Is Gardasil safe? Was the HPV vaccine promoted unfairly? Will H1N1 vaccinations injure?

Teresa Binstock
Researcher in Developmental & Behavioral Neuroanatomy
August 19, 2009

Are vaccinations as safe as we are led to believe?  Perhaps not! Are vaccination recommendations biased by lucrativity? Apparently so!

An editorial and paper in JAMA (the Journal of the American Medical Association) sound an unexpected alarm regarding the risks and marketing Gardasil (1-2). The editorial is free online (2). Similarly, is the highly promoted rush to vaccinate against H1N1 occurring with medical-association promotionalism and with complete disregard for adverse effects?

For now, let's focus upon Gardasil. A CBS headline asks, "Is the HPV Vaccine Safe?" The news article's subtitle states, "First Major Study Released on [HPV] Vaccine's Side Effects, Plus a Review of Merck's Marketing Tactics". (3)  The advertisers-role played by medical societies is summarized: "Critics question the vaccine maker's aggressive ad campaign, because it paid medical societies to help spread the word, and underplayed the importance of evaluating the vaccine's risks and benefits. (3)  In other words, marketing efficacy had priority over safety.

Indeed, JAMA's editorialists wrote, "The fact that the medical societies repeated this message is what concerns us." (4)  As a parallel, this year's ongoing hyper-promotion of H1N1 vaccinations comes to mind.

Back to Gardasil. Consider a summary by Diane Harper, M.D., "Although the number of serious adverse events is small and rare, they are real and cannot be overlooked or dismissed without disclosing the possibility to all other possible vaccine recipients," said Dr. Diane Harper, director of the Gynecologic Cancer Prevention Research Group at University of Missouri. "The rate of serious adverse events is greater than the incidence rate of cervical cancer." (4)

We repeat and emphasize, "The rate of serious adverse events is greater than the incidence rate of cervical cancer." We wonder how many of Gardasil's adverse events further boosted revenues for physicians, hospitals, and pharmaceutical companies?  And more generally, has the medication- and vaccination-delivery system come to have built-in incentives whereby poorly tested and untested vaccinations and their adverse effects are too profitable?

Noteworthy are the facts (a) ABC's Tim Johnson, M.D., recommends parental caution regarding Gardasil (5), and (b) U.S. Senator Charles E. Grassley, (R-Iowa) is attempting to correct pharmaceutical promotionalism inherent in medical ghostwriting, whereby seemingly peer-reviewed articles are "carefully calibrated to help the manufacturers sell more products". (6).

The CDC's findings about Gardasil's adverse events and JAMA's editorial about reckless marketing have a larger context: (i) the high profitability of vaccines and vaccinations (eg, 7-8), and (ii) the marketing boost given by trade groups known as medical associations: "Merck & Co. paid three medical associations to promote Gardasil, a vaccine that protects against a sexually transmitted disease, a U.S. medical journal reports." (9) 

Let us be aware: Will today's rush to H1N1 vaccinations become next year's headlines describing adverse effects and medical promotionalism? (10)


1. Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine
Barbara A. Slade, MD et al.
JAMA. 2009;302(7):750-757.

Context:  In June 2006, the Food and Drug Administration licensed the quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine (qHPV) in the United States for use in females aged 9 to 26 years; the Advisory Committee on Immunization Practices then recommended qHPV for routine vaccination of girls aged 11 to 12 years.
Objective:  To summarize reports to the Vaccine Adverse Event Reporting System (VAERS) following receipt of qHPV.
Design, Setting, and Participants:  Review and describe adverse events following immunization (AEFIs) reported to VAERS, a national, voluntary, passive surveillance system, from June 1, 2006, through December 31, 2008. Additional analyses were performed for some AEFIs in prelicensure trials, those of unusual severity, or those that had received public attention. Statistical data mining, including proportional reporting ratios (PRRs) and empirical Bayesian geometric mean methods, were used to detect disproportionality in reporting.
Main Outcome Measures:  Numbers of reported AEFIs, reporting rates (reports per 100 000 doses of distributed vaccine or per person-years at risk), and comparisons with expected background rates.
Results:  VAERS received 12 424 reports of AEFIs following qHPV distribution, a rate of 53.9 reports per 100 000 doses distributed. A total of 772 reports (6.2% of all reports) described serious AEFIs, including 32 reports of death. The reporting rates per 100 000 qHPV doses distributed were 8.2 for syncope; 7.5 for local site reactions; 6.8 for dizziness; 5.0 for nausea; 4.1 for headache; 3.1 for hypersensitivity reactions; 2.6 for urticaria; 0.2 for venous thromboembolic events, autoimmune disorders, and Guillain-Barré syndrome; 0.1 for anaphylaxis and death; 0.04 for transverse myelitis and pancreatitis; and 0.009 for motor neuron disease. Disproportional reporting of syncope and venous thromboembolic events was noted with data mining methods.
Conclusions:  Most of the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events. The significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system.

Author Affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia (Drs Slade, Vellozzi, Markowitz, and Iskander and Ms Leidel); US Food and Drug Administration,Washington, DC (Drs Woo, Hua, Sutherland, Izurieta, Ball, Miller, and Braun).

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