Minimizing the Generation of Adverse Event Reports

There are only two large databases of information on anthrax vaccine and adverse reactions. The first is the Defense Medical Surveillance System (DMSS) database, which the two Institute of Medicine Committees (reporting in 2002 and 2003) studying anthrax vaccine said should be opened to independent researchers, and should receive more resources to better study anthrax vaccine safety. The second is the Vaccine Adverse Event Reporting System (VAERS), which is a collection of voluntary reports sent to FDA and CDC.

The DMSS database info has been hidden from the public since some of its data was given to the Institute of Medicine committee in 2001. (I have excerpted from this 2001 data in other parts of the blog.) That leaves us the VAERS reports. How are they being evaluated?

FDA allegedly has a terrible data management system for adverse events of both vaccines and drugs. Some employees said it wasn't fully computerized. FDA has just had to scuttle a very expensive, contracted upgrade to the system, and is starting out to develop another one. As if that wasn't bad enough, it appears that FDA does not get the reports from patients and medical providers directly. Instead, they go first to a private VAERS contractor, which processes the data and regularly presents it to FDA and CDC.

Because the VAERS system is so critical to identifying signals that require more investigation, and to assuring vaccine safety in general, three different federal advisory groups emphasized the importance of improving and increasing the generation of VAERS reports for anthrax vaccine:

1. In 1999, after many reports of military medical provider refusals to file VAERS reports when asked to do so by ill soldiers, the General Accounting Office (the investigative arm of Congress) reported the following to Congress:

We recommend that the Secretary of Defense direct the Secretary of the Army to improve DOD guidance and training on how to report adverse events to the Vaccine Adverse Event Reporting System... [Medical Readiness: DOD faces challenges in implementing its anthrax vaccine immunization program. GAO/NSIAD-00-36. October 1999.]

2. In 2000, the CDC's Advisory Committee on Immunization Practices, which formulates all vaccine policy recommendations for the United States, wrote the following:

To assess the safe use of anthrax vaccine in humans, the Advisory Committee on Immunization Practices recommends several areas of research. Adverse event surveillance through VAERS [FDA and CDC’s Vaccine Adverse Event Reporting System] should be enhanced, which could include development of electronic reporting capability and implementation of strategies to facilitate reporting. [Use of Anthrax Vaccine in the United States. MMWR 2000; 49: RR-15: 1-20. December 15, 2000.]

3. In 2002, the Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine recommended that DOD increase and improve VAERS reporting by using codes to flag vaccine-related medical encounters:

DOD should develop and implement a system to automate the generation of VAERS reports with the military health care system, using codes to identify from automated records those health care visits that are potentially vaccine related. [Institute of Medicine Committee to Assess the Safety Safety and Efficacy of Anthrax Vaccine. The Anthrax Vaccine: Is It Safe? Does It Work? National Academies Press, Washington, D.C. March 2002].

At first, DOD appeared to make an effort to comply. The Vaccine Healthcare Centers website states that "The Vaccine Healthcare Center Network is dedicated to program development for quality improvement in VAERS." This webpage also says, "The VHC is also available to assist you in filing a VAERS. Anyone can file a VAERS, to include the patient and the patient's family."

However, although the VHC network at first filed VAERS reports for all the individuals they were evaluating for alleged vaccine reactions, this policy subsequently took a 180 degree turn. It has become apparent that for the past several years the VHC Network has not been filing VAERS reports for its patients, even for those whose records show the VHC believed them to have a serious adverse reaction to a vaccine.

Thus, the VHC website is apparently communicating a form of DOD doubletalk: its message should be interpreted as, "You, not we, can file a VAERS report, because we will not do so unless you demand our help."

What is the upshot of this failure to file? Probably 1,500 serious reactions that have been evaluated at the Vaccine Healthcare Centers, which produces extremely detailed, complete and accurate reports, have not been shared with FDA, CDC or the public. Thus, although the VHCs try to assist individuals who have been badly injured by the vaccine, they simultaneously collude to avoid sharing this information with the regulatory agencies which assess vaccine safety. This leads to poor regulation and more injured servicemembers. Thus the VHC data go into a black hole, the data that need to be evaluated by FDA and CDC and can be reviewed by the public on-line disappear, and the recommendations of the expert committees are bypassed by DOD--again.