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  • E-Articles - Stop The Nonsense--Put Blame Where It Belongs

    Now we are having a "War On Childhood Obesity." Okay, I agree, we do have a national problem. For the first time in the history of the United States, the current generation will probably live fewer years that their parents unless changes are made. We need to recognize the numbers of children now being diagnosed with adult-onset diabetes, hig
    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
    h blood pressure and other illness normally associated with age.

    It does not matter whether you look at the public service broadcasts on television or read the newspaper and magazine stories. The target is childhood obesity. Children's health must be improved--that goes without questioning.

    My objection is making children responsible and th
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    object of ALL the war efforts. Obese children are the result, not the cause, of the problem. Yes, the child has the choice of what foods to eat or avoid. No one is force-feeding forbidden foods to him or her. However, the child is not responsible for selecting and buying food for the family!

    Question--who taught the child what and how muc
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    to eat? From babyhood on, children learn by observing and listening to instructions from the adults surrounding them. The parents, especially, are their role models. When they start school the circle of "teachers" expands.

    Food is not the problem--it is all the feelings that surround it. For example: dessert is the bribe for eating vegeta
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    les. Food is the reward for good behavior; the way parents show their love; the way to celebrate special occasions; the way to keep in touch with friends (meet me for lunch); the outing that gets the whole family together; and many more. (You can add other ways that occur in your life.)

    It is no wonder that food becomes a source of comfort.
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    The reasons can range from giving yourself rewards when no one else does to a way to soften the hurt feelings from unfair criticism or a misunderstanding.

    Added to my pet peeve list was a mom on a television talk show insisting that the child needed help. All of her efforts had failed. Talking, advice, etc., just went in one ear ad out the o
    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
    ther. All of the harping was because she wanted a better future for the child without the problems she had faced from being overweight. No thought was given to mom and the child both trying out a new way of eating.

    The child was being signaled out to change his eating habits--but the refrigerator and cupboards were still filled with all the
    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
    oods he should not eat. The logic: We must not deprive the rest of the family from enjoying their favorite foods just because one child was obese.

    The mystery to me: Why should a child have more determination and willpower than the parents? They had 10, 20 or even 30 more years of living with opportunity to change IF they really believed w
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    at they were saying about healthy eating. Instead, the lecture becomes do what I say, not what I do.

    It would be no surprise if the child started to believe his parents did not love him or that he was being punished for some reason he did not understand. Next stop: go to food for comfort missing in his life!

    It would be a wise idea for the
    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
    est of the family to get thorough physical examinations. The other family members may not have the outward appearance of obesity but that does not guarantee they are in perfect health. I seriously doubt whether their eating habits are that different. Kind of foods matter just as much as the quantity. How many fruits and vegetables are the o
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    her family members eating? How good is their consumption of healthy foods providing necessary protein, minerals, vitamins and phyto-nutrients.

    Healthy living should be a goal for the entire family. Put the emphasis on total lifestyle. Families can have fun time together without food as the centerpiece. Try having a game of catch after dinn
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    er instead of the mad dash to the television with a bag of potato chips as company.

    Changes in the diet should never be called or thought of as a "diet" forced on the family because of the obese child. It is a change to a healthier lifestyle for everyone. Weight, of course, will improve with food and activity changes. Equally important, all
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    family members will notice how much their energy and vitality has improved.

    I can understand why the advertising was done--hit the "guilt" track and offer a take-home bucket of fried chicken, french fries and mayonnaise-laden coleslaw as the way to have a family meal around the dinner table. Now really! It may have increased sales for the re
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    taurant but food does not transform from bad to good simply by changing where it is consumed.

    One suggestion is to start making the preparation of the evening meal a family project, at least once or twice each week. There is absolutely no logical reason why mom is the only personal capable of cooking a meal. It does not matter if mom is a st
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    y-at-home or outside-the-home working mother. It is no gift to any child to grow up without being able to prepare a meal, do laundry or cleaning. Whether or not the skills are ever needed later in life, it does a lot for individual self confidence when you are able to take care of yourself.

    Preparing a meal as a family provides some of that
    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
    quality" time you keep reading about. It is also a great way to enlarge a child's experience with food. There is a special lure to eating something that "I" made. Not everybody can do it, but letting children grow their own vegetables can make a world of difference in their choices at the table. They enjoy watching a tiny seed become a pla
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    nt and then transform into food for dinner.

    There are easy ways to reduce calories without changing the appeal of favorite foods. Luckily, there is a new group of experts on the PBS weekend food classes. You will find many ideas on small changes to make for fast, healthy meals. A lot of small changes, added together, makes a big total effec
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    .

    We have been conditioned to expect immediate and large weight losses. The television advertisements for the various weight loss programs are impressive. For me what is missing is information on what percentage of total diet program participants had similar results. Or, are the examples the rare exceptions?

    Research has shown that any die
    .

    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
    "works" if calories are reduced sufficiently and exercise is increased. Weight loss is another one of the "easier said than done" projects. It is a complicated issue to find the real causes for overeating. Just another example of one size does not fit all! What works for me may not work for you. Each one of us must find our own way to suc
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ess--and that means not only the obese child but also mom, dad and any sisters or brothers.

    No longer do we have this either/or attitude about foods: healthy diets OR indulgence. Small changes allow us to eat foods which are healthy yet give us the enjoyment we crave--the kind of food we can happily think about eating for the rest of our life


    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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