Kuklo was under federal investigation after members of the U.S. Army accused him of fabricating data for a bone-growth drug study, which he performed at Walter Reed Army Medical Center in Washington, D.C. Now, a University committee says the claim that Kuklo made up data cannot be supported, though this does not mean he has been found innocent.

“This is akin to a finding of insufficient evidence, and should not be characterized as a complete exoneration,” the University said in a statement released Thursday.

The University committee found that Kuklo violated school research integrity policies and guidelines for human subject research in other ways.

History: Kuklo, Infuse and the University’s investigation

The committee’s findings come after seven months of investigation into Kuklo’s case.

Last spring, The New York Times printed allegations from several U.S. Army officials who claimed that Kuklo altered research data on Infuse, a bone-growth hormone used to treat wounded soldiers at Walter Reed.

The Army members alleged that Kuklo had inflated the number of soldiers with leg injuries who were able to be treated effectively with Infuse. Kuklo was also accused of forging the signatures of four Army doctors when submitting the results of his study for publication.

Controversy heightened around the case when it was revealed that Kuklo had been paid $800,000 by Medtronic, the company that makes Infuse. The University said later that Kuklo had not disclosed to the school his financial ties to Medtronic.

After the allegations surfaced, Kuklo took leave from the University in May. An article on his study was retracted from the medical journal that printed it. Sen. Chuck Grassley, R-Iowa, the ranking Republican on the Senate Finance Committee, began a federal inquiry into Kuklo’s case. Kuklo later resigned from the University.

A University committee was then formed to investigate the allegations brought against Kuklo.

The committee’s findings

Although the University’s full findings have not been made public, The New York Times reported Friday that the committee found it possible that Kuklo had not misrepresented the number of leg injuries that had been successfully treated with Infuse.

The committee based this conclusion on the assumption that Kuklo could have defined the leg injuries he studied more broadly than other Army officials would have. The committee also suggested that some of the questionable data tied to Kuklo could have resulted from problems with recordkeeping at Walter Reed.

But the committee found no justification for Kuklo’s forging four doctors’ signatures. The New York Times reported that Kuklo asserted he had only included the doctors’ names as a courtesy, but the committee determined that his forgeries suggested an “intentional deception.”

The University stated that it is not reconsidering Kuklo’s resignation in light of the committee’s findings.

University sharpens focus on research integrity

News of Kuklo’s clearing came at the end of the University’s inaugural Academic Integrity Week.

The week’s events, which culminated this weekend with the Center for Academic Integrity International Conference on campus, included several panel discussions and speakers on research integrity.

Last Monday, for example, student group Controversy N’ Coffee hosted a forum on cheating called, “Could my Wash. U. Degree Lose its Credibility?”

Tuesday saw a panel discussion on intellectual property law, and another panel was held Wednesday on integrity in job and graduate school applications.

On Thursday, David Callahan, public-policy activist and author of “The Cheating Culture” and “The Moral Center,” delivered an Assembly Series lecture titled, “Creating a Culture of Integrity.”

Kuklo, associate professor of orthopedic surgery, submitted a letter of resignation on July 30, effective Sept. 30, according a statement issued by the University.
“Dr. Kuklo has agreed to voluntarily resign from the University, effective September 30, 2009,” the statement said. “Dr. Kuklo will have no clinical, research, or educational duties for the University between now and that date.”

Kuklo has been the subject of federal scrutiny over a study the U.S. Army alleges he falsified while working at Walter Reed Army Medical Center in Washington, D.C. He performed the study, which was about the benefits of a bone-growth drug, before coming to the University in 2006.

Medical school spokesman Don Clayton declined to comment further on Kuklo’s resignation because school officials are conducting an investigation.

The drug, Infuse, is produced by a Minneapolis, Minn., company called Medtronic, which hired Kuklo back in 2006 as a consultant around the time he came to the University.
The New York Times reported that Medtronic suspended Kuklo from his consulting duties last spring after word of the falsified study came out. The journal in which the study appeared retracted the article.

Medtronic reportedly paid Kuklo $800,000 from 2001 to 2009 to attend conferences while he was in the military. Just recently, the company acknowledged also paying Kuklo to train doctors and speak at conferences on the company’s behalf.

The Army prohibits its doctors from accepting money for consulting without permission. Investigators reportedly found no sign that Kuklo had gotten proper permission. The University said Kuklo also failed to disclose his relationship to Medtronic as part of the school’s required conflict-of-interest filings.

The Times also reported that Kuklo’s Medtronic dealings drew the scrutiny of Sen. Chuck Grassley, R-Iowa, who wrote a letter to the company asking why Kuklo’s name was missing from a list of its consultants.

Kuklo, associate professor of orthopedic surgery, submitted a letter of resignation on July 30, effective Sept. 30, according a statement issued by the University.

“Dr. Kuklo has agreed to voluntarily resign from the University, effective September 30, 2009,” the statement said. “Dr. Kuklo will have no clinical, research, or educational duties for the University between now and that date.”

Kuklo has been the subject of several federal inquiries over a study he allegedly falsified while he worked at Walter Reed Army Medical Center. He performed the study, which was about the benefits of a bone growth drug, before coming to the University.

Medical school spokesman Don Clayton declined to comment further because school officials are conducting an investigation.

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