FDA recordkeeping in clinical trial on Mids probed

Files of 92 students in nutrition study lost

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 recordkeeping 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.

"That work is ongoing and examines FDA's clinical trial management in greater depth," the report noted.

Among other deficiencies, the audit found that the FDA did not have accurate or fully supported documentation for the $496,704 it spent on the never-completed study. For example, it recorded paying $5,987 to a research consortium helping to coordinate the bone-mass study when it really had paid $54,423.

The Army commissioned the bone-mass study to develop methods to lower the incidence of fractures. An FDA employee oversaw it, along with another researcher from the Henry M. Jackson Foundation, a private foundation for the advancement of military medicine.

At least 260 midshipmen signed consent forms to participate beginning in July 1999. Each was to answer anxiety questionnaires, submit blood and urine samples and provide medication and food records that were to be stored in medical folders.

But many midshipmen dropped out of the study and the FDA halted the dietary records, urine collection and blood-testing components in May 2001 because there weren't enough participants left.

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.

"FDA had not established clear responsibilities for creating, updating and filing the study folders," the audit noted, adding that failing to do so is critical to protecting human research subjects, as required by federal law. "As a result, the exact number of folders and their contents may never be known."

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