To inform or persuade? Direct-to-consumer advertising of prescription drugs.
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Advertising↗
Biomedical subjects
Ernst R Berndt
Publications and source records attributed to Ernst R Berndt.
Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates.
The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite the FDA drug-review process. Here, we review data on drug approvals and drug-approval times, both as a whole and by therapeutic class, which demonstrate that implementation of the PDUFAs led to substantial incremental reductions in approval times beyond what would have been observed in the absence of these legislative acts. In addition, our preliminary examination of the trends in the number of new molecular entity withdrawals, frequently used as a proxy to assess the FDA's safety record, suggests that the proportion of approvals ultimately leading to safety withdrawals prior to PDUFA and during PDUFA I and II were not statistically different.
Drug Approval↗
Effects of pharmaceutical promotion on adherence to the treatment guidelines for depression.
OBJECTIVES: We sought to examine the impact of direct-to-consumer advertising (DTCA) and pharmaceutical promotion to physicians on the likelihood that (1) an individual diagnosed with depression received antidepressant medication and that (2) antidepressant medication was used for the appropriate duration. RESEARCH DESIGN AND SUBJECTS: A quasiexperimental design was used to examine treatment patterns of 30,621 depressed individuals whose insurance claims were included in the MarketScan database from 1997 through 2000. The main explanatory variables were spending on DTCA, detailing to physicians, and free samples for 6 antidepressant medications. RESULTS: Individuals diagnosed with depression during periods when class-level antidepressant DTCA spending was highest (cumulative spending more than US 18.5 million dollars) had 32% higher relative odds of initiating medication therapy compared with those diagnosed during periods when DTCA spending was lowest (P < 0.0001). Free samples of medications dispensed to physicians had no effect on odds of initiating antidepressant use. Class-level DTCA spending on antidepressants had a small positive effect on the duration of antidepressant use, whereas DTCA spending for the specific medication taken by an individual had no effect on treatment duration. Detailing spending at the class or product level had no significant effect on duration of treatment with an antidepressant medication. CONCLUSIONS: Our results suggest that DTCA of antidepressants was associated with an increase in the number of people diagnosed with depression who initiated medication therapy. DTCA was associated with a small increase in the number of individuals treated with antidepressants who received the appropriate duration of therapy. Promotion to physicians was not associated with either the initiation of treatment with an antidepressant or with the duration of therapy.
Adolescent↗
The clinical and occupational correlates of work productivity loss among employed patients with depression.
Employers who are developing strategies to reduce health-related productivity loss may benefit from aiming their interventions at the employees who need them most. We determined whether depression's negative productivity impact varied with the type of work employees performed. Subjects (246 with depression and 143 controls) answered the Work Limitations Questionnaire and additional work questions. Occupational requirements were measured objectively. In multiple regression analyses, productivity was most influenced by depression severity (P < 0.01 in 5/5 models). However, certain occupations also significantly increased employee vulnerability to productivity loss. Losses increased when employees had occupations requiring proficiency in decision-making and communication and/or frequent customer contact (P < 0.05 in 3/5 models). The Work Limitations Questionnaire can help employers to reduce productivity loss by identifying health and productivity improvement priorities.
Absenteeism↗
Unemployment, job retention, and productivity loss among employees with depression.
OBJECTIVE: This study comprehensively assessed the work outcomes of employees with depression. METHODS: We collected baseline and six-month follow-up survey data from 229 employees with depression and two employee comparison groups: a group of healthy patients for the control group (N=173) and a group with rheumatoid arthritis (N=87), a frequent source of work disability. Outcomes included new unemployment and, within the employed subgroup, job retention (versus job turnover), presenteeism (that is, diminished on-the-job performance and productivity), and absenteeism. RESULTS: At the six-month follow-up, persons with depression had more new unemployment--14 percent for persons in the dysthymia group, 12 percent for persons in the major depression group, and 15 percent for persons in the group with both dysthymia and major depression, compared with 2 percent for persons in the control group and 3 percent for persons in the rheumatoid arthritis group. Among participants who were still employed, those with depression had significantly more job turnover, presenteeism, and absenteeism. CONCLUSIONS: In addition to helping employees with depression obtain high-quality depression treatment, new interventions may be needed to help them to overcome the substantial job upheaval that this population experiences.
Adaptation, Psychological↗
Changes in the costs of treating mental health disorders: an overview of recent research findings.
This article reviews recent evidence on changes over time in the direct medical costs of treating three of the more common mental health disorders in the US: the acute (16-week) phase of major depressive disorder, the ongoing treatment of schizophrenia, and the ongoing treatment of bipolar I disorders. The three studies discussed in this article cover various time intervals over the decade from 1991 through 2000, and encompass both private sector and governmental funding sources. Although there has been a shift over time away from intensive psychosocial/psychotherapy and towards increasingly expensive psychopharmacotherapy for all three disorders, total direct medical costs of treatment for each of these three mental health disorders have been declining over time. However, a substantial portion of treatment is not supported by clinical evidence.
Drug Therapy↗
Benefit plan design and prescription drug utilization among asthmatics: do patient copayments matter?
The ratio of controller-to-reliever medication use has been proposed as a measure of treatment quality for asthma patients. In this study we examine the effects of plan-level mean out-of-pocket asthma medication patient copayments and other features of benefit plan design on the use of controller medications alone, controller and reliever medications (combination therapy), and reliever medications alone. The 1995--2000 MarketScan claims data were used to construct plan-level out-of-pocket copayment and physician/practice prescriber preference variables for asthma medications. Separate multinomial logit models were estimated for patients in fee-for-service (FFS) and non-FFS plans relating benefit plan design features, physician/practice prescribing preferences, patient demographics, patient comorbidities, and county-level income variables to patient-level asthma treatment patterns. We find that the controller-to-reliever ratio rose steadily over 1995--2000, along with out-of-pocket payments for asthma medications, which rose more for controllers than for relievers. After controlling for other variables, however, plan-level mean out-of-pocket copayments were not found to have a statistically significant influence on patient-level asthma treatment patterns. On the other hand, physician/practice prescribing patterns strongly influenced patient-level treatment patterns. There is no strong statistical evidence that higher levels of out-of-pocket copayments for prescription drugs influence asthma treatment patterns. However, physician/practice prescribing preferences influence patient treatment.
Adult↗
Prescriber intent, off-label usage, and early discontinuation of antidepressants: a retrospective physician survey and data analysis.
BACKGROUND: Many patients discontinue antidepressant therapy long before the 6-month minimum duration recommended for the treatment of major depression and many other diagnoses. We explore various possibilities, including prescriber intent and patient diagnosis, to explain some of this early discontinuation. METHOD: Patients from a single health maintenance organization who filled at least 1 prescription for an antidepressant during the first 4 months of 2001 and who did not fill an antidepressant prescription in the 6 months prior were identified retrospectively. Prescribers of those patients' antidepressants were surveyed for patient diagnosis and length of intended treatment with antidepressant medication. Actual length of treatment was then obtained from pharmacy data and correlated with survey data and other variables. RESULTS: Prescriber surveys were returned for 51% (485/951) of the patients identified. Surveys indicated that for 34% of initial antidepressant prescriptions, < 6 months of treatment was intended. Important determinants of the length of antidepressant therapy included prescriber specialty area, number of prescribers, prescriber intent, diagnosis, specific antidepressant used, and concomitant benzodiazepine use. CONCLUSIONS: Prescriber intention to treat many patients with short courses of antidepressants, often for off-label, non-mental health indications, was correlated with early discontinuation and needs further study of both its rationale and efficacy. Although less prevalent, short-term treatment of mental health disorders, including depression, was also intended by psychiatrists and other prescribers. The widespread practice of intended short-term treatment with antidepressants needs to be understood better, since it results in guideline-incompatible, early antidepressant discontinuation.
Adolescent↗
Relationship of employee-reported work limitations to work productivity.
BACKGROUND: Work limitation rates are crucial indicators of the health status of working people. If related to work productivity, work limitation rates may also supply important information about the economic burden of illness. OBJECTIVE: Our objective was to assess the productivity impact of on-the-job work limitations due to employees' physical or mental health problems. RESEARCH DESIGN: Subjects were asked to complete a self-administered survey on the job during 3 consecutive months. Using robust regression analysis, we tested the relationship of objectively-measured work productivity to employee-reported work limitations. SUBJECTS: We attempted to survey employees of a large firm within 3 different jobs. The survey response rate was 2245 (85.9%). Full survey and productivity data were available for 1827 respondents. MEASURES: Each survey included a validated self-report instrument, the Work Limitations Questionnaire (WLQ). The firm provided objective, employee-level work productivity data. RESULTS: In adjusted regression analyses (n = 1827), employee work productivity (measured as the log of units produced/hour) was significantly associated with 3 dimensions of work limitations: limitations handling the job's time and scheduling demands (P = 0.003), physical job demands (P = 0.001), and output demands (P = 0.006). For every 10% increase in on-the-job work limitations reported on each of the 3 WLQ scales, work productivity declined approximately 4 to 5%. CONCLUSION: Employee work limitations have a negative impact on work productivity. Employee assessments of their work limitations supply important proxies for the economic burden of health problems.
Adolescent↗
Promotion of prescription drugs to consumers.
BACKGROUND: Spending on prescription drugs is the fastest growing component of the health care budget. There is public concern about the possibility that direct-to-consumer advertising of prescription drugs will result in inappropriate prescribing and higher costs of care. Guidelines issued in 1997 by the Food and Drug Administration (FDA) regarding advertising to consumers through electronic media are considered by some to be responsible for unleashing a flood of direct-to-consumer advertising. METHODS: Using data on spending for promotional purposes and sales of prescription drugs, we examined industrywide trends for various types of promotion. We also tracked the relation between promotional efforts and sales over time. Finally, we documented the variation in direct-to-consumer advertising among and within five therapeutic classes of drugs and compared the variation in the intensity of such advertising with variation in the intensity of promotion to health care professionals. RESULTS: Annual spending on direct-to-consumer advertising for prescription drugs tripled between 1996 and 2000, when it reached nearly $2.5 billion. Despite this increase, such advertising accounts for only 15 percent of the money spent on drug promotion and is highly concentrated on a subgroup of products. Within a therapeutic class, there is marked variation in the intensity of direct-to-consumer advertising, and the amount of such advertising for specific products fluctuates over time. The initial surge in direct-to-consumer advertising preceded the 1997 FDA guidelines that clarified the rules for electronic direct-to-consumer advertising, and thus the 1997 guidelines may not have been the most important reason for the overall increase. CONCLUSIONS: Although the use of direct-to-consumer advertising has grown disproportionately to other forms of promotion, it continues to account for a small proportion of total promotional efforts. Nevertheless, physicians must assist patients in evaluating health-related information obtained through direct advertising.
Advertising↗
The medical treatment of depression, 1991-1996: productive inefficiency, expected outcome variations, and price indexes.
We examine the price of treating episodes of acute phase major depression over the 1991-1996 time period. We combine data from a large retrospective medical claims data base (MarketScan, from the Medstat Group) with clinical literature and expert clinical opinion elicited from a two-stage Delphi procedure. This enables us to construct a variety of treatment price indexes that include variations over time in the proportion of the "off-frontier" production, as well as the corresponding variations in expected treatment outcomes. We find that in general the incremental cost of successfully treating an episode of acute phase major depression has generally fallen over the 1991-1996 time period. Based on hedonic regression equations that account for the effects of changing patient mix, we find reductions that range from about -1.66 to -2.13% per year.
Cost of Illness↗
Pharmaceuticals in U.S. health care: determinants of quantity and price.
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Drug Costs↗
The impact of treatment-resistant depression on health care utilization and costs.
BACKGROUND: Approximately 50% of patients diagnosed with major depressive disorder will experience a recurrent or chronic course of illness for which long-term treatment is recommended. Moreover, at least 20% of patients diagnosed with depression do not respond satisfactorily to several traditional antidepressant medication treatment trials. Very little is known about the health care costs of patients with treatment-resistant depression. METHOD: Based on medical claims data (MarketScan Research Database, The MEDSTAT Group, Cambridge, Mass.) from January 1, 1995, to June 30, 2000, a naturalistic, retrospective analysis was conducted to study the characteristics and health care utilization of patients with treatment-resistant depression. All patients having an International Classification of Diseases, Ninth Revision (ICD-9), diagnosis code for unipolar or bipolar depression with specified antidepressant dosing and treatment durations were initially selected. Patients were then classified as "treatment resistant" if either they switched from or augmented initial antidepressant medication with other antidepressants at least twice (outpatient treatment-resistant group) or they switched from or augmented their initial antidepressant medication and also had a claim for either a depression-related hospitalization or suicide attempt (hospitalized treatment-resistant group). Those meeting the initial medication and diagnosis selection criteria but not meeting the treatment-resistance criteria constituted the comparison group. Members of the comparison group had comparatively stable antidepressant medication use patterns, consistent with an acceptable response to treatment. Patients were followed for a minimum of 9 months. Resource utilization was calculated from index date to last available claims data point and then annualized. RESULTS: Treatment-resistant patients were more likely to be diagnosed with bipolar disorder or concurrent substance abuse or anxiety disorders than the comparison group (p <.001). Treatment-resistant patients were at least twice as likely to be hospitalized (general medical and depression related) and had at least 12% more outpatient visits (p <.02). Treatment resistance was also associated with use of 1.4 to 3 times more psychotropic medications (including antidepressants) (p <.001). Patients in the hospitalized treatment-resistant group had over 6 times the mean total medical costs of non-treatment-resistant depressed patients ($42,344 vs. $6512) (p <.001) and their total depression-related costs were 19 times greater than those of patients in the comparison group ($28,001 vs. $1455) (p <.001). CONCLUSION: Treatment-resistant depression is costly and associated with extensive use of depression-related and general medical services. These findings underscore the need for early identification and effective long-term maintenance treatment for treatment-resistant depression.
Adult↗
Treatment costs of venlafaxine and selective serotonin-reuptake inhibitors for depression and anxiety.
In this article, health care expenditures are assessed for patients diagnosed with depression who are being treated with either venlafaxine (immediate or extended release) or a selective serotonin-reuptake inhibitor (SSRI). Patients beginning treatment for a new depressive episode were identified retrospectively from 1994 to 1998. Before beginning therapy, patients prescribed venlafaxine (N = 353) had more nonmental illnesses (0.84 vs. 0.75 clinical events/patient, respectively; P < .01) and hospitalizations for mental illness (0.56 vs. 0.30 hospitalizations/patient; P = .06) than patients prescribed SSRIs (N = 7,330). In the six months after initiating treatment, venlafaxine was associated with lower hospitalization expenditures for nonmental illness than were SSRIs ($206 vs. $472, respectively; P = .02), but total health care expenditures were not significantly different.
Adult↗
Depression treatment: a lifelong commitment?
Depression is associated with considerable disability, morbidity, and mortality. In many patients, depression follows a course of relapse and/or recurrence. However, there is significant evidence that the majority of patients with depressive disorders are undertreated and this imposes a substantial economic burden on society. The reasons for undertreatment include patient, provider, and healthcare system factors. It is vital that treatment be targeted appropriately to break the cycle of relapse/recurrence. Rather than short-term improvement of symptoms, the optimal outcome of treatment of depressive disorders should be full symptom resolution (remission) and long-term recovery. Patients with histories of recurrent depressive episodes may require long-term, indefinite treatment with antidepressants. Currently, few data exist on the outcome and appropriate duration of maintenance pharmacotherapy. The benefits of psychotherapy have recently been demonstrated in a 12-week, randomized, controlled study, which also includes a maintenance phase that has not yet been completed. Additional well-designed studies addressing these issues are urgently needed.
Antidepressive Agents↗
An analysis of the diffusion of new antidepressants: variety, quality, and marketing efforts.
BACKGROUND: We are not aware of any published research that quantifies and compares the importance of effectiveness and side effects for pharmaceutical sales, and that simultaneously incorporates the impacts of marketing efforts on the diffusion of new pharmaceutical agents in the U.S. The overall level and market share success of the various selective serotonin reuptake inhibitors ( SSRIs ) relative to a representative older generation tricyclic (such as amitriptyline) provides a useful focus for studying such issues. AIMS OF STUDY: To model jointly the marketing and sales relationships of the SSRIs in the U.S., to quantify the extent to which marketing efforts are responsive to the availability of new scientific information accompanying changes in quality and increases in product variety, and in turn to assess how the new FDA indication approvals and the enhanced marketing initiatives involving product quality and variety affect sales of the SSRI and other novel antidepressants. METHODS: Quarterly US sales, price, quantity and marketing data 1988Q1-1997Q4 are taken from IMS Health for the eight new antidepressants introduced into the US during this time period. Measures of physician-perceived quality attributes of the antidepressants are drawn from Market Measures, Inc., a medical survey research firm. These data are used to construct measures of product quality (effectiveness and side effect profile), and attribute variety across all antidepressants. Multivariate regression methods are used in estimating parameters of a marketing efforts model, a sales demand model encompassing the aggregate of the newer antidepressants, and a product share model. Simulation methods are employed to quantify elasticities. RESULTS: Since 1988, and relative to amitriptyline, there has been only a rather modest increase in the perceived average effectiveness of the SSRIs and related products, but the side effect profiles have improved substantially. Variety measures for effectiveness show greater increases over time than do those for side effects. Marketing efforts respond to science-based events, such as new FDA indication approvals, and to effectiveness and side-effect quality improvements. Total antidepressant sales are positively and significantly related to price reductions, increased marketing efforts, and the level and variety of side effect profiles involving antidepressants. The level and variety of effectiveness does not significantly affect total antidepressant sales. Order of entry effects are important in affecting product market shares, while marketing efforts and relative quality attributes (particularly a more favorable side effect profile) have positive and significant impacts on relative market shares. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: Since patient response to SSRIs and related products is idiosyncratic, greater product variety facilitates better matching of antidepressant with patient. Much of the growth of the SSRIs and related antidepressants since 1988 can be attributed to increased product attribute variety, to improved changes in side effect quality relative to that of the tricyclics, and to the marketing of those improvements. IMPLICATIONS FOR HEALTH POLICIES: Marketing efforts play an important role in diffusing product information. Marketing efforts increase considerably following FDA approval for indications other than depression, and also increase with the average effectiveness and the average side effect rating of the products. IMPLICATIONS FOR FURTHER RESEARCH: Whether the relatively minor role that perceived effectiveness has in affecting sales relative to perceived side effect profile is unique to antidepressants, or generalizes to other therapeutic classes, merits further examination.
Adverse Drug Reaction Reporting Systems↗
The economic burden of anemia in cancer patients receiving chemotherapy.
BACKGROUND: Anemia is one of the most common hematologic complications of cancer and cytotoxic treatment. The economic burden associated with anemia in patients with malignancy has not yet been extensively studied. METHODS: Patients receiving chemotherapy within 6 months of initial cancer diagnosis were identified in a database of commercial health-care service claims and encounters. Patients with anemia were identified through a coded diagnosis of anemia, transfusion, or erythropoietin treatment. Exponential conditional mean models and a decomposition analysis were used to analyze mean 6-month health-care expenditures. RESULTS: Twenty-six percent (26%) of 2760 cancer patients with recently diagnosed invasive cancer treated with chemotherapy had anemia. Mean (SD) 6-month unadjusted total expenditures were 62,499 dollars (78,016 dollars) for anemic patients and 36,871 dollars (52,308 dollars) for nonanemic patients (P < 0.0001), with inpatient services representing the largest cost differential between the groups. The adjusted mean 6-month expenditure for the average anemic patient receiving chemotherapy was 57,209 dollars. If anemic patients had the same average health status as nonanemic patients, their predicted 6-month expenditures would have been 19% lower (46,237 dollars). Alternatively, if anemic patients had the same expenditure structure or parameter estimates as nonanemic patients, their predicted expenditures would have been 51% lower (27,847 dollars). Thus, for any given health status, treating a patient who is anemic is associated with considerably higher expenditures. CONCLUSIONS: Anemia among cancer patients receiving chemotherapy is associated with a substantial burden in terms of direct medical costs. Implications for the treatment of anemia are suggested by this research and should be confirmed in prospective studies.
Aged↗