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Jerri Johnson
*OAH_RuleComments.OAH
Immunization Rules docket 0900-30570
Wednesday, July 24, 2013 2:11:49 PM
Response to MDH response.docx
Response to MDH response to testimony at hearing and comments submitted.
Jerri Johnson
Public Relations Coordinator
National Health Freedom Coalition'
651 688 6515
[email protected]
A Response to the
MDH Response to Comments Document submitted 7/17
The MDH Response to evidence of harm submitted by citizens is inadequate to deny the reality
of adverse effects caused by vaccines. Two comments by MDH summarized their view on
adverse effects of these vaccines:
“At the hearing and in comments, parents spoke and wrote about very real and quite severe health
problems their children suffer, conditions they attribute to vaccine injuries. Such suffering garners
sympathy and should not be minimized in any way. But, evidence for a causal connection between
vaccines and those injuries for many of the stories is weak or implausible.
“The evidence shows that serious adverse reactions from vaccines are extremely rare. As Dorit
Reiss wrote, “The fact that a parent believes a child’s problems stem from a vaccine is relevant,
but often not sufficient, especially when the research goes the other way.” Ms. Reiss also
included a link to an AAP’s document entitled “Vaccine Safety: Examine the Evidence”
(http://www2.aap.org/immunization/families/faq/vaccinestudies.pdf) As she points out, “In
contrast, evidence for the harms of the diseases in question is well documented and supported by
medical evidence and objective tests.”
“It is important to stress that Ms. Johnson and others rely on VAERS reports and anecdotal evidence for
their assertion. Such reliance is misplaced. As stated in the SONAR and at the hearing, VAERS cannot be
relied upon to make any inferences of causation, a fact that Ms. Johnson acknowledged in her testimony
(See hearing transcript, page 112)”
Vaccine Safety Council of Minnesota and other groups pointed out evidence of vaccine harm
from four sources: 1) Clinical studies documenting harm, 2) compensation of cases for death
or disability from the National Vaccine Injury Compensation Program (VICP), 3) the federal
Vaccine Adverse Events Reporting System (VAERS) and 4) the reports of parents.
In their Response to Comments, the MDH addressed only two of these components, alleging
that “VAERS cannot be relied upon to make any inferences of causation”, and, regarding
parents’ experience, that “evidence for a causal connection between vaccines and those injuries
for many of the stories is weak or implausible.” This statement is interesting in itself, because
for most, if not all, of the experiences described by parents of vaccine injury in their child, or by
health care professionals in their clients, MDH had absolutely no opportunity to review the
evidence for connection to a vaccine. The claim that the “evidence is weak or implausible”
reveals the underlying assumptions made by the Department about vaccine injuries that
parents describe: “it couldn’t have been the vaccine”. In fact, the evidence is often
overwhelming and undeniable.
But MDH completely ignored the other two important sources of evidence of vaccine harm:
independent studies showing harm, and cases compensated for injury by the federal
government.
Studies showing harm from vaccines
The studies relied on by the MDH in proposing the rule tend to come primarily from either
government-related groups, including the CDC, the HHS, and the Institute of Medicine, which is
often funded through Congress or government agencies, or from studies funded by
pharmaceutical companies. These groups all have a stake in proving vaccine safety, and these
studies tend to conclude that a given vaccine is safe.
Other studies, however, especially those done by independent scientists and published in peerreviewed journals, often come to different conclusions: i.e. that a vaccine is not safe.
An example of a study examining the research done on the hepatitis B vaccine, for example,
concluded:
“According to Hippocratic tradition, the safety level of a preventive medicine must be
very high, as it is aimed at protecting people against diseases that they may not
contract. This paper points out that information on the safety of hepatitis B vaccine
(HBV) is biased as compared to classical requirements of evidence-based medicine
(EBM), as exemplified by a documented selectivity in the presentation or even
publication of available clinical or epidemiological data. Then, a review is made of data
suggesting that HBV is remarkable by the frequency, the severity and the variety of its
complications, some of them probably related to a mechanism of molecular mimicry
leading to demyelinating diseases, and the others reproducing the spectrum of nonhepatic manifestations of natural hepatitis B. To be explained, this unusual spectrum of
toxicity requires additional investigations based upon complete release of available
data.”
Autoimmunity Reviews 4 (2005) 96– 100 Autoimmune Hazards of the hepatitis B Vaccine
http://www.ncbi.nlm.nih.gov/pubmed/15722255 Marc Girard* 1 bd de la Re´publique 78000-Versailles, France
There are hundreds of studies demonstrating that vaccines can and do cause death and
disability. Some of them have been submitted for your review that relate to the four vaccines
in question. One website that links to hundreds of such studies is
(http://www.greatergoodmovie.org/learn-more/science/)
Studies that the MDH relies on
The MDH claims that they rely on science. However, many of the studies on vaccine safety
have huge methodological flaws: 1) They do not use a placebo group that received no vaccine,
to compare rates of adverse effects, and 2) they rarely do long-term follow-up of recipients to
look for adverse effects that develop slowly.
Unfortunately, for the vaccines in question in this proposed rule, it was not possible to access
the original data on the clinical safety trials. Calls to the pharmaceutical company revealed that
that is proprietary information, not available to the public or to review by independent
scientists. We don’t know whether they used a true placebo in their safety studies. We do
know that they only followed most of their subjects for five days.
An example of the information that should be made public is the safety study done on the
pneumococcal vaccine, (analysis submitted previously.) The data showed that within 60 days of
receiving the vaccine, 513 infants, (3% of the study group), required hospitalization. The
authors of the study stated that none of the 513 hospitalizations were related to the vaccine.
There were 1188 visits to the emergency room within 30 days following the vaccine, (7% of all
infants receiving the vaccine), with a spike in ER visits in the first 72 hours after the vaccine.
The authors of the study concluded that none were related to vaccination.
They concluded this by comparing the study group to the “control group”, which had a similar
number of hospitalizations and ER visits. But the control group had not received a placebo – it
had received an experimental meningococcal vaccine! Both groups had similar spikes in
emergency room visits in the 3 days following the vaccine!
The authors of the study concluded, "This trial included an extensive evaluation of the safety of
both the pneumococcal and meningococcal conjugate vaccines. Safety monitoring in this
cohort of >37,000 children did not reveal any severe adverse events related to vaccination
that resulted in hospitalization, emergency visits or clinic visits."
Parents are now told on the Vaccine Information Sheet they receive from their doctor, "So
far, no serious reactions have been associated with this vaccine."
This is the kind of non-scientific science that many of the “safety studies” on vaccines use, and
come to the conclusion that the vaccine is safe. Almost no clinical studies done for the FDA to
establish safety of a vaccine use a placebo group for a large number of subjects. It is routine for
them to use a different vaccine for the control group. And only for small groups of recipients
do they typically follow them for long-term observation.
Wyeth Pharmaceuticals, to their credit, at least released the data from their studies. For the
vaccines in question for this rule, the pharmaceutical companies will not release the data on
the safety studies.
Compensation of cases by the VICP demonstrates harm caused by vaccines
VSCM submitted evidence that over 3,000 people have been compensated by the federal
government’s National Vaccine Injury Compensation Program for death or disability from a
vaccine. In the case of hepatitis B vaccine, at least 262 people have been compensated. That is
an average of 1 person per month since the hepatitis B vaccine became licensed. This is
evidence that injury from this vaccine is not rare, but all too common, and all too great a risk for
our state to mandate it for infants.
Here is the MDH response to the issue of compensation by the federal government for vaccine
injuries:
Many testifiers and commenters deemed the National Vaccine Injury Compensation Program
(NVICP) to be inadequate. Yet at the same time, they cited this program to show that people
were compensated for injuries related to vaccines. This federal program is outside the scope of
these proposed rules so MDH makes no further comment.
I’m not sure what is meant by “outside the scope of these proposed rules.” Does that mean
that MDH did not research this data, or did not consider it as part of its decision to require
these vaccines? Was MDH surprised to hear that 262 individuals have been compensated for
severe harm or death from the hepatitis B vaccine? MDH should be accessing all data on the
safety of any vaccine it considers requiring. Why would this program be “outside the scope of
these proposed rules?” This federal program (NVICP) is extremely relevant to these proposed
rules because it demonstrates that many people have been harmed by the vaccines MDH is
proposing to require.
Circular thinking which concludes vaccines are safe
Here is how the thinking goes by those proposing these rules: Our research shows that the
vaccine is safe and that adverse effects are rare. We will ignore any evidence from studies that
say otherwise or from cases compensated by the government. Based on these assumptions,
then any reports in VAERS, which does not prove causality, must be coincidental. And any
conclusion by parents that their child was disabled by a vaccine must be based on evidence that
is “weak or implausible.”
The MDH has chosen to deny the reality of vaccine injuries from the vaccines that they are
proposing to add to the vaccine schedule.
They completely ignore the hundreds of studies by scientists not connected with the CDC, IOM,
or with pharmaceutical companies, studies published in peer-reviewed journals, that point out
disability and death following these particular vaccines.
And they completely ignore the thousands of cases where Americans have been compensated
by the federal government after going through exhaustive review to document the disability or
death following a vaccine. They continue to repeat the mantra that “this vaccine is safe”, based
on studies designed to show that it is safe.
Based on this thinking, they then dismiss any evidence of harm derived from VAERS data as
coincidental and not causative. And they dismiss the conclusions of parents who watched their
child regress after a vaccine.
MDH claims it is relying on science, and thus reports from VAERS and parents must be
mistaken. But the science they are relying on does not use placebo control groups. It refuses
to do large-scale studies on vaccinated vs unvaccinated children. It refuses to open up the
Vaccine Safety Datalink Database to review by independent scientists. It refuses to reveal the
raw data on clinical studies (like Wyeth, to their credit, on the pneumococcal study did).
In this “hear no evil, see no evil” kind of reality, the risk/benefit ratio of the vaccination
program is seen as “the benefits outweigh the risks.” But wise policy makers will choose to let
in the truth from all sources on the safety of the vaccines. They will absorb information with an
open mind from the studies that show serious adverse effects from vaccines, and they will
acknowledge that compensation has been paid to thousands of people who actually have been
disabled or killed by a vaccine. In so doing, they may have to face the possibility that the VAERS
reports actually point to a causal connection to vaccine injury, and that parents aren’t making
this up when they see their child regress from a vaccine. But facing the truth is the first step
toward making good policies that promote a healthy society.
I remembering chatting with Dr. Mark Geier, MD, some years ago. He was telling me that in his
earlier career as a doctor, he had given many pregnant women the drug Rhogam, to deal with
rH factors. At some point, he came to realize that this drug contained a large amount of
mercury, which was harmful to the mother and the fetus. I said to Dr. Geier, “It must be very
difficult for doctors to recognize that something they did for a patient inadvertently turned out
to be harmful.” “Oh,” he said, “it is horrible. But we have to face it. Otherwise we will
continue to harm them.”
Federal and state public health officials need to open their eyes and let in the truth – the reality
that severe vaccine injuries occur as often as they do – to real people. And then re-calculate
the risk/benefit ratio. At the very least, they should not be using the police power of the state
to require these vaccines.
Judge Lipman, we request that you rule that adding these vaccines to the required list is not
needed and not reasonable.