Call to review cancer vaccine after Germany demands more medical proof

NEWS.Scotsman.com

Published Date: 02 June 2009

THE Scottish Government has been urged to review its cervical cancer vaccination programme and follow the lead of Germany, which ordered experts to show hard evidence the jab is effective and safe in the long-term.

The International Coalition of Advocates for the People (ICAP) – a group raising concerns of the safety and efficacy of Cervarix and its rival, Gardasil, to health ministers and researchers worldwide – want a thorough investigation into the vaccine. The organisation successfully lobbied the health minister and medical experts in Germany. Now the country’s Federal Joint Committee, which decides on the formula for the country’s social insurance system, has called for all recommendations on Cervarix and Gardasil to be revised and demanded a new report based on detailed evidence.

Yesterday, The Scotsman revealed more than 150 girls in Scotland have suffered adverse reactions after receiving the vaccine, which was introduced last autumn and is being given to all girls in S2 and to girls in S5 and S6 in a catch-up programme.

Campaigners are concerned about the long-term effectiveness and safety of the vaccine. Six families in England are taking legal action against the maker of Cervarix, GlaxoSmithKline, after serious side-effects they claim are linked to the vaccine.

Freda Birrell and Christina England from ICAP said: “We would welcome a decision by the Scottish and UK governments to put a hold on Cervarix and to carry out a similar thorough investigation as is now being carried out in Germany.

“GlaxoSmithKline admits ‘there are no data on the use of Cervarix in subjects with impaired immune responsiveness’, that ‘duration of protection has not been fully established’ and ‘Timing and need of booster has not been investigated.’

“So why was a vaccination programme in Scotland and England introduced before this was researched?”

The review in Germany came after a team of 13 experts studied all publicly available data on the effectiveness of both vaccines on the market and found the evidence lacking.

Dr Ansgar Gerhardus, a public health expert from the University of Bielefeld in north-west Germany, was part of the team.

He said: “We did not go into further details regarding Cervarix, simply because the evidence base was even more sparse than for Gardasil.

“We did not find any results on the overall protection against pre-cancerous lesions – which would be a relevant endpoint (ie, a way of judging a link to cervical cancer] for individual girls as well as from a public-health perspective. Only in a recent study have selected data for Cervarix been presented. However, many relevant data are still missing, so no conclusions should be drawn until they are made available.”

This statement has not been scientifically challenged.

ICAP added: “We believe the health and welfare of young people is of paramount importance and would welcome a delay in the Cervarix vaccination programme until all avenues are thoroughly investigated.”

The Scottish Government and GlaxoSmithKline insist detailed tests were carried out and that any reactions to Cervarix are within the range expected of a mass vaccination programme.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.