"Vaccines: Finding the Balance Between Public Health and Personal Choice"

Tuesday, August 3, 1999, 2:00 p.m.

2157 Rayburn House Office Building
Washington, D.C. 20515

We are here today to expand upon the work of our two of Subcommittees. Both the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, and the Subcommittee on National Security, Veterans Affairs, and International Relations have conducted hearings on vaccine issues. I’m thankful to my two Subcommittee Chairs, Mr. Mica and Mr. Shays for being so diligent in pursuing issues regarding safety, efficacy, and the mandating of the Hepatitis B and Anthrax vaccines.

In this country, and around the world, we have made a decision to vaccinate the entire population against dreaded infectious diseases. Children are required to receive numerous vaccines before they enter day care centers and schools -- vaccines that we now know contain mercury. Adults in certain professions are required to receive vaccinations for employment.

This policy creates an inherent conflict between the interests of the individual and the community. The tension between individual risks and public benefit is the classic ethical dilemma for public health. Some have described the current mandating of an increasing number of vaccines to children to be a good intention gone too far.

Many of you may remember the polio crisis earlier this century. It was through the work of brilliant scientists like Jonas Salk and Albert Sabin and their colleagues that the polio vaccines were developed.

It was a mad dash to the finish line of licensing for the manufacturers of these vaccines. Wild polio -- which caused so much illness, appears to have been eradicated. But there are still cases of polio today -- cases caused by the vaccine. Jonas Salk spent the last months of his life pleading with the Government to stop the use of the live vaccine because of the cases of polio it was causing.

Adverse events

Both the Food and Drug Administration and the Centers for Disease Control have adverse events monitoring systems. The FDA’s system, the Vaccine Adverse Events Monitoring System (VAERS), is a passive monitoring system. Medical professionals, the pharmaceutical industry, and the public report adverse events. Over 11,000 adverse events were reported last year. And over 5,900 adverse events so far this year -- about one-sixth of those are considered serious. In all, 95,103 adverse events have been reported to this system since its inception. The former FDA Commissioner estimated that only one in ten adverse events are reported. What is a serious event? It includes events that require hospitalization, events that cause disability, and events that kill.

When asked about the safety of their vaccines, one pharmaceutical representative told my staff,

"everything has adverse events, including aspirin."

In the academic or bureaucratic realm, the risk/benefit ratio is numbers on a page, but to the parent of a child who suffered a serious adverse event from a vaccine, that risk became a reality.

The risk was too real for the Nelson's whose one-month old daughter, Abby, born healthy and hardy. She died less than a month after coming home from the hospital. They later learned from the doctor who performed the autopsy that it was a death related to the Hepatitis vaccine given their daughter in the hospital when she was 2 days old.

To Rick Rollens, whose son acquired autism from a vaccine reaction, the risk was too great. The autism - vaccine link is very controversial, but we have verified with current and former NIH neurologists that any injury to the brain can cause autism including the shock to the neurological system of a vaccine.

They will testify today.

To Michelle Clements, who was not able to be with us today, but who has submitted written testimony, whose son has spent the last three years in a coma as a result of the DTP vaccine, the risk was too great.

We as a Government can no longer keep our heads buried in the sand like an ostrich, pretending there is no problem.

And on the flip side of this discussion is the need to protect the public at large from vaccine-preventable diseases. I am not stating or implying that we should not have vaccines -- they are crucial to public health.

We will hear today from Carola Zitzman, whose son was born in 1964 with severe disability after being exposed to rubella during her pregnancy. We will also hear from Rebecca Cole, whose child died from Chicken Pox and from Dr. Keith Van Zandt, a pediatrician, whose child is living with hepatitis.

Choice and Medical Privacy

In 1997, President Clinton directed Secretary Shalala to work with the states to develop an integrated immunization registry system and to require that all children in Federally subsidized child care centers be immunized. This mass tracking of childhood vaccinations has created state registries that are tracking children from birth to grave. With these state systems reporting back to the Federal level, we have instigated something the American people have strongly and loudly opposed -- national medical tracking -- an invasion of the American public's privacy.

One report stated that the long-term tracking strategy had three steps -- first to notify families with a post card when their child was late for a vaccine. Second, if they did not comply, then a Government Official would call them on the telephone and remind them, and third, if they still did not comply, a Government Official would visit their home.

And what of attaching immunizations to Federal Child Care Centers -- does this mean if your child has a medical or religious exemption that he or she will be not be allowed access to a Federally subsidized facility? In our rush to vaccinate everyone, have we informed members of the public that they have choices? No, we do not. In our rush to vaccinate, do physicians and health care providers keep current in the medical literature, conscientiously reviewing medical histories and read package inserts and the Physicians Desk Reference for contraindications and clearly discuss these with their patients (or parents)? Not often.

Have we gotten complacent in protecting our children just so that we can meet a quota?


We will hear today from Antonio Spaith, a Department of Defense civilian employee who suffered serious adverse events after taking the anthrax vaccine, and other vaccines. The mandating of anthrax vaccine in the military is a grave concern to many in Congress. I have joined my colleagues Congressmen Walter Jones and Ben Gilman in sponsoring legislation to stop the mandating of this vaccine. From intensive investigations, it has been learned that the decision to use this vaccine is fraught with errors. The adverse event rate is much higher than indicated and the military knows it. The research into its safety and efficacy does not provide any sense of security. We are using a vaccine that does not provide protection against strains of anthrax that would most probably be used. As we have learned at the Subcommittee level, this issue is adversely affecting military readiness. We are losing vast numbers of our military who choose to leave the military rather than take this vaccine, morale is low as a result of the misinformation campaign on the lack of adverse events. We learned that there is fear in the ranks about reporting. We learned that the Department of Defense filters these reports before sending them to the FDA. We also learned that in complete defiance of regulations, the manufacturing facility was not inspected until 1996 (over 20 years without inspection) -- at which time it was learned that the quality control was deplorable. No vaccine has been produced and distributed since that inspection. Instead, we have stock-piled vaccines that are likely adulterated and being given to our service members while the plant is being updated. Yesterday, a member of my staff reviewed a test video being prepared by the military to show to its members to inform them about this vaccine. It is full of intentionally misleading statements.

National Vaccine Injury Compensation Program

In order to keep the pharmaceutical industry in the vaccine development business, Congress created what was supposed to be a no-fault system for vaccine victims to receive compensation. There is concern that the Department of Health and Human Services has modified the Injury Compensation Table, and in doing so, excluded those injuries that were most likely to apply to the program.

We are pleased that Dr. David Satcher, U.S. Surgeon General and Assistant Secretary for Health will be testifying on behalf of the Department of Health and Human Services. We are also pleased that Dr. Marcel Kinsbourne, Dr. Ronald Kennedy, and Dr. Samuel Katz will also be testifying today.

The hearing record will remain open until August 25th for all those who wish to make written submissions to the record.