2/4/2007

AAPS Statement on Human Papillomavirus (HPV) Vaccine
(updated Feb 5, 2007)

The Association of American Physicians and Surgeons is a national group of physicians in all specialties founded in 1943. It represents thousands of physicians who care for millions of patients in all states.

AAPS makes the following observations about HPV vaccine:

1. The vaccine is claimed to prevent cancer�of the cervix. Pap smears have already made advanced cervical cancer rare in the United States. Money spent on this very expensive vaccine could likely prevent more cancer if spent on screening clinics and colposcopy clinics for women unable to afford vaccine, Pap smears, or treatment.

2. At best, the vaccine is only partly effective; vaccinated women still need Pap smears. A MedLine search of the medical literature shows that no study has actually shown cancer prevention yet, only a reduction in abnormal Pap smears. This is called a �surrogate endpoint� (a substitute for the real thing), in the words of Dr. Kenneth Hatch of the University of Arizona, in a presentation to hospital medical staff about the vaccine. Such findings may resolve on their own, or may progress to cancer, over a period of years. The longest follow-up period in published vaccine studies is about 5 years; it usually takes decades for cervical cancer to develop. By 2020, there may be proof of efficacy against cancer (carcinoma in situ) in an ongoing Finnish study, which has enrolled 2,404 of 24,046 women invited to receive vaccine (Intl J STD & AIDS 2006;17:512-521). The vaccine only protects against 70 percent of the strains associated with invasive cancers, according to the Gardasil package insert.

3. Vaccine protection may only last a few years. Boosters may be needed every 10 years (Clin Obstet Gynecol 2005;48:226-240), or perhaps every 5.

4. There is no public-health purpose for mandating HPV vaccine for schoolchildren. HPV is a sexually transmitted disease.

5. Proof of safety is unconvincing to many. The vaccine is claimed to be safe and �well-tolerated,� but studies have involved fewer than 20,000 women, most of them over 16 years of age, for less than 5 years. According to the package insert, �arthritic symptoms� occurred three times as often in subjects who got the vaccine, compared to subjects who only got the �adjuvant� components of the vaccine (aluminum-containing compounds to increase effectiveness). And side effects from the �placebo� containing adjuvant were far more frequent than with a saline placebo, as shown in the package insert. An increased risk of juvenile rheumatoid arthritis�a deforming, devastating, lifelong disease�is being watched for, stated Dr. Hatch. Many people would not trade even a 1 in 1,000 or 1 in 10,000 increased risk of JRA for partial protection against warts, which are usually the only effect of HPV. Risk of autoimmune diseases may be greater with boosters.

6. Mandates are medically unethical. AAPS believes that all medical procedures, including vaccines, require informed consent, with very rare exceptions. Concerning HPV vaccine, which it believes can be �recommended,� the Department of Family Medicine and Clinical Epidemiology, University of Pittsburgh School of Medicine, concluded: �[G]iven concerns for autonomy, justice, as not all persons are at risk, and non-maleficence, HPV vaccine should not be mandated for school entry� (Vaccine 2006;24:4812-4820).

Contact: Jane M. Orient, M.D., F.A.C.P., 800.635.1196