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Editorial: Hard questions for the FDA

BY DI EDITORIAL BOARD | FEBRUARY 24, 2015 5:00 AM

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Last week, news broke that U.S. Food and Drug Administration has known about the dangers of unsafe medical devices in use at a medical center in Los Angeles and elsewhere for several years, but hadn’t made any recommendations for different safety requirements or cautioned against their use.

The revelation has called into question the FDA’s regulatory practices and has roiled the UCLA Ronald Reagan Medical Center, where 179 patients have been exposed to pathogens as a result of the devices. Hospitals in Seattle, Pittsburgh, Chicago, and other areas have also reported cases of infection.

In 2013 and 2014, the FDA reportedly received 75 reports of harmful effects associated with the reusable devices, known as duodenoscopes. Inserted down the throat, the devices are used to examine the part of the throat from which it gets its name, the duodenum. The trouble comes when they are reused. Over time, bacteria gradually accumulate on the devices, and they have proven resistant to conventional cleaning and antibiotics.

Yet even with this defect well known, neither the FDA nor the manufacturers (Olympus Corp., Pentax, and Fujifilm Holdings Corp.) had publicly acknowledged the issue until the news broke. The Daily Iowan Editorial Board believes this is problematic and a sign that the FDA may need to be subjected to additional oversight.

The issue, known as the “superbug” outbreak, has drawn attention in Congress. Rep. Ted Lieu, D-Calif., has requested a congressional committee hearing to investigate the devices and the drug-resistant bacteria that can gather on them.

In a letter to Congress, Lieu wrote that the cost of Enterobacteriacae outbreaks could rise if left unchecked and threaten the lives of not just the patients who were exposed to the bacteria but also friends, family members, and hospital staff who interact with them.

This is certainly not the first time the FDA’s procedures have been called into question. A 2009 New York Times editorial detailed various times the agency has failed to inform the public of potentially deadly effects of drugs or medical devices under the agency’s purview. That includes a diabetes drug and a painkiller that increased risk of heart attacks and antidepressants that increased suicidal thoughts and behavior in teens.

In 2007, the FDA voted to keep the diabetes drug Avandia on the market despite the acknowledgement of an FDA panel that the drug had a significant role in raising the risk of heart attacks. David Graham, an FDA drug-safety officer, estimated that the drug has led to the deaths of more than 80,000 people.

It is true that the FDA is under certain pressure from the medical industry to withhold certain information that could threaten trade secrets and internal reports. Yet it has demonstrated a pattern for going above and beyond those restrictions, sitting on data that clearly show risks in certain procedures or drugs.

We believe this is dangerous and antithetical to the mission of the regulatory agency. Congress should raise these issues in an oversight hearing. The American public deserves to know how the FDA’s practices affect them.


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