Will the initiative help make pharmaceuticals safer, or is it only window dressing?
In a June 15, 2015 article the International Business Times reported (quite responsibly) that “Once a prescription drug hits the market, it’s hard for pharmaceutical companies and government agencies to monitor the thousands of patients [taking it] in [order] to pick up on harmful side effects. But a single allergic reaction can require an expensive hospitalization or even result in a patient’s death.”
The IBT described the Food and Drug Administration’s announced new collaboration with an online social networking and data-sharing site for patients. The agency said that it will “tap” data provided by a website called PatientsLikeMe.com to detect adverse events associated with prescription medicines that the agency and drug manufacturers “may have missed during clinical trials.” The continued focus by drug companies and the FDA on learning of sometimes deadly side effects after the fact is disturbing.
But the timing of this initiative is also suspect, and you can’t help but question the FDA’s motivations here. With further budget cuts on the way for the department, a relatively low-cost, high-publicity endeavor like partnering with a patient-networking website could mean a credibility boost, albeit a facile one, for the beleaguered agency.
When pharmaceutical companies feel that they have been “made aware of a bad reaction to a drug that they produce,” then and only then does the FDA currently require them to report it. Patients and doctors can also voluntarily submit reports directly to the department if they experience a questionable effect.
The IBT reports that PatientsLikeMe.com has worked on projects with the National Institutes of Health and the Centers for Disease Control and Prevention. “PatientsLikeMe.com, which is based in Cambridge, Mass., is a portal that allows people to share information and data about treatments, symptoms and side effects with other patients who are dealing with the same disease. With 350,000 users logging 28 million data points on more than 2,500 conditions, the site bills itself as the largest digital patient community in the world. The company has already collected data on 110,000 adverse events from 1,000 medicines that the FDA will now be able to access,” says the business journal.
Bloomberg Business chimed in the same day, reporting that “The [FDA] said it hopes to learn more about side effects that might look harmless to a government drug reviewer but are troublesome to patients. Although the research is in the exploratory phase, it carries potential for influencing changes in drug labeling or how fast the agency might react to a safety issue.” It also has potential to add another smoke screen between patients and hard results from unsponsored, randomized, placebo-controlled trials.
“We’re hoping we can find information on the impact of adverse events on patients’ day-to-day lives,” Gerald Dal Pan, director of the Office of Surveillance and Epidemiology at the FDA told Bloomberg. “We don’t know if it will give us the kind of information that will be sufficient to make label changes. That’s what we’re trying to find out.”
Currently, the agency relies on drug companies, doctors, and patients to report adverse events.