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BELGISCHE DOKTOREN: GEBRUIK

PANDEMRIX OP ZWANGEREN IS
ILLEGAAL!
2009/11/15 ERIC BEETH <ERIC.BEETH@GMAIL.COM>

Belgian doctors claim in court: Experimental use of PandemRix on


pregnant women is illegal.

The only available pre-clinical reproductive safety data is NOT


reassuring. No other data exists.

Thanks to a PDF published by PDF published by Glaxo-Smith-Klein


in Canada, pregnant women may now read the “reassuring”
results of reproductive pre-clinical trials before the use of
PandemRix / ArepanRix on pregnant women.

It turns out that this is the ONLY experimental reproductive


toxicity data that existed before PandemRix was tried out on an
observational study on 8000 Swedish pregnant women in October
2009.

When it comes down to using this on pregnant mothers, I


consider this illegal experimentation.

Together with a colleague and three other Belgian citizens, I have


taken the Belgian Government to court to denounce the
experimental character of this vaccination, without the approval of
an ethical board, nor the most elementary pre-clinical data, more
comprehensive reproductive toxicity studies, and longer term
safety studies on healthy adults.

I do not want to alarm too much the future mothers who have
received this vaccine from their doctors who have perhaps not
received ALL pre-clinical data, due partially to illegal RED
LISTS* restricting their acces to relevant information for their
medical decisions. Most often, all will go well, and worrying is
NEVER good for a pregnancy! But to all those pregnant mothers
who are currently contemplating the pro’s and con’s of taking the
PandemRix vaccine, it may be interesting for them to, together
with thier doctor, reflect on the meaning of what seems to be the
only preclinical reproductive-data at our disposal: it is available
for those who can read English on Page 18 of this 24 page PDF
made available for Canadian potential consumers of the
ArepanRix vaccine, which is the Canadian equivalent of the
PandemRix vaccine. The tests were done with the bird-flu antigen
(Pre-PandRix) but with the identical ASO3 adjuvant used in
PandemRix.

http://www.gsk.ca/english/docs-
pdf/Arepanrix_PIL_CAPA01v01.pdf

PRE-CLINICAL SAFETY DATA

Two reproductive studies were conducted with ASO3-adjuvanted


H5N1 antigen and evaluated the effect on embryo-fetal and peri-
and post-natal development in rats, following intramuscular
administration. Although no definite conclusion could be reached,
regarding a possible relation to treatment with the H5N1 vaccine
and/or the adjuvant ASO3, and other findings were considered
normal, the following observations deserve to be mentioned:

In the first study, there was an increased incidence of fetal


malformations with markedly medially thickened kinked ribs and
bent scapula as well as an increased incidence of dilated ureter
and delayed neurobehavioral maturation.

In the second study, there was an increased incidence of post-


implantation loss, and the fetal variation of dilated ureter. Not all
findings were observed in both studies, and hence the
toxicological significance is uncertain.

Basically, the pregnant woman who agrees with her doctor to be


vaccinated with the thiomersal and squalene containing
PandemRix vaccine can be reassured that (1) the first 8000
Swedish pregnant women who received PandemRix in Oct 2009
did not die like flies after receiving the vaccine, although an
unspecified amount of them apparently lost their pregnancy, had
bleedings, or started having contractions. Prior to that recent and
un-quantified observational data, (2) no other reproductive study
on the safety of PandemRix existed, except for the knowledge
that ASO3 (+ H5N1 antigen) given intra-muscularly to pregnant
rats caused an increased incidence of post-implantation loss of
the pregnancy, physical birth defects, and a delayed
neurobehavioral maturation.

This known data, along with an understanding of what the toxic


constituents of the vaccine, could be one of the reasons that so
few of GlaxoSmithKlein’s own employees wanted to be vaccinated
by PandemRix. It is of interest to note that the GSK employees
who did vaccinate themselves had to sign an informed consent
form, declining all legal pursuits of the employer in-case of
serious side effects from the (experimental) vaccination.

Our Court Action aims to oblige an informed consent form


specifying the experimental nature of the vaccination, and
agreeing to notify any serious side effect, both by the classical
way of voluntary pharmaco-vigilance notification done by doctors,
but also by a direct route of notification available to the patient.
The informed consent form should specify the Absolute and
Relative Contra-Indications for taking the vaccine. An
independent ethical board should decide if pregnant women and
children younger than 10 years old be included in the Absolute
Contra-Indications, or the Relative CI. Among the relative CI are
for example all auto-immune diseases, or a family history of auto-
immune diseases. All chronic inflammatory states with a chronic
over-activation of the immune system. Recent angor, especially in
inflammatory patients, and patients with severe tendencies
towards allergies. From our observational studies of the side
effects now raining in, we will probably need to enlarge this list

For those who read French, I encourage them to read the


following article:
http://www.asanat.org/Vaccination_de_femmes_enceintes_avec_
PandemRix_-_une_experimenation_illegale.pdf

Best regards from Belgium,

Dr Beeth

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