Too Fast or Not Too Fast: The FDA's Approval of Merck's HPV Vaccine Gardasil

Journal of Law, Medicine and Ethics

Volumn 40, Issue 3, 2012, Pages 673-681

  Tomljenovic, Lucija ^a   Shaw, Christopher A ^a  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN PAPILLOMAVIRUS VACCINE L1, TYPE 6,11,16,18; WART VIRUS VACCINE;

ADOLESCENT; ADULT; ARTICLE; CHILD; CONFLICT OF INTEREST; DRUG APPROVAL; DRUG INDUSTRY; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; MANAGEMENT; PATIENT SAFETY; POLITICS; POSTMARKETING SURVEILLANCE; TIME; UNITED STATES; YOUNG ADULT;

ADOLESCENT; ADULT; CHILD; CONFLICT OF INTEREST; DRUG APPROVAL; DRUG INDUSTRY; FEMALE; HUMANS; PAPILLOMAVIRUS VACCINES; PATIENT SAFETY; POLICY MAKING; POLITICS; PRODUCT SURVEILLANCE, POSTMARKETING; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 84867616480     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2012.00698.x     Document Type: Article

References (49)

1. "Flogging Gardasil, " Nature Biotechnology 25, no. 3 (2007): 261.
2. S. M. Rothman and D. J. Rothman, "Marketing Hpv Vaccine: Implications for Adolescent Health and Medical Professionalism, " JAMA 302, no. 7 (2009): 781-786.
3. Food and Drug Administration (FDA), News Release, June 8, 2006, FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus: Rapid Approval Marks Major Advancement in Public Health, available at (last visited September 11, 2012).
4. I. Frazer, "God's Gift to Women: The Human Papillomavirus Vaccine, " Immunity 25, no. 2 (2006): 179-84.
5. C. Mcgreal and I. Sample, "Michele Bachmann HPV Row Prompts Fears for Vaccine Programme in US, " The Guardian, available at (last visited September 6, 2012).
6. American Academy of Pediatrics (AAP), Statement on HPV Vaccine, Press Release, September 11, 2011, available at (last visited September 6, 2012).
7. USNewswire, "Michele Bachmann Correct to Criticize Gardasil Mandate, Doctors Say, available at (last visited September 6, 2012).
8. Centers for Disease Control (CDC), "National and State Vaccination Coverage among Adolescents Aged 13 through 17 Years" MMWR 60, no. 33 (2011): 1117-23.
9. L. O. Gostin, "Mandatory HPV Vaccination and Political Debate, " JAMA 306, no. 15 (2011): 1699-700.
10. C. Haug, "The Risks and Benefits of HPV Vaccination, " JAMA 302, no. 7 (2009): 795-6.
11. Medical News Today, "Merck Launches National Advertising Campaign for Gardasil, Merck's New Cervical Cancer Vaccine, " available at (last visited September 18, 2011).
12. G. McGee, and S. Johnson, "Has the Spread of Hpv Vaccine Marketing Conveyed Immunity to Common Sense?" American Journal of Bioethics 7, no. 7 (2007): 1-2.
13. Food and Drug Administration (FDA), "Fast Track, Accelerated Approval and Priority Review, " available at (last visited September 6, 2012).
14. World Health Organization/Institut Catala d'Oncologia (WHO/ICO) HPV Information Centre, Human Papillomavirus and Related Cancers: Summary Report Update, November 15, 2010, available at (last visited September 6, 2012).
15. World Health Organization/Institut Catala d'Oncologia (WHO/ICO), Information Centre on Human Papilloma Virus and Cervical Cancer, available at (last visited September 6, 2012).
16. Tomljenovic and A. E. Shaw, "Human Papillomavirus (HPV) Vaccine Policy and Evidence-Based Medicine: Are They at Odds?" Annals of Medicine (2011).
17. D. M. Harper, P. Nieminen, J. Paavonen, and M. Lehtinen, "Cervical Cancer Incidence Can Increase Despite HPV Vaccination, " Lancet Infect Dis 10, no. 9 (2010): 594-595; author reply 95.
18. L. Villa, R. L. Costa, C. A. Petta, R. P. Andrade, J. Paavonen, O. E. Iversen, S. E. Olsson, J. Hoye, M. Steinwall, G. Riis-Johannessen, A. Andersson-Ellstrom, K. Elfgren, G. Krogh, M. Lehtinen, C. Malm, G. M. Tamms, K. Giacoletti, L. Lupinacci, R. Railkar, F. J. Taddeo, J. Bryan, M. T. Esser, H. L. Sings, A. J. Saah, and E. Barr, "High Sustained Efficacy of a Prophylactic Quadrivalent Human Papillomavirus Types 6/11/16/18 l1 Virus-Like Particle Vaccine through 5 Years of Follow-Up, " British Journal of Cancer 95, no. 11 (2006): 1459-1466.
19. L. E. Markowitz, E. F. Dunne, M. Saraiya, H. W. Lawson, H. Chesson, and E. R. Unger, "Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), " Morbidity and Mortality Weekly Report: Recommendations and Reports 56, no. RR-2 (2007): 1-24.
20. A. G. Ostor, "Natural History of Cervical Intraepithelial Neoplasia: A Critical Review, " International Journal of Gynecological Pathology 12, no. 2 (1993): 186-92.
21. D. M. Harper and S. L. Vierthaler, "Next Generation Cancer Protection: The Bivalent Hpv Vaccine for Females, " ISRN Obstetrics and Gynecology 2011 (2011): 457204.
22. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC), May 18, 2006 VRBPAC Meeting, Background Document: Gardasil™, HPV Quadrivalent Vaccine, available at (last visited September 6, 2012).
23. J. P. Spinosa, C. Riva, and J. Biollaz, "Letter to the Editor Response to the Article of Luisa Lina Villa Hpv Prophylactic Vaccination: The First Years and What to Expect from Now, in Press, " Cancer Letters 304, no. 1 (2011): 70
24. A. Gerhardus and O. Razum, "A Long Story Made Too Short: Surrogate Variables and the Communication of Hpv Vaccine Trial Results.?" J Epidemiol Community Health 64, no. 5 (2010): 377-8.
25. Merck & Co., "Protection with Gardasil, " available at (last visited September 6, 2012).
26. Centers for Disease Control (CDC), Information from FDA and CDC on Gardasil and its Safety (Archived). Last updated: February 7, 2011, available at (last visited September 20, 2011).
27. D. M. Harper and K. B. Williams, "Prophylactic Hpv Vaccines: Current Knowledge of Impact on Gynecologic Premalignancies, " Discovery Medicine 10, no. 50 (2010): 7-17.
28. Food and Drug Administration (FDA), "Gardasil (Human Papillomavirus Vaccine) Questions and Answers, " available at (last visited September 6, 2012).
29. Z. Mendoza Plasencia, M. Gonzalez Lopez, M. L. Fernandez Sanfiel, and J. R. Muniz Montes, "[Acute Disseminated Encephalomyelitis with Tumefactive Lesions after Vaccination against Human Papillomavirus], " Neurologia 25, no. 1 (2010): 58-9
30. B. Wildemann, S. Jarius, M. Hartmann, J. U. Regula, and C. Hametner, "Acute Disseminated Encephalomyelitis Following Vaccination against Human Papilloma Virus, " Neurology 72, no. 24 (2009): 2132-2133
31. F. J. DiMario, Jr., M. Hajjar, and T. Ciesielski, "A 16-Year-Old Girl with Bilateral Visual Loss and Left Hemiparesis Following an Immunization against Human Papilloma Virus, " Journal of Child Neurology 25, no. 3 (2010): 321-327
32. J. E. McCarthy and J. Filiano, "Opsoclonus Myoclonus after Human Papilloma Virus Vaccine in a Pediatric Patient, " Parkinsonism & Related Disorders 15, no. 10 (2009): 792-794
33. I. Sutton, R. Lahoria, I. L. Tan, P. Clouston, and M. H. Barnett, "CNS Demyelination and Quadrivalent HPV Vaccination, " Multiple Sclerosis 15, no. 1 (2009): 116-119.
34. C. A. Shaw and M. S. Petrik, "Aluminum Hydroxide Injections Lead to Motor Deficits and Motor Neuron Degeneration, " Journal of Inorganic Biochemistry 103, no. 11 (2009): 1555-62
35. E. Israeli, N. Agmon-Levin, M. Blank, and Y. Shoenfeld, "Adjuvants and Autoimmunity.?" Lupus 18, no. 13 (2009): 1217-25
36. M. Couette, M. F. Boisse, P. Maison, P. Brugieres, P. Cesaro, X. Chevalier, R. K. Gherardi, A. C. Bachoud-Levi, and F. J. Authier, "Long-Term Persistence of Vaccine-Derived Aluminum Hydroxide Is Associated with Chronic Cognitive Dysfunction, " Journal of Inorganic Biochemistry 103, no. 11 (2009): 1571-1578
37. E. Passeri, C. Villa, M. Couette, E. Itti, P. Brugieres, P. Cesaro, R. K. Gherardi, A. C. Bachoud-Levi, and F. J. Authier, "Long-Term Follow-Up of Cognitive Dysfunction in Patients with Aluminum Hydroxide-Induced Macrophagic Myofasciitis (MMF), " Journal of Inorganic Biochemistry 105, no. 11 (2011): 1457-1463.
38. Y. Shoenfeld and N. Agmon-Levin, "'ASIA'- Autoimmune/Inflammatory Syndrome Induced by Adjuvants, " Journal of Autoimmunity 36, no. 1 (2011): 4-8.
39. N. Agmon-Levin, Hughes, and Y. Shoenfeld, "The Spectrum of ASIA: 'Autoimmune (Auto-Inflammatory) Syndrome Induced by Adjuvants, '?" Lupus 21, no. 2 (2012): 118-120.
40. C. Exley, "Aluminium-Based Adjuvants Should Not Be Used as Placebos in Clinical Trials, " Vaccine 29, no. 50 (2011): 9289.
41. Merck & Co., Gardasil Product Sheet, Date of Approval 2006, available at (last visited September 11, 2012).
42. M. Angell, "Industry-Sponsored Clinical Research: A Broken System, " JAMA 300, no. 9 (2008): 1069-1071.
43. See Tomljenovic and Shaw, supra note 22; L. Tomljenovic, and C. A. Shaw, "No Autoimmune Safety Signal after Vaccination with Quadrivalent HPV Vaccine Gardasil?" Journal of Internal Medicine (2012).
44. Future II Study Group, "Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions, " New England Journal of Medicine 356, no. 19 (2007): 1915-1927.
45. Food and Drug Administration (FDA), Workshop on Nonclinical Safety Evaluation of Preventative Vaccines: Recent Advances and Regulatory Considerations, December 2, 2002, available at (last visited September 6, 2012).
46. J. Lenzer, "FDA Is Incapable of Protecting Us against Another Voxx, " BMJ 329, no. 7477 (2004): 1253.
47. H. M. Krumholz, J. S. Ross, A. H. Presler, and D. S. Egilman, "What Have We Learnt from Vioxx?" BMJ 334, no. 7585 (2007): 120-123.
48. Food and Drug Administration (FDA), FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, 2007, available at (last visited September 6, 2012).
49. Centers for Disease Control (CDC), CDC WONDER VAERS Request, available at (last visited September 11, 2012).