BROOKE GLADSTONE: Here's a quandary for an advertiser. You have a product to sell, but the product can't be bought legally - at least not without the help of a middle man. What do you do? Gently implore your audience to gently implore the middle man. [TV COMMERCIAL MONTAGE PLAYS]

WOMAN: When will you ask your doctor about Lunesta?

MAN: If you've always gotta go, you may have a treatable medical condition. So ask your doctor about Detrol LA.

MAN: Talk to your doctor and find out if Nexim…

MAN: Ask your doctor about Vitorin.

WOMAN: Ask your doctor about the benefits of Lipitor.

MAN: Ask your doctor about Plavix today, because no matter how formidable you are, you're no match for a dangerous clot.

BROOKE GLADSTONE: Direct to consumer advertising accounts for some four billion dollars a year in ad spending, and nearly a third of the ad buys on the nightly network news. And so network execs are no doubt watching anxiously as the entire enterprise comes under increasing scrutiny. Ever since last year's safety scare over the heavily-marketed arthritis medications Vioxx and Celebrex, critics have called for stricter limits on the production of so-called DTC ads, and so have several bills now pending in Congress. Even the acting chief of the FDA has called for a crackdown. But the pharmaceutical industry is hoping to head off regulation with its own set of voluntary guidelines due out later this summer, and just last week, Bristol-Myers Squibb announced that it was imposing its own moratorium on all advertising of new drugs for at least a year after they'd been approved for sale. We called on advertising counsel Jim Davidson for his perspective. Jim, Welcome to the show.

JIM DAVIDSON: Thanks very much, Brooke.

BROOKE GLADSTONE: So could you explain briefly how we got to the point we're at right now with direct to consumer ads? I mean it's a fairly new phenomenon. As recently as ten years ago, doctors were the primary target of pharmaceutical ads.

JIM DAVIDSON: Direct to consumer advertising has been in the print media since the early 1980s, and then in 1997, they made a determination that, at FDA, that it would permit this type of advertising to appear in broadcast ads on television and radio.

BROOKE GLADSTONE: The loosening of the guidelines there was that instead of having to list every single potential side effect, you only had to list the major ones, and then direct them to some sort of a web site or a place they could get more information.

JIM DAVIDSON: That's correct. And remember that information in the hands of the consumer can empower them to get treatment that they need. 56 million Americans have high blood pressure, but 18 million of them don't know that they have that silent killer.

BROOKE GLADSTONE: That's the bright side. The darker side, as suggested in a recent FDA study, is that physicians report that fewer than half of them believe that patients really understand the possible risks of a lot of these DTC advertised drugs, and 38 percent of doctors believe the ads cause patients to question their diagnoses and more than a quarter say that it leads to tension between doctors and patients.

JIM DAVIDSON: I, I know that survey intimately, inside and out, and I can give you countervailing percentages. For example, 72 percent of those doctors believe that the ads educate and inform patients about treatments that are available to them. And 42 percent of the doctors agree the ads make the patients more involved in their health care. I think the most important statistic, and this is one that came from a survey that the Food & Drug Administration did, and it was backed up by another survey that Prevention magazine did. This survey showed that 25 to 30 million Americans, because they saw an ad for a prescription drug, went to a doctor to talk about a medical condition they had never discussed before. That is a public health revolution.

BROOKE GLADSTONE: Jim, I have to question whether or not some of these people are being over-medicated, because of the impact of these direct to consumer ads. According to a study in the Journal of the American Medical Association this past spring, doctors posed as patients with some symptoms that sort of resembled depression, like fatigue, stress, trouble sleeping but that don't necessarily require medication. When these people specifically asked their doctors about Paxil, more than half of them walked out with the drug. When they didn't, only ten percent of them did.

JIM DAVIDSON: The people that went into these doctors' offices were trained actors, and they were rehearsed specifically not only how to present a condition relating to depression, but then trained to respond to how the doctors would ask questions. So they were basically trained to fool the doctors. I'm not sure that I've got a lot of confidence in that study.

BROOKE GLADSTONE: Do you think that physicians should be taking cues on prescriptions from their patients?

JIM DAVIDSON: Well, I think that that's an issue really for the medical profession to look at in terms of how its medical education trains people in understanding pharmacology and diagnosis and prescriptions. That's where you should deal with that. The role of the advertising is to get the patient to go in and visit with the physician so the dialogue can start, and about a third to 40 percent of all the cases where advertising has prompted someone to go visit a physician, the patient came away with a recommendation that had nothing to do with a drug. It was a recommendation for a change in lifestyle or diet or exercise. More importantly, we haven't seen any reported cases anywhere, and it's always difficult to prove a negative, but we haven't seen any reported cases of individuals who have been harmed by a prescription given by a doctor as a result of seeing an ad.

BROOKE GLADSTONE: There may not be, but there is the situation, as I mentioned earlier, of Vioxx and Celebrex last year which were among the most heavily marketed drugs and have created some of this backlash against direct to consumer ads, and many, many doctors are saying let us have some time before you rush your advertisements along with the drugs to market. Let us see before they're out in the hands of millions of people how well they work. What's so bad about the Brisol-Myers Squibb idea of a year moratorium on new drug advertising?

JIM DAVIDSON: Information delayed is information denied. I think a generic rule that says that all medicines should be delayed from being advertised for any period of time hurts people who need treatment that a new drug could provide, and so keeping it arbitrarily away from people I don't think is a good public policy.

BROOKE GLADSTONE: Jim, thank you very much.

JIM DAVIDSON: Thank you, Brooke, very much.

BROOKE GLADSTONE: Jim Davidson is counsel to the Advertising Coalition, a group of advertising and media trade associations. [MUSIC]