October 26

FDA Requests Fed Investigation Of Itself After It Lost Medical Records

FDA Requests Fed Investigation Of Itself After It Lost Medical Records

Wed, 16 Apr 2003

FDA Commissioner, Dr. Mark McClelan has requested an independent investigation of a bone density study conducted jointly by an FDA investigator and another affiliated with the Henry Jackson Foundation for the Advancement of Military Medicine. During the course of the study, 92 of the 262 sensitive medical records of participating subjects– who were Navy midshipmen–were “lost.”

The Bureau of National Affairs (BNA) and the Baltimore Sun reported that Dr. McClellan requested the Office of the Inspector General of DHHS to conduct the investigation of this study. The purpose of the study was to test whether protein bars and calcium supplements increase bone density. Within a year, only 52 subjects were willing to go on, too few to provide statistically meaningful data, therefore too few to justify continuing the study. It cost the army $610,000.

Recognizing that beyond the bone density study, systemic problems may exist at the agency, McClellan also ordered the FDA’s six research centers “to conduct a sweeping review of their procedures and policies for monitoring agency-sponsored clinical studies.”

The Alliance for Human Research Protection commends Commissioner McClellan for recognizing the need for an independent investigation of safety violations by the Inspector General, and for ordering an agency-wide review to prevent future violations.

This action by the FDA Commissioner contrasts sharply with the Department of Veterans Affairs which has abolished even the quasi-independent Office of Research Compliance Assurance (ORCA). The VA administration is pretending that the VA can conduct a credible investigation of research violations at its own facilities. [See: U.S. to Review Research at Hospitals for Veterans Nationwide By ROBERT PEAR in New York Times http://www.nytimes.com/2003/04/13/national/13VETS.html ]


Privacy concern, violation of guidelines are issues

By Ariel Sabar
Sun Staff

April 9, 2003

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 a broader effort to discover the best mix of calcium, protein, potassium and vitamin K to reduce the number of bone fractures troops suffer 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 at any time 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 any of 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, Naval 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.

Dasey 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.”

Copyright (c) 2003, The Baltimore Sun

Bureau of National Affairs (BNA)
FDA Requests Federal Investigation
Of Its Own Study’s Lost Patient Records
By M. Alexander Otto

The Food and Drug Administration has requested a federal investigation into an FDA-sponsored bone density study after the agency employee running the clinical trial lost the medical records of 92 of the 260 participating Navy midshipmen.

In a March 21 letter to Department of Health and Human Services Inspector General Janet Rehnquist asking Rehnquist to investigate the matter, FDA Commissioner Dr. Mark B. McClellan said that, because FDA employees were involved in the study, “in the interest of transparency, openness, and objectivity, I request that your office initiate an independent investigation.”

The FDA has never asked an outside government body to look into one of its own studies before, according to FDA spokesman Lawrence Bachorik, though the agency often investigates alleged research misconduct by people studying drugs and devices for FDA approval. “The commissioner wants to make sure our own research house is put in order,” Bochorik said, and that the agency “understands the universe of clinical trials” at FDA.

Mona Calvo, an FDA calcium expert, ran the study along with David Armstrong, an investigator from the Henry M. Jackson Foundation in Bethesda, Md. The goal of the experiment, which an FDA research review board approved in 1999, was to see if protein bars and calcium supplements increase bone density. The study was funded by the army.

Broad Investigation

Midshipmen were asked to provide sensitive medical information as part of the trial. Although the lost charts do not contain patient names, the agency is concerned that identities could be reconstructed, resulting “in divulging personal medical information in the study files to persons not associated with the study.”

FDA said it plans to notify the affected patients. The agency also has halted the trial, forbidden publication of its findings, and conducted its own investigation into the matter. In the meantime, McClellan asked Rehnquist to assess whether FDA’s efforts to locate the missing records are sufficient; if FDA’s current and planned corrective actions will ensure that such problems do not recur; and if the study’s financial management practices and financial integrity were sound.

The mishap also has prompted the agency to take other steps, including: auditing all FDA-sponsored clinical studies to make sure they comply with FDA and HHS research rules; tightening study oversight; holding FDA center directors “directly accountable” for research conducted by their employees; increasing funding of study oversight; and educating all FDA investigators on proper ways to conduct trials.

The move comes at a time when medical research is under heightened scrutiny following a string of research deaths and other mishaps in studies across the country. FDA’s steps to correct research problems are similar to a plan initiated by the Department of Veterans Affairs research division in early March.

Copyright © 2003 by The Bureau of National Affairs, Inc., Washington D.C.

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