47 results on '"Wolfe, Sidney"'
Search Results
2. Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review.
- Author
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Hines, Jonas Zajac, Lurie, Peter, Yu, Eunice, and Wolfe, Sidney
- Subjects
MEDICAL equipment ,SCIENTIFIC apparatus & instruments ,MARKETING research ,LAW ,MARKETING - Abstract
The article offers an overview on the premarket review on medical device. It also determines eight weaknesses in the review process that could be addressed such as excessive reliance on a fast-track procedure. It relates that a series of recent issues have raised public awareness concerning the shortcomings in the regulation of medical device by the U.S. Food and Drug Administration (FDA). It illustrates each weakness based from the paradigmatic cases drawn from the FDA's regulatory proceedings.
- Published
- 2010
- Full Text
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3. Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Death.
- Author
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Natanson, Charles, Kern, Steven J., Lurie, Peter, Banks, Steven M., and Wolfe, Sidney M.
- Subjects
BLOOD substitutes ,MYOCARDIAL infarction ,CORONARY disease ,BLOOD transfusion ,PATIENTS ,SAFETY - Abstract
The article presents a study assessing the safety of hemoglobin-based substitutes (HBBSs) used in surgical, stroke and trauma patients. The study involved a review of data of patients who received HBBSs therapeutically between 1980 and 2008 as well as the results from a U.S. Food and Drug Administration review and two clinical trials. Among the outcomes measured were mortality and myocardial infarction (MI). Researchers concluded that the use of HBBSs was linked to a significant increase in the risk of death and MI.
- Published
- 2008
- Full Text
- View/download PDF
4. WORST PILLS, BEST PILLS.
- Author
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Wolfe, Sidney M.
- Subjects
- *
PHARMACODYNAMICS , *INFORMATION resources , *DRUG side effects , *PHARMACEUTICAL policy - Abstract
The article discusses issues and topics contained in the book "Worst Pills, Best Pills," by Sidney M. Wolfe. Originally, the book listed about a hundred or so drugs that showed negative side-effects and a corresponding safer alternatives for everyone of them. The purpose of the book, in parallel with the efforts to get the Food and Drug Administration to ban or put stronger warnings on these drugs, is to try to encourage patients to do something about it.
- Published
- 2006
5. Violations of Exhibiting and FDA Rules at an American Psychiatric Association Annual Meeting.
- Author
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Lurie, Peter, Tran, Tung, Wolfe, Sidney Manuel, and Goodman, Robert
- Subjects
PHARMACEUTICAL industry ,PAMPHLETS ,MEETINGS ,AMERICAN business enterprises - Abstract
We conducted a cross-sectional study of all exhibit booths for the 14 pharmaceutical companies at the 2002 American Psychiatric Association (APA) convention. We collected and categorized one of each item distributed by the companies at each booth. A total of 268 items were collected from 24 companies (median = 8). The most common categories of items were "reprints or pamphlets" (37%) and "non- educational gifts" (27%), including music CDs and invitations to dinners and museums. There were a total of 16 violations of the APA's own exhibit rules: eight companies had one violation and two companies had four violations. Four companies engaged in FDA-prohibited off-label promotion; one also violated the APA code. Over half of all companies (54%) were in violation of either APA rules or FDA regulations. The APA's voluntary code has failed to adequately reduce inappropriate promotional activity at the annual APA meeting. [ABSTRACT FROM AUTHOR]
- Published
- 2005
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6. Quality of care in investor-owned vs not-for-profit HMOs.
- Author
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Himmelstein, David U., Woolhandler, Steffie, Hellander, Ida, Wolfe, Sidney M., Himmelstein, D U, Woolhandler, S, Hellander, I, and Wolfe, S M
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HEALTH maintenance organizations ,MANAGED care programs ,GROUP medical practice ,NONPROFIT organizations ,ECONOMICS ,HEALTH facilities ,ACQUISITION of property ,CLINICAL medicine ,COMPARATIVE studies ,RESEARCH methodology ,MEDICAL quality control ,MEDICAL cooperation ,MULTIVARIATE analysis ,PREVENTIVE health services ,RESEARCH ,EVALUATION research ,KEY performance indicators (Management) ,FERRANS & Powers Quality of Life Index ,STANDARDS - Abstract
Context: The proportion of health maintenance organization (HMO) members enrolled in investor-owned plans has increased sharply, yet little is known about the quality of these plans compared with not-for-profit HMOs.Objective: To compare quality-of-care measures for investor-owned and not-for-profit HMOs.Design, Setting, and Participants: Analysis of the Health Plan Employer Data and Information Set (HEDIS) Version 3.0 from the National Committee for Quality Assurance's Quality Compass 1997, which included 1996 quality-of-care data for 329 HMO plans (248 investor-owned and 81 not-for-profit), representing 56% of the total HMO enrollment in the United States.Main Outcome Measures: Rates for 14 HEDIS quality-of-care indicators.Results: Compared with not-for-profit HMOs, investor-owned plans had lower rates for all 14 quality-of-care indicators. Among patients discharged from the hospital after myocardial infarction, 59.2% of members in investor-owned HMOs vs 70.6% in not-for-profit plans received a beta-blocker (P<.001); 35.1% of patients with diabetes mellitus in investor-owned plans vs 47.9% in not-for-profit plans had annual eye examinations (P<.001). Investor-owned plans had lower rates than not-for-profit plans of immunization (63.9% vs 72.3%; P<.001), mammography (69.4% vs 75.1%; P<.001), Papanicolaou tests (69.2% vs 77.1%; P<.001), and psychiatric hospitalization (70.5% vs 77.1%; P<.001). Quality scores were highest for staff- and group-model HMOs. In multivariate analyses, investor ownership was consistently associated with lower quality after controlling for model type, geographic region, and the method each HMO used to collect data.Conclusions: Investor-owned HMOs deliver lower quality of care than not-for-profit plans. [ABSTRACT FROM AUTHOR]- Published
- 1999
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7. Epidemiology of failed tobacco control legislation.
- Author
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Moore, Stephen and Wolfe, Sidney M.
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TOBACCO laws - Abstract
Evaluates the influence of the tobacco industry campaign donations, district location and political party affiliation on tobacco control legislation among members of the US Congress. Data source; Amount of donations; Use of regressional analysis.
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- 1994
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8. Physicians disciplined for sex-related offenses.
- Author
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Dehlendorf, Christine E., Wolfe, Sidney M., Dehlendorf, C E, and Wolfe, S M
- Subjects
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PHYSICIAN malpractice , *SEX crimes , *STATISTICS - Abstract
Context: Physicians who abuse their patients sexually cause immense harm, and, therefore, the discipline of physicians who commit any sex-related offenses is an important public health issue that should be examined.Objectives: To determine the frequency and severity of discipline against physicians who commit sex-related offenses and to describe the characteristics of these physicians.Design and Setting: Analysis of sex-related orders from a national database of disciplinary orders taken by state medical boards and federal agencies.Subjects: A total of 761 physicians disciplined for sex-related offenses from 1981 through 1996.Main Outcome Measures: Rate and severity of discipline over time for sex-related offenses and specialty, age, and board certification status of disciplined physicians.Results: The number of physicians disciplined per year for sex-related offenses increased from 42 in 1989 to 147 in 1996, and the proportion of all disciplinary orders that were sex related increased from 2.1% in 1989 to 4.4% in 1996 (P<.001 for trend). Discipline for sex-related offenses was significantly more severe (P<.001) than for non-sex-related offenses, with 71.9% of sex-related orders involving revocation, surrender, or suspension of medical license. Of 761 physicians disciplined, the offenses committed by 567 (75%) involved patients, including sexual intercourse, rape, sexual molestation, and sexual favors for drugs. As of March 1997, 216 physicians (39.9%) disciplined for sex-related offenses between 1981 and 1994 were licensed to practice. Compared with all physicians, physicians disciplined for sex-related offenses were more likely to practice in the specialties of psychiatry, child psychiatry, obstetrics and gynecology, and family and general practice (all P<.001) than in other specialties and were older than the national physician population, but were no different in terms of board certification status.Conclusions: Discipline against physicians for sex-related offenses is increasing over time and is relatively severe, although few physicians are disciplined for sexual offenses each year. In addition, a substantial proportion of physicians disciplined for these offenses are allowed to either continue to practice or return to practice. [ABSTRACT FROM AUTHOR]- Published
- 1998
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9. Nurse-midwifery.
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Gabay, Mary and Wolfe, Sidney M.
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MIDWIVES - Abstract
Promotes the use of certified nurse-midwife (CNM) care as the standard of practice for healthy pregnant women in the United States. Number of in-hospital midwife-attended births; Percentage of live births in which selected obstetric procedures were used; Restrictions on nurse-midwifery practice; Three general recommendations for low risk pregnant women. INSET: Midwifery care in 20th century America..
- Published
- 1997
10. Letters.
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Upton, Jessica, Himmelstein, David U., Woolhandler, Steffie, Wolfe, Sidney M., Young, Quentin, Angell, Marcia, Katz, Sue, Troxell, Richard R., and Lindsay-Poland, John
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LETTERS to the editor ,MEDICAL care ,OLDER people's sexual behavior ,HOMELESSNESS ,HOME prices - Abstract
Several letters to the editor are presented in response to article in previous issues Including "Public Option Now!" in the July 20-27 2009 issue, "Subject to Debate," by Katha Pollitt in the June 15, 2009 issue, and "Tales of the Tent City," by Ben Ehrenreich in the June 22, 2009 issue.
- Published
- 2009
11. Accountable Care Organizations' Payments to Physicians: Patients Should Have the Right to Know.
- Author
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Mansour, Mayce, Favini, Nathan, Carome, Michael A., Wolfe, Sidney, Woolhandler, Steffie, and Himmelstein, David U.
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ACCOUNTABLE care organizations ,PHYSICIAN salaries ,PATIENTS' rights ,PAYMENT ,HEALTH maintenance organization finance ,LABOR incentives ,PATIENT Protection & Affordable Care Act ,PHYSICIAN-patient relations ,ECONOMICS ,PAY for performance ,PHYSICIANS ,SURVEYS ,HEALTH insurance reimbursement ,GOVERNMENT regulation ,ACCESS to information - Abstract
An editorial is presented which addresses the authors' claim that patients should have the right to know about payments made by accountable care organizations to physicians in America as of 2017, and it mentions physician payment arrangements involving health maintenance organizations (HMOs) in the country. The U.S. Patient Protection and Affordable Care Act and the nation's Medicare health insurance program are assessed, along with incentives in medicine.
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- 2017
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12. Carcinogenicity Alert.
- Author
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Lurie, Peter and Wolfe, Sidney
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- *
GOVERNMENT policy on hazardous substances , *EMPLOYEES , *HEALTH - Abstract
Unravels the reasons for the failure of the United States Occupational Safety and Health Administration (OSHA) to regulate hexavalent chromium. Health implications of the substance to workers; Actions taken by OSHA to control the substance; Details on the study of the toxicity of the substance; Health cases related to exposure to the substance.
- Published
- 2000
13. Post Hoc Analysis Does Not Establish Effectiveness of rTMS for Depression.
- Author
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Hines, Jonas Z., Lurie, Peter, and Wolfe, Sidney M.
- Subjects
LETTERS to the editor - Abstract
A response by Jonas Z. Hines to a letter to the editor about his article on the U.S. Food and Drug Administration's post hoc analysis.
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- 2009
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14. Ephedra -- Scientific Evidence Versus Money/Politics.
- Author
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Wolfe, Sidney M.
- Subjects
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DIETARY supplements - Abstract
At a U.S. Senate Hearing on ephedra alkaloids, acting the U.S. Food and Drug Administration commissioner Lester Crawford conceded that if these products were drugs, not dietary supplements, they would be off the market. But he also stated that unreasonable risk of harm at the recommended doses, is sufficient for withdrawal under the 1994 Dietary Supplements Health and Education Act (DSHEA), which allows marketing of naturally occurring products without requirements for safety or efficacy studies and is the legal standard for FDA withdrawal (2).In June 2001, the Canadian government warned Canadians not to use these products, and in January 2002, it announced a recall of “ephedra/ephedrine products with labelled or implied claims for appetite suppression, weight loss promotion, metabolic enhancement, increased exercise tolerance, body-building effects, euphoria, increased energy or wakefulness, or other stimulant effects”.
- Published
- 2003
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15. Direct-to-Consumer Advertising — Education or Emotion Promotion?
- Author
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Wolfe, Sidney M.
- Subjects
- *
DRUG advertising , *DIRECT-to-consumer prescription drug advertising , *PUBLICITY , *MEDICAL care , *PHYSICIANS , *HEALTH products , *PATIENTS , *PHYSICIAN-patient relations - Abstract
The article discusses various issues related to direct-to-consumer advertising in medical care in the U.S. It is reported that, direct-to-consumer advertising has changed the nature of the doctor-patient relationship, the patients are now seeking much more medical information and are actively participating in decisions he affect their health. One benefit from such advertising is that, it increases patient's access to accurate, objective information about tests to diagnose and drugs to treat his illnesses. But, at the same time, confusion is said to arises when commercially motive promotional information is represented as educational. Several studies on direct-to-consumer advertising are also referred in the article.
- Published
- 2002
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16. U.S. PHYSICIANS DISCIPLINED FOR CRIMINAL ACTIVITY.
- Author
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Jung, Paul, Lurie, Peter, and Wolfe, Sidney M.
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DISCIPLINE of physicians , *CRIMINAL behavior , *PROFESSIONAL ethics , *MEDICAL practice , *MEDICAL ethics - Abstract
The article focuses on the discipline of physicians engaged in any criminal behavior in the U.S. The Federation of State Medical Boards, the association of state medical boards responsible for disciplining doctors, recommends that all state medical boards conduct criminal records checks as part of the licensure application process. Although criminal activity by physicians is of great concern both to the medical profession and the general public, state medical boards vary in their monitoring and discipline of criminal activities by licensed physicians.
- Published
- 2006
17. Bad Doctors Get a Free Ride.
- Author
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Wolfe, Sidney M.
- Subjects
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PHYSICIAN malpractice - Abstract
Comments on the malpractice of doctors in the U.S.
- Published
- 2003
18. Don't weaken the FDA laws.
- Author
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Zieve, Allison M. and Wolfe, Sidney M.
- Subjects
DRUG laws - Abstract
Discusses the plan by Senator Bill Frist, to remove a 34-year-old ban which ensures that drug companies do proper testing, before a drug or medical device for a particular purpose is promoted. Proposal from Frist; What the move by Frist would indicate for the Food and Drug Administration; Disadvantages of the plan by Frist; What the proposal by Frist threatens.
- Published
- 1996
19. High Drug Prices: For Research or Profit?
- Author
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Wolfe, Sidney
- Subjects
DRUG prices ,PRICE regulation ,PHARMACEUTICAL industry ,PRICES - Abstract
Focuses on several issues disputing the need for United States (U.S.) pharmaceutical companies to control drug prices in order to facilitate research for new treatments. Profit margin of U.S. pharmaceutical companies in 2000; Percentage of drug companies' budgets devoted to research and development.
- Published
- 2001
20. Ephedra-Free Is Not Danger-Free.
- Author
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Marcus, Donald M., Grollman, Arthur P., and Wolfe, Sidney M.
- Subjects
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FOOD additives , *PUBLIC health - Abstract
The sale of ephedra-containing dietary supplements should be banned by the United States Food and Drug Administration (FDA). Many companies have responded to the adverse publicity about ephedra by introducing new "ephedra-free" supplements. By inappropriately classifying herbal medicines as dietary supplements, Dietary Supplement Health and Education Act (DSHEA) freed supplement manufacturers from requirements to provide evidence that their products are safe and effective and from the need to base health claims on sound scientific evidence. It is dangerous enough that the FDA lacks the legal authority to require evidence of safety and efficacy for dietary supplements, but a recent Harris Poll revealed the extent to which people are woefully unaware of the lack of such FDA requirements for marketing these products. The majority of people incorrectly thought that the FDA must approve dietary supplements before they are sold, that manufacturers are not allowed to make claims concerning safety unless supported by scientific evidence, and that the FDA requires label warnings about potential dangers. But, without a significant modification if not a repeal of the FDA-disabling 1994 Dietary Supplement Health and Education Act, more ephedrines and Bitter Oranges will surface, to the detriment of public health.
- Published
- 2003
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21. PRESCRIPTION DRUGS. Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals.
- Author
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Frank, Cassie, Himmelstein, David U., Woolhandler, Steffie, Bor, David H., Wolfe, Sidney M., Heymann, Orlaith, Zallman, Leah, and Lasser, Karen E.
- Subjects
- *
DRUG approval laws , *DRUGS , *DRUG labeling , *PRODUCT recall - Abstract
After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently. [ABSTRACT FROM AUTHOR]
- Published
- 2014
- Full Text
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22. Suboptimum use of FDA drug advisory committees.
- Author
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Tapley, Asa L, Lurie, Peter, and Wolfe, Sidney M
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LETTERS to the editor - Abstract
This article presents a letter to the editor regarding the U.S. Food and Drug Administration drug advisory committee system.
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- 2006
- Full Text
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23. SURVEY OF STATE MEDICAL AND OSTEOPATHY BOARD DISCIPLINARY WEB SITES IN 2006.
- Author
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Larson, Meredith, Lurie, Peter, Marcus, Benita, and Wolfe, Sidney
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HEALTH policy , *WEBSITES , *MEDICAL practice , *OSTEOPATHIC physicians - Abstract
The article reports on the result of the study on physicians' disciplinary information provided in Websites of state medical and osteopathic boards in the U.S. in 2006. It is stated that the Websites have featured hospital, state board and federal government actions, as well as malpractice judgments information. It provides various profiles of attending physicians for their customers direct accessibility.
- Published
- 2009
24. Time to End Physician Sexual Abuse of Patients: Calling the U.S. Medical Community to Action.
- Author
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AbuDagga A, Carome M, and Wolfe SM
- Subjects
- Female, Humans, Male, Physicians standards, Professional Misconduct legislation & jurisprudence, Sex Offenses prevention & control, United States epidemiology, Malpractice legislation & jurisprudence, National Practitioner Data Bank legislation & jurisprudence, Physician-Patient Relations, Physicians legislation & jurisprudence, Sex Offenses legislation & jurisprudence
- Abstract
Despite the strict prohibition against all forms of sexual relations between physicians and their patients, some physicians cross this bright line and abuse their patients sexually. The true extent of sexual abuse of patients by physicians in the U.S. health care system is unknown. An analysis of National Practitioner Data Bank reports of adverse disciplinary actions taken by state medical boards, peer-review sanctions by institutions, and malpractice payments shows that a very small number of physicians have faced "reportable" consequences for this unethical behavior. However, physician self-reported data suggest that the problem occurs at a higher rate. We discuss the factors that can explain why such sexual abuse of patients is a persistent problem in the U.S. health care system. We implore the medical community to begin a candid discussion of this problem and call for an explicit zero-tolerance standard against sexual abuse of patients by physicians. This standard must be coupled with regulatory, institutional, and cultural changes to realize its promise. We propose initial recommendations toward that end.
- Published
- 2019
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25. Crossing the line: Sexual misconduct by nurses reported to the National Practitioner Data Bank.
- Author
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AbuDagga A, Wolfe SM, Carome M, and Oshel RE
- Subjects
- Adult, Confidentiality, Female, Humans, Male, Malpractice statistics & numerical data, Middle Aged, National Practitioner Data Bank, United States, Nurse-Patient Relations, Professional Misconduct statistics & numerical data, Sex Offenses statistics & numerical data, Sexual Behavior statistics & numerical data
- Abstract
Objective: The objective of this study was to examine nurse sexual-misconduct-related reports in the National Practitioner Data Bank (NPDB) and to compare them with reports for other types of offenses., Design and Population: We analyzed NPDB's reports of adverse state nursing board licensure actions and malpractice payments for all nurses from January 1, 2003, to June 30, 2016., Results: Overall, 882 nurses had sexual-misconduct-related reports. Most were aged 35-54 (63.2%), male (63.2%), and registered or advanced practice nurses (61.5%). The disciplinary actions noted in the 988 nurse sexual-misconduct-related licensure reports were more frequently serious than those noted in the 207,023 reports for other offenses committed by nurses (90.8% vs. 74.8%, respectively; p < 0.001). Of the 33 nurses with sexual-misconduct-related malpractice-payment reports, 48.5% were not disciplined by any state board of nursing for these offenses. Three-quarters of the victims in the 47 sexual-misconduct-related malpractice-payment reports were female, with "emotional injury only" reported as the severity of injury in 91.5% of these reports., Conclusions: Very few nurses have been reported to the NPDB due to sexual misconduct. We welcome a zero-tolerance standard against sexual misconduct involving patients by all types of health care professionals, including nurses., (© 2018 Public Citizen Foundation. Public Health Nursing Published by Wiley Periodicals, Inc.)
- Published
- 2019
- Full Text
- View/download PDF
26. Cross-Sectional Analysis of the 1039 U.S. Physicians Reported to the National Practitioner Data Bank for Sexual Misconduct, 2003-2013.
- Author
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AbuDagga A, Wolfe SM, Carome M, and Oshel RE
- Subjects
- Adolescent, Adult, Aged, Child, Child, Preschool, Crime Victims, Cross-Sectional Studies, Female, Humans, Infant, Male, Middle Aged, Retrospective Studies, United States, Young Adult, National Practitioner Data Bank statistics & numerical data, Physicians statistics & numerical data, Professional Misconduct statistics & numerical data, Sexual Behavior
- Abstract
Background: Little information exists on U.S. physicians who have been disciplined with licensure or restriction-of-clinical-privileges actions or have had malpractice payments because of sexual misconduct. Our objectives were to: (1) determine the number of these physicians and compare their age groups' distribution with that of the general U.S. physician population; (2) compare the type of disciplinary actions taken against these physicians with actions taken against physicians disciplined for other offenses; (3) compare the characteristics and type of injury among victims of these physicians with those of victims in reports for physicians with other offenses in malpractice-payment reports; and (4) determine the percentages of physicians with clinical-privileges or malpractice-payment reports due to sexual misconduct who were not disciplined by medical boards., Methods and Results: We conducted a cross-sectional analysis of physician reports submitted to the National Practitioner Data Bank (NPDB) from January 1, 2003, through September 30, 2013. A total of 1039 physicians had ≥ 1 sexual-misconduct-related reports. The majority (75.6%) had only licensure reports, and 90.1% were 40 or older. For victims in malpractice-payment reports, 87.4% were female, and "emotional injury only" was the predominant type of injury. We found a higher percentage of serious licensure actions and clinical-privileges revocations in sexual-misconduct-related reports than in reports for other offenses (89.0% vs 68.1%, P = < .001, and 29.3% vs 18.8%, P = .002, respectively). Seventy percent of the physicians with a clinical-privileges or malpractice-payment report due to sexual misconduct were not disciplined by medical boards for this problem., Conclusions: A small number of physicians were reported to the NPDB because of sexual misconduct. It is concerning that a majority of the physicians with a clinical-privileges action or malpractice-payment report due to sexual misconduct were not disciplined by medical boards for this unethical behavior.
- Published
- 2016
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27. Rosuvastatin: winner in the statin wars, patients' health notwithstanding.
- Author
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Wolfe S
- Subjects
- Advertising, Drug Approval, Humans, Kidney Diseases chemically induced, Rhabdomyolysis chemically induced, Risk Assessment, Rosuvastatin Calcium, United States, United States Food and Drug Administration, Fluorobenzenes adverse effects, Fluorobenzenes therapeutic use, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Pyrimidines adverse effects, Pyrimidines therapeutic use, Sulfonamides adverse effects, Sulfonamides therapeutic use
- Published
- 2015
- Full Text
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28. Proposed US Food and Drug Administration guidance for industry on distributing medical publications about the risks of prescription drugs and biological products: a misguided approach.
- Author
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Wolfe SM
- Subjects
- Drug Industry trends, Drug Labeling trends, Humans, Practice Guidelines as Topic, Publications, Risk, United States, United States Food and Drug Administration, Biological Products adverse effects, Drug Industry standards, Drug Labeling standards, Information Dissemination methods, Prescription Drugs adverse effects
- Published
- 2014
- Full Text
- View/download PDF
29. Does $760 m a year of industry funding affect the FDA's drug approval process?
- Author
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Wolfe SM
- Subjects
- Humans, Product Surveillance, Postmarketing, Safety-Based Drug Withdrawals trends, Time Factors, United States, United States Food and Drug Administration, Drug Approval economics, Drug Industry, Financing, Organized
- Published
- 2014
- Full Text
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30. Escalating criminal and civil violations: pharma has corporate integrity? Not really.
- Author
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Wolfe SM
- Subjects
- Civil Rights, Female, Humans, Male, United States, Criminal Law, Drug Industry ethics, Drug Industry legislation & jurisprudence, Drug Industry standards, Ethics, Business, Malpractice legislation & jurisprudence
- Published
- 2013
- Full Text
- View/download PDF
31. Selling amphetamine emblazoned athletic shirts v overselling amphetamines: a tale of two entrepreneurs.
- Author
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Wolfe SM
- Subjects
- Female, Humans, Male, United States, United States Food and Drug Administration, Advertising, Amphetamines, Clothing, Small Business legislation & jurisprudence
- Published
- 2013
- Full Text
- View/download PDF
32. When EMA and FDA decisions conflict: differences in patients or in regulation?
- Author
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Wolfe SM
- Subjects
- Europe, European Union, Humans, United States, United States Food and Drug Administration standards, Drug Approval organization & administration, Drug Industry standards
- Published
- 2013
- Full Text
- View/download PDF
33. US study criticized for experimentation with premature infants.
- Author
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Wolfe SM
- Subjects
- Female, Humans, Infant, Newborn, Male, United States, Human Experimentation ethics, Human Experimentation legislation & jurisprudence, Infant, Premature, Informed Consent
- Published
- 2013
- Full Text
- View/download PDF
34. Survey of state medical and osteopathy board disciplinary web sites in 2006.
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Larson M, Lurie P, Marcus B, and Wolfe S
- Subjects
- Employee Discipline statistics & numerical data, Health Care Surveys, Humans, United States, Employee Discipline legislation & jurisprudence, Internet, Osteopathic Physicians legislation & jurisprudence, State Government
- Abstract
We sought to describe doctor disciplinary information provided on the web sites of state medical and osteopathic boards. Information collected included state board, hospital and federal government actions, as well as malpractice judgments and settlements and conviction information. Web sites were also assessed for user-friendliness, primarily their searchability. Expert reviewers provided weights for these elements, yielding a 100-point score. The median score was 42.4 (range: 12.3-83.7). All sites provided physician profile information and 92% offer at least some board disciplinary information. Thirty-two percent provided non-state disciplinary information and 13 states' web sites were not searchable. We conclude that some boards provide very limited information and many do not facilitate efficient consumer access. The findings were released on Public Citizen's web site on October 17, 2006.
- Published
- 2009
35. The role of tax reform in health care reform.
- Author
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Floyd JS, Wolfe SM, and Angell M
- Subjects
- Policy Making, United States, Health Care Reform, Politics, Taxes
- Published
- 2009
- Full Text
- View/download PDF
36. This Wolfe isn't in sheep's clothing.
- Author
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Wolfe S
- Subjects
- Advisory Committees, History, 21st Century, Humans, United States, United States Food and Drug Administration, Consumer Advocacy history, Drug and Narcotic Control history, Drug-Related Side Effects and Adverse Reactions
- Published
- 2009
- Full Text
- View/download PDF
37. Schroeder Lecture. Worst pills, best pills.
- Author
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Wolfe SM
- Subjects
- Advertising legislation & jurisprudence, Age Factors, Aged, Drug Approval, Drug Industry economics, Drug Industry legislation & jurisprudence, Drug Prescriptions, Drug Utilization standards, Humans, Law Enforcement, Middle Aged, Publishing, United States, Consumer Organizations, Drug-Related Side Effects and Adverse Reactions, Product Surveillance, Postmarketing, United States Food and Drug Administration
- Published
- 2006
38. U.S. physicians disciplined for criminal activity.
- Author
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Jung P, Lurie P, and Wolfe SM
- Subjects
- Adult, Age Distribution, Certification statistics & numerical data, Crime classification, Crime statistics & numerical data, Data Collection, Demography, Disclosure legislation & jurisprudence, Humans, Middle Aged, National Practitioner Data Bank legislation & jurisprudence, Physicians statistics & numerical data, Specialty Boards standards, State Government, United States, Crime legislation & jurisprudence, Licensure, Medical statistics & numerical data, Physicians legislation & jurisprudence, Specialty Boards statistics & numerical data
- Published
- 2006
39. Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings.
- Author
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Lurie P, Almeida CM, Stine N, Stine AR, and Wolfe SM
- Subjects
- Cross-Sectional Studies, Disclosure, Drug Evaluation, Financial Management, Research Support as Topic, United States, Advisory Committees economics, Advisory Committees ethics, Conflict of Interest economics, United States Food and Drug Administration economics, United States Food and Drug Administration ethics
- Abstract
Context: In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings., Objectives: To characterize financial conflict disclosures at drug-related meetings, and to assess the relationship between conflicts and voting behavior at meetings that considered specific products., Design and Setting: Cross-sectional study using agendas and transcripts from all FDA Drug Advisory Committee meetings (2001-2004) listed on the FDA Web site., Main Outcome Measures: Conflict rates, type, and size. The relationship between having a conflict and voting in favor of the index drug was described for each voter using Mantel-Haenszel relative risks and Monte Carlo simulations; Spearman rho was used for a meeting-level analysis comparing rates of conflict with voting patterns. The impact of the removal of persons with conflicts of interest on the vote margins was also evaluated., Results: A total of 221 meetings held by 16 advisory committees were included in the study. In 73% of the meetings, at least 1 advisory committee member or voting consultant disclosed a conflict; only 1% of advisory committee members were recused. For advisory committee members (n = 1957) and voting consultants combined (n = 990), 28% (n = 825) disclosed a conflict. The most commonly specified conflicts were consulting arrangements, contracts/grants, and investments. Nineteen percent of consulting arrangements involved over 10,000 dollars, 23% of contracts/grants exceeded 100,000 dollars, and 30% of investments were over 25,000 dollars. The meeting-level analysis did not show a statistically significant relationship between conflict rates ("index conflict," "competitor conflict," or "any conflict") and voting patterns, but a weak, statistically significant positive relationship was apparent for competitor conflict and any conflict in the Mantel-Haenszel analyses. The Monte Carlo analyses produced similar findings in the competitor conflict analysis only. In all 3 conflict categories, the exclusion of advisory committee members and voting consultants with conflicts would have produced margins less favorable to the index drug in the majority of meetings, but this would not have changed whether the majority favored or opposed the drug., Conclusions: Disclosures of conflicts of interest at drug advisory committee meetings are common, often of considerable monetary value, and rarely result in recusal of advisory committee members. A weak relationship between certain types of conflicts and voting behaviors was detected, but excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.
- Published
- 2006
- Full Text
- View/download PDF
40. There have been inadequate warnings that erectile dysfunction drugs can cause blindness.
- Author
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Wolfe SM
- Subjects
- Drug Prescriptions statistics & numerical data, Drug-Related Side Effects and Adverse Reactions, Humans, Incidence, Male, Phosphodiesterase Inhibitors therapeutic use, Purines, Risk Factors, Sildenafil Citrate, Sulfones therapeutic use, Tadalafil, Triazines therapeutic use, United States epidemiology, Vardenafil Dihydrochloride, Vasodilator Agents therapeutic use, Video Recording, Blindness epidemiology, Carbolines therapeutic use, Erectile Dysfunction drug therapy, Erectile Dysfunction epidemiology, Imidazoles therapeutic use, Piperazines therapeutic use, Risk Assessment methods
- Published
- 2005
41. America's neglected veterans: 1.7 million who served have no health coverage.
- Author
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Woolhandler S, Himmelstein DU, Distajo R, Lasser KE, McCormick D, Bor DH, and Wolfe SM
- Subjects
- Adolescent, Adult, Aged, Child, Female, Health Services Accessibility organization & administration, Health Services Accessibility statistics & numerical data, Health Status, Humans, Insurance Coverage economics, Insurance, Health economics, Male, Middle Aged, United States, United States Department of Veterans Affairs economics, Insurance Coverage statistics & numerical data, Insurance, Health statistics & numerical data, United States Department of Veterans Affairs organization & administration, United States Department of Veterans Affairs statistics & numerical data, Veterans statistics & numerical data
- Abstract
Many U.S. military veterans lack health insurance and are ineligible for care in Veterans Administration health care facilities. Using two recently released national government surveys--the 2004 Current Population Survey and the 2002 National Health Interview Survey--the authors examined how many veterans are uninsured (lacking health insurance coverage and not receiving care from the VA) and whether uninsured veterans have problems in access to care. In 2003, 1.69 million military veterans neither had health insurance nor received ongoing care at Veterans Health Administration (VHA) hospitals or clinics; the number of uninsured veterans increased by 235,159 since 2000. The proportion of nonelderly veterans who were uninsured rose from 9.9 percent in 2000 to 11.9 percent in 2003. An additional 3.90 million members of veterans' households were also uninsured and ineligible for VHA care. Medicare covered virtually all Korean War and World War II veterans, but 681,808 Vietnam-era veterans were uninsured (8.7 percent of the 7.85 million Vietnam-era vets). Among the 8.27 million veterans who served during "other eras" (including the Persian Gulf War), 12.1 percent (999,548) lacked health coverage. A disturbingly high number of veterans reported problems in obtaining needed medical care. By almost any measure, uninsured veterans had as much trouble getting medical care as other uninsured persons. Thus millions of U.S. veterans and their family members are uninsured and face grave difficulties in gaining access to even the most basic medical care.
- Published
- 2005
- Full Text
- View/download PDF
42. Dangers of rosuvastatin identified before and after FDA approval.
- Author
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Wolfe SM
- Subjects
- Humans, Muscular Diseases chemically induced, Renal Insufficiency chemically induced, Rhabdomyolysis chemically induced, Rosuvastatin Calcium, United States, United States Food and Drug Administration, Drug Approval, Fluorobenzenes adverse effects, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Pyrimidines adverse effects, Sulfonamides adverse effects
- Published
- 2004
- Full Text
- View/download PDF
43. Administrative waste in the U.S. health care system in 2003: the cost to the nation, the states, and the District of Columbia, with state-specific estimates of potential savings.
- Author
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Himmelstein DU, Woolhandler S, and Wolfe SM
- Subjects
- Canada, National Health Programs economics, National Health Programs organization & administration, United States, Delivery of Health Care economics, Delivery of Health Care organization & administration, Efficiency, Organizational economics
- Abstract
This report provides nationwide and state-specific estimates of U.S. health care administration spending and potential savings in 2003 were the United States to institute a Canadian-style national health insurance system. The United States wastes more on health care bureaucracy than it would cost to provide health care to all its uninsured. Administrative expenses will consume at least dollar 399.4 billion of a total health expenditure of dollar 1,660.5 billion in 2003. Streamlining administrative overhead to Canadian levels would save approximately dollar 286.0 billion in 2003, dollar 6,940 for each of the 41.2 million Americans who were uninsured as of 2001. This is substantially more than would be needed to provide full insurance coverage. The cost of excess health bureaucracy in individual states is equally striking. For example, Massachusetts, with 560,000 uninsured state residents, could save about dollar 8,556 million in 2003 (dollar 16,453 per uninsured resident of that state) if it streamlined administration to Canadian levels. New Mexico, with 373,000 uninsured, could save dollar 1,500 million on health bureaucracy (dollar 4,022 per uninsured resident). Only a single-payer national health insurance system could garner these massive administrative savings, allowing universal coverage without any increase in total health spending. Because incremental reforms necessarily preserve the current fragmented and duplicative payment structure, they cannot achieve significant bureaucratic savings.
- Published
- 2004
- Full Text
- View/download PDF
44. Medicine. Ephedra--scientific evidence versus money/politics.
- Author
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Wolfe SM
- Subjects
- Ephedrine economics, Humans, Legislation, Drug, Legislation, Food, Plant Preparations adverse effects, Plant Preparations economics, Product Labeling, Product Surveillance, Postmarketing, United States, Dietary Supplements adverse effects, Dietary Supplements economics, Ephedra adverse effects, Ephedrine adverse effects, Politics, United States Food and Drug Administration
- Published
- 2003
- Full Text
- View/download PDF
45. Remedies needed to address the pathology in reporting adverse reactions and Food and Drug Administration use of reports.
- Author
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Wolfe SM
- Subjects
- Dissent and Disputes, Drug Industry, Humans, United States, Adverse Drug Reaction Reporting Systems organization & administration, United States Food and Drug Administration organization & administration
- Published
- 2003
46. Continuing exposure to hexavalent chromium, a known lung carcinogen: an analysis of OSHA compliance inspections, 1990-2000.
- Author
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Lurie P and Wolfe SM
- Subjects
- Feasibility Studies, Guideline Adherence statistics & numerical data, Humans, Labor Unions standards, Linear Models, Lung pathology, Maximum Allowable Concentration, Occupational Exposure statistics & numerical data, United States, Carcinogens, Environmental adverse effects, Chromium adverse effects, Lung drug effects, Occupational Exposure standards, United States Occupational Safety and Health Administration standards
- Abstract
Background: Hexavalent chromium is widely recognized to be a lung carcinogen. However, the U.S. Occupational Safety and Health Administration (OSHA) has failed to reduce the permissible exposure limit (PEL), despite having acknowledged in 1994 that the current limit is too high. In 1993, Public Citizen and the Paper, Allied-Industrial, Chemical and Energy Workers International Union (PACE) petitioned to lower the PEL from the current 100 microg/m(3) to 0.5 microg/m(3) as an 8-hr time-weighted average (TWA)., Methods: To assess industry compliance with the current PEL, and to determine the feasibility of achieving the proposed lower limit of 0.5 microg/m(3), we conducted a secondary data analysis of OSHA's Integrated Management Information System (IMIS) database. This database contains 813 measurements of hexavalent chromium exposure from inspections performed during the years 1990-2000., Results: There was a statistically significant decline in the annual number of measurements over the study period from 127 in 1990 to 67 in 2000 (F = 0.0009; linear regression). The median TWA measurement was 10 microg/m(3) (range: 0.01-13,960 microg/m(3)) and the median ceiling measurement was 40.5 microg/m(3) (range: 0.25-25,000 microg/m(3)). Neither median TWA nor median ceiling exposures (if hexavalent chromium was detected) declined significantly during the study period (F = 0.065 and 0.57, respectively). Overall, 13.7% of TWA measurements were at or below the Public Citizen/PACE proposed standard; 65.0% were between the Public Citizen/PACE proposal and the current OSHA PEL; and 21.3% exceeded the OSHA PEL. Compared to OSHA measurements, state measurements were less likely to detect hexavalent chromium (40.2% vs. 52.1%; P = 0.0007; chi-square) and less likely to issue any citation (9.3% vs. 19.1%; P = 0.0003), including citations for overexposure if the exposure exceeded the PEL (54.8% vs. 78.8%; P = 0.012)., Conclusions: U.S. workers continue to be exposed to dangerously high hexavalent chromium levels, but low exposure levels were found in some industries. Further investigations should examine whether state plans provide weaker enforcement than federal OSHA., (Copyright 2002 Wiley-Liss, Inc.)
- Published
- 2002
- Full Text
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47. Relationship between low quality-of-care scores and HMOs' subsequent public disclosure of quality-of-care scores.
- Author
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McCormick D, Himmelstein DU, Woolhandler S, Wolfe SM, and Bor DH
- Subjects
- Access to Information, Cohort Studies, Community Participation, Data Collection, Health Maintenance Organizations classification, Health Services Research, Humans, Public Opinion, Quality Assurance, Health Care, Quality Indicators, Health Care, Retrospective Studies, Social Responsibility, United States, Disclosure, Health Maintenance Organizations standards, Information Management standards, Information Services supply & distribution, Quality of Health Care classification
- Abstract
Context: Public disclosure of quality data on health maintenance organizations (HMOs) might improve public accountability, inform consumer decision making, and promote quality improvement. But, because disclosure is voluntary, some HMOs could subvert these objectives by refusing to release unfavorable data., Objective: To determine the association between HMO quality of care and withdrawal from public disclosure of quality-of-care data the subsequent year., Design and Setting: Retrospective cohort study of administrative and quality-of-care data on HMOs from the National Committee for Quality Assurance (NCQA) annual Quality Compass databases for 1997, 1998, and 1999, including Health Plan Employer Data and Information Set (HEDIS) quality scores., Main Outcome Measure: One-year rates of HMO withdrawal from public disclosure of HEDIS scores for plans in the highest and lowest tertiles of HEDIS scores, adjusted for method of data collection and plan model type., Results: Of the 329 HMOs that publicly disclosed HEDIS scores in 1997, 161 plans (49%) withdrew from public disclosure in 1998. Of the 292 HMOs that disclosed their scores in 1998 (including 130 newly participating plans), 67 plans (23%) withdrew from public disclosure in 1999. Plans whose scores ranked in the lowest-quality tertile were much more likely than plans ranking in the highest-quality tertile to withdraw from public disclosure in 1998 (odds ratio [OR], 3.6; 95% confidence interval [CI], 2.1-7.0) and 1999 (OR, 5.7; 95% CI, 2.7-17.7)., Conclusion: Compared with HMOs receiving higher quality-of-care scores, lower-scoring plans are more likely to stop disclosing their quality data. Voluntary reporting of quality data by HMOs is ineffective; selective nondisclosure undermines both informed consumer decision making and public accountability.
- Published
- 2002
- Full Text
- View/download PDF
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