Drug bulletins and politics

1
Drug bulletins and politics

• Jörg Schaaber
• Pharma-Brief Gute Pillen Schlechte Pillen

2
Why should we lobby?

• The vast amount of misleading influence cannot be
  corrected by giving good information in a
  bulletin only
• My example HPV-vaccine
• As a result of massive PR Gardasil was the most
  visited consumer website in 1 Q. 2007 (nearly 1
  million users)

3
Organizations as front for industry

• Grünes Kreuz with focus on vaccination
• Message on HPV vaccine by star designer Jette Joop

4
HPV-vaccine How effective?

• First vaccination against cancer
• 98?
• Lifelong vaccine efficacy of 92,5?
• 98 HPV 16 and 18?
• 70 against cervical cancer?

5
Prevention of high-grade intracellular neoplasia

• 7,8 (Future I /quoted by EMEA 2008)
• 17 (Future II)

6
Prevention of high-grade intracellular
neoplasiaHPV 16 and 18 negative

• 16,9 (FDA 2006)
• 27 (Future II)
• 37,9 (EMEA 2006)
• 46,1 (EMEA 2008)
• after exluding more than half of the women

7
Countering the misrepresentation

• arznei-telegrammDec 2006 June and Nov 2007
• Gute Pillen Schlechte Pillen Oct 2007
• Used for info leaflets
• Going to press

8
Working with scientists

• Pick up the anger of misleading information
• Advice them how to proceed
• analysis of the data in arznei-telegramm (Nov
  2008)

9
How it was done

• Find medical scientists who support the demands
• Drafting of a statement
• Identifying an interested journalist

10
Launch 26 Nov
Prof. Martina Dören Prof. Wolf-Dieter Ludwig
Charité, Berlin Dr. Ansgar Gerhardus Prof.
Claudia Hornberg Prof. Oliver Razum University
Bielefeld  Prof. Ferdinand M. Gerlach
University Frankfurt Prof. Michael M. Kochen
University Göttingen Prof. Petra KolipCorinna
SchachProf. Norbert SchmackeUniversity Bremen
Prof. Ingrid Mühlhauser University Hamburg Prof.
Rolf RosenbrockWZB, Berlin Prof. Jürgen
WindelerMDS, Essen

• Full page in Süddeutsche Zeitung
• Good uptake in media
• 13 medical scientists
• 2 members of State Health Experts body

11
Reactions 27 Nov 2008

• Sanofi Pasteur MSD slams criticism of data
  behind Gardasil vaccination programme
• A spokesman for Sanofi Pasteur MSD, which makes
  Gardasil vaccination, told APM,The statements
  about efficacy and data are wrongly-interpreted.

12
Von Hausen (Frankfurter Allgemeine Zeitung Blog
1 Dec 2008)

• Richtig ist, dass in annähernd 20-30 dieser
  Krebserkrankungen andere HPV Typen gefunden
  werden, die zum Teil relativ nahe mit den
  Prototypen 16 und 18 verwandt sind, so dass bei
  vorliegenden Antikörpern gegen die Impfviren
  sogar eine gewisse Kreuzneutralisierung schon
  theoretisch vorausgesetzt und erwartet werden
  darf. Entsprechende Beobachtungen sind inzwischen
  auch publiziert.Dies dürfte eher dafür sprechen,
  dass der Impfschutz höher als die erwarteten 70
  sein wird.
• The protection of the vacccination against
  cervical cancer will rather be higher than the
  expected 70.

13

• Only 17 less high-grade intracellular neoplasia
  caused by HPV 16 and 18
• Correct Overall 17 less high-grade
  intracellular neoplasia

While women that have not yet been sexually
active are protected 98. Correct 98 less
high-grade intracellular neoplasia caused by HPV
16 and 18
14
Von Hausen

• Auf den 13 Experten des Gesundheitswesens lastet
  eine hohe Verantwortung. Die Öffentlichkeit darf
  darauf bestehen, dass sich diese Experten
  zumindest über die Grundlagen ihrer Aussagen
  korrekt informieren müssen und sich dieser
  Verantwortung dann auch stellen.
• The public may insist that these experts at
  least inform themselves about the basis of their
  claims and take responsibility. for their
  misdoings?

15
A Nobel reaction?
I have not seen the Manifesto therefore I can
only relate to the statements of the journalist
in this newspaper article.
16
What now?

• Demand that STIKO does a re-assessment
• Publicises data used
• The German drug committee (Gemeinsamer
  Bundesausschuss) may decide about limiting the
  use
• Statement translated to English
• Start international debate?

17
(No Transcript)