Trend Gives Cause for Concern
The authors in their conclusion unfortunately do not mention some further important aspects of clinical drug research. The 12th revision of the German Drug Registration and Administration Act has resulted in extreme amounts of bureaucracy. Further, the financial costs of drug studies have vastly increased. For investigator-initiated trials, the full legal responsibility lies with the investigator or study center. A study in which we wanted to investigate polyneuropathies as adverse effects after administration of cytotoxic drugs failed, for example; legally this would have been research under the drug law, with all consequences in reporting much more than the intended study of drug safety. The intended improvement to all patients’ safety has resulted in obstacles to and ultimately discrimination against independent drug research. Among the last 67 drug studies in our ethics committee, not a single one had as main outcome parameter adverse effects or safety concerns. Since the 12th revision of Germany’s drug law, drug research has changed its course towards primarily industry studies and efficacy studies and away from long-term safety studies. In the face of these worrying trends, the demands made by Schott et al are unsatisfactory. A paradigm shift in clinical drug research is what is needed. The costs would have to be shared among everyone—for example, through a joint fund: the pharmaceutical industry, the funding bodies—even if only to reduce the costs of treating adverse drug reactions. The authors from the Drug Commission of the German Medical Association should have deduced the necessary suggestions from their analysis in order to avoid future drug scandals effectively. This entails not only a full disclosure of competing interests and substantial support from industry-independent research funds, but also the acceptance and publication of negative findings (1). However, more than all that it requires a de-bureaucratization of safety studies for medical drugs.
Prof. Dr. med. Christoph Maier
44789 Bochum, Germany
Prof. Dr. med. Michael Zenz
Vorsitzender der Ethikkommission
44789 Bochum, Germany
Conflict of Interest Statement
Professor Maier declares that no conflict of interest exists according to the guidelines of the International Committee of Medical Journal Editors. Professor Zenz reports ties to Janssen-Cilag, Grünenthal, Mundipharm.
|1.||Breivik H: Merits of publishing a negative and prematurely ended study on intrathecal methylprednisolone for severe and longstanding complex regional pain syndrome (CRPS-I). Eur J Pain 2010; 14: 453–5. MEDLINE|
|2.||Schott G, Pachl H, Limbach U, Gundert-Remy U, Ludwig WD, Lieb K: The financing of drug trials by pharmaceutical companies and its consequences: Part 1. A qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials [Finanzierung von Arzneimittelstudien durch pharmazeutische Unternehmen und die Folgen: Teil 1: Qualitative systematische Literaturübersicht zum Einfluss auf Studienergebnisse, -protokoll und -qualität]. Dtsch Arztebl Int 2010; 107(16): 279–85. VOLLTEXT|
|3.||Schott G, Pachl H, Limbach U, Gundert-Remy U, Ludwig WD, Lieb K: The financing of drug trials by pharmaceutical companies and its consequences: Part 2. A qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication [Finanzierung von Arzneimittelstudien durch pharmazeutische Unternehmen und die Folgen Teil 2: Qualitative systematische Literaturübersicht zum Einfluss auf Autorschaft, Zugang zu Studiendaten sowie auf Studienregistrierung und Publikation]. Dtsch Arztebl Int 2010; 107(17): 295–301. VOLLTEXT|