Conflict of interest in biomedical research.
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Biomedical Research↗
Biomedical subjects
David Blumenthal
Publications and source records attributed to David Blumenthal.
A Potential Role for PGE and IL-14 (HMW-BCGF) in B-Cell Hyperactivity of Patients with Systemic Lupus Erythematosus.
Systemic lupus erythematosus (SLE) is a disease characterized by the prolonged production of high-affinity autoantibodies resulting in direct and immune complex-mediated tissue damage. Because autoantibody responses occur over several years, memory B cells are likely to be involved. Interleukin-14 (IL-14) is a cytokine implicated in the generation and maintenance of normal memory B cells. Many of the actions of IL-14, including inhibition of antibody synthesis and upregulation of IL-14 receptors (IL-14R), are dependent on the formation of prostaglandin E (PGE) and subsequently cAMP. We observed that IL-14 induces phospholipase A(2) (PLA(2))-dependent release of arachidonic acid from phosphatidylcholine and phosphatidylinositol. Production of PGE is blocked by the PLA(2) inhibitor bromophenacyl bromide. Exogenous PGE (misoprostol) induces similar inhibition of antibody synthesis and increases in IL-14R as IL-14. Lymphocytes from patients with inactive SLE were noted to spontaneously produce PGE. Lymphocytes from normal donors produced PGE only after Sac-activation and IL-14 stimulation. Peripheral B and T lymphocytes from SLE patients, but not normal donors, spontaneously produced IL-14. Increased numbers of peripheral B lymphocytes from patients with inactive SLE expressed IL-14R, when compared to normal donors. Thus, increased production of IL-14 and PGE in SLE may result in expansion of a memory B-cell population capable of long-term autoantibody production. Further study will be necessary to confirm these preliminary findings and to examine in greater depth the regulation of PGE and IL-14 in SLE patients and normal donors.
Journal Article↗
Data withholding in academic genetics: evidence from a national survey.
CONTEXT: The free and open sharing of information, data, and materials regarding published research is vital to the replication of published results, the efficient advancement of science, and the education of students. Yet in daily practice, the ideal of free sharing is often breached. OBJECTIVE: To understand the nature, extent, and consequences of data withholding in academic genetics. DESIGN, SETTING, AND PARTICIPANTS: Mailed survey (March-July 2000) of geneticists and other life scientists in the 100 US universities that received the most funding from the National Institutes of Health in 1998. Of a potential 3000 respondents, 2893 were eligible and 1849 responded, yielding an overall response rate of 64%. We analyzed a subsample of 1240 self-identified geneticists and made a limited number of comparisons with 600 self-identified nongeneticists. MAIN OUTCOME MEASURES: Percentage of faculty who made requests for data that were denied; percentage of respondents who denied requests; influences on and consequences of withholding data; and changes over time in perceived willingness to share data. RESULTS: Forty-seven percent of geneticists who asked other faculty for additional information, data, or materials regarding published research reported that at least 1 of their requests had been denied in the preceding 3 years. Ten percent of all postpublication requests for additional information were denied. Because they were denied access to data, 28% of geneticists reported that they had been unable to confirm published research. Twelve percent said that in the previous 3 years, they had denied another academician's request for data concerning published results. Among geneticists who said they had intentionally withheld data regarding their published work, 80% reported that it required too much effort to produce the materials or information; 64%, that they were protecting the ability of a graduate student, postdoctoral fellow, or junior faculty member to publish; and 53%, that they were protecting their own ability to publish. Thirty-five percent of geneticists said that sharing had decreased during the last decade; 14%, that sharing had increased. Geneticists were as likely as other life scientists to deny others' requests (odds ratio [OR], 1.39; 95% confidence interval [CI], 0.81-2.40) and to have their own requests denied (OR, 0.97; 95% CI, 0.69-1.40). However, other life scientists were less likely to report that withholding had a negative impact on their own research as well as their field of research. CONCLUSIONS: Data withholding occurs in academic genetics and it affects essential scientific activities such as the ability to confirm published results. Lack of resources and issues of scientific priority may play an important role in scientists' decisions to withhold data, materials, and information from other academic geneticists.
Communication↗
Changes in career satisfaction among primary care and specialist physicians, 1997-2001.
CONTEXT: A number of forces have changed the practice of medicine in the past decade. Evidence suggests that physicians are becoming less satisfied in this environment. OBJECTIVES: To describe changes in career satisfaction in a large, nationally representative sample of physicians and to examine market and practice factors associated with changes in physician satisfaction. DESIGN AND SETTING: Data were collected from the first 3 rounds of the Community Tracking Study (CTS) Physician Survey, a series of nationally representative telephone surveys of physicians in 60 US sites conducted in 1996-1997 (round 1: 12 385 respondents; 65% response rate), 1998-1999 (round 2: 12 280 respondents; 61% response rate), and 2000-2001 (round 3: 12 389 respondents; 59% response rate) for the Center for Studying Health System Change. The second and third rounds of the survey included physicians sampled in the previous round, as well as new physicians. PARTICIPANTS: Primary care and specialist physicians who spent at least 20 hours per week in direct patient care activities. MAIN OUTCOME MEASURES: Changes in physicians' overall satisfaction with their career and the proportion of dissatisfied physicians in particular sites. RESULTS: Physician satisfaction levels declined marginally between 1997 and 2001, with most of the decline occurring between 1997 and 1999. Among primary care physicians, 42.4% were very satisfied in 1997, as were 43.3% of specialists, compared with 38.5% and 41.4%, respectively, in 2001. There were nearly equal increases in those who reported that they were somewhat satisfied. Overall means mask significant differences across the 60 sites. Among 12 sites randomly selected for more intensive study, the proportion of respondents who were somewhat or very dissatisfied ranged from 8.8% of physicians in Lansing, Mich (1999), to 34.2% in Miami, Fla (1997). Between 1997 and 1999, 25.6% of primary care physicians reported decreased satisfaction and 18.1% reported improved satisfaction, while approximately equal percentages reported increased (19.8%) and decreased (20.4%) satisfaction between 1999-2001. Findings were similar for specialist physicians. In multivariable models, the strongest and most consistent predictors of change in satisfaction were changes in measures of clinical autonomy, including increases in hours worked and physicians' ability to obtain services for their patients. Changes in exposure to managed care were weakly related to changes in satisfaction. CONCLUSIONS: Our findings demonstrate that overall physician satisfaction levels over this time period did not change dramatically. In addition, satisfaction and changes in satisfaction vary greatly among sites. Rather than declining income, threats to physicians' autonomy, to their ability to manage their day-to-day patient interactions and their time, and to their ability to provide high-quality care are most strongly associated with changes in satisfaction.
Cross-Sectional Studies↗
Institutional academic industry relationship: results of interviews with university leaders.
The purpose of this study was to explore qualitatively the nature, consequences and management of institutional academic industry relationships (IAIRs) in the life and health sciences. The results of our interviews suggest that in the institutions we visited IAIRs are common and deeply embedded in the academic enterprise both among institutional officials and the organization itself. Many believe these relationships have potential benefits for the research and education mission while creating the potential for conflicts of interest. Further tracking and study of the IAIRs is required to understand and anticipate the full effects of these relationships on the scientific enterprise in the United States.
Administrative Personnel↗
Improving the generation, dissemination, and use of management research.
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Delivery of Health Care↗
A research agenda for bridging the 'quality chasm.'.
Realizing the vision of the IOM's landmark report, Crossing the Quality Chasm, will require new knowledge to support new policy and management. This paper lays out a research agenda that must be pursued if the health care system is to bridge the quality chasm. Based on a consensus process involving leading health care researchers and authorities, the paper highlights knowledge gaps and research directions in five areas identified by the Quality Chasm report as critical to its goals of building organizational supports for change; applying evidence to health care delivery; developing information technology; aligning payment policies with quality improvement; and preparing the workforce.
Education, Continuing↗
The impact of a national prescription drug formulary on prices, market share, and spending: lessons for Medicare?
Several recent bills in Congress to add a Medicare prescription drug benefit would allow the use of formularies to control costs. However, there is little empirical evidence of the impact of formularies among elderly and disabled populations. We assess the effect of a closed formulary implemented by the Veterans Health Administration (VHA) in 1997 on drug prices, market share, and drug spending. We find that the VHA National Formulary was effective at shifting prescribing behavior toward the selected drugs, achieving sizable price reductions from manufacturers, and greatly decreasing drug spending.
Aged↗
Federal health information policy: a case of arrested development.
Computerized patient records (CPRs) have reached a state of technical maturity that makes them an essential component of modern patient care. However, because uniform technical standards do not exist, CPRs constructed by different vendors do not convey clinical information easily from provider to provider. Moreover, unequal access to capital may mean a two-tier clinical information environment in the future. HIPAA, while important, did not anticipate the CPR revolution. New federal activism is required to assure not only interoperability of clinical data systems, but also that providers who lack capital and technical resources can make the needed digital conversion.
Ambulatory Care Information Systems↗
Toil and trouble? Growing the physician supply.
Richard Cooper outlines several obstacles to increasing the supply of U.S.-trained physicians. His analysis paints a bleak picture, but he may be underselling the possible benefits of technological advances that could increase medical school capacity and of increasing the volume of qualified applicants by broadening eligibility criteria. Another issue that would confront medical educators is that imbalances between supply and demand would not be uniform across states. This development could signal increased involvement from state policymakers, but public and private policymakers should take steps to assure that resources are funneled to where doctors are needed most and to exploit opportunities for innovative curriculum development.
Education, Medical↗
Estimating the mission-related costs of teaching hospitals.
Academic health centers and other teaching hospitals face higher patient care costs than nonteaching community hospitals face, because of their missions of graduate medical education (GME), biomedical research, and the maintenance of standby capacity for medically complex patients. We estimate that total mission-related costs were dollar 27 billion in 2002 for all teaching hospitals, with GME (including indirect and direct GME) and standby capacity accounting for roughly 60 and 35 percent of these costs, respectively. To assure their continued ability to perform important social missions in a competitive environment, it may be necessary to reassess the way in which these activities are financed.
Academic Medical Centers↗
Limits to the safety net: teaching hospital faculty report on their patients' access to care.
Many major teaching hospitals might not be able to offer adequate access to specialty care for uninsured patients. This study found that medical school faculty were more likely to have difficulty obtaining specialty services for uninsured than for privately insured patients. These gaps in access were similar in magnitude for public and private institutions. Initial treatment of uninsured patients at academic health centers (AHCs) does not guarantee access to specialty and other referral services, which suggests that there are limits to relying on a health care safety net for uninsured patients. AHCs and affiliated group practices should examine policies that limit access for uninsured patients.
Academic Medical Centers↗
Physicians' views of formularies: implications for Medicare drug benefit design.
As Congress considers introducing a drug benefit for Medicare, it will more than likely adopt a program that uses a formulary. We examined data from the Community Tracking Study Physicians Survey, a large, nationally representative study of physicians, to learn about physicians' views of formularies. Our results suggest that several aspects of formularies are associated with physicians' positive views about them. Policymakers should consider imposing limits on the number of competing Medicare formularies operating in a particular area, promoting the adoption and use of information technology, and incorporating financial incentives for physicians to adhere to formularies.
Adult↗
Inside the triple helix: technology transfer and commercialization in the life sciences.
The transfer and subsequent application of academic research results has demonstrable benefits for health care, researchers, universities, companies, and local economies. Nonetheless, at least three general concerns exist: bias in the reporting of results, limited revenues from these activities, and the lack of data to evaluate technology transfer activities. Future efforts with regard to technology transfer in the life sciences will need to recognize its importance without ignoring concerns or overestimating benefits. Next steps include better monitoring of university-industry relationships, the development of a better data system, the dissemination of best practices in technology transfer management, and evaluation of national technology-transfer policies.
Biological Science Disciplines↗
Overcoming barriers to adopting and implementing computerized physician order entry systems in U.S. hospitals.
Few U.S. hospitals have implemented computerized physician order entry (CPOE) in spite of its effectiveness at preventing serious medication errors. We interviewed senior management at twenty-six hospitals to identify ways to overcome barriers to adopting and implementing CPOE. Within the hospital, strong leadership and high-quality technology were critical. Hospitals that placed a high priority on patient safety could more easily justify the cost of CPOE. Outside the hospital, financial incentives and public pressures encouraged CPOE adoption. Dissemination of data standards would accelerate the maturation of vendors and lower CPOE costs. These findings highlight several policy levers to speed the adoption of this important patient safety technology.
Attitude of Health Personnel↗
Functional gaps in attaining a national health information network.
We describe the health information technology (HIT) required for a model of a national health information network (NHIN). Specifically, we define the functional HIT capabilities of an attainable NHIN and determine the gap between the current state of HIT and its likely state in five years, given current trends of adoption. Administrative functionalities will be more prevalent than clinical functionalities in five years. Smaller stakeholders, such as home health care agencies, will lag in adoption. Policy changes, such as financial incentives to HIT end users or regulatory measures, may help accelerate the adoption of HIT for a model NHIN.
Diffusion of Innovation↗
Consumers' reports on the health effects of direct-to-consumer drug advertising.
We conducted a national telephone survey about health care experiences associated with direct-to-consumer advertising (DTCA) of prescription drugs. Among the 35 percent of our sample who had a physician visit during which DTCA was discussed, 25 percent received a new diagnosis, of which 43 percent were considered high priority according to authoritative sources. More than half also reported actions taken by their physician other than prescribing the advertised drug. Despite concerns about DTCA's negative consequences, we found no differences in health effects between patients who took advertised drugs and those who took other prescription drugs.
Adult↗
Physicians report on patient encounters involving direct-to-consumer advertising.
We surveyed a national sample of 643 physicians on events associated with visits during which patients discussed an advertised drug. Physicians perceived improved communication and education but also thought that direct-to-consumer advertising (DTCA) led patients to seek unnecessary treatments. Physicians prescribed the advertised drug in 39 percent of DTCA visits but also recommended lifestyle changes and suggested other treatments. Referring to visits when the DTCA drug was prescribed, 46 percent said that it was the most effective drug, and 48 percent said that others were equally effective. Prescribing DTCA drugs when other effective drugs are available warrants further study.
Advertising↗