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Peddling pills: the rise of direct-to-consumer prescription drug advertising and the dangers to consumers.

"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.

"Our ads elevate patients' awareness of many diseases, educate them about symptoms and encourage them to seek treatment," said Sidney Taurel, chair of the board of the Pharmaceutical Research and Manufacturers Association (PhRMA) in a 1998 address. "They provide information that many consumers need during a time when they want to assert more influence over their health care."

However, DTC ads cannot fulfill their purported educational function if they are misleading or incomplete, or if cautionary information is presented in such a way that consumers do not read it.

A 1996 Consumer Reports study suggested that DTC prescription drug ads are frequently tilted to emphasize the advertised product's advantages and to deemphasize its hazards. While this may be standard practice for advertising goods from paper towels to razors, it can present life-threatening hazards in the case of prescription drugs.

In the study, Consumer Reports reviewed the accuracy of 28 DTC prescription drug ads that appeared in U.S. magazines.

A panel of 32 medical specialists evaluated ads in their own areas of medical specialty. They concluded:

* Two-thirds of the ads were factually accurate and backed by scientific evidence. But many left out important information or such information was only in the fine print.

* Only half conveyed important information on adverse effects in the main promotional text.

* Approximately 40 percent were honest about efficacy and fairly described the benefits and risks in the main promotional text.

According to one reviewer participating in this study, 39 percent of the ads were "more harmful than helpful."

It should come as little surprise that DTC advertising may be misleading, because industry advertising of prescription drugs to doctors has also long been accuracy-impaired.

A major 1992 study published in the Annals of Internal Medicine assessed both the accuracy of scientific data presented in 109 full-page prescription drug advertisements appearing in 10 leading U.S. medical journals and the compliance of these advertisements with FDA standards. The study concluded:

* 38 percent of the ads potentially violated five or more FDA regulations.

* 40 percent did not present a fair balance between effectiveness and adverse effects.

* 47 percent of the 49 ads where such information was relevant did not highlight potential problems with the drug in special patient populations such as the elderly.

In 44 percent of ads, reviewers felt that the advertisement would lead to improper prescribing if a physician had no other information about the drug other than that contained in the advertisement.

Moreover, there is considerable published evidence that ads do influence doctors' prescription decisions, leading them to sometimes prescribe inappropriate or dangerous drugs when there are more effective, safer alternatives available.

DTC'S "SUCCESS"

After pharmaceutical company representatives finish explaining how DTC prescription drug ads will empower consumers, they are willing to acknowledge that the ads also serve the companies' commercial interests.

"Of course, these ads represent a core communications tool for our companies during a very competitive era," said Taurel in his 1998 address.

Since by definition consumers cannot purchase prescription drugs without a doctor's authorization, the key to DTC ads' effectiveness is not just to transmit information to consumers, but to encourage consumers to ask their doctors to prescribe specific advertised drugs.

On this score, DTC ads seem to work well. Industry market research studies have found that a quarter of consumers exposed to DTC ads said they changed the way they took care of their medical problems after being exposed to DTC promotion. One in five claimed the ads led them to have called or visited their doctors or made them more likely to call or visit.

As a marketing strategy, DTC advertising may in part an attempt to challenge the efforts of managed care corporations to hold down costs by limiting the drugs doctors can choose.

The singular purpose of DTC drug advertising was summed up in Medical Marketing & Media, a medical advertising industry trade publication, in 1995: "In the old marketing model, pharmaceutical companies created patient demand by influencing doctors to write prescriptions. In DTC promotion, companies listen to the patient, respond to their needs and hope to increase sales by driving consumers to a doctor's office and requesting their product."

There is little question that DTC advertising works at building sales and market share. Consider the case of nabumetone (brand name: Relafen), a nonsteroidal anti-inflammatory drug (NSAID), approved by the FDA for the treatment of rheumatoid arthritis and osteoarthritis in 1992.

Smithkline Beecham, the manufacturer of nabumetone, claims that the drug is as effective as ibuprofen (Motrin and generics) and naproxen (brand name: Naprosy). The most serious adverse effects associated with the use of NSAIDs are hemorrhage or perforation of the gastrointestinal tract. By 1994, it was clear that ibuprofen shows the least risk and naproxen shows an intermediate risk. The risk of gastrointestinal hemorrhage or perforation with nabumetone in relation to these other two NSAIDs remains unknown.

In 1995, the cost to a pharmacist of a month's supply of nabumetone was $58.68 - about seven times the cost of a comparable supply of generic naproxen or generic ibuprofen.

It is difficult to imagine why a prescription drug consumer given accurate complete comparative information would accept the unknown risk of toxicity and the higher cost of nabumetone as a treatment over ibuprofen or naproxen.

But thanks to a DTC advertising campaign - costing $11 million in 1995, with heavy placements of ads in Arthritis Today magazine, a publication of the Arthritis Foundation - 7 million prescriptions of nabumetone were dispensed in 1995.

That advertising campaign alleged that nabumetone had a "low potential" for creating ulcers. In 1997, and again in 1998, the FDA found that SmithKline Beecham had conducted a false and misleading promotional campaign aimed at doctors claiming that nabumetone was safer than other NSAIDs. In the summer of 1998, the FDA required Smithkline Beecham to correct the information given to health care professionals about naumetone.

More evidence of the potential effect of DTC prescription drug advertising on sales - and on health - comes from the notorious case of the diet drug fenfluramine (Pondimin), one-half of the once popular "fen/phen" combination.

Fenfluramine was withdrawn from the market in 1997 because it caused heart valve damage in potentially tens of thousands of consumers. Although the manufacturers of fenfluramine or phentermine (Fastin and generics) did not promote their products directly to consumers, the DTC advertising was done for them by an unscrupulous diet clinic industry.

The DTC promotion of fen/phen and resulting disaster and the success of nabumetone in the marketplace despite its high cost and unknown toxicity, demonstrates that doctors cannot be relied on to protect consumers from inappropriate drugs and potential drug-induced injury.

HAWKING DRUGS OVER THE AIR

As serious as are the problems with print DTC ads, the problems with broadcast advertising are inherently worse, because - even if a pharmaceutical company were so inclined - there is not adequate time to present remotely sufficient information on health risks or comparative drug treatment options.

In practice, the situation is often worse than in theory. On August 19, 1997, just 11 days after the agency announced voluntary guidelines for broadcast DTC ads, the FDA cited the Schering Corporation for two misleading TV commercials for the widely prescribed antihistamine loratadine (Claritin).

The FDA letter to Schering stated that "both advertisements are misleading because the risk information disclosed as part of the required 'major statement' is not presented in a manner comparable to that used to present the information relating to efficacy." The agency asked Schering to "immediately discontinue the use of the advertisement[s]."

In the first part of both 30-second ads, Schering hyped the benefits of loratadine clearly and slowly in easy-to-understand language.

But when it came time to tell consumers about the adverse effects of loratadine, the company skillfully hid them from public view. While the adverse effects of loratadine were being read by the announcer, there was a competing message on the screen and the description of the drug's adverse reactions were read so quickly that it was difficult for the typical consumer to understand.

In one ad, consumers were told that additional information on loratadine's adverse effects could be found in a Newsweek magazine ad for the drug, but the message was obscured at least half the time by using white letters on a white background.

As the quantity of prescription drug broadcast advertisements continue to increase, it will become increasingly difficult for the overstretched and underfunded FDA to police abuses - even as industry standards inevitably degrade over time.

As the pharmaceutical industry moves from broadcast advertising of antihistimines and hair-growth drugs to birth control pills and more dangerous pharmaceuticals, the risks to consumers will grow more severe.

DENYING INFORMATION TO CONSUMERS

Overarching the potentially serious public health issues surrounding DTC prescription drug advertising is the fact that consumers do not have access to objective information that places the risks and benefits of prescription drugs in a context that can be used to make informed decisions about drug treatments.

Since 1979, when the agency proposed the idea, drug companies have prevented the FDA from mandating the distribution of useful drug information, in the form of "patient package inserts," written specifically for consumers. Now, the only written drug information readily available to prescription drug consumers are unregulated patient information leaflets (PILs) distributed by pharmacists that are produced by commercial information vendors. In some cases, these PILs have been found to be dangerously misleading by omitting vital risk information or containing risk information that is out of date.

The best consumers can get in connection with DTC advertising is the drug's approved labeling - and, in the case of broadcast ads, consumers have to search for print ads or an Internet site to find even this. FDA approved labeling contains important information, but it is written for professionals in technical language.

Additionally, the small print of the labeling information precludes many older consumers from even being able to read the approved labeling.

Absent altogether from approved labeling is objective, comparative information about other drugs or non-drug treatment options for their illnesses. While comparative information is absolutely essential for consumers to make informed decisions about drugs, the barriers to finding and interpreting comparative drug information are almost insurmountable for the average consumer.

Without the protection of objective drug information, consumers are naked in the pharmaceutical marketplace, subject to the misleading influence of billions of dollars worth of slick advertising, promoting new drugs that may be less safe and effective and more expensive than older drugs or non-drug treatments.

Larry D. Sasich, Pharm. D., M. RH., FASHP works with Public Citizen's Health Research Group.
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Title Annotation:Commercialism Run Amok
Author:Sasich, Larry
Publication:Multinational Monitor
Article Type:Cover Story
Date:Jan 1, 1999
Words:2366
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