Saturday, April 7, 2012

FDA Approved Gardasil Without Safety Testing: Proof in FDA Document


Would you willingly use a pharmaceutical product or subject your child to one if it hasn’t been safety tested?

If you’ve had the Gardasil vaccine or have allowed your daughter, and now your son, to be injected, that’s precisely what has happened. The proof has been hidden in plain sight on the FDA’s website since 2006.

The Food and Drug Administration’s (FDA’s) approval letter went out with statements saying that both short and long term studies were to be done.

Approval was immediate, not predicated on the results of those studies.

From the approval letter sent to Merck in 2006:

"You have committed to conduct a short-term safety surveillance study in a U.S. Managed Care Organization (MCO). The study will include approximately 44,000 vaccinated subjects who will be followed for 60 days for assessment of general short-term safety (i.e., emergency room visits, hospitalizations, and deaths). The subjects will also be followed for 6 months subsequent to vaccination for new autoimmune disorders, rheumatologic conditions, or thyroiditis. … The final study report will be submitted by September 30, 2009."

That references a single study that was to be performed in the United States for a short term 60 day assessment and another short term 6 month assessment.

It’s now nearly 2½ years after the date that study was supposed to be submitted to the FDA. I searched the FDA’s database for a reference to it … any reference to it. The search terms used were “merck gardasil safety assessment”. I also tried to find a reference in the journal literature.

All that exists on the FDA site is information based on the sorely inadequate VAERS (Vaccine Adverse Event Reporting System) data, where it’s estimated that less than 10% of all adverse events are reported.

In A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD, I found a reference to a study that appears to be a match for the requirement stated in the FDA’s letter. It was described as being done in association with Merck, planned for an MCO, and to include 44,000 vaccinated subjects. The sample size is referenced as being an FDA requirement. In fact, the study is clearly one published in the Internal Medicine study that I reported on in Farcical Study of Gardasil Safety: Medscape Gives CME Training Credit for It. It was published in November 2011, more than 2½ years later than the Gardasil approval requirement specified.

The FDA didn’t pull Gardasil from the market for the lack of safety data that Merck had agreed to produce. But it’s even worse than that. The requirement, as stated above, was for reporting of adverse events that occurred up to 60 days after vaccination and up to 6 months after. The study didn’t even touch on those time spans. It reported on a select group of diseases, which were chosen by the FDA. As the Farcical Study… article indicates, they are not the problems that are generally reported as adverse effects of Gardasil.

Clearly, the FDA does not stand as a guardian of the public’s health. They operate as a pusher of Big Pharma’s products. The Gardasil disaster demonstrates it clearly:

The FDA approved the vaccine without adequate testing for either safety or efficacy.
When the required testing hadn’t been done, or at least no report of it has been produced, the FDA allowed Merck to continue marketing the product.

When the study was finally published, it did not contain the documentation required by the original agreement.

In October 2009, shortly after the September 2009 deadline for reporting on the safety test had passed, the FDA actually expanded application of Gardasil to include boys.

To further exemplify the FDA’s utter lack of concern for the public’s health, the same document that granted approval to market Gardasil specified that efficacy against cervical cancer and prevention of the HPV variants included in the vaccine be monitored in a group of 5,500 Norwegian women. They are also supposed to investigate “pregnancy outcomes, especially congenital anomalies” in the study participants.

According to A summary of the post-licensure surveillance initiatives…, this study appears to be in process. But one must wonder how it will be adulterated, as the previous one was—and as the FDA clearly collaborated in the first study’s adulteration by providing a list of specific diseases to search for, rather than simply report on any and all adverse effects, how likely is it that December 31, 2018 will come and go with no study report or that the report, when it is produced, is done in a manner designed to give the false impression that Gardasil is safe?

Clearly, the FDA is not acting for the benefit of the people:

The FDA approved Gardasil without first making reasonable assurance that it was safe in anyone.
The FDA approved the mass use of Gardasil without having any information to indicate whether it will cause fetal harm. Remember thalidomide? Apparently, the FDA doesn’t.

The FDA turned their heads when Merck didn’t come up with the first safety study. They left Gardasil on the market.

The FDA approved Gardasil’s use in boys shortly after the first safety study wasn’t delivered. Can we assume that this approval was planned even before initial approval was given? It seems that the FDA was punked by Merck when it didn’t produce the trial, but went ahead with their approval plans anyway.

The FDA aided Merck in scamming the report of that first study by specifying conditions that weren’t those that people were reporting.
What more could we possibly need to know that the FDA is corrupt and should be disbanded?

Here is the FDA’s letter to Merck granting approval to market Gardasil and specifying the study requirements, which are highlighted in yellow, so you can scroll to them quickly:

June 8, 2006 Approval Letter – Human
Papillomavirus Quadrivalent (Types 6, 11,
16, 18) Vaccine, Recombinant

June 8, 2006 Approval Letter – Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant.pdf


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