By Peter C. Gøtzsche at Brownstone dot org.

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."

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."

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. 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. 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."

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). 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.

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. 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).

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. 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 a...