FDA's poor record-keeping, loss of files in clinical trial on Mids investigated

October 05, 2004|By Julie Bell | Julie Bell,SUN STAFF

The Food and Drug Administration is under scrutiny after losing track of the medical files of at least 92 U.S. Naval Academy midshipmen enrolled in a study of nutrient bars and calcium supplements.

The FDA also kept poor records of the $496,704 it spent on the trial, according to an audit released yesterday by the Office of the Inspector General in the Department of Health and Human Services.

The study of how nutrient bars and calcium supplements affect bone mass ended inconclusively three years ago because too few midshipmen were participating, officials said.

Naval Academy officials had no immediate comment on the report, and there is no evidence that of the subjects suffered medical consequences from participating.

After a contractor reported the files missing, the FDA asked the inspector general to look into the matter. The record-keeping problems detailed in the audit were serious enough that the inspector general's office is studying the FDA's overall ability to manage clinical trials.

At least 260 midshipmen signed consent forms to participate beginning in July 1999. The agency hasn't determined how many medical folders were missing after one of the researchers moved them in May 2001, from the academy to an office in Bethesda, from which they were later moved again. Finding any of them now is considered so hopeless that the inspector general's office recommended that the FDA give up the search.

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