Testosterone Patients Not Told About Anemia : Shots - Health News Low levels of iron in the blood may indicate a serious but treatable medical condition if caught early, but patients in a testosterone trial were not informed, a bioethicist finds.
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Researchers Failed To Tell Testosterone Trial Patients They Were Anemic

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Researchers Failed To Tell Testosterone Trial Patients They Were Anemic

Researchers Failed To Tell Testosterone Trial Patients They Were Anemic

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ARI SHAPIRO, HOST:

We have an important postscript to that study you just heard about. A journal reviewer discovered a design flaw that raises an ethical issue. NPR's Richard Harris has more.

RICHARD HARRIS, BYLINE: One ethical rule for clinical studies is if you find a health issue among your participants, you should inform them so they can get it checked out. That didn't happen in this case. More than a hundred men in the study had suffered from mild anemia at the time they enrolled, and nobody thought to tell them.

BERNARD LO: Abnormal results on this simple blood test could have been an early warning sign of a serious illness.

HARRIS: Bioethicist Bernard Lo at The Greenwall Foundation says the anemia could indicate colorectal cancer, which is most treatable when caught early.

LO: Why wasn't this picked up until the astute journal noticed it after the study was done?

HARRIS: After all, the study had a dozen different institutional review boards that were supposed to look for ethical issues. Two dozen well-regarded scientists ran the experiment with funding from the National Institutes of Health. And to top it off, the study was overseen by a data and safety monitoring board, Dr. Lo notes in an editorial in JAMA Internal Medicine

LO: And the system didn't work. And so we're saying, there needs to be in-depth analysis of what happened here and how to prevent it from happening again.

PETER SNYDER: It didn't occur to anybody until this reviewer pointed it out.

HARRIS: Dr. Peter Snyder at the University of Pennsylvania was in charge of the study in question. Speaking via Skype, he said he and his colleagues had focused their concern on the potential risks of testosterone itself, which can promote prostate cancer and possibly heart disease.

SNYDER: And that's where our focus was.

HARRIS: As soon as the lapse came to his attention, he recognized it as a problem. The study officials sent a letter to all the participants, giving them their blood test results before and after the experiment. So far, he says he has not heard of anyone who was harmed. Richard Harris, NPR News.

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