Many of us have heard that the pneumococcal vaccine, Prevnar, is supposed
to provide protection against ear infections -acute otitus media (AOM). The
National Academy of Science, the Institute of Medicine, the CDC, AAP, etc.
base this assertion on the Prevnar vaccine trials. Dr. Steve Black oversaw the
results of the clinical trial in California and stated before an FDA Advisory
Committee Meeting held in May 2002 that the control group had 7% more cases of
AOM than the group given the Prevnar vaccine. In a clinical trial in Finland,
Dr. Terry Kilpi showed there were 6% more cases of AOM in the control group
than the group given the Prevnar vaccine. So, does this mean that Prevnar
vaccine protects children from contracting AOM?
To answer our question and understand some of the flaws in the vaccine
trial, consider this analogy:
In an alcohol trial, 20 subjects were randomized to receive either free
whiskey or free vodka.
The next morning 10 whiskey drinkers had 10 hangovers, 100%.
The 10 vodka drinkers had only 9 hangovers, 90%.
Therefore, vodka has an overall protective efficacy of 10 percent against
hangovers. Comparison to non-drinkers or moderate drinkers was not made as it
is unethical to withhold alcohol from individuals.
Before we discuss the flaws in this logic, let us restate the same analogy:
In California, a number of children received all standard vaccines on the CDC
recommended schedule. Half the children were also given Prevnar vaccine, and
the other half the Investigational meningococcal group C conjugate vaccine (MnCC),
the 'control'.
In Finland, a number of children received all standard vaccines on the US CDC
recommended schedule. About one third also received Prevnar vaccine, another
one third also received Hepatitis B vaccine which formed the 'control' group.
The remaining one third also received another investigational vaccine which is
discussed very little at the CDC hearing.
The control groups had 6 to 7 percent more AOM than the Prevnar groups.
Therefore, Prevnar 'must be protective' against AOM?
Comparison to an unvaccinated group was not made as it is believed to be
'unethical to leave children unvaccinated.' Comparison was not made between
the Prevnar group and a group receiving only routine vaccines because, "it
seemed to be the right thing to do to offer something to the control group
also, something beneficial."
It is obvious that drinking an excess of alcohol causes hangovers, and in
comparison a non-drinking group would have NO hangovers. Not equally obvious
is that vaccines at least contribute to the causes of AOM. A group of
non-vaccinated children would have perhaps HALF the cases of AOM compared to a
vaccinated group. The trials do not prove Prevnar prevents any degree of AOM,
even the small 6-7 percent quoted. A more likely to be correct interpretation
of the available data is that the combination of Prevnar and routine vaccines
caused 6-7% less AOM in the trial groups than either 'control' group caused.
Using vaccines for 'controls' is flawed methodology and biases results for
both safety and effectiveness. The Hepatitis B insert lists Earache and
Tinnitus in the reported adverse side effects list.
Many people have observed that unvaccinated children have overall better
health than vaccinated children when there is otherwise equal opportunity for
attaining optimal health. For more information on the connection between
vaccines and increased incidence of ear infections (AOM, etc) see:
http://www.vaclib.org/links/ears.htm
In the Finland trial, it was admitted that Prevnar caused a 33%
increase in non-vaccine serotype AOM while claiming a 57% decrease of vaccine
serotype AOM. ("vaccine efficacy against AOM due to vaccine serotype, 57
percent; there was an increase with non-vaccine serotypes with a negative
efficacy of 33 percent;") So does this mean that Prevnar actually prevents
more AOM than it causes? First note that this 57% is measured against another
vaccine combination, not against an unvaccinated group. Secondly, what does it
mean that there was less of a certain serotype AOM? A mucus discharge from the
body, whether ear, eye or nose is the bodies effort to detoxify. Serotypes are
identified by 'protein signatures'. Since the Prevnar vaccine contains seven
of these 'protein signatures' or serotypes then why is there not more of these
serotypes present in the AOM ear discharges in the Prevnar group rather than
less? I believe the answer lies in Aluminum. Aluminum is a so called adjuvant,
but in reality aluminum 'bonds' (adsorbs) to the vaccine proteins and
decreases the rate these proteins eliminate from the body while allowing other
undesirable protein combinations to be eliminated at a faster rate. A vaccine
may change the toxic content that the body is working to eliminate, but this
will not make for less illness, only a different diagnosis as to the 'cause'.
It will argued that the reported adverse events of AOM following are too
few for the above to be true. However, if there is a large incidence to report
ratio, as is commonly verified (10-1 to 100-1 according to the FDA, CDC and a
vaccine manufacturers representative.), then it becomes quite feasible that
Prevnar does not cause any reduction in the incidence of AOM. Even the Finnish
study states that six percent fails, "to reach statistical significance ..."
It must also be noted that vaccine trials are only conducted on healthy
children. Logically, both the Prevnar and control groups should have a lower
incidence of all diseases than the national average (for vaccinated children).
Yet in the Finland trial, it was stated that, "It was suggested that
because of the close follow-up during the study that subjects actually sought
treatment with ear tubes more often than would ordinarily be the case in
Finland, and these rates actually were higher, I think, tenfold higher, nearly
tenfold higher than common practice in Finland and also much higher than
practice in the Kaiser system." This 10 fold increase in ear-draining
tubes is 'explained away' by the fact that during the trial the procedure was
provided free. A valid study would have been able to supply data showing what
part Prevnar played in either increasing or decreasing the need for ear tubes.
Ideally, a vaccine study requires data from many groups, but perhaps four
groups from the same time and place would be adequate: a totally unvaccinated
group, a group vaccinated only with Prevnar, a group vaccinated with all
routine vaccines, and a fourth group vaccinated with Prevnar plus all routine
vaccines. Close followup of these children would have provided data for a
valid judgement on the effect of Prevnar on AOM. The method used in both the
Finland and California trials each contained only one of the required groups,
thus NO VALID comparisons could be made.
Entirely too much faith is put on the theory of vaccine protection
(antibodies and serotype matches) versus actual measured (clinical) results.
Preconceived conclusions currently make it unnecessary for the vaccine
industry to conduct valid scientific studies before marketing a vaccine. Even
regulatory agencies assume that vaccines give far more benefit than damage
even when results are borderline and methodology flawed as was the case in
these Prevnar trials. Tests using flawed methodology is the standard in the
vaccine industry. Both researchers and regulatory agencies continually assume
that vaccines give far more benefit than damage even when methodology is
flawed and results are borderline as was the case in both of the cited Prevnar
trials. Future vaccine trials and hearings need to have unbiased people with
training in modern science to supervise these trials and point out defects in
trial design and conclusions. This may not happen soon enough due to the fact
that a fair implementing of such oversight would spell the end of vaccines
ever reaching the marketplace. However, as more and more people wake up from
the vaccine paradigm, changes in the way studies are conducted will be
inevitable.
Following is the link to the very long transcript of the FDA hearing on
Prevnar/Otitis_Media, LYMErix, etc discussed in this article:
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3854t1.htm
FDA hearing on Prevnar/Otitis_Media, LYMErix, etc
AOM = Acute Otitis Media
Some Additional Comments
Pneumococcal disease has dropped much faster than vaccine usage has risen.
So the vaccine is more than 100% effective. Way to go!
Wow, Could the reduction be due to anything other than the vaccine?
* Were the pre-vaccine stats 'cooked' (inflated) to start with?
* Or post vaccine disease incidence is simply not being fully reported?
* Or factors other than vaccine is causing a lowering of disease incidence?
About 55% of children in an small area of Finland were enrolled in the
vaccine trial.
No mention was made of the Otitis Media rate in the remaining 45%.
Remember only healthy children were included in the vaccine trial which means
the number of expected AOM or any other disease should have been lower than
the national average.
Even with all the flawed methodology for testing, these two trials for
Prevnar are refered too as, "two randomized, well controlled trials". ...
And as to why they used Hepatitis B for the control substance instead of a
Placebo, "it seemed to be the right thing to do to offer something to the
control group also, something beneficial." SOMETHING BENEFICIAL!
(Didn't anyone tell them that Hepatitis B vaccine causes more adverse events
in this age group than Hepatitis B disease causes?)
Unfortunately, using a vaccine for the 'control' to another vaccine
introduces unknowns, and biases both safety and effectiveness measurements,
the exact opposite of what a 'control' is supposed to do. 'Unknowns' include
the effect of combining multiple vaccines on the incidence total of AOM.
Prevnar plus California routine*, Prevnar plus Finland routine, Hepatitis B
plus routine, and meningococcal C plus routine* might all have bias toward
different rates of AOM. (*The routine schedule of recommended vaccines changed
during the California trial.) All of the vaccines, and more so all of the
combinations would likely contribute to causes of AOM. One of the causes would
likely be the foreign matter introduced into the body from the vaccines.
Another likely contribution to AOM might be treating the side effects of
vaccination with antibiotics. Even fever reducing procedures may keep the body
more toxic than procedures of allowing the body to fully heal.
Still, none of the discussing group condemned the study as 'flawed
methodology'. I think may individuals who have woke to the dangers of vaccines
would agree that adequate scientific testing of vaccines is badly needed.
Hearings such as this need to have at least one unbiased person who is
knowledgeable in modern science, and who answers only to consumers to
supervise the trials and point out defects of trial design and conclusions.
-----Following quotes are 'highlights' from the original---------
Source:
http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3854t1.htm
UNITED STATES OF AMERICA FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING
This transcript has not been edited or corrected, but appears as received from
the commercial transcribing service. Accordingly the Food & Drug
Administration makes no representation as to its accuracy.
TUESDAY, MAY 21, 2002
[Following excerps are only a very small part of the original document.]
[California trials:]
So, in summary, we've observed a dramatic reduction in basic pneumococcal
disease in childhood within our population. The magnitude of the reduction in
the first year, which was much greater than the vaccine coverage, and the
reduction observed in adults suggests herd immunity effect. ...
So at the moment, you may be aware that the package insert makes no mention
whatsoever about otitis media with regard to Prevnar efficacy, and we are here
today to propose that otitis media be included in the package insert and that
the indication be that Prevnar is indicated for active immunization of infants
and toddlers against invasive disease and otitis media caused by Strep.
pneumoniae due to the capsular types included in the vaccine.
And some of the reasons why we believe this is to be important is that
there are now two randomized, well controlled trials that you'll hear about
which show statistically significant decreases in otitis media outcomes. ...
[Finland trials:]
DR. KILPI: Good morning. I'm going to present the main efficacy results of the
Finnish otitis media vaccine trial that evaluated the efficacy of two seven-valent
pneumococcal conjugate vaccine for prevention of acute otitis media due to
vaccine serotypes in children less than two years of age.
And this study was conducted in the Tampere area in Finland, and the
clinical phase started in December '95 and ended in March '99, and during this
time, we had almost 2,500 children were enrolled in the study. This is
approximately 55 percent of the birth cohort in the area.
And all of these children were randomized to receive either one of the two
pneumococcal conjugate vaccines used in the study, the PncCRM vaccine labeled,
licensed as Prevenar or the PncOMPC vaccine or the control vaccine that was
Hepatitis B vaccine in our study. ...
And this is a summary of the main efficacy results, AOM,
vaccine efficacy against AOM due to vaccine serotype, 57 percent;
against culture confirmed pneumococcal AOM, 34 percent;
against pneumococcal AOM confirmed by either culture or PCR, analyzing PCR or
both, 20 percent.
These are all statistically significant.
Against any AOM, six percent, and recurrent AOM, 16 percent.
The latter two failed to reach statistical significance in our study. ...
And so principally, the indications for tympanostomy tube placement were
the same during the vaccine trial and after the trial when the children had
returned to the normal life situation, but access to treatment became
definitely more difficult when the trial follow-up was over due to the reasons
here.
And this makes plain why the incidence of tympanostomy tube placements in
the FinOM children during the vaccine trial follow-up was considerably higher
than what it is in the children of the same age in Finland in general.
And it also makes plain why this incidence of tympanostomy tube placement
dramatically dropped when they returned to a normal life situation. So it
appears that milder cases of recurrent AOM and otitis media with effusion were
treated with tympanostomy tube placement during the trial and after it, and
this makes plain why the effect of the vaccine on the incidence of tube
placement was different here from what it was here. ...
And these are the tympanostomy tube placements in the fully evaluated
children. During the trial follow-up from two months to two years of age, 20.3
percent of the children in the PncCRM group as compared to 23.8 percent of the
children in the control group had tympanostomy tubes place, and the incidence
rate of events is here. So the difference between the vaccine group and the
control group is 12 percent, and this is not statistically significant. ...
However, when the normal life situation started during the period from two
years to four to five years, only 8.2 percent of the children in the PncCRM
group as compared to 13 percent of the children in the control group had a
tympanostomy tube placement. ...
As shown here, actually the rates of first ear tube placement, number of
subjects with events in this table were quite similar and no efficacy estimate
was provided. It was suggested that because of the close follow-up during the
study that subjects actually sought treatment with ear tubes more often than
would ordinarily be the case in Finland, and these rates actually were higher,
I think, tenfold higher, nearly tenfold higher than common practice in Finland
and also much higher than practice in the Kaiser system. ...
Only in Finland did we have data on vaccine related serotype OM and the
related serotypes also showed a significant reduction at 51 percent with
reasonably narrow confidence interval, and there was an increase with
non-vaccine serotypes with a negative efficacy, as you've heard, of minus 33
percent.
Nevertheless, that increase was counterbalanced by the positive effects
within that efficacy for the vaccine against all pneumococci, 33 percent or 34
percent with, again, a reasonably narrow confidence band. ...
DR. KATZ: I guess I wondered why you picked Hepatitis B as the control
vaccine. What was the motivation for that?
DR. KILPI: Well, it's not included in the routine program in Finland. It's
only recommended for risk groups, and it seemed to be the right thing to do to
offer something to the control group also, something beneficial. ...
DR. KILPI: We do. We looked at -- what we have in the database is the data
on penicillin resistance, but the resistance situation in Finland is very
different from that in the U.S. So that almost all of them were susceptible to
penicillin.
However, if they were not susceptible they were usually or I think they were
exclusively vaccine serotypes. ...
In the Finnish study, subjects were randomized equally to one of three
vaccines, Prevnar, PnbcOMP manufactured by Merck, and the Hepatitis B vaccine
control.
However, only data related to Prevnar were provided in the application and
only data related to Prevnar will be discussed today.
The study was double blind, and eligible subjects were in good health as
determined by medical history, exam, and clinical judgment.
Of note, infants born prematurely could be enrolled in the study if they were
judged to be in good health. ...
[following is some stuff I clipped from the package insert info:
Hep B Recombivax HB (Recombinant)(Merck and Co.)
Special senses
Earache (clinical trials = or < 1% within 5 days)
Tinnitus (post marketing reports)
Engerix-B ®
Hepatitis B Vaccine (Recombinant) (SmithKline Beecham Biologicals)
Additional adverse experiences have been reported with the commercial use of
Engerix-B. Those listed below are to serve as alerting information to
physicians.
Special senses: Conjunctivitis; keratitis; visual disturbances; vertigo;
tinnitus; earache.]
From the Prevnar Insert:
Of the 17,066 subjects who received at least one dose of Pneumococcal 7-valent
Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar®, in the
efficacy trial, there were 24 hospitalizations (for 29 diagnoses) within 3
days of a dose from October 1995 through April 1998. Diagnoses were as
follows: bronchiolitis (5); congenital anomaly (4); elective procedure, UTI (3
each); acute gastroenteritis, asthma, pneumonia (2 each); aspiration, breath
holding, influenza, inguinal hernia repair, otitis media, febrile
seizure, viral syn-drome, well child/reassurance (1 each). There were 162
visits to the emergency room (for 182 diagnoses) within 3 days of a dose from
October 1995 through April 1998. Diagnoses were as follows: febrile illness
(20); acute gastroenteritis (19); trauma, URI (16 each); otitis media (15);
well child (13); irritable child, viral syndrome (10 each); rash (8); croup,
pneumonia (6 each); poisoning/ingestion (5); asthma, bronchi-olitis (4 each);
febrile seizure, UTI (3 each); thrush, wheezing, breath holding, choking,
conjunctivitis, inguinal hernia repair, pharyngitis (2 each); colic, colitis,
congestive heart failure, elective procedure, hives, influenza, ingrown
toenail, local swelling, roseola, sepsis (1 each).
For a wonderful in depth article:
http://www.whale.to/v/prevnar2.html
PREVNAR A Critical Review of a New Childhood Vaccine
© Michael Horwin, MA
http://www.vaclib.org/links/ears.htm
Index: Vaccines, Ear Infections & related articles, otitis media
Ingri Cassel, President
Vaccination Liberation - Idaho Chapter
P.O. Box 1444
Coeur d'Alene, Idaho 83816
(208)255-2307/ 765-8421
vaclib@coldreams.com
"Free Your Mind....From The Vaccine Paradigm"
www.vaclib.org
Page last modified: - - 10/24/2002 20:31:42 http://www.vaclib.org/email/prevnarfda.htm
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