Judicial Watch Special Report on Gardasil: How Safe And Effective Is It?
A few years ago, Judicial Watch, a non-partisan educational foundation dedicated to transparency and accountability in government, published a review of FDA (Food and Drug Administration) records relating to Gardasil, the HPV vaccine marketed by Merck, that it had requested under the Freedom of Information Act. Although it was published in 2008, this Special Report is still relevant to the vaccine safety debate today.
What is HPV?
HPV, or the Genital Human Papillomavirus, is the most common sexually transmitted disease in the world, with at least 50% of sexually active men and women getting it at some point in their lives (according to estimates by the Center for Disease Control). There are around forty strains of genital HPV, of which fifteen are considered high-risk by the National Cancer Society. Of these, two strains, HPV-16 and HPV-18, are responsible for approximately 70% of cervical cancer cases worldwide.
HPV clears the body on its own, usually without any treatment. Many people who are infected with HPV do not even know they have the disease, since they never show any symptoms. According to Dr. Diane Harper, one of the researchers who developed the vaccine for Merck, the body’s immune system fights of the virus within two years in 90% of HPV cases. However, when the body is not able to fight it off, genital warts or Cervical intraepithelial neoplasia (CIN), also known as cervical dysplasia and cervical interstitial neoplasia, can occur, which can lead to cervical cancer in a small percentage of cases . The CDC estimates that around 12,000 women are diagnosed with cervical cancer every year, and the disease kills 4,000 American women each year.
What is Gardasil?
Gardasil is a vaccine created by Merck that is supposed to protect against four types of HPV – two that can cause genital warts, and two that may lead to cervical cancer. The vaccine is a recombinant vaccine, which is made from genetically engineered material. For more information about recombinant vaccines, see our post on the subject here. The vaccine does not contain the entire virus, so it cannot cause the HPV infection, according to the FDA.
The vaccine was approved by the FDA on June 8, 2006, after a six-month priority review process. It was fast-tracked for approval by the FDA despite concerns about Gardasil’s safety and long-term impact. Although the FDA did request further study on the vaccine, it was still licensed for use before this research was completed. Since then, Merck has lobbied aggressively towards mandating the vaccine for young girls and, more recently, young boys as well.
Problems with Gardasil
The Judicial Watch Special Report highlights a number of concerns with the vaccine:
- As is obvious above, Gardasil guards against only four strains of HPV. There are forty strains of the disease, with fifteen of those believed to cause cancer. Gardasil, therefore, is not as effective as it is marketed to seem.
- Gardasil is a preventative drug. It does not treat pre-existing HPV infection, so it was not tested on women with pre-existing HPV. This is problematic because many women do not know they have HPV, and Gardasil does not require pre-screening before vaccination, although, according to patient and doctor reports on the Vaccine Adverse Event Reporting System (VAERS), the vaccine can aggravate symptoms of pre-existing HPV (and has done so in at least 78 separate cases, although, due to under-reporting, the actual number of adverse events occurring after Gardasil vaccination is probably far higher). Women who are not aware they have the virus but get the vaccine anyway, as Merck suggests, could suffer outbreaks of genital warts or abnormal precancerous lesions. Both of these require extensive treatment.
Some patients even experienced outbreaks of warts on the face, hands, and feet,and a chart in the FDA’s Vaccines and Related Biological Products Advisory Committee’s report shows that patients who had already been exposed to HPV had a vaccine efficacy rate of -44.6%. In other words, these patients were very likely to suffer adverse events. It is perhaps for this reason that the FDA denied Merck’s application to begin marketing Gardasil to women ages 27 through 45 in 2008, as well as an application to expand the vaccine to include more HPV strains.
- Merck tested Gardasil’s effectiveness and safety against a placebo that contained an undisclosed amount of aluminum (Gardasil itself contains 225 mcg of aluminum). We have often discussed the problems with aluminum, a known toxic substance, on this site. It can cause a variety of problems, including permanent nerve damage. Using a reactive placebo that contains a known toxic substance rather than a non-reactive saline based placebo can make the vaccine appear safer than it is, since the placebo itself causes adverse effects. The only table in Merck’s report that compared the vaccine with a saline-based placebo in addition to the aluminum-containing placebo looked at adverse experiences at the injection site, so it did not give an accurate representation of Gardasil’s overall safety and effectiveness. However, it did show that white the vaccine and the aluminum placebo had similar rates of adverse effects, the saline-based placebo had far fewer of these. For example, only 7.3% of patients receiving the saline placebo experienced swelling after receiving it, as contrasted with 25.4% of those receiving Gardasil, and 15.7% of those receiving the aluminum placebo.
- Merck scientists did not study cancer in designing the vaccine. In fact, they admitted in a report on testing protocol that they did not even check whether their own vaccine is carcinogenic – an important concern, given that the vaccine is supposed to protect against cancer, contains aluminum, a known toxic substance, as well as genetically modified material, and is supposed to work by causing spontaneous reactions and cell-mutations.
- Although Merck claims that they studied the vaccine’s interactions with common adolescent vaccines, their own documents show that they tested Gardasil only with the Hepatitis B vaccine. This is disturbing, since reports from VAERS contain 220 cases of adverse effects when Gardasil was administered at the same time as the Menactra vaccine that guards against meningitis, and which is required for attendance at many schools and colleges.
- Gardasil’s ad campaign does not warn women who are breastfeeding against the vaccine, although Merck’s own June 2006 briefing to the FDA notes that “It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk,” and “A higher number of breastfeeding infants (n=6) whose mothers received Gardasil had acute respiratory illnesses within 30 days.” This number is three times higher than that of the placebo group.
- Gardasil’s impact on fertility is as yet unknown, since the only fertility tests were conducted on rats.
- The vaccine is highly expensive, at about $130 per dose, and three doses required. As such, mandating the vaccine puts a great burden on state governments, who will need to provide the vaccine for low-income families, which burden will be passed on to taxpayers. This seems an unnecessary expense, since all women will still require regular pap smears, and hundreds of thousands of women who are vaccinated and do get yearly pap testing will still get high-grade cell abnormalities.
- Nobody knows whether Gardasil will really prevent cancer, since the testing period has been so short. The long-term effectiveness of the vaccine is also unknown. This is all highly problematic since cervical cancer is most common in wimen in their late forties, while the vaccine is only given to young women between nine and twenty-six. It could therefore be decades before we really know how effective Gardasil is at preventing cervical cancer.
- Cervical cancer deaths have been decreasing steadily even without Gardasil. According to American Cancer Society estimates, deaths from cervical cancer fell by 74% between 1955 and 1992. The rate continues to fall 4% annually.
- In total, almost 9,000 VAERS reports had been filed at the time the Judicial Watch Report was published. These included 38 reports of Guillain-Barre Syndrome, a potentially devastating illness that attacks the nervous system and can result in paralysis, as well as 18 deaths. The most common diagnosed cause was blood clotting, which is cause for concern, since many birth control drugs increase the risk of developing blood clots, and many women who receive Gardasil will be on birth control, as were some of the women who died shortly after receiving the vaccine. One of the deaths was from a severe allergic reaction to the vaccine.
In addition to the facts pointed out by the Judicial Watch Special Report, one compelling reason to doubt the effectiveness and safety of the vaccine is that among its numerous critics is one of the very same people who developed the vaccine – Dr. Diane Harper, whom we mentioned earlier. In an interview with ABC News, she stated that “The rate of serious adverse events [in reaction to Gardasil] is greater than the incidence rate of cervical cancer.” Meanwhile, at a briefing in 2009, she pointed out that the vaccine had not been tested in girls younger than fifteen, while it was being marketed to girls as young as nine.
After considering all these facts, it seems clear that there are some serious doubts regarding Gardasil’s effectiveness and safety. At the very least, parents should be aware of these issues before they make the choice whether to vaccinate or not.