Zeus creates Pandora

The power of Web 2.0 collaboration may extend into the clinical development and marketing phases of the drug lifecycle, where its demonstrable benefits may potentially be overshadowed by some major risks. The risks to which I am referring are related to the open, collaborative discussion of drug efficacy and safety in communities of physicians and patients. As I will show, this might even extend to a quasi-analytical analysis of data that may be highly influential. A Web 2.0 community with huge potential benefits and risks is PatientsLikeMe, and will be the focus of our discussion.

PatientsLikeMe ( http://www.patientslikeme.com/) is a beautifully constructed social networking Web site that allows patient communities to form around the diseases they jointly suffer from. Unlike many bulletin board attempts at this concept, PatientsLikeMe provides patients with diseases such as ALS, MS, Parkinson's, and HIV/AIDS to create a publicly viewable (in most cases), structured Web site with their photo, a narrative, and a longitudinal collection of the most important objective and subjective variables in following the course of the particular disease.

In addition to individual data, the site aggregates data so that an MS patient with anxiety can discover, with one click, a pie chart of its severity in thousands of patients with anxiety and a list of dozens of medications prescribed for anxiety. In addition, they can link to the profile of other patients with anxiety and search for discussions on anxiety on the forum.

PatientsLikeMe is not alone. Similar sites exist for diabetes, depression, alcoholism, and other health issues. If one of my relatives or I had MS or any other serious disease, the information on such sites would be powerful and compelling. These sites are, in their construction and attractiveness, quite beautiful and seductive—just like Pandora.

Pandora opens her jar

The nature of openly available, patient-reported data found on these sites is disconcerting in some aspects. The first, and most immediate concern, is that such patient-reported information contains a potentially enormous number of reported adverse events. Will regulatory agencies hold companies responsible for identifying and reporting such data as they must for published reports? If that is the case, will they have to pay each Web site for the aggregated data and manually sift through narratives to identify issues? These are not new ideas and are being actively considered on both sides of the regulatory divide.

Another concern relates more to the synergistic power of collaboration in this setting. The power of suggestion and confirmation bias will surely lead patients to cluster in their reporting of symptoms. The aggregated statistics on symptoms and medications are presented with scientific graphing techniques, suggesting an accuracy and quality that may not be inherent in the source of the data. A patient reading these graphics who discovers that most other patients have a particular subjective symptom or side effect from a medication may over report such a symptom. If an influential member or two from the community start on a new medication and report a particular adverse effect, the occurrence of that adverse effect may be magnified within the community. With diseases like ALS, where a substantial percentage of the patient community may be participants in such a Web site, the effect of this could be unfairly damaging to a new, potentially effective medication.

Finally, there has recently been a very interesting development at PatientsLikeMe that holds amazing opportunity but increases potential risks. On a public blog at the site ( http://blog.patientslikeme.com/), one of the founders discusses a recent paper suggesting a benefit for lithium in slowing the progression of ALS. Rather than wait for the slow process of a follow-up clinical trial, PatientsLikeMe started "the first real-time, real-world, open and nonblinded, patient-driven trial" now with 117 patients involved. These patients have started lithium with their physician and are tracking their progress on the Web site.