[e-drug] Germany reviews its policy on HPV vaccination for age 12-17

E-DRUG: Germany reviews its policy on HPV vaccination for age 12-17
------------------------------------------------------------------
[copied as fair use; WB]

Published 27 April 2009, doi:10.1136/bmj.b1692
Cite this as: BMJ 2009;338:b1692

Germany reviews its policy on HPV vaccination for 12-17 year olds

Ned Stafford, Hamburg

Germany’s Robert Koch Institute is reviewing its recommendation that all 12-17 year old girls should be vaccinated against the human papillomavirus (HPV) to reduce the risk of cervical cancer, after criticism from experts.

A group of 13 medical scientists publicly criticised the institute’s recommendation in November 2008 (Sueddeutsche Zeitung, 26 Nov).

Susanne Glasmacher, spokeswoman at the Berlin based institute, which is responsible for disease control and prevention in Germany, told the BMJ that the institute’s standing vaccination committee was undertaking the review because new studies had been published and because of the "public discussion" generated by the 13 scientists.

However, she hinted that the committee would not reverse the original recommendation, saying: "The committee will publish a statement within the next few weeks; but there is no reason to change the HPV recommendation at the moment."

The institute’s vaccination committee made the recommendation in March 2007 to the Federal Joint Committee. This committee, whose members include representatives from medical, hospital, and public health insurer associations, determines which medical services and medicines will be paid for by public health insurance companies, which cover more than 90% of all Germans.

A few months after the Robert Koch Institute’s recommendation, the Federal Joint Committee voted to add the HPV vaccine to the public health insurance list of covered vaccinations.

But in November 2008, Dr Ansgar Gerhardus of the School of Public Health at the University of Bielefeld and 12 other scientists issued a statement calling for "a reassessment of the HPV vaccination and an end to misleading information."

They wrote: "We strongly object to stirring up fear regarding the risk of cervical cancer and feelings of guilt by disseminating incorrect information. We demand that gaps in the data be discussed openly. Assertions that a vaccine reduces the risk of cervical cancer by 70% or even 98% should simply not be made at this point in time."

Within a week of the statement’s release, the institute’s vaccination committee and the Federal Joint Committee received high profile backing for their original decision to support the vaccine from Dr Harald zur Hausen of the German Cancer Research Centre in Heidelberg; in October 2008, Dr zur Hausen was awarded the 2008 Nobel prize for medicine for his discovery of human papillomaviruses causing cervical cancer.

Dr zur Hausen defended the HPV vaccination in an article published on 1 December 2008 in the national German newspaper Frankfurter Allgemeine
(http://faz-community.faz.net/blogs/planckton/archive/2008/12/01/unsichere-hpv-krebsimpfung-die-antwort-des-nobelpreistr-228-gers.aspx).

Despite Dr zur Hausen’s public criticism of the 13 scientists’ joint statement, the Federal Joint Committee’s spokesman said that the committee found merit in the concerns and submitted a list of questions to the vaccination committee at the Robert Koch Institute .

After the institute’s vaccination committee answers all the questions, the Federal Joint Committee’s members will discuss the matter.

Kai Fortelka, spokesman for Federal Joint Committee, told the BMJ that the total cost of the three part HPV vaccination in Germany was around {euro}500 (£447; $652) per person, nearly twice as much as in most other European Union nations.

Mr Fortelka said there were no plans to reverse the coverage decision but added: "If there is concrete scientific evidence, hard scientific facts that the Federal Joint Committee cannot ignore, it is possible to make a new decision."

Cite this as: BMJ 2009;338:b1692

An English translation of the scientists’ statement is at
www.uni-bielefeld.de/gesundhw/ag3/downloads/Statement_HPV-vaccine.pdf

---------------
May I add as patient representative in the German Federal Joint Committee that the decision is open and dependent on the evidence - though one has to admit that the political pressure is high due to the successful PR of the HPV-vaccine manufacturers. Those who can read German will find more information on this in Pharma-Brief 3-4/2009
www.bukopharma.de/uploads/file/Pharma-Brief/Phbf2009_03_04.pdf

Jörg Schaaber
Pharma-Brief
BUKO Pharma-Kampagne
August-Bebel-Str. 62
33602 Bielefeld
Germany
Fax +49-(0)521-63789
jschaaber@bukopharma.de
www.en.bukopharma.de