Medtronic Reveals Massive Payments to Doctor Accused of Falsifying Medical Research

Michael Phelan — Thu, 18 Jun 2009 16:02:51 GMT

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.

Originally posted at InjuryBoard by Michael Phelan

"All-Hands Meeting" Called At FDA To Discuss Lax Medical Device Oversight

Michael Phelan — Tue, 28 Apr 2009 11:20:27 GMT

Nine scientists signed letters to President Obama charging that Food and Drug Administration officials had acted illegally and that patients were routinely put at risk by unsafe medical devices approved by the FDA for sale despite significant and often unanimous objections from scientific reviewers at FDA. These scientists sent many e-mails to the FDA's prinicpal deputy commissioner, seeking his intervention, but the deputy commissioner, Joshua Sharfstein, M.D., replied that he was "already burning the candle at both ends to keep up with his job." The nine dissident scientists sent an extensive memorandum to Dr. Sharfstein charging that the "regulatory review process for medical devices has been severely distorted" and that those who raised concerns about unsafe devices had been retaliated against by agency managers.

Amond the devices alleged to have been approved inappropriately are imaging equipment for detecting breast cancer and an orthopedic knee device. The FDA also allowed hospitals to wash and reuse sterile surgical devices intended for just one use. Sounds like a great idea in this era of MRSA and other deadly bacteria and viruses. Undue influence from the device manufacturers is no-doubt a cause for some of these inappropriate approvals. The other reason is captured in Dr. Sharfstein's above-cited quote- the agency is too understaffed to do its job; hence it relies too much on safety and efficacy information provided by the drug and device manufacturers. The fox has been allowed to guard the chicken house. This is why preemption arguments are such a joke. When Newt Gingrich introduce the Contract With America, it contained a provision to turn the FDA over completely to the drug and device industry and let them regulate themselves. Thank God that did not happen.

There are signs that the FDA may take steps to kick the fox out of the chicken house. On April 10, Donna-Bea Tillman, director of the FDA's office of device evaluation, announced an "all-hands meeting" of all scientists within the office to discuss the strategic direction of the device center. This would be the first meeting of its kind in years. Under the previous administration, meeting time was awarded to industry lobbyists rather than the scientists charged with evaluating safety.

Originally posted at InjuryBoard by Michael Phelan

Richmond Virginia Personal Injury Lawyer - Medical Devices

Medtronic Reveals Massive Payments to Doctor Accused of Falsifying Medical Research

"All-Hands Meeting" Called At FDA To Discuss Lax Medical Device Oversight