Direct-to-consumer advertisements for prescription drugs: what are Americans being sold?

BACKGROUND: Pharmaceutical companies spent US$1.8 billion on direct-to-consumer advertisements for prescription drugs in 1999. Our aim was to establish what messages are being communicated to the public by these advertisements. METHODS: We investigated the content of advertisements, which appeared in ten magazines in the USA. We examined seven issues of each of these published between July, 1998, and July, 1999. FINDINGS: 67 advertisements appeared a total of 211 times during our study. Of these, 133 (63%) were for drugs to ameliorate symptoms, 54 (26%) to treat disease, and 23 (11%) to prevent illness. In the 67 unique advertisements, promotional techniques used included emotional appeals (45, 67%) and encouragement of consumers to consider medical causes for their experiences (26, 39%). More advertisements described the benefit of medication with vague, qualitative terms (58, 87%), than with data (9, 13%). However, half the advertisements used data to describe side-effects, typically with lists of side-effects that generally occurred infrequently. None mentioned cost. INTERPRETATION: Provision of complete information about the benefit of prescription drugs in advertisements would serve the interests of physicians and the public.

Women's views on breast cancer risk and screening mammography: a qualitative interview study.

BACKGROUND: To promote informed decision making about mammography, clinicians are urged to present women with complete, relevant information about breast cancer and screening. Understanding women's current beliefs may help guide such efforts by uncovering misunderstandings, conceptual gaps, and areas of concern. OBJECTIVE: The authors sought to learn how women view breast cancer, their personal risk of breast cancer, and how screening mammography affects that risk. METHODS: Forty-one open-ended semistructured telephone interviews with women selected from a national database by quota sampling to ensure a wide range in demographics of the participants. RESULTS: Almost all respondents viewed breast cancer as a uniformly progressive disease that begins in a silent curable form (typically found by mammograms) and, unless treated early, invariably grows, spreads, and kills. Some women felt that any abnormality found must be treated, even if it was not malignant. None had heard of potentially nonprogressive cancers, and when informed, most felt that the uncertain prognosis of such lesions reinforced the need to find and treat disease as soon as possible. Women expressed a wide range of views about their personal risk of breast cancer. Although some saw breast cancer as a central threat to their health, many others cited heart disease, other cancers, violence, and trauma as greater concerns. Most recognized the importance of "uncontrollable" factors for breast cancer such as age, sex, family history, and genetics. However, other "controllable" factors with little or no demonstrated link to breast cancer (e.g., smoking, diet, toxic exposures, "bad attitudes") were given equal or greater prominence, suggesting that many women feel considerable personal responsibility for their level of breast cancer risk. Similarly, although women recognized that mammography was not perfect, almost all believed that failure to have mammograms put one at risk for premature and preventable death. When asked how mammography worked, almost all repeated the message that "early detection saves lives," suggesting that advanced cancer (and perhaps most cancer deaths) reflected a failure of early detection. The belief in the benefit of early detection was so strong that some women advocated scaring other women into getting mammograms because it is "better to be safe than sorry." CONCLUSIONS: Women view breast cancer as a uniformly progressive disease rarely curable unless caught early. The exaggerated importance many attribute to a variety of controllable factors in modifying personal risk and the "danger" seen in failing to have mammograms may lead women diagnosed with breast cancer to blame themselves.

US women's attitudes to false-positive mammography results and detection of ductal carcinoma in situ: cross-sectional survey.

OBJECTIVE: To determine women's attitudes and knowledge of both false-positive mammography results and the detection of ductal carcinoma in situ after screening mammography. DESIGN: Cross-sectional survey. SETTING: United States. PARTICIPANTS: A total of 479 women aged 18 to 97 years who did not report a history of breast cancer. Main outcome measures Attitudes and knowledge about false-positive results and the detection of ductal carcinoma in situ after screening mammography. RESULTS: Women were aware that false-positive results do occur. Their median estimate of the false-positive rate for 10 years of annual screening was 20% (25th percentile estimate, 10%; 75th percentile estimate, 45%). The women were highly tolerant of false-positive results: 63% thought that 500 or more false-positives per life saved was reasonable, and 37% would tolerate a rate of 10,000 or more. Women who had had a false-positive result (n = 76) expressed the same high tolerance: 30 (39%) would tolerate 10,000 or more false-positives. In all, 62% of women did not want to take false-positive results into account when deciding about screening. Only 8% of women thought that mammography could harm a woman without breast cancer, and 94% doubted the possibility of nonprogressive breast cancers. Few had heard of ductal carcinoma in situ, a cancer that may not progress, but when informed, 60% of women wanted to take into account the possibility of it being detected when deciding about screening. CONCLUSIONS: Women are aware of false-positive results and seem to view them as an acceptable consequence of screening mammography. In contrast, most women are unaware that screening can detect cancers that may never progress but think that such information would be relevant. Education should perhaps focus less on false-positive results and more on the less-familiar outcome of the detection of ductal carcinoma in situ.

A new scale for assessing perceptions of chance: a validation study.

BACKGROUND: Clinicians and researchers often wish to know how patients perceive the likelihoods of health risks. Little work has been done to develop and validate scales and formats to measure perceptions of event probabilities, particularly low probabilities (i.e., <1%). OBJECTIVE: To compare a new visual analog scale with three benchmarks in terms of validity and reliability. DESIGN: Survey with retest after approximately two weeks. Respondents estimated the probabilities of six events with the new scale, which featured a "magnifying glass" to represent probabilities between 0 and 1% on a logarithmic scale. Participants estimated the same probabilities on three benchmarks: two linear visual analog scales (one labeled with words, one with numbers) and a "1 in x" scale. SUBJECTS: 100 veterans and family members and 107 university faculty and students. MEASURES: For each scale, the authors assessed: 1) validity-the correlation between participants' direct rankings (i.e., numbering them from 1 to 6) and scale-derived rankings of the relative probabilities of six events; 2) test-retest reliability-the correlation of responses from test to retest two weeks later; 3) usability (missing/ incorrect responses, participant evaluation). RESULTS: Both the magnifier and the two linear scales outperformed the "1 in x" scale on all criteria. The magnifier scale performed about as well as the two linear visual analog scales for validity (correlation between direct and scale-derived rankings = 0.72), reliability (test-retest correlation = 0.55), and usability (2% missing or incorrect responses, 65% rated it easy to use). 62% felt the magnifier scale was a "very good or good" indicator of their feelings about chance. The magnifier scale facilitated expression of low-probability judgments. For example, the estimated chance of parenting sextuplets was orders of magnitude lower on the magnifier scale (median perceived chance 10(-5)) than on its linear counterpart (10(-2)). Participants' assessments of high-probability events (e.g., chance of catching a cold in the next year) were not affected by the presence of the magnifier. CONCLUSIONS: The "1 in x" scale performs poorly and is very difficult for people to use. The magnifier scale and the linear number scale are similar in validity, reliability, and usability. However, only the magnifier scale makes it possible to elicit perceptions in the low-probability range (<1%).

Are increasing 5-year survival rates evidence of success against cancer?

CONTEXT: Increased 5-year survival for cancer patients is generally inferred to mean that cancer treatment has improved and that fewer patients die of cancer. Increased 5-year survival, however, may also reflect changes in diagnosis: finding more people with early-stage cancer, including some who would never have become symptomatic from their cancer. OBJECTIVE: To determine the relationship over time between 5-year cancer survival and 2 other measures of cancer burden, mortality and incidence. DESIGN AND SETTING: Using population-based statistics reported by the National Cancer Institute Surveillance, Epidemiology, and End Results Program, we calculated the change in 5-year survival from 1950 to 1995 for the 20 most common solid tumor types. Using the tumor as the unit of analysis, we correlated changes in 5-year survival with changes in mortality and incidence. MAIN OUTCOME MEASURE: The association between changes in 5-year survival and changes in mortality and incidence measured using simple correlation coefficients (Pearson and Spearman). RESULTS: From 1950 to 1995, there was an increase in 5-year survival for each of the 20 tumor types. The absolute increase in 5-year survival ranged from 3% (pancreatic cancer) to 50% (prostate cancer). During the same period, mortality rates declined for 12 types of cancer and increased for the remaining 8 types. There was little correlation between the change in 5-year survival for a specific tumor and the change in tumor-related mortality (Pearson r=.00; Spearman r=-.07). On the other hand, the change in 5-year survival was positively correlated with the change in the tumor incidence rate (Pearson r=+. 49; Spearman r=+.37). CONCLUSION: Although 5-year survival is a valid measure for comparing cancer therapies in a randomized trial, our analysis shows that changes in 5-year survival over time bear little relationship to changes in cancer mortality. Instead, they appear primarily related to changing patterns of diagnosis. JAMA. 2000.

US women's attitudes to false positive mammography results and detection of ductal carcinoma in situ: cross sectional survey.

OBJECTIVE: To determine women's attitudes to and knowledge of both false positive mammography results and the detection of ductal carcinoma in situ after screening mammography. DESIGN: Cross sectional survey. SETTING: United States. PARTICIPANTS: 479 women aged 18-97 years who did not report a history of breast cancer. MAIN OUTCOME MEASURES: Attitudes to and knowledge of false positive results and the detection of ductal carcinoma in situ after screening mammography. RESULTS: Women were aware that false positive results do occur. Their median estimate of the false positive rate for 10 years of annual screening was 20% (25th percentile estimate, 10%; 75th percentile estimate, 45%). The women were highly tolerant of false positives: 63% thought that 500 or more false positives per life saved was reasonable and 37% would tolerate 10 000 or more. Women who had had a false positive result (n=76) expressed the same high tolerance: 39% would tolerate 10 000 or more false positives. 62% of women did not want to take false positive results into account when deciding about screening. Only 8% of women thought that mammography could harm a woman without breast cancer, and 94% doubted the possibility of non-progressive breast cancers. Few had heard about ductal carcinoma in situ, a cancer that may not progress, but when informed, 60% of women wanted to take into account the possibility of it being detected when deciding about screening. CONCLUSIONS: Women are aware of false positives and seem to view them as an acceptable consequence of screening mammography. In contrast, most women are unaware that screening can detect cancers that may never progress but feel that such information would be relevant. Education should perhaps focus less on false positives and more on the less familiar outcome of detection of ductal carcinoma in situ.

Women's understanding of the mammography screening debate.

BACKGROUND: The fractious public debate over mammography screening recommendations for women aged 40 to 49 years has received extensive attention in medical journals and in the press. OBJECTIVE: To learn how women interpret the mammography screening debate. METHODS: We mailed a survey to a random sample of American women 18 years and older, oversampling women of screening age (40-70 years). Sixty-six percent of women completed the survey (n = 503). MAIN OUTCOME MEASURES: The main outcome measures were women's reactions to the debate, their suggestion for the starting age for mammography screening, and their understanding of the source of the debate. RESULTS: Almost all women (95%) said that they had paid some attention to the recent discussion about mammography screening. Only 24% said the discussion had improved their understanding of mammography, while 50% reported being upset by the public disagreement among screening experts. Women's beliefs about mammography differed from those articulated by experts in the debate. Eighty-three percent believed that mammography had proven benefit for women aged 40 to 49 years, and 38% believed that benefit was proven for women younger than 40 years. Most women suggested that mammography screening should begin before age 40 years, while only 5% suggested a first mammogram should be performed at 50 years or older. In response to an open-ended question about why mammography has been controversial, 15% cited concerns about the potential harms of radiation and another 12% cited questions about efficacy. Nearly half (49%), however, identified costs as the major source of debate (eg, "Health maintenance organizations [HMOs] don't want to pay for mammography"). CONCLUSIONS: Most women paid attention to the recent debate about routine mammography screening for women aged 40 to 49 years, but many believed the debate was about money rather than the question of benefit. Policy makers issuing recommendations about implementation of large-scale mammography screening services need to consider how to effectively disseminate their message.

Teaching evidence-based medicine: caveats and challenges.

Evidence-based medicine (EBM) is an important new paradigm of the medical profession. While the quantitative approach of EBM has its place, clinical medicine must take into account many subtleties that EBM fails to consider. In this article, the authors describe three caveats to this quantitative approach: (1) the detection of "maybe disease" (physiologic, anatomic, or histologic abnormalities that may not ever be overtly expressed in the patient's lifetime) inflates apparent diagnostic test performance; (2) probability revision is valuable primarily as an exercise to gain qualitative insights; and (3) patients are likely to be interested more than just central tendencies in making treatment decisions. They then consider some challenging questions facing clinician-educators: how do they prepare students for situations where there is an absence of rigorous evidence? Should they teach students that the burden of proof lies in demonstrating efficacy or in demonstrating ineffectiveness? And what should they tell students about when to seek evidence to aid diagnostic and treatment decisions?

Telephone care as an adjunct to routine medical follow-up. A negative randomized trial.

CONTEXT: In 1992, a randomized trial at one outpatient clinic demonstrated that making telephone appointments part of routine medical follow-up could save money and reduce hospitalization. OBJECTIVE: To ascertain the effects of telephone care in other clinics. DESIGN: Consenting patients of 20 physicians were randomly assigned to receive telephone care or usual care. SETTING: Veterans Affairs General Medical Clinics in Denver, Colorado, and Sioux Falls, South Dakota. PATIENTS: 512 predominately male elderly veterans (mean age, 68 years) who had a broad range of chronic medical conditions. INTERVENTION: At the intake clinic visit, the recommended revisit interval (e.g., return in 3 months) for telephone care patients was doubled (e.g., return in 6 months) and three intervening telephone appointments were scheduled. Three telephone appointments were also scheduled at all subsequent clinic visits. MAIN OUTCOME MEASURES: Utilization of services and self-reported health status. RESULTS: More than 2000 calls were made during the 2-year study period. Although the revisit interval was longer for telephone care patients after the intake visit (as was expected), it was the same for both telephone care and usual care patients after all subsequent visits, despite the scheduling of three telephone appointments for telephone care patients. The intervention had no effect on self-reported health status, hospital admission, or number of deaths. The intervention also had no effect on the total number of clinic visits, outpatient laboratory tests, or radiologic tests. Telephone care patients had fewer unscheduled visits than did usual care patients (2.0 vs. 2.8 visits/patient; P = 0.01). CONCLUSION: Telephone care had little effect in this study. Instead of providing a way to maintain contact with patients without requiring them to appear in clinic frequently, telephone appointments became simply an additional service.

The cost-effectiveness of treating all patients with type 2 diabetes with angiotensin-converting enzyme inhibitors.

BACKGROUND: Although guidelines recommend angiotensin-converting enzyme inhibitors for diabetic patients with microalbuminuria, this strategy requires that providers adhere to screening recommendations. In addition, the benefit of angiotensin-converting enzyme inhibitors in normoalbuminuric patients was recently demonstrated. OBJECTIVE: To evaluate the cost-effectiveness of treating all patients with type 2 diabetes. DESIGN: Markov model simulating the progression of diabetic nephropathy. DATA SOURCES: Randomized trials estimating the progression of diabetic nephropathy with and without angiotensin-converting enzyme inhibitors. TARGET POPULATION: Patients 50 years of age with newly diagnosed type 2 diabetes (fasting plasma glucose level > or = 7.8 mmol/L [140 mg/dL]). TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTIONS: Patients received angiotensin-converting enzyme inhibitors, screening for microalbuminuria, or screening for gross proteinuria. OUTCOME MEASURES: Lifetime cost, quality-adjusted life expectancy, and marginal cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: Screening for gross proteinuria had the highest cost and the lowest benefit. Compared with screening for microalbuminuria, treating all patients was more expensive ($15240 and $14940 per patient) but was associated with increased quality-adjusted life expectancy (11.82 and 11.78 quality-adjusted life-years). The marginal cost-effectiveness ratio was $7500 per quality-adjusted life-year gained. RESULTS OF SENSITIVITY ANALYSIS: Results were sensitive to the cost, effectiveness, and quality of life associated with angiotensin-converting enzyme inhibitor therapy, as well as age at diagnosis. The model was relatively insensitive to adherence with screening and costs of treating end-stage renal disease. CONCLUSIONS: Treating all middle-aged diabetic patients with angiotensin-converting enzyme inhibitors is a simple strategy that provides additional benefit at modest additional cost. The strategy assumes that patients meet the older diagnostic criteria for diabetes and makes sense only for those who are not bothered by treatment.