What Moratorium?

For years now, politicians have been calling for a moratorium on direct-to-consumer drug advertising. Most recently, presidential hopeful John Edwards announced that he will seek a two-year hold on all DTC ads so that the drugs will have time to prove their efficacy and safety on the marketplace. That's all fine and dandy, but politicians are not physicians, and they do not have insight into doctors' prescribing habits or patients' actual response to consumer ads.

David Kweskin

To find out what doctors really think about consumer marketing, TNS Healthcare interviewed more than 1,000 physicians in an Internet study. According to the results, nearly two-thirds of physicians favor a moratorium on DTC advertising, with half supporting a one- or two-year wait before manufacturers can begin promoting new drugs directly to consumers. Pharmaceutical Executive talked to TNS Senior Vice President David Kweskin to learn more.

Why did you do this study?

We did it as a way of educating ourselves about the people who would be most affected by any kind of moratorium. Rather than blue-sky what we think people thought, we decided to find out directly from them.

Are any specific types of doctors more likely to be for or against DTC ads?

There seems to be a uniformity. We didn't see one particular group as very different from any other. There's always variation, of course, but it was more interesting to see that different specialists were largely thinking along the same lines.

This study was done before the moratorium failed to get congressional approval. Do you think physicians would respond differently today?

The question we asked was: Are you aware of the FDA revitalization legislation that recently passed in the US Senate 93 to 1 and that had the DTC ad moratorium removed from the bill? Only 10 percent were aware that this was going on—there was hardly even any recognition of the legislation. Therefore, I'm surmising that if they weren't aware then, chances are there's not much change subsequently. I just don't think physicians are sitting on the edge of their chairs waiting to see what the FDA is going to do about DTC ads.

What did doctors say was the biggest hindrance to their job caused by DTC?

Physicians are of a mixed mind: They see positive aspects and things they find annoying. I don't think they're rejecting DTC out of hand. For example, one of the most frequent answers was that ads increase drug costs. Now, you can interpret that a couple of ways. One is you can say, "The pharma companies are taking the cost of the ads and putting it into the cost of the drugs and, ultimately, the consumer is suffering." On the other hand, you can look at it as, they're bringing the consumer a solution. I'll give you an example. In the erectile dysfunction category, there are a lot of men out there who had no idea that there was something that they could do about it. So there is a sense adds a cost to one's way of life, but it also provides a solution.

The study found that more than 50 percent of doctors feel that patients misunderstand the ad messages and pressure doctors to prescribe inappropriate medication. Was that a major concern?

I think from a physician's point of view it's often "I'm the gatekeeper here, so whatever you ask me." But we've also seen on the positive side that physicians say it brings in patients who otherwise wouldn't have been there. Or, for example, it helps patients feel comfortable bringing up questions or concerns about symptoms or conditions. That was something that was agreed upon.

Did you have any physicians tell you that they didn't know about a drug until a patient brought it up?

I'm sure it does happen. And, in fact, likely one of the reasons there's usually a pause once a drug is approved and before a marketer will begin advertising is because the drugmaker wants to give the physicians time to become familiar with it and to let the reps talk to the physicians.

I think the physician would be more receptive to a patient coming in and making requests if he's at least beginning to become more familiar with the new drug than he would finding out about it almost at the same time as the patient. I think the physician's probably a little bit put out by that.

What was the most surprising response you received?

The wariness of physicians about what's going on at the government level regarding FDA and revitalization. The fact that hardly any of them were aware of it. I thought we would have a much higher awareness and a lot more point of view being stated by the AMA. We're not hearing from them. So it seems to me that these may be issues more for pharma companies and for pro or con advocates of DTC.

If FDA has approved a drug and the advertiser is not misrepresenting what the drug does, shouldn't the company have the opportunity to say whatever it wants to say about its drug?

As long as the statements in the advertising are not misleading or clearly untruthful, then yes. I think that has been the way that it's been in this country for the last 10 to 12 years. DTC advertising is something that is felt to be helpful to the consumer.

Do you think DTC advertising keeps consumers from fully understanding the risks of the drug?

If someone wants to bury something that's negative, yes, they can do that. I'm not saying that advertisers are doing that in the pharmaceutical industry, but I'm saying clearly that can happen. So I think it behooves everyone to be sure that they are being open about that. The pharma industry has been very careful about being open and not being accused of hiding because there's absolutely no benefit to the industry to be accused—or to be doing that intentionally. It absolutely will backfire on them.

The PDUFA IV legislation passed in the fall includes a provision that FDA can levy hefty fines against companies that do falsely advertise.

Under the system, if FDA determines an ad to be false or misleading and if the company chooses to challenge the decision, the matter goes to an administrative law judge. It's $250,000 for each day a defending ad ran after notification.

If the Vioxx events hadn't happened, do you think there would've been this much of a call for a moratorium?

The Vioxx situation had a lot to do with raising everyone's yellow flag. It made people think, "Maybe we need to step back a little bit here and take a harder look at what's going on." Not to say that we're arbitrarily throwing out the baby with the bathwater, but are we giving it a hard look? Are we doing the right thing? Or do we need to be modifying what we do? And I think the answer is that there's a need to modify the current rules.

According to the survey, doctors and consumers are calling for some kind of moratorium, but it doesn't look like industry's heading that way. Do you see any reasons why?

In the survey, under the level of agreement with a DTC ad moratorium, half of the people interviewed said that they really had no opinion—"I haven't decided whether I'm in favor of the moratorium or not." Though there was a large minority who said they did, in fact, favor a moratorium. So the question is, if we have something like 44 percent of the people saying they do agree with a moratorium of some length, why didn't it happen? I'm not seeing groups and advocates screaming and yelling for such change.

Large amounts of money are being spent right now on DTC advertising, particularly on television. Do you have clients who might reevaluate their approach to DTC because of this study?

I would certainly say to you that our clients are concerned about the public's perception of what they're saying about their brand and that it's being understood as being truthful and forthright. Once a consumer loses trust in a company or a brand, that's the death knell. They are very eager to have the right message understood about their brand.

Do you think the negative perception of DTC will change in the near future?

We've just entered a political season when a lot of people are going to be taking shots—maybe fairly, maybe unfairly—at the healthcare industry. So I think that the healthcare industry has to be alert and sensitive to that and to be willing to fight back when unfair accusations are made. It's going to be potentially a rough season for the pharmaceutical industry.