In a move likely to fuel the debate over Merck & Co.’s Gardasil cervical-cancer vaccine for young women, a conservative watchdog group disseminated new reports of serious adverse events linked to the vaccine. The reports included problems in pregnant women who had received Gardasil.

Health officials and Merck dismissed the adverse events as probably unrelated to the vaccine, which targets the human papillomavirus strains linked to most cervical cancers. Adverse events with drugs and vaccines are routinely reported to the Food and Drug Administration by doctors. But they don’t necessarily indicate that the medication or vaccine caused the event, which might be related to a person’s underlying health or other factors.

Eighteen women who received the vaccine while pregnant experienced complications, ranging from miscarriages to fetal abnormalities, according to new FDA data. The data were obtained by Judicial Watch, a group based in Washington, through a Freedom of Information Act request. Some states are debating whether to make the vaccine mandatory for schoolgirls. Judicial Watch opposes such school requirements. The new data also show that three female patients who received the vaccine died. However, Merck, the FDA and the Centers for Disease Control and Prevention, which helps the FDA monitor vaccine adverse events, said the deaths were unlikely to have been caused by Gardasil. Two of the women were taking birth-control pills and died from blood clots, a known risk of contraceptive medication, according to the CDC. The third, a 12-year-old girl, suffered from heart disease and died from a heart inflammation brought on by the flu, the CDC said. …

Some scientists have also raised doubts about the vaccine’s efficacy against cervical cancer and suggested that the billions of dollars likely to be spent on it in coming years might be better used to expand Pap screening among low-income women. Of the 1,637 adverse-event reports, 136 have been deemed serious by the FDA, ranging from seizures to Guillain-Barre Syndrome, a rare life-threatening disorder in which the immune system attacks nerves and induces paralysis.

Read more: http://online.wsj.com/article/SB117997026351112898.html

To summarize this published, peer-reviewed medical journal article: http://content.nejm.org/cgi/content/full/356/19/1991

1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the only recognized precursors to cervical cancer.

2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the strongest (and many would argue only valid) precursors to cervical cancer.

3. GARDASIL’s protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer “raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18.”

4. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias — many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That’s about $60,000 per dysplasia prevented.

This is all directly from the article linked above.

I myself would add that the use of a highly pharmacologically alum adjuvant as the sole “placebo” in both the FUTURE I & FUTURE II studies makes it impossible to accurately assess the overall risks of vaccination vs. non-vaccination in the real world. Furthermore, the fact that GARDASIL has been studied for safety in just a few hundred pre-teens (again using an alum injection as the “placebo”) is highly problematic.

Finally, even though we don’t have any decent quantitative numbers concerning GARDASIL’s safety (especially on a pre-teen population), we must consider that vaccines in general are not 100% safe. They can cause juvenile arthritis, Guillain-Barre syndrome and other major complications (such as temporary paralysis, fainting, and persistent pain, swelling and itching) in a small subset of the population. Vaccines are not like other medicines in that they are given to a lot of healthy people who would not otherwise contract any disease with or without vaccination. So vaccines must be reasonably effective for their benefits to outweigh their associated risks.