E-DRUG: Risky business: Human testing for a profit
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[copied as fair use; WB]
Risky business: Human testing for a profit
New scrutiny needed after two commercial clinical trials go wrong
COMMENTARY
By Arthur Caplan, Ph.D.
MSNBC contributor
Updated: 3:24 p.m. ET March 20, 2006
Last week, six very healthy men suddenly wound up in a London hospital
in critical condition. Earlier this month, 11 otherwise well people
tested positive for tuberculosis, according to Montreal’s health
department. What do these people have in common? All were human subjects
in research paid for and conducted by private companies. These mishaps
mean that the time has come to take a closer look at how commercialized
research involving human subjects is being conducted all over the world.
The people in England were involved in a study of an experimental
leukemia drug. It was paid for by a German pharmaceutical company but
run by a U.S. company, Parexel. In Montreal, volunteers apparently
caught TB from an infected subject they'd been housed with as part of a
study paid for by a Canadian company but administered by another U.S.
research company, SFBC International.
It's certainly true that human research is risky business. Even when
people are in safety studies and only exposed to relatively small doses
of experimental drugs, things can go terribly wrong. That's why it's so
important for healthy volunteers who are recruited into clinical
research to fully comprehend the reality that there are real risks
involved in biomedical research. And it's equally important that those
who conduct these studies — drug companies, contract research
organizations and the review committees who by U.S. law must approve all
human trials before they can begin — put the informed consent and safety
of subjects first. There are reasons to think this didn't happen in
either the British or Canadian trials.
In the case of the British subjects, who went into acute organ failure
and suffered excruciating pain immediately after being exposed to a new
substance intended to fight some forms of cancer, some doctors are
outraged that the study was allowed to even start given that there had
been previous problems in animals and people with very a very similar
substance.
The recruitment of the participants into the British trial certainly
left much to be desired ethically. As Bloomberg News reported, the Web
site which announced the opportunity to enroll in the study for healthy
volunteers said almost nothing about risks but went on and on about good
pay, free medical care, free food and "plenty of time to read or study
or just relax, with digital TV, pool table, video games, DVD player and
free Internet access.'' This is not the sort of language that tells
people eager to make some easy money that they are entering into the
risky world of high-stakes medical research.
SFBC has also had its share of ethical missteps beyond the problems in
Montreal. Bloomberg also reported that the company’s major facility for
housing subjects in long-term studies in Miami, Fla., had received
numerous safety and fire code violations. When subjects went public with
complaints about problems they had seen at SFBC’s Miami testing
facility, at least three of them said they were bullied and threatened
with deportation by SFBC officials.
Twenty years ago most clinical research was conducted in academic
medical centers. American companies did their research in the United
States. Most research was paid for by government money. All that has
changed.
Today private companies pay for the bulk of clinical research on new
drugs, medicines and devices. They hire private companies to run their
studies and to review them. And a lot of this research is done using
poor people or students, sometimes in the United States but often in
Europe, India and Southeast Asia.
The business of conducting medical research is profitable. Private
companies running studies for pharmaceutical and device companies are
now a $14 billion industry in the United States alone.
The problem with the intense commercialization of research is that it's
not clear that contract research organizations such as Parexel and SFBC
that make their living meeting deadlines for drug company sponsors
always put subject welfare first. There is plenty of room for conflicts
of interest when the person recruiting volunteers for research is being
paid to get subjects enrolled and data generated as quickly as possible.
The recent events in London and Montreal make it clear that it is time
for Congress and other regulatory bodies here and overseas to take a
hard look at how clinical research is being done these days. Many of
those in the for-profit business of conducting clinical research may be
doing their best, but they and their sponsors had best be putting the
safety and welfare of their subjects first. Otherwise they should have
no business doing clinical research.
Arthur Caplan is director of the Center for Bioethics at the University
of Pennsylvania.
© 2006 MSNBC Interactive
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