Our medical experts systematically analyze highly-technical FDA documents in order to bring you the facts about prescription drugs.
- Increase the use of and adherence to effective drugs
- Decrease the use of ineffective or harmful drugs
- Improve the quality of drug research by increasing transparency about what drugs do
The Informulary Process
- We examine publicly available Food & Drug Administration (FDA) approval documents – supplemented by high quality systematic reviews – to extract the most important data on each prescription drug. We are then able to formulate an overall picture of the drug's benefits, harms, and uncertainties.
- We build a complete library of drug facts that can be used to develop a number of tools to help consumers, providers, and pharmacy managers choose the safest and most effective drugs.
- We present the most relevant facts in a neat, simple format, which can be interpreted by both physicians and consumers.
Problems with the data available today The label -- or tissue-paper insert -- that accompanies a prescription should summarize the information physicians need for the safe and effective use of the drug. Unfortunately, the label -- which is written by industry and then approved by the FDA -- sometimes fails to present data about drug benefit.[i] Medical literature is also problematic -- there is selective reporting of favorable trials, a bias towards favorable outcomes within trials, and the “spinning” of unfavorable results to maximize benefit and minimize harm.
The FDA's data is unfiltered In contrast, the publicly available FDA reviews always include the Phase III clinical trial data on benefits and harms that form the basis of drug approval. These reviews are rich with valuable information, including studies in specific populations that rarely see the light of day. However, because these reviews are lengthy, poorly organized, and weakly summarized, these reviews are practically inaccessible.
The solution: increasing access to data about medication you can actually use To improve accessibility of this meaningful information, the co-founders of Informulary, Inc., Lisa Schwartz MD and Steven Woloshin MD, developed the DrugFactsBox™, a summary of benefit and harm data for each indication of a drug. A series of studies by Schwartz and Woloshin, including national randomized trials, demonstrate that most consumers understand the information presented in a DrugFactsBox™ and that it improves decision-making. [ii] Given the potential public health impact, physicians and the public should not have to wait for better drug information.
To read more about the research that developed and tested the DrugFactsBox™, click here.
[i] Schwartz, L. and Woloshin, S., "Lost in Translation," New England Journal of Medicine, 361;18, October 29, 2009: 1717-1720.
[ii] Schwartz, Lisa M., Steven Woloshin, "Using a Drug Facts Box to Communicate Drug Benefits and Harms – Two Randomized Trials," Annals of Internal Medicine, April 2009, Volume 150, Number 8: 516-527.