VACCINE SAFETY TESTINGS: WHAT ARE THEY & WHY DO WE NEED

[Health 1]

VACCINE SAFETY TESTINGS: WHAT ARE THEY, AND WHY DO THEM?
(As Related to the Current Epidemics of Childhood Autism, Learning Disabilities, and other Medical-legal Issues)

Harold E Buttram, MD, FAAEM

Introduction

At the present time America and America's children are in the midst of an
epidemic of chronic disease and disability. The Centers for Disease Control
admits that 1 American child in 166 has been diagnosed with autism spectrum
disorder. (1) In 1970, autism affected 4 in 10,000 children. (2) By 1991, 5,000
autistic children were in the public school system; by 2001, that number had
grown to 94,000. (3)

Today, the CDC reports that 9 million American children under 18 have been
diagnosed with asthma, (4) whereas in 1979 asthma affected approximately 2
million children under age 14. (5)

Today, nearly 3 million children in public schools are classified as
learning disabled as compared with 796,000 in 1976. (6) Comparable increases have
been taking place in the attention deficit hyperactive disorder (ADHD) with 4
million children between ages 3 and 17 being diagnosed with this condition.
(7-8)

In spite of the work of medical pioneers such as AJ Wakefield (9) and VK
Singh (10), the Institute of Medicine (IOM) and Centers for Disease Control
(CDC) continue to deny a causal relationship between the current epidemics of
childhood diseases and immunizations, stating that such a relationship has never
been proven. It is the purpose of this paper to demonstrate that their
positions on this issue are untenable.


What Constitutes Scientific Proof?

Since the issue before us is that of scientific proof, what would constitute
proof of safety for vaccines? Generally speaking, as established by
customary practices in licensing of pharmaceutical medications, there would need to
be sufficient numbers of test subjects (in this case children receiving
immunizations) compared with sufficient numbers of non-immunized children serving
as controls, and continued for sufficient periods of time (months or years) to
be meaningful. In addition there would need to be before-and-after tests
that would screen for adverse effects to the neurological, immunologic, and
hematological systems of the body.

Based on many years of observation, there have never been any studies
meeting these criteria for any vaccine in use today. Consequently there are
legitimate grounds for suspecting that many vaccine reactions are taking place today
unrecognized as to their true nature. All we have are epidemiologic studies,
which are indicators but not proof in and of themselves, and a few limited
before-and-after studies, most of which have never been repeated.



Why Are Safety Studies Needed?

Turning to the next question, as to why safety testing should be done, the
obvious answer is that when adverse effects are discovered, then we should
seek safer methods of vaccine administration.



Examples of Tests Needing Further Study

The relatively few examples of before-and-after testing of vaccines that
have been garnered through the years are too small and limited to approach proof
one way or the other, but these few are far from reassuring about the safety
of current vaccine programs. A few will be cited here:

In 1984 Eibl et al reported a study which involved the testing of
T-lymphocyte subpopulations (white blood cells which help govern the immune system) in
11 healthy adults before-and-after routine tetanus booster immunizations.
(11) The results showed a significant though temporary drop in T-helper
lymphocytes. Special concern rests in the fact that in 4 of the subjects the T-helper
lymphocytes dropped to levels found in active AIDS patients.

In 1990 S Nouno et al did before-and-after testing of 61 children with
epilepsy or a history of febrile seizures which showed significant increases in
"epileptic spikes" on electroencephalograms following DTP, DT, or BCG vaccines.
(12)

As reported from Russia in Mediators Inflammation (2003), a study was
undertaken to analyze the immune responses of live attenuated Rubella vaccine in
eighteen school girls ages 11 to 13 years by collecting blood before
immunization and again at 7 and 30 days after immunization to test whether or not there
would be immune suppression. (13) Subclasses of lymphocytes were tested
before and after vaccine. Also plasma samples were tested for cytokines (cellular
messengers) including interleukins (IL) 4 and 10, tumor necrosis factor,
and gamma-interferon (all pro-inflammatory messengers). It was found that
certain lymphocyte subsets were decreased and that IL 10 and tumor necrosis factor
were markedly increased following Rubella vaccine. The study concluded: "Our
data indicate that the vaccination with live attenuated rubella vaccine
results in moderate but sustained immune disturbance. The signs of
immuno-suppression, including defective lymphocyte response to mitogens and cytokine
production, may persist for at least a month following vaccination."

From Johns Hopkins University (2001), F Imani and KE Kehoe demonstrated
that infection of human B cells with rhinovirus or measles virus could lead to
the initial steps of IgE class switching. Since many viral vaccines are live
viruses, the authors speculated that live virus vaccines may also induce
(genetic) IgE class switching in human B cells. To examine this possibility, the
authors selected the commonly used live attenuated measles mumps rubella (MMR)
vaccine, in which they demonstrated that infection of a human IgM B cell
line with MMR resulted in an increase in the expression of (allergy inducing)
IgE. (14)


Injustices Directly Related to Deficiencies in Safety Testing

Based on personal experience (6 cases) of testifying in behalf of parents
applying for government compensation under the U.S. Congressional Vaccine
Injury Compensation Act of 1986, all of which were denied, and review of many
medical records in which parents or caretakers have been accused of inflicting
infant injury by the "shaken baby syndrome," cases in my opinion in which
clinical evidence weighed heavily towards vaccine reactions as cause of injuries
rather than inflicted child abuse, one is left with impressions that
widespread injustices are taking place in these cases. In these situations parents or
caretakers are required to provide proof of vaccine injury. This is
impossible, since controlled safety studies meeting criteria of scientific proof have
never been done.

Summary and Conclusions

In today's society parents are commonly placed in positions in which they
are required to provide proof of vaccine injury. However, proof requires prior
safety studies which meet criteria of scientific proof and which show both
the incidence and types of adverse reactions resulting from vaccines. Such
studies have never been done, thus leaving parents in impossible situations.

Should it not be the other way around? Should it not be incumbent on our
health agencies to perform adequate safety studies, thus assuring reasonable
safety, before mandating vaccine programs on an unsuspecting public? In medical
legal cases should it not be incumbent on the courts to provide evidence of
reasonable safety of the vaccines before requiring parents of provide proof of
vaccine injury? If so, where is that evidence?



References


(1) American Academy of Pediatrics, Autism A.L.A.R.M., January, 2004.

(2) California Department of Developmental Services, 2003 DDS report,
www.dds,ca.gov.

(3) U.S. Department of Education, National Center for Education
Statistics: Digest of Education Statistics (2002).

(4) B.Bloom et al, Summary Health Statistics for U.S. Children: National
Health Interview survey, 2001," National Center for Health Statistics, Vital
and Health Statistics Series 10, No. 216 (November 2003).

(5) DM Mannino et al, Surveillance for asthma: United States, 1960-1995, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, April, 1998, 47 (no. SS-1).

(6) See note 3

(7) See note 4

(8) The above references and related information came from an article by
Barbara Loe Fisher, "In the Wake of Vaccines," Mothering Magazine,
September-October, 2004.

(9) Bradstreet JJ, El Dahr J, Anthony A, Wakefield AJ, Detection of
measles virus genomic RNA in cerebrospinal fluid of three children with regressive autism: a report of three cases, J Assoc Amer Physic Surg, Summer, 2004, 9(1):38-47.

(10) Singh VK, Rivas WH, Prevalence of serum antibodies to
caudate nucleus in autistic children, Neuroscience Letters, 2004; 355:53-56.

(11) Eibl M et al, Abnormal T-lymphocyte subpopulations in
healthy subjects after tetanus booster immunization (letter) NEJM, 1984;
310(3):198-199.

(12) Nouno S et al, Adverse effect on EEG and clinical
condition after immunizing children with convulsive disorder, Acta Paediatr Japan,
Aug., 1990; 32(4):357-360.

(13) Pukalsky AL et al, Cytokine profile after rubella vaccine
inoculation: evidence of immunosuppressive effect of vaccination, Mediators of
inflamm., August, 2003; 12(4):203-207.

(14) Imani F, Kehoe KE, Infection of human B lymphocytes with
MMR vaccine induces IgE class switching, Clinical Immunology, Sept., 2001; 100(3):355-361.