Source: Oakland Tribune Contact: Mon, 02 Feb 1998 Author: Lynn Christiansen PUSHING PILLS DEPRESSION isolates. Prozac can help," pronounces a three-page magazine advertisement. A few pages later there's another one tucked between an article on makeup tips and a celebrity interview. You've grown up," it observes. "So should your acne medicine. Differin adapalene gel." Regular readers of almost any magazine, whether it be U.S. News & World Report, Readers Digest or Cosmopolitan, undoubtedly have noticed a recent surge of ads touting prescription drugs. Mainstream newspapers and television also are increasingly showcasing drugs that treat for everything from high cholesterol and nicotine addiction to cancer or AIDS. But despite the fact that these drugs must be prescribed by a doctor, ads these days are targeting consumers directly. But why? The reason, according to the phar-maceutical companies, is that ads aimed at consumers are instrumental in helping to push over-the-counter drug sales toward the $100 billion-per-year mark [Yes, that is a "b" in billion, not an OCR error]. But some health professionals and consumer advocates say it may be dan-gerous to convince patients through a combination of marketing-induced emotionalism and often-overlooked fine print to demand drugs from their doc-tors that may not be appropriate. "To my mind, these ads subvert the doctor-patient relationship and foster drug-seeking behavior," said Jon Zwelg, a doctor of internal medicine for Kaiser Permanente in Redwood City. "It makes the doctor the barrier between the patient and the drug brand the patient wants." Pharmaceutical advertising in the United States is really a fairly recent phenomenon. Drug manufacturers started in the mid- 1980s by placing "reminder" ads in magazines that would either mention the name of the drug without saying what the treatment was for, or list symptoms of health problems and hint there might be a treatment. Then Pharmacia & Upjohn in the late 1980s began producing 30-minute infomercials for its Rogaine hair-loss treatment, complete with full discussions on significant side ef-fects and lengthy small-print warnings that scrolled down the screen, Other drug companies soon followed suit. The early print and broadcast approaches adhered to federal Food and Drug Administration rules requiring drug advertisements to explain side effects thoroughly if the ads mentioned both the product name and the ailment. But under more relaxed FDA guidelines passed last year, companies need only mention significant side effects and refer consumers to toll-free numbers or Internet sites for details. The result has been an un-precedented barrage of brand-name drug advertising and mounting frustration for some health-care professionals who say they're witnessing a rise in unneeded or misguided prescriptions. "There's nothing educational about the advertising," said Larry D. Sasich, a pharmacist and a research analyst with Washington, D.C,-based Public Citizen, a consumer advocacy group founded by Ralph Nader. "Consumers don't have access to objective information,." Pharmaceutical companies, however, say their advertising really does do a public service by bringing health information directly to consumers and encouraging them to seek their doctors' advice. Ads for Prilosec, a top-selling ulcer drug manufactured by As-tra-Merck in Pennsylvania, include 60-second animated television spots quizzing con-sumers on their heartburn. The object, said company spokesman Jim Coyne, is to help people determine whether their heartburn really might be a symptom of something more serious. "We're not trying to make a diagnosis or evaluate people's problems over the air," Coyne said. "The Idea is to encourage people to think about their symptoms and to talk to their physician." For Michigan-based Pharmacia & Upjohn - which manufactures treatments for sensitive or embarrassing ailments such as impotence, incontinence and hair loss - the ads serve to remind consumers that a medical treatment is available, said spokesman Tom Vance. Another Impotence drug manufacturer, Vivus Inc. of Mountain View, launched a major television and print ad campaign this weekend during the AT&T Pebble Beach National Pro-Am tournament. Its promotions for the drug MUSE are an attempt to fill waiting rooms with men who might not otherwise have been aware they have a treatable physical problem. "Our main challenge with the ad campaign is to debunk the myth that impotence is a psychological condition," said Ju-han Gangolli, vice president of sales and marketing at Vivus. But while education is one goal of the ads, increasing sale is the ultimate goal. Drug makers spent $277 million on television advertising alone in the first nine months of 1997, 52 percent more than they spent during the same nod in 1996, according to Nielson Media Research. "One of the big issues all drug companies have is to locate enough patients," admltted Ed Jacobs, senior vice president of commercial operations for Sequls Pharmaceuticals, Menlo Park. "They feel these campaigns can focus on consumers who will take the names of those drugs to their doctors and trigger some sort of response." Additionally, pharmaceutical companies say direct-to-consumer advertising has the potential to impact health maintenance organizations' for-mularies, which are the limited lists of drugs each managed-care group has approved for prescription based on price. and effectiveness. Oakland-based Kaiser Permanente accounts for about 2 percent of all pharmaceutical purchases in the United States, said David Campen, chairman of Kaiser's formulary committee. But the HMO's formulary includes only about 750 or 800 approved drugs, effectively shutting out thousands of similar drugs manufactured by other pharmaceutical companies. It's in those companies' best interest, then, to try to convince massive HMOs such as Kaiser to replace the drugs in their formularies with their own versions - a maneuver that could mean millions more dollars in sales. And it certainly helps to have legions of consumers asking for a specific drug by name. "In some situations, the industry spends an amount in advertising similar to what they've spent in research," Campen said. "Stop and think about that; it's a huge amount. But there's no doubt it works." Most Bay Area doctors can cite anecdote after anecdote of patients trouping into their offices and demanding a drug they've seen while watching "Chicago Hope" or "20/20." "It happens all the time," said Campen, who nevertheless said Kaiser doesn't change its formulary based on patient demand or advertising. Nationwide, nine out of 10 physicians surveyed In 1997 by industry researcher IMS America said they've gotten more brand-name drug requests from patients over the last year, even In cases where no drug treatment is needed. But though doctors admit they have the final say in whether a patient receives a prescription, many managed-care physicians say that the patient pressure puts them in an awk-ward position. On one hand, they're guided by their organizations' formularies. But on the other hand, they're also overseen by powerful HMOs reluctant to anger their members - and which often give them leeway to prescribe drugs not on the formularies, even if insurance doesn't cover the treatments. So unless a drug will have significantly adverse effects or doctors can successfully defend their own preferences, pushy patients usually will walk away with what they came in for. A physician's prescribing behavior, too, can be influenced by the advertising, Sasich of Public Citizen said. But going along with advertising-driven demand can be dangerous, uneconomical or both, he said. Advertised products likely aren't always the most cost-effective or best treatments available. Sasich described a favorite example: G.D. Searle manufactures and aggressively advertises a high blood pressure drug named Covera-HS, which retails for about $60 for a month's supply. But many doctors prefer similar drugs by other manufacturers, some of which not only sell for about $3.95 for a month's supply, but which have been proven to also reduce the risk of heart attack and stroke - a claim Covera can't share. It's not hard to guess which drug advertising-driven consumers request by name. "In the face of science and in the face of national health recommendations, doctors are being asked to prescribe this other drug," Sasich said. "That's what happens when consumers don't have enough information to make an informed decision." The Information actually available - drug package inserts meant for physicians' use or the fine-print, page-long masterpieces featured in print ads - are written in a regulatory language that is nearly incomprehensible to those without an extensive education in health care. Sasich and others are working to change FDA guide-lines so that drug manufacturers must provide consumers with plain-English translations of the package inserts when they're given their prescriptions. Pharmaceutical companies long have argued that doing so would be tooexpensive. or would scare patients into not taking their medicine. But one class of pharmaceu-ticals already does provide consumer-friendly package-insert translations: women's health drugs such as estrogen replacement therapy and hormone replacement therapy. The National Women's Health Network was instrumental 25 years ago in convincing the FDA that scientifically balanced information was needed, said Lisa Cox, the organization's program and policy director. "Consumers shouldn't be put into the position that they should have to beg for balanced drug information. We feel it should be very available," Cox said. "We're very supportive that the rest of the industry should have to comply to the same standards we've achieved." But Sasich says he doubts that will happen anytime soon. Pharmaceutical companies have spent millions lobbying Congress to make and keep advertising rules as loose as they are now. The FDA Modernization Act of 1997, in which the more relaxed drug-advertising guide-lines were included, was an industry-sponsored bill phar-maceutical lobbyists pushed through with the help of more than $30 million in contributions to the Senate and House of Representatives, according to Public Citizen. The result: Consumers increasingly need to get involved in their own care, advocates say. The best thing patients can do for themselves is to encourage an open consultation with their doctor on treatment options, Zweig at Kaiser said. Consumers also should read and attempt to understand the package inserts included with their prescriptions, then invest In a Physicians' Desk Reference and continue to educate themselves on their own treatinents. "Consumers need to get information anywhere they can if they're going to take charge of their own care," said Jamie Court, director of the Santa Monica-based consumer group Consumers for Quality Care. "They shouldn't demand a pre-scription without the facts, but unfortunately that happens far too frequently." Sidebar: Big Budgets (in millions $) in year: 1997 Pharmacia & Upjohn 125 Schering-Plough Corp. 145 Glaxo 90 year: 1996 SmithKline 70 Warner-Lambert Co. 140 Johnson & Jonhson 214