SaneVax Open Letter to Kathleen Sebelius, Secretary of Health and Human Services

31 January 2012, Open Letter

To:  Kathleen Sebelius, Secretary of Health and Human Services – Kathleen.Sebelius@hhs.gov

Subject: Rescind approval of Gardasil^® due to lack of efficacy during post-licensure monitoring

Dear Ms. Sebelius:

The quadrivalent human papillomavirus (HPV) vaccine, Gardasil^® was approved for marketing as a drug to prevent cervical cancer under the fast track drug development program despite the fact the proposed vaccine did not qualify to use this program under FDA regulations. Since it was ‘fast-tracked,’ the manufacturer was allowed to use self-reversible precancerous lesions as surrogate endpoints for the evaluation of its efficacy to potentially prevent cervical cancer 30-40 years down the road. As you know, Fast Track Drug Development Programs are governed by the following stipulation:

“Where an accelerated approval is based upon a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity, post-marketing studies are ordinarily required “to verify and describe the drug’s clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit, or the observed clinical benefit to ultimate outcome” (57 FR 58942, December 11, 1992).”

In compliance with the required post-marketing monitoring surveys, the CDC published the following guideline:

“While there are well established cancer registries in the United States, it will take decades before the impact of vaccine on cervical cancer is observed. More proximal measures of vaccine impact include outcomes such as prevalence of HPV vaccine types, incidence of cervical pre-cancers and genital warts.” ^[1]

According to a recently published, industry-sponsored study conducted on 12,852 young women, HPV vaccination was found to reduce 0.6% of HPV-16 infections, while increasing the rate of other high-risk (carcinogenic) HPV infections among the vaccinated women by 2.6-6.2% compared to the non-vaccinated women. The latter increased rate of infections caused by carcinogenic HPVs other than HPV-16 and HPV-18 in vaccinated women is 4 to 10 times higher than the reduced rate in HPV-16 infection. ^[2]

In the interest of public health and safety, due to this demonstrated lack of efficacy among consumers during post-licensure monitoring that used CDC recommended ‘more proximal’ measures to monitor vaccine impact, we hereby request the Secretary take immediate action to rescind the approval of Gardasil^® for marketing in the United States until additional post-licensure data is available to support the efficacy of this new drug.

Thank you for your kind attention to this matter.

References

1. Markowitz LE, Hariri S, Unger ER, Saraiya M, Datta SD, Dunne EF. Post-licensure monitoring of HPV vaccine in the United States. Vaccine. 2010; 28:4731-7.
2. Wright TC Jr, Stoler MH, Behrens CM, Apple R, Derion T, Wright TL. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol. 2012;206:46.e1-46.e11. (See Table 3)
3. Human papillomavirus (HPV) vaccine policy and evidence-based medicine:
   Are they at odds? Lucija Tomljenovic, Ph.D., Christopher A. Shaw,
   Ph.D., Annals of Medicine, Jan. 2011