By Kay Lazar and Carolyn Y. Johnson Globe Staff / July 1, 2011
Federal health regulators have accused a research team led by a Harvard doctor of ethical violations after the scientists failed to inform elderly nursing home residents of serious health risks discovered during a study of hip fractures.
In a letter sent last week to a Harvard-affiliated institution and two other major research universities, the Department of Health and Human Services concluded that the scientists suppressed information about the dangers to elders participating in research on how to reduce often lethal hip injuries. The regulators said the scientists should have shared their findings about the use of protective padded underwear with patients and safety boards that routinely oversee medical studies.
As a result, the federal agency is now ordering the researchers to develop a plan to contact nursing home residents in Boston, St. Louis, and Baltimore who participated in the study and may unwittingly have been placed in peril.
The conclusions of the federal report were based, in large measure, on private e-mails exchanged among the researchers, including Harvard Medical School gerontologist Dr. Douglas P. Kiel.
“The investigators themselves, in candid e-mails to one another, recognized the significance of these findings,’’ the letter states. “Yet, in the face of these developments, efforts were made to either ‘slant,’ or completely fail to report . . . information to the groups . . . that might have found this information highly relevant in their deliberations.’’
The study included more than 2,000 patients, many of whom had significant cognitive impairments.
Nursing home patients often wear padded underwear to protect their frail hips. Typically, the underwear is padded on both hips. But in the study, researchers were assessing garments that were padded on just one side.
After they started to enroll patients in 2002, data from the study increasingly indicated that the one-sided padded underwear might be causing the very problems it was designed to prevent - seniors were more often having serious falls on the padded hip side than the one unprotected, according to the regulators.
Despite the fact that investigators learned risks existed, federal regulators said, they failed to disclose it to research participants; to the National Institutes of Health, which funded the study; and to other officials overseeing the research.
The regulators found that by October 2004, if not earlier, investigators had become “sufficiently aware of the risk of increased falling to the pocketed side and the associated risk of possible hip fractures, but failed to inform subjects who were enrolling during this time of these reasonably foreseeable risks.’’
The researchers continued to enroll patients in the study until summer 2006, according to the letter sent by federal health authorities June 23.
Kiel, who is also a researcher at the Harvard-affiliated Institute for Aging Research at Hebrew SeniorLife in Boston, declined to comment yesterday when reached by phone at his office.
“I have a grant due I am working on, and I can’t talk right now,’’ he said.
Kiel’s attorney, Robert P. Powers, said in an e-mailed statement last night that Kiel disagrees with federal regulators’ conclusions.
In a statement, Dr. Lewis Lipsitz, director of the institute, said the organization disagrees with regulators’ findings and will request that the conclusions be reviewed.
“During the study, patient safety was a paramount concern,’’ Lipsitz said, noting that a Hebrew Rehabilitation Center board and a safety monitoring board convened by the National Institutes of Health approved the study design and closely monitored the work, meeting twice a year to review results.
“The study was conducted in good faith using rigorous methodology to inform the growing debate on the efficacy of hip protectors in preventing hip fractures,’’ Lipsitz said in the statement.
By February 2004, federal regulators wrote, researchers apparently were aware that the design of the undergarment might be a problem, and they proposed to modify the design of the underwear but did not fully disclose the problems to independent boards overseeing their work.
Bruce A. Barton, a statistician at the Maryland Medical Research Institute who was a member of the study’s steering committee, pointed out in an August 2004 e-mail the tendency for falls to occur on the padded side.
“If I were on the [Data and Safety Monitoring Board], I would question the entire study design at this point,’’ he wrote in the e-mail.
Barton, who now works at the University of Massachusetts Medical School, said in a brief telephone interview yesterday that he was unaware of the details raised in the letter from federal authorities, but he defended the scientists’ work.
“We took every precaution,’’ he said. “The data was reviewed at every point; there was never any attempt to cover anything up. . . . I’ve been in this business 30-odd years and am fully satisfied that everything we did was above board.’’
Federal regulators quote in their investigation a June 2004 e-mail sent to Kiel that raised concern, from Dr. Stanley Birge, an investigator at Washington University School of Medicine. It paints a clear picture of doubts emerging not only from the researchers leading the study but also at nursing homes.
Birge wrote that the morale of his staff was waning “as they continue to see most of the hip fractures on the padded hip. The staff is also being asked by the [nursing home] staff what are we finding? Some of the [nursing] homes have had 4 fractures of which 2 or 3 have been on the padded hip. Their enthusiasm for the study is also’’ waning.
Kay Lazar can be reached at klazar@globe.com ; Carolyn Y. Johnson can be reached at cjohnson@globe.com
© Copyright 2011 Globe Newspaper Company.
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