When Dr. Timothy R. Kuklo, was a surgeon at Walter Reed Army Medical Center in Washington, D.C., he carried out a Medtronic study on bone treatment. Since then he joined Washington University in St. Louis in mid-2006. When an article on the study written by Dr. Kuklo was retracted by the Journal of Bone and Joint Surgery, a British publication, a panel of army investigators commenced an investigation.
Consequently, this investigation made its way onto a page 1 article in The New York Times in May, leading Senator Charles Grassley (R-IA), ranking member of the Senate Finance Committee, to begin his own investigation of Dr. Kuklo’s practices.
Lieutenant Colonel Romney C. Andersen first brought the problem to the Army’s attention last year, prompting the inquiry. In its March edition, at the Army’s request, the journal retracted the article. The Army then released an executive summary of its investigation to The New York Times. Colonel Norvell V. Coots, one of the army investigators, claimed in the panels report that Dr. Kuklo “inflated the number of combat soldiers whose leg injuries had been successfully treated with the product.”
The report also indicated that Dr. Kuklo had forged the names of four Army doctors before submitting the study to a medical journal for publication. Upon review of this claim, the panel did find instances of research misconduct in connection with the forgery of the other doctors’ names.
During the panels review, Dr. Kuklo maintained that he had included “the other doctors’ names as a courtesy and had not intended to mislead any one.” The committee however viewed Dr. Kuklo’s decision to use four different handwriting styles to sign for the physicians as an “intentional deception.”
Army officials said that Colonel Coots sent the results of their investigation late last year to Medtronic’s chief executive and to the dean of the Washington University School of Medicine. Colonel Coots said he decided to handle the matter by notifying the journal, university and Medtronic, as well as several orthopedics professional groups, rather than recalling Dr. Kuklo from retirement to face possible Army discipline.
When the final report on the investigation came out last week, “the Washington University panel concluded that it had been possible for Dr. Kuklo to support the number of leg injuries he reported if such injuries were defined broadly,” according to the New York Times article. The panel also raised the possibility that some of the data discrepancies had reflected problems in Walter Reed’s patient record-keeping system.
Mr. Grassley claimed in his investigation report that while there were instances of research misconduct, the investigation failed to find proof that Dr. Kuklo had falsified data. In response to the lack of evidence Mr. Grassley’s investigation found, Dr. Kuklo’s lawyer sent a letter Thursday to Senator Grassley, describing it as “exonerating his client.”
Washington University issued a statement in response to Dr. Kuklo’s lawyer Mr. Dane, clarifying that although the panel’s review had found “insufficient evidence” of research fraud, their findings did not exonerate him.
The panel also found that Dr. Kuklo had committed research misconduct in connection with representations he made about another study. As a result of the controversy surrounding his Infuse study, Medtronic suspended his consulting agreement.
Going after doctors with “insufficient evidence” sounds like legal or political malpractice, especially when that doctor is saving the lives of our veterans and service members. While the committees findings suggest that Dr. Kuklo may have had discrepancies, these mistakes should not overshadow the importance of his work and collaboration with industry and academic medical centers in helping our nation’s wounded soldiers. Certainly, future inquires should use a higher standard than insufficient evidence before their inquisitions remove one more talented pair of hands from helping our soldiers walk again.