The CRE Infections: No One Warned the Patients

“I want to know what the hell is going on and I want to know right now,” Sheila Adamczyk said. “They had two deaths. They knew this had taken place.”

Sheila is talking about the endoscope-caused CRE, or carbapenem-resistant Enterobacteriaceae, superbug outbreak at the Ronald Reagan UCLA Medical Center this winter that killed 2 people, seriously infected 5 more, and put 179 other people on notice that they, too, might become infected.

informed consent 4Her worry is that her 16-year-old daughter, Bailee, whose recent cancer screening involved a scope similar to the ones involved in the outbreak at UCLA, is now at risk. The problem is, no one told her this could happen. Sheila learned about in news coverage and has been trying to reach her doctor ever since.

And this is the position approximately 500,000 people across the country find themselves in, the number of people who annually undergo the procedure.

But there’s an even deeper story. According to specialists like Dr. Andrew Ross, head of gastroenterology at Virginia Mason Medical Center in Seattle “You have to understand that this issue dates back to 2011 – 2012.”

For example, we saw the emergence of the CRE deadly pattern of illnesses in 2012 – 2013 at hospitals in Seattle (11 deaths, 32 infected), Chicago (38 infected) and Philadelphia (8 infected). In each case investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of patients to treat GI tract illnesses.

The agency responsible for oversight of these outbreaks, the U.S. Food and Drug Administration, also knew about them. In a March 4 letter from Congress to the head of the agency, demanding answers, they write: “It appears that the FDA has known for at least two years that the design of [endoscopes] could result in CRE outbreaks.”

Remarkably, the knowledge trail is actually decades long. “We have known about this even as early as 1983 or 1984,” says John Allen, of the Yale School of Medicine. In 1987, Allen wrote in an academic journal about 10 of his patients in Minnesota mysteriously becoming infected with a bacteria that they traced to a single endoscope.

And in this case, knowledge is power. Because in hospitals where outbreaks occurred they immediately fixed the problem, preventing any further infections.

For example, at Seattle’s Virginia Mason Hospital they put used scopes in quarantine for 48 hours after disinfecting and then retested them to make sure no bacteria had regrown before reuse.

So what we have here is everybody knew – the hospitals, the Feds, and the scientists – everybody, that is, except the patients.

The National Law Review, commenting on the pending CRE lawsuits in California and Pennsylvania, issued a clear warning: “Health care personnel should … thoroughly explain associated risks to patients when using reprocessed endoscopic devices.” (My emphasis.)

This is not only how you avoid lawsuits, it’s also how you keep innocent people like Sheila, young Bailee, and others across the country from feeling they were sucker-punched by a “nightmare bacteria.”

So now – and only now – are we seeing places like Cedars-Sinai Medical Center in Los Angeles, also the scene of a recent outbreak, issuing directives that physicians will discuss with the patient “the current unresolved national questions regarding [endoscopes] and CRE.”

While that may be a start, Lisa McGiffert, consumer advocate and director of the Safe Patient Project at Consumers Union in Austin, Texas, says this comes too late for some patients: “It’s really horrific to know so many people underwent these procedures when they could have known the danger beforehand,” she said. “They went in trusting the system, and the system broke down.”

It came too late for Lori (a nurse) and Glenn Smith, the adoptive parents of 18-year-old high school student Aaron Young. Aaron has been in the UCLA hospital since January, bedridden, trying to overcome his CRE infection. We know how Sheila Adamczyk feels because she told us. Here’s a picture of Lori and Glenn taken at their home last month.

How do they feel?

aaron 7

 

 

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