Columbia Medical School's 200 Dirty Little Secrets

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.

The issues raised by the Columbia study, which was indirectly funded by a pharmaceutical company, reflect the ongoing national debate over flaws in the system designed to protect people who participate in medical research. The federal oversight office has cited more than 40 hospitals and academic medical centers in the past two decades for falling short. The Columbia case stands out for the bitter controversy it has engendered for years inside the hospital, the courts and the federal government – reported here for the first time – and for the hospital’s failure to contact patients even after federal investigators recommended it do so in 2003.

The study, conducted between December 1999 and February 2001 in the famed heart surgery unit at what is now called New York-Presbyterian Hospital/Columbia University Medical Center, involved four blood expanders approved by the U.S. Food and Drug Administration. The fluids are generally administered by anesthesiologists and combat medics when patients or soldiers have lost significant quantities of blood.

Two of the blood expanders in the study contained a substance known as hetastarch, a clear fluid made of a starch and salt solution. Published studies dating back to 1981 showed that hetastarch can prevent blood from clotting properly, especially when used at higher doses. According to documents filed by the hospital in New York state court, one purpose of the Columbia trial was to test whether a new formulation of hetastarch, manufactured by Abbott Laboratories, was less likely to trigger serious bleeding at high doses than the other fluids. It was largely funded from a $150,000 unrestricted grant given by the drug company to the hospital and lead researcher, records show.