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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

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


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."...


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."...


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