Weakening Objections

The Safety of Drug Therapy in Children by Stefan Wimmer, PD Dr. rer. nat. Antje Neubert, and Prof. Dr. med. Dr. h.c. Wolfgang Rascher in issue 46/2015

There is a lack of awareness that, after licensing, further reporting is essential to sufficiently detect risks. This is especially drastic following vaccinations, for which a mandatory reporting of suspected cases of reactions surpassing those expected (with a non-compliance penalty of up to 25 000 Euro) is in place since 2001 as part of the German Infection Protection Act (Infektionsschutzgesetzes). However, the leaflet is usually not even handed out („Please read this information carefully before your child receives this vaccine“). The lack of reporting procedures within the medical community—which unfortunately also applies to the „alternative“ providers (including naturopaths) who like to discuss vaccination effects—was highlighted by the Paul-Ehrlich-Institute (PEI) in 2002 (1): a maximum of 5% of severe adverse drug reactions are reported. Ways to improve this were also indicated, for instance through training, which Scott et al. (2) reported in 1990 to increase reporting rates by up to a factor of 17. Deutsches Ärzteblatt also published articles about this in 1991 and 1999. Thus, 95% of such adverse drug reactions cannot be analysed, leaving large gaps in our knowledge (Dittmann, in Vaccines, 1999 and [3]). How is it even possible to carry out benefit–risk evaluations for licensing, vaccine recommendation, and usage when the risk can not be calculated and the effectiveness of vaccination programs can not be evaluated, as was published 2004, 2009, and 2013 in the same journal? Why is nothing concrete being done by PEI or RKI (which hosts the German Standing Committee on Vaccination [STIKO]), drug commissions, professional unions, or others to change this condition and thereby weaken the important objections raised by critical people?

DOI: 10.3238/arztebl.2016.0364a

Jürgen Fridrich

Sevenich

Conflict of interest statement

Mr. Fridrich has received reimbursement from Libertas & Sanitas e. V. for publication fees, conference registration fees, travel and accommodation expenses, and scientific meeting preparation fees. He is the author of several books about vaccinations.

References

1. Keller-Stanislawski B, Hartmann K: Auswertung der Meldungen von Verdachtsfällen auf Impfkomplikationen nach dem Infektionsschutzgesetz. Bundesgesundheitsbl 2002: 344–54

2. Scott HD, Thacher-Renshaw A, Rosenbaum SE, et al.: Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project. JAMA 1990; 263: 1785–8

3. Dittmann S: Risiko des Impfens und das noch größere Risiko, nicht geimpft zu sein. Bundesgesundheitsbl Gesundheitsfo Gesundheitssch 2002; 45: 316–2

4. Wimmer S, Neubert A, Rascher W: The safety of drug therapy in children. Dtsch Arztebl Int 2015; 112: 781–7