Gardasil’s clinical trials were seemingly designed to downplay injuries

Gardasil’s clinical trials were seemingly designed to downplay injuries

Slate‘s 2017 investigation into the Gardasil safety trials is surprisingly detailed and straightforward. The article, ‘Flaws in the clinical trials for Gardasil made it harder to properly assess safety‘, gave a detailed look at several victims who had developed severe neurological disorders, such as chronic fatigue syndrome, postural orthostatic tachycardia syndrome, and others, after participating in the trials.  Most of these symptoms were completely ignored, or attributed to “new medical history”, and investigators refused to consider the vaccine as the cause. From the article:

“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…”

“…Interviews with five study participants and more than 2,300 pages of documents obtained through freedom-of-information requests from hospitals and health authorities suggest inadequacies built into Merck’s major clinical tests of Gardasil. To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its yearslong trials. At all other times, individual trial investigators used their personal judgment to decide whether or not to report any medical problem as an adverse event—essentially, as a potential side effect worth evaluating further. Other health issues went on a worksheet for “new medical history,” reserved for conditions that bore no relation to the vaccine. This study design put the cart before the horse, asking investigators to decide which symptoms might be side effects, rather than tracking everything in the same way. While the company now says otherwise, there is no indication in the confidential study protocol that it submitted to regulators for approval that it would use new medical history as a safety metric. And it hardly would have qualified as such: The worksheet allotted just one line per entry, with no measurement of symptom severity, duration, outcome, or overall seriousness. Even if the company then used the data in subsequent safety assessments, the lack of detail would have hampered meaningful analysis.”

“…In all the trial locations, Merck also chose to restrict the reporting of adverse events—what the study protocol calls the “clinical follow-up for safety”—to just 14 days following each of the three Gardasil injections in the trial. Illness occurring outside these narrow time slots again was relegated to a single line on the medical-history worksheet, whereas for each adverse event, several assessments would need to be carried out and reported. There was an exception: Deaths or serious adverse events brought to the investigator’s attention and felt to be related to the vaccine or a study procedure were to be reported at any time. This design put individual investigators in charge of deciding, for most of the trial’s duration, what would be assessed and reported as a potential side effect.”

One interesting aspect of the article is that Slate also posted a “companion piece” to the article by science editor Susan Matthews, justifying their investigation of the safety of a vaccine. In no other instance would a news outlet feel compelled to justify their investigation into the safety of a drug or consumer product. In this case they did, and the author makes clear that it is due to the fact that the product in question is a vaccine. The author also makes clear that she would still receive the Gardasil even had she known about the negligent safety trials conducted for the vaccine.

The “companion piece” is instructive because it reveals why so many news outlets, regulators, and governments refuse to entertain any criticism of vaccines, or report the reality of vaccine injury. It’s the Noble Lie, a deliberate falsity maintained by the elite for an ostensibly greater good. The greater good in this instance being a high vaccination rate. Any criticism or report of injury is seen as a threat to high vaccine uptake, and is immediately ignored, suppressed, and ridiculed. This includes self-censoring behavior on the part of the press and regulators, who apparently believe that high vaccination rates trump critical inquiry into the safety of the vaccines themselves.

It should also be pointed out that a lot of money was riding on the success of Gardasil’s clinical trials, so there was plenty of incentive to commit fraud in order to ensure all the investment would produce a comfortable profit.

Author: S. Smith