Quoted message said:Subject: Re: Available Clinical Trials
From: "Peter Moran" [email hidden]
Date: 5/26/2004 1:56 PM Pacific Standard Time
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"M.a.r.k P.r.o.b.e.r.t-May 26, 2004" <M.a.r.k P.r.o.b.e.r.t
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Quoted message said:
<[email hidden]> wrote in message
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Quoted message said:Is that the norm? For participants to pay for a clinical trial, as all
the Burzynski trials require?
Participants in clinical trials are often compensated for their
invovlement.
Quoted message said:
I did not find one trial on this site, other than the Burzynski ones, that
requires the participant to pay for medical care.
It is normally regarded as quite unethical. Participants in clinical trials
may run unknown risks with no certainty of benefit.
Peter Moran
Peter Moran is speaking of unethical.
Let's take a look.
http://tinyurl.com/2l7ps
http://www.bizjournals.com/sanjose/stories/2003/05/12/story6.html
The company has a partnership with GlaxoSmithKline on the drug now in clinical
trials and has a collaboration with Exelixis Inc. to design more small-molecule
compounds that Cytokinetics and Exelixis can each use in its drug discovery
efforts.
http://www.poz.com/index.cfm?p=article&art_id=533
Today's Competitor Is Tomorrow's Collaborator"
Drug development is a famously high-stakes enterprise. Only one in 10 compounds
in phase III human efficacy trials gets Food and Drug Administration (FDA)
approval; only one in three of these ever turns a profit; and pharmaceuticals
depend on 20 percent of these winners to create 70 percent of their profits.
These odds encourage drug companies to avoid research long shots and any data
that might be damaging to their meds already on the market.
http://www.amnestyusa.org/amnestynow/bitterpill.html
U.S. drug companies tested Milltown, a tranquilizer, at an insane asylum in
Haiti, 1954. (© Eve Arnold / Magnum)
Amnesty Now > A Bitter Pill
A Bitter Pill:
Exporting Drug Trials to the Developing World
WARNING: Side effects of globalizing human experimentation may include
questionable ethics, preventable deaths, and violations of international
agreements.
BY DAVID CONCAR
David Concar is a London-based journalist and deputy editor of New Scientist
magazine.
When a deadly epidemic of bacterial meningitis swept through northern Nigeria
in 1996, Samaila Musa’s parents did the obvious thing. They took their
stricken 7-year-old to the infectious disease hospital in the nearby city of
Kano. Amidst an anguished dispute over what happened next, one thing is clear:
The world’s richest pharmaceutical company enrolled Samaila, and hundreds of
infected children like him, as test subjects in a now-notorious drug trial. A
team from Pfizer Inc. had learned of the outbreak on the internet and flown to
Kano armed with a promising new antibiotic called Trovan (trovafloxacin). With
meningitis rare in the West, it was a golden opportunity to put the drug
through its paces, compare it to a rival company’s approved treatment, and
gather the data needed for a license to market the potentially lucrative drug.
Trovan, alas, was no miracle cure. Several (the exact number is disputed) of
the sick children given the experimental drug died. Many more suffered lasting
injuries from their infections. Samaila, now a teenager, was struck deaf and
dumb. Pfizer says that Trovan worked better than any other treatment
administered in Kano. But lawyers representing outraged Nigerian families
dispute that view and claim that the trial violated international agreements,
including the Nuremberg Code. These international guidelines were drawn up in
1949 to protect human subjects from the kind of appalling experiments Nazi
doctors performed on concentration camp inmates.
“The Kano patients didn’t know they were being enrolled into a for-profit
study. It is absolutely abhorrent that you can use sick children as guinea pigs
without informed consent,†says Elaine Kusel, the legal partner handling the
case at Milberg Weiss in New York.
http://www.hei.org/research/depts/clinstud/questdy.htm
Jan