The BMJ did it again. Published a highly misleading news piece about a major public health intervention: “HPV vaccine safe and reduces risk of cervical cancer, anti-misinformation review finds.”1
There is no such thing as an “anti-misinformation review.” What we have are systematic and unsystematic, also called narrative, reviews. And there is no such thing as a safe drug. All drugs, including vaccines, cause harm in some people.
But now we have something we could call a misinformation news piece, better known as fake news, and this is what the BMJ article is. Already the first sentence is wrong: “Human papillomavirus (HPV) vaccination reduces the incidence of cervical cancer by 80% in people vaccinated at or before the age of 16, according to two Cochrane reviews.”2,3
The Cochrane Review of the Randomised Trials
The two Cochrane reviews were published on 24 November. One of them was a network meta-analysis of the randomised trials of the HPV vaccines.2 The abstract noted that: “The studies were not of sufficient duration for cancers to develop … No cancers were detected … No data were available for cervical cancer or other cancer outcomes, and no data on pre-cancer outcomes were available for vaccination under age 15 years.” So, how could it show an 80% reduction in cervical cancer?
The Cochrane authors noted that they included more Clinical Study Reports (CSRs) than my research team did for our systematic review from 2020.4 It took us three years to obtain 24 of our 50 eligible CSRs from the European Medicines Agency (EMA) and we based our review on those, as one of us needed to do the review for his PhD. The Cochrane authors included 60 trials and they had CSRs for 33 of them, but nowhere in their 344-page review did they say how many patients these 33 trials included. In their meta-analysis, they also included published trials reports. They had roughly double as many patients with serious adverse events than we had but they noted that “Conclusions about serious nervous system disorders could not be drawn in our review.”
The HPV vaccines had been suspected of causing neurological harms for a long time. In 2008, GlaxoSmithKline informed parents they asked to enrol their daughters in a Cervarix trial that the vaccine had “affected the nervous system.”5
In contrast to Cochrane, we found, against all odds, as the control groups, apart from two small studies, had active comparators, that the HPV vaccines increased serious nervous system disorders significantly: 72 vs 46 patients, risk ratio 1.49 (P = 0.04).4 We called it an exploratory analysis, but it was the most important one because the suspected harms to the autonomic nervous system were what caused EMA to assess vaccine safety in 2015.5
Postural Orthostatic Tachycardia Syndrome (POTS) and Complex Regional Pain Syndrome (CRPS) are rare neurological syndromes that are difficult to identify, and we knew that the companies had deliberately concealed what they found in their trials.5 To assess if there were signs and symptoms consistent with POTS or CRPS in the data, we did another exploratory analysis where we asked a blinded physician with clinical expertise in these syndromes to assess the MedDRA preferred terms (which are code terms the companies use to categorise and report adverse events). The HPV vaccines significantly increased serious harms definitely associated with POTS (P = 0.006) or CRPS (P = 0.01). New onset diseases definitely associated with POTS were also increased (P = 0.03).4
In my role as an expert witness in a lawsuit against Merck, I read 112,452 pages of confidential study reports and documented that Merck used numerous tactics to avoid reporting serious neurological harms of Gardasil, which, in my view, in some cases constituted outright fraud.5 I did several meta-analyses and concluded that there is no doubt that HPV vaccine harms are very common and sometimes severe or serious, and that Merck’s aluminium adjuvant is also harmful. Other expert witnesses documented the same, using other data.6
The Cochrane Review of the Observational Studies
The other Cochrane review3 couldn’t say anything reliably about preventing cancer. It was a review of observational studies, which we know are heavily biased because of the healthy volunteer effect: Those who decide to get vaccinated are generally healthier than others and they are also more likely to get screened for HPV infection.
The Cochrane review documented this. In the cohort studies, the odds of getting screened were double as high for the vaccinated as for the unvaccinated people.3 Since cervical cancer grows so slowly that regular screening is close to 100% effective for its prevention,5 this bias invalidates the Cochrane review totally. But the authors did not mention this issue in their discussion or abstract, which are therefore highly misleading. They did not even include the healthy volunteer effect in a list of six confounders although it is the most important one.
The Cochrane authors quoted several observational studies for their lack of neurological harms. During my deposition, Merck’s lawyer counted on some of the same studies, but I have shown that they are highly flawed.5
The authors quoted one of these studies for having found a “markedly lower” risk of death with vaccination, incidence rate ratio for all-cause mortality 0.52 (95% confidence interval 0.27 to 0.97).3 This demonstrates the authors’ bias. A confidence interval with an upper bound close to 1 is not a “markedly lower” risk. Moreover, it is extremely unlikely that HPV vaccination lowers total mortality; in fact, many studies have found that non-live vaccines tend to increase total mortality.6
It is surreal that the authors started out by considering all their studies “high-certainty evidence” (unless specific issues with them were found), which means they were very confident that the true effect lies close to that of the estimate of the effect. It is impossible for a genuine scientist to have such an optimistic starting point for observational studies of preventing cancer.
Another issue that invalidates the Cochrane review is the poor quality of the included studies. It is shocking reading:3
Of 20 studies reporting on cervical cancer, 9 were at critical risk of bias overall because they failed to control for any potential confounding, 7 were at serious risk of bias, and 4 were at moderate risk of bias.
This leaves only one study! For CIN3+, a cancer precursor, not a single study was without important bias: 22 of 23 studies were at critical or serious risk and one study was at moderate risk of bias.
It defies reason how the Cochrane authors on this background could call it “moderate‐certainty evidence” that, for those vaccinated at or before 16 years of age, “there was an 80% reduced risk of cervical cancer (RR 0.20, 95% CI 0.09 to 0.44; I2 = 69%)” with no mention that the serious biases invalidate their claim.
Long-Term Vaccine Harms
The second sentence in the BMJ news piece is also highly misleading:1 “The comprehensive systematic reviews also found vaccination was not associated with an increased risk of long term side effects or infertility.”
Under the obligatory Cochrane heading, “Agreements and disagreements with other studies or Reviews,” the Cochrane review of observational studies only mentioned our review this way:3 “The evaluation of specific adverse events that are commonly discussed on social media has been more limited than vaccine effectiveness outcomes. These events are rare and often not evaluated in clinical trials (Jørgensen 2020).”
The third sentence in the BMJ news piece was:1 “Researchers said they wanted to share high quality data to counter misinformation spread on social media, which has had a massive impact on vaccination rates.”
To call seriously flawed observational data “high quality” is as bad as it gets. Whitewashing dirty data, Cochrane was the vaccine industry’s useful idiots, and the BMJ happily joined the party.
Cochrane’s and BMJ’s Scare Campaign
The industry’s marketing strategy is to scare the public with big numbers for disease prevalence and its death toll, and to offer a solution, with impressive numbers for the effect while ignoring the harms and omitting any mention of the financial cost.
Cochrane uses the same playbook. Nine of the authors on the two reviews were the same and much of the text in the Background section was identical: “Cervical cancer is the fourth most common cancer and the fourth leading cause of death from cancer amongst females worldwide, with an estimated 570,000 new cases and 311,000 deaths in 2018 (Bray 2018). Cervical cancer is a common cancer in young women and people with a uterine cervix, particularly in the 25 to 45 age group (Bray 2018) … even in the UK, with a world-leading screening programme, cervical cancer in females aged 25 to 49 is the fourth highest cause of cancer death.”
Cochrane is nauseatingly politically correct. Why talk about “young women” and “people with a uterine cervix”? Do young women not have a cervix, and are people with a cervix not women? When The Lancet in 2021 had a front-page message about “bodies with vaginas,” many women got offended and one noted that, in a tweet posted on prostate cancer only 4 days earlier, Lancet didn’t refer to men as “bodies with penises.”7
Instead of scaring women with big numbers, Cochrane could have reassured them that their risk of dying from cervical cancer is miniscule. According to official UK statistics, cervical cancer deaths constitute only 0.5% of all cancer deaths and only 0.1% of all deaths.8
Moreover, it is misleading to focus on the 25 to 45 age group. It will surprise most people to learn that about half of those who die from cervical cancer are over 70 years of age5 and that mortality rates in the UK are highest in females aged 85 to 89.8 It therefore rings hollow when Jo Morrision, senior author of the two Cochrane reviews, says that cervical cancer is “still very much a disease of young women, leaving them either unable to have families or leaving young families without their mothers.”1
The BMJ noted that HPV vaccine uptake has dropped by 20% among female students and 16% among male students, and Jo Morrison, said: “The phenomenon of misinformation is worldwide, and vaccine scares in other countries have had a massive impact on vaccination rates in the UK.”
How can she know that? Perhaps people are just better informed today than they were ten years ago and therefore more reluctant to get vaccinated?
Jo Morrison was the editor9 who approved the first Cochrane HPV vaccine review, published in 2018,10 which my research group criticised heavily.11 The Cochrane review was disgraceful. It had missed nearly half of the eligible trials and at least 25,000 females and was influenced by reporting bias and biased trial designs. Moreover, the authors mistakenly used the term placebo to describe aluminium-based adjuvant comparators, even though GlaxoSmithKline had stated that the adjuvant causes harms, which I and others have documented.5
Back then, Jo Morrison tried to get me fired for my criticism of the first Cochrane HPV vaccine review.9 She wrote a complaint to the Cochrane leadership, which accused my team of causing reputational damage to the organisation, fuelling anti-vaxxers and risking “the lives of millions of women worldwide by affecting vaccine uptake rates,” as Morrison had claimed.12
Vaccine researcher Tom Jefferson from our team said: “If your review is made up of studies which are biased and in some cases are ghost written or the studies are cherry picked and you don’t take that into account in your review, then it’s garbage in and garbage out … with a nice little Cochrane logo on it.”12
More Cochrane and BMJ Nonsense
The BMJ noted that the Cochrane review of the randomised trials found “high certainty evidence” that there was no increased risk of serious adverse events with all four HPV vaccines.1
This is ridiculous. When drug companies have committed fraud by omitting serious harms of their products in their publications, they should not be rewarded for their misconduct by calling it “high certainty evidence.”
On top of this, the Cochrane review2 has an analysis that shows significantly more serious adverse events with Gardasil 9 than with Gardasil in a large trial comparing the two (P = 0.01, my calculation). This is a smoking gun because Gardasil 9 contains five more HPV antigens and more than double as much aluminium adjuvant as Gardasil.5
Unsurprisingly, the Cochrane review of observational studies3 “was also found not to be associated with a range of specific adverse events that the researchers had seen commonly linked to the jab on social media.”1 Of course not. These studies adressed the benefits of the vaccination, not its harms.
The BMJ’s final remark was one of political correctness: “Research recently published in the BMJ showed that the HPV vaccination programme was associated with a substantial reduction in incidence of cervical cancer across all social economic groups and can help reduce health inequalities.”1
What the BMJ and the Cochrane authors didn’t say is that people don’t need the vaccine if they are regularly screened.
BMJ and Cochrane Also Failed Badly in Relation to Mammography Screening
Only two months before these calamities, the BMJ also failed public health badly, this time in relation to mammography screening. It published a cohort study of screening13 and an editorial,14 which I commented upon the next day, also in the BMJ.15
The editorial claimed falsely that “Mammograms can detect breast cancer early, often before a lump can be felt, which improves the chances of successful treatment and survival.”14
First, mammography screening does not detect cancers early but very late. The average tumour size in the randomised trials was 16 mm in the screened groups and 21 mm in the control groups.16 It takes only one more cell division for a 16-mm tumour to become one of 21 mm. If we assume that the observed doubling times are valid from initiation till the tumour becomes detectable, the average woman has harboured the cancer for 21 years before it acquires a size of 10 mm.
Second, in screening propaganda, “successful treatment” usually means less invasive treatment,17 which is also false. Because of substantial overdiagnosis, and because the earliest cell changes, carcinoma in situ, are often diffusely spread in one or both breasts, screening increases mastectomies.18,19
Third, screening does not improve survival. The editorialist claimed that screening reduces breast cancer mortality by 15% and then made the error of equating this with a reduction in mortality. Breast cancer mortality is a flawed outcome that favours screening, mainly because of differential misclassification of cause of death, but also because treatment of overdiagnosed women increase mortality,17,18 and screening does not reduce total cancer mortality (including breast cancer), or total mortality.18 The newest data showed that for the trials with adequate randomisation, the risk ratio was 1.00 (95% confidence interval 0.96 to 1.04), for total cancer mortality, and 1.01 (0.99 to 1.04), for all-cause mortality.20
The editorialist talked about “potential overdiagnosis.” It is not potential; it is an unavoidable consequence of screening.16-19
Moreover, the editorialist claimed that an observational study13 provides “concrete evidence that initial screening reduces mortality,” which is false. The study only claimed that screening reduces breast cancer mortality. It is a huge error that the authors of this study, which was performed in Sweden, did not tell their readers about cancer mortality and total mortality, which would have been very easy to document.
Screening doesn’t reduce mortality and observational studies can never demonstrate reliably that screening reduces breast cancer mortality. They are all biased by the healthy screening effect, which no amount of statistical adjustment can make up for. We should ignore observational studies claiming that mammography screening works. And we should abandon mammography screening, as it is harmful.17
The editorial followed the same deplorable playbook as for the HPV vaccines, with big numbers and fantasies:14 An estimated 2.3 million new cases and 670,000 deaths in 2022. The incidence is projected to increase by 38% to 3.2 million and the mortality to increase by 68% to 1.1 million by 2050, if the current trend continues.
About the cohort study,13 the editorialist said that women who did not attend their first screening were less likely to participate in future screenings and more likely to experience advanced stage breast cancer and higher breast cancer mortality, so “the message is clear: participating in early mammography screening can have a lasting benefit.”14
This message is invalid. We have known for decades that women who do not attend screening cannot be compared with those who attend. It was not surprising to me that the studies the editorialist quoted were published by some of the most dishonest researchers in this area, e.g. Stephen Duffy, Lázló Tabár, Peter Dean, Robert A. Smith, Sven Törnberg, and Daniel Kopans.
I have documented that some of them even lied about their own research when I caught them in making a serious scientific error.21 Tabár, Duffy and Smith have reported a 63% reduction in breast cancer mortality in those who attended screening and they have even claimed a 13% decrease in all-cause mortality, which is mathematically impossible, as breast cancer constitutes only 2% of all-cause mortality.8
In November, the BMJ finally woke up and published a so-called expression of concern about the editorial and the study it quoted, using British understatements:22
“BMJ was alerted to concerns that messaging in key areas may not be sufficiently supported by the data presented in the work … There is concern that a lack of data about all cause mortality, and/or lack of emphasis on those data, is a critical limitation. This may impact the implications of the work and BMJ is conducting additional statistical review … Both the authors of the research paper and the editorial conclude and/or call for interventions to improve adherence to screening … The call is not sufficiently grounded in the conclusions of the data analysed in this paper … BMJ is in discussion with the authors about what post-publication change to their work is required to ensure that it accurately reflects the results and other relevant evidence, and is transparent about uncertainties.”
The BMJ and Cochrane are onboard the same sinking ship.9,12 When I first published my Cochrane review of mammography screening in 2001, Cochrane refused to let me include the major harms of screening, overdiagnosis and overtreatment.21,23 It took me five years of hard struggle before I got these data into the Cochrane review, which I updated several times later on. When we updated it recently with more mortality data, Cochrane refused to publish the update, with no plausible arguments. This was another major scandal for Cochrane, which caused me to publish the article, “Cochrane on a suicide mission.”23
Is BMJ on a suicide mission, too? Some of us think so and one of my highly respected evidence-based colleagues in the UK says the journal is already dead. Other major scientific journals are also making themselves redundant.24 What we see these years are tragedy upon tragedy in scientific publishing where scientific honesty is less important than political expedience, personal biases, and guild and financial interests. When I analysed 33 BMJ articles about Kennedy’s much-needed vaccine reforms, I found they amounted to character assassination; it was all about faith, not about science, or about the merits of his reforms.25
