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     Fact sheetIn Focus: Project BioShield

Parney Albright
Parney Albright
Assistant Secretary for Science and Technology - US. Dept. of Homeland Security

July 22, 2004

Parney Albright

I'm really pleased to be able to join you and answer your questions today about the President's BioShield initiative and how it affects this Administration's ability to protect the American public against the threat of terrorism from biological, chemical and radiological threats.

Stephanie, from San Antonio, Texas writes:
How is BioWatch being benefitted by the passage Project BioShield, and what improvements are being made at this time?

Parney Albright

BioWatch and BioShield are two important components of the President's overall strategy to protect the homeland against bioterrorism. BioShield provides incentives for the pharmaceutical companies as well as for new authorities to the National Institutes for Health to provide an efficient and expedited manner new medical countermeasures to these terrible threats.

BioWatch detects these threats when we are attacked. It is part of a much larger biosurveillance initiative that the President put forward in his FY 05 budget, that also includes not just monitoring environmental monitoring of cities but also includes work by CDC and USDA and DOD in monitoring medical clinics for people displaying unusual symptoms, or monitoring over the counter drug sales to see if there are unusual public health event occurring...

So, all of these things combined to provide a very robust capability for protecting the homeland against this awful threat.

Penny, from Tampa writes:
Will family doctors begin to suggest vaccinations against things like anthrax and smallpox? I am wondering because I have a 2-year old son and am worried these vaccines wouldn't be good for him.

Parney Albright
Well first, none of the vaccines or therapeutics that we will produce under BioShield under normal circumstances would actually be deployed to the public unless they went through the entire FDA licensing process.

So the safety and efficacy of these drugs and vaccines will be just the same as anything else. Just like for measles or mumps, etc.

Having said that, we are not suggesting that we go on a mass vaccination campaign across the nation. We would never recommend that unless we had something that was safe to use by the American public.

Under BioShield nothing would be deployed unless it was safe to be used.

Joyce, from Fairfax writes:
How will this law make it easier for company to manufacture antibioterrorism products?

Parney Albright
This law from the commercial side of the law (point of view from the pharmaceutical industry), it basically has the govt coming in early in the process and guaranteeing it will buy a certain quality of the drug.

It tells the pharmaceutical firm that as long as you can take this drug through the FDA licensing process. As long as you can prove that it is safe and effective, the govt is going to buy this quantity.

So it eliminates a big risk for the pharmaceutical industry. They have a guaranteed market for the medical countermeasure.

It allows them with some certainty to proceed through what can be a very expensive development process in order to deliver these kinds of medical countermeasures.

It removes some risk for the pharmaceutical industry and it provides the nation with a more effective and efficient way of getting these medical countermeasures into our inventory.

Kelly, from Crystal Lake writes:
I know that this allows for the medical community to act more quickly and thoroughly once they detect a bioterror attack, but what about prior to attacks? Does this act allow for more funding so that the medical community can be more pro-active about this?

Parney Albright
Absolutely it does. There is a provision in the act that allows us, in the event of an emergency, to deploy medical countermeasures that FDA deems safe and effective but haven't quite finished through the licensing process.

You are exactly right Kelly. This does allow the medical community to act more quickly and thoroughly once we've had an attack occur.

However, a big part of BioShield legislation also gets to the point you are making and that is it provides new authorities to the researchers of the National Institute of Health to allow them to more effectively conduct research on drugs that we don't even have yet.

It also provides incentives to the pharmaceutical industry to actually develop and bring to the market drugs that for bioterrorism purposes that otherwise would not necessarily be brought to the market because of the uncertainties associated with the marketplace and the risks involved with that.

This legislation addresses the entire gamut of issues associated with the development of medical countermeasures

Jon, from Colorado Springs writes:
Why would our governement want to use and distribute treatments that have not been approved by the FDA? Doesn't that contradict our rules that all drugs need to be approved by the FDA? Please explain why this is a good idea. I'm concerned.

Parney Albright
You've raised a good point. Under normal circumstances, under BioShield or other authorities we have, we would not distribute countermeasures to the American public unless they have gone through the entire FDA licensing process.

However, you can imagine where there are cases where we have bioterrorism attack and we don’t have any available countermeasures except one that hasn't quite gotten through the licensing process. But nevertheless has been put into the category of investigational new drug.

For years, we have been using investigational new drugs in the treatment of all kinds of diseases in the past. It requires a formal consent from the person who receives the countermeasure. There are a lot of safeguards built into it. And there are also a lot of extensive follow-up monitoring that occurs.

So, clearly if we had an event that occurred where we were attacked us with a bioterrorism agent of some kind, and we didn't have a drug quite ready to go through licensure but we had it on our shelves and we were in a position where we could actually deploy it to start saving people. It would be irresponsible for us not to do that.

Joe, from Bay City, Michigan writes:
Dr. Albright, I noticed at the event there were quite a few members of Congress from the opposing party. Does this mean that signing this act was a real bi-partisan effort?

If so, please tell them--keep up the good work working together productively.

Parney Albright
We've had a lot of support from people on both sides of the aisle. The BioShield passed both houses with overwhelming majorities. The President was very pleased that both parties responded to this initiative of his. This is a good example of both parties working together.

Shelby, from Michigan writes:
I keep wondering why, if no biological weapons or chemical weapons have ever been used against us with the exception of anthrax, do we spend so much money on this? Or was the money for this type of funding nonexistant before the previous terrorist attacks? thanks you.

Parney Albright
That's a very good question, Shelby. Let me try and answer it in a couple of ways.

The first is that the anthrax attacks were not the first time we had had an incident of bioterrorism in this country. You might remember many years ago a cult in Oregon tried to poison a whole bunch of local salad bars with botulism in order to disrupt a local election. So these sorts of things--bioterrorism--has a very long history to it, going back to millennia, when people used to catapult diseased animals over city walls to infect the population of the city under siege.

So, the other issue here is that the technology required to put together a bioterrorism agent is not that difficult and the advances we have had in biotechnology have had a great impact on our public health. The other side to it is that might make it perhaps easier for people with very bad intent against us to attack us. So I think it is prudent given the potential impact of such an attack on the nation that we plan and prepare accordingly.

Charity, from California writes:
First, I would like to take this opportunity to express my sincere apprecation for all of the time and efforts that the you and the Science and Technology Directorate at DHS have put into making our nation a safer place, thank you. On July 21st President Bush stated that Project BioShield gives the government new authority to expedite research and development on the most promising and time-sensitive medicines to defend against bioterror. As such, how will the S and T Directorate coordinate on an interagency level with NIH and HHS as a whole to expedite their R and D recommendations?

Parney Albright
That’s a really, really insightful question, Charity. Homeland Security—you have to look at it very broadly—involves almost every department in the federal government. The Department of Interior has a stake in this and obviously the Department of Commerce has a stake in this. And so the Department of Homeland Security does not have a monopoly on the issues associated with homeland security.

One very important partner we have is the Department of Health and Human Services. They of course are the primary developers of medical countermeasures for this country—not only for bioterrorism—but for health in general. They partner obviously with the private sector and conduct a lot of basic research. They basically oversee the drug development process in this country. So, they are a very, very partner for us.

I meet on a regular basis with the senior management at the Health and Human Services. Many of my staff are heavily—on an almost daily basis—working with the staff over at HHS. We are all engaged in a partnership across the federal government, led by the President, to better protect the nation and be able to respond to bioterrorism attacks.

Michael, from University of Kentucky writes:
Universal Detection Technology recently unveiled an Anthrax "smoke detector" which is pretty cool. What happens when a company develops something like this? Do they work with Homeland Security to get it out to the public?

Parney Albright
Well, that’s a good question Michael. We have a number of programs within the Department of Homeland Security that are aimed at developing technologies much like this to be able to detect whether a bioterrorism attack is occurring or has recently occurred, so we can treat the people in a timely manner that have been affected. One very important thing we have initiated is the development of performance standards to help guide industry and guide people who would buy these kinds of technologies, such as local public health officials or local public safety officials in the kinds of performance they should be looking for from these kinds of systems. I am not familiar with the particular technology you are referring to in your question, but the Department both funds the development of these technologies and then makes sure they meet the appropriate performance standards.

Pasha, from Indiana writes:
What type of bio-drugs are the most needed and why?

Parney Albright
We have a wide variety of drugs that we would like to see developed. Clearly, we are most interested in those drugs that deal with what are called Category A pathogens—things like anthrax, smallpox, Ebola—some of the kinds of things that people have talked about over the years in terms of weaponized bioterrorism pathogens. Let me make an important point here—this BioShield legislation not only deals with bio threat, it also deals with developing medical countermeasures for all of the threats. It includes medical countermeasures for chemical attacks. It includes medial countermeasures for radiological attacks as well. The kinds of drugs we are interested are of course vaccines. Ideally you would like to develop a vaccine that would in effect take a particular pathogen off the table entirely. But we also understand that is hard to do and that in many cases what makes more sense to do is to develop a therapeutic to help people who have been exposed. You might recall when we had the anthrax attacks over here on the East Coast, the treatment of choice was something called Cipro. We need to develop more block spectrum anti-virals such as Cipro so that we can deal with a wide variety of threats and we can also deal with threats after the attack has occurred.

Charles, from Portland, Maine writes:
Because we have troops in areas that are probably more likely to be exposed to bio and chemical weapons, will they be the first American citizens to see the positive affects of this Act? Please protect our troops. thank you.

Parney Albright
Obviously the Defense Department will reap significant benefits from this act. One of the tings that has changed over the years, is that most of the development of medical countermeasures in the past were aimed at protecting our troops overseas.

But now that we are concerned so much about bioterrorism attacks on the homeland -- after all we were attacked with anthrax and the availability of bioterrorism type of agents getting easier and easier -- the kinds of quantities that we'll be buying for the civilian population with the BioShield legislation will be very large.

The military can then piggyback on these purposes and reap huge benefits on the economies of scale we get by having such large production lines.

So absolutely the military people will benefit greatly from this legislation. The DOD and I worked closely with HHS to set priorities for how we should spend the funding.

Michael, from Powell, TN writes:
What are some simple things individuals can do for themselves to guard against bioterrorism?

Parney Albright
One of the problems with bioterrorism is it is a kind of thing where you don't know when you'[ve been attacked typically. Unless you have something like the BioWatch system or like a medical surveillance system that we are putting into place that is focused on detecting these types of attacks.

You won't see the anthrax in the air, you won't know the person you've bumped up against has smallpox. So there's not a lot you can personally do along these lines except to be alert and if you are ill to seek medical attention.

The medical public health community will be able to detect an attack. It won't just be one or two people getting sick, it will be a number of people. They will detect it because we have BioWatch deployed and we'll detect it as it occurs.

The best thing you can do is to work with us, the federal government, and to be aware of the fact that we are putting together systems to detect these types of attacks and putting into effect things like BioShield which allows us to respond effectively to these attacks to protect the population.

Lane, from Mt. Hood writes:
A Russian scientist working at a former Soviety biological weapons laboratory, stuck herself with a Ebola viruscontaining needle and died in May. Seeing that mistakes like these can happen, how worried are you that an accident could occur affecting millions of people?

Parney Albright
The research that we do to develop countermeasures to these horrible diseases we do under very carefully controlled conditions.

We conduct them in special laboratories in what is called BioSafety Level 4 or BioSafety Level 3 facilities. If you watch the movies, you know these are the kinds of places where people walk around in spacesuits and multiple layers of protection.

We are extraordinarily confident that the type of research we are doing, the pathogens we are researching -- we have to do this research or we can't protect the public should an attack occur.

But we are confident that the research we are doing is very safe.

It is good to point out that both the National Institutes of Health and the Department of Homeland Security are spending significant dollars over this fiscal year and the next fiscal year to increase the number of labs that have that kind of safety level associated with them to allow more researchers to get involved in this kind of work.

Parney Albright
I'm really happy to have talked to you today. Good insightful questions. Hopefully will be able to do this again soon.