In mid 2006, a new vaccine against 4 strains of Human Papilloma Virus (HPV) was approved by the FDA for use in girls and women aged 9-26 years of age. Named Gardasil, it has been shown to effectively prevent acquisition of the strains of HPV that cause some 70% of cervical cancer cases and 90% of genital warts. Before being approved, the vaccine was tested on over 21,000 females and shown to be safe and extremely (99-100% depending on virus strain) effective – so much so, that the clinical trials were terminated early on the grounds that it was not ethical to deny the vaccine to the group receiving the placebo. Many US states have since implemented (or are in the midst of implementing) programs to routinely give the vaccine to girls entering the sixth grade.
It is certainly legitimate to debate whether this vaccine should be one routinely given to girls so young, if the vaccine’s effects will last into young adulthood for those given it as little girls (so far we know the effects last at least 5 years), and whether the girls will interpret having gotten the vaccine as carte blanche to have sex – unsafe or otherwise. But the attacks on the vaccine, both from the far right and the usual anti-vax contingent, have been to portray the vaccine as dangerous to the point of deadly: “Death toll from vaccine rises”, cries one such headline. And as to be expected, the personal injury lawyers are girding their loins.
The claims of death from the result of vaccination with Gardasil are based upon reports submitted to VAERS. As of late October, over 10,000 reports of adverse reactions (most of them – 94%, to be precise – minor) have been reported for Gardasil, among them 27 reports of deaths following receipt of the vaccine – this after about 20 million doses of vaccine have been given. However, as VAERS itself takes pains to point out:
When evaluating data from VAERS, it is important to note that for any reported event, no cause and effect relationship has been established. VAERS is interested in all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.
It’s important to note that deaths among the participants of the Gardasil trials were also noted, but when you see the breakdown of the causes of death, it’s fairly obvious that none of them had any clear connection to the vaccine (emphasis mine):
Across the clinical studies, 17 deaths were reported in 21,464 male and female subjects. The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (4 subjects who received GARDASIL and 3 placebo subjects), followed by overdose/suicide (1 subject who received GARDASIL and 2 subjects who received placebo), and pulmonary embolus/deep vein thrombosis (1 subject who received GARDASIL and 1 placebo subject). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, and 1 case of arrhythmia in the group that received GARDASIL, and 1 case of asphyxia in the placebo group.
Luckily for us, the VAERS has a searchable database, so we can search for the deaths reported after Gardasil administration. If the cause of death were really the vaccine, we would expect the deaths to be grouped within a certain (short) time period after administration and manifest in similar manners.
Here are the results of my VAERS database search for deaths associated with Gardasil. As you can see, I’ve managed to find 20 cases out of the 27 reported as of late August. The deaths are at variable times after administration of the vaccine. after different numbers of vaccine doses, and of what seem to be variable causes. This is consistent with the CDC’s assessment of the deaths, and why it considers them almost certainly not the result of the vaccine:
As of August 31, 2008, there have been 27 U.S. reports of death among females who have received the vaccine. There was no common pattern to the deaths that would suggest that they were caused by the vaccine. Of the 27 U.S. reports:
* 3 reports were related to diabetes or heart failure
* 3 reports were related to viral illnesses or meningitis (an infection in the brain)
* 2 reports were related to drug use
* 2 reports were related to blood clots
* 5 reports are being evaluated (attempting to follow up/identify case)
* 1 report is still under review or VAERS is still waiting for additional medical records, such as an autopsy report or death certificate
* 1 report of seizure disorder (history of seizures)
* 3 reports had an unknown cause of death
* 7 reports that could not be evaluated because they did not have enough information to identify the person, or to verify that a person had died.
According to the National Center for Health Statistics, the death rates for young women in 2005 (the latest year available) were:
10-14 years: 14.4/100,000 population
27 deaths out of 20 million doses Gardasil given (which translates at the very least to over 6 million girls) falls well within the expected death rates from any cause. Some of those deaths, unfortunately, will fall into the time period following a vaccine. Ditto for any other adverse reaction that may happen.
In fact, Siegrist et al tried to pre-empt this line of thinking by checking the incidence rate of various adverse events in a female population that happened at various time points after a given day, chosen arbitrarily. It’s a pity they didn’t look at death as an adverse event as well, but the results, as shown in the table below (courtesy of a book I’ve already recommended, Do Vaccines Cause That?), are pretty startling (click on the table to see it full-size):
In the interest of full disclosure: unless there are any unexpected revelations about Gardasil in the next four years, I intend to give it to my daughter when she comes of age – even though she’s going to an all-girls school. (She does have a boyfriend, however. And they play ‘getting married’ very often. Sometimes she wears the white dress, sometimes he does 🙂 . ).