Wednesday, May 13, 2009

New Hippocratic Oath?

First, Do No Harm...

Then, Forge No Signatures

And Finally, Fudge Not Lest Ye Be Fudged

From a Retraction Notice:


Withdrawal of a paper

A paper entitled “Recombinant human morphogenetic protein-2 for type grade III open segmental tibial fractures from combat injuries in Iraq” was submitted to the JBJS[Br] with a covering letter dated 9 October 2007 which was signed by the authors. The corresponding author was Dr. T. Kuklo. The letter of transmittal included the statement that each of the authors had read and approved the final manuscript. It also said that the authors were employees of the United States Government and that the submitted work was performed as part of their official duties.

Shortly after the paper was published we received correspondence from one of the persons identified as a co-author indicating that the alleged co-authors had not seen the manuscript prior to publication and that they had not signed the letter of transmittal. It was further disclosed that much of the paper was essentially false.

Appropriate representations were made to the Walter Reed Army Medical Center in Washington DC, the alleged source of the paper, even though Dr Kuklo had retired from the US Army and left Walter Reed well before his paper was submitted for publication. A local investigation was instigated and we received further correspondence dated 6 November 2008 including the following

The results of the investigation establish

that Dr Timothy R Kuklo did not submit the article through the Office of Clinical Investigations or the Public Affairs office, as required by Army regulations,
before he submitted the article to your publication;

that the signatures of the supposed co-authors of the article were, in fact, forged;

that Dr Kuklo acted without any involvement of personnel at the Walter Reed Army Medical Center;

and that the article was in no way vetted through Walter Reed’s Publication process before publication.

As you are aware, once the article was reviewedby the purported co-authors of the article, a number of serious questions were raised regarding the validity of the information and the conclusions made in the article."

Under these circumstances the paper published by this Journal has been formally withdrawn from the scientific literature and Dr Kuklo banned from submitting further papers to this Journal.

J. Scott, MA, FRCS, Editor
Journal of Bone and Joint

J Bone Joint Surg [Br]

Well the NYT has finally tumbled to this situation and has an article with some local color. Perhaps this is an indication that self-policing is not going to be effective here either?

From the New York Times:

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.

[Unfortunately, Dr. Polly, in addtion to being a Medtronic consultant is also a physician at the University of Minnesota. Overblown, Dr. Polly? I don't think so...]

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.”

This episode has been overblown, Dr. Polly? Wow.

I thank a regular reader for calling this situation to my attention.

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