Jeanne Lenzer and Shannon Brownlee, in investigative coverage published by the Huffington Post, report that the Office of Human Research Protections have requested Columbia University to notify research subjects that they may “have suffered harms that were a function of the design and procedures of [a] study” conducted a decade ago. According to the Huffington Post, some of the patients in a study (“Effect of different intravenous fluids on thromboelastography during cardiac surgery”) had adverse reactions to a blood-expanding solution (a potential substitute for blood transfusion) which contained hetastarch. Some patients, in the study partially funded by Abbott Laboratories, suffered from excess bleeding during surgery and at least two patients died.
Howard Brody at Hooked: Ethics, Medicine, and Pharma observes that this case has been “tossed around since 1999″ and that it “defies a quick summation.” Lenzer and Brownlee, however, do a good job of digging up key documents and of telling a story obscured by past (and future?) lawsuits. Clearly the study was a nightmare for all involved: the PI (Elliott Bennett-Guerrero), the IRB at Columbia University College of Physicians and Surgeons, Abbott Laboratories, the surgeons, and (most importantly) the patients. One gets the impression from reading this story that no one wanted to harm patients and that, while all the parties involved were doing their jobs, they were trying to do too much–a member of the IRB lamented “[m]ost of us barely get to read the birthday cards from our kids . . .” and Bennett-Guerrero was “simultaneously running 25 clinical trials.”
According to Lenzer and Brownlee, the OHRP’s letter to Columbia (June 8, 2009) requires the institution to draft a letter explaining the study and the likelihood that patients who received hetastarch did worse than the others (including excess bleeding, decreased renal function, and an increased need for re-operation). Assuming that Columbia will comply with this request, what will these patients do now?
Other Research Ethics News
John Schmid. UW calls proposal to change patent law ‘reckless’. Milwaukee Journal Sentinel. October 9, 2009.
Meg Tirrell. Doctors Fail to Report $12 Million in Industry Fees at Meeting. Bloomberg.com. October 7, 2009.
Chris Kaposy. The H1N1 Vaccine and Pregnant Women. Bioethics Forum. October 6, 2009.
John Timmer. Anonymized genetic research data still carries privacy risks. Ars Technica. October 6, 2009.
IU Center receives NIH grant to improve privacy protection in medical research. IU News Room. October 5, 2009.
Ed Silverman. Out of sight. Portfolio.com. October 5, 2009.
Michael Rugnetta. Collins Reports to Colbert. Science Progress. October 2, 2009.
Shelley Wood. New “principles” on authorship and COI from PhRMA get mixed response. TheHeart.org. October 2, 2009.
- J.O.
2 Comments
October 19, 2009 at 11:33 am
An interesting story, for sure. I’m curious as to whether you’ve been able to find any other corroborating stories or sources. I have been unable to find any other reports about this seemingly devastating story (with some serious claims being made against institutions and individuals) 0ther than legal documents that the Huffington Post authors also located (and you’ve highlighted here). They provide only pieces to the puzzle though and it’s still very incomplete.
I’m hoping that you can provide an update to the story when more facts come to light.
October 28, 2009 at 4:16 pm
I agree; I don’t think we have the full story yet. Unfortunately, I haven’t found anything online. I’d like to read the letter from OHRP. If I learn anything new, I’ll be sure to share.
Thanks for the comment!