500 Tote pro Jahr: Und die Pillenpolizei schaut zu
Transcrição
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 2 1 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) 3 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) 4 2 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 6 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 7 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 8 4 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 9 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 11 12 6 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 • 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 14 7 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 15 8