Landmark National Children’s Study Launches in US

In the United States today, 1 in 25 children have autism spectrum disorder; 1 in 4 children in Queens, New York, have asthma; and 30% of the kindergarten children in a North Florida school district are overweight. Today, these statistics don’t seem unusual. Obesity, childhood diabetes, autism, and other diseases afflict more and more children every year. Without a doubt, these statistics should alarm us. And the trend toward increased childhood disease seems to be on an irreversible path. But what if we knew what caused these diseases? Could we then figure out how to stop them?

Yesterday, the National Institutes of Health announced the launch of the National Children’s Study, an ambitious, decades-long project that may well reveal the causative factors of a host of childhood — and adult — illnesses.

One of the key figures behind the study is Phil Landrigan, MD, MSc, who directs the Children’s Environmental Health Center at Mount Sinai School of Medicine in New York City. Landrigan is also the chairman of the Department of Community & Preventative Medicine, as well as a professor of pediatrics there.

If you don’t recognize Dr. Landrigan’s name, you will recognize his critically important contribution to your health. In 1976, Landrigan, along with Dr. Herb Needleman, documented widespread lead poisoning in children. This information persuaded the US government to mandate an end to lead in paint and gasoline. Referring to Landrigan’s and Needleman’s work, Dr. Michael Shannon, chair of the American Academy of Pediatrics Committee on Environmental Health, was quoted in The Lancet as saying, “In complete correlation with the reduction of lead from these sources, the blood lead level of every child, actually every American, fell by more than 40%. It was an absolute monumental achievement.”

Landrigan will head the first of seven Vanguard study sites, all of which will open in 2009. Some 40 centers are planned. Landrigan’s center, in Queens, New York, began to recruit study volunteers January 13.

We spoke with Dr. Landrigan by phone from his New York office. What follows is the first of two interviews. Our second interview, with Dr. Jeff Murray of the University of Iowa Hospitals and Clinics, will run tomorrow.

Every child deserves a healthy environment in which to grow and learn.

BPGL: Tell us about the National Children’s Study.

LANDRIGAN: The National Children’s Study is the largest research study of children’s health that’s ever been undertaken in this country. It’s what we call a prospective epidemiologic study, which means it’s going to enroll moms very early in pregnancy and follow the children out to at least age 21.

The goal of the study is to identify factors in the environment that cause disease in children, like autism and childhood cancer, attention deficit disorder, asthma, diabetes, birth defects, prematurity, and low birth weight.

To assess environmental exposure, we’ll do a history for every mom in the study during her pregnancy. We’re going to get samples of blood and urine from each mom at several points in pregnancy, to measure levels of several hundred chemicals in the blood of each mother. We will also be assessing personal behaviors such as drug, alcohol and tobacco consumption, the social environment and the environment of the community in which each mom resides. We are looking at those issues, because we strongly suspect that social and community factors interact with chemical exposures in the causation of disease in children.

We’ll get a sample of umbilical cord blood from each baby at the time of delivery. We’ll be tracking the babies very closely as they grow up, with exams at 1, 2, 3, 5, 8, and 10 years of age, with very thorough developmental assessments at several points along that ladder. The overall goal is basically to link environmental exposure in early life to the subsequent development of these kinds of diseases in kids.

Children in the study will be followed from before birth through young adulthood.

BPGL: I understand the NCS is similar to the Framingham Study of heart disease and stroke. Can you elaborate on that?

LANDRIGAN: The Framingham Heart Study is the model for the National Children’s Study. Back in 1948, at a time when rates of heart disease and stroke were rapidly skyrocketing in this country, the Public Health Service went to the city of Framingham and undertook a prospective study of the population of the whole city. They signed up people for the study, took a history and physical examination on each person, measured their blood pressure, and so on. They tracked the people prospectively through the years to see what the risk factors were for heart disease and stroke. It was out of Framingham that we learned everything that we now understand today about the risks for cardiovascular disease.

So, for example, it was Framingham that taught us about cigarette smoking, high blood pressure, cholesterol, triglycerides, obesity, diabetes, sedentary lifestyle — all that information came first from Framingham and has since been replicated in other studies. It’s acting on that information about preventable risk factors for disease that we have succeeded in this country in knocking down the rates of heart disease and stroke by about 60 percent. It’s really one of the biggest triumphs in public health in this country in the last half century — and one of the least broadcast.

Study results will be used to improve children's health and well-being.

BPGL: I read on the NCS website that finding the causes of diabetes one of the primary foci. What else are you planning to study?

LANDRIGAN: There are about 20 primary foci. And they’re all specified in the planning of the study. I mentioned autism, diabetes, childhood cancer, asthma, attention deficit disorder, also in older children, mental health problems like depression and schizophrenia.

BPGL: Will you follow diet as well?

LANDRIGAN: Yes. We’re also getting DNA on everybody, so we’ll have a chance to look at genetic factors.

BPGL: Are you also looking at immunizations?

LANDRIGAN: Absolutely.

BPGL: Since most kids are required by their school system to be immunized, will you have enough controls for comparison?

LANDRIGAN: The study is going to be following 100,000 children. So, in a population as large as this, there will be children who do not get immunized. We know from national vaccine rates that this large number of children will give us a substantial number of kids who are not immunized.

If you’re thinking about autism, the math says that 1 in 150 children is currently diagnosed with autism. In a population of 100,000, we will have about 600-700 hundred kids with autism, or at least with autism spectrum disorder. So that should be enough to really take a very careful look at if vaccines are related to autism or not. If they are, we’ll have a chance to look at that. And we’ll also have a chance to look at a lot of other potential factors for autism, like prenatal exposure to pesticides or lead or other chemicals.

BPGL: Will you be sampling the air in the environment as well?

The National Children's Health Study will assess physical and mental development over two decades.

LANDRIGAN: Yes. We’ll doing sampling in the home, in the air, and as I mentioned, sampling of the mother herself during pregnancy, so that we can see what chemicals the baby is seeing during the nine months of pregnancy.

BPGL: In the recruitment process, is there any danger that parents may be self-selecting?

LANDRIGAN: We hope not. There’s an element of risk of that, of course. The study is set up according to very strict principles of statistical sampling so that it can be conducted in 105 counties across the U.S. Those counties were selected entirely according to statistical methodology. Then within the counties, we’ll be going to certain communities and certain neighborhoods, which again, have been selected entirely according to principles of statistical sampling. And then, the way we try to avoid self-selection is that we try to maximize the percentage of families that join the study. The higher the percentage of families in a given community that join the study, the less the risk of self-selection. It’s always a concern. We’re always worried about it, but we try hard to avoid it.

BPGL: I’m curious why the research study is just getting started in 2009, when it was authorized in 2000.

LANDRIGAN: There are a couple of factors. This was an enormous planning effort. So, from 2000 to 2005, we spent planning. The first contracts to actually do the study were awarded in September of 2005. Our group in New York was one of seven groups around the country who got contracts in the first wave. If all had gone according to schedule, we would have started sometime in 2006.

But what happened was, in February of 2006, President Bush declared that the study was not a funding priority, and he directed the NIH to close it down. We therefore had to postpone our fieldwork and instead work through the Congress to save the study. We had to do that each of the last three years. So, only now, we’re getting into the field.

All children will benefit from the results of the study in years to come.

BPGL: Do you have confidence that you’ll receive steady government funding once the study launches, so that you can continue your important work?

LANDRIGAN: We’ll be working to ensure that. We’ve survived so far through some very tough times, so we hope that we can continue [for the full term of the project]. Because we’re increasingly concerned that early exposures may be the root cause of disease later in life, things like cancer, Parkinson’s disease, dementia … my own feeling is that once you launch a study like this and once you invest the extraordinary amount of energy that you must invest to sign up families and keep them with the study for 21 years, that nobody, least of all the families themselves, are going to want to break away at that age.

The Framingham study is still going after 60 years. They’re now in the third generation. In Framingham, they were signed up as adults, but they picked up the kids who were born to those adults and followed them through. And now they’re into the third generation.

BPGL: Could you tell me briefly about your instrumental role in setting this study up?

Dr. Philip Landrigan, one of the driving forces behind the National Children's Study and head of a Vanguard study center in Queens

LANDRIGAN: I was part of it. Back in ’96 – 97, I served for about a year as a special assistant to Carol Browner, when she was the administrator of the US EPA. I set up the Office of Children’s Environmental Health at EPA. It was basically out of the work of that office that we conjured up the idea for this study.

We came to realize that rates of disease like cancer, asthma, autism, were rising in this country. We realized that kids are surrounded by chemicals, that kids are very susceptible, very vulnerable to chemicals, and that we knew far too little about the effects of the chemicals on kids’ health. So we said to ourselves, Hey, we need a big study that builds on the little bits and pieces of evidence that we have, and create a much more systematic body of knowledge about the impact of chemicals on children’s health.

BPGL: Was Carol Browner supportive of that?

LANDRIGAN: Extremely.

BPGL: Is there anything else you’d like to our readers to know?

LANDRIGAN: Here at Mt. Sinai Medical School, where I’m situated in New York City, we’re not only doing the National Children’s Study, we’re also very much involved in training the next generation of pediatricians who are going to be the leaders in this country in the field of environmental pediatrics. Be sure to mention that it’s so important to couple research with training and education.

Part 1 of 2

Part 1: Landmark National Children’s Study Launches in US (Top of Page)

Part 2: National Children’s Study to Assess Environment and Genetics

Julia Wasson

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