10 years after, Columbia heart surgery study still causing problems

A study that started in 1999 and ended in 2001 is still causing problems for Columbia University Medical Center, according to a detailed investigation by Jeanne Lenzer and Shannon Brownlee in the Huffington Post.

Lenzer and Brownlee report that Columbia has performed three separate internal reviews of the study which “raised serious questions about the drug trial’s design, management and oversight” but found no evidence that patients were harmed and concluded “that there was no need to provide the patients with additional information about the study.”

Now, however, the US Office of Human Research Protections has determined that “at least some of the subjects appear to have suffered harms that were a function of the design and procedures of the study.” OHRP is “demanding that Columbia track down the patients and their families, and acknowledge that they never were informed about the ‘true nature’ of the drug study, the risks they faced or the consequences of their participation.”

According to the article, the Columbia study was run by Elliott Bennett-Guerrero, who was then the clinical director of Columbia’s division of cardiothoracic anesthesiology, and was partially funded by Abbott Laboratories to test hetastarch, a plasma expander, during cardiac surgery. Problems with the trial began to surface when two other Columbia anesthesiologists, Marc Dickstein and Mark Heath, told the head of Columbia’s IRB about hemorrhages that had occurred while they had been in the operating room. However, it wasn’t until after the study had ended that Gerald Fischbach, the dean of Columbia’s medical school, began to take action. Eventually Bennett-Guerrero left Columbia for Duke. (Bennett-Guerrero was also one of the subjects of “Doctors’ Diaries,” a Nova documentary from PBS.)

Following another Columbia internal review that began in 2007, the OHRP told Columbia “to draft a letter explaining the study to its former patients,” and to provide “a full accounting of what happened to the patients who agreed to be part of its study. The federal agency has issued such a directive only three other times since 2000.”

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