Direct to Consumer Advertising HISTORY OF DRUG ADVERTISING

THE DTC ADVERTISING PHENOMENON

CREATING DEMAND

DECEPTIVE ADVERTISING - A WOLF IN SHEEP'S CLOTHING

CAUSE OF DEATH

PROFIT

UTILIZATION, PRICING, AND DEMOGRAPHICS

LEGISLATION, POLITICS AND PATENTS

LEGISLATIVE INITIATIVES REGARDING DTC

RECALLED and/or DEADLY DRUGS

In order to provide the most efficient method of evaluation, the study will utilize existing stores of qualitative and quantitative data from reliable sources, such as U.S. Government statistical references, University studies, and the studies and publications of non-profit and consumer oriented organizations. Every attempt will be made to avoid sources of information sponsored by or directly influenced by the pharmaceutical industry.

Existing data regarding the history, levels, content and growth of direct-to-consumer advertising will be examined. In addition, the industry's composition prior to and after the proliferation of direct-to-consumer advertising will be examined, with regard to market share, type of substances sold, benefits of substances sold, and consumer benefit (or lack thereof). Perceptions regarding direct-to-consumer advertising will be revealed, from the points-of-view of the consumer, the government, the industry, and outside observers. Arising from the data gathered, a conclusion will be drawn which reflects the pros and cons of direct-to-consumer advertising and the resultant issues.

HISTORY OF DRUG ADVERTISING

To understand the current trends in pharmaceutical advertising and their implications, it is important to have an appreciation for the evolution of its history. The earliest formal structure governing the production and distribution of drugs was the 1906 Pure Food and Drug Act, prior to the existence of the FDA (Food and Drug Administration, est. 1938). The 1906 Act was administered simultaneously by the Secretaries of the Treasury, Agriculture and Commerce and essentially defined adulterated and misbranded drugs as unlawful. Adulterated drugs referred to drugs that deviated from declared standards without clearly identifying deviations on package labels. Misbranded drugs were drugs that imitated another named product, or removed or substituted contents. In addition, it was mandatory to state the quantity (or proportion) of narcotics contained within a drug and it was prohibited to falsely claim a therapeutic or curative effect of a drug.

In 1938 the FDA was established. The basis for its establishment was the mandatory disclosure of information about product uses and risks by manufacturers, packers and distributors. Specifically, the section of the United States Code (U.S.C.) establishing the FDA stated: "Advertisements must contain information in brief summary relating to side effects, contra-indications, and effectiveness" (21 U.S.C. 352 (n)). Further, the FDA regulations specify that drugs are deemed to be misbranded if their labeling or advertising is false or misleading in any particular way, or fails to reveal material facts (21 U.S.C. 352(a) and 321 (n) and 202.1 (e)).

The FDA formally became the primary governing body for regulating food and drug products in the U.S., but not until 1962. Prior to that, the jurisdiction for regulating advertisements and other prescription drugs fell under the Federal Trade Commission, who was responsible for regulating all domestic commodities in interstate commerce. The norm until the eighties was for pharmaceutical companies to market their products directly to medical professionals (sometimes by offering such incentives as paid vacations and merchandise). After all, the formally educated medical practitioner has the expertise with which to recommend an elixir that is appropriate to the affliction. And, up until now, the doctor was the only source of information between a patient and prescription medicine. Doctors were the incidental sales men and women of pharmaceuticals.

During the late eighties and early nineties, the advent of alternative medicine hit the marketplace. Consumers were willing to spend out of pocket for goods and services not covered by insurances in the interest of obtaining higher quality and/or alternative treatments. The determination of quality is subjective; it could relate to how effective a product or treatment was or it could be based on the fact that the product be derived from organic materials. It was sometimes preventative rather than reactive in nature, an area often not covered by insurers. Nonetheless, the pharmaceuticals took notice of this wayward element of market share (estimated at 30% to 40% of consumers). (Loomis, Howard F. Subluxation-Based Nutrition. How to compete for recognition and revenue in today's health care marketplace - Part I. The Chiropractic Journal. July 2002. (http://www.loomisenzymes.com/articles/wca/wca0207.html) study was commissioned by the New England Journal of Medicine to examine this shift in consumerism. The results were reprinted in Oriental Medicine, Vol. 3, No. 2, in the fall of 1994. The study isolated areas of medicine in which consumers were turning their backs on traditional medical treatment....

Recognizing a shift in consumer patterns towards alternative medicine, the pharmaceutical industry reacted by adopting a consumer oriented promotional strategy.
The FDA's requirement that all advertising list all side effects posed a challenge to this new strategy, however. In addition to dampening the product's appeal, the sheer length of the lists of side effects in some cases was prohibitive to placing effective ads. What to do? Well, this is America. When we don't like the rules, we can change them. After three years of lobbying and unverifiable sums of millions of dollars in contributions, Congress enacted new legislation in 1997. The legislation relaxed the previous guidelines so that the FDA now granted pharmaceutical companies permission to advertise prescription drugs using the names of products and specifying the condition that it is designed to treat, dubbed "direct-to-consumer advertising."

The FDA set forth parameters for acceptable advertising standards under this new auspice. For instance, the ads must indicate where consumers can get more information and must refer physicians and pharmacists as information sources. Major side effects and risks (no longer "all") must be stated explicitly, although this is often accomplished in small print or spoken rapidly. Specifically, the new regulations, formally referred to as Guidance for Industry: Consumer-Directed Broadcast Advertisements, "requires manufacturers to: "provide an effective mechanism by which the majority of a potentially diverse audience can receive the advertised product's approved labeling." (http://www.acponline.org/hpp/pospaper/dtcads.htm)

The Guidance further states that ads utilizing broadcast media must contain the following elements: (1) a toll-free number, (2) a reference to DTC print advertisements, (3) an Internet web page address and (4) a statement that directs consumers to physicians and/or pharmacists for additional information about the product. It is noteworthy that all of the requirements are predicated on the underlying assumption that the advertisements are truthful and are depicting an adequate notion of risks and effectiveness. Misleading implications, such as using a proprietary name to imply unique effectiveness, or comparing the effectiveness of the drug to other products using outdated or incomplete data, are in direct violation of FDA standards. The ads are supposed to be, according to FDA guidelines, understandable to the audience, i.e., the general public. These broad guidelines apply to all audiences and all medications, and are not delineated by target population or specialty.

The interpretation of what constitutes "fair balance of risk and benefit information" may vary by audience or specialty; hence a wide window of speculation exists in defining what constitutes adherence to the FDA's guidelines. The FDA does not presently have any authority to pre-screen advertising, so that any identification of non-compliance to these broad standards would occur post-haste. In essence, the FDA is relying on pharmaceutical companies to voluntarily comply with the standards set forth.

The first true Direct-To-Consumer advertising campaign occurred in 1981 when an ibuprofen producer ran an ad in a consumer-oriented magazine touting the virtues of the pain reliever, which at the time was available only by prescription. (Pines, WL. Direct-to-consumer promotion:

An industry perspective. Clinical Therapeutics. 1998;20:96-99.) More ads surfaced mimicking the ibuprofen model, until the FDA in 1983 requested that manufacturers voluntarily halt the practice until they could sufficiently regulate it. The moratorium remained in place until 1985, when, unable to directly prove that the advertising was endangering consumers, the practice continued. However, as a safeguard against misleading claims, companies were either allowed to advertise a new therapy for a particular disease without stating the drug involved, or if the drug was named, the condition had to be omitted. The rules requiring full disclosure of side effects were still in effect, and print ads usually satisfied this requirement by reprinting the package insert or labeling within the advertisement itself. It was the 1997 Act by Congress, however, that opened advertising up to broadcast media.

Broadcast media includes not only television and radio, but also the Internet, which is presently not regulated and falls outside the jurisdiction of U.S. law. This alone poses concerns about the ethical fabric of advertising through that medium. In addition, the design of television and radio do not allow for the inclusion of the entire contents of packaging labels to be contained as part of a spoken or visual ad lasting a fraction of a minute. The relaxing of rules to requiring only the disclosure of "major" side effects is equally disconcerting, because by definition this means that some potential side effects, although applicable to a minority of the population, will not be revealed.

THE DTC ADVERTISING PHENOMENON

The National Institute for Health Care Management, a nonprofit watchdog agency, estimated that expenditures in pharmaceutical…