A leave of absence and silence in the Kuklo case

Recently in the New York Times, it was reported that Dr. Timothy Kuklo, the Washington University School of Medicine surgeon accused of falsifying data, has taken a leave of absence in order to, as the University states, “focus on responding to queries about his research and consulting”.

Here is a link to the story: Former Army Doctor Accused of Research Fraud Takes Leave from University

Dr. Kuklo, an associate professor of orthopedic surgery, will not perform operations, conduct research or teach 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.

Kuklo’s apparent wrongdoings came to light last week when it was revealed that he had falsified data and had forged other physicians’ signatures on an article published in the British Journal of Bone and Joint Surgery— which has now been retracted. From a period of about 2000 -2006, Kuklo, an orthopedic surgeon, was a physician with the US army at the Walter Reed Army Medical Center and was working with Medtronic (the largest manufacturer of medical devices in the USA) investigating the efficacy of “Infuse”, a bioengineered product given to promote bone-growth after severe bone-shattering leg injuries sustained by American soldiers injured in the Iraq war. In his published research, Kuklo presented “Infuse” in a more favourable light than the data supports, according to the Army, who first brought the issue into the public eye a few weeks ago, and contacted the journal in which Kuklo published, along with the University and Medtronic. As Kuklo is now retired from the military, the Army are not investigating the matter further.

So far, no one involved has said very much. Kuklo has not spoken publicly about his involvement with Medtronic nor about the claims of falsifying data and forging signatures. Representatives from Medtronic have not spoken publicly either — except to say that they “had no involvement with the disputed research”. That’s a strange statement, given that Kuklo was researching their product and they were not only funding the work but also providing thousands of dollars for Kuklo to travel extensively during the time he worked with the company, according to a related story on the Center for Public Integrity’s blog, The Paper Trail.

Here’s a link to the Centre for Public Integrity story: Accountability: Kuklo, Target of Army Probe, A Top Recipient of Medtronic Travel.

Between 2001 and 2006, Medtronic paid for at least 15 trips taken by Dr. Kuklo, worth more than $13,000, according to travel disclosure records obtained from the Office of Government Ethics. Kuklo, now an associate professor at Washington University medical school in St. Louis, took more than 20 privately-funded trips.
“There’s no lack of creativity in how the industry tries to influence studies,” said Shahram Ahari, a medical ethicist and former drug sales representative. “This is what marketing is about, you take people with that position of respect and credibility, and every once in a while they spin one out that helps the marketing, and it’s hard to distinguish the marketing from the science.”

So far, this story is pretty murky, and no doubt will only get murkier as new details emerge and perhaps, the key players offer some kind of public statements about what went on. At this point however, it is clear that this is yet another story demonstrating the kinds of blatant conflicts of interest and complexities in the relationships that exist between researchers and industry. It’s also clear that there is blame to be laid here but so far, most involved are either denying wrongdoing or providing no clear statements of explanation. The four physicians whose signatures Kuklo forged haven’t made public statements, the Army is washing its hands of the ordeal, Kuklo is silent and Medtronic denies being involved in research on their own product. At the end of the day, in this flurry of denial of involvement and wrongdoing, it remains a fact that the only ones who were involved were the participants: severely injured American soldiers returning from the Iraq war. Someone here owes them an explanation.

~ by Nancy Walton on May 24, 2009.

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