Human Papillomavirus (HPV) Vaccines as an Option for Preventing Cervical Malignancies: (How) Effective and Safe?

Abstract

We carried out a systematic review of HPV vaccine pre- and post-licensure trials to assess the evidence of their effectiveness and safety. We find that HPV vaccine clinical trials design, and data interpretation of both efficacy and safety outcomes, were largely inadequate. Additionally, we note evidence of selective reporting of results from clinical trials (i.e., exclusion of vaccine efficacy figures related to study subgroups in which efficacy might be lower or even negative from peer-reviewed publications). Given this, the widespread optimism regarding HPV vaccines long-term benefits appears to rest on a number of unproven assumptions (or such which are at odd with factual evidence) and significant misinterpretation of available data. For example, the claim that HPV vaccination will result in approximately 70% reduction of cervical cancers is made despite the fact that the clinical trials data have not demonstrated to date that the vaccines have actually prevented a single case of cervical cancer (let alone cervical cancer death), nor that the current overly optimistic surrogate marker-based extrapolations are justified. Likewise, the notion that HPV vaccines have an impressive safety profile is only supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities). We thus conclude that further reduction of cervical cancers might be best achieved by optimizing cervical screening (which carries no such risks) and targeting other factors of the disease rather than by the reliance on vaccines with questionable efficacy and safety profiles.

How Silencing of Dissent in Science Impacts Woman. The Gardasil® Story

“…so the question is not whether Gardasil ® has the potential to cause serious AEs but the frequency with which this occurs, information that is not always revealed to parents. As of 2015 serious adverse events (AE's) following Gardasil ® vaccination that have been reported in the medical literature include: premature ovarian failure [78], Guillian Barre syndrome and lupus and a host of other autoimmune related diseases [79], erythema multiform and other dermatological disorders [80], nervous system disorders such as POTS and many others [34], including death [81]. Most of these events are dismissed by pharmaceutical company experts as coincidental, occurring no more often then they might have with a placebo.…”

“…While CIN 3 infections may be a better marker, with Pap smears and treatment it too will eventually clear. Tomljenovic notes that the use of HPV of any severity is a poor marker for cervical cancer because most infections clear within 3 years [34]. In phase 3 randomized, placebo-controlled, double-blind studies, labeled the FUTURE I and FUTURE II studies, designed and funded by Merck, Gardasil ® showed a 98% effective against HPV 16 and 18 CIN 2/3women who tested negative for HPV at the beginning of the study.…”

“…Even with the reported evidence that statins prevent premature death we don't stop investigating the safety and efficacy of these drugs? And, as we have seen from the additional studies the data have raised questions as to their safety and efficacy [34]. Do media reports with this conflicting data confuse the public, and cause some to make decisions to with valid scientific information from a concerned parent it is automatically assumed that the information must be from one of those "conspiracy websites.…”

Human Papilloma Virus (HPV) Vaccines: Scope and Implications

“…The preliminary results of advanced phase 3 clinical trials of this vaccine indicate its efficacy to be at least comparable to Gardasil with additional protection against five more cervical cancerinducing HPV types apart from 16 and 18 [43,44]. The additional HPV types targeted by Gardasil9 are HPV 31/33/45/52/58 [45].…”

Why is it appropriate to recommend human papillomavirus vaccination as cervical cancer prevention?

“…27,29,30 While this is borne out from natural history studies of HPV infection, 43–45 >26% of young women monitored for >38 months on average during a large longitudinal study who acquired an incident infection with HPV type 16 or 18 developed biopsy-confirmed CIN 2/3 within 36 months. 34 Regression from CIN 2 and CIN 3 to lower-grade lesions is estimated to occur in 43% and 32% of cases, respectively, with approximately 5% of CIN 2 and 12% of CIN 3 progressing to invasive cervical cancer.…”