Peddling Pills: The Rise of Direct-to-Consumer Prescription Drug Advertising and the Dangers to Consumers
Sasich, Larry, Multinational Monitor
"Rezulin, once a day, could change the way your doctor treats type 2 diabetes." So reads an ad by Rezulin's maker, Parke Davis, a division of Warner Lambert, in the December 1998 El Tiempo Latino. El Tiempo Latino is a publication distributed with newspapers in cities with large Spanish-speaking populations, is promoted as "The Magazine for All Hispanics" and has a circulation of more than 1.1 million.
The ad presents the good news about Rezulin (the brand name for the dangerous diabetes drug troglitazone) and promotional information in Spanish - but the official labeling with warnings and risks appears in English.
At the end of the ad, consumers are instructed in Spanish to "read the important information which appears on the back," referring to a brief summary of the full professional product labeling or package insert. However, the brief summary is in English. The brief summary, required by Food and Drug Administration (FDA) guidelines, contains some risk information that is important for consumers but it is written for health professionals, in dense technical jargon, and assumes a high level of medical knowledge on the part of the reader.
While many Spanish-speaking people in the United States are excellent English speakers as well, many are not. And the confusing technical language of the Rezulin warning - difficult even for those who speak English as a first language would be extremely hard to decipher for those not completely fluent.
The Rezulin ad is one of the most egregious abuses of direct-to-consumer (DTC) pharmaceutical advertising, but it is nonetheless emblematic of the problems inherent in DTC advertising.
Pharmaceutical DTC advertising has soared in recent years, resulting in sharply increased prescriptions and use of unnecessary, unnecessarily expensive and dangerous drugs.
THE RISE OF DTC ADVERTISING
The United States is the only country that permits DTC advertising. But there arc no U.S. regulations that directly address the issue of DTC advertising. The FDA has promised to write such regulations since the mid-1980s, but for now continues to apply the direct-to-physician regulations to consumer advertising.
The Food, Drug, and Cosmetic Act requires prescription drug advertisements intended for physicians and other health professionals to contain the product's established name and quantitative composition, and also "such other information in brief summary relating to side effects, contraindications, and effectiveness." It does not differentiate between advertising intended for trained medical professionals and the general public.
Until the mid-1980s, the pharmaceutical industry respected a voluntary moratorium, at FDA's prodding, on DTC advertising.
When that moratorium was lifted, DTC advertising quickly took off. Drug companies expenditures on DTC advertising rose from $25 million in 1988 to more than $225 million in 1994. The total skyrocketed to $610 million in 1996 and exceeded $1 billion in 1998. In 1992, 17 prescription drug products were advertised in consumer media, in 1995 the number increased to 50 and hit 79 by 1997.
Magazines remain the primary outlet for DTC ads, but DTC television advertising - led by the omnipresent Claritin (loratadine) "blue skies" ads - are becoming increasingly prevalent.
Until 1997, the FDA required television and radio DTC ads to contain complete information on the advertised drug's side effects and risks. These requirements deterred DTC over-the-air ads. In August 1997, the FDA announced guidelines - it has yet to promulgate DTC regulations - which require only that health risks be summarized in DTC ads, with more complete information made available through an advertised 800 number, Internet site or print advertisement.
EDUCATE OR MISLEAD?
Proponents of DTC prescription advertising say its purpose is to educate and inform the public about drugs, so that consumers can be aware of and active participants in choosing treatment options. …