HPV vaccine investigation leaves crucial questions unasked

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 taboo. 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?

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.

• 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.

• 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.

SaneVax response 10:36 am, 20 July: 

Subject: Re: SV: SaneVax Inc. on behalf of Danish Medical Consumers

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

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:

1. 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?
2. 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?
3. 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?

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.

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 occurred 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.

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?

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.

• 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 unvaccinate!

Image credit

Norma Erickson is the President of SaneVax, Inc.