The report's conclusion, written in crisp and withering language, left no room for ambiguity about the transgressions of surgeon Timothy Kuklo, MD.
“What has transpired here is the ultimate tragedy and catastrophe in academic medicine,” wrote Col. J. Edwin Atwood. “The breach of research integrity and academic integrity is one of the most destructive and egregious violations which can occur in academia–truly an academic institution's greatest nightmare.”
The report, completed in October 2008, capped the Army's investigation of Dr. Kuklo, a former Walter Reed Army Medical Center orthopedic surgeon who had since moved to Washington University in St. Louis. Dr. Kuklo, who received $800,000 in compensation from the Minneapolis-based medical technology company Medtronic Inc. between August 2006 and early 2009, is accused of falsifying a study favorable to the company.
His case reveals the at-times unseemly relationship between drug and medical device companies and academic medicine, and offers a potent reminder that medical institutions must continually safeguard themselves from such fraud. It also suggests that medical journals must do better in policing their pages.
The Kuklo matter came to light through reporting by the New York Times and the investigative efforts of Iowa Sen. Charles Grassley, senior member of the Committee of Finance, who has sought to highlight the issue of medical fraud. Grassley introduced the Physician Payment Sunshine Act in January, which would require makers of pharmaceuticals, medical devices and biologics to publicly report annual payments greater than $100 to physicians.
“Transparency fosters accountability, and the public has a right to know about financial relationships,” Grassley said.
The Army report on Dr. Kuklo, obtained for this story, describes a sordid tale beginning in 2004. The lead witness is Romney C. Anderson, MD, a surgeon at Walter Reed who worked with Dr. Kuklo. That year, during an internal meeting at Walter Reed, Anderson presented a small series on his work with recombinant human bone morphogenetic protein-2 (rhBMP-2)–Medtronic's Infuse bone graft–to treat fractures incurred by soldiers. Dr. Kuklo, a West Point graduate who had treated wounded soliders since the 1990s, assisted in the presentation.
At the annual meeting of the Orthopaedic Trauma Association in 2005, Dr. Kuklo gave a presentation on rhBMP-2's impact, and, without informing Dr. Anderson, included the assistant chief of orthopedic surgery's name as a co-presenter. When he found out shortly before the meeting, Dr. Anderson said he didn't confront Dr. Kuklo because the abstract seemed reasonable.
Four years later, in August 2008, Dr. Anderson was congratulated by a neighbor on a research paper in The Journal of Bone and Joint Surgery, published in Britain, about the treatment's efficacy in soldiers. The only problem was that Dr. Anderson hadn't contributed to the 2008 article on rhBMP-2, which listed Dr. Kuklo as the lead author.
In his sworn statement Dr. Anderson said he found the original data Dr. Kuklo had presented at the Orthopaedic Trauma Association meeting in 2005. Some of the pictures were the same as Anderson's internal presentation, but the data, which was the basis of the journal article, didn't match up.
Dr. Kuklo's results, in fact, showed that Medtronic's bone growth product had performed strikingly better at treating fractures of the tibia sustained in the Iraq war than traditional bone grafting.
Dr. Anderson's questions led to Atwood's internal investigation.
“Ironically I believe that rhBMP-2 is a good product that helps heal difficult tibia fractures such as the ones we are presented with from the Global War on Terror and helps reduce the number of infections; however, I do not want to be associated with what I feel is fictitious or possibly fraudulent research,” Dr. Anderson told Atwood's investigation.
Dr. Kuklo didn't respond to the Army's investigation, nor has he spoken to the media.
Since the Army's report Washington University has begun its own investigation of Kuklo. Pending this, “Timothy Kuklo is a tenured associate professor of orthopedic surgery and is on voluntary leave,” said Joni Westerhouse, a spokeswoman for the university.
In a letter to Grassley, Larry J. Shapiro, MD, Executive Vice Chancellor for Medical Affairs, said Dr. Kuklo failed to disclose his relationship with Medtronic to the university.
“In the last several months, Washington University has received–and discovered–many disturbing allegations and concerns regarding Dr. Kuklo's activities, and we are conducting detailed investigations of these issues,” Dr. Shapiro wrote.
Medtronic has denied any involvement in the Army research, saying Dr. Kuklo performed unrelated work for the company. The US Department of Justice is investigating. The British journal retracted the article in March, and has banned Dr. Kuklo from its pages.
Some medical ethics experts say there are several lessons to be taken away from the case. First of all, the affair raises the familiar specter of ghostwriting in academic journal articles, as it appears likely that Dr. Kuklo used the names of Romney Anderson and 2 other orthopedic surgeons to bolster the credibility of his paper.
“Many journals will only contact the lead author on a paper, and that's something that might be considered as a reform,” said Valerie Gutmann, a faculty member at Seton Hall University School of Law's Center for Health & Pharmaceutical Law & Policy.
The Kuklo case also screams for more transparency in medicine, she said, from companies disclosing relationships with academic researchers to journals demanding such disclosures. Since the Kuklo affair, Grassley's investigation has continued, including the identification of David Polly, MD, a University of Minnesota spine surgeon who received nearly $1.2 million in consulting fees from Medtronic over 5 years.
No one is accusing Polly of fraud like that potentially in the Kuklo case. Nevertheless, both affairs clearly indicated that more reform is needed to cleanse the relationships between physicians, medical companies and academic journals.
“What has transpired here has profound consequence to all who are involved,” Atwood wrote in the Kuklo report. “When something like this happens there are no winners, nevertheless this can be a moment for learning, reexamination and renewal.”
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