Spine procedures conducted on 35 soldiers by University of Minnesota surgeon Dr. David Polly and two others in 2002 were recently questioned in a letter to the U.S. Army surgeon general from Dr. Charles Rosen, orthopedic spine surgeon and president and founder of the Association for Medical Ethics.
Rosen’s letter questioned the spinal fusions done on patients at Walter Reed Army Medical Center. The spinal treatments involved inserting lumbar Hydrosorb implants packed with a bone growth product called Infuse. Both were Medtronic products.
In July, Polly was critiqued by Sen. Chuck Grassley, R-Iowa, for not fully disclosing his relationship with Medtronic, where he received $1.2 million in consulting fees from 2003 to 2007.
The treatment was published in a neurosurgery journal in 2004 by Dr. Timothy Kuklo who conducted the procedures with Polly.
A colleague showed Rosen the article in August and he looked into the case. Rosen sent the letter to the surgeon general with his concerns on Sept. 29. He wanted to know whether the patients gave informed consent and if an institutional review board approved the treatment. He said the article published in the journal did not indicate either of these, although it is common practice to do so.
Soldiers are supposed to do what they are told, and that could be abused, Rosen said. “The idea of experimenting on soldiers — it is just revolting,” he said.
He received a response Oct. 9 saying the office was looking into it, but he has not heard anything conclusive.
Amid the controversy surrounding Polly, the University has reevaluated its conflict of interest policy.
It is common for researchers to be contracted with medical device or pharmaceutical companies, said Melissa Anderson, a professor at the University’s Center for Bioethics.
Anderson said most universities combat the appearance of any conflicts of interest with disclosure.
“As long as everyone knows what the conflict of interest is, then people [with that knowledge] can make their own decisions as to whether or not the information is tainted or not,” Anderson said.
Dr. Charles Burton, a neurosurgeon who worked for the FDA, said these things occur, but the circumstance was unique because Infuse was only recently approved, and Hydrosorb was not yet approved.
Rosen said the Army use of Hydrosorb was “specifically counter-indicated by the FDA,” Rosen said.
Polly’s lawyer, John Lundquist, said there was no experimenting taking place. He said many products have never been formally approved by the FDA, and there are many cases of products being used in pediatrics that were off-label, or not specifically approved by the FDA, and “no one would say that that requires institutional review board approval or is in any way unlawful,” he said.
“Anyone who works in this area knows that an institutional review board is used in a clinical trial. This is not a clinical trial,” Lundquist said.
He said the article Kuklo wrote was a retrospective review of the cases, and not part of a study. The results of the treatment for patients have been generally positive, Lundquist said.
Lundquist said “physicians can use drugs and devices for indications the FDA has not yet approved, that’s been the case for decades.”
“There’s nothing wrong with the process; it’s really a matter of using the process that is in place to protect the patient’s best interest,” Burton said.
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