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).
In 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.
No Facts 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.
I 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) Vaccine.
The HPV-Mental 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.
Of 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.
Broadening the 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.
It 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.
Other HPV 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.
4609 Reported 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 year.
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 report.
Manufacturers 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.
Vaccine 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.
Going 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.
Be 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 rates.