Relaxed advertising regulation concerns physicians

WASHINGTON -- "Blue skies smiling at me... Nothing but blue skies do I see."

Set to a catchy tune and images of a colorful soaring balloon, the Schering-Plough commercial for its Claritin allergy medicine, and others like it, are increasingly spurring patients to ask for specific drugs when they visit allergists like Stanley Lane. The inquiries have become more common since last August, when the U.S. Food and Drug Administration took controversial steps to relax standards for broadcast advertising of prescription drugs, the American Medical Association says.

Lane, who practices in Moorestown, N.J., estimates between 10 percent and 15 percent of his patients ask for specific brands. While he says his patients listen to him if he thinks a different drug would be more appropriate, "usually, you want to go along with what they're asking -- it makes for a better relationship." That's music to the ears of companies such as Schering-Plough, which in 1997 tallied up worldwide sales of $1.7 billion for its Claritin, up from about $1.2 billion in 1996. It's not such good news for managed care companies, which face rising drug costs, helped along by increased demand for pricey drugs advertised directly to patients. "This appears to be primarily a tool of the pharmaceutical manufacturers to bypass some of the managed care interventions that we have," said Robert Seidman, vice president of pharmacy for Blue Cross of California, an operating subsidiary of Wellpoint Health Networks. Foes of direct-to-consumer advertising, including consumer groups, medical associations and a majority of doctors, say the commercials aren't properly emphasizing the risks inherent in prescription drugs. And managed care companies worry that the ads are adding to their costs by prompting patients to see a doctor unnecessarily to ask about getting an advertised drug. "The advertising is purposely directed at driving patients to demand medications -- irrespective of whether those medications are medically necessary," said Francis Crosson, the top physician at Kaiser Permanente. He added that doctors are spending more time with patients "dealing with prejudices" they've garnered from ads. For managed care companies, demand from consumers targeted by the ads will help drug costs at health plans continue to rise 12 percent to 15 percent per year, according to Norm Fidel, an analyst and money manager at Alliance Capital Management with $600 million in health funds under management. While direct-to-consumer advertising is a good concept, the FDA's guidelines are too lax on drug companies, according to Seidman. Many of the ads don't properly convey the risks that come along with any prescription drug and could lead to problems down the road, he argued. "When you see the commercial, you see all the bright and happy people. And then at the end, very quickly you hear all the side effects," Seidman said. "There's a lot of fizzle associated with this." His concerns are echoed by the watchdog group Public Citizen, the American Medical Association and a majority of doctors, according to surveys by the industry consulting group IMS Health. Results to date of an updated survey by the group found that about 65 percent of doctors want to see direct-to-consumer advertising decrease or stop altogether. "There are circumstances where physicians sometimes feel that they need to give into a patient's demand" for a certain drug, said Edward Benz, physician-in-chief at Johns Hopkins University's hospital. While Benz said he thinks the advertising to date has been "fairly low key," he's worried about what might be in store in the future. Other doctors are already worried. "Diagnosis and treatment should be done in the physician's office and not in the living room," said Donald Palmisano, a New Orleans surgeon and member of the American Medical Association's board of trustees. The FDA, however, shows no signs of going back. In fact, the agency is even considering helping industry draft less formal print ads -- modifying the page of fine print containing prescribing information and notes about a drug's risk that many drug ad readers currently gloss over. Ideas range from a more generic warning that could be applied to different groups of drugs to a streamlined, more "consumer-friendly" page about risks and benefits, said Nancy Ostrove, branch chief in the FDA's marketing oversight division. A decision likely won't come before next year, she added. The agency is keeping close tabs on drugmakers. Over the last year, the agency has sent companies at least seven so-called notice of violation letters about improper advertising, mainly complaining that the companies didn't provide enough information about a drug's risks along with glowing reports of its benefits. For instance, in April, the FDA took issue with a Glaxo Wellcome ad for its stop-smoking pill Zyban. The ad features matches, a lighter and cigarettes falling, given up by a former smoker, apparently helped by Zyban. The images "interferes with the viewers' ability to listen to and process" information on "the most important risks associated with the use of Zyban," the FDA told the company. "We have been giving guidance" to companies, Ostrove said. Still, she said, "In general, we feel that there have been a lot of relatively well done ads that have appeared." While supporters and opponents of looser advertising regulation disagree about its benefits and drawbacks, they all agree on one thing: it works. "The advertising has greatly increased the public's understanding and knowledge that these products exist," said Greg Crawford, an analyst who covers managed care companies for Fox-Pitt, Kelton. "Patients now come in and say I want to be on Zocor, I want to be on Pravachol," two popular and widely advertised cholesterol-lowering drugs sold by Merck and Bristol-Myers Squibb. It's a phenomenon that shows no signs of ending. The drug industry spent $844 million on direct-to-consumer advertising in 1997 compared to $595 million in 1996, according to information jointly reported by IMS Health and Competitive Media Research. While "it's very hard to quantify" how much advertising is adding to drug companies' bottom lines, "every major pharmaceutical company is looking at it," said Alex Zisson, a drug industry analyst with Hambrecht & Quist.

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