Gardasil safety trials relied on “guesswork,” critics say

Merck’s Gardasil human paillomavirus (HPV) vaccine could pose a significant health threat to the public because the U.S. Food and Drug Administration (FDA) relied on guesswork when it approved the drug, says Dr. Hanan Polansky of the Center for the Biology of Chronic Disease (CBCD), a not-for-profit organization devoted to understanding the underlying causes of cancer and other systemic diseases.

That guesswork, Dr. Polansky says, involved Merck scientists using “surrogate endpoints” in clinical safety trials of Gardasil rather than focusing on the effect of the HPV vaccine directly on the development of cancer.

Clinical drug trials that aim to demonstrate a reduction in mortality must be large and conducted over a long period of time. A study published in the Annals of Internal Medicine explains that drug researchers use surrogate endpoints to reduce the cost and duration of clinical trials. Surrogate endpoints allow the researchers to observe today what would otherwise take years or decades to predict.

In the case of HPV, for instance, it takes 20 to 40 years from infection to the onset of cervical cancer, but Merck theoretically shortened that time span to just five years in clinical trials by using surrogate endpoints.

The problem, however, is that in practice, surrogate endpoints frequently fail.

According to Dr. Thomas Fleming and Dr. David DeMets, who authored the study “Surrogate End Points in Clinical Trials: Are We Being Misled?” there are a number of explanations for this failure, including possible “unintended, unanticipated, and unrecognized mechanisms of action” in operation beyond the study’s scope.

Dr. Polansky’s research postulates that the Gardasil vaccine introduces foreign DNA fragments into the patient’s body, spurring a process he calls microcompetition, which can lay the foundation for major diseases, including autoimmune disorders.

Since Gardasil was introduced in 2006 until September 2011, more than 20,000 reports of side effects ranging from mild to deadly have been reported to the Vaccine Adverse Events Reporting System (VAERS), jointly run by the FDA and CDC. Pain and swelling at the injection site, fever, dizziness, nausea, loss of consciousness, seizures, blood clots, and Guillain-Barré Syndrome (GBS) are some of the more serious reactions reported following doses of Gardasil. The vaccine is also suspected in at least 71 cases of death, according to VAERS data.


The Annals of Internal Medicine

The Center for the Biology of Chronic Disease

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