The authors asked for medical drugs to be licensed only in the context of proven additional benefit for patient-relevant end points relating to the indication. That may be honorable but it does not get us anywhere. The difficulty lies in particular in defining the additional benefit and the patient relevant end points. And that is where the pharmaceutical industry with its licensing studies dominates.
The 12th revision of Germany’s drug law has resulted in dramatically more difficult conditions and greater costs for scientifically driven studies. As a result, even the large scientific studies are now strongly dependent on industry funding and lose independence in terms of their research questions.
We suggested establishing a national foundation for cancer research in order to fund studies. In Germany, more than Euro250bn are spent on health, and of that, more than Euro41bn on medical drugs. At the same time, there is practically no public funding for studies. Activities of this kind can be supported by a small percentage of the total healthcare costs. Why are we not spending this money? The dividends would be ample.
If there is no will to provide public funding for clinical studies, then the results should surprise nobody.
Footnotes
Conflict of Interest Statement
The author declares that no conflict of interest exists according to the guidelines of the International Committee of Medical Journal Editors.
References
- 1.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. Dtsch Arztebl Int. 2010;107(16):279–285. doi: 10.3238/arztebl.2010.0279. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 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 2. A qualitative, systematic review of the literature on possible influences on authorship, access to trial data, and trial registration and publication. Dtsch Arztebl Int. 2010;107(17):295–301. doi: 10.3238/arztebl.2010.0295. [DOI] [PMC free article] [PubMed] [Google Scholar]