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Friday, April 14, 2006

Bird Flu: UK And US Government Responses

There's considerable consternation on the bird flu front, sparked largely by the news that DEFRA screwed up on two counts. DEFRA is the UK agency that conducts bird flu testing. First, DEFRA wrongly identified the swan that was found in Scotland and tested positive for H5N1. It was a whooper swan instead of a mute swan. Second, DEFRA seems to have screwed up the entire surveillance testing program. From the PROMED posting:
Suspicions have been raised because DEFRA's tests revealed none of the ordinary flu that ducks and geese normally carry. Of the 3343 fecal samples from wild birds taken for DEFRA by the conservation group the Wildfowl and Wetlands Trust (WWT) in December [2005], only 2 were shown to contain low-pathogenicity bird flu (0.06 percent). In a parallel study for DEFRA conducted by hunters, bird flu was found in only 3 of 423 freshly shot ducks, or 0.7 percent. "We thought there was an unusually low level," says Ruth Crommie of the WWT, "but perhaps that happens in some bird populations."

Flu experts contacted by New Scientist disagree. "There's something wrong with those numbers," says Bjorn Olsen of the University of Kalmar in Sweden, who tests up to 10 000 wild birds per year in Europe's biggest monitoring program for avian flu. Normally, he says, around 10 percent of dabbling ducks and one percent of geese should be carrying low-pathogenicity bird flu in Europe in December.

Richard Slemmons of Ohio State University in Columbus has tested 2000 to 3000 water birds per year for 20 years. His chief technician, Jacqueline Nolting, told New Scientist that "at least 6 or 7 percent should be positive" at any time.

The problem may have been DEFRA's method of collecting samples. Crommie says DEFRA told WWT samplers to moisten a sterile swab on a stick with saline, take a fecal sample from the bird, then put the swab back in its dry plastic tube. The tubes were then kept at refrigerator temperature and taken to the testing laboratories the next day.
That dries out the samples and kills virus. So now the risk for poultry in the UK is unknown, and DEFRA has also been refusing to test lone dead birds on the basis that it is not necessary because of their surveillance program. From ThePoultrySite, here's a posting about sick cockerels in Scotland with blackened combs and wattles, plus one report of seeming neurological illness:
Another cockeral in the flock does not have the severe blackening but is not walking well and is staggering around alot we have seperated all the cockerals from the hens as the hens do not appear to have any symptoms. They are eating some greens but not much else. Any ideas ???
In the meantime, there are rumors in the US. Here's what one commenter has to say about Arkansas on FluClinic:
Scientists should be looking in their own back yards, looking north seems to be the daily news. In Arkansas around Howard county arkansas numerous quarantines of poultry houses have been underway for 40 days and 40 nights.
The last poultry farm is a tyson farm houses had poultry dieing with bleeding
and the all chicken out phase started with moon suits plastic wrapped semi trailers in orange plastic workers were decontaminated and all clothes destroyed. Local news personnel were banned and removed from site by law enforcement no news in no news out. Tysons in Nashville ark has elevated the bio security sign out side their processing plant to high level with no new hires permitted. Nashville news nbr is 1-870-845-2010 if you wish to call and ask was there strange problems in the poultry industry in arkansas.
I've been too busy to call and check on this one. In the meantime in the US the FDA has released guidelines for rapid-response bird flu tests, and the guidelines are such that there aren't going to be any. For one thing, the FDA wants them qualified by testing on human beings. How can anyone do that? It's ludicrous, but no reporters seem to have picked this up. Reporters, I have concluded, are really lazy and don't read primary sources at all. No one who read this guidance could miss what is being done, which is to establish a government monopoly on H5 testing in the US.

I have listed the relevant sections from the guidance below. What all this means is that no rapid-response test can be marketed in the US until after H5 has already gone human to human. In other words, the CDC-approved labs have control over all H5 testing in the US, including on whether testing will be performed at all. They can prevent the detection of H5 by controlling guidelines for surveillance. Since current guidelines are for people coming in from outside the country who may have been exposed outside the US, we have a Catch 22 situation. There is no domestic H5, thus no need to test for H5 in humans who have not been outside the US, and therefore we would not ever catch H5 in humans who contracted it within the US. Since many countries have picked up their first human cases before they have picked it up in poultry, this does not inspire confidence!

This is very similar to the approach taken with BSE (mad cow), in which the government simply does not allow beef producers or exporters to test their own product.

In theory the guidance is non-binding, but in practice it is not. The FDA's guideline for in-vitro testing is here. This is the recommended labeling for current A/B tests:
"If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing . Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens."
And the FDA makes it clear that marketing in-vitro devices is not legal unless you establish "equivalence":
Although devices within the classification described in 21 CFR 866.3330 are Class I devices, which are generally exempt from premarket notification, under FDA regulations, a premarket notification must be submitted and the new test found to be substantially equivalent to a legally marketed predicate device before an influenza test device intended to detect an influenza A virus infecting humans directly from human specimens may be legally marketed.
Performance characteristics for generally detecting influenza A virus should be established by comparing the device test results to culture performed under standardized conditions, or other acceptable methods, using the device in the same manner that it will be used during clinical practice, and using specimens obtained from patients with an influenza-like illness. Thus, the performance should be described in relation to the influenza A subtype(s) infectinghumans during the influenza season in which the evaluations are conducted.
This is the recommendation for clinical testing to establish H5 detection:
To provide FDA with a basis to assess the performance of a device that detects a specific novel influenza A virus (subtype or strain), we recommend that you submit data from clinical evaluations with fresh specimens from patients with influenza caused by the novel influenza A virus and other commonly circulating influenza viruses, along with specimens from patients with influenza-like illness not due to influenza viruses. Fresh samples are preferred for obtaining these data. However, archived samples may be useful to expand representation of specimens (e.g., geographically diverse, different specimen types recommended). Archived samples may be useful to provide the variety of specimen types from patients who have other respiratory infections, and from whom fresh specimens may not be readily available .
The samples listed above do not exist. The FDA also issued guidelines for Emergency Use Authorizations here.

I cannot stress to you how much money is at stake. The moment that H5N1 is confirmed in the US our poultry exports will be shut down. In other news, a coworker of mine in his twenties who developed partial facial paralysis after getting ill was sent for a CAT scan. Preliminary diagnosis was stroke, because a lesion showed up in the temporal lobe. The next step is an MRI....

I do not do this for my own pleasure. You should not be frolicking in bodies of open water this year. You should be handling uncooked poultry only with gloves. You should be eating eggs only if they have been hardboiled long enough to shrink inside the shell, or thoroughly baked in dishes. If you are in a rural area you should remove your shoes before you enter your home, wash your hands well before eating or touching your face, and clean all bathrooms, knobs, taps and faucets with bleach once a day at a minimum. I would try to avoid exposure to dirt and dust blowing from newly worked fields.

Have a Happy Easter, but don't give the kids chicks for Easter, okay?

Thats good advice,



Depressing, but prudent.

If H5N1 surfaces (and with the Tyson/Arkansas news blackout, maybe that should be "has surfaced"), we can expect the following:

"There is no H5N1 in the States; Move Along Everybody, there's Nothing To See Here."

"Click your heels together three times and repeat There Is No Bird Flu Here, There Is No Bird Flu Here, There Is No Bird Flu Here..."

And everybody pretends the poultry industry is OK. Just like airline security. Ah, the magic of campaign contributions...
It's hard not to suspect that you have something there, Anon. After all, look at the Mad Cow debacle. There is precedent.

What possible reason could there be for preventing private producers from testing every cow so they could export to some markets?

I can easily imagine everyone looking at each other and muttering "Well, we can't stop it and whatever's going to happen is going to happen, so...."

By nature I am reflexively contrary to theories of vast conspiracies. In general, I think we can assume that human stupidity accounts for almost all such incidents. But the Mad Cow thing doesn't fit in that category. Neither does the FDA guidance.
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