From Our 2011 Archives

Study: Americans Confused on Drug Benefits vs. Risks

Researchers Find That Many in U.S. Have Poor Understanding of Drug Approval Process

By Kathleen Doheny
WebMD Health News

Reviewed by Laura J. Martin, MD

Sept. 13, 2011 -- U.S. adults are not fully aware of drug benefits and harms, new research shows.

Many also do not understand what the FDA drug approval process means for the safety of a drug, says study researcher Steven Woloshin, MD.

"If they have these mistaken beliefs, they may make choices and expose themselves to harm," he tells WebMD. Woloshin is a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and co-director of the VA Outcomes Group at White River Junction VA Medical Center.

However, Woloshin found that when given more information, consumers do make better choices about drugs.

His study is published in the Archives of Internal Medicine.

Improving Drug Choices

Woloshin wanted to see whether simple explanations about drugs improve people's choices.

First, people were asked to choose between one of two cholesterol-lowering drugs. One had been approved because it lowered cholesterol. Another was approved because it reduced heart attacks.

The people were assigned to one of three groups:

  • One group received no explanation.
  • A second group was told that outcomes such as cholesterol lowering don't always mean heart attacks will be reduced.
  • A third group was told the same information as the second group but were also told to ask for the drug that reduces heart attacks.

Woloshin found that 71% of the second and third groups chose the drug that reduced heart attacks. But just 59% of the group given no information did.

Next, the people were assigned to one of three groups and asked to choose between two different heartburn drugs. One was newly approved. The other had been approved for eight years.

Again, Woloshin assigned them to one of three groups:

  • One group received no explanation.
  • A second group was told it takes time to establish the safety of a new drug.
  • A third group was told the same information as the second group, but were also told to look for the drug with a longer safety record.

Woloshin found that 53% of the second and third groups chose the older drug. But just 34% of the group getting no information did.

When the people were asked what they would do if their doctor suggested they take the drug only known to lower cholesterol, the group getting information plus advice did best. While 61% of those given information plus advice said they would request the drug known to reduce heart attacks, 58% of those only given information would. And just 49% of those given no information or advice did.

Woloshin says the studies prove that ''the public need more information, not just numbers. They also need explanations."

The explanations used in the two studies were just 23 and 37 words long, he says. He says the FDA could easily incorporate this information to accompany drugs.

"If you read the whole package insert, you might get some of this information," he says. However, he points out that few patients do so.

Patients Need More Information

The study shows that just giving people information about drug benefits and harms isn't going to solve the problem, says Michael Steinman, MD, associate professor of medicine at San Francisco VA Medical Center. He wrote a commentary to accompany the study.

People need to know what questions to ask, he says.

Suppose there is a new cholesterol-lowering drug. "There are some important questions you would want to ask," he says. Among them:

  • Has the drug been shown to reduce strokes and heart attacks?
  • Does it reduce them more than the other choices?
  • Has the drug been around long enough that we have a good sense of its true benefits and harms?

The latest, greatest drug is not always best, he says. As an example, he and Woloshin point to Vioxx. The anti-inflammatory drug had sales of $2.4 billion before being withdrawn in 2004 due to its link with heart attacks and strokes.

Another expert, Michael Cohen, RPh, ScD, president of the Institute for Safe Medication Practices, thinks some of the study findings will be a surprise to consumers. "I would suspect that many consumers are unaware that not all adverse events can be detected during clinical trials."

When a drug is approved and becomes more widely used, new side effects can surface, he says.

Consumers can keep tabs on this information, he says. One option is by checking Medwatch, the FDA Safety Information and Adverse Event Reporting Program. The Institute for Safe Medication Practices also posts drug alerts on its consumer site, consumsermedsafety.org, Cohen says.

SOURCES: Schwartz, L. Archives of Internal Medicine, Sept. 12, 2011; vol 171: pp1463-1468.Steinman, M. Archives of Internal Medicine, Sept. 12, 2011; vol 171: pp.1468-1469.Michael Steinman, MD, associate professor of medicine, San Francisco VA Medical Center.Steven Woloshin, MD, professor of medicine, Dartmouth Institute for Health Policy; co-director, VA Outcomes Group, White River Junction VA Medical Center.Michael Cohen, RPh, ScD, president, Institute for Safe Medication Practices, Horsham, Pa. ©2011 WebMD, LLC. All Rights Reserved.