This Date in UCSF History: U.S. Wants Drug Ad Reforms
Originally published in Synapse on April 10, 1978.
The content of advertisements for non-prescription, over-the-counter drugs is under close scrutiny by the federal government and may be required to undergo radical changes.
The Federal Trade Commission, which oversees truth in advertising, has proposed to limit nonprescription drug ads to the language officially approved for use in drug labelling by the Food and Drug Administration.
The FDA has over the past five years been developing stringent labelling requirements in accord with the results of a major series of investigations into the efficacy of the over-the-counter (OTC) health aids.
The FDA initiated its studies and labelling requirements in the late 1960’s after evidence of massive deception in promotion and poor quality in content of the drugs was presented.
Authority over drug selling materials is split between the FTC and the FDA. In its proposal, the FTC wants to accept the expert findings of the FDA as standards for the newspaper, television and billboard advertising that it regulates.
The FTC sees the wholesale adoption of the FDA standards as necessary in order to avoid the costly and time-consuming procedure of fighting each case of fraudulent ad claims in the courts.
While an average advertising campaign may run for six to 12 months, a successful lawsuit against false claims requires an average of four years, according to Dr. Robert Day, Associate Dean of Pharmacy at UCSF and a consultant for a consumer group fighting for more stringent controls.
The FDA provides a list of appropriate phrases that reflect documented efficiencies of particular drugs, from which pharmaceutical companies can choose in writing their label materials.
The FDA bans the use of any other language. The drug industry has been fighting the FTC proposal with all the resources at its command.
Hearings, re-hearings and rebuttals have occupied the FTC for three years since the proposal was originally made and Dr. Day expects the fight to continue for at least another two.
Last year the FTC conducted massive hearings on the proposal and heard lengthy testimony from 41 experts from the drug and advertising industries against the proposal and six representatives of various consumer groups in favor, according to Dr. Day.
The files of consumer groups and the federal agencies are full with examples of drug advertisements which exaggerate the number of medical problems for which their product is effective or which distort the evidence presented for the effectiveness.
Drug companies have in the past freely indulged in the creation of new pathologies such as the “blahs” or “environmental depression” for which their new cures are indicated.
After the increased interest on the part of the FDA in OTC medications during the past decade, drug claims have become more subtle, according to Dr. Day.
He said that current drug ads more likely are carefully written to give the impression of making a claim rather than actually making it.
Thus, what the consumer thinks he or she understands from the ad is something different than what the company can claim it was actually saying if questioned later by the FDA.
Dr. Day gave examples of potentially misleading claims:
The “major hospital reports” ads for Excedrin. “One, now two, now three hospital reports show that Excedrin is better than regular aspirin for the treatment of certain types of pain. Yes, there may be something more effective than aspirin for certain types of headache pain.”
The problem with this ad, said Dr. Day, was that the hospital studies were for post-partum pain, something completely unrelated to headaches. There is absolutely no evidence available that Excedrin is better than aspirin for headaches, he said.
“Dristan contains more for the flu miseries than the leading capsule.” Neither Dristan nor the leading capsule, Contac presumably, is indicated for combatting the flu virus itself.
As for the symptoms, Dristan may have more different ingredients than the other drug but these ingredients are only helpful if your “flu miseries” contain all of the possible different symptoms. It is not better than the “leading capsule” for any particular symptom. But then again it doesn’t actually claim that it is.
“Listerine, more than a mouthwash.” Several years ago, Listerine was openly advertised for curing or preventing the spread of the common cold, something which it has not the ability to do.
The FDA forced the company to halt those ads. The new ads show someone with an obvious common cold and claim that the ordinary mouthwash is somehow “more than a mouthwash.”
How can a mouthwash be more than a mouthwash except if it can do something for the obvious problem at hand, the common cold? Dr. Day asks.
But the ad does not explicitly recommend Listerine for colds.
The hearings last year before the FTC centered around the issue of whether different terms could really signify the same concept.
Drug and advertising industry experts attempted to make the argument that their phrasings are just as good for communicating the basic message as those devised by the FDA.
Furthermore, they said that the FDA’s language was too technical and dry to be understood by the public.
Consumer groups and the FDA testified that different terms generally do not connote identical messages and can be manipulated so as to make misleading claims.
They also pointed out the ease with which the advertising medium allows companies to create new terms and new words and make them widely recognized by the public in a short period of time.
The FDA terms, if not so easily recognized now, would become increasingly so after intensive advertising campaigns, according to the consumer groups.
The California Citizens Action Group (CAL/CAG), of which Dr. Day is a consultant, came out in favor of even stricter regulation of OTC drug ads than proposed by the FTC.
Dr. Day sees the visual aspect of broadcast and billboard promotion as equally important as the verbal, but the FTC proposal limits itself to the actual language of advertising.
At the hearings last year Dr. Day testified against any use of animation, in which for example an antacid is shown coating a pane of glass although the stomach in no way operates similarly, or of testimonials, in which neighbors or postmen or people looking like physicians advise the protagonist of the commercial to use the medication because it worked on them, without citing any controlled studies of efficacy.
Dr. Day mentions two common examples of visual deception, video unrelated to audio and inadequate explanation of time intervals.
A Geritol ad shows a happy couple energetically running through a field and then flashes to the message “Take Geritol.” No actual claim is made that Geritol gives energy or happiness but the claim is made implicitly.
Or the Solarcaine advertisement which invariably shows a beautiful and healthy woman floating on a boat or raft suntanning herself.
The next scene shows her very red (retouched photography), flinching when someone touches her shoulder.
She gratefully accepts a spray of Solarcaine. The next scene is a nighttime party with the woman dancing in the arms of a handsome man, her burn now a tan and her back appreciating his touch.
The ad message simply states, “For sunburn pain, take Solarcaine” without telling how long it takes to work. There is no way that a mild pain reliever such as Solarcaine could allow a badly burnt person to recover within one or two days.
In fact, Dr. Day said, there is some evidence that surface anesthetics such as Solarcaine are irritants to the skin.
The OTC industry
The drug and advertising industries are so vehement in their opposition to the FTC proposal because there is so much at stake.
While exact figures are hard to come by, all analysts agree that the OTC drug industry and its advertising budget are huge.
A 1973 survey of the national advertising picture conducted by Advertising Age magazine found that $1.1 billion of the $5.3 billion spent by the 100 top advertisers in the nation was spent by the drug and cosmetics industry, a major portion of that sum being devoted to OTC drugs.
Three of the largest 10 advertisers were drug corporations.
An FTC official has testified, on the basis of 1969 figures, that the advertising budget for OTC products represented 37 percent of domestic sales income.
Different estimates exist as to the actual size of the OTC drug industry, as measured in sales, mainly due to different definitions as to what constitutes an OTC drug.
While non-prescription antacids, laxatives and analgesics are accepted by everyone, there is less consensus as to medicated soaps, powders, deodorants, contraceptive jellies, etc.
Estimates of the total sales vary between $2 and $10 billion per year, with the most commonly accepted estimate being over $4 billion.
For domestic sales in 1970, 27 companies received 85 percent of this total and five firms controlled 45 percent among themselves, according to a survey in Manufacturing Chemists and Aerosal News.
There are an estimated 12,000 firms marketing OTC drugs. The FDA estimates that there are between 100,000 and 200,000 different OTC products.
All these products are composed of only 250 different active ingredients.
Officials of the American Pharmaceutical Association have estimated that less than a dozen new active ingredients for OTC products have been permitted by the FDA to reach the market during the past 15 years.
Beginning in the late 1960’s the FDA began to study OTC drug efficacy. The first study of 400 products found only one fourth of them to be “effective.”
In 1970 the FDA initiated a massive survey of OTC drug efficacy that treats individual products as members of classes, for the purpose of speeding up the evaluation process.
Thus, the FDA has one panel of experts working on analgesics, one on vitamins, etc.
So far, only the panel on antacids has finished its study, providing the basis for language of package inserts.
Dr. Day sees the FTC proposal, if passed, as only the beginning of a wider effort to improve consumer access to information.
The next big issue he sees is whether OTC advertising should be required to carry the warnings about possible side effects and contradictions which the FDA requires for its package inserts.