Hearing of the Senate Homeland Security & Governmental Affairs Committee - Six years after Anthrax: Are we better prepared to respond to Bioterrorism

Interview

Hearing of the Senate Homeland Security & Governmental Affairs Committee - Six years after Anthrax: Are we better prepared to respond to Bioterrorism

BREAK IN TRANSCRIPT

SEN. SUSAN M. COLLINS (R-ME): Thank you, Mr. Chairman.

Six years ago, anthrax-laced letters resulted in the deaths of five people, widespread concern about the safety of postal workers and the U.S. mail, the treatment of thousands of people with powerful antibiotics and the evacuation of the Hart Senate Office Building.

Today's hearing concerns two matters of great importance for this committee and for all Americans: our preparedness for bioterrorism and efficiency in government operations. Unfortunately, the report that Senator Lieberman and I requested from the GAO makes clear that the federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine but, instead, a textbook example of prodigious waste.

As the GAO also discovered, taxpayers stand to lose $128 million in 2008 as the stocks of the current vaccine expire.

The Department of Health and Human Services currently has no system to transfer them for use by the Department of Defense, the only large-scale user of anthrax vaccine, before the stocks expire.

In 1996 former Army Chief of Staff Gordon Sullivan wrote a wise book on a systematic approach to management in settings of uncertainty and change. Its title alone offers a kernel of wisdom: "Hope is Not a Method."

The story of the now-cancelled $877 million procurement contract between HHS and VaxGen demonstrates the danger of relying on hope for progress. The department hoped that a small company could not only develop an effective vaccine but also could obtain approval for it and manufacture 75 million doses, all on an unrealistically fast track.

VaxGen officials hoped that they could meet the terms and deadlines of a contract that lacks specific requirements and was critically vulnerable to future decisions by the Food and Drug Administration. VaxGen also hoped that its small staff, lack of expertise in vaccine formulation and limited access to additional capital would not impede the required rapid progress to contract fulfillment. Not one of these hopes survived the collision with reality.

The reality is that HHS's contracting practices for Project BioShield have displayed many of the same problems that this committee has observed in procurements in other departments and agencies related, for example, to Hurricane Katrina and to reconstruction work in Iraq and Afghanistan, flaws that we hope to correct through contracting reformed legislation.

HHS was responding to a crisis in the wake of the 9/11 terrorist attacks and the anthrax mailings. No one knew how soon or in what number follow-on attacks might appear. But the risks, uncertainties and vulnerabilities revealed by the anthrax attacks made a methodical approach to vaccine procurement more, not less, important.

A methodical rather than a hopeful approach to Project BioShield contracts might have included a more realistic evaluation of the suitability of using a small vendor with limited experience, a vendor that had been delisted from the NASDAQ securities market three months before the November 2004 contract signing. A methodical approach would have included a factor of an assessment, a vaccine development prospect and production capabilities: an assessment that GAO's interviews with industry experts suggest would have been bleak, indeed.

And perhaps most important, a methodical approach would have identified and specified contract requirements up front. I have no doubt that many lessons could be drawn from this very troubling story, but as the GAO notes, HHS has yet to conduct a formal lessons learned study.

We will spend additional time today discussing two other disturbing issues outside the immediate ambit of the VaxGen contract: the lack of a process to move the stocks of current anthrax vaccine to the military before they expire and the reported willingness of HHS to deploy the vaccine even if it has expired.

I look forward to hearing the testimony of our witnesses today on the procurement and the other challenges we must address to ensure that our Strategic National Stockpile fulfills its purpose of maintaining readily available stocks of biomedical supplies for victims of major disasters.

I'm particularly interested in hearing Admiral Cohen's thoughts on how the findings from the GAO report can be applied to the important work he is leading at DHS.

The only good news in the GAO report was the obvious observation that we have suffered no new anthrax attacks since 2001. If we had, our hearing could have unfolded in the wake of another tragedy.

We must apply the lessons learned from the failures documented by the GAO to improve our preparations for a possible terrorist attack using biological weapons before it is too late.

BREAK IN TRANSCRIPT

SEN. COLLINS: Thank you, Mr. Chairman.

Dr. O'Toole, you made a very interesting comment when you said that we need to be building systems that can deliver the countermeasures or the technologies. And then you went on to make a very interesting comment about the BioWatch Project; this is the project that deploys sensors in some 30 cities.

I've always thought that it was an excellent idea, an early warning system, but I think you're causing us to take a second look at how we're deploying our resources. If there is a biological agent that is detected by Project BioWatch, how prepared do you think state and local first responders and emergency managers are to respond?

In other words, we may have a great technology in place to detect a biological agent's release, but if we don't have the system in place to respond to that detection, are we any further ahead?

DR. O'TOOLE: Yes, well that's the question, Senator. And I can't directly answer your query as to whether -- how the public health officials who are charged with triggering response would react.

But I can tell you that at a meeting called by the White House last spring, which included about 60 public health officials and emergency response experts, there was a quite widespread articulation of skepticism about BioWatch. And I have heard in other hearings of users being very critical of the resources BioWatch takes, of the lack of coordination in some places -- not all -- between those who operate the BioWatch system and those who are charged with public health.

I'm sure those kinds of problems are fixable, but they do need attention because this complaint litany has been going on for years now.

My concern is that we can't afford to put sensors in every nook and cranny of every city or every town in the country, so the first question is, will the BioWatch sensors detect a release?

The second question is, basically, the hinge point upon which BioWatch -- at least its efficacy -- depends. The whole idea is that early warning gets you early response and a better response. But it isn't clear that public health is going to be willing to pull the trigger to move the stockpiles that tell everybody that we've had an anthrax attack until they have clinical evidence of an attack -- someone who's sick with symptoms, or a lot of people who are sick with symptoms similar to what they're worried about, or clinical diagnostic tests, cultures, PCRs saying, yeah, this person's infected with anthrax. That's been the case so far, all right?

Now, they do go out with the BioWatch alert and they start actively looking in emergency rooms and so forth for people who are sick and fit the description of this disease.

My question is, would we be better off investing some -- if it's a zero-sum game -- investing some money in rapid point-of-service diagnostic tests so that a doctor can tell you immediately or within an hour you have anthrax/you don't?

Would we be better off making electronic links between hospital emergency rooms and public health -- which more or less don't exist in most places today, with some exceptions. And are we spending too much of our attention on detecting a bioattack based on the unproven and untested assumption that early detection improves response? Or would we be better off investing in systems that are going to give us more situational awareness during an attack, which is going to be critical to managing it effectively and mitigating the consequences.

We're spending almost nothing on situational awareness right now, comparatively, in terms of energy and talent and money as well, and I think that would be, you know, a very important part of the strategy.

SEN. COLLINS: Thank you.

Admiral Cohen, I'm going to ask you to comment on Dr. O'Toole's comments. I know that you're working on second-generation technology that's going to shorten the time involved in issuing an alert and I've always thought the idea of sensors in key places and key cities was an excellent idea, but I think Dr. O'Toole also raises a very good point about what happens next.

What's your response? Are we prepared in terms of public health authorities, emergency managers, medical personnel, first responders to react quickly when you issue a report based on the BioWatch sensors?

MR. COHEN: Well, Senator, first of all I think your question is right on the mark and I think Dr. O'Toole's comments are very articulate and very thoughtful and get right to the heart of the issue.

In my prepared statement I told you that the existing BioWatch sensors have processed over 4 million samples and we have had no false positives, but we have had close to two dozen positives in that same period of time.

All of those positives were determined to be valid; they were environmentally based. In the 14 months that I've been on board in this position, I've had an opportunity to see how different cities, different health organizations at the state, city and local level respond to the report of those valid positives, and I must tell you it varies significantly.

In some of our larger metropolitan areas, they go to what we say the battle stations. They take it very seriously. They bring in secondary sensors. They do surveys, they check the pharmacies to ensure that the Tylenol shelves are not emptied. They check with the emergency rooms. They do all of the things that you and Dr. O'Toole indicated would be necessary as part of a system-of-systems approach.

In other areas, it's "well, it's a timely sample, and if something is going to develop, we'll know about it anyway."

You know, the Founding Fathers were very wise. Those powers not specifically given to the federal government are retained by the states and locals. So we wanted an inefficient and confrontational form of government, and the good news is that's what we have, and the bad news is that's what we have.

In defense it was quite easy; we can tell medical doctors and we can tell the patients what to do, what vaccines you're going to take, when to report to sick bay. It's not that simple or straightforward in health care at certainly the distributed health care or public service health care that we have throughout.

So as we go forward, I do think Dr. O'Toole has one thing especially right: The more ubiquitous the sample, the less expensive the sampling, the more responsive in a short time and accuracy the sampling -- whether it's at point of care or it's distributed throughout a city or it's on mobile trucks or -- one of the things we're working on in my high-risk portfolio is what we call "Cell-All."

There are 2.8 billion cell phones today. Now a cell phone is no longer just a phone; it is a minicomputer that has computing powers that exceeds what a super computer had 10 years ago. It has voice, it has video, it can take pictures. It has GPS in it. So if we could have even a single sensor, whether it's radiological or biological, every one of us would have a sensor and would then report through 911 the location, the fact there was a radiological or biological event occurring.

We're not talking about a CO carbon monoxide monitor that has numbers; it's a one or a zero. Did it hit the trip point that was established by HHS, CDC, et cetera? And then if we have multiple of these in a metro station or in a hospital, et cetera, we know an event is occurring.

Now this is, on the high end, this is the 9/11 commission of, you know, not suffering from a lack of imagination, but I can tell you we're actively pursuing this. And coupled with BioWatch 3, which will be more near-term, wireless, more digital than BioWatch 2, and because it will be cheaper, we will be able to put it -- we hope -- in four times as many cities. But we've got to go in the direction that Dr. O'Toole has said, in the area of the response and the linking of emergency rooms, et cetera.

Critically important, but I really do think that this is an HHS, CDC and congressional area. We can give the tools; we can't mandate their use.

SEN. COLLINS: Thank you.

BREAK IN TRANSCRIPT

SEN. LIEBERMAN: Okay. Senator Collins?

SEN. COLLINS: Dr. Parker, I want to go back to the issue of the stockpiled anthrax vaccine. It seems so logical to me for you to have a joint effort with DOD, whereby as your vaccine is getting closer to the expiration date, you rotate it out to DOD to use and then you buy new and repeat the process over and over again.

And if that kind of system doesn't occur, we know from GAO's estimates that it's going to cost the taxpayers $128 million in 2008 and then each year another 100 million.

Now, you said you're working with the Defense Department on such a plan, but you alluded to certain obstacles. What are those obstacles? Are they legislative obstacles? Are they funding? What's the problem? It just seems like a common-sense solution to a problem that otherwise is going to cost the taxpayers hundreds of millions of dollars.

DR. PARKER: Well, first, it does seem like a common-sense solution and we are working to try to find that common sense solution. But there are realities and the contracting issues, because we use two different contracts. And we're working on that too; that's another issue because we work very closely with the Department of Defense, particularly on all of our medical countermeasures but even more specifically on anthrax vaccine absorbed.

But there are liability issues associated with our each individual contracts and all that's associated with some legal issues. Both the department and I, though, feel pretty optimistic that we can work through those issues. I haven't identified that there's any need for legislative help on this, but we'll be looking for that if it comes up. But so far those have been, but we will do everything we can to work through that and overcome it.

But let me just talk also about the expense. I'm not quite sure I agree with the $100 million figure in '08, but that's something we can talk offline and work on that. But nonetheless, fortunately -- let me just start this way -- fortunately, we have not had to use these medical countermeasures and we will also be in a position that hopefully we will never have to use these medical countermeasures.

They are part of our preparedness activities. But as medical countermeasures expire, though, we will have to discard medical countermeasures. So I think it's a -- I'm not sure if I'd want to couch the fact that we have to discard expired medical countermeasures in our stockpile because they've passed their expiration -- we can use them -- as wastage.

That's part of our cost of being prepared. We know we're going to have to lose some of that. We will work and redouble our efforts with the Department of Defense to try to do everything we can to minimize what has to be discarded and make sure it can be appropriately utilized. But just knowing the requirements, what the Department of Defense does and how our stockpile's going to grow, we can never eliminate it. We're always going to be in the position that this sum will have to be expired.

SEN. COLLINS: Mr. Rhodes, do you see a potential for saving literally hundreds of millions of dollars over the next decade if we are able to come up with an integrated system whereby the BioShield vaccines are rotated to DOD to use?

MR. RHODES: Yes, ma'am. I know Dr. Parker and I will probably always disagree on the exact number, and that's fine. But I think this also gets to the larger discussion that leads back to Dr. O'Toole's point about strategic vision. It's one thing to store vaccine in a vial; it's another to store it in bulk. It's one thing to rotate vials out of the Strategic National Stockpile and into DOD usage, the coordination between there. But it's also a function of how are we going to use it.

Dr. O'Toole is absolutely right: A series of vaccines that have gone a certain period of time beyond their expiration date may indeed be better than nothing.

But that's the discussion that needs to take place at the strategic level based on scientific data, so that we can maintain the public's confidence in our nation's ability to respond.

Dr. Parker is absolutely right: Biologics expire, they get old, they die, they lose their efficacy. The point is to make certain that we have the strategy in place, tied to the systems that Dr. O'Toole is describing, where we can deliver the countermeasure and that we do have a pipeline for the countermeasure, and we understand how the countermeasure is going to be used for emergency use.

Is it directly in its most effective time of life? Can we rotate it to DOD? That's ultimately the message we're trying to deliver, is that broader view, whether it's looking at what's the next generation of anthrax vaccine going to be and how are we going to procure it or how are we going to store what we already have.

SEN. COLLINS: Mr. Rhodes, my time has almost expired. Let me just ask you one final question.

We still need an improved anthrax vaccine, one that's easier to administer, less painful, et cetera. How prepared do you think DHS -- HHS rather -- is at this point to award a new contract for the development of a new vaccine that does not have the same very unfortunate and expensive ending that the previous one had?

MR. RHODES: I would say that barring -- I mean, I appreciate the committee asking Dr. Parker to put together the lessons learned. Based on documentation that we have, I cannot give you the assurance here now that the next contract will be successful, because I don't -- I do not know that the lessons have been learned and incorporated directly into the process for acquiring the next version -- letting the next contract.

While we were having discussions this summer, we were told that there were -- there was internal analysis about the lessons learned; we haven't seen it. And at the same time the contract was being let, so I have to go with what I have, and what I have does not counter the position -- the track record that I've already seen.

SEN. COLLINS: Thank you.

BREAK IN TRANSCRIPT

Source