Health Study Progress

FAQs

1. What progress has ATSDR made on the proposed study of drinking water at Camp Lejeune?

ATSDR has made solid progress since the study was announced in summer 2003. Much of that progress has been in guiding the proposal for a new study through the proper approval channels.

The new study is called, "Exposure to Volatile Organic Compounds in Drinking Water and Specific Birth Defects and Childhood Cancers at United States Marine Corps Base Camp Lejeune, North Carolina."

ATSDR submitted a study protocol for peer review in August 2003. We received comments back the following month. ATSDR's responses to the peer reviewers' comments were approved by ATSDR's Office of the Associate Administrator for Science in October 2003.

The agency then began the approval process. The first step was to submit the proposal to the Centers for Disease Control's (CDC's) Management Analysis and Services Office and to the CDC Privacy Act Officer. On July 18, 2003, ATSDR announced its proposed study in the Federal Register. Following the announcement, citizens had 60 days to request the plan and to provide comments. We provided the information to the one private citizen who asked for it.

ATSDR then submitted the protocol to the Institutional Review Board (IRB) in February 2004. The Agency submitted the package to the federal Office of Management and Budget (OMB) Desk Officer in April 2004. The IRB/OMB review process will take approximately 60 days.

We can begin interviewing participants for the study once IRB and OMB formally approve the study. These interviews may begin as early as summer 2004.

2. What new or updated information has become available since the release of the Survey Progress Report in July 2003?

In July 2003, ATSDR reported the results of a health survey of 12,600 children born to mothers who were pregnant at U.S. Marine Corps (USMC) Base Camp Lejeune from 1968 through 1985. That survey yielded 103 potential cases of birth defects and childhood cancers.

Further research has led ATSDR to revise this total. Of the 103 cases first identified by the survey, seven were potential cases of non-Hodgkin's lymphoma. ATSDR could confirm just two of these seven cases. One of the other potential cases was ineligible (diagnosed after 20 years of age). Two more refused to participate. Necessary medical records were unavailable for the remaining two. In the end, ATSDR was left with no more than four possible cases of non-Hodgkin's lymphoma. Therefore, cases of this disease will no longer be part of the study.

Even so, further research has allowed ATSDR to confirm three additional cases of neural tube defects (NTDs). Adding these three to the 96 remaining after the non-Hodgkin's lymphoma cases were excluded gives a total of 99 potential cases (of all types) for the study.

3. Does ATSDR's decision not to include the cases of non-Hodgkin's lymphoma as part of the study rule out a link between this disease and Camp Lejeune's drinking water?

No. This decision means only that not enough cases of non-Hodgkin's lymphoma could be confirmed to include the disease in the study.

4. Which conditions will ATSDR's study now include? How many of each type have been reported?

The 99 total cases of selected birth defects and cancers break down as follows:

• 35 neural tube defects (NTDs);
• 42 oral cleft defects (OCDs); and
• 22 childhood leukemias.

5. What medical records has ATSDR been able to obtain so far?

ATSDR has obtained medical records for the following (by case type):

• NTDs: 20 (15 confirmed as having NTDs; five confirmed as not having NTDs; one was ineligible; one refused to participate; and 13 are still pending).
• OCDs: 23 (20 confirmed as having OCDs; three confirmed as not having oral cleft defects; three refused to participate; and 16 are still pending).
• Childhood leukemias: 17 (12 confirmed as having leukemia; five confirmed as not having leukemia; two were ineligible; and three are still pending).

6. The Survey Progress Report mentioned the need for a water distribution model. What progress has ATSDR made on that part of the study?

The 1968-1985 water distribution model for the base is not yet complete. ATSDR is still reviewing data and taking other steps needed to develop an accurate model.

These efforts actually began in July 2003 when ATSDR staff visited Camp Lejeune to collect data. USMC was able to provide some information at that time, but more is needed.

Further progress on the water modeling depends on ATSDR's acquiring this additional information. The agency is currently gathering this data.