Surgeon questions study led by U doc with Medtronic tie

A California spine surgeon who leads a medical ethics organization has written to the Army Surgeon General raising questions about a 2002 Army study that used Medtronic spine products on soldiers in ways not approved by federal regulators.

One of the physicians leading the study at Walter Reed Army Medical Center was Dr. David Polly, now chief of the spine unit at the University of Minnesota's Department of Orthopaedic Surgery. Although Polly was not a Medtronic consultant while at Walter Reed, his subsequent relationship with the medical device giant has come under scrutiny from congressional investigators after he was paid at least $1.2 million by the company between 2003 and 2007.

The letter from Dr. Charles Rosen, president of the Association for Medical Ethics, is the latest chapter in a bitter controversy over financial ties between doctors and medical device companies, a ruckus that has ensnared the nation's top military hospital. Device companies argue that the feedback they receive from doctors is crucial to make their products better. But critics like Rosen claim these often-lucrative relationships pose a conflict of interest and can skew the care doctors provide patients.

This month, a St. Paul neurosurgeon, Dr. Charles Burton, joined the argument, saying on his website that he is "outraged'' by the Walter Reed study and troubled by excessive consulting fees paid to doctors by medical device companies.

Ethics questions

In his Sept. 29 letter, Rosen, a professor of orthopedic surgery at the University of California-Irvine, asked Army Surgeon General Eric Schoomaker whether patients involved in the Walter Reed study were given informed consent before spine surgery. Specifically, he asked if they knew the products used in their surgeries were not approved by the Food and Drug Administration (FDA).

Rosen also asked if an Institutional Review Board -- an independent ethics board that oversees clinical studies -- was engaged at Walter Reed "to oversee and approve this experiment on the men and women of the armed forces."

The spine fusion surgeries performed at Walter Reed involved 35 patients with back problems who were treated with a Medtronic bone-growth product called Infuse. The material was packed into a bioabsorbable implant called Hydrosorb, distributed by the Fridley-based company, and inserted between the vertebrae. The results of the study were subsequently published in a 2004 edition of the medical journal Neurosurgical Focus.

At the time, Infuse was approved by the FDA only for single-level fusion surgeries in the lower back using a different type of supportive cage than Hydrosorb. Fourteen of the patients in the Walter Reed study had multiple-level fusions, two of which involved fusing five spinal levels, according to the Neurosurgical Focus article.

It is not illegal or unusual for doctors to use a medical device off-label, but companies are prohibited from promoting this kind of use. Some industry sources estimate that at least 80 percent of Infuse is used off-label.

Last year, Medtronic received a subpoena from the U.S. Department of Justice indicating the government is investigating off-label use of the blockbuster product. In addition, the FDA has warned doctors about using Infuse off-label in neck surgery, a procedure that can lead to serious complications.

'Appropriate care'

John Lundquist, a Minneapolis attorney representing Polly, said the patients described in the 2004 article "were not part of any clinical trial or 'experiment,' as erroneously assumed by the person who wrote the letter."

Rather, Lundquist said, the article was a "historical review of surgeries. ... This type of 'look-back' inquiry is generally considered a positive aspect of medical research. Each of the patients received treatment most appropriate to their individual circumstances based on an independent determination by their care teams."

Patients were "properly informed of alternative treatments, as well as the risks and benefits of the surgery," Lundquist said.

Polly was involved in 10 of the 35 cases cited. Lundquist said the outcomes for Polly's patients were "very good."

Two other Walter Reed surgeons, Drs. Michael Rosner and Timothy Kuklo, were also listed as authors on the 2004 journal article.

Earlier this year, Kuklo was accused of falsifying data and forging the signatures of colleagues in another study at Walter Reed that was published in a British medical journal in 2008.

After leaving the military in 2006, Kuklo became a paid consultant for Medtronic, earning about $850,000 between 2001 and this year, when his contract was terminated. Last month, an academic panel at Washington University in St. Louis, where Kuklo held an academic post until recently, found there was some indication of research misconduct, but no proof he falsified data.

Lt. Gen. Schoomaker has acknowledged receipt of Rosen's letter, but has not issued a formal reply. Walter Reed officials said last week they would need more time to respond, since the study Rosen questioned is seven years old and the materials have been archived.

Meanwhile, Rosen's letter prompted Burton, a co-founder of the Association for Ethics in Spine Surgery, to criticize the 2002 Walter Reed study on his website, the Burton Report.

Burton wrote that use of the Hydrosorb cages before 2002 "had been associated with significant concerns" regarding their safety and effectiveness -- "which have been subsequently borne out."

A former Navy neurosurgeon, Burton admitted in an interview it is unusual for one doctor to publicly question the care bestowed on patients by other physicians.

But, he said, "I'm outraged by this case. No one's hands have been slapped. It's like insider trading in the stock market. It won't stop until someone's hands have been slapped.''

Janet Moore • 612-673-7752