Direct-to-consumer branded advertisements are more effective in motivating patients to visit their doctors than disease awareness ads, Pfizer President-U.S. Pharmaceuticals Patrick Kelly said Nov. 1.

"General disease awareness and help-seeking ads do not drive patients to the doctor to anywhere near the degree that information about a solution or a potential solution will," Kelly said at an FDA public hearing on DTC advertising held Nov. 1-2.

For an ad to be effective it must overcome patient inertia "associated with perceived barriers to them seeking help and seeking treatment," as well as a tendency for patients to minimize the seriousness of a condition, Kelly said.

If an ad solely expresses that there is a medical condition or disease that you should be aware of "it doesn't generate as much action as if you then say 'and there might be potential solutions that you should consult with your provider about.' So it is the other connection that is important towards motivating action," Kelly said.

Observing that "product ads can have help-seeking components," FDA Office of Medical Policy Director Robert Temple asked: "Do you have any insight into whether those elements contribute to better understanding" regarding the "long-term use of these agents and compliance?"

"There is a very important component in these ads relative to trying to continue treatment in those patients that have received medical treatment," Kelly replied. "The ads do serve as a reminder to them," however, it is unclear "as to how much of a degree that reminder helps."

Pfizer is looking to combine aspects of brand and disease awareness ads to maximize the public health benefits of its ads, the company's Director-US Marketing Jim Maffezzoli said at the Pharmaceutical Leadership Forum Nov. 7.

At the DTC hearing, FDAers seemed intrigued by the suggestion that branded DTC ads are more effective at motivating patients than disease awareness ads and addressed the issue in questions to consumer and pharmacy groups advocating increases in disease awareness ads.

"Somebody put forth the idea that if a general health awareness ad doesn't name a specific product nobody actually goes to the doctor," Temple said. "If that were true, that would argue that even if you have a health awareness component of your ad, you may need to name a product anyway," he said.

FDA Office of Policy Senior Advisor for Risk Communications Nancy Ostrove raised the question of whether disease awareness ads should be judged by the same standard as branded DTC ads.

"At least the way it's been done," disease-oriented promotion "doesn't seem to be as effective in getting the patients in to see the doctor....Is that the right thing that we should be looking at?" Ostrove asked. Or, "is there something else that you all would have in mind...as an assessment of the value of the disease-oriented promotion as opposed to product-oriented?"

"We do know that DTC is prompting people to talk to their doctor about a drug. It seems like if we could do [disease awareness] ads right we could prompt more people to talk to their doctor about a condition or disease," National Consumer League Health Policy Director Rebecca Burkholder said.

Some consumer, pharmacy and managed care groups expressed concern about the potential over-utilization of drugs promoted through DTC advertising.

FDA Division of Drug Marketing, Advertising & Communications Director Thomas Abrams observed that increased use of drugs "could be a positive thing or a negative thing. The negative is that it increases cost, but if that utilization is for appropriate use for under-treated conditions then it is positive for public health."

Pennsylvania State University researcher Andrew Kleit presented unpublished study findings showing DTC ads positively affected prescribing behavior for COX-2 inhibitors. In the study, DTC ads for Vioxx and Celebrex increased the rate at which osteoarthritis patients with gastrointestinal difficulties adopted COX-2s while decreasing the rate at which patients with cardiovascular problems adopted the pain therapies.

"DTC advertising for Vioxx and Celebrex did affect prescribing behavior and did so in exactly the direction you might want," Kleit concluded. "Good candidates for the drug got the drug sooner, poor candidates got the drug later."

Brand DTC Better Than Disease Awareness Ads At Driving Patients To Doctor

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