20th August 2009 Latest HPV update

Dr Downing's latest HPV update 20th August 2009

Several items in the Journal of the American Medical Association (JAMA) on 19th August 2009, looked at the safety of Gardasil. These statements, in the thoroughly mainstream JAMA, highlight once again the serious concerns over the HPV vaccine, it's safety, efficacy and marketing.

Safety

The safety of current HPV vaccines is unclear; postlicensure reports of adverse events are much higher than for any other vaccine, and highest in the 13-26 age group. Not mentioned in this article is the fact that in the safety trials a "placebo" containing aluminium was used, leading to a falsely optimistic figure for the comparative safety of the vaccine. The safety trials also completely ignored the possibility that the vaccine might actually cause cancer; an obvious risk when injecting into people a modified form of a known cancer-causing agent. Product information leaflets also state that the data "are insufficient to recommend use of Cervarix during pregnancy" -suggesting that it's a matter of not having studied enough cases to be sure of safety. But the manufacturers' data actually shows that a massive 27% of pregnant women given the vaccine suffered adverse effects, including miscarriages.

Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine

The Vaccine Adverse Event Reporting System (VAERS) reporting rate for qHPV is triple the rate for all other vaccines combined. The significance of these findings must be tempered with the limitations (possible underreporting) of a passive reporting system.

Efficacy

The efficacy of current HPV vaccines was completely unknown when it was fast-tracked to licensing in the USA in June 2006, because studies on its effect on the incidence of clinically relevant end points—cervical intraepithelial neoplasias (CIN) grades 2 and 3 — were not published until May 2007. It remains unknown now because studies on the effect regarding the risk of cervical cancer have never been published and cannot be for decades. Indeed there have since been no further, longer-term, studies on risk of CIN.

The Risks and Benefits of HPV Vaccination

The virus does not appear to be very harmful because almost all HPV infections are cleared by the immune system (look at points 7 and 8). In a few women, infection persists and some women may develop precancerous cervical lesions and eventually cervical cancer. It is currently impossible to predict in which women this will occur and why. Likewise, it is impossible to predict exactly what effect vaccination of young girls and women will have on the incidence of cervical cancer 20 to 40 years from now.

Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk of harmful effects from the vaccine.

When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence be put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed.

Marketing

By funding medical associations to produce "educational programs" for which they also provided much of the material, and paying doctors $4500 a time to lecture on the benefits of Gardasil, manufacturers "did not provide balanced recommendations on risks and benefits" - to put it extremely mildly. 

To read about Marketing HPV Vaccine Implications for Adolescent Health and Medical Professionalism please click here

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