In Through the Looking Glass by Lewis Carroll, Alice asks Humpty Dumpty what the word “slithy” means, from a nonsensical poem “Jabberwocky.” He tells her, “’Slithy’ means ‘lithe and slimy.’ . . . You see it’s like a portmanteau—there are two meanings packed up into one word.”
When Lisa Schwartz and Steven Woloshin, both Geisel professors of Community and Family Medicine and at the Dartmouth Institute for Health Policy and Clinical Practice, were trying to come up with a catchy name for their new company, they were stumped. Woloshin thought of Lewis Carroll and got a perfect idea: make a portmanteau. He decided to name their for-profit company “Informulary,” combining both “inform” and “formulary.” Informulary’s mission is to provide people with information about the benefits and harms of prescription drugs through use of a formulary, or drug database.
When completed (they plan to finish in less than a year), the database will be an enormous online library of drug facts that will give patients, doctors, health care insurers, publishers, and pharmacy managers “transparent, clear information that supports good decision making,” says Woloshin. It will include a database of drug facts boxes, which Schwartz and Woloshin have already been creating over the past decade. A drug facts box is a tabular summary—much like a nutrition label on a box of cereal—of a drug’s benefits, harms and uncertainties based on clinical trial data. It gives the benefits of a drug versus placebo, the most prevalent side effects, how long the drug has been in use, who the drug is for, and precautions to follow when taking the drug.
Schwartz and Woloshin say the database will help address two main questions. “One is whether to use a particular drug and the other is how to best use that drug. And there’s lots of information when we mine through the FDA documents in terms of dosing. You may find out the higher dose was tested for a drug and in fact doesn’t work any better but just has more side effects,” she says.
Prescription drug advertising is a huge industry in the U.S. In 2012, U.S. pharmaceutical companies spent $27 billion promoting drugs. The problem is that drug advertising can be very misleading to consumers. And even though the FDA approves a drug, it does not necessarily mean the drug is very effective and safe; it merely means it has shown effectiveness. Drugs that are approved often do not have a long track record and there may be uncertainties about serious side effects. Pharmaceutical drug advertising generally does not address these concerns, or if it does it tends to be buried in a mass of fine print.
An example is the weight loss drug Belviq. Schwartz and Woloshin have created a drug facts box for the drug, and Consumer Reports, one of Informulary’s customers, published an article about the Belviq drug facts box on their website, highlighting the benefits and limitations of the drug. Belviq was approved by the FDA and has been popular in the United States, yet studies have not ruled out the possibility that it could cause heart valve issues like other diet drugs. So the FDA has required post-marketing studies on Belviq to determine if the drug has caused problems. Informulary will include this information about Belviq in their database. “The fact that the FDA is worried that Belviq might actually harm people is something people would want to know, that there is a question mark,” says Schwartz.
The drug ad for Belviq promises consumers that with diet and exercise, it “may help you lose weight and keep it off.” Yet according to a clinical trial of over 6,000 adults, people on Belviq lost only a mean of 6% body weight over a year compared to 3% taking a placebo. Belviq and Qysmia (another weight loss drug) are the first two new weight loss drugs approved by the FDA in a decade, “so there was a lot of excitement about them. Problem is if you look at how well they work, then your excitement starts to diminish,” says Woloshin. Qysmia results in more weight loss, he says, but has more side effects including increased heart rate. Because both drugs may cause cardiovascular harm, neither drug is on the market in Europe.
Communicating to the public and health professionals effectively about drugs is where Informulary steps in. “This is very necessary to have unbiased information to make better decisions about drugs for both physicians and patients,” says Rachael Bornstein, DC ’14, an employee of Informulary. “The whole mission of the company is a cool and worthy cause.”
Schwartz and Woloshin spent over a decade trying to get the FDA to adopt drug facts boxes in the packaging for prescription drugs and finally realized the process was not going to work—the FDA was interested but it was clear they were moving at a snail’s pace. Then the Robert Wood Johnson Foundation (RWJF), which funded their first effort to change FDA policy, urged them to create a self-sustaining model that would make change on its own. RWJF gave them two starting grants to work with a business consultant and shape the project.
After their initial funding from RWJF, Dartmouth-Hitchcock has invested in Informulary since the two share a similar mission, says Rick Adams, director of external relations at DH. “The work of Dr. Woloshin and Dr. Schwartz illustrates the kind of transparency that better informs patients to make better decisions about their health care,” he says, “a philosophy that is consistent with Dartmouth-Hitchcock’s mission of population health and value in health care.”