BGH setzt Pharmawerbung Grenzen

Brief an Boehringer Ingelheim (leicht modifiziert)

mit Verwunderung habe ich Ihre ganzseitigen Silomat®-Inserate in mehreren Fachzeitschriften und auch in der Ärzte Zeitung gesehen. Zur Untermauerung von Wirksamkeit und Verträglichkeit gegenüber Codein führen Sie 2 Studien ein und desselben Autors an:
Matthys et al. Schweiz Med Wochenschr. 1985 Mar 2; 115 (9): 307-11
und
Matthys et al. J Int Med Res. 1983; 11 (2): 92-100

Ich halte die Firma Boehringer-Ingelheim für ein seriöses Pharmaunternehmen. Ich frage mich allerdings:
1. warum die Literaturhinweise bei ganzseitiger Zeitungs-Veröffentlichung so klein gedruckt sein müssen; gerade so, als würden sie diese schamhaft verstecken wollen?
2. was 28 und 30 Jahre alte Literaturhinweise beweisen sollen, denn die damaligen Codein-Vergleichssubstanzen sind ebenfalls mittlerweile 28 bzw. 30 Jahre alt?
3. weshalb sie gleichzeitig Silomat® INTENSIV Kapseln intensiv bewerben, das wegen fehlendem klinischen Nutzennachweis nicht mal erstattungsfähig in der Gesetzlichen Krankenversicherung (GKV) ist?

Es kommt allerdings noch schlimmer. Denn unter:
Schweiz Med Wochenschr. 1985 Mar 2;115(9):307-11.
[Objectivation of the effect of antitussive agents using tussometry in patients with chronic cough]. Matthys H, Erhardt J, Rühle KH.: Abstract
"The antitussive effect of several antitussive agents has been objectively evaluated in patients with chronic stable cough due to bronchial carcinoma, pulmonary tuberculosis or chronic obstructive lung disease. The patients received the active antitussive drugs or placebo in a double-blind, randomized crossover design. The preparations were administered at 10 p.m. and 2 a.m. on 7 consecutive nights and no antitussive was given for the following 20 hours. Cough frequency and intensity were recorded from 10 p.m. until 6 a.m. The active medications were noscapine (30 mg), dextromethorphan (20 mg), dihydrocodeine (30 mg) and codeine (20, 30 and 60 mg) at 10 p.m. and 2 a.m. Cough frequency and intensity were objectively assessed with a pressure transducer placed over the trachea and recorded on a chartrecorder. Statistical analysis was performed with analysis of variance and multiple range testing. Noscapine, dextromethorphan, dihydrocodeine and codeine (60 mg) significantly (p less than 0.001) reduced the cough frequency compared to placebo. They also produced a greater reduction of cough intensity than placebo, codeine (20 mg) and codeine (30 mg) (p less than 0.001). The duration of action of low-dose codeine (6 hours) was unsatisfactory. Subjective preference for dextromethorphan indicates a psychotropic central nervous action of this drug not assessed by the measuring device. Noscapine was equally well tolerated but more neutral psychologically." PMID: 3885387 [PubMed - indexed for MEDLINE] -
findet sich für Dextromethorphan nur eine „subjektive Präferenz“ bei der von Ihnen beworbenen besseren Verträglichkeit.

Die vorhergehende Publikation ist ebenfalls von Evidenz-basierter Medizin entfernt: J Int Med Res. 1983;11(2):92-100.:
Dextromethorphan and codeine: objective assessment of antitussive activity in patients with chronic cough. Matthys H, Bleicher B, Bleicher U.: Abstract
"Dextromethorphan, the most widely used cough suppressant in the U.S.A., was compared with codeine, the traditional European antitussive, in a double-blind, crossover trial using both an objective and subjective assessment of efficacy in sixteen patients with chronic, stable cough. Both preparations, at a dose of 20 mg, were similarly effective in reducing cough frequency. Dextromethorphan lowered cough intensity to a greater degree than codeine (p less than 0.0008) and was considered the better antitussive by the majority of patients (p less than 0.001). In view of its lack of side-effects, its safety even in overdose and its non-narcotic status, the increasing trend in Europe to use dextromethorphan as a substitute for codeine in the treatment of cough is to be w