Background Briefing

Mr. Bacon: Hello. I have a whole team of briefers coming to talk to you about anthrax. The main topic today is the renegotiation of a contract with Bioport, the company that makes the anthrax vaccine, and this is all on background attributable to either senior Army or defense officials.

The briefing will be basically in three parts. The first part will be a brief description from the Joint Staff of the threat and the military requirements from a warfighter's standpoint for the anthrax vaccine.

Second, we will have two briefers from the Army who administer this program as the executive agent, to talk about the contract renegotiation and what's been achieved and why.

Then we'll have a representative from Health Affairs, a doctor and flag officer talk about the health aspects of the vaccine. He will be able to answer your questions on adverse reactions or anything else that you may have that you need answered. Obviously, the Army briefers will be able to answer your questions on the contract itself.

The first briefer, even though this is on background, is well known to you because he's been here many times before. He will be followed by the following briefer who is the head of the team who renegotiated the contract here.

Q: Why can't this be on the record?

Mr. Bacon: This is pretty technical stuff and I thought it would be a freer flow, more of a dialogue, if we did it this way.

Q: But (inaudible) the program part of the problem here with...

Mr. Bacon: I think this will be a highly credible briefing and you'll get all your questions answered.

Q: There won't be any names attached to it, though.

Mr. Bacon: We're going to do it this way, and there will be future opportunities to talk about that. Let me just, again -- for the bonafides here... this is also part of the Army team who is involved in the negotiations. Then finally, the Health Affairs, and doctor who will be here with you. Then we also have from the Army Surgeon General's office another doctor who will also be able to answer questions if they should arise.

With that we'll turn it over to the first briefer.

Briefer: Good afternoon. I really want to talk to you today about the operational imperatives of the anthrax vaccination program. As Ken said, we've got some technical experts here and some medical experts to really answer your questions on -- if you would -- the inner workings of the program itself, but I really want to talk to you about the imperatives, the need for a vaccination against this threat.

As you know, or if you don't know, there's ten countries that we know have this capability to kill our troops. I mean that's the bottom line.

When you think about threat as an operational commander, and I'll relate my experiences as a commander, we do all we can do to ensure the safety of our troops. I'd like to relate vaccination to force protection, because that's exactly the way any good commander would view it. When we put troops in harm's way, we don't give them the choice of wearing a kevlar helmet or not wearing a kevlar helmet. We know there's a threat and we protect them accordingly. If we're putting soldiers or Marines, Special OPS, whatever that may be into a certain type of environment, close combat in a built-up area, we would normally require them to wear body armor. It protects them from direct-fire and indirect-fire.

When we put a soldier, a sailor, an airman, a marine into an area where there is a known threat, in this case we're talking about anthrax, we want to equip that trooper so he or she can survive against that threat, to do the best we can do.

So when I look at vaccination, I look at that as an attempt to give that soldier, sailor, airman, Marine the best chance they can to survive whatever threat or whatever condition they're in.

I'll go back to an operation that I was a line commander in when we went into Haiti. It was originally going to be a combat operation. It was called Restore Democracy, and it evolved to Uphold Democracy. One of the big concerns was the disease problems in Haiti. I spent as much time as an operational commander then making sure that every soldier -- and I was commanding an Army unit -- that was going in on that deployment into Haiti had all of the vaccinations that they needed to make sure that they were medically ready and fit to be able to encounter that threat.

The threat of anthrax is there. We absolutely have to have our troops prepared to handle that threat.

Let me paint a picture for you. Fighting is tough. It's a team issue. Soldiers, sailors, airmen, Marines rely on each other.

If you were to take a unit on a battlefield in this environment that happened to be exposed to the anthrax threat -- those that were vaccinated survive. Those that were not vaccinated, the medical evidence is within a couple of days they're close to being incapacitated, and as you have been told before, this terrible agent, in fact, is worse than Ebola. You have in the high 90s fatality rate.

So now we took a unit, and you can look at any size, whether it's a battalion, a company, whatever it may be. You just reduced the fighting effectiveness of that unit by 50 percent.

So not only do you have the difficulty of the evacuation of these troops that have been exposed to this terrible agent. You now have taken a unit that was a fit fighting force and you've reduced it 50 percent and now it in fact can be in harm's way for a period of time because of other threats, and also it no longer is an effective fighting force towards the accomplishment of your mission.

So this is about force protection, and that's all it's about. And giving our soldiers, sailors, airmen, Marines, the opportunity to survive on a very, very lethal battlefield.

I've got to tell you, personally it would be irresponsible and it's unconscionable that we would take a trooper into that threat area and not be vaccinated. That's not a choice of the soldier as to whether he or she is not, because it's a matter of being part of that team. And I would have great difficulty coming to one of you, for those of you who are old enough to have children of military age and look you in the eye and tell you that your soldier died or your son died or your daughter died because they weren't vaccinated. I'd have grave difficulty with that. And as a leader, I can't fathom that we would ever take a trooper into that threat environment without being vaccinated.

That's really the operational commander's feeling, and that's what we're really talking about here.

I'll be glad to answer some operational questions, then I'll turn it over to the experts who are technical.

Q: Sir, if the enemy knows that all your troops are vaccinated and they use a different agent that's not anthrax, then what do you do?

A: I'm going to let the chemical experts answer that question when they come up here and talk about that. There are some solutions there.

Let me make a comment, though. Our protection issue, force protection issue, is just not the vaccination. We also have a program going on to try and detect different agents. Also you get protection from the use of your chemical protective gear because it actually filters out the spores.

However, when you go back to that, if you were in an environment where you actually use the protective masks, if you inhaled it before you got the mask on and you weren't vaccinated, it's like not having the mask. Period. But I'll let somebody else talk about the other agents.

Q: If for some reason this program were stopped, what signal would that send to your adversaries, and how might that affect potential use? Does it raise the value of their stockpile of material?

A: You can look at it several ways. I would tell you that it sends a strong signal to your adversary that he or she might be more inclined to use it. So I can't fathom, like I said, taking soldiers, sailors, airmen, or Marines into an environment where we're not vaccinated against this threat where it's a known threat.

Clearly if you're not going to protect yourself from it, it makes that capability seem or appear to be or in fact will be much greater.

Q: Since you and the other people here are advocating this program, have you had your anthrax shots yet?

A: I've had the first three. I get the fourth one here in another five months. I have great confidence in it.

We have a very sophisticated vaccination program, and have had. I've been vaccinated... I've been in early deploying units all my life so I've been vaccinated many times. In fact, I've learned to keep my shot records with me so I didn't have to take the yellow fever shot as many times as I've had to over the years because I couldn't, because it hurts. But I've never had yellow fever.

So I have total confidence in it. It's 30 years old. We don't seem to get this blow-back on our other vaccines, but I'll let the docs talk about that.

Q: Why do you think that is? Why so much trouble with this one in particular?

A: I think a lot of it has to do with the Internet age. There's this tremendous amount of information out there that our youngsters can go right to the net and pull down information, and in fact there's a lot of disinformation on the Internet. Very, very aggressive, I think, disinformation about the program. We have a different generation today and they have that access to that.

Q: What do you say to those that have trouble, whether it's valid or not in your mind, what do you say to them that say, 'I don't want to do it?'

A: First of all, you need a very, very strong education program, and we owe our troopers that and we give them that. And we're doing it all the time. But the bottom line is it's not a voluntary program. It should not be a voluntary program. Again, I'll go back to this team effort. If you're going to go into combat you don't want to wear your helmet, I'm sorry. You're going to wear your helmet. We know there's a threat there and you can lose your life.

Q: You equated the anthrax vaccine to the kevlar helmet and your flack jacket and that sort of thing. Before those were given to the troops they were thoroughly tested and you knew what protection they provided.

What the (inaudible) seems even among the medical profession of this vaccine is that it was not tested with the long term consequences or (inaudible) utilization or its effectiveness against the kind of germ distribution that you're going to face in a combat situation which is airborne.

A: Let me let Mike talk to you about the medical piece of it, but I want to clarify something. I also consider yellow fever, hepatitis, plague, diphtheria, all of the other vaccinations that we take also equal to the kevlar helmet and to any issue. I also look at the fact that we go in and do as much work as we can in medical surveillance to determine types of diseases and other things we have in a given area to force protection. I mean you can look at each of the activities that we go through to try and make it as safe as possible, and that's kind of an oxymoron when you're thinking about combat, to give our soldiers the most protection that we can. So it's not just anthrax versus those, it's all of the pieces of force protection. Anthrax vaccination being one piece of that.

Q: What do you know about the folks whose religion prohibits vaccinations? They're just not allowed...

A: I'll defer that also to the experts on that.

A: I'll try to answer that briefly. I am from Health Affairs, I am a doc, and I've been involved with this for some time now. I was recently, until the last few weeks, involved with sending out troops, providing protection in the field, so I've been concerned about this not only from an operator's point of view but now for the last several weeks from the policy point of view.

There are exemptions. There's medical exemptions and there's a process for religious exemption for people who don't take vaccinations. We have them scattered throughout the services. We can get you as much information on that process or how may people avail themselves of that and those sorts of things.

I'd like to take exception to your assertion that we haven't proven this as effective. We have. Period.

You can't ever have an absolute 100 percent certainty in science, and especially medical science. We bring scientific methods to the art of medicine. So every doctor that you've ever seen is always to a small extent playing the probabilities.

We know this. We know that in a relatively small human study of occupational exposure, that the vaccine, in lower doses than we give now was effective. Period. I'll show you that study. We know that in primate studies, which is our nearest biological kin, we have overwhelming evidence that the vaccine is effective against inhalation anthrax.

Now I can raise the probability by experimenting on humans, but there's no ethical experiment that I or anybody else can think of that would prove this to a higher degree than what we have now. Because to really know, you would have to take two groups of people and give some of them a placebo so they thought they were getting vaccinated, and some of them the vaccine, then challenge them with lethal doses of the anthrax and there would have to be enough lethal doses that all of the placebo, all of the untreated would contract the disease. Then to see how many of the people who had the vaccine did not.

I wouldn't volunteer for that. That's the only way we can prove it to any further extent than what we have now. We know when we did the primates, I think they were Rhesus monkey studies, we found the antibody levels that were protective; we know that with our vaccine we get antibody levels in humans that are even higher than that. So to say that it is not effective is unsupportable.

Q: ...primate tests conducted (inaudible) widely known (inaudible)...

A: Well it is widely known, and I can give you those studies and they were done in the '90s.

Q: Can you compare the kind of reactivity that you're getting to the injections, how many people have been vaccinated from skin rash to flu symptoms, anything else.

A: Yes, sir. I can give you a site picture of that.

May I ask that we hold that for a moment, because we may be getting the cart ahead of the horse and we wanted to bring out the topic of the day and then I'm supposed to be kind of wingman to help answer those kind of questions so if we could do that I'd appreciate it and then I'm very happy to come back up and continue.

Briefer: Good afternoon. I want to follow up on the issue of the premises of providing protection to the total force. The only way you're going to do that is to have a source of that vaccine. We have a problem in this country. We only have one single source of the anthrax vaccine.

Prior to Secretary Cohen's decision to immunize the total force, the State of Michigan subsidized the production of anthrax vaccine at a state-owned facility called MBPI, Michigan Biological Product Institute.

Both the government and the state believed that $4.36 was a practical and reasonable price to charge for the production of one dose of anthrax vaccine or per dose of vaccine.

In June of '98, the State of Michigan in a business decision made a decision to sell MBPI to the highest bidder. Bioport was the highest bidder. They consummated that sale in September of '98 at a total price of approximately $25 million.

What's important to understand about that sale is, we call it a novation, but it really wasn't a novation. It was the people who were there that worked for the state, the facilities were the same. They simply brought in new management to take over that contract. Indeed, they renegotiated that contract with DoD at a price of approximately about $4.36.

Six months into the contract, Bioport made a discovery. That discovery was that the $4.36 did not cover all of the costs to maintain and operate that facility. Let me give you an example.

There were state employees that were on the state payroll that worked at MBPI. Grounds and maintenance facilities, janitors, one example. The utilities -- state owned, under the state payroll, not under MBPI. Maintenance of the facilities, again, a state payroll price, not under the MBPI. So you can see the discrepancies here.

Bioport had a choice at that time. They came to the Department of Defense and requested an exceptional, extraordinary exception or relief on this contract. We put a team together and for two months we studied what options and alternatives we had at that time to help Bioport.

After two months of extensive study, findings were presented to a contract arbitration board. That board concurred and believed that Bioport was in fact in financial distress. It also made a decision at that time what we needed to do was go back and renegotiate the contract.

We also in DoD wanted, at that time, to make sure there would be a continuous and uninterrupted supply of anthrax vaccine to ensure our soldiers, sailors, airmen and Marines would have that force protection.

What I want to do right now is bring up the task force leader who provided the lead for the government on negotiating this contract and give you the specifics of what we negotiated or renegotiated.

Briefer: Good afternoon.

As the other briefer said, we spent the last several months working this issue. It is important that we restructure this contract because we must have this vaccine to protect our troops.

There were three major key elements that we renegotiated. One was an increase in price from $4.36 to $10.64. That increased the total contract by $24.1 million.

The second key factor was that we will be providing advance payments against future production. We'll be providing $18.7 million of the $24.1 million to Bioport prior to completion of production. But they will repay that at $4.60 every time they bill a dose to us.

In order to protect our investment we put in several safeguards. First and foremost, we will have liens on all of Bioport's assets. We will also have a renegotiation provision so that nine months into this contract we can look at it again, reassess the price and determine if the price is appropriate.

We have established a special bank account that requires that the government contracting officer sign off on all withdrawal of funds to Bioport.

We will be putting several people on the ground at the Bioport facility in Michigan to oversee the effort between now and the end of the new contract, next year in December.

The Defense Contract Audit Agency will do a follow-up audit in six to nine months to ensure that Bioport is working as we expected.

One other aspect that we did with this contract was authorized them to use government-furnished equipment that is now in the plant so they could go for commercial sales. So eventually this company will not be dependent on the Department of Defense as its sole provider of funding.

I'll be happy to answer any questions.

Q: Can you give some of the figures about how much... what's the total value of this contract? How much we've already spent on anthrax vaccines, how much is anticipated? How much money are we talking about all together here?

A: The total value of this contract now, from the beginning of September of '98 to December of 2005 is $49.8 million.

Q: How does that compare with what you've already spent in the past on the anthrax vaccine?

A: This is the first time that we have had a contract for significant production. I don't have the answer specifically of how much we spent in the past. I can get you that.

Q: So you've doubled the price basically, from whatever it was to $49; it's a $24 million increase.

A: Yeah.

Q: It does seem like an extraordinarily large jump to a layman, even if the janitors are paid at a different wage.

A: I understand that. But there was approximately, as far as we can tell, about $5 million that Michigan actually was paying that was not being credited to this account. That's the first thing.

The second thing is, when Bioport took over -- and you have to remember this is a small, brand new company, and all companies have startup problems -- when they took over this company, the state-run facility was in the middle of renovating the production suite. There were some delays in that. So consequently, they're not getting paid as soon as they had expected.

In addition, they had expected to be able to sell more commercially than they were able to. So they had fewer revenues than they expected.

Q: How many doses does the $49.8 million buy?

A: Approximately 5.3 million.

Q: That's a reduction in the amount of doses, is that correct? You're getting less vaccine out of this contract...

A: We are getting less vaccine because the contract called for a total, a larger stockpile than we actually needed. What we had put on contract was their maximum capability which is not really a reasonable thing to do. After the new management took over they looked at it and said a normal pharmaceutical company does not count on 100 percent production. What they count on is about 75 percent production.

So what we're looking at now is about 75 percent production and it still meets Department of Defense needs.

Q: Can you talk to the safeguards to guarantee the government's financial investment in this company. What about, are there any safeguards in this contract to guarantee the quality or effectiveness of the vaccine?

A: Just as normal. This contract change did not affect that. No lot is releasable without FDA approval.

Q: You're getting 5.3 million doses instead of how many?

A: We were getting 7.6.

Q: The quality assurances, one of the reasons for the sale was Michigan didn't want to pay to make the improvements that were required by FDA (inaudible) the lab was inspected. Have the inspections been completed in the testing to determine whether it can now release the new doses?

A: Not yet. We expect that they will submit their first request for inspection early next month, and then the FDA will come in and inspect the new production suite.

Q: You're still using the untested vaccine?

A: No, as the gentleman said, this vaccine has been tested and this contract change does not affect that.

Q: (inaudible)

A: I'll have to refer that.

Q: Can I ask another contract question, please? Can you just tell us what the profit structure is in this, if any, per dose? In other words, is this new price straight covering of costs or is it...

A: It's just covering costs. There is no profit in this.

Q: What percentage of the anthrax vaccination... what percentage of Bioport's business is the anthrax?

A: It's the majority of it right now. I don't know what the exact percentage is, but it is... They are almost a one product...

Q: ...question about negotiating with these folks. The other briefer said a moment ago that Bioport made the discovery six months into the contract. Actually at a congressional hearing some time ago the President of the company, if I recall correctly, said that he knew all along that most likely Bioport would not be able to make that price and that something would have to be done later on.

How were you able to negotiate and determine this was a trustworthy company to negotiate with after that experience?

A: We sent the Defense Contract Audit Agency in there three times in the last month and they audited the financial capabilities of the company, they audited the accounting system, and then the audited specifically this request and this price increase.

And they determined that the accounting system, that they were in financial trouble and that this company would not survive unless we increased the price.

Q: My point is that they seemed to know all along they were going to have to come back, that something like this was going to happen all along. How can you know you can trust them now?

A: I don't know what was said. I don't know exactly what you're referring to. But I believe that they did not know exactly what the price should be because of the things we said; then the other things of the commercial sales that did not materialize; and then the delays in the production suite.

Q: ...know what the cost of this stuff is?

A: Yes, we have done... Frankly, we have spent the last two months almost in Michigan. I've been in Michigan more than I've been here and the DCAA has been also.

Q: This is a non-profit profitmaking company?

A: They will be able to make a profit on their commercial sales.

Q: If anybody buys it.

A: If anybody buys it. But there's no profit included in our price.

Q: So the incentive to them, just to clarify this point, is that they continue to produce this vaccine, the government covers their costs of production, they get to stay in business, and they have the potential to make a profit with other customers, and without this help they'd probably not remain in business. Am I reading this correctly?

A: That's correct. But let's not forget that the key here is that we get our vaccine.

Q: One more point. When you mentioned the window, nine months, where you could renegotiate the contract, is that, would that renegotiation take place if it was determined that the actual cost of producing the vaccine was lower or higher than projected?

A: Correct.

Q: Would it be adjusted to cover, again, the actual cost?

A: Yes.

Q: Are there any (inaudible) penalties in this contract if they don't meet the contract standards?

A: There are performance requirements but there are no standard incentives that you're thinking about. The important thing is that this company maintain its financial viability so that we can get our vaccine. However, we have provisions in the contract that our needs are met first. They can't sell it to anyone else until our needs are met.

Q: What is your latest thinking about whether or not it's practical or viable to even begin to look for a second supplier, a competitive supplier?

A: Actually the Department of Defense is looking into that and it's going to make an analysis. But the problem is that it takes six, seven, eight years before we could bring another producer on board, so we can't wait that long.

Q: There's just nobody else in the United States that...

A: They're the only licensed manufacturer.

Q: What about other countries? Are there...

A: There's no one else that's licensed by the FDA.

Q: ...in Iraq. (Laughter)

Q: There were other companies that bid on this, and I realize that Michigan made the sale, not the Pentagon. But who are those other companies, and how did this company end up in the hands of this holding corporation that's based in the Caribbean and apparently doesn't have a lot of resources to sustain itself? How did that happen? Have you explored that at all?

A: I really wasn't involved. That was completely between the State of Michigan and Bioport. I can't really answer that.

Q: The other bidders, are they potential, as you look at other producers for this thing?

A: There were only two bidders. Bioport was only one of two bidders, as I understand it.

Q: Who was the other one?

A: I don't remember the name. Sorry. I wasn't involved in it.

Q: Bioport I think said they wanted to keep 70,000 doses for commercial sales earlier this year. Is that allowed under this renegotiation?

A: Yes, it is. Assuming that they meet our requirements, our cumulative requirements every month first.

Q: And how much profit can they expect to make off of that? Would they be selling it for the same... I can't imagine that...

A: No, they will be selling it for a higher price.

Q: And is DoD paying all of their overhead so that anything that they sell is pure profit?

A: Actually if they sell commercially... and what we've done is negotiate a quantity and an amount... If they sell above that amount, then we will get a percentage of that back if they sell it.

Q: Can you put some numbers on that, please? How much are they expected to produce for DoD a month?

A: I can't do it by month. I could look it up...

Q: ...quantity?

A: It's in the contract. I just don't remember off the top of my head. I'm sorry. But in total... First they have to meet our requirements every month and that is laid out in detail. I'm sorry, I just don't have that. But in total, they cannot, they will give us a credit back if they sell over 300,000 at a price greater than $30 a dose.

Briefer: We're the medical health team representing the Army as the executive agent and the policy.

The first one that's sort of hanging in the background and I think needs a direct answer is the FDA having to shut the plant down for renovations. That's another one of those urban legends or something that just keeps cropping up.

We planned to shut the plant down to modernize it because the manufacturing techniques and the size of the cooking vats and all of those sorts of things were insufficient for what we needed. It was plenty sufficient for veterinarians and agricultural workers, but we greatly upscaled the whole program and had to have modernization of the factory. It was not an FDA requirement, it was a planned upgrade.

The other question that has been kind of hanging since right at the beginning was, 'Why use this when if you use this somebody would then attack you with something else'?

This is classic deterrence. The answer is, we try to deter the known and most dangerous threats. If we can make it harder for an enemy to attack us, if we can make him use his second best gun, his third best weapon, then we do that. We have our people wear kevlar vests. They don't stop all sorts of ordnance, but they stop some, and they stop the ones that are easier to use. So that's I think the question is the deterrence of using a vaccine under the envelope of force health protection which is our overarching plan -- to try to use every means we have from detection to deterrence to mitigation to masks to protective gear, on and on and on, because no one thing is perfect. But all of them put together increases the odds of survival of each and every soldier.

Q: Do you believe a bio threat (inaudible) that this strand of anthrax is the most likely, the easiest to weaponize, the most stable? Can you run through...

A: Anthrax, if you want to use a biological weapon of mass destruction, is the weapon of choice. It's sturdy. It's easy to find. It's easy to grow in massive quantities. When you get it in massive quantities, it's easy to get it to turn into a spore form which is sort of like a seed which is very, very resistant to the usual things that inactivate or kill bacteria and viruses. It's easy to weaponize in a variety of weapons, both terrorists' and using rather conventional delivery systems. And the unfortunate thing is that the first indication you may have of it is when people begin to die.

Q: Are there other strains of anthrax that you can -- as a weapons designer -- you slightly alter that and therefore bypass your vaccine?

A: There are a couple of answers to that. One is, it's theoretically possible to alter anthrax so that our vaccine would not be effective against it. It's theoretically possible. Nobody has one that we know of. And it would not be an easy trick. So even if that existed perhaps in the hands of an enemy, it would not make it any less valuable against another who didn't have that, who was using one of the common strains.

Also, this is a vaccine, and it's a vaccine against the inner poison of anthrax that makes anthrax deadly. So if you change anthrax, you have to change that. If you change the anthrax to make it resistant to our vaccine, you have to change the very thing about anthrax that is anthrax. If you do that, you have something, but you don't have anthrax anymore.

So we think that the idea of a strain that's resistant is very unlikely, and we think the idea of somebody altering this into something else is possible -- both these things are possible -- but they're not very likely.

Q: I want to go back to your statement that you planned to shut down the plant. The GAO testified at the congressional hearing that the state decided to get out of the anthrax business when FDA came in and inspected them and they weren't prepared to make the financial commitment to make the improvements that were necessary.

A: There's been a great deal of confusion about that, and that may be worth another day altogether. At that time, Michigan did a number of things.

In each of the areas of operation they had difficulties with the Food and Drug Administration. In the area of the anthrax vaccine production, and step in if I say anything that's not exactly right, they had some bookkeeping difficulties. There were no issues that FDA had with the purity, the strength, any of the things that they want when that vaccine rolls out at the end, but there were bookkeeping difficulties. They dinged them for that. But there was nothing about what was going on in the anthrax production that made them shut down to do that. It was an upgrade of the plant because of the modernization and increased production requirements.

Q: Do you think, in your opinion, is the resistance to taking the anthrax vaccine and the opposition by some to it, which it was said earlier it's a disinformation campaign... Is that just hysteria?

A: I think the answer to the last part is no. It's not hysteria. I think we have people who develop symptoms and illnesses that have had the anthrax vaccination. We know -- and the third question I was going to get to in a moment also bears on that. People are having side effects. But I think that a great deal of the fear of it is being stoked by people who simply want the vaccine program stopped. A great deal of the misinformation we have is misinterpretation and different presentations of the kind of things like the safety that we talked about earlier.

It's very clear -- I'm sorry, the efficacy.

It's very clear that this is efficacious.

Q: What are the side effects that you can reasonably connect to this vaccine as opposed to just other illness that people may have and think they're connected to the vaccine?

A: Let me try and answer that. I don't think there's anything unique about this vaccine and the side effects, the normal expected side effects we see when we immunize servicemembers. And we're not aware of any systemic or large number of unique, in fact we're not aware of anything that we could say is specifically attributed as a trend to the vaccine. We have seen a handful of individuals with longer term illnesses and conditions that we're continuing to evaluate that may be associated, when you consider that we have vaccinated 320,000 servicemembers. But when you talk about soreness in the arm, fever, that's actually very much a profile for most vaccines to one extent or another.

Q: Are there more severe than that? Are there people who are crippled because of this? Are there people who...

A: We're not aware of anyone who's crippled...

Q: ...reactions that you are getting? Is it three people?

A: It's on the order of three to five people. We've had one individual we think may have a long term pulmonary problem. We've had a couple of individuals that have had total body rashes that have resolved. We have seen a couple of individuals complaining about autoimmune type of conditions that we haven't fully evaluated yet -- aches and pains, arthritis, those kinds of things.

A: If I can put this into a little bit of historical perspective, when we first started the best information we had from the experience in the field of using this in smaller numbers, was that the side effects, including the lumps and bumps and aches and pains and fevers, were extraordinarily low. So we gave you that information. I stood on this podium and said it's really, really low.

As we have gained experience, we have found that those sort of local, self-limited, and actually harmless reactions are much higher than we thought. We have initiated two ongoing surveys of large numbers of people so that we can get an exact handle on that and know exactly what to tell our folks in what to expect. The unexpected and the unknown is a lot more fearful and dismaying than knowing you're going to get a lump on your arm and it's going to hurt for a couple of days.

The rest of the answer is -- I mentioned earlier that in medicine it's using the science to advance the art... There's always the question of the unknown, the unexpected.

For example, recently vaccinations against rota viruses, I believe, were found to be associated with an increased number of intussusception, which is a bowel problem, and that was stopped.

We have set up both active and passive sentinel systems where we're trying very, very hard, and paying a great deal of attention, to make sure that we are not inadvertently creating some disease with this vaccine that was not known to be associated with the vaccine before.

The answer to your question is, so far we have not found any association that we would not expect to see in just the background population that we're dealing with.

Q: Is the kind of reaction, can you compare it to diphtheria, tetanus? When I take my routine shots that everybody takes before they go overseas or to Africa, how does the anthrax shot compare to the side effects that you get from any of these other more accepted...

A: I think it would be best to answer that by saying we are seeing more local, self-limited site reactions than we thought we would.

Q: More sore arms, more rashes.

A: More bumps on the arm. My arm was sore one time. I had a bump on my arm another time. Another time I had nothing. Self limiting.

Q: They go away.

Q: They don't require any or minimal, you know, two aspirins and see me in the morning kind of things.

What we are continuing to monitor and have sentinel systems looking for is some disease line intussusception following rota virus vaccination. That we haven't seen. But we are very vigilant for that. So we're seeing more of the local reactions but we have not... With a million vaccinations more or less, and 300,000 people, we now have a pretty good sample, and we probably would start seeing things by now if we had associations, and we don't.

And if we do see anything we will obviously take the appropriate steps because this is a force health protection measure and we'll do whatever needs to be done if this turns out not to be that.

Q: So what percentage of the people who are getting the shots are coming up with some sort of reaction on their arm? Twenty percent, 40 percent?

A: The data I'm aware of would say closer to the order of 40 to 50 percent would have something. They'll have some soreness, redness. The number that are going to have systemic illness with fevers, they're going to have to be hospitalized, are still extremely small. Much less than 40 to 50 percent.

Q: So 100, 1,000 people out of your million shots, out of your 320,000?

A: I don't have a number for you of that order. We looked at two small subsets. The numbers that have got fevers were probably in the 7 to 10 percent. If you want to extrapolate that.

Q: How much do you think the kickback on this program stems from the lingering problems with the Gulf War syndrome? A lot of the people who are testifying on the Hill are saying to the congressman, are reporting symptoms quite similar to, that fall within the, if you want to call it a syndrome, from the Gulf War. Is there a feedback relationship between these two?

A: I think medicine is based on trust. If for whatever reason, in any individual's mind he loses trust in his medicine, in his doctor, or he loses trust in his government, then those sorts of feelings will fall on more fertile ground. Maybe in some people's cases that's so, but we might be feeling repercussions of that. Our job is to regain that trust and make sure that our message is clear, that we're protecting our people, that we're doing everything we possibly can to make sure we're not harming them with the thing we give them to protect them. If we're digging out of a hole from Gulf War syndrome suspicions, we just have to keep digging out.

A: I think the numbers of individuals who are presenting with those kind of symptom complexes, if we could use that, that someone might try to label as Gulf War syndrome, are so small by comparison to the vast number of servicemembers that we've already immunized, 320,000 plus, that I think it's a little bit of a stretch to say this is exactly the same thing as those individuals that came out of the Gulf and are ill and the ones that are working their way through there. So I'm leery to try to make that kind of connection.

Q: What is your latest statistic on how many servicemembers have refused the vaccine?

A: We don't have a formal tracking mechanism where we query and require commanders in the field to report back to us the numbers. Our best estimate is around 200 soldiers, sailors, airmen and Marines total, plus or minus, and I don't want to get fixed on that number, but that's a rough approximation.

Q: Just to clarify, that's both the active and the Reserve?

A: Right.

Q: My other question, I don't know if it's best addressed to you two gentlemen, but perhaps. What is the current policy now on disciplinary action for those who do refuse? Is there a military-wide, department-wide policy? Is it left up to individual commanders? What happens...

A: It's a refusal to follow a lawful order, and that's a number [violation] in the UCMJ and it's left a great deal to the individual commander's discretion as to what he does about it.

Q: Is there any thinking that this is a problem that's serious enough that some additional policy needs to be made on disciplinary action? Have you given any consideration to that? Implementing some specific department-wide policy?

A: We would have to pass on that. That's at a pay grade level well beyond ours. And here he comes. (Laughter)

Mr. Bacon: The answer is I'm not aware that any specific... We have approximately 200 people out of 320,000 who have received this vaccine have come into the disciplinary system. It's a small number. There is some indication that, in fact, some soldiers have said that they refused to take the vaccine because they didn't want to deploy to some place such as Korea where they would be required to have this vaccine.

So sometimes there can be various reasons why people refuse to take the vaccine, even to avoid a deployment.

I don't think that this problem is large enough to warrant restudying the penalties of the disciplinary system. I think the system is perfectly...

Q: ...on the Hill. You've got two pieces of legislation...

Mr. Bacon: We're not disciplining the people on the Hill.

Q: But you've got to deal with them. There are two pieces of legislation introduced in the House, a growing number of cosponsors. And they're holding more and more hearings. Any information (inaudible) to try to stop the legislation that might cut...

Mr. Bacon: The answer is yes, we're engaging fully with people on the Hill. We're giving them threat briefings, we're giving them medical briefings. We're answering their questions the same way we're answering your questions here, and we will do that thoroughly and aggressively.

The point is, I believe most people on the Hill when they understand this vaccine and they understand the threat that our military people are facing today will say not to give people this vaccine would be irresponsible. It would be like sending people into combat without helmets. To make vaccine use voluntary would be irresponsible because it could lead to the hollowing out of units where one soldier lives and the person next to him dies. That is not an intelligent way to go into battle.

The whole point here is to protect our soldiers, sailors, airmen and Marines in the most thorough possible way, and that's why we have made the vaccine use mandatory.

We have a problem, which is General Craddock is coming on here by phone in five minutes. We'd be glad to run out the clock right up to 2:00 o'clock if you have more questions on this. But I just want to announce that we have to end at 2:00 because he will then be on the phone from Kosovo.

So if there are two or three more questions we can take them quickly. Otherwise we'll give you a five minute break and come back at 2:00 o'clock.

Anything else?

Thank you very much.

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