February 22, 2016
As superbug outbreaks raised alarm across the country last year, a prominent doctor at a Philadelphia cancer center wrote in a leading medical journal about how to reduce the risk of these often-deadly patient infections.
Dr. Jeffrey Tokar, director of gastrointestinal endoscopy at Fox Chase Cancer Center, pointed to recent outbreaks from contaminated medical scopes and discussed steps doctors and hospitals should take to ensure patient safety in his Sept. 22 article in the Annals of Internal Medicine.
“Health care facilities and providers should strive to establish an environment of open information exchange with patients about what is being done to maximize their safety,” Tokar and his two co-authors wrote.
What Tokar didn’t mention was that a tainted device at his own cancer center may have infected three patients with drug-resistant bacteria. In accordance with federal rules, the hospital reported the possibility to the manufacturer, Fujifilm, in May 2015, and the manufacturer filed the information with U.S. regulators.
But the public was none the wiser. The information only came to light last month when a U.S. Senate committee unveiled the results of a yearlong investigation into scope-related infections that sickened nearly 200 patients across the country from 2012 to 2015, including those potential cases at Fox Chase in Philadelphia.
The incident in Philadelphia illustrates a larger problem, experts say: a lack of public disclosure when medical devices are suspected of posing a risk to patients.
“This culture of secrecy is not in patients’ best interest,” said Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pennsylvania. “Hospitals don’t realize the more transparent they are, the more infection risks would decrease. It looks like important information was missing from this paper” by the Fox Chase doctor.
Tokar, who has identified himself as a paid consultant to the scope manufacturer, didn’t respond to requests for comment. A spokeswoman for Fox Chase also declined to answer questions.
Dr. Michael Kochman, one of Tokar’s co-authors and a gastroenterologist at the University of Pennsylvania Health System, said he wasn’t aware of the Fox Chase incidents while working on the journal article. Had he known, he said, he would have published some of the details.
“I can’t directly fault my co-author. I don’t know what Dr. Tokar knew when,” Kochman said. “I would hope we would be able to add a personal experience comment within the paper if any of us had known we had dealt with the issue. It helps others on how to approach it and deal with it.”
Under current federal rules, hospitals must report serious injuries potentially caused by devices to the manufacturer within 10 business days and notify both the manufacturer and the FDA about any suspected device-related deaths. Manufacturers are required to file reports to the FDA within 30 days of learning about an injury or death that may have been caused by a device.
Senate investigators said the present system fails patients because it ignores “the reality that manufacturers and health-care providers have strong competing priorities that weigh against rapid and robust disclosure, such as moving new products to market quickly and avoiding costly litigation.”
Fox Chase did follow federal rules and notify the scope manufacturer. In response, Fujifilm sent employees to the medical center to learn more and ultimately the company quarantined the scope.
But the cancer center — and its GI endoscopy chief — made no public disclosure of the incident, nor were they legally required to. It’s not known whether the three unidentified Fox Chase patients mentioned in the federal injury report were told that a bacteria-laden scope may have caused their antibiotic-resistant infection. The infections can kill up to half of affected patients, though the fate of the three at Fox Chase could not be determined.
Across the country, there is no easy way for the public to learn about where such infections are occurring. In fact, the FDA says it is bound to keep the names of hospitals and other medical providers who report them confidential.
“The Food, Drug and Cosmetic Act prohibits the public release of the identity of the user facility that submits a medical-device adverse event,” agency spokeswoman Deborah Kotz said.
As a result, the agency redacts the names of hospitals and other medical facilities from its public database of “adverse-event” reports. Fox Chase was identified only because the Senate report published additional documents that did name the hospitals involved.
It’s standard practice for federal and state health officials to keep outbreak information confidential. Regulators say it encourages hospitals to be forthcoming and quickly report adverse events.
Kochman said those rules also are beneficial because it often takes time to determine what sickened patients, and immediate public scrutiny could do more harm than good.
“Confidentiality encourages reporting,” said Kochman, chairman of the American Gastroenterological Association’s Center for GI Innovation and Technology. “There are early warning signals but one has to be careful not to scare the public. Within 30 days of an event, it may not be known if an infection was truly related to a device.”
The medical detective work involved in these cases can be complicated. Some hospital officials told Senate investigators they didn’t see a need to report their superbug infections to manufacturers until they were conclusively linked to the scopes.
But the Senate report said hospitals were applying too high a standard and waiting too long to share important details.
The investigation, launched by Sen. Patty Murray, D-Wash., after superbug outbreaks in Seattle, Pittsburgh and Los Angeles, also faulted manufacturers for failing to fully comply with federal reporting requirements.
Asked about the Fox Chase incident, a spokeswoman for Fujifilm declined to comment on the hospital or the company’s report to the FDA.
“We are committed to working together with all stakeholders, including hospitals, regulators and lawmakers, to ensure the long-term sustainable use of duodenoscopes,” the company said in a statement.
Tokar and Fox Chase have worked closely with Fujifilm for years.
In October, a month after his article on the scopes, Fujifilm touted Tokar as an industry expert in a company press release and said he was leading a hands-on workshop for doctors at a medical conference in Honolulu where the company also pitched its products.
In 2014, Tokar received $6,366 from Fujifilm for travel and lodging in Tokyo, where the company is based, according to a federal database on industry payments to doctors and teaching hospitals. Temple University Hospital, which is affiliated with Fox Chase, also received $134,697 from Fujifilm that same year for consulting work.
In 2010, Fujifilm announced a five-year research and development deal with Fox Chase for endoscopy products. The company hailed its partnership with “one of the most prominent cancer prevention and treatment facilities in the United States.”
Academic medical centers say patients benefit from these industry ties because they can lead to medical breakthroughs. But critics say it can create conflicts of interest and make hospitals hesitant to share information that reflects poorly on an industry partner.
Consumer advocate Helen Haskell, founder of Mothers Against Medical Error in Columbia, South Carolina, said patients deserve to know all the available facts so they can make an informed decision on where to seek care.
Haskell also said outside pressure is necessary to force hospitals to tackle problems more urgently.
“Patients could be walking into a potentially fatal situation,” she said. “It’s time for everything to be on the table.”
This story was produced by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.