As Our Children Wait – Part 2

AsOurChildrenWaitPart2_edited-1“As Our Children Wait, Part 1”  discussed the Children’s Health Act of 2000, which was passed after extensive work by a White House task force recognized concerns about children’s health. The Children’s Health Act required the National Institute of Health (NIH) to carry out many projects including focus on improving outcomes for children with cancers, creating a Pediatric Research Initiative and requiring facilitation of pediatric research.


The Children’s Health Act authorized the NIH to conduct the National Children’s Study. The NCS was aimed at determining environmental influences that might impact children’s health, with the intent that understanding children’s diseases would aid in finding cures or preventing conditions from occurring in children.  Congress intended that the study would address the major effects on and high costs of child morbidity due to potentially preventable conditions in the U.S. The NCS proposed to examine the effects of environmental influences on the health and development from birth to age 21, of a cohort of 100,000 children.


The preliminary development of the NCS was long and arduous, 2002 saw the establishment of the NCS Advisory Committee. In 2003 the NCS Program Office was established — many working groups were created, many white papers were produced and workshops were held. By 2005, the NCS initiated what was identified as three milestone events:

  1. NCS first-stage sample
  2. Data management
  3. Initial Vanguard Centers contract

In 2007, five years later,  the Research Plan for NCS was completed and reviewed by an outside panel and Congress appropriated funds for implementation.


Real implementation of the NCS and sample recruitment, was scheduled to begin in 2008 with addition of more Vanguard centers in 2009. There were delays during 2008 and 2009 and when real recruitment began in 2009-2010 it was revealed that the intended approach was going to be more costly and time consuming than planned. In 2011 the Program Office begin testing alternative recruitment methods.

In 2009 the original NCS lead was ousted for misleading Congress about the cost of the study. A new lead was appointed and many researchers blame his decision making for the ultimate collapse of the study. In 2011 the NCS lead as well as the Director of NIH were advised that the study was at high risk of scientific failure and corrections were recommended to get the study back on track. The new lead was accused of mismanagement. The NIH Director, Francis Collins, subsequently defended the NCS lead and advised that Congress deserved some of the blame saying, “There was an effort initially put forward by the Congress which maybe from the start was likely to run into serious trouble.”


In 2013 the study design was revised with a 2015 start date set for the main study. The revised study was seen as having problems with concept, methodology and administrative challenges continued.   In its 2013 budget request, the NIH decided to reduce the budget and scope of the children’s study. Subsequently, expert advisors of the Advisory Committee begin to resign. Ellen Silbergeld an environmental scientist resigned charging that the study had been “significantly abrogated” by managers at NIH.


Congress required NIH to contract with the National Academy of Sciences to conduct a review of the NCS, the Academy published this review in June 2014. They stated their “deep concern about the overall leadership and management of the NCS,”  but concluded that the study was not beyond saving and identified feasibility and pathways for success. NIH leadership ignored these recommendations.

The Director of NIH, Francis Collins, placed the launch of the main study on hold and charged a working group of the Advisory Committee to determine the viability of the NCS. That working group came up with basically the same conclusions as the National Academy of Sciences, advising that the NCS was not practical as currently designed and they too recommended that the NIH champion and support new study designs. The working group felt that utilizing advances in technology and research in a redesign could make the original goals of the NCS more “achievable, feasible and affordable.”


Director Collins ignored recommendations from both groups. In December 2014, the NIH Director announced the closure of the study and the transition of the NCS program office. He stated, “I am disappointed that this study failed to achieve its goals. Yet I am optimistic that other approaches will provide answers to these important research questions.”

In the past two decades since the White House task force identified trends in children’s health issues, passage of the Children’s Health Act, design of the National Children’s Study not much has happened in terms of childhood cancer research. During this time more than 300,000 children have been diagnosed with cancer, more than 40,000 children have died, tens of thousands of children suffer life altering impacts of treatments largely due to the lack of research and related development of pediatric drugs, cures, treatments, protocols. The children wait … and without significant investment in research now, children will be in a similar place two decades into the future.


Some critics of the study say that researchers spent years debating which questions to investigate. It is reported that while 100 scientific papers based on pilot research have been published many focused on methods of study design and data collection rather than the original intent of the study. An advisor from Brown University recently stated, “At some point, you have to come to grips with reality: this much time, this much money, make it happen.”   At some point we may have to consider that brilliant scientists may not be the best business managers, budget managers, the best CEOs. What we often see is analysis paralysis, over-analyzing, too many detailed options, a lack of choice. The cost of decision analysis exceeds the benefits that could be gained by enacting a decision or pursuing a plan. There is no awareness that time is money, and in this case, time is also the lives of our children.


The National Children’s Study struggled for over a decade and cost tax payers more than $1.2 billion, there’s little to show for this effort.   In the first 7 years, NIH spent $54 million on planning. In 2007 Congress approved $69 million to start the project and continued appropriations through 2015. A cohort of 100,000 children was envisioned in 2000 and 15 years later only around 5,000 children were enrolled. In the private sector there is no doubt what would happen with this type of management, heads would roll. In this instance there seems to be no accountability, the leaders not only do not get penalized, but they make the decisions on how to spend money originally intended to positively influence outcomes regarding children’s health.


Questions remain about what NIH will do with the appropriations provided in 2015, and what happens with the original legislative intent of The Children’s Health Act.

In 2015, Congress appropriated $165 million to carry out the work of the NCS. Congress directed in Bill language for 2015 …”that $165 million shall be for the National Children’s Study or research related to the Study’s goals and mission, and any funds in excess of the estimated need shall be transferred to and merged with the accounts for the various Institutes and Centers to support activity related to the goals and objectives of the NCS: Provided further, that NIH shall submit a spend plan on the NCS’s next phase to the Committees on Appropriations of the House of Representatives and the Senate not later than 90 days after the date of enactment of this Act.” The legislative date for the spend plan was March 14, 2015.

In January 2015 NIH presented a plan for reallocation of the funds indicating that Bill and report language (there is no report language on the website) direct NIH to maintain the mission and goals of the NCS with flexibility on how to carry this out. A slight stretch!

The NIH, the agency that couldn’t successfully manage the NCS, has come up with three initiatives for spending the $165 million. They propose to —

  1. develop tools to enhance studies of environmental influences on pediatric diseases
  2. study the influence of the environment on in utero development with the goal of identifying the “seeds” of future diseases and conditions
  3. expand examination of environmental influences on later child development by leveraging extant programs.

The proposal to spend 2015 funds seems to be more of the same. What are the expected goals, objectives, results of these three initiatives? Are these projects already in place or new programs? Are these short term projects and is funding sufficient to deliver real results, outcomes? Why wouldn’t NIH use these funds to support pediatric research grant proposals in keeping with the original legislation? Was there consultation with other agencies, as required in the original legislation, with external entities?


The legislative intent of the Children’s Health Act was concern about children’s health and rising rates of childhood cancer. There has been virtually no progress over the past 15 years. A simple analogy — we have a pipe leaking in our home, we put a bucket under the leak and go down to the water company to determine the external source that might be causing the pipe to leak. In the meantime the bucket overflows, the basement floods, the structure begins to rot and mold. Childhood cancer is in a similar boat, the children wait for cures while we seek reasons why children are getting cancer. We need cures now, studies simultaneously but don’t ignore the current problem – children are suffering, children are dying. Children need specific childhood cancer research to develop pediatric cures. Many current treatments are a guessing game, using downsized adult protocols, developed for adult cancers to treat kids.


NIH does not seem to have a plan, or at least any plan about childhood cancer research goals that are transparent to the public. Thankfully, the Senate has started to ask questions about how NIH sets priorities.   I think the general public would agree that more taxpayer dollars should be invested in childhood cancer research.

Perhaps we should leave the study of possible environmental impacts, cancer clusters, etc. to the research community at the Environmental Protection Agency and research to develop cures — childhood cancer research to NIH, the nation’s medical research agency.

We have evidence that investment in childhood cancer research has changed the picture dramatically for childhood leukemia, but according to NCI’s own study, childhood leukemia accounts for less than one-third of childhood cancers. It is undeniable that the lack of research in all childhood cancers leads to pain, suffering and all too often a death sentence for kids.

In Part 3 we pursue legal requirements for demonstrating results, transparency and setting priorities. Stay tuned ……….

Author: Donna Carroll Carmical

Want to help make childhood cancer a priority? Ask lawmakers who help determine the budget for the National Cancer Institute for more than 4% of the research budget is one way to show support.

Related Articles:

“As Our Children Wait, Part 1”

“Moving the Needle”

This entry was posted in Cancer, Childhood Cancer, Pediatric Cancer, Rare Disease and tagged , , , , , . Bookmark the permalink.

4 Responses to As Our Children Wait – Part 2

  1. Pingback: As Our Children Wait – Part 1 | Four-Square Clobbers Cancer

  2. Pingback: As Our Children Wait – Part 3 | Four-Square Clobbers Cancer

  3. Teresa Bryan says:

    Children deserve more than #MoreThan4.My grandbabies and I are in the processes of raising money now for childhood cancer. None of my grandbabies have cancer but if they did this would be just as important me as it is now.

  4. Pingback: As Our Children Wait – Part 4, Conclusion | Four-Square Clobbers Cancer

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