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.
Keywords: HPV vaccines, Gardasil, Cervarix, adverse reactions, vaccine efficacy, vaccine safety, conflict of interests, clinical trials, cervical cancers, safety profile
Current Pharmaceutical Design
Title:Human Papillomavirus (HPV) Vaccines as an Option for Preventing Cervical Malignancies: (How) Effective and Safe?
Volume: 19 Issue: 8
Author(s): Lucija Tomljenovic, Jean Pierre Spinosa and Christopher A. Shaw
Affiliation:
Keywords: HPV vaccines, Gardasil, Cervarix, adverse reactions, vaccine efficacy, vaccine safety, conflict of interests, clinical trials, cervical cancers, safety profile
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.
Export Options
About this article
Cite this article as:
Tomljenovic Lucija, Pierre Spinosa Jean and A. Shaw Christopher, Human Papillomavirus (HPV) Vaccines as an Option for Preventing Cervical Malignancies: (How) Effective and Safe?, Current Pharmaceutical Design 2013; 19 (8) . https://dx.doi.org/10.2174/1381612811319080014
DOI https://dx.doi.org/10.2174/1381612811319080014 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
Call for Papers in Thematic Issues
"Tuberculosis Prevention, Diagnosis and Drug Discovery"
The Nobel Prize-winning discoveries of Mycobacterium tuberculosis and streptomycin have enabled an appropriate diagnosis and an effective treatment of tuberculosis (TB). Since then, many newer diagnosis methods and drugs have been saving millions of lives. Despite advances in the past, TB is still a leading cause of infectious disease mortality ...read more
Current Pharmaceutical challenges in the treatment and diagnosis of neurological dysfunctions
Neurological dysfunctions (MND, ALS, MS, PD, AD, HD, ALS, Autism, OCD etc..) present significant challenges in both diagnosis and treatment, often necessitating innovative approaches and therapeutic interventions. This thematic issue aims to explore the current pharmaceutical landscape surrounding neurological disorders, shedding light on the challenges faced by researchers, clinicians, and ...read more
Emerging and re-emerging diseases
Faced with a possible endemic situation of COVID-19, the world has experienced two important phenomena, the emergence of new infectious diseases and/or the resurgence of previously eradicated infectious diseases. Furthermore, the geographic distribution of such diseases has also undergone changes. This context, in turn, may have a strong relationship with ...read more
Melanoma and Non-Melanoma Skin Cancer Treatment: Standard of Care and Recent Advances
In this thematic issue, we aim to provide a standard of care of the diagnosis and treatment of melanoma and non-melanoma skin cancer. The editor will invite authors from different countries who will write review articles of melanoma and non-melanoma skin cancers. The Diagnosis, Staging, Surgical Treatment, Non-Surgical Treatment all ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Synthesis of Unsymmetrical C5-Curcuminoids as Potential Anticancer Agents
Letters in Drug Design & Discovery Anaesthesia in Cancer Surgery: Can it Affect Cancer Survival?
Current Clinical Pharmacology Mycotoxins Levels in Human Milk: A Menace to Infants and Children Health
Current Nutrition & Food Science Beyond Stressed Self: Evidence for NKG2D Ligand Expression on Healthy Cells
Current Immunology Reviews (Discontinued) Stem Cell Therapy for Spinal Cord Injury
Current Medicinal Chemistry Facile Eco-compactable Design for the Synthesis and Characterization of Silver Nanoparticles
Nanoscience & Nanotechnology-Asia LncRNA HOTAIR Polymorphisms Association with Cancer Susceptibility in Different Tumor Types
Current Drug Targets Targeting the Akt/PI3K Signaling Pathway as a Potential Therapeutic Strategy for the Treatment of Pancreatic Cancer
Current Medicinal Chemistry Deregulation of HOX B13 Expression in Urinary Bladder Cancer Progression
Current Medicinal Chemistry EGFR Inhibitors and Radiation in HNSCC
Current Cancer Therapy Reviews 2,3-Dichloroquinoxaline in Cross-coupling Reactions: A Single Substrate, Many Possibilities
Current Organic Chemistry Molecular Aspects of Stromal-Parenchymal Interactions in Malignant Neoplasms
Current Molecular Medicine Oridonin, a Promising Antitumor Natural Product in the Chemotherapy of Hematological Malignancies
Current Pharmaceutical Biotechnology Advances in the Development of Class I Phosphoinositide 3-Kinase (PI3K) Inhibitors
Current Topics in Medicinal Chemistry Reposition of the Fungicide Ciclopirox for Cancer Treatment
Recent Patents on Anti-Cancer Drug Discovery Risk Factors for Node Affectation and Recurrence in Endometrial Cancer
Current Women`s Health Reviews Current Concepts on the Management of Chordoma
Current Drug Therapy Phytoestrogens: Implications in Neurovascular Research
Current Neurovascular Research Promising Chemoprevention of Colonic Aberrant Crypt Foci by <i>Portunus segnis</i> Muscle and Shell Extracts in Azoxymethane-Induced Colorectal Cancer in Rats
Anti-Cancer Agents in Medicinal Chemistry Radiolabeled Oligonucleotides for Antisense Imaging
Current Organic Synthesis