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Most news stories only deal with adverse effects of drugs (both
existing
and experimental) they overlook the far larger and subtler effects
due to
toxicity and their use to mask symptoms (palliative). Hence the
underling
disease is prolonged, under such conditions, if indeed the patient
is not
killed outright from the compromised immune system. This the medical
community then proudly calls "disease management"! Recovery
is not only
delayed, it is not so complete; the patient is greatly weakened,
and the
ultimate restoration to normal health is long drawn out. One is
usually
left with some sequelae or chronic after-effect, from which he/she
recovers, if ever, only after a long time has elapsed. That is,
if she/he
is not treated again with some other toxic and palliative drugs
to deal
with side effects of the original palliative treatment...
Chris Gupta
Cancer drug consent forms don't mislead: review Last Updated Fri,
27 Dec
2002 20:08:34 BETHESDA, MD.
Cancer patients who take part in experiments to test experimental
drugs may
mistakenly believe they'll benefit from the treatment, but it's
probably
not the consent form that leads them to think so, researchers say.
American ethicists reviewed 272 consent forms for experimental
cancer
studies, called Phase 1 trials.
Experimental trials test the safety of a drug INDEPTH: Drug Regulation
http://www.cbc.ca//news/indepth/background/drug_regulation.html
They found the forms nearly always say the goal of the study is
to test how
safe the medicine is, not to help patients.
Christine Grady of the bioethics department at the National Institutes
of
Health's Warren G. Magnuson Clinic in Bethesda, Maryland, led the
study.
Grady said patients may misunderstand the purpose of the study
due to other
reasons, such as their desperate hopes. The researchers found:
fewer than five per cent of forms said a cure was possible about
80 per
cent stated severe or permanent harm was possible two-thirds mentioned
death as a risk one consent form promised direct benefit to subjects
The
researchers said there is room for improvement. Grady said the main
problem
is that forms repeatedly used the word "treatment" without
qualifying it as
"experimental." She said when people see "treat,"
they might get the
impression the drug is more established.
About 80 per cent of the consent forms reviewed were from top cancer
centres in the U.S., or from six large pharmaceutical companies.
"Consent
forms for Phase 1 oncology studies almost never promise direct benefit
to
subjects, rarely mention cure, and usually communicate the seriousness
and
unpredictability of risk," the researchers concluded. The study
appears in
Thursday's issue of The New England Journal of Medicine.
Written by CBC News Online staff
http://cbc.ca/storyview/CBC/2002/12/27/consent021227
Telling the Truth: What Drug Companies Don't Want You to Know
..."Equally troubling, drug companies frequently own and control
the data
collected in drug trials. Even the university scientists conducting
the
trial may not be given all the data they need. Companies sometimes
publish
data favorable to their product while suppressing unfavorable data.
Take
the case of Dr. James O. Kahn, who not long ago published a study
in the
Journal of the American Medical Association. His study concluded
that a
vaccine for AIDS simply didn't help patients. The corporate funder
of that
study refused to give Dr. Kahn (the principal investigator) all
the data.
It then tried to block publication of the research. When the study
was
finally published, the corporation initiated a $7 million-10 million
legal
action against Dr. Kahn and his employer, the University of California
at
San Francisco. In light of such intimidation, few researchers will
have the
courage to stand up to the companies that fund them."...
http://www.cspinet.org/integrity/tell_truth.html
Drug Industry - Conflicts of interest
..."The investigative series in the Seattle Times provides
insight into
that changed culture at the Fred Hutchinson Cancer Center during
the mid
1980s. The copiously documented series examined the conduct of research
and
patient care in two cancer trials. It illustrates how a new entrepreneurial
culture in medicine encouraged doctors to push the limits beyond
what can
be considered, ethical research, by subjecting patients to unjustifiable
risks and increased suffering. At the Hutch a physician with a conscience
who clearly did not embrace the new entrepreneurial ethos blew the
whistle.
It has been said, "Doctors fear drug companies like bookies
fear the mob."
Researchers whose findings collide with corporate interests, are
finding
out that academic freedom is no longer operational. Two high profile
examples from our Canadian neighbors illustrate that researchers
can face
intimidation by both corporate sponsors and university administrators.
In
1996 Dr. Nancy Olivieri found that a generic drug for thalassemia,
manufactured by Apotex, the sponsor of the tirals, failed to sustain
long-term efficacy. Dr. Olivieri informed Apotex and the chair of
the
institution's research ethics board (REB) and moved to inform patients
in
the clinical trials of the risk-as is her ethical obligation. Apotex
terminated the two trials and warned Olivieri of legal consequences
if she
informed patients or anyone else. Apotex, meanwhile had reportedly
contributed $13 million to The University of Toronto.
When Olivieri attempted to publish her findings, Apotex threatened
to sue
her for breach of confidentiality. The University failed to defend
Olivieri
and the principles of research ethics or academic freedom. The University
threatened to dismiss her, initiating a biased inquiry and knowingly
relied
on false accusations by company- funded investigators-all of which
were
later discredited by an independent investigation by the Canadian
Association of University Teachers.11 Olivieri's publication of
her
negative findings was delayed for two years. The case is a dramatic
illustration of conflicts of interest and the collision between
corporate
interests and the right of research subjects to be informed of any
identified risks-as required by the principle of informed consent.
Another example of the clash between academic freedom and corporate
interests, again involving retribution by the University of Toronto,
involves Dr. David Healy, a prominent psychopharmacologist and historian
of
psychiatry at the University of Wales."...
http://www.webnat.com/healthinfo/DrugIndusConflict.htm
see also:
http://www.commondreams.org/headlines02/0630-03.htm
http://www.wave-guide.org/archives/emf-l/Jun2000/Press-(lack-of)-coverage-viz--conflict-of-interest--(guru)--.html
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