Human Papilloma virus (HPV) Vaccine Policy and evidence-based medicine: Are they at odds?

Please read this paper very carefully, perhaps one of the most important ever to be written with regard to the HPV vaccines.  Here is the Abstract and Concluding Remarks.  There are also key points highlighted on the front of the paper but please read it in detail as it answers many questions and put the answers out there in such a prestigious Journal.  It is now there for all to see.   The Annals of Medicine is one of the most prestigious Journals and to have accepted this paper is a wonderful miracle.  Lucija and Chris Shaw are two wonderful scientists doing marvellous work.

Abstract

All drugs are associated with some risks of adverse reactions. Because vaccines represent a special category of drugs, generally given to healthy individuals, uncertain benefits mean that only a small level of risk for adverse reactions is acceptable. Furthermore, medical ethics demand that vaccination should be carried out with the participant’s full and informed consent. This necessitates an objective disclosure of the known or foreseeable vaccination benefits and risks. The way in which HPV vaccines are often promoted to women indicates that such disclosure isn’t always given from the basis of the best available knowledge. For example, while the world’s leading medical authorities state that HPV vaccines are an important cervical cancer prevention tool, clinical trials show no evidence that HPV vaccination can protect against cervical cancer. Similarly, contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries. In the western world cervical cancer is a rare disease with mortality rates that are several fold lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination. Future vaccination policies should adhere more rigorously to evidence-based medicine and ethical guidelines for informed consent.

Concluding remarks

Regulatory authorities are responsible for ensuring that new vaccines go through proper scientific evaluation before they are approved. An equal fiduciary responsibility rests with the medical profession to only promote vaccinations with those vaccines whose safety and efficacy have been thoroughly demonstrated. The available evidence, however, indicates that health authorities in various countries may have failed to provide an evidence-based rationale for immunization with HPV vaccines and in doing so, may have breached international ethical guidelines for informed consent. Contrary to the information from the US CDC, Health Canada, Australian TGA and the UK MHRA, the efficacy of Gardasil and Cervarix in preventing cervical cancer has not been demonstrated and the long-term risks of the vaccines remain to be fully evaluated.

Current worldwide HPV immunization practices with either of the two HPV vaccines appear to be neither justified by long-term health benefits nor economically viable, nor is there any evidence that HPV vaccination would reduce the rate of cervical cancer beyond what Pap screening has already achieved. Furthermore, the frequency, the severity, as well as the consistency of the patterns of ADRs reported to various governmental vaccine surveillance programmes for both Gardasil and Cervarix (Figures 2 and 3) raise significant concerns about the overall safety of HPV vaccination programmes. Because these programmes have global coverage (Table I), the long-term health of many women may be unnecessarily at risk against still unknown vaccine benefits. Altogether these observations suggest that a reduction in the burden of cervical cancer globally might be best achieved by targeting other risk factors for this disease (i.e., smoking, use of oral contraceptives, chronic inflammation) (85) in conjunction with regular Pap test screening. The latter strategy has already been proven successful in developed nations where the incidence of cervical cancer is very low (Table I).

According to the Helsinki Declaration and the International Code of Medical Ethics (104), the well-being of the individual must be a physician’s top priority, taking precedence over all other interests. Although the Declaration is addressed primarily to physicians, the World Medical Association encourages other participants in medical research involving human subjects to adopt these same principles (104). Greater efforts should thus be made to minimize the undue commercial influence on academic institutions and medical research, given that these may impede unbiased scientific inquiry into important questions about vaccine science and policy.

The almost exclusive reliance on manufacturer’s sponsored studies, often of questionable quality, as a base for vaccine policy-making should be discontinued. So should be the dismissal of serious ADRs as co-incidental or “psychogenic” in spite of independent research suggesting otherwise. It can hardly be disputed in view of all the evidence (i.e., case reports and vaccine-ADR surveillance in various countries) that HPV vaccines do trigger serious ADRs. What does remain debatable however is the true frequency of these events because all systems of monitoring for vaccine-ADRs currently in place rely on passive reporting. Passive ADR surveillance should thus be replaced by active surveillance to better our understanding of true risks associated with particular vaccines (especially new vaccines). The presentation of partial and non-factual information regarding cervical cancer risks and the usefulness of HPV vaccines, as cited above, is, in our view, neither scientific, nor ethical. None of these practices serve public health interests nor are they likely to reduce the levels of cervical cancer. Independent evaluation of HPV vaccine safety is urgently needed and should be a priority for government-sponsored research programmes. Any future vaccination policies should adhere more rigorously to evidence-based medicine as well as strictly follow ethical guidelines for informed consent.

LT&Shaw Annals Med 2011, HPV vaccines & EBM