Doctor Falsifies Study In Favor of Medical Product Infuse - Chapter 2

Bret Hanna

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Last week, I reported that ex-army doctor and paid consultant to medical product manufacturer Medtronic, Timothy Kuklo, falsified a study which overstated positive results with his use of the bone graft product Infuse in soldier patients injured while serving in Iraq. After an alleged co-author doctor alerted the Army, the Army investigated and found that Dr. Kuklo forged the names of four doctors he claimed helped author the study, and that he over-stated his findings because the numbers of patients chronicled in the study were larger than they could have been given the census of patients treated by the Army with Infuse for the period covered by the study. The Army called for and the British journal that reported the study retracted it.

My post generated some immediate commentary. One comment was authored by "david," who some suspect may be affiliated with Medtronic:

Posted by david
May 16, 2009 10:59 AM

Let's get the facts straight. Innovation in medical devices is commonly the result of industry and physicians working together.

Medtronic did not participate in the collection or analysis of the data, the preparation of the manuscript for the journal article, or the submission of the journal article for publication. Additionally, the study was not funded by Medtronic, either directly or indirectly.

Neither the JBJS article, nor the data presented in that article, was used by Medtronic to secure any current indication for any product, including INFUSE Bone Graft. And since the article was called into question, we are not using it or the data to seek regulatory approval for any product.

Dr. Kuklo has been involved in a large number of research projects in his own right and he is also an author of numerous scientific papers and published journal articles. Neither the retrospective study conducted between 2003 and 2005 that formed the basis for the JBJS article, nor the submission and publication of this particular journal article was related to Dr. Kuklo's role as a consultant to Medtronic.

Regardless of whether "david" has an official affiliation with Medtronic, he certainly is/was a Medtronic cheerleader. But Medtronic itself is now back-pedaling from Dr. Kuklo as fast as it can. Yesterday, The New York Times reported that Medtronic has suspended its consulting contract with Dr. Kuklo and that Sen. Charles Grassley (R. Iowa) "rebuked" Medtronic for the failure to report Dr. Kuklo's involvement with consultation on Infuse. Chapter 2 of this story seems to highlight further the cozy relationship between big medicine and big business; perhaps Chapters 3 and beyond will reveal the truth for the patients who are on the receiving end of this "medicine" because they are the most deserving of the truth.