Origins:   Gardasil is a vaccine intended for girls and young women between the ages 9 to 26 to protect against human papillomavirus (HPV), a virus which is currently linked to an estimated 70% of known cervical cancer cases. Because Gardasil prevents only the onset of HPV infections (rather than curing those who have already been infected by HPV), health officials have advocated that girls be vaccinated for HPV prior to adolescence (or as soon as possible thereafter) in order to head off the occurrence of cervical cancer later in life.

The message quoted above warns that the Centers for Disease Control (CDC) has already received nearly 12,000 complaints about adverse medical issues related to Gardasil vaccinations, and that 32 young women died after receiving Gardasil vaccinations. Although this information is accurate in a strictly literal sense, it is a misleading presentation of raw data that does not in itself establish a causal connection between Gardasil and the posited medical dangers.

The CDC, in conjunction with the Food and Drug Administration (FDA), operates a program known as the Vaccine Adverse Event Reporting System (VAERS). The VAERS program collects and analyzes reports on adverse events following immunizations in order to help track the safety and efficacy of various vaccines. It is important to note that reports collected by VAERS are raw data; they do not in themselves establish causal connections between vaccines and adverse medical issues — such determinations cannot be made until the reports have been investigated, evaluated, and analyzed.

(To illustrate this concept, we offer the following [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][admittedly far-fetched] scenario: A man who received a flu vaccination and then accidentally hit his hand with a hammer a few hours later might legitimately report that soon after he received the flu vaccine, his hand began to throb painfully. Although such a report would be literally true, it would not establish any causal connection between the flu vaccine and the adverse medical symptom of a throbbing, painful hand.)

As the CDC stated in its 2009 article on “Reports of Health Concerns Following HPV Vaccination,” before the Gardasil HPV vaccine was licensed it was studied in five clinical trials involving over 21,000 girls and women of ages 9 through 26. Since that licensing the “CDC and FDA have been closely monitoring the safety of the HPV vaccine” and found that:

All serious reports for Gardasil have been carefully analyzed by medical experts. Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine.

As of December 31, 2008, there have been 32 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.

From June 2006 to March 2013, approximately 57 million doses of HPV vaccines were distributed and VAERS received approximately 22,000 adverse event reports occurring in girls and women who received them. As noted in a 2013 CDC follow-up announcement, 92% of those reports were classified as “non-serious,” the other 8% generally encompassed symptoms such as “headache, nausea, vomiting, fatigue, dizziness, syncope, and generalized weakness,” and adverse events reported to VAERS were “consistent with those identified during the vaccine’s pre-licensure clinical trials.” The CDC also noted that:

In 2011, the VSD (Vaccine Safety Datalink) studied the occurrence of specific adverse events following more than 600,000 doses of Gardasil. Adverse events in the HPV vaccinated population were compared to another appropriate population (such as adolescents vaccinated with vaccines other than HPV) and included Guillain-Barré syndrome (GBS), stroke, venous thromboembolism (VTE), appendicitis, seizures, syncope (fainting), allergic reactions, and a potentially life-threatening allergic reaction called anaphylaxis. None of these adverse events were found to be any more common after HPV vaccination than among the comparison groups.

As Matthew Herper wrote for Forbes about the reported “deaths caused by Gardasil” phenomenon

[L]et’s take a look at those 20,000 adverse events and 100 deaths and figure out what they mean. It’s absolutely clear that these are for the most part not side effects from Gardasil. Nor is the vaccine, which has been given to more than 10 million people, likely responsible for those deaths.

The Vaccine Adverse Event Reporting System was put in place in 1990 as a result of a 1986 law that requires health providers to report harm that comes to patients within a specific time period after vaccination. A great many of these reports can come from sales reps for drug manufacturers who hear about the incidents.

Unfortunately, VAERS data is notoriously spotty — better than nothing, but there’s no way to insure that potential side effects are reported. When a product gets bad press, the number of reported “adverse events” goes up. And there is no way to tell if a particular side effect is linked to the vaccine. Some people will die after any vaccination, not because vaccines cause death but because people, even babies and adolescents, die with terrible regularity.

It’s true that there have been 24,000 reports of adverse events with Gardasil. There have also been 60,000 reports of death with the mumps, measles, and rubella vaccine, and 26,000 following vaccination with Pfizer‘s Prevnar, for pneumococcus bacteria. And yes, it’s true that there have been 106 deaths reported after Gardasil vaccination. There have also been 101 deaths reported after vaccination with Prevnar 13, a new version of Prevnar introduced in 2010. It’s normal for these reports to pour in for safe vaccines.

You can’t directly link any of those adverse events or deaths directly to the vaccines, any more than you could blame it on my morning coffee if I got hit by a truck later today. So to try to make use of this data, researchers compare the rates at which negative side effects are reported for different vaccines. The CDC and FDA did this for HPV vaccines in 2009, looking at the first 12,424 reports to VAERS and publishing the result in the Journal of the American Medical Association. They did note 2 cases of unusual neurological symptoms similar to Lou Gehrig’s disease, and there was an increase in patients who had potentially dangerous blood clots, although 90% of those patients had a risk factor for those clots, such as taking birth control pills, that might explain the increase. The researchers specifically looked at Guillain-Barré Syndrome, a neurological disorder that had been linked to a bad batch of flu shots; there wasn’t a signal that this was a problem with Gardasil. The study did result in the FDA advising doctors to watch adolescents after they get their shots, because some faint.

Based on that analysis, it seems that of those dozens of deaths, only a handful could possibly be linked to Gardasil. And based on the data available, it is unlikely (though not impossible) that even those deaths were caused by the vaccine. The risks from the vaccine are very small and may be limited to headaches and fainting caused by the needle, not the vaccine itself. Gardasil has been studied in clinical trials of more than 30,000 people; Cervarix, the competitor vaccine, has run a similar gantlet.

A couple of other pieces of anti-Gardasil misinformation have been widely circulated, such as the video featuring Jenny Thompson of Health Sciences Institute which is linked at the end of the warning reproduced at the head of this page:

Note that this video deals primarily with subjects such as the political and moral issues involved with requiring HPV vaccinations for young girls, the notion that vaccinated girls might mistakenly believe they had been immunized against contracting sexually transmitted diseases (other than HPV), and the claim that cervical cancer deaths can be effectively eliminated through means other than HPV vaccinations. It offers no real evidence that Gardasil vaccinations are dangerous other than to cite the raw VAERS data referenced above (without noting that analysis of those reports failed to establish a causal link between HPV vaccinations and the reported serious adverse events).

Likewise, another much-reproduced article claims that in 2009, Dr. Diane Harper (who is consistently misidentified as “the lead researcher in the development of Gardasil and Cervarix”) gave a talk at which she “came clean” and admitted that “Gardasil and Cervarix don’t work, are dangerous, and weren’t tested.” That article grossly misrepresents what Dr. Harper actually said. Dr. Harper has expressed concerns such as how long protection from vaccines such as Gardasil will last (which is not a safety issue, but rather an issue of whether the expected results of an HPV immunization program will justify the financial costs), and whether the marketing of Gardasil might lead some women to avoid taking other STD-preventing precautions, but she has never said that Gardasil “doesn’t work,” “wasn’t tested,” or was “dangerous,” as explained in great detail at the Skeptical Report blog:

In a 2012 peer-reviewed article about Cervarix, Dr. Harper states that “Cervarix is an excellent choice for both screened and unscreened populations due to its long-lasting protection, its broad protection for at least five oncogenic HPV types, the potential to use only one-dose for the same level of protection, and its safety.” Again, she speculates that cervical cancer screening may be just as useful, but nowhere does she recommend that the vaccine not be used, that it’s safety profile is unacceptable, or that the vaccine cannot prevent cancer. In fact, she recommends expanding the guidelines for HPV vaccines for older women because as they age, they are more susceptible to other serotypes of HPV, against which Cervarix confers protection. She also states that Cervarix may also have a protective effect against some autoimmune disorders. This does not sound like a researcher who is losing sleep about the HPV vaccine, but who fully supports its use, with some exceptions.

Dr. Diane Harper is one of the leading researchers in biomedical science, an individual who has spent her life studying vaccines. She has the academic training and research credibility at a level that if she said “Gardasil is dangerous,” many of us would stand up and begin to wonder. But the facts are she has not said anything of the sort about Gardasil and Cervarix. In peer-reviewed articles published in important, high impact journals, she has given strong, but scientifically qualified, endorsements to HPV vaccines. These are the facts. Any other allegations about her lack of support for vaccinations is based on misinformation, disinformation and lies.

A 2009 CBS News interview with Dr. Harper is often cited as contradicting this assessment, but it does not: Dr. Harper did not state during that interview that Gardasil doesn’t work, is dangerous, or wasn’t tested. Given questions about how long the vaccine is effective for, she questioned the efficacy of giving shots to girls as young as 11 years old in parts of the world (such as the U.S.) where women regularly undergo safety Pap screening repeatedly over their lifetimes, saying that the chances of their contracting cervical cancer may be less than the “small” risks associated with the vaccine. But Dr. Harper also noted that the risks of death surrounding the administration of Gardasil were “very rare,” and that she “agrees with Merck and the CDC that Gardasil is safe for most girls and women.”