Feds fiddle while superbugs spread
Seven patients at Ronald Reagan UCLA Medical Center contracted a deadly superbug from an utterly routine medical procedure. Two have died. A third, an 18-year-old boy, fights on for his life after 83 days in the hospital, mostly in intensive care.
All this suffering was preventable. If the CDC and the FDA had alerted UCLA and other hospitals about medical equipment they knew was contaminated, patients would not have been put at risk. The agencies had already watched the same lethal problem unfold in Chicago, Seattle and elsewhere, but they swept it under the rug.
Imagine having a long flexible tube with a camera on the end threaded down your throat to treat gallstones, ulcers and the like, something half a million patients undergo every year. You assume it’s clean. But these reusable devices — a special type of endoscope — have a design flaw that prevents thorough cleaning. The result is that germs lurk inside the device. That’s what happened in L.A., where as many as 179 patients were exposed to a particularly deadly germ called carbapenem-resistant bacteria. The CDC nicknamed it “nightmare bacteria” because few if any antibiotics work against it, and close to half the patients who get it die.
UCLA didn’t start using the defectively designed scopes until June of 2014. That’s six months after the CDC knew that 91 patients in a suburban Chicago hospital had fallen victim to the same problem. The CDC responded to the Chicago outbreak with secrecy and inaction, doing nothing more than issuing a report in January of 2014 that conspicuously omitted the model number or manufacturer of the scope. At the time, I called the CDC to press them and was told it was the Pentax 3490 TX, information doctors and hospitals everywhere should have had. The report also referred to “hospital A” instead of naming the Chicago-area hospital and never mentioned that some infected patients died.
What did the CDC recommend in response to the Chicago outbreak? It lamely suggested that any other hospital experiencing an outbreak “should consider the possibility of endoscopic transmission.” That’s not prevention, just after-the-fact explanation. So hospitals are supposed to wait until after patients get sick and then look at their medical devices? That’s crazy.
The CDC also stifled news about an outbreak in Seattle, where 32 patients at Virginia Mason Medical Center contracted the same superbug from similarly contaminated scopes from 2012 to 2014. There, 11 patients died.
Just as troubling, the FDA — supposedly responsible for the safety of medical equipment — stayed mute as these outbreaks popped up across the country. For three years, that agency has been sitting on at least 75 reports of patients endangered by these contaminated devices.
Finally, this January the FDA made the underwhelming announcement that the problem is “on the agency’s priority list for guidance documents we intend to publish in 2015.” It noted that “effective cleaning of all areas” of these devices “may not be possible.” Too little too late for the victims in L.A. and elsewhere.
The agency now says it’s working with the three manufacturers — disclosed as Pentax, Olympus and FujiFilm — on a solution. In the meantime, it issued a stunning statement that the benefits of the procedure outweigh the risks of infection. Really? That should be for patients and their doctors to decide. The FDA had an obligation to inform them of the risk. It failed big time. Our FDA and CDC bureaucrats have a lot of explaining to do to the families grieving in L.A. right now.
Superbugs are making it increasingly dangerous to go to a hospital. The New York area has been the epicenter for this carbapenem-resistant “nightmare bacteria” for over a decade. Hospitals here are plagued with it. That’s bad enough, but when government health agencies dawdle and obfuscate, the risks to patients increase. We’ve seen it at the Veterans Administration, and now we’re seeing the same pattern of deception and bureaucratic dysfunction at the CDC and the FDA. Like at the V.A., heads should roll to excise the rot.
Betsy McCaughey is a senior fellow at the London Center for Policy Research and author of “Beating Obamacare 2014.”