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    We're back to the subject of ethics, more specifically, business ethics.

    But unlike ethical dilemmas we've discussed in the past - when people are confronted with bizarre, freak circumstances they had never planned for, and then face agonizing choices regarding how to react - I'm now t
    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
    alking about cases where people willfully and proactively steer events in a certain direction.

    Take the case of the owner of a $32 million business whose daring entry into entrepreneurship was recounted in a leading business magazine.

    Just over a decade ago, Kathy Taggares was itching
    ; 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 ditch her employer, frozen-food maker Chef Ready Foods, to start her own business.

    She decided to approach Marriott International about buying one of its salad dressing factories. Not that she was overly optimistic("As a young single woman, I'd already had so many doors slammed in
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    my face"), but what was there to lose?

    But surprisingly, her overtures met with a particularly warm reception. Marriott even offered to help her finance the $5 million purchase over several years.

    It seemed almost too good to be true. Actually, it was.

    Slowly it dawned on Kathy that
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    the Marriott people believed she was representing her employer, Chef Ready, as a solo entrepreneur. Had they realized that she was, in reality, representing herself, there was no way they would have taken her so seriously.

    If she had owned up to the truth, the game would been up, fo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    r sure. Yet another door would have been slammed in her face. So what did Kathy do now? Simple.

    "They never directly asked me," she confesses, "so I let them believe what they wanted to believe."

    Sure, they found out at the end - and they weren't at all charmed by the deception - but
    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
    by then, the deal had all but gone through. Twelve years and one more acquisition later, Kathy Taggeres' company, K.T's Kitchens, now employs 350 people.

    Effective communication? Having painted herself into a rather tight corner, our would-be entrepreneur yet managed to come up trum
    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
    s by simply NOT communicating, and doing it very effectively at that.

    It remains to answer our question: Was it straight?

    Well, now, can we accuse Kathy Taggares of lying? No, it seems she didn't - at least, not with words. "I just left some of the blanks empty", as she expresses it.
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    But do you have to SAY something in order to lie?

    Personally, I don't think so. I'd go along with Robert Louis Stevenson's definition of honesty: "not just to state the true facts, but to convey a true impression." If so, no objective person can sincerely deny that Taggeres lied.

    Th
    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
    at being the case, we're forced to ask ourselves another pertinent question: Is it ever legitimate to lie in business?

    Omitting cases of outright fraud where the law clearly says it's not, the author of the article I cited (Jeremy Useem: "Should You Lie?") writes that his magazine "pu
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t that question to dozens of entrepreneurs and ethicists. And while the answers that came back are neither black nor white, one thing is clear: Those who say that lying has no place in business aren't telling the truth."

    Mark well what is being said here, and let it sink in. Sure, w
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e weren't born yesterday. We know too much about the sharks that abound in the business world. Who is there amongst us who has not been bitten by them?

    But that's not what our author is saying here. He's saying that, in the eyes of the great masses of business people out there -includ
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ing some of the most respectable among them - lies and deception have a LEGITIMATE place in the world of business.

    This does not necessarily mean that some respectable entrepreneurs condone cheating and deceiving as a general practice. (Hopefully, they don't, and probably, they would
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    n't remain "respectable" too long if they did.) What it does mean it means many of them believe there's a time and place for everything. In other words, an occasional subtle deception,if not outright lie,is in order and appropriate when circumstances demand it.

    And to prove the point
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    the essay in Fortune Small Business presents a whole host of real life examples. Business person after business person is depicted as bending the truth in the most ingenious ways - whether through speech, deeds, or untimely silence - to mislead potential or existing clients, supplier
    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
    s or investors.

    Why do they do it? Sometimes, they feel they have no choice.

    One professor of business education says company founders often mislead people because they find themselves in an "expectations trap": No one will do business with them until they appear successful, yet they
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    can't be successful until people do business with them.

    One way to escape this "Catch 22" is to create the impression that they're bigger and more established than they are. Some might achieve this by playing office background noise in their home office or bringing in all their rela
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    tives to pose as staff members when a client comes to visit.

    Others don't hesitate to puff up their capabilities (Sure, we've built an aircraft hangar before,") or to describe their vision of their company's future as if it were happening already.

    Other academics point out that peopl
    .

    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 tend to live with two independent sets of ethical standards - one for their personal lives (what you might call "religious ethics"), and one for their business or professional lives. In our culture, moreover, it might seem natural to model the latter set on the prevailing ethics of
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    the world of sport, where shady practices are often seen as acceptable provided you don't break the Eleventh Commandment: "Thou Shalt Not Get Caught" (by the referee or umpire, that is).

    For my part, I'm not impressed. Not at all.

    Well, what do YOU say? Drop me a note and let me know


    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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