Army Report Finds Walter Reed Doctor Falsified Data

Academic physicians who hold senior faculty positions at prestigious medical centers, who have trained at the finest US medical schools, are found to have engaged in fraud and deception, shamelessly hawking products for companies that pay them.

A front page article in The New York Times reports that an investigation by Walter Reed Army Medical Center, found that Dr. Timothy Kuklo, a former surgeon at Walter Reed (2003-2007), who is currently an associate professor at Washington University, St. Louis, made patently false claims about the number of soldiers he claimed he successfully treated (92%) with Infuse, a Medtronic product.

"It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed," Colonel Coots said in a telephone interview on Tuesday. "So this really was all falsified information."

Dr. Kuklo is a paid consultant for Medtronic whose sales during a six month period for bioengineered products, principally Infuse, reached $419 million.

According to the investigation, he conducted an experiment on soldiers without the Army’s permission; he falsified signatures of co-authors in an article he submitted to British medical journal, and made presentations about Infuse at the professional orthopedic association meetings.

The investigation was prompted by a complaint from Lt. Col. Romney Andersen who was falsely named a co-author of the study published in Britain last August in The Journal of Bone and Joint Surgery.  The Journal retracted the study.

However, much like officials at Harvard University, who have taken a vow of silence to shield prominent Harvard faculty in the department of Psychiatry, whose research integrity and clinical recommendations appear to be tainted by commercial self-interest, officials at the University of Washington, St. Louis have put their heads in the sand pretending they are unaware of "a significant breach of academic protocol" by their faculty.

The Times reports that Dr. Kuklo made a presentation at the orthopedic academy’s national meeting in Las Vegas two months AFTER the Army investigation findings had been sent to the University of St. Louis and Medtronic.

We would say, that academic institutions that fail to repudiate wrongdoing by their faculty are themselves guilty of a breach of public trust.  Without that trust, academic institutions jeopardize the generous public support
they receive.   
 
Posted by Vera Hassner Sharav

THE NEW YORK TIMES
May 13, 2009
Army Disputes Doctor’s Claim in Study of Injured By DUFF WILSON and BARRY MEIER

A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday.

An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots.

"It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed," Colonel Coots said in a telephone interview on Tuesday. "So this really was all falsified information."

The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter.

Dr. Kuklo, 48, now an associate professor at the Washington University medical school in St. Louis, did not respond to numerous e-mail messages and telephone calls to his office and home seeking comment over the last two weeks. Walter Reed officials say he did not respond to their inquiries during their investigation.

Army investigators found that Dr. Kuklo forged the signatures of four Walter Reed doctors on the article before submitting it last year to a British medical journal, falsely claiming them as co-authors. He also did not obtain the Army’s required permission to conduct the study.

"This was a real letdown for us to have one of our former members do something like this," one of those doctors, Lt. Col. Romney C. Andersen, wrote in an e-mail message Tuesday. Dr. Andersen, now posted at a combat hospital in Baghdad, said he could not comment further without the permission of his commanders.

It was Dr. Andersen who brought the problem to the Army’s attention last year, prompting the inquiry. In its March edition, at the Army’s request, the journal retracted the article – something that has gone largely unnoticed outside orthopedic circles.

The Army released an executive summary of its investigation to The New York Times last Friday in response to a reporter’s questions, followed by the Tuesday interview with Colonel Coots.

A West Point graduate who also has a law degree from Georgetown University, Dr. Kuklo worked at Walter Reed from early 2003 until he retired from the Army in March 2007.

While at Walter Reed and since, Dr. Kuklo has given talks to other doctors around the country about the bone-growth product, a protein called Infuse, according to meeting agendas and published documents.

A Medtronic spokeswoman, Marybeth Thorsgaard, confirmed that Dr. Kuklo was a paid consultant to the company and that the company financially supported some of his research at Walter Reed, through a foundation affiliated with the hospital.

But she said Medtronic did not finance or review the Infuse study, which was published in Britain last August in The Journal of Bone and Joint Surgery.
She declined to say when Medtronic had hired Dr. Kuklo or how much it had paid him over the years.

Infuse is widely used in civilian hospitals and trauma centers around the country for spinal surgeries and to treat broken bones. The Food and Drug Administration issued a safety alert last year that Infuse, if used in neck surgeries – for which it has not been approved – could cause breathing difficulties.

Since last year, the Justice Department and Senator Charles E. Grassley of Iowa, ranking Republican on the Senate Finance Committee, have been investigating whether Medtronic illegally promoted unapproved uses of Infuse by paying doctors, among other measures. The company has denied those charges.

During the six-month period ending last October, sales of Medtronic’s bioengineered products, principally Infuse, reached $419 million, according to a company filing.

Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said he was unaware of any previous cases in which medical studies involving injured soldiers had been retracted because of such allegations. "People are very careful when they deal with this patient population," he said. "I think they understand that the stakes are pretty high."

The study claimed to be a review of soldiers who were treated at Walter Reed for gaping lower-leg wounds with open fractures caused by explosions in the Iraq war from March 2003 to March 2005.

Colonel Coots said that Walter Reed surgeons had used Infuse with good results on some soldiers – but not at the 92 percent success rate Dr. Kuklo claimed.

Several colleagues of Dr. Kuklo, who has published more than 100 articles on orthopedic topics, said they had recently become aware of the allegations and they were not in keeping with what they know of his work.

"It surprises me to hear this swirling around him," said Dr. Todd J. Albert, chairman of orthopedic surgery at Thomas Jefferson University Hospital in Philadelphia. "He’s a guy, anything he tells me, I take to the bank."

A former Walter Reed colleague, Dr. David W. Polly Jr., who is also a Medtronic consultant, said he believed that Dr. Kuklo’s data was "strong" and the episode had been overblown.

Army officials said that Colonel Coots sent the results of their investigation late last year to Medtronic’s chief executive and to the dean of the Washington University School of Medicine. A university official declined to say whether it was investigating Dr. Kuklo but added that he remained on the faculty.

Colonel Coots said he decided to handle the matter by notifying the journal, university and Medtronic, as well as several orthopedics professional groups, rather than recalling Dr. Kuklo from retirement to face possible Army discipline.

As recently as February, two months after Medtronic received the findings of the Army’s investigation, Dr. Kuklo made a general presentation about Infuse at the orthopedic academy’s national meeting in Las Vegas. In a disclosure filing for the event, he noted that he was a paid consultant, speaker and researcher for Medtronic. The filing did not specify any dollar amounts.

Back in 2005, while still at Walter Reed, Dr. Kuklo listed Medtronic as a financial supporter "in excess of $500" in a disclosure statement accompanying a preliminary report about the use of Infuse on American soldiers injured in Iraq. The Army is not disputing those early results.

Infuse was approved by the F.D.A. in 2002 for use in the lower spine and in 2004 for fractures of the shinbone. The studies on which the F.D.A. approved shin-bone treatment involved patients injured in accidents like car crashes and falls.

But because doctors are free to use any product approved by the F.D.A. for whatever purposes they see fit, surgeons at Walter Reed used the product to see if it could help soldiers with far more severe, combat-related injuries.

During his time at Walter Reed Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report.

The results reported by Dr. Kuklo in his Infuse study "suggested a much higher efficacy of the product being researched in the article than is supported by the experience of the purported co-authors," according to the Army’s investigation.

Colonel Coots said Tuesday that the total number of patients Dr. Kuklo reported as having been treated for extensive lower leg wounds at Walter Reed during the study period – 138 soldiers – was greater than the number for which the hospital could find records.

"It is a significant breach of academic protocol," Colonel Coots said. "It’s a breach of trust."

Copyright 2009 The New York Times Company