Scientific Fraud and Conflict Of Interest In Vaccine Research, Licensing &
Policymaking

 Reprinted by permission of Michael Belkin for EighthCity Dec. 8th, 2000
 Shoot First and Ask Questions Later
 Scientific Fraud and Conflict Of Interest In Vaccine Research, Licensing &
Policymaking
 The 2nd International Public Conference on Vaccination 2000, Arlington
Virginia
 
 By Michael Belkin © Sept 10, 2000
 
 In Business School, (Organizational Behavior) we studied what can happen to
organizations that suffer ethical management breakdowns (such as Johns
Manville with asbestos, Owens Corning breast implants, etc.). Nothing
illustrates the syndrome of management ethical failure more clearly than the
current scandal faced by Firestone and Ford. Those companies denied and
concealed deaths and injuries caused by tread separation and a high center of
gravity in the Ford Explorer for years. Management knew, denied and concealed
that their products were defective and were killing people -- the classic
ethical breakdown.  In the vaccine industry, scientific fraud and conflicts
of interest are causing a similar (but much larger) cycle of deaths and
injuries that is being concealed and denied by regulators and vaccine
manufacturers. However, (as with Firestone and Ford) a noose of their own
making may be slowly tightening around the vaccine scandal perpetrator's
necks.   Financial conflict of interest is a complex issue -- because few
investors (except perhaps Tibetan Monks or Jesuit Priests) are likely to not
have pharmaceutical shares in their diversified portfolios in this day and
age. But financial conflicts of interest and scientific fraud (that lead to
corrupt public policy) damage the public interest and could eventually
bankrupt vaccine manufacturers that have perverted the regulatory process.
Shareholders should investigate the issue carefully.    There's only about
100 US Deaths from Firestone tire blowouts. There are thousands of deaths and
many thousands of cases of disability and neurological damage lurking in the
FDA Vaccine Adverse Event Reporting System (VAERS). This is a potential legal scandal of much larger scope than the Firestone/Ford episode.
 
 

US vaccines are licensed by the FDA and immunization recommendations are
made by the Advisory Committee on Immunization Practices (ACIP), which is a
committee whose members are appointed by the Centers for Disease Control
(CDC). ACIP immunization recommendations are enacted into law by public
health departments and/or legislatures at the state level, via the energetic
efforts of vaccine manufacturer sales representatives. While the ACIP does
nothing more than craft and finalize the exact wording detailing recommended
doses and ages for administration of vaccines, ACIP recommendations are
extraordinarily influential, because they get turned into mandates at the
state level.
 
 These vaccine mandates are despotic intrusions into personal liberty and
democracy. School districts and social service departments demand that: You
must inject these viruses and bacteria into your body (or your child's body)
or you (or your child) may not attend school, you may be charged with child
abuse and your children may be removed from your home, placed in foster care
and forcibly vaccinated.  Such intimidation is taking place with greater
intensity and frequency as more and more ACIP recommendations and subsequent
state vaccine mandates are enacted. Furthermore, parents are being wrongfully
accused and convicted of shaken baby syndrome in cases where their children
die immediately after vaccination and have swollen brains in the autopsy
report (brain inflammation is a classic vaccine adverse reaction).
 
 The enforcement of ACIP vaccine recommendations at the state and local level
by plodding and heavy-handed health and social service department employees
is a threat to the neurological systems of those vaccinated. Vaccine adverse
reactions are defined as the same thing as disease complications in the
medical literature -- encephalitis. "Acute disseminated encephalomyelitis
(postinfectious encephalomyelitis--see also Acute Viral Encephalitis and
Aseptic Meningitis) is characterized by perivascular Central Nervous System
demyelination, which can occur spontaneously but usually follows a viral
infection or VIRAL VACCINATION (or, very rarely, BACTERIAL VACCINATION),
suggesting an immunologic cause."---Merck Manual
 

   Thousands of reports of adverse reactions such as convulsions, brain inflammation,
inconsolable screaming syndrome, SIDS and neurological diseases such as
Multiple Sclerosis, Transverse Myelitis and Guillain-Barre Syndrome continue
to flood into the FDA Vaccine Adverse Event Reporting System (VAERS), where
they are largely ignored or tolerated as the cost of some mythical victory
over disease. Children and adults are developing the same encephalitic and
neurological complications after vaccination that science takes credit for
eliminating through immunization -- but the CDC, ACIP and American Academy of
Pediatrics all insist the vaccine adverse reactions don't exist or are
coincidences.   Their double standard is: You are required to receive this
vaccination so you and society don't develop encephalitic and neurological
complications from disease, but if you die or develop encephalitic or
neurological complications immediately after receiving the vaccine (which
contains the same virus or bacteria that causes the neurological
complications), then it's all in your imagination, it's a coincidence or
we're still doing studies and we'll get back to you when they are done. Shoot
first and ask questions later.
 
 Unelected, unregulated and unaccountable ACIP medical bureaucrats have
blatant financial conflicts of interest and are committing scientific fraud
by recommending administration of vaccines that have not been tested for
safety in the age groups or populations targeted. Dr. John Modlin, current
Chairman of the ACIP (Merck Immunization Advisory Board 1996-present, Merck
shareholder) gave his definition of scientific validity in a March 1999
University of New Hampshire debate: "Has the information withstood the test
of peer review? Has the information been published in a respected medical or
scientific journal? ... this is the standard that you should hold me to today
... has the information been published in a scientifically reputable
journal?"  One month earlier at the February 1999 ACIP meeting Chairman
Modlin lobbied for the ACIP to recommend the Rotavirus vaccine for premature
infants, although no safety studies had been done, much less peer reviewed or
published:  ".. available data are insufficient to fully establish the safety
and efficacy of rotavirus vaccine in premature infants ... there is a section
under Adverse Events that details what little information there actually are
with respect to premature infants ... To my knowledge we don't have data from
a clinical trial specifically ... Some bit of information from Seattle, as I
recall, that had suggested that was a slight increase in relative risk for
hospitalization for premature infants ... Obviously a situation where we have
to make a judgment in the absence of data, and with a vaccine that has not
yet been tested in the group ..." (ACIP transcript, pages 102-112) Modlin
then held a vote and the recommendation for premature infants passed nine to
one -- Modlin voted yes. Shoot first and ask questions later.
 
 

As a member of The Vaccines and Related Biological Products Advisory
Committee (VRBPAC) and Chairman of the Rotavirus working group, Modlin had
data showing a risk of intussusception (life threatening bowel obstructions)
in clinical trails of Rotavirus vaccine before that February 1999 ACIP
meeting. The Rotavirus vaccine was withdrawn from the market in October 1999
after 113 cases of intussusception. One premature baby died after getting
rotavirus vaccine in a vaccine cocktail and another five-month-old infant
died after developing intussusception five days after receipt of the vaccine.
By ACIP Chairman Modlin's own definition, the ACIP's recommendation was
scientifically invalid.  I'll go one step further and say the ACIP Chairman
committed blatant scientific fraud by issuing an ACIP recommendation that
Rotavirus vaccine be given to premature newborns without scientific proof
that it was safe to do so. And what was the penalty? Modlin was apparently
reappointed to another term as ACIP Chairman by the CDC. Commit scientific
fraud that causes death and grievous injury -- and get reappointed. That is
the incentive system in the US vaccine regulatory system.
 
 Another case suggesting scientific fraud is the still-existing 1991 ACIP
recommendation that every newborn baby receive the hepatitis B vaccine in the
hospital within hours of birth. Samuel L. Katz, MD, who instituted that
policy when he was ACIP Chairman in 1991 has admitted they had no
peer-reviewed, published studies showing that it was safe to give to newborns
when the ACIP made that recommendation. (Katz is former Chairman Committee on
Infectious Diseases of the American Academy of Pediatrics, former Chairman of
the Public Policy Council of the Infectious Diseases Society of America).
 
 When I asked Katz in the question/answer session after his April 12, 2000
NY/Cornell Medical School lecture on "Vaccines in the New Millennium" what
peer-reviewed, published safety study he used when he was ACIP Chairman to
recommend at-birth immunization of newborns in 1991 he answered: "you are
quite right there was no published peer-reviewed study" (tape and transcript
available). Newborns have negligible risk of contracting the hepatitis B
virus, unless the mother is infected. That risk can easily be determined by a
maternal blood test. No US vaccine had ever been mandated for newborn babies
before. But Katz and the ACIP decided it was safe to vaccinate not-at-risk
for hepatitis B newborns without any proper safety study. Shoot first and ask
questions later.
 
 The results of that uncontrolled experiment are in: upwards of 36,000
adverse reactions and more than 440 deaths (VAERS). My daughter died after
receiving the hepatitis B vaccine. Katz also admitted that vaccine adverse
reactions are the same thing as neurological complications from disease when
I pressed him if he disagreed with that definition from the Merck Manual
saying "with measles vaccine it is possible that maybe one out of 150,000
children who get the vaccine may get something that mimics measles
encephalitis."  Parents report their children were perfectly normal until
receiving the MMR measles/mumps/rubella vaccine, at which point the children
became autistic after a neurological adverse reaction to the MMR vaccine
("something that mimics measles encephalitis"). The incidence of measles
disease may be down to about 100 cases annually in the US, but the rate of
Autism has soared hundreds of percent -- a disease historically called
"post-encephalitic syndrome."
 
 For vaccine manufacturers -- the ACIP is a gold mine. ACIP recommendations
are a license for vaccine manufacturers to use state governments, school
systems and social service systems as a marketing department for their
products. With an ACIP recommendation in hand, vaccine manufacturers use the
government to say "you must buy my product and inject it into your body, even
if it kills you or causes brain damage." This is a huge Anti-Trust violation.
The Orwellian spectacle of monopolistic and oligopolistic pharmaceutical
manufacturers subverting government agencies to ram unsafe products down
children's veins is a violation of the basic principals of the Constitution
and Bill of Rights. Our forefathers said "No Taxation Without Representation"
to their British oppressors. I say "No Vaccination Without Representation" to
the corporate tyrants at Merck, Smithkline and other vaccine manufacturers
who have so utterly subverted the US vaccine regulatory process.   Dr. John
Modlin must be removed as Chairman of the ACIP and the scientifically invalid
newborn hepatitis B vaccine policy instituted without safety studies by Dr.
Katz must be revoked. The investors and directors of vaccine manufacturers
such as Merck and Smithkline must recognize that those companies are
conducting the classic ethical blunder of selling products that are killing
and injuring people -- and then concealing and denying the evidence.   A
Canadian doctor who treats hepatitis B vaccine adverse event victims told me
when he called Merck, they told him he was the first one who had ever called
them with such a problem. There are upwards of 36,000 reports in VAERS and I
would be delighted to provide them to anyone who cares to investigate the
issue for themselves, sorted by deaths, convulsions, screaming syndrome,
liver disorder and neurological damage -- median onset one day after
vaccination.
 
 This is the CDC's Mission Statement
 
 "To promote the health and quality of life by preventing and controlling
disease, injury and disability." "CDC pledges to to be a diligent steward of
the funds entrusted to it." "CDC pledges to base all public health decisions
on the highest quality scientific data, openly and objectively derived." CDC
Core values: Accountability -- we ensure that our services are based on sound
science and meet real public needs ..."
 
 That's What They Say, Here's What They Do
 The CDC misallocated funds that were targeted for chronic fatigue syndrome
(a vaccine adverse event) to some other non-vaccine related pet project. The
ACIP Chairman recommended the Rotavirus Vaccine for premature infants without
any data whatsoever showing that it was safe. The ACIP recommended the
hepatitis B vaccine for newborns without any public, peer-reviewed, published
study showing it was safe. The head of epidemiology of the CDC presented a
slide showing serious reactions to the hepatitis B vaccine were approximately
10 times higher than for other vaccines at the February 1999 ACIP meeting.
The CDC has ignored FOIA requests for the scientific data used to justify the
1991 newborn hep B vaccine mandate.
 
 The CDC has violated its own mission statement and current leadership needs
to be replaced. Most people don't realize that the CDC is a quasi-Military
organization that takes great pride in dressing up in uniforms and strutting
around one day a week.
 
      Dr. James M. Hughes, CDC Director
       Why are public health officials (doctors) wearing uniforms?
     
 
 That might be part of the problem. If they were just dressing up and playing
soldier marching around their compound in Atlanta and not harming anyone than
they would just be comical figures like Colonel Klink of Hogan's Heroes.
 
      Colonel Klink (Hogan's Heroes) 
 
 But it's not funny -- the reality is that these vaccine mandates are being
rammed down the US public health system by the CDC and ACIP and are being
imposed at the local level like the US is ruled by some Vaccine Gestapo. The
agenda for recent CDC and vaccine industry conventions has had numerous
panels on "How Can We Communicate Our Message to the Public More
Effectively." Obviously the CDC, ACIP and National Immunization Program (NIP)
are extremely concerned with brainwashing the public to keep vaccinating no
matter how defective the vaccines are and how many kids die or become
autistic.  Personally I think that's the wrong message and they ought to stop
killing people and destroying lives. But if the CDC wants to communicate
their message more effectively, as a management consultant I have a
suggestion. They need a more charismatic front man. I suggest they get
someone like Joseph Goebbels -- propaganda chief of the Third Reich to go out
and carry the CDC-ACIP-NIP message to the airwaves.