Drug Facts Box
A consumer looking for a healthy breakfast cereal can easily compare different products by examining the ingredients and nutritional contents that appear on every box. But when it comes to comparing prescription drugs or understanding their risks and benefits, that information can be hard to find. Even if a consumer reads through the fine print of an advertising message or package insert, they find only partial information. These mandated messages tell you the purpose of the drug, and what side effects you might experience. What it doesn’t tell you is how effective it is and what its comparative benefit is.
Drug Facts Boxes are simple 1-page summaries of drug benefits, harms and uncertainties.
Woloshin S, Schwartz LM. Think inside the box. New York Times. July 5, 2011. Op-Ed A21.
Schwartz LM, Woloshin, S. Communicating uncertainties about prescription drugs to the public. A national randomized trial. Arch Intern Med 2011;171:1463-1468.
Schwartz LM, Woloshin S, Welch HG. Communicating drug benefits and harms with the drug facts box: Two randomized trials. Ann Intern Med 2009;150: 516-527.
Schwartz LM, Woloshin S, Welch HG. The drug facts box: Providing consumers with simple tabular data on drug benefit and harm. Med Decis Making 2007;27:655-662.
Woloshin S, Schwartz LM, Welch HG. The value of benefit data in direct-to-consumer drug ads. Health Affairs 2004;W234-245.
Billions of taxpayer dollars have been allocated to support comparative effectiveness research about medical treatments. No money has been allocated — and relatively little would be needed — to disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs. Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles. Working within and outside FDA, we have tried to document and disseminate missing evidence.
Schwartz LM, Woloshin S. Not so stories: How the FDA forgot the evidence: The case of donepezil 23mg. BMJ 2012;344:e1086
Woloshin S, Schwartz LM. Bringing FDA's information to market. Arch Intern Med 2009;169: 1985-1987.
Schwartz LM, Woloshin S. Lost in transmission – FDA drug information that never reaches clinicians. N Engl J Med 2009; 361: 1717-1720.