I have great respect for Governor Hogan. I appreciate and admire his empathetic desire to reduce and prevent cancers that cause terrible suffering and death for Maryland residents and others. A secretive campaign to market human papillomavirus (HPV) vaccinations in Maryland state schools is not a proper public health policy strategy to accomplish those goals.
I learned about this ”under the radar” campaign after my op-ed No Ironclad Case for HPV Vaccine Yet was published January 13, 2018 in The Annapolis Capital Gazette (annotation 15 below). A career registered nurse in Montgomery County schools gave me two letters attached above (“HPV1” and “HPV2”). She told me that she felt she was being “forced” to market the vaccine to students, that she objected to the policy, and that she was scared to speak out for fear of losing her job.
The first letter (HPV1) was authorized by Dr. Ken Lin Tai , Director, Maryland Department of Health Center for Cancer Prevention and Control. Her office originated, wrote, and approved the letter. Dr. Jinlene Chan MD, MPH, and Dr. Dennis Schrader signed off on it. Per my conversation with Dr. Chan Thursday Feb 16 2018 at 10:07am, it was sent to every school superintendent in the state of Maryland.
The second letter (HPV2) is from Montgomery County Assistant Superintendent Dr. Johnathan T. Brice, instructing all the principals in his district to comply with the DOH directive.
The letters detail a surreptitious campaign to market the HPV vaccine in State schools. There was no public discussion, approval process, or any effort to inform parents. The ethical violation is obvious. Dr. Tai’s directive is strongly coercive state action interfering with free and informed consent – using words like “imperative” to give the vaccine, pressing it through schools, and blurring the line between mandated “school-entry” required vaccines and an ACIP-recommended vaccine. The fact that HPV is a sexually transmitted disease is simply not disclosed.
In addition to the ethical concerns, the letters contain fraudulent information and thus potentially might be considered part of a conspiracy to defraud consumers and children in particular. The following inaccurate statements in the Tai/Chan letter are in quotes, with my rebuttal following:
• “the critical public health crisis of under-vaccination Maryland adolescents against HPV”- low uptake rates of HPV vaccine does not constitute a “critical public health crisis.” The uptake rate in Japan is now less than 1%, country wide.
• HPV “pos[es] a significant public health risk” – not true. More than 98% of HPV infections clear naturally (WHO info).
• The vaccine can protect “before exposure” – Evidence strongly suggests that a significant proportion of preteens have HPV infections at the time of vaccination that they acquired other than by sexual contact. Children who are HPV positive at the time of vaccination (PCR or serology) are likely at increased risk of HPV infection based on clinical trial data (“negative efficacy” for those positive for HPV at time of vaccination).
•“It’s imperative” that providers give this. – this is a recommended vaccine, not mandated vaccine, therefore it is not “imperative.”
•“A preventive measure exists to protect against HPV-related cancers.” – No, the vaccine’s efficacy against cancer has never been proven. So far, there is evidence that cervical lesions from the vaccine-targeted HPV types are less common among those who’ve gotten HPV vaccines, but there is yet no evidence that any HPV-related cancer prevalence has diminished due to the vaccine. Clinical trials used cervical lesions as “surrogate endpoints,” not cancer; there is as yet NO proof that HPV vaccination has reduced the overall burden of cervical or other types of HPV-related cancers. On the contrary, there is some evidence that cervical cancer rates have increased in places where the HPV vaccine uptake rate has been high because young women wrongly assume that cervical screening is no longer necessary.
To be clear, the intent of the campaign revealed by these two letters has absolutely nothing to do with reducing the spread of HPVs among our children. The MD DOH had a highly successful campaign to do just that, resulting in a measureable decline in cervical cancer incidence and mortality between 2000 and 2012- starting well before the vaccine was even available. If Dr. Tai’s objective is reduction in HPVs her letter would have included references to the only public health strategies that are actually proven to be effective. She would have emphasized education about known HPV cancer risk factors, such as: promiscuity; smoking; and intravenous drug use. In addition, she would have discussed the importance of regular pap smears.
I request that Dr. Tai’s conduct in this matter be investigated for possible ethical and legal violations of Maryland DOH and School Board Policies. She should immediately step down as director of the MD DOH CCPC until her role in this unfortunate matter is better understood. Further, we need to understand the financial relationship between Merck and Maryland DOH Cancer Prevention and Control. The “HPV Vaccination” section of their website reads like a paid advertisement for the Merck product, as do the letters attached above.
Based on egregious ethical and probable legal issues with the above attached letters, and the underlying clandestine activity demanded by the letters, Governor Hogan should immediately instruct all divisions of state and local governments to rescind recommendations and support for the vaccine (as the government of Japan did in 2013), pending a thorough and independent safety, efficacy, and necessity review. Dr. Peter Doshi, PhD, assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and associate editor at The BMJ, would be an excellent candidate to lead such an investigation, or supervise the creation of a qualified, independent review board. It is instructive to note the government Japan to this day has not resumed its recommendation for the shot.
I implore you to contact the Governor’s office immediately and politely request that this matter be thoroughly investigated, and to ask him to denounce in the strongest possible terms this concerning breach of the public trust. No parent should have to worry that their child is being secretly targeted for sale of an HPV vaccine, or any other product, while they are in their Maryland schools.
I enjoy my cordial and constructive relationship with the Anne Arundel County public school system, where our three children have all received excellent education, socialization, and are generally surrounded by caring and compassionate teachers, administrators, and staff. However, I wish to make my position absolutely clear: if this stealth marketing campaign is not immediately denounced at the highest levels of our state government, and if action is not taken to investigate the potentially fraudulent claims about the vaccine contained in Dr. Chan’s letter, I will examine legal options to force this issue.
Respectfully-
Josh Mazer
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);” 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 exposed general 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. 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 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.
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 system for VAERS reporting- 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.
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 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?
“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 girls who took the HPV4 vaccine are at greater risk for HPV infection than those that did not take the vaccine.
8) 2015: New York Times Wellness Blog:
“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) 2017 Journal 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” 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 (adverse events) 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)
)
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.”
17) 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.
18) 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.”
