Breaking News: Attack By Nordic Cochrane Calls Cochrane Review Of HPV Vaccines Into Question But Has Wider Implications
An astonishing attack by three members of the Nordic Cochrane group in BMJ Evidenced Based Medicine on the recent Cochrane review of HPV vaccines, Arbyn et al Prophylactactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors calls not only the integrity and competence of the review into question, but poses by implication the most serious questions about how the products themselves were designed, trialed, licensed and marketed. The authors of the present of review of the review have been associated with a series of complaints against the European Medicines Agency concerning the vaccines and their safety. The Arbyn paper concludes:
There is high-certainty evidence that HPV vaccines protect against cervical precancer in adolescent girls and young women aged 15 to 26. The effect is higher for lesions associated with HPV16/18 than for lesions irrespective of HPV type. The effect is greater in those who are negative for hrHPV or HPV16/18 DNA at enrolment than those unselected for HPV DNA status. There is moderate-certainty evidence that HPV vaccines reduce CIN2+ in older women who are HPV16/18 negative, but not when they are unselected by HPV DNA status.
We did not find an increased risk of serious adverse effects. Although the number of deaths is low overall, there were more deaths among women older than 25 years who received the vaccine. The deaths reported in the studies have been judged not to be related to the vaccine. Increased risk of adverse pregnancy outcomes after HPV vaccination cannot be excluded, although the risk of miscarriage and termination are similar between trial arms. Long-term of follow-up is needed to monitor the impact on cervical cancer, occurrence of rare harms and pregnancy outcomes.
The key findings new paper by Jørgensen, Gøtzsche and Jefferson are:
-The Cochrane human papillomavirus (HPV)
vaccine review missed nearly half of the eligible
trials.
-The review was influenced by reporting bias
and biased trial designs.
-Authors of Cochrane reviews should make
every effort to identify all trials and the trials’
limitations
They found that the authors had included in the review only 26 of 46 eligible trials and state for this reason alone the conclusion "'that the risk of reporting bias may be small' was inappropriate" and they warn that none of the trials included were anyway for the new product Gardasil 9 which many countries are switching to. They further castigate the Cochrane review for using misleading language, referring to trials against placebo when all those included in the review were against "active comparators: adjuvants (aluminium hydroxide (Al[OH]3) or amorphous aluminium hydroxyphosphate sulfate [AAHS]) or hepatitis vaccines". They identify this as a bias in the original design of the trials masking the harm of the vaccines, and they note that women were excluded from trials if they had received adjuvants before or a history of immunological or nervous disorders. They say that this lowered the validity of trials and suggested that the manufacturers were concerned about the harms of the product in these groups, although no packet warnings are included.
They further complain that Arbyn failed to mention cases of cervical cancer in the trial groups but also that the relationship CIN2 lesions and cancer was uncertain since they regressed spontaneously in women under 30 who were mostly the subjects of the trial. They also say that the review misreported trials. In the so called PATRICIA trial where Cochrane reported 701 vs 699 from the trial publication, and 835 vs 829 in its "Clinical trial.gov" entry the Nordic Cochrane group found 1046 vs 982. Some trials recorded no adverse events at all and had very short follow up periods. While the original review could detect no pattern to the greater risk of death in the vaccinate vs comparator groups (51 vs 39) the Nordic Cochrane point out:
A death may be coded in a way that does not raise suspicion that the vaccine caused it; for example,a ‘traumatic head injury’ or ‘drowning’ could have been caused by a ‘syncope’, which is a recognised harm.
A meta-analysis which sought determine funding bias was flawed because the one trial which was deemed to be not funded by manufacturers was in fact funded by GSK by a circuitous route, and they failed to mention a report by the WHO Uppsala Monitoring Centre which found:
that found serious harms following HPV vaccination overlapping with two syndromes: postural orthostatic tachycardia syndrome (POTS) and complex regional pain syndrome (CRPS).
Instead they had relied on assurances from the European Medicines Agency handed down from the manufacturers. They note that in contravention of Cochrane guidelines 14 of the authors on the original protocol for the review had significant conflicts, as did three of the four authors of the final paper. While the main thrust of the paper is that Cochrane - to which the authors are affiliated - needs to clean up its act, we all may wonder at how the governments of the world have allowed pharmaceutical companies to subject young women to these ill-tested and dangerous products for the last dozen years, and even at how the pre-marketing trials in the format described were ever allowed. We shudder over the fact that in the last week the recommendation for Gardasil 9 has extended to boys and young men in the United Kingdom, and that in France the vaccine is about to be made compulsory. We know we cannot trust the pharmaceutical industry but how can we ever trust our governments?
John Stone is UK and European Editor of Age of Autism
"International Study: An Honest Look at the Statistics Shows that the HPV Vaccine is Not Safe"
by Brian Shilhavy Editor, Health Impact News
A new study was published earlier this month (July 2017) in the journal Clinical Rheumatology looking at serious adverse events after HPV vaccination. The title of the study is: Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.
This is an international peer-reviewed journal that has been around since 1945. It is the “Journal of the International League of Associations for Rheumatology,” and is the official journal of the Belgian Rheumatology Society.The study was conducted by doctors from the Rheumatology Department and the Immunology Department at the National Institute of Cardiology in Mexico City.
The results of their study found:
The lack of inert placebo in the vast majority of prelicensure HPV vaccine randomized studies
Large randomized trials disclosed significantly more severe adverse events in the tested HPV vaccine cohort
Pooled safety analysis found more post-immunization symptoms in bivalent HPV vaccine vs. hepatitis A vaccine
Post-marketing HPV vaccine adverse events case series describe similar cluster of symptoms than those reported in pre-clinical trials
The European Medicines Agency report on HPV vaccine safety looked at specific diagnoses and not at symptoms clusters
In-depth analysis of some supportive post-marketing HPV vaccine safety studies discloses disquieting findings
The study found the statistics regarding the new Gardasil 9 particularly troubling, as the statistics suggest that severe harm is suffered every 140 injections. ..
A link to the study, and study highlights in full article http://healthimpactnews.com/2017/international-study-an-honest-look-at-the-statistics-shows-that-the-hpv-vaccine-is-not-safe/
Posted by: Margaret | April 13, 2019 at 09:57 PM
International Study: An Honest Look at the Statistics Shows that the HPV Vaccine is Not Safe- Health Impact News
A new study was published earlier this month (July 2017) in the journal Clinical Rheumatology looking at serious adverse events after HPV vaccination. The title of the study is: Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.
This is an international peer-reviewed journal that has been around since 1945. It is the “Journal of the International League of Associations for Rheumatology,” and is the official journal of the Belgian Rheumatology Society.
The study was conducted by doctors from the Rheumatology Department and the Immunology Department at the National Institute of Cardiology in Mexico City.
The results of their study found:
The lack of inert placebo in the vast majority of prelicensure HPV vaccine randomized studies
Large randomized trials disclosed significantly more severe adverse events in the tested HPV vaccine cohort
Pooled safety analysis found more post-immunization symptoms in bivalent HPV vaccine vs. hepatitis A vaccine
Post-marketing HPV vaccine adverse events case series describe similar cluster of symptoms than those reported in pre-clinical trials
The European Medicines Agency report on HPV vaccine safety looked at specific diagnoses and not at symptoms clusters
In-depth analysis of some supportive post-marketing HPV vaccine safety studies discloses disquieting findings
The study found the statistics regarding the new Gardasil 9 particularly troubling, as the statistics suggest that severe harm is suffered every 140 injections...
Some highlights from the study:
Proper placebos not used in pre-market trials. Instead of an inert placebo, aluminum adjuvants were used.
The overwhelming majority of randomized HPV vaccine trials did not use inert placebo. They used aluminum containing placebo or other aluminum-adjuvanted vaccines.
For clinical studies, a placebo is defined as a “pharmaceutically inert” substance. This definition cannot be applied to an adjuvant substance.
Aluminum adjuvant mechanism of action remains poorly understood and its safety has been questioned. Aluminum adjuvants are known to stimulate TH2 immune response, activate dendritic cells, and activate NLRP3 inflammasome.
Large randomized trials disclosed significantly more severe adverse events in the tested HPV vaccine cohort.
In randomized double-blind trials, confounding variables are canceled out minimizing the influence of external factors on the results.
The two relatively small randomized trials testing HPV vaccine against true inert saline placebo revealed a tendency to have more adverse events in the vaccine group.
Two of the largest HPV vaccine randomized trials showed significantly more severe adverse events in the investigated vaccine arm of the study: Compared to aluminum placebo, bivalent HPV immunization was accompanied by significantly more vaccine-related general solicited symptoms during the 7-day post-vaccination period and a statistically significant four-fold increase in death rate.
The unquestionable statistical results derived from two of the largest HPV vaccine randomized trials must take preeminence over the investigators’ judgment ascribing the disproportionate severe adverse events and excessive death rate to external factors.
Post-marketing HPV vaccine adverse events case series describe similar cluster of symptoms than those reported in pre-clinical trials.
Both pre-licensure randomized trials and postmarketing-independent reports describe similar cluster of adverse events symptoms, namely, headache, fatigue, dizziness, musculoskeletal pain, and gastrointestinal symptoms among others.
In the postmarketing studies, this cluster of symptoms was labeled with different diagnoses such as complex regional pain syndrome, chronic fatigue syndrome, fibromyalgia, or postural orthostatic tachycardia syndrome. When looking at these diagnoses separately, HPV vaccine safety signals may be diluted.
This possible post-marketing HPV vaccine adverse reaction under-recognition is reinforced by the recent WHO VigiBase report.
In-depth analysis of some supportive post-marketing HPV vaccine safety studies discloses disquieting findings.
HPV vaccine post-marketing safety studies done in Valencia, Spain, and Alberta, Canada, endorsed HPV vaccine safety.
Nevertheless, these investigations contain disquieting findings. It seems perilous to blame “Bad press” for the 10 times higher than expected HPV vaccine adverse events notification by Valencian doctors and nurses. Similarly intriguing is the description of 10% of HPV-vaccinated healthy Canadian girls needing to visit a hospital emergency department within 42 days following HPV immunization.
The researchers conclusions:
Scrutiny of two of the largest randomized trials unveiled significantly more serious adverse events in the investigated HPV vaccine arm of the study.
Compared to the 4-valent dose, 9-valent HPV vaccine had significantly more serious adverse events. Considering this statistical difference, the reported 0% incidence of vaccine-related serious adverse events is probably an under-estimation.
Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Nine-valent vs. 4-valent HPV vaccine local and systemic adverse events disparities raise the possibility of a dose-dependent untoward effect.
Compared to aluminum placebo, the group of individuals receiving the bivalent HPV vaccine had more deaths on follow-up. Pre-clinical randomized trials and independent post-marketing case series describe similar post-HPV immunization symptom clusters.
These findings raise further doubt on HPV vaccine safety. The full article includes a link to the study. http://healthimpactnews.com/2017/international-study-an-honest-look-at-the-statistics-shows-that-the-hpv-vaccine-is-not-safe/
Posted by: Margaret | April 13, 2019 at 09:48 PM
recent developments at Cochrane
https://blogs.bmj.com/bmjebmspotlight/2018/09/16/cochrane-a-sinking-ship/
Posted by: greyone | September 16, 2018 at 06:59 PM
GemmA O'Dohery is running for Irish president
https://www.irishexaminer.com/breakingnews/ireland/gemma-odoherty-annou
nces-intention-to-run-for-presidency-863161.html
And she is asking questions about Gardasil !!
Posted by: Hans Litten | August 24, 2018 at 04:48 AM
Another for the culpable list.
Pharma For Prison
MMR RIP
Posted by: Angus Files | August 07, 2018 at 06:35 AM
Dear John, thanks for your feedback! there seems to be good news from Italy. Financial Times reports "Italian Senate Ends Mandatory Child Vaccination Law" https://www.ft.com/content/afd472be-996c-11e8-9702-5946bae86e6d
Posted by: sabine | August 07, 2018 at 05:58 AM
http://www.thejournal.ie/hpv-vaccine-boys-4160987-Aug2018/
Boys to get HPV vaccine in 2019
The Taoiseach said plans are already getting underway to rolling out the vaccine to boys.
THE HPV VACCINE is to be extended to boys next year, according to Taoiseach Leo Varadkar.
Following a report by HIQA which recommends the vaccine be extended to boys, a public consultation to gather the views of various stakeholders was launched last month.
Varadkar said he anticipates the public consultation “will come out in favour of doing it”.
HPV is very common virus or infection, and is the most common sexually transmitted infection worldwide. Most HPV infections have no noticeable symptoms and over 90% are cleared by the body’s immune system.
However, in some cases HPV can be a precursor to pre-cancerous cells, which can lead to a number of cancers including cervical cancer.
Although both boys and girls can contract HPV, it’s been the approach to make the HPV vaccine available for free to girls of school-going age. If a high enough number of girls are vaccinated against the virus, the government’s ambition was to then roll it out to boys.
“Minister Harris and I spoke about this [extending the vaccine to boys] in the last couple of days. And we are going to put in train the procedures needed to introduce that next year to extend the vaccine to boy,” said Varadkar.
Varadkar said a number of other countries have already extended the vaccine, and Ireland would be following, however, he said the costs have to be worked out.
“There is a cost associated with it obviously in purchasing the vaccines, we need to negotiate payment with GPs and setup all the logistics around it, but we believe it is the right thing to do- both in terms of reducing incidents of cervical cancer among women into the future, but also HPV infections in men which give rise to anal cancer, penile cancer, head and neck cancer, which can be particularly nasty.
“I’m glad we have the report and we intend to act on it and make it a reality in 2019.”
Posted by: Hans Litten | August 07, 2018 at 04:59 AM
Sabine,
I am grateful for the update - at the time of writing my understanding was that the move to add HPV vaccines to the schedule in France was likely to get political approval: the predicament of French citizens after the mandating of 11 infant vaccines is certainly appalling - the corruption of Buzyn is repulsive but the entire political class seemed set on this monstrosity.
Posted by: John Stone | August 07, 2018 at 04:48 AM
Dear John, I live in France, mandatory vaccination at 2month for 11 diseases for all newborns from 2018 onwards ("thanks" to health minister Agnes Buzyn, formerly remunerated by Pharma industry).
Concerning the HPV vaccination a deputy recently proposed to add the HPV vaccine to the 11 shots, but this is far (for now) to become compulsory. http://www.assemblee-nationale.fr/dyn/15/dossiers/vaccin_papillomavirus_obligatoire#
The vaccination rate for Gardasil here in France is about 15%.
Posted by: sabine | August 07, 2018 at 02:52 AM
http://gaia-health.com/conventional-medicine/vaccines/coming-push-give-hpv-vaccines-infants/
If you can push the most dangerous vaccines in use today on teen and pre-teen girls, and later on boys of the same age, without any proof that they work, then why not give them to newborn infants—plus another ‘booster’ later on? That appears to be planned for Gardasil and Cervarix, along with a slick new marketing program, thanks to the vaccine-industrial complex.
A review published in the journal Vaccine was produced to justify injecting the HPV vaccines into tiny babies.[2] The authors wrote:
On a global scale, vaccination of newborns and infants is well established and has developed a successful working infrastructure. The hepatitis B virus (HBV) vaccination programs offer a model for HPV introduction in which newborn and infant immunization achieves a rapid reduction in the prevalence of the HBV carrier rates in immunized cohorts of children, and of liver cirrhosis and liver cancer decades later. [Emphasis mine.]
It was financed by major governmental agencies, including the European Commission, the Instituto de Salud CarlosII of the Spanish government, and the Agència de Gestió d’Ajuts Universitaris i de Recerca–Generalitat de Catalunya of the Catalonian government. The authors and their employers are:
◾F. Xavier Bosch: Cancer Epidemiology Research Program (CERP), Institut Català d’Oncologia–Catalan Institute of Oncology, L’Hospitalet de Llobregat (Barcelona), Spain
◾Vivien Tsu: Director of PATH’s HPV vaccine projects, Seattle, WA, USA—a partner of the Bill & Melinda Gates Foundation
◾Alex Vorsters and Pierre Van Damme: Centre fo the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Belgium
◾Mark A. Kane: Consultant on Immunization Policy, Mercer Island, WA, USA
The authors’ employers are obviously are deeply tied to the vaccine industry. However, their personal ties to the vaccine-industrial complex is stunning:
Posted by: Hans Litten | August 02, 2018 at 05:36 AM
For anyone who has not seen it yet, I think the only thing we need to know about HPV vaccines is encompassed in the Youtube Vaxxed bus tour story of "Colton in Utah"
With the permission of Colton's mother, I think his photo should accompany every article on HPV vaccines.
Posted by: Cherry Misra | August 01, 2018 at 01:28 AM
Oh yeah, Katie Couric did have a bunch of fraudulent studies to omit. Good for her.
Posted by: Benedetta | July 31, 2018 at 11:31 PM
Posted by: Hans Litten | July 31, 2018 at 04:16 AM
Well done the three members of the Nordic Cochrane group for questioning the standards of the review ,at least they have the guts and backbone to do so.
If the same had been done with Vioxx in 1999 noting the increased risk of strokes and heart attack my mum Donalda would not have been prescribed Vioxx for over a year and ending up with an aortic stenosis of 88mmhg in jJan 2005 and given a years life expectancy at best ,but she still managed to keep going with three strokes later until 2013 ,
Self determination won't fail folk ,but the health and safety risk assessments often do ,
What a serious mess to get "Sorted and Settled " Someone might want to send the review team some trauma teddies for a comfort blanket ,as the evidence based standards are definately heading towards
tears before bedtime .
Posted by: Morag | July 31, 2018 at 02:07 AM
Thank you for this review. It's good to see some in the Cochrane Collaboration make efforts to correct the course.
Particularly curious, or telling maybe, that some of the HPV vaccine trials would not admit persons who'd received adjuvants before (throughout their lives? ...that could be pretty close to being completely unvaccinated), so the vast vaccinated western adolescent population, now targeted by this vaccine, would have not qualified to be in at least some of these trials?
Posted by: Jeannette Bishop | July 30, 2018 at 04:30 PM
I've said here that I didn't trust Cochrane reviews. They ALWAYS say that unconventional findings should be viewed with caution, and then follow-up studies to confirm or deny are never done (to my limited knowledge). Cochrane said that the Bangladesh study from the early '80s which showed that 1,000 mg of vitamin C saved the lives of ALL the children in the study with tetanus, and many of the adults (who would probably also have recovered with a larger dosage of vitamin C), should be viewed with caution. And so nearly everyone who has died of tetanus in the last forty years could have been saved had they been given enough cheap, readily available vitamin C. And Cochrane could have recommended it, expressed joy and astonishment at how effective it was, and saved lives. Instead they were noncommittal at the cost of many lives.
http://www.mv.helsinki.fi/home/hemila/CT/Jahan_1984_bm.pdf
Posted by: cia parker | July 30, 2018 at 12:36 PM
And they talk about FAKE news :
https://medium.com/@gidmk/eliminating-cervical-cancer-2d1e0f77222
And cervical cancer is no exception. It is one of the biggest killers in developed countries, and is responsible for nearly 10 million deaths each year worldwide, despite only impacting about half of the population.
Except, in some places, not for long.
Some countries may eliminate cervical cancer entirely within our lifetimes. Gone.
It’s amazing.
Get Vaccinated
Unfortunately, the HPV vaccine has had a lot of bad press. People have raised concerns about the vaccine leading to teenagers having more sex, or serious health problems, despite the strong and consistent evidence to the contrary. With a decade of research, we can confidently say that the HPV vaccine is one of the safest medical interventions around. It also doesn’t lead to more unsafe sex in teens.
What it does do is save lives.
Posted by: Hans Litten | July 30, 2018 at 12:15 PM
Posted by: susan welch | July 30, 2018 at 09:14 AM
JCVI :
Disbanded you say !
I say prosecuted, for crimes against humanity.
The little old swiss lady who looks like Julie Gerberdings evil twin.
I think she should be paid special attention.
Posted by: Hans Litten | July 30, 2018 at 10:10 AM
Is this the link and reference:
https://ebm.bmj.com/content/early/2018/07/27/bmjebm-2018-111012
The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias
Lars Jørgensen 1, Peter C Gøtzsche 1, Tom Jefferson 2
Nordic Cochrane Centre, Rigshospitalet (dept. 7811), Copenhagen, Denmark
Centre for Evidence Based Medicine, University of Oxford, Oxford, UK
Posted by: Alessandro | July 30, 2018 at 10:08 AM
If you listen carefully, I think you will be able to hear Bill Gates yelling.
So is there a split within the Cochrane Collaborators ?
Posted by: Hans Litten | July 30, 2018 at 09:34 AM
I love your conclusions, John. I would just add that the JCVI should be disbanded (and new members should have no conflict of interest), in view of the fact that they have just recommended this dangerous vaccine for boys.
It is good too note, however, that the Nordic Cochrane group is ethical and willing to fight to keep their integrity.
Posted by: susan welch | July 30, 2018 at 09:14 AM
Jenny
Yes, the clues were there, many of us savaged it but it is a great boon that other members of the Cochrane group have stepped forward.
A first conclusion to be drawn from it is that the review must be withdrawn: it is obviously irredeemably flawed. A second even more important conclusion is that the products shown be withdrawn. A third conclusion is that all the officials involved in the licensing or promotion of the products should summarily sacked. Fourth, the path to the courts should be opened to citizens so they can sue the manufacturers to Kingdom Come. Five, the police should be looking at it too.
Posted by: John Stone | July 30, 2018 at 07:03 AM
https://pompiliomartinez.wordpress.com/2018/07/27/report-of-the-research-carried-out-by-universidad-de-cartagena-on-teenagers-who-developed-adverse-events-after-vaccination-with-gardasil-in-carmen-de-bolivar-colombia/
Seems they have attempted to perform a whitewash in Colombia too.
Posted by: Hans Litten | July 30, 2018 at 07:00 AM
I think the original Arbyn Cochrane review can be summed up in this short excerpt:-
http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD009069.pub3/full
"Studies were not large enough or of sufficient duration to evaluate cervical cancer outcomes. All but one of the trials was funded by the vaccine manufacturers. We judged most included trials to be at low risk of bias."
"Low risk of bias"? - "Funded by the vaccine manufacturers"? " Not large enough or of sufficient duration"?
YEAH RIGHT!!
Posted by: Jenny Allan | July 30, 2018 at 06:49 AM