Research Ethics Blog

A recent story from the Huffington Post, as reported by Jeanne Lenzer and Shannon Brownlee, highlights a story about a cardiac surgery trial at Columbia that began in ~ 1999.

The story reports that the Office of Human Research Protections (OHRP) in the US has requested that Columbia University notify participants enrolled in the trial entitled “Effect of different intravenous fluids on thromboelastography during cardiac surgery” that they may “have suffered harms that were a function of the design and procedures of [a] study” (quote from OHRP as reported in HuffPo) conducted a decade ago. According to the story, some of the patients in the trial had severe adverse reactions to a blood-expanding fluid used in surgery. The main goal of the trial was, in fact, to test different kinds and doses of blood-expanding fluids in surgery (used to replace lost blood volume). In high doses, some of these fluids had previously been shown to cause serious bleeding. According to the story, a number of participants received excessively high doses (higher than recommended safe maximum amounts) of the fluids. Two patients in the trial died and many more required transfusions as a result of serious bleeding.

Here is the story as reported in the Huffington Post: Government Orders Columbia to Tell Patients ‘True Nature’ of Drug Study

The main criticisms of the trial include the claim that participants were not fully informed of the goals of the study and potential risks of trial participation, including the potential risk of serious bleeding. Additionally, the authors claim that there may have been some misconduct in the recruitment of patients who were Spanish-speaking only, socio-economically disadvantaged or considered to be more vulnerable.

This story has been reported all over the Internet by sources such as The Indiana University Center for Bioethics (IUCB),the Google group on progressive activism, The Alliance for Human Research Protection, Cardiobrief, and finally, the law firm of Weitz & Luxenberg who are asking that patients of the trial contact them as part of a “lawsuit review”.

Here’s what worries me. This seems, at first glance, to be an extremely serious potential breach of research ethics. It also is a pretty monumental medical story — a clinical trial resulting in deaths and serious morbidity. Yet I haven’t been able to find any sources, other than HuffPo, that have corroborated this story. The blogs and newsgroups I note above each cite the HuffPo story only. The story has not been picked up by mainstream media. Documents supporting the story, such as the letter to Columbia from OHRP, are not publicly available. The Huffington Post has had its share of criticism over their coverage of science, medicine and health-related reporting. It may not be the most reliable source for science and medicine stories. And yet it’s still the only one for “this” story.

Why are there no corroborating sources? Why, when you search for more information on what appears to be a “breaking news” clinical trial story, do you simply end up back at the original Huffington Post report? With a story as potentially serious as this, with lives lost, with people hurt and with even more lives and careers at stake, I’d feel much better about this story if someone else were asking these questions. And getting some answers from more than one place.

~ by Nancy Walton on October 29, 2009.

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