Abby Lippman, Alana Cattapan, and Kelly Holloway argue for rigorous, conflict-free research into the safety and effectiveness of the HPV vaccine and for a critical approach to its use.
In a recent post on Impact Ethics, Juliet Guichon focuses on the Calgary Catholic School Board’s inclusion of a letter from Catholic authorities in the information and consent packages for the in-school administration of an HPV vaccine. Guichon objects to one of the claims in the letter—that the vaccine is not the best way to prevent cervical cancer. She insists that the vaccine is “safe and effective.” Although Guichon’s overall goal to prevent cervical cancer is a laudable one, her unequivocal endorsement of the HPV vaccine as “safe and effective” can be challenged. The vaccine may have been deemed safe and effective enough for distribution, but we simply do not know enough about it at this stage to make any definitive claims.
To be clear, we agree with Guichon that all who are offered an HPV vaccination in-school or elsewhere (and their parents) must be given accurate and full information in order to make truly informed choices. But we have concerns about evidence and the marketing of the HPV vaccine, particularly as HPV vaccination programs have been made a systematic part of public healthcare in several provinces.
To start, many of the studies supporting the safety and effectiveness of the HPV vaccine are compromised by conflict of interest. Nearly all of the research cited by the American College of Obstetricians and Gynaecologists in its 2014 opinion paper endorsing the use of the vaccine was partially or completely funded by Merck (the makers of one HPV vaccine, Gardasil) or by GlaxoSmithKline (the makers of a similar HPV vaccine, Cervarix). While such conflicts of interest are common practice in pharmaceutical research, they are not to be taken lightly, as industry-funded studies are widely reported to produce results favourable to their sponsors. In some cases, the research was actually designed by and/or reported in publications written by employees of the vaccine manufacturers. Moreover, these studies, and particularly the randomized control trials, have focused on short-term (mostly immunologic) effects of the vaccine. This makes them insufficient for determining the long-term risks and effectiveness of inoculation.
While we do not claim that the vaccines are unsafe, there is no conclusive evidence that they are safe. Interpreting the many reports of adverse reactions to the vaccine in the United States and elsewhere is difficult, if not impossible: there is no complete and independent process for reporting all adverse effects. Furthermore, there is no conclusive evidence demonstrating that they are safe in the long-term.
Finally, there is still no conclusive evidence that the HPV vaccine will reduce mortality rates any more than can be achieved through conventional screening practices based on annual Pap testing, which will, in fact, still be needed by all who are vaccinated. It is young girls who are being vaccinated, and given the usual later-in-life onset of cervical cancers, we will not know about the effectiveness of the vaccine for decades. Thus, we need to do more to improve screening for all women, and particularly to monitor the effects on cervical cancer rates now that official guidelines have been changed to encourage Pap tests only every three years (rather than annually).
The lack of long-term evidence for the safety and effectiveness of this vaccine and the relative effectiveness of the Pap test, a long-standing preventative measure, beg the question of why the HPV vaccine has been so thoroughly endorsed by federal and provincial governments. It is noteworthy that in 2007 the Government of Canada invested $300 million to support school-based HPV programs, following an extensive lobbying and marketing campaign by Merck.
In sum, then, what girls and young women in Canada need is a fully rigorous and conflict-free body of evidence on the safety and effectiveness (in the real world) of the HPV vaccine. They will also need to know other relevant facts about HPV infections (e.g., the range of viral types, the near ubiquity of HPV infections, the natural history of infections, the fact that most HPV infections are cleared on their own by healthy girls and women, etc.). As well, they should be given solid and comprehensive sex education about HPV, other sexually transmitted infections, and sex itself. Sadly, all of this is in very short supply in Canada today.
And though we should indeed object when Catholic authorities let religion get in the way of public health policy, we need to be accurate in our protests and not raise new errors in rebuttal. All these issues are legitimate bases for respectful and thoughtful discussion and debate by those who seek to promote and protect the health of women and girls in Canada.
Abby Lippman is a professor emerita at McGill University.
Alana Cattapan is a PhD Candidate at York University and a research associate at Novel Tech Ethics at Dalhousie University. @arcattapan
Kelly Holloway is a Post-Doctoral Fellow at Dalhousie University. @kellyjholloway
I wrote this response as a young, open-minded PhD student at McGill University I have absolutely no ties to any pharmaceutical companies, past or present. I ask the authors to consider: Why are they so concerned about changes in the prevention paradigm? Is it to highlight their opposition against ‘big pharma’?
Many individuals often feel overwhelmed by the conflicting health information coming from news outlets regarding vaccines; a healthcare professional may say one thing while the news says another. And this blog post is another perfect example of the sheer confusion. The authors speak to “Guichon’s overall goal is to prevent cervical caner”, but what about their goals? What about their interests? This remains unclear to me. As some one involved this area of research, I found this blog to be confusing. The authors write “While we do not claim that the vaccines are unsafe, there is no conclusive evidence that they are safe.” Firstly, there are no references to support that there is no evidence that they are safe. Secondly, is this a dichotomous yes or no [safe or unsafe?]. So if they are “not unsafe”, but they are not “safe”, what is the HPV vaccine with respect to safety? Neutral? Numerous large-scale studies on HPV vaccine safety have been published and show little or no evidence of severe side-effects associated with vaccination (Agorastos et al., 2009; Chao et al., 2012; Gee et al., 2011; Klein et al., 2012; Lu et al., 2011). A thorough discussion of tho issue of vaccine safety is beyond the scope of this reply. I believe the resources section, including the JAMA summary on adverse reports of the HPV vaccine might be helpful to the reader. http://www.cdc.gov/vaccinesafety/Vaccines/HPV/Index.html
Providing references/links can help the reader navigate this huge volume of information.
The crucial question to ask is: Do real divergences exist in the scientific community pertaining to the vaccine a person is considering? Or is the ‘fire’ maintained artificially by a few individuals?
The authors make the point to be a lingering insistence that there should be clear proof of reduced risk of cervical cancer and long term efficacy.It is true that the impact of cancer rate reduction will only be measurable in a couple of decades. However, all existing scientific data points to the vaccine as an important measure of prevention against persistent HPV infection and pre-cancerous lesions. In addition, in Australia, Denmark, and Sweden, studies have already shown that use of the vaccine has led to a strong protective effect as well as a decline in genital warts in the population. Should we ignore these data and leave women at risk for HPV-related diseases, or should we take action to prevent them? Would it be better to sit around and wait for cancers to develop to confirm vaccine efficacy? Thats a huge issue to consider. But for now, my own evaluation of the literature as a researcher, leads me to conclude, that all the high-quality, existing scientific data indicates that a high-level of long-term protection against HPV-causing cancers is expected from HPV vaccination.
Finally, it would be really helpful for the authors to define what evidence would be needed to determine “safe in the long-term”? What would be long, enough? What is their definition of safe?
Critically dissecting the arguments and information one reads or hears about vaccination accurately can be quite difficult. It is also challenging for scientists and clinicians to explain probability and numeracy concepts clearly. I wholeheartedly agree that we should continue to talk openly about vaccines, about vaccine safety, efficacy and all the points in between. But at the very least, the pre-condition must be that we use scientific data in our debates and not speculations, bias or broad claims.
A reply to authors Abby Lippman, Alana Cattapan and Kelly Holloway.
We are people who have the privilege of knowing a public health nurse who is currently on a Canadian palliative care ward suffering from HPV related disease: cervical cancer. She writes this in response to the article which she would like us to post to preserve her confidentiality:
screening failed me; I had yearly pap tests and ended up with a 4 cm. tumour at time of diagnosis, which was said to be very slow growing; this implies screening failure for me
the virus does not always clear on its own, or may clear and return, and what a horrible risk to take with someone’s life. I am seeing younger women, 20’s and early 30’s, who are not clearing the virus, and are having multiple colposcopies and LEEP biopsies; this is terribly stressful for them; they may still end up with invasive disease
a few doses of vaccine, even if there is a very small chance it may not “take” in certain individuals, is still an effective barrier to this terrible disease; we know the virus runs an unpredictable course once in the body so why not try something to block it that is low risk and minimally invasive, even if there are some who are not entirely convinced? Vaccination seems a no-brainer compared to risking invasive cancer
I have been dealing with cervical cancer for almost 5 years; it has taken my physical health, my emotional well being and my future: I will not see my daughter marry, I will not see my grandchildren; I would ask these authors if they would wish this outcome for their children or grandchildren.
think of the cost of my treatment over these past years vs. the cost of vaccination; such health costs don’t even include lost productivity from not being able to work. I have met a lady who is 8 years post treatment who is still unable to work and is on disability; she is in her 30’s.
these authors seem to think that as long as not many people are affected negatively by the virus, then vaccination is not worth the effort; I would ask them to consider what I have offered here and the palliative care bed from which I am writing.
Reblogged this on Canadian Gardasil Awareness Network and commented:
HPV vaccine marketing: symptomatic of a system that shoots first and asks questions later.
As a Registered Nursing student I remember being told of the Canadian Cancer Society’s new recommendations for health care providers to NOT educate women to examine their own breasts for lumps and bumps. Their position was that self examination led to un-necessary Dr.s visits and mammograms. This created an uproar in the classroom as we had been preached to in our very first year about Primary Care/ Preventative Medicine and Upstream (vs. Downstream) approaches to health care. Prevention is the key to fending off the doctors visit and the costly treatments that ensue, and this is the goal of vaccination programs. But from it’s inception, the HPV vaccine has reeked with problems including the governments cozy relationship with Ken Boessenkool of H & K (a lobbying firm) who was Stephen Harper’s campaign manager with the Progressive Conservatives in Alberta, to the FDA’s flip-flopping over the presence of viral DNA in the L1 strand adsorbed to the aluminum adjuvant (don’t even get me started on THAT!). Yes, the question of this vaccines safety has been only the tip of the HPV vaccine iceberg and the young women who received the vaccine, despite the lack of long-term safety and efficacy data, are in essence the guinnea pigs of a system that seems all to often to shoot-first and ask questions later.