The Laboratory Bio-Safety Backlash Continues

Credit CDC

 

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The groundswell of concern over controversial `gain of function’ laboratory experiments, and recent high-profile lapses in biosecurity at the nation’s top labs, continues to grow with a scathing editorial appearing yesterday in the Annals of Internal Medicine penned by Deputy Editor Deborah Cotton, MD, MPH.

 

While much of the editorial is behind a pay wall, you can find a readable scan of the first page at the link below.  Fortunately, Medscape Medical News  published a detailed summary, and interview with the author, yesterday (more on that after you return).

 

Editorials | 29 July 2014

Biocontainment Laboratories: Addressing the Terror Within 

Deborah Cotton, MD, MPH, Deputy Editor

Ann Intern Med. Published online 29 July 2014 doi:10.7326/M14-1668

Recently revealed safety lapses in U.S. government facilities that work with deadly pathogens suggest that, despite efforts to protect us from bioterrorism as well as naturally occurring infectious diseases, there is another grave bioterror threat: the risk emanating from biocontainment laboratories themselves. This commentary discusses possible factors contributing to the safety lapses and strategies to prevent future incidents.

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The following lengthy report from Medscape provides more detail on the above editorial, along with comments from the author, and additional input from by Nancy Kingsbury, PhD, of the Government Accountability Office and  by Richard H. Ebright, PhD, professor of chemistry and chemical biology at Rutgers University  (see House Subcommittee Hearing on Biosafety  for their recent testimony). .

 

Suspend Work, Close Most High-Level Biosafety Labs, Experts Say

Janis C. Kelly

July 29, 2014

( UPDATED July 29, 2014 ) Management of US government bioterrorism research facilities is so lax that work in biosafety level (BSL) 4 laboratories (which house deadly organisms for which there are no effective treatments or vaccines) should be suspended pending a complete safety overhaul, Annals of Internal Medicine deputy editor Deborah Cotton, MD, MPH, writes in an editorial published online July 28 in the journal

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Beyond suspension of work pending a a safety overhaul, experts are calling for a dramatic scale back in the number of BSL-3 and BSL-4 labs in the county that are allowed to work on the most dangerous pathogens.  Currently, there isn’t even a good count on the number of BSL-3 labs in operation, and there is no one single regulatory agency in charge of monitoring their operations.

 

While we continue to get bland assurances from researchers that their work is both safe and essential (“We’re scientists . . . trust us” )  we are also hearing from others – like the Director of the CDC - that there  remains an insufficient `culture of safety’ among research scientists.  

 

We are also seeing reports  that the number of laboratory `incidents’ may be far higher than is reported.

 

While many researchers will be justifiably dismayed by the draconian recommendations made in the above editorial, and I doubt that we’ll see anything close to the reduction in BSL-3 labs they are calling for, it is obvious that serious changes are needed.  

 

For the past ten years – spurred on in part by national security concerns – there’s been an `anything goes’ attitude when it comes to biomedical research.  Since the 9/11 attack, the number of BSL-4 labs in the United States has jumped from 2 to 14, and the number of BSL-3 labs has grown from around 400 to over 1400 (although the exact number is murky).

 

Although BSL-3 and BSL-4 labs are essential parts of national security, biomedical research, and the testing of pathogens - the more of them that are in operation - the better the chance of a seeing a serious accident.

 

How many are too many, will be one of the major decisions facing regulators.

 

Given the money, power, and prestige at stake, I don’t expect to see many BSL-3 labs voluntarily sacrifice themselves on the altar of public safety.  So we should expect more than a little resistance to any reductions.

 

For more on this growing debate, you may wish to revisit:

 

Scientists For Science: GOF Research `Essential’ & Can be Done `Safely’

Updating The Cambridge Working Group

ECDC Comment On Gain Of Function Research

CDC: Press Conference Transcript, Audio & Timelines For Lab Incidents

Cell Host & Microbe: 1918-like Avian Viruses Circulating In Birds Have Pandemic Potential

Lipsitch & Galvani: GOF Research Concerns

CDC/Medscape Video: Expert Guidance On The H3N2v Virus

 

 

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While we’ve heard very little over the past two months regarding the small number H3N3v (formerly called trH3N2) cases detected last fall across five states, the CDC continues update their guidance information, and has taken steps towards developing a seed vaccine.

 

This novel swine-origin virus is a reassortant between swine H3N2 and the 2009 H1N1 virus, and while it does not appear to be transmitting efficiently, some human-to-human transmission is suspected.

 

A sampling of earlier blogs on this emerging virus include:

 

WHO/FAO/OIE: Call It A(H3N2)v

WHO Comment: Testing For Novel Flu Viruses

Branswell On The New trH3N2 Flu Virus

CIDRAP: New Details In The trH3N2 Story

CDC Update On Iowa trH3N2 Cases

 

The CDC, in partnership with Medscape, produces a series of Expert Commentary videos aimed at physicians, nurses, pharmacists, and other healthcare professionals.

 

Earlier this week they posted an Expert Commentary video on the H3N2v virus.  Follow the link below to watch:

 

Variant H3N2 Influenza Virus: What You Should Know

Michael Jhung, MD, MPH

H3N2v Vaccine Trials

 

Photo Credit PHIL

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In a bit of a follow up to yesterday’s blog (see H3N2v: Three’s A Crowd) - where we looked at the impact that a newly emerging influenza A virus might have on next fall’s flu vaccination program - we’ve a report from Medscape News (free registration req.) on the development of a vaccine for the novel H3N2v virus.

 

 

Trials for Novel Influenza Vaccine Likely by Spring

Robert Lowes

January 5, 2012 — A precautionary vaccine against the novel swine influenza virus, which has sickened 12 people in 5 states since July, is in development and will likely be ready for clinical trials this spring, a spokesperson for the Department of Health and Human Services (HHS) told Medscape Medical News.

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Early in December we learned from CIDRAP NEWS that the CDC was working on a `seed vaccine’ against this emerging strain, based on an older H3N2 swine flu virus collected from Minnesota in 2010 (see Vaccine virus for novel H3N2 based on 2010 swine flu strain).

 

At that time scientists were running into some problems getting the new H3N2v virus to grow well in eggs, a crucial first step in the process of creating a high-yield reassortant virus.

 

A high-yield reassortant is a laboratory-created hybrid that contains the surface genes of the target virus – which provides its antigenic qualities - combined with the internal genes of a virus already known to grow rapidly and dependably in eggs.

 

You may recall that in the summer of  2009 there were early problems in the production of the H1N1 pandemic vaccine (see Vaccine Yields Continue To Disappoint). 

 

Working out the development and manufacturing kinks now, before a novel virus can pose an imminent threat, is only prudent.  It can save weeks, or even months, in the rolling out of a vaccine in the event of a pandemic.

 

Candidate vaccines have been developed for a number of novel flu strains in recent years, including several clades of the H5N1 virus, H7N5, and last September we learned that Bangladesh had sent an H9N2 virus to the CDC for development of a seed vaccine.

 

It’s not completely clear from this Medscape article whether this investigational vaccine will be based on the 2010 Minnesota H3N2 virus, or if they’ve managed to turn one of the newer H3N2v isolates into a high yield reassortant.

 

Hopefully we’ll get more details in the near future. 

Referral: Medscape - 10 Valuable Lessons From The Pandemic

 

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An overview of lessons learned from the pandemic of 2009 by Dr John G. Bartlett, Professor of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland appeared in Medscape Infectious Diseases yesterday.

 

Dr. Bartlett provides 10 `valuable lessons’ that we can take from the past twelve months.  

 

This is a good article, and rather than try to excerpt any part of it, I’ll simply suggest you follow the link below and read it in its entirety.

 

Access requires (free) Membership to Medscape.   A hat tip to Tetano on FluTrackers for passing on this link.

 

John Bartlett's Postmortem on 2009 H1N1 (Influenza A): 10 Valuable Lessons

John G. Bartlett, MD