October 2001 Study Assembly Meeting Director Remarks

 

 

DR. ALEXANDER: Woodie, thank you very much. And thank you for providing me with the opportunity to speak to you on this very important and significant occasion, and for your contributions to the important effort of the National Children’s Study. This is a huge turnout. Dr. Scheidt tells me there is over 350 people registered and here for this event and all of you have left important other work back home or at work, business, to come here to share your expertise, talents and enthusiasm with us on this important piece of work. It gives us an indication of how important you consider this when we recognize what you have left behind to come and share your time and your efforts and skills and knowledge with us, and we very much appreciate it.

Few of us thought when the concept of such a prospective longitudinal cohort study of children first surfaced in the Developmental Disabilities Work Group about three years ago that we would actually see this study coming to fruition and have a gathering such as this today so soon but, in fact, it has happened and I think it is, in part, the merit of the idea and part the enthusiasm of both the federal and nonfederal participants in this effort that has made us come this far this fast.

It is a daunting responsibility to be given congressional authority and responsibility for putting together and overseeing the development and implementation of such a huge study. And I can sleep at night, I tell you, only because I have such outstanding staff working on this with enthusiasm, with vigor, with intelligence and skill and devotion that they bring to this task. Thanks to them, thanks to your efforts, this is going to happen.

The events of September 11th highlight even more the critical importance of protecting our children and understanding the possible effects that many exposures may have on them. Many meetings in Washington since then have been canceled, postponed, rescheduled, but we went ahead with this one anyway. We felt that it was important to do and that the importance of this study is impossible to overestimate and we needed to get on with this.

This study is going to help us learn what is harmful, what is helpful to children and their families, and from many standpoints in the environment. From the physical environment, the social environment, the behavioral, the cultural, the medical, the educational environment, all impacting together on child development.

It is also going to help us because of its broad focus over time from before pregnancy, before birth, during pregnancy, the process of labor and delivery, the time period of the newborn infant and infant’s development, the toddler stage, middle childhood, adolescence and even young adulthood.

This study is going to provide the scientific basis for high quality clinical care, for smart public policy, for healthy growth and development of future generations of children. it is also going to provide a valuable national resource for child health research for decades.

There has really never been anything quite like this study before. The forbearers of this study are several. The Collaborative Perinatal Study of the 1950s and ’60s run by the National Institute of Neurological Disorders and Stroke. That was a study of about 60,000 pregnancies followed for seven years focusing just on one outcome. Cerebral palsy in relationship to the pregnancy, labor and delivery experience. A relatively simple study when compared to the magnitude of what we are undertaking here.

Another parallel is the Women’s Health Study of much more recent vintage, the early 1990s. There the cohort is of comparable size. Around 100,000 women but in three different protocols all looking at three intervention studies with about ten year outcomes but much more limited in size and scope than what we are talking about here.

Possibly the closest counterpart is the Framingham Study that has been going on for many years. It is clearly a very pointedly longitudinal study but it started with adults, not with children or infants. It was conducted only at one site and though we have learned an enormous amount from it, its applicability has some limitations because it is just one site and not a particularly diverse population.

With this study, the National Children’s Study, we are talking about recruiting 100,000 families some time during the process of -- during pregnancy. We are going to follow them to 21 plus years of age. We will be recruiting from 50 sites around the country and efforts to make their sample as representative as possible.

There is not an intervention, not a specific intervention. There are, in fact, many, many, many interventions and we must take account of all those interventions in children’s lives as we gather our data in an attempt to analyze it.

There will be a huge number of variables, observations, tests and outcomes to assess in a very diverse population.

So really we are trying something on a scale and magnitude that has never been tried before in the United States or anywhere else but we have the technology, the ability, the knowledge to get it done.

Much progress has been made already implementing this study and you have been part of that process and will be a part as it continues. A structure that involves the best federal and nonfederal scientists is available for planning and oversight, and you are part of that. We have had a chartered advisory committee approved and is being established within the Department of Health and Human Services.

Initial pilot studies have been designed and are actually underway and funded. Studies of various design methods for the study, various ways of recruiting samples, various ways of sampling the environment, including microanalysis capabilities, and various ways of data management just to mention a few.

Working groups are established for detailed scientific planning and you are already starting to hear progress reports from several of those here today.

There is an almost unprecedented degree of interagency participation, partnership and coordination from the Federal Government. If you just look at the agencies that are presenting as part of your agenda, you notice that there is the National Institutes of Health, the Centers for Disease Control and the EPA, the triumvirate of leadership for this study but also the Agency for Healthcare Research and Quality, the Office of the Secretary of Health and Human Services, the National Institute of Standards and Technology, and top people from outside the government as well.

The consortium of federal agencies numbers in excess of 40, counting institutes, centers, offices that are all meeting partly at this conference and have met in the past to get on with the work of this study.

A web site has been established and a new independent web site is currently being developed.

As you heard announced here the name for the study has been selected, the National Children’s Study, and the logo is being developed and finalized.

What about the status of funding? Everybody needs to know where are the dollars going to come from this? What are our chances of getting them? Well, so far the National Institute of Child Health and Human Development, the Environmental Protection Agency, the National Institute of Environmental Health Sciences, and the Centers for Disease Control have invested sums from their budget allocations and appropriations in fiscal 2001 to begin this process. We have awarded funds for studies as well as sponsoring the meetings and other activities totalling over $2.5 million in fiscal ’01. For fiscal ’02 we have identified $5-6 million for continuing this process and we anticipate at least $10 million in fiscal 2003. This is not as much as we would like to have, not as much as we could usefully spend, but it will get us well underway with this process.

We are still hopeful that we will get additional funds from fiscal 2002 from the existing agencies as well as possible contributions from elsewhere -- other agencies as well.

Nonetheless, there is a consensus that for the full national study substantial newly appropriated funds are going to be required. Our budget projections suggest that at peak enrollment time this study may cost $150 million a year and that will run for several years. With the dollars dropping off after enrollment while we maintain the cohort, do periodic evaluations and follow-ups.

We are working with the Department of Health and Human Services and with the Environmental Protection Agency in preparation for visiting with Office of Management and Budget officials to plan for the future funding of this study, identifying where the funds will be placed, whether there will be one site, several sites, many sites, and assuring that the funds that the Congress has directed to be appropriated will, in fact, be made available.

We anticipate a core for this study that will entirely funded by the Federal Government with the possibility of some additional or adjunct studies funded with nonfederal public-private partnerships. This is still in the discussion stages and we will see how this plan evolves over the course of the next year or two.

I can tell you that the support for this study is strong and broad in the Congress and in the various federal agencies. The report language most recently from the appropriations committees and the House and the Senate expresses pleasure with the progress that is already being made on this study and encourages us to proceed vigorously with its implementation and planning. We also -- this is a follow-up to the mandate that we received to do this study from the Children’s Health Act of 2000.

We believe that the prospects for funding and carrying out this study are quite realistic and with continued support from nongovernment entities we will, I think, be able to go over the top in achieving the funding that we need as we raise awareness and promote the study.

I would urge you to provide this activity on the part of those -- on the outside nongovernment agencies and organizations. I rarely speak to any group these days without mentioning the study and its applicability to their interests and concern. When I talk to groups involved with autism, with birth defects, with mental retardation and developmental disabilities, with learning disabilities, and with many other conditions affecting children and adults, I talk about this study and what it holds in terms of information that it can provide in their area of interest and concern.

Never is there a lack of enthusiasm and excitement generated as a consequence of those remarks and I suspect that many of you as you have talked with organizations about the study and the potential that it holds have had similar experiences of an excited and enthusiastic response.

It is our job together, both those of us on the federal side and those of you in outside organizations, to try to generate just this kind of enthusiasm and excitement because we are going to need this if we are going to get the bill paid to do this study.

So I urge you to do the same as we are doing on the federal side in trying to generate enthusiasm from the populous at large as they interact with their members of Congress to provide the funding that is going to be needed for a project of this magnitude.

The funding of projects this size from the Federal Government is always uncertain and incremental. We often shudder when we remember the supercollider/superconductor project that got underway only to have its funding withdrawn. So we do live in an uncertain environment, an uncertain time, but we hope that with the enthusiasm that is generated by those of us on the inside and those of you on the outside, we can maintain the enthusiasm for this project even at the cost that it is going to require because of what it promises to deliver.

We all need to make this study so good, so exciting, so full of potential for a wide variety of questions and issues that the only questions from funders when we present it to them will be, one, why haven’t you asked us to do this before and, two, will this money that you are asking for be enough to tap the potential or do you need more?

(Laughter.)

DR. ALEXANDER: Now you all are a key component of our efforts to generate these two questions. Partly by your help in planning to make the study so good that it has that kind of appeal and partly by your efforts to help sell it to the public and generate the broad support that is needed for a project of this size and price tag. We at NICHD, NIEHS, the CDC and EPA are committed to doing our part to make this happen and with your help I am confident that it will happen.

Thank you very much for your help and your assistance and your presence here today.

(Applause.)