Tuesday, May 27, 2014

NIMBY in Cambridge (and New Haven) - the gown itself debates novel potential pandemic pathogens (and Godwin's Law)

A little over a month ago, I wrote a post entitled NIMBY in Boston that detailed a debate between the town (Charles Yancey and Tito Jackson) and the gown (Boston University's Gloria Waters) regarding research into Biosafety Level 4 agents - pathogens for which there is no known cure. Yancey and Jackson want to ban such research within Boston's city limits; the university wants to continue to conduct this research.

Now a similar debate is taking place - only this time the universities themselves (or individuals within them) are raising the alarm. If you haven't read your copy of PLOS Medicine yet, you may want to peek at one of the articles, Ethical Alternatives to Experiments with Novel Potential Pandemic Pathogens. It was written by Marc Lipsitch of Harvard (just up the road from Boston) and Alison P. Galvani of Yale. Let's look at the abstract.

Two recent publications reporting the creation

Stop right there. Note the word "creation." OK, continue.

of ferret-transmissible influenza A/H5N1 viruses [1],[2] are controversial examples of research that aims to produce, sequence and characterize “potential pandemic pathogens” (PPPs) [3], novel infectious agents with known or likely efficient transmission among humans, with significant virulence, and for which there is limited population immunity. There is a quantifiable possibility that these novel pathogens could be accidentally or deliberately released. Exacerbating the immunological vulnerability of human populations to PPPs is the potential for rapid global dissemination via ever-increasing human mobility.

Shades of Yancey and Jackson, without the talk of the pathogens being "weaponized." In other words, yeah right. Or is it?

The dangers are not just hypothetical. The H1N1 influenza strain responsible for significant morbidity and mortality around the world from 1977 to 2009 is thought to have originated from a laboratory accident [4].

For the record, the U.S. Centers for Disease Control (CDC) states the following:

The 2009 H1N1 influenza virus does not have the adaptations that are typical of influenza viruses grown or created in laboratories. For example, the standard method of growing influenza virus in laboratories involves injecting the virus into fertilized chicken eggs. The 2009 H1N1 influenza virus lacks the properties associated with growth in eggs....

In this case, the reassortment appears most likely to have occurred between influenza viruses circulating in North American pig herds and among Eurasian pig herds. Reassortment of influenza viruses can result in abrupt, major changes in influenza viruses, also known as “antigenic shift.” When shift happens, most people have little or no protection against the new influenza virus that results.

And yes, the CDC writer did use the phrase "when shift happens."

But scientists do not always agree.

The new H1N1 strain ... may be the product of three strains from three continents that swapped genes in a lab or a vaccine-making plant, [Adrian] Gibbs, and fellow Australian scientists wrote in Virology Journal. The authors analyzed the genetic makeup of the virus and found its origin could be more simply explained by human involvement than a coincidence of nature.

Their study, published in a free, online journal reviewed by other scientists, follows debate among researchers six months ago, when Gibbs asked the World Health Organization to consider the hypothesis. After reviewing Gibbs’ initial three-page paper, WHO and other organizations concluded the pandemic strain was a naturally occurring virus and not laboratory-derived.

Back to Lipsitch and Galvani's study; you'll recall that the authors worried about the accidental or deliberate release of novel pathogens. They propose an alternative:

Focusing on influenza, the object of most current PPP experimentation, we further argue that there are safer experimental approaches that are both more scientifically informative and more straightforward to translate into improved public health through enhanced surveillance, prevention, and treatment of influenza.

I am not a scientist, but it appears that the case outlined here is slightly different from the Boston University case (although I could be wrong). In this case, the authors are discussing deliberate creation of new strains of pathogens, rather than working with existing ones.

But for a sobering reminder of how critical all of this is, check this sentence from the authors' conclusion.

We urge that proposals for any future experiments on PPPs be evaluated according to quantitative risk–benefit analysis guided by the principles of the Nuremberg Code.

Yes, we're talking about the Nuremberg Code here. This code originated during the post-World War II Nuremberg trials, in which Nazi scientists were accused of extremely unethical practices. The authors appear to focus on the second point of the Code:

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

However, I guess that one could argue that if a pathogen is released into the wild, the first point comes into play:

1. The voluntary consent of the human subject is absolutely essential.
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