Feds take Columbia to task over decade-old study

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The run of intriguing health journalism from the Huffington Post Investigative Fund continues this week, as Jeanne Lenzer and Shannon Brownlee look at the federal government’s entrance into an internal conflict at Columbia University’s medical center over the legality and morality of a heart-related study that took place from 1999 to 2001, one in which some experts say it was “virtually guaranteed” that some patients would suffer hemorrhaging.

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Milstein Hospital Building at Columbia Presbyterian Medical Center, photo by Samat Jain via Flickr.

Columbia has already conducted three internal investigations on the matter. Now, the federal government has asked for a full account of what happened to the study’s participants and ordered that Columbia write a letter to the study’s participants and disclose the “true nature” of what some contend was a deceptive study.

NOTE: In addition to the story itself, the reporters have posted a selection of key documents online.

Lenzer and Brownlee explain that the study went wrong when participants (some of whom were “Spanish-speaking patients who lived in low-income neighborhoods near the hospital”) “were not told that they could be given high doses of the fluids or that they faced a risk of serious bleeding.” Then, despite protests from hospital doctors that patients hadn’t been informed of what were serious possible health risks, the local Institutional Review Board allowed the study to continue. This was followed by years of internal fighting, and finally capped by the HHS’ Office of Human Research Protections entrance into the fray.

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