500 Tote pro Jahr: Und die Pillenpolizei schaut zu

Safety of Medicines and the Media
Recent examples regarding risk communication
Joachim Gross, Head Press Relations, Swissmedic
Rudolf Stoller, Head Safety of Medicines, Swissmedic
Swissmedic
•
Schweizerisches Heilmittelinstitut
•
Hallerstrasse 7
•
CH-3000 Bern
•
www.swissmedic.ch
500 Tote pro Jahr: Und die
Pillenpolizei schaut zu
Sonntagsblick 18. Dezember 2005
Behinderter Dean: Kein Fall für die
Pillenpolizei
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Antibabypille mit schlimmen Folgen
Schwerstbehindert nach Antibabypille
Swissmedic plant keinen Rückruf von «Yasmin»
Swissmedic unter Druck
Schlagzeilen in der Hauptausgabe der Tagesschau und in dem News-Magazin 10 vor 10 (vom 28.5.2009 bis 31.5.2009)
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Schwerstbehindert nach Pille – Celine Risiko besteht bei allen Pillen
Blick (30.05.09)
ist kein Einzelfall
20min (29.05.09)
Antibabypille birgt auch Risiken
Schwerstbehindert - durch die Pille
Berner Zeitung (30.05.09)
Tages-Anzeiger (29.05.09)
Antibabypille Yasmin in der Kritik
Malgré un drame, la pillule Yasmin
reste en vente
24heures (30.05.09)
Rückruf von Yasmin steht nicht zur
Debatte
Lichtensteiner Vaterland (30.05.09)
Wirbel um eine Antibabypille – Der
tragische Krankheitsfall eines
Mädchens als Medienhype
NZZ (30.05.09)
Basler Zeitung (30.05.09)
Sie sagte „Mami, mir wird schlecht“,
dann brach sie zusammen
Fünf Frauen in der Schweiz starben,
weil sie die Pille nahmen
Tagesanzeiger (30.05.09)
Blick (30.05.09)
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The pill scare 2009
R. Stoller
Division Safety of Medicines
June 2nd 2010
Swissmedic
•
Schweizerisches Heilmittelinstitut
•
Hallerstrasse 7
•
CH-3000 Bern
•
www.swissmedic.ch
Source: http://images.easyart.com/i/prints/rw/lg/7/1/Maxi-Posters-Die-Simpsons---Der-Schrei-71474.jpg
The facts
• Spring 2008; Young lady suffering severe hypoxic brain injury
after resuscitation for central pulmonary embolism. She had
been on a combined oral contraceptive (COC) for 3 months
• Mai 2010 Swiss television, informed by lawyer, contacts
Swissmedic
• In 2 large epidemiological studies incidence of venous
thromboembolism similar for involved (antiandrogenic) product
and other (2nd and 3d-generation COCs)
• Extensive warnings in professional and patient product
information
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3
Facts: Swissmedic spontaneous reports
1.January 2004 – April 2009
All ADR
reports
HC
All Hormonal
Contrac.
Involved (antiandrogenic)
contrac.
PE
Pulmonary
Embolism
with or
without VT
VT Venous VTE:
Thrombosis
without PE VT or PE
692
31
19
50
105
19
9
28
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Swissmedic Media Information Mai 2009
• well known rare, but serious risk with all combined oral
contraceptives (COC)
• existing warnings in product information
• statistics on Swiss spontaneous reports for all COC,
no class or product specific data
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Swiss Television SF DRS
•
•
•
about 500‘000 Swiss women use COC
market share of the anti-androgenic product 20%
but it is involved in about half of Swiss VTE-reports
epidemiological data from company-sponsored studies
only and therefore questionable
-> the product is more dangerous!
-> other Swiss and German media follow
– resulting in the 2009 Swiss pill scare
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Bringing science back to the public
Swissmedic
• involves expert committee
• for comprehensive reanalysis of all data
• update to be published in autumn 2009,
does not provide new data until that deadline
• regular follow-up on homepage since
10
5
Good and evil…
Bad journalism, wrongly blaming a product group, BUT
• shows importance of a „well-known“ risk:
very serious, large population at risk, „lifestyle“ indication
• doctor‘s versus public perception – doctors have
„got used to it“
• consumers awareness decreased (last big pill scare in 1995)
-> precautions and controls mandatory (HISTORY TAKING)
-> early warning symptoms of pulmonary embolism,
diagnostic tests (d-dimer…)
-> regular updates on Swissmedic homepage (awareness)
-> spontaneous reporting very valuable for known risks too:
help to identify what went wrong
& thus to define preventive action
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LESSONS LEARNED (V)
• Be prepared and expect the worst
• trust is built before it is challenged and based on
• knwoledge and expertise
openness and honesty
care and concern
• calm, measured, reassuring not in the least defensive
• Your contribution
* Melissa Sweet, Australia,
http://inside.org.au/swine-flu-vaccination-and-other-matters-of-trust/print/
Swissmedic
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Schweizerisches Heilmittelinstitut
•
Hallerstrasse 7
•
CH-3000 Bern
•
www.swissmedic.ch
The search for media hype
- Members of the media create products that must be sold
on a hard market
- the more pithy, more emotional the stories are, the more
interest they arouse. What is "normal" is not interesting.
- Finding a "scoop" or at least being the first to report
something is considered a proof of success
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Communication regarding medicines is
always one of communicating risks
Basic principles
- Provide technically accurate information
- Make sure the content is truthful
- Know your own facts
- Use clear, precise language
- Show understanding in the face of criticism
- Be prepared to engage in dialogue
- Make sure of internal information
- Don't let yourself be provoked
- Fairness
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