A former military surgeon accused by the Army of falsifying a medical journal study involving one of Medtronic’s products received approximately $800,000.00 from Medtronic between 2001 and 2009, according to information released on Wednesday by the company. Medtronic said the payments to Dr. Timothy R. Kuklo were reimbursement for travel expenses, speaking engagements, training other doctors or other consulting services. The Justice Department is currently investigating whether Medtronic paid doctors like Dr. Kuklo to help market medical devices for unnaproved uses.
The surgeon, Dr. Timothy R. Kuklo, claimed in the study that the use of a Medtronic bone growth product called Infuse had proved highly beneficial in treating leg injuries suffered by American soldiers in Iraq. The British medical journal that published the article retracted it this year after an internal Army investigation found that Dr. Kuklo had forged the names of four other doctors on the study and had cited data that did not match military records. Other doctors at Walter Reed Army Medical Center, where Dr. Kuklo worked until August 2006, said that he had also overstated the benefits of the Medtronic product.
Medtronics is under investigation by the Justice Department and Senator Charles Grassley, Republican of Iowa, in connection with possibly illegally marketing of Infuse through outside physicians like Dr. Kuklo who work for it as consultants. The company has denied doing so. Last month, it suspended Dr. Kuklo’s consulting contract. In information released on Wednesday, Medtronic said that it made about $788,280 in direct payments to Dr. Kuklo between 2001 and 2009. It described those funds as either reimbursement for travel expenses, or payments for speaking or training other doctors on Medtronic’s behalf, or for consulting. The company said that those consulting services included working on the design of new or existing orthopedic products and surgical instruments.
It is legal for military doctors to receive payments from medical products companies, but they are supposed to seek permission from officials. Army officials have said they have not found records to indicate that Dr. Kuklo sought or received such clearance.
Those who still support the concept of preemption for medical device manufacturers need to explain to the rest of us how the FDA is supposed to protect patients from this ubiquitous greed. Studies and clinical trials used by the manufacturers to gain approval of devices and drugs are sometimes rigged and the medical literature is sometimes ghost-written by industry insiders. The FDA is under-staffed and underqualified to root out this corruption. The primary examples of this type of corruption being exposed are private lawsuits.