DTC Principle Statements From Drug Companies Urged By Lilly's Taurel

Pharmaceutical companies should develop direct-to-consumer advertising principles, outgoing Pharmaceutical Research & Manufacturers of America Chairman Sidney Taurel declared in his May 11 address to the association annual meeting.

"All PhRMA member companies" should "consider formalizing and publicly stating corporate standards for direct-to-consumer advertising," Taurel said.

"There's plenty of evidence that we're already behaving according to sound principles," Taurel remarked. "For instance, our campaigns implicitly reflect our commitment to enhance the physician-patient relationship, to encourage the appropriate use of products, to provide external audiences feedback mechanisms for commenting on our ads, and much more," Taurel said.

"Now we should consider making these standards explicit and get credit for living up to them," Taurel declared.

Taurel's company, Lilly, finalized corporate DTC standards in March. The policy statement was adopted by Lilly's senior management policy committee, headed by Chairman Randall Tobias. The principles were developed in consultation with physician and patient groups, Lilly said. The company also worked with its two consumer advertising agencies: Leo Burnett and Gramercy.

Lilly has approached consumer advertising relatively conservatively thus far. The company markets three products to consumers: the antidepressant Prozac, the insulin analogue Humalog and the osteoporosis agent Evista. The campaigns have been restricted to print.

Lilly has pledged to "educate physicians and other health care professionals about Lilly medications before advertising them to the public." In addition, the company will "inform key constituencies prior to a launch of a campaign." The company is not committing to a defined time period between product launch and the first consumer ads, but noted that it has rolled out ads for Evista slowly.

Lilly will also "involve patients, physicians and advocacy groups in the development process to learn their desires and concerns regarding DTC campaigns," the company said. "Lilly DTC campaigns will include significant information about recognizing and understanding the illnesses that are treated by the medications."

Lilly's DTC campaigns "will enhance, rather than damage, the physician/patient relationship," Lilly pledged. "Lilly will always protect the confidentiality of patient information generated in the creation of campaigns or through the use of campaigns."

In addition, Lilly will "advertise in ways that encourage appropriate uses of products"; "will design DTC campaigns with only adult audiences in mind"; will "adhere to FDA standards regarding DTC campaigns and cooperate with FDA regarding advertisement development"; and will "provide external audiences with feedback mechanisms on the campaigns."

Taurel urged the PhRMA membership to be proactive in addressing DTC advertising to prevent the industry's critics from defining the significance of the new advertising efforts.

"DTC advertising has serious implications for our image, our credibility, our public mandate," Taurel said. "The key here is that this communications tool is outside the mainstream of our heritage." DTC "advertising is creating a new ball game that's transforming our sales and marketing programs from something small and specialized to something big and public."

"Will people react any differently to reports about higher drug expenditures if they know we're spending hundreds of millions of dollars annually on advertising?" Taurel asked.

"Will people feel any differently about drug safety if they think our advertising implicitly suggests we're becoming less scientifically focused? Will people have a different opinion about our capacity for engaging bioethical issues if they associate us with product-related ads in People magazine?"

"I suspect that people will see us differently because of DTC ads," Taurel continued. "And, because our constituencies see us differently, this medium could affect the public mandate on which we're so dependent as we advocate an agenda that's so important to our customers and our industry."

In addition to providing ammunition for its critics, direct-to-consumer advertising carries with it the risk of alienating the pharmaceutical industry's strongest ally, prescribing physicians.

American Medical Association Group VP for Professional Standards Reed Tuckson, MD, described the discomfort of physicians with DTC promotion.

"On the one hand, we as physicians are caught, because we absolutely believe...that the fundamentals of the doctor/patient relationship cause us to celebrate the empowerment of the patient to participate more fully in the processes of their care," Tuckson said. "On the other hand, we are concerned that this advertising will continue to cause patients to have expectations and demands that are inappropriate for them as individuals."

"It is often very difficult to explain to a patient that their condition is not appropriate for the wonderful new product presented by the very convincing and attractive sales model or advertisement," Tuckson said. "I remember how many times in my own experience how difficult it was not to prescribe that antibiotic for the patient with the viral syndrome."

"We wonder whether it will be long before your motives are put under severe scrutiny and your trustworthiness is eroded," Tuckson said. "Is this appropriate information or inappropriate advertising? We wonder if it will be long before cost-sensitive and aware consumers begin to wonder about the cost that they are underwriting for such advertising."

"I don't know what the right answer is going to be," Tuckson added. "The one thing that makes sense for us is [to] do the studies together. Let's do the monitoring together. Let us survey our members...and find out whether patients really are coming in with demands that we cannot achieve."

"We don't need to be enemies and draw lines in the sand on such a fundamental issue," Tuckson concluded. "Let us continue the conversation."

Hoffmann-La Roche, Inc. CEO Patrick Zenner pressed Tuckson to affirm a communications role for the industry. "In an information age, where a person can go and get so much information, I hope that the people who are most knowledgeable about it are allowed to be part of it in a way that is constructive."

"It would be difficult to imagine that the AMA, even though it is very clear in its policy about concern for direct-to-consumer advertising...would not see a role for the pharmaceutical industry in educating physicians or in supporting physicians to educate patients," Tuckson responded. "What we would only ask is...let's talk a little bit more together before we do some of these things so that we can at least get past the fear and anxiety."

DTC advertising is also changing the nature of the pharmaceutical industry's relationship with voluntary health associations, National Health Council President Myrl Weinberg pointed out.

DTC advertising "means that you...are building your own databases. You are creating consumer and patient information programs, etc., and in some ways competing directly head on with the voluntary health agencies," Weinberg commented.

"This does, in fact, change the way we then forge the relationships between each other," Weinberg said.

"Most companies are no longer comfortable...providing the unrestricted educational grants," she said. VHAs instead leverage their credibility as an information source to establish partnerships with industry.

VHAs have a reputation as "credible, believable sources," Weinberg pointed out, which allows them to argue that "if it is our product and it is coming from us with your support, in fact, you'll be more successful."

"When companies have gone and done focus groups, quite often they'll come back and say, 'You're right. That's the way we'd like to cut this relationship."

VHAs have organized themselves to operate "much more as a business," Weinberg continued. "There are...very sophisticated kinds of business deals going on...in how we use each others' databases."

"There are many other ways than just money for these voluntary health agencies to feel that you are really there for them," Weinberg advised. "Do the marketing for us. Do the public relations. Form the messages. Loan us people."

National Institutes of Health Director Harold Varmus had another suggestion for how the industry could use its people for extramural activities. "You folks really have more expertise than anyone in teaching clinical pharmacology....We're willing to help with some of the financial resources, but I think you guys have some of the talent that it will be very important to incorporate into the faculties that oversee such training."