After all the time, money and paper spent on HIPAA, we are now discovering that many patients actually don't want to hide their data, they want to share it openly. Why? Because they believe it may lead to more effective therapies in their lifetime. PatientsLikeMe (PLM), a well-known social network for patients with chronic or fatal diseases, was one of the first companies to promote the idea of public access data. In 2008, after learning that a small clinical study in Italy suggested that lithium might postpone the progression of ALS (commonly referred to as Lou Gehrig's disease), PLM encouraged those taking the drug to track their regimen and its effects using tools created for them by PLM programmers. Those participating discovered that lithium was not the panacea they had hoped - the drug had neither positive nor negative effects on their ALS. While this was not a scientifically orchestrated study funded by pharma, overseen by a KOL principal investigator, and run by a Top 5 CRO, its findings were later validated by such a study published last month (May 2010) in Lancet Neurology. It showed that lithium did nothing to slow the course of ALS. While this type of qualitative/directional research will not replace double-blind, placebo trials, it does show the benefits of data collection and aggregation freom the real world of patients. We all know that trials are based on proscribed audiences, not everyday people. So it is important to have the data from the real world in addition to that of the "ideal patient" world.
The MIT Technology Review wrote a story about this. They spoke to Mark Roberts, a physician and professor of Health Policy and Management at the University of Pittsburgh, who offered this assessment: "The beauty of observational trials is that you can see how an intervention works in the real world. For example, many trials eliminate patients with secondary ailments, such as renal failure or chronic obstructive pulmonary disorder. All my patients have those things, so how do I know it works in people I see?" Exactly!
Similarly, the patient-driven social network TuDiabetes launched TuAnalyze, an application that lets those with diabetes track, share and compare their data. Members of the community choose how much information (if any) to share about their hemoglobin A1c levels. The program was developed in collaboration with Children's Hospital Boston with funding from a CDC grant.
So the open data movement is on. Let's see where things go over the next year.