By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
In September I traveled to Boston to meet with the Jamie Heywood, cofounder and chairman of PatientsLikeMe, a for-profit company that has created a platform where patients can share, learn from, and contribute real-world outcome-based data to research. During our conversation around the current state of drug development, Heywood provided an alternative viewpoint of how clinical trials could be conducted, which will probably blow your mind. But given the mounting Ebola hysteria eagerly being generated by the media, his concept isn’t as far-fetched as you might first think. In fact, perhaps it holds the key to successfully stopping the Ebola Virus, as well as other diseases.
Who Decides Which Discoveries To Develop?
If I were to ask you how we discover drugs you would probably tell me that the process is driven by the disease (i.e., researchers set out to find cures for diseases). That’s false. Typically, discoveries are made in the animal laboratory or at the bedside by acute researchers/clinicians and chance observation. If I were to ask you who decides which discoveries are developed into drugs you would probably say, biopharmaceutical companies, government agencies (e.g., NIH) and regulatory bodies (e.g., FDA). That’s true. While each entity plays a key part in drug development, it is mostly companies driving which discoveries are attempted to be developed into drugs, with influence from the FDA and NIH via regulatory and financial incentives. Profitability modeling is the primary driver behind why a company decides which drugs to develop, for which diseases, as well as how and where to conduct clinical trials. Jamie Heywood says, “Instead of companies making these decisions, imagine you have a disease that is continually figuring out how to best measure and optimize management of the disease itself in the real world and is willing to look for drugs to try in their population to prove they work.” WHAT?!?!?
Now before you dismiss this idea as crazy, stop and take a minute to think about it since this already happens. Diseases determine which antibiotics will and won’t work and in which populations. Further, viruses and diseases are continually upgrading, mutating, changing, whatever term you want to use to describe the process of disease and virus’ adaptation, the fact is they transform because they are living organisms — fighting for survival. Conversely, we are seeking their destruction. However, to be successful we need to help diseases get organized to the benefit of their own demise.
Diseases As Organized Developers Of Their Own Demise
Jamie Heywood told me when he first described to people within industry the concept of diseases being organized to develop drugs, “This is where understanding breaks apart into two distinct camps — those that clearly get it, and those that don’t.” My goal is not to try to blow your mind. Rather, I want to see if I can clarify Heywood’s visionary thinking into something we can execute. “Imagine a world where a disease is so well organized and so engaged that physicians are all on a network, that the patients are all on a network, that mathematical modelers are continuing to build better predictions of outcomes and stratify the population, that biomarkers are continuously being introduced and tested and developed in the real world, and that patient outcome measures are continuously improved to align with measuring disease and well-being all while meeting regulatory standards” Heywood pontificates. “In short the disease learns how to measure and stratify itself without trials. In that world, diseases now look for companies with drugs, as opposed to companies with drugs selecting diseases they can test them on. It flips the entire economics.” While diseases may be living organisms, they are not yet self organizing as Heywood envisions, at least not without our help. Heywood was discussing chronic health conditions, but I suggest we may be able to extend his thinking to our current crisis. If we want to find a cure for Ebola before it blossoms to the worst scenario of 1.4 million cases worldwide by this coming January, we need to help it and other diseases get organized (i.e., creating a structure where people involved with Ebola [e.g., patients, physicians, researchers] can network and share information in real time toward a solution). But where to start and who will drive?
We Need Course Changers At The Ebola Helm
First, we need an open-access database platform made available to researchers, clinicians, health authorities, clinics, hospitals, FDA, CDC, academia, companies, foundations, and so on. Wait a minute, we already have one — the Internet. Second, we need a portal on that platform and to find an organization to oversee. We probably have that in place too (e.g., CDC). The missing link is the artificial intelligence, let’s call it Doogle (a disease search optimization engine), that can computationally and through crowd solutions and data generation create the links between the information and its sources to accelerate collaboration toward an Ebola cure. Who should drive and fund it? While the World Health Organization might be able to drive such an initiative, what is needed are three “Course Changers.” If you are familiar with chaos theory’s butterfly effect which grants the power to cause a hurricane off the coast of the United States to a butterfly flapping its wings in Japan, I contend that in the business world there exist Course Changers — human butterflies who can and do dramatically impact outcomes and alter courses well beyond their immediate environments. One of these Course Changers needs to be a highly placed government individual with Ebola knowledge. Another person must be from the private sector (e.g., the Human Genome project, Francis Collins and J. Craig Venter) and have similar Ebola expertise. The third Course Changer needs to have the wherewithal to figure out how to make Doogle a reality — I submit that Jamie Heywood might be good in this capacity. But we don’t have to stop there, let’s consider Ebola a pretty worthwhile pilot study and see if we can create a revolutionary Course Change in the way we discover and develop drugs.