Lack of quantitative clinical results and FDA regulatory uncertainty leave unclear benefits for this $300-billion problem
Medication adherence today is like walking down a long, quiet hallway, opening a door and finding raucous party going on, with the partygoers all enthusiasts of applying social-media and mobile-health (mhealth) techniques to this longstanding problem. There’s a lot of buzz and excitement—but the jury is very much out whether it will make a difference. Two newer entrants in this buzz are the MediSafe Project (out of Haifa, Israel), and Abiogenix (Cambridge, MA). Both come out of the growing stew of organizations using novel startup technologies like crowdsourcing to ramp up.
MediSafe is an iOS (Apple)/Android app, available for free download, that combines a smartphone (conventional telephony is also in the works) with a cloud-based database system. According to Omri Shor, CEO, the app creates an ecosystem of care providers (such as family and friends) that share notifications of when a patient has taken their medications, and can act as support and reminders for missed dosages; texting and callbacks can be programmed for the patient as well. Pills can be identified, even by photos compared to a stored database, to confirm the right meds. That’s the patient-facing aspect, says Shor; a healthcare-system and pharma-facing part collects usage patterns and demographics to provide insights into patient habits; Shor says that this is done in a HIPPA-compliant manner. Discussions are ongoing with several pharma manufacturers to sponsor the application.
Abiogenix is going the hardware route, having developed what it calls the uBox, a day-by-day pillbox loaded with communications-enabled electronics to transmit usage patterns to the “circle of care” of a patient—again, friends and family. Based on company literature, targeted customers (besides individual patients) include healthcare systems, and clinical research organizations conducting trials.
While healthcare providers and the pharma industry spend millions annually funding medication adherence, these organizations have followed their own path. MediSafe has been supported by the Azure Accelerator program, organized by Microsoft in support of its Azure cloud service. Abiogenix is one of the awardees of Healthbox, a Boston group that provides venture funding and incubator support. It has also gone the crowdsourcing route, offering varying price points at Indiegogo.com (the support page is located here).
Medication non-adherence’s cost to the US healthcare system has been estimated at over $300 billion by Express Scripts (in its 2011 Drug Trends report), and a global missed-revenue opportunity for the pharma industry alone of $188 billion by Capgemini. CVS Caremark has just publicized a study it sponsored (published in the J. of Managed Care) looking specifically at social media tools for supporting adherence. “Leveraging a patient’s existing social contacts and networks . . . could be both an effective and cost-effective way to help improve adherence,” according to Dr. Niteesh Choudhury, of Brigham and Women’s Hospital and Harvard Medical School, after participating in the meta-analysis of 50 adherence studies the authors had collected.
But the details of the study—which the authors say is a qualitative analysis limited by the small scale of each study and problems inherent in observational data—did not clearly endorse social media or social networks. “While specific types of social support were associated with varying levels of adherence, the strength of the effect of each type has not been clearly quantified,” they conclude, calling for more study of the subject. The clearest message was that “practical support”—such as transporting patient to pharmacies to pick up meds, or helping with medication administration—provided the best benefits. Interestingly, some of the studies evaluated found a negative implication for friends and family involved in medication adherence.
MediSafe and Abiogenix are by no means the first to apply mhealth to medication adherence. There are hundreds of reminders, schedulers and drug-identification apps in the Apple Store or at Google Play. Remedy Health, which taps into 150 million readers and website visitors annually, has had the MyRefill Rx app available for over a year; Jim Curtis, chief revenue officer at the company, says that it has been downloaded 8,000 times for use with one drug (Novartis’ Diovan, a cardiovascular therapy)—which is a promising but not revolutionary result. Apps from healthcare providers, pharmacy chains and others show downloads in the tens to hundreds.
Some of the pharma industry hesitation about mhealth is to be expected; the industry is still cowed by FDA regulators who watch what efforts take place, but have been unable to issue clear guidance on acceptable mhealth practices. The FDA Safety and Innovation Act passed last summer stipulated that FDA will issue such guidance—but the deadline is January 2014.