Experts Warn of Pandemic Risk as US Struggles with Avian Flu Testing

US Struggles with Avian Flu Testing

United States: The US government announced an avian flu-linked outbreak around three months ago, and the World Health Organisation has also announced that there is a high chance that this outbreak might change into a pandemic. But still, only 45 individuals have been testes against the infection across the United States.

“We’re navigating blindly,” stated Jennifer Nuzzo, head of the Pandemic Center at Brown University School of Public Health. With such minimal testing, she noted, it is impossible to ascertain the extent of farmworker infections or the severity of the disease. The dearth of testing implies the nation might remain oblivious if the virus begins transmitting between humans, potentially heralding another pandemic.

“We undoubtedly need more testing,” affirmed Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention. Currently, the CDC’s avian flu test is the sole test authorized by the Food and Drug Administration. Shah mentioned that the agency has disseminated these tests to approximately 100 public health laboratories across various states. “We have about a million tests available now,” he said, “and anticipate another 1.2 million within the next two months,” as per KFF Health News.

Nonetheless, Nuzzo and other researchers express concern as the CDC and public health labs are not typically the entities from which physicians requisition tests. That role generally falls to major clinical laboratories operated by corporations and universities, which lack authorization for avian flu testing.

As the outbreak intensifies — with 114 herds infected in 12 states as of June 18 — researchers criticize the CDC and FDA for not expediting the removal of barriers that impede clinical labs from conducting tests. In one instance, diagnostics company Neelyx Labs experienced a month-long delay in resolving a query.

“Clinical labs are integral to the public health infrastructure,” commented Alex Greninger, assistant director of the University of Washington Medicine Clinical Virology Laboratory. “Engage us. We’re sidelined,” Greninger added.

The CDC acknowledged the necessity of clinical labs in a June 10 memo, urging the industry to develop tests for the H5 strain of the avian flu virus, the strain circulating among dairy cattle. “Limited diagnostic test availability and accessibility for Influenza A(H5) presents several challenges,” the CDC wrote, highlighting the potential test shortage if demand escalates.

Researchers, including former CDC director Tom Frieden and Anthony Fauci, who spearheaded the nation’s covid response, attribute testing deficiencies as a significant factor in the US’s poor performance during the covid pandemic. They argue that the widespread availability of covid tests early in 2020 could have identified numerous cases before they escalated into outbreaks necessitating business closures and loss of life.

In a recent publication, Nuzzo and colleagues emphasized that the issue was not the capacity to test but the failure to deploy that capacity rapidly. The US reported excess mortality rates eight times higher than other technologically advanced nations.

By mid-January 2020, the WHO had validated a covid test. Instead, the US pursued its own multi-stage process, consuming several months. This involved the CDC developing a test, disseminating it to local public health labs, followed by the FDA authorizing tests from clinical diagnostic labs serving hospital systems, which then had to scale up their operations. This protracted process resulted in fatalities amidst outbreaks in nursing homes and prisons, awaiting test results, as outlined by KFF News.

Conversely, South Korea rapidly deployed testing via private sector laboratories, enabling it to keep schools and businesses operational. “They mobilized swiftly, recognizing the imminent need for extensive testing,” said Frieden, now president of the public health organization Resolve to Save Lives. “Engaging commercial entities was essential.”

Nuzzo and her team propose a detailed strategy for emergency testing deployment, learning from the covid missteps. However, in the current avian flu outbreak, the US lags behind this protocol.

Robust testing is crucial for two main reasons. Firstly, infected individuals need prompt diagnosis for timely treatment, Nuzzo explained. Over the past two decades, about half of the approximately 900 global bird flu cases have been fatal.

Although the three farmworkers diagnosed with the disease this year in the US exhibited only mild symptoms, such as runny nose and conjunctivitis, others might not be as fortunate. The antiviral medication Tamiflu is effective only if administered shortly after symptoms appear.

The CDC and local health departments have attempted to enhance avian flu testing among farmworkers, urging those feeling unwell to get tested. However, farmworker advocates point out several reasons for the ineffectiveness of these outreach efforts, including language barriers and concerns about job security.

Should farm-adjacent individuals seek medical attention when they or their children fall ill, these cases could be overlooked if doctors send samples to their usual clinical laboratories. The CDC has requested doctors to forward samples from symptomatic individuals with livestock or poultry exposure to public health labs. “If you work on a farm with an outbreak and are concerned about your health, you can get tested,” Shah said. However, sending samples to public health departments requires awareness, effort, and time.

“I am apprehensive about a testing system requiring busy clinicians to navigate this complexity,” Nuzzo expressed.

The second reason for involving clinical laboratories is to enable the nation to scale up testing if bird flu is detected in individuals who did not contract it from livestock. Although there is no current evidence of human-to-human transmission, this could change as the virus evolves.

To expedite clinical labs’ involvement, Greninger suggested allowing them to utilize the FDA-authorized CDC test. On April 16, the CDC facilitated this by offering royalty-free licenses for its bird flu test components to accredited labs, according to the reports by KFF Health News.

Several commercial labs have requested licenses. “We aim to be prepared before the situation escalates,” said Shyam Saladi, CEO of diagnostics company Neelyx Labs, which provided tests for covid and mpox during shortages. His recent experiences highlight the barriers preventing swift lab action.

In email exchanges with the CDC shared with KFF Health News, Saladi detailed the labs’ need for licenses and a “right to reference” the CDC’s data in their FDA application.

This “right to reference” allows a new company to bypass certain analyses done by the original developer by directing the FDA to review the original data. This approach was common with covid tests during the pandemic’s peak.

Initially, the CDC appeared cooperative. “A right of reference to the data should be available,” Jonathan Motley, a CDC patent specialist, wrote to Saladi on April 24. Over subsequent weeks, the CDC provided information on transferring licenses and details about the test, prompting Neelyx’s researchers to procure components and trial the CDC’s process.

However, Saladi became increasingly concerned about securing the data reference for the FDA application. “Any update on the right of reference?” he asked the CDC on May 13. “If there are potential issues, please inform us.”

He persisted over the following weeks as the avian flu outbreak worsened and more farmworker cases emerged. “Given that it is May 24 and the outbreak has expanded, can CDC specify a response date?” Saladi wrote.

The CDC eventually signed a licensing agreement with Neelyx but denied the request for data reference. Without it, Saladi said he could not proceed with the CDC’s test without further information. “It’s frustrating,” he remarked. “We believed they intended to support test development for potential needs.”

Shah from the CDC insisted that manufacturers must generate their own data to validate their use of the CDC’s test. “We’re not facing a shortage that warrants cutting corners,” he asserted. “Quality is paramount,” as highlighted by KFF News.

The CDC has issued licenses to seven companies, including Neelyx, but none have received FDA clearance. Shah noted that only one company requested the data reference. The CDC is now developing additional material to assist labs in completing their analyses independently.

“This should have occurred sooner,” Saladi told KFF Health News upon learning about the pending material. “There’s been no communication about this.”

Greninger likened the delays and confusion to the initial covid months when federal agencies prioritized caution over speed. While test accuracy is crucial, excessive scrutiny can be detrimental in a rapid outbreak. “The CDC should enable reputable labs with national reach to prepare,” he said. “It’s a straightforward decision.”

Meanwhile, clinical labs are cautiously developing their own tests due to a recent FDA rule extending the agency’s oversight of lab-developed tests, complicating the approval process. In an email to KFF Health News, FDA press officer Janell Goodwin indicated gradual enforcement of this rule.

However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group including the nation’s largest commercial diagnostic labs, called for more clarity: “This rule is creating delays and confusion about what is permissible.”

Developing avian flu tests is a risky investment due to uncertain demand. It remains unclear whether this cattle outbreak will escalate into an epidemic or dissipate. Besides CDC and FDA issues, clinical labs are assessing whether health insurers or the government will cover bird flu test costs.

These issues will eventually be resolved. Until then, the minimal number of tested individuals, along with the lack of cattle testing, may attract international criticism.

“Consider our judgment of China’s transparency at covid’s onset,” Nuzzo said. “The current situation jeopardizes America’s global standing.”

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