Given those seven restrictions, this research seem reasonable. Virii are constantly mutating, and being reactive rather than proactive could cost lives.
1. The research addresses a scientific question with high significance to public health;
2. The research does not intend, nor is reasonably anticipated to yield a HPAI H5N1 experimental virus which has increased transmissibility, pathogenicity, or expanded host range, unless there is evidence that such a virus could be produced through a natural evolutionary process in the foreseeable future;
3. There are no feasible alternative methods to address the same scientific question in a manner that poses less risk than does the proposed approach;
4. Biosafety risks to laboratory workers and the public can be sufficiently mitigated and managed;
5. Biosecurity risks can be sufficiently mitigated and managed;
6. The research information is anticipated to be broadly shared in order to realize its potential benefits to global health; and
7. The research is supported through funding mechanisms that facilitate appropriate oversight of the conduct and communication of the research.
There are two main things that worry me here; one related to carelessness / ineptitude, the other something more sinister, but which might be given an opportunity due to carelessness / ineptitude.
First, let's take a step back, in two different directions. They Hippocratic Oath states: "First, do no harm." But there is potential for harm here. And of several different kinds.
Unfortunately, it's kind of hard to discuss, because each of the issues I bring up is kind of a double-edged sword in terms of debate. But, let's take a stab anyhow.
If confronting the issue of a potential serious health risk with viruses (rule #1), one can run into dangers either from action or inaction. IF one decides to stand pat, banking on nature not going ballistic on us, and there does happen to be a virulent outbreak, then we may be up the creek. Remember the classic example of the 1918 flu which killed millions worldwide, in a time before nearly instantaneous (during the symptom-free incubation period) for the flu: and, considering that there were people who went to bed healthy and "woke up dead" during the epidemic, that's saying something.
Complicating that is the fear that terrorists may be trying to cook up a nasty version of H5N1 akin to the 1918 Flu, and we don't want to get caught flat-footed by *that*.
The difficulty I see there, is that if terrorists *do* make a virulent strain, then all of the "early warning" systems mentioned above, which are meant to track slowly evolving natural strains which are (say) one or two spot mutations away from virulence, will be useless.
The other difficulty with worrying about a terrorist strain is SlingsandArrows' statement that "Virii are constantly mutating" coupled with the remarks of Peter Palese from the article:
""Gain-of-function experiments are almost always loss-of-function experiments for another property. For example, making H5N1 influenza viruses more transmissible in ferrets (gain-of-function) results in a loss of pathogenicity of these [viral] mutants in the ferret (loss-of-function). Thus, the NSABB looks only at one side of the coin!" "
This is a double-edged sword, in that it implies that a very transmissible strain will be less virulent, and a more virulent strain will be less transmissible: if that's the case, can't we just be prepared for social distancing (e.g. consider the scenarios in Tom Clancy's Executive Orders and let the virus mutate itself away? But on the other hand, the 1918 flu took *months* and/or *years* to mutate away, and there were three separate waves of the flu, months apart, each of which caused its own round of fatalities. And the other end of this, is that if the H5N1 is constantly mutating, what good is a vaccine going to do? Look how much work we have to do just to keep up with a 40% chance of immunity to regular flu from standard flu shots, which mutate away from the vaccine within a year, and yet still manage to get plenty of people ill in their new form. I see the risk of throwing a LOT of money at something that may not do all that much good.
But there is another type of risk, too, and this risk revolves around points #2, #6, and #7.
We kind of already touched on #2: but another issue comes when dealing with engineered viruses. Genome sequencing is getting comparatively cheap and easy, as is other bioengineering; it is not without the realm of possibility that a terrorist group could fund capability in this area, and just wait to see *when* the US starts a "crash program" on natural H5N1, thereby "tipping off" the terrorists that a natural strain is very close to virulence. (Telling them when and where to start experimenting.)
A second issue is that of "opsec" -- many scientists argue that "knowledge should be shared" -- and we saw how well that worked out during the Cold War. All it takes is one Klaus Fuchs or some misguided Kumbaya ninny (and it need not be a researcher, or someone with access to the Level 4 Hot Zone, it might be a secretary who Xeroxes the weekly reports) "accidentally" dropping a thumb drive at a Starbucks, and the risks of bio-proliferation (to coin a phrase) are right on top of us.
And finally, there is the danger of the government deciding to play a little bit clever with us: I posted ages ago a tin-foil hat report of a Chinese general discussing biowarfare against the US in order to free up Lebensraum for the Chinese, while sparing our infrastructure and raw materials; but there is also the possibility of Maoists or Earth-First type nuts (some of whom are prominent in academia, think tanks, and advisory roles to this administration) who would like nothing better than to thin the ranks of the World's Population by five billion or more; or, alternatively, clear out all the pesky older people in the US who are owed pensions and Social Security and the like, and of whom a disproportionate share still remember when the Constitution was taught in schools and was the law of the land. Not to mention the drug companies who would *love* to have a monopoly on a "life or death for EVERYONE" drug, to recoup their losses from Obamacare (and if you think I'm crazy, try reading this: East Germany's STASI Sold Citizens to Western Pharmaceutical Companies as Human Guinea Pigs).
And with point #7 ("appropriate oversight" usually means some god-awful boilerplate report issued once a year), I fear that the safeguards in place will not be adequate to prevent malfeasance from whatever source.
Thoughts, comments?