The paper begins by summarizing one of the key points in the vaccine safety debate: since vaccines are given to healthy people to guard against diseases to which they may never be exposed, it is important that there is little risk associated with the vaccine. In other words, healthy people should not be risking their health in taking a vaccine for a disease they may never have caught in the first place. This is something that the US Food and Drug Administration (FDA) itself stated in 2002, and is therefore an accepted point of view in the vaccine world.
It follows that, since the vaccine is given to healthy people, those people must understand the costs and benefits associated with the vaccine before agreeing to be vaccinated. Informed consent therefore needs to be a fundamental part of any vaccination program, and many developed countries acknowledge this in their vaccination policy. In Australia, doctors are legally required to explain a vaccine’s potential risks and benefits in order to gain a patient’s consent. Similarly, in the United Kingdom, patients must receive information on vaccine risks and side effects before deciding whether or not they will accept or refuse a vaccine. The United States, however, despite its stated commitment to individual liberty, does not legally require a person’s informed consent for a vaccination.
In place of informed consent laws, America has regulatory agencies like the FDA – which is supposed to ensure vaccine safety and effectiveness – and the US Centers for Disease Control and Prevention (CDC) – which provides expert information about the risks and benefits attached to drugs. However, in 2006, the FDA Science Board itself released a Science and Mission at Risk Report in which it concluded that the FDA was “…not positioned to meet current or emerging regulatory responsibilities” because “its scientific base has eroded and its scientific organizational structure is weak.” The report went on to say that the FDA is unable to “keep up with with scientific advances,” putting American lives at risk.
With the FDA itself admitting that it is incapable of playing as strong a role in regulating drug safety as is required, it is not unreasonable to question its approval of a vaccine like the HPV vaccine, which appears to have far less evidence supporting its benefits than is generally advertised. For instance:
- Merck, the manufacturer of one of the HPV vaccines, Gardasil, claims on its website that “Gardasil does more than help prevent cervical cancer, it protects against other HPV diseases, too,” with the caveat that “Gardasil does not prevent all types of cervical cancer.” The CDC and FDA also claim that Gardasil “is an important cervical cancer prevention tool that will potentially benefit the health of millions of women.” However, there’s no significant data actually supporting these claims. The testing period used for both Gardasil and Cervarix (produced by GlaxoSmithKline) was too short to evaluate the vaccines’ long-term benefits. Invasive cervical cancer takes 20-40 years to develop from the time that one is infected with the HPV infection. The longest trials for the vaccines lasted 5 years for Gardasil and 8.4 years for Cervarix.
- The vaccines have been demonstrated to prevent two particular strains of HPV )HPV-16/18), as well as associated lesions in young women who did not have the HPV infection when they were first vaccinated. Thus, although cervical cancer can be caused by persistent exposure to 15 out of 100 HPV strains in existence, the vaccine only prevents against two of them. Also, even persistent HPV infections caused by ‘high risk’ HPVs generally do not lead to lesions, let alone to cancer in the long term. In fact, as much as 90% of HPV infections resolve themselves within 2 years. Of those that don’t heal by themselves, only a small amount might lead to cancer. Without long term data, as those mentioned above, it’s impossible to know for sure whether HPV vaccines actually prevent some cervical cancers, or simply postpone them until later.
- Neither of the existing HPV vaccines can clear existing HPV infections, or even prevent the development of precancerous lesions. In fact, Merck has noted that Gardasil can actually increase the risk of cervical disease in women who are vaccinated after being infected with HPV. The company’s own report to the FDA shows that “Gardasil had an observed efficacy rate of –44.6% in subjects who were already exposed to ‘relevant HPV types’.” As we have noted elsewhere, not all women know that they have HPV – many people contract it and have it heal spontaneously without ever knowing. As such, this is a major source of increased vaccination risk.
- The FDA itself has indicated that the long-term benefits of the HPV vaccine rest more on assumptions than actual scientific data, saying that “It is believed that prevention of cervical precancerous lesions is highly likely to result in the prevention of those cancers” (emphasis added).
- As mentioned in another post, the HPV vaccine trials were deliberately constructed to mislead the consumer about the safety of the vaccine. Specifically, the HPV vaccine was tested against a placebo that contained aluminum, a known toxin. Many of the adverse effects of the vaccine probably stem from the fact that the vaccine itself contains aluminum, so it’s not surprising to note that the rate of adverse events related to the placebo and to the vaccine were similar. (For more on this issue, check this article).
- According to data from the World Health Organization, the current age-standardized death rate from cervical cancer is 2.5 times lower than the rate of serious adverse reactions resulting from Gardasil alone, as reported to the Vaccine Adverse Event Reporting System (VAERS). Meanwhile, in the Netherlands, the reported rate of such reactions is almost 4 times higher than the age-standardized death rate from cervical cancer. In other words, you are far more likely to have a reaction to the HPV vaccine than you are to die from cervical cancer.This directly contradicts the FDA’s own assertion that vaccines must carry a minimum of risk since they are given to people who are already healthy. This is particularly true given that the numbers of reported adverse events are probably lower than the number of actual adverse events since at least in America, this data relies mainly on patients and doctors self-reporting. Many people who suffer an adverse event probably do not report it due to misdiagnosis, or simply a lack of knowledge that reporting is even possible. Thus, some studies have estimated that only 1-10% of adverse events are actually reported in the US.
- Despite the unreliability of data regarding adverse events, it seems likely that the HPV vaccine is the cause of many such events. For instance, the total numbers of such events reported for Cervarix is 24-104 times higher than those reported for any other vaccine in the UK immunization schedule. Meanwhile, in Australia, nearly 50% of adverse events reported in 2007 dealt with the HPV vaccine, which was the only suspected vaccine in 96% of cases.
- The HPV vaccine is incredibly expensive. This is an issue because, in developed countries like the US, the vaccine is really only cost-effective if, firstly, one assumes that it offers life-time protection from cervical cancer, and secondly, 75% of the pre-teen population gets vaccinated. There is no reason for us to believe the first, and thus funding the second seems impractical.
- To date, the paper states, “the list of serious ADRs related to HPV vaccination in the US, UK, Australia, Netherlands, France, and Ireland includes deaths, convulsions, syncope, paraesthesia, paralysis, Guillain–Barré syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and pancreatitis.” As the authors note, “It may be thus appropriate to ask whether it is worth risking death or a disabling lifelong neurodegenerative condition such as GBS at a preadolescent age for a vaccine that has only a theoretical potential to prevent cervical cancer, a disease that may develop 20–40 years after exposure to HPV, when, as [Dr. Diane] Harper [one of the researchers who developed the vaccine] noted, the same can be prevented with regular Pap screening?”
In the face of all this data regarding the problems associated with the HPV vaccine, current American vaccine policy is difficult to understand. It becomes even harder to justify when one realizes that the rate of cervical cancer itself is very low in developed countries. While the vaccine is marketed as guarding against the second-highest cancer in women, cervical cancer rates are only this high globally due to the lack of affordable gynecological services in developing countries. In countries like America, regular Pap screenings result in an already low rate of cervical cancer, and cervical cancer is a far less common cause of death. In fact, even if a woman gets the HPV vaccination, she still needs to continue to get regular Pap screenings in order to stay healthy, since the vaccine only guards against two of the strains that are linked to cancer.
Meanwhile, the high number of reported adverse events linked to the HPV vaccines, as well as their consistent pattern (the number of reported events is high across countries, and many of the reported events are similar) leads one to think that perhaps the HPV vaccine trials were not entirely effective in determining vaccine risks. Many of these trials, as well as studies related to the vaccine, have been funded by Merck and GlaxoSmithKline – the manufacturers of the HPV vaccine, presenting a clear conflict of interest. None of these studies have focused on autoimmune disorders, which can be triggered by vaccines (and some of which, like acute disseminated encephalomyelitis, have been related to the HPV vaccine).
In fact, many health authorities dismiss the scientific data in front of them that suggests a link between the HPV vaccine and serious adverse events in favor of data provided by the vaccine manufacturers. In one such case, the UK Medicines and Healthcare products Regulatory Agency (MHRA) refuses to consider certain suspected adverse reactions partly because they are not recognized as side effects of the vaccine. In other words, If the manufacturer does not mention them as a possible risk, then there cannot possibly be a risk (even though, of course, there really is!)
It’s clear that there are many reasons to doubt the HPV vaccine. Why, then, is the vaccine being supported by health authorities and the public alike? Check in later this week to read the rest of my summary of this paper, focusing on the ways in which pharmaceutical companies marketed the HPV vaccine through fear-mongering, among other things.