http://gaia-health.com/gaia-blog/2012-03-04/fda-approved-gardasil-without-safety-testing-proof-in-fda-document/
From the approval letter sent to Merck in 2006:
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 journal 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:
Hur många vetenskapligt utförda studier har presenterats till läkemedelsverket och regering/riksdag? Vilka är de studier som ligger till grund för det beslut som riksdagen har fattat?
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 followedThat 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.
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.
Failure to Produce the Required Study
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 journal 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.
Hur många vetenskapligt utförda studier har presenterats till läkemedelsverket och regering/riksdag? Vilka är de studier som ligger till grund för det beslut som riksdagen har fattat?
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