H5N1 Rapid Tests in Agriculture- Why Not??
H5N1 Rapid Tests in Agriculture- Why Not??
We're in a new political world in the U.S. - with traditional regulatory and scientific research paradigms under assault - how do we respond to rejection?
Friday Katelin Jetelina, “Your Local Epidemiologist”, summarized my feelings regarding the latest news of Trump Administration appointments:
Your Local Epidemiologist-Body as a shell
If you have not subscribed, you should; here is a small section of her comments:
Yesterday, I tried—over and over—to find the right words for a YLE post, struggling to convey what feels like an assault on our work and our mission.
How do you express, in a few lines, the unsettling reality that someone with a catalog of lies so long is now tapped to be in charge of the public’s health? From his false claims that vaccines cause autism (they don’t), or that HIV does not cause AIDS (it does), or antidepressants are linked to mass shootings (they aren’t), or chemicals in water making kids trans (they don’t), or to Wi-Fi causing cancer (it doesn’t). The list of falsehoods feels endless.
How do you effectively warn about the oncoming hurricane of confusion and anxiety? Or, worse, the heartbreak because people will make ill-informed decisions when they really are just trying to do what they think is best? The dread because I know damn well that a “lie can go around the world before the truth gets its pants on.”
How do you capture the gravity of the moment as public health workers and scientists brace for the undermining of critical health programs and resources—built over decades—to be dismantled or misdirected?
For USDA leadership, we don’t have much hard information yet; however, the Texas Agricultural Commissioner, Sid Miller is leading the search team and has reportedly been directed to find people comfortable with RFK’s views on human health and nutrition. Sid himself is reportedly in the running to be named Secretary of Agriculture. If Texas’ philosophical approach to the national H5N1 response is indicative, we can expect state-centric and limited governance of animal and zoonotic disease response activities, depending on how the new administration chooses to handle zoonotic risks (or not). Regardless, it’s a pretty good bet that poultry will continue to die from H5, and USDA will have to choose a path forward in dealing with that issue while trying to keep its promise for “cheaper food”. If people start to die, that is a separate issue…
Much distrust and outright hatred have been directed against the federal administrative “deep state” by those now coming into power. An article in The Atlantic does a great job of demystifying this foreboding terminology: There Really Is a Deep State - The Atlantic:
The reality is that the same members of the so-called deep state that Trump and Kennedy are threatening to fire are also essential to making anything the administration wants to do happen. Seminal parts of the “Make America healthy again” agenda would have to run through this deep state. If Kennedy, a champion of psychedelics, wants the FDA to approve a new psilocybin-based treatment, the medicine must be reviewed by the scientists and doctors who review other drugs for safety and efficacy. If he wants a national ban on fluoride in water, that must go through the EPA. There is no way around this: Even if Trump appointed Kennedy as the unilateral king of every single federal health agency, Kennedy cannot make these decisions on his own.
A central tenet of the “Make America healthy again” agenda is removing potentially dangerous chemicals from food. Although the FDA has been slow to ban certain chemical additives, the agency seems to have recently seen the light. Earlier this year it set up a new initiative for reassessing the safety of these substances. But if Kennedy guts the FDA, no one might be there to do that review.
The Trump administration could hypothetically hold a massive job fair to get cronies into all of those roles—especially if the president-elect makes good on his promise to make hiring and firing bureaucrats easier—but few people can successfully perform these highly technical jobs, not to mention that hiring in the federal government typically takes forever. (The average hiring time in 2023 was 101 days).
We really can’t ban the “Deep State” because it safely makes possible the changes we demand of government (as required by our Congress in enabling legislation). Moreover, legally produced and marketed foods and additives can’t be banned just on the whims of activist groups. The “deep state” protects the rights of all as ensured under the U.S. legal system, including food processing companies which have provided us the most nutritious, varied, and economical diets on the planet.
So, while I share Katelin’s despair over the loss of trust in established science and public health institutions as evidenced by RFK’s ascendance, I’m also a “bit” older and maybe can offer some perspective regarding where the scientific-regulatory establishment has perhaps lost its way.
In my opinion this election was a huge repudiation of trust in the “educated class”, a giant finger to the “college educated coastal elite ruling class”:
Let’s narrow our discussion to emerging and zoonotic pandemic threats. This national referendum implies that reasoned arguments for: 1) centralized shared information; 2) restrictions on movement of animals and people; and 3) the need for widespread vaccination in some cases will fall on extremely suspicious ears. The “smart people” have lost permission to manage public health crises by traditional rules and roles by fiat alone.
Public health and higher education have given us the healthiest lives ever experienced by humans. Our critical institutions and functions will hold - but we may redefine critical functions and replace some of the institutions that perform them! We can no longer assume that existing governing and educational/research structures have intrinsic trust as a base of support. Every communications group in every public-facing institution should put the following in their manuals - I know what’s best for you NEVER works - nor does its corollary, I’ll tell you what you need to know when you need to know it.
So, what WILL work? That’s a very fair question that neither I nor anyone else has a good answer to right now. However, let’s start with the basics of respect, transparency, honesty, and open communications! Looking back at both the national public health COVID response and the USDA H5N1 in dairy response to date, I’d argue that those in charge failed to:
openly acknowledge uncertainty, floating uncertain talking points to avoid “panic” or market disruptions that most people could easily see through.
openly share information and encourage research through regulatory approaches that encouraged open testing and inquiries by non-regulatory and private entities; actions in both outbreaks hindered rather than facilitated determination of the scope and characteristics of the outbreaks
encourage independent and internal inquiry and discussions, through outright muzzling of employees in some cases and pushing of “unified” messages long after their loss of utility.
We live in times of escalating speed of communications and scientific capabilities. Yet, we still vainly attempt to control “official disease” testing protocols and release of information through 1980’s Foreign Animal Disease Investigation (FADI) policy structures. National lab confirmatory testing and announcements make sense for confirmation of first cases. However, the whole process has become a game of “I’ve got a secret” and press release timing played by both federal and state officials to optimize messaging over the course of longer outbreaks. I know what’s best for you NEVER works - nor does its corollary, I’ll tell you what you need to know when you need to know it.
We now have over 500 H5 dairy herd cases in at least 15 states; yet every one of them must be confirmed at NVSL, requiring physical shipment and resulting testing and announcement delays. Is our NAHLN system not to be trusted after millions of dollars invested in capacity building, requiring that every dairy and poultry H5 detection be confirmed nationally? Is H5 sequencing limited to NVSL only because of unique capabilities or because of desire to manage information flow and release? A transparent disease reporting process would encourage qualified rapid complete diagnostics closer to the case with faster reporting to national and international databases for further curation and analysis.
Recall that during the logarithmic growth phase of COVID in the U.S. in the early spring of 2020, CDC and FDA left the public health community begging for test authority as they refused to allow WHO-approved COVID tests into the U.S. to partially meet demand unfilled by a defective CDC assay. Federal laboratories are quick to expect compliance with and trust in federal requirements but can be quite slow in returning that trust to partners while remaining tone-deaf to capacity and logistics issues.
As we move forward, transparency and public trust should extend to “point of care” (POC) testing for both human and animal pathogens of concern. CDC-FDA has begun to see the light and has actually approved release of consumer-based influenza-COVID Rapid Tests:
While this test is not H5-specific, I assume that animal health official now realize that dairy farmers can now go to Amazon to pick up a $10 test to screen their bulk tanks for H5? (Amazon.com: CorDx TyFast Flu A/B & Covid-19 Multiplex Rapid Test.) It is not validated for that purpose, but it will be used, as similar prescription tests already have been by producers and veterinarians seeking to know herd status prior to conducting official testing (or not).
Note: It’s even possible to buy a molecular (PCR-based) test from Amazon- Amazon.com: LUCIRA® by Pfizer COVID-19 & Flu Home Test, First and Only at-Home Molecular Test for COVID-19 and Flu A/B, Single Use ($40 for one use). Some consumers elect to purchase the additional sensitivity that PCR-based testing can provide them for added assurance.
The following article from STAT advocates for POC H5 testing for humans:
Triple rapid tests are necessary to contain mpox, H5N1 bird flu | STAT
I’d argue that the same logic applies for approving rapid H5 tests for animal species. Similar kits may work across multiple species with supplemental validation done to standardize sampling processes. That leads to another point raised in the article which continually stops POC approval - test validation standards! The article advocates the following regarding human POC tests:
Finally, the U.S. government should streamline regulatory approval for rapid tests, as demonstrated with the Independent Test Assessment Program. During Covid-19, the U.S. got rapid tests much later compared with countries like the U.K. or Slovakia. One key reason for this was the Food and Drug Administration’s stringent accuracy standard for Emergency Use Authorization. But for public health screening, early, quick, and frequent testing is at least as important as accuracy. After all, in the face of an emerging outbreak, a good test in hand today is far more valuable than a laboratory test next month.
To address this, the FDA should evaluate rapid tests based on broader public health benefits, not just clinical accuracy metrics. …
Agriculture has failed to utilize inexpensive screening or group testing (think oral fluids in swine) for high consequence diseases because the assay methodology fails to meet the gold standard for test sensitivity as measured by a validated laboratory test (usually PCR) on a preferred sample type. That’s great logic if we could collect and test sufficient numbers of these samples at the right stage of the disease process across the population at risk to insure early detection. However, the real world doesn’t work that way.
Instead, we use compatible clinical signs (case definitions) in observed populations to trigger a foreign animal disease investigation (FADI) and collection of a preferred sample type followed by use of an expensive gold standard test. The result is a low volume, late-detection, but expensive foreign animal disease process extended to emerging disease surveillance programs. Widespread creative use of “cheap” rapid test molecular screening in high-risk areas for agents of concern could improve targeting for diseases of concern and official testing resources, while greatly improving potential time to detection capabilities across a much wider population at risk.
My point is that the animal health community can either fight a losing battle, or we can develop flexible disease surveillance scenarios that reward producer screening and incentivize animal health diagnostic providers to market validated POC H5 tests for multiple species, an urgent current need. I’ll grant that some unscrupulous people may attempt to utilize POC testing to avoid short-term consequences; however, too much information and testing potential is widely available for that gambit to pay for long. We’re much better off receiving early results from 85% of producers doing the right thing, than foregoing test approvals to prevent cheating by the 5% that might actively game the tests.
The final big issue with POC testing in livestock species in the U.S. is trade implications. We have traditionally held ourselves out to be transparent and held our trading partners to the same standards. “Deregulated” POC testing threatens market stability when rumors of disease outbreaks can lead to trade bans. This is no doubt a valid concern, but can the genie be put back in the bottle? Is the proper role of government to suppress testing until a finding comes through official channels, or is it to encourage testing, confirming or disproving screening results as rapidly as possible in a transparent manner? False positive results can be investigated and disproven. Assay non-approval leads to a series of false negatives (through non-testing) in a testable population. It is obvious to foresee the potential pitfalls for disease screening; the opportunity costs for NOT screening are less obvious, but immense, given the high infectivity and risk of spread of today’s high consequence viral agents.
This has been a big picture blog; I’ve neglected what’s happening on the ground recently with H5. The picture remains grim and getting grimmer by the day as bird migration moves south and human cases continue to crop up, some with more concerning mutations. H5 is completely oblivious to politics. We’ll see how the new administration reacts to H5. Reality has a sobering effect on rhetoric - we’ll see…
John