Columbia Medical Center has been firmly scolded, says the Huffington Post, for unethical and unsafe practices employed by a study the Medical Center has been running for over a decade. After three internal reviews, a lawsuit or two, and an extensive federal review of the study, federal overseers “have taken the rare action of 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,” writes HuffPo.
The study was set up to test a new blood-thinner called Hextend, a new version of “a commonly used intravenous surgical fluid that previous studies had shown could cause hemorrhaging at high doses.” Columbia’s internal reviews of the study conclude that no one did anything wrong, but federal reviews conclude that Hextend in doses “up to three times the level recommended” may have contributed to the deaths of several patients following open-heart surgery.
To add injury to injury, the study has been running off of a large “unrestricted grant” (commonly used for their flexible structure) from the pharmaceutical company Abbot Laboratories, the manufacturer of Hextend. HuffPo also reports that “some of the subjects were Spanish-speaking patients who lived in low-income neighborhoods near the hospital and were admitted through the emergency room.” Given the stress of the situation and the language barrier, these patients may have been even less informed of the risks than their English speaking counterparts in non-emergency conditions. Piling onto the scandal are two anesthesiologists from the Medical Center who say they recommended to that the Internal Review Board suspend the study due to the apparent risks. The board did not.
Not surprisingly, no comment yet from the Medical Center or the university administration.
– Photo by “mecurialn” via Flickr.