Regulating the content of drug advertising is the task of the FDA's Office of Medical Policy Division of Drug Marketing, Advertising, and Communications (DDMAC). Drug makers fear their products earning a "black box" label designation which requires prominent warnings of risks on the label. The FDA required such black box warnings be added to some anti-depressants after the recent controversy over their effects in children and teens. Black box categorization means that advertisers cannot use "reminder ads," those which simply name the drug without describing their use — or their possible side effects. But while the number of direct-to-consumer ads may change due to the recent controversies, the airwaves are full of those from law firms directed at Vioxx users.

For the past decade or so there has been a debate in the medical academy and the popular press over what appears to be a growing reliance on prescriptions and pills to cure all ills. This desire is hardly new. Just take a brief look back at the history of medical advertising, and the regulations that now help govern our wish for an easy solution.

				The Age of Miracle Cures Until the early 20th century newspapers, store shelves and billboards were full of "patent medicines" all claiming healing powers. These "medicines" were unregulated formulas, sold to make money for their patent holders. They sold because the American population had little access to qualified medical staff and little money to purchase expensive doctor-prescribed medicines. The list of diseases that one patent medicine could "cure" is amazing. Ayer's Sarsaparilla could help with "tired feelings...which are the result of an impure, impoverished, or scrofulous condition of the blood." For dyspepsia, liver and kidney diseases, jaundice, and dropsy "the best remedy that can be used is Ayer's Sarsaparilla." Dr. Morse's Indian Root Pills went another route, saying simply it is "The Best Family Pill in Use." Testimonials from users claimed that it cured Mr. Z. Bliss of troublesome worms; Miss Whitmore from five years of suffering with the "gravel" (kidney stones); and Andrew Patterson of bolts, and eruptions of the skin.

				Muckraking on Medicines Many patent medicines contained high levels of alcohol (Hostetter's Bitters was 44.3% alcohol, while beer contains 5%). Other popular remedies put babies to sleep with a dose of morphine. Still other medicines relied on ingredients now known to be extremely dangerous — like mercury, borax, salicylic acid, and formaldehyde. At the end of the 19th century, muckraking journalists took on a variety of industries in the name of the health and safety of the American public. One such crusader, Samuel Hopkins Adams, wrote a series for COLLIER'S WEEKLY called "The Great American Fraud." This series, later a popular book, spurred Dr. Harvey Washington Wiley, a chemist at the Department of Agriculture, to press Congress for action. The result was the Pure Food and Drug Act of 1906, which assured that such products could no longer tout themselves as either medicines or cures.

				The Age of Legislation Legal reform of the patent medicine and drug industry continued. In 1927, a separate law enforcement agency, the Food and Drug Administration, was formed. Since 1962 the FDA has also regulated advertising for prescription drugs; advertising for over-the-counter drugs is overseen by the Federal Trade Commission. Advertising directed at consumers helps spur drug sales, as it is designed to do. In 1983 the FDA requested a voluntary hold on drug ads until it could study the effects of advertising on the market. In 1985 the FDA ruled that such ads must also list the possible side effects of any medication. Then came the era of "reminder ads," those vague images of happy users with mention of the brand name, but no mention of the condition it was to treat. The FDA was again disturbed, and studied the issue. This led to new guidelines in 1997, which required television advertising to mention side effects, but didn't require extensive detail. This ruling signaled disappointment for some consumer groups. The controversy over the best way to regulate direct-to-consumer advertising goes on.

				Drug Advertising in the 21st Century There is no doubt that the ads are effective. A recent study done by The Intermedia Advertising Group found that consumers had good recall of ads and products. Additional studies conducted by the FDA and the Kaiser Family Foundation showed that nearly 50 million people had responded to drug advertising by asking their doctors about a specific product.

Sources: The National Library of Medicine; THE NEW YORK TIMES; THE NATION; The Food and Drug Administration "Direct to You: TV ADs that Make Sense;" Vanderbilt University School of Medicine; The Wellcome Trust, Great Britain