Investigative report on patient safety issues in drug study

See the Huffington Post investigative fund piece by Jeanne Lenzer and Shannon Brownlee, “Government Orders Columbia to Tell Patients ‘True Nature’ of Drug Study: Officials Say Research May Have Caused Harm to People Who Had Heart Surgery.” Excerpts:

“….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. …

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.”

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