The Failure Of Merck’s HPV Vaccine, Autoimmune Disorder Study

Study showing Gardasil is not associated with the development of autoimmune disorders is not so clearcut.

HPV, or human papillomavirus, is an extremely common virus that is most commonly passed on through genital contact.  Merck’s HPV vaccine Gardasil was approved by the FDA in June 2006 and concerns over potential negative side-effects, including the development of autoimmune disease, soon followed.

A two-year study looking at the association between Gardasil and autoimmune disorders, such as lupus, multiple sclerosis, and rheumatoid arthritis was recently completed by the manufacturer Merck.  The study found no association between the use of Gardasil and the development of autoimmune disorders.

The study was performed in California by Kaiser Permanente on 190,000 females over a six-month period. These females ranged in ages from nine to 26 between 2006 and 2008 when they received the three necessary Gardasil injections for disease prevention. Over the course of the six-month evaluation, there was no rate increase in autoimmune disorder occurrences within the test group.  The study was published in February of 2012 in the Journal of Internal Medicine by Chun Chao, lead research analyst at Kaiser Permanente.

This is not a slam dunk for Merck’s blockbuster product. This current Kaiser Permanente study was funded by the vaccine’s maker, Merck & Company.  The source of study funding is widely recognized by epidemiologists to influence results.  Furthermore, the follow-up period was only 6-months after the last receipt of Gardasil.  Most autoimmune disorders develop slowly and a 6-month window could be considered inadequate.  Finally, the age range of nine to 26 years should also be extended to females in their 30s and 40s; the Gardasil vaccine may affect older females differently than younger females.

The bottom-line is that the design of this study fails to prove or disprove any association between Gardasil and autoimmune disorders.  It should be back to the drawing board for Merck & Co.

Please visit the original article for reference: HPV Autoimmune Disorders

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