“They want to talk to the study authors,’’ Ingmire said.
At the same time, the Harvard-affiliated Institute for Aging Research at Hebrew SeniorLife in Boston, where Harvard Medical School gerontologist Dr. Douglas P. Kiel presided over the hip study, said it would also investigate.
“We will conduct an objective, independent review of the [federal regulators’] findings because this is the best way to assure our overriding commitment to patient safety and scientific integrity,’’ Len Fishman, Hebrew SeniorLife’s chief executive, said in a prepared statement.
“We have the highest respect for the scientists at the Institute for Aging Research, and deeply support the institute’s ongoing mission to conduct studies that improve the standard of care for seniors,’’ Fishman said.
Kiel’s team tested whether padded underwear could protect the hips of nursing home patients from shattering during falls. Typically, the underwear is padded on both hips, but in their study, researchers assessed garments padded on just one side.
After they started enrolling patients in 2002, data from the study indicated that seniors were more often having serious falls on the padded side than the one that was unpadded.
But the scientists failed to disclose that risk to patients; to the National Institutes of Health, which provided $8.6 million funding for the study; and to other officials overseeing the research, according to findings issued June 23 by the Department of Health and Human Services. An HHS spokeswoman declined to comment, citing her agency’s ongoing investigation.
A Harvard Medical School spokesman referred questions to Hebrew SeniorLife.
A Canton businessman who alleged the scientists were concealing information from officials said his complaint to federal regulators sparked their inquiry.
Ed Goodwin, president of HipSavers Inc., a maker of padded hip protectors, sued Kiel in 2008. Goodwin’s lawsuit accuses Kiel of unfairly disparaging Goodwin’s product, because Kiel’s team concluded in its 2007 study that they could find no evidence that padded undergarments protected patients from fractures. The team did not study products made by Goodwin.
