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Write You - Can We Win Without Free Speech?
It goes without saying that for any endeavor to have a chance of success, it has to fulfill two conditions. First, it needs to be physically doable. Second, the action it requires must be legal.
Both preconditions are fulfilled less often than one would wish. Inter-galactic travel is legal, but is not achievable. Becoming wealthy through stealing another’s property may be achievable, but it is not legal
Both preconditions are fulfilled less often than one would wish. Inter-galactic travel is legal, but is not achievable. Becoming wealthy through stealing another’s property may be achievable, but it is not legal
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
. Fulfillment of our dreams is hostage to the combination of physical limits, and of human laws.
These two hurdles do not remain static, but are constantly shifting. Two centuries ago human voice could travel no further that a few dozen feet – but today we routinely talk to people who are half a world away from us. Back then, it took weeks to cross the oceans; now it takes hours. And the human laws are
These two hurdles do not remain static, but are constantly shifting. Two centuries ago human voice could travel no further that a few dozen feet – but today we routinely talk to people who are half a world away from us. Back then, it took weeks to cross the oceans; now it takes hours. And the human laws are
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
changing too, forbidding what used to be allowed, and allowing what used to be forbidden.
Among many aspects of human life affected by shifts in what is doable and what is legal, our ability to speak up our minds and to broadcast our ideas is arguably the most important one.
Given the impact which ideas have on a society – for creatures as different as Nazis and Quakers, as Communists and evangelicals,
Among many aspects of human life affected by shifts in what is doable and what is legal, our ability to speak up our minds and to broadcast our ideas is arguably the most important one.
Given the impact which ideas have on a society – for creatures as different as Nazis and Quakers, as Communists and evangelicals,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
as Al-Quaeders and Americans, as republicans and democrats differ only in the ideas that make sense to them, the ability to express one’s ideas has been tightly controlled throughout history, being rightly perceived by those in power as a potential threat to the established order. Beginning with the inquisition, state control over the press remains in place in countries like China, Iran, North Korea and
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Saudi Arabia. There, speaking up one’s mind is not legal.
The West, however, was able to overcome the legal hurdle some three hundred years ago. In 1695 the English parliament allowed censorship laws to lapse, and the speech in English-speaking world became free of legal constraints.
This elimination of legal hurdles restricting speech coincided with the absence of physical constraints on publishing. B
The West, however, was able to overcome the legal hurdle some three hundred years ago. In 1695 the English parliament allowed censorship laws to lapse, and the speech in English-speaking world became free of legal constraints.
This elimination of legal hurdles restricting speech coincided with the absence of physical constraints on publishing. B
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ck then, the entire English-speaking world consisted of some five million people – a bit more than half of today’s population of the New York City, with only 20% of the men, and 5% of the women being literate (with literacy defined as an ability to sign one’s name.) The literary output of such a community was of necessity tiny and the words of everyone who cared to put his or her thoughts on paper could
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
be given to a publisher, and see the light of day.
But the explosive growth in population and literacy exposed a physical limit to publishers’ ability to process public’s literary output, which became evident by mid 20th century. With the number of writers increasing dramatically the publishing industry became simply incapable of coping with writers’ submissions. While the legal hurdle on what could, an
But the explosive growth in population and literacy exposed a physical limit to publishers’ ability to process public’s literary output, which became evident by mid 20th century. With the number of writers increasing dramatically the publishing industry became simply incapable of coping with writers’ submissions. While the legal hurdle on what could, an
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
what could not be said, was no longer in place, the limit to publishers’ physical capacity stymied the exercise of free speech. As in the case of any other shortage, the shortage of publishing capacity meant that only those with the back-door connections to the publishers could avail themselves of their free speech rights. Outsiders no longer stood a chance of seeing their work in print, of making their
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ideas influence the public discourse.
But there was nothing to prevent authors from bypassing this particular hurdle by publishing their works themselves, all the more that speaking for oneself, without publisher-middleman meddling, is the most natural way of doing it anyways.
To the established publishers, this is a serious treat. For their entire business model of wedging themselves in between the w
But there was nothing to prevent authors from bypassing this particular hurdle by publishing their works themselves, all the more that speaking for oneself, without publisher-middleman meddling, is the most natural way of doing it anyways.
To the established publishers, this is a serious treat. For their entire business model of wedging themselves in between the w
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
iter and the reader and milking both not to fail, they needed a system of de-legitimizing author-published books, a way to spray them with poison to make them unusable. In early 1970es, the government came to the rescue. The Library of Congress established a pre-publication cataloging program which distributes information about forthcoming worthwhile books far and wide. And how does the Government know w
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
hich books are good – and are “most likely to be widely acquired by the nation’s libraries,” and which are not? According to the government, this does not require examining the book in question itself. Was it published by a big publisher? If so, it must be good. By a small publisher or the author? Then it must be bad. And why review a bad book, why stock it? No matter how really important and how really
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
good, an author-published book is “dead in the water.” Mission accomplished.
To protect the publishing industry from losing control and profitability after its physical capacity peaked and became exhausted, the government imposed an additional legal hurdle that de-legitimizes one’s speaking in one’s own voice. The occasional success of a “self-published” book merely proves that the system is utterly cor
To protect the publishing industry from losing control and profitability after its physical capacity peaked and became exhausted, the government imposed an additional legal hurdle that de-legitimizes one’s speaking in one’s own voice. The occasional success of a “self-published” book merely proves that the system is utterly cor
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
upt. Success of such book is a news story – it is something that was not supposed to happen, but happened. But it shouldn’t be a news story. We will know that publishing is healthy when a success of an author-published book is no longer a “man bites a dog” situation. When only its quality matters to a book’s success, it will be normal for books to be published by their authors, just as it is normal for a
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
n owner of an oil well not to sell it, but to develop it himself.
How to bring this about? I filed a lawsuit arguing that the government policy violates free speech, intellectual property, and due process rights, so hopefully, this singularly un-American rule will be annulled, and free speech given back to the Americans.
Contrary to publishers’ view of publishing, it is not merely the means for them to
How to bring this about? I filed a lawsuit arguing that the government policy violates free speech, intellectual property, and due process rights, so hopefully, this singularly un-American rule will be annulled, and free speech given back to the Americans.
Contrary to publishers’ view of publishing, it is not merely the means for them to
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
make a living, but rather a way to facilitate an exchange of ideas – which is achieved far more effectively when the authors can speak for themselves by publishing their works themselves, then by the present-day half-Kafkaesque, half-Swiftean world of publishing, where in a procedure worthy of a Swift, an author cannot speak for himself but has to whisper in a publisher’s ear, hoping that he will condesc
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
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
end to repeat it aloud in return for most of the profits from the book, and the path to that ear is as dark, uncertain, and predicated on back-door connections as the way into the Kafka’s Castle.
The result is terrible. Consider this: at the end of his term as the defense secretary, Donald Rumsfeld made a remarkable admission: “The long struggle we are in is complex, it's unfamiliar, and it's still lit
The result is terrible. Consider this: at the end of his term as the defense secretary, Donald Rumsfeld made a remarkable admission: “The long struggle we are in is complex, it's unfamiliar, and it's still lit
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
le understood.” What he implied is clear: we would have made more progress in the war on terror have we had a clearer understanding of our enemy.
But why don’t we understand the enemy’s mind? Is it because no one in America has a clue, or because those who do, have no access to the publishers, and cannot enlighten the Secretary? Isn’t over 3,400 Americans killed in Iraq, and $400 billion dollars sunk in
But why don’t we understand the enemy’s mind? Is it because no one in America has a clue, or because those who do, have no access to the publishers, and cannot enlighten the Secretary? Isn’t over 3,400 Americans killed in Iraq, and $400 billion dollars sunk in
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to the war, a bit too much of a price to pay for shielding established publishers from competition?
Rather than follow Swift and Kafka, we should base our exchange of ideas on the model advocated by John Milton back in 1644 in his greatest, and “self-published” prose work, Areopagitica. He summed up his argument in a quotation from Euripides, the Greek author who lived in the heyday of Athenian democrac
Rather than follow Swift and Kafka, we should base our exchange of ideas on the model advocated by John Milton back in 1644 in his greatest, and “self-published” prose work, Areopagitica. He summed up his argument in a quotation from Euripides, the Greek author who lived in the heyday of Athenian democrac
.
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
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
:
“This is true liberty, when free-born men, Having to advise the public, may speak free, Which he who can and will, deserve high praise, Who neither can nor will, may hold his peace – What can be juster in a state than this?”
It was the aim of the First amendment to achieve this “just” state of affairs, yet the fundamental right to free speech has become badly abridged as a result of the natural
“This is true liberty, when free-born men, Having to advise the public, may speak free, Which he who can and will, deserve high praise, Who neither can nor will, may hold his peace – What can be juster in a state than this?”
It was the aim of the First amendment to achieve this “just” state of affairs, yet the fundamental right to free speech has become badly abridged as a result of the natural
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
limitation of the publishing industry, and government’s eagerness to shield the industry from the consequences of its impotence. As a result, many important ideas have been lost, to the detriment of us all. We owe it to ourselves to have our free speech restored back to the American people, so we could win the war on terror – and achieve victories in other areas of human endeavor, too.
© Vel Nirtist 200
© Vel Nirtist 200
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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