We are two doctors who have created the DrugFactsBox™ so that you can get the facts about medicine straight from FDA -- not the drug companies.
To choose a drug, you need more information than a list of side effects. You need to know just how much benefit you should expect, and how often side effects occur. Enter the DrugFactsBox™.
FDA approved Addyi based on 3 six-month trials that had similar results. Results below are for the largest trial. 1087 women in stable relationships very distressed by at least 6 months of low desire - NOT caused by a medical condition, medications or relationship problems (average age 36 (19 to 55), had 2 satisfying sexual encounters a month) were given ADDYI or PLACEBO for 6 months. Get the box to see what happened:
FDA approved DICLEGIS based on the 1 trial below. 261 healthy women (average age 25, 9 weeks pregnant, morning sickness score of 9 on a scale from 3 [no symptoms] to 15 [most severe]) were given DICLEGIS or PLACEBO for 2 weeks. Get the box to see what happened:
Features of the DrugFactsBox™
Benefit and side effect data presented together
Informulary brings together quantified data about benefits and harms in one table, including details about the study participants. This presentation makes it easier to weigh the tradeoffs and make an informed decision about whether or not to take the drug.
We source our data from FDA's review of the drug's approval
We examine publicly available Food & Drug Administration approval documents – supplemented by high quality systematic reviews – to extract the most important data, then highlight the benefits, harms and uncertainties of prescription drugs. Exclusively using clinical trials, we report on the facts about who was studied, with what severity of disease, and for how long. The information in the approval documents reveal drug benefits and harms that aren’t always conveyed clearly to the general public. Our medical experts examine the extracted data and use it to make our DrugFactsBox.
FDA’s level of certainty about drugs
The clinical trials that are the basis of FDA drug approval are generally short (typically lasting months) and small (typically involving less than 1,000 patients). As a result there may be important open questions about long-term drug benefit and safety. We highlight these issues to help give doctors and patients a fuller picture of what is and is not known about approved drugs. We cite the conclusions of FDA reviewers, quantify the strength of evidence behind approval (for example, how many pivotal trials were completed, and how many were positive), and show a drug's track record (for example, the number of years on the market) . We also note if the FDA has required post-marketing studies to resolve uncertainties.
Context when considering other choices: What are doctors taught?
Getting people good information about drug benefits, side effects, and uncertainties is even more valuable with some context. When people seek information about a drug they are usually interested in broader questions: What are all the choices? Are there non-drug options? Or, they may want to know where a particular drug fits in the doctor's algorithm - is it a first choice treatment? In our experience as doctors, people often ask us for our take.
Informulary collects information on all evidence-based treatment choices from professional guidelines and systematic reviews. This is typically publicly available information from major government agencies (such as the Agency for Healthcare Research and Quality's Effective Health Care reports or the Centers for Disease Control) and major professional organizations (such as the American Heart Association).
When available, we also include the FDA medical reviewer's conclusion in the "review of efficacy." This gives the FDA reviewer's opinion on the benefit/harm tradeoff.