Bachmann Was Right: Government Database Contains Reports of Mental Retardation as Vaccine Adverse Event
Posted Sep 01 2012 12:00am
By Beth Clay
The United States’ Election Day 2012 is less
than 60 days away. The Republicans and
the Democrats have selected their candidates and platform. President Barack
Obama and Vice President Joe Biden (Democrats) are in a dead heat in the race
to retain their positions rather than be replaced by former Massachusetts Governor
Mitt Romney and Congressman Paul Ryan of Wisconsin (Republicans).
the months since Minnesota Representative Michele Bachmann was vilified on the
Presidential campaign trail for calling Governor Rick Perry on the carpet during
a debate for his circumventing the Texas legislative process and issuing an
executive order to mandate the HPV vaccines for girls age 12 years and older in
Texas. The death knell to her campaign
was sharing the story from a woman whose daughter suffered mental retardation as
a result of that vaccine. She was
vilified for raising a safety alarm, with attacks from the American Academy of Pediatrics;
the vaccine industry’s favorite paid spokesperson, Dr. Paul Offit, and media
outlets both conservative and liberal.
Presented: What was missing from the dialogue at the
time, and to my knowledge remains an area unexplored, is what the facts are on
the matter. No one in the media took the
time to verify anything about vaccine adverse event reports. A simple
review on the publicly available database of the Vaccine Adverse Event
Reporting System (VAERS), available at http://wonder.cdc.gov would have been
an eye opener for any reporter.
conducted a simple search for reports received from 2000 to July 13, 2012, in
the United States for all vaccines in which ‘mental retardation’ is listed as
symptom in the vaccine adverse events and found 394 reports. Two of these reports are for the Gardasil (HPV)
Retardation Reports Were Very Limited:
A review of what is published about these two reports finds very limited
information. One was from a reporter
from a television show in which a mother reported that her daughter developed
mental retardation after the Gardasil HPV vaccine. The second report notes that a doctor of
psychology called to report that she heard a news report on 13 September 2011 a
report of Gardasil causing mental retardation.
This report was classified as hearsay.
the remaining 392 “Mental Retardation” reports, the notations are much more
specific and cover many vaccines including (but not limited to) the anthrax
vaccine, various combinations of vaccines for haemophilus influenzae type B
vaccine, hepatitis B, diphtheria, tetanus, pertussis, measles, mumps, rubella
(MMR), influenza and varicella.
Search Terms: A broader search including the terms “mental
impairment, mental status changes, mental disorder as well as mental
retardation" as symptoms of a vaccine adverse event that occurred in the United
States from 2000 to July 13, 2012, returned 1221 reports. Of these, 65 were HPV reports.
should be noted as well that the Rotavirus vaccines have 18 reports - Rotateq
has 15 reports, Rotashield has 1, Rotarix has 1 and a rotavirus vaccine, brand
not known in 2012 has 1.
Adverse Events: A review of the
VAERS reports for HPV without specification of the symptom locked up the
database for returning too many responses.
Multiple more narrow searches found 55 VAERS report of death under the HPV
vaccine. In the first seven months of
2012 there have been 3339 VAERS reports on HPV. Some of these reports are for
non-life threatening/life altering reactions such as nausea, dizziness and
fainting. However, there were also 38 reports of Uticaria (Hives) some of which
may have been life threatening. There
were several reports of Stevens-Johnson Syndrome, somnolence, seizure-like
phenomena, 4 cases of cervical cancer, 7 cases of alopecia, and 4 deaths. There were also several reports of women who
were vaccinated while in the early stages of pregnancy. The reports state these individual received a
uterine dilation and curettage (D&C) but did not report whether there was a
spontaneous abortion or a determination to terminate pregnancy. There were also
multiple reports of abnormal PAP smears, sensory loss, and speech disorder.
Deaths Since 2000: A search for
deaths reported in the VAERS system since 2000 produced a list of 4609 reports. Deaths were reported in many vaccines each
Required by Law
to Report Adverse Events: When
Congress passed the National Childhood Injury Act of 1986 as part of PL-99-660
(which created the National Vaccine Injury Compensation Program) a provision
was included to mandate the Department of Health and Human Services to manage a
post-marketing surveillance system for vaccine injuries and required that healthcare providers who
administer vaccines report certain adverse events which are included on a list. The agency encourages healthcare
professionals “to report any clinically significant or unexpected events (even
if not certain the vaccine caused the event) for any vaccine, whether or not it
is listed.  One of the challenges to this mandate is that
there are no consequences if a health care professional fails to submit a VAERS
are also required by regulation (21CFR 600.80) to report to the VAERS program
all adverse events made known to them for any vaccine. Adverse event reports
can be filed online at http://vaers.hhs.gov/index or submitted by mail by
printing out and completing the form available at http://vaers.hhs.gov/resources/vaers_form.pdf.
Reports can be made by individuals who are not healthcare professionals as
well. Parents, grandparents, the adult
injured party, even neighbors or others may submit reports.
Information Statements (VIS): The
law also requires “all health care providers in the United States who
administer, to any child or adult, any of the following vaccines – diphtheria,
tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B,
Haemophilus influenzae type b (Hib), trivalent influenza, pneumococcal
conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella
(chickenpox) – shall, prior to
administration of each dose of the vaccine, provide a copy to keep of the
relevant current edition vaccine information materials that have been produced
by the Centers for Disease Control and Prevention (CDC): to the parent or
legal representative of any child to whom the provider intends to administer
such vaccine, or to any adult to whom the provider intends to administer such
vaccine.”  ,  If you are not offered a VIS, ask for
it. In addition to information about the
vaccines benefits and risks, contact information to report a vaccine adverse
event is included.
A Signal Not
Proof: It is widely acknowledged that VAERS has
limitations. It is intended as a
centralized database to monitor expected and unexpected adverse events, and
form the basis for investigations. The
VAERS system is one of several vaccine adverse event tracking systems
maintained and utilized by the agency.
One of the challenges to evaluating the data is that many reports (such
as the two on HPV discussed above) are not from primary sources, or are mostly
incomplete. Reports are most useful when
as much information about the vaccine such as including lot number,
manufacturer, date of administration, and contact information for the parent of
the vaccine injured are included. While the reports may only act as a signal,
if the signal is ignored, how the public benefits from the use of
increasingly limited resources is unclear.
Forward: There are 165
publications listed in PubMed that discuss VAERS. I am unaware of any unbiased expert review of
these papers, and the studies which some of these papers discuss. Some of the
articles only describe VAERS, others are not research.
Proactive: If you or your
child suffered a vaccine adverse event, have you submitted a VAERS report? If you have not submitted a report, please do
so, keep a copy. If you submitted a report, do you still have a copy? Have you looked it up online to see if your
report is registered? Do you know what the agency did with your report?
Conclusions: The attacks on Representative Michelle
Bachmann were based more on a desire to protect vaccine policies rather than to
discuss the facts of vaccine adverse events.
It was a prime example of the industry’s heavy influence with news
outlets, which has been lamented by many who have been working since Congress
engaged in looking at vaccine injuries in 1999. Rather than seek the truth of the statement,
there was an attack on the individual.
Any reporter, radio talk show host, or political operative could have
visited the CDC’s website the same way that I did and confirm that indeed there
were reports of mental retardation a year before Representative Bachmann shared
the personal story of a mother, who sadly has not reported this incident to
Beth Clay, a Concept Doula who consults with corporate and non-profit
organizations is the former Senior Professional Staff member who led the
Congressional investigation that regarding epidemic rise in autism