HPV Vaccine: Safety Research/Clinical Trials

What Do the Clinical Trials Really Tell Us?

Gardasil started as a vaccine against four types of

Gardasil vaccine package insert

Section:
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

“GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility [see Pregnancy (8.1)].”

Please note:

Section 8.1 did not evaluate impairment to female fertility, only pregnancy outcomes. 2. The testing was only for female rats and not for women.
“A genotoxin is a chemical or agent that can cause DNA or chromosomal damage. Such damage in a germ cell (sperm or egg) has the potential to cause a heritable altered trait (germline mutation). DNA damage in a somatic cell (any cell except a germ cell) may result in a somatic mutation, which may lead to malignant transformation (cancer)¹.”
“Mutagenesis is a process by which the genetic information of an organism is changed, resulting in a mutation. It may occur spontaneously in nature, or as a result of exposure to mutagens. It can also be achieved experimentally using laboratory procedures².”

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Examining the FDA’s HPV Vaccine Records

Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment

Judicial Watch Special Report
June 30, 2008

“This Judicial Watch Special Report is an analysis of records obtained from the Food and Drug Administration (FDA) concerning a recent vaccine called Gardasil. Gardasil helps protect against four types of human papillomavirus (HPV). The vaccine was approved in May 2006 and was created and marketed by Merck & Company Incorporated.

“The records include Merck’s patent and drug information submitted to the FDA, transcripts and briefing material from approval meetings, and reports documenting health, safety, and efficacy test results, as well as Vaccine Adverse Event Reporting System (VAERS) documents detailing 8,864 cases of adverse effects experienced by people after receiving the Gardasil vaccine. VAERS reports show that at least eighteen people have died after receiving Gardasil.1 Many health officials believe that adverse reactions to medications are widely underreported, therefore the actual number of adverse events occurring after vaccination with Gardasil is likely to be higher.

“Judicial Watch obtained these records under the provisions of the Freedom of Information Act (FOIA), 5 U.S.C. § 552. The request, asking for documents concerning Gardasil, was originally submitted to the FDA on May 9, 2007. The FDA produced documents on May 15, 2007; September 13, 2007; February 27, 2008, and June 10, 2008. Judicial Watch uncovered thousands of pages of material pertaining to Gardasil, which is designed to prevent cervical cancer. The controversial vaccine was fast-tracked for approval by the FDA despite concerns about Gardasil’s safety and long-term effects. The vaccine is still in the testing stages (final report due September 30, 2009), but it is already being administered to thousands of young girls and women.…”

DNA Contamination in HPV vaccines

A serious safety issue that should not be swept under the regulatory carpet.

Professor Joe Cummins
Article first published Sept. 12, 2012

“When the Human Papilloma Virus (HPV) vaccine Gardasil was recently found to be contaminated with DNA, the US Food and Drug Administration (FDA) lost no time in declaring that the DNA was not a contaminant but a harmless by-product of vaccine production. I disagree; that extraneous DNA is potentially harmful. It should also be noted that the safety and efficacy of HPV vaccines have been controversial from the start (see [1] The HPV Vaccine Controversy and other articles in the series, SiS 41).”

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What the Gardasil Testing May Have Missed

Slate Magazine
December 17, 2017
Frederik Joelving

” An eight-month investigation by Slate found the major Gardasil trials were flawed from the outset, however, and that regulators allowed unreliable methods to be used to test the vaccine’s safety. While these flaws do not mean Gardasil caused the rare crippling illnesses reported by the media, they are troubling. Public health officials use trials like these both to determine safety and, as evidenced by Merck’s statement above, to reassure the public when concerns like the ones about Gardasil arise. A flawed study design can complicate both tasks. “
…

“European health regulators worried about Merck’s methods during a review of the company’s marketing application for Gardasil 9, the latest version of the vaccine, but have not made their concerns public. In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.”

Why Is Slate Questioning Gardasil?

Slate Magazine
December 17, 2017
Susan Matthews

“From my perspective, this story has important ramifications for public health. Because even if it turns out that Gardasil does not cause autoimmune disorders in anyone (which is possible), the fact remains that these trials were designed in a way that meant they would probably be unable to reliably assess this potential relationship. And to me, that’s worrying because clinical trials, particularly those used to assess medicine that will be used on large numbers of people prophylactically, ought to be able to make such assessments. And if we’ve been failing on this front, we should know that, so we can correct for it. This is how science is supposed to work.”

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Statistical Shenanigans with Gardasil Research

Hormones Matter
May 8, 2013
Chandler Mars, PhD

“Something’s hinky in the land of Gardasil surveillance and it’s not just the vaccine. It’s the statistics used in one of their widely reported surveillance studies on Gardasil-suspected autoimmune conditions. From the medical marketing and even the abstract of the study, which is all that most will ever read, it looks like there is no connection between the vaccine and the onset of autoimmune conditions. Indeed, all of the major media reported the appropriate PR:

“One organization even failed to change the url before directly copying the press release from another agency; (guess which one, I was surprised). It is unlikely that anyone read this study before blasting the PR far and wide. Otherwise, if they had read the dubious and creatively contorted statistical manipulations, the headlines would have been much different. Perhaps, Researchers Choose Statistics Least Likely to Find Results in Gardasil Study, would have been more appropriate.”

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FDA approved Gardasil 9: Malfeasance or Stupidity?

Norma Erickson
December 17, 2014

“Malfeasance is when a public official violates the public trust by performing an act that is wrongful, legally unjustified, or contrary to law. Nonfeasance is the failure to act where there is a duty to act. Misfeasance is conduct that is lawful but inappropriate. Perhaps, when it comes to the recent approval of Gardasil 9 all of these apply.

“10 December 2014: The FDA approved the use of a reportedly ’new and improved’ version of Gardasil, which will be marketed as Gardasil 9. According to the FDA approval letter, this action was taken without consultation with VRBPAC (the Vaccines and Related Biological Products Advisory Committee) which is responsible for reviewing and evaluating data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products.

“The FDA approval letter, signed by Marion Gruber, Director of Office of Vaccines Research and Review CBER, states the reason for bypassing the advice of VRBPAC writing:

‘”We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.”

“So, the Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER) committee took it upon themselves to decide there were ”no concerns or controversial issues” regarding the approval of Gardasil 9?

“This division of CBER decided there would be no benefit from ”an advisory committee discussion”?”

Read more
Read the FDA letter to Merck here

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