sup)1(/sup)These statistics are not exactly encouraging when it comes to demonstrating efficacy for Gardasil®. In fact, quite the opposite – these figures seem to indicate that women who receive Gardasil® may indeed increase their risk of developing cervical cancer from high-risk HPV types that are not targeted by the vaccine.
Medical consumers cannot afford to take the chance of increasing their risk of contracting a disease that has been virtually eradicated by good gynecological care in the United States (cervical cancer) by taking a series of HPV vaccines and hoping they will find out decades later the vaccine worked. It is certainly not a risk children should have to take.
Armed with the knowledge that any drug approved under the FDA’s accelerated approval process using a surrogate endpoint, such as Gardasil®, requires post-marketing studies “to verify and describe the drugs clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit… ,”(sup) 2(/sup) the SaneVax Team felt compelled to appeal to the person in charge of FDA/CDC oversight, Kathleen Sebelius, Secretary of Health and Human Services.
On 31 January 2012, SaneVax Inc. sent an open letter to Ms Sebelius(sup)3(/sup) asking her to rescind approval for Gardasil® based on the lack of efficacy demonstrated in the ATHENA study referenced above.
If the Department is truly interested in public health and safety, they will do the right thing and rescind Gardasil® approval until the manufacturer can provide scientifically sound data proving this new drug is actually effective.
In the meantime, medical consumers around the globe have a choice. Is poke and hope good enough for you and your children? Or, are you going to demand scientific proof of efficacy before submitting to HPV vaccination?
1. http://www.ncbi.nlm.nih.gov/pubmed/21944226 (see table 3, The ATHENA human papillomavirus study: design, methods, and baseline results.)
2. http://www.fda.gov/ohrms/dockets/ac/03/briefing/3936B1_0 … (57 FR 58942)
3. Copy of letter to Kathleen Sebelius, Secretary of Health and Human Services at http://sanevax.org/sanevax-open-letter-to-kathleen-sebel …