House of Representatives I am grateful to this committee for allowing me to address the issue of vaccine safety. I am Dr. Howard B. Urnovitz.  In 1979, I received my doctorate degree in Microbiology and Immunology from the University of Michigan, where I studied vaccines. I am testifying today as the Scientific Director of the Chronic Illness Research Foundation. For the record, I am also the chief science officer of a biotechnology corporation.

My testimony will describe the insights of recent scientific studies into the health consequences of exposing individuals to both toxic and foreign biologic materials, particularly multiple bacterial and live virus vaccines.  The conventional wisdom concerning the use of vaccines needs to be reconsidered, taking into account the adverse medical effects that vaccines can have on the human body. Vaccine science must evaluate not only acute adverse side effects, but also possible associated chronic illnesses such as learning and behavior disorders, Autism Spectrum Disorders, intussusception, arthritis, cancer, diabetes, chronic fatigue syndrome, multiple sclerosis, autoimmune thyroiditis, and other chronic health problems.  These chronic illnesses are increasingly costly to society in both human and financial terms.

By year's end, the Chronic Illness Research Foundation and its research colleagues will have published four peer-reviewed papers on the genetic basis of four different chronic diseases: vaccine associated human cancers, Gulf War Syndrome, multiple sclerosis, and AIDS.  The implications of these findings for vaccine safety are:

1. the human body retains a genetic memory of the foreign substances to which it has been exposed, including viral and bacterial vaccines;

2. each individual responds to foreign substances differently, based on his or her own unique genetic background;

3. there appears to be a limit on how much foreign material to which the human body can be exposed before some level of genetic damage occurs and a chronic disease initiates.

It is known that our genetic blueprints for life, received from our mother and father, create new genetic material, allowing each individual to cope with toxic environmental exposures.  Research needs to focus more intensely on precisely how the body handles the unprecedented level of gene-damaging substances in our air, water, food and even some medicines.  These substances range from infectious agents, both natural and vaccine-related; pesticides, herbicides, petroleum byproducts and other synthetic chemical hazards; and physical hazards such as radiation.  Regarding vaccine safety, I suggest the initiation of
serious inquiries into the following research areas:

1. How do genes change in response to vaccines, and what are the chronic consequences of these changes?

2. What are the acceptable limits of dose, age, timing, and combinations of vaccines that the body can handle? (Not only with respect to their ability to create an immune response to the infectious agent, but also with respect to their acute and chronic health effects.)

3. How might we minimize vaccine adverse effects on our genome through life style, diet, and pharmaceutical intervention?

4. How can we repair or minimize the effects of genetic damage?

Today, we are beginning to understand the indirect mechanisms that link toxic exposures and chronic disorders. Unfortunately, efforts by scientists to explore fully the possible negative effects of vaccines mandated by public policy has been met with stiff resistance by public health agencies.

Let me give you two examples of vaccine programs that are underway that lack a solid scientific foundation. First, several of my colleagues and I currently have a peer-reviewed paper in a major medical journal due out in September that contains the medical profile of a woman who died from a mysterious case of AIDS.  Over several years, her laboratory tests showed a consistent pattern of negative or indeterminate HIV-1 blood antibody tests.

However, when an alternative fluid test was used, she was HIV-1 antibody positive in her urine. The virus was eventually isolated from this woman and sequenced.  This HIV-1 variant came to be known as HIV-1 Group O. Analyses of the viral genetic material suggest that the virus originated, in part, from genetic reshuffling of human chromosomal material. HIV-1 could have serious consequences with respect to the initiation of autoimmune diseases. To put it simply, are we embarking on a course that will vaccinate people against their own genes?

The second example concerns the intensive effort to create a vaccine for the hepatitis C virus.  If you read the literature very carefully, you will find that, while there is a strong marker for the disease, there is no hard scientific evidence to support the existence of a hepatitis C virus. Clearly, a non-A, non-B hepatitis disease exists, but the science behind an associated virus is weak at best.  As a scientist I am compelled to ask, how can we vaccinate people against a disease-causing agent that has not been fully characterized?

Protecting the public against vaccine related chronic diseases is and will be a difficult task.  Not only must researchers  meet the scientific challenges, but increasingly they also must battle the politics of science.  Research is showing that our understanding of chronic diseases, as illustrated by my two examples, often is seriously inadequate.  Because the issue of vaccine safety involves both policy and science, the public needs to be better represented in the decisions made by public health agencies. In this realm, where science and politics collide, Congress should take a more active role in representing the public interest during the formulation of public health policies.

On the issue of informed consent: Had my mother and father known that the poliovirus vaccines of the 1950s were heavily contaminated with more than 26 monkey viruses, including the cancer virus SV40, I can say with certainty that they would not have allowed their children and themselves to take those vaccines.  Both of my parents might not have developed cancers suspected of being vaccine-related, and might even be alive today.  Government, industry, and medicine should embrace the ethical principle of informed consent about possible adverse reactions associated with vaccines.

I appreciate the opportunity to discuss with you my research findings that span a quarter of a century.  I will continue to work with my colleagues to unravel the links between toxic exposures and chronic illnesses.  While others seek to map the human genome, our goal is to study the detours the human body's genes must take to survive in an increasingly toxic environment.   I ask that the full text of my statement be submitted for inclusion in the record of this hearing.
Thank you.

[Burton]  [Vaccination]