For decades, pharmaceutical companies and regulators have relied on reports from doctors and patients to monitor the side effects of drugs. Although the U.S. Food and Drug Administration collects hundreds of thousands of these records each year, that’s a sliver of patients’ negative experiences. Researchers estimate more than 90 percent go unreported. It can take years for the FDA to detect a pattern of problems that leads to changes in how a drug is prescribed.
Some technology companies are betting that combing through patients’ social media posts will yield crucial insights that drugmakers will buy. “Hundreds of millions of people are waking up every morning and writing about their personal experiences,” says Ido Hadari, chief executive officer of Treato, a six-year-old startup based outside Tel Aviv. Treato scours thousands of sites for patient feedback, from Facebook (FB) and Twitter (TWTR) to small patient forums. The challenge is to extrapolate meaningful signals from all that noise, says Hadari: “It’s a huge pile of coal filled with diamonds.”
Estimated share of negative side effects that patients don’t report
Researchers from Boston University, the FDA, Harvard Medical School, and other institutions examined 6.9 million Twitter posts over seven months and identified 4,401 tweets that seemed to describe the types of side effects worth reporting to the FDA, known as “adverse events.” Their study, published in the journal Drug Safety last month, found that the proportion of tweets about particular types of complaints, such as gastrointestinal problems or psychiatric effects, roughly mirrored FDA data. “Some high-volume products had hashtags for reporting” adverse events, the authors wrote, citing tweets with the hashtag #accutaneprobz as a way to collect reports about acne drug Accutane.
Clark Freifeld, lead author of the Drug Safety paper, says most people won’t fill out the four-page form required to alert the FDA. “If you have a headache or you’re itching, you might casually post about that,” he says. Despite Twitter’s apparent correlation with FDA reports, he says, “there’s still a lot of questions about what kind of signal is there, is it something usable?”
Freifeld is a co-founder of Epidemico, a 10-employee startup created in 2012 using research from Boston Children’s Hospital and Harvard Medical School. With FDA funding, Epidemico has built MedWatcher, an app that lets people search the newly accessible FDA database of side effects for drugs and medical devices. Patients can also report their own experiences through the app, which are relayed to the agency. Like Treato, Epidemico is trying to glean insights about drugs from the Web. Freifeld says two pharma companies he wouldn’t name have signed on for its service.
Treato’s Hadari, whose 40-employee company has attracted $25 million in venture funding, has spent years refining algorithms to weed out spam and translate patients’ expressions into meaningful data. The company’s software has to understand that a post saying “someone startled me and I almost had a heart attack” doesn’t actually refer to a medical emergency. It also has to tell when a reference to “BP” means blood pressure, bipolar disorder, or the oil company. It does this all “on massive scale and in real time,” Hadari says.
Anyone can search the name of a drug or condition on Treato’s website to get a summary of commonly reported side effects or symptoms, as well as links to posts from around the Web by patients discussing the treatment. The top searches are for pain management, pregnancy, and weight issues. Hadari says the site got 20 million unique visitors last year. Nine pharma companies pay Treato for more detailed analyses of what patients are saying about their drugs: how they’re using the medication, what reactions they experience, or why they switch from one pill to another.
Scanning the Internet for drug safety data may put companies in uncomfortable new territory. When drugmakers learn of adverse reactions from doctors or patients, they’re required to relay the reports to regulators. That obligation extends to companies that host forums to promote medications, says Rick Huddleston, a 33-year veteran of Eli Lilly (LLY) who advises pharma clients at consultant YourEncore.
But does a drug company have to tell the FDA every time it sees a Twitter or Facebook post that mentions medication side effects? Epidemico’s Freifeld says his company must be judicious about how the information it collects is shared with pharma clients because they “need to be careful about what their regulatory obligations are.” Huddleston says drugmakers are also worried that they might be required to report possible problems they learn about on the Web. “The industry is a little bit hesitant to go into that space,” he says.