Drug Promotion Research Articles

Cancer prevention or drug promotion? Journalists mishandle the tamoxifen story.

The results of a study on the use of tamoxifen as a preventive treatment for women at high risk for breast cancer have been uncritically hailed and widely mishandled by the U.S. media. Journalists need to take a closer look at the creative manipulation of data, the "scientific method," and the potential drug-company profits associated with this study and the resulting recommendations on tamoxifen use.

The Marketing of Direct-to-Consumer Prescription Drugs

The promotion of prescription drugs directly to consumers is a rapidly-growing phenomenon. The regulatory aspects of prescription drug advertising beg the question: To what degree do the ads inform versus persuade consumers? This study examines the advertising appeals of prescription drug advertisements aimed at consumers. A content analysis of prescription drug advertisements in eight popular magazines between 1992 and 1995 was undertaken to develop a typology of appeals used by drug manufacturers to promote their brands. The use of promotional techniques, such as coupons, toll-free numbers and web sites and the incidence of self-diagnostic “tests” in DTC prescription drug ads are also examined.

Trends in antihypertensive drug advertising, 1985-1996.

Over the past decade, calcium channel blockers (CCBs) and ACE inhibitors have been used increasingly in the treatment of hypertension. In contrast, beta-blocker and diuretic use has decreased. It has been suggested that pharmaceutical marketing has influenced these prescribing patterns. No objective analysis of advertising for antihypertensive therapies exists, however. We reviewed the January, April, July, and October issues of the New England Journal of Medicine from 1985 to 1996 (210 issues). The intensity of drug promotion was measured as the proportion of advertising pages used to promote a given medication. Statistical analyses used the chi2 test for trend. Advertising for CCBs increased from 4.6% of advertising pages in 1985 to 26.9% in 1996, while advertising for beta-blockers (12.4% in 1985 to 0% in 1996) and diuretics (4.2% to 0%) decreased (all P<0.0001). A nonsignificant increase was observed in advertising for ACE inhibitors (3.5% to 4.3%, P=0.17). Although the total number of drug advertising pages per issue decreased from 60 pages in 1985 to 42 pages in 1996 (P<0.001), the number of pages devoted to calcium channel blocker advertisements nearly quadrupled. Increasing promotion of CCBs has mirrored trends in physician prescribing. An association between advertising and prescribing patterns could explain why CCBs have supplanted better-substantiated therapies for hypertension.

FDA's role in anesthetic drug development.

FDA's role in anesthetic drug development.

Information contents of drug advertisements: an Indian experience.

To critically analyze the drug information contained in Indian pharmaceutical advertisements. Analysis of pharmaceutical advertisements supplied by drug representatives (DRs) to prescribers from July 1, 1995, to June 30, 1996. A university-affiliated urban teaching hospital in India. 585 pharmaceutical ad pamphlets. The ads supplied by DRs to physicians in different clinical departments of the hospital were collected. These were distributed to different systems/categories and a special reference to fixed-dose drug combinations was given. The drug information contained in these ads was evaluated by using a checklist, framed by incorporating the World Health Organization ethical guidelines for medicinal drug promotion and some relevant items from other studies. The most frequently occurring ads were for antimicrobial agents. The ads on fixed-dose drug combinations constituted 37.9% of the total. More than 85% of the ads mentioned the generic name, brand name, contents, and pharmaceutical dosage forms, as well as the name and address of the company. The information concerning adverse effects, precautions, contraindications, warnings, major interactions, ingredients known to cause problems, pharmacology, drug overdose, references, drug storage, and cost was present in less than 40% of these ads. There has been inadequate information in pharmaceutical ads supplied by DRs to the physicians in India. The current scenario could be improved by formulating some definite legislative guidelines for the minimum level of information to be included in pharmaceutical ads and adhering to that legislation.

Resistance to antimicrobial agents: a personal view.

Problems of antimicrobial drug resistance are presently serious, but not yet desperate. The principal areas of concern are two-fold: multiresistant opportunist bacteria that affect vulnerable patients in high dependency areas of hospitals (the most pressing problem for developed countries); and multidrug resistance among classic pathogens like Mycobacterium tuberculosis, Salmonella typhi, Shigella spp., Neisseria gonorrhoeae and Plasmodium falciparum (mainly, although not exclusively, a problem for developing countries). The first type can be contained to a large extent by good infection control practices and careful prescribing based on agreed policies of antimicrobial drug use. The input of infection control nurses and laboratory-based clinical microbiologists is crucial and these services deserve full support. The second type additionally requires coordinated action to regulate more effectively the manufacture, availability, promotion and use of antimicrobial drugs. In this case the input of governments, international agencies and pharmaceutical companies is essential. Prescription-only status for antimicrobial drugs used in man and animals should be the norm. The number of drugs available for the treatment of viral, fungal and parasitic infections is comparatively small and much less is known about resistance. More research in these areas would be welcome. Teaching good prescribing habits to medical students is presently haphazard and needs to be formalised. Surveillance needs to be improved. The second half of the 20th century has been a golden age of antibiotics, but the outlook is uncertain. If antimicrobial chemotherapy is to have a secure future, prescribers must learn to use these powerful tools with greater discretion and their use worldwide must be regulated effectively.

The Food and Drug Administration's regulation of drug labeling, advertising, and promotion: looking back and looking ahead.

Clinical Pharmacology & Therapeutics (1998) 63, 607–616; doi:

Marketing Health Care Products on the Internet: A Proposal for Updated Federal Regulations

The Internet offers pharmaceutical companies and medical device manufacturers a dynamic new medium for promoting their products—a medium that might actually be better suited for health care product promotion than print or television. On the Internet's World Wide Web (Web) pages, drug and device makers can produce interactive marketing and advertising material that more easily complies with current Food and Drug Administration (FDA) and Federal Trade Commission (FTC) disclosure requirements. Navigation buttons and hypertext links can facilitate compliance with such information disclosure requirements by allowing drug and device makers to “hide” the brief summaries or labels until interested viewers “click” on them.Despite the appropriateness of the medium, however, a Web search today will turn up less drug and medical device promotion than one might expect. In fact, the Web, which represented $7 billion in commerce in 1997 and is expected to account for $20 billion in 1998, is strangely quiet on this front.

Regulation of prescription drug promotion: direct-to-consumer advertising

The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency's views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.

Análise da adequação das propagandas de medicamentos dirigidas à categoria médica distribuídas no Sul do Brasil

Drug advertisements for prescription drugs gathered from private clinics and hospitals in southern Brazil were analyzed. None of the 127 advertisement inserts that were analyzed complied with all the criteria specified by Brazilian legislation. The official Brazilian generic drug name was present in 95% of the advertisements, but always in finer and/or fainter print. With regard to the WHO ethical criteria for medicinal drug promotion the study showed that only 59% of the advertisement inserts declared the product composition and only 43% provided information on precautions, and in most of these cases (73%(, the precautions were in fine print and difficult to read. Most of the advertisements declared the product dosage in more properly-sized print. The main advertising claims were efficacy, safety, faster action, and high tolerability. In conclusion, the analysis demonstrated that most advertisements fail to comply with either the Brazilian legislation on medicinal products and/or the WHO ethical criteria for medicinal drug promotion. To improve this situation it thus seems necessary to develop more effective instruments to monitor quality of information provided to prescribers by the drug advertisers.

The Marketing of Estrogens for Menopausal and Postmenopausal Women

Menopausal and postmenopausal women are a targeted consumer group in the promotion of hormone drugs. The marketing of these plutrmaceutical products aims directly at prescribing medical professionals and indirectly at women. The promotion seems intended to creating a collective consciousness that women over 40 need medical and pharmacological treatment.

Deception by Design: Pharmaceutical Promotion in the Third World

Joel Lexchin Consumers International Regional Office for Asia and the Pacific, $15 + postage, pp 91 ISBN 967 9973 68 9 Developing countries are being flooded with drugs, most of which are useless, expensive, or dangerous. All too often the pharmaceutical industry's promotion of drugs leads to irrational prescribing by doctors. Companies spend about 20-30% of their sales budget on promotion, providing free samples to doctors to create demand for their products. In recent years in many developing countries with developing market economies, prices of medicines have sometimes risen by 400-500%. The main sources of information on new and existing products are the drug companies, either through mailings or visits by …

British rules outlaw disguised promotion of drugs

EDITOR,—The articles debating financial ties as part of informed consent to postmarketing research1 omit to mention that, …

An Analysis of Risk Reduction among Organized Groups That Promote Marijuana and Psychedelic Drugs

This article offers an ethnographic perspective on risk reduction among the many groups in the United States that are devoted to the promotion of marijuana and psychedelic drugs. These groups as a whole do not advocate the indiscriminate use of these substances, but instead offer marijuana and psychedelic drug users social support, and accurate information on how to use these drugs responsibly. A key finding of this study is that not only do these groups attempt to reduce the physical and psychological risks associated with drug use, but also reduce what they believe to be the greater risks associated with draconian laws against drugs, overzealous law enforcement practices, and mainstream views about marijuana and psychedelic drugs that are based on misinformation and prejudice.

Drug Promotion

Drug Promotion

Ciprofloxacin use under a reserved drug and stepdown promotion program.

This study retrospectively evaluated the use of parenteral ciprofloxacin (PC) under the influence of a reserved antimicrobial drug program and an intravenous-oral stepdown program. During the first three months following its formulary introduction, 92 PC treatment courses were initiated. Fifty of these treatment courses in 49 adults were randomly selected for study. The hematology service accounted for 50% of the courses reviewed. The balance were initiated in the intensive care unit (16%), and six other services (34%). PC was used for the treatment of febrile neutropenia (50%), respiratory tract infections (20%), gram-negative sepsis (10%), and five other indications. Initial use of the intravenous formulation was considered appropriate in 92% of courses. Stepdown therapy occurred in 17 (34%) of treatment courses. Of the 26 patients considered candidates for oral therapy, seven patients (27%) were eligible for earlier stepdown and nine patients (35%) did not receive oral drug. According to our criteria, unnecessary use of the intravenous route occurred in 20% of PC treatment days. Mean total cost (acquisition plus delivery) of therapy per course was $668. This cost was higher in the hematology service (mean $990) than any other service (p = 0.0015). When stepdown therapy was employed the mean daily cost of therapy was $43.63 vs. $55.61 when the oral dosage form was not used (p = 0.04). Parenteral drug costs totalling $6245 were avoided by subsequent use of the oral dosage form. If full compliance with stepdown criteria had occurred, an estimated total savings of $10,769 could have been realized.

Promoting rational prescribing: an international perspective.

Irrational prescribing is a global problem. Rational prescribing cannot be defined without a method of measurement and a reference standard. The former is now available but the latter needs further development. Proven effective interventions to promote rational prescribing in developed countries are treatment protocols based on wide consultation and consensus, properly introduced and with a possibility of feedback; face-to-face education focussed on a particular prescribing problem in selected individuals; structured order forms; and focussed educational campaigns. Essential drugs lists are probably effective when based on consensus and used within a comprehensive educational programme. Printed materials alone are not effective. In most cases the usefulness of such strategies in developing countries has not been proven and should be studied. Medical education in clinical pharmacology and pharmacotherapy should be based on the practical needs of future prescribes, should include the principles of rational therapeutics and problem solving, and should immunize the students against the influences they are likely to encounter in their professional life, such as patient pressure, drug promotion and irrational prescribing by peers. Within the scope of a national formulary, specialist departments in teaching hospitals should define prescribing policies as the basis for prescribing, teaching, examinations and medical audit.

Therapeutic-Class Wars -- Drug Promotion in a Competitive Marketplace

In today's prescription-drug marketplace a host of similar products compete for essentially the same population of patients. Between 1989 and 1993, for example, the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA) approved 127 new molecular entities (excluding generic drugs), but only a minority offered a clear clinical advantage over existing therapies1. Many of the others are considered “me too” drugs because they are so similar to brand-name drugs already on the market. The preponderance of “me too” drugs has created a highly competitive marketplace for prescription drugs. Pharmaceutical companies are waging aggressive campaigns . . .

Pharmaceutical Promotion and Physician Requests to Hospital Formularies-Reply

In Reply. —We thank Dr Rubin for his comments and for the chance to experience what for us is an unfamiliar sensation— being regarded as champions of the social value and value to patients of the promotional expenditures of pharmaceutical companies. That interpretation of our data is incorrect, however. Rubin argues that drug promotion to physicians benefits patients. Why? Because it works, and patients receive better and cheaper drugs as a result. We reject this logic for three reasons. First, there are no data that drug promotion by manufacturers improves the treatment or outcomes of patients. We found no evidence that physicians who requested drugs with more therapeutic advantage were more likely to have interacted with the manufacturer. Moreover, as Avorn et al 1 and others have demonstrated, physicians' beliefs about drugs often match advertising claims that conflict with independent data. Second, no data indicate that drug promotion to physicians

Book Review: Bad Prescription for the First Amendment: FDA Censorship of Drug Advertising and Promotion

Book Review: Bad Prescription for the First Amendment: FDA Censorship of Drug Advertising and Promotion