Terveys

Kirsi Lohtaja – New Finnish HPV Vaccine Study has many conflicts of interest

16.01.2019, Katri Laitila

Tämän artikkelin pohjana on Suomen HPV-rokotetutkimusta koskeva luku
05/2018 ilmestyneessä Kirsi Lohtajan ja Elina Hytösen kirjoittamassa
kirjassa ”Rokotteet ja vaiettu tieto”. Artikkelissa on mukana myös
tutkimukseen ja tutkimusaiheeseen liittyvää lisätietoa.

 

 

 

 

 

Kirsi Lohtaja 11/11/2018:

New Finnish HPV Vaccine Study has many conflicts of interest

A large HPV vaccine survey was done in Finland during the years 2007-2009. Several things seem to indicate that this quite newly published study is not impartial and neutral. Many researchers get money support from vaccine manufacturers, plus researchers have some other meaningful conflicts of interest.

A large survey was done in Finland during the years 2007-2009, regarding human papillomavirus vaccine (HPV) Cervarix and hepatitis B vaccine Engerix-B. The wide primary information can be found on website NIH/ClinicalTrials.gov. The study is registered under the name Effectiveness, Safety and Immunogenicity of GSK Biologicals’ HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents. Identification number is NCT00534638.

Several things seem to indicate that this quite newly published Finnish HPV study is not impartial and neutral. Instead, it is apparent that the researchers seek to support HPV vaccinations and to let lead people to believe that the HPV vaccine is absolutely safe and essential. You can see the same names of the main researchers at almost every Finnish HPV vaccine study report. They all are string supporters of vaccinations. In addition to that, many researchers get money support from vaccine manufacturers, plus researchers have some other meaningful conflicts of interest. Also, a connection to Bill and Melinda Gates Foundation is to be suspected. It is very widely and well known that Bill Gates is strongly supporting vaccines. He has declared 2010’s to be a decade of vaccinations.

For me, it rang the bell and I decided to take a deeper look into this study.

 

TRIAL INFORMATION

It was a community-randomized trial on the protective effectiveness (vaccine efficacy + herd effect). The researchers randomized 33 Finnish communities into three groups: 1) gender-neutral vaccination with AS04-adjuvanted HPV16/18 vaccine Cervarix, given to 90 % of boys and girls; and the rest of the group got hepatitis B vaccine Engerix-B, 2) HPV vaccination of girls – 90 % of them was given Cervarix; 10 % of girls got Engerix-B; and all boys got Engerix-B, 3) both girls and boys got Engerix-B. In 2007-2009 were invited 39 420 females and 40 852 males. From those people, 11 662 males and 20 513 females were vaccinated and they all received three doses. Their age during the vaccinations were between 12-15 years. After four years (2010-14), 11 396 cervicovaginal samples (obtained from 18.5 year-old women) were tested for HPV DNA. Prevalence of cervical HPV infections by trial arm and birth cohort was the main outcome measure, meaning they wanted to know which group had more cervical HPV infections.

 

STUDY REPORTS

A study report Evaluation of HPV type-replacement in unvaccinated and vaccinated adolescent females—Post-hoc analysis of a community-randomized clinical trial (II) was published 12/Febr./2018 (International Journal of Cancer: Infectious Causes of Cancer). The first part of this study goes under the name Impact of gender-neutral or girls-only vaccination against human papillomavirus—Results of a community-randomized clinical trial (I). International Journal of Cancer wrote about it on 9/Nov./2017.

There exist also several other reports, at least the next ones: Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial (Vaccine 12/Jan./2015); Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years: Interim analysis of a large community-randomized controlled trial (Hum Vaccin Immunother. 12/2016).

 

ABOUT VACCINE EFFICACY AND HERD EFFECT – THEY WANT TO VACCINATE FINNISH BOYS, TOO

I was not surprised, when I found out what was stated in the end of the abstract (trial part I): “In conclusion, while gender-neutral strategy enhanced the effectiveness of HPV vaccination for cross-protected HPV types with low to moderate coverage, high coverage in males appears to be key to providing a substantial public health benefit also to unvaccinated females.“ – As I know, adding this dangerous vaccine also into boys’ vaccine schedule seems to be in the agenda of the Finnish health authorities. A Finnish newspaper Kotimaa wrote about it (8/31/2017) in an article named “Boys are on their way to get HPV vaccines – proofs about benefits, the decision depends on money” (originally Pojat matkalla HPV-rokotuksen piiriin – hyödystä näyttöä, päätös kiinni rahasta).

And according to the report Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial, this herd effect of vaccinating both girls and boys with moderate vaccine coverage will be only up to 31 %. If this so-called “herd effect” isn’t any higher, it sounds like the most benefits are only on the vaccine manufacturers’ side.

And then, in the report of the follow-up trial (part II) is said: “Efficacy of human papillomavirus (HPV) vaccines promises to control HPV infections. However, HPV vaccination program may lay bare an ecological niche for non-vaccine HPV types.” In other words, HPV vaccine may – at best – only give a temporary (for some years) protection against only those HPV types targeted by the vaccines, leaving all the numerous other types outside its scope. I quote the comment from the website of Jeffrey Dach, an American doctor: “In actuality, the Finnish study shows reduction in HPV rates, not in cervical cancer rates. No long term study has shown reduction in cervical rates from HPV vaccination.”

 

ADVERSE EVENTS OF HPV AND HBV VACCINES

But now, let’s take a deeper look into adverse events of both vaccines, HPV vaccine and hepatitis B vaccine.

For example, all HPV vaccines (Cervarix and Gardasil/Gardasil 9) contain aluminum, which can cause autoimmune diseases like celiac disease and psoriasis. Here are some of the known adverse events of HPV vaccines: anaphylaxis, bad stomach ache, difficulty breathing, syncope – sometimes associated with tonic-clonic movements and other seizure-like activity, pulmonary embolism and pneumonia. And according to vaccine manufacturer Merck, both Gardasil and Gardasil 9 are able to cause death.

In this HPV vaccine study, they used Cervarix.

And by the way – even the control vaccine Engerix-B can cause the same kind of autoimmune diseases, it has aluminum, too.

In this survey, the researchers found out that both vaccines, HPV and control vaccine, were able to cause New Onset of Autoimmune Diseases (NOADs). The morbidity of female subjects was 144/12 399 (Cervarix pooled group) and 176/8 119 (Engerix-B pooled group). I was unable to find the information concerning male subjects.

In both groups, 5 subjects (5 + 5) died. I was unable to find the reasons to that. Numbers of subjects reporting any Serious Adverse Events (SAEs) were 58/2 436 (Cervarix pooled group) and 25/1 267 (Engerix-B pooled group). SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

In addition to that, some female subjects in both groups reported pregnancies with onset during the study.

There were reports of spontaneous abortion no apparent anomaly (58/Cervarix, 41/Engerix-B), elective termination no apparent anomaly (431/Cervarix, 314/Engerix-B), ectopic pregnancy (5/Cervarix, 5/Engerix-B), stillbirth no apparent congenital anomaly (1/Engerix-B) and molar pregnancy (2/Cervarix, 1/Engerix-B).

In both vaccine groups, there were also lots of subjects reporting Medically Significant Conditions (MSCs), in a subset of subjects (47/643 Cervarix and 76/1 047 Engerix-B).

And when one looks at the list of “Any, grade 3 and related to vaccination solicited general symptoms, in a subset of subjects”, one realizes that it really looks like every subject in both vaccine groups has had at least some of these symptoms: this includes arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash or urticaria.

 

DEATHS AFTER HPV VACCINATIONS

I have to say that considering the serious adverse events and even deaths after HPV vaccinations, the dangers are far more bigger than the benefits of HPV vaccines. According to VAERS database (http://www.medalerts.org/vaersdb/index.php) on 1/Oct./2018, there were “39 cases where vaccine is HPV2 (= Cervarix) and patient died” in the USA. In 34 cases of them, Cervarix had been the only given vaccine. In 4 cases, they had given BOTH Cervarix and Gardasil. And in 1 case, there was given hepatitis B vaccine + Cervarix.

In addition to these numbers, 312 had died after vaccine HPV4 (= Gardasil). From them, 286/312 had been given only Gardasil, some had got both Gardasil and Cervarix.

And 12 cases had died after receiving vaccine HPV9 (=Gardasil 9), 9/12 had received only HPV vaccine.

Data search found 2 765 cases where vaccine targets any kind of HPV and patient did not die but disabled.

 

THE BACKGROUND OF RESEARCHERS – MANY CONFLICTS OF INTEREST

Let’s now take a look at people behind this big study. There are some people from THL (National Institute for Health and Welfare, Finland): Heljä-Marja Surcel (Department of Children, Young People and Families), Marko Merikukka (Department of Welfare) and Simopekka Vänskä (Department of vaccination and Immune Protection). The information can be found from Research Gate website. And as we know, THL is strongly for vaccines and decides about Finland’s vaccine schedule.

Among ordinary nurses, doctors, and people working with statistical and epidemiological cancer research, microbiology or biomedical sciences, who worked for this new study, there are some very interesting names. In the text below, behind the names of researchers, you’ll see their employers. Some of the researchers worked only in the trial part I and some in part II, some both.

Dan Apter (Family Federation Finland), Joakim Dillner (Karolinska Institute), Jorma Paavonen (University of Helsinki), Matti Lehtinen (Karolinska Institute and University of Tampere) and Geoff Garnett (Imperial College London) have received grants from vaccine manufacturers Merck & Co Inc. or the GSK group of companies through their employers. Geoff Garnett has had consultancies with Sanofi Pasteur. Gary Dubin is currently a full-time employee of Takeda Vaccines, but was working for GSK Biologicals at the time the study was planned and conducted. He holds several patents in the HPV field, which have been assigned to the GSK groups of companies and has stock shares in both the GSK groups of companies and Takeda.

(Lehtinen Matti et al.: Impact of gender-neutral or girls-only vaccination against human papillomavirus – Results of a community-randomized trial (I). International Journal of Cancer/Infectious Causes of Cancer 21 Oct 2017.)

Matti Lehtinen, a professor and a virologist, is a leader of effectivity research of HPV vaccine at University of Tampere, Finland. Lehtinen has also earlier been part of THL team for preventing HPV disease. It was found out from a THL article Terveyden ja hyvinvoinnin laitoksen asettaman papilloomavirustautien torjuntaryhmän selvitys 30.4.2011.

University of Tampere publishes a journal, called Aikalainen. The article Kuinka papilloomavirus lannistettiin (How papilloma virus was broken, 27th Apr. 2015) sheds light on this HPV vaccine research. According to this article, Tampere, Stockholm, Oxford, Heidelberg, Philadelphia and Seattle work as hubs for the network of HPV researchers. Lehtinen is also a visiting professor at Karolinska Institute of Stockholm. He has researched HPV viruses now about 28 years. After he met a Swedish collegue, Joakim Dillner, around year 1990, began the collaboration with Karolinska.

Joakim Dillner has developed methods for measuring HPV antibodies. Lehtinen and Dillner contacted vaccine manufacturer MSD (Merck, Sharp & Dohme, Philadelphia) in 1995 for the first time. They told MSD about the possibilities to test HPV vaccines in Scandinavian countries. The first trials began already 1999. After that they did investigations for the trading licence of HPV vaccine. The trials were done in Finnish University cities, plus in Espoo and Vantaa. In addition to that, trials were done with GSK HPV vaccine in 12

capital cities of counties. These trials began in 2002 and 2004. The Center of Population Registry (Väestörekisterikeskus) called in girls aged 16-17. Half of them got a HPV vaccine, the rest got a control vaccine. There was also a control group, which did not get either of those vaccines. A follow-up study has been done largely over 10 years.

Years ago, Lehtinen visited Oxford University and introduced the so-called maternity clinic serum bank, which had been established at Finland’s Public Health Institute (Kansanterveyslaitos). That serum bank contains samples from Finnish mothers, taken during the first part of pregnancy: “two million samples from a million women”. The first samples date from the 1980’s. Nowadays this serum bank collaboration is European wide.

In Oxford, Lehtinen became acquainted with biologist Geoff Garnett, a pioneer in mathematical modelling on the subject of HIV. He has modelled the efficiency, coverage and strategies of vaccines. Garnett, Lehtinen and Eero Pukkala formulated an idea: “Vaccinating as many people as possible could accomplish a herd immunity, even if the vaccine would not be very effective”. The trials (mentioned at the beginning of this article) began after developing a community-randomized layout of study.

Garnett is also Professor of Microparasite Epidemiology at Imperial College London, and has worked as a Reader at Oxford University, working on the epidemiology, evolution and control of sexually transmitted infections (including HIV and HPV). And among other things, Garnett has also served on a number of Institute of Medicine and Wellcome Trust (biomedical research) panels, according to information from the website of Gates Foundation and HIV Modelling Consortium.

At first I was wondering if a person Geoff Garnett, mentioned in Finnish HPV studies, was the same researcher who works for Gates Foundation. But he seems to be. In some connections, you can find his whole name Geoffrey Garnett or his nickname Geoff Garnett (f.ex. HIV Modeling Consortium and DCP3 websites).

And from the study report Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial you find the information that Geoff Garnett works for Bill and Melinda Gates Foundation, Seattle, WA, USA. And Seattle is mentioned as one of the hubs for the network of HPV researchers behind this new Finnish study.

In 2016, “Geoff Garnett from Gates Foundation” was one of the lecturers at the Finnish Medical Convention, held in Helsinki, Finland. He was lecturing about Elimination of major oncogenic HPV types.

I just wonder why… in the list of conflicts of interest of researchers, there is no mention about Garnett’s employer – vaccines promoting Gates Foundation.

How about ”a full-time employee of Takeda Vaccines” Gary Dubin, who holds several patents in the HPV field and has stock shares in both the GSK groups of companies and Takeda? A Japanese journal Nikkei BP tells more about Dr. Dubin. According to Nikkei BP:

Dr. Dubin is Senior Vice President and Head of the Global Medical Office in the Takeda Vaccine Business Unit (VBU). He leads the Medical Affairs and Policy functions for vaccines. He also serves as the Global Program Leader for Takeda’s Zika vaccine development program.

Prior to joining Takeda, Dubin spent 20 years at GlaxoSmithKline (GSK) Biologicals (now GSK Vaccines) where, between 2010-2015 he held the role of Vice President and Head, Global Late Clinical Development. At GSK, he led global teams responsible for the clinical development and licensure of a broad range of vaccines, including seasonal influenza (Fluarix Quadravalent and FluLaval Quadravalent), pandemic influenza (Pandemrix and Aprepandrix), meningococcal meningitis (Menhibrix and Nimenrix); human papilloma virus (Cervarix), rotavirus (Rotarix), strep pneumonia (Synflorix) and many other vaccines.

Dubin also supported Medical Affairs activities for these development programs and served as a core member of all major medical governance committees at GSK. He holds numerous patents in the vaccine field.

And then the last name, Dan Apter. Jyrki Kuoppala from webmagasine Uusi Suomi wrote about him 24/Sept./2012: Ympärileikkaus liittyy uskontoon vain löyhästi (Circumcision is only loosely related to religion).

Dr. Dan Apter was charged for grave assault, because he circumcised a child against his mother’s will. Charges against him were dropped (District Court of Helsinki, case R11/10004, 2 nd March 2012). According to District Court, Apter made a mistake, when he didn’t confirm mother’s consent “till the end”. But the Court deemed that it was not an intended assault.

According to this article, Apter has done the same thing earlier, too. And according to District Court, Apter has told that he has done about 10-40 male circumcisions a year, during last 30 years. According to Court, Apter has also previously removed healthy tissue from the genitalia of Nigerian children.

Dan Apter is CEO at company by name VL-Medi Oy. That company has done vaccine research with grants from vaccine manufacturers. The journalist mentions: …”f.ex. HPV vaccine studies in collaboration with University of Tampere, after assignment from a medical company. …VL-Medi has also done research concerning contraceptive and has got grants from Population Council, USA, which founder was John D. Rockefeller III. VL-Medi belongs to Väestöliitto concern (Family Federation).”

The journalist also wondered in his article, why Apter had told that he had used the same anesthetic about 5 000 times. In the light of those numbers mentioned, the amount of circumcisions should have been – mostly – around 1 500. There’s a big question which came into my mind… has there also been some illegal circumcisions?

 

VACCINATING IN FINLAND AGAINST PARENTS’ WILL

There is also evidence that the authorities in Finland would like to vaccinate children without parential consent. According to documents (named later), it would be enough if a child wants to get that vaccine. Right now this is not legal. But it has happened anyway, even against parents’ will. In the worst cases, the child has been vaccinated even when she has had a medical condition or a disease that has been a clear contraindication to vaccination. (Kuoppala Jyrki: Ympärileikkaus liittyy uskontoon vain löyhästi. Uusi Suomi 24th Sept. 2012. / Oikeusjakohtuus.blogspot.com: Laiton painostus HPV-rokotteen ottamiseksi jatkuu edelleen. 31st Oct. 2015.) – And I just heard that a sister to my godchild had recently been HPV vaccinated – against her mother’s written will, who by the way happens to be a nurse. The school nurse had put pressure on the girl.

 

CONCLUSIONS AND SOME FINAL WORDS

As mentioned earlier, considering the serious adverse events and even deaths after HPV vaccinations, the dangers are far more bigger than the benefits of HPV vaccines.

I have realized that hepatitis B vaccine is used as a control vaccine in many vaccine studies. And I believe I know why. Hepatitis B vaccine is a vaccine, which is able to give very serious adverse events. This makes it as an exellent control vaccine: it would be easy to say that the new vaccine under the test is as safe as the control vaccine.

The authorities and the mainstream media here in Finland seem to think that if you don’t see or hear something, it doesn’t exist. Finland keeps silent about the connections of vaccine studies to vaccine manufacturers, researchers’ background, and the information about the serious dangers of HPV vaccines.

One more thing – does somebody still believe that this study is impartial or scientifically totally neutral? According to NIH webpages, vaccine company GlaxoSmithKline (GSK) has been “responsible party, study sponsor, investigator and study director”.

 

Kirsi Lohtaja is co-author of newly published Finnish vaccine book Rokotteet ja vaiettu tieto. In English the name would be Vaccines and untold facts. Kirsi Lohtaja is Medical-Surgical-Psychiatric Nurse and Mental Health Nurse. In addition to that, she has a degree in Traditional Chinese Medicine and Acupuncture. She’s also a mother of a vaccine injured child.

 

REFERENCE LIST

Achté Pirjo: Kuinka papilloomavirus lannistettiin. Aikalainen, Tampereen yliopiston julkaisu 27.4.2015. https://aikalainen.uta.fi/2015/04/27/kuinka-papilloomavirus-lannistettiin/

Dach Jeffrey, MD: HPV Vaccine The Greatest medical Scandal of Our Time. jeffreydachmd.com 2.2.2018. http://jeffreydachmd.com/2018/02/hpv-vaccine-greatest-medical-scandal-time/

DCP3 (Disease Control Priorities): Geoffrey Garnett, Bill and Melinda Gates Foundation. http://dcp-3.org/author/geoffrey-garnett

Gates Foundation/General information/Strategy leadership/Integrated delivery, Geoff Garnett. https://www.gatesfoundation.org/What-We-Do/Global-Health/HIV/Strategy-Leadership/Geoff-Garnett

Gray Penelope et al.: Evaluation of HPV type-replacement in unvaccinated and vaccinated adolescent females – Post-hoc analysis of a community-randomized clinical trial (II). International Journal of Cancer/Infectious Causes of Cancer 12 Febr 2018. https://doi.org/10.1002/ijc.31281

HIV Modelling Consortium/Steering Committee: Professor Geoff Garnett. https://www.hivmodelling.org/about-us/steering-committee/professor-geoff-garnett

Kuoppala Jyrki: Ympärileikkaus liittyy uskontoon vain löyhästi. Uusi Suomi 24.9.2012. http://jyrkikuoppala.puheenvuoro.uusisuomi.fi/118154-ymparileikkaus-liittyy-uskontoon-vain-loyhasti

Lehtinen Matti et al.; Characteristics of a cluster-randomized phase IV human papillomavirus vaccination effectiveness trial. Vaccine 2015 Mar 3;33(10):1284-90. doi: 10.1016/j.vaccine.2014.12.019. Epub 2015 Jan 12. https://pdfs.semanticscholar.org/3804/25c83ef3261df5765ad42fa7a89cfff476c5.pdf

Lehtinen Matti et al.: Impact of gender-neutral or girls-only vaccination against human papillomavirus – Results of a community-randomized trial (I). International Journal of Cancer/Infectious Causes of Cancer 21 Oct 2017. https://doi.org/10.1002/ijc.31119 https://onlinelibrary.wiley.com/doi/abs/10.1002/ijc.31119

Lehtinen Matti et al.: Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years: Interim analysis of a large community-randomized controlled trial. Hum Vaccin Immunother. 2016 Dec;12(12):3177-3185. doi: 10.1080/21645515.2016.1183847.

NIH/ClinicalTrials.gov: Effectiveness, Safety and Immunogenicity of GSK Biologicals’ HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents. https://clinicaltrials.gov/ct2/show/results/NCT00534638

Nikkei BPnet: Dr. Gary Dubin. http://ac.nikkeibp.co.jp/4thnac/okinawa2017/pdf/Dr.GaryDubinMD.pdf

Oikeusjakohtuus.blogspot.com: Laiton painostus HPV-rokotteen ottamiseksi jatkuu edelleen. 31.10.2015. http://oikeusjakohtuus.blogspot.fi/2015/


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