Story in Journal of Bioethics finds study ‘ethically questionable'

PORTLAND — Medical ethics scholars from around the country have blasted a study of drug testing in high schools conducted by Oregon Health & Science University, but researchers there are defending their study as well-designed, but misunderstood.

The cover story in the current American Journal of Bioethics argues 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.

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.

Debate began 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.