Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Dr., Rm.. 1-23
Rockville, MD 20857
RE: Direct-To-Consumer Promotion (Docket No. 95N-0227)
Public Citizen’s Health Research Group, representing consumers nationwide, submits the following statement in response to the Food and Drug Administration’s (FDA) request for comments on direct-to-consumer (DTC) prescription drug promotion dated May 14, 1996.
The FDA has the legal responsibility for regulating the labeling and advertising of prescription drugs and the obligation to ensure that consumers are adequately safeguarded from false or misleading drug promotion. Under the Federal Food, Drug, and Cosmetic Act an advertisement for a prescription drug must contain, in addition to the product’s established name and quantitative composition, “such other information in brief summary relating to side effects, contraindications, and effectiveness . . .”.
Drug advertising provisions in the Federal Food, Drug and Cosmetic Act do not differentiate between advertising intended for trained medical professionals and the general public, containing no specific language that is directed at DTC promotion. As a consequence there may be differences between prescribers and prescription drug consumers in perceptions, comprehension and interpretation of promotional claims. Any misunderstanding and misinterpretation of claims made about powerful drugs is potentially dangerous.
If the purpose of DTC prescription drug advertising is to educate and inform the public about drugs, it would not be unreasonable to assume that complete and accurate information would best accomplish this goal. Then a key question is whether current DTC advertising of prescription drugs can be expected to result in consumers receiving more appropriate treatment of their health problems, or conversely, leads to choices of less appropriate, perhaps more dangerous, or needlessly more expensive therapy. If the latter situation is found to be true, the FDA must act immediately to halt DTC advertising of prescription drugs until regulations specific to this form of promotion are finalized that will ensure the public safety.
To address these issues our initial comments will focus on the following:
– The use of DTC advertising
– The purpose of DTC advertising
– Accuracy of prescription drug advertising to consumers and doctors
– The effect of prescription drug advertising on consumers and doctor
– Nabumetone (Relafen) as an example of DTC advertising
– Evidence that DTC promotion leads to better health outcomes
Our final comments will directly address the following questions asked by the FDA in their May 14, 1996 request for comments:
– Are there differences in the information needs of professionals and consumers?
– What information should be included in DTC prescription drug advertising?
– Should the FDA permit different disclosures for different media?
The Use of DTC Prescription Drug Promotion by Pharmaceutical Manufacturers
Evidence from surveys of total advertising expenditure and the number of products advertised shows that DTC prescription drug advertising is increasing.
In 1988, $25 million was spent on DTC advertising. By 1994, this figure had increased 10 fold to between $225 and $250 million. DTC expenditures increased by 65 percent in 1994 alone. In 1992, 17 prescription drug products were advertised in consumer media, in 1995 the number increased to 50. More than 60 percent of the ads appear in magazines, including the news magazines, women’s magazines, People and Reader’s Digest most notably. Another 15 percent are in newspaper Sunday magazines and about 15 percent on television.
The Purpose of DTC Prescription Drug Advertising
One of the primary purposes of consumer product advertising is to generate brand-name awareness in the minds of the public. The clear goal of advertising is to generate product demand and increase sales. One action that consumers can take as a result of effective advertising is purchasing the product which is the most desirable to marketers. However, prescription drugs are not like consumer products and consumers have had a relative lack of authority in the decision process. Drugs that are only available by prescription are selected by physicians, managed care organizations and hospital formulary committees and are purchased only through a pharmacist in a licensed pharmacy.
If prescription drug consumers have a relative lack of authority in choosing a drug product why then should drug companies invest in DTC drug advertising? One of the most compelling explanations is the increasing ability of consumers to influence physicians prescribing decisions. In a 1995 survey, 99 percent of 4,000 physicians said they would consider prescribing, or would prescribe a drug suggested by a consumer, compared to 84 percent in 1989. (Contact the Health Research Group to receive exhibit one)
DTC advertising as a marketing strategy may in part be due to an attempt to challenge the efforts of managed care corporations to hold costs by limiting the drugs doctors can choose. An advertising agency executive has been quoted as saying; “Pharmaceutical companies are realizing that the patient is a major force in determining which prescriptions get written.”
The singular purpose of DTC drug advertising is summed up in a quote from a recent issue of Medical Marketing & Media, a medical advertising industry trade publication:
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.
The Accuracy of Prescription Drug Advertising To Consumers
The chief legal councel for the Washington Legal Foundation, an organization frequently supporting the view of drug companies, has been quoted as saying: “…the FDA has chosen to erect needless barriers to advertising that hinder health care….” and implies that consumer advertising plays an important role in health care by making medical information readily available. An executive of a major pharmaceutical manufacturer has stated: “A properly educated, properly motivated patient-partner is the best bet the physician has for getting a good outcome for the patient overall….”
Proponents of DTC promotion imply it serves a vital public health role by improving health outcomes through education of the public about drugs. If the primary purpose of DTC is improving health outcomes through consumer education then there is the reasonable assumption that more complete and accurate information in DTC ads would lead to even better health outcomes.
Consumer Reports reviewed the accuracy of 28 DTC prescription drug ads that appeared recently in U.S. magazines. The accuracy of the ads was assessed by a panel of 32 medical specialists who evaluated ads in their own areas of medical specialty. The findings of the study are as follows:
– Two-thirds of the ads were judged to be factually accurate and backed by scientific evidence. But many left out important information or it was only in the fine print.
– Only half were judged to convey important information on adverse effects in the main promotional text.
– Approximately 40 percent were judged 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”.
Effect of DTC Advertising on Consumers
The goal of DTC advertising to build awareness and market share appears to be working. The chief executive officer of Scott-Levin Associates, a pharmaceutical market research and consulting firm has been quoted as saying: “Our 1995 survey of DTC ads show that they are having the impact sponsors [drug companies] hoped for. Patients are asking doctors about advertised drugs more often, and they are more likely to get the product they ask for.”
NPD Group, a market research company, surveyed 175,000 consumer households and found that 25 percent of consumers said they changed the way they took care of their medical problems after being exposed to DTC promotion. Twenty percent of consumers claimed they called or visited or were more likely to call or visit their doctors.
The Accuracy of Prescription Drug Advertising To Doctors
The pharmaceutical industry also has a dismal record of accurate advertising to physicians. A major study published in 1992 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 major findings of this study are as follows:
– 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.
Effect of Prescription Drug Advertising on Doctors
Research has shown that scientifically unsupported information used in drug advertising had greater influence on physician’s prescribing decisions than the scientific literature. Physicians were surveyed as to what sources of information they used to make drug therapy decisions, academic or commercial. Academic sources were defined as the scientific medical literature such as journal articles. Commercial sources were defined as visits from drug company representatives and journal advertising.
The source of prescribing information used by the physicians was determined indirectly by asking their beliefs about a drug where information about the drug given in commercial sources from drug companies was opposite to information found in academic sources. For example, a physician may respond that she or he bases prescribing on the scientific literature alone and never reads drug company advertisements or pays attention to representatives. However, answers in another part of the survey may reveal that the physician believes cerebral vasodilators are effective in the treatment of senile dementia. Such information is highly unlikely to have come from the scientific literature since it does not demonstrate efficacy of cerebral vasodilators in the treatment of senile dementia.
An important observation made by the authors of this study, in addition to their conclusion, was that initial advertising of a new drug is accompanied by extensive promotion of its virtues either real or manufactured. However, if with continued experience the benefits are found to be lower and the risks higher for a given drug, this information is reported in the academic literature or in the small print in the prescribing information sections of the advertisements, neither of which places for such information apparently strongly influence physicians’ knowledge about drugs.
Nabumetone (Relafen) the Remarkable Success of an Unremarkable Drug
Nabumetone (Relafen), a nonsteroidal anti-inflammatory drug (NSAID), was approved by the FDA for the treatment of rheumatoid arthritis and osteoarthritis in 1992. The manufacturer claimed that nabumetone is as effective as other NSAIDs (ibuprofen or Motrin and naproxen or Naprosyn are two examples) and causes a relatively low incidence of ulcers.
The following two statements come directly from the CLINICAL TRIALS section of the FDA approved labeling (package insert) for nabumetone:
Osteoarthritis: The use of Relafen in relieving the signs and symptoms of osteoarthritis was assessed in double-blind controlled trials in which 1,047 patients were treated for 6 weeks to 6 months. In these trials, Relafen in a dose of 1,000 mg/day administered at night was comparable to naproxen [Naprosyn] 500 mg/day and to aspirin 3,600 mg/day.
Rheumatoid Arthritis: The use of Relafen in relieving the signs and symptoms of rheumatoid arthritis was assessed in double-blind, randomized, controlled trials in which 770 patients were treated for 3 weeks to 6 months. Relafen, in a dose of 1,000 mg/day administered at night was comparable to naproxen 500 mg/day and to aspirin 3,600 mg/day.
The most serious adverse effects associated with the use of NSAIDs are hemorrhage or perforation of the gastrointestinal tract. By 1994 clear evidence was emerging of differences in the risk of gastrointestinal toxicity with different NSAIDs. Ibuprofen (Motrin and many generics) clearly was showing the least risk and naproxen, the drug mentioned in the nabumetone package insert, was showing an intermediate risk of severe gastrointestinal toxicity. The risk of gastrointestinal hemorrhage or perforation with nabumetone in relation to these other two NSAIDs remains unknown.
The difference in average wholesale costs for nabumetone and naproxen in 1995, in doses shown to be equally effective, was over seven fold. Using the 1995 Drug Topics Red Book, a standard price guide, the wholesale cost to the pharmacist for enough nabumetone to last 30 days at a dose of 1,000 milligrams per day, its minimum recommended dose, was $58.68. By comparison the cost to the pharmacist for enough generic naproxen to last a month at its minimum recommended dose of 500 milligrams per day was $8.08. The wholesale cost of a month’s supply of generic ibuprofen at a usual starting dose of 1,200 milligrams per day was $8.64.
SmithKline Beecham sales of nabumetone during the second quarter of 1994 were boosted by a DTC advertising campaign and were increased by 52 percent. Nabumetone moved from the 48th most frequently prescribed drug in the U.S. in 1994 to number 44 with more than 7 million prescriptions dispensed in 1995. SmithKline Beecham spent $11 million on DTC advertising for nabumetone in 1995.
It is difficult to imagine a set of circumstances in which 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.
Evidence that DTC Promotion Leads to Better Health Outcomes
We are aware of no valid scientific evidence that suggests DTC prescription drug advertising leads to better health outcomes for the public. On the contrary, based on the prevailing evidence presented above unregulated DTC advertising as currently allowed may induce needless economic hardship and perhaps physical harm to consumers.
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Our remaining remarks directly address the questions asked by the FDA in their May 14, 1996 request for comments.
ANSWERS TO SPECIFIC FDA QUESTIONS
Are There Differences in the Information Needs of Professionals and Consumers?
Consumers have become an integral part of their own prescription drug selection process, as they should be, and have the same need for objective accurate and complete drug information as health professionals. However, by virtue of their training skillful health professionals know how to find and interpret the complex medical literature to make rational comparative decisions between drugs and non-drug treatments. Comparative information is absolutely essential for consumers to make informed decisions about drugs, however barriers to finding and interpreting comparative drug information are almost insurmountable to the average consumer. In order that DTC advertisements are not misinterpreted and lead to drug treatment choices that are needlessly expensive or potentially harmful, it is paramount that consumers be presented with comparative information in all DTC advertising.
What Information Should Be Included in DTC Prescription Drug Advertising?
Given that consumers and health professionals have the same need for objective drug information, the existing Federal Food, Drug and Cosmetic Act must be redesigned to apply to DTC advertising and be enforced. In addition, DTC ads, depending on the therapeutic class of drug being advertised, should contain comparative information for all drugs with the same approved indication(s) and information about non-drug treatments.
Should the FDA Permit Different Disclosures for Different Media?
Any but the most stringent regulation of DTC prescription drug advertising risks misleading the public and it would be illogical and dangerous to permit different levels of disclosure for different media.
Evidence shows that physicians are influenced by advertising; that consumers are persuaded by DTC ads to sway physicians’ prescribing decisions; and that drug advertising both to health professionals and directly to consumers is frequently misleading. This is a formula for potential harm, both physical and economic, to consumers.
Advertising of prescription drugs whether directly to health professionals or to consumers serves no purpose other than to sell products. Promotion of prescription drugs directly to the public, as is done with consumer goods, requires that every DTC ad gives full and complete disclosure of a drug’s risks regardless of the advertising media in which the ad appears. In the absence of valid evidence showing that present DTC prescription drug ads promote the appropriate selection or the safe and effective use of prescription drugs or improves health outcomes, we are opposed to any but the most stringent regulations and their enforcement to ensure the public’s safety.
Because of obvious differences in training and background between consumers and health professionals, consumers are much more vulnerable to the influences of misleading drug advertising. Given the evidence presented in these comments, it is critical that DTC prescription drug advertising be stopped until consumer protective regulations can be proposed and finalized. The only reliable way to ensure that consumers will not be misled is to require that all DTC advertising be approved by the FDA prior to its distribution.
Drug manufacturers who are truly committed to educating consumers about drugs will not object to full and complete comparative disclosure of adverse effects, contraindications and effectiveness of their products with respect to those of their competitors or to prior approval of their advertising by the FDA.
Larry D. Sasich, Pharm.D., FASHP
Public Citizen’s Health Research Group
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group