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Deliberations at the discussion meeting (*1) on HPV vaccines (cervical cancer vaccines) and at the Health Sciences Council meeting (*2) held on February 26th, 2014 revealed the prejudicial attitudes of both the Ministry of Health, Labour and Welfare (MHLW) and the Council.

At the discussion meeting held in the morning, presentations were made by two overseas researchers who had published findings that vaccine adjuvants may cause side effects and by a Japanese researcher. After a 10-minute presentation each, however, so-called “comments” were made by another two overseas researchers (one participated through video conference), Council members, and other experts in succession, all of whom were in the opposition against the presenters. As presenters were given extremely short time to refute, the meeting was far from something called “discussion.”

At the beginning of the afternoon Council meeting, Dr. Kurane Ichiro, a Council member and Deputy Director-General of National Institute of Infectious Diseases, reported on the “discussion” in the morning. However, Dr. Kurane only mentioned the presentations very briefly which can hardly be called reporting, while he introduced critical opinions in details and concluded as “presentations given seemed lacking scientific evidence.”

Then, a presentation was made about a treatment of functional somatic symptoms based on the premise of the Council deliberation results on January 20th, in which side effects of widespread pain and dyskinesia were defined as psychogenic responses induced by the painful stimulation of needle piercing. In response to the presentation, the Council confirmed four points as “precautions for inoculation,” one of which is to explain before inoculation that the vaccine may cause pain.

Given that the critical opinions against the morning presentations and Dr. Kurane’s requiring scientific evidence are valid, the “psychogenic response” theory also lacks scientific evidence. Specifically, the presentation discussing the causality of the observed side effects with the adjuvant was criticized because no control group was assigned; however, the “psychogenic response” theory has not been proved by any controlled trial. Rather, the theory was drawn by an extremely unscientific logic as we pointed in our Position Document issued on February 24th (*3). The Council’s attitude to require a scientifically rigorous verification only to their opponents but not to themselves and arguing side effects as “psychogenic responses” is extremely arbitrary and unjust.

In the past drug-induced disasters in Japan, we have experienced repeated failures of delayed responses and expanded damages because scientific verifications were required before responding to alarming information on side effects. If we learn the lessons from the past failures, safety measures should be taken without eliminating any possibilities, without easily eliminating alarming information by saying that they have not been scientifically verified yet or they do not match the existing knowledge. New events that are unable to be explained by existing knowledge may have been occurring.

Although the Council confirmed “precautions” for inoculation, they did not present any scientific evidence endorsing the adherence to the precautions actually prevents further damages as well as the righteousness of the “psychogenic response” theory, premise of the precautions. The actual damages have been caused. If the active recommendation for HPV vaccinations is resumed without sufficient grounds supporting that further damage will be prevented, similar damages should occur, again.

There is still a good chance that vaccine ingredients such as adjuvants cause unexpected side effects. What required now to doctors, researchers, and the government is to investigate the cause of side effects with scientific humility, without denying any possibilities, and to determine if HPV vaccines are safe enough to be a part of the mandatory vaccination schedule.

To achieve this, it is needed to conduct a thoroughly scientific epidemiological investigation to find out the occurrence of side effects and its frequency.

Medwatcher Japan expresses our opposition to the resumption of active recommendation for HPV vaccinations, otherwise.

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