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  • Summary - Growing Up Canadian

    Growing up Canadian is a rare thing these days. What I mean by that is growing up as a person who is the embodiment of all those things we cherish and would call “Canadian”.

    A few years’ back I was in a sweat lodge with guest-elder, Michael Thrasher, and he was angry with us. Really angry. He challenged us to heal, to grow, to better our
    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
    selves and then get back out there (into the world) and BE PARENTS to the next generation who is growing up empty out there. He taught that we had a responsibility to get outside and LOVE our children. If the current cycle wasn’t stopped, and stopped right now – by this generation – then there may not even be a next generation to be conce
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    rned about.

    I read a disturbing article in the Province newspaper. A 29-year-old man was on his way to work at a construction site when he began experiencing a diabetic seizure. He got off the Skytrain and collapsed on the station floor. As he slipped into a coma, the rest of the people around him just stepped over him, stepped around hi
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    m, ignored him. He was a clean cut, clean looking fellow dying there on the ground. It was almost an hour of morning rush hour traffic before someone finally called for help. His girlfriend wrote an emotionally scathing letter that summed it up quite well.

    “Almost everyone owns a cell phone. Why did none of you call the police or an ambu
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    lance? Are we so disconnected from each other and so concerned about our own agendas that we cannot stop for two minutes and help a fellow human being?”

    The Province followed up the next day with an Editorial that ended on this question.

    “In creating a modern, progressive society, have we lost our most important quality – our humanity
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ?”

    The following week saw our news blitzed with three days of “Top Story” coverage of a whale beached in the sound and the public’s efforts to rescue it. I commend those who helped the whale but have to shake my head at the priorities of our populace. Michelle Joyal-Blumenfeld mirrored my thoughts in her letter to the Province.

    “I find
    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
    it appalling we make such a big deal about a beached whale yet we step over a 29 year old man suffering from a diabetic seizure after stumbling off a crowded Skytrain.”

    Is it that we so consumed by what is going on in our own lives that we don’t want to see the world around us? We even feel assaulted if someone pushes his or her “life” i
    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
    nto ours. Walking foreword with the blinders on full. Well that’s not working!

    We live in a society where 12 & 13 year olds are robbing and beating the elderly – for fun. Not even because they needed the money; they are just looking for a way to have fun. How we have failed the next generation as parents when this is looked at as, “oh we
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ll…, it happens”. The next generation are the future leaders and decision-makers of our country. They’re not growing up Canadian; they’re growing up empty. The newest virtue is apathy.

    Reading those newspaper stories I am reminded of Michael Thrasher’s words and the responsibility we have of helping our children to grow up Canadian.

    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
    ere was a time that our hearts would leap at the cry of the voice of Humanity. Closer to my home, in prison that is, I can see the end of public compassion. Just 25 years ago Claire Culhane would speak out against the dehumanizing of prisoners and demand that we, the public, actually see them. Work to accept them, and accept the concept o
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    f rehabilitation, to embrace the idea of prisoners coming back into society as people.

    It was at that time Canada abolished the death penalty (1977). While there were many good arguments why they should, the bottom line was that we would rather have to live with more guys in prison, than accept the possibility of somehow, just maybe kill
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ing that one prisoner who was innocent. Canadians had too much respect and compassion towards humanity to allow for the possibility of executing an innocent person, so it was abolished. Now, just a quarter century later, during the last federal election, I read in some of the “Party Platforms” that they want to bring the death sentence ba
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ck. Seems they just can’t stand paying taxes to house all those prisoners. Society has become more concerned with what you can do for me, than with what I can do for you.

    Remember when families left their front doors unlocked? Children played in the street blissfully unaware of the evils man is capable of. I remember “block parties” whe
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    re all the families on a street got together for a BBQ and games, fun and love. It was because Bill knew Tom, and John, and Jeff. But more important than just knowing the names of your neighbors, people were friends with their neighbors. There was a connection to the lives of the people around them. Seems like now the only notice we take
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    of our neighbors is to see if my car is better than his.

    Last fall CBC ran a series called “The Greatest Canadian” and we, the public, picked who we wanted, and then voted on the final 10. As I sat and watched the cases made for which of these 10 was the one, the Greatest, person to represent what Canada is I saw a startling trend. While
    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
    all the people in the top 10 accomplished many great and wonderful things, what became apparent was that every single person showed an amazing capacity for Compassion, lived with and in Humility, and was unbelievably Tenacious in whatever they tackled. Quite simply, they loved humanity and desired to better it in whatever way they could.
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    The argument became, they simply were Canadian. Period. End of story.

    For me I had my favorite, Terry Fox. All 10 are great, but Terry tips the scale for me. Maybe it’s the BC connection, I don’t know. I read an article written by Terry’s brother. He had wanted to experience a marathon, know just a taste of what Terry did;

    - He trained
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    for one year – ran one race – and had to recover for 6 months.

    Terry did that every day for nearly 143 continuous days.

    Doctors still claim that what he did was outright impossible. The human body is just not capable of that amount of activity and abuse. So how did he do it? I like to believe that a part of his ability came from being
    .

    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
    Canadian. That somewhere amid the love and life he experienced growing up, Terry got it, he understood the Canadian zeal that saw over one million men volunteer for the 1st and 2nd World Wars. He respected his fellow human beings and wanted, hoped, even prayed that he could somehow improve their lives. Not because he wanted to be great, o
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    r even thought that he was great, it was simply who he was and he couldn’t be any less than that. Terry had grown up Canadian.

    It is my hope that more of us remember what it means to live this way and passionately instill these qualities in our children in the hope that they too, will grow up Canadian.

    Use your voice, it can be worth it


    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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