Medicine in the Age of Pandemics: why our innovation system for new drug discovery is failing and how to fix it
posted by Kathryn Ibata-Arens on March 16, 2020 - 12:00am
Covid-19 is our wake-up call. Deadly pandemics are expected to keep growing in the future and our innovation system for life-saving drug development is ill equipped to deal with it. Here is why and how to fix it.
Medicines - the drugs used to treat disease conditions - have a four-thousand-year history of discovery and development. Diseases were diagnosed at the bedside of patients, and natural medicines, usually from plants, were developed to treat them. Now we have the reverse: a bench-to-bedside innovation system. Pharmaceutical companies test many thousands of synthetic chemical drugs, looking for “hits” that might be useful in treating disease. To be sure, advances in big data and artificial intelligence have helped to accelerate a process that used to be the modern equivalent of searching for a needle in a haystack. Further, standardizing the manufacturing process is easier when you are dealing with small molecule type drugs: called “new molecular entities” (NMEs).
The drawbacks of this structure are threefold. First, there is a limit to the number of synthetic chemicals that can be used in human bodies to treat disease without harming the patient. The 1960s thalidomide crisis in Europe was the first of a number of chemical drug scandals in which pharmaceutical companies were found to put their profits above the safe use of drugs in patients. Second, given the time, technology, and effort required to test the limited number of potential compounds, it is understandable that companies are reluctant to share their discoveries in an open innovation commons. Third, private firms, outside of their CSR activities, are not in the business of philanthropy. This means that new drugs and diagnostics are developed to treat diseases in patients (and insurance schemes) that will pay leading to disinvestment in diseases affecting the developing world. This has led to a global innovation system for drug development that is closed, and less innovative over time. This slow, incremental structure is fine if the global environment is business as usual. The problem is that most, if not all, of pandemic diseases emerge from the socio-spatial intersection of the poor and less developed. But, pandemics respect neither national boundaries nor class distinctions.
A global pandemic of the magnitude of the corona virus – not to mention the rising specter of bacterial plague and parasitic infection – presents challenges that we can, and should, meet by innovating our innovation system. This requires leadership and vision at the top levels of national governments in partnership with private companies, supported by community stakeholders. In sum, we need a Human Genome Project (HGP) for pandemic disease. The HGP, completed in 2003 was an international research consortium that mapped the entire human genome, sharing findings and transferring technology to the private sector. Its success led to development of treatments and potential cures for cancer, diabetes, leukemia, and many other diseases. The HGP was led by National Institutes of Health (NIH) and Department of Energy, with support from private foundation Wellcome Trust. Wellcome Trust focuses on global health and research and policy advocacy preparing the world for the “next major epidemic.” Other efforts underway by the World Health Organization are commendable, but without the buy-in of national governments and leading private firms, progress will be limited, and slow. The United States used to be the beacon-on-the-hill, investing public funds into the NIH and National Science Foundation to support essential basic scientific research that could be shared in a global innovation commons. Likewise, the Human Genome Project benefitted from leaders with a long-term, global vision. An open, and inclusive innovation architecture was created, encouraging the various national teams to share their progress across institutional boundaries. The successes of the Human Genome Project led directly to the ability for Chinese scientists and entrepreneurs to quickly map the genome of the 2002 SARS virus, facilitating the launch of treatments – and also innovative new business ventures. Covid-19 is a SARS type virus.
The death rate of Covid-19 may not reach the near ten percent of SARS, but the scale of the devastation wreaked on the global economy for the foreseeable future is unavoidable – this time. Next time, and unfortunately there most certainly will be a new pathogen to face, we can be ready to act swiftly, and efficiently to lessen the level of damage to global health and economic activity. With foresight and fortitude by our political and business leaders, our global innovation system can rebound, facilitating a rapid response to develop and launch life-saving diagnostics and treatments. A potential new innovation model leading transformational change can be seen in the Global Health Innovative Technology (GHIT) Fund public-private partnership, created by venture capitalists, leading Japanese pharmaceutical firms, and Japan’s Ministry of Health, Labour and Welfare, with support from the Bill & Melinda Gates Foundation.
I joined GHIT’s 2019 annual Research and Development Forum in Tokyo, and had the opportunity to interview the venture capitalists, scientists, entrepreneurs, and policymakers behind the concept. Two features of the GHIT innovation architecture are noteworthy. First, such pharmaceutical companies as Takeda and Eisai have put millions into the funding pot and shared their compound libraries in a semi-open resource pool – removing barriers to information exchange. Second, in a public health meets corporate social responsibility structure, projects selected for investment are completely on merit – based on independent assessment by a global team. Several promising diagnostics and drugs are already under development since the fund’s launch in 2013 – targeting diseases of the developing world.
It may be that to do well in the long-term, it will serve us, meaning human health and humanity writ large, to do good.
Kathryn Ibata-Arens is Vincent de Paul Professor of Political Economy at DePaul University. She is working on a book manuscript called “Medicine in the Age of Pandemics” analyzing the politics and business of innovation in new drug discovery. Ibata-Arens is the author of Beyond Technonationalism: Biomedical Innovation and Entrepreneurship in Asia.