"MEDICAL DISASTER":

Columbia University Study May Have Caused Severe Harm To Heart Patients
Government Orders Columbia to Tell Patients 'True Nature' of Drug Study

NEW YORK -- The man who would be known as Patient No. 1 emerged from routine open-heart surgery at Columbia University Medical Center in stable condition. Then he began to bleed uncontrollably. Surgeons rushed him back to the operating room to reopen his chest, but by the time they could stop the hemorrhaging, Patient No. 1 was barely breathing and in a coma.
On Aug. 15, 2000, shortly before he was discharged on his way to a nursing home, a physician wrote a terse final diagnosis in his chart: "Medical disaster."
Patient No. 1, along with more than 200 other open-heart surgery patients, was part of a two-year medical study at Columbia that government regulators now say was carried out with ethical and regulatory mistakes and may have caused harm to some patients. The study was testing a commonly used intravenous surgical fluid that previous studies had shown could cause hemorrhaging at high doses. At least two patients in the study died shortly after receiving the fluid and more than two dozen others required transfusions, according to documents submitted to the federal government by the hospital and obtained by the Huffington Post Investigative Fund.
In the past decade, Columbia has conducted three separate internal reviews of the study. The reviews raised serious questions about the drug trial's design, management and oversight. But they concluded that there was no evidence that the fluid caused deaths or other medical problems for the patients and that there was no need to provide the patients with additional information about the study.
Now federal regulators have decided not to accept that conclusion. They 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, the risks they faced or the consequences of their participation.
New information shows that "at least some of the subjects appear to have suffered harms that were a function of the design and procedures of the study," the federal Office of Human Research Protections wrote to the hospital in a June 8, 2009, letter obtained by the Investigative Fund.
Federal officials also demanded that Columbia turn over a newly completed internal analysis of how the patients fared in the study. LinkHere