CDC had past missteps with Zika
Four years before the federal Centers for Disease Control and Prevention fumbled the nation’s chance to begin effective early testing for the novel coronavirus, the agency similarly mishandled its efforts to detect another dreaded pathogen.
Amid a feared outbreak of the newly emerged Zika virus, senior CDC officials in 2016 sidelined an effective test for it — and instead directed public health laboratories nationwide to use a more complicated test that failed about one-third of the time.
The agency’s response to Zika now stands as an unheeded prequel for how the CDC stumbled this year as it confronted the coronavirus pandemic, which has claimed more than 125,000 lives nationwide.
Both Zika and the coronavirus originated overseas and became American health emergencies that have challenged the CDC’s ability to carry out its fundamental mission to rapidly identify and contain newly arrived pathogens.
In both emergencies, the CDC pressured the public health labs to shelve the effective tests and to use less reliable test kits manufactured by the agency that sought to detect multiple pathogens. The agency stood behind the troubled test kits despite internal data indicating they were flawed. Ultimately, the CDC notified the public lab officials that they could switch to more effective tests.
With Zika, the CDC took nearly a year to change course. With the coronavirus, the agency took more than a month, delaying a nationwide rollout of effective testing as the malady it causes, COVID-19, erupted into the nation’s most deadly infectious disease in a century. Clinicians and public health officials believe the delay caused additional deaths, although the total number is uncertain.
The component of the CDC’s coronavirus test kits that was designed to detect strains other than SARS-CoV-2 became contaminated during manufacturing at the agency in January, causing false-positive results at 24 of 26 labs that first tried out the kits, the Washington Post revealed in April. The CDC waited until Feb. 28 before dropping the problematic “pan-coronavirus’’ segment from the kit — while the public labs were blocked from using an effective test made available in mid-January by the World Health Organization.
The parallels in how the CDC responded to the two health crises emerge from a Washington Post examination of federal investigative and regulatory records, congressional testimony, CDC emails and documents, and interviews with scientists and other technical experts.
“It’s painful to watch the same challenges again and again,’’ said Timothy M. Persons, who has reviewed the efforts to counter Zika and the coronavirus as chief scientist of the U.S. Government Accountability Office. “As I think we saw with Zika, we need to apply lessons learned to definitely try and respond better.”
An audit that Persons led three years ago for the government faulted CDC leaders for not being more rigorous in evaluating the troubled test for Zika.
Reliable early testing “is a critical piece of the overall preparedness and response system,” Persons said in an interview.
President Donald Trump and his appointees have generally praised the administration’s response to the coronavirus. But a review released on June 19 by the Department of Health and Human Services said that CDC officials — despite seeing worrisome “anomalies” — skipped standard quality control checks before distributing the test kits for detecting the nation’s earliest cases of the virus. The review also confirmed that the kits were “likely” contaminated during the CDC’s manufacturing.
Robert S. Lanciotti, a virologist who headed the CDC’s diagnostic efforts with Zika until May 2016 — when the agency stripped him of his leadership role after he warned against distributing the deficient test kits — said the decision-making with the coronavirus mirrored what he witnessed.
“This is exactly the same mistake I saw during Zika,’’ Lanciotti said in interviews with the Post.
Lanciotti said that by shelving effective tests in favor of less reliable approaches, CDC officials “slowed things down and screwed things up.’’
As reported in the Post in 2016, Lanciotti had raised concerns then that the CDC’s preferred Zika test missed infections and that the agency withheld information about its deficiencies from local lab officials.
CDC officials did not respond to questions for this article.
On Saturday, an HHS spokeswoman, Caitlin Oakley, said the government at no point blocked the public health labs “from using any other” available test for the coronavirus. Representatives of the labs, however, have complained that then-existing regulations tethered them to the CDC’s troubled test.
Former CDC Director Tom Frieden, who led the agency’s efforts against Zika in 2016, praised its overall performance with that virus and defended the decisions made with the Zika test.
“Any test can get improved with time,” Frieden said. “And any action can be looked back on . ... In the course of refining the test, you expect it to get better with time.”
In June 2007, the CDC first dealt with Zika when the agency’s diagnostic lab in Fort Collins, Colo., received blood samples from physicians in Yap state, a cluster of tiny Pacific islands about 500 miles east of the Philippines in the Federated States of Micronesia. The island doctors suspected that an epidemic of rashes, eye redness and joint pain had been touched off by disease-carrying mosquitoes.
At the time, Lanciotti was chief of the lab, which specialized in diseases spread by mosquitoes and ticks.
Using a well-established molecular testing technique called polymerase chain reaction, or PCR, Lanciotti and his colleagues discovered that the epidemic in Yap was caused by the Zika virus. Lanciotti also developed a separate enzymebased test, which showed whether a person’s blood carried Zika antibodies, another sign of infection.
His lab continued to use those tests on Zika samples as small outbreaks emerged in the coming years elsewhere in the Pacific, still thousands of miles from the U.S. mainland.
The CDC’s concern rose by late 2015, after Zika infections were detected widely along the northern coast of Brazil. This marked Zika’s first confirmed appearance in the Western Hemisphere — and the stakes were made more urgent by mysterious clusters of microcephaly, a birth defect that left newborns with tiny heads.
In December 2015, Lanciotti began distributing instructions for how to conduct the molecular test, which his team was already using, to public health labs in 21 states and the District of Columbia, along with several counties, records show.
A top priority, Lanciotti recalled during recent interviews, was to prevent Zika’s spread in the United States by likely hosts — including infected airline passengers returning from the 2016 Summer Olympics in Rio de Janeiro. If an infected person were bitten by a mosquito, Zika might spread to whomever the insect next found. Zika, he knew, could also be transmitted sexually.
“When this hit in 2015, we weren’t taken by surprise,” Lanciotti recalled. “We had testing in place . ... We knew there would be travelers returning, potentially infected with Zika.”
Lanciotti said the CDC did not manufacture the Zika test kits, but told others how to build them.
By early 2016, CDC scientists based in Puerto Rico and at agency headquarters in Atlanta saw the emerging Zika crisis as an opportunity to deploy a new — and more elaborate — approach to detecting the virus.
Instead of using the molecular test to look only for Zika, they would also target five additional pathogens: chikungunya virus and four strains of dengue fever. The new test, referred to by scientists as an “assay,” was called “Trioplex,” and was intended to provide convenience for labs that wanted to look simultaneously for Zika and the other pathogens.
The portion of the Trioplex test targeting the four strains of dengue fever was known as the “pan-dengue” component. Four years later, the CDC would complicate its SARS-CoV-2 test with the “pan-coronavirus” component, designed to search for additional coronavirus strains.
Unlike Lanciotti’s test, the CDC would manufacture and distribute the Trioplex test kits, each with 41 pages of instructions, versus two for Lanciotti’s concise protocol.
On March 17, 2016, the Food and Drug Administration, which regulates some disease tests, granted the CDC an emergency use authorization for Trioplex, signifying it “may be effective.” The CDC then directed public health labs to use the test for Zika, records show.
A senior CDC official who was involved with the Zika response from the outset said the agency did not take “enough time to evaluate” Trioplex before distributing it.
“We made a bad decision with this Trioplex,” said the official, who spoke on the condition of anonymity because they were not authorized to comment publicly. “We already knew how to diagnose for Zika virus. We already had the tests, which were developed in Rob Lanciotti’s lab.”
Lanciotti, meanwhile, was conducting his own studies in early 2016 on the reliability of Trioplex.
In mid-April, Lanciotti sent emails to a handful of senior CDC colleagues, reporting that analyses performed on patient samples in his lab found that “Trio misses 30-39 percent of the Zika positives.”
One of the email recipients, Ronald M. Rosenberg, CDC’s associate director of vector-borne diseases, suggested informing the state labs.
But On May 17, 2016, Rosenberg informed Lanciotti that the agency was stripping him of his duties as lab chief, but Rosenberg relayed no reason for the demotion, according to Lanciotti.
Within days, Lanciotti filed a whistleblower complaint with the U.S. Office of Special Counsel. In his complaint, Lanciotti alleged that the CDC had endangered public health by withholding the data about Trioplex’s sensitivity. He spoke recently about the issue with the Project on Government Oversight.
On July 1, 2016, the special counsel’s office, which protects federal employees who reveal potential wrongdoing, determined there was a “substantial likelihood” that Lanciotti’s allegations were credible.
Special counsel Carolyn N. Lerner contacted the CDC to recommend Lanciotti’s reinstatement as lab chief, according to people familiar with the matter. The CDC promptly restored Lanciotti’s title — but continued to exclude him from the agency’s response to Zika.
On Jan. 12, 2017, 10 months after the rollout of Trioplex, the CDC informed users of the test that they could discard the non-Zika components of Trioplex. This essentially reduced Trioplex to the original Singleplex test.
In the end, Zika did not inflict widespread harm within the United States.
Reported Zika infections — mostly among returned travelers — totaled 5,168 in 2016 before declining to 452 in 2017, 74 in 2018 and just 22 last year, according to CDC records and interviews.
Lanciotti retired in December 2018, after 29 years with the CDC.