Dear Members, The New York Times reports yet another “paid expert” caught forging drug company research reports. This time the hammer falls on a former surgeon from Walter Reed Army Hospital, Dr. Timothy Kuklo, an associate professor of orthopedic surgery and the guilty party in this report. Dr. Kuklo forged names and appended them to a published journal article which falsified research data conducted on U.S. soldiers to support exaggerated claims about the effectiveness of Infuse, a bone- growth product made by Medtronic which is already under investigation for false claims and off-label marketing. Not surprising, Medtronic was a company with whom Dr. Kuklo had significant undisclosed financial ties, and this time a separate 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. However, despite the report, 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 peer review British publication, the Journal of Bone and Joint Surgery, that published the fraudulent article later retracted it, but neither the University nor Medtronic had taken any disciplinary action against Dr. Kuklo.
In response to an inquiry from U.S. Senator Grassley (Sept. 2008) Medtronic provided him with a partial list of outside doctors who were listed as paid consultants for the Infuse drug. Dr. Kuklo, who has personally conducted about 15 paid presentations for Medtronic about the product, was interestingly NOT on that list.
In response to an inquiry by the NY 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!
Not easily satisfied with Medtronic’s dubious reply Sen. Grassley is now demanding much more detailed information from Medtronic – including all undisclosed financial arrangements between the company and academic faculty.
The company since has announced its “disengagement from Dr. Kuklo,” a graduate of West Point, the University of Connecticut medical school and Georgetown Law Center.
Given the serious and potentially criminal 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 more aggressive investigation headed by Sen. Charles Grassley brought pressure to bear, speaks volumes about a pervasive culture of arrogance in the drug company “sponsored” academia.
The University of Washington did not see fit to take action until Friday, May 22, when a spokesperson there indicated that Dr. Kuklo would take a leave of absence from the University.
How many of these incidents of falsifying study results, drug company payola and massive criminal and class action settlements need to be revealed before the FDA is jarred out of its complacent support and lack of real oversight of the pharmaceutical industry?
I say, we already passed that number!
What do you say?
All the best,
Rudi C. Loehwing Managing Director World Institute of Natural Health Sciences www.winhs.org