Pubdate: Wed, 17 Mar 2004 Source: Oregonian, The (Portland, OR) Copyright: 2004 The Oregonian Contact: http://www.oregonlive.com/oregonian/ Details: http://www.mapinc.org/media/324 Author: Andy Dworkin Bookmark: http://www.mapinc.org/topics/OHSU Bookmark: http://www.mapinc.org/testing.htm (Drug Testing) Bookmark: http://www.mapinc.org/find?225 (Students - United States) 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 - --- MAP posted-by: Richard Lake