Army Doctor Accused of Research Fraud Takes Leave From University

Following accusations by three physicians who asserted that Dr. Timothy Kuklo, a former surgeon at Walter Reed Army Hospital (2003-2007) had forged their names and appended them to a published journal article which falsified research data conducted on US soldiers to support exaggerated claims about the effectiveness of Infuse, a bone-growth product made by Medtronic, a company with whom he had significant undisclosed financial ties, an investigation by the Walter Reed Army Medical Center confirmed the charges.

The Walter Reed report, issued in late 2008 was sent to Medtronic’s chief executive and to the dean of the Washington University School of Medicine, where Dr. Kuklo was employed. As late as May 13, 2009, a university official declined to say whether it was investigating Dr. Kuklo but confirmed that he remained on the faculty.

The Journal of Bone and Joint Surgery that had published the fraudulent article retracted it, but neither the University nor Medtronic had taken any disciplinary action against Dr. Kuklo.

In response to an inquiry from Senator Grassley (Sept. 2008) Medtronic provided him with a partial list of outside doctors who were paid consultants for Infuse. Dr. Kuklo, who has made about 15 paid presentations for Medtronic about the product, was not on that list.

In response to an inquiry by the Times, a written statement by a Medtronic spokeswoman indicated that Dr. Kuklo was not included because “some consultants, like Dr. Kuklo, have general agreements that are not specific to a single therapy or subject matter.”

In other words, such doctors are on unspecified retainer with the company, promoting any number of Medtronic products!

Sen. Grassley has now requested complete information from Medtronic–including undisclosed financial arrangements between the company and academic faculty. The company then announced its disengagement from Dr. Kuklo, a graduate of West Point, the University of Connecticut medical school and Georgetown Law Center.

Given the serious charges against Dr. Kuklo–including fraud, forgery, and conducting an unapproved experiment on soldiers–the University of Washington’s failure to take action until a series of articles in The New York Times and Sen. Charles Grassley brought pressure to bear, speaks volumes about a pervasive culture of arrogance in academia.

The University of Washington did not see fit to take action until Friday, May 22, when a spokesperson indicated that Dr. Kuklo would take a leave of absence from the University.

Medical faculty members at premier universities such as Harvard and institutions that carry lesser prestige, such as Emory, continue to operate within a culture that condones lawlessness by high ranking academics who have trampled the foundation of medicine and the integrity of medical research with impunity.

They have done so, much as predatory priests continued to abuse children in the knowledge the Catholic Church would shield them from prosecution. Given the universality of human nature, independent oversight and accountability are the essential safeguards for ensuring against abusive conduct–especially by a powerful elite.

Posted by Vera Hassner Sharav

THE NEW YORK TIMES
May 19, 2009
Senator Asks About Doctor Who Army Says Falsified G.I. Study
By BARRY MEIER and DUFF WILSON

A top Republican lawmaker has opened an inquiry into a former Walter Reed Army Medical Center doctor whom the Army has accused of falsifying a medical study involving a product made by Medtronic Inc., a company for whom he works as a paid consultant.

Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee, released letters Monday seeking information about the physician, Dr. Timothy R. Kuklo. The letters were sent late Friday to Walter Reed officials, two medical journals and the head of Washington University in St. Louis, where Dr. Kuklo works as an associate professor in the medical school.

The New York Times reported last week that a British medical journal had retracted an article by Dr. Kuklo earlier this year after learning from Army officials that he had, among other things, forged the names of four other doctors he cited as the study’s co-authors.

Army investigators determined that Dr. Kuklo’s article had overstated the benefits of a Medtronic bone-growth product, called Infuse, that was used at Walter Reed to treat American soldiers who had suffered severe lower leg injuries in Iraq.

Army officials also cited discrepancies in the data cited by Dr. Kuklo, saying he had described more injuries than Walter Reed records showed.

Dr. Kuklo, who worked at Walter Reed between 2003 and 2007, has declined to respond to numerous telephone calls and e-mail messages seeking comment. Officials of Washington University have also declined to say whether they are investigating Dr. Kuklo, although Army officials and others say that the school is conducting such an inquiry.

Medtronic may also face repercussions from the incident. Since last year Senator Grassley and, separately, the Justice Department have been investigating whether the company illegally promoted uses of Infuse that were not approved by the Food and Drug Administration — by paying doctors, among other alleged measures. The company has denied doing so..

Medtronic, while acknowledging that Dr. Kuklo is a company consultant, has repeatedly declined to say when it hired him as a consultant or how much it has paid him over the years, either directly or to support his research.

But the company’s and doctor’s financial relationship goes back to at least 2001. Between 2001 and 2006, Medtronic spent more than $13,000 to pay Dr. Kuklo’s travel expenses to numerous medical conferences and other professional meetings, according to Defense Department records reviewed by the Center for Public Integrity and Northwestern University’s Medill Journalism School.

In a response to an inquiry last September from Senator Grassley, Medtronic provided the lawmaker with a list of outside doctors who were paid consultants for Infuse. Dr. Kuklo, who has made about 15 paid presentations for Medtronic about the bone growth product, was not on that list, a spokesperson for Senator Grassley said.

Asked last week by a reporter about that issue, a Medtronic spokeswoman, Marybeth Thorsgaard, said in a written statement that the doctor was not included because “some consultants, like Dr. Kuklo, have general agreements that are not specific to a single therapy or subject matter.”

In the Friday letter to Walter Reed officials, Senator Grassley asked for information about, among other things, direct or indirect payments by Medtronic to Dr. Kuklo and other Army doctors involved with Infuse or other company products. He is also seeking the full report of the Army’s investigation as well as relevant conflict-of-interest policies.

Col. Norvell V. Coots, commander of the Walter Reed Health Care System, said Monday that he welcomed the review.

"My guess is we will probably find something more here," the colonel said in a telephone interview. One of the medical journals that received the lawmaker’s inquiry was the British periodical The Journal of Bone and Joint Surgery, which published and later retracted Dr. Kuklo’s Infuse study.

The other was an American journal that has the same name but operates separately from the British publication. It had read but rejected Dr. Kuklo’s article before he submitted it to the British publication.

Senator Grassley asked the journals to provide him with any information relevant to the submitted article, including whether Dr. Kuklo disclosed receiving funding from Medtronic. The published article did not contain such a disclosure.

Copyright 2009 The New York Times Company

THE NEW YOURK TIMES
Former Army Doctor Accused of Research Fraud Takes Leave From University
BARRY MEIER
May 22, 2009

Dr. Timothy R. Kuklo, a former Army physician accused of falsifying research involving injured soldiers, has taken a leave of absence from the Washington University School of Medicine in St. Louis and its affiliated hospitals, the medical school said Friday.

Dr. Kuklo, an associate professor of orthopedic surgery, will not be performing operations, conducting research or teaching students, said a medical school spokeswoman, Joni Westerhouse. The university granted the leave, she said, so that Dr. Kuklo “can focus on responding to queries about his research and consulting.”

Ms. Westerhouse declined to say whether the leave, which began Thursday, was paid or unpaid. She said she did not know its duration or whether Dr. Kuklo requested it or it was imposed on him. The university has declined to say whether it was investigating Dr. Kuklo.

“We know this is a major situation,” Ms. Westerhouse said.

Dr. Kuklo did not respond to e-mail messages and a telephone call to his home Friday seeking comment. A receptionist at his clinic said he was not in.

Dr. Kuklo, who previously worked at the Walter Reed Army Medical Center in Washington, had been accused by four former colleagues there of falsifying research on a bone-growth product made by Medtronic that was used on severely injured soldiers. He was also accused of forging the other doctors’ signatures when he submitted a research report to a medical journal last year.

The Army, which investigated the matter, issued a report rebuking him. It did not take any further disciplinary action, Army officials said, because Dr. Kuklo was now retired from the military. But Walter Reed notified Washington University of its findings five months ago.

The Journal of Bone and Joint Surgery, a British publication, retracted Dr. Kuklo’s article in March after receiving a report of the investigation from the Army. But the episode largely escaped public notice until last week.

This week, a leading Republican senator, Charles E. Grassley of Iowa, sent letters seeking more information about Dr. Kuklo from Walter Reed, Washington University, two medical journals and Medtronic.

Dr. Kuklo has been a consultant to Medtronic, and the company has also paid for some of his research and writings.

Medtronic, the nation’s largest medical-device maker, announced Wednesday that it was suspending Dr. Kuklo’s consulting contract, which had started in August 2006 as he left Walter Reed for the university position. Medtronic has declined to provide details of its consulting payments but said it had no involvement with the disputed research.

Army investigators said Dr. Kuklo’s study had cast Infuse, a bioengineered bone-growth product sold by Medronic, in a misleadingly favorable light compared with conventional bone grafts in repairing severely shattered shin bones of American soldiers injured in the Iraq war.

Dr. Kuklo, 48, is a graduate of West Point, the University of Connecticut medical school and Georgetown Law Center. He has been a prolific researcher, writer and speaker on orthopedic issues, specializing in the spine.

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