Hostname: page-component-76fb5796d-vvkck Total loading time: 0 Render date: 2024-04-27T02:55:30.440Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  01 January 2021

Lucija Tomljenovic  and
Christopher A. Shaw
Get access Rights & Permissions [Opens in a new window]

Extract

There are not many public health issues where views are as extremely polarized as those concerning vaccination policies. Ever since its Fast Track approval by the U.S. Food and Drug Administration (FDA) in 2006, Merck's human papilloma virus (HPV) vaccine Gardasil has been sparking controversy. Initially, the criticism has been focused at Merck, due to their overly aggressive marketing strategies and lobbying campaigns. According to a 2007 editorial in Nature Biotechnology, Surrounded by a chorus of disapproval, Merck cracked. As Nature Biotechnology went to press, the company announced a cessation of all efforts to lobby for US state laws requiring compulsory vaccination. Subsequently, questions have been raised whether it was appropriate for vaccine manufacturers to partake in public health policies when their conflicts of interests were so obvious. Some of their advertising campaign slogans, such as cervical cancer kills x women per year and your daughter could become one less life affected by cervical cancer, seemed more designed to promote fear rather than evidence-based decision making about the potential benefits of the vaccine versus any risks.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 3 , Fall 2012 , pp. 673 - 681
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

“Flogging Gardasil,” Nature Biotechnology 25, no. 3 (2007): 261.CrossRefGoogle Scholar
Rothman, S. M. Rothman, D. J., “Marketing Hpv Vaccine: Implications for Adolescent Health and Medical Professionalism,” JAMA 302, no. 7 (2009): 781–786.CrossRefGoogle Scholar
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 <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm>(last visited September 11, 2012).(last+visited+September+11,+2012).>Google Scholar
Frazer, I., “God's Gift to Women: The Human Papillomavirus Vaccine,” Immunity 25, no. 2 (2006): 17984–17984.CrossRefGoogle Scholar
McGreal, C. Sample, I., “Michele Bachmann HPV Row Prompts Fears for Vaccine Programme in US,” The Guardian, available at <http://www.guardian.co.uk/world/2011/sep/14/michele-bachmann-hpv-vaccine>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
American Academy of Pediatrics (AAP), Statement on HPV Vaccine, Press Release, September 11, 2011, available at <http://www.aap.org/advocacy/releases/hpv2011.pdf>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
USNewswire, “Michele Bachmann Correct to Criticize Gardasil Mandate, Doctors Say, available at <http://www.prnewswire.com/news-releases/michele-bachmann-correct-to-criticize-gardasil-mandate-doctors-say-129824558.html>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
Centers for Disease Control (CDC), “National and State Vaccination Coverage among Adolescents Aged 13 through 17 Years” MMWR 60, no. 33 (2011): 1117–23.Google Scholar
Gostin, L. O., “Mandatory HPV Vaccination and Political Debate,” JAMA 306, no. 15 (2011): 1699700–1699700.CrossRefGoogle Scholar
See Rothman, Rothman, , supra note 2; Tomljenovic, L. Shaw, A. E.,“Human Papillomavirus (HPV) Vaccine Policy and Evidence-Based Medicine: Are They at Odds?” Ann Med (2011); Tomljenovic, L. Shaw, A. E., “Who Profits from Uncritical Acceptance of Biased Estimates of Vaccine Efficacy and Safety?” American Journal of Public Health 102, no. 9 (2012): e13–4; see note 1; Rothman, Rothman, , supra note 2.Google Scholar
See “Flogging Gardasil,” supra note 1.Google Scholar
See Rothman, Rothman, , supra note 2.Google Scholar
Haug, C., “The Risks and Benefits of HPV Vaccination,” JAMA 302, no. 7 (2009): 795–6.CrossRefGoogle Scholar
Medical News Today, “Merck Launches National Advertising Campaign for Gardasil, Merck's New Cervical Cancer Vaccine,” available at <http://www.medicalnewstoday.com/releases/57419.php>(last visited September 18, 2011).(last visited September 18, 2011).' href=https://scholar.google.com/scholar?q=Medical+News+Today,+“Merck+Launches+National+Advertising+Campaign+for+Gardasil,+Merck's+New+Cervical+Cancer+Vaccine,”+available+at+(last+visited+September+18,+2011).>Google Scholar
See Rothman, Rothman, , supra note 2.Google Scholar
McGee, G. Johnson, S., “Has the Spread of Hpv Vaccine Marketing Conveyed Immunity to Common Sense?” American Journal of Bioethics 7, no. 7 (2007): 1–2.Google Scholar
See FDA, supra note 3.Google Scholar
Food and Drug Administration (FDA), “Fast Track, Accelerated Approval and Priority Review,” available at <http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
See FDA, supra note 18.Google Scholar
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 <http://apps.who.int/hpvcentre/statistics/dynamic/ico/country_pdf/XWX.pdf?CFID=5169709&CFTOKEN=39667351>(last visited September 6, 2012).(last visited September 6, 2012).' href=https://scholar.google.com/scholar?q=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).>Google Scholar
World Health Organization/Institut Catala d'Oncologia (WHO/ICO), Information Centre on Human Papilloma Virus and Cervical Cancer, available at <http://apps.who.int/hpvcentre/statistics/dynamic/ico/SummaryReportsSelect.cfm>(last visited September 6, 2012).(last visited September 6, 2012).' href=https://scholar.google.com/scholar?q=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).>Google Scholar
Tomljenovic, Shaw, A. E., “Human Papillomavirus (HPV) Vaccine Policy and Evidence-Based Medicine: Are They at Odds?” Annals of Medicine (2011).CrossRefGoogle Scholar
Harper, D. M. Nieminen, P. Paavonen, J. Lehtinen, M., “Cervical Cancer Incidence Can Increase Despite HPV Vaccination,” Lancet Infect Dis 10, no. 9 (2010): 594–595; author reply 95.CrossRefGoogle Scholar
Villa, L. Costa, R. L. Petta, C. A. Andrade, R. P. Paavonen, J. Iversen, O. E. Olsson, S. E. Hoye, J. Steinwall, M. Riis-Johannessen, G. Andersson-Ellstrom, A. Elfgren, K. Krogh, G. Lehtinen, M. Malm, C. Tamms, G. M. Giacoletti, K. Lupinacci, L. Railkar, R. Taddeo, F. J. Bryan, J. Esser, M. T. Sings, H. L. Saah, A. J. Barr, E., “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.CrossRefGoogle Scholar
See Tomljenovic, Shaw, , supra note 22.Google Scholar
Markowitz, L. E. Dunne, E. F. Saraiya, M. Lawson, H. W. Chesson, H. Unger, E. R., “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.Google Scholar
See FDA, supra note 18.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Villa, et al. supra note 24.Google Scholar
Ostor, A. G., “Natural History of Cervical Intraepithelial Neoplasia: A Critical Review,” International Journal of Gynecological Pathology 12, no. 2 (1993): 18692–18692.CrossRefGoogle Scholar
Harper, D. M. Vierthaler, S. L., “Next Generation Cancer Protection: The Bivalent Hpv Vaccine for Females,” ISRN Obstetrics and Gynecology 2011 (2011): 457204.CrossRefGoogle Scholar
See Villa, et al. supra note 24.Google Scholar
Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC), May 18, 2006 VRBPAC Meeting, Background Document: Gardasil&trade;, HPV Quadrivalent Vaccine, available at <http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006–4222B3.pdf>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
Spinosa, J. P. Riva, C. Biollaz, J., “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; Gerhardus, A. Razum, O., “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.CrossRefGoogle Scholar
See Gerhardus, Razum, , supra note 35.Google Scholar
See FDA, supra note 18.Google Scholar
Merck & Co., “Protection with Gardasil,” available at <http://www.gardasil.com/what-is-gardasil/cervical-cancer-vaccine/index.html>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
See AAP, supra note 6.Google Scholar
Centers for Disease Control (CDC), Information from FDA and CDC on Gardasil and its Safety (Archived). Last updated: February 7, 2011, available at <http://www.cdc.gov/vaccine-safety/Vaccines/HPV/HPVArchived.html>(last visited September 20, 2011).(last+visited+September+20,+2011).>Google Scholar
See CDC, supra note 8.Google Scholar
Harper, D. M. Williams, K. B., “Prophylactic Hpv Vaccines: Current Knowledge of Impact on Gynecologic Premalignancies,” Discovery Medicine 10, no. 50 (2010): 7–17.Google Scholar
Food and Drug Administration (FDA), “Gardasil (Human Papillomavirus Vaccine) Questions and Answers,” available at <http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm096052.htm>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
See FDA, supra note 34; Spinosa, et al. , supra note 35.Google Scholar
See Tomljenovic, Shaw, , supra note 22.Google Scholar
Mendoza Plasencia, Z. Gonzalez Lopez, M. Fernandez Sanfiel, M. L. Muniz Montes, J. R., “[Acute Disseminated Encephalomyelitis with Tumefactive Lesions after Vaccination against Human Papillomavirus],” Neurologia 25, no. 1 (2010): 589–58; Wildemann, B. Jarius, S. Hartmann, M. Regula, J. U. Hametner, C., “Acute Disseminated Encephalomyelitis Following Vaccination against Human Papilloma Virus,” Neurology 72, no. 24 (2009): 2132–2133; DiMario, F. J. Jr. Hajjar, M. Ciesielski, T., “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; McCarthy, J. E. Filiano, J., “Opsoclonus Myoclonus after Human Papilloma Virus Vaccine in a Pediatric Patient,” Parkinsonism & Related Disorders 15, no. 10 (2009): 792–794; Sutton, I. Lahoria, R. Tan, I. L. Clouston, P. Barnett, M. H., “CNS Demyelination and Quadrivalent HPV Vaccination,” Multiple Sclerosis 15, no. 1 (2009): 116–119.Google Scholar
See Tomljenovic, Shaw, , supra note 22.Google Scholar
Shaw, C. A. Petrik, M. S., “Aluminum Hydroxide Injections Lead to Motor Deficits and Motor Neuron Degeneration,” Journal of Inorganic Biochemistry 103, no. 11 (2009): 155562–155562; Israeli, E. Agmon-Levin, N. Blank, M. Shoenfeld, Y., “Adjuvants and Autoimmunity.” Lupus 18, no. 13 (2009): 1217–25; Couette, M. Boisse, M. F. Maison, P. Brugieres, P. Cesaro, P. Chevalier, X. Gherardi, R. K. Bachoud-Levi, A. C. Authier, F. J., “Long-Term Persistence of Vaccine-Derived Aluminum Hydroxide Is Associated with Chronic Cognitive Dysfunction,” Journal of Inorganic Biochemistry 103, no. 11 (2009): 1571–1578; Passeri, E. Villa, C. Couette, M. Itti, E. Brugieres, P. Cesaro, P. Gherardi, R. K. Bachoud-Levi, A. C. Authier, F. J., “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.CrossRefGoogle Scholar
Shoenfeld, Y. Agmon-Levin, N., “‘ASIA’ - Autoimmune/Inflammatory Syndrome Induced by Adjuvants,” Journal of Autoimmunity 36, no. 1 (2011): 4–8; Agmon-Levin, N. Hughes, Shoenfeld, Y., “The Spectrum of ASIA: ‘Autoimmune (Auto-Inflammatory) Syndrome Induced by Adjuvants,’” Lupus 21, no. 2 (2012):.CrossRefGoogle Scholar
Exley, C., “Aluminium-Based Adjuvants Should Not Be Used as Placebos in Clinical Trials,” Vaccine 29, no. 50 (2011): 9289.CrossRefGoogle Scholar
Merck & Co., Gardasil Product Sheet, Date of Approval 2006, available at <http://Www.Fda.Gov/Downloads/Biologics-bloodvaccines/Vaccines/Approvedproducts/Ucm111263.pdf>(last visited September 11, 2012).(last+visited+September+11,+2012).>Google Scholar
Angell, M., “Industry-Sponsored Clinical Research: A Broken System,” JAMA 300, no. 9 (2008): 1069–1071.CrossRefGoogle Scholar
See Tomljenovic, Shaw, , supra note 22; Tomljenovic, L. Shaw, C. A., “No Autoimmune Safety Signal after Vaccination with Quadrivalent HPV Vaccine Gardasil?” Journal of Internal Medicine (2012).CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
See Haug, , supra note 13.Google Scholar
Food and Drug Administration (FDA), Workshop on Non-clinical Safety Evaluation of Preventative Vaccines: Recent Advances and Regulatory Considerations, December 2, 2002, available at <http://www.fda.gov/downloads/biologicsblood-vaccines/newsevents/workshopsmeetingsconferences/transcriptsminutes/ucm054459.pdf>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
Lenzer, J., “FDA Is Incapable of Protecting Us against Another Voxx,” BMJ 329, no. 7477 (2004): 1253.CrossRefGoogle Scholar
See Lenzer, , supra note 57.Google Scholar
Id.Google Scholar
Krumholz, H. M. Ross, J. S. Presler, A. H. Egilman, D. S., “What Have We Learnt from Vioxx?” BMJ 334, no. 7585 (2007): 120–123.CrossRefGoogle Scholar
Food and Drug Administration (FDA), FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, 2007, available at <http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007–4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf>(last visited September 6, 2012).(last+visited+September+6,+2012).>Google Scholar
See Tomljenovic, Shaw, , supra note 10; See Tomljenovic, Shaw, , supra note 53; Tomljenovic, L. Shaw, C. A., “Mandatory HPV Vaccination.” JAMA 307, no. 3 (2012): 254; author reply 545–54; see Spinosa, et al. , supra note 35; Gerhardus, Razum, , supra note 35; Haug, , supra note 13.CrossRefGoogle ScholarPubMed
See CDC, supra note 40.Google Scholar
Id.Google Scholar
See Tomljenovic, Shaw, , supra note 22.Google Scholar
Centers for Disease Control (CDC), CDC WONDER VAERS Request, available at <http://wonder.cdc.gov/vaers.html>(last visited September 11, 2012).(last+visited+September+11,+2012).>Google Scholar
See CDC, supra note 66.Google Scholar
See FDA, supra note 61.Google Scholar