FDA study of Mids comes under scrutiny

Privacy concern, violation of guidelines are issues

April 09, 2003|By Ariel Sabar | Ariel Sabar,SUN STAFF

A clinical trial on the effects of dietary supplements on Naval Academy midshipmen is drawing scrutiny from federal investigators, in part because of concerns that researchers may have violated study guidelines and imperiled the students' privacy.

The Food and Drug Administration halted the study last month after discovering that its researchers were unable to account for the medical records of at least 92 of the 260 midshipmen subjects.

FDA Commissioner Mark B. McClellan asked the U.S. Department of Health and Human Services Inspector General to investigate, noting "important concerns about the integrity" of its study.

The FDA's request for an investigation of itself - and its decision to go public with that request - is a rare move that appears to reflect a desire to avoid being caught on the defensive over the botched study.

"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 March 21 letter to HHS inspector general Janet Rehnquist requesting the investigation.

McClellan has ordered the FDA's six research centers to conduct a sweeping review of their procedures and policies for monitoring agency-sponsored clinical studies.

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

In 1999, the researchers recruited about 260 midshipmen in the Class of 2003. The students agreed to provide blood and urine samples, undergo bone scans and share dietary records at the military college's health clinic.

Study protocols allowed the students to drop out of the two-year study without explanation. Within a year, only 52 were willing to go on - so few that Calvo was no longer able to collect statistically meaningful data, according to agency documents.

The FDA began its first review of the study after an exchange of charges and countercharges between Calvo and a co-researcher, Dr. David W. Armstrong III of the Henry M. Jackson Foundation for the Advancement of Military Medicine, a private group in Rockville.

The disappearance of private medical records was just one of the problems FDA inspectors identified. An investigative report posted on the FDA's Web site notes a number of possible deviations from the study protocol, including an alleged failure to perform some pregnancy screenings and a switch from a liquid supplement to solid nutrition bars without notifying the study's review panel and obtaining additional consent from the midshipmen.

Researchers also couldn't account for all of the nutrient-fortified fruit-and-grain bars. The investigative report says that Calvo had consumed some, and that her son had taken about 200. Calvo did not return telephone messages yesterday.

FDA officials say there is no evidence that the alleged lapses harmed the midshipmen or that any of the still-missing records wound up in the hands of people not involved in the study.

A lawyer for Armstrong said that he was cooperating with the investigation. Cmdr. Bill Spann, academy spokesman, referred all questions to the FDA.

Chuck Dasey, a spokesman for the Army Medical Research and Materiel Command, the Fort Detrick agency that paid for the study, said the doctors chose midshipmen as subjects because they matched the demographic group in which the military is trying to reduce injuries.

He said the agency is grateful for the scrutiny the study is receiving. "This is a case where we didn't get the results we hoped for," he said. "There's a concern when funds are invested and you don't get research benefits."

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