The body count is now mounting among girls adversely affected by Gardasil, the vaccine that's supposed to prevent cervical cancer.
As of March in the US, more than 7000 incidents were reported to the Vaccine Adverse Event Reporting System (VAERS), with 13 deaths, 204 hospitalizations and 124 chil-dren left disabled. Those who died suffered heart attacks or blood clots. However, if 10 per cent of all doctors reported vaccine reactions, the true US total would be closer to 70,000. Several deaths have also been recorded in the EU.
What went wrong? When Gardasil was licensed by the U.S. Food and Drug Administration (FDA) in June 2006, the vaccine was studied for its ability to prevent a condition that may or may not lead to cancer. The rationale for this vaccine is based
on the assumption that abnormal, or 'precancerous', cells in the cervix inevitably lead to cancer. However, there are four categories of abnor-mal lesions, or 'cervical interstitial neoplasia'-CIN 1, 2, 3 and cancer-and it is impossible to determine which of the early-stage lesions (CIN 1-2) will progress to cancer. Some will regress if left alone, while others will progress rapidly.
Medicine now agrees that, in the majority of cases, CIN 2 or even 3 does not become cancer. CIN 2 leads to true invasive cancer in only 5 per cent of cases, and CIN 3, just 12 per cent of the time (J Clin Pathol, 1998; 51: 96-103).
All of Gardasil's efficacy data shows that it can prevent certain strains of the human papillomavirus (HPV), but there is not one shred of evidence that it has prevented a single case of cancer.
Although some early reports claimed 100-per-cent efficacy, the larger FUTURE I and II trials, pub-lished last May (N Engl J Med, 2007; 356: 1915-27, 1928-43) found absolutely no clinical efficacy for the higher-grade levels of CIN-the very ones that are more likely to turn into cancer. In the larger, FUTURE II trial, signifi-cant clinical efficacy was demon-strated against CIN 2 lesions (the vast majority of which revert to normal on their own), but not the higher-grade ones-again, the only state that can validly be called a precursor to cancer.
Furthermore, the vaccine is only effective against those who have not been exposed to HPV. Yet, even in this group, it was only 17-per-cent effective against all dysplasias (N Engl J Med, 2007: 356: 1991-3).
Most worrying, the latest studies have found that protecting women against HPV strains 16 and 18 can lead to an increase of 20 per cent or more in other HPV-associated dysplasias that do lead to cancer. The vaccines target only four types of HPV, when at least 15 have been identified, and FUTURE II showed that the non-vaccine strains of HPV were responsible for a sizeable number of dysplasias recorded.
New dangers emerging
At the Immunotoxicology IV meeting in 2006, a small group of vaccine-company executives, plus several members of the FDA's Center for Drug Evaluation and Research, met to discuss toxicity associated with 'immunostimulation', as seen with a vaccine like the new HPV vaccine. The problems they identified in-cluded: cell and tissue abnormalities or injury; a cytokine 'storm', an excessive immune-system response; tumor lysis syndrome, a serious metabolic disorder causing break-down of cell DNA; and autoimmunity. These are the very conditions now being reported with Gardasil (J Immunotoxicol, 2008; 5: 33-41).
Besides damage to the girls and women themselves, the vaccine may cause congenital defects in the fetus of women who are pregnant when vaccinated. In Merck's initial studies, of the pregnancies that occurred within 30 days of vaccination, five cases of congenital anomalies were observed in those given Gardasil compared with 0 in those given a placebo. These birth defects included pyloric stenosis, serious damage to the colon and kidneys, hip dysplasia and club foot. Furthermore, among nursing mothers who were vaccinat-ed, a greater number of them had children with respiratory distress.
Despite these concerns, last April, the Scottish government announced ambitious plans to vaccinate all females under 18, and it appears that the UK-as in most things-is following in America's footsteps. Once again, we will only know if we have unleashed another carcinogen on an entire generation of women after the fact.
Side-effects coming to light
Thus far, the US Vaccine Adverse Event Reporting System (VAERS) database has received the following reports with Gardasil:
- blood and lymphatic system disorders
- nervous system disorders such as seizures, dizziness, headache and Guillain-Barr'e paralysis
- nausea, vomiting
- joint and muscle pain
- anaphylactic (extreme allergic) reaction and bronchospasm.