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Fri July 25, 2014

How Well Does A Drug Work? Look Beyond The Fine Print

Originally published on Fri August 1, 2014 11:31 am

Anybody who has ever seen a drug advertisement or talked over the pros and cons of a medicine with a doctor can be forgiven for being confused.

Sorting out the risks and benefits of taking a medicine can be complicated even for professionals.

This spring, the Institute of Medicine convened a workshop with the Food and Drug Administration. The topic: How best to communicate to doctors and patients the uncertainty in the assessment of benefits and risks of pharmaceuticals.

The FDA not only approves drugs, it also approves the prescribing instructions that come along with them. For some drugs, the wad of paper filled with fine print about the risks and benefits of using the drug is accompanied by a medication guide that is supposed to summarize the main points.

During one question-and-answer session, Dr. Robert Temple of the FDA's Center for Drug Evaluation and Research, acknowledged that those guides are full of information. "But it's remarkably nonquantitative for the most part," he said. "And I think we should try to think about whether there are quantitative ways of presenting that stuff."

He then referred to Drs. Steven Woloshin and Lisa Schwartz, two of his fellow panelists, who have said it's possible to pull that off.

The husband-and-wife team from Dartmouth are on a decade-long mission. They have been pushing the FDA to get useful and readable quantitative data about drugs to doctors and their patients.

Schwartz and Woloshin have designed a format they call a drug facts box. It shows the gist of what they say is buried in all the fine print: How does the drug compare to a placebo?

That's in contrast to what usually happens, Schwartz says. "The prescribing info is written by industry, and then negotiated with FDA, and then FDA ultimately approves it. And we have documented examples where important info — like how well the drug works — is not in the label."

This drives Schwartz and Woloshin crazy.

Better Than A Sugar Pill

So, here's their experiment: They showed people ads for two competing heartburn drugs, one plainly more effective than the other.

They also showed people two of their drug facts boxes, one for each of those two heartburn drugs, showing how each drug fared against a placebo (a sugar pill) in testing.

"When the people are presented with the standard information they see — like a drug ad — about 30 percent of people chose the better drug," Woloshin says. "But when we showed them information in the drug facts box form, 68 percent of people were able to choose the objectively better drug. So that's a really dramatic improvement. It just shows you that if you show people information in a way that's understandable, they can use it, and it can improve their decision."

Using FDA data, Woloshin and Schwartz developed a drug facts box for the sleep aid Lunesta.

Two columns compare people with insomnia who took Lunesta and people with insomnia who, unknowingly, took a sugar pill.

The results? Those who used Lunesta took 30 minutes to fall asleep. Those who got a sugar pill took 45 minutes — a difference of 15 minutes. Those who took Lunesta stayed asleep 37 minutes longer than those who took a sugar pill.

Woloshin and Schwartz say some people might consider those benefits worth taking the drug, and some might not.

"That's the whole point of the drugs facts box," Woloshin says, "to let people look at the evidence and come to their own judgments. But you can't make those judgments without the facts.

He and Schwartz believe passionately in the numeracy of patients. They say we can handle numbers, like percents. It's just that too often we're given incomplete or misleading information.

How Good A Deal Is That Sale?

For example, a claim that some drug reduces the likelihood of a particular disease by 50 percent can be misleading.

Woloshin explains why. "If you heard about a sale, and it said 50 percent off, would you travel a great distance to go to the sale? Well, you might if it was on things that are really expensive, like a flat-screen TV or something," he says. "But what if the thing that was on sale was gum, and you save only a couple of cents? So when you hear 50 percent reduction, you have to ask 50 percent of what?"

The doctors' dream is to get those drug facts boxes into health systems and electronic medical records, so that doctors and patients can study the information and decide what's best before the drug is prescribed.

"What we hope is that the box will encourage people to take drugs that are effective and that work, and discourage people from taking drugs that don't work or are just harmful," Woloshin says. "And also that just having this information in front of people will stimulate better drug research, because drug companies realize people are paying attention and looking at these numbers — and then we'd have a better quality of drug trials."

Woloshin and Schwartz say medical information should be as quantitative as other information. And we digest quantitative data all the time.

"If you were reporting on an election, you wouldn't say Obama won by a little," he says. "You'd give the numbers. If you were reporting sports scores, you wouldn't say the Celtics, won, hopefully won, by a bit. You'd give the score."

Why should health care be different?

He and Schwartz are convinced that we can understand risk described by numbers, provided the numbers are clearly and honestly presented.

They have been lobbying the FDA to develop drug facts boxes, but say that seems unlikely. So they started their own company to do it — Informulary. It's funded by the Robert Wood Johnson Foundation, which also supports NPR.

This is the final part of an All Things Considered series on Risk and Reason.

Copyright 2014 NPR. To see more, visit http://www.npr.org/.

Transcript

ROBERT SIEGEL, HOST:

This week we've been hearing about our encounters with probability. Does it help to hear that there's a 20 percent chance of rain or that you face a 12 percent chance of a heart attack? Do numbers help or can word suffice? Well, today in the last piece of this series, probabilities of success and side effects from prescription drugs. This spring the Institute of Medicine convened a workshop with the Food and Drug Administration. The topic was how best to communicate uncertainty in the assessment of benefits and risks of pharmaceuticals, how to communicate that to doctors and to their patient's. The FDA not only approves drugs, it also proves the package inserts, the wads of paper filled with fine print about the risks and benefits of using the drug, as well as the med guides, the boiled down version of that information that's meant to hit the right points. But during one question and answer session, Robert Temple, of the FDA's Center for Evaluation and Research, acknowledged that those med guides are full of information.

ROBERT TEMPLE: But it's remarkably non quantitative for the most part. And I think we should try to think about whether there are quantitative ways of presenting that stuff and certainly doctors, Woloshin and Schwartz , have been saying for a long time, that there are.

SIEGEL: He was referring to Steven Woloshin and Lisa Schwartz, two of his fellow panelists. They are a husband and wife team of doctors from Dartmouth, who are on a decade-long mission. They've been pushing the FDA to get useful and readable quantitative data about drugs to doctors and their patients. Schwartz and Woloshin have designed a format they call, a drugs facts box, it shows the gist of what they say, is buried in all the fine print. How does the drug compare to a placebo?

LISA SCHWARTZ: The prescribing information is written by industry and then it's negotiated with FDA and FDA ultimately approves it and we have documented examples were important information like how well the drug works is not in the label.

SIEGEL: That drives them crazy. So, here's an experiment of theirs. They showed people ads for two competing heartburn drugs, one plainly more effective than the other. They also showed people two of their drug facts boxes, one for each of those two heartburn drugs showing how each drug faired against a placebo, a sugar pill in testing.

STEVEN WOLOSHIN: When people were presented the standard information they see like, a drug ad, about 35 percent of people chose the better drug. But when we showed them information in a drug facts box form, 68 percent of people were able to choose the objectively better drug. So, that's a really dramatic improvement and it just shows you that if you show people information in a way that's understandable they can use it and it can approve their decisions.

SIEGEL: Of course no drug company advertises its product by saying, this is better than a sugar pill.

(LAUGHTER)

WOLOSHIN: Well, that would be refreshing.

SIEGEL: You think that would be in many cases an honest statement about what they're doing?

SCHWARTZ: Or it might be fairer to say it's barely better than a sugar pill.

SIEGEL: You can quickly see where drug company resistance would set in, Using FDA data, Woloshin and Schwartz developed a drug facts box for the sleep aid Lunesta. Two simple columns compare people with insomnia, who took Lunesta and people with insomnia who unknowingly took a sugar pill. The results, well, those who took Lunesta took 30 minutes to fall asleep, those taking a sugar pill took 45 minutes, a difference of 15 minutes. Those who took Lunesta stayed asleep for 37 minutes longer than those who took a sugar pill. Well Woloshin and Schwartz say some people might consider those benefits worth taking the drug and some might not.

WOLOSHIN: That's the whole point of the drug facts box, is to let people look at the evidence and come to their own judgments. But you can't make those judgments without the facts.

SIEGEL: The two of them believe passionately in the numeracy of patients. They say, we can handle numbers like percents, it's just too often we're given incomplete or miss leading information. For example a claim that this drug reduces the likelihood of that disease by 50 percent. Here's what's wrong with that.

WOLOSHIN: If you heard about a sale and it said 50 percent off, would you travel a great distance to go to the sale? Well, you might if the sale was on things that are really expensive, you know, like a fat screen TV or something. But what if the thing that was on sale was gum and you save only a couple of cents. So, when you hear 50 percent reduction you always have to ask, 50 percent of what.

SCHWARTZ: I mean it could be the difference between going from 20 percent to 10 percent or it could be the difference from going from two in a million to one in a million. In either case if you don't know the rate of how often that happens you could be totally misled.

SIEGEL: Their dream is to get those drug facts boxes into health systems and electronic medical record. So, that doctors and patients can study the information and decide what's best before the drug is prescribed.

WOLOSHIN: What we hope is that the box will encourage people to take drugs that are effective and that work. Discourage people from taking drugs that don't work or that are just harmful. And also that, just having this information in front of people will stimulate better research because drug companies will realize people are really paying attention and looking at these numbers and then we'd have better quality of drug trials.

SIEGEL: Doctor Steven Woloshin and Lisa Schwartz say, medical information should be as quantitative as other information and we digest quantitative data all the time.

WOLOSHIN: If you were reporting on an election, right, you wouldn't say, oh Obama won by a little. Right, you'd give the numbers. Or if you were reporting the sports scores you wouldn't say, the Celtics los- won, hopefully won by a bit.

SIEGEL: You'd give the score. We'd give the score.

WOLOSHIN: You'd give the score. But there's this idea that when it comes to medical information that all the sudden people's ability to handle numbers goes at the window. And we think that's not the case and we've shown in studies that it's not the case.

SIEGEL: All of this rests on their conviction that we can understand risks described by numbers, provided the numbers are clearly and honestly presented. Doctors Woloshin and Schwartz have been lobbying the FDA to develop drug facts boxes, but that seems unlikely. So they started their own company to do it. It's funded by the Robert Wood Johnson Foundation, which we should say also supports NPR. Transcript provided by NPR, Copyright NPR.