Major Gaps in Oversight of Human Medical Research

Jeanne Lenzer — Wed, 28 Oct 2009 19:02:18 +0000

Columbia Hospital Case a Cautionary Tale

Ten years ago, an 18-year-old student named Jesse Gelsinger died during a medical research trial involving gene therapy at the University of Pennsylvania. The teenager’s death, caused by a violent immune reaction to an injection, triggered a federal inquiry, a review of human protection standards in clinical trials and, ultimately, tougher national standards for patient consent. Read more »

Government Orders Columbia to Tell Patients 'True Nature' of Drug Study

Jeanne Lenzer — Wed, 07 Oct 2009 14:59:25 +0000

Officials Say Research May Have Caused Harm to People Who Had Heart Surgery

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.” Read more »

COLUMBIA UNIVERSITY - Huffington Post Investigative Fund

Major Gaps in Oversight of Human Medical Research

Government Orders Columbia to Tell Patients 'True Nature' of Drug Study