September 4, 1996

Loews L'Enfant Plaza Hotel

480 L'Enfant Plaza, S.W.

Washington, D.C.

Proceedings By:

CASET Associates, Ltd.

10201 Lee Highway #160

Fairfax, Virginia 22030

(703) 352-0091


Michael Kowalok

Clifford Gabriel

Thomas Cross

Andrea Kidd Taylor

Philip Landrigan

Marguerite Knox

Robyn Nishimi

Joyce Lashof

Rolando Rios

Donald Custis

Elaine Larson

Arthur Caplan

John Baldeschwieler

Thomas McDaniels

Joan Porter

Paul Schulte

Timothy Tinker

Kathi Hanna

Holly Gwin

Victor Sylvester

Kelly Brix

Lois Joellenbeck



Call to Order and Opening Remarks

Dr. Clifford Gabriel 1

Dr. Joyce C. Lashof 1

Risk Communication

Dr. Timothy L. Tinker 1

Dr. Paul A. Schulte 18

Dr. Thomas A. Burke 46

Dr. Bruce B. Dan 62

Mr. Michael F. Doble 71

Public Comment 106

Staff Briefing and Committee Discussion: 114

Reproductive Health

What's New for Bosnia

Lieutenant Colonel Robert DeFraites 171 Mr. John Resta 180

P R O C E E D I N G S (9:05 a.m.)

DR. GABRIEL: I would like to call this meeting to order and with that, turn it over to Dr. Lashof.

DR. LASHOF: Good morning. Welcome everyone to this meeting of the Presidential Advisory Committee.

We usually begin each session with a period of public comment. Usually veterans or others have asked to speak and are on our agenda. At this meeting, no one has requested permission to speak during the public comment period. However, if there is anyone in the audience who would like to address the Committee before we begin our scheduled deliberations, we would be willing to take some time at this point to hear anyone who wishes to make any public comment.

Okay. Hearing none, the first thing on our schedule was a discussion of risk communication and I believe the presenters, although originally scheduled to not come on until a little later, are here. So, if Dr. Timothy Tinker and Dr. Paul Schulte, we would be very happy to hear from them now.

Dr. Tinker, I believe you wished to start. Is that correct?

Agenda Item: Risk Communication

DR. TINKER: Good morning. I would like to thank the members of the Advisory Committee for inviting me to be part of this distinguished panel on risk communication.

As a communication specialist at the Agency for Toxic Substances and Disease Registry, a federal public health agency, I interact daily with members of communities located near hazardous waste sites, who are often very concerned about their potential exposures to hazardous substances.

That concern can make effective communication difficult. However, effective communication is a cornerstone of public outreach and involvement.

Involving people in decisions that affect their lives is central to the definition and meaning of "health risk communication." At ATSDR, we define "health risk communication" as an interactive process of exchange of information and opinion among individuals, groups and institutions about health or environmental risks.

The key word in this definition of "health risk communication" is "exchange." If our communication is to be truly meaningful, relevant and effective, it has to involve a two-way flow of information, opinions and perceptions. It is not just me as a representative of a federal public health agency coming into a community to convey or transmit information without receiving any type of input or feedback.

Risk communication focuses on those factors that underlie what should be communicated, to whom, in what form and with what expected outcome. Health risk communication is about us, our beliefs, values and behavior. Health risk communication messages enter our lives in many forms; advertisements, solicitations, health campaigns, medical care requirements and word of mouth.

This suggests many compounding factors, many problems and many challenges. It suggests that health risk communication is fraught with difficulty because the definition of a criterion for success or, for that matter, lack of success will be elusive. Yet, effective and meaningful communication practice is becoming increasingly important because citizens wish to be informed and to participate in all areas that affect their quality of life and personal health.

Second, a growing public demand about a variety of health risks has placed new requirements and demands on federal health agencies for information that clearly describes and explains the nature of health risks. Federal public health agencies have been at the front line of health risk communication for many years because a major proportion of morbidity and mortality is preventable through changes in health behavior, useful and effective communication about health risk and benefits is critical.

Health risk communication campaigns have been used to address many issues, including adverse health effects from environmental tobacco smoke, the importance of testing for radon in homes, childhood lead poisoning prevention and overall health and fitness.

With attention focused on a growing number of environmental health problems in recent years, federal public health agencies have found the task of communicating health risk to be an increasing challenge. When confronted with a potential health hazard, a federal public health agency typically responds by examining the public health implications of the environmental health assessment and then working within legal and economic constraints to recommend and provide the best solution.

The assessment is often technical in nature and is sometimes poorly received by a public that, one, seeks absolute answers to questions for which high levels of scientific uncertainty may exist; two, can be resistant to a negative finding of no adverse health effects and, three, is particularly sensitive to health risk perceived to be imposed involuntarily; an example, exposures to hazard waste sites in their communities.

Unfortunately, when government agencies do not understand and deal effectively with public perceptions of health risks, public alarm about the risk and hostility toward these agencies may increase. Agency credibility suffers and the public becomes skeptical or indifferent to information about health risks provided by experts.

Poor health risk communication may also lead to ineffective public health interventions. Because agency assessments of health risk and public concerns may not be correctly communicated, some public health concerns go relatively unaddressed, while others command a disproportionate amount of attention and resources.

Now that I have described some of the difficulties federal agencies face in communicating to the public about risk, allow me to describe some of the strategies the Agency for Toxic Substances and Disease Registry has effectively used to provide to and receive from the general public needed health information about environmental exposures and disease.

ATSDR has made a strong effort to implement various communications' models and practices in its planning process. I would direct your attention to Tab B in the notebook. There are a number of items under that tab, which I have provided as reference documents for our discussion this morning, the first of them being a planning framework. I believe that is inside that blue text called "A Primer on Health Risk Communications: Principles and Practices." It should look like this.

The fundamental premise of ATSDR's health risk communications programs is an understanding of the needs and perceptions of our target audiences. The communications framework ATSDR uses for planning and implementing its health risk communications programs consists of ten steps.

Number one, review background information.

Two, set communication objectives.

Three, analyze and segment target-to-target audiences.

Four, identify message concepts and pretests.

Five, select communication channels.

Six, create messages in the materials and pretests.

Seven, develop a promotion plan.

Eight, implement communication strategies.

Nine, assess effects.

Ten, provide feedback.

The ten stages constitute a circle in which the last stage feeds back to the first in a continuous process of planning and improvement. Note that the concept of client-based research is at the center of all health risk communication activity and please note the importance of formative research and evaluation to the planning of health risk communication activities.

Any public outreach and education strategy should be coordinated with the planning of the other program components, which in the case of Gulf War veterans' illnesses, are: number one, medical and clinical issues; number two, research and, three, chemical and biological weapons.

I reviewed the outreach portion of the Advisory Committee's interim report and with the Committee's permission, would like to make the following six observations based upon the communications planning framework to help strengthen your communications activities in the future.

First, setting communications objectives that are clear, time specific, measurable and state the expected outcome of the communications activities. For example, health risk communications objectives to promote changes in public awareness, knowledge, attitudes or beliefs should support or be derived from the goals and objectives of the total program design.

Second, analyze and segment target audiences. Careful audience analysis will reveal that imbedded within the broader Gulf War veteran population are multiple, less visible audiences. Examples: women, children, relatives, non-English speaking individuals. I believe in the report a couple of those audiences are identified, each having their own distinct information needs and concerns.

The goal of audience segmentation is to identify the largest possible groups of people sharing key attributes that affect their attentiveness and response to a health issue and message. For some issues and messages it may be sufficient to segment along physical characteristics -- example: exposure to health risk -- or demographic and cultural characteristics. Or for others, it may be appropriate to consider characteristics, such as communications channels or how individuals obtain information.

Third, develop and pretest message concepts. Formative research and evaluation are essential to determine what message ideas or concepts have the best chance of connecting with the target audience and will influence their decisions and actions. In-depth interviews and focus groups with Gulf War veterans and their families are examples of formative research, which can be helpful in identifying key message concepts.

A combination of formative research techniques can be used to help determine if one concept is more salient than another and which concept should be developed into specific messages. The general approach to pretesting concepts is to share them with members of the target audience and gauge their reaction.

Fourth, create and pretest your messages and products. Pretesting of the messages for effectiveness is done while materials are in draft form to allow changes to be made without great expense if testing reveals waste to improve the messages or materials.

Methods of pretesting include intercept interviews with members of the target audience. In the case of Gulf War veterans, this may involve conducting brief interviews at a central or convenient location, such as a popular gathering spot on or off the military base. Pretest results can be used to revise messages and materials before proceeding with finished products.

Fifth, develop a well-designed and targeted promotion plan. Developing an integrated promotion plan for communications activities is critical to ensure that messages reach their audience. The framework for the promotion plan should be tied to the communication objectives in the context of the broader program.

A comprehensive promotion plan should describe target audience in channels, describe activities and events to promote and broaden the communication effort, describe methods to disseminate materials, describe mechanisms to store and track quantities of materials used and those remaining as in a clearinghouse function, describe logistical support for all of the above tasks and provide an implementation timetable.

Finally, conduct process and outcome evaluation. Evaluation does not end with implementation. Process and outcome evaluation is needed to determine if mass media and organization gatekeepers are active in the communication activities, if messages and materials are reaching target audiences and if the overall activity is proceeding on time, on strategy and within budget.

Process evaluation can also provide measures of message dissemination and exposure, using techniques, such as clipping services, public service monitoring reports, surveys and measures of the numbers and types and calls to hotlines and changes in inventory of materials.

I would like to shift the focus slightly to some of the specific strategies that we use on a day-to-day basis at ATSDR for reaching individuals, groups and communities with information and education, the first being a primer on health risk communication principles and practices. This is the blue covered document here.

In 1995, the ATSDR produced a publication, a Primer on Health Risk Communications, Principles and Practices. It was developed to provide a framework of principles and approaches for the communication of health risk communication to diverse audiences. It was published for ATSDR staff, health care professionals, practicing their hazardous waste sites and personnel from other government agencies and private organizations, who must respond to public concerns about exposures to hazardous substances in the environment.

The primer is available on the Internet through ATSDR's home page and ATSDR can certainly provide the Advisory Committee with additional copies of this resource tool to further assist in the planning and implementation of your communication efforts.

The next item is the case studies in environmental medicine. It is on skin lesions. In 1990, ATSDR began developing a series of monographs, case studies and environmental medicine, to educate health professionals about the health effects caused by hazardous substances in the environment. These self-instructional exercises in environmental medicine are designed to guide primary care practitioners through the diagnosis and treatment of illness in persons exposed to hazardous substances in the environment.

The case studies are used for training health care professionals, who practice near communities affected by a hazardous waste site or sites, at undergraduate medical schools and residency programs and environmental courses at schools of public health, to educate health care professionals about how to identify, treat and prevent human exposure to hazardous substances.

The case studies in environmental medicine can be approved for continuing education units for other health professionals. In addition, the case studies are acceptable for credit by professional organizations, including the American Academy of Family Physicians, the American College of Emergency Physicians, the American Osteopathic Association of Occupational Health Nurses and the American Board of Industrial Hygiene.

The Advisory Committee may want to consider developing case studies using a similar format to address the specific health concerns of Gulf War veterans.

Public outreach and information dissemination, a common strategy that we use at ATSDR is called Public Availability Sessions. ATSDR also is increasing its use of public availability sessions, informal drop-by meetings at which community members can meet one on one with ATSDR staff, to discuss health and site concerns.

Other site specific community involvement activities that ATSDR has found useful include small group briefings for key community leaders. These meetings enable ATSDR to solicit information from grass roots leaders about how best to interact with their constituents and to address their concerns and to provide up-to-date information about ATSDR's activities in their community.

Community assistance panels. ATSDR continues to expand its use of community assistance panels or CAPs, which the agency has found to be an effective means of fostering communication between ATSDR and site communities. CAPs have three primary purposes: one, to facilitate communication between ATSDR and the affected community; two, to provide an ongoing series of community-based meetings to ensure community involvement throughout the public health assessment process and, three, to provide information to ATSDR on the community's health concerns for inclusion in the public health assessment process.

The next item in your packet is this particular fact sheet on the subject of lead. These are in the first chapter of an ATSDR toxicological profile, is intended to be a health effects summary written in lay language for the target audience, the general public, especially people living in the vicinity of a hazardous waste site or a chemical release.

Similar substance-specific fact sheets for Gulf War veterans may be appropriate for providing updates and important facts about Gulf War health conditions.

Also, the Committee is to be commended for using the Internet and ATSDR and, I believe, a number of the other public health agencies are beginning to recognize the value and the utility of reaching broad audiences through the use of the Internet.

ATSDR established a home page on the Internet in late FY 1994. During FY 1995, a variety of ATSDR documents became available through the agency's World Wide Web server, including public health statements, the document which I just spoke about from toxicological profiles, the toxicological fax sheets derived from the public health statements, the hazardous substances and public health newsletter and congressional testimony by ATSDR staff members.

The Worldwide Web also provides access to portions of ATSDR's comprehensive on-line hazardous substance release and health effects database, HAZDAT(?). During FY 1995, more than 60,000 users accessed the ATSDR home page server and nearly 462,000 requests for information were recorded.

To close out my discussion, I would like to provide a very specific case example of our efforts in a community of how we have taken some of these principles and their strategies and applied them to the development and implementation of our public outreach and education efforts.

Chattanooga Creek in Chattanooga, Tennessee is located near 42 suspected hazardous waste sites, is a predominantly African American urban community with a low income average and a large youth population. The creek runs 24 miles northward from Georgia through Tennessee to the Tennessee River.

The creek is a lot of things to a lot of people. For children, it is a place for summer thrills, swimming and playing. For some it is a perfect place for sports fishing. For others, such as Chattanooga's homeless population, it is a source of water and food. But for some industries that lined the creek in the past, Chattanooga Creek was a place to dump their waste, often toxic, transforming the creek from a source of life and enjoyment to a public health hazard.

The waters of certain contaminated sections still look inviting, but contain harmful chemicals and heavy metals, such as lead and arsenic. In 1992, ATSDR was petitioned by a community group, STOP, Stop Toxic Pollution, to provide assistance. The community and ATSDR worked together to assess and increase the awareness of the hazard posed by the creek and provided health education for the schools, the community at large and local health care providers.

Despite posted warning signs and obvious pollution, many people continue to use the creek for swimming and fishing. Public health advisories were issued and community involvement began to warn people to stay away from the creek. The community and ATSDR developed education programs at four public schools and one high school near the creek.

Area teachers incorporated lessons in the curriculum and agreed to talk to their classes every year about the creek's hazards. A "Don't Be a Creek Geek" drawing context was held in the lower grades, teaching children that it is uncool to play or swim in a creek and a fish dance and rap song were developed as part of the overall program.

For local health professionals, ATSDR provided health education to increase their ability to diagnose and treat potential health effects associated with exposures to hazardous substances found in the creek. As a result of ATSDR's and the community's public outreach and education efforts, children no longer use the creek for recreational purposes.

Local residents are adhering to the warning signs to not fish, swim or bathe in the creek. STOP, a local community organizations, has developed partnerships with a local school of nursing for technical assistance and education efforts are ongoing and actions to reduce pollution levels in the creek have begun.

Some of the key lessons we have learned in building trust and credibility in the community are as follows. Number one, make the information of a manageable size. We have a tendency as federal agencies to overload or to overwhelm our audiences with information. Narrow the focus of your communications to three to five key messages. What is it that you would like your audience to know about an issue and, in turn, what it is that the audience would like to know about this issue?

Number two, speak in terms that people can understand. Eliminate the technical language and the jargon.

Number three, explain the basic principles that govern the scientific studies and data. Help interpret risk estimates. The audience's understanding of the science is often as important as the final result.

Number four, communicate at regular intervals. At the community assistance panels, we have a timetable of 30 days, 60 days, 90 days, but the importance being that we need to communicate at regular intervals. Ongoing contact and interaction can help to avoid surprises or leaving critical information unstated.

Number five, be very candid about the limits of what you know from the science about possible health conditions and exposures.

Lastly, recognize that everyone's opinions and ideas are equally important, but at the same time, acknowledge that not everyone's expectations and needs can be fully met when high levels of scientific uncertainty may exist.

Madame Chairman, this concludes my presentation. I will be happy to answer any questions you might have.

DR. LASHOF: Thank you very much, Dr. Tinker.

I think we will proceed to hear Dr. Schulte and then open it up for questions for both of you.

Dr. Schulte.

DR. SCHULTE: Thank you and good morning.

My name is Paul Schulte. I am the director of the Education and Information Division at the National Institute for occupational Safety and Health and I am here today to discuss with you the experience NIOSH has had in what we call worker notification.

Worker notification is the informing of subjects of epidemiologic studies of the results of those studies. It is, in a sense, a subset of risk communication and it is part of a broad range of information dissemination programs that NIOSH conducts. I am trained as an epidemiologist and have been working with the NIOSH effort to evaluate epidemiologic research since the late 1970s. Through that period and into the 1980s, NIOSH has investigated the issues involved with notifying subjects of epidemiologic studies. The studies that we most have attended to are essentially known as record linkage studies, cohort mortality studies.

These are studies of the population of people that might work in a particular factory or plant or company. We identify from records who works at that company, who is the whole population, who is alive, who is dead and then we look at the patterns of mortality in the people who have died compared to some standard, usually the U.S. national population.

So, the issue of worker notification then is notifying the surviving members of those cohorts of the results that occurred in the people who have died. So, in one sense, it is a bit of an extrapolation. It doesn't necessarily mean that the risk to the surviving people is the same as the risk to the people who died. That, in part, depends on the exposure.

Also, epidemiologic research produces results about groups of people. It doesn't say anything about a specific individual within that group. This is an issue that needs to really be considered when one talks about notifying subjects of an epidemiologic study. All you can say is that an individual within that group, to the extent that they have the exposure that is similar to the people on whom you have determined the risk, will have then themselves the same risk.

So, it is a group risk concept and that needs to be made clear in the communication.

Secondly, a basic principle that we have utilized is that we need to communicate the realization that epidemiologic findings are probablistic findings. They are not deterministic. In other words, a finding doesn't indicate that a person will develop a disease, only that they have the risk, the probability, the possibility of developing the disease.

Since the early 1980s, NIOSH has conducted over 25 individual notification efforts involving over 48,000 workers. In all studies that we do, all of these kinds of cohort mortality studies, we routinely do a number of dissemination efforts. We share the results with the company involved. We share the results with the unions involved.

We disseminate the information in the scientific literature. So, it is not as if we don't inform and, in part, the population. It is that we don't -- we historically and in the field in general, epidemiologists had historically taken that step of going individually to the surviving members of a cohort and informing them of the results. So, that is the issue or the area that worker notification is addressed at.

So, today, I will tell you a bit about our efforts at worker notification. When you hear that term then, think of the concept, individual notification of the subjects of record linkage-based epidemiologic studies.

Where we do studies where we have participation of subjects, we give them a questionnaire or we draw blood or take some sort of information from them, we always notify them of the results. With record linkage studies, we think about a certain set of criteria that allow us to evaluate whether or not there is reason to actually individually notify subjects of studies.

So, as I said, worker notification, and I have submitted for the record two published papers that give you the background on our efforts in worker notification and within them are further references, where we have addressed the epidemiologic issues in more detail. But as I said, worker notification refers to the results of epidemiologic studies, to the notification of surviving subjects. Where there is active participation, we always notify and for record linkage studies, it is only done when the risks exceed a certain threshold.

That threshold is essentially a threshold that is a composite of criteria and the underlying trigger is essentially that it is to consider each study on a case-by-case basis and to use these criteria to inform professional judgment.

So, to start off, we tried to take a broad net to consider the findings. And you have to remember, if you are not familiar with these kinds of mortality studies, they are done with what are known as life table programs. Typically, we will identify the causes of death or a wide range of causes of death. The NIOSH life table program identifies over 90 different causes of death.

So, in any study just by chance alone, it is likely that some of those might be increased and some might be decreased. So, you need to sort out which of those would determine whether or not you have a positive study and, hence, one on which you would notify.

So, we start out with a broad net and we look at all findings that achieve at least a 90 percent significance level. Eventually, we put more weight to those that are statistically significant at the classic 95 percent confidence interval level. Also, we put more weight in determining whether to notify on whether or not there are strong evidence of positive findings, where we have an a priori hypothesis as opposed to findings that we identify as a posteriori, after the fact, which are sometimes more likely to be the result of just chance occurrence.

So, we go into the study with a study plan or a protocol. We identify or hypothesize associations that we would expect to see and then we look to see if they are there and if, indeed, they are, we weigh those kind of findings more than ones that just occur unexpectedly.

The notification criteria also is based on looking at the strength of the evidence and that in a sense pertains to methodologic characteristics of the study, the study design, the study power, the way the groups in the study were identified and particularly in the occupational environment, the extent to which we have good exposure information.

Our criteria for doing notification in part is specific to occupational kinds of studies and is derived from a history of doing occupational studies, where generally we only have one or two, in these kinds of studies, causal agent that we are most concerned with, where we have pretty well identified it up front and where we often have exposure information that indicates high and low risk subgroups within a population. So, we can see if you have more exposure, do you have more risk.

We can make those kinds of estimations and it gives us more confidence in the results of our findings and we can assess then the strength of the evidence. We also consider whether or not the findings are biologically plausible. In other words, do they make sense in a biologic realm.

Now, remember, we notify the public. We disseminate the information on all our studies through the literature and in talking with unions and companies, as I said. So, these more rigorous criteria are only if we decide to take that extra step of actually informing by letter generally individual surviving subjects. The reason for that is some of the things that I mentioned earlier, that we only have group information, not individual specific risk information. We only have probablistic information and not deterministic information.

So, in balance then we use individual notification only for studies where there is moderate to strong evidence and as I said, that is essentially a professional judgment. Usually, when we have relative risks over two or 200 -- an SMR of 200 in a mortality study, do we consider that a strong risk and we look at the evidence that relates to that.

This next slide shows you then the contents of a notification and as I certainly concur with the remarks of Dr. Tinker, that risk communication and its subset notification is really an exchange. It really needs to be considered as a two-way effort and it really needs to be considered as a process, not just the issuance of one in particular notice. So, in doing that, we try to think of it as a process and we try to attend to a variety of the needs of the people who are going to be the recipients of that communication and as much as possible, we try to get their involvement before we do it to find out what they are interested in.

So, we develop our notifications and obtain review by workers and management and we try to pilot test the notifications where possible. We aim to use an understandable language. The literature says that a Grade 8 target language is a good one to shoot for. In fact, that is what we try to shoot for, between Grades 6 and 8.

Even with an educated work force, if they are not familiar with the language and processes of epidemiologic research, it can be complicated and it is important to find the appropriate language.

In assessing eight notifications that we have done in just looking at bounce back response cards, still, 15 percent of people said that they thought that they didn't understand the information that we had provided.

Also, it is very important to appreciate the needs of cultural and ethnic subgroups in various work forces, in various geographic locations in the country. This can be to a greater or lesser extent an important issue.

Medical screening is a crucial issue, not because in the occupational area there is so much that you can do with regard to medical screening. In fact, it is quite the opposite. For many occupational diseases that we study, particularly the cancers, occupational cancers, there aren't effective medical screening tests that have been identified. Still, when you tell someone as the Federal Government by letter that they are at risk or part of a cohort that is at risk, you engender in them a whole range of needs.

So, if you figure a hundred people you notify and you figure ten will get the disease, still all 90 will proceed through time once being notified as labeled, at being at risk, and then, hence, as concerned about being at risk and will need a broad range of medical and other kinds of counseling and social type of services.

It is only the 10 who actually develop the disease, who actually need the medical-related treatment services, but the other 90 still might have concerns, still might legitimately require medical monitoring or screening. So, in some cases, medical screening is possible. In some cases, it is not and in that case, we try to look for early recognition. So, as part of our process of notification, we often develop a letter for the worker's physician and we ask them to provide that information to the worker's physician to keep in their medical file and so that the physician can use that much as they use information about any other risk factor on the worker, whether they smoke or drink or are overweight or so forth.

So, as part of our effort to notify, we not only send a letter to the workers, but we develop one for the physicians. In addition to describing the study in clear language and really the methodology, we also try to put other kinds of ancillary information in our notifications that will be helpful to people. We identify various support services. We routinely talk about the association of occupational and environmental health clinics. We talk about particular support services within the geographic region, where the cohort lives, any services that might be available after our discussions with workers, unions and management.

So, we try to anticipate the needs of the people receiving our communication. I think that is really the key message is it is not just a communication but it is an anticipatory response that results in a dialogue that then results in us providing the kind of information that they need up front.

We also institutionalize an 800 number for immediate response by the people if they have immediate questions. Sometimes the urgency and anxiety when you get a letter from the government, especially one that puts you in a health risk category, can be great and you want to be able to respond quite fast.

We then realize that we are really talking about sort of the horse after it is out of the barn and we want to get back toward primary prevention. So, in our notification material, we also talk about the current exposure limits for the chemicals of concern in the work place, so that those workers can have some input and impact on the exposure situation in their work place. Which also reminds me that we also talk about in notification, even when there isn't a medical reason for notifying people, we still think there is an ethical reason based on the issue of self-determination, that these people have a right to know their information if a government agency has some belief that there is a health risk.

That gets us back to our judgment, based on our criteria. But when we finally find that a study meets our criteria, then we feel that we have an obligation to do that.

Dr. Tinker talked about the importance of having an evaluation mechanism in risk communications. We certainly do that in notification. In the short run, as I said, we have both the 800 telephone number for dealing with anxiety, but it also serves as an evaluation mechanism. We have bounce back postcards that we put in and that allows people who have specific concerns to respond. That is clearly a voluntary kind of evaluation.

We also are designing a more scientific approach, where we would take random samples from the cohorts that we notify and contact them three to six to twelve months afterwards to assess the impact and effectiveness of the notification from their point of view.

So, as I said then, we do all this by first pilot testing it with the workers, unions and management.

So that generally is the approach that NIOSH uses. As I said, we have conducted over 25 notifications at 90 work sites throughout the country. Our approach has been one that was a pioneering approach in that epidemiologists in general, companies, unions, in particular, didn't do this until we started to move on it as standard practice.

Now, it seems that it is standard practice for people doing these kinds of cohort mortality studies to consider the need to do individual notification.

So, with that, I would be glad to answer any questions or elaborate.

DR. LASHOF: Thank you very much. Both of your testimony, I think, was very helpful and very clear.

I would open it up for questions from the Committee at this point.

Let me start off by asking both of you, one of the issues that is key in terms of where people get their information is, indeed, information from the media and I wonder whether either of you have developed any special workshops for science writers for newspapers or other methods for trying to educate that part of the media that are doing much of the science writing around those issues, as one.

Secondly, whether there are other approaches to be used in getting to the media that are more of a tabloid type media, both TV and newspaper, which tend to play up the human interest story and often ignore the science and whether you -- how you have dealt with that in your experience.

DR. TINKER: As to your first question to the mainstream media, ATSDR maintains regular contact with mainstream media, both print and broadcast media. Our approach is to be very proactive and nurturing those relationships with science and environmental reports.

Internally, we provide training to our own staff on how to respond effectively to the media's questions and inquiries.

As to the use of the tabloid media, I don't think we have ventured out into those territories, but I think the focus of our efforts because a vast majority of the people do obtain their information through mass mediated approaches, the print and broadcast media, the focus of our efforts is providing and nurturing those relationships with reporters, with editorial staffs, so that they can provide information that is meaningful, that is accurate and that is clear.

DR. LASHOF: Do you want to comment on that also, Dr. Schulte?


As part of our efforts, as I said, we do individual letter-based notifications, but we consider the process also to include the need to inform the media in the areas where the study's plant resides, about the study and about the notification. So, we make efforts to try to get in touch with the media in those areas.

We realized in our very first pilot notification that really the media plays a bigger role in a sense than our letter and, in fact, in our first notification in Augusta, Georgia, the first notification occurred via the media and our letter became more of a confirmatory effort than the actual notification.

I think it is probably incumbent on us to think more about using the media and maybe doing as you suggest, consider holding workshops for science writers. Certainly, in our broad dissemination efforts, we are moving in that direction, but for our individual notification of epidemiologic study subjects, there still might be a role for the individual letter kind of notification, supplemented by an informed media presentation.

MR. RIOS: Dr. Schulte, you indicated that you have taken somewhere in the area of 90 notifications. Were there any of them directed at specific racial or ethnic groups? And maybe you could tell us a little bit about that and what the peculiarities were if there were some specific adjustments that have to be made.

DR. SCHULTE: Yes, I will.

There were 25 notifications at over 90 work sites. In each of them, we take -- each of the notifications that we do, we take pains to provide the results in race and gender specific categories. If there is a disparity in any of those categories, we discuss that. We try to point that out and often we find that historically in the work force, different races will have been relegated to different types of jobs, possibly the dirtier jobs for one race versus another. So, we sometimes try to identify if that issue has occurred and if there are cultural and language issues pertinent to different ethnic or racial or gender groups, we try to identify that and focus our messages in that way.

So, the way we handle it is we give specific information for racial and ethnic and gender groups and then we try to explain that in our information.

DR. TINKER: May I also address that question?

MR. RIOS: Please.

DR. TINKER: I always have to come back to the role and the importance of formative research. Formative research methods are those methods either through individual interviews or through a focus group format that you are able to identify what are the specific themes, what are the specific concepts and the messages that are going to appeal to this audience.

It is also going to reveal what is the most appropriate format, what is the length, what is the style, what is the appeal in the message that needs to be used in order to reach this audience. Maybe there are language preferences. Maybe there are cultural considerations. But it is through formative research that we are able to get a better handle on what some of those issues are.

DR. TAYLOR: I am interested -- I am familiar with both of your programs, but I am just interested how you were able to develop communication with the local community groups, your outreach programs and how that was such a good relationship.

DR. SCHULTE: In the programs that we have done, we try to use the offices of the unions that are involved in the cohorts if they exist in those studies and try to get leads from them. We also try to find stakeholders in the community, who might be important representatives of the cohort. Especially if there is no union, then we try to do more with community stakeholders.

In some cases, we have encouraged the formation of a community-based representative group to sort of be our conduit to the cohort during the process. We don't do that extensively, but we have done it in the past and would that we had more resources, I think that would be more along the lines that we would go.

Clearly, that amplifies the idea that it is a process or dialogue rather than sort of an issuance.

DR. TINKER: Our communications, our activities are organized at three levels. We feel it is important that if we are going to reach communities, we can't rely on a single strategy. The three levels from which we organize our strategies are at the first level, are face-to-face communications. We conduct what are called key informant interviews.

We talk to key opinion leaders, grass roots leaders in the communities about what they see as the communications needs of the communities. At the second level are small group and community-based organizations. We are working with them in terms of organizing strategies and not just using just the mainstream media, but looking at more informal channels, such as working through the churches, through the youth organizations and then at the broadest level, we do work with the local print and broadcast media publishing announcements of public meetings and local newspapers, having Q&A sessions on local radio stations.

By using this three level or threefold strategy, we try to cover -- we try to reach maximum coverage of the audiences that we are trying to educate and to provide information to.

DR. TAYLOR: And piggyback to that, I guess one of the things that I see or note in some cases is that there is a level of mistrust in some communities. And I was just wondering, you have been able to get around that through making sure that there is sort of -- you know, scientists are looked as scientists basically and not being able to communicate locally. So, I guess you have been able to establish some sort of local communication that kind of bridges that gap.

DR. TINKER: The role of intermediaries are imperative. They represent the voice of the community and it is in our interest to work with not only them as individuals, but as groups to craft our messages based on what the information needs and concerns and priorities of that community are.

DR. LANDRIGAN: This is for Dr. Schulte. Paul, i would really like to commend you on what you have done here. It sounds very logical and very straightforward when you presented this morning, the part of it that I heard, when Delta finally got me here, but what -- I think what is extraordinary about what you have done here is that this represents the fruit of 20 years of work.

I mean, when you started out with this notification in the cohort down in August, Georgia, who had been exposed to the bladder carcinogens, people threw up their hands and rolled their eyes. I think the epidemiologic community in general said it couldn't be done. It is foolish. It is not something that we should do. It is going to raise undue anxiety in the hearts of those who were reached and their families.

And what you have done is through 20 years of this extraordinary combination of biomedical and ethical research is you have advanced the state of the art so that, as you said, this has become close, at least, to being standard practice today in epidemiology, that people are notified.

So, having said that, I would like to ask you what are some of the remaining obstacles? Are there still people or groups or stakeholders who resist notification? What are some of the research needs? You have taken this a long way. What do you need to do to take it further?

DR. SCHULTE: Well, I think, as you have described, it is close to being accepted in the epidemiologic community. In fact, the Chemical Manufacturers Association references it in its Good Practices in Epidemiology manual. There have been articles in the epidemiology monitored newsletter essentially establishing it as an approach that needs to be considered by epidemiologists and their funding organizations.

That is where I think the next step needs to be taken. The funding, the parent organizations then need to devote the appropriate resources to doing this. Clearly, it is seen as an after thought rather than a thought that needs to be thought of up front when you are developing your plan and anticipating the resources for doing the study.

Secondly, I think we still need to consider how you convert complex epidemiologic concepts into terms that people can understand, especially as increasingly we are going to be dealing with mixtures of exposures, very low levels of exposures and a broad range of kinds of effects. We still don't have a lot of experience in doing notifications in that context. The experience that I shared with you is essentially the well-known, large carcinogen, large effect kind of association.

And you can pretty well develop a logic relating to that. When you get into more diffuse kinds of effects with mixtures of exposures, poor exposure information, I don't think we have experience doing that and we need to move in that direction.

Then, finally, there is this whole evolving area known as molecular epidemiology, which essentially is maybe a term that doesn't convey much, but it involves using biologic measurements to supplement epidemiologic research and measurements at the molecular and genetic level, which in part help us really understand mechanism and may give us insight and may supplement exposure information, help us to take fairly heterogeneous disease categories and make them narrower and this is a useful area that needs further consideration.

It provides a lot of potential. It also opens up an additional set of ethical and social issues, as well. So, I would say those three areas are really sort of the next steps in considering doing worker notification.

DR. LANDRIGAN: Is there residual resistance yet to notification from some quarters?

DR. SCHULTE: I think so because of the fact that it isn't -- you know, it isn't practiced everywhere. Places aren't devoting resources to them and there is still a lot of concern that telling people will lead to litigation and heightened anxiety to the point that it is not worth doing.

I don't think that represents the general tenor of the field, but there are still pockets of resistance in that regard.

DR. LANDRIGAN: Thank you.

DR. CUSTIS: Privatization in federal programs seems to be on the ascendancy. Would you care to comment on what you think the consequences of privatizing the worker portion may be?

DR. SCHULTE: No, I don't -- I haven't really thought that through. I don't really have a --

DR. LANDRIGAN: If he can't, I will say it would be a grievous error.

DR. SCHULTE: So, yes -- as far as privatizing the notification of subjects of epidemiologic studies, I think it would result in certainly the need for those private organizations to accept the possibility and then budgeting for those kinds of resources, which they may or may not be willing to do.

So, I am not trying to avoid your original question, but I hadn't really thought about it and don't really have an answer.

DR. LANDRIGAN: Don, could I say, historically, back in approximately 1981, when there was substantial downsizing of OSHA, one of the immediate consequences in the private sector was the number of corporations that did away with their occupational medicine departments; TWA for one, I remember.

DR. MC DANIELS: Dr. Tinker, in communities that are located near these toxic areas or near Superfund areas, have you noticed over the past decade an increase in the public's trust or confidence in what the government is trying to do in their efforts to clean that up? The type of work the ATSDR has done, have you noticed that the public is feeling that the government is genuine in trying to work with these efforts?

DR. TINKER: Over the past decade, no. Over the past two to three years, we have made progress in establishing that trust and credibility. The process has been slow. We have had to learn a lot of hard lessons, especially in our work. There are usually multiple players at a site. There are other federal agencies. There are state and local health departments. There are grass roots community organizations. And finding the balance and the optimal mix in working with all of these different agencies and organizations is often a complex process.

But as I would have to concur with Dr. Schulte that risk is not only about the content of our messages, but more importantly it is about the process. And the focus of our risk communications efforts every time we go into a community is a focus on process. We are not there just to deliver public health messages. We are there to work alongside the community members, alongside the community groups.

One of our major goals in going into a community, we go in with the understanding that ATSDR cannot be in a community indefinitely. So, we need to work with that community to help them build the capacity to build the infrastructure within that community to sustain those communications efforts, to sustain those education efforts and information outreach efforts so that once ATSDR leaves a community or leaves a site, those activities can be self-sustaining. And from that standpoint, risk communications is very much of a process.

DR. NISHIMI: Dr. Schulte, when you -- you mentioned sort of two thresholds that needed to be met before worker notification; strength of the evidence and biological possibility. So then, if you had little evidence, but it was biologically plausible, I take it that you would not notify. Is that correct? And that if you had some evidence but it was biologically implausible, you also wouldn't move forward. Is that sort of one way to look at it?

DR. SCHULTE: Well, the underlying criterion is the case-by-case judgment using these criteria. So, it wouldn't necessarily be either of those ways, but it could. It depends on how little evidence and how strong the plausibility was. It sort of gives you freedom -- the approach gives you freedom to sort of make a professional judgment in each case.

We also look at other extenuating situations, circumstances, like whether it is feasible to be able to do it and we also look at whether or not the findings were related, as I said, to the a priori hypotheses.

DR. NISHIMI: So, what -- since you introduce this feasibility concept, what is not feasible or feasible, I guess, I --

DR. SCHULTE: Well, in some cases, we may not be able to find the cohort.


DR. SCHULTE: -- their current location. They may be from a company that is widely dispersed and we might be missing part of the records, something like that.

DR. LASHOF: One of the questions, one of the issues or problems the VA is going to face, as well as DOD, is the broad group. It is not like they can go into a community with a specific problem, as you just described, in working with the community.

I just wondered what thoughts you might have about what is the most appropriate way for the VA, for instance, to transmit the information concerning its mortality study, which it has done, and at this point has not shown a difference in mortality, but will be an ongoing one for follow-up in case of chronic.

How does one -- what would be an effective way of communicating that information to a group as broad as a million veterans, who served in the Gulf, as well as the public?

DR. TINKER: I would see three possible strategies. The first would be to provide an overall summary of the study to the general public as to which channels you use. I don't have the information in my disposal to make any informed judgment about that.

At the second level is to provide a somewhat more specific summary to the Gulf War veterans themselves. And third is a very individualized message to those Gulf War veterans, who have a specific health concern or an interest about how they may have been exposed to certain types of contaminants.

I would also emphasize the importance of not just having a mass mediated type of approach, but really working closely with the intermediaries that are important to you, your partners, through either public health service agencies, through universities, through medical schools, through schools of public health, through state and local health departments.

We found that in terms of disseminating the message, if our message is being disseminated through these types of intermediaries, it has a much better chance of connecting with the audiences that we are trying to reach.

DR. SCHULTE: In NIOSH efforts, we have found that no matter how extensively we try to refine a message and how well we think we have said it, when we get the group involved who is supposed to read it, they have concerns and complaints. So, we have gone to trying to involve them in the process and we find that that alleviates a lot of the concerns that otherwise would have arisen.

So, I strongly promote encouraging people who are the targets of health communication to be involved in the development of the message.

DR. LANDRIGAN: Have the VA or the DOD sought your consultation?

DR. SCHULTE: Not mine specifically, no.

DR. LANDRIGAN: Or the agencies that --

DR. SCHULTE: Not that I know of. I haven't -- I don't know necessarily if they have, but I haven't heard of any.

MAJOR CROSS: Gentlemen, can I ask both of you, at your place of work, do you interface with the military at all in your normal work routine?

DR. TINKER: We do extensively through the Office of Federal Programs at ATSDR. The focus of those efforts is on conducting public health assessments, as well as reaching communities around federal facilities, where there are military bases. These military bases have been identified as Superfund sites. So, we do have extensive public health assessment activities, as well as public outreach and education activities to these communities.

MAJOR CROSS: Okay. You don't necessarily get involved in communicating health risks to individual military personnel by nature of the types of equipment that they operate. You know, you are talking about local communities around bases. I understand that, but military individuals, by just the nature of their work and the places that they can be deployed to, are going to be exposed to health risks. You don't get involved in any of that?

DR. TINKER: No, we don't. Our mandate pretty much limits us to public health assessment and outreach activities that focus almost exclusively on human exposures to hazardous substances around Superfund sites.

DR. SCHULTE: We generally don't get involved with the military in communicating health information either, but we have had some experiences where we have conducted some health studies with the military or as part of the military bases. And, so, we have a little bit of experience in that regard, but it is just very small.

DR. CUSTIS: The military has a real capability in this regard, do they not?

DR. LASHOF: Is that a statement of fact or a question you are asking?

DR. CUSTIS: I think, as far as I know, that is a statement of fact. They may well call upon other federal agencies for consultation, but they are not void of their own capability.

DR. LASHOF: Thank you very much. I think this testimony has been much appreciated by the Committee.

DR. TINKER: Thank you.

DR. SCHULTE: Thank you.

DR. LASHOF: We are ahead of schedule and we will just try to find out whether the next people who are due to testify are here and whether we shall start with them or take an early break.

We will take a break now and return at 10:45.

[Brief recess.]

DR. LASHOF: I think we are ready to resume. If everyone will take their seats, we are ready to resume our session.

Joining us for further discussion of the issue of risk communication are Dr. Thomas Burke from Johns Hopkins University, Dr. Bruce Dan from the Center for Biomedical Communication and Mr. Michael Doble from Fleishman-Hillard, Incorporated.

Thank you very much and we will begin with Dr. Burke.

DR. BURKE: Thank you very much. I am grateful to be here to have this opportunity. I am an academic, but I am going to take a slightly different approach than we have heard this morning because I am a relatively new academic. I have spent most of my career as a public health practitioner as the Deputy Health Commissioner of the State of New Jersey.

I was asked to come here to share with you some of the practical realities of risk communication in a fishbowl. But I would also like to mention a little bit about the academic side of things because I will try to throw in a little bit of science here about risk communication.

I am an epidemiologist. I am the co-director of the new Risk Sciences and Public Policy Institute at the Johns Hopkins School of Public Health and our research is really trying to bridge the gap between the science of risk assessment and epidemiology in order to improve the public policy process.

We realize the disconnect, unfortunately, between our sciences of exposure assessment and epidemiology and the need to make public policy. So, that is a new initiative at Hopkins.

I might also add that my father was a decorated combat veteran, who served in the Pacific, was severely wounded. I count among my students many of the highest ranking public health officials in the military. So, I feel that I am familiar with the very unique situations of combat, acute risk versus chronic risk, and the very difficult decision-making that is faced in combat.

So, with that,I would like to talk a little bit about science and a lot about credibility. Credibility is everything in risk communication. And when I was asked to prepare this and asked to kind of draw upon my experience in New Jersey, I see that there is nothing new under the sun. I have been involved over the decades really since the mid-seventies with many major environmental crises in New Jersey, from dioxin, the Agent Orange Commission, concern about Vietnam veterans and their dioxin exposure, the siting of incinerators, the emergence of the HIV epidemic and the protection of the blood supply, occupational exposures, radon, outbreaks from everything from sick buildings to infectious disease, the hysteria of asbestos removals and trying to put some science behind that, contaminated drinking water.

But I have also had to meet and work with the parents of leukemia victims, who live near hazardous waste sites. So, on the personal level, I think I took it from the realm of the population-based epidemiology right down to dealing with parents mourning the death of a child and trying to seek environmental answers. And you learn a lot along that course.

Today, I would like to talk about perhaps one of the most impossible risk communication things I have ever been involved with and that is the Jersey ocean pollution. In retrospect, it is kind of a neat example. There isn't a real big public health threat there, but there certainly was a big political risk involved in that. So, why don't I have the first slide.

The summer of 1988, you may remember, was a presidential election year, I think, which environmental crises tend to come to the fore, particularly in New Jersey, where unlike most people's perception that the number one industry is chemical production -- it used to be -- it is now tourism with a little bit of gambling mixed in with that. But these are the kind of headlines as the state's top environmental health official I had to deal with and these are the kind of perceptions that were going on.

This was -- again, we talked about the media and their role in risk communication. This was the constant bombardment that the nation was getting about the Jersey shore. The fundamental concern there was not just pollution, but that people would get sick by going into the ocean along 129 miles of Jersey coast.

So, we had all kinds of headlines and accusations. We had closures, more beach closures, than I want to imagine. We had campaign speeches by all the candidates on the Jersey shore. We had incredible media attention. We had New York trying to capitalize and other places in competition for tourism trying to siphon off the tourism trade.

But perhaps most importantly for this commission, we had experts disagreeing on health dangers. We had a demand for an epidemiological answer and we had accusations of a coverup. I had physicians down at the shore, who were convinced that we were hiding something terrible because the casino industry was holding a gun to our head. They would never hold a gun to anyone's head.

I couldn't help but -- also, I might add the concerns at the Jersey shore, which were legitimate -- any kind of a crisis like this has at its root some legitimate exposure and there was industrial dumping. There was sludge dumping off the coast. There was contamination of the beaches, which mandated closure of the beaches. But then there was the hysterical part of that, too; concern that you could get AIDS from swimming in the water, that a washed-up hypodermic needle on the beach could cause AIDS.

These are the kind of things that we had to deal with and then suddenly from whatever source, vials of blood showing up on the beach actually from a laboratory that was illegally dumping their medical waste and they washed up on the beach. But every conceivable type of environmental insult, once you get under the microscope, you could find along those 129 miles of beach.

I was called upon daily to give press updates, to try and balance the pressures from the Governor's Office to salvage the tourism industry, while being a public health official; very unique and very interesting.

But -- if I could have the next slide -- not all that unique. Just since I have been asked to speak, I have been looking at the newspapers. Here, again, you have the press characterizing the risk to the Gulf War veterans, very similarly to the beach, ocean pollution situation, where virtually everyday there are new claims, disagreement among the experts, unfortunately, flip-flops from the Pentagon as new science emerges.

The result of this is very similar; confusion among people with legitimate concerns about illness and a lack of credibility. Who do you trust in a situation like this?

I wanted to get back to -- I think this was raised before by Dr. Tinker, but what is this risk communication thing all about. If you go back to the National Academy definition of it, it is an interactive process, exchanging information. I stress "interactive." I heard a lot about getting a message across today. In my involvement -- I am now involved in a very large study in the city of Philadelphia, trying to understand environmental health impacts -- I don't like to consider it as getting you a message out there. I like to consider risk communication as answering the questions that people have about their health.

If you frame it as getting my message out there, I think it sends the wrong message and that -- it is certainly not in the definition, the scientific definitions of "risk communication." It is a dialogue.

And success is not making people agree with you. It is raising their level of understanding of the issues within the limits of available knowledge. Being very frank about the limits of available knowledge is also very important. Risk communication does not always lead to better decisions because it is only part of the risk management process and it certainly doesn't result in consensus and we must blend expert messages about science in the communication process and address those critical questions if we are to be successful.

But perhaps most importantly, good risk communication may not improve the situation, but poor risk communication will almost always make it worse. I would have to say unfortunately -- and I have read your interim report. You certainly have your finger on some of the issues, but the risk communication as a lay person that I am reading about the Gulf War is certainly different than I have as a teacher, teaching military officials, public health officials, and the message going out to the American public is being characterized in a way that is not scientific and is making a situation worse, very much like I have lived through with Agent Orange and other kinds of issues.

So, is there a way we can anticipate this and how, if you had a scorecard, to look at the Gulf War illnesses and the issues there? Well, behavioral scientists and others have done a lot of thinking about the kinds of things that affect risk perception and dimensions of risk. I have put these together in a chapter I am working on, "The Integration of Social Values into Risk Decision-Making," and adapted the work of many others.

But if you look at the dimensions of risk, and I kind of run down a quick checklist -- unfortunately, it is kind of like those popular quizzes, where you can measure your stress level; you know, just started school, just moved, all that. Well, if we did a popular kind of ranking of the kinds of things that can make risk communication difficult in a case study of the Gulf War illnesses, you have them all, from severity of consequences, probability of occurrence, catastrophic potential, reversibility, concern about irreversible effects, latency of effects, conditions with higher perceived risk or those chronic effects that are delayed in time.

Honestly, the veterans that I know are much more concerned about those latent effects than the acute wounds of battle because it is unknown; it is more of a mystery. They are very informed about the risks of battle in the traditional sense, not in the chemical sense.

Impact on future generations. Obviously, conditions that may bear a risk for future generations are very important and raise the perception of risk. Impact on children, we have that here. Victim identity, do we have statistical victims or identifiable victims? In this case, we have clearly identifiable victims, who have come forward, who are concerned.

Familiarity. I don't think anyone is familiar with the risk of combat, particularly in modern warfare. So, we are dealing with an unfamiliar risk. Understanding of the risk. Is there a lack on a lot of the risk takers of a personal understanding of the mechanisms of the risk involved? Absolutely there is. The scientific community doesn't understand the mechanisms of risk in this particular situation.

Scientific uncertainty. We have heard a lot about that in the epidemiologic perspective today, our inability to really differentiate those risks. Are the risks unclear to the scientists? Yes. Does that lead to a higher perceived risk? Yes, it does.

Dread. Are the kinds of impacts we are talking about, do they evoke fear and anxiety? Yes. We are talking about illness, chronic illness and disability to healthy young men and the potential impacts on future generations.

Voluntariness. Well, we had a lot of volunteers in the Gulf. They volunteered for combat and they were willing to make sacrifices, but I don't know that they volunteered for things that they didn't understand about, immunizations and exposures, chemical exposures there. So, in a way, the kinds of exposures that we are dealing with now were involuntary with very little personal control over those risks on the battlefield.

Clarity of benefits. What are the benefits from the kinds of risks that were taken? Again, that adds to the high perception of risk.

Then, finally, is it fair? Is there a direct benefit for those who were put at risk? Well, not really understanding whether there was secrecy involved or there was a straight scoop going on about the exposures, there is a sense of unfairness. Let me emphasize institutional trust. The lack of trust in institutions responsible for risk management cuts to the heart of the issue here and to the heart of the success of communicating this risk.

I know as an official when you are involved in the agency, it is very hard to gauge. There is a self-denial going on there that people couldn't possibly mistrust me when I go there and I am trying to tell them the truth. I know this as a health official, but they do. They hate your guts. They are not going to believe it. And institutional trust is at the core of these kinds of things.

Personal stake. Individuals personally at risk. Attribution of blame. Was the risk caused by a human failure? Did somebody know they were putting me in harm's way and not do something about it? Well, certainly those are the popular accounts that I have heard of recent times.

Then, finally, media attention. There couldn't be any grander international media attention to the plight of the Gulf War veterans.

So, how do you deal with this? Well, EPA and a fellow named Vince Cavello(?) worked with the National Science Foundation to kind of come up with seven cardinal rules for -- which I present in my risk communication classes and they are kind of nice. This is risk communication ala mid-eighties.

Rule 1, accept and involve the public as a partner. Plan carefully and evaluate your performance. List to your audience. Be honest, frank and open. Coordinate and collaborate with other credible sources. Very important. Try to meet the needs of the media and speak clearly.

This is nice but that and a dollar ten will get you on the subway at the Jersey shore in the height of summer when you are up to your neck in medical waste. So, I came up with my own cardinal rules, which I would like to share with you a little bit.

I think they fit most risk communication situations that I have been in and sometimes they are tough to accept their reality. Involuntary risks are unacceptable after people have been subjected to them. They are not going to turn around and say, well, okay. They are going to remember that and they may have to live with the risk for a lifetime and it is unacceptable.

Once people make up their minds about a risk, it is almost impossible to change them. So, we can't change minds. We can only work toward prevention. Trust and credibility are essential to risk communication, but they require a long term effort. You can't do a band-aid risk communication.

Unfamiliarity breeds contempt. People don't know what you are talking about if there is a lot of uncertainty. The risk is tremendously exaggerated. Health risks may be secondary. In the controversy, health risks may be brought to the floor to bring attention to an issue, as I have certainly seen in many political campaigns. They were very secondary to the real motives of the involved parties, whether they be financial gains, whether they be property values or whether they be getting elected.

You have to kind of cut through what is going on here. Risk communication is a political process. We have to realize health is often secondary to the true motivations there.

That values and beliefs can outweigh science. The answer is not to throw the best scientists alone at it.

And then finally that the best communication can't reverse bad management decisions. Those are the seven realities.

To kind of finish up, I would like to go through I think it is the agency evolution and it is the history of risk communication of those of us who have tried to do it for a long time. As you can see from the things that shape perception, there is great commonality, whether it is a local school board or a national/international problem.

The first stage, well, at that point we thought if we only got the science right, if we could just measure these exposures, we will do it okay. These stages of risk development were developed by Baruch Fishoff(?) at Carnegie Mellon University, by the way. But they ring true to anyone who has been in the public arena trying to work with the public or exposed populations.

If we could just get the science right, it will be okay. Well, that doesn't work. All we have to do is tell them the numbers. If somehow the public, the affected population, could somehow get these numbers and understand them, well, that is important. They have a right to know. We need to do notification, but that is not it alone either.

A third stage was, well, we really have an obligation to explain what we mean by the numbers. We have spent a lot of effort doing that.

And then the fourth stage is, well, now they have the numbers. We have explained them. Let's show them that related to other everyday risks, it is no big deal. Being in combat is like eating peanut butter, right? We have all seen those ridiculous comparisons to scientific risk assessments. That doesn't work either.

The fifth stage, all we have to do is show them that this is a good deal for them, kind of co-opt the population into understanding, well, this I see with incinerators and other kinds of things. This risk really is a good deal for you. There are economic benefits.

The sixth stage, treat them nice. And that doesn't work either.

The final stage, which I think the point we are at now, which my work with the National Academy Committee on Risk Characterization in a new report is really changing the way we do risk characterization because all we have to do is make them partners. We have to realize we are doing this communication not to deliver a message from an agency, but to answer questions. We can't even ask the right questions unless we have involvement from the design of the studies all the way through.

It is not the time when a study is done to begin to worry about communication. The time is at the very beginning. So, I have found this, unfortunately, in the "School of Hard Knocks." But the reality of that works. My current experience in the city of Philadelphia dealing with a population that has a twofold increase in cancer mortality just by the fact that they are poor, minority and live in a very contaminated environment and have other social and behavioral risk factors is very important to them and trying to come to grips with that in a multifactorial, environmental situation.

The most important element was building their trust. We couldn't possibly do epidemiology with a variety of exposures and a variety of health outcomes. What we have to do is try and answer the right questions.

I urge the Committee to recognize that and my final recommendations are: Don't expect science to define the answer. The beginnings of the answer have to start with that trust. Right now, unfortunately, I would have to say there is not a lot of trust.

Secondly, and this is a tough one, but maybe the Defense Department, the Department of Defense, can't do it this time because of the credibility issue. Certainly, I have seen that in the past, where there is such an amount of mistrust that it has to be done by someone else. Maybe the emphasis on exposure assessment and epidemiology at this point is misplaced and it should be about trust building.

Certainly, I am not urging that we stop our quest for the scientific answers, but that is, perhaps, secondary to the building of trust. Finally, emphasize communication and prevention before deployment. A lot of these things are in the past and I really don't know what we can do about past exposures, but perhaps the biggest reassurance to the veterans can be that this won't happen again. We want you to be part of the process of prevention.

A lot of the things that we are seeing now, that we are hearing anecdotal information about can be part of a prevention process that I think is very important.

Finally, there is -- particularly among agencies, there is a frustration that people are out to get you and there is fundamental mistrust. I have found even the most zealous advocates to be reasonable people when they feel they are getting a fair deal, when they are part of the process. Don't underestimate the ability particularly of the military to be involved in that process, to be very reasonable as you lay out the risk.

They were willing to take tremendous risks to be involved in combat and I think they are willing to be part of a solution. So, those are my recommendations.


DR. LASHOF: Thank you very much.

We will save the questions until later.

DR. DAN: Madame Chairman, members of the Committee, I would like to thank the Committee for its invitation to speak before you here today. I have submitted written remarks to the Committee and I, in the interest of time, hope to summarize them here this afternoon.

I hope my remarks will be helpful to you in your deliberations and would be glad to answer any questions afterward.

I am an infectious disease specialist and epidemiologist, but I had a foot in another profession. I was a journalist for about 12 years. I was the senior editor of the Journal of the American Medical Association and on-the-air medical reporter and medical editor for ABC News in Chicago.

Like many health professionals and most physicians, I suspect, I have spent too many hours in medical school, residency and specialty training to read newspapers, listen to the radio or watch much television. My only notice of the latter was to get a glimpse in patient rooms on my morning medical rounds. It wasn't until my tenure as an epidemic intelligence service officer at the Centers for Disease Control and Prevention that I came face to face with the necessity for and the power of the media.

I was the deputy chief of the Toxic Shock Syndrome Task Force, a hastily-gathered group of young epidemiologists, given the mission of dealing with the sudden emergence of a deadly nationwide epidemic. Solving the problem was, indeed, demanding and at times all-consuming work. But because we had been given the epidemiological skills and tools to handle the problem, it was a manageable task. However, dealing with the media attention generated by the problem was not.

I knew nothing of who the media were, how they worked or what they wanted. I had no idea how to communicate effectively to them or to their publics. I apparently didn't even speak English. I spoke another language, the language of most professionals; jargon.

My ability to communicate a simple understandable coherent message to the American public and, in particular, to the menstruating women at risk for the illness was hampered by both my scientific sophistication and my media illiteracy. I was frankly playing in a game whose rules I did not know in a uniform I had never worn before and with the wrong equipment.

I, obviously, needed to learn some new skills and become acquainted with some new tools, once that were not taught to me in my public health training, but ones that greatly increase the likelihood that the media would get the story right and, in turn, deliver the message I wanted to get out to the American public.

I did that by sleeping with the enemy. I became a print and electronic journalist. I have been engaged in medical journalism for some 14 years now.

Risk communication is a field in which much has been written and to my knowledge, my contributions have not been original. However, I will be glad to share with the committee what insight I have learned working both as a public health official and professional journalist.

Americans no longer receive their medical information from health professionals. For example, a recent Gallup Poll found that more than half of all Americans said they received their nutritional information from the mass media. Less than a third said they got it from their doctor.

They learned what little they know about medicine, science and health from reading newspaper articles, health magazines, diet books and by watching television news, celebrity fitness tapes and late night infomercials. In fact, the 1995 Nielsen Report on Television shows the average American has its television turned on more than seven hours a day, seven days a week.

Public health information is of little use unless it can be communicated effectively and clearly to those who will benefit from it most; the public. And the public gets its information from the mass media. The public naturally turns to medical experts during times of uncertainty. Their health may depend upon the immediate advice of medical authorities; for example, after a natural disaster. Or they may just need to have their fears calmed about a proximate or a distant health risk.

But risk is more easily tolerated if those at real or perceived risk feel they have control over it. Acquiring information is one form of control in dealing with a perplexing situation. In communicating health risks to the public, it is paramount to remember that the primary task is to deliver a single, logical, simple message. It is often referred to as the single, overriding communication objective.

Multiple messages cannot be retained. Complex messages are lost in the mass media. Our political figures learned some time ago the power of speaking in sound bytes. From Ronald Reagan's first foray in New Hampshire stating that, "I paid for this microphone," politicians have learned to use the media to their advantage. Their messages are succinct, emotion-laden and usually spoken in monosyllabic, Anglo-Saxon words.

Entire campaigns have become bumper stickers. George Bush, "Read My Lips, No New Taxes;" Bill Clinton, "I Feel Your Pain." And the latest, it either does or doesn't take a village, depending upon your point of view.

The success of communicating a single message is directly proportional to it being understood by the greatest number of people. The reading, listening and viewing public has no tolerance for technological jargon or complexity. The public wants simple, direct, black and white answers, regardless of how gray or complex the scientific questions are.

Conflicting messages foster confusion, uncertainty and invariably lead to distrust, anger or apathy. Scientists are often ill at ease in dealing with emotional conflicts but controversies in the media are seldom based on arguable facts. Those delivering information must learn how to show concern for those involved, to be responsive to their needs, to find common ground among them, to use everyday language and analogies to make their facts understandable.

The electronic media does not disseminate information. It gives perceptions. It does not deliver facts. It leaves impressions. As intolerant as the public is about uncertainty, they are totally unforgiving about perceived dishonesty. Credibility is, perhaps, the most important attribute for individuals or institutions appointed as message bearers, as Dr. Burke has alluded to.

Information leaked out from sources other than the appropriate message-bearers sows suspicion and is compounded when the information is perceived to be withheld. Given the choice between ascribing an event to confusion, incompetence or malice, most people will choose the latter.

The underlying principle in uncertain situations is if you don't know the answer, say so. Probably more damage is done in responding to a question whose real answer is "I don't know," than by any other interaction with the press.

What lessons can be learned from previous episodes in health risk communications? Let me list a few examples. Perhaps the first of the more prominent medical mysteries that the public became aware of was Legionnaire's disease, an outbreak that occurred in Philadelphia in 1976. Although it took many, many months for the true cause of the disease to be elucidated, a previously unrecognized and inhaled bacteria, two factors made the situation more manageable; the group of individuals at risk, while spread across the U.S., were currently identified early on as only those who were at a single place at a single time in and around a single hotel in Philadelphia during a one-week stay.

No other Legionnaire, no other Philadelphian perceived that they were at risk. And despite the fact that numerous theories were espoused explained the mysterious disease, health officials early on simply said they didn't know what caused the problem but were making every effort to find out.

Toxic shock syndrome was probably the first nationwide epidemiological mystery. Although the answer to the riddle, why women suddenly and unexpectedly became seriously ill during their menstrual period, a vaginal infection with a toxin-producing bacteria was the cause and even though this was not immediately recognized, the disease's link with newly-introduced super absorbent tampons was. It was possible to quickly identify those at risk. Again, those involved were able to say they did not know what the cause was, but they did know who might be affected.

Women were told that they could eliminate any risk by not wearing tampons. For those who wished to continue using them, they could reduce their risk by wearing them sparingly. And any woman who developed fever or rash during their period were told to remove their tampon and call a doctor; an effective strategy to allow women to choose their risk and if affected, have an intervention available.

An episode that typifies the importance of quick and credible response involved Johnson & Johnson's experience with cyanamide contamination of Tylenol that has become a case study in how to handle a difficult situation. Although it was clear early on that the contamination was probably limited to only a small and identifiable locale, Chicago, the company, in the form of public messages from its CEO, virtually pulled this product from the U.S. shelves and advised Americans not to use it.

The company that made band-aids and shampoo that didn't cause babies to cry said it would rather go out of business than hurt any one of its customers. After a brief and predictable decline of its stock price, the company went on to become one of the most successful and credible corporations in America.

Although intensely painful, lancing an abscess is better than living with a smoldering infection. Considering contrasts, the American public's perception of how well the Exxon Valdez incident was handled or the lasting impression of a half a dozen or so tobacco executives testifying that their product was not addictive.

I must relate to you one anecdote of recent public health incidents, the suspected contamination of food products from cyclospora. While the public was confused about whether they should abstain from strawberries or raspberries, they may have been more confused when a Centers for Disease Control researcher said on the evening news that they were busy looking for, and I quote, the vehicle of transmission. If the remark would have been accompanied by a video of unloading a flatbed truck, it would have completed the circle of confusion. Some 20 million Americans saw that report, probably wondering where the vehicle of transmission was.

Perhaps closer to the problems presented by illnesses of Gulf War veterans is the exposure of Vietnam military personnel to dioxin. Despite numerous studies showing the actual number of veterans potentially exposed was small and that the effects of exposure were definable, most Americans probably believe that GIs were exposed to -- most GIs were exposed to it during the war and that it caused of many of the varied illnesses that had developed in Vietnam veterans to this day.

The American public thinks it has not been told the entire truth about that problem. Scientists and epidemiologists are loath to rule out any possibility during their exploration of a problem. They are comprehensive in their inclusion of any potential sign, symptom or factor or cause that is appropriate. We label things as syndromes, disorders, illnesses for the purposes of scientific inquiry, but this imprecision is antithetical to the public's desire for specificity and clarity.

The public will learn about the Gulf War veterans' illnesses from the mass media. The more quickly, the more credible and the more simply they learn the answers to their questions, the easier it will be to resolve the uncertainties they feel.

Thank you very much.

DR. LASHOF: Thank you.

MR. DOBLE: Madame Chairman, thank you. I want to thank you very much for the opportunity to address this distinguished Committee on the subject of risk communications from the perspective of those who provide public relations counsel. I am especially honored to share this meeting with such an impressive group of experts.

Today, I will examine the communications environment we face today, take a look at risk communications and then move on to what happens if your risk issue gets to the crisis stage and, finally, how we might, quote, paint some of this camouflage at the end.

As you can see in my biography, I don't have any medical training. I served a career in the Army, the last six years of which was spent at the Pentagon. I spent the Gulf War in the Pentagon Press Room, three years as spokesman for the Strategic Defense Initiative and was one of the first public affairs officers on the ground when U.S. forces entered Haiti in 1994.

In other words, I have had plenty of opportunities to communicate in crisis environments, from staying ahead of Wolf Blitzer's play-by-play in the Gulf War to explaining just why some of our rockets were exploding in tests, to fending off the mob media that preceded and I might add outnumbered us in the early days in Haiti.

Over that six years, I developed a fair understanding of the communications dynamics faced by senior military and civilian leadership in the worldwide stage upon which their decisions played out each day. It is not an easy job and every spokesperson faces a landscape full of potential bear traps.

Furthermore, I found that most of the principles and lessons that I learned at the Pentagon are equally applicable now that I am out in the business world. Since going to work for Fleishman-Hillard, I have been a crisis counselor for a railroad, a chemical company and a food processing company, all industries that have a great deal of potential for daily risk communications challenges.

Now, how do you succeed at risk communications? In my opinion, let me admit right up front here that no matter how much you pay for your public relations counsel, there is no silver bullet approach that will guarantee your success. I would be wary of anybody who promises you that they are going to have a certain outcome of this kind of risky communications.

So, let's take a look at the environment as I see it that we deal with here in my last six years in Washington as the testing ground for this.

Our 24 hour news environment presents a unique challenge for organizations, who must communicate risk to a complex system of audiences, most often through the filter of the news media. I use the term "complex system of audiences," because for the interconnectedness of our world in the information age.

Our information systems bring local issues to national prominence instantly. Further, as Dr. Tinker has observed, the audience can also be divided into sub-audiences, each with a unique set of needs and communications objectives. The Worldwide Web makes volumes of information available any time to anyone, who can log on from anywhere and CNN and soon the other networks have a 24 hour news hole to fill.

C-SPAN brings legislative decision-making and deliberation to us as it happens. In short we are flooded with information and want someone to help us sort it all out. All this instantaneous communications, coupled with our intense belief as a culture about the right to know, that Dr. Schulte mentioned, puts a tremendous premium on being able to create simple, easily understood materials that put risk in perspective without appearing to minimize that risk.

Now, let's take a look at the role of the media in risk communications. Reporters, and the press who are here today are no different, are under immense pressure to cover a wide variety of complex and unrelated topics under very tight deadlines. Therefore, it is critical to explain risk factors clearly. Reporters don't have time to boil down huge volumes of data. They need executive summaries and your main messages up front, not buried on page 10.

The media filter almost guarantees that those who oppose your point of view will appear on the same news story as you do. This is called balanced reporting. Facing this reality, it is imperative that spokespeople be accessible to the news media at all times and on reporters' schedules. The news cycle waits for no one, not even a CEO of a major corporation or a senior government official.

Accessibility is critical not only for balance in the story but for your point of view to appear at all, the broadcast and print media can find a talking head expert on anything in minutes. If you choose not to provide input to a news story in your area of risk, the great truth is that your critics are always available for interviews.

Reporters can find someone who purports to speak for your side of the issue and, unfortunately, those that they find may not actually hold your point of view at all. If an organization decides to withdraw and not participate in a news story directly related to them, the analogy that I use in my media training is a courtroom. You have a judge, a skeptical jury and a prosecutor, but no defense attorney or defendant.

The judge and jury can only conclude one or two things if you don't appear; one that you are guilty or two that you don't care. Either way, I would submit to you that these are not helpful to your cause or to your organization's credibility.

Now, as an overall concept, we cannot think of risk communications as business as usual. To do so is to put the standard decision-making and bureaucratic processes of your company or organization in motion and that motion is not particularly rapid. This is the same whether you are part of corporate America or an agency of government. The normal communications mechanisms of a company or organization are not really designed to handle the high risk, fast-paced world of risk communications.

The first step is to provide a fast track for information flow and to cut out as many layers in the process as possible for as long as the need exists. In fairness to large corporations and agencies of government, they must get over a formidable hurdle in dealing with a skeptical public. Most people don't trust government or big business. Recent studies place public relations firms above the government when it comes to believability in cases of exposure to chemicals, for example. How can we increase the believability of large organizations who are communicating risk?

The following are some of the factors which can either magnify or reduce the perception of risk. First, the perception of openness. Now, the opposite of openness is appearing to stonewall or withhold information, which makes your audiences and the media suspicious, as already discussed by Dr. Dan.

Second, we must allow for feedback and dissenting opinions. As Dr. Tinker has observed, this is all about two-way communication, to listen first and speak next. The opposite of this is to attack critics and go negative. This also creates the perception that there is something out there to hide. They are able to acknowledge that nothing is zero risk. Where we can go wrong here is comparing risk with some well-known and familiar activity, for example, comparing the safety of driving your car when considering the safety of air travel.

People feel that they can control risk in their cars, but are not exactly at the controls in an airliner. It doesn't matter that a purely statistical analysis, indeed, does conclude that air travel is far and away the safest way to travel, but statistics do not carry the day in communicating risk.

The need to disclose as much helpful, meaningful information as possible in a short time is a tremendous balancing act. Here are some tips.

To do research on your audience. I agree with Dr. Tinker regarding the importance of doing front end and evaluative research. We have to do a lot of listening and a lot of exploring before we get out there with our messages. We need to find out what scares people. This allows us to emphasize more with the audiences and put the human face on the situation.

We must pretest the key messages on samples of the audience. There is no reason to fly blind on this. For a relatively small investment of time and effort, you can eliminate a lot of false starts and lateral movements by simply researching whether your messages resonate or not with the audiences you are trying to reach.

Next, you have to gauge the hazard and your audience outrage. You must accept the fact that people will worry and acknowledge their right to be upset. As Dr. Burke said, involuntary risk creates an especially high form of outrage.

We must find credible, third party spokespeople to help explain the realities of the risk in what I would call simple fifth grade English -- in fact, I would have said between sixth and eighth grade level, but somewhere where it is fairly elementary.

We must over-communicate and follow up with measurable action. Again, getting away from the business as usual approach, you must talk to these audiences over and over. And our greatest credibility is gained by actually doing something and then holding up the results for open examination.

We must gather allies. One of my favorite books is called Murphy's Laws and one of those laws is that friends come and go, but enemies accumulate. Nowhere is that more true than here in Washington.

More than just gathering allies and partners, you should aim to consistently listen first and then communicate your point of view to the subject matter experts on the network short list, for the talking head circuit and to the reporters who cover the business and government beat. That is somewhat on risk.

Now, let me shift gears for a minute here and move over into what happens once you have a crisis in your lap, that your risk communications has maybe not been totally successful for whatever reason. Now, if risk communication spills over into the crisis mode, it is crucial to have a current, tested, crisis communications plan. It sounds simple, but only 50 percent of Fortune 500 companies actually have a crisis plan.

My recommendation has always been to have a plan in the wings ready to go. It must be an "In Case of Crisis, Break Glass" kind of plan that is current, ready to go immediately. Just as you want to find a loaf of bread in your breadbox and not a recipe of how to make bread, you don't want to find a note to yourself telling you to write a crisis plan when you are staring a crisis in the face.

Corporate reputations are earned over years and can be lost in an instant in the early hours of crisis. By a crisis, I mean anything that interrupts the normal flow of your business, puts you under a media spotlight, reduces your profitability or risks your reputation.

Now, there are no microwave oven solutions to crisis management and the resulting impact on your reputation. The reputations that your organization builds day in and day out are those that lay the ground work for successful crisis response. Relationships must be cultivated with the media, regulatory agencies and anyone else that you would have to deal with in a crisis.

There are a few principles of crisis management. One of my favorite crisisologists is Norm Augustine, the CEO of Lockheed Martin. He submits to you that you cannot ignore crises and his quote is that there is no magical 911 you can call to extricate yourself from crisis. There is no way to run the sausage machine backwards and gets pigs out the other end. They understood this at my food processing company plant.

Once embroiled in a crisis, here are some tips on navigating through the mine field. Again, referring to the wisdom of Norm Augustine, his crisis maxim is tell the truth and tell it fast. Bad news doesn't improve with time.

Next, as mentioned earlier, you must have a plan that clearly identifies where you are most vulnerable to crises. Identify a crisis team. Identify the equipment and other resources that you need to support that team. List the outside agencies with bearing on your business. List the media contacts and identify as a primary spokesperson.

Another critical step is to develop clear, consistent messages to be interwoven into all of your crisis communications. Plan for the worst case. Remember, if you hope it will go away, it won't. The plan itself must flow from a company mission statement or corporate credo. What Dr. Dan had said a minute ago about the Johnson & Johnson Tylenol case is very true. They had a corporate credo, which was very specific and they followed it to the letter and they reaped the positive benefits of that.

Also, the plan must be rehearsed with as many of the outside agencies, for example, state and federal regulatory and emergency response agencies or health agencies. Rehearsing with these outside agencies has a double benefit for your organization. It allows you to test your plan and build relationships that show their value when you are thrown together with those same outside agencies in an actual crisis.

Finally, a word about painting this camouflage. I can't think of much that I have said today that cannot be adapted for government use. The principles of openness, simplicity and empathy will carry you a long way in communicating risk. In dealing with the media, remember, there are pressures in the news cycles that don't always move at the speed of your answers and the importance of boiling down your facts into simple digestible English that will make your point of view more understandable and usable in news stories.

For risk communications, doing adequate research, identifying what scares the public most and dealing with outrage in an empathetic and human way is also key. Once into the crisis mode, have a plan, test it and rehearse it regularly.

My presentation here today has covered some of the highlights of counsel that we provide to corporate America. Much of it is very simple and that is exactly the point. Despite the complicated subject matter of communicating risk, if you stick to basic principles, you will be best prepared to navigate through the tricky communications environment of today's information age.

Thank you very much for the chance to provide this overview of risk communications and crisis management.

DR. LASHOF: Thank you very much. They were really excellent presentations and quite sobering ones.

I am sure there are a lot of questions that are generated by that.

DR. LARSON: I will start with Mr. Doble and the others chime in if you wish.

Let's say, Mr. Doble, that you got a call from Exxon maybe three years after the spill and let's just imagine that there were problems that occurred, but there was also higher level of public mistrust and perception of what went wrong and so forth. Now, this CEO is asking you years later to take on this case and do something because their sales are still down.

Would you take the job and what would you do? Besides telling them that next time they need a crisis plan.

MR. DOBLE: That is right. Well, like I tell my people in media training, you know, you want to take a minute to think about your answer here, which is why I have had the dramatic pause here.

I think that I would take the -- take on the initial work and then as you get a little further down the road, you know, we have fired ourselves from some accounts that we have had in the past because we have had a philosophical parting of the ways with clients, in which I am not really at liberty to talk about who they are specifically, but suffice it to say that they were highly risk oriented communications situations in which they chose to do some of the "how not tos" and we decided we would rather not cash their checks, to be dishonest to our principles that we deal with corporately.

I think that one little bit of advice that I would give to them is to perhaps admit things were not handled well in the past. If they can get over that hurdle, which is out there, whether or not you want to jump over it or not, that is a perception that we didn't do things as well as we might have in the past. However, we have learned from that and here is what we have done to correct it, one, two, three, four, and come up with some solid, measurable, visible measures of something you can measure that is a commitment by the industry to right some of the wrongs of the past and to change their procedures on the basis of past problems. Then you form a public relations plan basically around that core.

DR. BURKE: I would like to add a little bit of public health to the public relations. Success depends upon that being founded on public health. This is a public health issue we are talking about with illnesses. You have, in effect, corporate profits and issues like that when you have a crisis, but really the fundamental issue is how do you protect people, how you prevent these kinds of things from happening, so you don't have this concern about illness and risk.

I think it is very important to package the message. I think it is very important to understand the informational arena that you are entering into, but the fundamental basis for credibility is that you are doing the right thing to protect the population. That shouldn't be lost in the message.

Very often it is, I think. You can watch an awful lot of news stories, particularly about federal facilities and agency decisions and if you analyze them and think, well, was there really any scientific information conveyed in this news story? In the quest for sound bytes, we have forgotten the basic point of the public health message. So, I would just urge that -- I don't think it is impossible to merge the two. I just say we haven't done a very good of that.

I know from my experience it is possible.

DR. DAN: Let me just add that as has been said many years ago, sunlight is the best antiseptic. In a problem like this, I would admit that the people who are trying to find out the problem are as interested about it as the people who have been affected by it. I would probably pick a credible spokesperson to lead the charge of finding out exactly what happened, when it happened and who has been effected and what we are going to do about it.

If I had to make a suggestion right now, it is probably the ideal person who would be believed to be the most credible person in this country right now to look into this problem, I suspect, it will be Colin Powell, who probably has all the attributes. The public would believe in him, thinks that he is connected to the problem in such a way that he would find out the truth.

Now, whether it is he or someone else, there has to be someone in which the public has ultimate confidence in that they are getting an honest, straight story from a person who cares and cares about them. That applies to this problem as with any other problem.

DR. LASHOF: Very interesting suggestion.

MAJOR CROSS: Mr. Doble, do you agree with that assessment?

MR. DOBLE: Well, I think certainly in terms of polling data, I don't think there are many people, maybe Walter Cronkite or someone, who is more trusted than General Powell. I think he would fit the bill of someone who would be a credible source, although he was involved. The only down side of that is that he was directly in the decision-making chain for all the activities of that period. So, I mean, that -- and I certainly have no reason to believe that he is hiding it, would hide anything, but I am just saying that that -- there might be a perception there, regardless of his high standing, that you may want somebody more independent. I don't know.

DR. LASHOF: Do you want to respond to that?

DR. BURKE: We talked about getting Marcus Welby to go to the Jersey short, too, because people trusted him.

I didn't show my last slide. I just want to show you that even if you are a nobody in public health, if you do the right thing, you don't have to be a Colin Powell. In fact, I would venture that Colin Powell's political career would be over if he took this on because we don't have the answers. He probably knows that.

So, it is more than the messenger. The messenger is important, but the message has to be credible regardless of who you put up there.

So, anyhow, it took three years and maybe these headlines weren't quite as dramatic, but after the good epidemiology, after focusing on all the concerns of the medical community in New Jersey and the tourists and studying 10,000 beach-goers and doing the right science, we got the right kind of editorials. We were able to quantify the risks. The science crafted a new message. It is not an issue anymore. Right? In the height of a crisis, sometimes you forget that the fundamental issue is the public health science. And I would much rather have had Marcus Welby go down there in the height of a political campaign and everything else, deliver some kind of message, but the fact was we didn't have the message then because we didn't know.

Once you know, even humble physicians and public health practitioners can be credible.

DR. LASHOF: I think this is a very good point. Let me ask you to further elaborate on what you did during that period of time when you didn't have the answers because that clearly is what the VA and the Pentagon face today. Our committee was really asked to look at is the government doing everything it should be doing to get the answers and is it doing everything it should to communicate where it stands and so forth. It is not our charge to necessarily -- well, I know it is not our charge to find the answer. It wouldn't be possible nor necessarily to do the total communication scenario, but to make the recommendations to the agencies that do have to carry on.

We are a short-lived commission that -- advisory committee, that goes out of business when we submit our report in December. But we do have to make strong recommendations to the agencies.

A couple of questions I would have and to sort of follow up on the questions you have been answering is with a perception of lack of credibility that now exists around this because -- well, for many reasons and we won't go -- it is probably impossible to analyze them all, but certainly among them are media's desire to respond to human interest stories.

Frankly, I have been disturbed as we have had these committee hearings, that the group this morning excepted, that we usually have a great deal of the media come for the public comment period and the vast majority leave when we go on into the scientific discourse on all of the issues.

So, comments in response to any of that would be helpful. You have worked with the Pentagon and DOD has itself in a crisis situation in a way. It is one that has built over time and may not be helped by some of our criticisms, which we will make. Where do they go from here on this, and VA, and how do you weather this period of uncertainty, where the most you can say scientifically is, well, there are a lot of studies going on. We will be getting answers. We don't have those answers now.

MR. DOBLE: I can only offer a personal opinion about the -- you know, I think Dr. Joseph and General Blank are pretty credible spokespeople. At least my impression and those of the people I talk with is they presented themselves as good as you were going to get. I mean, they laid out, I think, in a very credible way what was known at the time. Again, I don't know, having not been in the rooms where all this was discussed, not being privy to the information that they had, you know, I don't know what all the factors are that impacted on their communications, other than to have dealt with both men and have a great deal of respect for each one of them.

The other observation I would make in a blinding flash of the obvious, but this is Washington and there are many pressures brought to bear on the communications of people speaking for government agencies. I would not be foolish enough to jump off that cliff and start describing all those, but I would just say that there are a lot of factors bearing on their communications and I think where they go from here is -- I don't know, as has been observed

-- are they the right -- is that the right agency? I don't know, to continue to do this. Should there be some independent organization, which carries this work forward, because as I observed in my talk, the normal, business as usual apparatus of any organization, DOD or General Motors or whatever, is not really geared for this kind of crisis, which is -- this is one that goes on and on and partly out of the control of the agency. I mean, this is something which has mystified the experts. It is not going to go away and it is not going to be easily explained in a sound byte anytime soon.

So, perhaps there is another -- there may be some other organization, which should pick up the ball on this and move forward.

DR. DAN: Let me agree that I think in this case a new broom does sweep clean. You, unfortunately, have an agency that has been saddled with memorandum that popped out of files and studies that certainly come to fore that no one knew before, previous denials, which are now denied. I think in this particular instance they have lost their credibility with the audience they are trying to get their message across to.

But I think the public is very tolerant of their uncertainty when they really believe there is an honest, credible, working effort to find out the answer. I think they would put up for that a long time if they knew that it was an honest attempt to find out what the problem was. It is the lack of credibility that is going to hurt the DOD even if they find the answer.

DR. BURKE: I would just like to comment that I think the Department of Defense is doing a lot now in retrospect and they had done a lot before deployment in the Gulf as well. But it is a steep learning curve and we are trying to climb up that, but I think the efforts of the Department to really understand pre-deployment risks were evidenced, I think, in Bosnia when environmental assessments were done prior to troops being deployed there and trying to anticipate these kinds of things.

Now, that wasn't necessarily the heat of combat that the Gulf presented, but the fundamental mission of defense is to defend and that is a problem. You know, should the Department of Energy, whose fundamental mission was to make nuclear weapons, clean up the environment? That is a tough one, too. We face that in a number of agencies. Unfortunately, I think, some of the best expertise on these kinds of issues resides with the military and we have to trust them and do what we can in partnership mode to raise the credibility of the military because they can be tremendously good at preventing harm to their troops.

But we have to improve their credibility, hopefully, by a more transparent process. I wouldn't say throw out the baby with the bath water. The experiences that we have learned in military operations are invaluable. Those folks should be involved, but at the same time, the initiation of prevention that I have seen since the Gulf War is important.

What we did in the intervening years before the epidemiology at the Jersey shore was prevention, the kinds of things that would reduce and eliminate exposure were immediately initiated as we tried to understand the mechanisms of disease.

DR. CAPLAN: I have three questions actually directed to anyone who cares to answer them.

The first is to your knowledge does the Pentagon, Department of Defense, have the equivalent of the code of ethics about communication that you were talking about that some of the private agencies should have? Could we hold them to that test? Is that something that they ought to refine and develop down the road?

Second question in the spirit of hypotheticals, if you saw information coming out hypothetically about chemical weapons being discovered at a dump that were clearly marked and allowed to be blown up by troops and hypothetically you thought maybe that wasn't so, would you expect quick responses back from appropriate military, civilian officials or would you let that go until the story had been clearly established as to what exactly took place?

In other words, would you counter punch quickly if you thought something was falsely said in the media, hypothetically, recently about some of the events that took place in the destruction of weapons or would you wait until you had all the facts straight?

Lastly, I would be interested in your thoughts about what you would do to set up ongoing supervision? Hypothetically, this committee might have a lot of respect as a group trying to stumble around and find out what did go on and lent some trust or credibility to telling the story of Gulf War illnesses, but it is going to go out of business in December and, therefore, the external oversight seems to me to disappear at that point and what can be done structurally? Do we need to have some watchdog agency in place on the health department or the defense department equivalent at all times or is that just one more layer of bureaucracy and you can't do much about that except periodically have a committee or commission take a look-see?

There are three questions lying but we will let the first one -- is there an ethos of corporate --

MR. DOBLE: Well, I think it is the ten principles of communication, I believe it is. I think that is what it is, the first of which being maximum disclosure with a minimum delay. I mean, that is one of the big principles. You can get this. I mean, I don't have a copy with me here, but the Pentagon can flag you those principles of communication, which are very good and that is sort of a good blueprint for the communications process.

The second question was on the -- if I observed the destruction of weapons and all this, I, again, not having been in those -- wearing those boots, so to speak, I would still take a proactive rather than reactive approach to it and if I were in the apparatus -- because you have to deal with this quickly because if you don't tell the truth and tell it fast, as Norm Augustine would tell you, that you have what grows up between that report and then you are eventually being dragged into it in a reactive way is all this erroneous reporting in the middle, which I would try to avoid if I were in those shoes.

So, the faster you get into the news mix, the better you are because they will fill -- the reporters will find someone to fill that gap. As I have observed, they are not necessarily going to be taking your point of view.

In terms of how to carry this forward as an external apparatus, I mean there is probably an established interagency working group kind of structure, which is done all the time in government, which might be appropriate in this case or some hybrid of that and some kind of an independent commission, but -- and I am trying to think of how to say this without getting fired or something here, but you have to keep it independent enough to be insulated a little bit from the political winds, but you cannot disengage yourself from that totally or you have lost a whole bunch of communication and resources.

So, I mean, this is a real big balancing act and I don't envy you the task of making a recommendation on this.

DR. BURKE: I thought the code was loose lips sink ships. I have to admit in my familiarity with the military there is this tremendous balance, informational balance that they have to achieve and we certainly don't want to give our adversaries an advantage in the interest of public health or national defense. How do you balance this? This is really tough. And there that difficult process of dissecting the mission, the fundamental mission from the public health mission is so important.

I think in the national interest, there is reason for secrecy in warfare. It has been very effective and we have to balance that. There are people who are expert at that, but they haven't had any kind of public health orientation. I have been to meetings in the wake of the Gulf War where it is really the first time a public health person was ever really invited to the table to be part of the defense strategy.

I think we have to involve the public health community a little bit more in that and at the same time respect the need for a different approach to information because it is in the national interest.

DR. MC DANIELS: With an emotionally-charged issue like birth defects or exposure to chemical weapons, are there specific techniques that can be used to diffuse the emotion and present memorable scientific evidence, along with the emotional images and sound bytes that you get in the media?

DR. BURKE: I can tell you some don'ts. When you are meeting with the parents of a sick child, of a deformed baby, epidemiology goes out the window. Statistical significance means nothing and we continue to make that mistake by trying to use population information, population inference, even sometimes, toxicological risk assessment to try and tell people about probabilities.

When you are dealing on the individual level with a public interest story with an individual patient, that is out the window and you have to acknowledge the specific needs, the emotional burden of those people regardless of the cause. And there are things that you can do, I think, to avoid those mistakes but to get into defensive mode about probability, to try and argue causality when we don't know, is in vain.

So, to attack some of the very emotional public interest stories, I think, is the wrong way to go. In the long run, it takes apart your credibility and I think my own experience where I have had environmental activists, who had family members die from lung cancer, blame air pollution when the guy smoked three packs a day, given the right kind of trust building, you can get through that. You can explain the risk factors for that public health outcome and you can also express your uncertainty about causality. But in the heat of the moment, don't take on that approach. It is only through trust that you can get there.

DR. DAN: Tommy LaSorda once said that you should never argue with people who buy ink by the barrel. If you are going to play that media game, you are playing on their home court. The media, reporters, journalists know how to get the maximum impact out of a story. They spend their professional careers learning how to do that.

They are going to get the best video of a child who has a problem or someone else who has a problem. You are not going to be able to fight that. Michael Deaver learned very early on that video overwhelms text. He is perfectly happy to have reporters saying things about Ronald Reagan as long as the President was standing in front of an American flag. They are basically going to paint an American flag up there. They are going to have a video image that is compelling, moving, emotionally moving and no sort of scientific text that you can come up with can compete with that.

DR. BURKE: New Jersey recently made the national news because of three children having brain cancer in a neighborhood around a chemical plant and it is now in the middle of a Senate campaign and everyone jumped on that story. I am an adviser to the -- a scientific adviser to the state on that issue.

The unfortunate approach was to present epidemiologic data, a ratio of incidences to say what would be expected and whether or not this was an unusual event from an epidemiological perspective. That is wrong. You are never going to get the scientific explanation to that in that emotional arena right now. What is needed is a way to attend to the needs of those families, understand what is going on there and do the best you can to assure people that the exposures that may lead to that disease are prevented.

But it is a hornet's nest. It is the same kind of thing -- it happens in communities all throughout the country and unfortunately without, I think, the kind of knowledge on dealing with the media and presenting the science effectively to the media in an understandable way. We continue to kind of reinvent the wheel on that, but case after case you see it happen.

DR. LASHOF: If you could go over the story -- the current situation you are in with the cancer site. Okay. You can't put forward the statistical data. What do you do or what goes on in the political campaign to diffuse or --

DR. BURKE: What goes on in the political campaign and what goes on in trying to do good public health are, unfortunately, very often two different things. What goes on in the political arena is pointing fingers. The health department knew about this. We knew that the Environmental Protection Agency knew this was a Superfund site and there was ground water contamination. Those kinds of things are all too familiar to this committee because the same kind of accusations --

Will we ever be able to link those childhood cancers to a specific exposure? No, not in my lifetime. Can the parents of those children understand that? Yes. We have all had to deal with chronic illnesses, with the loss of loved ones due to cancer, which is now a very common disease. And with the right kind of trust, usually with a personal physician, people come to grips with the risks that they have taken and the disease that befalls them. It shouldn't happen on the front page. It shouldn't happen as part of a political event, but it does.

But in the meantime, I think, there are basic epidemiologic principles of getting the best experts in there, trying to eliminate exposures and doing what you can to learn from that to go forward. It is never going to erase the scar to the agencies and the accusations, but eventually just like I pointed out -- it may take three years. You can satisfy the majority of the people involved and interested that you have done the right thing. You can't do it quickly.

DR. LARSON: Let's just carry that one step further with that example of the brain cancer. There are three possible scenarios. One is that you have a very high level of security that it is unlikely to be caused from x exposure. Your example, for example, of the lung cancer with someone who smoked three packs a day is unlikely to be from air pollution.

Another is you are not sure and you will never know. And another is you are sure or you are pretty sure there is a high level of probability that there was something. Is your response different given those three scenarios?

DR. BURKE: Well, since the mid-seventies, I was the chief investigator for a number of cancer clusters throughout New Jersey from a very famous case in Rutherford, New Jersey with five kids in the same school having leukemia, to the Toms River issue, which in the mid-eighties I was aware of a blip in cancer incidence there, which was not statistically significant, but given the concern from that particular site for that community, I recommended that certain preventive measures be undertaken.

My sense is reassurance to the general community that they are not living with a risk is a first step as you then deal with those individual cases.

Do I have a gut feeling that the environment plays a role in disease? Yes. But I also understand the genetic, the behavioral influences on risk, particularly of chronic disease and that has to be packaged as part of your plan. Will we ever know? I hope so. But I have never solved the cluster.

DR. LARSON: Well, that answers the question for scenario B, which is when you are not sure. What about if you are pretty sure there wasn't any risk? Let's go through that --

DR. BURKE: I have been at occupational centers where they are pretty sure.


DR. BURKE: Dye workers in New Jersey. Usually in the occupational setting. There you have high exposures. There you have solid epidemiology and there you have clear preventive measures. That has been the model for the epidemiology of environment. But when the exposures get more complex and it is multifactorial, it is not all that easy. Does that stop prevention? No.

And I think environmental regulation to reduce exposures has been the prudent way to do that.

DR. BALDESCHWIELER: Another confounding factor, of course, is that often these arguments go to the courts and there is an active attempt to find a target of litigation. How does one communicate under those circumstances? Is preemptive surrender the right approach? But, clearly, juries are influenced by exactly the same factors as the more general public.

DR. DAN: Certainly they are influenced by the emotional content and, as you well know, the legal system is very different in that it is easier to reward somebody or compensate them for a problem than to really search out whether there was a cause and effect, a relationship. So, I think it is a separate kettle of fish and I don't think there is any way to deal with that in a logical sense.

DR. BALDESCHWIELER: I mean, it is sort of like the Agent Orange controversy that didn't end up in the courts and I think preemptive surrender was the route taken after several years of litigation.

Is that a model that you would advise?

DR. BURKE: No. As an academic expert who does not do expert witnessing, science in the courts is a tough place to get good credible science and peer review. The stakes are high, emotions are high and the definition of causality that I teach in epidemiology classes is not relevant very often when evaluating the emotional impact or the potential for harm in litigation.

I think litigation has been very important in providing the motivation for prevention in the corporate world with worker protection and environmental protection. But at the same time, it is a hornet's nest of bad science and emotional definitions of causality. So, I would hope that wouldn't be a role model.

Right now, we do see a lot of preemptive surrender based upon the inability from an epidemiological perspective to really prove or disprove. Disproving causality is impossible and really impossible with the right lawyers attacking you.

DR. BALDESCHWIELER: For example, in your cancer cluster cases, if there happens to be a hapless chemical company that 20 years ago had discharged into the stream, but ceased doing that long ago, if they become a target --

DR. BURKE: Well, we have certainly seen that in Woburn, Massachusetts, where there was a major settlement for children who were ill because of the contamination of the environment. And there are individual cases where there is an increasing trend toward settlement, but they are individual.

I think it bodes well for all of us to understand the importance of public health science and getting to the root of exposure and understanding the epidemiology above and beyond the communication hassles and everything else because understanding the risk factors that lead to disease, when we know the risk factors -- and there are a lot of models from the world of infectious disease, where we can identify the agent. We can clarify what caused the disease and we can eliminate the cause. There is no questions asked about that.

We are still just beginning to understand that in terms of chemical exposures. But when we do have that good science, I think a lot of these issues go away. So, in the meantime, I think, we have this dilemma. The question is do we give the right kind of public health emphasis on understanding these exposures and preventing them right now? I say "no." We are still learning.

DR. NISHIMI: Dr. Burke, you talked about the need for timely release of data in informing the public, but sometimes it seems to me that this can be sort of at odds with the scientist's desires and needs to have his or her research published in a peer reviewed fashion.

So, do you have any general guidelines on how this should be handled, given that the peer review process can sometimes take a year and get bogged down and in the meantime how might an organization use that data without running into the other problem?

DR. BURKE: I don't think this is as much of a problem as sometimes it is made out to be. I am involved now in research that is being published that I am not too concerned about, where I have community members formulating the research questions with me. Hopefully, they will be co-authors. There are ways to do that. There are ways to work with agencies to share information where that is understood.

There is also, I think, a mechanism to convey preliminary information to the press to have a transparent process to build trust that doesn't necessarily undermine the, quote, secrecy of scientific publication. I understand the sensitivity. I mean, that is the bread and butter of academics, but I think that is changing.

DR. DAN: Let me support that as a formal medical journal editor. All major medical journals have a policy that for important public health reports, they will allow the release of full information without jeopardizing beer review and publication later on.

DR. LASHOF: Thank you very much. It has been a very interesting session and we appreciate your time and effort and we may call you for more advice before we finish up.

Before we adjourn for lunch, it turns out that there is an individual, who did arrive for public comment just after we began. He actually flew in from Texas and was late. So, we are going to let him make his statement now. Then we will be breaking for lunch and we will come back afterwards at 1:45.

But if Mr. Sylvester wants to come forward -- as I understand it, someone else was supposed to appear and then couldn't and then at the last minute you came and got here. So, we -- you know the ground rules. You have been here before. Five minutes to summarize your remarks. You can submit anything you would like for the record and we will have five minutes for questions and then we will break for lunch.

MR. SYLVESTER: Thank you. Madame Chair and members of the Committee, I appreciate you and thank you for allowing me to speak.

First of all, as you come close to the conclusion of your charter, may I say on behalf of my organization, although we may not agree with many things that you say, we do appreciate what you are trying to do and the massive effort that you have put in towards the Gulf War illnesses.

For myself and the members of my organization, at least, I would like to say thank you.

We have submitted the written testimony and there are copies that have been given. So, I am just going to hit a couple of highlights, so I can get through this for you.

As I just heard from your distinguished presenters just previously here, I also am a member of the -- ex-member of the U.S. Military Public Affairs Program. I was acting command information officer for the 101st Airborne Division in 1994, during the histoplasmosis scare down there. I was also acting public affairs officer in Korea in 1975 during the Paul Bunyan incident, when the two officers were beheaded by the North Koreans.

I also worked for the U.S. Army Research and Development Command as their exhibit NCOIC. So, I am quite familiar.

On the question that one of the panel members asked about the military guidelines, I would suggest the Committee contact the Defense Information School for the guidelines that the military public affairs officers are given to respond to crisis programs. It is documented. It is there. All you have to do is call them.

As far as the Desert Storm community, if you want to reach the Desert Storm community, the best ones to talk to are the Desert Storm community. When we look for information, we go to what is available to us. We may not have the scientific information. This is our bible. When people say that there is no smoke and the National Geographic says there is smoke and it reached all the way down into Oman, we think that maybe the exposures that were exposed in that smoke and that bomb, maybe it went down there. That is just a quick thought.

The major issue, as far as our organization is concerned, Madame Chairman and members of the Committee, is not one of bureaucratic misinformation, veteran suffering or national product. It is one of national security and government trust. Based on the first hand experience revelations of the Gulf War illness issues that have been reviewed, it is our opinion that this nation is in a disastrous position if there were ever a major biological, chemical warfare terrorist attack on the shores of the continental United States.

There is a serious question in our opinion as to whether the DOD has the true capabilities to operate and survive in a chemical, biological warfare environment. There is a serious question in our mind as to whether the DOD medical community has the true capabilities to provide effective mass casualty medical support just for the active duty and DOD community.

There is no doubt in our collective minds that there is no apparent effective, broad-based civilian medical community expertise that is fully trained or in most regions even familiar with chemical, biological warfare of our environmental hazard exposure.

I visited with a number of our physicians in the Permian Basin, the center of the oil fields in Texas, over the weekend. I asked 90 percent of the medical and emergency medical technicians and medical professionals in our community if there was a siren, nerve agent or chemical warfare attack in the Permian Basin did they know what to do? We had two that said "yes." And that was because they were reserve chemical officers in the reserve unit. That is it.

It is also in our opinion that there is no definitive civilian ethical or legal control system outside of government control and in the military medical community that oversees military government experimental, investigational, medical or environmental practices and procedures.

Taking into consideration all of the aspects, the Operation Desert Shield/Desert Storm Association recommends the following initiatives for consideration: the present and future military veterans community and their families cannot be allowed to continue to suffer continued trepidation as they have with the Gulf War syndrome, Agent Orange, mustard gas and radiation exposures. The civilian medical community who have to treat the members of the military community, their families, on a private basis cannot be denied the medical information it needs to treat the pain and suffering of those victims as has happened over the last five years.

The nation's emergency medical community must be fully trained and prepared to act immediately to respond to any terrorist chemical, biological attack on the shores of this nation. We, therefore, recommend in conjunction with the investigational drug programs that the United States legislative bodies pass legislation that mandates by law that DOD, not VA, provide continued, with non-discretionary budget funding, lifelong medical care and medical support for all military personnel and their families to second generation levels, who are required, ordered or recruited to participate voluntarily or involuntary in any experimental drug or investigational drug program.

It is our belief that if DOD forces somebody to participate in this program, then they should take care of the troops. If the troops don't have an option, the DOD should take care of it, not the taxpayers.

We also believe that what we need to do in this program -- we don't say we want all this stuff without at least a quick thought of maybe a solution for consideration. Coming into the fact that we have the problems with the various civilian medical emergency personnel and medical professionals that don't know how to handle all of this and have to deal with these families after they have come out of the service, after they have been released and will have to handle medical emergencies in the case of a terrorist attack -- and we have had it in the news here over the last year, where members of certain groups have been found and arrested with chemical and biological warfare materials in their home, besides bomb-making materials.

Our solution for consideration will be to assign one of the military bases slotted for closing with appropriate housing, family and individual barrack environments with the medical and research support facilities and a rehabilitation environment for a five-year test program, with appropriate dedicated, non-discretionary budget funding. This program would explore the realms of both community and military chemical, biological and medical research support and rehabilitation training of hazardous warfare and military conventional warfare environmental victims and their families, provide hands-on training for the civilian emergency medical community, training for both military and civilian medical professionals, who have to provide long and short term care for the victims and also training for the government administrative entities, who would have to design the government guidelines and regulations for such programs.

Military or veteran personnel suffering from possible chemical, biological radiation environmental hazard exposures or undiagnosed illnesses could be assigned to this facility under government support and control until a complete diagnosis, course of treatment and a rehabilitation program has been completed.

Members of both the military, civilian and emergency medical communities and the civilian medical practitioner community could be afforded the opportunity for hands-on training and participation in medical research to the victims, placing them in a position of preparedness in the case of a terrorist attack on the population of this nation.

The retraining and development of new independent living skills for chemical, biological warfare environmental hazard victims and their families would after a period of time return these victims and their families to the community as viable contributing members of their economic communities.

The vision of freedom for the veterans of this nation has become endangered. It is as close to us, as important to us as the air we breathe. Freedom is in our homes, in our schools, in our churches. It is in our work, in our government and the right to vote as we please and the motivation behind many of the sacrifices of life and limb has been made by so many in its name.

Because our liberty and freedom is in danger, the Desert Shield/Desert Storm community has and will continue to be united in their defense. Let no government bureaucratic agency or foreign aggressor think we are divided. Our great strength is in the loyalty, love and fellowship of the free people and those who laid their lives on the line to preserve it, a family, a veteran's family.

Thank you.

DR. LASHOF: Thank you very much, Mr. Sylvester.

Are there questions anyone has for --

MR. SYLVESTER: The secret behind the communication skills of the Desert Storm community as has been evident over the last five years, is family. We pick the phone up and we talk to each other. I am serious. Ma'am, if you called us and you said you were sick, we would throw you a line. We would tell you to tie it around your waist and the other line is in our hand. If you need us at 4 o'clock in the morning, we are there. The DOD is closed at 5:00 in the evening. The VA is closed at 5:00 in the evening.

I apologize for a number of people that were not here today. They are in Junction City, Tennessee, burying a 25 year old Desert Storm veteran, who died on Saturday. They send their apologies, but they, too, appreciate what you are doing.

Thank you.

DR. LASHOF: Thank you very much. We appreciate your coming and we appreciate your comments.

With that, we will adjourn for lunch and we will resume at 1:45.

[Whereupon, at 12:25 p.m., the meeting was recessed, to reconvene at 1:45 p.m., the same afternoon, Wednesday, September 4, 1996.]

A F T E R N O O N S E S S I O N (1:55 p.m.)

DR. LASHOF: I would like to resume.

Agenda Item: Staff Briefing and Committee Discussion: Reproductive Health

I think we will begin this afternoon and work through some staff memos and the first one is on reproductive health outcomes. Holly Gwin and Kathi Hanna of our staff will be presenting. Who is kicking it off? Kathi, you?

DR. HANNA: Good afternoon.

In the years following the end of the Gulf War, media reports have appeared that assert increased rates of birth defects in children born to Gulf War veterans. An apparent cluster of birth defects and health problems in children was reported in National Guard units in Jackson, Mississippi.

Nationally, the popular press has featured stories of veterans' families and children with birth defects. The government has responded with a series of investigations into the prevalence of birth defects among children of Gulf War veterans, as well as the prevalence of other adverse reproductive outcomes, such as infertility, pregnancy loss, prematurity and stillbirth.

Could I have the first overhead, please.

To evaluate potential associations between Gulf War service and adverse reproductive outcomes, the following tasks were undertaken: first, an appraisal of the biological plausibility of such an association; second, an assessment of government studies in this area and, third, an evaluation of government services that are relevant to addressing the reproductive, health-related medical needs and concerns of veterans.

I will not be discussing the issue of potential Gulf War risk factors in reproductive health, as this analysis was presented and discussed in the context of the risk factor memos, which were reviewed by the Committee in Chicago.

I will conclude with staff suggestions for Committee findings and recommendations.

Perhaps the most critical consideration in determining if there is an association between birth defects, adverse reproductive outcomes in Gulf War service is biological plausibility. Many things can go wrong in a pregnancy and many scientists posit that it is miraculous that most often children are born healthy.

Major birth defects are diagnosed in 3 to 4 percent of infants in the first year of life. Birth defects are the leading cause of infant mortality in the United States, accounting for more than 21 percent of all infant deaths. The cause of birth defects in general can be determined in just over half of all cases.

Genetic causes, which are chromosomal abnormalities, single mutant genes and familial inheritance account for roughly 28 percent of birth defects. Multifactorial inheritance, which is the combination of genes and the environment, account for another 23 percent. Exposure to teratogens, which are environmental agents that adversely effect the fetus in utero, account for 3 percent of all birth defects.

In the vast majority of cases, birth defects occur in families where there is no history of the disorder. In addition, more than 1 in 8 couples in the United States is classified as infertile. Approximately 20 percent of pregnancies end in spontaneous abortion or miscarriage between the 4th and 28th week of pregnancy. And as many as 50 percent of conceptuses are lost in the first four weeks of the pregnancy, often without the woman ever knowing she was pregnant.

Staff reviewed the literature on biological factors related to reproductive and developmental toxicity, as well as interviewed numerous experts in the field. If, as in the case of Gulf War veterans, an environmental exposure is suspected as the cause of a birth defect, association between exposure and outcome alone is rarely sufficient to establish etiology. There must be a valid, even if hypothetical, explanation consistent with what is known about reproductive biology, to determine that a particular agent or agents could have acted biologically to produce a particular effect.

Over the past 30 years, a significant amount of data has been collected on the reproductive risks of exposing pregnant women to infectious agents, drugs, chemicals and physical environmental agents, such as ionizing radiation or heat. The dangers to children of maternal exposure during pregnancy, a process called teratogenesis, is well-established.

It is likely that some teratogens were present in the Kuwaiti theater of operation. For this and other reasons, pregnancy was cause for either non-deployment or evacuation. Pre-deployment pregnancy screening, however, was not always conducted.

According to a published review of 300 health care visits by women at the 8th Evacuation Unit in Saudi Arabia, pregnancy was a significant cause of medical evacuation. From the records available for this review, there was insufficient information to determine the number of pregnancies conceived prior to deployment.

Anecdotal evidence available to staff, however, did not reveal any birth defects resulting from Gulf-exposed fetuses.

It is important in reviewing biological plausibility to recognize the difference between teratogens, which affect the developing fetus in utero, and mutagens, which are agents that permanently alter ova or sperm. There is a handout in your briefing book that goes into more detail on this.

Ovarian toxicity in humans has been less well-studied than spermatogenic damage because of the relative inaccessibility of the female germ cell. However, ovarian exposure to toxins can disrupt the ovarian cycle and damage the oocyte, resulting in potential infertility or birth defects. Because females receive a fixed amount of oocytes before birth, chronic or long term exposures to ovarian toxicants can have a cumulative and permanent effect on the health and viability of ova.

In the male, however, certain characteristics of reproductive biology holds special significance in determining susceptibility to occupational and environmental toxins minimizing the probability that birth defects result from male exposures.

Males manufacture millions of sperm daily in a cyclical, constantly renewing process of cell division. As long as toxic insult spares the primitive stem cell pool, damage to the sperm pool is likely to be reversible. The adverse effects of most toxicants are likely to dissipate in 90 days, which is the time required for complete turnover of sperm, after the exposure ends.

If conception were attempted within that 90 day period and the exposure had a mutagenic effect, infertility or pregnancy loss would be the most likely outcomes. Either the sperm would be too damaged by the mutagen to fertilize the egg or the sperm would contribute to the creation of an embryo that carried too many mutations to survive beyond a few days.

Pregnancies attempted or achieved within 90 days of a veteran's return home could be affected through this mechanism. In most cases, potentially damaging reproductive-related exposures to males are transient and adverse effects cease once exposure has ended. In a few documented exposures, such as cancer patients exposed to high does of radiation and chemotherapy, sterility can be permanent because of damage to the stem cell pool.

Male exposures that persist through conception and pregnancy, however, such as those reported in certain occupational settings, could potentially have a teratogenic effect on the developing fetus, either by transfer via the semen during intercourse or by exposure of the pregnant woman to the toxic agent via the clothing of the male.

However, exposures unique to the Gulf War environment were highly unlikely to have affected children via this mechanism. Thus, the mechanisms of male reproductive biology make it unlikely that acute exposures to environmental agents in Southwest Asia would present adverse reproductive outcomes beyond 90 days of exposure.

Under the circumstances surrounding possible exposures to males in the Kuwaiti theater of operation, an increase in one type of birth defect beyond 90 days is biologically implausible. If there were demonstrable effects resulting from conception within that 90 day period, infertility or reduced fecundity or ability to get pregnant are the most expected outcomes.

Finally, data available concerning the types and levels of exposures that occurred during the Gulf War do not indicate the presence of potent mutagens. Furthermore, most reproductive toxins exert other more general health effects. If reproductive toxicants were present in the Gulf War theater of operations, one would expect to see an association between acute health effects in the exposed person and adverse outcomes in subsequent reproductive attempts by those individuals.

Studies of reproductive failures and, therefore, complicated by the following: Reproductive failures are common. They affect a substantial portion of the population and they have occurrence patterns that vary and are, therefore, not always predictable.

Reproductive problems include a variety of pathological conditions that may or may not be mechanistically related to each other. The known etiologies for reproductive problems include both genetic and environmental factors. And, finally, toxicologic research, which uses animal models, is less useful for reproductive hazard assessment of human outcomes.

In animal models, the primary measurable outcome of a known agent usually manifests as a birth defect; whereas, in humans, the outcome is usually infertility or early embryo loss.

In addition to establishing biological plausibility, epidemiologic studies are necessary to determine whether there is a connection between exposures experienced while in the Gulf and subsequent adverse reproductive outcomes. If such an association exists, two outcomes of studies would be expected.

First, a higher overall prevalence of adverse outcomes than would be expected in the normal population should be demonstrated. If approximately 200,000 children are born to Gulf War veterans, approximately 6 to 8 thousand congenital malformations would be expected based on general population risks.

Second, if an association exists, one might see an unusual cluster of a specific type of birth defect appearing across multiple independent studies. Should either of these results occur, investigators could then work backwards to evaluate whether there is some commonality among those who are affected.

Even with sophisticated epidemiological studies, however, caution must be exercised. Any study dealing with all birth defects invariably will find some birth defect occurring at an increased incidence; that is, a cluster in the study population. Researchers can assess and monitor approximately 60 major birth defects. In a properly designed protocol that encompasses an appropriately large sample size, one would expect that three birth defects would appear to be substantially increased, just by chance alone.

In other words, any single study of birth defects in children of any cohort is likely to reveal, based on chance alone, a cluster of defects unrelated to exposure. In fact, it has been argued that if a properly-designed study of birth defects generally does not result in a statistically significant cluster, this finding in and of itself would be particularly noteworthy.

Thus, before a cluster can be validated as linked to an exposure, additional investigations of similar but distinct populations must be conducted to determine whether the cluster is true. Only by surveying the total relevant population, which is usually prohibitive for practical and economic reasons, could one be absolutely certain of determining the true prevalence rate.

Well-designed scientifically valid epidemiologic studies comparing events among a random sample of Gulf War veterans to an appropriate group are required to determine whether an association exists between Gulf War service or experiences and the risk of adverse reproductive outcomes.

Two early surveys based on self-reporting suggested an association between Gulf War service and adverse reproductive outcomes, but they are unreliable because they depend on self-reported data.

A 1994 survey by VA reported a 3.6 percent birth defect rate among children of Gulf War veterans. Among the children with reported birth defects, the proportion of those conceived after Gulf War service was slightly higher than those conceived prior to deployment. This survey, however, was comprised of a self-selected population of individuals.

For the nearly 9,000 participants in DOD's comprehensive clinical evaluation program who responded to both pre and post-war reproductive outcomes questions, there were increases in self-reported infertility, miscarriages and birth defects.

Given the self-selected nature of the CCEP population, however, these data are questionable, as persons electing to participate in a clinical examination might not be representative of the general population. In addition, the questionnaire design is suspect with respect to determining meaningful reproductive health data and most of the reproductive questions were answered by males, when the information requested concerned female reproductive outcomes.

Several government-funded epidemiologic studies have been completed or are currently underway. These investigations will contribute to a greater understanding of the rates of adverse reproductive outcomes in the Gulf War population, but are unlikely to be definitive. As in any epidemiologic study, there are limitations to interpretation based on sample size, study design, accuracy and validity of data and comparability among experimental and control groups. Each study suffers from one or more of these limitations.

Taken together, however, this research could produce a weight of evidence on which conclusions can be drawn about reproductive outcomes among Gulf War veterans. And I will briefly describe these studies.

In 1993, the VA in Jackson, Mississippi and the Mississippi State Department of Health conducted a collaborative investigation of an apparent increase in birth defects and other health problems among children born to veterans of two Mississippi National Guard units. Medical records of all 55 children conceived by and born to veterans of the two units after deployment were reviewed.

The total number of all types of birth defects was not found to be greater than expected, but whether the number of specific birth defects was greater than expected could not be determined due to the very small sample size. The Naval Health Research Center in San Diego has sponsored three major epidemiologic studies of reproductive and birth outcomes. In 1994, DOD funded a record-based evaluation of the risk of birth defects in military service in the Gulf War. This protocol involves a historical cohort of all Gulf War veterans and a random sample of service members, who did not service in the theater.

More than 62,000 live births were identified for male service members and more than 12,000 live births for female service members. Researchers found that risks of birth defects, whether broadly or narrowly categorized, were not different among the deployed or non-deployed groups.

Another DOD project aims to determine whether Gulf War veterans are experiencing partial or total infertility at rates greater than would be expected, as well as other reproductive outcomes.

Four categories of a total of 16,000 couples will be compared for different reproductive experiences. The survey, which is still underway, has been plagued by a low response rate. Some data will be available in the fall of this year.

A third study, which is also known as Study No. 7, has been designed to determine if the prevalence and types of major congenital anomalies among children born between January 1989 and December 1993 differ among Gulf War veterans, non-deployed military personnel and civilians and among active duty and separated veterans and, finally, among pre and post-deployment conceptions.

This study has considerable advantages over previous studies, assessing the reproductive health of Gulf War veterans. It relies on active surveillance data from birth through one year of age. Data are abstracted from a wide array of sources and this research provides a more complete ascertainment or classification system of the birth defects.

A substudy of this investigation involves evaluation of the prevalence of Goldenhar's syndrome, a combination of birth defects of the ears, jaw, eyes and spine among children born or hospitalized in DOD medical treatment facilities. Anecdotal media reports posit an excess of Goldenhar's syndrome among children born to military personnel deployed to the Gulf.

In this study, investigators are analyzing medical records of suspected Goldenhar's cases, blinded to the Gulf War status of the child's parents. To date, the rate of cases of Goldenhar's among Gulf War veterans and non-deployed veterans is not statistically significant, although the study is bounded by a small sample size.

One problem that plagues all birth defects surveillance projects is the accuracy of records. Vital records, birth certificates and hospital discharge summary data are used according to availability and cost. An issue of concern to epidemiologists studying military populations is whether the data provided through military health care is comparable to that collected in civilian populations. Thus, studies that rely on data purely from military sources often lack an appropriate control.

One longstanding approach to studying birth defects are birth defects surveillance programs, such as those operated and coordinated by the Centers for Disease Control and Prevention. In addition to being used to search for increases in the incidence of specific malformations, surveillance systems can be used to develop baseline data, provide timely rates, identify geographic areas of concern for cluster investigations and provide the basis for ecologic investigations. No such baseline data collection system specific to the reproductive health of military personnel currently exists.

I would like to turn briefly to activities of the VA. In April of 1996, VA established the examination program for spouses and children of Persian Gulf veterans to fulfill a legislative mandate. Under this authority, VA may provide examinations to any individual, who is the spouse or child of a veteran as listed in the Persian Gulf War Veterans Registry, and is suffering from illness or disorders, including a birth defect, that cannot be disassociated from the veteran's service in the Southwest Asia theater of operations.

The program funded at $2 million is open to the first 4,500 individuals who call VA's Help Line and it expires September 30th of this year. Exams are provided by university-affiliated physicians at contractor sites. The program does not pay for travel or reimburse for incurred expenses.

Following the exam, a letter with the results and any recommended medical follow-up is sent to each participant. The letter includes a statement that VA is not responsible for any medical follow-up or treatment of conditions diagnosed by medical examination. VA lacks the authority to provide benefits or services on the basis of adverse health effects in children, which are shown to result from their parents' service experience.

VA reports it is evaluating whether current scientific data warrant the change in the law. In May 1996, VA solicited applications to establish a research center for epidemiologic, clinical and basic science studies of environmental hazards and their effects on reproductive and developmental outcomes.

The third area reviewed by staff is the medical care and genetic counseling available to veterans and their families. In the military health care system, a comprehensive range of services from primary to tertiary care are available to couples experiencing infertility, women in high risk pregnancies or infants with a birth defect.

If the direct care system cannot provide services, then services can be sought under CHAMPUS or Tri-Care. Beneficiaries, who experience fertility problems, can use their benefits to obtain a variety of reproductive health services, including infertility testing and treatment. During pregnancies, genetic counseling and prenatal testing may also be covered when appropriate.

The determination of medical necessity for prenatal testing is made on a case-by-case basis, as it is in the civilian sector. A child with special health needs receives a full range of medical and related health care benefits to the full extent of his or her disability.

The situation with respect to medical care and counseling for individuals no longer on active duty stands in stark contrast to coverage for active duty service members. Currently, VA lacks the authority to provide benefits or services on the basis of adverse health effects in children even if the effects are shown to result from their parents' service experience.

Even evaluation and treatment for infertility of veterans is limited to a small number of situations in which the cause of the infertility could have been detected and treated while on active duty; for example, diabetes in women or service-related spinal cord injury in men.

In general, obstetrical services are not offered to female veterans through the VA medical system. They are no policies in place to systematically address the concerns of Gulf War veterans concerning reproductive health.

Based on in-house expert consultations, a review of the literature, interviews and the meeting we held in Seattle this year, staff suggests the Committee make seven findings and adopt several recommendations as follows:

First, it is unlikely that exposures in the Gulf War theater are responsible for the birth defects of children born to veterans. DOD is taking reasonable steps to determine through epidemiologic research whether there is an increased prevalence of birth defects and other adverse reproductive outcomes among Gulf War veterans.

Study No. 7, in particular, seems best equipped to provide meaningful data. Given the low response rate to current surveys of reproductive outcomes, however, it is unlikely these studies will provide a definitive answer to whether infertility rates were higher among veterans in the years after they returned from the Gulf War.

Second, the VA examination program for spouses and children of Gulf War veterans has little or no value as a research program and offers no incentive for participation; thus, raising expectations in veterans and their families that are impossible to meet.

Third, the absence of baseline data regarding the reproductive health history of military personnel makes determinations of the effect of exposures during deployment more complex and difficult, if not impossible.

Fourth, reproductive health care benefits available for military health service systems' beneficiaries are comprehensive and the standard of care.

Fifth, VA's May 1996 solicitation for applicants to establish a research center to study environmental hazards and their effects on reproductive and developmental outcomes is an important first step to devise future policies for the treatment of veterans and their concerns.

Sixth, the Department of Health and Human Services has significant expertise in basic and clinical research related to birth defects, chiefly through the National Institute of Child Health and Human Development and significant expertise in data collection related to reproductive indicators. DOD and VA do not adequately avail themselves of these sources.

Seventh, because birth defects most often occur in families with no previous history of the disorder, genetic counseling should include the understanding that genetic disorders often occur unexpectedly among children of healthy parents and healthy siblings. Against a background of scientific uncertainty in general about the etiology of birth defects and lack of information from reliable sources, DOD and VA health providers, as well as health care providers counseling veterans in civilian health care settings, must grapple in a void with their patients' concerns.

Neither DOD nor VA have widespread or systematic policies in place to address the concerns and questions of Gulf War veterans concerning reproductive health. Concerns are addressed on a case-by-case basis within DOD and no evidence exists that they are addressed at all within the VA medical system.

Therefore, staff recommend that the Committee consider the following recommendations:

First, VA should not renew its examination program for spouses and children of Gulf War veterans unless it can clearly define a useful purpose for the program and provide incentives to enhance participation.

Second, DOD should consider methods for obtaining baseline data on the reproductive health of military personnel, so that post deployment concerns can be addressed more expediently.

In particular, DOD should consult with the National Center for Health Statistics of the Department of Health and Human Services and strongly consider its survey and methodologies.

Third, both DOD and VA should more thoroughly consult with the Department of Health and Human Services on basic, clinical and epidemiologic research on reproductive health issues.

Fourth, VA should conduct a thorough review of its policies concerning reproductive health. VA should seek statutory authority to treat veterans and their families for service connected fertility problems and birth defects, including the provision of genetic counseling.

That concludes my remarks.

DR. LASHOF: Thank you.

DR. CAPLAN: Kathi, does staff want to suggest that VA develop an internal capacity or simply make sure that these services are available to veterans? In other words, you could say they are out there and creating a new set is not the most efficient way.

DR. HANNA: Well, I think that very often when a service is not available through the VA system, they will make a referral out into the civilian system. The issue then is are they going to pay for it. I think there are very good services available in most medical centers in most cities. There certainly is no need to reinvent the wheel.

MAJOR KNOX: Kathi, the program that is available, you said the cut is for 4,500 people who responded?


MAJOR KNOX: Do you know how many people have responded to that?

DR. HANNA: The last I heard, it was in the 400s.

DR. GWIN: Actually, one of the staff attended a briefing last week and I think the number is closer to 900 now.

MAJOR KNOX: 900. Because there is no pay for travel. So, the access to health care due to the distance has been one of the complaints.

DR. HANNA: For some families it is a -- it can be an eight hour drive depending on where they are being referred.

DR. LARSON: What is known about the etiology of Goldenhar's syndrome? Has it ever been associated in any groups with exposures to anything that you are aware of?

DR. HANNA: Well, if you look up Goldenhar's in Cusick's(?) Compendium, it shows up as an autosomal dominant and autosomal recessive animal type factorial disorder, which means it has been seen in all forms in different families. In some families, there have been multiple affected siblings born to parents who were both carriers. In some families, there has been -- it appears to be dominant, where the child is severely affected, but when they actually do a very thorough exam of both parents, they find actually that one of the parents is very mildly affected, but it was never clinically detected.

In most cases, it appears just spontaneously as a mutation. There have been some theories that come and go, saying that because it appears to be a midline defect. Where there is insufficient growth on one side of the body, it has been attributed to things as different as fetal stroke at some point very early on in the pregnancy and also in some studies, it is attributed to some maternal infections.

So, I think the answer is it has been diagnosed in families that show all different types of inheritance. And I don't think there is any one mechanism that can explain it. It is really a very broad syndrome.

DR. LASHOF: We heard at one of our sessions about the study on Goldenhar's that Madecki(?) was doing. When was her report supposedly that she was working on to be available? And have we gotten anymore information from her?

DR. HANNA: We have not received anymore data. I recall her saying that she would have some more available in September, this month. But we haven't seen anything yet.


On the issue of male responsibility, shall we say, of the sperm, defective sperm, due to exposure, clearly, the 90 day turnover is key. In animals, have they demonstrated at all any stem cell effect? I know it has not been demonstrated in humans, but have there been any animal experiments that would show that the stem cells can be affected and you could get sperm that would produce offspring rather than infertility further down after exposure or not?

DR. HANNA: Yes. There have been some studies that have shown usually, as is typical with animal studies, very high level exposures for a very prolonged period of time have had an effect on the spermatogonium and it is -- I believe the best studies have been done with lead and some organophosphates.

DR. LASHOF: In view of that, do we feel comfortable to say that it is biologically implausible as compared to biologically impossible? Where do we stand on implausibility versus possibility on the effect of the stem cell?

DR. HANNA: Well, I think one of the panelists this morning said that a good scientist never says is impossible. I think that -- I don't think we can ever say it is biologically impossible. There have been studies that have shown that there is a paternally mediated effect under very strict conditions, where the exposure is prolonged and high levels, with certain types of agents.

I think that given the duration of exposure, that most veterans experienced and the fact that several of the experts that we interviewed felt that even given an exposure, that the types of exposures, while they might cause other general health effects, were not known mutagens, I think we can safely say it is biologically implausible.

I think the epidemiologic studies are -- they fill in the extra piece. In a way they are a safeguard against stopping at the point of saying something is biologically implausible. We can say that, but I think we still need to have these studies done because in the event that it is biologically plausible, one would hope that it would show up in an epidemiologic study. So, I think the two things complement each other.

DR. LASHOF: So, you think that we should continue the epidemiologic studies. You are not feeling so strongly about the implausibility as to say, you know, we are wasting a heck of a lot of money doing a lot of epidemiologic studies for something that just doesn't happen.

DR. HANNA: No, I don't think -- I think they need to be done. I think that both epidemiologic and biological approach have to be taken. They complement each other and one enlightens the other. The fact that I think the -- especially the Study No. 7 has been designed with, I think, a fairly well defined a priori type of a design, where they actually have theorized what they are looking for.

I think that they will tell us something.

DR. LASHOF: Do you think any further animal or other research -- well, it would have to be animal -- is indicated to shed further light on the biological plausibility issue of the spermatogonia being affected? Would there be any value or do you think it has been pretty well studied as much as it can be studied in the laboratory?

DR. HANNA: I think we can always learn more. I think what -- and certain agents are being looked at where there are high levels of exposure in particular occupations. Those agents are being studied and I do think that -- I am not saying that anyone has to redesign studies or do new research. I do think that those studies have to be carefully consulted to determine whether veterans would be exposed to any of those agents, which have already been documented.

I do think, however, that we do need to know a little bit more about the effect on ova of some of these exposures. That is one area where we just haven't learned that much and I think a lot more can be learned about what is happening to women as more and more women are deployed and are exposed. There, we have a high level of biological plausibility.

DR. GWIN: We did, in the risk factors that we reported on in Chicago, look across the board for reproductive effects as an end point, found a fair amount of data and did not find anything that indicated that we should expect to find birth defects or infertility as a result. So, we don't have a specific candidate to suggest for study among the risk factors that this committee have studied.

DR. LASHOF: Back to the other study that they now have 900 responses, that is one that they are looking at 16,000 and they have got 900. Is that right?

DR. HANNA: No. The VA exam program is the one, I think, that Holly was referring to.

DR. LASHOF: Oh, okay.

DR. HANNA: The 16,000 couples is a survey.

DR. LASHOF: A survey, a 16,000 couple survey.

That one you indicated also, though, that was plagued by a low response rate.


DR. LASHOF: How low? And is there anymore information on that?

DR. HANNA: I don't know if there is anyone in the room that can answer that better than I. When we spoke to them, the principal investigators several months ago, they were still well below 50 percent. Now, that might have improved. I think they have concentrated their efforts in trying to get a better response rate.

DR. LASHOF: Are there other questions?

Yes, Rolando.

MR. ROLANDO: Kathi, you said that VA should seek statutory authority to treat veterans and their families for service-connected fertility problems. Have you gotten any feedback from them on this recommendation? And do you know if they are already seeking any kind of legislation in this area?

DR. GWIN: They are seeking legislation specifically on spina bifida in Vietnam vets right now. What they lack is sort of generic authority to look at these problems if there is a service connection.

MR. ROLANDO: Have you talked to them about it?

DR. NISHIMI: We talked to them before we talked to you. We are floating before you first and then --

DR. LASHOF: Just for the process for the moment, if we could keep our questions to the summary and then we will take up each of the findings. So, if people have questions about any of the material in the summary first, then I will proceed to ask us to go through each finding and see whether anyone has questions around each finding and whether we agree with the findings and then I will proceed to go through the recommendations and take each one of those up one by one.

So, just to try to keep the process cleaner.

Phil, did you have a question?

DR. LANDRIGAN: Technical question. Thinking about the information that has become available over the last several months, that various war gases were released from these bunkers that were exploded and setting aside the question of actual exposure or level of exposure to the American troops, is there any toxicologic information about the reproductive toxicity of these particular compounds and have they been studied with state of the art technology to look at their effects on sperm, for example, or ova?

DR. GWIN: We have found specific data on serine and mustard gas that indicate no mutagenic effects for serine, possible mutagenic effects for mustard at very high exposure levels, but I --

DR. LANDRIGAN: My recollection is mustard -- it behaves in the human body as an alkylating agent, right? It cross links DNA. It certainly in occupational populations, chemical workers who made mustard gas, there is an excess of lung cancer, which is pretty clearly borne out in the literature and I think the IOM committee that reviewed nitrogen mustard reaffirmed that conclusion, if I am not mistaken.

I am sure that mustard has got to be a mutagen. It just eats DNA. It is like Pac Man.

DR. HANNA: And it is documented that it does increase cancer rates among those who are exposed. It is quite different, though, to say that it has an effect on the germ line.

DR. LANDRIGAN: I understand, but at least that -- the mere fact that it is a mutagen in somatic cells, at least, I think elevates the plausibility that it could be a germ line mutagen. That is not to say that it is, but it pushes it closer to reality. Serine is an organophosphate, right?

DR. HANNA: Correct.

DR. LANDRIGAN: Okay. So, probably less likely.

DR. HANNA: I think we will -- I mean, we are going to -- we will obviously reconsider based on the new findings, but, once again, the issues of duration and levels of exposure and the fact that it was most often in -- at least in that case whatever exposures there were most likely to be to men. I think it is still -- I don't think it changes the picture too drastically.

DR. LANDRIGAN: I don't think either of those compounds have a particularly long residence time in the human body. My understanding is that they are both metabolized and excreted but it is not like DDT, for example. You don't have to introduce that element into the equation.

But I think the fact that at least the mustard is -- I am sure it is a somatic mutagen. It behooves somebody to look again at the reproductive literature and see what is there for that compound.

DR. GWIN: We did look at that and DOD recently requested the Armed Forces Epidemiologic Board to look at it and we just received their report and they confirm that it is a mutagen at high doses, but cast doubt on the idea that if you failed to see the acute toxicity that you would see mutagenic effects.

DR. LANDRIGAN: I worked for a long time in occupational epidemiology. People used to always make those arguments about a number of compounds. It used to be said that in the case of benzene you didn't have to worry about long term effects unless the person had acutely developed aplastic anemia from an acute, overwhelming dose of benzene. We now know that that is not true, that people can develop leukemia from chronic low level exposure in the work force.

I know we frequently used to hear, well, you don't have to worry about the results of animal experiments because they are only done at high dose, but the trouble is, of course, the human species is very outbred. We vary enormously in our genetic susceptibility and one person's high dose is another person's low dose.

So, I think one has to be cautious about rejecting that argument too rapidly as well. Whether any of this really matters in the real world is not the question, but I think there are some toxicologic issues here that have to be thought about.

DR. LASHOF: Let us turn then to the findings.

The first finding dealing with the exposure and the unlikeliness of the exposure. Is there anybody who has any reservation about Finding No. 1? I am not going to reread them. You have got them in front of you.

I will assume if I hear no objection and no question raised to a finding that you will accept it and see that it should be included as one of our findings. If you have any reservations, speak up. Okay.

Now, on Finding No. 2, dealing with the examination, the research program. Okay.

Finding No. 3? Okay.

Finding No. 4? I am going too fast?

DR. BALDESCHWIELER: The question on 4.

DR. LASHOF: Yes, please.

DR. BALDESCHWIELER: For certain genetic diseases, for example, where the carrier gene is well-known and the trait is recessive, for example, the probability of birth defects in the offspring is quite predictable. What are you suggesting that the policy of the VA, for example, be in this regard? That is, there will be a certain fraction of offspring that carry the defect no matter what.

DR. NISHIMI: Finding 4 goes to the DOD system.

DR. BALDESCHWIELER: But it says the VA should seek statutory authority.

DR. NISHIMI: No. We are on the findings not the recommendations.

DR. LASHOF: No, I am going down the findings. I am going through the findings first. Do we agree with the findings that we have before we get to the recommendations?

So, I am on Bullet No. 4, reproductive health care benefits, a comprehensive standard of care. Are you with me? Okay.

The next one is again a finding. It is a statement of fact. Next -- the last one on that page? Okay.

Let me also ask whether if on anyone else's reading of the summary they feel there are other important findings, which should be highlighted as findings?

Hearing none, we will now go to the recommendations as to whether or not we want to put in our final report the recommendations as listed.

The first recommendation dealing with the examination program?

Can you tell me before I am completely satisfied with this recommendation, I guess clarify for me a little bit about what the VA really thought it was going to accomplish by this and why they really got into it and what their current feeling is about how it is going and what they are doing?

DR. GWIN: VA was responding to legislation that prescribed a study on reproductive health effects and said under that study examinations should be available to any spouse or child who has a problem that they feel like is associated with the Gulf War and is not clearly unassociated with the Gulf War. And I believe basically that was it. They felt like they were responding to a congressional mandate, but they are unable to articulate at this point what useful purpose they think this serves, other than being responsive to our --

DR. TAYLOR: -- another way, I guess, would be the question.

DR. LASHOF: Do they have to do this? In other words, does the law require they do it? In which case, it would be meaningless for us to --

DR. GWIN: -- current interpretation of their general counsel is that the law requires this activity. This law is -- the program expires at the end of this fiscal year and what this recommendation would do is put us on record as discouraging VA from seeking renewal of authority to --

DR. NISHIMI: It would not, obviously, prevent Congress from re-mandating the program.

DR. LASHOF: Never prevent Congress from doing anything.

DR. NISHIMI: And then VA would be in the position of bowing to the rule of the Congress.

DR. LASHOF: I think we need to put it in that context to make it clearer that -- maybe that was in there and I missed it, but if this is something they have been doing under a mandate that expires and we don't see any reason for it to be renewed, then maybe Congress as well as VA will listen to us. Who knows? But I think it will go better if we --

DR. NISHIMI: Yes, we can take it in that context, sure.

DR. BALDESCHWIELER: Stopping them from doing something should be a popular recommendation.

MAJOR CROSS: Correct me if I am wrong, but we are making the assumption that the program really didn't work as well as it was intended to. Is that correct?

DR. GWIN: Well, it certainly didn't attract the number of participants that were eligible. Only 900 people have signed up out of a possible 4,500 that they could accommodate and at our hearings, the reason most often cited for this is the travel time involved, time away from work, lodging, expenses, which VA is not in a position to reimburse now.

DR. NISHIMI: But also, I think, Tom, the point is that even if they had been fully enrolled, the program in and of itself couldn't fulfill research purposes. So, it is a two-prong thing. It was under-subscribed and it was

not --

DR. LASHOF: Well, it wasn't a research and it had no particular service function, did it?

DR. HANNA: It has no service function. I mean, other than, perhaps, providing a diagnosis, the -- no treatment whatsoever can be provided.

DR. NISHIMI: Congress passed it on VA's behalf as a research program.

DR. LASHOF: Okay. Any further questions about that recommendation?

[There was no response.]

Okay. The next one on baseline data.

DR. CAPLAN: I have a comment on that.

It seems to me one of the things we have been around on this baseline issue is not just getting good general information but some sort of good sub-sample. And that is what I would like to see. I would like to see an in-depth sub-sample. Maybe we will hear more about that in the next session.

But I am not persuaded that giving a lot of general information is going to be the baseline that is needed to pick up these kinds of problems. So, I would rather see us add something about in-depth review prior to deployment.

DR. LARSON: Maybe you could say a little bit more about the NCHS survey and its methodology before we recommend that. Explain it a little bit.

DR. HANNA: We heard testimony from two people from the National Center for Health Statistics at the Seattle meeting. They described their family growth survey, which is conducted periodically. What they do is they collect data about reproductive outcomes, contraceptive use. I mean, it is conducted anonymously. I mean, there are no identifiers on there. The surveys are conducted by telephone and by mail with women, since they have found that women are the most reliable reporters when it comes to reproductive data.

They have collected data, I think the first survey was done in the seventies. So, they now have trend data on -- not only by age groups in terms of infertility rates, pregnancy loss, birth defects, by age groups, by socioeconomic status, by race, ethnicity, by geographic region and even some more refined data, based on occupational history, nutritional, therapeutic drug use, illegal substance abuse.

They have a lot of data that they have been able to report trend data over time and it has provided a good baseline for when CDC has to go in to an area where there is a suspected agent to try and determine whether, in fact, rates are significantly different in a specific population.

They have tested their survey out quite well and I guess staff could not see any good reason why DOD could not just adopt their survey and conduct it in military populations. They are prohibited -- NCHS is prohibited from collecting the data from military populations.

DR. LARSON: This would be some kind of sampling scheme. Not everybody has --

DR. HANNA: Correct.

Could I just ask a question, Art, for clarification? When you say a sub -- that there not be just baseline data, are you suggesting that it be -- that certain questions -- you try to address certain questions through data collection; therefore, not trying to be too general in collecting it on everybody, but, for example, previous studies have shown that women in the military who are career military have lower pregnancy rates and have fewer children than women in -- you know, comparable women in age groups in the civilian sector. That kind of information is useful when you are trying to determine whether, in fact, infertility rates are higher or lower.

So, are you suggesting that certain questions be posed and answers be sought or just --

DR. CAPLAN: Yes. Well, I don't know the survey as well, but just if you were taking genetic histories, do they, don't they? I don't know. That kind of baseline. But if we are going to get into arguments about exposure rates and do they take a pedigree? Do they have some sub-sample like that? I don't know what this survey is doing. My hunch is they don't and that is exactly what you want if you are going to really do this baseline pre, post-deployments and so on.

DR. GWIN: The Committee did recommend in its interim report that better baseline data be extracted from a subset of each deployment population that would be, you know, directed toward any follow-up to a conflict.

DR. CAPLAN: That is what I am thinking of here.

DR. GWIN: And we intend to follow up on that some more in our briefings in October, but I think this is directed more at just obtaining general population data from the military population.

DR. NISHIMI: Because if you have your sub-sample pre and post, you still have no baseline against which to compare it for reproductive -- so, that is what this recommendation goes toward.

DR. LASHOF: We may have to clarify that when we write this in such a way that -- because I am not sure I know who we are gathering the baseline data from now. I am confused.

DR. NISHIMI: The military population in general.

DR. LASHOF: In general. Oh, the whole thing. You would just do a sampling in the military population as a whole.

DR. GWIN: Every year or every five years or -- what is the CDC sample?

PARTICIPANT: Every five.

DR. CAPLAN: The military get exempted in the first place. What is that about?

DR. HANNA: I would guess that is an issue of administrative law. Maybe Holly can answer that.

DR. GWIN: I don't know.

DR. LASHOF: Then what I gather what we are really recommending here is that there is this survey done by NCHS that doesn't include the military. We think the same survey should be done in the military so that there is general baseline.

DR. HANNA: Correct, because we don't know --

DR. LASHOF: Let's say it a little more clearly --

DR. HANNA: We don't know if military populations are different from civilian populations. So, we just can't compare military against civilian. We need to compare military against military.

DR. LASHOF: Okay. So, let that be a finding and then let this be a recommendation that this particular survey be carried out in the military, comparable to the civilian, to give us this information.

DR. BALDESCHWIELER: So, this is not a pre-deployment?


DR. LARSON: That was my confusion because I think the word "post-deployment" implies that the baseline data were on those who were deployed. So, I think clarify that this is just a routine sampling of military populations.

DR. NISHIMI: Right. There is no data set right now. That is what this went to. Okay. I think we know how to clarify it then.

DR. LASHOF: Okay. The next one.

I think this one when we get to our next meeting and talk about generally the coordination of all research and how it is done and so on -- I mean, I think we could save this now and leave it here, so we don't lose it, but we may want to put it in the context of how all the epidemiologic studies should be done and what kind of expertise is necessary and how that ought to be structured in a way that we get the kind of consultation and so forth that we have talked about.


DR. LANDRIGAN: I wanted to raise a specific point following up on the earlier conversation and that is I wonder if we shouldn't specifically recommend that toxicologic research be done into the potential reproductive toxicity of these war gases. I mean, the problem is is that there seems the likelihood in this troubled world that American troops are going to run into those compounds again. And we have tools today that weren't available five or ten years ago to look into those toxic effects. And it seems like we ought to deploy them.

DR. NISHIMI: And the research portfolio in general on these issues, obviously, broader than reproductive health, will be a major focus in October.

MAJOR CROSS: Joyce, I am a little concerned with the wording. We keep on -- we say here "DOD should consider methods and consider these surveys..." -- given that DOD has the option to put money and manpower into surveys or, let's say, new weapon system research, I think they are going to choose weapon system research. Why wouldn't you say contract with the agencies that have the expertise and let them do the surveys and then use that data? They have the expertise. They have the methodology. It seems a simpler way of doing it that way to me.

DR. LASHOF: I think that is a very good point, Tom, and maybe we could ask Holly to look into why they are precluded from -- why the National Center is precluded from doing the military when they do the general and deal with it by trying to attack that requirement and make a recommendation that the NCHS should be given the authority to extend its survey, its family survey, to the military population and let them fight over that jurisdiction rather than trying to get the expertise into DOD to do what NCHS is supposed to do.

DR. HANNA: My suspicion as to why NCHS has not done it in the past could be the fact that military populations are hard to track and it would require that they have significant cooperation from DOD in tracking active duty military. That is a whole different set of problems that they don't have to deal with in the civilian population. So, it could be as simple as a logistics type of an issue that --

DR. LASHOF: Well, then, maybe our recommendation should be that NCHS should do this and that DOD be obligated to work out the logistics and make it possible for NCHS to do its study of the military.

MAJOR CROSS: Kathi, I understand what you are saying but I also would say maybe no one has even asked the question.

DR. BALDESCHWIELER: I would say that Joyce's formulation of this is far better than what is written here, which is so global that it seems to me it will never be done. This is like saying General Motors and Ford should consult with Procter & Gamble and, you know, that is never going to happen.

DR. LASHOF: Okay. All right. We will revisit it.

So, now we are up to the fourth recommendation.

DR. CUSTIS: For the record, the four main service organizations that each year put out the independent budget have for some time repeatedly submitted legislative proposals to Congress for statutory authority for the VA to treat veterans and their families for service-connected fertility problems.

It has been discussed in VA committees in Congress, but it has never -- the proposal has never gotten beyond committee consideration.

DR. LASHOF: Well, maybe we ought to -- that is an interesting bit of additional information that ought to be in the findings somewhere. We ought to look into that and make a finding that this has been considered but not -- and then make a recommendation that this, again, be pursued with the --

DR. CUSTIS: It was the Paralyzed Veterans of America that persuaded the other service organizations to sponsor it.


DR. HANNA: And VA indicated to us that they have sought -- they have, you know, continuously sought to have this kind of authority and have ended up in a very complicated system of determining what they can and what they can't provide when it comes to reproduction.

DR. CUSTIS: Also, there is the business of authority to treat dependents of veterans. It opens up that whole question, but paradoxically, the VA is authorized to take care of the dependents of the military retired through CHAMPUS authority.

DR. LASHOF: Would you care to put in a recommendation at this point for a national health insurance?

DR. CUSTIS: That would be an excellent idea. Universal coverage.


DR. GWIN: Doesn't anybody want to go for no more war?

DR. BALDESCHWIELER: Let me come back to the question of what do you do with predictable genetic issues. That is where --

DR. HANNA: I am more concerned with what you do with the ones that aren't predictable. I mean, I think if it is very clear that you are providing service connected -- you are providing services for military connected problems, that is the hard thing to determine. If a child is born to a family and let's say the child has cystic fibrosis and you do genetic testing on both parents and determine that they are both carriers, there is your answer and it is, obviously, not service connected.

I think what is more problematic are the children that are born where there is no clear cut mode of inheritance and it is very difficult to determine what the etiology is and whether, in fact, it is service connected or not. That is the hard part, I think, of the question is determining what is service connected and what isn't. I think for many diseases, you can obviously exclude them as being service connected. There are just as many, however, that I don't think you can.

DR. BALDESCHWIELER: That is the sense of the recommendation where it is clear cut, that there is no service connection, that the VA would not be required to provide service, but they would provide genetic counseling.


DR. BALDESCHWIELER: But it is a basis of testing?

DR. HANNA: I think it helped -- to make that determination, I do think that -- if the concerns are due to service, I do think that it has been staff's conclusion that we feel that the VA should provide at the very least genetic counseling to help the veteran understand whether, in fact, it is service related or not and get them to the proper referral sources to follow up on that. I think that is the sense, I think, of our -- you might have to do the genetic counseling first to determine -- then maybe you can make the determination whether it is service connected. But I think that the point behind the recommendation is that VA should provide that genetic counseling.

Whether it finds out whether it is service connected or not is the second set of issues. Right now, many veterans are not able to get answers pertaining to their particular situation and you can only do that through genetic counseling.

DR. LASHOF: Yes, but if we do the genetic -- obviously, it seems to me that we want to recommend that genetic counseling be available to anyone who has a child with a congenital defect. If genetic counseling or genetic testing and counseling shows that it is clearly a genetic familial hereditary, they are not service connected. If it doesn't show that, then we are into that whole bind of trying to decide whether it is service connected or not.

Are we going to make a presumption that anything that is not genetic is service connected or are we going to make the presumption that it probably isn't but then they have to prove service connection? I mean, this is the morass we are in right now over Agent Orange and we are going to just continue this morass.

Is there any way around that morass?

[Multiple discussions.]

DR. NISHIMI: You are back at the starting point. You know, you have to sort of think of it as service connected, not service connected and the only way to get yourself out of the problem that you just raised is to remove that and the only way to address that is to have universal access. And I think that is something that is bigger than this committee can chew, bite off and chew right now in this report.

DR. LARSON: But the way this recommendation is worded now, their genetic counseling appears to come only with service connected problems and that is different than what we are saying now.

DR. HANNA: I agree. I think it is not worded properly.

DR. NISHIMI: So, the Committee's recommendation would be that the genetic counseling be independent of service --

DR. LARSON: Well, genetic counseling be --

DR. NISHIMI: Because you have to determine --

[Multiple discussions.]

DR. LASHOF: -- child and if it is determined that the defect is service connected by whatever mechanism, epidemiologically and biologically plausible, then --

DR. NISHIMI: I think we know where we are at now.

DR. CAPLAN: I am just going to whine on this, too, that this is an area that I follow somewhat closely at my own institution in terms of provision of service and to be efficient, we should not just call for VA to invent its genetic counseling system, which would be quite a thing to do since there aren't many genetic counselors around anyway, who don't have jobs already, but to get access to the service and that gets back to the obstacles of the service problem anyway.

So, you want to --

DR. NISHIMI: Right. We can cast it as provide access to or provide services.

DR. HANNA: I think we also have to step back once and, again, think about right now we are talking about the family that comes in with a child with a birth defect. So, that is maybe 4 percent of all veterans, if we assume their risks are the same. In half those cases we are going to be able to figure out what is from. So, we are really talking about 2 percent of the veterans are going to fall into this morass, Joyce, of not being to determine.

The rest of them, the 96 percent are going to come in either with a healthy child or they are contemplating their first pregnancy and they have a lot of concerns. They haven't had a child with a birth defect but they have read the Life magazine article. They are scared and they need to get the right information and they need to have it provided by somebody who is skilled at doing that.

So, I think we are focusing on the worst case scenario, which is that 2 percent of cases that are going to come in that a determination cannot be made, but I know, sitting in my office in Washington that I have gotten calls from genetic counselors around the country, who have said what are we supposed to tell these people. I mean, we can't find anything in the literature and they are seeing people in their private clinics and they need good information.

So, in many cases, it is really just dealing with the concerns of people. In a very few cases, it is dealing with an actual child with a severe problem.

DR. LASHOF: But are we suggesting here that genetic counseling be offered prior to having a child, I mean, just to a couple that are considering pregnancy because they -- and they want to know. So, are we suggesting that genetic counseling be available across the board for every couple that are in the military?

DR. NISHIMI: Well, if a veteran were to come into a VA facility and express concerns, what I believe we are recommending once this is recast is that VA either provide the service or refer out as a service genetic counseling to help that individual.

DR. LASHOF: But if this counseling says -- we don't even know what to tell them about whether there is a risk, do we -- I am struggling whether we are encouraging the veteran to be concerned that they are at risk because they have served when there may not be a risk. Do they need genetic counseling more than any other couple in the general population?

I mean every young couple who are going to have a kid don't go in and ask for it unless there is some family history or they have been in an occupational setting that is known. If there is not a known risk in the military --

DR. CAPLAN: But you would write it in a way so that they get it if there is a basis for it, but that they don't just --

DR. NISHIMI: I am sorry. This is done against the backdrop again of a great deal of media attention for this specific population, not veterans generally, but Gulf War veterans. So, I do think that we are not encouraging every veteran or every active duty who is now --

DR. LASHOF: Yes, but as Kathi says they show up at the genetic counselor and the genetic counselor says what do I tell them. We don't have any data. Wouldn't it be more important for us to try to get the data and make that information available and recommend genetic counseling where indicated -- should be supplied where indicated and leave that where indicated sort of open for policy to develop as knowledge develops.

DR. NISHIMI: Well, I think genetic counselors deal with the lack of knowledge in many areas, not just this area and the fact is that genetic counselors can tell them if they are properly informed, you know, veterans -- DOD and VA have these studies ongoing. We don't know right now, you know, et cetera, et cetera.

DR. LASHOF: All I am trying to get at is I wouldn't want to see this worded in such a way that we feel every veteran needs genetic counseling before they make a decision now about a baby because that just, I think, plays into it. Hopefully, these recommendations would be long lasting and not have to be visited after each military incursions, of which we are not going to have anymore,

but --

DR. NISHIMI: I think I see where you are coming from.

[Multiple discussions.]

DR. LASHOF: So, I think it should be -- this should be available and indicated and the decision on when it is indicated is going to have to be decided at various times, according to the current knowledge that we have --

DR. NISHIMI: Well, but it would be indicated based on the individual not by the circumstances --

[Multiple discussions.]

-- and wants information, I think that VA should, in fact, refer them out for genetic counseling or at least know to do that. If a person is legitimately concerned about their reproductive future, I would argue that there needs to be a mechanism to help that person understand.

DR. BALDESCHWIELER: How much work does a genetic counselor actually do? I mean, do they do a complete family history and do they do some diagnostic testing, karyotyping? I mean, is that -- or do they just kind of --

[Multiple discussions.]

This could be a substantial amount of work.

DR. LASHOF: Yes. I understand what you are saying, that if someone comes in and is concerned and wants it, go, but, you know, in the world of medicine today, someone comes into the primary care doc and they are a young couple and there is no reason for them to be concerned if raise -- well, gee, I would really like genetic counseling before I have a kid. The doc is going to sit down and say, well, you know, let me go over your history and is there any reason for you to be concerned and take some kind of history and might well say, you know, I don't think this is necessary, you know. Go ahead.

I think there ought to be some physician judgment on when a referral is made. That is all I am saying and not that we lock this into a way where it is automatic.

DR. HANNA: This is available for active duty personnel right now and perhaps if we really wanted to find out what the impact of this might be, we can try and find out if there is any -- if anyone knows how many genetic counseling counselors there are in the military --

DR. LANDRIGAN: Kathi, what specifically is available because I would think in practice, it is sort of like what Joyce said, that if a couple is concerned, they would come in and speak with the doc, but they wouldn't get referred unless there was a reason to do so. Or are they automatically referred? I would doubt it.

DR. HANNA: In general, and I can only speak from the civilian sector, where I practiced, the first referral comes in, either it is a self-referral or from the patient's OB/GYN, and the family comes in and they sit down and they discuss their family history, their own health history, nutrition, if they are currently pregnant, what their pregnancy -- that particular pregnancy history has been and counselors are trained to then make a determination whether -- what the next step is, whether blood tests are indicated, whether records should be requested from other family members and it is really more of a building process.

In most cases, there is not a whole lot of information available.

DR. LANDRIGAN: Do people actually make it to the genetic counselor, though, if there is not some reason in the history to suspect --

DR. HANNA: If they have a concern. If there has been an exposure and they have a concern or if they have taken a medication or --

DR. CAPLAN: The biggest reason that somebody would get there is by age. The fact is that this counseling we are talking about is going to be done by doctors or somebody else. There are only about 2,000 genetic counselors in the United States. They are not going to deal with even these kind of inquiries. This is going to be done at the doctor base level to make a referral about whether they think there is enough risk or background or factors involved.

That is what we want to make sure we get addressed that in the sense that we are talking about is adequate, genetic concerns about reproductive health get worked into the primary care of veterans. That is what we want. It is not that they have to see genetic counselors. If they started doing that, there would be a line from here to --

DR. NISHIMI: Yes. This is genetic counseling with a little "g" and "c," as I --

[Multiple discussions.]

Because there are nurses who practice this as well as capital "G," capital "C" genetic counselors.

DR. LASHOF: Holly, do you have a reservation? I can see you are struggling.

DR. GWIN: Well, I am because it is a little bit different from saying we are working genetic counseling into the primary care for veterans because, unless you have established something like the VA's Persian Gulf Health Registry. These veterans are not eligible for free primary care, like the protocol exam, from VA. So, it is unlikely they would go see a VA physician as their primary care physician.

So, what we are suggesting in this recommendation is a service outside the general consult with your family doctor. We are providing a --

DR. LASHOF: That is a good point. That is right. We have forgotten that these are people who aren't getting any medical care through the VA. These are healthy people going to a private doctor on the outside and we are offering them -- trying to offer them a service at the VA to supplement what the -- boy, it gets complicated, doesn't it?

DR. NISHIMI: Maybe what we can do is recast the recommendation now that we have kind of twisted it in about ten different directions and then --

DR. LASHOF: Give us another shot at it.

DR. NISHIMI: -- this particular --

[Multiple discussions.]

DR. LASHOF: Let me do some more thinking.

DR. NISHIMI: I think we get the general sense and -- but there are like now five permutations that have to be accounted for and we will see what we can do and then roll through it again.

DR. CUSTIS: You know, at the present time, the service connected veteran, who is rated a certain percentage of compensation, they receive care not only for their service connected disability, but also for any other disability that has no connection to service.

So, it won't make any difference whether the genetic -- whether it is a genetic problem or a service connected injury. If they are service connected, they have access to the VA and there is about to be a change in that. They want to limit care for non-service connected problems in the service connected community that is compensated 30 percent or more. It used to be 0 percent.

I am getting a little complex here, but I think the point I am trying to make is you don't have to differentiate whether or not this is service connected. The service connected also has eligibility for non-service connected problems.

DR. LASHOF: Yes, but that would apply to those who have some service connected, but if you have got a healthy veteran with a healthy wife, who because of publicity have heard about congenital defects or they want to have a baby, want to get genetic counseling. Where do they go? Do they come to the VA and ask for it? Do they go to the primary care doc and say what do you think? And if their doctor refers it, then the VA would make it available.

I would be tempted to go in that direction to

say --

DR. HANNA: If they have health insurance, they will go to their -- to a private provider. It is the people that don't have a choice.

DR. LASHOF: I know. This gets us back to health insurance again.

DR. HANNA: Well, but that is the gap that -- where people fall through.

DR. CUSTIS: There is also the means test. If they are medically indigent, they would have entitlement for VA care.

DR. LASHOF: Rework it and see what you can come up with. I will think about it some more and be in touch with you.

Is there anything else on this one? If not, I think we will take our break now. We are 15 minutes behind time. Let's come back at 3:30 and we will find out what is new in Bosnia, but maybe we ought to find out what is new in Iraq.

[Brief recess.]

DR. LASHOF: Sorry to delay. We are running a little behind.

Agenda Item: What's New for Bosnia

DR. DE FRAITES: Dr. Lashof, good afternoon, and other members of the Committee.

I am Lieutenant Colonel Bob DeFraites. I am a preventive medicine physician assigned to the Office of the Army Surgeon General.

For about the next 20 minutes, I will be informing you about the DOD-wide efforts to improve medical surveillance during deployments that have occurred since Operations Desert Shield and Desert Storm. Some of the concepts in our medical surveillance are being implemented in Operation Joint Endeavor, which is taking place in Bosnia, Croatia and Hungary, even as we speak.

Since the end of the Persian Gulf War, the military medical community has recognized the need for improved efforts in medical data collection in support of major troop deployments. This, in turn, has led to a series of improvements in the capabilities of deployed medical units that conduct medical surveillance.

For the discussion today, "medical surveillance" can be defined as the collection, analysis and dissemination of disease and injury data that are accurate and timely and lead to appropriate medical actions.

For Operation Restore Hope in Somalia in 1992 and 1993, for example, a theater-wide, joint medical surveillance system of central data collection and supported by an advanced infectious disease diagnostic capability was deployed. Disease and injury data were collected from Army, Navy, Air Force and Marine units in an identical manner. That is why we say it was joint because all services contributed to the system and were treated equally.

Epidemiologists were able to identify trends and bring appropriate public health actions to bear. The surveillance system that was used in Somalia had been partially deployed during Operations Desert Shield and Desert Storm and was further codified by the joint staff in a message to all combatant commands in January of 1993.

The joint staff guidance required weekly reporting of diseases and injuries in the categories shown on this slide. This was henceforth to be carried out on all joint operations since January of 1993. During Operation Vigilant Warrior in Kuwait and Saudi Arabia in the fall of 1994, advanced environmental laboratory capability was added to the infectious disease and the epidemiological expertise in the theater of operations.

For the firs time, the assessment of potential environmental hazards was performed in a scientifically sophisticated manner in the theater of operations actually during a deployment. These recent successes in theater medical surveillance comprise one aspect of the larger DOD effort to develop a comprehensive medical surveillance policy. Since 1994, a joint preventive medicine working group has worked to draft this policy.

Policy has two large goals. A long range goal is to document medically relevant exposures and events throughout a service member's military career. A shorter range goal is to develop uniform deployment medical data collection policies and procedures that can be consistently applied to major deployments by all four services, the joint staff and the rest of the DOD.

As of today, the work of this work group has produced a draft DOD instruction for medical screening and surveillance procedures applied to all major deployments before troops deploy, while they are deployed and as or after they return. Major efforts focus on four areas as shown on the left hand side of the slide.

First of all, identifying the population at risk; secondly, defining and measuring exposures of medical significance; thirdly, determining the appropriate protective countermeasures, such as immunizations and, fourth, the assessment of health status and outcomes within the population at risk.

Some of these requirements, such as health status assessments, are continuous requirements, independent of deployment. This slide shows the framework and the concept of this DOD deployment surveillance initiative.

As I will discuss in a moment, several of the key components of this plan were implemented for Operation Joint Endeavor, which started in December of 1995. However, even before then, progress toward meeting some of the requirements of the plan had been made.

For example, the Armed Forces Medical Intelligence Center in collaboration with preventive and operational medicine representatives from the Armed Forces had developed and field tested a CD ROM product now called the MEDIC, M-E-D-I-C, which stands for medical environmental and disease intelligence and countermeasures. This CD ROM provides military medical planners with country specific infectious disease and environmental health threat information along with corresponding preventive medicine recommendations.

This approach represents a major advance in providing correct, relevant, consistent information updated regularly to military medical planners. Medical planners can more efficiently define the health threats and link them with appropriate uniform countermeasures in advance of operations into high risk areas.

Operation Joint Endeavor provided a unique opportunity to implement many aspects of the joint medical surveillance plan. For the first time, a deployment roster containing identifying data for the deployed population, along date of deployment and return, has been developed as the operation has progressed, rather than being retrospectively constructed.

We have used this roster to determine the number of troops who have already returned from the operation and who require medical processing. Pre-deployment evaluations for Joint Endeavor included an overall estimate of the disease and injury threats, recommendations for countermeasures and troop education.

Finally, a serum archive data of the services has been linked to the deployment personnel database for future use. Here are some examples of the troop educational pamphlets and pocket cards that have been produced by the Army Center for Health Promotion and Preventive Medicine and the U.S. Army Medical Research Material Command. And I have some examples of these here if the Committee would like to have some samples.

Now, in addition to this, preventive medicine units in the theater also produced pre-deployment and deployment health briefings for the troops to reinforce these other methods that were distributed to the troops.

Another aspect of Joint Endeavor that is new is the patient accounting and reporting real time tracking system, which -- this is my acronym slide. It is called PARRTS, P-A-R-R-T-S. Although primarily a patient administration database, PARRTS has allowed the calculation of disease specific hospital admission rates to military hospitals in theater to be conducted remotely and automatically and accessible to parties who need to know on a 24 hour basis.

Here is how the data from the PARRTS has been used to calculate the weekly admission rates. What this slide shows is the rate for all cause admissions, which is the top line and we broke down all these admissions into those for

-- just for the sake of simplicity on the slide to all diseases, which is the line with the round dots; non-battle injury, which are the triangles, and battle injury, which are the squares. Of course, there are only two admissions for battle injuries; one from a gunshot wound and one from a land mine injury.

These data are also published in tabular form with diagnosis coded in accordance with International Classification of Diseases, Version 9, Clinical Modification.

Also new for Operation Joint Endeavor has been the first operational medical surveillance laboratory to enter the Armed Forces inventory. It is called the 520th Theater Army Medical Laboratory, activated October 19th, 1995. It was deployed a little over three months later to Bosnia, where it remains today. We call it the TAML for short. The TAML staff includes an epidemiologist, an infectious disease physician, a microbiologist and two environmental health officers.

Outpatient and inpatient disease and injury surveillance are being conducted throughout the theater, coordinated by the TAML. Environmental hazard surveillance is also being conducted throughout the theater of operations, but this topic is going to be discussed in some detail by Mr. Resta, who follows me.

Finally, for Joint Endeavor, as troops leave the theater, they receive medical screening and processing in three phases. This slide shows Phase 1. Phase 1 is administered to all troops before they depart the theater. It includes brief medical and mental health screening questionnaires reviewed by a health care professional. Serum specimen is obtained and medical information briefing and a fact sheet is provided to all troops.

Phase 2 is administered within 30 days of departure from the theater. A medical questionnaire is repeated and again reviewed with a service member. Additional medical information briefings and fact sheets are provided. An update in the medical record from any changes from Phase 1 is made at this time.

For Phase 3, consists of a tuberculosis skin test administered 90 days after departure from the theater. All data from Phases 1 and 2 are being collected and archived by a DOD deployment surveillance in Falls Church, Virginia.

What have we learned about the health threats and health outcomes so far in Bosnia. The most serious health outcomes, several fatalities have resulted from trauma due to land mines and motor vehicles. As far as infectious diseases, one soldier developed hemorrhagic fever with renal syndrome, H-F-R-S, and he has recovered. There have been no cases of tick-borne encephalitis. There have been several small food-borne diarrhea outbreaks, the largest to date involving approximately a hundred persons linked to salmonella at a dining facility. All affected persons have recovered completely.

As far as outpatient and inpatient disease and injury rates, on this and the next slides are some of the most recent data, which are pretty much representative of the deployment. This slide shows outpatient visits from the period 13 July through 10 August of this year. Total outpatient visits for all causes of illness and injury have averaged about ten visits per thousand troops per day.

Overall rates of visits to outpatient clinics during recent operations in Somalia and Haiti, where a similar system was in place, were in the range of about 14 visits per thousand troops per day. So, the experience here in Joint Endeavor is about the same -- in the same ballpark as Somalia and Haiti.

This slide has the data broken down into some of the categories that -- those joint categories that I showed you earlier in the presentation and for sake of clarity on the slide, I only have the respiratory and other medical and ortho and injury problems broken down.

Hospital admission rates of from 0.15 to 0.3 admissions per thousand troops per day are occurring during Operation Joint Endeavor. By comparison, in 1995, Army-wide rates of hospitals to all Army hospitals worldwide were .4 admissions per thousand troops per day.

What does the future hold for deployment surveillance in the DOD? Operation Joint Endeavor was the first practical experience in the implementation of some aspects of this plan that is still undergoing final coordination drafts among the services. Some of these elements will probably need to be altered or replaced. Future deployments will require more individual pre-deployment health status measurements. Lessons learned from this operation will be incorporated into templates for future deployments; namely, Operation Desert Focus, which started late last month, has already incorporated some of the lessons we have learned from Joint Endeavor.

Finally, the ultimate success of this ambitious plan requires automation of as many components of the plan as possible, which are not available today.

That concludes my prepared statement.

DR. LASHOF: Thank you very much, Dr. DeFraites.

I think we will proceed to Mr. Resta's presentation and then address questions to you.

MR. RESTA: Good afternoon, Dr. Lashof, distinguished Committee members. My name is John Resta. I am the manager for the Deployment Environmental Exposure Surveillance Program at the U.S. Army Center for Health Promotion and Preventive Medicine. Our acronym is CHPPM. So, I will probably use it throughout.

I have been there -- I am an environmental engineer. I have been employed by the Army as a civilian for 16 years. I have been working in this field for awhile. What I want to speak to you about is the ongoing efforts of the Department of Defense regarding environmental quality monitoring in Operation Joint Endeavor.

This is my acronym slide I always try to use. These efforts have been accomplished primarily by the military preventive medicine personnel deployed to Bosnia Hercegovina with the U.S. forces. They include personnel from 30th Medical Brigade, 71st Preventive Medicine Detachment, 133rd and 255th Preventive Medicine Detachment, the Naval Environmental Preventive Medicine Unit No. 7, 520th Theater Army Medical Lab and preventive medicine personnel from the First Armor Division with, as this slide indicates, support from personnel throughout the Department of Defense.

This has not been an easy effort for us. Many of these individuals are still deployed in Bosnia as we speak. Luckily, everyone there so far is safe.

Following my prepared statement, I will be happy to address any questions that you might have.

Early in the planning for Operation Joint Endeavor, potential environmental health threats from exposure to contaminated air, water and soils were identified by personnel from AFMIC, the Armed Forces Medical Intelligence Center. They published this in their environmental health risk assessment disease and environmental alert report. They call it the DEAR. Now it is replaced by the MEDIC.

Basically, what at that point we talked about were that we had primarily environmental health risks from contaminated water sources, extremes of heat and cold and localized contamination of air and soil from hazardous industrial wastes. So, we knew that we had some problems before we went in there.

They considered the presence of war damaged industrial facilities throughout the U.S. sector in Bosnia Hercegovina, water supplies, air, soil, power plants, industrial facilities, agricultural and mining operations and U.S. military activities. So, basically, we had a feel. We knew where we were going.

Some of the potential contaminants and potentials of concern include a variety of inorganic and organic pollutants, heavy metals, volatile organics, polyaromatic hydrocarbons, radioactive materials, a soup-to-nuts suite of potential environmental contaminants that you might see on a Superfund site.

In recognition of these potential threats, the Operation Joint Endeavor leadership passed the 520th TAML, which was established in October 1995, to deploy to Bosnia Hercegovina with a mission to assist preventive medicine units deployed to the U.S. sector and to include environmental monitoring within their capabilities. While the 520th TAML was preparing for this mission, personnel from CHPPM York(?) -- we have a subordinate command in York -- were tasked to serve on a preliminary environmental assessment of proposed U.S. forces locations surrounding Tuzla.

This occurred 8 through 12 January 1996. The assessment included a visual site inspection of proposed U.S. forces locations and very limited soil and water sampling. Following the deployment of the bulk of the U.S. forces to the U.S. sector in late January, the 30th Med Brigade requested that the CHPPM conduct a preliminary evaluation of the ambient air quality at the Lukavic(?) and Tuzla troop locations and any associated environmental health risks.

This occurred 8 through 17 February 1996. Additionally, this team assisted the 520th TAML in placing ambient air monitoring equipment on their arrival on 17 February 1996. As the operations evolved, concerns regarding the ambient air quality at other U.S. forces locations throughout the U.S. sectors were raised by the 520th TAML personnel.

They did not have sufficient personnel or equipment to conduct additional monitoring as they had been deployed shortly after activation of the monitor staff. The task force medical leadership requested additional assistance from the CHPPM to augment the TAML's efforts. Ambient air monitoring stations were installed at six regional locations throughout the U.S. sector, as well as at the intermediate staging base in Katlazore(?), Hungary, the life support area at Tazar(?), Hungary and a baseline condition station at Lonstel(?), Germany.

An additional station was installed at Slavonski Brod in accordance with the Operation Joint Endeavor redeployment plan. To date, personnel from the 520th TAML, 71st, 133rd, 255th PM detachments, NEPMU-7, First Armor Division and CHPPM have collected over 1,300 environmental samples of air, water, bottled water, soil and other miscellaneous materials, such as coal from locations throughout the U.S. sector.

When I saw that, I recall, a third of the U.S. sector. That is the upper northwestern quadrant of Bosnia. U.S. forces are not deployed throughout Bosnia. These have resulted in over 60,000 different analyses. As you can see from this slide, basically, we have been at every location where there are U.S. soldiers right now in the U.S. sector.

I show this just to show you some of the teamwork that got involved in terms of getting the samples back to Europe and also getting the results back to there. They have been transported to the CHPPM laboratories both in Europe and Maryland for analyses. They come from wherever within the theater. They get to Germany. From Germany, they either get analyzed in Germany or they are shipped back to the United States. From there they are analyzed and then the information and data goes back to York via the various chains of command, to include the local preventive medicine detachment that collected the samples, the 520th TAML, 30th Med Brigade or the European Command Surgeon.

Our interim conclusions and recommendations, based on the available data are as follows: water, no significant risk. U.S. forces are using bottled water from commercial European sources for potable consumption. These sources were inspected and approved by U.S. forces veterinarian personnel. Bottled water has been sampled and complies with EPA drinking water quality criteria.

U.S. forces are using reverse osmosis water purification units to treat water use for laundry, showering and cooking. These supplies have been sampled and comply with EPA drinking water quality criteria.

Air, no significant risks. Chronic risks from inhalation exposures were calculated using EPA risk assessment guidance and were within EPA acceptable risk ranges.

Respirable particulates at Lukavic, which is considered the worst case location, exceeded EPA's two-week duration, no-effects level, during a two-week period in April; 129 micrograms per cubic meter versus 125 micrograms per cubic meter.

Continued exposure to these levels for the expected deployment duration could cause increased adverse health risks, such as bronchitis, reactive airway disease or reversible decrements of pulmonary function. Medical outpatient data collected to date has not discerned any increased incidence of these potential outcomes, however.

As part of the scheduled operation during the deployment plan, Lukavic closed in 28 August 1996. The troops previously billeted there were relocated to Slavonski Brod.

Soil, no significant risk. Soil contaminant concentrations found at most locations are within Environmental Protection Agency Region 3 screening levels for the cleanup of hazardous waste sites. These screening levels are health-based concentrations designed for cleanup of hazardous waste sites. They are designed to protect sensitive members of the population from lifetime exposures.

We chose these screening levels as there are no national soil contaminant standards akin to the national air and water standards. A few location soils contain compounds, which could potentially pose non-carcinogenic risks. These risks are not considered significant because of the safety factors used by the EPA to protect sensitive populations; for example, children and the elderly, and the minimal exposure duration in contact with the soils.

Carcinogenic risks from soil exposures were within EPA acceptable risk ranges. Additional soil sampling is currently underway to increase the sample size and to reduce the uncertainties associated with the risk characterization, based upon the limited sampling.

Our interim recommendations are as follows:

Continue additional comprehensive environmental sampling at all main troop locations within the OJE area of operations and employ prudent field sanitation to minimize exposure with potentially contaminated media; i.e., wash your hands.

We have learned significant lessons from previous deployments. They have included such accomplishments as integrating environmental considerations into the pre-deployment intelligence assessments used for planning. We were able to assess some preliminary environmental baseline conditions prior to the full deployment of U.S. forces. We bolstered environmental monitoring capabilities of the theater preventive medicine units by deploying the 520th TAML. We augmented the 520th TAML with resources of the CHPPM, both in its European subordinate command and its Maryland headquarters locations.

Finally, while not as quick as we would like, we provided timely environmental health risk assessment consultative assistance and feedback to the deployed forces medical leadership to allow adjustments in countermeasures as needed.

Despite these accomplishments, we still have many challenges facing us. These include such items as the need to improve the information transfer to the deployed forces. Currently, we are using a combination of telephonic electronic mail and regular mail to get analytical results and interpretation to the 520th TAML and other medical personnel.

We need to improve the overall analytical, interpretative and communication processes to speed up the feedback to as close to real time as possible.

The second challenge has been the logistical requirements for conducting a large scale environmental study during the deployment. Environmental sampling requires a large amount of sophisticated equipment that is not designed for deployment conditions, such as reduced mobility, unreliable electrical power, transportation restrictions and other factors that are common during a military deployment.

We need to improve overall environmental sampling efficiencies to allow the most effective collection of environmental data with the least amount of resources.

Finally, the most important lesson we have learned is the limitation of the environmental health risk assessment techniques when used during a deployment. The techniques used to assess potential adverse environmental health risks are selected from the EPA's guidance for cleanup of hazardous waste at Superfund sites.

They are designed to predict potential adverse health risks to a diverse population, from long term exposures to potential contaminants. The methodology consists of an exposure assessment that examines the potential pathways of exposure and determines the concentrations of chemicals a population could come into contact with. This step is followed by a toxicity assessment of the chemicals, which are estimated to be present and a characterization of the risks to a population that may be exposed to these chemicals for a specified time period.

Each of these steps poses uncertainties, which need to be quantified as best as possible, but cannot be completely determined using the techniques currently available. In particular, we need to approve our assessment of the impact of short term exposures to the typical soldier; for example, a healthy, young adult in good physical condition.

In summary, we have accomplished many tasks and overcome many challenges during the environmental quality monitoring in support of Operation Joint Endeavor. We have assessed the environmental conditions more thoroughly during this deployment than we have ever done during any deployment of U.S. forces.

This information was used to protect U.S. soldiers. We have also learned many things and have many additional challenges facing us, but feel these are solvable.

That ends my prepared remarks. I will be glad to answer any questions. I have included my phone number if you have any future questions.

DR. LASHOF: Thank you very much. That is extremely helpful.

Let me ask any of the Committee if they have any specific questions they would like to address to either Dr. DeFraites or John Resta.


DR. LANDRIGAN: I thought that was very interesting.

You said something, Colonel DeFraites, that I wanted to make sure I heard it correctly. Did you say that the health records are not yet computerized? They are in paper form.

DR. DE FRAITES: That is right.

DR. LANDRIGAN: Is there a plan afoot to computerize that? I mean, it would seem to me it would be very efficient if you had some kind of direct data entry into laptops or something like that.

DR. DE FRAITES: Well, there are two -- well, there are a number of efforts in DOD in the medical information management program -- it is a large program -- there are many efforts going on to automate medical records from many different -- the clinical direction, the preventive medicine perspective, but they certainly are not deployable.

We separately are trying to at least automate this limited amount of medical screening information that we are getting from Bosnia and we are moving from a -- since we had to deploy something right away as a contingency, we started with a stubby pencil approach and we are working to automate, so that we do have actually direct data entry into a database.

Right now, we are going with pieces of paper and turning them into a database right now. At least, these single medical questionnaires are being entered by hand.

DR. LANDRIGAN: It is a good beginning.

That leads to my next question. Is there any way that the environmental data that are being collected can be linked to a medical record? In other words, the hypothetical situation, five years from now, one of the service members who has been in Bosnia appears at a VA hospital with symptoms and wonders whether he or she was exposed to something in the air and the soil over there while they were in Bosnia. Is there any way that five years hence that the two sets of records can be linked?

DR. DE FRAITES: Yes. Certainly indirectly and we may be able to do it directly, depending on their location. We have a database of everyone who is deployed and that is being updated on a daily basis as new troops go over and others come back. So, we will know the dates that a certain person with a social security number was over there.

Secondly, we will have an idea of what their health status was at the time they left theater, based on this Phase 1 through 3 screening. So, we will have that information as sort of, you know, a little bit of information.

Then the environmental data certainly is geographically linked and we have some limited amount of ability to geographically link a person with a location, but we have not gotten to where we can track geographically a person throughout their entire time in Bosnia. We can't track their every movement.

We will know where the person was most of the time. We won't know every single location the person might have visited. We don't have that capability.

DR. LANDRIGAN: You are not doing any personal breathing zone sampling. It basically is area sampling?

MR. RESTA: We are doing ambient air sampling and we have also done some limited personal breathing zone sampling in what we would term industrial areas, heavy maintenance areas, refueling operations and the like, but not as a normal, across the board -- if you are standing at a command post or a guard post where you are getting personal air sampling.


DR. TAYLOR: How often are you conducting sampling, environmental sampling?

MR. RESTA: It varies. We will have finished in terms of water. We will have two complete data sets of all potable water by the time we are finished. In terms of soil, we will have two complete data sets of the soil conditions at all U.S. forces locations.

We have had semi-continuous -- and I use the word "semi-continuous" because the power goes out -- at the Tuzla locations for ambient air quality. We have had 30 days worth of data at six additional regional places throughout Bosnia that represent the regional conditions.

We did not set up an ambient air quality station at every U.S. -- we selected -- Camp Kine(?) would represent the camps in this area for 30 days for this summer. We have the same for Slavonski Brod, the same for the two locations in Hungary, and we have continuous baseline conditions at Lonstel, Germany, to represent what the U.S. forces in Germany would be exposed to.

DR. TAYLOR: Just to clarify in my mind, you mentioned that the levels of particulates in -- is it Lukavic --

MR. RESTA: Lukavic.

DR. TAYLOR: Are there industries there, the reason that is so high?

MR. RESTA: The reason that is there, we had U.S. forces billeted at a coke plant, not as Coca Cola, as coal. It is like Sparrows Point. They burn a lot of coal. We were using the steam and electricity. They don't have any air pollution abatement equipment.

MAJOR KNOX: Colonel DeFraites, could you tell us what is different about the pre-deployment health screening that the soldiers who are going to Bosnia are receiving versus the ones who went to Desert Storm? I mean, I see the Phase 2 and the Phase 3 are additions. But I don't really see what the difference is in the pre-deployment screening.

DR. DE FRAITES: I don't think we have made much progress in pre-deployment screening in terms of -- there is a level of individual pre-deployment screening for each person that deploys. What we don't have is a way to centrally collect that information and comment on it. You know, we have confidence it is being done on the individual basis, just like for every deployment, a medical and immunization record is reviewed and if we need updates to the immunizations, those are done. That is part of every deployment process.

So, that process is going on, but that is the same as it was in Desert Storm. We do know some data from one of the points, Fort Benning, Georgia, where troops were being deployed, gathered up in the United States and then deployed overseas. Fort Benning, Georgia was one of the sort of focal gathering, marshaling areas. We do know some basic data about what proportion of troops that showed up had a condition that required them not to deploy, just a percentage and the percentage was like, I think -- I don't really want to quote it -- somewhere around 1 percent, I believe. It was very much lower than it had been for Desert Storm. Of course, this is a whole different ball game here.

But that is all the data we have. We haven't gotten very far in terms of documenting and being able to comment on the population status pre-deployment.

MAJOR KNOX: So, we still don't have a subpopulation that we are doing a very thorough physical exam and certain lab work that we can compare post-deployment to do an epidemiological study if we needed to?

DR. DE FRAITES: Well, we do have baseline serum specimens.

MAJOR KNOX: What does that include? Is that just a Chem-7(?) or --

DR. DE FRAITES: No, it is just serum drawn and stored. We haven't done any tests on it.

MAJOR KNOX: Oh, okay.

DR. DE FRAITES: It is part of the force testing for HIV. Since the late 1980s, we have had a database and serial specimens like, for me, for example, I have four specimens in the repository that can be linked to my personnel record and you can go back and so -- we have used this repository to get baseline sera for certain limited studies we have done.

There was a question about Q fever in a unit in Desert Storm. We were able to get pre-deployment sera on a number of the troops to check to see if antibodies had preexisted from Desert Storm. We used it in investigation of malaria in Somalia to see if they had preexisting antibodies -- actually, not malaria -- excuse me. It was a murine typhus, to see if there was preexisting antibodies.

So, we are able to use it for some limited epidemiological purposes. That is the purpose it serves today. The nice part about it today is that we are able to look, given that we have a deployment roster to work with now, is that we could tell that over 93 percent of the Army troops that deployed had at least one serum in this repository. So, at least we have some baseline that we can go back to. What we don't have is a statement of what the health status was.

For this Operation Desert Focus that I mentioned, there is an -- we are making a bigger attempt to try to get documentation of health status on individuals and get that automated. So, that is the next step. We are kind of trying to take it the next step --

MAJOR KNOX: So, I guess my question -- and Phil and Andrea might answer this as well -- if someone was exposed to benzene or toluene, while they were in Bosnia, years later, if they thought they had some type of cancer from that, you could go back and check the serum samples and say whether or not there was a positive finding based on whether or --

DR. DE FRAITES: I think serum is very limited in what you can tell. One of the discussions we have had is what is serum good for and it is good for antibodies for infectious diseases but for some of these, you can't -- without knowing what the risk might be, it is very difficult to plan ahead of time of what specimens you need to get at what time.

All we are going to have is some pre-deployment sera available and then at the point they leave theater, another one. Now, most of the time in epidemiology what you do is you start with a case of a disease and then work backward to what the exposures might have been. That is the way we try to work it for the most part. So, working in this new era of trying to guess what the outcomes are going to be in advance makes it difficult to figure out what you have to gather in advance to prepare for that eventuality.

I mean, we can get the environment sample to get an idea of what the threats are and that helps. If we have to change our approach and get additional specimens, we can do that, but so far there has been nothing coming out of our surveillance efforts to date that made us feel that we needed to change our approach.

So, right now we are still sticking with the serum specimen as they leave theater. That hasn't changed. But I don't think we can guarantee that we could tell who was exposed to benzene because that is such an individual exposure in a closed location. A lot of things are going to go without our ability to detect it right now.

DR. TAYLOR: But if environmental records are kept, then there might be --

DR. DE FRAITES: Oh, sure, on a more ecological basis, but not an individual basis, no.

DR. CAPLAN: Well, I think these are still exciting steps that are being taken and I am glad to see both more attempts to coordinate where people are with medical records and the environmental sampling going on. I think that is great.

I think it is important, though -- you know, we listened to complaints about chronic fatigue, diarrhea, immune disorders, burning sperm, all kinds of symptoms and we keep coming back time and again to the need to have a good mental and physical, emotional, in-depth assessment of some subpopulation of people likely to be deployed.

I understand these are quite likely to be pretty healthy populations, at least on the face of it, but, nonetheless, one question I have is do you see this program evolving toward what we are starting to ask about in terms of a better subsample, not necessarily every soldier, but a better subsample being able to be monitored in some depth, so that we have a better health profile against which to then assess things later?

Is that momentum there, given where we have come so far or are we down the road about as far as you think we are going to be for awhile?

DR. DE FRAITES: Well, in terms of -- I guess what we haven't tackled yet is exactly how -- what we would need to do to get adequate information on an identified subset because for one thing that I have been struck with is, number one, is most persons who come into the military are gone in three years. If we could identify in advance who was going to stick with it, then for one thing we may treat those more likely than not. On the other hand, not everybody can be generals. So, it would be good to have some of these people that come for three years and leave.

But that makes it a challenge if you are going to start a mini-Framingham-type cohort approach. It is a very expensive undertaking and your attrition rate is going to be tremendously high. If you start your cohort at the beginning of a contingency operation, you don't have much time to do anything and everything that you will do will have to be done on the fly, which makes it sort of limited what you are able to do right at the spot.

A combination of what I heard with, you know, some more baseline, ongoing assessments that you can then later tap into might be the way to go. We are still -- the work group and this draft DOD instruction, we are still wrestling with a lot of these ideas and what is going to be feasible and actually produce something that is worthwhile.

For Joint Endeavor, one of the things we are going to do is revisit some of these health threats. I mentioned hantavirus and tick-borne encephalitis and there are some plans right now to use some of the serum and actually do a study to see what the rate of seroconversions might have been, even though we only had one case. I mean, how many subclinical infections -- what was the real risk?

That, we see, is a real practical application to having to go back in this area or some other area in the future that has this problem. So, that is how we are trying to see what we have done that actually turns out to be of some practical use.

DR. CAPLAN: My other question for Mr. Resta is, you know, this committee has heard a lot of testimony about attempts to detect chemical, biological weapons in the battlefield theater. You are out there trying to do some environmental sampling, kind of baselining, and I think that is a very useful thing to have, too.

To what extent are you able to coordinate with what the combat monitoring is in terms of what suddenly might appear on the battlefield in terms of unspent rocket fuel or whatever?

MR. RESTA: During this deployment, the personnel from the 520th TAML, again, when we talk environmental monitoring, we are talking four individuals. There are force protection issues in Bosnia that you need a minimum of a four vehicle convoy with a gruserved(?) weapon. It is not a walk down the street.

They partnered with -- I don't know if you are familiar with the Fox Recon Vehicles. They partnered with the --

DR. CAPLAN: More than I ever wanted to be.

MR. RESTA: They partnered with the Fox Vehicle teams and actually conducted joint recon missions with these teams, such that they had the wheels. We had the people and it was an ideal partnership. We are looking at that in terms of doctrine now, how that is going to work. You know, they are different branches of the Army, but they all still wear green.

DR. CAPLAN: Just to follow up there, should Bosnia turn into a war theater or this kind of deployment be attempted somewhere else, I guess the basic question I was going to ask is -- the intention isn't to pull you out. It is to keep you there, right? In other words, as risky or as dangerous as this might be --

MR. RESTA: All the individuals with the medical lab are military. They all carry weapons. They are Medical Service Corps officers, but so are most of the people in the hospitals. So, they are there for the duration.

DR. DE FRAITES: I think at the work combat operations, one thing you have got to appreciate that makes this already difficult job that much tougher and I think, you know, we have talked here about Somalia and Vigilant Warrior and now Bosnia. There has been very little shooting, very little combat at all. It is one thing to sort of stand on our laurels, but we really don't know how this will stand up once there is an actual combat situation. It will make it a lot more difficult to do some of this environmental sampling and some of this in-depth surveillance. It is going to be a little bit harder to do.

DR. CAPLAN: That was actually the question for you because one thing that stuck in my mind that we heard about at an earlier hearing was the relative unwillingness of people leaving the Gulf theater to hang around for a physical or fill out anything or look at a form once they were told they could go home. They tended to exit rapidly.

Has there been some attention paid on the leaving the theater to the importance of having this paperwork done, that physical done and so forth? Is that something that in order to round out this picture, so if there may be problems later, we can say, you know, we are working to make sure that they are going to get the physical when they are discharged or let out of the battlefield theater or shortly -- if they came back to Germany or wherever it is going to be as their release point back to the States.

DR. DE FRAITES: Well, that is one of the reasons for having the Phase 1 before leaving the theaters. You have them all in one place and you still have a great deal of control and they are not scattered to the four winds. So, that was sort of the rationale behind trying to get at least Phase 1 done while they were still in one place. We have had good success getting the mental health screening, the blood draw. That is why we put the serum there, so we could get good capture on pretty much a hundred percent of the population as they left.

This is all part of their redeployment processing. So, they have to check this box off on the form. So, using some of these administrative controls has turned out to be pretty successful because trying to gather them up after they have gone back to Germany and the U.S. is a lot harder to do.

DR. BALDESCHWIELER: Another question, Colonel.

I noticed in your early slides that you mentioned some more sophisticated environmental monitoring in the Kuwaiti theater of operations. I wondered if there are results back; that is, have you seen anything interesting or unusual in that monitoring?

MR. RESTA: I think there is a report published on that and from recollection, and don't quote me directly, but basically the conditions were better than during the Gulf War or mostly during post-Gulf War and that is due to the extinguishment of the oil fires.

DR. BALDESCHWIELER: But there are also people currently deployed, aren't there, to Saudi?


DR. BALDESCHWIELER: And Kuwait as well?


DR. BALDESCHWIELER: Are they being monitored to see if they are picking up anything unusual?

DR. DE FRAITES: This is part of this Operation Desert Focus. That is the redeployment of troops within Saudi Arabia. That environmental is part of that operation. There have been -- I think the report of Vigilant Warrior goes into some of the revisits to the Saudi and Kuwait theater that the environmental group from the Center for Health Promotion and Preventive Medicine have made.

So, there has been an ongoing relationship with troops that are over there and there has been a limited amount of environmental surveillance, mainly because the troops are in one location, have already characterized that location about as best as it can be and nothing has changed.

DR. BALDESCHWIELER: And how about the troops, is there any evidence of pathology of any kind?

DR. DE FRAITES: No. The ones that have spent time in Kuwait and -- no, there hasn't been any.

DR. BALDESCHWIELER: And rotated out, of those who were there.

DR. DE FRAITES: Some of those, of course, were Desert Storm veterans that have gone back on subsequent tours of duty. But there has been no recognized problems with people that served a regular tour of duty over in Kuwait. The numbers are very small, though, very small populations.

DR. BALDESCHWIELER: Roughly, what are the numbers?

DR. DE FRAITES: I am not a -- I don't know.

DR. BALDESCHWIELER: 10,000 or 20,000 people

or --

DR. DE FRAITES: No, not 20,000, no.

DR. BALDESCHWIELER: Less than 10,000?

DR. DE FRAITES: Yes. It may be hundreds rather than thousands. I don't know. It is a very small number when you compare it to half a million in Desert Storm.

DR. BALDESCHWIELER: It seems to me that is a wonderful control group in the sense that, for example, if one is dealing with significant effects of stress or other combat-related matters, this is a -- I mean, this is potentially a very useful control.

DR. DE FRAITES: Control for?

DR. BALDESCHWIELER: For the source of the veterans' illnesses that we perceive from the group that was exposed to combat conditions.

DR. DE FRAITES: Well, they were also not exposed to oil fires and the threat of biological and chemical weapons. I mean, there are so many -- I don't know if it is a good control group or not. I would have to think about it. On the surface, I can think -- and also the environment now in terms of the recognition of the threat and how these people perceive a threat. But it may be. It may be a --

DR. CAPLAN: I think what is being suggested, too, is that we have heard about tick-borne, flea-borne particulate matter in the air. There are some things that are still there affecting this population that maybe could be ruled out if their health is still good that aren't related to combat or battlefield deployment or depleted plutonium or 50 other possible causes. Some have remained steady. We have heard about certain environmental exposures that might be the cause of illness. Those are assumably still there, some of them. I never say this right, lestosomiasis(?), whatever that --

DR. DE FRAITES: Leishmaniasis.

DR. CAPLAN: Leishmaniasis.

That sort of -- assumedly, the fleas didn't leave. They did not redeploy.


DR. BALDESCHWIELER: And you have environmental monitoring of certain levels in certain places of chemicals and particulates. So, if you have repeated those measurements, then you must have a relatively interesting time line.

DR. DE FRAITES: It could be. I would have to see the report.

MR. RESTA: Essentially what we have is another data point and we are in the process of trying to collect a third data point as we speak now.

DR. BALDESCHWIELER: By one data point, you mean in a --

MR. RESTA: Another event, another sampling event, during another --

DR. BALDESCHWIELER: A summary of measurements over a geographic --

MR. RESTA: Geographic area, different clime conditions.

DR. PORTER: I have a question. I wanted to step back for a moment and ask to what extent the data collection efforts in the TAML and in Operation Joint Endeavor are integrated into the larger information collection picture. Are these efforts part of the theater medical information program, the TMIP? And is there a medical desk in Bosnia or in Europe, where all of the information coming from these various endeavors is collected and then are decisions made on the basis of a number of kinds of data that are coming in? Can you comment on that?

DR. DE FRAITES: Right now, probably the focus for those data are -- is here in Washington with a Joint Preventive Medicine Policy Group, which is comprised of the preventive medicine representatives from the services and the joint staff in health affairs.

All the information from -- that is gathered in Bosnia is also given to the European Command Surgeon in Germany, who has overall command and control of the whole operation. In terms of the raw data, that is scattered right now.

We have a deployment surveillance -- a DOD deployment surveillance team, which is a data gathering and analysis group that is in Falls Church. That is a DOD organization, right now ad hoc, but it is where most of the data is being collected. If there was one location you had to go to for the data, they have the deployment personnel rosters, all the data that is being collected in the screening and the locators for the serum specimen; in other words, the identifiers for the serum specimens.

DR. PORTER: So, it is really in the U.S. So, the equivalent of a medical anchor desk is really stateside?

DR. DE FRAITES: That is right. Well, in terms of in-depth analysis of the data that is true. I mean, there are medical desks elsewhere and the data sort of summarized is given to those people, too. That is one of the points in surveillance is to try to gather it up, you know, analyze it at one place and then feed it back down the chain to make sure everyone is informed of what is going on.

That is what is being done. That is one of the challenges that John was mentioning about how to get this data back in a form that can be used in an expeditious way, to all members of the chain of command, all the way down back into theater again, which is the ones that really need to know.

DR. LASHOF: Any other questions?

DR. BRIX: Dr. DeFraites, I have a question about the form that medical surveillance takes out in the field. By that, I mean, are there two ways that outpatient visits could be recorded? They could be recorded as part of an individual medical record. Someone comes in with a cut finger or low back sprain and so on. Or they could be recorded as part of a medical log that has data for individuals listed -- several individuals listed on one page.

My question is how is that data currently collected in the outpatient forum and if it is kept as a medical log, is that information then transferred to the -- an individual's medical record that could be accessed after they come back to the States?

DR. DE FRAITES: Each outpatient visit results in a form being generated that records the details of the visit and then separately is a log sheet with a diagnosis on it. That is the way it works. So, for your surveillance purposes, you go with the log sheet, but for the medical record, you have got this, you know, handwritten form that the doctor fills out at the time.

DR. BRIX: So, it is recorded two ways then?

DR. DE FRAITES: Right. And usually you go with the log sheet is how they sign into the aid station. I mean, you go back and the physician puts the diagnosis next to the --

DR. BRIX: But on that progress note where that patient is seen, that stays in country and then has to marry up with the individual's --

DR. DE FRAITES: Right. And there are different ways that that gets done or doesn't get done.

DR. LASHOF: That is the question. Have we improved the system, that it does get done instead of not getting done?

DR. DE FRAITES: I can't say that we have improved the system by which those individual sheets of paper are put back in medical records. That is a challenge for the future is how to get these records done. I think automation of the medical record is the way to go. Everybody, I think, knows that, but just how to accomplish that is the big sticking point and what time line, I really couldn't say.

DR. JOELLENBECK: For Mr. Resta, you had a slide that was describing the flow of information and how it -- the results of your analyses at CHPPM get back to various points. Where are the decisions made that would be in response to that analysis of the environmental data?

MR. RESTA: In terms of decisions, you would probably -- assuming you are referring to, say, a countermeasure, somebody stopping something, changing something --


MR. RESTA: -- that would be made down -- what we say down range. That would be made in Bosnia by the commander on advice from medical. So, it would go to the 520th TAML or the 30th Medical Brigade or a preventive medicine detachment. Wherever it went to, they would advise the commander that we would need to stop drinking that water or not drink that water.

In the case of water, they didn't drink it until we told them it was clean essentially. So, they would say that water is not approved for consumption, something like that, but it happens locally. It doesn't happen back here.

DR. JOELLENBECK: Was the movement of the troops from Lukavic, did that have any connection to the ambient --

MR. RESTA: None whatsoever. That was part of the redeployment plan as we -- I think the term is "retrograde" out of Bosnia, we have moved most of the people in Lukavic who were support staff, logistics and the like, they have already moved to Slavonski Brod, which is where the main U.S. forces go through on their way out of the theater.

DR. JOELLENBECK: You also spoke about improving the amount of time that it all takes. About what is that now?

MR. RESTA: In terms of chemical analyses, it is averaging about seven days from the time it hits our door at Edgewood. For drinking water in Europe, it is 48 to 96 hours. And then the trick is to assemble enough data to make sense out of -- make information out of the data. Right now we probably, I would say, estimate two to three weeks. That is simply because we didn't feel like we should rush to report negatives.

We haven't had anything of concern. So, we didn't need to create a process to, you know, fire up an alarm or anything like that. If we had had a problem with heavily contaminated media somewhere, we would have probably sped up that whole process. But we didn't feel the need to do that, make people work, you know, 24 hours a day just to tell them there is nothing there.

DR. JOELLENBECK: Are you sharing the results of your analyses with the other coalition forces?

MR. RESTA: We are sharing, I guess on the -- within the U.S. sector, there is a Nordic Brigade and a Russian Brigade, where we have done -- we, the U.S. forces, have done environmental health surveillance of their locations. They have gotten the results. I am not aware of any sharing with, say, the Brits in their sector or the French in their sector, although we did do one mission in Sarajevo, where some NATO -- U.S. forces attached to NATO were stationed and we probably shared that with the French. But I am not aware of any, you know, high level sharing of information. We have been talking to the Brits a little bit. They are interested in what we are doing here, but nothing formal.

DR. BRIX: I have one more question for Dr. DeFraites.

In your testimony, you mentioned that some of the elements of the deployment surveillance program that you outlined for us probably need to be altered or replaced as a result of some of the lessons learned in Bosnia. I realize that everything takes time and resources and staff and so on, but what are some of the elements that you think need some improvement?

DR. DE FRAITES: Well, I think one of the things we were concentrating on and it is something I already alluded to is what is the proper timing of redeployment screening. There is a tradeoff between getting good capture of a hundred percent or nearly a hundred percent of the people but then do you get information that is of any use to you? I don't know the answer to that right now.

I think it really depends on what you think your outcomes are going to be. Are they going to be delayed or are they going to be immediate? If for acute effects there is nothing that -- which some of these mental distress and mental health issues, the timing of doing the screening at the time they are leaving a theater may be the most appropriate. It may not be. I think we are going to be revisiting that issue of, you know, do we need to do more or change the timing of the mental health questionnaires and sort of the stress evaluation because for all we know, the high stress time may be 30 days or 60 days after you redeploy back home or you may have to do it twice.

That is one example, I guess, is just the timing. You know, this is the first time we have really done it this way and I think we will just have to see when we look at the objectives that we hope to accomplish with a screening and whether or not we have reached them.

Another one would be the serum specimen, how useful is this going to be to collect thousands and thousands of serum specimens for each major deployment? Are we going to use them? Is it really worth doing that way or is there some better way to do it?

DR. BRIX: Since you mentioned mental health, I have a related question to that.

Can you describe how the combat stress control teams' efforts have been accepted so far by the troops and by senior commanding officers? And also, what kind of interaction feedback is there between the preventive medicine teams and the combat stress control teams?

DR. DE FRAITES: Well, I don't know if we have any data about acceptance of the combat stress control teams. The combat stress control units are very much involved in doing the screening as the units are leaving country, as people are leaving the theater. I don't know how that translates into acceptability.

There have been some -- in addition to the screening, there is a study of a sample of troops that actually started before they deployed. So, for the mental health part of it, actually your desire for a focused sample was already anticipated by the Army's medical research unit in Europe, who specialize in combat stress. They had identified the pre-deployment time as a time of stress. They had identified some troops to do targeted screening before they deployed, mid-deployment and then after they return. Of course, they haven't -- I think they are only halfway through that. They have done the mid-deployment screening.

I think those are -- that type of approach is also dovetailed with what is called a human dimensions team, which does some focused mental health type surveys in units, similar to in Haiti. When there was a cluster of suicides in Haiti, there was a concentrated effort to address the mental health concerns at that time. I think in that type of crisis circumstance that they are very well accepted.

Fortunately, we haven't had nearly the amount of concern generated in Bosnia. So, I don't really know how acceptable, but I do know the human dimensions teams deploying as part of deployments has been a regular way of doing business since at least Desert Storm. So, I would think that by now, I think you could say by the fact that they keep going back and are invited back to the theater, that they are accepted at some level.

The other question was?

DR. BRIX: The other question is there is interaction and feedback between the combat stress control teams and the preventive medicine teams? Is there any kind of interaction between them?

DR. DE FRAITES: I don't know. They are not part of the -- the combat stress control teams are, of course, part of the 30th Medical Brigade structure. So, they are members of the same team. How much professional interaction there is, I couldn't say. I think we could find out and get back to you on that, though. I think we could look into that a little bit more and get back to you on that.

DR. BRIX: Please.

DR. PORTER: I have one more question for Dr. DeFraites.

You mentioned health education and training. The question is what topics are covered in the health education and training for the troops before deployment and is that kind of training reinforced after they arrive in theater? How do we know that the information is in understandable language?

DR. DE FRAITES: That is a great question.

The types of information that is covered -- actually, I have it on these little forms, but generally we use the -- the basis for the information is derived from the health -- from the medical threat, the environmental, infectious disease, plus the mental health aspects of what we consider to be the whole picture of what the medical threat is.

So, we give -- for Bosnia, for example, we gave briefings on tick-borne encephalitis; so, in other words, precautions you need to take against tick bites, what hantavirus infections could do, since hantavirus was one of these infections that was certainly highly endemic in the Balkans. So, for infectious diseases, those were two examples.

We also cautioned people against drinking enough water and getting food from unapproved sources for reducing the risk of diarrheal diseases. From the environmental side, we talked about, as John mentioned in one of his slides, he had what exactly the threat information was. That was restated in the format of briefings giving to troops before they deployed, as well as these little individual handouts that were given to them.

And that message was reinforced by the preventive medicine units actually in country. So, they do things like -- for every deployment, there is usually a tabletop publication, like a newspaper or a newsletter and they always have preventive medicine issues as columns in that newspaper since, other than sports scores, I mean, you have got to find something to fill it with. So, they sometimes will ask the -- we can sometimes get some column space in those newsletters.

So, that is used. And then after they return as part of their redeployment, we also reinforce some of these things, emphasizing those things that may not be present now but will be a problem, perhaps a problem, after you get home, that if you have a fever, you should go see a physician or you may well have some of these -- depression or stress may be a problem and to be aware of that.

We are making some effort with the reserve units especially to -- there is going to be some mailed questionnaires to the reserves, who were mobilized and deployed, actually asking them whether they thought this was of any use, some of these interventions that we thought were useful, to see if really they remembered even seeing them, number one, and secondly, if they thought on a personal level they were of any use.

That is about our extent right now of how we are determining the efficacy of this type of approach. But we will try to hit them from a number of different media, from that -- you know, that approach, just to see and, again, that is kind of the extent of what we have done so far.

MAJOR KNOX: I would just like to make a comment that, you know, it sounds as though you are trying to improve the efforts and you should be commended for doing that. We are pleased to see that you are looking at pre-deployment screening a little harder.

DR. LASHOF: Thank you very much. We do appreciate your appearing.

We will adjourn now. Let me say, though, tomorrow -- or recess, we don't adjourn until -- sorry. I am very technical around here. We recess until tomorrow. We are beginning at 9:30. There is a change in the agenda. We will begin with the discussion of stress. Dr. Hamburg will have to leave early. So, the first thing on the agenda, 9:30 tomorrow morning will be the staff memo on stress. Then we will move to access to care. We will be hearing from the principals in the afternoon at 3:00.

[Whereupon, at 4:45 p.m., the meeting was recessed, to reconvene at 9:30 a.m., the following morning, Thursday, September 5, 1996.]