The coronavirus pandemic has shattered the status quo on drug development. We should build on that
If, like me, you need a mental break from the COVID-19 pandemic, let’s take an excursion to the future, when we emerge from it. Specifically, let’s think about how the world can build on this moment to develop a more open and effective drug discovery system: a system that will allow us to develop vaccines and treatments not only for future pandemics, but also for the pandemics of heart disease, cancer, and brain and nervous system diseases that already exist.
What has been percolating for a while is that the global drug discovery system is increasingly unsustainable. U.S. consumers see this in significantly escalating prices for common drugs—such as insulin, EpiPens, and Humira—but the problem is much deeper. According to the U.S. Census Bureau, the government has been pouring money into all research, including medical research, at an exponential rate since the 1960s. This might have been acceptable if, in return, the outcome had been better drugs. But the trend is going in the opposite direction: New drugs produce on average either flat or declining additional benefit over their predecessors, according to a 2018 study on cancer drugs. In fact, a recent working paper by Stanford and MIT researchers found that the U.S. must double its investments every 13 years just to stay at the same level or, in some cases, fall behind.
Thankfully, there is reason to be optimistic that the world can improve the drug discovery system. Those studying the problem know the barriers to change: collective comfort with the status quo and the associated lack of flexibility. The COVID-19 pandemic shattered this status quo. In the face of this, scientists and governments turned to a new model of drug discovery: open science partnerships.
Open science—the free sharing of scientific research—has been a critical pillar of modern science since mid-16th-century Europe. It has lived symbiotically with more proprietary science, in which research over practical products remains controlled by a single inventor or firm. The key to this symbiosis is that the two systems—open and proprietary—remain in balance, according to Paul David, a Stanford economist. So while open science leads scientists to develop a fundamental understanding of biology and common tools and evidence, proprietary science permits individuals and firms to develop specific products based on that fundamental understanding.
There are many reasons for the current crisis in drug development, but one key reason is that proprietary science is increasingly encroaching into the domain of open science. Courts, universities, and firms extended patent law to cover the foundations of biology and the tools and methods that scientists use to understand our bodies. Universities, the former bastions of open science, adopted more proprietary approaches. Rather than sharing information, more and more knowledge is stuck in silos. Publications that used to be easily available are hidden behind paywalls, data balkanized, and the materials underlying research held tightly. Rather than complementing open science, proprietary science is consuming it.
The result of the imbalance between proprietary and open science is that ideas that generate new products and services are harder to develop. Getting into partnerships takes significantly longer, and the results flow more slowly to patients.
All this is happening at exactly the wrong moment. Scientific questions are increasingly complex, requiring larger and more diverse partnerships, while training takes longer—the age of those winning their first grants from the National Institutes of Health increased from about 36 to 44 years between 1980 to 2011—as each new scientist is expected to absorb ever more knowledge. Scientists and pharmaceutical and biopharmaceutical firms need more sharing and more partnerships to fast-track discovery—but the roadblocks of proprietary science get in the way.
It is thus not surprising that scientists and governments quickly abandoned proprietary science when faced with the COVID-19 pandemic. They shared data, molecules, and genetic sequences as they were identified and worked together to develop diagnostic kits and repurpose existing drugs. Scientists did the same thing 30 years ago when the world came together in the Human Genome Project to sequence the entire human genome. Other open projects seek to cure malaria or protect the Linux core. More recently, the Structural Genomics Consortium—a partnership funded by governments, philanthropies, and international Big Pharma—has developed drug targets and drugs, and conducts clinical trials through its nonprofit spinout, M4K Pharma, without patents and with open sharing. It has created a drug discovery model that transfers drugs to the private sector with price caps to ensure access and availability. The Montreal Neurological Institute and Hospital followed suit, announcing in 2016 that it would be going open science. So far, however, these efforts are the exception, not the rule.
It is time to change this. Open science partnerships play a critical role in drug development by de-risking innovation through cost sharing, leveraging financing, and bringing together actors with diverse skills, tools, materials, and knowledge. All stakeholders have a role in promoting these partnerships. This requires new forms of research grants targeting open science, increased corporate funding and participation, and changing university promotion and tenure rules to reward data and materials sharing. Researchers should also more actively share data, tools, and materials before publication, such as through e-lab books and regular data uploads. Establishing the adoption of open science standard form agreements would also reduce the time it takes to set up a partnership.
If all we do on exiting the pandemic is return to business as usual, we will have wasted this crisis. We need to make open science partnerships a central pillar in fighting not only the next global pandemic, but also the pandemics we already face.
E. Richard Gold is a professor in McGill University’s Faculty of Law and Faculty of Medicine. Follow him on Twitter.
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