“Think Inside the Box” – call for plain English facts labels about Rx drugs

Catchup from last week:

Dartmouth’s Steve Woloshin and Lisa Schwartz had a New York Times op-ed piece last week, “Think Inside the Box,” promoting their terrific idea of “a simple model” for conveying “independent, plain-English facts” about prescription drugs. They write:

“The government should follow through on proposals to require fact boxes, similar to those that appear on food packaging, in every ad drug makers produce and along with every package of medication they sell.”

They provided the TImes with one mockup example of such a drug box for the drug Abilify, which I’ve included here:

“Abilify, an antipsychotic drug with domestic sales of $4.5 billion in 2010, which is approved for a variety of disorders, including depression that is only partly responsive to another drug. According to an Abilify advertisement, “approximately two out of three people being treated for depression still have depression symptoms”; the ad then suggests that people ask their doctor about adding Abilify to their drug regimen.

But, as is generally the case, the ad doesn’t tell them how well the drug works. And the professional label for doctors says only that the drug was “superior to placebo,” not by how much. These advertising and labeling practices are neither unusual nor unique to Abilify, and are in compliance with federal regulations.

The box, on the other hand, would quantify the benefits and side effects of Abilify used in combination with other antidepressants, drawing on the larger of the two six-week trials that formed the basis of its approval by the F.D.A. First, it would show how the drug scored versus a placebo (in Abilify’s case, not much: only three points lower on a 60-point scale, and it resolved depression for only 10 percent of patients — that is, 25 percent with Abilify versus 15 percent with just the placebo).

The box would also highlight Abilify’s most important side effects: it caused 21 percent of patients in the trials to develop akathisia, or severe restlessness, and 4 percent to gain a substantial amount of weight. And, as with all anti-depressants, there is a small increase in suicidal thoughts and behavior among many young adults.”

I’m sure Woloshin and Schwartz will discuss this concept this week when I join them as they co-host one of the consistently most helpful health care journalism training opportunities, the NIH Medicine in the Media workshop, held this year at Dartmouth in Hanover, NH. I’ll be a presenter during two sessions at the workshop.