“It is Imperative that FDA Take Immediate Steps” to Fix the Broken Review System for Medical Devices

The figure is staggering, the implications sobering. Senator Charles Grassley has revealed that a prominent University of Wisconsin researcher and surgeon has received $19 million over five years from Medtronic, one of the country’s largest medical device manufacturers. Sen. Grassley is investigating potential conflicts of interest in medicine.
As part of a growing movement for more detailed disclosure of financial ties between doctors and industry interests, Sen. Grassley has written to the president of the University of Wisconsin. The letter details that the fees the medical device manufacturer paid to the university’s lead researcher to promote that company’s spinal products were far above the “over $20,000” the doctor reported to the university. The president of the Association for Medical Ethics commented that the University of Wisconsin and other educational institutions have insufficient policies regarding staff doctors’ payment by outside interests. According to Charles Rosen, MD, “the public has a right to know exactly how much doctors are paid by medical device companies.”
The revelation comes just as the Government Accountability Office (GAO) is reporting back to Congress regarding the FDA’s approval of 228 medical devices that did not receive a full scale review from 2003 to 2007. According to Public Citizen, the devices include an external defibrillator to assist heart attack victims, which has been recalled due to malfunctions.
Nine FDA scientists wrote the Obama transition team the week of January 5 to complain that a “corrupted” review process is putting public health at risk. The New York Times reported that while the company and the FDA knew of faulty devices, often the doctor and the patient were deliberately “kept in the dark” in order to protect the company’s trade secrets.
Many believe the process became corrupted after Congress set up a three-tier classification system for medical devices in 1976. Manufacturers could circumvent the lengthy and expensive FDA review process by convincing the FDA that their devices were substantially equivalent to their precursors. The GAO report urged the FDA to promptly resolve the problem. However, while they acknowledge the problem, the FDA has failed to set a timetable to resolve it—and this lack of rigorous review puts Americans at risk.
It is time to completely overhaul every part of the FDA. AAHF and other organizations have banded together to persuade the American public and Congress that a total reform of the FDA is absolutely necessary. We must to rebuild the American healthcare system and once again make it the envy of the world. Visit www.ReformFDA.org to sign the petition and learn more.