FDA halts study into dietary supplements

Thursday, April 10, 2003

ANNAPOLIS, Md. -- The Food and Drug Administration is seeking an investigation of whether its own study of Naval Academy midshipmen broke federal research rules on privacy and record-keeping.

The FDA said researchers couldn't account for the medical records of at least 92 of the 260 midshipmen, and FDA Commissioner Mark B. McClellan asked for an investigation by Janet Rehnquist, the Department of Health and Human Services' inspector general.

"As the institution of the federal government that oversees the integrity of much of the nation's clinical trials, I want to assure that FDA is held to the same -- if not higher -- standards regarding clinical trial conduct to which we hold others," McClellan said in a letter obtained by The Baltimore Sun.

McClellan also ordered the FDA's six research centers to review procedures and policies for monitoring agency-sponsored clinical studies, the newspaper reported Wednesday.

FDA officials said there is no evidence showing midshipmen were harmed or that their records wound up in the wrong hands.

The clinical trial, led by FDA calcium expert Dr. Mona S. Calvo, examined whether midshipmen who ate specially formulated nutrition bars developed denser bones. Paid for by a $610,000 grant from the Army, the study is part of an effort to determine the best mix of dietary calcium, protein, potassium and vitamin K to help reduce bone fractures suffered by troops during training.

About 260 midshipmen from the class of 2003 were recruited in 1999 for the study. The students agreed to provide blood and urine samples, undergo bone scans and share dietary records. Within a year, the number of participants was down to 52, so few that Calvo was no longer able to collect statistically significant data, according to FDA documents.

The FDA began reviewing the study following an exchange of charges between Calvo and fellow researcher, Dr. David W. Armstrong III of the Henry M. Jackson Foundation for the Advancement of Military Medicine, a private group in Rockville.

A telephone call by The Associated Press to Calvo's office, seeking comment from the researcher, was not immediately returned Wednesday.

Other problems noted by the FDA included alleged failure to perform some pregnancy screenings and inability to account for the nutritional bars.

On the Net:

FDA: http://www.fda.gov

Naval Academy: http://www.usna.edu

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