{"id":106275,"date":"2025-02-24T02:32:32","date_gmt":"2025-02-24T02:32:32","guid":{"rendered":"https:\/\/peraltafinancing.com\/alternative-medicine\/what-it-means-for-public-health\/"},"modified":"2025-02-24T02:32:32","modified_gmt":"2025-02-24T02:32:32","slug":"what-it-means-for-public-health","status":"publish","type":"post","link":"https:\/\/fivemor.com\/?p=106275","title":{"rendered":"What It Means for Public Health"},"content":{"rendered":"


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Newly classified documents in the landmark lawsuit against Merck reveal that Merck and the FDA knew the vaccine maker didn\u2019t conduct proper testing for DNA contamination, but covered it up. Children\u2019s Health Defense is supporting the lawsuit.<\/strong><\/em><\/p>\n

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A\u00a0landmark lawsuit against Merck<\/a>\u00a0is underway in a Los Angeles courtroom, marking the company\u2019s first jury trial over claims it misrepresented the safety of its highly profitable\u00a0Gardasil HPV vaccine<\/a>.<\/p>\n

Newly declassified documents in the trial have revealed troubling details about Merck\u2019s failure to conduct key safety tests.<\/p>\n

Internal emails reveal that Merck knew its Gardasil vaccine was contaminated with HPV DNA fragments from\u00a0the vaccine<\/a>\u2018s manufacturing process and lobbied regulators to bypass testing requirements.<\/p>\n

Uncovering residual DNA contamination<\/strong><\/p>\n

Concerns over Gardasil\u2019s residual\u00a0DNA contamination<\/a>\u00a0have persisted for over a decade.<\/p>\n

In 2011, Dr. Sin Hang Lee, a pathologist with extensive experience in DNA analysis, discovered high levels of HPV DNA fragments in 16 Gardasil vials from several countries, including the U.S., New Zealand, Australia, Spain, Poland and France. (See previous story\u00a0here<\/a>.)<\/p>\n

These\u00a0DNA fragments<\/a>, originating from the\u00a0plasmid DNA<\/a>\u00a0used in vaccine production to code for the HPV virus\u2019s L1 protein, are supposed to be removed during manufacturing.<\/p>\n

Instead, high levels of HPV DNA fragments remain in the final product and tightly bind to the\u00a0aluminum adjuvant<\/a>. Unlike free DNA molecules in solution, the aluminum-bound HPV DNA is stabilized and resists breakdown by enzymes.<\/p>\n

Once injected, these aggregates are absorbed by immune cells and\u00a0activate Toll-like receptor 9<\/a>\u00a0(TLR9), triggering pro-inflammatory responses.<\/p>\n

According to Lee, for some individuals, particularly those with genetic predispositions, this can lead to\u00a0autoimmune conditions<\/a>\u00a0such as postural orthostatic tachycardia syndrome (POTS<\/a>) or, in rare cases, sudden death.<\/p>\n

Notably, Gardasil\u2019s package inserts make no mention of the presence of HPV DNA or its potential to trigger immune responses.<\/p>\n

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Internal emails reveal negligence and cover-up<\/p>\n

Lee is set to testify in the lawsuit, and his witness statement provides key evidence suggesting Merck was aware of the issue of HPV DNA contamination but failed to act.<\/p>\n

Following\u00a0Lee\u2019s findings<\/a>\u00a0in 2011, Merck was asked by the Swiss drug regulator, Swissmedic, to provide data on HPV DNA levels in Gardasil.<\/p>\n

In response, Merck\u2019s Chief Medical Officer Carlos Sattler made a revealing admission to his colleagues in an internal email. On Sept. 8, 2011, Sattler admitted \u201cWe did not specifically look for the HPV L1 plasmid DNA.\u201d<\/p>\n

Despite this, Sattler downplayed the significance of the contamination, stating that Merck had \u201cno plans\u201d to conduct any testing and that, even if small amounts were present, there was \u201cno evidence that this would be associated with any risk.\u201d<\/p>\n

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The next day, Merck scientist Annie Sturgess confirmed, \u201cWe have not directly measured HPV DNA\u201d in the\u00a0vaccine<\/a>.<\/p>\n

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Merck attempted to satisfy Swissmedic by estimating the level of HPV DNA using \u201cyeast DNA\u201d content as a proxy, but the regulator rejected this approach.<\/p>\n

Thomas Hottiger, Ph.D.<\/a>, of Swissmedic warned Merck that its method was \u201cnot entirely fit for purpose\u201d and explained that the company would need to use a PCR test specific for detecting HPV plasmid DNA, which behaves differently from yeast DNA.<\/p>\n

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Merck\u2019s North American representative, Dave Wohlpart, expressed reluctance to perform such testing and proposed to his colleagues that Merck \u201cnot do testing\u201d altogether.<\/p>\n

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On Oct. 21, 2011, the U.S. Food and Drug Administration\u00a0(FDA) made a public announcement<\/a>\u00a0claiming that Merck had actually known that \u201csmall quantities of residual recombinant HPV L1-specific DNA fragments remain in the vaccine.\u201d<\/p>\n

This disclosure came as a surprise to Merck.<\/p>\n

Frank Vandendriessche, Merck\u2019s director of Regulatory Affairs in Europe, reacted to the FDA\u2019s announcement, writing in an email that the company had \u201cnever tested specifically for HPV L1 DNA fragments.\u201d<\/p>\n

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Merck used the situation to its advantage to suggest it was now a moot point. Armed with the FDA\u2019s announcement, Merck lobbied Swissmedic to withdraw its request for new data.<\/p>\n

Swissmedic obliged, granting a waiver for specific HPV DNA testing. Instead, Merck was instructed to make a minor change to the product\u2019s label \u2014 effectively burying the issue.<\/p>\n

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Regulatory failure: Complicity or incompetence?<\/strong><\/p>\n

Gardasil was approved and distributed globally without proper testing for HPV L1 DNA contamination. Instead of enforcing rigorous safety standards, regulators allowed Merck\u2019s flawed testing procedures to pass unchecked.<\/p>\n

Even when evidence of contamination surfaced, regulators largely overlooked it, revealing a pattern of negligence and wilful blindness.<\/p>\n

Their reluctance to demand accountability suggests either regulatory capture or gross incompetence \u2014 both of which have devastating consequences for the millions who have received the vaccine.<\/p>\n

This trial may not only determine Merck\u2019s liability \u2014 it could force a long-overdue reckoning with the\u00a0regulatory agencies<\/a>\u00a0that have shielded\u00a0pharmaceutical giants<\/a>\u00a0from scrutiny for far too long.<\/p>\n

Lee will take the stand and testify at the trial on Feb. 13.<\/p>\n

Originally published on\u00a0Maryanne Demasi\u2019s Substack page<\/a>.<\/em><\/p>\n<\/div>\n

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The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children\u2019s Health Defense.<\/p>\n<\/div>\n

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