HPV Vaccine Causes Public Concern despite FDA/CDC Support

The US Food and Drug Administration (FDA) has documented more than 9700 adverse events related to HPV vaccine, as of June 30, 2008 – numbers that are causing public concern. HPV vaccine “side effects that have been reported are real and they cannot be brushed aside," according to Diane Harper, MD, from the Dartmouth Medical School, in Hanover, New Hampshire in, a statement to Medscape Oncology. Dr. Harper was a principal investigator during clinical trials of the vaccine.

The most serious complications include neurologic, thromboembolic (blood clot), and autoimmune events in those who received HPV vaccine. Guillain-Barré syndrome, headache, thrombembolism, gastrointestinal complaints, disorders of the lymphatic system, hypersensitivity reactions, bronchospasm, musculoskeletal disorders, connective tissue abnormalities, and generalized rash (urticaria) are among the most serious documented effects seen in women who have received the vaccine. More common, and less worrisome difficulties include fainting, nausea, fever, and pain at the site of injection.

Sixteen million doses of HPV vaccine have been supplied to the US, many stocked by school clinics. The reports of serious events has women wondering what to do next, especially given the fact that no one knows exactly what in the vaccine is responsible for the complications.

Many anti-vaccine proponents believe that aluminum salts in vaccines are dangerous, but according to Dr. Harper, “The scientific work to date seems to suggest that aluminum salts in vaccines are safe." The vaccine manufacturer insists HPV vaccines is safe - "Merck has analyzed the adverse events reported for Gardasil relating to the recent reports of death and paralysis, and based on the data available to Merck, believes that no safety issue related to the vaccine has been identified. These types of events are events that could also be seen in the general population."

Unfortunately, public confidence is lacking, even from the medical community. Scott Ratner, MD, a cardiologist with a practice in Franklin Square, New York, and his wife, a rheumatologist had their daughter vaccinated. Dr Ratner says, "She went from being a healthy, active teen running, playing lacrosse, and participating on swim team to becoming a chronically ill patient," showing signs of autoimmune disease. Christiane Northrup, MD, on the Oprah Winfrey show, told women that healthcare spending might be better utilized on promoting good nutrition, and wellness. She feels that a focus on healthy immunity is likely to remain a better approach for preventing and fighting disease.

The FDA and the Centers for Disease Control and Prevention (CDC) issued a joint statement on reassuring doctors and patients about the safety of Gardasil, in response to public concerns, but there is no question that HPV vaccine is not the only player in cervical cancer prevention. Andreas Ullrich, MD, medical officer at WHO's department of chronic diseases and health promotion, said in a news release, “There is no question that early detection will continue to be a key element."

Abby Lippman, PhD, from McGill University, in Montreal, Quebec, chair of the policy committee at the Canadian Women's Health Network, expresses concern about public policies that promote the vaccine, saying - "Why the hurry, especially in developed countries where there is no epidemic of infection and mortality rates from cervical cancer have been in decline.” The statement appears this month's issue of the Journal of Epidemiology and Community Health. Dr. Lippman also supports the role of natural immunity, saying that 90% of HPV infections will resolve within 1-2 years in healthy, immunocompetent women. Dr. Lippman’ concern that “the very short-term immunogenicity and safety, and not the efficacy, of Gardasil was studied” in clinical trials, leaves many questions for the medical community and consumers alike.

Healthcare providers and consumers should report any adverse events associated with Gardasil to the company and to the US Vaccine Adverse Event Reporting System at 1-800-822-7967.


Human papillomavirus (HPV) vaccination and the development of public policies
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Information from FDA and CDC on Gardasil and its Safety