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Medical device labeling and advertising: an overview.

The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the labeling of all medical devices. This statement, however, is not as simple as it appears. The regulation of medical device labels and labeling, closely linked to the advertisement of medical devices, is a dynamic area, and FDA is struggling to address the new issues that arise daily in this area. This article seeks to: 1) provide the background necessary to understand the current law and FDA's regulation of medical devices; 2) summarize the law and regulations governing medical devices; 3) define "intended use" and explain its importance; and 4) discuss several areas that are of particular interest to FDA, including promotion of uncleared or unapproved devices and uses, Internet promotion, press releases, and comparative claims.

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Do ads really drive pharmaceutical sales? The true effects of DTC advertising remain a mystery.

The growth in mass media drug advertising has coincided with a rapid rise in spending on prescription drugs in the United States. Our research examines the potential link between increased ad spending and the rising use and sale of these drugs. We found strong circumstantial evidence that ad spending is one of many important elements driving the sharp rise in pharmaceutical sales to consumers.

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Salient stimuli in advertising: the effect of contrast interval length and type on recall.

Salient auditory stimuli (e.g., music or sound effects) are commonly used in advertising to elicit attention. However, issues related to the effectiveness of such stimuli are not well understood. This research examines the ability of a salient auditory stimulus, in the form of a contrast interval (CI), to enhance recall of message-related information. Researchers have argued that the effectiveness of the CI is a function of the temporal duration between the onset and offset of the change in the background stimulus and the nature of this stimulus. Three experiments investigate these propositions and indicate that recall is enhanced, providing the CI is 3 s or less. Information highlighted with silence is recalled better than information highlighted with music.

Adult↗

[Advertising promoting self-referral in Cairo and in Los Angeles].

After being a long-time resident of Cairo (Egypt) and then Los Angeles (California), the author noticed some unexpected similarities between the two cities, especially when compared to the Netherlands. In the medical field most of these similarities are related to the privatisation within the health-care system. This gives rise to a high degree of self-referral by patients and, consequently, encourages health-care providers to advertise in a sometimes aggressive manner, for example for specific hospitals, doctors, blood pressure measurement in the corner of a supermarket and even for a CT body scan.

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Assessing the impact of direct-to-consumer advertisements on the AA patient: a multisite survey of patients during the office visit.

The method by which patients receive health information continues to change in this new age of increased information and technology. Long gone are the days of the mystique surrounding the physician's prescribing of a medication to cure their patients ailment. In recent years, this mystique has been replaced with more informed patients that bring their questions and concerns their doctor in anticipation of open dialogue. At the other end of the spectrum are the patients that come to the visit armed with notes, copies of Web pages, information from their home medical reference books and information heard or seen from the latest advertisements directed to the consumer about a medication for a self diagnosed disease. The majority of physicians have welcomed and encouraged patients to take on more responsibility of their health and appreciate the dialogue. This is preferred to the patient who sits motionless and nods his/her head in blind agreement with the proposed plan of action. Physicians have read the data on patient compliance and medical outcomes and understand that an informed patient is an ally and not an enemy. However, is there a difference between an informed patient that asks questions seeking a more active role in their healthcare versus a demanding patient that believes that their knowledge base is equal to the physician, thereby reducing the physician to a vending machine dispensing requested prescriptions with little insight or deviation from the patient's demands? Fundamentally, we know that physicians agree that our profession dictates that we use all of the medical knowledge at our fingertips, our interpersonal skills and judgment in making recommendations to our patients. We refuse to be reduced to a simple dispenser of desired medications with no regard to the patient and their well being and in fact are incensed with the assumption that our profession has been reduced to such mediocrity. However, we prefer the middle ground with our patients, neither the demanding or the complacent are our preference, we want relationship and believe that this will improve the patient's health status. The question is whether the increased information, dialogue, and patient involvement utilizing the information from new sources are a good thing, a bad thing or simply a reality of medicine's entrance into the information age. Must we encourage our patients to take an active role in their healthcare but place boundaries on the venues by which they receive information? How do patients interact with their physician in the office after exposure to an ad for a prescription medication? How do physicians react to the questions and do we encourage the interaction? What is the effect of the pharmaceutical industry marketing directly to our patients? Do we know and how will we ever fully assess the impact? Although these questions have no succinct answer, the physician and the patient dyad must be the guiding barometer.

Adult↗

[New forms of medical profession--advertising].

Particularly in the last two years, the legislation of Part V of the German Social Code has challenged the time-honoured system of the physician's own medical practice as the panel doctor's registered office. New forms of outpatient care, for example the health centres, "Heilkunde-GmbHs", and the recently-developed medical care centres, are intended to impact on patients' ambulatory healthcare. Due to the partial employee status of practice owners, and thus the relinquishing of the independent entrepreneurial structuring of their own practices, the construct of the traditional professional code of conduct for physicians is beginning to totter. It remains to be seen whether liberalisation of the model code of conduct will provide a remedy. The principle should, however, be adhered to that advertising in the physician sector must not be unethical, if we understand this to mean not strident, not confusing, and not comparative.

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US regulation of Advertising and promotional materials.

Medical device manufacturers do not always properly control the development of new or modified promotional labelling and advertising materials. This lack of control can lead to unexpected regulatory problems. This article discusses United States requirements for these materials and the type of controls that companies should exercise.

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Public attitudes regarding limits on public smoking and regulation of tobacco sales and advertising--10 U.S. communities, 1989.

The national health objectives for the year 2000 emphasize the need for policies and laws that restrict smoking in public places, restrict minors' access to tobacco products, and restrict minors' exposure to tobacco product advertising and promotion. To characterize public attitudes regarding policy issues related to the prevention and control of tobacco use, the National Cancer Institute surveyed communities participating in the Community Intervention Trial for Smoking Cessation (COMMIT). This report describes the results of a baseline COMMIT survey in 10 U.S. communities.

Adult↗

Outdoor advertising of addictive products.

Billboards in black and hispanic neighborhoods in four selected New Jersey cities disproportionately contain advertisements for tobacco and alcohol products and are designed with images of sex, youth, and affluence to promote the use of addictive products.

Advertising↗

Attitudes of dental practitioners towards advertising and competition.

This paper examines the attitudes of dental practitioners towards competition and advertising and the changes that have occurred there between 1985 and 1988. It provides an insight into the views of members of the profession as they dealt with the issue of commercialisation. The study came at a time when proposed legislative changes would profoundly impact upon the profession's stance on business ethics and upon the business practice of its members. The data were derived from a self-completion questionnaire, 1,500 of which were evenly distributed among the members of five professions, doctors, dentists, lawyers, accountants, and veterinarians. The main findings were that the dental profession had moved along the collegiality-competition continuum only slightly, preferring to shun the use of overtly competitive behaviour while seeking to improve the efficiency of practice management.

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[Advertising and communicative attitude: towards an ethics of publicity in medicine].

Starting of from the notion that medicine presents a plurality of aims, it is proposed that it should be conceived as a "science of actions" rather than as a "science of objects". Health is not a neutral "object" that could be unambiguously defined and approached from any vantage point solely with the standards of a detached impersonal generalized observer. It is a construction in at least three domains: the personal, the scientific and the societal. Against this background, medical acts (as those performed in other "ethical professions") are construed as occurring in a communicative context which can be differentiated from the context of marketing and advertising on the basis of reciprocity and respect. Implications of this proposed framework are examined in terms of axiologic dimensions of health care and medical practice.

Advertising↗

Changes in the advertised demand for nurse practitioners in the United States, 1975-1986.

Legislative and reimbursement policies have presented barriers to employment and autonomy for nurse practitioners since the beginning of the nurse practitioner movement in 1965. Greater resistance to NPs in the 1980s was predicted because of a sluggish economy and burgeoning oversupply of physicians. In this study, quantitative content analysis was used to examine 1,022 job advertisements published in The Nurse Practitioner: The American Journal of Primary Health Care from 1975 to 1986. Unstandardized regression analysis was used to compare changes in the demand for nurse practitioners by region, employment setting, job duties, specialty, employment time (full- or part-time), degree required or preferred for the position, and whether the ad specified a joint practice arrangement. Contrary to the predictions of past research, the demand for nurse practitioners increased during this time period, with a greater tendency toward primary care.

Advertising↗

Results of a television-advertised public screening program for colorectal cancer.

We report the results of a free, television-advertised mass screening program for colorectal cancer using stool guaiac kits. A total of 57,000 test kits were picked up and 29,619 (53%) were returned; 3.9% (1165) of the tests were positive. Ninety-three percent of persons with a positive screen sought medical evaluation after screening. Detailed follow-up was available on 744 persons. Fifty-eight persons had large-bowel carcinomas diagnosed, 80% of which were localized. One hundred sixty persons had adenomatous polyps removed. Forty percent of cancers and 58% of polyps were detected in persons with only one or two positive test slides out of a total of six. In 33% of persons with a positive screen, the diagnostic workup consisted of a repeated stool guaiac test and/or sigmoidoscopy only. A major drawback to improving the results of mass screening programs for colorectal cancer is the limited gastrointestinal workup conducted by physicians in many persons with a positive fecal occult blood test.

Adult↗

Cigarette advertising and black-white differences in brand preference.

Anecdotal evidence indicates that the cigarette industry is targeting the sale of specific brands, notably menthol cigarettes, to black consumers. This paper presents data on the types of cigarettes smoked by white and black smokers. The cigarette brand preferences of two populations of smokers were examined. The first comprised 70 white and 365 black adult smokers seen at the Deaconness Family Medicine Center located in Buffalo, NY. The second population included 1,070 white and 92 black smokers who called a Stop Smoking Hotline in Buffalo. The results showed that, in both populations, blacks were twice as likely to smoke mentholated cigarettes compared with whites. In an attempt to evaluate the targeting of cigarette ads to black smokers as a possible explanation for black-white differences in brand preferences, cigarette ads appearing in magazines targeted to predominantly white or black readers were compared. Cigarette ads appearing in seven magazines were reviewed, four directed to predominantly white readers (Newsweek, Time, People, Mademoiselle) and three with wide circulation among black audiences (Jet, Ebony, Essence). The results showed that the magazines targeted to black readers contained significantly more cigarette ads and more ads for menthol brand cigarettes than magazines similar in content but targeted to white readers. The observation that a higher percentage of blacks smoke menthol cigarettes than do whites is consistent with the findings regarding differences in the type of cigarette ads appearing in magazines intended for black or white readers. However, it is not possible to determine from this study whether cigarette advertising is the cause of the differences in preference of cigarette brands between white and black smokers. Future research focusing on understanding the reasons for cigarette brand preferences may provide ideas for anti smoking campaigns aimed at specific target groups.

Adolescent↗

[Representation of the aged in magazine advertisements].

A content-analysis of 125 magazine advertisements from 1975 to 1977 dealt with the image of old people especially sex-related aspects of their representation. This image can be described as positive, the two sexes being similar in all relevant dimensions. Most important result, however, is that old people are underrepresented and that their representation is not very differentiated including even restrictive elements. This is especially true for the old woman.

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The effects of video advertising on physician recruitment to a family practice residency program.

BACKGROUND: The number of medical students entering family practice residencies has been decreasing in recent years. In an effort to increase this number, many family practice residencies send videos describing their programs to prospective applicants. This study was designed to evaluate the effects of video advertising on resident recruitment. METHODS: In the fall of 1992, a short promotional video was produced to highlight many aspects of the University of Maryland Family Practice Residency Program. The video was sent to half of all persons who applied to the program. RESULTS: Of the 248 inquiries, 120 (48%) received the video. Of these, 35 (29%) completed the application compared with 69 (54%) who received routine materials only. Applicants who did not receive the video were 2.86 times more likely (95% confidence interval 1.6-5.0) to apply to our program (P < 0.0001). None of the applicants who received the video matched with the program (P < 0.005). CONCLUSION: Residency recruitment videos may have a negative impact on residency recruitment.

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