All who drink of this treatment recover in a short time, except those whom it does not help,who all - PowerPoint PPT Presentation

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All who drink of this treatment recover in a short time, except those whom it does not help,who all

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The FDA, Business and One Hundred Years of Regulation. The Grand Bargain ... 1. news reports outline the problem. 2. Reformers campaign for change. ... – PowerPoint PPT presentation

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Title: All who drink of this treatment recover in a short time, except those whom it does not help,who all


1
All who drink of this treatment recover in a
short time, except those whom it does not
help,who all die.It is obvious, therefore, that
it fails only in incurable cases.--Galen,
129-199 AD
2
Civilizing Capitalism
  • The FDA, Business and One Hundred Years of
    Regulation

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The Grand Bargain By the 1950s, Smith, Kline
had dropped 14,940 of its products, setting aside
all its dubious or worthless chemicals, and
instead began to research and sell only 60
drugs. It made a better profit with a few, real
drugs.
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The Scientific Base ...Adequate and
well-controlled investigationsby people
qualified in science505 (d) 7 1962
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Historical Requisites for Reform1. news
reports outline the problem.2. Reformers
campaign for change. 3. Laws are drafted,
debated in Congress.4. Reform is killed by
special interests.5. A Crisis intervenes
(involving children), and reform law is passed.
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Back to the 19th Century
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I think something more than 40,000
tuberculars alone have died in this country who
conceivably could have been saved by a drug that
has been used widely in the last few years
throughout Europe.---- Ronald Reagan, press
conference, American Enterprise Institute, 1975
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When he said it, the drug had already been on
the market for several years. He said it took
more than two years to approve---in fact the
approval came through in five months. The
manufacturer was the one who had held back.The
idea that 40,000 people died because of the lack
of the drug was absurd. In the entire decade from
1968 to1978, a total of 28,000 people died of TB
in the U.S. There were three effective drugs on
the market to treat it. The reason for death in
virtually all cases was that people came in for
diagnosis very late in the progress of their
disease, too late for any drug to help.
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Tacrine(Cognex) During the seven years
it took to approve Tacrine, thousands of
Alzheimers patients gradually lost their
memories. Nobody knows how many died.
----Washington Legal Foundation
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Cognitive CosmeticsTacrine would not have
prevented any deaths. Nor would it have halted
the progress of Alzheimers disease. The United
States was the first to approve the drug many
countries did not follow its example. The FDA
sometimes allows early access to treatments that
are only marginally useful. Such a case was
Tacrine. The drug causes liver damage in many it
does nothing to treat the underlying disease and
very little to treat the symptoms.
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