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  • Full of Articles - Shaman Harvey Foretells My Future and Ruins My Hard-Earned Scientific Arrogance

    After I completed a double Ph.D. in social science at the University of Michigan (in 1981), a much broader form of education began. Having disabled my body while training my mind, I went to see a highly recommended healer in Denver, Colorado. He was known simply as Harvey (his little-used last name was Bevier). I was suffering from crippling back pain which
    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
    endless graduate school had exacerbated. Harvey helped me with my spinal problems and also with my academic blinders; he provided me with a stunning spiritual and mystical education--all without ever mentioning it!

    Harvey's approach to instruction was unique. He rarely explained the extraordinary mystical laws he lived by as he worked on a hundred
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    r more people a day, looking inside the mind and the body and the history of one client after another. His chosen method was to tell colorful, symbolic stories while treating the individual and allow all awaiting a session to witness the spiritual magic that followed. This left each person free to draw their own conclusions--with no debate required. Had he e
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ver told me, for example, that he could see my future and prove it to me, I would have argued endlessly. Never a fan of argument, he made his point in ways that left me no room to object.

    A Harvey "treatment" was a form of "karate chiropractic" with visionary elements. While awaiting my turn on the stool in front of his, Harvey told another of his
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ndless stories to the dozen clients seated on folding chairs about the dining room of the little house on Hooker street.

    "I had this friend..." Harvey began, "it was right after World War II and he had just bought himself four new tires for his old Packard sedan. Now, rubber was very dear after the war and he complained to the high heavens about
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    the cost of those tires. On the third day after he'd had them installed at the tire shop, he came out to take a kind of victory stroll around his cherished vehicle, admiring every aspect, when he saw--and greatly to his distress, I might add--that his right rear tire was as flat as a pancake! Oh my, you should have heard some of the passionate vocabulary wo
    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
    ds he had saved up for such an occasion--he had quite a mouth on him for a deacon of the church. Now on that... you just have to keep your eyes open, you never know what destiny has in store for you."

    Harvey's stories were always told with multiple layers of meaning and purpose hidden in them. They were as filled with symbolic metapho
    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
    r and valid predictions as the dreams I interpreted for a living. I always spent the whole week after every Harvey visit deciphering any stories he told, and they never failed to teach me something immediately relevant and crucial. I didn't have a clue what the lesson was in this latest story, but I knew there was one. Should I simply not take things for gra
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ted? What exactly was I taking for granted, I began to wonder. Or was his point that I might need to watch my vocabulary in moments of stress?

    On the Saturday following that Monday's Harvey visit, I was driving my Toyota Starlet across Boulder, CO on an errand when Harvey's story popped into my mind for further reflection. After a few minutes, I realized--w
    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
    ith a jolt--that I, myself, had just bought four new tires two days after his story; what a coincidence. I hadn't even planned to buy them on Monday, how could he have known? And, I next recalled, I had, indeed, complained mightily to two different friends about the high cost of those four tires (even though I did not have the excuse of wartime rubb
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    r prices).

    "When exactly did I get those tires?" I wondered. "Actually today would be the third day since the shop installed them... hmmmm," I pondered, "Is there any way in hell that Harvey's story could have something to do with me? Well, of course not!" my scientifically trained mind asserted. He can't predict the futur
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e. No one can. (A fact I took completely for granted!) He couldn't possibly know how my tires were going to function before I had even bought them. Why should I have to worry or bother to check up on my brand new tires?

    Still, I felt such a strong compulsion to check that right rear tire--even though I would sound like a total foo
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    if anyone were to ever hear of it: I pulled abruptly off the road near the downtown telephone company offices, jumped out of my car and ran directly around to the right rear tire. That's the only one I was interested in... and indeed, it was almost totally flat! I was flabbergasted.

    I felt so grateful that having caught the problem early,
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    I could still drive to the shop with the air remaining in the tire. But my entire scientific, rationalist (know-it-all) understanding of the universe had been destabilized in the exchange! What a price to pay! (Or, what an amazing extra benefit to receive!) It was then that I heard, in my mind, the following thought: "Well, son, you don
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t have to believe anything that doesn't please you... but you will have to change your own damned tires!" Such language for a minister of the (metaphoric) "church" in which I was to become a (metaphoric) "deacon!"; another accurate prediction that was hidden in Harvey's story.

    This was just one of many lessons that Harvey taught me (an
    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
    d others) in his daily performance of the impossible. He taught us many facts of the shamanic realm that I would have argued against all day long, if I had ever been allowed to. But Harvey didn't need the credit for his esoteric wisdom, and he didn't allow the hassle. He continued to hide his lessons in stories that proved his point beyond any debat
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    . He never called himself a shaman, but shamans are the "technicians of the sacred," and that's what Harvey was.

    Harvey had such amazing knowledge that I began writing down my questions in a note pad to ask him at each weekly visit, and in his typical unorthodox style, he would answer my questions before I could ask them, by telling stories to othe
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r people in the room that directly answered my questions! He not only answered every question I brought, he would address them in the exact order I had written them down.

    One week I paused in front of his office before entering and renumbered my list of five questions backward, clever trickster-student that I was... and that day he answered them al
    .

    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
    in reverse order. I had finally accepted that he could foresee the future and now I had to entertain mental telepathy too (which Harvey always called "mind to mind communication"). What would my professors at the University have said about that? I recalled, however, that they had taught me to trust observable, testable, repeatable facts over th
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    eories, no matter how established (or taken for granted) the theory might be. And that may be precisely why Harvey insisted on providing me with one mind blowing, observable, testable, and repeatable fact after another until he forced my entire theory of how reality works to change. And I do still watch my mouth, being a deacon and all


    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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