Merck Sponsored Study Returns Dubious Gardasil Autoimmune Safety Results

The Best Years in Life

by Tony Isaacs
October 2010

A new Merck funded study has concluded that Merck’s controversial Gardasil HPV vaccine poses no risk for developing autoimmune conditions. The conclusions come as no surprise to those who have seen other self-serving results from other Merck funded studies, many of which were later proven false or misleading. Ironically, shortly after Merck announced the study results the FDA approved the addition of an autoimmune related disease to the side effects listed for another HPV vaccine.

An article posted on September 3 in Infectious Disease News reported that study data was presented at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy which showed that Merck’s quadrivalent human papillomavirus vaccine (Gardasil) did not raise the risk for developing autoimmune conditions. The study was sponsored by Merck and conducted on behalf of the Gardasil Safety Team.

Ironically, only a day earlier on September 2, a letter was issued by the FDA Department of Health and Human Services to GlaxoSmithKline Biologicals on September 2, 2010, granting their request to “add lymphadenopathy to the Adverse Reactions” in the full prescribing information for their HPV vaccine Cervarix.

In Wikipedia lymphadenopathy is described as “a term meaning ‘disease of the lymph nodes.’ It is, however, almost synonymously used with ‘swollen/enlarged lymph nodes’. It could be due to infection, auto-immune disease, or malignancy. Autoimmune etiology includes sarcoidosis, systemic lupus erythematosus, and rheumatoid arthritis all giving a generalized lymphadenopathy.”

Further casting doubt on the Merck study is the fact that thus far over 300 events have been reported to the Vaccine Adverse Event Reporting System (VAERS) where the vaccine is HPV or HPV4 (Gardasil) and the symptom is lymphadenopathy. Norma Erickson, President of S.A.N.E Vax, Inc., referred to the Merck funded study as “an outrageous excuse for a scientific study. There are over 60 autoimmune disorders reported to VAERS and the 16 least likely to exhibit (even with Gardasil) were chosen with percentages compiled on only 11 of those – and they were probably randomly sampled.”

The new study is hardly the first Merck funded study that has vouched for the safety of its pharmaceutical products which was later proven false. The most blatant examples were the Merck funded studies on what came to be known as “the Vioxx Scandal”. Besides self-serving studies, Merck was found to also be guilty of hiding proof of harm, especially increased risks of heart attack. Merck was also found to have paid doctors and researchers to put their names on papers Merck wrote. Before Vioxx was finally pulled from the shelves over 60,000 deaths were attributed to Vioxx.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.