Friday, February 03, 2012

Pathogens, Publishing, And The Precautionary Principle

 

 

# 6118

 

 

Over the past few months we’ve been witness to a fascinating, volatile, and sometimes unseemly debate over controversial `dual use’ H5N1 research.  I’ve tried to present both sides of this issue as fairly as possible, without interjecting my own opinion.

 

Not because I don’t hold an opinion on this topic (I most certainly do), but because I believe that these issues are far too important this non-scientist to marginalize either side by taking pot shots at them in this blog. 

 

I certainly understand (and share) the deep feelings that many scientists hold regarding the sanctity of independent and unfettered scientific research, and their abhorrence of anything that smacks of government censorship.

 

And from a practical standpoint, given the backchannel communications in the scientific community, I have considerable doubts as to whether this H5N1 genie can now be coaxed back into its bottle. 

 

But I also know from my years working as a paramedic –where patient safety and the principle of Primum non nocere ("First, do no harm") reign supreme - why the NSABB would have been hard pressed to come up with any recommendation other than the one they did.

 

And it boils down to the Precautionary Principle, which is a basic tenant of public policy which says:

When the health of humans and the environment is at stake, you need not wait for scientific certainty of risk before taking protective action.


So basic and widespread is this ideal that its use has become a statutory requirement in many countries.

 

In 1998, the Wingspread Conference on the Precautionary Principle summarized the policy as:

 

When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.

 

Essentially, if an action, or a byproduct of some action can reasonably perceived as being potentially harmful to the environment or to public health, the onus of proof of its safety falls to the activity’s proponent.

 

The NSABB’s role, as defined in their FAQ, is to

` . . . provide advice, guidance, and leadership regarding biosecurity oversight of dual use research to all Federal departments and agencies with an interest in life sciences research.

 

The NSABB advises on and recommends specific strategies for the efficient and effective oversight of federally conducted or supported dual use biological research, taking into consideration national security concerns and the needs of the research community.’

 

In other words, it was their job to look at these research projects, and if they found a reasonable concern for public safety, to raise a red flag.

 

Which is precisely what they did. 

 

The dismissive arguments over the true CFR of the H5N1 virus, or whether transmissibility in ferrets necessarily translates transmissibility in humans, completely misses the point.

 

Whether you agree or disagree with the committee’s conclusions, the NSABB simply did what they were designed to do as part of a system of checks and balances.

 

While there is no scientific certainty that any harm would come from the publication of these papers, it can be reasonably argued that - in the wrong hands - this information could potentially lead to a serious, even catastrophic mishap.

 

And under the Precautionary Principal, the NSABB had little choice but to raise their concerns, with the onus then falling on those wishing to proceed to prove the safety of doing so.

 

Although there has been a lot of outrage and posturing on both sides of this issue - it seems clear to me that however flawed - the system has worked this time.

 


The NSABB committee raised their concerns, and in doing so, has forced a conversation that’s been too long overdue.

 

 

How are we to handle this brave new world of life sciences, where new viruses and other life forms can be created in the laboratory?

 

Who decides what is appropriate, or safe research? Or what should be published, and who should have access to redacted information?

 

What laboratory protocols and protections are necessary for working the the H5N1 virus?

 

And under the WHO’s PIP (Pandemic Influenza Preparedness) Framework, adopted last May by the 64th World Health Assembly, who is entitled to receive samples of these new strains of the virus?

 

Over the past few weeks I’ve been saddened to see some of the world’s best scientists and researchers maligned by the media as crazed present day Dr. Frankensteins – ready to unleash a killer plague that would wipe out half of humanity for the sake of getting another research grant.

 

While those urging caution - recommending a review of research protocols and possible redaction of these papers - have been characterized as being tools of an oppressive and paranoid biosecurity industry.

 

When the simple truth is, both sides are simply doing the job we rightfully expect of them. They may have different mandates, and priorities, but both are valid and important.

 

If we manage to keep ahead of the H5N1 virus, it will be due in large part to the kind of groundbreaking work being done in the labs of Ron Fouchier, Yoshiro Kawaoka, and others. 

 

But these research projects are not without some risk, and that is why some oversight is necessary.

 

While the NSABB won’t be the final arbiter of this case (this needs to have an International solution), the only reason we are now having this conversation today is because they took a difficult and unpopular stance.

 

The hard work lies ahead; forging some sort of workable compromise that will protect important scientific research, and at the same time shield the public from unnecessary and avoidable risks. 

 

I don’t pretend to have the answers.  And I fully expect that there is no `perfect’ solution to be had.

 

But I do know that the first step towards reaching any meaningful compromise is for all sides involved to accept as valid the concerns held by the other stakeholders in this debate, instead of simply trying to dismiss them as unfounded or overblown. 

 

And discouragingly, so far I’ve seen precious little of that in the debate so far.