When Army Major Walter Reed established the United States Army Yellow Fever Commission in 1900 his medical staff used themselves as volunteers to be bitten by mosquitoes infected with yellow fever. Their selfless actions stand as one of many fine examples of medical self-sacrifice throughout American history. It is unfortunate that not all military physicians following in Major Reed’s footsteps have been guided by the same moral compass as Major Reed and his associates.
Orthopedic Spine Surgeon Charles Rosen, President of the Association for Medical Ethics, in September 2009 sent a letter to the U.S. Army Surgeon General reporting that in 2002 and 2003 Orthopedic Spine Surgeons David W. Polly Jr. and Timothy R. Kuklo, (U.S. Army surgeons in the Department of Orthopaedics and Rehabilitation at Walter Reed Army Hospital) had performed instrumented spinal fusion procedures with unapproved medical devices based on published data. The letter was in reference to 35 patients at Walter Reed during that time period. Some of the fusions in question appeared to have been as extensive as five spinal levels.
Information obtained by Burton Report indicates that during this period of time, in addition to being army officers Drs. Polly and Kuklo were paid consultants who were traveling to medical conferences throughout the world at the expense of Medtronic, Inc. of Minneapolis, the world’s largest spinal device company and marketing their products.
All of the thirty five surgical procedures performed by Drs. Polly and Kuklo at that time involved the use of biodegradable polylactide (Hydrosorb™) intervertebral disc prosthetic cages distributed by Medtronic which were not approved by the U.S. Food and Drug Administration for use in the human spine. In addition, these Hydrosorb™ cages were packed with a bone growth potentiator rhBMP-2 (Infuse™) which was an off-label use of a biologic substance which had only recently been introduced for limited and specific spinal use.
Infuse™ was also a Medtronic product.
Under the documented circumstances it should have been mandatory that such surgery be reviewed, authorized, and monitored by an Institutional Research Review Board (or equivalent) and include full pre-operative disclosure to all patients regarding these most unusual and important circumstances.
Fortunately, in the history of American medicine there have been only a few examples where physicians have exploited captive hospital patients in such a manner. The past actions of Colonel Stafford Warren has represented such an example.
Drs. Kuklo and Polly were among the first surgeons in the world to implant the unapproved Hydrosorb™ intervertebral cages. Previous use of these spinal implants had been associated with significant concerns. In 2001 spine investigators in Europe expressed their view that “further in-vivo animal experiments are essential prior to the clinical application of biodegradable lumbar interbody fusion cages.” The concerns regarding the safety and efficacy of the Hydrosorb™ cages included mechanical failure, premature decay, and extrusion sometimes associated with neurologic impairment. These respresent concerns which have been subsequently born out.
It does not appear that the U.S. Army or Walter Reed Hospital were aware of the actual circumstances under which these surgeries being performed on their hospitalized soldiers or patients by Drs. Kuklo and Polly at that time. They were probably also unaware of the patient selection process and whether or not these spinal fusions were appropriate in the first place. It is important, in the light of what is now known about the Hydrosorb™ devices to follow-up on this operated patient population and determine their surgical outcomes.
It is now clear from reviewing the medical literature that Drs. Kuklo and Polly intended to use the Walter Reed experience as a means of advancing both the continuing use of Hydrosorb™ as an intervertebral device as well as promoting the future use of Infuse™.
In 2009 a prospective, randomized study published in the journal SPINE indicated that the efficacy of the polylactide cages in enhancing interbody spinal fusion had yet to be established.
Dr. Rosen has asked that the Army look into this serious situation which appears to Burton Report to be in violation of the Nuremberg Laws. Given the present concerns regarding unnecessary spinal surgery in the United States; most specifically its being performed as a treatment for low back pain due to disc degeneration (something that 80% of the population experiences) it will also be important to identify who these patients were, what were the indications for their surgery, and how they have fared since that time.
According to an article published by Duff Wilson in the New York Times on December 27, 2010, the Walter Reed Medical Center had not yet replied to the concerns initially expressed by Dr. Rosen or to subsequent inquiries made by Senator Charles Grassley (Iowa).
Further inquiries made by Senator Max Baucus (Montana), the present head of the Senate Finance Committee, again supported by Senator Grassley, to Col. Norvell Coots, commander of the Walter Reed Healthcare System indicated that Walter Reed planned to take no action against the surgeons involved although their investigators had concluded that: “the doctors violated Army rules by failing to seek or receive permission” to conduct their research on hospital patients. What exactly constitutes “conduct unbecoming an officer” has been further clouded by the events surrounding the case of Capt. Matthew Webb.
As of this time there continues to be no indication that the dearth of ethical behavior exhibited by Drs. Kuklo and Polly has even occasioned a reprimand by the Walter Reed Army Hospital.