Healthy Skepticism Library item: 15977

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Meier B, Wilson D.
Medical School Says Former Army Surgeon Hid Ties to Medtronic
The New York Times 2009 Jul 15
http://www.nytimes.com/2009/07/15/business/15device.html?_r=1

Full text:

A former military doctor and Medtronic consultant at the center of a research scandal did not tell his medical school employer for a year about his Medtronic ties even as he was conducting company-sponsored research, according to that institution, Washington University in St. Louis.

The new disclosures, which the medical school made in response to a Senate investigation, may intensify the controversy surrounding the physician, Dr. Timothy R. Kuklo, an orthopedic surgeon who formerly worked at the Walter Reed Army Medical Center.

The Army has accused Dr. Kuklo of falsifying a medical journal study about the use of a Medtronic bone-growth product on American soldiers with severe leg injuries, reporting more favorable results than other Walter Reed doctors found.

The medical school documents also shed new light on Medtronic’s financial support of Dr. Kuklo’s research on those soldiers, who were treated with the company’s bone-growth product called Infuse.

Since the Kuklo controversy was the subject of a front-page New York Times article in May, Medtronic has consistently said it was not aware of, and had not supported, the Walter Reed study about Infuse, which Dr. Kuklo published last August in a British medical journal. The journal retracted it in March after the Army discredited it.

But the documents show that for more than a year Medtronic financed a separate, unpublished research study by Dr. Kuklo while he was at Washington University that also reviewed the use of Infuse on Walter Reed patients with combat-related leg injuries.

Dr. Kuklo has not responded to interview requests over the last two months and did not do so on Tuesday. Medtronic acknowledged that it had supported Dr. Kuklo’s second Walter Reed study but stated, “Washington University discontinued the study in question, thus it was never completed, nor was a manuscript ever submitted for consideration.”

Washington University told Senator Charles E. Grassley, Republican of Iowa, that Dr. Kuklo had stopped that study in 2008 after school officials confronted him about not disclosing his ties to Medtronic when he began the study two years earlier. It was not until mid-2007, nearly a year after joining the medical school, that Dr. Kuklo disclosed in a filing that he was a Medtronic consultant, making more than $50,000 annually from the company.

Given the option of reducing those financial ties to below $10,000, Dr. Kuklo opted to stop the study, the school said.

In addition to the Senate investigation, being led by Mr. Grassley, the Kuklo matter is the subject of a Justice Department inquiry. Washington University has told the senator that it is continuing to investigate Dr. Kuklo’s apparent failure to adequately disclose his Medtronic ties as required in conflict-of-interest filings with the school.

“Dr. Kuklo’s relationships to Medtronic and the adequacy of his related disclosures to the University are also of great concern to us,” the medical school’s dean, Dr. Larry J. Shapiro, wrote in a letter to Senator Grassley that the senator’s office released Tuesday along with other documents from the university’s investigation.

A company spokeswoman declined to say whether Dr. Kuklo had submitted to Medtronic any data from his retracted study before it was published last August.

Dr. Kuklo joined the medical faculty of Washington University in August 2006, when he still was on military active duty. Medical school officials said they were unaware of that continuing military relationship, and Army officials are currently investigating whether Dr. Kuklo sought and received their permission to take the teaching job.

While at Walter Reed, Dr. Kuklo had received research and travel support from Medtronic, according to Army records.

The school said it later discovered that Dr. Kuklo had signed a personal consulting agreement with Medtronic just three days after submitting a conflict-of-interest form in September 2006 in which he stated he did not have or anticipate having any financial ties to companies involved in his research. The consulting deal was also retroactive to Aug. 1, 2006.

Dr. Kuklo, while still at Walter Reed, had presented data at a 2005 conference about the use of Infuse at the medical hospital – information that he would later develop into a substantive report that he began submitting to medical journals starting in 2007.

It was around that same time, university information indicates, that Medtronic also began to underwrite another, related follow-up study of Infuse’s results on the injured Walter Reed soldiers.

The published report, eventually retracted by The British Journal of Bone and Joint Surgery, dealt with single doses of Infuse. The second study, never completed or published, was meant to review the effect of multiple doses of the bone growth product on soldiers treated at Walter Reed.

The university told Senator Grassley that its review of Dr. Kuklo, which is continuing, began in February, a month after it received an Army report that he had falsified the published Infuse study and forged the names of four other military doctors on it.

In late May, Medtronic suspended its consulting relationship with Dr. Kuklo, and the doctor took a paid leave from Washington University at the school’s request.

Medtronic recently said that it had paid Dr. Kuklo nearly $800,000 in fees since hiring him as a consultant in mid-2006, including more than $132,000 this year. It was in December that the Army told Medtronic about the results of its inquiry.

Dr. William C. Doukas, a former chairman of the orthopedics department at Walter Reed, said in a recent interview that he often gave Dr. Kuklo permission to take leaves while working at the military hospital to speak about Infuse at medical conferences.

“I defended him, not knowing what he was doing,” Dr. Doukas recently said. “I thought he was speaking forthrightly.”

But last year, when Dr. Doukas learned about Dr. Kuklo’s fabricated study, he told an Army investigator then he believed that the orthopedist should be brought back from retirement for punishment, according to a previously undisclosed portion of the Army’s report.