CDC Used Merck’s Cherry-picked Data to Claim No Link Between Gardasil Vaccine and Neurological Disorder

According to a court document obtained by The Defender, Merck cherry-picked vaccine injury data to prove its Gardasil HPV vaccine didn’t cause serious neurological side effects.

by Brenda Baletti, Ph.D.

Merck cherry-picked vaccine injury data to prove its Gardasil HPV vaccine didn’t cause serious neurological side effects, according to an expert report submitted during a landmark trial accusing Merck of hiding the dangers associated with the vaccine.

European regulators used Merck’s analysis to declare the vaccine was safe, while U.S. regulators replicated Merck’s data selection methods to do their own study drawing the same conclusion.

The Defender obtained the report, which was entered into the public record before the trial against Merck was put on hold last month. Children’s Health Defense is supporting the trial.

When Danish regulators in 2015 asked the European Commission to investigate the possible link between HPV and serious neurological disorders — including postural orthostatic tachycardia syndrome (POTS) and chronic regional pain syndrome (CRPS) — regulators at the European Medicines Agency (EMA) relied on data provided by Merck to do their evaluation.

The EMA — which like the U.S. Food and Drug Administration (FDA) is almost completely funded by the pharmaceutical companies it regulates — asked Merck to analyze its own data on vaccine injuries to determine whether there was evidence for a causal association between its vaccine and disorders like POTS.

Evidence suggests the company decided which data to include in its evaluation in a way that would almost guarantee it would find no link.

Other European researchers provided compelling research to the EMA that Merck was wrong. And experts, including some appointed to the investigation by the EMA, raised serious doubts about Merck’s conclusions, as leaked documents reported by BMJ Evidence-Based Medicine revealed.

Yet, the EMA rubber-stamped Merck’s findings, concluding that the evidence does not support a causal association between HPV vaccination and CRPS and/or POTS.

Two years later, researchers at the Centers for Disease Control and Prevention (CDC) and the FDA published their own analysis of the U.S. Vaccine Adverse Event Reporting System (VAERS) data on POTS and Gardasil. Among its many alleged flaws, that study replicated Merck’s data selection strategies — apparently under Merck’s confidential guidance — and concluded there was no safety signal.

Months after the CDC’s analysis was published, the lead researcher on the study, Dr. Jorge Arana, left his decade-long career at CDC and took a position at Merck overseeing vaccine pharmacovigilance. Today, he works for Moderna.

Revelations about Merck’s flawed methodology, later replicated in part by U.S. regulators to justify the claims that the Gardasil vaccine has no link to POTS and other neurological disorders, are laid out in an expert report submitted as part of the landmark Robi v. Merck lawsuit.

Lucija Tomljenovic, Ph.D., a biochemist whose research focuses on the mechanisms through which vaccines can cause autoimmune disorders, authored the report.

Her findings raise serious questions about the HPV vaccine safety claims by Merck and global regulators and about why truly independent safety studies have not been conducted for a vaccine that is being heavily promoted for every child globally.

EMA asks Merck to do safety analysis

Concerns about adverse events from the HPV vaccine in Japan and Denmark prompted the Danish Health and Medicines Authority to ask the European Commission to investigate the safety of the HPV vaccine.

The commission launched an investigation. Four months later, it issued a report concluding there was no link between HPV vaccines and serious neurological adverse events and discouraging further research into the issue.

Rather than performing its own independent assessment, the EMA asked Merck — and GSK, maker of the HPV vaccine Cervarix — to evaluate the safety of their drugs.

The companies used their own post-marketing data to do an analysis comparing the number of “observed” adverse events — number of cases of that disease reported in pharmacovigilance systems related to a vaccine — to the number of “expected” adverse events — based on the “background rate” at which a disease occurs in the general population.

If the observed rate is significantly higher than the background rate, there is a signal. However, in Merck’s analysis for POTS, Merck found the opposite — the number of reports following vaccination was lower than the background rate.

Merck overestimated POTS rates in general population

To get this outcome, Merck underestimated the number of POTS adverse events and overestimated the background rates, according to Tomljenovic’s report. And it did so with the EMA’s endorsement.

When Merck did its analysis, there were no published reports on incident rates for POTS — so there was no good way to get a background rate from the published literature. The company estimated its POTS background rates based on the background rates for chronic fatigue syndrome — a different syndrome with different diagnostic criteria.

The vaccine maker estimated extremely high background rates of between 15 and 140 cases per 100,000 women. Subsequent published papers found background rates to be substantially lower.

A study by the Mayo Clinic estimated background cases to be 17.6 per 100,000 in the U.S. in 2016. Another study by Croatian researchers found the background rate to be 2.2 per 100,000. A third study found estimated background rates to be two to three times lower than the lowest incidence rate assumed by Merck during the Article 20 Review Assessment Report.

Taken together, Tomljenovic concluded: “Merck’s lowest estimate for the background incidence of POTS corresponds to the highest estimate available in the scientific literature to date. This makes Merck’s [observed v. expected] analysis results and conclusions endorsed by the EMA null and void.”

Merck underestimated the post-vaccination POTS rates

To estimate the number of adverse events post-vaccination, Merck analyzed cases reported to the Merck Adverse Event Reporting and Review System (MARRS), which is similar to VAERS, but it is proprietary — kept private and released to plaintiffs suing Merck only under court order — and often contains more extensive information than databases like VAERS.

All pharmacovigilance systems suffer from limitations, Tomljenovic explained. First, in spontaneous adverse event reporting systems like MARRS or VAERS, there is a very high rate of underreporting because only a small fraction of side effects are ever reported.

For example, Researchers have found that the number of injuries reported to VAERS is less than 1%. Underreporting rates of between 94%-98% have been reported in other systems.

The quality of reports can also vary. Since anyone can report adverse events, the validity of the reports has to be assessed. And often, they are made by busy clinicians who don’t have time to do highly detailed reporting.

There is an additional challenge with illnesses like POTS. Because it’s a poorly understood condition, frequently missed or underdiagnosed, it is more likely than other vaccine injuries to go unreported — a fact Merck acknowledged in its response to the EMA. “There is no way that POTS is reported at high rates,” Tomljenovic said.

Tomljenovic’s report showed that Merck ran its analysis estimating that reporting rates accounted for 1%, 10%, 20% and 100% of actual cases. Only 1% was realistic, according to Tomljenovic.

In addition to exaggerating POTS background rates and likely overestimating reporting rates for POTS cases, Merck also greatly underestimated the number of “observed” POTS cases following Gardasil vaccination. It did so by setting the requirements for what constituted a likely case of POTS to be extremely — and unreasonably, according to Tomljenkovic — narrow.

The company identified 83 reports — then eliminated 40 of them because they didn’t satisfy the four diagnostic criteria for POTS. Even if a physician confirmed the diagnosis, if details of the basis for the diagnosis weren’t included, Merck threw out the report.

Danish authorities and other experts criticized Merck’s exclusion — and by default, the EMA’s exclusion of POTS case reports.

Danish dysautonomia clinician and specialist Dr. Louise Brinth had cautioned the EMA that “it is rare that any spontaneous report will meet diagnostic criteria.” She said physicians aren’t expected to provide those details, so eliminating cases on that basis is “too limiting.”

Ralph I. Edwards, former director of the WHO-Uppsala Monitoring Centre in Sweden that accepts reports of suspected harms of vaccines and other drugs, recommended instead including such cases in a transparent way — accounting for a difference between cases confirmed with full information and other cases — “to protect patients from possible harm.” But Merck declined to do that.

Uppsala Monitoring Centre provided data to the EMA showing that POTS was reported 82 times more often for HPV vaccines than for other vaccines — but the EMA ignored that data.

Using these flawed methods ensured that the “observed” count was less than the “expected” for all geographical regions and countries other than Denmark.

Merck concluded, and the EMA concurred, that the safety signal in Denmark was fake, and the high number of reports was simply stimulated by the media, which had given the topic a lot of coverage.

They also said the POTS cases reported were “cherry-picked in order to fit a ‘pre-specified hypothesis of vaccine-induced injury.’”

On that basis, the EMA said it was satisfied there was no safety signal and no evidence for causal association between the HPV vaccine and POTS or CRPS.

The agency also concluded there was “no evidence of a signal which warrants further investigation,” even though it listed several uncertainties and limitations of the data in the same document.

Some key text of the EMA’s final Article 20 Review Assessment Report was “nearly identical to Merck’s own assessment submitted to the EMA,” Tomljenovic reported.

CDC and FDA use Merck’s case selection method and reach same conclusion

Merck backs its claims that there is no link between Gardasil and POTS based on the EMA conclusions and on a 2017 study published by researchers from the CDC and the FDA, which jointly administer the VAERS database.

The CDC’s Dr. Jorge Arana was the lead author, and Dr. Tom Shimabukuro, who now leads the CDC’s Immunization Safety Office responsible for tracking safety signals for the COVID-19 vaccines, was a co-author.

The authors analyzed the VAERS database for POTS using empirical Bayesian data mining, which uses a statistical method to compare reports of POTS for the HPV vaccine with those related to most non-HPV vaccines to identify safety signals.

The FDA and CDC concluded, “POTS is rarely reported following HPV vaccination” and that there was “no evidence to suggest a safety problem with POTS following HPV vaccination.”

However, Tomljenovic reports that like Merck, the agencies used data analysis methods that minimized the number of POTS cases.

They estimated the frequency of POTS cases by counting the number of cases per number of vaccines distributed. However, the number of doses distributed is not the same as the number of doses administered, and many people receive multiple shots. This method underestimates the rate of POTS cases, which the EMA pointed out to Merck during its 2015 analysis.

Then, Tomljenovic said, the FDA and CDC underestimated the number of actual POTS cases. They identified 160 case reports in VAERS that had POTS symptoms. Then, like Merck in the EMA assessment, they eliminated cases that didn’t fully meet the POTS diagnostic criteria.

That left them with only 29 reports that fully met the criteria.

Pharmacovigilance expert Edwards recommended that the case reports should have been included in a separate sensitivity analysis that represents “the worst-case scenario,” which should be presented alongside the “best-case” scenario that includes only verified POTS cases — like the one the regulators did.

The analysts also failed to account for the fact that POTS is severely under- and misdiagnosed, and that non-specialist clinicians often ascribe POTS symptoms to psychological conditions — especially for people who think their symptoms were triggered by the HPV vaccine.

Tomljenovic’s report revealed that approximately a year and a half before the report was published, co-author Shimabukuro, then-deputy director of the Immunization Safety Office at the CDC, emailed “Barb,” Merck’s Barabara Kuter, asking the company to share its database analysis algorithm with the CDC.

Merck shared this information with the stipulation that the CDC “handle this information as confidential.” The CDC ultimately used the same review strategy as Merck for suggestive cases, the report said.

“So much for regulatory independence,’” Tomljenovic concluded, noting that Merck’s appeal to CDC’s study to say there is no safety concern “should not be deemed persuasive.”

The Arana et al. study was published in 2017, when Arana was an epidemiologist at the CDC, a position he held for 10 years.

Months after the study was published, Arana took a position as senior scientist leading the “risk management” division for vaccines at Merck. In May 2023, he moved to Moderna, according to his LinkedIn profile.

The CDC currently recommends a two-dose regimen of Gardasil for all adolescents in the U.S., starting before their 15th birthday. It recommends three doses for teens and young adults who start at age 15 or later.

There are more than 200 cases pending against Merck in federal court, and many more in state court by people seriously injured by the Gardasil vaccine.

The first of these cases, Robi v. Merck, which was suspended earlier this month, is set to begin again in September. Tomljenovic is an expert witness in the case.

Related stories in The Defender

• Bombshell Study Questioning HPV Vaccine Efficacy Appears as UK’s Cervical Cancer Rates Rise in Young

• Merck to Face California Jury as ‘Historic’ Gardasil HPV Vaccine Trial Gets Under Way

• Trial Alleging Merck Hid Dangers of HPV Vaccine Delayed Again

• Injured by Merck’s Gardasil HPV Vaccine? You or Your Child May Have a Case

• Gates-Funded Plan to Vaccinate 86 Million Girls Against HPV Will ‘Unleash Mass Casualty Event,’ Critic Says