Monday, July 28, 2014

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

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Credit CDC PHIL

 

# 8876

 

With three recent high profile laboratory `incidents’ at CDC and FDA labs in the past couple of months  – and ongoing concerns in the biosecurity and biosafety community over controversial `Gain of Function’ research (experiments that seek to enhance the virulence, transmissibility or host range of dangerous pathogens) – scientists are staking out their positions on both sides of this contentious debate.

 

Yesterday, in Updating The Cambridge Working Group, I highlighted the growing roster of scientists who have signed on to their consensus statement, which urges caution, and better regulation, of lab research on dangerous pathogens.

 

Today, I was made aware of another group – Scientists for Science – via a tweet from Professor Vincent Racaniello, which states their position that biomedical research on potentially dangerous pathogens is not only scientifically essential, it can be conducted safely.


The impressive list of founding scientists includes Professor Racaniello, Yoshiro Kawaoka, and Ron Fouchier – all familiar names to readers of this blog.

 

As I’ve printed the Cambridge Working Group’s consensus statement and list of supporters, in the interest of fairness, I’ll do the same with this group as well.

 

Scientists for Science

Scientists for Science are confident that biomedical research on potentially dangerous pathogens can be performed safely and is essential for a comprehensive understanding of microbial disease pathogenesis, prevention and treatment. The results of such research are often unanticipated and accrue over time; therefore, risk-benefit analyses are difficult to assess accurately.

If we expect to continue to improve our understanding of how microorganisms cause disease we cannot avoid working with potentially dangerous pathogens. In recognition of this need, significant resources have been invested globally to build and operate BSL-3 and BSL-4 facilities, and to mitigate risk in a variety of ways, involving regulatory requirements, facility engineering and training. Ensuring that these facilities operate safely and are staffed effectively so that risk is minimized is our most important line of defense, as opposed to limiting the types of experiments that are done.

In contrast to recombinant DNA research at the time of Asilomar in 1975, studies on dangerous pathogens are already subject to extensive regulations. In addition to regulations associated with Select Agent research, experimental plans on other pathogens are peer reviewed by scientists and funding agencies, and the associated risk assessments are considered by biosafety experts and safety committees. Risk mitigation plans are proposed and then considered and either approved or improved by safety committees.

If there is going to be further discussion about these issues, we must have input from outside experts with the background and skills to conduct actual risk assessments based on specific experiments and existing laboratories. Such conversations are best facilitated under the auspices of a neutral party, such as the International Union of Microbiological Societies or the American Society for Microbiology, or national academies, such as the National Academy of Sciences, USA. We suggest they should organize a meeting to discuss these issues.

Scientists for Science have a range of opinions on how risk is best assessed. However, maintaining dogmatic positions serves no good purpose; only by engaging in open constructive debate can we learn from one another’s experience. Most importantly, we are united as experts committed to ensuring public health is not compromised and the reputation of science in general, and microbiology in particular, is defended.

We will use this forum to provide both scientists and the general public accurate information and to foster open and unbiased discourse on how to address these important contemporary issues in microbiology.


Founding Scientists

  • Raul Andino, University of California, San Francisco
  • Wendy Barclay, Imperial College London
  • Constance Cepko, Harvard University
  • Terence Dermody, Vanderbilt University
  • Dickson Despommier, Columbia University
  • Christian Drosten, University of Bonn Medical Centre
  • Peter Doherty, University of Melbourne
  • Paul Duprex, Boston University
  • Rebecca Dutch, University of Kentucky
  • Richard Elliott, University of Glasgow
  • Mary Estes, Baylor College of Medicine
  • Matthew Evans, Icahn School of Medicine at Mt. Sinai
  • Ron Fouchier, Erasmus Medical Center
  • Adolfo Garcia-Sastre, Icahn School of Medicine at Mt. Sinai
  • Elodie Ghedin, New York University
  • Yoshihiro Kawaoka, University of Wisconsin
  • Wyndham W. Lathem, Northwestern University Feinberg School of Medicine
  • Karla Kirkegaard, Stanford University
  • Elke Muhlberger, Boston University
  • Peter Palese, Icahn School of Medicine at Mt. Sinai
  • Ann Palmenberg, University of Wisconsin
  • Andrew Pekosz, Johns Hopkins University
  • Julie Pfeiffer, University of Texas Southwestern Medical Center
  • Glenn Rall, Fox Chase Cancer Center
  • Vincent Racaniello, Columbia University
  • Charles Rice, Rockefeller University
  • Erica Ollmann Saphire, The Scripps Research Institute
  • Stacey Schultz-Cherry, St. Jude Childrens Research Hospital
  • Bert Semler, University of California, Irvine
  • Peter Sarnow, Stanford University
  • Michael Schmidt, Medical University of South Carolina
  • Saul Silverstein, Columbia University
  • Derek Smith, University of Cambridge
  • Geoffrey Smith, University of Cambridge
  • Benjamin tenOever, Icahn School of Medicine at Mt. Sinai
  • Sean Whelan, Harvard University
  • Harald zur Hausen, German Cancer Research Center

 

Since I’ve blogged my concerns over this issue many times in the past (see here, here & here), I’ll not detract from today’s announcement by repeating them again here. 


My only hope is that scientists on both sides of this issue will engage in productive talks, and devise some workable solutions, rather than just setting off another round of heated debate that goes nowhere. 


Well, one can always hope.

BMC: Decline Of Antibody Titers With A(H1N1)pdm Over Time

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Credit NIAID

 

 

# 8875

 

The arrival of a novel H1N1 influenza pandemic virus in 2009 – the first one in more than 40 years – has provided researchers with unique opportunities to observe how a newly introduced flu virus behaves in humans, and quite frankly, in other species as well (see The 2009 H1N1 Virus Expands Its Host Range (Again)).

 

Serological studies that would have been impractical before on H3N2 or the old seasonal H1N1 virus – due to decades of ongoing exposure to these strains – suddenly became possible with a new flu in town.

 

One of the unanswered questions surrounding our immune response to influenza infection is how long does our acquired immunity last?  

 

Admittedly, the answer to that question will vary from one person to the next, and depend on a variety of factors including the strain of flu, the person’s age, general health, and state of their immune system.  And there seems to be a difference between the duration of immunity gained from actual infection vs. through vaccination.

 

Despite circulating now for more than 5 years, the (now seasonal) H1N1 virus remains antigenically very similar to the pandemic strain that emerged in the spring of 2009.  So much so that an an A/California/7/2009 (H1N1)pdm09-like virus will be used for the sixth year running in the flu vaccine. 


Yet, despite having a half of decade of vaccination and natural exposure to this new H1N1 virus, last year saw a particularly heavy H1N1 flu season in North America. Normally, we’d look to antigenic drift to explain a major resurgence of a seasonal flu virus after several years, but H1N1 has been remarkably (albeit, not totally) stable in that regard.

   

Drift is the standard evolutionary path of influenza viruses, and comes about due to replication errors that are common with single-strand RNA viruses (see NIAID Video: Antigenic Drift) Drift is primarily responsible for the need to change flu vaccine strains every couple of years (something that is yet to happen with H1N1).

 

Another possibility is waning immunity, something that is recognized (particularly with vaccines, and among the elderly), but has been difficult to quantify in the past.  Given the immune system’s tabula rasa with regards to the 2009 H1N1 virus, it has become possible to track the decline of antibody titers of a cohort of individuals who were first exposed five years ago.

 

Rate of decline of antibody titers to pandemic influenza A (H1N1-2009) by hemagglutination inhibition and virus microneutralization assays in a cohort of seroconverting adults in Singapore

Jung Pu Hsu, Xiahong Zhao, Mark I-Cheng, Alex R Cook, Vernon Lee, Wei Yen Lim, Linda Tan, Ian G Barr, Lili Jiang, Chyi Lin Tan, Meng Chee Phoon, Lin Cui, Raymond Lin, Yee Sin Leo and Vincent T Chow

BMC Infectious Diseases 2014, 14:414  doi:10.1186/1471-2334-14-414

Published: 28 July 2014

Abstract (provisional)

Background

The rate of decline of antibody titers to influenza following infection can affect results of serological surveys, and may explain re-infection and recurrent epidemics by the same strain.

Methods

We followed up a cohort who seroconverted on hemagglutination inhibition (HI) antibody titers (>=4-fold increase) to pandemic influenza A(H1N1)pdm09 during a seroincidence study in 2009. Along with the pre-epidemic sample, and the sample from 2009 with the highest HI titer between August and October 2009 (A), two additional blood samples obtained in April 2010 and September 2010 (B and C) were assayed for antibodies to A(H1N1)pdm09 by both HI and virus microneutralization (MN) assays. We analyzed pair-wise mean-fold change in titers and the proportion with HI titers >= 40 and MN >= 160 (which correlated with a HI titer of 40 in our assays) at the 3 time-points following seroconversion.

Results

A total of 67 participants contributed 3 samples each. From the highest HI titer in 2009 to the last sample in 2010, 2 participants showed increase in titers (by HI and MN), while 63 (94%) and 49 (73%) had reduction in HI and MN titers, respectively.

Titers by both assays decreased significantly; while 70.8% and 72.3% of subjects had titers of >= 40 and >= 160 by HI and MN in 2009, these percentages decreased to 13.9% and 36.9% by September 2010. In 6 participants aged 55 years and older, the decrease was significantly greater than in those aged below 55, so that none of the elderly had HI titers >= 40 nor MN titers >= 160 by the final sample.

Due to this decline in titers, only 23 (35%) of the 65 participants who seroconverted on HI in sample A were found to seroconvert between the pre-epidemic sample and sample C, compared to 53 (90%) of the 59 who seroconverted on MN on Sample A.

Conclusions

We observed marked reduction in titers 1 year after seroconversion by HI, and to a lesser extent by MN. Our findings have implications for re-infections, recurrent epidemics, vaccination strategies, and for cohort studies measuring infection rates by seroconversion.

The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.

 

The entire study is available, and well worth reading, but I’ve excerpted two paragraphs below that sum up their findings.  

Discussion


The objective of our study was to understand temporal changes in antibody titers following seroconversion during the initial epidemic of A(H1N1)pdm09 infections in  Singapore. Our results revealed a fairly rapid decline in antibody titers following seroconversion, with only a fifth of those who originally had HI titers of  ≥40 and half of those with MN titers of  ≥160 still  having  titers  above  the  respective  cut-off  points  after  a  year.  There  was  also  some indication  that  the  rate  of  decline  was  higher  in  older  individuals,  and  that  the  change  in antibody  titers  measured  by  HI  was  greater  than  by  MN.  Symptomatic  infections  were associated with higher starting antibody titers, and continued to have marginally higher titers in subsequent samples, at least by MN assays.


<SNIP>

Conclusions


Six  months  and  one  year  after  antibodies  peaked  following  presumptive  infection  with A(H1N1)pdm09, only 25% and 14% of participants respectively had antibody  titers against A(H1N1)pdm09 that would be considered protective (HI titer ≥40). The decline in antibody titers may explain susceptibility to re-infections, and recurrent epidemics following the initial epidemic of infections during the pandemic. It also suggests that influenza vaccination may have to be administered more frequently in the tropics where there is year-round circulation of influenza viruses. The rate of decline in elderly individuals may be even more rapid, and if our  findings  are  confirmed,  may  necessitate  alternative  strategies  of  influenza  vaccine development for this vulnerable group.

 

 

A pretty good reminder that even if you got the vaccine last year – or worse, endured the flu last winter – you may not be carrying sufficient immunity forward into the new flu season to protect you against re-infection. 

 

And given that H3N2, and two lineages of Influenza B, are also in circulation – your risks of catching some kind of flu are compounded further.

 

Which is why, even though the H1N1 component of the flu vaccine remains unchanged this year, it is a good idea to get the flu vaccine every year.  

 

Despite variable and sometimes disappointing VE (Vaccine Effectiveness) numbers (see CIDRAP: A Comprehensive Flu Vaccine Effectiveness Meta-Analysis) - particularly among the elderly (see BMC Infectious Diseases: Waning Flu Vaccine Protection In the Elderly) - we continue to see evidence of substantial benefit from the flu shot.

 

For more, you may wish to revisit:

 

CDC: Flu Shots Reduce Hospitalizations In The Elderly
Research: Low Vaccination Rates Among 2013-2014 ICU Flu Admissions
Two Studies On The 2009 Pandemic Flu Vaccine & Pregnancy

MERS: The Price Of Vigilance

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# 8874

 

Although there’s been a precipitous drop in the number of MERS cases reported by Saudi Arabia (and other) Middle Eastern nations over the past month, concerns remain that international travelers could carry the virus to other areas of the globe. 

 

While not always making headlines, many countries are engaged in testing for the virus among symptomatic travelers coming from the Middle East.  

 

Today, we’ve a report from Hong Kong’s CHP on three people being tested (1 has intially tested negative).  Over the past year Hong Kong has tested scores of travelers for MERS, and thus far, all have proved negative. First the report, then I’ll return with more:

.

Three suspected cases of MERS

 
The Centre for Health Protection (CHP) of the Department of Health (DH) is today (July 28) investigating two suspected cases of Middle East Respiratory Syndrome (MERS) affecting a 34-year-old man and a 45-year-old woman, and called on the public to stay alert and maintain good personal, food and environmental hygiene during travel. In addition, the CHP provided an update on the suspected case of MERS notified yesterday (July 27). The 2-year-old boy's respiratory specimen tested negative for MERS Coronavirus (MERS-CoV).


The first patient is a 34-year-old man with good past health. He travelled from Pakistan to Hong Kong via Dubai yesterday and arrived in Hong Kong today. He has presented with fever and vomiting and was screened to have fever at the Hong Kong International Airport today. He was subsequently transferred to Princess Margaret Hospital for isolation. He is currently in stable condition.


The second patient is a 45-year-old woman with good past health. She returned to Hong Kong from Paris via Dubai on July 25 and arrived in Hong Kong on July 26. She has presented with fever and diarrhoea since yesterday and was admitted to Princess Margaret Hospital for isolation today. She is currently in stable condition.


Both patients' respiratory specimens have been collected for laboratory testing by the CHP's Public Health Laboratory Services Branch (PHLSB). Their travel collaterals have remained asymptomatic.


Regarding the suspected case of MERS notified yesterday, the 2-year-old boy's nasopharyngeal aspirate tested negative for MERS-CoV upon preliminary laboratory testing by the CHP's PHLSB. The patient travelled with his family from Dubai to Hong Kong on July 23. He has presented with fever since July 24 and cough since July 26. He was admitted to Princess Margaret Hospital on July 26 and has been in stable condition. His travel collaterals remain asymptomatic. 

"We strongly advise travel agents organising tours to the Middle East not to arrange camel rides and activities involving camel contact, which may increase the risk of infection. In addition, travellers are reminded to avoid going to farms, barns or markets with camels, and avoid contact with animals, especially camels, birds, poultry or sick people during travel," a spokesman for the DH said.

(Continue . . . .)

 

The odds are that these cases, like the ones before them, will test negative for the virus.  

 

But the truth is, as long as the virus continues to occasionally infect humans in the Middle East, public health officials in Hong Kong – and around the world – must be alert to the possibility that international travelers could be arriving with the virus.

 

A little over a week ago, in EID Journal: Respiratory Viruses & Bacteria Among Pilgrims During The 2013 Hajj, we looked at the extraordinarily high percentage of Hajjis (approx. 80%)  who leave Saudi Arabia with some type of respiratory infection.  The vast majority of these respiratory infections were due to either rhinoviruses or influenza, with a smaller number of cases of pneumonia.

 

While MERS wasn’t a major factor among religious pilgrims last year, since that time the number of MERS cases in Saudi Arabia has increased five-fold, and any traveler leaving the region who develops respiratory symptoms is urged to be screened for MERS-CoV.


Whether or not MERS infections surge during the Hajj, public health agencies around the world are going to be taxed by the sheer volume of symptomatic (with `something’) travelers returning from the Middle East this fall.   Most (hopefully, all) will have something mundane, like seasonal influenza or the common cold.

 

Hong Kong’s CHP is particularly pragmatic when it comes to the potential for seeing MERS arrive in their jurisdiction.  In their new release, they also advise:

 

Early identification of MERS-CoV is important, but not all cases can be detected in a timely manner, especially mild or atypical cases. Health-care workers (HCWs) should maintain vigilance and adhere to strict infection control measures while handling suspected or confirmed cases to reduce the risk of transmission to other patients, HCWs or visitors. Regular education should be provided.


Travellers returning from the Middle East who develop respiratory symptoms should wear face masks, seek medical attention and report their travel history to the doctor. HCWs should arrange MERS-CoV testing for them. Patients' lower respiratory tract specimens should be tested when possible and repeat testing should be undertaken when clinical and epidemiological clues strongly suggest MERS.

 

While having more MERS cases spreading internationally this fall would be a serious public health concern, just the threat of seeing the virus arrive poses a tremendous challenge for public health agencies around the world.

 

And this comes at a time when public health funding and staffing in the United States continues to erode (see TFAH report Investing in America’s Health: A State-by-state Look at Public Health Funding & Key Health Facts).

 

Even as funding for public health declines, the number of global disease threats only seems to be increasing. 

To MERS-CoV we can add H5N1, H7N9, Chikungunya, Dengue, Ebola, Lassa Fever,  CCHF, Polio, NDM-1, CRE, XDR-TB  . . .  and of course the one we don’t know about yet . . . Virus X.

 

Faced as we are with an ever expanding rogue’s gallery of pathological fliers, the recent cuts in public health spending are all the more difficult to fathom.  And are an economy we could easily come to regret.

South Korea: Fresh Reports Of FMD & H5N8

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# 8873

 

For large scale agri-business, nothing conjures  feelings of dread like the emergence of a highly pathogenic strain of avian influenza, or an outbreak of FMD (Foot & Mouth Disease), as both threaten large segments of a region’s economy and food production, and neither are easy to eradicate.

 

Last January South Korea was hit by a new strain of avian flu H5N8 – which spread to scores of farms across the nation and led to the culling of more than 10 million birds.  Although the outbreak appeared to have been stamped out by May, last month (see Korea: Fears Of H5N8 Resurgence) a new outbreak was reported on a poultry farm in Daegu.

 

After a quiet month on the bird flu front, yesterday Korean media reported another outbreak of H5N8, this time in South Jeolla.

 

Avian flu confirmed at South Jeolla duck farm

July 28,2014

Avian influenza (AI) was confirmed yesterday at a duck farm in Korea, local officials said, just days after the government detected another instance of the potentially deadly foot-and-mouth disease.


The South Jeolla Livestock Sanitation Office said yesterday that a highly pathogenic strain of bird flu, H5N8, was discovered Friday at a duck farm in Hampyeong in the southwestern province. Upon official confirmation, approximately 42,000 ducks at the farm were immediately culled, officials said.

(Continue . . . )

 

 

Although there is a decided seasonality to avian flu outbreaks (peaking in winter & spring), theses viruses can continue to circulate year-round.  Areas where the H5N1 virus is particularly well entrenched – like Egypt & Indonesia – frequently report poultry outbreaks even in the heart of summer.


This is the first summer of H5N8, and thus far, the seasonal pattern of the virus appears to be consistent with what we’ve seen with H5N1 and H7N9.   

 

Earlier this year, in EID Journal: Describing 3 Distinct H5N8 Reassortants In Korea – we saw a report on the continual evolution of the H5N8 virus.  Like all flu viruses – H5N8 continues to mutate and adapt – meaning that the virus we see next fall, or next year, may not behave quite like the virus we have before us today. 

 

Adding insult to injury, last week South Korea also reported their first FMD case in three years (see OIE: Foot & Mouth Disease In South Korea), setting off alarm bells, and putting the nation on alert for this hard to eradicate disease.

 

FMD is a highly contagious viral disease that primarily afflicts cloven-hoofed animals (including cattle, sheep, goats, pigs, deer, etc.). Caused by a picornavirus, it has no relation to HFMD, which is a childhood disease in humans caused by a number of non-polio enteroviruses.

While there were hopes that the discover of FMD last week at a pig farm represented an isolated incident, today another outbreak has been reported on a pig farm 70 kilometers distant from the first report.   This from AFP.

 

S Korea detects second foot-and-mouth case

POSTED: 28 Jul 2014 17:56

South Korea on Monday (July 28) reported its second case of foot-and-mouth disease in less than a week. An official confirmed the case in a pig farm in North Gyeongsang province, but played down the threat.

(Continue . . . )

 

During the 2010-2011 FMD outbreak in South Korea, roughly 3.5 million animals were destroyed (151,425 cattle, 3,318,299 pigs, 8,071 goats, and 2,728 deer) and buried at more than four thousand locations around the country (EID Journal Control of Foot-and-Mouth  Disease during 2010–2011 Epidemic, South Korea).

 

While culling was a huge part of the control operation, South Korea also imported a Serotype 0 vaccine and instituted a `vaccinate to live’ policy, as described in the EID dispatch above:

 

According to national policy, culling began in November 2010 for all animals on farms with infected animals. Once vaccination was expanded nationwide in mid-January 2011, a vaccination-to-live policy was implemented; that is, vaccinated animals on farms with infected animals were culled only if the outbreak began within 2 weeks after vaccination but not if the outbreak began >2 weeks after vaccination.

 

As a result, a high percentage of South Korea’s livestock are vaccinated against the currently detected FMD serotype, which ought to help contain its spread.

 

Although the 7 serotypes of FMD are found all over the world, the United States has not seen an outbreak since 1929.

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OIE Disease Outbreak Map – Current FMD

 

A 2013 Homeland Security report (see A World Free of one of the Most Virulent Animal Diseases?) on the creation of a new, (single sero-type) non-live virus vaccine for FMD, warns that the costs of an outbreak in this country could exceed $50 billion.

 

While definite progress, with 7 sero-types, and more than 60 known subtypes, the world remains a long way from eliminating this scourge.

Sunday, July 27, 2014

Updating The Cambridge Working Group

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Credit CDC PHIL



# 8872

 


Two weeks ago in Reshuffling The NSABB & A New Biosecurity Working Group Emerges, we learned that the NIH had notified 11 of the 23 original members of the NSABB (or National Science Advisory Board for Biosecurity) - an under-utilized biosafety advisory committee, formed in 2005 - that their services are no longer required.

 

Gone were such well known (and frequently outspoken) experts as Paul Keim from Northern Arizona University, Arturo Casadevall from Albert Einstein College of Medicine, Michael Imperiale of the University of Michigan, and Michael Osterholm from CIDRAP.

 

Given the recent serious lapses in lab biosecurity at both the CDC and FDA, and continued work on `Gain of Function’ research (designed to enhance the virulence, transmissibility, or host range) of highly dangerous pathogens (see The Debate Over Gain Of Function Studies Continues), one might easily have assumed that the NSABB would have their plates full.

 

Although they made headlines in 2011-2012 over their cautionary stance regarding the publication of the Fouchier H5N1 ferret study (see The Furor Over H5N1 Research Continues), the NSABB been idle for the past two years, with no requests from the NIH to reconvene.

 

The day following the NIH’s decision to release 11 of their members, a new initiative appeared online called the Cambridge Working Group, with a consensus statement supported by 18 internationally known experts and researchers (including several former NSABB members).

 

Cambridge Working Group Consensus Statement on the Creation of Potential Pandemic Pathogens (PPPs)

Recent incidents involving smallpox, anthrax and bird flu in some of the top US laboratories remind us of the fallibility of even the most secure laboratories, reinforcing the urgent need for a thorough reassessment of biosafety. Such incidents have been accelerating and have been occurring on average over twice a week with regulated pathogens in academic and government labs across the country. An accidental infection with any pathogen is concerning. But accident risks with newly created “potential pandemic pathogens” raise grave new concerns. Laboratory creation of highly transmissible, novel strains of dangerous viruses, especially but not limited to influenza, poses substantially increased risks. An accidental infection in such a setting could trigger outbreaks that would be difficult or impossible to control. Historically, new strains of influenza, once they establish transmission in the human population, have infected a quarter or more of the world’s population within two years.


For any experiment, the expected net benefits should outweigh the risks. Experiments involving the creation of potential pandemic pathogens should be curtailed until there has been a quantitative, objective and credible assessment of the risks, potential benefits, and opportunities for risk mitigation, as well as comparison against safer experimental approaches. A modern version of the Asilomar process, which engaged scientists in proposing rules to manage research on recombinant DNA, could be a starting point to identify the best approaches to achieve the global public health goals of defeating pandemic disease and assuring the highest level of safety. Whenever possible, safer approaches should be pursued in preference to any approach that risks an accidental pandemic.

Original Signatories & Founding Members:

(Founding Members met in Cambridge on July 14 and crafted the statement)

  • Amir Attaran, University of Ottawa
  • Barry Bloom, Harvard School of Public Health
  • Arturo Casadevall, Albert Einstein College of Medicine
  • Richard Ebright, Rutgers University
  • Nicholas G. Evans, University of Pennsylvania
  • David Fisman, University of Toronto Dalla Lana School of Public Health
  • Alison Galvani, Yale School of Public Health
  • Peter Hale, Foundation for Vaccine Research
  • Edward Hammond, Third World Network
  • Michael Imperiale, University of Michigan
  • Thomas Inglesby, UPMC Center for Health Security
  • Marc Lipsitch, Harvard School of Public Health
  • Michael Osterholm, University of Minnesota/CIDRAP
  • David Relman, Stanford University
  • Richard Roberts (Nobel Laureate '93), New England Biolabs
  • Marcel Salathé, Pennsylvania State University
  • Lone Simonsen, George Washington University
  • Silja Vöneky, University of Freiburg Institute of Public Law, Deutscher Ethikrat

In the two weeks since that initiative appeared only, more than 50 more Charter Members have also signed, including such familiar names as John S. Brownstein from Harvard Medical School, Neil M. Ferguson of Imperial College, W. Ian Lipkin of Columbia University, Andrew Rambaut of the University of Edinburgh, UK, and Klaus Stöhr, Novartis Vaccines and Diagnostics.


Follow this link to review this expanding roster of supporters.

 

As you might imagine, urging caution over this sort of research won’t win popularity contests in some circles of academia, as these (often government funded) research projects can bring in large grants, along with substantial publicity and prestige to labs, universities, and researchers.

 

Suggestions that this sort of work be confined to biosafety level 4 facilities are often met with stiff resistance, as that would exclude most of the university based labs in this country.

 

The debate up until now over this type of research has been largely limited to academia, and has often been acrimonious.

 

The often promised  `thorough public discussion of the risks and benefits involved; never materialized as the issue exited the headlines, and GOF research resumed in early 2013 after Scientists Declare End To H5N1 Research Moratorium.

 

While undeniably bad timing for proponents of unfettered GOF research, three high profile lab incidents this summer involving anthrax, smallpox, and avian flu  have reawakened the public’s (and congressional) concern over lab safety and the wisdom of conducting certain types of research.

 

Despite the assurances from researchers on the relatively low risk of an accidental biological release, if we’ve learned nothing else this summer, it’s that accidents can happen even the best labs in the country.

 

And when dealing with Potential Pandemic Pathogens (PPPs), even a small mistake could have serious public health ramifications.

 

The stated goal here isn’t to ban GOF or DURC (Dual Use Research of Concern) studies, but rather to ensure they are only conducted in an appropriate high containment lab, are done in the safest and most responsible way possible, and only conducted when their benefits clearly outweigh the risks

 

While additional regulation is unlikely to be popular among many engaged in GOF research, these are all issues that need to be discussed, mapped out, and agreed upon.

 

And preferably before next high profile lab accident makes the headlines . . . or worse.

 

For more on the issue of Lab Safety,  GOF,  and DURC research, you may wish to revisit:

 

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

Saturday, July 26, 2014

CDC Interim Ebola Exposure Guidance For Airlines, Flight Crews

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Range of Reported Ebola Outbreaks 1976-2014 – Credit WHO

 

 

 

# 8870

 

The story – confirmed this morning in the latest WHO update (see WHO Ebola Update – July 25th) – that a `probable’ Ebola patient (who died in isolation yesterday) traveled by airplane from Liberia to Lagos, Nigeria last Sunday `while symptomatic’  has captured headlines overnight.

Although the WHO statement did not elaborate on his symptoms, according to multiple media accounts (see here, and here) the patient became ill on the flight and vomited, and was quarantined upon landing.

 

Although I’ve not seen any description of the type of aircraft or number of passengers, according to a BBC report today (see Nigeria 'placed on red alert' over Ebola death), Health Minister Onyebuchi Chukwu is quoted as saying `. . . the other passengers on board the flight had been traced and were being monitored’ .

 

You may recall that a little over a month ago, we saw Spain Testing Traveler For Possible Ebola Infection, but in that case the patient tested negative.

 

At the time, we looked at the ECDC’s  Rapid Risk Assessment on Ebola (June 9th), where experts worked out several scenarios where the Ebola virus might travel to the European Union, and their recommended response to Scenario 3: Passenger with symptoms compatible with EVD on board an airplane.


Similarly the CDC has also published their own guidance on how to deal with a probable or suspected Ebola case on an airplane.

 

Interim Guidance about Ebola Virus Infection for Airline Flight Crews, Cleaning and Cargo Personnel

Overview of Ebola Disease

Ebola hemorrhagic fever is a severe, often-fatal disease caused by infection with a species of Ebolavirus. Although the disease is rare, it can spread from person to person, especially among health care staff and other people who have close contact* with an infected person. Ebola is spread through direct contact with blood or body fluids (such as saliva or urine) of an infected person or animal or through contact with objects that have been contaminated with the blood or other body fluids of an infected person.

The likelihood of contracting Ebola is extremely low unless a person has direct contact with the body fluids of a person or animal that is infected and showing symptoms. A fever in a person who has traveled to or lived in an area where Ebola is present is likely to be caused by a more common infectious disease, but the person would need to be evaluated by a health care provider to be sure.

The incubation period for Ebola ranges from 2 to 21 days. Early symptoms include sudden fever, chills, and muscle aches. Around the fifth day, a skin rash can occur. Nausea, vomiting, chest pain, sore throat, abdominal pain, and diarrhea may follow. Symptoms become increasingly severe and may include jaundice (yellow skin), severe weight loss, mental confusion, shock, and multi-organ failure.

The prevention of Ebola virus infection includes measures to avoid contact with blood and body fluids of infected individuals and with objects contaminated with these fluids (e.g., syringes).

Management of ill people on aircraft if Ebola virus is suspected

Crew members on a flight with a passenger or other crew member who is ill with a fever, jaundice, or bleeding and who is traveling from or has recently been in a risk area should follow these precautions:

  • Keep the sick person separated from others as much as possible.
  • Provide the sick person with a surgical mask (if the passenger can tolerate wearing one) to reduce the number of droplets expelled into the air by talking, sneezing, or coughing.
  • Tissues can be given to those who cannot tolerate a mask.
  • Personnel should wear impermeable disposable gloves for direct contact with blood or other body fluids.
  • The captain of an airliner bound for the United States is required by law to report to the Centers for Disease Control and Prevention (CDC) any ill passengers who meet specified criteria. The ill passenger should be reported before arrival or as soon as the illness is noted. CDC staff can be consulted to assist in evaluating an ill traveler, provide recommendations, and answer questions about reporting requirements; however, reporting to CDC does not replace usual company procedures for in-flight medical consultation or obtaining medical assistance.
General Infection Control Precautions

Personnel should always follow basic infection control precautions to protect against any type of infectious disease.

What to do if you think you have been exposed

Any person who thinks he or she has been exposed to Ebola virus either through travel, assisting an ill passenger, handling a contaminated object, or cleaning a contaminated aircraft should take the following precautions:

  • Notify your employer immediately.
  • Monitor your health for 21 days. Watch for fever (temperature of 101°F/38.3°C or higher), chills, muscle aches, rash, and other symptoms consistent with Ebola.
When to see a health care provider
  • If you develop sudden fever, chills, muscle aches, rash, or other symptoms consistent with Ebola, you should seek immediate medical attention.
    • Before visiting a health care provider, alert the clinic or emergency room in advance about your possible exposure to Ebola virus so that arrangements can be made to prevent spreading it to others.
    • When traveling to a health care provider, limit contact with other people. Avoid all other travel.
  • If you are located abroad, contact your employer for help with locating a health care provider. The U.S. embassy or consulate in the country where you are located can also provide names and addresses of local physiciansExternal Web Site Icon.

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As you can see, the CDC (and ECDC) response to these sorts of exposures is far less draconian than movies and TV might lead one to assume.  Awareness and self monitoring for symptoms, not automatic quarantine, is the norm.

 

Although considered a low probability event, with millions of airline passengers every year, and an incubation period up to three weeks - it isn’t inconceivable for Ebola (or other viral hemorrhagic fever)  to board an airplane undetected.

 

After all, over the past decade we’ve seen three cases of Lassa fever imported in the United States (see Minnesota: Rare Imported Case Of Lassa Fever).

The bottom line  is that we ignore global healthcare and infectious disease outbreaks – even in the remotest areas of the world – at our own peril. Vast oceans and extended travel times no longer offer us protection. There are no technological shields that we can erect that would keep viruses like Ebola, MERS-CoV, or pandemic influenza from finding their way to our shores.

 

Which makes the funding and support of international public health initiatives, animal health initiatives, and disease surveillance ever so important, no matter where on this globe you happen to live.