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Breaking News: Attack By Nordic Cochrane Calls Cochrane Review Of HPV Vaccines Into Question But Has Wider Implications

image from upload.wikimedia.orgby John Stone

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

 

 

 

Comments

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greyone

recent developments at Cochrane
https://blogs.bmj.com/bmjebmspotlight/2018/09/16/cochrane-a-sinking-ship/

Hans Litten

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 !!

Angus Files

Another for the culpable list.

Pharma For Prison

MMR RIP

sabine

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

Hans Litten

https://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.”

John Stone

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.

sabine

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. https://www.assemblee-nationale.fr/dyn/15/dossiers/vaccin_papillomavirus_obligatoire#
The vaccination rate for Gardasil here in France is about 15%.

Hans Litten

https://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:

Cherry Misra

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.

Benedetta

Oh yeah, Katie Couric did have a bunch of fraudulent studies to omit. Good for her.

Hans Litten

https://www.sacbee.com/news/politics-government/capitol-alert/article215814025.html

This lawmaker blocked anti-vaccine activists on Twitter. Now he’s facing a lawsuit
July 30, 2018 06:42 PM

State Sen. Richard Pan, D-Sacramento, is being sued by anti-vaccine activists, who say he blocked them on Twitter in violation of their First Amendment rights.
The lawsuit argues Pan’s Twitter account is a modern public forum because he is a government official.
The suit, which was filed in federal court in Sacramento on July 27, alleges Pan blocks people with dissenting perspectives “based solely on his unconstitutional viewpoint discrimination.”
Suzanne Rummel and Marlene Burkitt, who could not be immediately reached for comment, are the two anti-vaccine activists who filed suit.

Morag

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 .

Jeannette Bishop

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?

cia parker

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.

https://www.mv.helsinki.fi/home/hemila/CT/Jahan_1984_bm.pdf

Hans Litten

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.

Hans Litten

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.

Alessandro

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

Hans Litten

If you listen carefully, I think you will be able to hear Bill Gates yelling.

So is there a split within the Cochrane Collaborators ?

susan welch

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.

John Stone

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.

Hans Litten

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.

Jenny Allan

I think the original Arbyn Cochrane review can be summed up in this short excerpt:-
https://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!!

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