Evidence is accumulating about the dangers of HPV vaccination and there are growing challenges to the claim that it prevents cervical cancer.

Proponents of HPV vaccination have long played down the harms caused by the Gardasil vaccines, despite reports of severe illness and injury and even deaths following their administration. However, Merck, the company that produces the vaccines, is increasingly facing accusations about scientific misconduct and even fraud in its marketing and testing of quadrivalent Gardasil and Gardasil 9.

There are lawsuits in the United States and a new book by Danish physician and researcher Peter C. Gøtzsche, and experts are continuing to expose the flaws in studies that make claims about the alleged effectiveness of HPV vaccination.

The much-awaited Robi v. Merck & Co. court case, in which proceedings were adjourned in February this year, is due to resume with a new jury in Los Angeles in October. The trial date has been set for October 13, with a Final Status Conference scheduled for October 1.

Gøtzsche says in his new book: “Merck had attempted to avoid the case going to trial, arguing that undisputed facts proved they had not violated the law. The court did not accept this argument.”

Jennifer Robi alleges that Gardasil caused her severe health problems, including a heart condition and nerve pain. In the lawsuit, it is alleged that Merck wrongfully marketed Gardasil, downplaying its risks and overstating its benefits.

Robi, a former athlete who has been confined to a wheelchair since receiving her third Gardasil vaccine at the age of 16, suffers from uncontrolled neuromuscular contractions (jerking), postural orthostatic tachycardia syndrome (POTS), and numerous other symptoms of systemic autoimmune dysregulation.

Gøtzsche, whose new book entitled ‘How Merck and Drug Regulators Hid Serious Harms of the HPV Vaccines’ was published on August 19, has submitted testimony as an expert witness in the Robi v. Merck & Co. court case.

In his expert report for the court, he says it is remarkable that drug regulators “accepted Merck’s contradictory, biased and misleading reports based on trials that were already flawed by design (using adjuvant as ‘placebo’ and using many manoeuvres that avoided reporting possible harms of the vaccine)”.

Gøtzsche (pictured left) is particularly critical of the European Medicines Agency (EMA), which he says has also committed scientific misconduct.

Merck’s quadrivalent Gardasil vaccine was given marketing authorisation by the European Commission on September 20, 2006, after a positive recommendation from the EMA and the commission authorised the use of Gardasil 9 in Europe on June 10, 2015. Bivalent Cervarix from GlaxoSmithKline (GSK) was authorised in Europe in September 2007.

Quadrivalent Gardasil was approved by the US Food and Drug Administration (FDA) in 2006 and the FDA approved Gardasil 9 in December 2014. Gardasil 9, which is nonavalent, is now the only HPV vaccine licensed for use in the US, but quadrivalent Gardasil is still available in some other countries.

Cervarix was approved in the US in 2009, but was discontinued there in 2016 because of low demand.

GSK had already found sig­nals of neurological harms in 2007, Gøtzsche notes. GSK, he says, is also guilty of committing fraud, having claimed that its adjuvant-controlled studies were placebo controlled.

Merck has committed scientific misconduct before, and, in his new book, Gøtzsche describes in detail the fraud related to the company’s arthritis drug, Vioxx, which, he notes, “killed tens of thousands of patients because Merck concealed that it causes heart attacks”.

In 2012, Merck pleaded guilty to a criminal violation of federal law related to its promotion and marketing of Vioxx and had to pay nearly a billion dollars in a criminal fine and civil damages.

Gøtzsche writes in his new book: “Merck’s clinical trials of Gardasil are so flawed that it is impossible for any scientist or regulator to fully assess the harms of the vaccines based on Merck’s study reports. However, there can be no doubt that vaccine harms are very common and sometimes severe or serious, and that Merck’s adjuvant is also harmful.”

His expert review of Merck’s HPV vaccine studies has been submitted as a pre-trial document (in the Motion for Summary Judgement) in Robi v. Merck & Co.

He says in his testimony that Merck used numerous tactics to avoid reporting serious neurological harms caused by Gardasil, including POTS and complex regional pain syndrome (CRPS), which, in his view, constituted outright fraud in some cases.

Gøtzsche studied the preclinical (animal) and clinical (human) reports about the Merck-sponsored studies of monovalent and quadrivalent Gardasil and Gardasil 9 and other related reports about Merck’s HPV vaccines.

He says in his expert report that he found numerous flaws in Merck’s clinical trials of its HPV vaccines “in its study reports, in the published clinical trial reports, and in its package inserts for Gardasil”.

After ploughing through 112,000 pages of documents, Gøtzsche concluded: “The issues I found … are so pervasive that Merck’s clinical trials cannot be used to fully assess Gardasil’s risks because of the design and conduct of the studies, and because Merck seriously underreported the potential harms of its vaccines and split the data in so many ways that it would be difficult if not impossible for any scientist, including regulators, to assemble them in a way that would allow a full evaluation of the risks.”

Merck counted serious adverse events only if they were deemed by a “study coordinator” to be vaccine-related¸ Gøtzsche states.

In addition, he says, Merck only counted adverse events if they occurred within 14 days, thus excluding (by as much as 90%) adverse events that took longer to manifest.

The company called adverse events that occurred after 14 days “new medical conditions”, he adds.

Merck also failed to delineate whether adverse events were mild, moderate, or severe, which was contrary to the study protocols, Gøtzsche says.

Gøtzsche says that the HPV vaccines were oversold to the public. “I never understood the reason for this enthusiasm and found it misplaced,” he writes in his new book.

“The alternative to reducing the risk of getting cervical cancer by vacci­nation is to attend screening. Screening with the Papanicolaou test (Pap smear) or an HPV test is close to 100 percent effective. Cervical cancer grows so slowly that screening can prevent virtually all cancer deaths, as cell changes can be removed long before some of them would have developed into cancer many years later.”

Another scientist who has submitted an expert repot in the Robi v. Merck & Co. court case, Sin Hang Lee, says in his expert report: “Merck has failed to inform the public that cervical cancer is a predictable, preventable, and treatable disease when detected early while serious adverse events of Gardasil vaccination can have unpredictable outcomes, are not preventable without adequate warning, and hard to treat when they occur.”

Autonomic dysfunction

Another expert witness, Danish physician and former Merck trial investigator Jesper Mehlsen, says epidemiological studies based on adverse events reports have shown clear signals of autoimmune conditions associated with HPV vaccination.

Mehlsen says he alerted Merck to signs of autonomic dysfunction after Gardasil vaccination, but the company’s director of clinical research in the US discarded his concerns.

In the expert report he has submitted for Robi v. Merck & Co. Mehlsen says clinical evidence suggests that Gardasil can trigger serious autoimmune reactions in certain vulnerable people.

Mehlsen, whose expertise includes leading the Syncope Centre at Frederiksberg Hospital in Copenhagen, says in his testimony: “In 2011, we saw the first patients complaining about symptoms starting shortly after their first, second, or third HPV vaccination.

“Their primary symptoms were orthostatic intolerance (lightheadedness, palpitations, fatigue, blurred vision, dizziness, nausea, chest discomfort, cognitive impairment, and near-fainting spells/syncope).”

Mehlsen recounts in his testimony how, in 2015, as a result of a dramatic increase in post-Gardasil vaccination injuries, the Danish government established five regional centres to assess and treat patients with possible adverse reactions to Gardasil vaccination.

He was appointed to lead the ‘Unit for Patients with Unexplained Symptoms Possibly Related to HPV vaccination’ in Denmark’s Capital Region.

“A total of 845 patients were then referred to the clinic as well as others that had been referred to the Syncope Centre before 2015,” Mehlsen writes.

“In total, by 2016, the Danish Medicines Agency had received >2,300 reports on suspected adverse events among approximately 600,000 HPV-vaccinated women. From these reports, >1,000 were categorized as serious.”

Concluding his expert report, Mehlsen says that cohort and case studies have shown “probable connection between HPV vaccination and autoimmune conditions and postural tachycardia syndrome as well as other generalised inflammatory conditions”.

He says it is his opinion “to a reasonable degree of medical and scientific certainty” that Gardasil has been the probable cause of POTS and an autoimmune condition resembling myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-Covid-19 syndrome.

“Dysfunction of the autonomic nervous system induced by Gardasil is prominent in these syndromes with manifestations of severe orthostatic intolerance i.e. POTS,” he writes.

Mehlsen says that, to the best of his knowledge, neither Merck nor the European Medicines Agency properly conducted research into the relation between Gardasil vaccination and side effects such as POTS.

As the head of the Coordinating Research Centre at Frederiksberg Hospital, Mehlsen oversaw more than 3,000 participants in trials of quadrivalent Gardasil and Gardasil 9. He acted as principal investigator in most of the studies and as national coordinator in some of them.

He says that, on December 2, 2014 he tried to draw the attention of Peter Aurup, then Merck’s vice-president and head of the company’s global clinical trial operations, to the fact that, since late spring 2013, they had received “a small number of referrals regarding patients with possible adverse reaction to HPV vaccination” and the background for referral was signs and symptoms of autonomic dysfunction.

“Merck Denmark were receptive, but Merck USA, specifically Alain Luxembourg, discarded my concerns,” Mehlsen says.

Mehlsen says he has personal knowledge that an investigator working under his supervision attempted to report cases of POTS in the Gardasil clinical trials, but Merck would not accept the reports as adverse events.

In his expert report, he adds that, based on literature reviews, data from the producers (Sanofi and Merck), and expert opinions, the EMA declared in 2015 that there was no link between HPV vaccination and serious autoimmune or neurological adverse events.

“For some reason EMA ignored data provided by the WHO collaborating center in Uppsala, Sweden, and the subsequent safety concern with HPV vaccine as well as other reports linking Gardasil to these adverse events,” he writes.

In a presentation about “Autoimmunity as an adverse effect of HPV vaccination” at a Dublin symposium in April 2018, Mehlsen said that HPV vaccination caused a very large increase in cytokines from the immune system.

“When you vaccinate with HPV it has what we would call a very, very high antigen density. That means that the rise in antibodies is to about 10,000 times the level you have if you have a natural infection,” he said.

“It’s a really, really hard rise, a really solid stimulation of the immune system.”

Dormant cells are woken up, Mehlsen says, and these cells start producing antibodies against the person vaccinated. This is known as bystander activation.

The presence of aluminium in the HPV vaccine increases the risk of bystander activation, Mehlsen adds.

“The number of viral matches and their locations make the occurrence of side autoimmune cross-reactions in the human host following HPV16-based vaccination almost unavoidable,” he says.

Mehlsen gives the example of one of the first patients who came to the Copenhagen centre for patients with suspected side effects to HPV vaccination. She was an 18-year-old who used to play on the national soccer team.

He says that 63 percent of the teenagers coming to the clinic because they were suffering adverse effects after HPV vaccination had what is described as an ‘elite’ level of physical activity.

“What was striking was that the level of physical activity was very high in these girls,” Mehlsen told attendees at the Dublin symposium.

“Elite level means that you’re training between ten and twenty hours a week. One third of our patients were on a national team in their sports so maybe there was a connection between training and this response.

“We know that if you exercise a lot it changes your immune system. My recommendation is that, if you are competing in sports, don’t get the vaccination.”

Mehlsen said that the 18-year-old soccer player suffered burning pain and muscle weakness within seven days of her first HPV vaccination and had to quit her studies at university.

In a peer-reviewed paper published in the ‘Journal of Autoimmunity’ in 2022, Mehlsen et al. conclude that “girls and young women with probable side effects to HPV vaccination have symptoms and biological markers compatible with an autoimmune disease closely resembling that seen in ME/CFS and subsets of long Covid”.

The researchers say it is probable that prior disease may precondition some individuals for vaccine-related adverse events.

“The HPV vaccine possesses a strong immunogenicity, and it is suggested that possible vulnerability should be further investigated and considered when counselling for such vaccines,” they write.

The researchers report that dysregulation of cardiovascular control in the form of POTS has been demonstrated in patients with possible adverse events after HPV vaccination in case reports and in a previous analysis in their cohort.

“We found a high prevalence of autoantibodies to cellular antigens (antinuclear antibodies, ANA) in our patients as compared to the background population which points to possible autoimmunity,” they write.

Gøtzsche: ‘Merck’s trials violated medical ethics’

In his new book, Gøtzsche details the ways in which he considers Merck’s trials to have violated medical ethics. He points in particular to the lack of placebo controls in pivotal Gardasil trials.

“Nearly all control patients in the HPV vaccine trials (99 percent in our systematic review) received an active comparator, either a strongly immunogenic adjuvant or a hepatitis vaccine, which makes it impossible to find out what the harms of the HPV vaccines are,” Gøtzsche writes.

“EMA allowed the manufacturers to lump the control groups in their trials and to call it all placebo. After we had alerted the European Ombudsman in October 2016 to this scientific misconduct, EMA’s Executive Director Guido Rasi claimed in a letter to the Ombudsman that ‘all studies submitted for the marketing authorisation application for Gardasil were placebo controlled’.”

Court documents revealed that, in addition to the aluminium adjuvant, there is an undisclosed adjuvant in Gardasil, Gøtzsche says. “In an act of corporate decep­tion, Merck kept this secret from the public, and the additional adjuvant does not have regulatory approval,” he writes.

“This revelation raises profound legal and ethical concerns regarding the informed consent of the millions who received Gardasil without full knowledge of its composition.”

Gøtzsche explains further: “Gardasil contains billions of fragments of HPV L1 DNA, which origi­nate from the synthetic DNA plasmid used in manufacturing. These frag­ments make Gardasil far more immunogenic than if they had not been present. Merck was not only aware of this but took deliberate steps to preserve and retain the DNA fragments in the final vaccine formulation.

“The drug regulators helped Merck cover this up, and there is nothing in Gardasil’s package inserts about the fragments.”

Gøtzsche quotes Sin Hang Lee, who has noted that, for some individuals, particularly those with genetic predispositions, this additional adjuvant can lead to autoimmune condi­tions such as POTS and, in rare cases, sudden death.

Conflicts of interest at the EMA were ignored, Gøtzsche says. He says the EMA concealed its literature searches for its own experts and distrusted independent research.

In its investigation, he says, the EMA trusted what Merck reported to them, “even though EMA already knew – not only in relation to Vioxx but also in relation to harms of Merck’s two HPV vac­cines, Gardasil and Gardasil 9 – that Merck cannot be trusted”.

In November 2015, the EMA issued a forty-page report concluding that, “the evidence does not support a causal associa­tion between HPV vaccination and CRPS and/or POTS” and that “the benefits of HPV vaccines continue to outweigh their risks”.

The EMA stated that the safety of the vaccines should continue to be care­fully monitored, which, Gøtzsche points out, “is a standard clause that exonerates the authorities should it later turn out that they overlooked something”.

In May 2016, Gøtzsche wrote a 19-page complaint about the EMA’s conduct. The EMA’s replies were disappointing, he says. “Some of our concerns were not addressed and several of EMA’s statements were incorrect or seriously misleading,” he writes in his new book.

The EMA asked the vaccine manufacturers to evaluate whether their vaccines were safe, review cases of POTS and CRPS in their trials, and go through their post-marketing surveillance data.

“The inadequacies in the scientific strategy employed by the companies when searching in their own databases were impossible to overlook,” Gøtzsche writes.

“But EMA’s official report did not show the search strategies or mentioned that they were grossly inadequate and must have overlooked many cases.”

Jesper Mehlsen has explained: “The things the company is look­ing for are not symptoms – they are diagnoses, and you can’t use that for anything. A patient would never approach me and say, ‘I have orthostatic intolerance’.”

Merck used an elaborate search algorithm for POTS, Gøtzsche says. They claimed that their search strategy involving various symptom group combinations was reasonable and not overly exclusive, but this, Gøtzsche says, was clearly not true.

Researcher Lucija Tomljenovic found several POTS cases in Merck’s own safety database that Merck failed to report to the EMA, Gøtzsche adds.

He cites the criticism by the EMA’s inspectors that three people diagnosed with POTS in the clinical safety database after receipt of Gardasil 9 were not reported as adverse events; that a case of POTS after Gardasil was called “new medical history” instead of an adverse event; that hospitalisation for severe dizziness was not reported as a serious adverse event (against the rules); and that, in the case of another person, the term “dysautonomia” was not included on the list of events.

“In their final report recommending conditional approval of Gardasil 9, the EMA rapporteurs asked Merck to discuss the impact of its ‘uncon­ventional and potentially suboptimal method of reporting adverse events and provide reassurance on the overall completeness and accuracy of safety data provided in the application’,” Gøtzsche writes.

“However, in EMA’s publicly avail­able assessment of Gardasil 9, all mention of its safety concerns had been scrubbed.”

We need to constantly keep in mind, Gøtzsche says, that the only large trial ever con­ducted that can tell us if the HPV vaccines cause serious harms and neu­rological harms found exactly that.

Merck harassment

Gøtzsche, who is the director of the Copenhagen-based Institute for Scientific Freedom, also describes in his new book how he was harassed by a Merck lawyer, Emma C. Ross, who tried to impugn his character and scientific credibility.

He says that, when he gave a day-long deposition in Los Angeles in October 2024, Ross “fired countless irrelevant questions the whole day, many of which were designed to impugn my character and scientific credibility”.

Gøtzsche details how he was subjected to aggressive questioning when making a deposition. Many times Ross misquoted his testimony, asked utterly unreasonable questions, and made inaccurate statements, he says.

“Merck did their best to prevent my testimony from appearing in court,” Gøtzsche writes. “Their lawyers sent a motion to the judge on November 5, 2024.”

Gøtzsche says that Merck also tried to prevent Lucija Tomljenovic from testifying. “She has written a brief and declaration refuting Merck’s arguments raised in their motion,” Gøtzsche writes.

“One of Merck’s false allegations was that she was guilty of ignoring supposedly inconvenient relevant data that runs contrary to her allegedly predetermined conclusions, and that she focused instead only on low-quality cases and case-series studies that supported her conclusions.

“I have read a lot of what Lucija wrote in her expert report, and Merck’s arguments for having her excluded are similarly void as their arguments against me.”

‘Disappointing data’

Gøtzsche cites cervical cancer statistics from Denmark. There were about forty new cases annually per one hundred thousand women in 1960, he says, and the number fell gradually to about eleven in 2020.

The data don’t suggest any effect on prevention of cervical cancer of the HPV vac­cines, which were introduced to girls in 2009, he says. “The accumulated data do not suggest that the HPV vac­cines decrease mortality from cervical cancer,” he writes.

“Data from Australia are also disappointing, and it seems that Merck misled the public on cervical cancer prevention and that widely cited observational studies of vaccine effects suffered from fatal flaws.”

Gøtzsche doesn’t think we will ever find out if HPV vaccination reduces the incidence of, or mortality from, cer­vical cancer because, he says, “the bias in observational studies is too large compared to the possible effect”.

Statistical adjustment for the baseline differences in the compared populations (vaccinated and unvaccinated) cannot solve this problem, he says.

If all women attended screening, the HPV vaccines might save no one from dying from cervical cancer, Gøtzsche says.

“And if the extensive propaganda lulls some women into believing they are safe and no longer need to attend screen­ing, there is even a risk that the vaccines could increase mortality from cervical cancer,” he writes.

“A systematic review of the published HPV vaccine trials from 2017 found more deaths in the vaccine groups than in the control groups (14 vs 3, P = 0.01). The numbers are small and … the report­ing of number of deaths in Merck’s trials is inconsistent and contradictory, but I find it concerning, nonetheless …”

Gøtzsche notes that, as of May 2018, the World Health Organisation’s pharmacovigilance database, VigiBase, listed 499 deaths reported as related to HPV vaccination. (There are 667 deaths listed as of August 24 this year.)

“It is difficult to know which of these deaths were caused by the vaccine and which were coincidental, but sometimes there is little doubt that the vaccine was the cause,” Gøtzsche writes.

He cites the case of a young woman in Spain who had asthma and had a severe exacerbation when she received the first shot of Gardasil.

“Despite that, she got a second shot a month later and developed severe dyspnea and seizures twelve hours later. She was admitted to an intensive care unit where she died two weeks later. The judicial ruling acknowledged a causal link to the vaccine,” Gøtzsche writes.

The media, however, and a host of people on social media continue to vaunt Gardasil as a panacea. The Economist recently ran an article bemoaning the fall in uptake of HPV vaccination in Britain, with the headline in the print edition ‘Falling off a cliff’.

The vaccination programme, the article said, was once a runaway success, but was now floundering. “Vaccination rates have fallen in all of Britain’s child-immunisation programmes, but the drop is sharpest for HPV,” it states.

The author of the article, which dismisses concerns about adverse reactions, blames what they call disinformation from those they refer to as anti-vax.

Screening changes

In 2017, Australia introduced a five-yearly HPV test for women aged 25 to 74 that replaced the two-yearly Pap tests that used to be carried out on women aged between 18 years and 69.

Australia’s Department of Health said the new test was more effective than the Pap smear at preventing cervical cancers, “because it detects HPV, whereas the Pap test looked for cell changes in the cervix”.

In the UK, a new five-yearly HPV test was introduced in 2019. It replaced the Pap test for primary screening.

The UK National Screening Committee recommended in 2019 that women aged 25 to 49 who tested negative for HPV should have their cervical screening interval extended from three to five years. Scotland and Wales were the first to implement the new intervals.

Previously, women aged 25 to 49 were invited to undergo a Pap smear every three years and women aged 50 to 64 were invited for screening every five years.

Again, it was claimed that the new HPV test detected those who were at higher risk of developing cervical cancer more accurately than the Pap test.

Flawed studies

An article published in the Journal of the National Cancer Institute in January 2024, which reported on an observational study about Gardasil conducted by researchers in Scotland, met with great excitement and such media headlines as ‘No cervical cancer cases in HPV-vaccinated women’.

The study is deeply flawed, however, as is another much-vaunted Swedish study, which compared cervical cancer rates in vaccinated and unvaccinated women.

Sin Hang Lee, who is the director of Milford Molecular Diagnostics in Connecticut in the United States, is highly critical of both studies.

“Gardasil has been marketed to the public as a vaccine for cervical cancer prevention since 2006. However, there is no evidence that Gardasil has prevented a single case of cervical cancer in the past 18 years,” Lee says in his ‘Expert report in the Matter of the Gardasil Litigation’.

In an article published in the New England Journal of Medicine on September 30, 2020, Jiayao Lei et al. compared cervical cancer rates in vaccinated and unvaccinated women in Sweden.

They used nationwide Swedish demographic and health registers to follow, from 2006 to 2017, 1,672,983 girls and women who were between 10 and 30 years old.

They concluded: “In this large, nationwide study of girls and young women 10 to 30 years of age who had been vaccinated through HPV vaccination programmes, we found that HPV vaccination was associated with a substantially reduced risk of invasive cervical cancer.”

They reported that cervical cancer was diagnosed in 19 women who had received the quadrivalent HPV vaccine and in 538 women who had not received the vaccine.

“The cumulative incidence of cervical cancer was 47 cases per 100,000 persons among women who had been vaccinated and 94 cases per 100,000 persons among those who had not been vaccinated,” they wrote.

Lee notes, however, that the women born between 1995 and 2007 were below age 23 and were not screened for cervical cancer between 2006 and 2017.

“Since invasive cervical cancer develops over a period of decades after initial HPV infection, it is unlikely to find any cervical cancers in the years 2006–2017 in the women born between 1995 and 2007,” he writes in his expert report about Gardasil.

“Inclusion of a large number of girls age 10–22 with 0% cervical cancer in the denominator created a bias in statistics.”

Lee (pictured left) adds that the percentage of cervical cancer among the women born in 1975–1979 is obviously higher than the percentages of cervical cancer among the women born in 1980–2007 in both unvaccinated and vaccinated groups, but the number of unvaccinated women and the number of vaccinated women (born between 1975 and 1979) who were included in the study were 258,244 and 190, respectively, “a highly disproportional ratio”.

Also, Lee says, the study failed to account for the “healthy user effect,” whereby vaccinated women are more likely to engage in preventive health measures like regular screening, which independently reduces cancer risk.

Lee is also critical of the study conducted in Scotland by Timothy J. Palmer et al., reported on in January 2024 in the article entitled ‘Invasive cervical cancer incidence following bivalent human papillomavirus vaccination: a population-based observational study of age at immunization, dose, and deprivation’. He makes observations that are similar to those he makes in the case of the Swedish study.

Palmer et al. reported that no cases of invasive cancer were recorded in women vaccinated at 12 or 13 years of age, irrespective of the number of doses.

“Women vaccinated at 14 to 22 years of age and given 3 doses of the bivalent vaccine showed a significant reduction in incidence compared with all unvaccinated women,” they added.

They said in conclusion: “Our findings confirm that the bivalent vaccine prevents the development of invasive cervical cancer and that even 1 or 2 doses 1 month apart confer benefit if given at 12-13 years of age. At older ages, 3 doses are required for statistically significant vaccine effectiveness. Women from more deprived areas benefit more from vaccination than those from less deprived areas.”

Lee says the women studied were too young for conclusions to be drawn about the effectiveness of Gardasil. (Girls born in 1996 were only 24 years old in 2020.)

He also notes that the age at which women were called for cervical cancer screening in Scotland changed in 2016. The age at which women were first invited for screening was raised from 20 to 25.

“As most cancers in women under 30 are diagnosed through screening, this change could explain any decline in cancer rates, rather than the vaccine itself,” Lee says.

And, Lee adds, as in the case of the Swedish study, the “healthy user effect” further confounded the results.

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UPDATE: Two researchers in Australia, Samir A. Saidi and Mark A. Jones, say that, when they reanalysed Palmer et al.’s data, they found inaccuracies.

“These inaccurate claims were reported widely in the media,” Saidi and Jones state in an article published in the September 2025 issue of the Journal of the National Cancer Institute (with advance publication in June 2025).

They cite a BBC news report in January 2024 headlined ‘No cervical cancer cases in HPV-vaccinated women’.

Firstly, Saidi and Jones state, the claim that “no cases of invasive cancer were recorded in women immunized at 12 or 13 years” is incorrect.

“There was a single case of cancer (sarcoma) in this group that was not reported (ID 361758), occurring the year after dose 3,” they write.

Secondly, they say they found that the prior probability of the finding of “no cancer” in an individual in the cohort (matched for age and length of follow-up) was 0.5 irrespective of the impact of vaccination on cancer risk.

“This is because the revised screening programme in Scotland meant that the probability of a diagnosis in that age cohort (under 25 by the time of data cutoff) was already near zero.,” they write.

Saidi and Jones say they identified “a critical anomaly” in the data that was also noted by the study authors and confirmed in their internal scripts, i.e., that the number of participants analysed far exceeded the same age population of Scotland based on the National Registry.

“This critical data anomaly remains to be explained,” the researchers write.

“Our reanalysis also found that older and unscreened women were over-represented in the unvaccinated population, significantly confounding the results.

“There was no explanation for the discordant screening populations.”

Saidi and Jones say their analysis of Palmer et al.’s data in its current form showed that any apparent benefit of vaccination was confined to the screened population.

“Conversely, there was a detrimental impact on the unscreened population, associated with vaccination, of around 12.7/100 000 – with an estimated net mortality detriment of 0.78 per 100 000 (range = −2.3 to +0.73) when all groups were combined,” they write.

“The context of this is important because the mortality rate of cervical cancer in unscreened populations is far higher than that in screened populations.”

Saidi and Jones say they welcome any measure that can reduce the incidence and impact of cervical cancer, but “it is imperative that a single measure must not be considered in isolation or undermine an effective screening programme shown to reduce cervical cancer mortality”.

It is also imperative, they say, that messages claiming efficacy of interventions to prevent cancer are not presented to the public without solid evidence. On this, they say, Palmer et al.’s article “fundamentally errs”.

The two researchers conclude: “If the impact of such messaging is to reduce the uptake of cervical screening, which is currently already on the wane despite extended screening intervals, it could have a serious and lasting net detriment to cervical cancer mortality.”

ENDS UPDATE

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Gøtzsche refers in his new book to an article by Palmer et al., published in the BMJ in April 2019, entitled ‘Prevalence of cervical disease at age 20 after immunisation with bivalent HPV vaccine at age 12–13 in Scotland: retrospective population study’.

The authors state that vaccination against HPV types 16 and 18 led to an 86 percent decrease in the occurrence of precursors to cancer and to some herd protection.

The study was flawed in many ways, Gøtzsche says. “The authors noted that the uptake of screening in fully vaccinated women was 51 percent, and only 23 percent in unvac­cinated women,” he writes. “That is a huge bias that totally invalidates the study.”

Pollock et al. refer to the above study in their article published in the Journal of the Royal Society of Medicine in January 2020. They note the limitations that Palmer et al. admit may have inflated measures of efficacy.

For example, the study gathered data only on the first round of cervical screening at age 20 years, with underrepresentation of the unvaccinated group.

There was a shorter follow-up time for women born in 1995 and 1996, which, Palmer et al. admit, necessarily affected the robustness of the estimation of vaccine effectiveness for younger women.

Pollock et al. say the basis for the claim of herd protection is not well explained for the unvaccinated women in the 1995–1996 cohort compared with unvaccinated women in the 1988–1990 cohort.

They add: “Nor do the authors consider how changes in sexual activity may have contributed to the observed decrease in CIN prevalence independent of the vaccine: between 2002 and 2014 (the latest period for which there are data) the proportion of 15-year-olds in Scotland who have ever had sex reduced, although socio-economic inequalities persist for sexual initiation and condom use. Screening uptake also varies by socio-economic status.”

Another study that is often cited by those promoting Gardasil is one that was published in The Lancet in November 2021, and is entitled ‘The effects of the national HPV vaccination programme in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study’.

Peter Sasieni et al. say they observed “a substantial reduction in cervical cancer and incidence of CIN3 in young women after the introduction of the HPV immunisation programme in England, especially in individuals who were offered the vaccine at age 12–13 years”.

They write: “We have shown that HPV vaccination with high coverage in 12–13 year old girls has almost eliminated cervical cancer and cervical precancer up to age 25 (the extent of the observed data).”

In their ‘Interpretation’ they state: “We observed a substantial reduction in cervical cancer and incidence of CIN3 in young women after the introduction of the HPV immunisation programme in England, especially in individuals who were offered the vaccine at age 12–13 years. The HPV immunisation programme has successfully almost eliminated cervical cancer in women born since Sept 1, 1995.”

Sasieni et al. used data from “13.7 million-years of follow-up of women aged 20 years to younger than 30 years.”

The researchers state: “The estimated relative reduction in cervical cancer rates by age at vaccine offer were 34% (95% CI 25–41) for age 16–18 years (school year 12–13), 62% (52–71) for age 14–16 years (school year 10–11), and 87% (72–94) for age 12–13 years (school year 8), compared with the reference unvaccinated cohort.

“The corresponding risk reductions for CIN3 were 39% (95% CI 36–41) for those offered at age 16–18 years, 75% (72–77) for age 14–16 years, and 97% (96–98) for age 12–13 years.”

These results remained similar across models, the researchers said.

“We estimated that by June 30, 2019 there had been 448 (339–556) fewer than expected cervical cancers and 17 235 (15 919–18 552) fewer than expected cases of CIN3 in vaccinated cohorts in England” they write.

Sin Hang Lee says there are several confounding factors that may invalidate Sasieni et al.’s conclusions.

“Since CIN3 is a potentially reversible lesion and the diagnostic criteria for CIN3 have been changing in recent years according to an AI overview, the registered reduction of CIN3 incidence may not be valid,” Lee told Changing Times.

“Specifically, the focus for diagnosing CIN3 in recent years has shifted from the isolated pathology report to a personalised risk assessment that also considers HPV status and patient history.

“The cohort offered HPV vaccine in school may have a different lifestyle from that of the unvaccinated cohort and less exposure to HPV infections.”

Invasive cervical cancer is the only valid endpoint for comparative studies of this kind, Lee says. He notes that invasive cancer is always preceded by years of precancerous changes in the transformation zone of the uterine cervix.

“These precancerous changes, often designated as CIN1, CIN2 and CIN3, can be detected by a cervical cytology screen [Pap smear] and confirmed by colposcopic biopsy,” he said.

Lee explains that, in the UK, Large Loop Excision of the Transformation Zone (LLETZ) is the most common treatment for CIN3 lesions and is a proven effective procedure to prevent cervical cancer.

The age at which the cohort was first invited for cervical screening and the cohort’s compliance with the screening schedule are crucial in final cervical cancer prevention, he says.

“If the cohort’s CIN3 lesions were timely treated by LLETZ, the cohort would be cervical cancer free,” Lee said.

“But, throughout the UK, around 1 in 3 do not attend cervical screening when they are invited. The unvaccinated cohort more likely did not attend cervical screening; therefore, they were more likely to develop cervical cancer.”

Pollock et al.: ‘Will HPV vaccination prevent cervical cancer?’

In their article in the Journal of the Royal Society of Medicine, entitled ‘Will HPV vaccination prevent cervical cancer?’, Pollock et al. reported their findings in their appraisal of 12 phase 2 and 3 randomised control trials of Cervarix and Gardasil.

“Our analysis shows the trials themselves generated significant uncertainties undermining claims of efficacy in these data,” they wrote.

“The trial populations did not reflect vaccination target groups due to differences in age and restrictive trial inclusion criteria. The use of composite and distant surrogate outcomes makes it impossible to determine effects on clinically significant outcomes.”

The researchers say that, although there is evidence that vaccination prevents cervical intraepithelial neoplasia grade 1 (CIN1) this is not a clinically important outcome as no treatment is given.

There are too few data to clearly conclude that HPV vaccine prevents CIN3+ – CIN3 and adenocarcinoma in situ (AIS), they say.

CIN in general is likely to have been overdiagnosed in the trials because cervical cytology was conducted at intervals of 6–12 months rather than at the normal screening interval of 36 months, they added.

“This means that the trials may have overestimated the efficacy of the vaccine as some of the lesions would have regressed spontaneously,” they wrote

Many trials diagnosed persistent infection on the basis of frequent testing at short intervals, i.e., less than six months, the researchers added.

“There is uncertainty as to whether detected infections would clear or persist and lead to cervical changes,” they wrote.

Pollock et al. noted that there were differences between trial and real world populations.

“Most of the people in the trials were older than the 9- to 13-year-olds who are typically offered vaccination. Efficacy in girls aged 9–13 years has been estimated using immunobridging trials (where immune response levels are measured) rather than using clinical efficacy outcomes,” they wrote.

“There is uncertainty about whether the vaccine will provide cross-protection against oncogenic HPV types not targeted by the vaccines. There is also a risk of substitution where a non-vaccine oncogenic HPV type fills the void left by the reduction of an HPV type targeted by the vaccines.”

Pollock et al. called for more research on HPV to be free from industry funding.

Cancer data

Sin Hang Lee says that, according to published data, the rate of mortality from cervical cancer in England did not decline after the introduction of HPV vaccination.

He notes that the rate of mortality from cervical cancer in England dropped from 2.7/100,000 to 2.4 /100,000 in 2016, i.e. eight years after introduction of Cervarix vaccination.

“Since cervical cancer takes at least ten years to develop after HPV infection, the drop in the cervical cancer death rate of 0.3/100,000 in eight years cannot be due to HPV vaccination,” Lee told Changing Times.

“The cervical cancer death rates remained unchanged from 2016 to 2021 at 2.4–2.5/100,000, confirming the fact that HPV vaccination did not reduce cervical cancer death rates in the period studied.”

Cancer Research UK data shows that cervical cancer incidence rates increased by 35% in 25- to 34-year-olds between 1993 and 2019, with the rise starting in 2003 and then accelerating.

The incidence in those aged 35 to 49 years decreased by 13%, in those aged 50 to 64 it decreased by 33%, in those aged 65 to 79 it decreased by 58%, and in those aged 80 and above, it decreased by 45%.

In February 2018, Peter Sasieni and Alejandra Castañön wrote an article entitled ‘Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern?’.

They said: “One may have expected to see a fall in cervical cancer rates resulting from HPV vaccination of women aged 14–18 yrs in 2008–2009. However, we consider it to be too early to draw conclusions regarding vaccine efficacy from CxCa incidence.”

This statement is at odds with Sasieni et al.’s claim in 2021 that the HPV immunisation programme had “successfully almost eliminated cervical cancer in women born since Sept 1, 1995”.

Sasieni and Castañön reported in 2018 that rates of cervical cancer in England among women aged 20 to 24 years increased from 2.7 in 2012 to 4.6 per 100,000 in 2014.

There was concern, they said, that the sudden increase was linked to the withdrawal of cervical screening in women aged 20 to 24 (a policy that affected women born since 1984).

They argued, however, that screening from age 20 years, rather than from age 25, would not prevent any more cancers from spreading beyond the cervix (stage II or worse) by age 27.

The substantial increase in stage I cervical cancers in 24- and 25-year-old women, they argued, corresponded to changes whereby a high proportion of women were being screened for the first time between ages 24.5 and 25.5 years.

Lee: ‘Most HPV infections are transient’

Lee says that infection with high-risk HPV alone does not cause cervical cancer. “Most HPV-infected epithelial cells do not even show precancerous changes, and the viral infection can be reversed, suppressed, or eliminated through innate immunity of the host and other life-style factors with no residual adverse health consequences,” he writes in his ‘Expert report in the Matter of the Gardasil Litigation’.

It is the persistent infection of a high-risk HPV, not the mere presence of the HPV virus itself, that is the pivotal promoter in causing cervical precancerous lesions and cancer, Lee says.

“Most HPV infections, even caused by high-risk genotypes, are transient with normal Pap cytology in sexually active young women,” he writes.

“In 93% of initially infected women, the same viral type is not detected upon re-examination four menstrual cycles later. The median duration of positivity detectable by PCR for a specific HPV type in these young women is 168 days. Therefore, 93% of the women residing in the United States do not need HPV vaccination to clear an HPV infection for cervical cancer prevention.”

Lee notes that it is uncommon to see invasive cervical cancers in women before the age of 30 in the US under the current healthcare system. Attributing the decline in cancer cases solely to HPV vaccination is misleading, he says.

He cites a “wait-and-see policy for a period of 24 months” that was adopted for a conservative precancerous disease treatment study in the Netherlands. A cohort of 114 women were studied, 80 of whom were diagnosed with CIN2 and 34 with CIN3. It was found that regression of precancerous lesions occurred in 67 of the women.

Histologic progression from CIN2 to CIN3 occurred in 20 women and one woman developed an AIS lesion, Lee notes, and none of the women were diagnosed with cervical cancer.

“Therefore, using the CIN2, CIN3 and AIS precancerous histologic changes as the surrogate endpoint to evaluate the efficacy of Gardasil as the vaccine for prevention of cervical cancer is inappropriate since most of these precancerous changes do not progress to invasive cervical cancer and may be self-regressing without intervention,” Lee states.

Lee also says there is evidence of HPV type replacement in the community after HPV vaccines were introduced.

Gøtzsche agrees and writes in his new book: “Other strains can cause cancer and might take over; viruses mutate, which may render a vaccine less effective; and we have no idea how long the immunity will last after vaccination.”

Legal actions over deaths

Michael Baum from the law firm Wisner Baum, which is representing Jennifer Robi in her court case, recently told journalist Maryanne Demasi, who is deputy director at the Institute for Scientific Freedom: “For many young men and women suffering from POTS, Gardasil is the common denominator.

“So many of our clients grew up healthy and active only to be broadsided by this life-changing condition after receiving the vaccine. It’s time for Merck to do the right thing and admit that this dangerous vaccine is capable of causing POTS and other serious health issues.”

Among the numerous lawsuits filed by Wisner Baum are those concerning the deaths of Haley Ferguson, who was 13 when she received the first of three Gardasil shots, was diagnosed with cervical cancer aged 18 and died in May 2023, and of Isabella Zuggi (pictured left), who received her first and only Gardasil injection on August 26, 2022, developed headaches, lethargy, stomach pains, body aches, and intermittent fevers two weeks after the shot and died on November 5, 2022.

The cause of Isabella Zuggi’s death was listed as acute encephalitis associated with anti-MOG antibody production.

(Anti-MOG antibody production is an immune response whereby the immune system mistakenly creates antibodies against myelin oligodendrocyte glycoprotein (MOG), a protein found in the central nervous system’s myelin sheath.)

Wisner Baum is also litigating in the case of Sydney Figueroa, who was 11 years old when she received her first dose of Gardasil on December 6, 2017, and 12 when she received the second shot. Before the vaccine, Sydney was advanced both academically and athletically. She played soccer and was very involved in school activities.

After the vaccinations, Sydney experienced headaches, brain fog, fatigue, dizziness, rapid heart rate, exhaustion, leg pain, ringing in the ears, light sensitivity, vision issues, respiratory complications, muscle weakness, involuntary movements of her neck, head, legs, and arms, an inability to walk normally, frequent stumbling, an inability to swallow that ultimately meant she required a feeding tube, and excruciating nerve pain.

Sydney was confined to a wheelchair and required full-time care. She was diagnosed with POTS, Tourette’s Syndrome, and Functional Neurological Disorder. She died on June 2, 2021 at the age of 14 from a pulmonary embolism directly attributable to prolonged immobility because of autoimmune diseases triggered by Gardasil.

The long list of other court actions in the US include the lawsuit about Noah Tate Foley, who received his first and only Gardasil injection on May 7, 2018, just after his 11th birthday

Prior to the Gardasil shot, Noah had no autoimmune diseases and no autonomic issues. He had received a clean bill of health during a medical check-up. About two weeks after the Gardasil shot, he experienced fevers as high as 102.9 degrees. He became extremely ill and, at a paediatric gastroenterology consultation in May 2019, an “autoimmune or inflammatory process” was mooted as a diagnosis. Noah died on October 8, 2020.

Wisner Baum are also litigating in the case of Caroline Cantera, in which they allege that Gardasil can actually cause cervical cancer.

Caroline was 19 when she received the first of three Gardasil injections. Prior to HPV vaccination, she was very healthy and active. She received routine Pap testing, which had always come back negative.

After her Gardasil injections, Caroline experienced a myriad of symptoms, including unexpected fatigue, intense stomach pain, and weakness throughout her body. She had menstruation that lasted more than four weeks.

Doctors diagnosed Caroline with stage four cervical cancer. She underwent multiple biopsies, CT scans, and MRIs and had six rounds of chemotherapy, 30 radiation treatments and three brachytherapy treatments.

Caroline’s ovaries were affected by the treatments and she went into menopause in her 20s and she will never be able to have children of her own because her eggs are no longer viable.

Other deaths

In September 2017, Special Master Christian J. Moran in the Office of Special Masters at the United States Court of Federal Claims awarded compensation to the family of Christina Richelle Tarsell from Sparks, Maryland, who died suddenly, aged 21, on June 21, 2008, after receiving a third Gardasil vaccination 18 days earlier.

Doctors determined that Christina Tarsell died from an arrhythmia. In February 2016, Moran ruled that Christina’s mother, Emily Tarsell, filing the case as the executrix of Christina Tarsell’s estate, had not met her burden of establishing her case with preponderant evidence.

“Ms Tarsell has not persuasively established a basic proposition of her claim, that Christina did not experience an arrhythmia until after the first dose of the HPV vaccine,” Moran said at that time.

He said the evidence was not sufficient to establish the causal relationship between the vaccination and the arrhythmia and Tarsell was consequently not entitled to compensation.

Emily Tarsell filed a motion for review and, in a later ruling in September 2017, Moran said that causation could be inferred and compensation should be awarded.

He stated: “Logically, because the undersigned does not find that preponderant evidence supports a finding that Christina’s arrhythmia started before the vaccination, Christina’s arrhythmia must have started after vaccination.”

He added that, “under the assumption that Christina’s arrhythmia started after the vaccination” he found that her arrhythmia began within a time that was “medically appropriate to infer causation”.

Moran concluded: “Ultimately, because of the finding that Christina began to experience arrhythmia after her HPV vaccination, Ms Tarsell has presented preponderant evidence of a logical sequence of cause and effect, connecting the HPV vaccination to the ensuing arrhythmia.”

He said that, “under the approach dictated by the court”, Christina Tarsell was entitled to compensation.

In another case brought before the Court of Federal Claims, the parents of 14-year-old Joel Gomez were awarded US$200,000 in compensation in September 2016.

Joel, who was an athletic boy, training for his high school football team for four to five hours a day, died in his sleep on August 20, 2013, the day after receiving his second dose of Gardasil.

The conclusion of the doctor who performed the autopsy was that Joel had myocarditis, an inflammation of the heart muscle (the myocardium).

The cause of death was listed as unknown, but Sin Hang Lee, who was Joel’s parents’ expert witness, said that “the most plausible cause” of Joel’s death was cardiac failure “brought about by a surge of myocardium-depressing cytokines … released from the macrophages activated by the HPV L1 gene DNA fragments present in the vaccine product”.

The respondent in the case, the Secretary of Health and Human Services, denied that the HPV vaccine caused Joel’s myocarditis, any other injury, or his death.

Fourteen-year-old Christopher Bunch from Moline, Illinois, in the US died on August 14 2018, just three weeks after receiving a Gardasil vaccination.

After receiving the vaccine, Christopher became ill almost right away. After being admitted to the hospital, he was diagnosed with acute disseminated encephalomyelitis (ADEM), which is listed on the Gardasil vaccine package insert as a reported adverse reaction.

Suffering teenagers took their own lives

American teenager Colton Berrett died on January 5, 2018, aged just 17. He took his own life.

When he was 13 years old, Colton was paralysed after receiving three Gardasil vaccinations. He was diagnosed with transverse myelitis, a rare clinical syndrome in which an immune-mediated process causes neural injury to the spinal cord.

A sports enthusiast from an early age, Colton loved baseball, riding motorcycles, indoor skydiving, skiing, and especially motocross.

Two weeks after his third Gardasil vaccination, in February 2014, Colton started to get severe neck ache. He felt nauseous and exhausted.

When his parents took him to the hospital the next morning, his mother had to hold his head up and he could no longer move his right arm.

Colton became paralysed from the neck down, and, at one stage, was only able to communicate with his eyebrows. He was in intensive care for more than twelve weeks.

He recovered sufficiently to be able to do some sporting activities, but his right arm remained paralysed and he had only minimal function in the left one. He had to have a breathing apparatus with him at all times.

Maddie Moorman, from Kansas City, Missouri, also took her own life at the age of 21. She had received her first Gardasil shot when she was 15 and was immediately unwell, but it wasn’t clear at the time whether this was because of the vaccination.  Her mother thought birth control pills were to blame.

After the second shot, Maddie couldn’t get out of bed for five days. “Her memory was gone,” her mother Tracie told a TV channel. “She used to have what she called a photographic memory.”

Prior to the vaccination, Maddie was healthy and active, but afterwards she suffered from chronic exhaustion, excruciating headaches, nausea, insomnia, and difficulties processing information. She also developed twenty food allergies and became extremely sensitive to light and sound.

Maddie battled depression because of her ill health and had a constant buzzing sound in her head. Her family described her as having been “an avid musician, a world traveller, a brilliant writer, and an unbelievably beautiful soul”.

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