Do the side effects outweigh the benefits? Real world data is hot. Real world data is just what it sounds like: information on how a drug acts in the marketplace where variables cannot be controlled.
For better or worse, the information submitted to the FDA for drug approval is limited. It is tested on a hand-selected group of people most often as the only drug the control group takes. Generally the questions the FDA focuses are are: is this drug better than a placebo? Is it safe to take? What about side effects?
Once approved and in the marketplace, real world data can result in much different information. Suddenly the new drug is being taken in combination with other drugs, it interacts with many different types of food, vitamins and other supplements.
It can take years for doctors to identify a pattern, even if they suspect one immediately. The users are spread across the country and most don’t conveniently fill out forms. However, a lot of prescription drug users will seek out information online and in chat rooms. Two studies released in the past six months find that patterns are revealed with the correct algorithms.
The first study, as reported in the Wall Street Journal article “Mining the Internet for Speedier Alerts on Drugs” on Oct. 8, 2012, presented research from the University of Virginia and West Virginia University. The second was reported this week in many sources. The New York Times article, “Unreported Side Effects of Drugs Are Found Using Internet Search Data.” The primary difference between the two is the UV/WVU study filters comments from chatrooms, websites and news stories. The second is a collaboration from scientists at Microsoft, Stanford and Columbia University and examines queries on search engines, much like Google Flu Alert.
In both cases, the goal is to alert the FDA of potential side effects earlier than has been possible in the past. It’s not conclusive, but rather it’s an early warning system. This is a great way to limit damages from unintended outcomes.
