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Sept, 10, 2012

Letter Recommends Independent Investigation of NIH’s Failure to Promptly Disclose Superbug Outbreak at Research Hospital

Patients, Public Health Officials and Public Kept in the Dark

WASHINGTON, D.C. – The Department of Health and Human Services (HHS) should open an independent investigation into the National Institutes of Health’s (NIH) handling of information related to a deadly outbreak of multi-antibiotic-resistant Klebsiella bacterial infections at the research agency’s hospital facility known as the Clinical Center, in Bethesda, MD, Public Citizen said today in a letter addressed to HHS secretary Kathleen Sebelius.

The outbreak, which reportedly started in June 2011 and lasted through December 2011, was not announced to the public until August 22, 2012. In addition, the Maryland health department was not notified until December 2011, despite a state law requiring that such outbreaks be reported. The NIH’s failure to promptly inform all potentially affected patients, public health authorities and the public-at-large raises troubling concerns, the letter said.

Public Citizen urged HHS to seek answers to the following questions, among others:

• Why did the NIH fail to publicly disclose this deadly outbreak for one year after having evidence that the outbreak stemmed from a single source and after new cases of the superbug infection began to occur at a rate of approximately one per week?

• Once the NIH recognized the seriousness of the outbreak, why didn’t it mandate that all patients already admitted or being considered for admission to the Clinical Center be informed of the risk of exposure to the deadly Klebsiella superbug?

• Why did the NIH fail to promptly notify the Maryland health department and Montgomery County public health officials about the Klebsiella superbug outbreak?

The August 22 press release announcing the outbreak coincided with the release of a scientific paper in the on-line edition of the journal Science Translational Medicine that examined how NIH scientists used sophisticated bacterial genome sequencing techniques to track the spread of the infection from patient to patient.

“The timing of the belated NIH announcement was not determined by any public health considerations or the need to inform the public about this dangerous health threat,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, “but rather by the desire to give itself a self-congratulatory pat on the back. This represents an egregious violation of a duty the NIH had to inform all potentially affected patients, public health authorities and the public at large about such threats.”

Public Citizen is also asking HHS to investigate the NIH’s preparedness for ensuring prompt disclosure and reporting of future outbreaks. The letter requests information on whether the NIH has now established formal policies for communicating information about such an event in the future.

“Unless a plan is in place for timely dissemination of information about this kind of potentially deadly outbreak, patients considering participation in clinical studies that may involve hospitalization at the NIH Clinical Center cannot weigh the risk of exposure to a superbug infection against the potential benefits of participation,” Carome said.

To read the letter, visit http://www.citizen.org/hrg2070.

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