Why We Need Open Source Pharma
BY ZAKIR THOMAS
Market forces drive innovation. This is true in any sector, including the pharmaceutical industry. All corporations have to maximize shareholder value. Following this, pharmaceutical firms focus on diseases with assured market and ensured return on investment leaving the neglected diseases out. A striking example is tuberculosis (TB) which is currently treated with a lengthy regimen discovered in the middle of the 20th century. The estimated global market for TB, estimated at US$400 million, does not meet the market threshold for commercial drug research, estimated to be more than a billion dollars.
The closure of Astra Zeneca’s R&D centre in Bangalore illustrates the challenge. The work done on TB at the Bangalore facility led to the discovery of a New Chemical Entity, AZ 584, a promising anti-TB candidate currently undergoing clinical trials. Astra Zeneca closed its infectious diseases unit to focus on three core therapy areas —oncology; cardiovascular and metabolic diseases; respiratory, inflammation and autoimmune—in other words, diseases with attractive commercial upsides. This news was received with dismay, prompting The Times of London to report the story as "Astra Zeneca turns its back on diseases of the poor."
Yet pharmaceutical companies, like Janssen Therapeutics and Otsuka Pharmaceuticals, have persisted with TB drug research despite many financial uncertainties. Janssen’s Sirturo (a.k.a., bedaquiline) was given priority approval by the FDA and is one of the most promising new therapies for Drug Resistant TB patients. One hopes that the Otsuka molecule will also reach the market soon.
Global Alliance on Tuberculosis (TB Alliance) has a promising pipeline and is experimenting with novel combinations. The success of this Product Development Partnership (PDP) in boosting TB drug discovery brings hope to the patients. Medicines for Malaria Venture (MMV) and Drugs for Neglected Diseases Initiative (DNDi) have spurred innovation on neglected diseases through collaborative approaches and are making available novel therapies for malaria, Leishmaniasis, Chagas Disease, and others. The achievements of the PDPs show the power of collaborative approaches to innovation. The need out there far outweighs what these well-meaning organizations are doing. Their efforts need be supplemented and supported, as well as the efforts of Janssen, Otsuka, and other for-profit companies working in this field.
The funding pattern of innovation for neglected diseases points to the need for alternative models in drug development. According to the G-FINDER (Global Funding of Innovation for Neglected Diseases) survey, industry investment was only about 17% across 33 neglected disease areas, with the rest of the funding coming from the governments of developed nations (63%) and philanthropic agencies (20%). Even this limited industry investment is focused on diseases with semi-commercial potential like HIV, TB, and malaria. Other so-called neglected diseases receive very limited funding and attention.
The absence of market pressure makes the IP-driven innovation system all but ineffective for finding cures for neglected diseases. Therefore, we need to seek alternate innovation models for neglected diseases. The viability of using an open source approach to R&D for neglected diseases was examined by the Expert Working Group (EWG), set up by World Health Organisation (WHO). After assessing various proposals around the globe, EWG recommended open source models as one of the most promising strategies. The EWG proposal was further examined by the Consultative Expert Working Group (CEWG) of WHO. CEWG, likewise, recommended open source approaches to R&D and innovation. The following is an excerpt from the CEWG report on open approaches:
Typically these involve innovative, or atleast more flexible applications of intellectual property inorder to minimize intellectual property barriers to innovation. Such approached could help to reduce the cost of R&D and accelerate product development, and we favored open and collaborative approaches that could also help to reduce duplication in research and widen the pool of researchers applying their expertise to the development of products needed in the developing countries. Thus these approaches could also contribute to capacity building and technology transfer.
Behind the collective of neglected diseases are individual, neglected patients. The lives of these patients are as valuable as any others. Just because their diseases do not have market potential should not be an excuse for not providing them the benefits of advances in pharmaceutical innovation. The logic of an open source pharma approach is to bring together all those who believe in making innovation matter to the neglected patients, to collectively deliver new therapies to them.
The question is whether an open source drug-discovery and drug-development process can develop therapies that will reach patients with the most pressing public health needs. The Bellagio Center conference is dedicated to this question.
Zakir Thomas is an open innovation expert based in Delhi. He is the former Project Director of Open Science Drug Discovery. He is @ZakirThomas on Twitter.
Other essays in this series:
James Kassaga Arinaitwe, Global Health Corps & Aspen Institute Fellow / Kampala
Manica Balasegaram, Exec. Director, Access Campaign, Médecins Sans Frontières / Geneva
Polly J. Price, Emory University law professor / Atlanta
John Wilbanks, Chief Commons Officer, Sage Bionetworks / Washington, D.C.
Dimitrios Tzalis, Founder & CEO, Taros Chemicals GmbH & Co. KG. / Dortmund
T.V. Mohandas Pai, Chairman, Manipal Global Education Services / Bangalore
Els Torreele, Director, Access to Essential Medicines Initiative, Open Society Foundations / NYC
Tomasz Sablinski, CEO of Transparency Life Sciences / NYCi
Matthew Todd, Founder of Open Source Malaria / Sydney & Cambridge