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  • Social Articles - A Letter to Americans: Is Freedom Slipping Away?

    My Fellow Americans:

    The United States is not a democracy, it’s a republic. Say the Pledge of Allegiance to yourself. What does it say?

    A republic has representative government. A democracy is governed directly by the people. The closest thing to a democracy is California where the people put proclamations on the ballet and let the public decide what is right, not the legislature.

    Be that as it may, our republic had faired well on the average over the years, but the President or the Congres
    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
    s sometimes takes over and rules with a mighty hand. Still, many American People feel that their Constitutional Rights are being infringed upon. Some think that the government verges on dictatorship.

    The Presidential Oath of Office

    Here is the Presidential Oath: I do solemnly swear (or affirm) that I will faithfully execute the office of President of the United States, and will to the best of my ability, preserve, protect and defend the Constitution of the United States.

    The Presiden
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    tial Oath is usually given by the Chief Justice of the Supreme Court. Because of the sad circumstances, the oath was given to LBJ on Air Force I at Love Field, Dallas, Texas by Sarah T. Hughes, U.S. District Judge, Northern District of Texas.

    The Congressional Oath of Office

    Here is the Congressional Oath of Office: I, (name of Member), do solemnly swear (or affirm) that I will support and defend the Constitution of the United States against all enemies, foreign or domestic; that I will b
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ear true faith and allegiance to the same; that I take this obligation freely, without any mental reservation or purpose of evasion; and that I will well and faithfully discharge the duties of the office on which I am about to enter. So help me God.

    These oaths require that the President and the Congress uphold constitutional law. The constitution can be modified by amendment. Three-fourths of the states must ratify an amendment to change the constitution. Seven years is the allowed time period.
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    (To see a list of amendments that have not been ratified go to: http://www.house.gov/house/Amendnotrat.shtml.)

    No where in the oath does it say that the President or a Congressman must be honest in all of his dealings. We need to add that, don’t we?

    How Presidents See Themselves

    How the President will fulfill his duties somewhat depends on how the President sees himself. President Bush sees himself as Commander in Chief. Woodrow Wilson saw himself as World Statesman. FDR befo
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    re World War II saw himself as Friend of the Down and Out. As war loomed on the horizon he saw himself as Defender of Freedom.

    Well, I made this up. How do you think the presidents thought of themselves?

    How the American People See Presidents

    The American people have always responded to how the President thinks. Some think that President Bush is a dictator. Some thought that President Wilson was giving our freedoms away to world government. Some thought that President Rooseve
    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
    lt should have let the starving American people fend for themselves and that he was a warmonger.

    Presidential Perspective

    Most presidents view themselves in history. They need something for their Presidential Library. Most have had a good grasp on history and precedent. President Bush is an exception. He is not an intellectual. That does not disqualify him from the presidency. The people “spoke” twice.

    Despite what Harriet Miers said about the President, he is not Mr. Swift. But as he serve
    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
    in the Presidency, he is getting smarter all the time. But don’t expect “former” President Bush to be a genius. He’ll be back driving his tractor and chopping wood on his ranch. Future presidents will ask him to drop by for an informative chat.

    My Last Gripe on Harriet Miers and Tyrannosaurus Rex

    Harriet Miers would have been a better selection to the Supreme Court than Samuel Alito, Jr. She has much broader experience and she has compassion.

    Miers received her bachelor's degree in mathema
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    tics in 1967 and JD in 1970 from Southern Methodist University. Upon graduation, she clerked for U.S. District Judge Joe E. Estes from 1970 to 1972. (See her amazing biography at http://www.washingtonpost.com/wp-dyn/content/article/2005/10/03/AR2005100300305.html.)

    She was raped of her intellectual virtues, and her chance to serve, by a hasty, unthinking, belligerent Congress.

    Orrin Hatch, who was a member of our church in Pittsburgh, gave her a loving hug after the beating.

    God Bless You, Orrin.
    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

    The Terrorist Attack on the World Trade Center

    The attack on September 11, 2001 on the Twin Towers of the World Trade Center in New York City demanded action by the President. He felt this to be his personal responsibility to the people of the United States. He took action accordingly on a global basis and a domestic basis.

    He didn’t particularly spend his time ironing out the facts or studying his constitutional rights. His objective has always been to stop the terrorist, never to negotiat
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    e with them, and to kill them dead in their tracks. He has focused on the terrorist, not the American People.

    He is acting as Commander in Chief.

    Historians will treat him kindly on this matter.

    The problem comes when the President changes emphasis. Why was the attack on Iraq to destroy “Weapons of Mass Destruction,” changed to an attack to “Remove a Vicious Regime,” and then to an attack to “Bring Freedom to Iraq?”

    I think if we had started with Number 2, to “Remove a Vicious Regime,” we would h
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ave been ahead. Maybe we could have left Iraq last year.

    The actions by the President to counter 9/11 have been costly. Many Americans blame Dick Cheney for the shortcomings of the 9/11 response. Some think that he has favored Halliburton and its subsidiaries. Some think that he just wanted to grab Iraq’s oil. Some think that the Vice President has a cartel that bypasses the president and constitutional law. Some think he is sneaky, cruel, and dangerous.

    Dick Cheney had a wonderful reputation durin
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    g Bush War I. He has faired less during Bush War II. The People have spoken.

    None of this has helped the President.

    Another major problem of the President is his Press Secretary. Certainly the most incompetent press secretary in history, Scott McClellan, continues to make the Administration look like a group of unthinking boobs. He lies, dodges, insults, and does everything a press secretary shouldn’t do. His treatment of the Press Corp is atrocious. He can’t seem to answer the simplest question. E
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    very question causes him to put his hands across his chest. Then he starts to mumble.

    Well, Scott doesn’t really mumble. I put that in there for effect. Actually, I think it would help if he mumbled. Try that, Scotty.

    Because of Scott McClellan, the President and Vice President are always on the road trying to explain what is going on. Unfortunately, they don’t always do this in front of a typical American group. When I hear some of the profanity when they do, I don’t blame them.

    Still, the govern
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ent is considered unresponsive, out of touch with the American people, and to some, downright evil.

    It Will All Come Out in the Wash

    Most Americans realize that the President is not trying to become a dictator, that he does not intentionally break laws, that he is completely stupid.

    Congress will take action as they always do to relieve major tensions.

    But Congress Will Not Change

    As congress writes new laws some but not all will continue to add riders creating roads and bridges n
    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
    amed after them, slip in a little pork barrel money for their constituents, and take money from special interest groups.

    After the President has finished his tenure, some members of Congress will continue to be their own nasty selves.

    The two-party system does not seem to work to the advantage of the American People. That was my leadin to the next item.

    I’m Against the Two-Party System

    The “two-party system” is killing America. The parties are not composed of thinkers. They too often vote
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    as a block. A senator or congressman that votes outside his party will not get that piece of pork he is after.

    The other day the Republicans were angry because not one Democrat voted that Judge Alito’s nomination be taken to the floor of the Senate. They said that they would remember that in the future. They didn’t mention that not one Republican voted against Judge Alito. Nobody said, "Bring back Harriet Miers."

    The system doesn’t cover Middle America who is neither left nor right.

    We need
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    more parties in the United States so that no party can gain a majority without responding to the people.

    America has had numerous political parties. Let’s resurrect the Federalist, the Whigs, and the Bull Moose parties. I want to be a Mugwump. The Mugwumps bolted the Republican Party in 1884.

    We have in the past had senators from these parties: Nullifier, Law & Order, Liberty, Independent Democrat, Free Soil, American, Unionist, Unconditional Unionist, Liberal Republican, Independent Republican
    .

    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
    , Independent, Readjuster (sounds like a humdinger), Populist, Silver, Populist, Silver Republicans, Progressive, Farmer-Union, and Conservative (see http://www.senate.gov/artandhistory/history/common/briefing/senators_thirdParties.htm).

    Here is my summary from association with our two parties: Each Democrat wants everybody to have a piece of the pie. Each Republican wants the whole pie for himself.

    I leaned the difference from actual experience.

    Well, let’s get things going again. Sta
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    rt your party now.

    Here’s A Law I Would Like to See

    The congress is always pasting their pork to the end of bills.

    I would say that no bill should cover more than one subject. If they want pork, put it in its own bill and state which special groups are supporting it.

    Why continually try to fool and trick the American People? There should be a law against it. Damn it, do it!

    I hope you didn’t read this whole article. I’m no expert on these matters.

    Sincerely, Taylor Jones, the hack writer


    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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