Dr. Kuklo and the Larger Lesson: Transparency in Medical Research
Flammarion Woodcut. First documented to 1888
[Ed. note: We are very pleased to welcome Valerie Gutmann, J.D. to the blog today. Valerie joined Seton Hall Law School in 2009 as a Faculty Researcher in the Center for Health & Pharmaceutical Law & Policy. She came to Seton Hall from Kirkland & Ellis LLP after having graduated from Harvard Law School, where she served as an author and Editor-in-Chief of the Recent Developments Section of the Journal on Law, Medicine, and Ethics. Prior to law school, Valerie worked at the National Academy of Sciences, the American Association for the Advancement of Science, and the ABA Coordinating Group on Bioethics & the Law. In 2001 she graduated from the Woodrow Wilson School of International Affairs and Public Policy at Princeton University, magna cum laude, where she was co-president of the Princeton Bioethics Forum.]
In a glaring example of the consequences of less-than full disclosure in research and publication, recent reports have shed light on Dr. Timothy R. Kuklo’s study of Infuse. Dr. Kuklo’s article on the bone-growth protein manufactured by Medtronic Inc. was published by the British Journal of Bone & Joint Surgery in August 2008, and was retracted in March 2009, after an army investigation found that Dr. Kuklo’s study had misleadingly promoted Infuse as “strikingly” better and more efficacious than conventional bone grafts in repairing severely shattered shin bones of Americans injured in Iraq. Kuklo has been accused of using “falsified information” that did not match with patient records and forging signatures of four doctors at Walter Reed Army Medical Center who he falsely claimed to be co-authors. Dr. Kuklo also neglected to disclose his relationship with the company.
Dr. Kuklo, a former army surgeon at Walter Reed, is currently on leave from Washington University School of Medicine in St. Louis, where he was associate professor of orthopaedic surgery, specializing in cervical spine, spinal deformity, spinal tumors, and spine trauma. From August 2006 through May 2009, Dr. Kuklo was a consultant to Medtronic, who recently announced that Dr. Kuklo’s consultancy contract was being suspended (some accounts controvert the alleged timeline, and Medtronic claims that it had no involvement in the study and did not depend on the study for government regulatory approval). While working for the army, Dr. Kuklo was also paid by Medtronic to speak on the company’s behalf at meetings and to train other doctors, and was a recipient of thousands of dollars worth of trips. Military officials have stated that there are no records that Dr. Kuklo had sought or received permission to accept money to consult for medical product companies.
Last year, Senator Chuck Grassley (R, Iowa) called for an investigation into Dr. Kuklo’s study. Senator Grassley requested information from Walter Reed, Washington University, Medtronic, and two medical journals. He has also publically released a list provided by Medtronic of consultants for the Infuse product, on which Dr. Kuklo had suspiciously not been included. Spokespeople for Medtronic noted that Dr. Kuklo was not on the list because he was a general consultant to the company, rather than specific to Infuse, although he has spoken on behalf of Infuse in the past.
The Kuklo case is further evidence of the implications of incomplete disclosure, which may lead physicians to make medical decisions without all the information that should be available to them. As we have noted in the past, the Center for Health and Pharmaceutical Law & Policy has vigorously called for such reform in its 2009 whitepaper:
All those engaged in medical research and publication, including medical professionals and institutions, medical journals, and industry, should undertake reforms to ensure the integrity of the medical literature. Transparency in the relationship of industry and physicians would be a critical tool in this effort.
