Like most social-networking sites, Inspire.com is a place where users talk about the most intimate details of their lives. They want advice on coping with stage III cancer or to offer encouragement to a mother deciding about life support for her premature baby. But Inspire's nearly 100,000 users aren't just sharing with each other (and the 62 nonprofits who partner with the site), they're also receiving targeted information from pharmaceutical companies who use the site as a recruiting tool for drug studies. Opening this door between patients and drugmakers has some obvious benefits but also raises a host of ethical and medical dilemmas.
On the plus side, those grappling with serious or chronic diseases get to hear about clinical studies and new treatments that they might not otherwise know about. Pharmaceutical companies get easy online access to highly engaged populations with specific medical conditions. "One day we come to you and say, 'There's a clinical trial going on, here's some information, now it's your decision.' It lets the patients raise their hand and say, 'I want to participate'," says Inspire's founder, Brian Loew. Social networks not only allow pharmaceutical companies to hone in on extremely specific populations, but also enable them to reach patients who live far from major medical centers and typically never hear about studies.
Recruitment has long been a bottleneck in medical research. Of the approximately 50,000 clinical trials currently underway in the United States, 80 percent are delayed at least a month because of low enrollment. One problem: potential trial participants are often skeptical and worried about safety. "There's an increasing wariness about the pharmaceutical industry and the clinical trial process," says Ken Kaitlin, director of the Center for the Study of Drug Development at Tufts University in Boston. "It's not uncommon to hear about drugs taken off the market because of major safety problems … that makes the public a little more concerned." Pharmaceuticals hope they can overcome such fears by building partnerships with social networks that they can mine for potential volunteers.
Loew launched Inspire in 2005, and spent the first three years building up members in partnership with nonprofits, including The Lung Cancer Alliance and National Organization for Rare Disorders. Now, with a core group of users on the site, two major pharmaceuticals have begun recruiting for clinical trials, one in the lung-cancer community and one in arthritis. Inspire has partnerships with two other major pharmaceuticals in the works. The drug companies pay Inspire a flat fee for the recruiting service; the Web site's compensation does not hinge on meeting a particular recruiting goal.
Three of the four pharmaceuticals working with Inspire declined to discuss their interest in social networks, or even reveal their names. The fourth, Merck, declined multiple requests for an interview but did issue a brief statement on their commitment to "rapid and effective enrollment of appropriate patients into trials" as to allow for "timely development of innovative medicines."
Novartis, one of the first drugmakers to engage research participants through a social network, partnered with PatientsLikeMe.com to recruit clinical-trial subjects for a multiple-sclerosis drug in 2008. "[Social networking] hadn't been applied to clinical trials," saysTrevor Mundel, head of exploratory clinical development at Novartis. "At the time, we were having a lot of difficulty enrolling patients."
In May 2008, the site sent out a message to the 8,000 members of their multiple-sclerosis community, alerting them to the Novartis trial. From that e-mail, nearly 1,500 members visited the Novartis Web site. After recruiting through PatientsLikeMe.com, Novartis saw a boost in registrations for the study, although they did not track which or how many individuals enrolled because of the campaign—due to patient privacy concerns. "The registration did start to pick up," says Mundel. "We don't have the tracking, but I've got to believe some of it was generated by the e-mails."
Nonprofits and government agencies remain hesitant about recruiting on social networks because they see them as a relatively untested medium. TrialCheck, a database of both private and public cancer studies, is interested in using social networks, but is holding off until they have more information. "Cancer patients should know all of their treatment options, not just a select few trials that are promoted," says Dianne Colaizzi, spokesperson for the Coalition of Cancer Cooperative Groups. "Another issue is how do patients discern the quality of the information they find on social-networking sites? Many of the sites lack high quality medical information from trusted sources."
Another problem: the reliability of data that comes from trials where the participants may be communicating with each other. That doesn't usually happen in medical studies. But if your study subjects are on the same social-networking group, what's to stop people from swapping enough information to figure out which of them is on the real medication vs. the placebo, essentially "unblinding" the study?
"If you know what to expect because you're going online and seeing what's happening [with other patients], the result is that the data could come out biased," says Paul Bleicher, the CEO of a health-tech startup in Cambridge, Mass., who has written on the role of social networks in medicine. He doesn't think that pharmaceutical companies have yet thought through these issues. Novartis's Mundel admits they haven't figured it all out yet. "It's something which hasn't been worked through, how [social networks] might worsen the accuracy of adverse-event reporting," he says. "That's one concern we have to think about and still don't totally understand."
Despite these drawbacks, clinical-trial recruitment on social networks is expected to increase. Inspire says that it is signing up 100 new members a week. As Bleicher writes in a recent article in Applied Clinical Research, "Technology is here to stay, and it will bring changes in communication and interactivity that we can't even anticipate, along with many opportunities and some risk."
But as with all things Web, when things go right, the power of connecting people is formidable. Take Susan Love's Army of Women, a site that launched in November 2008 to solicit volunteers for preventative breast-cancer research. The site capitalized on the grassroots-organizing powers of the Internet and, largely through members inviting friends, has amassed more than a quarter million members that researchers can recruit for research exploring potential risk factors for breast cancer.
The site is not a social network (although that may come soon), but does take advantage of many innovative Web 2.0 tools, like blogs written by researchers describing their study and how Army of Women members are having an impact. But even if Army of Women does become a social network, they're operating to collect information for prevention, not testing the effectiveness of drugs on various conditions, so they're less likely to run into problems where data is compromised by the interaction of patients.
Perhaps most important, this site has been able to reach hard-to-find but willing research participants including Theresa Passerelli. The 60-year-old hospital accountant lives in Warm Springs, a tiny town in central Georgia with no stoplights or grocery stores. She's 70 miles from a major medical center, but is participating in important breast-cancer research on sisters of women with breast cancer. "You have the walkathons, but those don't advance science," says Passerelli. "When I saw the Army of Women, I was more than willing to give them my body and let them do whatever, if there's a possibility there will be some kind of breakthrough."