Written by Veronika Bradley, Editor for Children's Health and Safety Association – February 3, 2013 and Republished by Diligencia Investigative Reporting – April 2019
It never entered my mind that Forbes Magazine, renowned for its lists of who's who in the millionaire and billionaire clubs, including the highest paid glitterati under the age of 30, would publish an article on a children's health study, but considering the dollar value relating to this story, I suppose it is understandable.
Ten years in the planning stages and one billion dollars later, the US federal children's health study is still not off the ground because the consortium of organizations involved in the study could not agree on the design, concept and operational procedures rather the attention went to the stakeholders with heightened marketing expectations. To add insult to injury Public Relations created the unrealistic notion that this study would answer every conceivable question with definitive responses instead of conducting a focused and feasible study. This scenario is a perfect example of "the cart in front of the horse" analogy on more than just one level.
Geoffrey C. Kabat, a senior epidemiologist, faculty member of the Albert Einstein College of Medicine and the school of medicine of the State University of New York at Stony Brook, and author wrote this profound and highly detailed article in Forbes Magazine. In it he states that Congress in 2000 passed the 'Children's Health Act' which summoned the National Institute of Child Health and Development in 2004 to lead a long-term study that would examine the effects of the environment and genetics on the growth, development, and health of children from pregnancy to adulthood across the United States. These studies have the potential to provide new scientific findings on diseases such as autism, childhood cancers, type 1 diabetes, congenital malformations and asthma and it is important to note that no previous study has collected both environmental and biomedical data starting in utero. More and more scientists are agreeing that the environment has a great effect on our children's health and that in the past twenty years, toxins like pesticides, plastics and metals have become more invasive.
The National Institute of Child Health and Development was responsible for the design and implementation of the study with participation from advisory and oversight committees, the Director of the National Institute of Health, and involvement of other government agencies including the Department of Health and Human Services, the Centers for Disease Control and Prevention and the Environmental Protection Agency.

The initial plan of this project which estimated at 2.7 billion dollars over a 25-year span, called for the recruitment of 100,000 pregnant women randomly chosen from about 100 communities across the United States where
researchers would obtain samples of placenta, blood, tap water, and household dust, and children's health data would be monitored with medical exams, home visits and interviews.
Unfortunately, the plan did not address the most important aspects and challenges in the design of such a study and instead of resolving the core issues at the onset, study sites were brought on board as funding dollars became available that had no clear outline or protocol as to how the work should be completed. Herein lies the first major mistake.
Researchers and statisticians could not agree on how to recruit pregnant women for this study. National Children's Study (NCS) was committed to obtaining a representative sample of the U.S. population that would reflect a true demographic including ethnicity, socio-economic status and urban versus rural residence, which would be accomplished by randomly selecting neighbourhoods within each county and whereby personnel would go door-to-door recruiting women who were pregnant or who were planning to become pregnant. The researchers were diametrically opposed to this method of recruitment stating it was inefficient and incompatible with the collection of detailed biomedical data rather they recommended the recruitment of pregnant women should be sourced from prenatal clinics and hospitals where they receive care. NCS was obstinate and nonflexible and as a result, the enrolment numbers in the project fell far short of its estimated projections.
New leadership took over the study at NIH and minimized the importance by labelling it as a "data collection platform" which initiated the second major mistake by allowing researchers to study a myriad of research questions and thereby losing focus on what was initially proposed as far back as 1990.
The control of this elaborate study was placed in the hands of bureaucrats with the wrong backgrounds and not in the

hands of experienced scientists that not only know what they are talking about but also know how to get the medical samplings and statistics that they require that will yield successful results. This was the third major mistake that caused the utter collapse of this most elaborate study. Sadly, scientists in the field of epidemiology and perinatal epidemiology were not seriously considered as leaders of this study, let alone as consultants in the design.
In the past eighteen months, the study has gone through three design changes and the NIH states it is moving ahead and will deliver as promised but the observation on the other side of the hill is austere and the reputation of the NIH has been substantially tarnished.
When Geoffrey Kabat asked Nigel Paneth, a prominent epidemiologist with Michigan State University, who also acts as investigator and advisor on the NCS, what lessons could be drawn from the NCS experience, he responded, "Hire the right people to do the job. This means not having people with no experience or expertise in epidemiology designing and running large cohort studies. And always keep science in the forefront of every decision in this and every other study. To build a building, you need a competent architect, a viable architectural plan, and a firm foundation. If you have no architect, if the plan keeps changing, and the foundation is lacking, you are likely to end with a pile of bricks instead of a home."
Geoffrey C. Kabat wrote a book called, "Hyping Health Risks" which relates to the environmental hazards of daily life and the Science of Epidemiology. He has also published over 100 scientific papers.
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