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I just finished reading Al Gore's new book, "An Assault on Reason," and was enormously impressed. I think this book should be read by everyone. The sad part is that it probably won't be. It's not a slick, easily assimilated DVD, with simple, predigested idea

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 ready to be ingested by an audience that only knows how to passively swallow network pap. And neither is it an easy reading book, written to the level of the average middle school child; sometimes one must read a sentence twice to grasp exactly what is bei

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

Examples of combination products may in

g said. But it needs to be read.

He totally decimates the current administration. Totally! Complete with very solid facts, footnotes and references, and, in a way that makes our gallery of presidential candidates look and sound like timid, compromising, cow

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ardly sellouts. But he never stoops to dirty, mud-slinging, partisan politics. Because of that and his very precise wording, he reads a little stiff. There is little of the passion of someone like Keith Olbermann, although he does warm up a bit in the latter

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

half of the book.

But the book is far more than a simple Bush-bashing. The book explains so much about what is broken and how it came to be broken - about our world, about our political process, about our democratic institutions, and about our corrupt leade

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ship. If you are baffled about why there is no oversight and no accountability, if you've been thinking you've somehow awoken into some kind of unbelievable nightmare of a quagmire that must belong in some alternate reality, you need to read this book. It's

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

all laid out here - all the missing pieces are in place. Liberally sprinkled with wonderful quotes from founding fathers to present time and presented against the backdrop of historical context, it makes it obvious how far off course this country has strayed

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

Bush is often portrayed by the liberal left as the simple buffoon, but, frankly, in my opinion, what's been accomplished here with the dismantling of our democracy and the reduction of a carefully constructed system of checks and balances to a heap of rubb

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

le is far more than the work of a buffoon. Bush, or whoever is behind him, pulling his strings, is a powerful force to be taken very seriously.

I believe due process and democracy itself is losing the fight for it's very life right now and if you don't see

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, you are blind. We have enjoyed over 200 years of mostly rule by law and government "of the people, by the people, for the people", but this is slipping from our grasp. God did not ordain that democracies must abide forever. There are no guarantees of inde

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

initely continuing freedom. There is no reason to assume that just because we grew up with democracy, that our descendants will. Ancient Greece and the Roman Republic were democracies that fell. Continuing democracy requires continuing vigilance and continui

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ng effort, but this is just not happening. I actually believe that, simply put, we've already lost it at this stage of the game and if we want it back, we will have to take action and fight for it.

From the book, page 221:

Our Founders were kee

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ly aware that the history of the world proves that republics are fragile. In the very hour of America's birth in Philadelphia, Benjamin Franklin was asked, "Well, doctor, what have we got? A republic or a Monarchy?" He replied cautiously, "A Republic, if you

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

can keep it." The survival of freedom depends on the rule of law. The rule of law depends in turn upon the respect each generation of Americans has for the integrity with which ours laws are written, interpreted, and enforced.

President Bush has repeatedly

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

violated the law for six years. In spite of the fact that the only judicial decision to have reached the question of legality has ruled comprehensively against the president's massive and warrantless surveillance program, both the Justice Department and the

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

ongress have failed to take any action to enforce the law. There has been no request for a special prosecutor, and there has been no investigation by the FBI. There has been only deafening silence. But the consequences to our democracy of silently ignoring s

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

erious and repeated violations of the law by the president of the United States are extremely dangerous.

The book doesn't leave us stranded in the quagmire, but finishes with specific direction and a hope for the future and so, is a huge wake u

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

call for us all to get involved in our political process before it's too late. And he does warn that it's already very close to too late. The question is, can "we the people" abandon our TV and fast food addictions, our apathy and inaction, our descent into

.

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

a dreamland of wishful thinking, fearful cowardice and naive gullibility long enough to rise to the challenge? That remains to be seen. We put some people in Washington with a simple mandate to stop the war and remove the corruption at the helm and they've

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

umbled the ball miserably. Now what? From the book, page 210:

The era of procrastination, of half measures, of soothing and baffling expedients, of delays, is coming to a close. In its place, we are entering a period of consequences.

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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