Please see the detailed supporting data below regarding the safety profile of the HPV vaccine, pre and post licensure
.
Safety Concerns- Pre Licensure:
The package insert page 7 shows that there were two large groups compared to each other to measure for serious adverse effects. Both groups received an equal amount of Amorphous Aluminum Hydroxyphosphate Sulfate, abbreviated as AAHS.
“Serious Adverse Reactions in the Entire Study Population Across the clinical studies, 258 individuals (GARDASIL N = 128 or 0.8%; placebo N = 130 or 1.0%) out of 29,323 (GARDASIL N = 15,706; AAHS control N = 13,023; Serious Adverse Reactions in the Entire Study Population Across the clinical studies: out of 29,323 (GARDASIL N = 15,706; AAHS control N = 13,023).” Thus the two largest groups compared both received AAHS- Gardasil group of 15,706 enrollees and AAHS “placebo” group 13,023 enrollees.
Accordingly it is accurate to state that Merck possibly engaged in Vioxx style research fraud by deceptively not including a properly inert placebo control group during the preclinical trials for the Gardasil vaccine.
This fact alone should be cause for immediate concern and investigation.
Why not compare the rate of serious adverse effects to similar sized groups that received a truly inert placebo?
2) Excess Deaths in Trial Groups:
FDA Package Insert: Pages 7-8 discloses: “Across the clinical studies, 40 deaths (GARDASIL N = 21 or 0.1%; placebo N = 19 or 0.1%) were reported in 29,323 (GARDASIL N = 15,706; AAHS control N = 13,023).” Accordingly, 140/100,000 enrollees in the study died from any cause. CDC death statistics for the same time period adjusted for age and sex are 79 deaths per/100,000.
The apparent relative risk for death from all causes is 1.77 or 177% higher than expected in the general non AAHS exposed age and sex adjusted populations.
The statement in the package insert page 7 paragraph 4 “The events reported were consistent with events expected in healthy adolescent and adult populations” is contradicted by CDC mortality tables for this same time period.
3) Excess Suicides in Trial Groups:
the package insert bottom of page seven shows there were eight suicides in the combined study groups, both receiving AAHS: “drug overdose/suicide (2 individuals who received GARDASIL and 6 individuals who received AAHS control.” Since there were 29,323 kids in the study groups, this equates to 27.2/100,000 study participants committing suicide. In the general population during that same time period there were 7.7/100,000 suicides age and sex adjusted per CDC death statistics.
The apparent relative risk from suicide in the AAHS exposed groups is 3.53 or 353% higher than expected compared to non AAHS exposedgeneral population, sex and age adjusted. This result is beyond alarming. Remember that study participants are carefully screened for psychological and physical issues before they are permitted to enroll in a research study, and they are carefully monitored during the study period. The rate of suicides in the study groups is a disqualifying result that should get the vaccine banned not only in Maryland, but in the entire vaccine taking world as well. We need to know why the kids who participated in the study killed themselves at a rate 3.53 times greater the national average for their age and sex adjusted peers. The CDC United States suicide statistics can be viewed here:
Note the title above graph one states “Suicide rates increased from 1999 through 2014, with greater annual percent increases after 2006.” 2006 was the year Gardasil was approved in the United States.
4) Page 10
: data in pregnant women: none.
5) Page 11
: data for child safety with breast feeding: none.
6) Page 13
: Clinical Toxicology Studies: none.
Conclusion:
The number one driving factor in phramacoviligence is the unshakeable principle of Safety Before Efficacy.
The FDA package insert clearly demonstrates there was no inert placebo used during testing. There are excess deaths from all causes and particularly from suicides in the trial groups compared to the general population. Accordingly Maryland should act immediately to rescind recommendation support for this vaccine pending a comprehensive independent safety review.
Post Licensure Safety Concerns:
The following items have been reported in medical journals and mainstream media describing negative safety signals that have occurred since the vaccine was licensed:
1) Vaccine Adverse Effects Reporting System (VAERS):
VAERS is a passive vaccine adverse effect reporting system created under the National Childhood Vaccine Injury Act of 1986 and maintained by HHS. VAERS review of HPV vaccine reports shows 54,105 adverse reactions. Among those, 2,227 are listed as “disabled,” 10,416 are listed as “did not recover,” 7,418 are listed as “serious,” and 409 deaths have been reported.
2) VIGIBASE:
VigiBase is the unique WHO global database of individual case safety reports (ICSRs). It is the largest database of its kind in the world, with over 16 million reports of suspected adverse effects of medicines, submitted, since 1968, by member countries of the WHO Programme for International Drug Monitoring. It is continuously updated with incoming reports.
A search of VIGIBSE for events associated with Gardasil shows:
Blood and lymphatic system disorders (1913)
Cardiac disorders (2349)
Congenital, familial and genetic disorders (276)
Ear and labyrinth disorders (1632)
Endocrine disorders (348)
Eye disorders (4778)
Gastrointestinal disorders (14997)
General disorders and administration site conditions (45387)
Hepatobiliary disorders (247)
Immune system disorders (1767)
Infections and infestations (4481)
Injury, poisoning and procedural complications (11684)
Investigations (12726)
Metabolism and nutrition disorders (1712)
Musculoskeletal and connective tissue disorders (14028)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) (1012)
Nervous system disorders (36915)
Pregnancy, puerperium and perinatal conditions (1178)
Product issues (86)
Psychiatric disorders (4896)
Renal and urinary disorders (1085)
Reproductive system and breast disorders (3065)
Respiratory, thoracic and mediastinal disorders (5562)
Skin and subcutaneous tissue disorders (14023)
Social circumstances (1778)
Surgical and medical procedures (2162)
Vascular disorders (5362)
3) 2009: Under Reporting of Adverse Events by Passive Monitoring Systems:
The Department of Health and Human Services (HHS) gave Harvard Medical School a $1 million dollar grant to track VAERS reporting at Harvard Pilgrim Healthcare for 3 years and to create an automated reporting system which would revolutionize the VAERS reporting system- transforming it from “passive” to “active.”
According to the grant final report:
“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these
doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified. This is an average of 890 possible events, an average of 1.3 events per clinician, per month.
These data were presented at the 2009 AMIA conference.
In addition, ESP:VAERS investigators participated on a panel to explore the perspective of clinicians, electronic health record (EHR) vendors, the pharmaceutical industry, and the FDA towards systems that use proactive, automated adverse event reporting.
Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events
and 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported.
Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants
responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.” In other words- after the researchers reported that they were detecting serious adverse events at a rate of 2.6%- the CDC terminated the study and quit calling them back.
4) 2013: Japan Withdraws Government recommendation for HPV vaccine after more than 1968 reports of serious adverse events:
“According to a report in the Japan Times, 8.29 million people had received the HPV vaccine as of December 2012, and there
were 1968 cases of concerning adverse events reported as of March 2013. Of these adverse events, 106 were described as "serious cases of pains or body convulsions, pains in joints, or difficulty in walking." Those numbers translate to a rate of 12.8 serious cases of adverse events per 1 million inoculations, according to the report.”
After the 2013 withdrawal, the Japanese Government empaneled a group of medical experts to hold a public debate regarding the pros and cons of the HPV vaccine. 5 years later, the vaccine is still not recommended and the uptake rate is less than 1% in Japan.
5) 2013: Journal Annals of Medicine: Human papillomavirus (HPV) vaccine policy and evidence-based medicine: are they at odds?
“The way in which HPV vaccines are often promoted to women indicates that such disclosure is not always given from the basis of the best available knowledge. For example, while the world's leading medical authorities state that HPV vaccines are an important cervical cancer prevention tool,
clinical trials show no evidence that HPV vaccination can protect against cervical cancer
. Similarly, contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries
. In the Western world cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination.”
6)
2015: Medical Textbook Vaccines and Autoimmunity published:
“Vaccines and Autoimmunity explores the role of adjuvants – specifically aluminum in different vaccines – and how they can induce diverse autoimmune clinical manifestations in genetically prone individuals.”
The editor Yehuda Shoenfeld works at Sheba Medical Center in Tel HaShomer and the Sackler Faculty of Medicine at Tel-Aviv University. He is the incumbent of the Laura Schwarz-Kipp Chair for Research of Autoimmune Diseases. Shoenfeld is the editor of two journals, Harefuah (Medicine) in Hebrew with English abstracts and Israel Medical Association Journal (IMAJ). He is co-editor-in-chief of Autoimmunity Reviews,[1] and co-editor of the Journal of Autoimmunity,[2] and member of the editorial board of the Clinical Reviews in Allergy & Immunology.
7) 2015: Serotype Replacement Risk: American Association for Cancer Research:
Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20-26 years): The American Center for Cancer Research reported in 2015 that girls who received the four strain HPV shot, when assessed 10 years later, were actually more likely to be infected with high risk, low risk, and all strains of HPV. The four vaccine strains were reduced- but other, possibly more pathogenic, HPV viruses moved in to fill the void. This shows the early HPV4 vaccine exposed the girls who took it to greater risk for HPV infection than those that did not take the vaccine.
8) 2015: New York Times Wellness Blog:
When people hear about vaccine deniers — anti-vaxxers, to some — they most often think about parents who are refusing to vaccinate their children. But there’s another type of vaccine refusal, and it’s important that we not ignore that
. Doctors sometimes promote the use of some vaccines with less enthusiasm than others. Sometimes, they don’t talk about them at all. This occurs most often with the human papillomavirus, or HPV, vaccine.
9) 2016: Nordic Cochrane Review Files Complaint with EMA over HPV Vaccine Safety Issues
: Denmark now has five regional uptake facilities for girls who were healthy before they received HPV shots and are now claiming serious medical harm.
“An official complaint has been filed by the Nordic Cochrane Center against the European Medicines Agency (EMA) over its handling of safety issues concerning human papillomavirus (HPV) vaccines. In the complaint, which runs to 19 pages, the Nordic group says that the official EMA report is flawed. It points out several issues with the way the safety review was conducted, including the fact that the manufacturers were asked to search their own databases and that they compared the vaccine to an aluminimum adjuvant instead of a saline placebo.
The group also highlights the "extreme levels of secrecy" that surround the EMA review process, in which experts who are involved in the process are not named and are bound by lifelong secrecy about what was discussed.”
10) 2017: Slate Magazine: What the Gardasil Testing May Have Missed: “An eight-month investigation by Slate found the major Gardasil trials were flawed from the outset, however, and that regulators allowed unreliable methods to be used to test the vaccine’s safety.”
11) 2017Journal Nature: Murine hypothalamic destruction with vascular cell apoptosis subsequent to combined administration of human papilloma virus vaccine and pertussis toxin: “In the case of the human papillomavirus (HPV) vaccine, an unexpectedly novel disease entity, HPV vaccination associated neuro-immunopathetic syndrome (HANS), has been reported and remains to be carefully verified.
Palmieri B. et al reported the occurrence of severe somatoform and dysautonomic syndromes after HPV vaccination9 and Brinth L. et al. also described the onset of autonomic dysfunction after the quadrivalent vaccination10
. Both reviews clearly indicated the presence of unique adverse reactions associated with the HPV vaccination including headache, fatigue, depression, cognitive dysfunctions, uncontrollable and involuntary movement, and limb weakness. For these clinical manifestations, we have coined these reactions as human papillomavirus vaccination-associated neuro-immunopathic syndrome (HANS) and proposed diagnostic criteria.
HANS syndrome is thought to consist of four clinical domains; (i) autonomic, endocrine and inflammatory symptoms; (ii) cognitive and emotional symptoms; (iii) environmental hypersensitivity and pain symptoms and (iv) locomotion and motor symptoms11,12. Several clinical studies on HANS symptoms have also shown that the HPV vaccines may influence the central nervous system (CNS)10,13,14,15.”
This result is particularly troubling in light of Dr. Chan’s directive to “bundle” HPV the HPV vaccine with DTaP that was in the DOH letter attached above.
12) 2017 The Tribune: Dubious vaccine for cervical cancer by Dr. Jacob Puliyel, Head of Pediatrics, St Stephen's Hospital, Delhi, and a member of the National Technical Advisory Group on Immunisation:
“In a few genetically predisposed individuals, Montoya told the Slate editor, it is “biologically plausible” that the vaccine, which mimics a natural infection, could also trigger an immune response powerful enough to lead to CFS. CFS is not the only serious adverse effect reported. The American College of Pediatrics has suggested one of the HPV vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.”
13) 2017 Drug Safety: Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®:
“CONCLUSIONS:
Cluster analysis reveals additional reports of AEs following HPV vaccination that are serious in nature and describe symptoms that overlap those reported in cases from the recent safety signals (POTS, CRPS, and CFS), but which do not report explicit diagnoses
. While the causal association between HPV vaccination and these AEs remains uncertain, more extensive analyses of spontaneous reports can better identify the relevant case series for thorough signal evaluation.”
14) 2017 Drug Safety: Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan:
“
Results
Overall, 43 female patients were excluded.
Among the remaining 120 patients, 30 were diagnosed as having definite vaccine-related symptoms, and 42 were diagnosed as probable
. Among these 72 patients, the age at initial vaccination ranged from 11 to 19 years (average 13.6 ± 1.6 years), and the age at appearance of symptoms ranged from 12 to 20 years (average 14.4 ± 1.7 years). The patients received the initial human papillomavirus vaccine injection between May 2010 and April 2013. The first affected girl developed symptoms in October 2010, and the last two affected girls developed symptoms in October 2015. The time to onset after the first vaccine dose ranged from 1 to 1532 days (average 319.7 ± 349.3 days).”
15) 2018: Annapolis Capital Gazette No Ironclad for HPV Vaccination Yet:
“Given the relatively high cost of each shot, either two or three are required, and the extremely low probability of the diagnosis, I question whether a mass vaccination program to prevent these cancers, as horrible as they are, is the wisest and best use of limited resources.
Would the same money spent countering opioid addiction, or drunken driving in Anne Arundel county perhaps save more lives?”
16)
It is instructive to note that Merck has a corporate history of engaging in criminal fraud with regards to pharmaceutical research:
Merck engaged in criminal research fraud with Vioxx:
A) CBS News: Merck Created Hit List to "Destroy," "Neutralize" or "Discredit" Dissenting Doctors:
“Merck made a "hit list" of doctors who criticized Vioxx, according to testimony in a Vioxx class action case in Australia. The list, emailed between Merck employees, contained doctors' names with the labels "neutralise," "neutralised" or "discredit" next to them.
B) Reuters: Merck is currently accused of vaccine research fraud in federal court:
“The two scientists…..filed their whistleblower lawsuit in 2010 claiming Merck, the only company licensed by the Food and Drug Administration to sell a mumps vaccine in the United States,
skewed tests of the vaccine by adding animal antibodies to blood samples. As a result, they said, Merck was able to produce test results showing that the vaccine was 95 percent effective, even though more accurate tests would have shown a lower success rate.”
C) New York Times: Merck to Pay $950 Million Over Vioxx:
“Merck
has agreed to pay $950 million and has pleaded guilty to a criminal charge
over the marketing and sales of the painkiller Vioxx, the company and the Justice Department said Tuesday.”