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1964 The fundamental principle of
the Declaration of Helsinki is respect for the individual (Article 8),
their right to self determination and the right to make informed decisions
(Articles 20, 21 and 22) regarding participation in research, both initially
and during the course of the research.
The investigator's duty is solely
to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while
there is always a need for research (Article 6), the subject's welfare must
always take precedence over the interests of science and society (Article 5),
and ethical considerations must always take precedence over laws and
regulations (Article 9).
1969
Congressional study reveals that
37 of 49 top officials of the FDA who have left the agency moved into high
positions within pharmaceutical corporations they had
regulated.
Senate hearings on Health and Scientific Research
confirm that 239 populated areas had been contaminated with
biological agents
between 1949
and 1969.
Some of the areas
included San Francisco, Washington, DC, Key West, Panama City, Minneapolis, and
St. Louis.
The DoD has also used hundreds of thousands of military
personnel as human guinea pigs
intentionally exposing them to dangerous and toxic
substances.
Materials included mustard and nerve gas,
ionizing radiation,
psychochemicals,
hallucinogens, and drugs used during the
Gulf War.
1970 FDA Commissioner Dr. Herbert Ley blows the whistle on the
FDA and its corrupt relationship with the medical and
pharmaceutical cartels.
Ley is forced out and replaced.
"IG Farben
is one of the most hated, feared, envied and misunderstood business entities to
ever exist.
With its slimy tentacles in everything from women's
underwear to the depths of secret Swiss bank accounts, IG Farben achieved a
near-mythic status.
Some have argued that the cartel is so enormous, so
complex, so deeply entrenched, that it can never be killed.
Neither the
Nuremberg tribunals (in which 24 of the IG's top men were tried for Nazi war
crimes), nor the power and determination of the victorious Allied occupation
forces, could truly dismember this archetypal "thousand-limbed predator
beast, this King Kraken with
countless snaking arms, writhing in a fever of
greed, deep in its lightless
lair."
There is truth mixed in with the outrageous
beliefs.
IG Farben was vast; it was deeply tied to the Nazi state; it
had power greater than many national governments; and the major companies which
came together in 1925 to form the cartel still live, in fact are
thriving.
From its labs come some of the most detested and terrifying
substances known to mankind: heroin, chlorine and phosgene gases (first poisons
used in World War One), methadone (originally called Dolophine), the death-camp
toxin Zyclon-B, and the still-used military nerve gases: tabun and
sarin.
On September 15, 1925, the complete merger was sealed and IG
Farben took its final form.
Within a year, it was the largest company
of any kind in Europe; only three worldwide were bigger.
Men served simultaneously in the Nazi Government
and the IG leadership." - Thomas A. Metzger |
1947 The Nuremberg Code creates legal medical experimental
standards now incorporated into all ethical medical codes that include:
- requiring voluntary consent of human subjects without coercion,
fraud, deceit, and with full disclosure of known risks (informed
consent);
- experiments should avoid "all unnecessary
physical and mental suffering
and injury;"
- experiments should never be conducted if there's "an a
priori reason to believe death or disabling injury will occur";
- "risk"
should never exceed that determined by the
humanitarian
importance of the problem to be "solved" and;
- experiments should
be terminated if there's reason to believe they'll cause "injury, disability,
or death to the experimental subject."
The Nuremberg Code has not been
adopted by the US government but has been adopted into the laws of the State of
California.
1965
Austin Bradford Hill proposes a set of nine criteria to provide epidemiologic
evidence of a causal relationship between a
presumed cause and an observed effect.
Strength: A small association
does not mean that there is not a causal effect, the larger the association,
the more likely that it is causal.
Consistency: Consistent findings
observed by different persons in different places with different samples
strengthens the likelihood of an effect.
Specificity: A specific
population at a specific site with a specific disease.
Temporality: The
effect has to occur after the cause.
Biological gradient: Greater
exposure leads to greater incidence of the effect.
Plausibility: A
plausible mechanism between cause and effect is helpful.
Coherence:
Coherence between epidemiological and laboratory findings.
Experiment:
"Occasionally it is possible to appeal to experimental
evidence".
Analogy: The use of similarities between the observed
association and others.
Reversibility: If the cause is deleted then the
effect should disappear. |
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