The Laboratory Bio-Safety Backlash Continues

Credit CDC

 

# 8892

 

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.

(Continue . . . )

 

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

(Continue . . .)

 

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

Study: Deaths Associated With H7N9

 

Credit CDC

 

 

# 7368

 

 

From the Annals of Internal Medicine we get a letter – published June 4th - from researchers at the Institute of Disease Control and Prevention, Academy of Military Medical Sciences, Beijing, China that looks at the characteristics of 24 recent H7N9 fatalities in China.

 

The letter is freely available, and I’ve only excerpted a small portion below.

 

The authors found that most deaths occurred in patients over the age of 60, suggesting this is a risk factor.  They find the virus isn’t easily transmitted, but that once a person is infected, the clinical course progresses rapidly.

 

Follow the link to read:

 

 

Deaths Associated with Avian Influenza A(H7N9) Virus in China

Yuehua Ke, PhD, MD; Yufei Wang, PhD, MD; Wenyi Zhang, MD; Liuyu Huang, PhD; and Zeliang Chen, PhD, MD

Ann Intern Med. Published online 4 June 2013 doi:10.7326/0003-4819-159-2-201307160-00669

(EXCERPT)

Discussion: Infection of humans by novel influenza A viruses that are distinct from circulating viruses and produce severe disease can lead to sporadic human infections or influenza pandemics (4 - 5). Therefore, the recent discovery of the H7N9 virus is of great public health interest. Because most of the deaths we report occurred in patients aged 60 or older, it is reasonable to consider this demographic at high risk while we learn more about age distribution. In addition, the illness progresses rapidly after symptoms first appear; therefore, in suspected cases clinicians should plan to test for the diagnosis and treat early.

The current case-fatality rate for H7N9 infection is 19%, which is much higher than that for seasonal influenza and pandemic H1N1 influenza (0.1% to 1%), but lower than that for avian influenza H5N1 (40% to 60%). However, the case-fatality rate for H7N9 infection should decrease as we learn more about the disease because cases with more severe illnesses are identified earlier in the study of most new diseases.

 

Moreover, no H7N9 virus infections were found among close human contacts of the patients who died, which may allow us to worry a little less about human-to-human transmission of this virus.

 

Collectively, our data suggest that H7N9 virus infection has a relatively high case-fatality rate and progresses rapidly from symptom onset to severe illness and death. Therefore, clinicians should start antiviral treatment when infection with H7N9 virus is first suspected.

Chinese researchers continue to release detailed information on their H7N9 outbreak with remarkable speed.  A mindset that we can only wish the Saudi’s would adopt with their emerging MERS virus.

 

The unanswered question right now is how many mild, or asymptomatic infections there have been with the H7N9 virus (see H7N9: CFR Considerations).

 

If infection is rare, and surveillance is picking up the bulk of them, then this is indeed a very deadly flu virus. 

 

But if there are hundreds of cases going undetected, as researchers at the University of Hong Kong have proposed (see H7N9: Trying To Define The Size Of The Iceberg) then the real case fatality rate could be far lower than it currently appears.

 

It is worth noting at this point that the CFR of the Spanish Flu of 1918 – at least in the United States and most of Europe – was about 2%, or 1/10th the apparent fatality rate of this emerging virus.

 

Which means we could be an order of magnitude too high on calculating the fatality rate, and still be facing a formidable viral foe. 

 

Which is why so much attention has been focused on the H7N9 outbreak in China. While we are seeing a lull in cases right now, officials are anxiously waiting to see what happens with this virus when cooler weather returns in the fall.