Wendy Wolfson
RedwoodAge.com

Boomers were subjected to about $5 billion in advertising for prescription medications, but the FDA is working on a cure.

Because of a series of studies by Dartmouth Outcomes Group researchers, the FDA is considering swapping that fine print summary on drug ads for a plain English label. Like the supermarket nutrition info, the drug labels would tell how well a drug really works and describe its potential side effects.

In a study published in the Annals of Internal Medicine, Drs. Lisa Schwartz, Steven Woloshin and Gilbert Welch conducted two randomized controlled studies to see if putting drug facts on an ad could help consumers to make better choices.

The researchers gave a group of 231 adults - average age 54 - direct-to-consumer ads for two drugs to treat heartburn symptoms, a H2 blocker, and a proton pump inhibitor that was more effective. Another group of 219 people got DTC ads for a statin, and clopidogrel, used to prevent heart disease.

The control group got 2 actual drug ads with the fine print summary. The others got the same ads, but researchers replaced the fine print summary with a drug facts box written in plain, everyday English. All the drug names were disguised.

It's important for patients and doctors to understand the data of how well a drug really works, the researchers wrote in a 2004 study, especially for drugs taken to reduce the risks of a condition like heart disease instead of treating an established condition.

Plain Talk
In a heartburn drug trial, 70 percent of the group looking at the drug facts box, but only 8 percent of the control group correctly chose the more effective drug. Four out of five looking at the plain language version understood the two drugs had similar side effect, but only 30 percent of the control group knew that.

When participants asked which drug they would take if they had heartburn but could have either drug for free, 60 percent of the plain English group chose the proton pump inhibitor, the more effective drug, compared to only 31 percent of the control group.

Likewise, in the heart attack prevention, the researchers found that a drug fact box improved people's ability to accurately understand benefits and risks.

Consumers who got the standard fine print overestimated disease risk, the drug benefit and side effect. It turns out that when given the real data devoid of marketing finesse, in standardized format and bigger print, people could make more accurate decisions.

Could it also just be a matter of it being hard to read fine print? Woloshin comments, "... I don't think much of the effect we saw could be attributed to this since there are NO data on drug benefit in any of the brief summaries. So even if they appeared in huge font it wouldn't matter."