The trials and tribulations of repurposing metformin and other generic drugs for tuberculosis
Abstract
There are a number of generic drugs that might be useful in treating tuberculosis, but will they ever get to the patients who need them? They might, but not without a lot of help. There are intellectual property issues, endpoint issues, cost of research issues, economic incentive issues, preclinical validation issues, “who is in charge” issues and many more. It is clear that repurposed generic drugs have the potential to make a safe, effective, quick and affordable impact on a global disease of poverty such as tuberculosis. But without the economic incentives that are usually in place for drug development, can we muster the scientific, economic and governmental support to bring them to the patients?
References
- 1 RARE List™. Global genes, allies in rare diseases, 2015. https://globalgenes.org/rarelist/.
- 2 Food and Drug Administration. Novel new drugs 2014 summary, FDA, 2015. www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM430299.pdf.
- 3 New York Times. $2.6 billion to develop a drug? New estimate makes questionable assumptions. ny times. www.nytimes.com/2014/11/19/upshot/calculating-the-real-costs-of-developing-a-new-drug.html?_r=0.
- 4 Wikipedia. Generic drugs. https://en.wikipedia.org/wiki/Generic_drug.
- 5 . Exploring the potential of adjunct therapy in tuberculosis. TIPS 36(8), 506–513 (2015).
- 6 Auranofin exerts broad-spectrum bactericidal activities by targeting thiol-redox homeostasis. Proc. Natl. Acad. Sci. USA 112(14), 4453–4458 (2015).
- 7 Metformin as adjunct antituberculosis therapy. Sci. Transl. Med. 6(263), 263 (2014).
- 8 . Metformin as a potential combination therapy with existing front-line antibiotics for tuberculosis. J. Transl. Med. 13, 83 (2015).
- 9 World Health Organization. What is TB? How is it treated? www.who.int/features/qa/08/en/.
- 10 Google Patents. Methods to inhibit intracellular growth of bacteria and to treat bacteria-mediated diseases: WO2014039011. www.google.com/patents/WO2014039011A1?cl=en.
- 11 . Regulatory strategy for the development of known drugs in new therapeutic areas, 2011. http://dgra.de/media/pdf/studium/masterthesis/master_papakrivos_j.pdf.
- 12 Slate Magazine. A giant pain in the wallet: how drug companies are making crucial, common drugs up to 100 times more expensive. www.slate.com/articles/health_and_science/medical_examiner/2011/03/a_giant_pain_in_the_wallet.html.
- 13 Barriers to successful tuberculosis treatment in Tomsk, Russian Federation: non-adherence, default and the acquisition of multidrug resistance. Bull. World Health Organ. 85(9), 703–711 (2007).
- 14 Use of crowdsourcing for cancer clinical trial development. J. Natl. Cancer Inst. 106(10), 258 (2014).