ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Sunday, January 19, 1997 TAG: 9701170057
SECTION: BUSINESS PAGE: 1 EDITION: METRO
DATELINE: NEW YORK
SOURCE: STEVE SAKSON ASSOCIATED PRESS
Ever try to learn about a prescription drug from a magazine ad? No problem, as long as you have a high-powered magnifying glass, a thick medical encyclopedia and plenty of patience.
In the name of consumer protection, federal regulations say every ad that promotes a prescription drug's benefits must also detail its risks, especially side effects and dangerous interactions with other drugs.
Drug companies and advertising agencies complain the rules are so tough, each ad must include a full page of fine print so jammed with medical jargon that it is useless to the average patient.
TV commercials can't accommodate the fine print, so they aren't allowed to say anything about the drug beyond its name, leaving some viewers baffled.
``You have this massive disclosure requirement that makes advertising of these products very much more expensive - and in some ways impossible - while not protecting the public in ways that make sense,'' said Dan Jaffe of the Association of National Advertisers.
Drug executives and advertisers want the Food and Drug Administration to loosen the regulations.
Consumer groups and doctors don't like the rules, either, but for a different reason. They contend the FDA allows companies to hype the benefits of drugs in the advertising's main body of text and leave most of the risks to the fine print - which nobody reads.
This, they say, can endanger lives, or at least prompt doctors to prescribe more expensive medicines when cheaper ones will do.
``Most companies are just trying to eke out an extra few percent of the market, and they're making various kinds of false and misleading claims,'' said Dr. Sidney Wolfe of the advocacy group Public Citizen.
Industry critics like Wolfe want the FDA to require that the main body of text contain more information about risks, along with alternative drugs and other nondrug treatments.
The FDA has been working on reforms for more than a year, but has yet to propose a plan acceptable to all concerned.
Meanwhile, the amount of prescription drug advertising to the public is growing rapidly. Last year alone, direct-to-consumer ads doubled to more than $500 million, outstripping traditional ads in medical journals for the first time, said Competitive Media Reports, an industry researcher.
Readers of Time, Newsweek and People magazines each saw more than 200 pages of ads promoting treatments for allergies, high cholesterol, migraines, ulcers - even toenail fungus.
As a result, some patients are demanding medicines they really shouldn't have, said American Medical Association vice chairman Dr. Thomas Reardon, a family doctor in Portland, Ore.
Doctors who refuse risk losing the patient. ``The patient says `You don't meet my needs. You don't do what I want you to do,''' he said.
On the contrary, industry executives argue, drug advertising educates patients and doctors about new treatments they may not be aware of.
For instance, ads for Merck & Co.'s Proscar actually led to an increase in the diagnosis of enlarged prostate glands, they say.
``Yes, we want to sell drugs, but this is a public service, too,'' said Jane Kramer, spokeswoman for Bristol-Myers Squibb Co.
Industry representatives contend that the FDA's required advertising disclosure statement - ironically called a brief summary - needlessly describes nearly every side effect, even ones that almost never occur.
``Is that useful to the patient? No, it's counterproductive because they may throw the drug in the trash and say `I don't want to use that stuff,''' said John Siegfried of the Pharmaceutical Research and Manufacturers of America.
While a few consumer-minded companies have rewritten the brief summary in plain English, others say it must be shortened or eliminated.
But are drug ads really fair and balanced? Evidence suggests otherwise.
A 1992 report in the Annals of Internal Medicine found that 62 percent of 109 ads published in medical journals were inaccurate or misleading, even for doctors, who should know better.
Included was a sleeping pill promoted as effective for the elderly, without explaining fully its severe side effects for that population. Another was an antibiotic advertised as the best choice for ear infections when another drug was just as good - and cheaper.
Consumer Reports magazine, in a study published last June of 28 ads in general interest publications, said only 40 percent fairly described the benefits and risks in the main text.
In addition, the drug industry has a questionable record involving its ads for nonprescription medicines, where regulations are more lax.
In the past two years, judges or regulators have ordered the makers of heartburn medicines Pepcid AC and Tagamet HB, the painkiller Orudis KT and Nicotrol nicotine patches to withdraw unfair ad claims. Last March, several television networks yanked ads for the painkillers Tylenol and Advil off the air, contending they were exaggerating each other's side effects.
Drug makers point out that nearly all prescription drug advertising is submitted to the FDA for approval before the public ever sees it.
``The companies know, you don't hype this stuff,'' said Jeffrey Trewhitt, a spokesman for the drug manufacturers group. ``You can run into serious problems if you cut corners. It's a grave situation with lawsuits, product liability and damaged credibility.''
Nancy Ostrove, an FDA public health analyst, said she thinks most prescription drug ads are fair and she noted that the agency has periodically ordered changes to make sure.
Still, Ostrove said no one really knows the effect of drug advertising on the practice of medicine. To find out, the agency hopes to persuade Clinton administration budget writers to authorize a national study of doctors and patients.
While the advertising stalemate continues, the government this month began a separate program designed to help patients understand their drugs.
The voluntary effort encourages pharmacists to distribute standardized information pamphlets to everyone who gets a new prescription.
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