefit everyone, but it will take time
Ethics, trust and loyalty are still there. Fundamental values have not changed. Companies who buck the “all-for-me” trend to garner respect and trust will benefit everyone, but it will take time
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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