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July 25, 2012 / Admin

Lawmaker Wants FDA to Probe Doctor Payments; Medtronic Recall Update

Is there a conflict of interest when a doctor testing a medical device manufacturer’s products before they are approved by the FDA has received compensation from the manufacturer? Does it depend on the type of payment involved? Senator Charles Grassley wants the FDA to explore this issue. On November 1, Propublica reported that Senator Grassley, R-Iowa, has asked the Food and Drug Administration to outline the circumstances in which such payments could present “too significant a conflict” for a physician to be involved in clinical studies of a medical device.

Just like drugs, medical devices have to be tested in clinical trials before they are approved by the FDA for use. These studies may be carried out by doctors who have been paid by the company that developed the product for speaking, consulting, or conducting research.  According to a letter he wrote to the FDA, Senator Grassley is concerned that such payments create a conflict of interest for the doctor. His concerns apparently stem from disclosures by medical device manufacturer Medtronic about compensation paid to its consultants and clinical investigators.

According to the Propublica report, Medtronic reported that it had paid individual physicians consulting payments ranging from $40,000 to $2 million. Other physicians received royalties, while one received Medtronic stock. Medtronic also disclosed information about more than 50 clinical investigators. Nearly all of these investigators received payments from Medtronic, while two of them reported having a “proprietary interest in the product tested and a financial arrangement where the value of compensation could be influenced by the outcome of the study.“ Medtronic insists that it is paying physicians fair market value for their work and that the company is committed to transparency.

Increased guidance on what exactly constitutes a conflict of interest would seem to be welcome. It certainly seems like it would be hard for a doctor to impartially conduct a study when he knows that the company paying him wants a certain result. And even harder to be impartial when the physician himself benefits from a certain result.

In related Medtronic news, the company’s recall of a tissue stabilizing device has been classified as a Class I recall by the FDA. A recall is classified as Class I when there is a “reasonable probability” that use of the product will “cause serious adverse consequences or death.”

The company initially recalled the Octopus Nuvo Tissue Stabilizer on September 14, 2010. The device is used to stabilize the heart during cardiac procedures. The recall was due to the potential that a component of the device could fracture during use, causing fragments to fall into the patient’s chest cavity and damage the heart tissue. Prior to the recall, the company received two reports that the device had fractured during use, but neither event resulted in permanent injury or death. Medtronic is working on retrieving the 571 devices that have been distributed to medical facilities worldwide.

Although it is lucky no one was injured by these malfunctions, some have pointed out that this kind of problem only makes a heart surgeon’s job harder. The last thing a doctor needs during a complex procedure is to worry about his equipment malfunctioning.

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