Merck rigged Gardasil trials in order to conceal harms, according to a newly unsealed submitted to an American court.

The expert report from Danish physician and world-renowned research methodologist Dr. Peter C. Gøtzsche, reveals that Merck intentionally misrepresented the safety profile of its Gardasil HPV vaccine.

Gøtzsche states that Merck distorted clinical trial data, making the results scientifically meaningless, and manipulated the recording and reporting of adverse events to minimise the appearance of harm.

Maryanne Demasi reports: In what could become one of the most explosive pharmaceutical lawsuits in US history, Robi v Merck & Co, centred on the Gardasil HPV vaccine, is set to resume in Los Angeles in September 2025.

At the core of the case are allegations that Merck misrepresented the safety profile of Gardasil – allegations now supported by powerful evidence.

A newly unsealed expert report from Danish physician and world-renowned research methodologist Peter C. Gøtzsche, submitted as part of the pre-trial motion, underpins the claims against Merck.

His 350-page forensic analysis—now part of the official court record—lays bare a chilling narrative of clinical trial rigging, regulatory failure, and global deception.

According to Gøtzsche, Merck distorted its clinical trial data so thoroughly that the results were rendered scientifically meaningless.

Gøtzsche’s assessment is stark and unequivocal.

“The Merck-sponsored trials cannot be used to properly assess the harms of the vaccines,” he writes, adding that the company “squandered the opportunity to legitimately study the safety of Gardasil.”

After examining 112,000 pages of regulatory documents, Gøtzsche concluded that Merck manipulated its data to such an extent that it would be “difficult if not impossible” for any independent scientist—or even government regulators—to accurately assess the vaccine’s harms.

It now raises the fundamental question — were millions of adolescents misled into consenting to a vaccine whose true safety risks were deliberately obscured?

Trials designed to mislead

From the outset, Gøtzsche argues that Merck engineered its clinical trials not to detect harms, but to mask them.

Rather than using an inert placebo—such as saline solution, the gold standard in clinical research—Merck used an aluminium-based adjuvant as the control in all but two small trials.

Aluminium adjuvants are known neurotoxins that trigger immune responses and can cause local and systemic side effects on their own.

“It is indefensible that Merck avoided comparing its vaccine with placebo,” Gøtzsche writes.

This tactic had a clear purpose: to minimise the appearance of adverse effects by ensuring that the “control” group would experience side effects similar to the vaccinated group, making the vaccine seem safer by comparison.

Even the World Health Organisation (WHO) has warned that using an active comparator like an adjuvant instead of a true placebo “makes it difficult to assess the harms of a vaccine.”

Only under pressure from regulators did Merck conduct two small trials using a saline placebo.