By
“Baum Hedlund Aristei & Goldman and Robert F. Kennedy, Jr., chairman of Children’s Health Defense, this week filed a wrongful death suit against Merck alleging the drugmaker’s Gardasil HPV vaccine caused the death of 13-year-old Noah Tate Foley.”
Category: HPV vaccine related death
New Nordic Cochrane Centre Complaint Destroying HPV ‘Safe and Effective’ Narrative#Gardasil#HPVVaccine#Cervarix
Written By: Jeffrey Jaxen
Piece by piece the foundation and historical legacy of the Human Papilloma Virus (HPV) vaccine is fast approaching the reality anticipated by former pharmaceutical industry physician with Gardasil manufacturers Merck when he stated in 2014, “I predict that Gardasil will become the greatest medical scandal of all times…”
In Europe, the ‘safe and effective’ HPV misinformation appears to have run its course. Receiving no coverage by mainstream media sources, the Nordic Cochrane Centre has filed its second complaint in five months – this time to the European ombudsman – over maladministration at the European Medicines Agency (EMA) in relation to the safety of the HPV vaccines.
According to the Nordic Cochrane Centre, its first complaint to the EMA filed on May 26, 2016 was met with replies that did not fully address their concerns. The Centre writes in its new complaint that…
Is HPV Vaccine Safety an Illusion Maintained by Suppression of Science?#android#iPad#retweet
By Norma Erickson
Breaking News: On January 14, 2016, Dr. Sin Hang Lee sent an open letter of complaint to the Director General of the World Health Organization, Dr. Margaret Chan, charging members of GACVS, the CDC, the Japanese Ministry of Health, Labor and Welfare, and others with manipulation of data and suppression of science in order to maintain the illusion of HPV vaccine safety in the face of valid contradictory evidence.
According to Dr. Lee’s letter, a series of emails recently uncovered via a Freedom of Information request submitted in New Zealand revealed evidence that Dr. Robert Pless, chairperson of the Global Advisory Committee on Vaccine Safety (GACVS), Dr. Nabae Koji of the Ministry of Health of Japan, Dr. Melinda Wharton of the CDC, Dr. Helen Petousis-Harris of Auckland University, New Zealand, and others (including WHO officials) may have been actively involved in a scheme to deliberately mislead the Japanese Expert Inquiry on human papillomavirus (HPV) vaccine safety before, during and after the February 26, 2014 public hearing in Tokyo.
The complaint letter states that the emails provided clearly demonstrate this group of WHO officials and government employees charged with the responsibility of advising the expert committee from the Japanese government on HPV vaccination safety knew before the February 26, 2014 Tokyo public hearing that one of their own experts showed scientific evidence that HPV vaccination does increase cytokines, including tumor necrosis factor (TNF), particularly at the injection site compared to other vaccines. Yet, they chose to suppress this information at the public hearing.
Of course, this piece of scientific data which was known to all members of the group is also missing from the GACVS Statement on the safety of HPV vaccination issued on March 12, 2014. Unfortunately for medical consumers, this is the same GACVS statement currently being used to assure health officials, political decision makers and medical professionals around the world there is nothing to worry about when it comes to the safety of HPV vaccines.
- Dr. Lee concluded his letter of complaint by clearly stating that there is at least one known mechanism of action explaining why serious adverse reactions occur more often in people injected with HPV vaccines than other vaccines, and why certain predisposed individuals may suffer a sudden unexplained death as a result. It appears this is part of the information the ‘experts’ deemed necessary to suppress.
Dr. Lee states:
Those whose names appear in my complaint and any who blindly dismiss valid safety concerns in order to continue promoting HPV vaccinations should be held accountable for their actions. There is no excuse for intentionally ignoring scientific evidence. There is no excuse for misleading global vaccination policy makers at the expense of public health interests. There is no excuse for such a blatant violation of the public trust.
Read Dr. Lee’s letter of complaint here.
Attachments to letter:
- GACVS Terms of Reference
- GACVS Statement on the continued safety of HPV vaccination on March 12, 2014
- WHO GACVS emails from February 18, 2014 to February 27, 2014 in chronological order
- Original FOIA – Attachment obtained in New Zealand – available upon request
Translations:
- Read this article in Spanish here.
- Read this article in Japanese here.
- Read this article in Italian here.
- Read Dr. Lee’s letter of complaint in Italian here.
- Read this article in German here.
- Read this article in Czech here.
- Read this article in Croatian here.
- Read this article in Hungarian here.
- Read this article in Serbian here.
Vaccine Injury Compensation Program: Fatality after Gardasil#android#iPad#retweet
By Norma Erickson
Gardasil®-related fatal myocardial infarction in a teenage boy – case filed in United States Court of Federal Claims Office of Special Masters.
Gomez versus USDOH: Petition No. 15-0160V1 filed by the Roberts Law Firm of Newport Beach, California for petitioners Adan Gomez and Raquel Ayon, on behalf of their deceased son Joel Gomez, states:
Joel Gomez received a Merck Gardasil vaccine on June 19, 2013 and again on August 19, 2013, and died in his sleep the following day on August 20, 2013. The death was caused in fact by receiving the Gardasil Vaccine.
This statement is reinforced by a supportive Expert Report written by Sin Hang Lee, MD, stating:
Gardasil® did cause or contributed to a myocardial infarction in the decedent, and that the second dose of Gardasil®finally caused a fatal hypotension in this case on the day of vaccination. There was no other plausible cause for the death of Joel Gomez at the night of August 19, 2013.
The record shows that Joel Gomez, the decedent, a 14-year old healthy boy who had regular visits to the pediatrician’s office for periodic check-ups since birth showed no evidence of any pre-existing health issues, specifically no evidence of cardiac abnormalities, psychological disorders or substance abuse. The teenager had been training for the high school football team from four to five hours a day for the two months prior to his death without incident.
On June 19, 2013, the boy was given the first dose of Gardasil® in his left arm in the doctor’s office. No adverse reactions were reported following this first vaccination by the boy to either his family or his physician. On August 19, 2013 the boy was given a second injection of Gardasil® as scheduled in the doctor’s office. Then he went home and went to sleep. The boy was found to be unresponsive in bed the following morning on August 20, 2013 at 7:00 a.m. by his family.
Paramedics were called in and the boy was transported to the hospital where he was pronounced dead at 9:07 a.m. on August 20, 2013.
An autopsy was performed on August 23, 2013 by a medical examiner (ME) of Los Angeles, California.
The autopsy report stated significant abnormal findings to include:
…a long narrow band of dark reddish discoloration which is somewhat darker than the rest of the myocardium, extends over a length of 6 cm and has a width of 0.4 cm extending from the anterior base of the heart almost to the apex. ..this lesion is limited to the anterior free wall. Both lungs are extremely heavy. The lung parenchyma is dark-purple-red and completely soaked with edema fluid and blood. Microscopically, a localized lesion was found in the left ventricle of the heart.
In the medical examiner’s opinion:
The Decedent died of myocarditis, which apparently was completely asymptomatic. By histology, the disease had been present for at least several days or weeks. The cause is unknown.
Dr. Lee reviewed the microscopic slides and concluded that the lesion of the heart was a healing myocardial infarct of a few weeks old after the first Gardasil® vaccination. In his opinion,
The HPV L1 gene DNA fragments bound to the aluminum adjuvant in Gardasil® can cause sudden and unexpected surge of tumor necrosis factor-α and other cytokines. Some of these cytokines released from macrophages are potent myocardial depressants, capable of causing hypotension with low cardiac perfusions in certain genetically or physically predisposed individuals.
Why is this case significant?
This was an obviously healthy, athletic young boy under the care of a pediatrician since birth. The myocardial infarction occurred between two injections of Gardasil as described in the medical examiner’s report. According to Dr. Lee, a healing infarct at the age of 14 is practically unheard of. In fact, Dr. Lee pointed out that the heart in this case presents a textbook description of myocardial infarction commonly observed in much older patients with a history of heart attack(s). The only factor in this boy’s life that changed was his Gardasil vaccinations.
According to the petition filed:
Petitioners contend that Joel suffered from Myocarditis which was caused in fact by the Gardasil vaccine. Petitioners contend that the logical sequence of cause and effect show that the vaccination was the reason for the death. Further supportive of the causal relationship is established by looking to the proximate temporal relationship between the vaccination and the death. The fact that Joel was a healthy 14 year old boy with no health problems is strong circumstantial evidence that the death was caused in fact by the Gardasil vaccine.
This means there is no way of knowing how many Gardasil-vaccinated girls (or boys) have developed permanent myocardial damage, whether one calls it myocarditis or infarct, either is a silent heart pathology. Is silent heart pathology no harm if the patient did not die?
In a telephone interview with Dr. Lee about the significance of this case for parents and medical professionals, Dr. Lee said:
Teenagers vaccinated with Gardasil® should stay away from competitive sports such as football for at least two months, and should have an electrocardiogram to rule out silent myocardial infarction if there is any incidence of syncope, chest discomfort, tachycardia or hypotension within two months after Gardasil® vaccination.
References:
- petition available on request – please email admin@sanevax.org or sanevax@gmail.com
This article in its entirety, is compliments of www.SaneVax.org
HPV Vaccines: Freda Birrell Addresses Scottish Petitions Committee#android#iPad#retweet
BY
I would like to thank the Committee for allowing me to provide additional information relating to my request for ‘A round table discussion to be held at Edinburgh between scientists and medical professionals from both sides of the HPV vaccine safety debate.’ I speak today on behalf of not only the UK Association for HPV Vaccine Injured Daughters who have had their lives turned upside down after HPV vaccine administration, but each of the 2019 people from 55 countries who signed because they are having similar experiences and support open scientific discussions.
Our association was organized at the beginning of this year when it became apparent that we needed to co-ordinate everyone’s individual efforts as a group. Our association represents families from Scotland, England, Wales and Northern Ireland operating under the banner of HPV Vaccine Injured Daughters (AHVID). As a group, we were able to receive greater publicity. The increased awareness caused our membership to grow by leaps and bounds. Our initial group of 60 members has expanded to 208 and rising. Despite the fact that Scotland only accounts for 8% of the UK population; 15% of the association’s members come from Scotland. We don’t know how many others are out there, but for now there appears to be no end in sight.
A senior politician within the Irish Government, Pashal Mooney, gave an impassioned plea to Irish Government officials regarding the Irish HPV vaccination program, lack of informed consent and the devastating effects on young girls around the country. He specifically mentions Irish girls being admitted to psychiatric hospitals following HPV vaccinations.
Japan has rescinded the government recommendation for HPV vaccines and initiated studies to determine whether there is a causal relationship between HPV vaccines and adverse outcomes as well as a 21 year study to determine whether HPV vaccines have an impact on cervical cancer diagnosis rates.
- In Denmark, the National Association of HPV Adverse Sufferers is hosting an HPV Vaccine Information Symposium to bring families together with medical professionals, health authorities and legal professionals to explore treatment options and potential legal remedies on October 31st. Denmark has just recently made the decision to change from Gardasil to Cervarix as the HPV vaccine of choice. 24 Oct 2015, at the urging of Liselott Blixt, Danish politician with a Gardasil injured daughter the Danish government has set aside 7 million kroner to conduct an independent investigation into the HPV vaccine and its side effects.
Our association is in the process of compiling information to submit to the EMA for consideration during their safety assessment of HPV vaccines. Of the 88 family reports analysed to date: 68% reported their daughters experienced health problems serious enough to interfere with their education; 24% reported symptoms so severe their daughter could no longer participate in educational activities; 70% required help with daily care; and a full 91% reported being told their daughters’ medical conditions were psychological in origin.
Psychological in origin? Interesting to note that national health authorities in Denmark, Norway, Japan, France, Spain, Colombia, Ireland, and many other countries have led doctors and other vaccine administrators to believe that any new medical conditions experienced after HPV vaccine administration are most likely psychosomatic. Consequently, when the average medical health professional is faced with a patient exhibiting symptoms they have never seen before; symptoms which do not fit neatly into any current diagnostic criteria, the natural assumption is psychological problems as have been experienced by many UK families.
So, I put forth these facts for your consideration:
- According to Merck’s Gardasil 9 package insert, 3.3% of participants who were given Gardasil during the most recent clinical trials “experienced new medical conditions potentially indicative of autoimmune disorders.” (3,300/100,000 recipients)
- According to a press release from Sanofi-Pasteur MSD dated June 17, 2015, 183 million doses of Gardasil have been distributed worldwide.
- Using Merck’s own clinical trial percentage, this means there could be as many as 6,039,000 girls around the world suffering autoimmune conditions which could very well influence their health for the rest of their lives.
- According to the World Cancer Research Foundation, there were 528,000 cases of cervical cancer diagnosed worldwide in 2012.
Is this worth the risk? I am very much aware HPV vaccines are a controversial issue and that this information puts Scotland at a cross-roads with a difficult decision to make.
Do we accept what the manufacturer and their list of experts are saying and assume HPV vaccines are safe and effective and there just happens to be an epidemic of psychosomatic disorders spreading round the world affecting certain young people who have one thing in common, they were injected with HPV vaccines?
Or, do we listen to experts from both sides, try to discover exactly what the situation is and make every effort we can to get the problem solved?
Do we sweep all of these families under the proverbial ‘psychological disorder’ carpet and ignore their misery; or do we treat them with the dignity and respect they deserve by using every means at our disposal to identify those at risk of serious adverse reactions and develop successful treatment protocols for those already suffering?
Please, demonstrate to the world that Scotland is still a country that does not ignore the suffering of innocents.
Show the world Scotland is not afraid to hold open, honest scientific discussions no matter how controversial the subject might be.
Witness Freda’s presentation here, beginning at the 1:00:00 mark.
Read this presentation in Spanish here.
References:
- http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf
- http://www.multivu.com/players/English/7543051-sanofi-pasteur-gardasil9/
- http://www.wcrf.org/int/cancer-facts-figures/worldwide-data
This article in it’s entirety, is compliments of www.SaneVax.org
United States Tracks Children to Push Gardasil Vaccine#android#iPad#retweet
by Jefferey Jaxen
Health Impact News
Parents Receive Letters from State Strongly Urging HPV Shots for Their Tracked Children
The United States continues to carelessly move forward with the HPV vaccine Gardasil. Meanwhile, due to its endless damage, the shot is the center of criminal lawsuits in Spain, India, France, Japan and many other countries. In the UK, the HPV vaccination push has 8,228 official reports of side-effects, almost more than all other vaccine reports combined. Dr. Dalbergue, a former pharmaceutical industry physician with Gardasil manufacturer Merck gave a 2014 interview stating that:
“Gardasil is useless and costs a fortune” as well as predicting “Gardasil will become the greatest medical scandal of all times…”
Ignoring data and worldwide protest, Departments of Health within the U.S. are now sending letters to parents advising them to submit their children to HPV vaccinations. With no prior announcement, parental consent given, or notice, the states of New York and Indiana have tracked HPV vaccine non-compliers and are now hassling them with physical letters…
HPV vaccine investigation leaves crucial questions unasked#android#iPad#retweet
By Norma Erickson
The SaneVax team believes the narrow scope of the current investigation regarding the safety profile of HPV vaccines being conducted by the European Medicines Agency (EMA), will leave parents and medical professionals without answers to questions which may help them solve the mystery surrounding new medical conditions being reported not only in Denmark, but around the globe, after the administration of HPV vaccines.
Has the EMA put POTS and CRPS under an investigative microscope in order to blur the overall picture regarding the safety profile of HPV vaccines? Have those in charge never heard the expression, “you can’t see the forest for the trees?”
Norwegian journalist, Per Egil Hegge, puts the entire issue into focus when he stated:
A scientific environment, no matter the subject, where it is not allowed to ask questions, has thrown its future on the scrap heap and nailed its own death sentence on the wall.
Apparently, open discussions on the topic of HPV vaccines are tabu. This is simply not acceptable. If open honest scientific investigations are not forthcoming, young people around the world will continue to have their futures thrown on the proverbial scrap heap.
If serious investigations are not conducted, it may well be the public’s trust in national health authorities that is thrown on the trash heap.
Parents and anyone who administers HPV vaccines need to ask:
- How is it possible that HPV vaccines account for as many adverse event reports as all other vaccines administered in most childhood immunization programs, yet national health authorities still consider them safe?
- HPV vaccines do not eliminate the need for regular cervical screening. They are simply an addition to current healthcare budgets. How can HPV vaccines be considered affordable in any country that currently has an established cervical cancer screening program?
- The HPV virus has never been proven to cause cancer without other risk factors being present. Pap screening programs with good follow-up care has proven to be a safe and effective means of controlling abnormal cervical cell growth prior to the development of cancer. How can HPV vaccines be deemed necessary?
- How can the efficacy of HPV vaccines be judged against endpoints that frequently resolve without medical intervention and still be considered effective?
Until such time as HPV vaccines are proven to be safe, affordable, necessary and effective – everyone needs to remember that national health authorities are not infallible. Questions must be asked – answers must be forthcoming!
In view of the fact a request from Denmark was the impetus responsible for instigating the EMA investigation, the Danish Health and Medicines Authority was the logical place to try and obtain some of the answers so desperately needed by medical professionals trying to diagnose and cure the survivors of potential reactions to HPV vaccines; answers which are also needed by the hundreds of Danish parents of affected girls.
Note from the SaneVax Team:
The following recounts a 2-day interchange initiated by us via email to Mr. Henrik G. Jensen, Unit Leader of the Family and Consumer Affairs Division, Danish Health and Medicines Authority (Sundhedsstyrelsen). Communications began at the request of multiple Danish parents concerned about their daughter’s future health due to the host of mysterious medical conditions experienced soon after the administration of HPV vaccines.
Mr. Jensen is to be commended for his rapid response to all communications from the SaneVax team. However, Mr. Jensen was not quite as efficient at answering the questions which were asked of him. This is unfortunate.
Mr. Jensen was not forthcoming with adequate answers to the questions posed by the SaneVax team and has declared, ”I think we should conclude our discussion here.”
Therefore, in the interest of public health and safety the SaneVax team is left with no alternative but to move the conversation to a public venue.
Original email from SaneVax to Mr. Henrik G. Jensen, Unit Leader Family and Consumer Affairs, Sundhedsstyrelsen transmitted at 9:20 am, 20 July 2015 (Denmark time zone):
Dear Mr. Jensen,
SaneVax Inc. is an international non-profit organization dedicated to the promotion of only Safe, Affordable, Necessary and Effective (SANE) vaccines and vaccination practices. As president of SaneVax, I am writing to you on behalf of the many Danish families who have daughters with mysterious new medical conditions after the administration of HPV vaccines.
One of these parents recently sent the SaneVax team a transcript of your interview for TV2’s Good Morning Denmark show which was broadcast on July 14th. During this interview, you were questioned about the current review of HPV vaccines being conducted by the EMA’s Pharmacovigilance committee (PRAC).
Some of the statements you made during this interview were mildly disturbing. For instance, you stated 2 women die of cervical cancer every week in Denmark, when the actual rate is only 1.5 according to the latest available World Health Organization statistics. But, we understand sometimes public health officials do things like rounding incident rates to the next higher number to make an impact on the public perception so as to help increase vaccination compliance.
The primary reason for this letter is your statement that Denmark is the only country having problems with high rates of serious adverse events after HPV vaccines. The interviewer responded to this by stating:
And let’s focus a bit on this, that it’s here in Denmark, that we experience that some of these girls who get the HPV vaccine get suspected symptoms afterwards. Because this is not the picture in, for example our neighboring country, Sweden, or basically in the rest of the world. They do not experience the girls come in and say that they are in pain, or I feel that my heart behaves ’weird’ after being given this vaccine. Why is it only here in Denmark?
You answered:
Yes. But that we, of course, have asked ourselves too, and we are also asked by our European colleagues – what is it that you experience? What is it that you are doing in Denmark? But Denmark is a tiny very well regulated, orderly country. We are good at reporting side effects. We care about it. And I think if there is a country you have to find something like this, it’s Denmark.
When we talk rare side effects, it may well be a side effect which is not found in any of the clinical trials as the basis for approval, and then it will typically be such a small Scandinavian country one finds it, as Denmark.
With all due respect, Mr. Jensen, this is simply not accurate. Please consider the following:
- India: 2009, Gardasil was administered to 13,791 girls in Khammam district in Andhra Pradesh. Cervarix was administered to 9,637 girls in Vadodara district in Gujarat. An estimated 5% of those were left with chronic health problems and/or autoimmune disorders. A case resulting from this is currently pending in the Supreme Court.
- Spain: AAVP is petitioning the government to stop HPV vaccinations until safety, efficacy and need are proven.
- Japan: 2013, after only 6 weeks of being included in the national vaccination program, the government rescinded their recommendation for the use of HPV vaccines due to the number of adverse events being reported.
- France: In 2014, MEP Michelle Rivasi called on all 28 members of the European Union to institute a moratorium on Gardasil vaccine until more studies are conducted on its effectiveness and its dangers.
- Scotland: A petition was launched less than a week ago on behalf of the UK Association of HPV Vaccine Injured Daughters calling on the Scottish Parliament to urge the Scottish Government to convene a roundtable discussion on the safety of HPV vaccines with medical/scientific professionals from both sides of the debate. There are over 1500 signatures from people around the world supporting the request.
This is but a small sample. According to the World Health Organization (WHO), as of January 2014 fifty-two countries have included HPV vaccines in their national immunization programs. The SaneVax Team has been contacted by representatives from well over half of them seeking to understand the vast array of new medical conditions occurring in the wake of these programs.
Can you please explain how a person in your position as a department head within an organization whose mission is ’health for all – through safe and effective prevention and treatment’ is not aware of any of these events?
Also, according to Dr. Jesper Mehlsen’s best estimate as of June 11th, one in 500 girls who were vaccinated with Gardasil in Denmark experienced serious side effects. This translates into 200/100,000. I am sure you are well aware of the fact that the cervical cancer diagnosis rate in your country is only 12.1/100,000.
Can you please explain why your advice to those you are charged with protecting is to continue to use HPV vaccines despite the fact that the reported rate of serious adverse events in your own country far exceeds the risk of obtaining a cervical cancer diagnosis?
Medical consumers anxiously await your reply.
Signed on behalf of Danish families,
Norma Erickson, President
SaneVax Inc.
References:
- India: Supreme Court HPV Vaccine Controversy Continues
- Spain: Stop vaccinations against HPV
- Japan and the HPV Vaccine Controversy
- Spotlight on Gardasil in France
- PE01574: HPV Vaccine Safety
- Doctors: One out of 500 girls become seriously ill from getting HPV vaccine
SaneVax received the response below from Mr. Jensen at 9:41 am the same day:
Subject: SV: SaneVax Inc. on behalf of Danish Medical Consumers
Dear Norma Erickson,
Please be aware that in 2013 (latest official update) 114 women died of cervical cancer in Denmark.
Denmark is in accordance with advice given from EMA, FDA and WHO.
Best
Henrik G. Jensen
Danish Health and Medicines Authority
SaneVax response 10:36 am, 20 July:
Subject: Re: SV: SaneVax Inc. on behalf of Danish Medical Consumers
Dear Henrik Jensen,
Thank you for your prompt response. I understand Denmark introduced HPV vaccines in 2008.
Do you have any theory as to why the cervical cancer mortality increased from 97 in 2012 to 114 in 2013?
Thank you for any insights you can offer.
Regards,
Norma Erickson
Mr. Jensen’s response 10:44 am July 20
Subject: SV: SV: SaneVax Inc. on behalf of Danish Medical Consumers
Dear Norma Erickson,
Tahnk you for your mail.
Do you recognize that the number in your mail ”1.5” is wrong?
Do you recognize that the discussion on the tv program was about POTS and CRPS and not a general discussion on ADR?
Please be clear!
Best
Henrik G. Jensen
SaneVax reply 8:38 am, July 21
Subject: Re: SV: SV: SaneVax Inc. on behalf of Danish Medical Consumers
Dear Henrik Jensen,
Thank you for bringing the error in the original letter to my attention. I went back and checked the figures and found that I had inadvertently transposed a number when calculating the number per week. I sincerely appreciate your assistance.
I did indeed recognize that the television program was limited to a discussion of POTS and CRPS. Once again, these are conditions being diagnosed after HPV vaccine administration in many countries – NOT just Denmark!
That being said, on behalf of all the families in Denmark whose lives have been transformed after HPV vaccine use, I renew my request for answers to the following questions:
- Can you please explain how a person in your position as a department head within an organization whose mission is ’health for all – through safe and effective prevention and treatment’ is not aware of any of the adverse events being diagnosed after HPV vaccines in other countries – particularly POTS and CRPS?
- Can you please explain why your advice to those you are charged with protecting is to continue to use HPV vaccines despite the fact that the reported rate of serious adverse events in your own country far exceeds the risk of obtaining a cervical cancer diagnosis?
- Since HPV vaccines were introduced in Denmark in 2008, do you have any theory as to why the cervical cancer mortality increased from 97 in 2012 to 114 in 2013?
Thank you in advance for providing this much needed information to the people of your country. Please show them you are not allowing POTS and CRPS to be put under the investigative microscope in order to blur the overall picture regarding the safety profile of HPV vaccines. Let them know you are looking out for their health and well-being.
Signed on Behalf of the Citizens of Denmark,
Norma Erickson, President
SaneVax Inc.
Mr. Jensen’s response 9:42 am
SV: SV: SV: SaneVax Inc. on behalf of Danish Medical Consumers
Dear Norma Erickson,
Thank you for your mail.
Your information ”I sincerely appreciate your assistance” is simply not good enough. You owe me an apology – I think you should be serious about this and think once again about the words you use.
About the number of POTS associated with Gardasil – please be aware of the official numbers in Europa. The last official information from EMA dated December 2014 was 66 cases of POTS with the largest number in Europe from Denmark – one of the smallest countries in the world. Please check the official numbers. The EMA conclude that a link between Gardasil and POTS can neither be confirmed nor be ruled out. Once again you owe me an apology.
As far as your first question EMA concludes that the overall benefit/risk balance of Gardasil remains positive. And please be aware that this opinion is shared by FDA, WHO and all European countries. And you also knows this!
Denmark included Gardasil in the childhood vaccination program January 1, 2009. As far as the mortality rate is concerned you have to look at a wider span of years to have the full picture. We will expect to see a significant decrease in the numbers in the years to come – and combining the screening and vaccination programs we will be able to almost eradicate cervical cancer. More than 20.000 European women die from cervical cancer every year.
New Danish research by the Danish Cancer Society has already shown that the Danish vaccination program for HPV works. Among the HPV vaccinated women born in 1993 and 1994, the risk of having precursors to cervical cancer is reduced by 73% compared with unvaccinated. Scientific studies from among others US, Australia and Sweden has shown the same.
I think we should conclude our discussion here.
Best
Henrik G. Jensen
Errors and Omissions by both parties?
First, it must be noted that there was an error in the initial email SaneVax sent to Mr. Jensen, a fact which he pointed out only after being asked if he had any theory as to why the cervical cancer mortality incidence in Denmark increased from 97 in 2012 to 114 in 2013 – an increase which occured after the introduction of HPV vaccines.
The information on 2013 cervical cancer mortality rates was not available to the SaneVax team at the time the email was written. Nevertheless, the 1.5 cervical cancer deaths per week in Denmark should have read 1.8 cervical cancer deaths per week according to the 2012 statistics compiled by the World Health Organization which were referenced in the email. Despite the math error (which was the author’s fault) the correct figure available to the author was still lower than the 2 cancer deaths per week Mr. Jensen quoted on the Good Morning Denmark Show.
The truth be told, whether the most accurate figure is 1.5, 1.8 or 2.0/100,00 is immaterial – all three numbers pale in comparison to the number of serious medical conditions occurring in Denmark (and other countries) after Gardasil administration.
Both Mr. Jensen and the SaneVax team were working with the data available to them at the time the emails were composed, hence some of the confusion. The truth of the matter is neither SaneVax nor Mr. Jensen have a clear picture of the benefit/risk profile of HPV vaccination programs. That is precisely why open scientific discussions are needed.
It is worth noting that SaneVax provided references to all data sources used in their communications, unless the information referenced had been provided by Mr. Jensen. Mr. Jensen did not grant SaneVax the same courtesy. The clear implication was the SaneVax team should simply trust his word. A prime example of this is Mr. Jensen’s request that SaneVax check the official numbers for POTS cases reported after HPV vaccinations in Europe without providing the source of said data.
Mr. Jensen stated,
The EMA conclude that a link between Gardasil and POTS can neither be confirmed nor be ruled out.
This statement is true. However, at no time has any SaneVax team member stated a link had been established between HPV vaccine administration and any subsequently experienced medical condition. Throughout the history of our organization, we have simply called for scientific investigations to determine whether or not such a link exists.
One could justifiably state a link between HPV vaccines and any adverse health condition will never be established unless one is looked for. Another reason open discussions with scientific professionals from both sides of the debate followed by serious investigations are such a critical need.
Mr. Jensen’s statements regarding the EMA/FDA/WHO positions on HPV vaccines was irrelevant to the subject being discussed. He was correct in stating that the SaneVax team was well aware of their position. However, all questions from SaneVax to Mr. Jensen were exclusively referring to Sundhedsstyrelsen’s position.
Mr. Jensen stated:
New Danish research by the Danish Cancer Society has already shown that the Danish vaccination program for HPV works. Among the HPV vaccinated women born in 1993 and 1994, the risk of having precursors to cervical cancer is reduced by 73% compared with unvaccinated. Scientific studies from among others US, Australia and Sweden has shown the same.
Mr. Jensen and all of the health authorities quoted should be well aware of the fact that reducing the prevalence of an infection which clears on its own 90% of the time (within two years) does not necessarily translate into a reduction of cervical cancer cases in the future. The same health authorities should be well aware of the fact that reducing so-called pre-cancerous lesions, which also frequently resolve on their own without medical intervention does not necessarily predict a reduction in cervical cancer rates.
Theoretically, these health authorities are aware of the following quote from Chapter 2 of the IARC’s COLPOSCOPY AND TREATMENT OF CERVICAL INTRAEPITHELIAL NEOPLASIA: A BEGINNER’S MANUAL, published by the World Health Organization, which states:
Despite women’s frequent exposure to HPV, development of cervical neoplasia is uncommon. Most cervical abnormalities caused by HPV infection are unlikely to progress to high-grade CIN or cervical cancer, as most of them regress by themselves. The long time frame between initial infection and overt disease indicates that several cofactors (e.g., genetic differences, hormonal effects, micronutrient deficiencies, smoking, or chronic inflammation) may be necessary for disease progression. Spontaneous regression of CIN may also indicate that many women may not be exposed to these cofactors.
The only true measure of HPV vaccine efficacy will be a reduction in diagnosed cervical cancer cases in those vaccinated along with a similar reduction failing to occur in those who are unvaccinated. All national and international health authorities referred to by Mr. Jensen should be well aware of this fact. If they are not, they are deluding themselves and the public.
Questions left unanswered by Sundhedsstyrelsen
Until such time as a real reduction in cervical cancer cases is demonstrated, medical professionals and medical consumers are left with multiple questions for which they deserve answers – if they are to have any hope of preserving the health and well-being of the next generation.
Among these questions are those Mr. Jensen left unanswered:
- Why is the staff of Sundhedsstyrelsen apparently not aware of the reports of adverse events after HPV vaccinations in other countries, particularly the reports relating to POTS and CRPS?
- Why is Sundhedsstyrelsen’s advice to doctors and medical consumers to continue to use HPV vaccines despite the fact that the number of serious adverse events currently being reported in Denmark far exceeds the risk of being diagnosed with cervical cancer?
- Since HPV vaccines were included in the Danish childhood vaccination program on 1 January 2009, do you/ Sundhedsstyrelsen have any theory as to why cervical cancer deaths in Denmark increased from 97 to 114 from 2012 to 2013?
These 3 questions are but the tip of the iceberg.
Questions Sundhedsstyrelsen left unasked:
If Denmark’s health authorities were seriously interested in determining the true risk/benefit profile of HPV vaccines, they would have considered posing some questions being put forth by medical professionals, scientific research teams and medical consumers in Denmark and around the world.
Some of these questions are:
- When vaccinating a healthy population, what is the rate of serious adverse event reports required before the risks outweigh the perceived benefits? Currently, serious adverse events after HPV vaccine administration in Denmark is estimated at 200/100,000 recipients; the cervical cancer diagnosis rate is 12.1/100,000.
- How much collateral damage is acceptable before a vaccine is no longer considered safe?
- Merck’s own Gardasil 9 prescribing information packet reports serious adverse event reported during clinical trials to be 2300/100,000 for Gardasil 9 and 2500/100,000 for Gardasil. This is higher than the cervical cancer diagnosis rate in any country in the world. Why does this not alter the perceived benefit/risk profile?
- What was the rate of cervical cancer cases in Denmark 5 years prior to the introduction of HPV vaccines versus the cervical cancer diagnosis rate 5 years after the introduction of Gardasil? At what ages were these cancers diagnosed? What were the rates in other European countries before and after HPV vaccine introduction?
- What was the hospitalization rate for the targeted population prior to including HPV vaccines in the Danish childhood immunization program versus the hospitalization rate in the same population after the inclusion of HPV vaccines? Other countries?
- How do the serious adverse event reports being filed in Denmark after HPV vaccine administration compare to the reports submitted in other countries?
- What is different about the girls reporting severe adverse events when compared to those who report minimal or no events after HPV vaccine administration?
- Why are the the vast majority of adverse event reports considered psychosomatic until proven otherwise; instead of being examined as potential side effects until proven otherwise?
Again, the above questions are simply a sample of the questions the Danish Health and Medicines Authority should have put forth to the European Medicines Agency (EMA) if they were serious about investigating the benefit/risk profile of HPV vaccines.
One has to wonder why Sundhedsstyrelsen seems content to put two quite specific conditions under the microscope while ignoring the rest of the picture.
Could it have anything to do with the fact that around half of the Danish Health and Medicines Authority’s (Sundhedsstyrelsen) funding comes directly, from global pharmaceutical giants? Only time will tell.
In the meantime, medical consumers and those who administer HPV vaccines are on their own. They need to start asking pertinent questions such as those listed above and demanding answers.
Until such time as HPV vaccines are proven to be safe, affordable, necessary and effective, everyone needs to remember that national health authorities are not infallible.
Every prescription medication ever removed from the market was first deemed safe and effective by national health authorities such as the FDA and Sundhedsstyrelsen, not to mention international authorities like the EMA. (A list of 35 such drugs approved by the FDA and later pulled from the market is here.)
Gardasil, Cervarix and Gardasil 9 are rapidly becoming ’poster children’ for vaccines by demonstrating everything that can possibly go wrong with a vaccine. The laundry list of unanswered questions about these vaccines seems to expand on a daily basis.
Medical consumers have a right to receive satisfactory answers to any questions they have regarding medical interventions prior to granting their consent. This is particularly true of vaccines – injected material is not easily removed.
Anyone who administers HPV vaccines has a duty to ask relevant questions until they are satisfied with the answers. No medical intervention is right for everyone. Clearly, HPV vaccine risks outweigh the benefits for some people. Medical professionals must be completely and accurately informed in order to make sure HPV vaccines are the right choice for the person sitting in front of them.
Medical professionals and medical consumers: Remember the consequences resulting from use of Thalidomide, Darvon, Darvoset, DES, antipsychotic drugs, and Vioxx – just to name a few. All of them were approved as safe and effective before leaving massive devastation in their wake.
Do your research – it is easy to halt medications when there is a problem – you cannot unvaccinated!
This article in it’s entirety, is compliments of www.SaneVaX.org
PE01574: HPV Vaccine Safety – Please Sign Petition#android#iPad#retweet
Calling on the Scottish Parliament to urge the Scottish Government to convene a roundtable discussion on the safety of HPV vaccines with medical/scientific professionals from both sides of the debate….