Doctors, Patients Wrestle With Drug Risks

March 10, 2005 — -- A new animated video finds something novel in the current debate over drug safety: humor.

The musical video, titled "The Drugs I Need," lampoons Americans' willingness to pop a pill for whatever ails them, and the drug industry's efforts to satisfy that urge.

The video was produced by Consumers Union, an independent, nonprofit product testing group and publisher of Consumer Reports magazine. The video's release was timed to coincide with a bill currently before Congress that would require manufacturers to make information on drug trials available to the public.

But at the heart of the comic video lies a serious question: When it comes to drugs, do consumers have realistic expectations?

Swinging 'From Panacea to Panic'

"We don't have realistic expectations right out of the chute," said Dr. Marc Siegel, an internist and associate professor of medicine at the New York University Medical School.

Siegel, author of the upcoming book "False Alarm: The Truth About the Epidemic of Fear," believes patients expect too much from new prescription medications, only to have their hopes crushed when unexpected side effects occur.

"The public often doesn't have a sophisticated enough view of drugs," he said. "They go from panacea to panic."

Siegel acknowledges doctors, too, can succumb to pressure from patients and drug companies to prescribe the newest drugs available, even when they may not be appropriate or necessary for a patient.

"The problem I feel is that we take the drugs too often and we prescribe them too readily," he said.

The solution, Siegel believes, lies in appreciating the fact that all drugs come with risks and benefits. Too often, drugs are used by the wrong patients for too long and at too high a dose.

"These drugs are not villains and they're not heroes," Siegel said. "It all comes under the perspective of finding the right niche for a drug."

Managing Drug Risks

Whether the issue is medicine or any other consumer good, the public makes choices using a combination of information and intuition, says David Ropeik, director of risk communication at the Harvard Center for Risk Analysis in Boston.

"We make judgments in our lives all the time about all sorts of things, comparing risks and benefits. We don't do it consciously -- we do it intuitively," Ropeik said.

"In the case of drugs, we take what information we have, we put that partial information with our instincts, and then determine how afraid to be."

Consumers, Ropeik believes, weigh the pros and cons of a drug in light of how much it will alleviate their suffering. "The more your head hurts, the greater the benefits of the aspirin, and the more you'll downplay the risks," he said.

But because trust plays such a significant role in consumer choices, Ropeik believes drug companies have fumbled the ball in managing the public's view of their product.

"Drug companies have not paid sufficient attention to people's perceptions of risk," he said. "Dealing with these issues clinically and economically is not enough."

An Industry Addresses Tough Safety Standards

But those in the pharmaceutical industry dispute charges they have a cavalier approach to drug risks or public perceptions.

Safety standards in their industry are much higher than in years past, says Kate Robins, a spokeswoman for drug giant Pfizer, and the drug approval process is made increasingly rigorous by more sensitive tools and testing procedures.

"Many of the drugs that don't make it today by our current standards of safety -- and more than 90 percent of what we have in the pipeline won't make it -- may be better than the drugs that were approved 30 years ago," said Robins.

"You're curing diseases by adjusting chemicals. And the diseases we're working on today are very complex -- look at HIV, look at Alzheimer's," she said.

Robins adds that all consumer products -- drugs, automobiles, food, children's toys -- are much safer now than even 20 years ago.

"It's a much safer world," she said.

"The whole concept of drug benefits and risks is something we all need to do a better job of communicating," said Alan Goldhammer, associate vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, a drug industry lobbying group.

"It's really important for patients and physicians that when they decide on a course of therapy that they have a clear understanding of how this drug is going to treat the underlying medical condition as well as the possible side effects," Goldhammer said.

Using Humor to Stir Debate

But critics charge that by withholding information about negative side effects -- such as the link between some antidepressants and suicide, and COX-2 painkillers' association with heart attack and stroke risk -- drug makers may have done irreparable damage to the perception doctors and consumers have of every product they make.

"Consumers have the right to expect full disclosure from drug companies of all findings when they become available, including information that shows negative side effects," said Rob Schneider of Consumers Union.

Schneider is director of Consumers Union's Prescription for Change campaign, an effort to make drug safety issues more transparent to the public and doctors. The campaign's lighthearted animated video represents a change in strategy for the normally straightlaced organization.

"Sometimes humor is the best way to focus attention on a serious problem," said Schneider. He said the video was partly inspired by the political satire of Jib-Jab, whose videos enjoyed wide circulation on the Internet during the 2004 presidential campaigns.

"The Internet is now the place where Americans can go to directly take action on issues that affect their lives," Schneider said.

But the drug industry isn't laughing.

"It's a catchy jingle all right and good for a laugh. But we really ought to be having serious conversations about how best to help doctors and their patients choose the right medicines," said Jeff Gilbert, director of media relations for the Pharmaceutical Research and Manufacturers of America.

Restraining Drug Companies

Consumers Union is throwing its weight behind the Fair Access to Clinical Trials bill, or FACT 2005, recently introduced in the Senate by Sens. Chuck Grassley, R-Iowa, and Chris Dodd, D-Conn.

FACT 2005 would require drug manufacturers to register all newly conducted clinical trials. Trials conducted in the past, however, would be exempt.

"It's a sound first step toward the goal of a clinical trials database," said Schneider.

But it may take more than this piece of legislation to bring drug companies into line. Among industrialized nations, advertising drugs to consumers is only allowed in the United States and New Zealand, says NYU's Siegel.

Siegel believes through these advertisements, and drug promotions aimed at doctors, drug makers have presented a distorted picture of their products' benefits and risks.

"They're unrestrained," said Siegel, who nonetheless says that drug makers shouldn't shoulder all the blame.

"They're in business to make money. It's up to us, and it's up to the government, to restrain them," he said.