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Can We Improve Safety at Bio-Containment Labs During a Pandemic?

What a Difference Just a Few Weeks Make

When we started this series on laboratory safety at the end of July, there was intense scrutiny over multiple security lapses at CDC research laboratories. You may recall that we reported on a scathing editorial condemning the current state of safety at U.S. government bio-containment laboratories, which was written by the Deputy Editor of the Annals of Internal Medicine, Dr Deborah Cotton, MD, MPH. We had intended to follow up our first article in this series with a report on the decisive steps taken by CDC leadership, including the temporary closure of the BRRAT and NCIRD facilities as well as a temporary ban on transportation of highly dangerous Select Agent pathogens. We include this information in today’s article. But in early August, the rarefied world of bio-containment research labs was once again thrust back into the headlines.

This time, the tables were turned 180° — security lapse failures at CDC laboratories were suddenly forgotten. Instead, the world’s attention turned to the Ebola crisis as a few precious doses of a new experimental serum were rushed to treat two American missionaries and a handful of others who contracted the lethal virus. Despite the calls for increased safety measures just weeks earlier, the experimental serum, known as ZMAPP, was administered prior to any human drug trials.

 

CDC Microbiologist Dr Taronna Maines inoculates a 10-day old emryonated hen′s eggs with a specimen containing an H5N1 avian influenza virus during an experiment at a BSL-3 laboratory to study  pathogenicity and transmissibility of newly emerging H5N1 viruses. Image courtesy Greg Knobloch, CDC.

CDC Microbiologist Dr Taronna Maines inoculates a 10-day old emryonated hen′s egg with a specimen containing an H5N1 avian influenza virus during an experiment at a BSL-3 laboratory to study pathogenicity and transmissibility of newly emerging H5N1 viruses. Image courtesy Greg Knobloch, CDC.


Where Do Things Stand Today?

The American missionaries, Nancy Writebol and Dr Kent Brantly, have been discharged from Emory University Hospital in Atlanta, apparently fully recovered and now presumably immune from the particular strain of Ebola virus they contracted in Monrovia, Liberia. Other patients who received the ZMAPP serum, including a Spanish priest, did not survive the disease’s onslaught however.

 

Ebola Continues to Spiral Out of Control in West Africa

The World Health Organization (WHO) has re-calibrated their earlier estimates of the extent of the disease outbreak– the crisis has been significantly under-estimated to date they say. WHO now reports that over 120 health workers have died from the Ebola outbreak, and yesterday they announced a withdrawal of WHO medical staff from Sierra Leone facilities after a WHO doctor working with patients himself became infected with the virus.

WHO now estimates that they will need more than $430 million to bring the epidemic under control (up from $71 million). Their new goal is to stop the upward trend in new cases during the next two months and prevent transmission of the disease in the region within 6 to 9 months.

 

Life or Death Situations Can Force an Immediate Shift in Priorities

For professionals working in the field of laboratory research, the whipsaw reversal of opinions by grandstanding media analysts and politicians has to be frustrating. Only one month ago, there were widespread calls in the press and on Capitol Hill to tighten up the safety culture in bio-containment labs in light of an anthrax and a bird flu scare at CDC facilities in Georgia as well as the discovery of some smallpox virus samples dating back to the nineteen-fifties stored in an NIH warehouse.

Then — just a few weeks later — the same media pundits were out in force stoking the (admittedly terrifying) prospect of an Ebola outbreak in this country — asking what could be done to make scientists speed up delivery of new treatments under development in the research laboratory in order to stem the tide of the epidemic. At this point, the fear of a domestic Ebola outbreak is now fully politicized, having landed front and center in the mid-term congressional elections, as evidenced by this political attack ad in the race for an Arkansas U.S. Senate seat released on Monday.

 

 

Policy Planners and Scientific Researchers Have to Look on This Kind of Political Bashing with Dismay

The political histrionics in the campaign ad video above underscore additional critiques made by Dr Cotton. She asserts that laboratory researchers operate in an environment where research portfolio(s) and priorities have shifted rapidly and we have acted more on emotion and less on scientific analysis. In her original editorial, Dr. Cotton was making references to Department of Homeland Security (DHS) laboratory research priorities set in place after September 11, 2001.

As we approach the 13th anniversary of the surprise attacks on the twin towers of the World Trade Center and the Pentagon — as well as the anthrax germ warfare scare following shortly thereafter —  it seemed like the passing of time was starting to make it easier to be a little more circumspect about the nature of political and policy decisions made during 9/11’s chaotic aftermath. Yet the past month has also been very instructive, reminding us once again that during a crisis public opinion can shift rapidly. Calls for a ‘go slow’ approach to bio-containment laboratories — based on an abundance of caution — have now been completely drowned out by vocal demands by media analysts and elected government officials. Their new mantra: Research scientists need to speed up and deliver an instant fix to the current crisis, no matter what the cost or consequence.

Ironically, these very rapid shifts in research priorities as well as ongoing ‘stop and start’ interruptions in research funding (as exemplified recently by the slashing of many public health research grants during the Government’s budget ‘sequester’) can’t help but derail efforts to establish and nurture a steady, sound, consistent and competent safety culture at our research laboratories.

 

CDC scientist Zach Braden counts viral plaques within fixed monolayers of cells over a light box in order to titrate a viral stock in BSL-4 Lab. Image courtesy James Gathany, CDC.

CDC scientist Zach Braden counts viral plaques within fixed monolayers of cells over a light box in order to titrate a viral stock in BSL-4 Lab. Image courtesy James Gathany, CDC.


 

Let’s Look at Some of the Other Points Made By Dr. Cotton

As a result of 9/11, Dr Cotton contends we’ve seen a large growth in the overall number of bio-safety lab facilities. The safety implication here is that as the number of facilities increases, so do the risks we face from accidental exposure to Select Agent pathogens. One might argue it may have also increased the need for effective scientific and safety oversight beyond our present managerial capabilities. The Government Accountability Office (GAO) certainly feels this way. They addressed this concern in their report titled High-Containment Laboratories: National Strategy for Oversight Is Needed first issued on September 21st, 2009.  This past February, the GAO provided an update of the report to Congress (PDF, opens in new window) where they once again recommended the need for…

… the National Security Advisor (to) identify a single entity, charged with periodic government-wide strategic evaluation of high-containment laboratories, that will

(1) determine (a) the number, location, and mission of the laboratories needed to effectively meet national goals to counter biothreats; (b) the existing capacity within the United States; (c) the aggregate risks associated with the laboratories’ expansion; and (d) the type of oversight needed

and (2) develop, in consultation with the scientific community, national standards for the design, construction, commissioning, and operation of high-containment laboratories, specifically including provisions for long-term maintenance.

With no exact laboratory count available, the GAO estimates the number of BSL-3 and BSL-4 laboratories in the U.S. at 1,362 in 2008, increasing to 1,495 in 2010. (The count is based on the number of facilities registered with the Federal Select Agent Program for dangerous Class A pathogens.)

 

Is There a Lack of Safety Culture in Our Laboratories?

Dr Cotton also contends that we lack an effective safety culture in laboratory research and that safety is as much about training, policies and procedures as it is about by identity scanning, air filtration systems, spacesuits and surveillance cameras. The safety lapses at NIH and CDC facilities, which came to light earlier this year, certainly serve as a wake-up call to improve laboratory safety culture. In this video, Dr Thomas (Tom) R. Frieden, Director of the CDC announces some of the sweeping changes made in light of these serious safety lapses:

 

 

As a result of Freiden’s changes, Michael Farrell, head of the BBRAT laboratory, was let go. Dr Michael (Mike) Bell was installed as Director of Laboratory Safety, CDC. Frieden also established an 11 member external oversight committee, called the CDC External Lab Safety Workgroup, to be chaired by Joseph Kanabrocki, Assistant Dean for Biosafety and Associate Professor of Microbiology, University of Chicago. Time will tell if these organizational changes and the new oversight committee will help improve laboratory safety at bio-containment laboratories in the U.S. We certainly hope so.

 

It’s Important to Not Overreact

In our view, some of the safety lapse disclosures made earlier in the year could actually be seen as positive developments, representative of a good working safety culture — one where accidents are reported, investigated and dealt with on a ‘lessons learned’ basis. For example, the discovery and disclosure of vials of smallpox, stored at the NIH since the 1950s, is, while scary on its face, actually indicative of a good laboratory safety culture. It demonstrates that laboratory researchers and facility workers are making good faith efforts to identify, document, and dispose of legacy materials, including those which have been misplaced, or misidentified.

This reminds us of the good housekeeping practices which are part of establishing a 5S program in the workplace. On the other hand, we share Dr. Frieden’s grave concern about the lack of a timely and forthcoming communication upon the discovery of errors in handling highly dangerous avian flu pathogens at the Southeast Poultry Research Laboratory (SEPRL).

 

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Breaking the Ebola Quarantine Puts Nigeria at Risk

Concerns About the Ebola Outbreak Have Risen Dramatically Now That the Disease Has a Toehold in Africa’s Most Populous Country — Nigeria.

During earlier outbreaks of Ebola, public health officials and epidemiologists were able to tamp down the spread of the virus in large part because the affected communities were so isolated. Because there used to be such minimal lines of contact between affected communities in Africa, strict quarantines were an effective control technique for eliminating earlier outbreaks of the Ebola virus — a remarkable feat considering there was no widely available treatment for the disease.

 

Ebola Virus Outbreak, image by Centers for Disease Control and Prevention

Ebola Virus Outbreak, image by Centers for Disease Control and Prevention

 

 

On the day that we posted our last article, the World Health Organization declared that the current outbreak of the Ebola virus in West Africa is a matter of international concern.

 

Dr. Margaret Chan, Director General of the World Health Organization

 

Ebola Quarantines are Not Working as Effectively as They Have in the Past

The major reason? The economic fortunes of Africa have changed dramatically over the last 10 to 15 years — generally for the better. In fact, there’s been a veritable race by Chinese, European and American multinationals to secure natural resources for extraction. Major investments have been made in minerals mining as well as oil and gas exploration and production. This in turn has dramatically increased commerce across the region, resulting in a strong surge in business travel between the growing African commercial centers.

But this dramatic increase in travel and commerce across the continent has wreaked havoc on the ability of public health officials to use quarantines to control the Ebola outbreak in this current epidemic. This past July, the Ebola disease outbreak in Liberia literally flew in a commercial flight over four countries — Ivory Coast, Donna, Togo and Benin — to land in Lagos, Nigeria, the capital of Africa’s most populous country.

 

Nigeria’s Patient Zero: Patrick Sawyer

The tragic story of Nigeria’s “Patient Zero” — the late Patrick Sawyer, a 40-year-old naturalized American citizen — illustrates the difficulty of relying on quarantine procedures to limit the outbreak. Mr Sawyer was an Liberia-based employee of ArcelorMittal, which, according to their website, is “the world’s leading integrated steel and mining company.” They have a presence in more than sixty countries. According to internal ArcelorMittal reports, Mr Sawyer’s sister died in Liberia from Ebola virus on July 8th.

Even though Sawyer had minimal contact with his sister, his employer ArcelorMittal followed Liberian Ministry of Health guidelines and put Sawyer on paid administrative leave so he could enter a 21 day period of isolation (the presumed incubation period for Ebola), during which he was to undergo daily monitoring for signs of the disease.

 

Sawyer Skipped Ebola Quarantine to Attend an Economic Conference

However, Sawyer did not stay in voluntary quarantine. Instead, in the meantime he had received clearance from the Liberian Department of Finance to travel to Nigeria for a conference organized by the Economic Community of West African States (ECOWAS) According to the Liberian newspaper, The New Dawn, a review of closed-circuit television footage from the Monrovia airport showed images of Mr Sawyer boarding an Asky Airline flight to Lagos on July 20. In the surveillance video, it was reported that Mr Sawyer looked unwell and appeared to be in severe pain. During the flight, he fell severely ill and upon landing at the Murtala Mohammed Airport, he was taken to the First Consultant Hospital, Obalende in Lagos. Despite his illness, officials from the hospital said in a prepared statement that they had to resist pressure from Liberian officials to discharge Mr. Sawyer, in order that he could still attend the ECOWAS conference in Calabar, Nigeria.

Four days later Sawyer died from Ebola Virus at First Consultant Hospital.

The frustration by Nigerian health officials was palpable. This past Monday, Nigeria’s Health Minister, Onyebuchi Chukwu, made a public statement that acknowledged they had received an apology from the Liberian Government. But Chukwu then went on to vent his frustration that his country Nigeria, which had been free from infection, now faced an enormous task of controlling the Ebola virus. To date, 10 cases of Ebola have been confirmed in Nigeria by the government. According to Chukwu, the most recent case is a female nurse who came in contact with Sawyer at the First Consultant Hospital.

 

Update From Emory Hospital’s Isolation Unit for Infectious Diseases

Meanwhile, here’s a quick update on the two American Ebola patients undergoing treatment at Emory University Hospital in Atlanta: Nancy Writebol, 59, continues to improve and she has been reunited with her husband David, who successfully passed a quarantine and has been declared free of the Ebola virus. Dr. Kent Brantly has also improved. He issued a lengthy statement expressing his belief in the missionary work he was performing at the ELWA Hospital in Liberia.

In an effort to tamp down widespread public criticism against bringing the two American patients from West Africa to mid-town Atlanta for treatment, Emory Healthcare’s Chief Nurse — Susan Mitchell Grant, RN — issued a very strong public letter defending Emory’s healthcare mission and the important role they play in medical research needed to secure public health threats like the Ebola virus.

 

The Public Affairs Department at Emory Went Into Overdrive

Dr. Alex Isakoff, Executive Director for Emory University Hospital’s Office for Critical Event Preparedness and Response, continued his media appearances with a long interview on Bloomberg’s BusinessWeek television.

 

 

Bruce Ribner MD, an epidemiologist at the Emory University School of Medicine, also spoke at the press conference (in the video above) to explain the high security measures in force at Emory’s Serious Communicable Disease Unit. The hospital also issued a diagram showing a portion of the Serious Communicable Disease Unit (isolation unit) at Emory University Hospital (See illustration below).

The facility, which was built in conjunction with the CDC, has been used in previous outbreaks of highly dangerous pathogens such as the SARS outbreak and MERS. According to Ribner, the original intended function of the Serious Communicable Disease Unit was  to serve as an isolation unit in support of CDC personnel who may have possibly contracted dangerous infections through their work — either at CDC’s Atlanta area research labs or while on remote field assignments, such as those the CDC is currently conducting in Africa.

 

Emory-University-Hospital-Serious-Communicable-Disease-Unit

 

The high security facility was opened in 2004 on the ground floor of Emory University Hospital’s General Clinical Research Center in mid-town Atlanta. The unit has three beds in total. The diagram above illustrates just one of the three beds in the facility. In this wing, a patient is treated in the room marked (1). Surrounding the patient are several ancillary support areas. Family members can see the patient through a highly protected glass window. Microphones and speakers allow for communication. Air circulation is tightly controlled and specially filtered in a separate, isolated HVAC system.

Finally, Emory University Hospital’s CEO Robert “Bob” Bachman took to the television airwaves to announce his unwavering support of the treatment of the two American patients who contracted Ebola while performing missionary work in Africa. “We are absolutely confident that our policies, our procedures, our structure, our containment unit are such that the virus will not get out into the rest of the hospital or anywhere else,” Bachman said. To underscore his confidence in his facility’s ability to contain and treat the contagion, Bachman says he has set up his command room just outside the Serious Communicable Disease Unit so he can monitor daily progress. He said has “zero anxiety” about being so close to the patients under treatment.

 

Next week we will look at the Laboratory Researchers working on vaccines and therapy treatments for Ebola and other related viruses under an NIH grant issued this past March.

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At Formaspace, we take laboratory safety very seriously. If you agree, you should give us a call at 800.251.1505 to learn more about our full line of stock, semi-custom and custom-made laboratory furniture, workbenches, lab benches and dry lab/wet labs — as well as our laboratory design / furniture consulting services.

We encourage you to join our roster of satisfied technical, manufacturing and laboratory furniture clients — including Apple Computer, Boeing, Dell, Eli Lilly, Exxon Mobile, Ford, General Electric, Intel, Lockheed Martin, Medtronic, NASA, Novartis, Stanford University, Toyota and more. Give us a call today.

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Race Against Time: Anti-Ebola Serum Flown to US

Since our first article in a series touching on safety lapses at laboratories operated by the Centers for Disease Control and Prevention (CDC) appeared last week, the Ebola virus outbreak in western Africa has escalated to become a 24×7 global news story. We now provide you with an overview of the fast moving events that have occurred during the past week.

 

This transmission electron micrograph (TEM) images reveals some of the ultrastructural morphologic changes in a tissue sample isolate due to an Ebola hemorrhagic fever infection, including the presence of numbers of Ebola virions. Image courtesy Cynthia Goldsmith and CDC.

This transmission electron micrograph (TEM) image reveals some of the ultrastructural morphologic changes in a tissue sample isolate due to an Ebola hemorrhagic fever infection, including the presence of numbers of Ebola virions. Image courtesy Cynthia Goldsmith and CDC.


Ebola Outbreak in Western Africa

In the worst outbreak of the disease since it was first discovered 38 years ago, the Ebola virus outbreak centered in Liberia, Sierra Leone and Guinea is reported to have infected over 1300 people and killed more than 730, according to the World Health Organization. In total, over 2,300 Ebola virus deaths have been recorded since 1976.

 

Ebola’s Symptoms Mirror Ordinary Flu… at the Beginning

The Ebola virus does not spread until the person begins to show symptoms; this typically takes 2 to 21 days. The lengthy incubation period before symptoms appear has ratcheted up the fear factor –because it’s long enough for infected persons to travel across the globe before they show signs of the virus. And, because the Ebola virus first presents itself with ordinary flu-like symptoms–  fever, headache and loss of appetite — it’s hard to differentiate it at first from other ordinary flu viruses.

This has led to public hysteria in New York City over the weekend, when a patient with flu-like symptoms was rumored to actually be infected with Ebola. At this moment, the case is still unresolved but most health experts do not expect Ebola to be implicated in the NYC case. After the flu-like symptoms appear, the Ebola disease then takes a terrible turn: patients experience blood clots, internal bleeding, vomiting and diarrhea. A skin rash breaks out. Blood can seep out from the eyes, nose or mouth. Patient that die from Ebola usually succumb to shock or multiple organ failure.

 

Fear of the Plague

Like the Black Plague in the Middle Ages, Ebola causes a hemorrhagic fever that is the stuff nightmares are made of.

“This outbreak is moving faster than our efforts to control it. If the situation continues to deteriorate, the consequences can be catastrophic in terms of lost lives but also severe socioeconomic disruption and a high risk of spread to other countries.”

Dr. Margaret Chan, Director-General of the World Health Organization

 

The American Patients

In the past few days, the world’s attention has focused on two American missionaries who have contracted the disease. Nancy Writebol, 59, along with her husband David, has been a missionary for 15 years in Ecuador, Zambia and most recently in Liberia. Working as a hygienist in a hospital, Writebol’s mission work for Service in Mission (SIM) is sponsored by her church, Cavalry Church in Charlotte, North Carolina. Dr. Kent Brantly, 33, married to wife Amber, is a general physician, trained in Fort Worth with ties to Texas and Indiana. As part of his missionary work for Samaritan’s Purse, he apparently contracted the virus when attending to Ebola patients at the same Liberian hospital where Writebol worked.

 

Diminished Trust in Science and Institutions

Distrust of both scientific laboratory research and Western medical institutions is playing a pivotal role in this epidemic. The populations of Western Africa are asking themselves how and why the Ebola virus outbreak has come to their countries when earlier outbreaks were centered far away in central Africa.

In many cases, they find it more reasonable to put the blame for the Ebola epidemic on the recent increase in the number of Europeans and Americans visiting their countries, including Western-trained doctors, scientists, missionaries, energy company executives and oil and gas workers. Some also take note of the CIA’s regrettable operation in Pakistan to track down Osama bin Laden through a fabricated polio vaccination campaign as evidence that any scientific explanations presented by Western officials are to be considered suspicious — if not outright falsehoods.

 

Colorized transmission electron micrograph (TEM) of an Ebola virus virion reveals some of its ultrastructural morphology. Image courtesy Cynthia Goldsmith, CDC.

Colorized transmission electron micrograph (TEM) of an Ebola virus virion reveals some of its ultrastructural morphology. Image courtesy Cynthia Goldsmith, CDC.

 

In contrast, Western infectious disease epidemiologists expect to uncover a much more prosaic explanation for the march of Ebola virus from Central Africa to the western African coast. They point to an extreme drought in sub-Saharan Africa over the past several years as the probable root cause for suspected disease vectors, like African Fruit Bats, to have shifted westward. In the minds of Western scientists, the common source of Ebola infection centers around the bush meat trade.

Bush meat, the common term for wild game– such as fruit bats, rabbits, or other small animals that are smoked and sold in local markets — provides much needed protein to populations where domesticated animals are too expensive or not available for purchase. Those handling, butchering and cooking bush meat are at the highest risk for Ebola infection as they can become infected by the small game animals that carry the Ebola virus. Many Africans scoff at this explanation. Bush meat is still widely prepared and sold in markets. And if they can’t eat bush meat, what source protein could they afford to eat? Lack of trust in scientific and medical institutions is not limited to the citizens of African nations, however. Here in the United States, angry, agitated citizens have called into talk radio programs and mounted Twitter campaigns seeking to bar Ebola patients from entering the country.

 

Secret Lab Formula for Anti-Ebola Serum: Is it a Miracle Cure?

Once again we want to emphasize we are not making light of the very serious situation surrounding the Ebola epidemic. However recent news developments have an uncanny similarity to the deus-ex-machina plot twists of a Hollywood suspense thriller. Enter Rev. Franklin Graham, son of famed evangelist Rev. Billy Graham. Franklin Graham runs Samaritan’s Purse, a non-denominational Christian charity based in Boone, N.C., which, as you may recall, employs Dr Brantly at the hospital in Liberia. It has been reported that Samaritan’s Purse made unofficial contact with the National Institute of Allergy and Infectious Diseases, part of National Institutes of Health (NIH) and was thereby able to facilitate acquisition of a heretofore undisclosed anti-Ebola serum, called ZMAPP, under development by San Diego-based Mapp BioPharmaceuticals.

Mapp BioPharmaceuticals revealed it has been working with Toronto’s Defyrus Inc., the Canadian Public Health Agency and the U.S. Government to develop the anti-Ebola serum. The drug itself is processed using tobacco leaves by Kentucky BioProcessing, (a subsidiary of Reynolds American Inc.) in Owensboro, Kentucky. A small quantity of the experimental serum was provided to Emory University Hospital in Atlanta, for the treatment of Dr Brantly and Nancy Writebol.

 

Race Against Time

With the experimental antivirus serum in hand, it was a race against time to fly the medicine across the Atlantic to treat patients Brantly and Writebol in time. Maddeningly, upon arrival, the serum had to be carefully defrosted for hours (without applying external heat) until it reached room temperature before it could be used. At first Brantley had insisted Writebol take the first defrosted dosage, but suddenly his illness took a turn for the worse. And so it was reported that Brantly was administered the first dose, along with a blood transfusion of one of his former patients, a 14-year-old boy he himself had earlier treated for the Ebola virus.

It was hoped that the transfusion of blood from this young boy, a former patient who had beaten back the disease, would give Brantly’s immune system an extra boost of antibodies as he lay in the hospital bed fighting his life.

 

Historical photograph from 1976, the year the Ebola Virus outbreak was first discovered, showing showing patient isolation chamber inside an Air Zaire “Fokker Friendship” airplane, which transported a suspected Ebola patient during his medical evacuation from Yambuku, Zaire to a hospital in Johannesburg, South Africa. Image courtesy Dr. Lyle Conrad and CDC.

Historical photograph from 1976, the year the Ebola Virus outbreak was first discovered, showing patient isolation chamber inside an Air Zaire “Fokker Friendship” airplane, which transported a suspected Ebola patient during his medical evacuation from Yambuku, Zaire to a hospital in Johannesburg, South Africa. Image courtesy Dr. Lyle Conrad and CDC.


 

Journey to America

Miraculously, Brantly’s condition took a turn for the better after the ZMAPP serum treatment and the blood transfusion. Writebol’s condition improved notably as well after she received her dosage of the serum. Now it was time to transport these two Americans to Emory University Hospital in Atlanta. A special air ambulance plane was sent. It was reported that Brantly’s strength had improved to the point he was able to stand on the airport tarmac before boarding the aircraft equipped with a special patient isolation chamber. Capacity of the plane’s isolation chamber? Just one patient.

That meant Writebol would have to wait for the plane to make the trip to Atlanta with Brantly alone before it could return to pick her up on a second trip to Emory University Hospital. Alexander Isakov, Executive Director for Emory University Hospital’s Office for Critical Event Preparedness and Response met the aircraft with a specially-designed ambulance, also equipped with its own patient isolation chamber. Isakov reportedly said they have been conducting drills for the last 12 years to be prepared for treating patients with highly infectious diseases like Ebola virus, so they are confident in their advanced preparations for Brantly and Writebol’s arrival this week.

 

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As we write this, both Brantly and Writebol are undergoing treatment at Emory University Hospital, and are reportedly showing signs of improvement. In our next article, we plan to take a look at the comprehensive planning that went into the construction of Emory University Hospital’s infectious disease isolation unit, as well as return to the discussion of how the CDC is addressing a recent series of laboratory errors at some of the select agent bio-security laboratories under CDC management. In the meantime, we want you to know we take laboratory safety very seriously.

We encourage you to join our clients — like Apple Computer, Boeing, Dell, Eli Lilly, Exxon Mobile, Ford, General Electric, Intel, Lockheed Martin, Medtronic, NASA, Novartis, Stanford University and Toyota. Call us at 800.251.1505 to learn more about our full line of stock, semi-custom and custom-made laboratory furniture, lab benches and dry lab/wet labs — as well as our laboratory design / furniture consulting services.

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Lab Safety Under Intense Scrutiny Amid Recent Incidents

Yesterday’s editorial in the Annals of Internal Medicine written by Dr. Deborah Cotton MD, MPH, certainly caught our attention. Dr. Cotton is both a Professor of Medicine at Boston University School of Medicine and a Professor of Epidemiology at Boston University School of Public Health. Additionally, she serves as a member of the Board of Directors of the Infectious Diseases Society of America (IDSA).

 

CDC scientist Thomas Stevens peers from inside the autoclave room of the BLS-4 laboratory to the outer corridor.  Photo Credit: James Gathany, Centers for Disease Control and Prevention

CDC scientist Thomas Stevens peers from inside the autoclave room of the BLS-4 laboratory to the outer corridor. Photo Credit: James Gathany, Centers for Disease Control and Prevention

 

Dr. Cotton addressed the recent spate of high-profile security lapses at U.S. government bio-containment laboratories head-on, with a blistering point-by-point attack that you rarely see in academic journals, much less in the otherwise staid Annals of Internal Medicine, where she holds the position of Deputy Editor. Without mincing too many words, Dr. Cotton contends that bio-containment laboratories, designed to protect us from bio-terrorism and natural disease outbreaks, are themselves becoming a large, looming bio-terror risk to the human population. In her editorial, Dr. Cotton identifies the following causation factors that may have contributed to the recent spate of safety lapses we’ve witnessed at the CDC and other government laboratories:

  1. Our research portfolio and priorities have shifted rapidly.
  2. We’ve seen large growth in the overall number of bio-safety lab facilities.
  3. We have acted more on emotion and less on scientific analysis.
  4. Grant money set aside for bio-terror research has attracted scientists with little experience working with dangerous pathogens.
  5. We lack an effective safety culture in laboratory research.
  6. Safety is as much about training, policies and procedures as it is about by identity scanning, air filtration systems, spacesuits and surveillance cameras.

 

CDC scientists connect to a supportive air hose to breathe air and to maintain positive pressure inside the protective, BSL-4 lab suit.  Photo Credit: James Gathany, Centers for Disease Control and Prevention.

CDC scientists connect to a supportive air hose to breathe air and to maintain positive pressure inside the protective, BSL-4 lab suit. Photo Credit: James Gathany, Centers for Disease Control and Prevention.

 

As Laboratory Safety Criticism Goes, This is Pretty Strong Stuff

So much so that we thought it would be useful over the next couple articles to evaluate Dr. Cotton’s assertion that we lack of an effective safety culture within the nation’s research laboratories that are tasked with handling the world’s most dangerous pathogens.

Today we begin by assessing the current situation, by building a timeline of recent events. Next week we’ll review the immediate corrective actions undertaken by CDC leadership. Then we’ll look at past and present safety recommendations, Congressional investigations and government oversight reports for more insight. Finally we plan to conclude with an assessment of what steps and priorities might assist in improving laboratory safety.

 

Current Situation: Grave Risk of Ebola Outbreak Complicates Laboratory Safety Review

But first let’s take a moment to establish a bit of situational awareness — by reviewing the current context we find ourselves in. Some weeks ago we featured a couple of articles on the danger posed by Middle East Respiratory Syndrome, or MERS, which was centered on an outbreak in Saudi Arabia. Fortunately MERS has not exploded into a widespread epidemic — yet. But it’s been knocked out of the news by another troubling, if not terrifying, resurgence of the Ebola virus, which is spreading throughout Liberia, Sierra Leone and Guinea.

Nigeria, Africa’s most populous nation, is now under threat of a potential Ebola outbreak after a Liberian man working as a consultant for the Liberian government arrived in Lagos, Nigeria, where he died from Ebola virus at a hospital (The facility is now shut down and quarantined). This makes the threat of the Ebola virus reaching the United States that much closer to becoming a terrifying reality, given the fact that daily nonstop flights, between Nigeria and Houston for example, transport hundreds of oil workers to and from Nigeria’s extensive network of oil fields and pipelines. In other words, now is not the best time for a series of laboratory safety incidents to derail scientific research designed to discover ways to treat the Ebola virus and prevent its transmission.

 

Laboratory Safety Incidents at CDC: A Timeline of Recent Events

Nonetheless, we have had a series of high-profile incidents occurring in rapid-fire succession that have come to light over the last two months. Let’s review the timeline of these key laboratory safety events.

 

Laboratory Safety Incident: Anthrax Virus, BRRAT Laboratory at CDC Roybal Campus in Atlanta, June 5 – June 18, 2014

This incident took place at the Bioterrorism Rapid Response and Advanced Technology (BRRAT) laboratory within the Center for Disease (CDC) Roybal Campus in Atlanta.

 

Timeline-for-Anthrax-Laboratory-Incident

 

On June 5, an infectious disease scientist working at the BBRAT Bio-safety Level III (BSL-3) laboratory prepared extracts from a panel of bacterial agents. One of the extracted pathogens was Bacillus Athracis, more commonly known as Anthrax. The intent of experiment was to determine if a laser technology could provide a faster way to detect anthrax. After a 24-hour test period, the plate was reviewed. As expected, no growth of Anthrax was detected; therefore it was deemed safe to transfer a portion of the supposedly inactivated anthrax bacteria to the adjoining BSL-2 and Core Lab facilities within the greater BRRAT campus for further downstream analysis.

 

Stock photo of the Gram-positive bacterium, Bacillus anthracis, cultured on phenylethyl alcohol agar (PEA) medium for a 24 hour time period at 37°C. Photo courtesy Dr. Todd Parker. Ph.D.; Assoc. Director for Lab. Science / DPEI (Acting) and LRN Training Coordinator, CDC

Stock photo of the Gram-positive bacterium, Bacillus anthracis, cultured on phenylethyl alcohol agar (PEA) medium for a 24 hour time period at 37°C. Photo courtesy Dr. Todd Parker. Ph.D.; Assoc. Director for Lab. Science / DPEI (Acting) and LRN Training Coordinator, CDC

 

Then, unexpectedly, on June 13, scientists in the BBRAT BSL-3 Laboratory discovered that their original, supposedly ‘inactivated’, anthrax specimens were nonetheless capable of growing live cultures of anthrax bacteria during a 10 minute subculture test. This sounded off the alarm: If these anthrax samples, originally thought sterile, were capable of growing anthrax colonies, that meant samples sent out on June 6 to the BSL-2 and Core Labs were at risk for containing live anthrax. In addition, the Special Pathogens lab facility was also implicated, because they had received specimen plates from the BSL-2 lab on June 12.

 

Laboratory Safety Incident: Influenza Virus Cross-Contamination at CDC and SEPRL, March 13 – July 9, 2014

On March 12, 2014, the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) in Atlanta shipped what it thought was a culture of low-pathogenic avian influenza to the U.S. Department of Agriculture’s Southeast Poultry Research Laboratory (SEPRL), a BSL-3 Select Agent facility located in Athens, Georgia.

 

Timeline-for-Influenza-H5N1-Laboratory-Incident

 

However, it was subsequently determined at SEPRL that the supposedly low-pathogenic avian influenza had been unintentionally cross-contaminated at the NCIRD with a highly pathogenic H5N1 strain of influenza. When the shipment arrived on March 13 at SEPRL researchers inoculated their laboratory test chickens with the supposed H9N2 virus. However, researchers quickly realized that something was wrong with their chickens, and they performed molecular analysis on the virus stock material sent by the CDC , which confirmed it also contained the highly pathogenic H5N1 virus.

This laboratory error was compounded by slow communication up the management chain; SEPRL did not notify the NCIRD of the contamination until May 23rd, and the NCIRD did not notify the responsible CDC official(s) until July 9th. The poor optics of this ensuing delay to disclose the initial discovery has caught the attention of a Congressional investigation in Washington, which we will cover in next week’s article.

 

Next Week’s Article: Decisive Corrective Actions Taken by the CDC

In our next article, we’ll review decisive corrective actions undertaken by CDC leadership, including the temporary closure of the BRRAT and NCIRD facilities, plus a temporary ban on transporting highly dangerous pathogens between facilities.

 

We’re Serious About Laboratory Safety

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