SCHOLARS CALL OHSU STUDY OF DRUG TESTING UNETHICAL

A Journal Article Essentially Agrees With a Ruling That Stopped The
Project in High Schools

A study of drug tests in Oregon high schools was unethical and
coercive, medical ethics scholars from around the United States charge.

The current American Journal of Bioethics features a cover story
critiquing Oregon Health & Science University's "Saturn" study, halted
by the federal government in 2002. The journal also includes a paper
by OHSU researchers defending their study as well designed but
misunderstood.

The cover story's authors argue that the Oregon study is "ethically
questionable" for reasons that mirror the government's concerns:
Mandatory drug tests were central to a supposedly voluntary study;
students were not fully informed of the study's workings and were
coerced to take part or risk their places on sports teams; and OHSU
broke some federal research rules.

Ethical considerations require that people be able to opt out of
medical studies without loss or retribution. That makes it hard to
study public health programs that people are required to take part in,
the authors wrote.

However, a University of Maryland ethicist, Adil Shamoo, one of the
authors, said such studies probably would be ethical if "designed much
better."

"They just have to go through more hoops" to protect people, he said.
"Our society demands more hoops."

Fourteen "peer commentaries" expand on the cover story, including one
by Portland resident Jonathan Eder, whose complaint letter prompted
the federal investigation of the study. Most of the commentaries fault
the study's design and criticize OHSU's Institutional Review Board for
approving it.

"What were they thinking?" wrote Angela Roddey Holder, a medical
ethics professor at Duke University. "It is difficult to imagine on
what grounds this 'study' was ever considered acceptable."

But OHSU authors, including study director Dr. Linn Goldberg, battle
back in a peer commentary that says the main article contains flawed
conclusions, "many factually incorrect statements, assumptions and
more than a modest amount of conjecture."

"It's important to note that the articles written there were written
by authors who didn't have the (research) protocols or any of the
materials reviewed by our (board)," said Dr. Gary Chiodo, a chairman
of OHSU's review board who co-wrote the journal's commentary. "That's
really how the whole dispute started."

Debate boiled up in 2002, two years after the National Institute on
Drug Abuse gave Goldberg $3.6 million to study whether mandatory
drug-testing programs discourage high school athletes from using
recreational drugs, alcohol or steroids.

Goldberg, head of OHSU's Division of Health Promotion and Sports
Medicine, planned to survey student athletes at more than a dozen
Oregon high schools about their drug use. Athletes at half the schools
got annual, random drug tests. All schools had agreed on their own to
start drug tests, but the study dictated who could test and which
tests to give. The study grant paid for the testing, and OHSU
researchers got the test results.

At OHSU, doctors maintain that the schools' random testing was
separate from their study, which involved only voluntary surveys. But
some students and parents complained that they were pressured to take
part in the study.

Dallas students filed a federal lawsuit in 2002, part of which is
pending. The federal Office for Human Research Protections
investigated and stopped the study in 2002, saying it was so
intertwined with the mandatory testing that students were coerced to
join the study.

Officials at OHSU proposed changes and tried to restart the study, but
the government rejected the proposals as inadequate. Chiodo said the
study is "permanently closed" now.

Goldberg is analyzing results collected before the study stopped, data
that have been stripped of information that could identify the
students. He probably will publish the analysis in several months,
OHSU spokeswoman Christine Pashley said.

Abstracts of the journal articles are on the Web at www.bioethics.net