December 27, 2010
2 Senators Raise Questions on Use of Medtronic Device
By DUFF WILSON

Two senators are raising new questions about an experimental use of a Medtronic device in spinal surgery on veterans and soldiers at the Walter Reed Army Medical Center from 2002 to 2004.

Senators Max Baucus, Democrat of Montana and chairman of the Senate Finance Committee, and Charles E. Grassley of Iowa, the committee’s ranking Republican, wrote the commanding general of Walter Reed on Dec. 17 to ask about safeguards in a study by three Army surgeons. Senator Grassley’s office provided the letter to The New York Times.

The senators asked what the Army was doing to investigate certain back surgeries at Walter Reed and whether patients had been told they were receiving devices for uses not cleared by the Food and Drug Administration. They also asked how Army protocols could ensure proper review of medical tests involving soldiers and veterans. The surgeons, who have received money from Medtronic, had implanted and written about a Medtronic device called Hydrosorb Mesh, which contained a bone-growth material called Infuse.

Hydrosorb was approved by the Food and Drug Administration for nonweight-bearing purposes but not for spines, the senators wrote. Doctors are free to use F.D.A.-approved medical devices for any purpose they see fit, but in this case, Army officials said the surgeons should have sought permission for the study.

The Army doctors had implanted Hydrosorb Mesh in spinal fusion procedures for 35 patients in an 18-month period, according to a study published in the journal Neurosurgical Focus in 2004. The study covered 22 patients, including 15 active duty soldiers, to determine whether the bio-absorbable Hydrosorb was possibly preferable to similar titanium mesh.

The study concluded, in glowing terms, that Hydrosorb might be “ideally suited” to spinal use. Medtronic has also made payments for consultancy or other services to the three doctors — Timothy R. Kuklo, Michael K. Rosner and David W. Polly Jr., all then with Walter Reed.

Six years after the implants, however, Hydrosorb has still not been approved for that use. The senators expressed safety concerns.

Mr. Baucus said in a statement, “Safety must come first, especially for America’s men and women in uniform, and putting soldiers’ health at risk is an unacceptable price to pay for medical advancements. This case raises serious questions about whether men and women in uniform always receive the best care — questions that need answers.”

Col. Norvell V. Coots, commander of the Walter Reed Healthcare System, said last week that he would respond to the senators by Jan. 14 with assurances of improved controls over research and publication.

Walter Reed plans no further action, he added, although investigators have concluded the doctors violated Army rules by failing to seek or receive permission to conduct research or publish the article.

Walter Reed has located 15 of the patients who had received the experimental back surgery, he said, and found all had been appropriate candidates for back surgery and were doing well.

“We never put our patients at risk,” he said.

Medtronic, based in Fridley, Minn., is one of the world’s largest medical device makers with sales of $15.7 billion in the year ended Oct. 29.

Marybeth Thorsgaard, a company spokeswoman, said Medtronic supported Walter Reed research through a grant to a foundation.

Dr. Kuklo, a West Point graduate, was found by Army investigators in 2008 to have fabricated signatures of co-authors of another journal article on a different Medtronic product and presented data that did not match hospital records, though he contests the data charge. He left the Army in 2006. Medtronic has disclosed it had paid Dr. Kuklo $823,339 from 2001 until early 2009, when the company suspended his consultancy.

Dr. Kuklo’s lawyer, Henry J. Dane, said Army doctors did not need to obtain permission for studies of fewer than 10 patients. The review of Hydrosorb cases included three doctors writing about 22 patients, he said, an average of seven each. Colonel Coots, however, said that is an incorrect reading of the rule.

Mr. Dane also said Dr. Kuklo was a dedicated researcher whose work improved treatment for soldiers with severe injuries. Colonel Coots praised Dr. Kuklo as a good surgeon but said he did not obtain the required permission for some research.

The issue was first raised in September 2009 by Dr. Charles D. Rosen, a clinical professor of orthopedic surgery at the University of California, Irvine. In a letter to the Army surgeon general, Dr. Rosen asked whether soldiers receiving the implants had been given informed consent. “I’m appalled that experiments are being done on our U.S. soldiers without their knowledge,” Dr. Rosen said on Monday. “And to not have follow-up is, I think, dropping the ball big time.”

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