, MD, Phd on Vaccine Safety

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http://www.ccid.org/safety.htm#

Copyright, , MD, PhD

Vaccine Safety

, MD, PhD

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One of society's highest obligations is the protection of its

children. Vaccine programs provide a proven method for childhood

disease prevention. The safety of such programs has been entrusted

to vaccine manufacturers and to government. regulatory agencies.

Although widely touted as the major medical triumph of the 20th

century, the development of viral vaccines has elements of less

than stellar performance. The discovery in 1960 of live SV-40

virus contamination in formalin-treated poliovirus vaccine,

produced in kidney cells cultures from rhesus monkeys, did not

lead to an immediate recall of the contaminated vaccines. Rather

the production method was switched to the use of kidney cells from

the much less well characterized African green monkeys. This

switch in monkey species was soon followed by the decision to

forgo formalin inactivation by using a weakened (attenuated) live

strain of poliovirus. Persisting concerns regarding contaminating

viruses in the live poliovaccine led in 1972 to a joint study

between the vaccine manufacturer and the United States Food and

Drug Administration (FDA). Kidney cultures from all 12 monkeys

tested grew African green monkey simian cytomegalovirus (SCMV).

Only 4 of the SCMV isolates were detectable using the regular

methods for virus detection. No changes in testing methodology

were imposed, nor was the scientific community alerted to the

findings. An excuse that was subsequently offered was that all

such information about the study was deemed to be proprietary. The

results of this earlier study were, however, not conveyed to me in

1977 when, as an FDA scientist, I notified the Director of the

FDA's Bureau of Biologics that certain poliovaccine lots contained

unexplained non-cellular DNA; and were therefore potentially viral

contaminated.

The issue of SCMV contamination of poliovirus vaccines was again

raised with the FDA in May 1995. I was then working as a

virologist at the University of Southern California. I had

developed tissue culture methods which indicated the presence of

atypical viruses in patients with complex neurological diseases.

The viruses were striking in that they failed to evoke an

inflammatory reaction in the patients from whom they were

isolated. They were termed stealth viruses on this basis and

seemingly they lacked target antigens for recognition by the

body's cellular immune system. Sequencing studies on a stealth

virus indicated it had originated from SCMV. Several meetings with

FDA and Center for Disease Control and Prevention (CDC) officials

clearly pointed to their unwillingness to allow any outside review

of vaccine safety procedures. For example, a simple request to

review histological slides of neurological tissue of monkeys

inoculated with poliovaccine was refused, again on the basis that

it was proprietary information. Noteworthy was the admission that

the vaccines were routinely tested in rhesus monkeys because

African green monkeys commonly show evidence of neurological

disease. Moreover, even in rhesus monkeys, the vaccine was said to

induce considerable damage, although less than that induced by

non-attenuated poliovirus.

The actual sequence data were published in a respected virology

journal in July 1995. The article aroused the interest of

anti-vaccine consumer groups. Through the efforts of one of these

groups, I was invited to attend a vaccine safety meeting of the

Institute of Medicine, National Academy of Sciences. The open

meeting held on November 6, 1995 was followed the next day by an

" executive session. " I was informed that several individuals at

this meeting were " furious " that I was allowed to speak. A very

much watered down account of what I said subsequently appeared in

the official report of the meeting.

Some insight into the lack luster nature of the existing system

was provided by several brief interchanges with Government and

other officials during the last several years. For example, I was

asked whether formalin treatment would inactivate stealth viruses.

My response was that I did not know. The chairman of the National

Immunization Advisory Committee suggested his advocacy of a split

protocol in which both formalin inactivated and live attenuated

poliovaccine would provide the necessary time window for the

manufacturer of the inactivated vaccine to develop the stocks

required for a complete switch. True to his suggestion, the

official switch to inactivated vaccine is scheduled for January

2000. Of course, those " in the know " would have already switched

to the inactivated vaccine. An FDA reform bill was being

considered by Congress in 1997. I suggested that the bill include

the provision that " If a safety issue is identified in the

regulation of a biological product, then Industry will waive its

proprietary protection so that the information could be made

available to the scientific community. " The suggestion was well

received by the counsel for the House Commerce Committee. It was

soon dropped, however, when support was not forthcoming from

Industry, FDA or the American Medical Association (AMA). In

speaking with an AMA lobbyist, I understood they " would not want

the public to know that their doctors were not in the knowledge

loop. " I once asked industry personnel involved in poliovaccine

production whether they were still encountering SCMV in

poliovaccine production lots. After some hesitation that

disappeared as we all identified ourselves as parents, the

straightforward answer was " not infrequently. " Armed with this

information I again requested of an FDA official to please use

modern techniques such as the polymerase chain reaction (PCR) to

screen poliovaccine lots for SCMV. " We would not know what to do

with a positive result " was his answer.

Continued sequencing of the prototype SCMV-derived stealth virus

have helped substantiate the original suggestion that stealth

adapted viruses simply lack the critical target antigens for

cellular immune recognition. More impressively, the virus has the

capacity to assimilate genes from infected cells and from

bacteria. The cellular genes identified within the stealth virus

include a gene with potential oncogenic (cancer causing) activity.

The bacterial genes serve a wide range of metabolic functions that

could enhance bacterial growth. Human and animal viruses with

bacterial sequences represent a novel life form that has been

christened viteria. The recombination of viral, bacterial and

cellular genes within broadly infectious viteria is clearly of

major medical and Public Health significance. For instance, it

could provide a viral explanation for positive findings in

clinical assays designed to detect various bacteria including the

Borrelia burgdorferi (the agent for Lyme disease), mycoplasma, and

chlamydia. FDA and CDC were informed of the publication of the

results. It was disheartening, yet challenging, that neither

organization responded. NIH was also notified but merely

acknowledged that research is supportable by grants.

During the last decade, I have written several clinical articles

describing stealth virus infected patients with complex illnesses.

The patients have included children with autism, adults with

psychotic disease and several individuals with chronic

fatigue/fibromyalgia syndrome. An additional recent publication

described a stealth virus infected child whose illness began in

1997 as a behavioral problem. It took over seven months before the

illness was attributed to brain damage, as confirmed by magnetic

resonance imaging (MRI). Even then the neurologist was unable to

detect impaired motor or sensory functions. A brain biopsy

performed shortly after the essentially normal clinical

examination showed marked vacuolating/spongiform change. The

child's clinical condition progressively deteriorated. He was

examined at several major medical centers where it was wrongly

concluded that he had a genetic disease from which he would soon

die. He was shown to be stealth virus infected by tissue culture

and significantly improved with anti-viral therapy, although he

still has major residual deficits.

Where is the Public Health concern that a childhood viral

infection was not recognized at major medical centers. Where is

the interest in the many other children who have tested positive

for stealth viruses. Why the lack of discussion about possible

brain damage causing national tragedies such as school shootings,

and the increasing prevalence of autism, attention deficit, asthma

and sudden infant death syndrome. Are stealth virus infected

patients populating our psychiatric institutions, allergy clinics

and even our cancer wards.

The world and, in particular, its children appear to be at risk

for stealth adapted viruses. The contribution of vaccines to the

formation and dissemination of these viruses should be an open

topic for scientific discussion. This is not occurring with those

presently in charge of overseeing the safety of the Nation's

immunization program.

W. , M.D., Ph.D.

Center for Complex Infectious Diseases

Rosemead CA 91770

www.ccid.org

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