Briefing on the Anthrax Vaccination and Immunization Program
Also Participating: Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs; Mr. David Oliver, Principal Deputy Under Secretary of Defense for Acquisition, Technology and Logistics; and Maj Gen Randall L. West, USMC, Special Advisor to the Under Secretary of Defense of Personnel and Readiness on Anthrax and Biological Defense Matters.
Mr. Bacon: Good afternoon.
Charlie, I know you're astonished that we're actually starting on time, but we are.
The topic of the briefing this afternoon is an update on the anthrax vaccination program. We have three people: first, Dr. Sue Bailey, who's the assistant secretary of Defense for Health Affairs; second, David Oliver, who's the principal deputy undersecretary of Defense for Acquisition, Technology and Logistics; and third, Major General Randall L. West of the Marine Corps, who's a special adviser to Undersecretary Rudy de Leon on anthrax and biological defense matters.
After they have finished making the presentation on the anthrax update and taking your questions, I have an announcement on another topic. But we'll save that until the end of the anthrax briefing.
Dr. Bailey: Good afternoon.
Two years ago, acting on the recommendations of the chairman and the Joint Chiefs of Staff, Secretary Cohen approved a program to vaccinate all active and Reserve members against anthrax.
Nothing the department has learned in the last two years has reduced our concern about the threat of a possible anthrax attack against our troops. Indeed, we know that Iraq and other potential adversaries have weaponized anthrax so that it can be used on the battlefield. As a result, military commanders consider vaccination against anthrax a necessary element of force protection as we prepare for the threats of the 21st century.
Last year we started vaccinating military personnel who are deploying to two high-threat areas, Korea and the Gulf. So far we have vaccinated 383,000 soldiers, airmen, sailors and Marines. This is the first phase of the program.
From the beginning, the safety of the vaccine has been a paramount consideration. Before we started the first vaccinations, Secretary Cohen ordered supplemental testing of the vaccine and a review of all the health and medical aspects of the program by a former dean of the Yale Medical School. The vaccine is safe and very effective. Secretary Cohen and Chairman Shelton both completed the vaccination program. The vaccine has very few side effects, and they are mild, and they are temporary.
When the program began, all of the nation's anthrax vaccine was made in a small single plant owned by the state of Michigan. We realized that this plant would not be able to meet the military needs. A private company, Bioport, purchased the plant from the state of Michigan. It tore down the old production line and built a larger more modern production facility.
That production facility is currently being certified by the Food and Drug Administration. The certification process for a new production facility is long and complicated. The FDA is applying state-of-the-art certification and standards for all vaccine makers.
We currently have enough vaccine to continue phase one of the program, the vaccination for all those troops deploying to the high- threat areas of the Gulf and Korea. We had hoped to begin the broader phase-two vaccinations earlier next year.
However, Secretary Cohen directed that phase two not start until Bioport had achieved assured production of this new vaccine. The plant has not yet begun such production, and we will not launch phase two vaccinations until we and the FDA are completely satisfied that the Bioport plant meets the highest possible safety standards. It is difficult to estimate precisely how long that this will take, but it could be in the range of six to 12 months.
The Anthrax Vaccination Program is a necessary part of our obligation to protect U.S. forces. It's important that all military personnel have complete confidence in the safety of this vaccine. This is not a question of if we will have confidence; it is a question of when we will have confidence, given the time it takes to certify this new plant.
Frankly, it has been more difficult than the department and Bioport expected to move from a small state-regulated production facility to a large, modern production facility that meets the state-of-the-art FDA requirements. Bioport has recently beefed up its management and production teams. At the same time, the department has augmented the team that supervises this program.
Let me review where we stand. We will continue with the highly successful program to vaccinate troops as they deploy to the Gulf or Korea. At any given time, we have about 23,000 soldiers, sailors, airmen and Marines in the Gulf and about 37,000 troops in Korea. And of course, troops rotate in and out on a regular basis. We will not begin phase two and phase three until the FDA completes its certification and Secretary Cohen is confident that Bioport meets the highest possible standards.
Phase two covers early deploying troops to high-threat areas. Phase three covers all other active and Reserve forces.
This program is safe, effective and necessary. And we will continue to meet the highest possible standards.
I will now be joined, as well, by General West and Secretary Oliver.
Q: Might I ask? You are saying you have so far inoculated -- is it 383,000?
Dr. Bailey: Three hundred and eighty-three thousand.
Q: Well, are those all in the Gulf -- were those all rotated in and out of the Gulf and Korea, or elsewhere also?
Dr. Bailey: These are those who either have deployed or will be deploying.
Q: So the Gulf and Korea, but not elsewhere?
Dr. Bailey: Yes.
Q: That's the whole course of six --
Dr. Bailey: They have begun. They may not have completed all six.
Q: How many troops are in the second phase?
Dr. Bailey: I would need to get the specific numbers of the second phase. But that basically includes -- the part of the force that would possibly be deploying could be first-responders or, on a contingency basis, ready to deploy to those high-threat areas. Then phase three would be all the rest of the force.
Q: So if you had a crisis, then your phase-two troops would not have the vaccination?
Dr. Bailey: At this time, until we begin the phase two, they would not be vaccinated.
Q: Are you essentially done with phase one, and now you are halting vaccination of new troops in phase two? Or what --
Dr. Bailey: No, we aren't halting the program because we are in phase one now and continuing phase one.
Q: Well, how many more do you have to go in phase one, how many more troops?
Dr. Bailey: I would need to get you those specific numbers.
Maj. Gen. West: But essentially you are rotating people in and out of theater all the time, and so you are continually having new people; plus, you have new troops coming into a unit. So you are essentially using about 75,000 doses a month.
Q: A couple weeks ago, Secretary Cohen offered to make the vaccine available to South Korea, if they wanted it. Has there been any follow-up on that? And what would do to the program, if you had to, you know, share it with South Korea?
Dr. Bailey: Well, we've had many different requests at times for this vaccine and for other medications and vaccines, and they are considered on a specific basis, according to the situation.
(To colleague.) Do you have anything to add to that?
Q: Have any been granted?
Dr. Bailey: To my knowledge, there have been grants at this point of smaller amounts.
Maj. Gen. West: There have been no vaccines given to other countries as yet, although several have asked for them. And -- but there have been small amounts that have been sold to State Department agencies, to veterinarians, to people that work in the hide industry, to give them protection against the disease.
Q: Well, has the South Korean military formally asked for this?
Maj. Gen. West: We're in discussion with them about providing it, and we think that they should take it. And we should make it available to them once we go into assured production. Having your forces, both the American forces and the Korean forces, vaccinated and protected make it less likely that the North Koreans would use it, and not only provides protection to our forces but to everybody that lives on the peninsula.
Q: Well, what would that do to the supply situation, given the shortages?
Mr. Oliver: If you make a decision like that, it affects it. We have essentially 430,000 doses right now that are approved by the Federal (sic) [Food and] Drug Administration, plus 600,000 that's in the pipeline -- so for about a million. We expect to -- I expect to get 600,000 approved within the next couple of months, and I also expect another 400,000 a few months after that. So that is the amount that you have total. We are using 75,000 a month.
In addition, there are over a million doses which are also in reserve at Bioport, which we could use if we had to. But we have not asked the FDA to approve those, nor do I intend to do so in the near future.
Q: Why has this process taken longer than expected? And what specific problems has the FDA come across at Bioport?
Mr. Oliver: It's taken longer than we expected because we underestimated the difficulty in going from a public state of Michigan facility to a federal facility. In addition, what you had was a facility in which you were doing a safe and effective vaccine for a fairly limited number of people for years and years and years, and you have a use demonstrated. And then you decide that you now have a new threat, right? You have -- they have these various companies that weaponize this, and so you have a new threat. So you -- so we need to change the quantity.
Essentially what we did was tore down that tried and proven facility, which is the same facility that's produced all the vaccine that people have taken and will take under phase one, and we're building a whole new facility. You build a whole new facility, you have to deal with all the changes in standards that have happened in the drug administration, in the federal -- FDA over those years, and you have to build those. We underestimated how difficult that was going to take (sic) to address. And to be honest with you, since the secretary said it has got to be safe and effective, we'll eat that time delay, and whatever extra money it costs, to make sure that what we provide to our troops is both safe and effective.
Q: What about those million doses in reserve? Why can't you just start getting those approved and using them?
Mr. Oliver: There are various technical reasons that I don't want to at this moment. I was just out there last Wednesday night, looking at them, and reviewing the documentation. I don't think we need them. I've got 14 to 16 months' worth of vaccine at the moment, and there are issues that I'm not ready to address.
Q: Can you talk a little bit more -- what is DOD doing to, quote, "augment Bioport"? How much is that going to cost in the near term? And how much more money are you going to have to put into this project?
The reason I ask -- I think it was back in September that you redid the contract. You said you underestimated -- you put more money in. Now another whole load of money?
Mr. Oliver: Yeah, different issues, essentially. In -- when we were looking at it before, what happened was, they estimated how much it was going to cost while they were a part of the state of Michigan. The state of Michigan was right that this was costing a lot more money; they just didn't know what. And so the price, when they were separated and you could actually determine the cost, turned out to be about three times what they'd estimated. That was to take care of this problem.
Now the question is, how do we get them through the FDA certification? I estimate that cost is going to be equivalent to the -- what the cost to maintain one airplane for one year, which is about --
Q: What kind?
Mr. Oliver: Any kind -- about $7 million. I mean, just to give you a feel for what the magnitude is, I think it's going to be another $7 (million) to $10 million we need to put in. And what we're doing is, the Army has -- the Army's sent a team of three generals to Bioport to look at it on Friday.
Q: (Off mike.)
Mr. Oliver: General Kern has assigned a brigadier general named Dean Ertwine to look after this program full-time. He is, in addition, going to identify some other -- Dean's going to identify some other people to help him with that. And we're going to buy several million dollars' worth of consultants to work on the problem.
Q: So is that several million in addition to the 7 to 10 (million dollars)?
Mr. Oliver: No, ma'am. That falls under the 7 to 10 (million dollars).
Q: And are you going to -- I guess I'm still confused, frankly, how you're feeling on how it got to this point. This was a project that was supposed to be a top priority in the Pentagon; how did it get to the point that it's going to cost another 10 million dollars, all of a sudden?
Mr. Oliver: Ten million dollars needs to be taken in perspective, as I just gave you. I mean, it is the amount of money it takes to maintain an airplane for a year, roughly, or two airplanes. It is essentially less than ten percent of what the program would cost, so -- which does not mean that I haven't yet figured out where to get the money from, because I haven't. And it's certainly a lot of money to me, but it's not a lot of money when you consider the threat that exists, and those people out there who have weaponized this problem, and to whom we are worried about, and also how important this is to the secretary of Defense.
Q: Could you give us a little more explanation on what the problem is? Is it that the equipment you want to buy isn't out there, or is it the accounting system that's hard to set up -- what is it?
Mr. Oliver: Let me give you three examples, because they did an inspection -- there's an inspection out there which has about thirty items. Let me give you three, and I'll try to make sure I give you some of equal weight.
For example, let's say you have sterilized the equipment. You sterilize the equipment, you put it in a room -- you're not going to use it. The question is, how long does it sit in this room before such time as you ought to re-sterilize it? Is that 24 hours; is that three days; seven days? In other words, you ought to be able to sterilize it and leave it for awhile. How long do you have before you start using equipment.
Technical question has to do with medical things. How long spores take to light. We don't know that answer; had never addressed it before. We're going to give that problem off to an independent company to look at so I don't have Bioport telling me that it's three months, and somebody else telling me it's two days.
Anyway, need to do some tests, check it out several times and write a report. That's an example. Let me give you another example. In the amount of time since we built the new facility there have been lots of good government tests that have changed with respect to how do you check out, how much of the spore you have, how do you check these various things. Those procedures need to be written and tested out for Bioport and established, and you need to run them over and over again, so you make sure people are doing right. That's the second one, for example.
A third one is, what happens when you come up with a thermometer that doesn't read what you thought it would do, or you break a glass beaker. How do you establish -- those are called deviation reports. How long do you have from when that happens until you write the report? Do you want to set 48 hours, which is perhaps reasonable. Do you want to set four weeks? You don't want to set four weeks because it's too long and people may have forgotten it. Right now, there is no specification that nor is where is it filed.
Q: Do these three examples then represent disputes that you've all had with Bioport? Bioport said we can leave this sterilized equipment --
Mr. Oliver: No. These are findings by the Federal (sic) [Food and] Drug Administration of things they think Bioport should do differently.
Q: Doesn't FDA have a set bit of criteria for something of a lab like this? That it is three months or it is two weeks that you can leave sterilized equipment?
Mr. Oliver: It's my understanding what the FDA has asked the lab what they believe should be done technically, then the FDA says that's okay or not. I went to an FDA meeting for two hours two weeks ago, and that was essentially -- it was a discussion of statistics, but that was essentially what happened.
Q: There are about thirty of these issues?
Mr. Oliver: Thirty of them, yes sir.
Q: Is there a copy of this FDA report?
Mr. Oliver: Obviously, there's a copy. I have no idea whether or not it's related to FDA -- I don't know whether it's restricted or not. I'll have to check.
Mr. Bacon: I'll check for you.
Q: Isn't there also a problem with being able to make your batches consistent, and so far Bioport has been unable to make consistent batches in terms of purity and potency?
Mr. Oliver: It's absolutely a question about making them consistent. I think Bioport -- I think the issue is, Bioport says we think they are pretty consistent. The FDA says it doesn't meet our specs yet. From the Department of Defense point of view, we're not going to do this until we're comfortable with what -- that meets FDA specs and we're comfortable with whether it's safe and effective.
Q: So if there's a six-to-twelve month delay in phase two, what is the specific impact on the U.S. military if it had to make a general mobilization and deployment today to either the Persian Gulf or Korea?
Maj. Gen. West: What we've done is used the vaccine that we had available to vaccinate -- in keeping with the protocol as fast as we could -- the forces that are already there on the ground. Then we began identifying the people that were soon to go; then we began vaccinating the people that were flying in and out of the theater. The next step, when we go to phase two would be to vaccinate the force that would be included in a build-up like we experienced in Desert Storm. We're not there yet; we couldn't do that today, and we won't be able to do that until we go to assured production. So, we're better off than we were two years ago, but we're not where we want to be.
Q: Well, let me just make sure I very precisely understand. You say we couldn't do that today. What could we not do?
Maj. Gen. West: We could not today do a full build-up to Desert Storm and have every serviceman and -woman that was sent there vaccinated on the battlefield.
If I could, while I'm here, add some information to the question that I answered earlier. While we have not sold any vaccine to any country since we received the request from Korea, if you go back across the complete history of the program since we've been making the vaccine, we've sold thirty thousand doses to Canada, a little over ten thousand (doses) to Australia, a thousand (doses) to Denmark and a thousand to Argentina. And those are the only ones that I know about at this time.
Q: The more --
Dr. Bailey: Let me give one other medical fact. In the response to what we are able to do to protect our troops, being that force health protection is a main mission when we deploy troops, in fact we would be able to provide, as we did during the Gulf, immunizations that would give protection. It doesn't have to be all of the six in order for our troops to receive some protection.
Also, from a medical point of view, we do have other mechanisms for protecting against an anthrax attack. And that would include both the gear that is worn -- the MOPP gear, and other gear that protects them against chemical and biologic weapons, biologic in this case -- as well as the ability to protect or provide medical backup with antibiotics. So we are able to provide, as we did during the Gulf, some significant protection against anthrax.
Q: Is it not the case, though, that in every one of the categories you've mentioned -- antibiotics, MOPP gear, and everything -- you also have shortages in all of those inventories and you couldn't possibly protect all the soldiers with that stuff?
Maj. Gen. West: The problems that you get into there are, we have good MOPP gear, and we have MOPP gear available to outfit a force of a Desert Storm size, but it has limitations in that you can't wear it and fight in it 24 hours a day. So, you desire and need additional protection. The best protection that we can find is the vaccine, and we want to vaccinate the whole force as soon as we can; but we also want to be sure that the vaccine that we use is totally safe, that there have been no shortcuts taken and no exceptions to the certification. But as soon as we have assured production, it's our goal and we want to vaccinate the first responders and then the total force, so that we can move people in and out of first responder units without having to worry that we have someone there that wasn't protected.
Q: Dr. Bailey, question. In your opening statement, you talked about the Secretary making a decision that phase two will not begin until both the FDA and you are satisfied that everything -- I want to understand, how much of it is just meeting the FDA legal requirements and how much does the Secretary have further discretion? Would the Secretary, for example, be able to say it doesn't have to be FDA-approved? It's important enough for national security that we go ahead anyway. Can you explain that?
Dr. Bailey: Well, that would not be the case. Clearly, we operate under the regulatory rules set forth by the FDA. So, it would clearly the production would need to be under those standards, and as well, standards that we set. We also test all of the lots for purity and sterility. So, we are testing as well as honoring all of the testing requirements of the FDA.
Q: Then, I guess I don't understand why you say this is Secretary Cohen's decision, when it seems that many of the problems that you've described are simply you don't have FDA approval yet. You're still working through that.
Dr. Bailey: It is a time-phased program. And, as you've heard we had three different phases to the program. So, it is more that in looking at where we are today and the production that we have capable, we are looking for the assured production that comes down the line which will let us launch the phase two program.
Maj. Gen. West: Maybe I can help with that just a little bit. If we mobilized to get at a Desert Storm scenario or something like that tomorrow, we would take the 400,000 doses that we have on the shelf and vaccinate as many people as quickly as we could, and then we would use those doses in the pipeline to continue that effort. But, without that mobilization requirement, we would rather proceed with phase one program, so that there is no danger of reaching a point in phase one where you have someone that started the six-shot protocol, and not have sufficient dosages to continue that protocol without interrupting it. So the step that we are taking to not begin phase two is a step that gives us more confidence that we will be able to continue and complete all the protocols that we began, as required by FDA.
Q: So it would just be a waste if you gave people just some of the doses but not the full six?
Maj. Gen. West: It wouldn't be a waste because you gain some immunity with each shot that you get. But it would be a deviation from the protocol that's established and approved by FDA, and we don't want to get ourselves in a situation where we might have to do that.
Q: Have you found that some of the doses that are in the pipeline have been rejected as you have looked at the lots; had 100 percent acceptance of the pipeline?
Maj. Gen. West: All the ones that have been released and are out to the troops -- and that's why I referred to it as a "pipeline" -- are fully accepted and met all the tests.
Q: But there's warehouses full of these doses that have not been released, and you --
Maj. Gen. West: I wish there were warehouses full; I mean, it's not quite that many.
Q: Refrigerators full, I'll put it that way. And my understanding is, is you have tested some of those. And you have rejected some, and you have passed some.
Maj. Gen. West: Mm-hmm. (In agreement.)
Q: Is there any sort of -- what chunk of those that you are looking at, are you throwing out? (Pause.) Half?
Mr. Oliver: No. It turns out it's a terribly difficult subject. It's the reason I was over at the FDA talking about this.
And -- there is nothing actually quite as much fun as spending an afternoon with statisticians locked and talking about double-tailed probabilities. But it essentially has to do with, "Does your test -- does the standards that you set, 40 years ago, where you said, 'It has to be this' -- is (sic) that makes sense today or else -- or does your data show that you should have said it can by anywhere in this ellipse?" That's a difficult -- that really is a complicated subject matter.
Q: (Inaudible) -- you're throwing out? Some --
Mr. Oliver: I am not throwing out; I am putting aside right now, some of them. And --
Q: Less than half; that's a million or -- (inaudible) -- a million?
Mr. Oliver: That's about a million.
Q: So they don't meet current new standards?
Mr. Oliver: No. What I have chosen to do -- for various reasons, I have chosen not to test them again. I have chosen just to put them aside.
I do not think we are going to need them. In other words, I spent some time looking at this, and I think we have enough that gives us time enough to get the new facility tested by FDA, and a safety factor. And, therefore, I am going to focus on that and focus the team's attention on making sure that Bioport gets requalified, and not focus on this other problem for all sorts of reasons having to do with distraction of key personnel.
Q: Are the million immediately usable, if needed; no?
Mr. Oliver: If you really needed them and you were -- no, no, I am serious. It's -- the question is if you're --
Q: (Inaudible) -- reasonable?
Mr. Oliver: -- yeah -- because the question is -- we get back to an issue about whether or not the president or the secretary of Defense could choose to do that. And let me leave that for a different time.
I think that I would take those doses. I think they would protect me from anthrax.
Q: Would they expose you to anything else?
Mr. Oliver: I don't think so. It's --
Q: How about these soldiers who might not feel exactly the same as you?
Mr. Oliver: Yeah. And so what happens is I am not going to even worry about -- what I am telling you is I have put aside a set of them --
Q: Not to back up, but just as a bunch of other reasons.
Mr. Oliver: For a whole bunch of reasons, which had to do with how much time we had and the facilities it takes to test them and -- and various questions I didn't want to address, and then because of what I looked at that I thought would fully meet the FDA's criteria was enough to give me phase one --
Q: Are all of these doses from the old plant?
Mr. Oliver: They are all from the old plant.
Q: And why was the old plant torn down?
Mr. Oliver: Because when I was providing the annual doses for 1,200 veterinarians who did large-animal care and for a few wool workers, and for some people in the laboratories like Anna, who works for me, who has had 18 anthrax doses, I was working at a level -- you know, I only was producing so many, right? That is about 2,000 a year, roughly. Okay?
Now, I want to produce 400,000 thousand a month, if I am going to worry about all of the military forces, plus the allies that I think are going to have to do this. That's a different facility.
And so we tore down the old one to build a new one. The new one can produce at its maximum -- I don't expect it to get there -- 400,000 a month. Do you understand what I am saying, a difference in magnitude?
Q: I am wondering why you tore it down before the new one was certified?
Mr. Oliver: I don't know. That was a different decision. But I'll give you a reason why I might have made that if I were in his place.
This a funny virus (sic) [bacterium] in that most viruses (sic) [bacteria] are -- and if you are doing most things in the pharmaceutical world, you would produce something; then you'd run through, and you'd flush the system, and you'd produce something else. In this case, the FDA rules are you cannot produce anything else in that factory once you've started; you can only do anthrax, because you expose it to a live virus (sic) [bacterium] and because it's really hardy and carried through the air -- lots of problems. So you are restrained -- have various restrictions on it for safety reasons. So I can see why one might have done that.
Q: What's the sort of endgame here? You say six to 12 months, but have you given Bioport, you know, some sort of date on the calendar by which they have to get their act together? And what's to prevent the situation from just drifting on and being here in another three months and having to give them more money?
Mr. Oliver: What's going to prevent this is the loyal fourth estate, which is going to help me by making this unpleasant until we get this resolved, right? That's -- let me answer the second one.
The first question is, I did not give them a date. Let me tell you why I don't want to give them a date. I don't want to give them a date because of the secretary's guidance, which is it's going to be safe and effective. If it's going to be safe and effective -- if I'm going to worry about safety paramount, I cannot also give them a date.
And at the same time, General Kern -- Lieutenant General Kern Saturday morning brought in a brigadier general, Dean Ertwine, and said, "This is your guy. He's running this place up in Aberdeen right now. He is your guy, full-time, till this is solved."
So I think you can get by this out -- there are going to be a lot of internal dates, but I'm not going to give them a date by which they have to produce.
Q: But if they're the only producer in the country, what's the stick for getting this solved? Why does it -- what avoids it (sic) from just drifting on and being a problem forever?
Mr. Oliver: Because I think the people are inherently good people. The people are inherently good people. People understand the problem. We're going to put a lot of assets in this. This is no different than all the depots that exist across this great country and lots of other things for which the government runs, because it feels like it must. It's absolutely no different. And the reason that works is because you have good people.
Q: Do you feel 7 to 10 million (dollars) will solve it?
Mr. Oliver: Yes. That was my estimate last Thursday, and I haven't looked at it since. I took this, asked my staff to review it -- they have not gotten back to me.
Q: Is this 7 to 10 on top of the 18.7 million that Bioport was given in August?
Mr. Oliver: To square away the contract because the contract price was all off because what the state of Michigan thought they were spending was not even close to what we were really spending, yes.
Q: So you're looking at 28 million, basically.
Mr. Oliver: Yes. I'm looking at 7 to 10 more.
Q: Exactly where is this plant being built, and how much of it has been completed?
Mr. Oliver: Same place -- same place, it's all completed.
Q: What's the town?
Mr. Oliver: Lansing, Michigan. East -- Lansing, Michigan. You go up to Lansing, land at the airport, drive out of town and take a right.
Q: I have just a math question. With these million doses that there are problems with, where did they come from? Did they come from the old facility? And if so, like, how does the math work out to give you two thousand a year?
Mr. Oliver: I didn't say they had problems. I didn't say they had problems.
Q: These million that you've decided not to deal with at the moment, where did they come from?
Mr. Oliver: (They) are from 1985 on, they were produced in excess and they're stored there. Essentially, they're stored in a cold-storage place.
Q: So they were producing it at a fairly high rate. I mean, it couldn't be two thousand a year since 1985 --
Mr. Oliver: No, they weren't -- what I'm saying is, that was the demand. So it was sized for the demand plus a chunk, but it wasn't sized for what we're --
Q: I guess that brings me back to Jim's question, which is, Why tear it down? You said it was a tried-and-true facility that was working. Why tear it down before you have another tried-and-true facility? When you look back on the decision, do you think that was a smart --
Mr. Oliver: I was driving west at the time -- (laughter).
Q: Do you think it was a smart decision?
Mr. Oliver: I was driving west, I was looking at the sunset -- I don't know.
Q: You have --
Q: Can you answer that, please?
Mr. Oliver: Yes, Randy will.
Maj. Gen. West: It's not like you tore down a facility so you could build another one somewhere else. There are economies of scale to building the new facility to increase the production rate where the original facility was, because, you know, there are levels, recontainment requirements and things like that. And part of the problem with the million doses that's out there isn't necessarily that there's been something found wrong with it, but rather that we haven't had time on the production line within the existing plant capacity to retest and recertify that vaccine.
So what we had to do was take an existing facility that couldn't meet our demand and upgrade it to meet the demand that we need to vaccinate a 2.4 million-man and -woman force.
Q: Just explain -- is this what you meant, then, that to build another facility alongside of it, then to close down the facility afterwards, you can't ever reuse it, you'd have to do some big, like, Superfund cleanup to get rid of all the anthrax, or what -- is that the idea?
Mr. Oliver: You have to burn -- yes.
Q: You burn it down.
Mr. Oliver: You have to burn it.
And what Randy's talking about is, it turns out there are bottlenecks in various procedures when you review it. And so we are going about looking at various parts of the country, not -- that don't produce the anthrax vaccine itself, that serum, but there are other parts to it -- there's the storage, there's the testing of it, and some other things. The question is, can we pass it on to some other agencies or other facilities around the country? I'll pass on another --
Q: And what was the original cost estimate again?
Mr. Oliver: It was $7 (million) to $10 million.
Q: No, that's the increase.
Mr. Oliver: Yeah.
Q: But what was the original cost estimate?
Mr. Oliver: The original cost -- I need to check and get back to you. I need to check and get back to you because I don't have the number. I think the original number was in the order of $130 million.
Q: The more you describe this FDA inspection, it sounds like basically Bioport failed the inspection.
Mr. Oliver: Yeah, except that what you're talking about is sort of a rolling inspection. In other words, the guys come in, and they look at it, and in some cases I have been told that the people end up with something like 100 deficiencies in the first test. And they do -- they go in, figure out a way to fix this, write a letter back to the FDA. The FDA comes back again and reviews. In other words, you ought to expect in this kind of inspection several inspections before you get to the point that the people are comfortable.
Q: How many inspections -- (off mike)?
Mr. Oliver: One. In November. They have not yet written their letter back. I've gone over and talked to the FDA. We're going maintain close contact with the FDA on this. We're --
Q: So you have --
Q: But the facility's done?
Mr. Oliver: Hm?
Q: Is the facility done, except for the certification?
Mr. Oliver: The facility is finished and has certification, but if -- there are probably -- that's not a -- the certification is at least 50 to 70 percent of the whole process, you know, that's not --
Q: So there are 30 issues that the FDA found needed to be addressed. But when they come back on subsequent inspections, they might find additional things. So the universe might go up, and so it would keep rolling until the whole --
Mr. Oliver: I would expect the universe to go down and up at the same time, right? And so what you have to do -- what Bioport has to do and we have to make sure they're doing is they not only have to address the deficiencies the FDA have found, they have to address the underlying cause and make sure they've addressed that.
Q: Can you go back over these different quantities of doses you mentioned? You say you have 430,000 --
Mr. Oliver: Four hundred thirty thousand that are ready for issue; 600,000 in the pipeline.
Q: In the pipeline means not certified.
Mr. Oliver: No, no. Fully certified, out in the world, going to various people, being distributed.
Q: So the difference between ready-to-use and in-the-pipeline is what?
Mr. Oliver: Nothing.
Q: Ready-to-use means it's in our refrigerator here, pipeline is it's in the --
Mr. Oliver: It's in our refrigerator here; it has not yet been sent out in the pipeline to the troops.
Q: Okay, so you got a million ready to use.
Mr. Oliver: Got a million ready to use.
Q: That's different from the million that you do not plan to use.
Mr. Oliver: Right -- separate million.
Q: The million that's ready to use are the 14 to 16 months' worth of vaccine.
Mr. Oliver: No, because I've got 600,000 -- let's take the million that's set aside and call that A. Let's put the million that is fully certified, has met all the FDA requirements, and we'll call that B. Then there are 600,000 that we'll call C, that's separate from all those, and which I expect Bioport to have discussions with the FDA and the FDA approve within the next thirty days. And then we'll call another category D, which is about 400,000 and I expect that to get approved by FDA within several months.
Q: So that's two million, when you add category B, C and D, right?
Mr. Oliver: Yeah. Just leaving A aside, B and C is two million, divide that by 75,000 and that's the number of months. Actually, I've got a couple extra months in there because we've got -- I mean, we are going to wait until this is absolutely safe and effective before we distribute it.
Q: There's a difference in the potency and purity requirements of the new batches than of the old batches, is that not correct?
Mr. Oliver: That's not correct, but I don't want to mislead you.
Q: The old process.
Mr. Oliver: The FDA has not approved the new process yet -- for potency. I know where you're going.
Q: Old process -- you were producing a vaccine that, when you finally have a certified new process, these will be qualitatively different, will they not? There will be more excess biological material in the old stuff than you will allow in the new stuff.
Mr. Oliver: Let me get back to you, because I could talk about potency, but I can't talk about the purity.
Q: Let me try it this way: Is it an issue that in the old plant the FDA, in sort of a grandfather clause situation -- that it had things that it had to meet under the -- when it was first set up and was operating under that, and as long as it continues to operate, then it's okay. But now you've got a new thing, and you've got a whole set of rules that are stricter than they used to be, and now you've got to jump through more hoops to make it work. Is that basically it?
Mr. Oliver: It's precisely it.
Q: The GAO in October raised some concerns about the monitoring of adverse reactions by the Defense Department. Has that concern been addressed?
Dr. Bailey: We have -- we'll both answer that. We at this point are monitoring side effects through the VAERS system, which is the Vaccine Adverse Effect Reporting System. And that system also is reviewed by our AVEC, which is an independent group that reviews it for us as well.
Maj. Gen. West: The VAERS system was already out there and is used by the complete medical profession, not just DOD.
What we did in response to the GAO report is go back out and be sure that all of our people were educated to know that any individual can decide to submit a VAERS report, and no one is going to stop him or her from doing that, and they're all going to get looked at.
We've also made sure that we have reeducated our doctors and nurses and corpsmen to know how to handle those and to be sure that they get -- they all get processed, and they get processed as promptly as possible.
But, I mean, the system that was there, other than additional attention to it and additional personnel that we've put on it to monitor it, is still the system that we're using.
Q: What are the chief minor side effects that --
Maj. Gen. West: The chief minor ones would be soreness, redness around the vaccination site, occasionally a small lump that accompanies or closely follows the vaccination.
Q: Can I go back and ask Mr. Oliver? I'm still confused on one point here. Is there any difference in the potency of the new -- of what is produced from the new facility versus what's in stockpile? Or are they identical?
Mr. Oliver: When the FDA finishes and approves it, we do not expect there to be any difference in the potency.
Q: But you do expect a difference in the purity?
Mr. Oliver: I don't know that. That's -- I took that for fraction -- I don't know the answer, because I didn't -- I have not focused on it. I've got to get back to you. There's not going to be a difference in potency now, but I don't want you think later on I misled you.
I do expect the FDA shortly to approve a change in the potency test, which is statistically identical and even better than the previous tests. Okay? That's what I was over there listening to these people argue about. So please don't get confused.
Q: So if there is a change in the potency test, do they have to go back then and look at what's in inventory before you give them to soldiers to --
Mr. Oliver: No, ma'am. No, ma'am.
Q: Why not?
Mr. Oliver: The answer is no.
Dr. Bailey: I just want to add, from a sort of biochemical point of view, the sum of what's happened here is that there have been advances in the ways in which vaccines are both produced and tested. And so that's some of what the changes are in the criteria.
For instance, there are immunoassays that can be done, that could not have been done 20 years ago, to check for potency, for instance.
Q: So in view of what's in stockpile since 1985, how can you be assured of both its purity and its potency if there's all this new testing out there?
Mr. Oliver: You have to test. Anything that comes through has to be tested new, anew. In other words, you can't take it and leave it alone. You have the requirements -- for example, either three years or five years -- that it has to be tested again before it's released, even though to go into the original stockpile it had to pass a test to start with it. Then it has to pass a test periodically while it's there. And then it's going to have to pass another test to be released.
Maj. Gen. West: And Secretary Cohen's mandate, when he reinstituted the program, was that it would all be retested using the current standards, using state of the art --
Q: Does that include the 430(,000) and the 600(,000) that's -- there were -- okay.
Mr. Oliver: Yes, ma'am.
Q: And none of this -- none of the 430(,000) or the two sets of 600,000 came from the new facility, correct? They're all --
Mr. Oliver: Everything came from the previous facility.
Q: Previous facility.
Mr. Oliver: There's nothing out there from the new facility, because it hasn't passed the FDA standards.
Q: Are you concerned that this is going to fan the flames of that minority of folks that are unhappy with taking this or refusing to take it?
Dr. Bailey: Well, I for one am concerned that we get that information out -- I think this is why this is helpful today -- that safety and efficacy are prime considerations in approval here of any new vaccine.
But I do want those who would consider not taking this vaccine for any reason to reconsider, given the deadliness of the anthrax biologic weapon and the effectiveness, the incredible effectiveness for protection, of the anthrax vaccine.
Q: When we were last briefed on this matter, the side effects were described as minor. Since that time, has anybody come up with -- have there been any serious illnesses or any deaths associated with this?
Dr. Bailey: There have not been any deaths, and that's important to note, because as you know, with other vaccines and medications, in fact, there are. This vaccine is as safe, and at times recorded to be safer than some of the vaccines that we give to children in America. We are actually seeing fewer side effects than might have been expected. Although we do see about thirty percent of the people who receive the vaccine get a sore arm. I, myself, in having taken it, have gotten a sore arm each time, but not unlike other vaccines that I have received. Occasionally, and I didn't have this occur, you'll get a little knot, and that will go away within a period of weeks. So, this vaccine has been shown to be not only effective, but in fact safe, and on par with other vaccines that we give. We are continuing to monitor those side effects, though.
Q: So, no new reports of side-effects?
Dr. Bailey: No, except I'd like to give you the update, in that we have reviewed of the VAERS Reports: 559 of those reports. And, I should tell you that out of that, we've had 22 people who had in fact to be hospitalized, but it was found that of those 22, only 6 were related the hospitalization were related to the vaccine.
Importantly, of those 6 -- now this is 6 out of over a million vaccinations -- 6 people had to be hospitalized, but all four allergic-type responses, which were severe enough to require them to be out of duty for 24 hours and hospitalized, but they were all related to the injection site. Soreness in the arm, redness in the arm that was beyond what we would ordinarily expect. So, again, very low incidents of side effects. Six people with the side effects that required that kind of a response from the medical team, and that was out of 383 thousand individuals who received those vaccine -- that vaccine.
Q: Of the six, after a few days what was their status?
Dr. Bailey: Exactly, they've completely recovered.
Q: Thank you very much.
Mr. Bacon: Dr. Bailey, Admiral Oliver, General West, thank you all. I have a brief announcement on "don't ask, don't tell." In 1997, Secretary Cohen ordered the first review of the implementation of the "don't ask, don't tell" policy which went into effect as a law in 1994. That review concluded that, for the most part, the policy has been properly applied and enforced. All of us have read, since then and in recent days the very disturbing charges that have come out of Fort Campbell, Kentucky, and many people have asked whether the charges made about Fort Campbell may apply to other installations in the military.
As for the Fort Campbell situation, as you know, the Fort Campbell command and the command of the 101st Airborne Division have made it clear that they are determined to comply with the policy and the law. And they have announced that, after the legal proceedings are over at Fort Campbell, that they will undertake a review of the compliance with these policies and the regulations at Fort Campbell, and to take any steps that are warranted from that review.
Today, Secretary Cohen has asked the Department of Defense Inspector General to check installations in all the services -- not every installation, but to check major installations in all the services -- to assess the human relations environment in the other military services with respect to the "don't ask, don't tell" policy. The extent to which disparaging speech or expression with respect to sexual orientation occurs or is tolerated by individuals in the chain of command will also be assessed. So, it will look at the climate for -- if there is an harassing climate, and whether this is condoned by the command. And he has asked that these assessments be presented to him in 90 days.
So there's a two-part approach here: one, the Fort Campbell assessment, which had been announced some time ago, will take place after those legal proceedings end. That could be another month or later, depending on how long the legal proceedings go. Second, there will be a DOD Inspector General investigation spot-checking the climate of major installations in all the services and reporting back within 90 days on those findings.
Q: Have you got a list of the bases --
Mr. Bacon: No, because they haven't been determined yet. The Department of Defense Inspector General will basically design a review procedure or assessment process, will choose the bases to look at and then go and put together a team, train the team up and send the team out to go and interview soldiers, sailors, airmen and marines at these installations, as well as their NCOs -- non-commissioned officers -- and commanders to get as clear an assessment as possible in 90 days of what the climate is, vis-a-vis the homosexual policy, "don't ask, don't tell."
Q: Are these both domestic and overseas bases?
Mr. Bacon: That will be up to the IG to decide, but there's nothing that rules out foreign bases.
Q: Does the secretary agree with the president's comments on this issue, that it's not working very well?
Mr. Bacon: The secretary shares the president's determination to make sure that this policy is executed as fairly as possible. He was very clear about that last August when we issued some new guidance. I think that guidance is extremely clear, and let me just read you two sentences from an August 12th memorandum that went to the secretaries of all the military departments, the chairman of the Joint Chiefs, and to the Inspector General as well.
It said, "Servicemembers should be able to report crimes and harassment, free from fear of harm, reprisal or inappropriate or inadequate governmental response. Commanders must take appropriate actions in such instances with due consideration given to the safety of the persons who report threats or harassment, and see that persons found to have made threats or engaged in threatening or harassing conduct are held full accountable."
Now this was guidance that was issued last August. It was -- and the secretary wants to make sure that this guidance is understood and that it's being followed. And he has asked this spot-assessment process by the IG as a way to get a window into how the policy is working.
Q: Ken, the president basically said that the military had not followed through on its pledge to implement "don't ask, don't tell" back in '93. And the last time this subject came up here, last week, the question was, what sort of training and instruction do you have on the implementation of "don't ask, don't tell"? And you were able to cite just one case of a commander at -- where was it? -- Fort Jackson in --
Mr. Bacon: Fort Jackson.
Q: -- in South Carolina.
Mr. Bacon: South Carolina.
Q: How can it be that six years after the military pledged to implement "don't ask, don't tell," you've only got one training course on it?
Mr. Bacon: Well, I think there are more training courses. The -- Fort Jackson was one that came to mind. I believe that there is training elsewhere as well. And certainly the regulations require that there be training on this, that commanders and NCOs and also troops are supposed to know what the policy is and what it requires, and its protections -- the protections that it provides.
Q: Is it part of basic training?
Mr. Bacon: It should be part of basic training. According to my reading --
Q: (Off mike.)
Mr. Bacon: Well, it certainly is at Fort Jackson, South Carolina, which is a basic training post for the Army, one of the major basic training posts for the Army. And my understanding is that this does occur elsewhere, but I don't have a -- I cannot give you a complete rundown at this stage.
Q: When Mr. Berger on Sunday said that the Defense Department had recently issued new policy guidances, was he referring to these August guidances? Is this --
Mr. Bacon: Yes, that's what he was referring to.
Q: And in these guidances, what kind of follow-up was done after they were issued? Were there meetings? Were there -- what kind of follow-up was done from August until now?
Mr. Bacon: Well, the main follow-up has not yet occurred, and that is that all the services are in the process of coming up with training guidance to their training posts. And those are done in draft form. They're in the process of review by the General Counsel's Office and by Undersecretary de Leon's office, and I assume that they will be out relatively soon, but I can't give you a final date on that.
Q: The "don't ask, don't tell" policy was basically designed to make the military more tolerant of gay lifestyles, as long as it was sort of kept quiet. But the figures show the numbers of discharges for homosexuality increasing every year. How do you explain that?
Mr. Bacon: Well, I think that the most fundamental fact to remember in evaluating discharges is that more than 80 percent -- in fact, I think close to 90 percent, somewhere between 85 and 90 percent -- of the discharges occur in so-called statement cases, where people -- generally, they're self-statement cases, where people make statements about their own sexual orientation. And remember what the policy says, that unlike prior to 1993, when homosexuals were barred from serving in the military, homosexuals may serve in the military as long as they do not announce their homosexual status, or as long as they don't engage in homosexual acts that could compromise good order and discipline. So, to the extent that -- so, the breakthrough in this policy was to allow homosexuals to serve in the military. Obviously, members of the gay community have said that the policy is unfair because it requires them to be silent about their sexual orientation, but that in fact is what the law says.
Now most, as I said, most of the discharges have occurred in statement cases, and most of those are self-statements, where people have made a declaration. I don't know the full reason why more declarations have been made in the last several years than before. Some of it may reflect a misunderstanding of the policy, some of it may reflect the fact that throughout society, institutions and people have become more open about their sexual orientation, and there may be a feeling on the part of some that the military should be able to accept that. But the fact is, that the law is very clear, that if you announce your homosexual orientation, it is grounds for dismissal. And most of these dismissals are uncontested.
Q: What are the numbers done on the acts cases?
Mr. Bacon: The acts actually have declined. The number of people dismissed for homosexual acts has declined, while the number of people dismissed for homosexual statements has increased.
Q: I am sort of new to the whole policy. Is it that they can't act at all, or is it just good order -- acts that affect good order and discipline, as in in the barracks, or --
Mr. Bacon: That seems that it's a very simple question that requires a very complex answer, but basically the policy prohibits homosexual acts.
Q: Was this decision -- you said something about doing the IG spot-check -- was this decision taken by the Pentagon after the president expressed his displeasure with how the policy was being carried out?
Mr. Bacon: Since the charges in the Fort Campbell case have become known, we have been looking at a number of options. This is one of the options we've been looking at, and there were meetings on this last week, on what courses to take, and this is the option that we've settled on. There may other actions forthcoming, but it takes a while. Is -- I hope you can appreciate that there's a certain amount of delicacy here, because we do have an ongoing case. And on the one hand, we don't want to compromise the rights of anybody involved in a legal proceeding at Fort Campbell. On the other hand, clearly there are issues that have to be addressed, and we're trying to address those issues as broadly as possible without any particular reference to what's going on at Fort Campbell.
Q: Will these spot checks -- will the installations and bases that are being evaluated in these spot checks -- will they know they're being evaluated, or will it be surreptitious? Will it be confidential? How will that work?
Mr. Bacon: I think it'll be very difficult for the IG to send a team of people in surreptitiously --
Q: (Off mike) --
Mr. Bacon: -- particularly to talk to commanders and NCOs and soldiers, sailors, airmen, and Marines. So my guess is that they will go and try to evaluate the climate by talking to people. I have never found that soldiers are reluctant to talk about their living conditions, so I assume that they will be able to ferret out what's happening.
Q: But in this case, aren't soldiers unlikely to be willing to talk about, you know, this particular issue, since if -- if soldiers who are gay -- if they declare themselves to be gay or indicate that they're gay, I mean, they open themselves up to possible reprisals?
Mr. Bacon: I think that the IG will be looking at the so-called human relations environment, and it will be easy to tell, from talking to people, whether anti-gay statements or harassment is a regular part of the life of the post, irrespective of whether the people doing the reporting may happen to be gay or not. In other words, somebody can -- other people can report on what is likely and what the climate is.
Let me give you an example. Several weeks ago we released the survey of racial attitudes, the 340-odd-page survey, and talked extensively about it here at a briefing. Many of you wrote that blacks and other minorities had said that they were aware of racially disparaging statements having been made. What the survey also showed was that 62 percent of the whites reported racially disparaging statements. So there was a degree of sensitivity on the part of the whites in the survey. They were sensitive to racially disparaging statements that might have been made against other ethnic groups.
So I think you can apply the same model here -- that people who are not gay could be aware of sexually disparaging statements and could be well concerned about sexually disparaging statements.
The goal of building military teams is to build trust and confidence, and that trust and confidence is compromised by harassment and by discrimination. So I think everybody wants to build teams that are as effective and trusting as possible, and that requires trying to get to the bottom of whether there is harassment or discrimination taking place, and to stop it.
Q: -- new guidance for the services. Will that, the guidance, will that be on implementing the policy, and will that mean loosing punishments for supervisors, for example? How will that guidance differ from what's in place now?
Mr. Bacon: Well, this is basically going from the general to the specific. I think if you go back and read the August 12th statement, from which I read earlier, and we'd be glad to provide that through Colonel Tom Begines, and if you read the guidelines for dealing with the implementation of the homosexual conduct policy that went out to the secretaries of all the departments on the same day, you'll see that it's clear but it's fairly general.
What the services have been dealing with now is drafting more specific training programs that are aimed at all levels of service, not only the command level, but the NCO level and the soldier level. This should make the training more consistent and more uniform throughout the services.
Q: And, brief update on what further legal proceedings remained on that. How many more folks are --
Mr. Bacon: Well, there is a trial pending against one other soldier at Fort Campbell.
Q: Thank you.
Mr. Bacon: You're welcome.