As microbes become resistant to treatments, the international community must pool its resources and expertise and create a not-for-profit taskforce to develop new drugs and prevent catastrophe, says Tadataka Yamada

THE treatment or prevention of infectious diseases has not made quantum advances since the early successes of vaccines and antimicrobial therapies. The world is headed backward, as once-treatable microbes become resistant to existing therapies, and new infections, for which there are no effective interventions, continue to arise.

This is a serious and imminent threat to the world. Witness the global impact of the 2014 ebola crisis in West Africa, or the 2003 Sars outbreak, which jeopardised even wealthy economies, like Singapore and Canada.

The emergence of a highly lethal, and rapidly spreading, antimicrobial-resistant infection would cause untold numbers of deaths and unimaginable misery. The consequences may be similar in magnitude to a large-scale terrorist attack. Communities may have to be walled-off, national borders closed, and travel restricted or suspended. Health systems could disintegrate or collapse, as could economies.

The threat of infectious diseases — either from microbes that develop resistance to existing therapies or from new microbes that emerge — is among the most important challenges that humankind faces. It is not just a public health risk; it is a threat to national and global security. Thus, it must be met with a comprehensive solution.

The research and development required to produce new medicines or vaccines is time-consuming, and often requires a dozen years. It is also very expensive, costing hundreds of millions of dollars for every new product. Moreover, there is no guarantee of success; indeed, for each successful product, there are as many as nine equally promising candidates that fail.

Given the risks involved, it is not surprising that pharmaceutical companies are careful in their choice of investments in new drug or vaccine programmes, selecting only those that promise financial gains sufficient to cover the costs of both successes and failures and which will provide a reasonable return on the investment.

Infectious diseases are a global calamity waiting to happen

Many solutions have been proposed for this investment problem, such as prizes for successful products, new incentives for industry investments, and novel funding mechanisms to support research that addresses emerging infectious threats. All have merit, but would lead to incremental advances at best. A more ambitious solution is needed.

Most countries are prepared to channel a large percentage of their GDP toward investments in national defence or security.

The global threat of emerging or resistant infections must be viewed in that context, with all countries committed to providing financing, intellectual capital, and available resources to support the discovery, development, manufacture, stockpiling, and equitable distribution of new antimicrobial agents and vaccines.

Unless countries recognise the risks, they are unlikely to make such a commitment.

It may help to inform them that the estimated cost of emerging, global infectious threats is $600bn (€546bn) per year; if investments are made upfront, the total costs could be smaller.

Country investments should be pooled to create a substantial pipeline of products to combat infectious threats.

There are many ways this could be done.

Infectious diseases are a global calamity waiting to happen

The easiest would be to spread the money around to scientists in academia, product-development partnerships, biotech firms, and larger pharmaceutical companies, as opportunities arise.

This might allow existing processes to move forward with new momentum, based on the availability of new funds. Unfortunately, history suggests that this wouldn’t lead to much progress beyond the state of the pipeline today.

An alternative would be a full-fledged, global, not-for-profit pharmaceutical company with a research budget equal to that of the world’s top five for-profit companies, and with the singular objective of creating a pipeline of products to address the challenge of infectious threats.

As with any of its for-profit peers, the management and scientific talent to undertake this effort would have to be the best available, and attracting it would require competitive compensation.

The management team would be held accountable for its performance by a board of investors, comprising representatives of countries that provide the funding and scientists who provide the intellectual capital.

In keeping with industry practice, the pipelines would have to be built with a combination of internal research and in-licensing, or acquisition of external innovation.

Adequate infrastructure for clinical trials would have to be built to support research, not only in developed countries, but also in remote regions where some of the infectious threats are likely to emerge.

Infectious diseases are a global calamity waiting to happen

The new company’s work would be aided by prior agreements, among regulatory agencies, on the requirements for registration of new products; among intellectual-property holders on waiving royalty rights; and among governments on liability-protection for the company, and compensation for the victims of unexpected adverse reactions to new products.

The international community would have to increase available manufacturing capacity, create new distribution channels, and reserve storage capacity for stockpiling products that have no immediate application.

This would be a complicated undertaking, with many details to be worked out. But, somehow, we must suspend disbelief and take action now, lest we be caught off-guard against an imminent global threat.

This is a battle we cannot afford to lose.

Tadataka Yamada, a venture partner at Frazier Healthcare Partners, was previously chief medical and scientific officer, and a board member, of Takeda Pharmaceuticals. Copyright: Project Syndicate, 2016.


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