By: Marcia G. Yerman
28 December 2009
Throughout my examination of the Gardasil vaccine, there has been a steady flow of information, disinformation, and new developments. In my opening article, I wrote about the mandatory ruling in July of 2008 by the U.S. Citizenship and Immigration Services (USCIS) that would require all female green card applicants and immigrants between the ages of 11-26 to receive the Gardasil vaccine. As of December 14, 2009, that ruling was reversed.
In the larger conversation, perhaps no one professional has been quoted, and misquoted, more frequently than Dr. Diane Harper. The recipient of a Masters Degree in Public Health, Dr. Harper is a Professor and Vice-Chair of Research at the University of Missouri-Kansas City School of Medicine, specializing in Community and Family Medicine, Obstetrics and Gynecology, Bioinformatics and Personalized Medicine.
I first contacted Dr. Harper in September 2009 to get a primer on the Gardasil vaccine, and to gain insight into the issues that were being raised about the marketing and the safety of the vaccine. In addition to the questions that I raised this month with Dr. Harper, I asked her to contribute a statement that would clearly elucidate her point of view in her own words. She sent me what follows via e-mail.
“The most important point that I have always said from day one, is that the use of this vaccine must be done with informed consent and complete disclosure of the benefits and harms of Pap screening and HPV vaccines. The decision to be vaccinated must be the woman’s (or parent’s if it is for a young child), and not the physician’s or any board of health, as the vaccination contains personal risk that only the person can value.
As all of the information in the United States concerned Gardasil, since that was the only vaccine approved in the U.S. from June 2006 until this past October 2009, my comments have been focused on Gardasil.
My points are as follows:
The Benefits of Pap Screening:
• Individual benefit to detect early precancers.
• Public health benefit: Only when 70% of the population has been screened will the population incidence of cervical cancer drop.
• Pap tests do not kill or handicap.
The Harms of Pap Screening:
• Screening must be repeated throughout a woman’s life. One screen is not sufficient to protect her from cervical cancer.
• False negative rate of cytology screening: Among the women who develop cervical cancer in the U.S., 30% are women who have been routinely screened, and all their Paps have been normal.
• False positive rate of cytology screening: Women who screen abnormal are psychologically upset, anxious and left doubting the medical process (i.e. Her Pap was abnormal, but her colposcopy and biopsy were normal, with no explanation why her Pap was abnormal).
• Quality of life harms: Women with abnormal Paps have anxiety as high as women diagnosed with cervical cancer undergoing their surgical treatment. The stress of going to colposcopy and biopsy can be high for many women. The contemplation of a cervical biopsy and a scraping of the endocervical canal can lead to fear of pain.
• Relationship harms: Once women are told they have an abnormal Pap and that the Pap is abnormal because of a STD called HPV, most relationships are stressed as the partners attempt to understand who brought the infection to the relationship.
• Excisional treatments for detected precancerous lesions cause preterm deliveries in subsequent pregnancies, with concomitant low birth weight infants (which puts the infant at risk for life). In addition, scarring from the treatments lead to an increased cesarean section delivery method (as the cervix does not dilate normally due to scarring from prior excisions). These reproductive morbidities occur between 70%-300% more often in women with excisions.
• Recurrence of HPV associated cervical/vaginal/anal cancers at a rate of 3-12 times higher than those women who never had a cervical cancer precursor or cancer. These recurrences happen around ten years after treatment with peak recurrences between ten and twenty years from the initial treatment.
The Benefits of HPV vaccination:
• Cervarix protects against five cancer-causing types of HPV, which lead to CIN 2+ (precancers and cancers).
• Gardasil protects against three cancer-causing types of HPV, which lead to CIN 2+ (precancers and cancers).
• Cervarix induces antibody titers for HPV 16 and 18 that are at least ten fold higher than natural infection titers; the antibody titers for the other three cancer causing types (HPV 31, 45, 33) are also significantly higher than natural infection titers, and the titers stay high for at least 7.4 years – lasting the longer of either vaccines.
• Gardasil only maintains antibody titers for HPV 16 (not 18, not 11, not 6) at five years, making the true long lasting (five years) coverage of Gardasil only for one type of cancer causing HPV.
• If vaccination occurs within one year of the onset of sexual activity, there will be 57/1000 cases of all CIN 2+ types and persistent HPV 16/18 infections prevented, as compared to only 17/1000 cases prevented if virgins are vaccinated.
The Harms of HPV Vaccination:
• Duration of efficacy is key to the entire question. If duration is at least fifteen years, then vaccinating 11-year-old girls will protect them until they are 26 and will prevent some precancers, but postpone most cancers. If duration of efficacy is less than fifteen years, then no cancers are prevented, only postponed.
• Safety: There is at least one verified case of auto-immune initiated motor neuron disease declared triggered by Gardasil [presented by neurologists at the 2009 American Neurological Association meeting in Baltimore, Maryland). There are serious adverse events, including death, associated with Gardasil use.
• No population benefit in reduction of cervical cancer incidence in the United States with HPV vaccination as long as screening continues.
• Incidence rate of cervical cancer in the United States based on screening is 7/100,000 women per year.
• Incidence rate of cervical cancer if women are only vaccinated with Gardasil is 14/100,000 per year (twice the rate of cervical cancer if young women vaccinated with Gardasil do not seek Pap testing at 21 years and the rest of their life).
• Incidence rate of cervical cancer with Cervarix vaccination is 9/100,000 per year– better than with Gardasil, but still more than with screening alone.
• Incidence of cervical cancer without screening and without vaccination is nearly 90/100,000 per year. The combination of HPV vaccine and screening in the U.S. will not decrease the incidence of cervical cancer to any measurable degree at the population level. Those women who do not participate in Pap screening, and who are vaccinated, will have some personal benefit for five years for Gardasil and 7.4 years for Cervarix (maybe longer), but they will not affect the population rates.
Boosters for Gardasil after antibodies wane makes the cost of vaccination escalate significantly, and cause implementation challenges to reach those women who might want to be revaccinated.”