SaneVax Writes Open Letter to Kathleen Sebelius, Secretary of Health: Rescind approval of Gardasil® due to lack of efficacy during post-licensure monitoring

February 2, 2012

By Norma Erickson, President

According to a recently published, industry-sponsored study conducted on 12,852 young women, HPV vaccination was found to reduce HPV-16 infections a mere 0.6% in vaccinated women versus unvaccinated women. At the same time, other high-risk (carcinogenic) HPV infections were diagnosed in vaccinated women 2.6% to 6.2% more frequently than in the unvaccinated women. The increased rate of infections caused by carcinogenic HPV types other than those targeted by Gardasil® in vaccinated women is 4 to 10 times higher than the reduction in HPV 16/18 infections.[1]

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…[2],” 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[3] asking her to rescind approval for Gardasil® based on the lack of efficacy demonstrated in the ATHENA study referenced above.

If the Department of Health and Human Services 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?





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[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_01_B-Attachment%201.pdf (57 FR 58942)

[3] Copy of letter to Kathleen Sebelius, Secretary of Health and Human Services

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