Evolution of U.S. Biodefense Policy
Biodefense Summit Transcript
Remarks by Robert Kadlec, Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services
>> ROBERT KADLEC: We are truly blessed to have that leadership, um, at the secretarial level, leading this effort, and we're also truly blessed for Captain Teresa Lawrence, who is my right arm as a deterrence into the implementation of this, so we're doubly blessed. Well anyway, folks, it is my opportunity now to spend a few minutes with you, um, to kind of give you a whirlwind tour of the evolution of biodefense policy. I'd like to make this a little lighthearted. It's a deep and serious, um, effort, but I would like to think that we could have a little fun with it. Um, so, we'll have a jeopardy like kind of quality to it. So, we know what biodefense, here's the first question, what is biodefense? The first answer to the question, and that is what has been outlined in the defense, the national biodefense strategy from September. Um, there are bioincidents that we worry about, those that are deliberate, those that could be criminal, those could be natural or accidental, and those are all comprehensively considered in this strategy, and we're, I think we're fortunate to have one document to kind of incapsulate all these things, but the first question of the day is which President, which was the first President to institute a biodefense policy? Any guesses? George Washington. Yes. George Washington, and that was on the basis of not, it actually was done before he was President, when he was the Commander in Chief of the Continental Army and they were faced with an epidemic of smallpox in New England, and they basically had to evaluate how they were going to protect the American soldiers, um, the volunteers of that day, um, from the ravages of smallpox, and so he ordered the variolation of the Continental Army.
For those who don't know what variolation is, it's a very simple process where you take pustules from a smallpox victim, um, you grind it up and dry it, and then you, um, sniff it like snuff, and if you're the 97 to 95 percent of the people who don't necessarily succumb to smallpox, you're protected, so it was an imperfect mechanism to do that, but in near time, or more recent time, it was FDR who really established what I would say the contemporary biodefense policy, and it was really both an offensive and defensive stroke, and it started with a bluff. During World War II, it was recognized that our adversaries, um, both Germany and Japan had biological weapons, or at least that's what our intelligence thought. You'll be surprised to know that intelligence isn't perfect, and they guessed wrong at least on one account, that the Germany had a biological weapons program. It didn't. It had done some research, but not actively involved, where Japan, um, surprisingly, had an advanced bioweapons program, which was a bit of a surprise to our U.S. intelligence service, and that should be something to remember.
So, we all know who the father of WMD was for the nuclear program, um, Dr. Oppenheimer, but can anybody tell me who was the father of the biological weapons program and the defensive program of the United States? You may own stock in him. George Merck, yes, and interesting enough, George Merck was that father of biological offense and defensive program, but during his tenure, even in effort that mimicked the Manhattan Project, they were unable to prove unequivocally that biological weapons could work on the battlefield, and, so, at the end of his tenure, he wrote a report that was, um, initially unclassified and published and then classified, because it freaked people out. The American public, um, was not quite ready to kind of get its head around the idea of using germs as a weapon. However, it was recognized by the National Security Infrastructure that that was, indeed, the potential out there, and so it really came to President Eisenhower to really kind of advance both the policy and the capabilities, but was previously a policy of just deterrence, the risk of retaliation in kind, it was realized that, based on an experiment that happened at Dugway Proving Ground in 1954, where they actually infected a group of soldiers on the battlefield, or simulated battlefield, with brucella, that you could actually infect troops in the field, and what doubled down on that concern was the fact that Zhukov, who was then the field Marshall of the Soviet Army, said that in any future conflict, that they would be using chemical biological weapons, and Eisenhower knew Zhukov, because they were counterparts in World War II, and he knew Zhukov wouldn't say anything that he didn't meant to basically do, so in 1956, the President decided that we would advise the policy, that we'd be prepared to use these weapons in a manner that would be advance, or advantage to our military forces, and he, both as President and a retired five star general, not a bad kind of gig, if you can get it, would decide.
What's also interesting is that in 1960, at the end of his tenure, he was presented in the National Security Council at the TS level technological advances by his scientific advisor at that time that said that there may be opportunities to use these kind of capabilities in a way that would be humane, in ways that we could basically infect or expose both hostile forces and incidents, not to hurt anyone necessarily, but incapacitate them for a period of time that would allow us to prevail. Now, to give you an idea of what they were able to demonstrate in 1959, this is just a little extract of something, and I'll read what really is the essence of this. A properly designed spray system could contaminate 50,000 square miles with a BW aerosol in a single sortie. That was one airplane, with one tank, with, um, several hundred gallons of a liquid agent. Now, once they developed dry agents, the ability to cover larger areas, um, was even more profound, and that was tested with live agents in the Pacific in the 1960s, as you'll hear, but it was their intent in the 1950s to use cruise missiles, yes, cruise missiles and drones even, um, as well as special forces to employ these weapons in strategic fashion. And, so, how good was the science? Um, well, we all know about ASM, right? Well, it's interesting to note that 20 out of the, of the presidents who served as, um, President of ASM actually served as consultants for the offensive and defensive biological weapons program through the 1960s, and that was only dissolved when the controversy around agent Orange surfaced, because Fort De trick, amongst its other duties and capabilities, was the organization that developed Agent Orange, the herbicide, but needless to say, this was the front edge of American microbial science at the time, and this gentleman here, interesting enough, was the technical director of that program, for both the offense and the defense at Fort Detrick, and simultaneously was the President of the American Society of Microbiology.
In his archives, he basically had it in view that said their job was to translate policy through science into reality, and that the whole effort was designed to do two things, really, was to develop a deterrence capability, which was on a scale and scope that never was curated before, and also to focus on the defensive side of this challenge, and, so, strategic policy objectives with strategic deterrence and enhanced war fighting, and some of these agents will be familiar to you, the Tularemia, anthrax, the plague, some others that may be a little more exotic, Venezuelan equine encephalitis, Q fever and the like, but it was the whole intent that, in some ways, we could demonstrate to our counterparts that we were serious about this, in a way that would prevent their use, and so their operational objective was to confound diagnosis and frustrate treatment. So, Dr. Housewright and his colleagues were saying how can we use virulent organisms that people are not immune to? How can we use non natural exposure routes, like aerosols? Use overwhelming doses, resistance to conventional treatments, and combination of agents to affect this, and they were able to do this in extraordinary fashion. So, when LBJ became President, he recognized, by the virtue of many large area coverage tests that were done, in light of, even in light of the prohibitions of nuclear test ban treaty, that they conducted several large tests in the Pacific that demonstrated this worked very well, and, um, they were able to demonstrate this to a point that at the end of his tenure, before he left the presidency, it was Johnson who actually signed a defense memorandum, ending the lethal part of the program, and so then became Nixon's charge to evaluate it in 1969 and recognize that, in some ways, this was a path that brought ruin only, which was the malicious use of science, particularly microbial science, in a way that could endanger future generations, and so he was the one who basically decided that we would stop all work on this, but with reflection on the fact that we still had to do scientific research to understand the nature of these kinds of risks and also develop the countermeasures for them.
So, here goes our second question, which President issued executive order 11490? A little guess here. I'll give you a little clue. Secretary of Health and Education and Welfare shall, it's been a few decades since we heard that term, right? But it was Richard Nixon, a month before he ended the, um, the biological program, he tasked HEW then with responsibility to develop chem biodefenses for the American public. Now, if you're like me and you do a little bureaucratic forensics, you will find not much in the way of evidence that anything was done following that.
>> ROBERT KADLEC: The campus at Fort Detrick was closed, and a lot of that was turned over to the National Cancer Institute, but beyond that, it was very hard to find what would be a focus on chem biodefense. So, I think the thing is, to take away from this, um, quick walk around of history is that when Dr. Housewright wrote his summary for the National Security Council in May of 1969, here was his outtakes of the experience of the American program. It was a strategic weapon, designed to attack civilians and economic targets. You could cover extensive areas with this. It worked too well, oftentimes, the effects were more pronounced than even, um, they anticipated, that, by design, that these are not natural weapons, that, in fact, you design them to be non natural weapons, and the impacts were devastating in terms of the environment, because once you released a contagious aerosol, everything, every living thing in that downwind area was potentially infected, and that's not only humans, that's animals, and that means animals that become reservoirs, that makes a, um, if you will, an epidemic, an endemic disease, and creates, as he said, a total ecologic threat, and then their last thought, which was, again, profound, was intelligence is not always the solution to try to figure this out, that science is a fundamental part of the equation to develop countermeasures, as well as defenses. So, jeopardy moment, in 1993, which President said this? Saddam Hussein is right. That is correct. You cheated, Dr. Epstein.
>> ROBERT KADLEC: But as a member, former member of OSTP, well done.
>> ROBERT KADLEC: And, yes, it was Saddam Hussein, a different President, but President Clinton was a significant mover in this, and as Secretary Azar had mentioned, Secretary Shalala, in 1998, the fact that HHS had a significant role to play in national security, and that role was really around how to protect the American public from a variety of chem bio threats, and, so, it was President Clinton who signed a presidential directive that directed HHS to develop, then it was the National Pharmaceutical Stockpile with $300 million. You know how much that's worth today? $7.6 billion and growing, and, so, each of these incremental steps, I think, led to something significant. So, here's a real tough one, and Jerry, don't say a word.
>> ROBERT KADLEC: Prior to 9 11, which President wrote this in 2000? His ideas about bioterrorism, about the need for stockpiles of antibiotics, about the need for sensors, about the need to basically ensure that former Soviet scientists would be, um, employed, so they couldn't be hired by, um, terrorists or other nation states, and that we needed to prepare for attack. Any guesses? Donald Trump. Yes, the man that signed the national biodefense strategy, back in 2000, understood the nature of this challenge, and so it's not a surprise that, um, when you look at the incremental effects that multiple presidents have had over time, and again, Secretary Azar talked about the bioterrorism act of 2002, going forward, that we've had incremental improvements. Um, the things in black are congressional actions, called laws, and the things in red are presidential actions, either called executive orders or presidential directives, but you see every President, since 9 11, and even before 9 11, has made incremental improvements in our nation's ability to respond to these, and so, now, we have a capstone document, and why is that document so important? Because consistent with imperfect incrementalism, um, during the Bush Administration, you had the drafting of the national, or the biodefense for the 21st century, HSPD10, which focused only on deliberate events, and then the creation of a national strategy for pandemic influenza, focused only on natural events, and then you had presidential directive number two during the Obama Administration, that really focused on how do we prevent these kinds of events from happening. Why? Because HSPD10 was focused principally on the preparedness and response piece, not on the prevention piece, and so, today, by the virtue of the President's signature, we have a comprehensive document that looks at the entire spectrum of the challenges that confront us from biological threats, um, and the young lady to your right, Hillary Carter, is she here this morning? Anyway, she is the person who drafted that, and, um, someone, if you don't know, you need to know, because, um, she's now a senior policy advisor to the Homeland Security Advisor.
So, there's much work to do. As you can see, there's much work that has been done, but we're still down the trail of, um, nirvana, as I call it, the perfect biological preparedness effort, but I think it's the key thing to realize, as it says in the opening line of this national biodefense strategy, that it is a vital interest of the United States to manage these risks. That's no stronger word, or set of words that could be used to define this. So now, after all this heavy stuff, I figured I'd end up on a lighter note. So, first of all, we know that the national biodefense has five goals, to enable awareness, to basically prevent events, to be prepared, to respond and recover, and again, if you haven't had the chance to read that strategy, it's a very comprehensive document that we're basically going to enable and implement, but I do want to leave you with some lighter thoughts about this. From Hagar the Horrible, um, that not only the future challenge will not only be bigger, but it will potentially be better, when you consider the combination of things like synthetic biology and artificial intelligence, Brewster Rocket, and then lastly, it's just going to be harder to identify and control, and so it really is going to take our best efforts to not only prevent, but prepare and hopefully never have to respond to these events, but I think as Secretary Azar said very prophetically during his first tenure in HHS and now in his second tenure in HHS, we have had to do both repeatedly, and there's no reason to believe otherwise going forward. So, with that, ladies and gentlemen, I'm very honored and privileged to have been here today. I look forward to hearing the comments from you all, and thank you so much for your attendance and your participation.