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.