9 June 2015

ANTHRAX SCARE: REMAIN CALM! ALL IS WELL!

Al Mauroni
June 8, 2015

The recent announcement that Dugway Proving Ground may have shipped live anthrax organisms through the mail to more than 20 laboratories and three foreign countries (Australia, Canada, and South Korea) has a lot of people excited right now. People are no doubt flashing back to the fall of 2001 when the specter of anthrax in the mail resulted in draconian mail screening processes and vigorous sales of antibiotics. The thousands of “white powder” scares over the years (and that continue today) have contributed to the dread we have seen in much of last week’s media coverage. To the great many people who are wondering how the Army laboratory got into the business of shipping out one of the most deadly biological organisms through FedEx, I want to say, in the spirit of the closing scene of “Animal House,” remain calm! All is well!

The press has been aggressive in its coverage of this issue, as it should be. Of all the biological agents, anthrax is particularly dangerous because of the toxic effect it has once a person has inhaled the spores. After a person becomes symptomatic from inhalation anthrax, often within a week of exposure, they will die without aggressive medical treatment. Anthrax spores are particularly hardy and long-lasting, which makes them a dangerous threat wherever they land. When the U.S. government says, yeah, we might have shipped live anthrax samples to a large number of private and government labs without intending to, that sets off alarm bells, especially given recent fears about disease outbreaks and Ebola.

But let’s get real about exactly what’s going on here.

Q: Why is the Department of Defense breeding anthrax in the first place?

A: We’ve been looking at anthrax for decades. The U.S. government needs to have samples of anthrax organisms so that scientists and doctors candevelop defensive equipment, such as biological detectors, protective masks, medical vaccines and antibiotics, and decontaminants. If we can’t verify that the equipment works the way it should, then our troops won’t be protected against an enemy using anthrax as a weapon.

Q: What are the numbers? How bad is this problem?

A: There are two different strains of Bacillus anthracis (the micro-organism that causes anthrax) that are suspected of being the source of the “live anthrax” shipments. Four batches of biological material were manufactured and, from those four batches, 400 samples (called lots in the defense brief) were sent out to 51 private and government laboratories in 17 states, the District of Columbia, and three countries (Australia, Canada, and South Korea). That number might be higher, but this is what we know so far.

Q: Wow, that sounds like a lot! Why is the Defense Department shipping dangerous organisms to so many laboratories?

A: Because Dugway is one of the very few U.S. facilities allowed to breedB. anthracis in support of research and development programs, in addition to testing military biological detectors and diagnostic equipment. Following the 2001 Amerithrax incident, the public’s dread over exposure to “white powder” (to include innocuous baking powder, laundry detergent, and crushed TicTacs), and the U.S. government’s desire to quickly improve its readiness against terrorists who might get their hands on biological organisms, Congress pumped billions of dollars into biological defense research and development programs aimed at improving homeland security and protecting our military forces. The pandemic scares between 2005 and 2009 fanned the flames of that research and development, causing the proliferation of more than a thousand biosafety level 3 laboratories(capable of handling live anthrax organisms) and dozens of biosafety level 4 laboratories (capable of handling Ebola viruses). Today, there are more than 300 laboratories in the United States that are authorized to handle B. anthracis organisms. It’s big business.

Q: When did this problem with sending live anthrax lots through the mail start? When did they find out about this event?

A: It looks like it started in 2008 and was discovered more than a year ago. It might sound crazy that this was going on for over five years without anyone knowing, but there is an explanation for that. Here’s what happened: The four batches from which all of the suspect lots came were manufactured in 2008. That doesn’t mean that every sample sent out from these four batches since 2008 was live, just that all of the lots in question were sent out between 2008 and 2014. Anthrax spores can live a long time, especially if they are refrigerated, so there’s no need to create fresh batches every year. It appears that one of the private laboratories discovered that they had live anthrax when they cultured (grew) anthrax from one of the lots, which they should not have been able to do. This was more than a year ago. Most of the receiving laboratories did not culture their B. anthracis, which is why no one else identified this issue.

Q: Why are these samples being sent through the mail? That seems to be a very casual approach.

A: Actually, there are well-established procedures to send biological samples through the mail, regulated by the federal government to ensure public health is not imperiled. Given the huge volume of biological material that hospitals and laboratories deal with every day, there has to be. When it comes to dangerous organisms like B. anthracis, people have to use gamma irradiation to inactivate the organisms prior to shipping. This is a very safe and accepted process, and if conducted successfully, ensures that there is no risk to public health.

Q: Obviously your “safe and accepted process” didn’t work. Who screwed up?

A: That’s a fair question, and one that cannot be answered right away. It looks like the irradiation process may not have been carried out correctly for a number of years. We should know more soon. The Defense Department is in the process of investigating where the process went wrong, and should have a report in 30 days. It’s hard to say at this time whether it was human error, machine error, process error, or all of the above. But until that is clearly known, there won’t be any more anthrax in the mail — dead or alive. Regardless of the source of the error, it’s safe to say that there’s no risk to public health.

Q: How can you be so confident that there’s no threat to public health?

A: There are two parts to this. First, the Department of Defense issueddirectives and instructions on safeguarding biological select agents and toxins between 2004 and 2006, followed by Army regulations on biosurety in 2008. Everyone understands the need for strict guidance and oversight on this topic. This leads to the shipping process involved — the lots contain one milliliter of liquid, in which a very low concentration of biological organism is suspended. What’s considered “very low?” According to defense officials, less then what is required to infect a healthy individual, which is generally considered to be 8,000-10,000 organisms. That is to say, you can be exposed to small amounts of B. anthracis and not get infected. The lots are triple-wrapped — once in a Ziplock bag, wrapped with absorbent material, sealed in a hardened container, and inserted into a mailing box with dry ice. That’s pretty secure for a fifth of a teaspoon of liquid.

Second, without reviewing the protocols at all of the receiving laboratories, I am willing to bet that all of them had trained technicians who understand how to handle biological organisms (dead or alive) and who were vaccinated against anthrax infection. Anthrax vaccinations are more common than you think. If you know anyone in the military who has deployed to Iraq or Afghanistan, odds are you know someone that was vaccinated against anthrax. And even if they were not vaccinated, it’s not as if technicians could inhale the liquid holding anthrax spores. I say this because there has been absolutely no indication that any samples were lost and we know that no one became ill from exposure. If someone were to have died from anthrax exposure, doctors in the respective areas would have recognized it immediately and reported it by now. These were trusted laboratories with procedures to ensure that the public health was not imperiled.

Q: So here’s the part where the federal government promises it will never happen again, right?

A: I don’t speak for the federal government, but the answer is still no. Mistakes happen, even in secure labs with highly trained personnel. Despite strict regulations, redundant layers of protective measures, safety protocols, scientists and laboratory analysts can get casual attitudes after working with dangerous chemical and biological warfare agents for years, even when the work is involving live anthrax spores. They might not see the consequences of a mistake as high enough. They are vaccinated against anthrax and have ready access to antibiotics, so things can get sloppy. This is obviously not acceptable and we need to guard against such incidents — in fact, you can probably expect oversight and regulations to get even stricter — but no one is going to tell you in complete honesty “never again.” It’s the price of research driven by the demand that the federal government has to “do something” against the potential threat of terrorists using anthrax against the public.

In 1968, there was a similar safety incident at the same place — Dugway Proving Ground — in which Utahan ranchers alleged that chemical weapons testing had resulted in the death of nearly 4,000 sheep. Another 2,000 sheep were put down because of the suspicion that they might have been exposed, and therefore they could not be sold on the market for meat or for their wool coats. No other animals or humans were affected, which led some to believe that other causes, such as the illegal use of pesticides by local farmers, might have been the source. It was hard to work out how a small amount of a persistent nerve agent (VX) traveled on the winds for 30 miles, rose over a mountain range, and settled on three sheep herds without injuring any other bird, mammal, or human. But the political fallout regarding the incident was quick and final, leading to the end of open-air testing of chemical and biological warfare agents in the United States.

The result of that decision means that the U.S. military is unable today to conduct tests on chemical and biological warfare agents — in any quantity, under any condition — in the open environment, which limits our ability to understand their effects in the environment and on surface. This makes it more difficult and expensive to ensure that the defensive equipment the U.S. military has today will work as it is intended on the battlefield. At the least, the U.S. military ought to tread carefully in this current investigation to ensure that it does not stifle or kill a vital capability needed to create countermeasures with which to face adversaries that do have biological warfare agents in their arsenals. At the same time, there ought to be a review of the existing biological defense research and development to ensure that all of the work is necessary for protecting our forces and not duplicative of existing public health research better conducted by other federal agencies.

Al Mauroni is the Director of the U.S. Air Force Center for Unconventional Weapons Studies. The opinions, conclusions, and recommendations expressed or implied within are those of the author and do not necessarily reflect the views of the Air University, U.S. Air Force, or Department of Defense.

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