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  • Just Answers - From Heroes To Zeroes

    Last evening (September 10th, 2006), the CBS news show, Sixty Minutes, devoted a segment to the medical and financial problems, that people are suffering from, who worked at Ground Zero in the aftermath of 9/11.
    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
    A few of these rescue workers have already died - a mere five years after 9/11. Thousands upon thousands more are suffering from severe respiratory problems - that they will never recover from, and will indeed ev
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    entually die from.

    Common sense alone, would tell anyone - at least anyone without an agenda - that there has to be a connection between the unbelievable number of rescue workers who have already developed respi
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ratory problems (most of the them being relatively young, fit NYC firefighters and cops) and the fact that two 110 story towers composed of steel, glass, asbestos - and Lord knows what else - were essentially red
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    uced to dust that hung in the air for weeks.

    And if common sense isn’t good enough, medical tests and autopsies have confirmed that connection according to Sixty Minutes.

    In short, the connection between workin
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    g at Ground Zero and the ridiculously large number of respiratory problems is an open and shut case - that is, to everyone but the Bush administration.

    For many families, their medical problems have led to sever
    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
    e financial problems as well as ‘twilight zone’ government decisions. For example, one worker described how he was denied worker compensation benefits - as pathetically inadequate as those would have been.

    It is
    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
    an absolute moral disgrace how our government has abandoned these heroes. And since the entire federal government is controlled by Republicans - the buck stops with them.

    The only reason Bush even stood next to
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    the cops and firefighters at Ground Zero for a few minutes, expressing his ’solidarity’ with them and proclaiming them “heroes”, was for political reasons. That is the only reason Bush does anything. Bush doesn’
    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
    t, and never did, care about those men and women.

    If Bush and the Republicans truly cared about these heroes, they would be outraged by some of the ‘twilight zone’ government decisions that have been made. But t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ey’re not.

    If Bush and the Republicans truly cared about these heroes, they would set aside a relatively tiny sum of money and make sure that these heroes at least enjoyed quality medical care for the rest of th
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    eir shortened lives. It’s not like giving these people quality medical care is going to materially impact the gargantuan Republican fiscal deficits. But there are no plans for that.

    Is it asking too much of Bush
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    and the Republicans to at least give these heroes the peace of mind that their medical problems aren’t going to bankrupt their families?

    The answer is sadly yes.

    Republicans are the ultimate hypocrites. They l
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ove to wrap themselves in the American flag and question the patriotism of their opponents. But when push comes to shove, when you look at nothing but facts, the facts are rather ugly.

    The fact of the matter is
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    that providing quality medical care to these heroes is a tiny fraction of the tax cuts that the Republicans have given to billionaires - without even taking into account the tax cuts to individuals who are ‘only’
    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
    worth hundreds of millions of dollars.

    It is also a tiny fraction of the tens of billions of dollars that Bush and the Republican congress gave to the airlines - many of which were ineptly run, on the verge of
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    bankruptcy to begin with - and that have since gone bankrupt. Talking about flushing money down a toilet…

    Bush truly is a moral disgrace. He’s the biggest hypocrite and back stabber in the world. When someone is
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    useful to Bush for political reasons, he stands next to him, smiling, shaking his hand, telling him he’s an American hero - but when the American hero finds out that this lungs are so full of tiny particles of s
    .

    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
    teel, glass and asbestos that he can no longer work, and his disability pension doesn’t cover his medical bills - Bush discards him like trash.

    Anyone who knew a ‘regular person’ who had the ethics of Bush - who
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    callously used people like Bush does - would be considered a complete sleaze bag - by everyone, Democrats and Republicans alike.

    So, let’s call a spade a spade - Bush is a moral disgrace and complete sleaze bag


    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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