The World Needs Open Source Pharmaceuticals

With COVID, the black box of pharma has been opened and laid bare for the world to see. We have all inherited a pharmaceutical system that professes to reduce human suffering but doesn’t seem to work when we need it the most. Around the world people are asking the same questions: “Why is COVID data secret?”, “Why do critical medicines cost so much?” and “Is there another approach?”.  We’ll take a quick look at the existing drug development process and then propose a new open source model that is more aligned with public health policy. 

The core problem with the existing pharmaceutical business model is the high cost of new drug development compels companies to be secretive and maximize profits. Currently the average cost to bring a new drug to market in the USA is $2Billion over a 12.5 year period. Moreover 80% percent of clinical trials are delayed or closed due to the difficulty of finding the right patients.

With the onset of COVID performing large scale clinical trials is even more difficult. Patients today seldom participate in physical clinical trials due to risk of infection, and the burden of travel and illness. Many patients feel the lack of transparency is a de-motivator to participate.  

Pharmaceutical executives responsible for overseeing life saving drug developments and protecting intellectual property (IP) rights are now beginning to feel public pressure to share their scientific knowledge and trial failures but are reluctant to do so. IP restrictions and lack of sharing slow the development not only of a single drug but also the use of that drug for different applications.  The siloing of scientific information hurts everyone via unnecessary parallel development.  Not surprisingly, people all over the world have lost trust in the system due to the lack of transparency.

Even when successful the current pharma development process often produces cures which are too expensive.  For example, the drug Folotyn for treating peripheral T-cell lymphoma, a form of blood cancer, can cost $793,870 annually.  Adding to the black box of pharma is that companies often transfer costs from a failed drug to a successful drug.  Subsequently the sunk cost of failed drugs gets passed on to patients dependent on a completely different drug further increasing the financial burden.  

Competitive pressure between pharmaceutical companies means there is no economic incentive to share failed trial data between companies or public health officials. From a public health perspective the current situation is unsustainable.  The world needs a different approach.

Borrowing from the software industry, the open source development process provides an alternative model to develop and produce pharmaceuticals. While open source pharmaceutical development is not a new idea, new social media, mobile phone and cloud computing technologies can reduce the cost of running large scale trials across multiple countries.  More importantly by expanding the size of human trials, the quality of analysis can be improved and expensive Phase 2 and 3 trial failures can be avoided. An open source pharmaceutical model also opens the door to parallel drug development across multiple teams – something financially impossible for even the biggest pharmaceutical companies as they can only afford to make bets on a single drug. 

The enabling technologies to support open source pharmaceutical development are the same ones used for software development.  Web conferencing enables medical professionals to share the real world data across time zones just like distributed software development teams.  Patient data can be collected on mobile phone apps that anonymize identity and securely loaded to cloud-based data lakes just like social media apps collect and store game or shopping data.  Data can then be analyzed by machine learning programs that have the ability to process Petabytes of data within hours similar to how high resolution behaviour profiles are created today.  These new technologies, all commercial and relatively inexpensive, provide front line medical personnel and public health officials around the world an opportunity to own the output of their clinical trials.  

Without the need to keep the data secret the door to global cooperation between independent researchers and small regional manufacturers to non-governmental organizations (NGOs) is opened. Trial data can also be shared with patients and the general public which builds trust via transparency. 

Properly implemented, open source pharmaceutical development helps all players from patients and public health agencies to the large pharma companies by avoiding costly mistakes.   Additionally, pharma companies can focus on new areas such as nano-based cellular level targeting of open source drugs.  Thus the goal of open source pharmaceuticals is not to eliminate existing companies but allow a wider set of products at different price points just as open source software has not eliminated for-profit companies. 

If we are to move into a more equitable and healthy world we must learn from the software industry.  We have the tools, the networks, the scientists and manufacturers distributed across the world to achieve Open Source Pharmaceutical Development.  We now only need the courage to do it.

This article was authored by Junaid Islam, Partner OODA.COM, USA and Dr Rodney Sappington, CEO, Epic Advanced Materials, USA.