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Biology and Security
An Interview with Dr. Leslie Z. Benet
Dr. Leslie Z. Benet is Professor of Biopharmaceutical
Sciences and Pharmaceutical Chemistry at the University of California,
San Francisco. He recently chaired a congressionally mandated study
Full Measure to Countermeasures: Addressing Problems in the DoD
Program to Develop Medical Countermeasures Against Biological Warfare
Agents", which called for a new agency to oversee the Department
of Defense's biodefense activities.
Please briefly describe your profession.
I am a professor of biopharmaceutical sciences at the University
of California San Francisco. My expertise is what happens to drugs
in the body after they are dosed, how those changes affect patients,
and how that affects drug development. So I am an expert in metabolism,
elimination and toxicology related to drug disposition. I am an
expert in drug development.
As chair, I believe you stand by the final decision of the
I do. I strongly support them.
Is there anything specific as a scientist that you disagree
with, or would otherwise want to emphasize?
There is nothing I disagree with; the committee was in consensus.
There were people in the committee--and it is obvious in the report--there
were people that were particularly debating whether this research
and development should remain in the DoD [Department of Defense]
or whether it should be taken out and, for example, put into NIH
[National Institutes of Health]. That was the main area of the committee
where there was not general agreement. But this is sort of a compromise,
as is presented in the report, which says the DoD probably should
[conduct this research] now because they have the most interest
in it, but if they do not do it successfully, then Congress should
really move it someplace else. That is the one area where, within
the committee, there were differences of opinion.
In the report, it was mentioned that the reason the DoD
should create a new branch instead of moving it to the National
Institutes of Health was that the DoD's work was for military
That is correct. There is a different sense--what you need to do
in the military is to protect the warfighters as they go in the
zone, as opposed to reacting to it afterwards. So you want to pre-protect,
or be ready to pre-protect. That is not the same emphasis you would
have in the general population.
Would you feel that the results of the study would apply
to some degree, no degree, or a large degree to a civilian defense
There is a lot of overlap- a tremendous overlap. I think another
big issue that would be different between [a military effort and
a civilian effort] is the licensure aspect. We feel very strongly
that these should be licensed by the FDA [Food and Drug Administration]
because of the concerns that happened in the Gulf War--because of
warfighters' feelings that they were taken advantage of in
terms of what they were given . This should be fully licensed. If
you were doing this after the fact, as a protective mechanism in
biodefense, it is probably not as critical [to seek licensure].
In terms of the science, there is a tremendous overlap, and how
you need to develop the drugs.
So you would recommend a larger interaction between government
discovery and scientific research on the commercial aspect?
We do. We feel that this cannot be successful without attracting
the expertise that is outside the DoD to actually be involved in
this. We make recommendations specifically related to that. Congress
has the Bioshield legislation directed towards that.
Regarding government/scientist relations: the Thomas Butler case
ended with a guilty verdict, but largely on counts that originally
were not raised, and that many people in the scientific community
were worried about.
I actually was at the DoD when that broke, and
it was very interesting. I think it is critical--more a biodefense
concern than a biowarfare concern. We have changed our whole procedure
on how we monitor and follow those kinds of potential lethal weapons.
I think it was very unfortunate what he did, and I do not think
he recognized when he did it what the implications would be.
So you feel the government on the judicial/FBI side is acting
appropriately to protect citizens from problems such as this?
I think they are trying to. I think it is very difficult. But there
will be concerns--there will be privacy concerns related to this
too. But this was straight out--he said he did it.
What would you consider the biggest obstacles between government
and scientists right now in terms of sharing research and in terms
of encouraging scientific development?
In the DoD or in general? If you look at NIH, I do not think there
are obstacles--I think there is a strong interactive nature. But
I think, in the DoD, the history has been: "We are going to
do it our way, we are concerned about confidentiality and not outside
interests," and a variety of things that have prevented good
interactions from occurring. Now, at the bench level, the scientists
at USAMRIID [US Army Medical Research Institute of Infectious Diseases]
are excellent scientists--the best in the world. And we are losing
them. We are losing them because of this view. There is no appreciation
[of interaction]; [the scientists] are not allowed to interact with
their outside colleagues--they are facing roadblocks in terms of
their ability to work together with outside individuals. I think
that is the basis of some of our recommendations.
So you would say that this problem is mostly restricted to the DoD,
not government institutions in general?
Yes, I think strong interactions between the NIH and outside scientists
exist. Recently, even in the FDA, there has been much more interaction
with outside scientists than in the past.
In the study, you mentioned newer, stricter guidelines involving
Well, not stricter. New guidelines in the Animal Efficacy Rule.
It goes back to the licensure issue. For a drug or any prophylactic
to be licensed by the FDA, it has to be proved to be safe and effective
in humans. It is possible to show that these vaccines are safe in
humans, because you can give them to healthy volunteers. But the
only way to prove they are effective is to have an attack, or to
have someone be a guinea pig--have someone get the disease, and
then treat it. That cannot happen. So the new FDA rule allows effectiveness
to be based on animal studies. Safety must still be carried out
in humans. This is an advance--it now allows the DoD and other scientists
to get products licensed, where in the past this was a problem.
If you had the option to increase or improve the situation
regarding the bioterrorism scare in general, what do you think would
be the most effective way to aid the situation? What do you think
is the most serious problem, and what would you do to solve it?
Part of the bioterrorism problem is fear that is not necessarily
founded on a good scientific basis. It gets amplified, and people
are concerned about it more than they need to be. I am not saying
it is not a real fear--a real danger. I think what we need is good
science that goes outside of what are the traditional threats.
Let me expand on that. This was not a specific recommendation in
the report, but it is implied. The DoD, in developing countermeasures
to biochemical warfare agents, has to have a validated threat. In
other words, the intelligence community has to say that this is
a real threat, and in fact a weapon has been developed, before they
are allowed to spend money on it. And that is really out-of-date.
What has happened in terms of science and molecular biology and
our ability to modify genes and proteins, is that it is possible
for a terrorist to change a particular, relatively harmless virus
and make it very infective.
The biggest concern is that we go outside the boundaries of the
past--we bring the science and understand that we have to develop
what we might call a "multivalent" vaccine - something
to protect us against things that we have not anticipated up to
the present time. There is a lot of initial work on that, and a
lot of that is outside the military, but it was funded in some cases
by DARPA [Defense Advanced Research Projects Agency], the agency
within the DoD that looks at these far-out approaches. That is why
we recommend in the report that DARPA portions related to this kind
of science be included in the new agency.
Submitted by: William Yoon, American University, spring/summer