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Sidney M Wolfe

Publications and source records attributed to Sidney M Wolfe.

18 recordsLinked to original sources
PubMed2006

Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings.

CONTEXT: In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings.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.

Advisory Committees↗
PubMed2005

America's neglected veterans: 1.7 million who served have no health coverage.

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.

Adolescent↗
PubMed2004

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.

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.

Canada↗
PubMed2002

Relationship between low quality-of-care scores and HMOs' subsequent public disclosure of quality-of-care scores.

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.

Access to Information↗
PubMed2002

Timing of new black box warnings and withdrawals for prescription medications.

CONTEXT: Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs. OBJECTIVE: To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market. DESIGN AND SETTING: Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning). MAIN OUTCOME MEASURES: Frequency of and time to a new black box warning or drug withdrawal. RESULTS: A total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years. CONCLUSIONS: Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.

Adverse Drug Reaction Reporting Systems↗
PubMed2002

Continuing exposure to hexavalent chromium, a known lung carcinogen: an analysis of OSHA compliance inspections, 1990-2000.

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.

Carcinogens, Environmental↗