Some inexpensive and for decades used drugs may through their positive side effects benefit patients with diseases such as metastatic cancers. The drugs are unpatentable and out of interest of pharmaceutical companies. For example, it was recently demonstrated in phase II clinical trial based on previous scientific evidence that an old anti-alcoholic drug disulfiram (Antabuse) at low dose shows significant benefit for patients with metastatic lung cancer (Nechushtan et al. Oncologist 2015). For further clinical development of disulfiram the funding is critical. The aim of the following trials will not be profit-making, but low-cost, globally available drug, i.e. nonprofit drug, for such metastatic cancer(s) for which the trails will be successful. In our project, we pursue:
1. To encourage clinical trials of disulfiram (or other unpatentable generics) by systematic search for positive side effects in oncology patients taking disulfiram (or other unpatentable generics) for alcoholism (or generally: diseases other than cancer). We will discuss individual case reports with our collaborators (e.g. Vikas Sukhatme who is Victor J. Aresty Professor of Medicine at Harvard Medical School) and, together, evaluate them. If encouraging data is seen, it will spur clinical testing of particular drug combinations in cancer patients. In this way, our project is a pilot case of systematic search for positive side effects of a generic drug.
2. To offer a way how to design and conduct clinical trials of a nonprofit drug, in our case disulfiram, funded by public investment in public interest. As late-stage clinical trials are generally very expensive and financed by pharmaceutical companies, we will – in discussion with public authorities and our collaborators (e.g. Bohuslav Melichar, head of Department of Oncology at Palacky University) – pave a way for a standard procedure how to develop nonprofit drugs.