by Brenda Baletti, Ph.D., Childrens Health Defense:
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, and the FDA and CDC replicated Merck’s data selection methods for their own study drawing the same conclusion.
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.
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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.
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