Talk about the HPV vaccine has reached a fever pitch as thousands of parents with daughters entering their first year of secondary school will face a decision whether to vaccinate them against HPV in the coming weeks. Controversy surrounded the HPV vaccine in Ireland from the start but not for the same reasons as today. Before it was introduced in 2010, there were protests calling on the Irish government, who were reluctant to delve into sparse finances, to introduce the vaccine. Now reports from parents who claim their daughters have experienced chronic adverse side effects have called administration of the vaccine into question. Uptake of the vaccine has declined in recent years from an initial figure of 87% to 50% as a result. Parents both for and against the vaccine have publicly discussed why their reactions are born out of genuine concern for their children. In this week’s Limerick Life Focus we examine both sides of the divide.
HPV and Cervical Cancer
According to the Marie Keating Foundation, around 80% of all women will have a HPV (Human Papilloma Virus) infection in their lifetime. The most common way of contracting the infection is through a sexual partner. Most people fight off the infection but there are some strains which bear a high risk of developing into cervical cancer. Over 300 women are diagnosed with the disease in Ireland each year, and around 90 women will die from it per year. Roughly 6,500 women receive treatment for precancerous cells in the cervix annually.
In Ireland, women are eligible for the cervical cancer screening process, which involves a smear test every three years, after the age of twenty five. Many women will be called for further investigation, sometimes multiple times in their lifetime. Further treatment can range from a colcoscopy to a biopsy to the destruction of abnormal cells in the cervix by burning them off. Cervical Check screening has been running successfully since 2008.
Nevertheless, the HPV vaccine provides a less invasive and more cost-effective alternative. Although women who’ve received the vaccine are still encouraged to get pap smears regularly to monitor changes in their cervixes, the likelihood of contracting cancer or requiring further treatment for them is dramatically reduced. HPV can also lead to cancer of the vulva, vagina, penis, anus, and throat, which regular cervical screening will not detect. Treatment for cervical cancer ranges from radiotherapy and chemotherapy to a partial or full hysterectomy, and sometimes the removal of the ovaries, fallopian tubes, and even pelvic lymph nodes. The HSE advises that parents who do not immunise their children against the virus risk their daughters getting cervical cancer later in life.
Gardasil – The Vaccine
Most girls will receive the Gardasil HPV vaccine in first year of secondary school with two doses separated by six months. Girls over fifteen will receive the vaccine in three doses, with the first two administered six months apart, and the final one given four months after the second injection. The reason for the latter increased dosage is that girls over the age of fifteen are more likely to already be sexually active.
The most common reactions to the vaccine are localised site irritation like swelling, redness, and muscle pain, as well as short-term complications such as nausea, vomiting, headache, fever, and fatigue. These are considered mild and low risk issues, and are the common side effects of most vaccines. On rare occasions, patients who are allergic to one or more of the components of the vaccine can go into anaphylactic shock. The WHO states, in its 2017 report, that the risk of anaphylaxis is 1.7 in a million and that “syncope [fainting] was established as a common anxiety or stress-related reaction to the injection.”
The FDA first approved Gardasil in 2006 after clinical trials involving 29,000 subjects before approval and is subject to continuous monitoring. Gardasil 9 was released in 2014 and protects against 5 additional strains of the virus. It was tested on 15,000 individuals before it was licensed. The CDC website goes into extensive detail on how the vaccine is tested and monitored. The WHO have a list of committee reports on the safety of the vaccine listed on their website. According to the HSE, Australia, being one of the first countries to introduce the vaccine, has seen a decrease in excess of 50% in cervical cancer rates in the last ten years.
R.E.G.R.E.T. (Reactions and Effects of Gardasil Resulting in Extreme Trauma), is an anti-vaccine group operating in Ireland who have gathered testimonies of “victims” of Gardasil as well as articles. They did not respond to requests for comment for this report. The mission statement on the organisation’s website states that the support group was set up by parents of girls who have “developed serious health problems after entering secondary school,” which the parents attribute to the use of Gardasil. It also says that they feel that information about the vaccine from the HSE is “incomplete and biased, downplaying the safety issues while exaggerating its effectiveness.” There is no elucidation regarding where this bias may stem from or why the HSE may benefit from releasing a vaccine at their own expense that is neither safe or effective.
Another group, Irish Vaccination Awareness, claim that their aim is to help parents make informed decisions.
Both groups have gained increasing support over the last few years as parents come together to exchange stories regarding their daughters’ health after they’ve received the vaccine. The groups provide reports on the HPV vaccine from non-mainstream sources in the interest, as they say, of giving parents the full picture before making a decision on allowing their daughter to receive the injections. Some have accused the organisation of spreading inaccurate information.
However, there are varying degrees of opposition to the vaccine. Many of those opposed to Gardasil in Ireland say they are not opposed to all vaccines. A spokeswoman for TD Clare Daly told the Irish Times “[Parents] are not hysterical anti-vaccine conspiracy theorists. They are parents who allowed their daughters be vaccinated, as Clare did,” and that Daly is “struck by the frenzy that is whipped up against anyone who seeks information or asks questions.” She says that there is nothing wrong with parents seeking transparency on issues that have the potential to have negative effects on their daughters’ health.
Many of the long-term side-effects that have been reported by parents whose daughters have received the vaccine are hard to pin down in the first place. Chronic Fatigue Syndrome, the main prolonged adverse impact suggested by parents to be caused by Gardasil, has always been difficult to attribute to a specific physiological source. The Mayo Clinic suggests several prominent theories as to the cause, ranging from post-viral infection to pre-existing issues with the immune system to hormonal imbalances. But it stresses that they are no more than theories. Parents whose daughters are affected by CFS must indeed be exasperated by this condition for which no clear, identifiable cause has been discovered yet.
Since the introduction of Gardasil, the Marie Keating Foundation says that there is no increase in the number of girls experiencing long term health issues, including Chronic Fatigue Syndrome. In fact, it states that, according to the Health Products Regulatory Authority (HPRA), reports of CFS are less than what they were anticipated to be.
REGRET include a link to the 2015 HPRA Adverse Reactions Report for Gardasil, which is a list of negative reactions reported to the HPRA. It is not necessarily a conclusive document since “in many cases only limited details about each suspected adverse reaction report are received,” according to the document itself. It also states that “reporting tends to be highest for newly authorised medicines during the first one or two years on the market and then falls off over time,” and that “report rates may also be stimulated by promotion and publicity about a drug.” Not only is there no clear or significant increase in the number of CFS patients reported, but the HPRA must always accommodate fluctuations in reports of symptoms when there is media focus on vaccines, particularly when they are new.
Lack of Trust
The health system in Ireland has a history of failing the public and it is no surprise that some parents are reluctant to trust what health authorities in this country have to say as a result. Thalidomide was sold as a sedative that was supposedly “especially safe for infants” and gave relief for morning sickness in pregnant women. It was only withdrawn from the global market in 1961, resulting in over 10,000 babies being born with birth defects worldwide. The drug was not removed from Irish pharmacies for an entire year after it was discontinued globally. Even after the drug was finally removed from shelves in Ireland, many women who were already in possession of it continued using it since the media were complicit in covering up the truth about the harmful effects of the drug.
Similarly, in 1994, news broke of the anti-D scandal, in which over a thousand pregnant women were contaminated with Hepatitis C-infected blood from donors who donated blood without knowing they were infected. They were not screened for the virus by the Blood Transfusion Service Board before donating. Some patients with kidney issues were also infected. A report of the National Hepatitis C database in 2015 showed that at least 260 of those infected by contaminated blood donations died over the course of 20 years, with many more still experiencing chronic health issues.
It comes as no surprise that many are prone to mistrust the HSE as a result. Nevertheless, the HPV vaccine is not limited to Irish medicine and extensive research has been conducted in a transparent manner that is readily available from national and international sources. It is not just the HSE who defend the vaccine. International medical bodies such as the World Health Organisation, the Centres for Disease Control and Prevention, and the European Medicines Agency provide similar information on their websites and encourage parents to immunise their daughters. A spokesperson for the HSE told Limerick Life that “Over 220,000 Irish girls have safely received the HPV vaccine and over 200 million doses of the HPV vaccine have been given around the world. No serious side effects in any country can be scientifically attributed to this vaccine.”
Even considering the lack of trust some may have in the HSE, it is still true that the Gardasil vaccine has been subject to extensive testing by medical professionals globally. This is in comparison to anecdotal references regarding the dangers of the vaccine. This is not to say that the input of parents should be ignored. The HSE have encouraged parents to submit suspected reactions to the vaccine to the HPRA.
However, many believe that we must put more faith in the evaluations of professionals who are trained in this field to interpret the results. Social Democrat representative for Limerick, Sarah Jane Hennelly, told Limerick Life that “policy makers, ministers, legislators and clinical professionals alike simply must only deal in evidence and fact when taking positions on issues which can cost people their lives.” She mentioned that “public opinion can be shaped so much by misinformation and the internet” and called for “strong and honest public figures that refuse to compromise the truth in the interest of appeasing public opinion.”
At the start of September, Minister for Health Simon Harris called anti-vaccine groups scaremongers who must “butt out” of the discussion. Although this may seem like a strong reaction to parents who are only looking to know the full story before they allow their children to undergo treatment, it is worth considering the significance of the abundance of readily-available medical evidence in support of the vaccine. A spokesperson for the HSE said “The HSE is promoting HPV vaccine because we know the vaccine works and we know it works very well.”