November 6, 2019

Why did FDA wait 6 weeks to tell the public about an E. coli outbreak?

Daily Briefing

    An E. coli outbreak tied to romaine lettuce infected 23 people between July and September of this year, and while CDC and FDA learned the source of the outbreak in early October, FDA just announced the outbreak publicly for the first time last week.

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    Background

    Two major E. coli outbreaks in the United States last year sickened hundreds of people across the country.

    An E. coli outbreak in March 2018 sickened 210 people across the United States and killed five people, the Washington Post reports. The outbreak was eventually linked to romaine lettuce grown in Arizona, and CDC officials warned consumers to avoid eating lettuce from the Yuma, Arizona area.

    Then, in November 2018, people in 11 states were sickened by a strain of E. coli linked to romaine lettuce. CDC in November 2018 issued a warning that U.S. residents should not eat any romaine lettuce from the United States.

    The delayed announcement

    FDA last Thursday announced that a new E. coli outbreak sickened 23 people across 12 states between July 12, 2019, and Sept. 8, 2019. Eleven people affected by the outbreak were hospitalized but no deaths were reported, according to an FDA release.

    CDC alerted FDA of the outbreak in mid-September and on Sept. 19 officials had found initial evidence that lettuce was the source of the outbreak, according to Brian Katzowitz, a health communication specialist at CDC. The agencies officially determined romaine lettuce was the cause of the outbreak on Oct. 2 and FDA alerted the public of the outbreak on Oct. 31.

    FDA last week said the agencies delayed the announcement about the outbreak because by the time the agencies identified romaine lettuce as a likely source, there was nothing "actionable" for consumers to do to prevent infection. FDA said the infected lettuce had already been taken off the shelves. 

    "When romaine lettuce was identified as the likely source of the outbreak, the available data at the time indicated that the outbreak was not ongoing and romaine lettuce eaten by sick people was past its shelf life and no longer available for sale." Officials said the outbreak has no ongoing risk to public health.

    Reaction

    According to Katzowitz, agencies have a "few variables to consider when posting an outbreak," adding that CDC generally only "posts outbreak warnings when there is something actionable for consumers to do."

    Although this year's outbreak did not have any actionable information for consumers, an FDA spokesperson told The Hill that the agency publicized the information "to ensure full awareness by the public."

    The spokesperson added, "FDA and CDC's proactive sharing of information in this incident in a more timely manner in this particular case is part of our ongoing commitment to transparency. We also intend to follow up with the more traditional communications tool at a later date."

    But some took issue with the agencies' delay, the Post reports.

    Bill Marler, a food safety lawyer, said it was negligent for the agencies to delay the public announcement about the outbreak, especially since more than 75,000 people in the United States are infected with E. coli each year, often due to similar outbreaks.

    "All of those outbreaks share the same fact pattern as this one—the only difference is they decided not to tell us about this one," Marler said, referring to the outbreaks in 2018. "If I eat romaine lettuce, and I found out romaine lettuce poisoned 11 people and put them in the hospital, I may not want to eat romaine lettuce," Marler said. "It's a lie to the public in all respects" (Brice-Saddler, Washington Post, 11/1; Mohan, Los Angeles Times, 11/1; Bowden, The Hill, 11/4; Associated Press, 11/1; FDA release, 10/31). 

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