PubMed Health⌕ Search

Biomedical subjects

Peter Lurie

Publications and source records attributed to Peter Lurie.

16 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CONTEXT: In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings.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↗
PubMed2006

Selected science: an industry campaign to undermine an OSHA hexavalent chromium standard.

While exposure to hexavalent chromium (Cr(VI)) has been associated with increased lung cancer risk for more than 50 years, the chemical is not currently regulated by the U.S. Occupational Safety and Health Administration (OSHA) on the basis of its carcinogenicity. The agency was petitioned in 1993 and sued in 1997 and 2002 to lower the workplace Cr(VI) exposure limit, resulting in a court order to issue a final standard by February 2006. Faced with the threat of stronger regulation, the chromium industry initiated an effort to challenge the scientific evidence supporting a more protective standard. This effort included the use of "product defense" consultants to conduct post hoc analyses of a publicly-funded study to challenge results viewed unfavorably by the industry. The industry also commissioned a study of the mortality experience of workers at four low-exposure chromium plants, but did not make the results available to OSHA in a timely manner, despite multiple agency requests for precisely these sorts of data. The commissioned study found a statistically significant elevation in lung cancer risk among Cr(VI)-exposed workers at levels far below the current standard. This finding changed when the multi-plant cohort was divided into two statistically underpowered components and then published separately. The findings of the first paper published have been used by the chromium industry to attempt to slow OSHA's standard setting process. The second paper was withheld from OSHA until it was accepted for publication in a scientific journal, after the rulemaking record had closed. Studies funded by private sponsors that seek to influence public regulatory proceedings should be subject to the same access and reporting provisions as those applied to publicly funded science. Parties in regulatory proceedings should be required to disclose whether the studies were performed by researchers who had the right to present their findings without the sponsor's consent or influence, and to certify that all relevant data have been submitted to the public record, whether published or not.

Carcinogens, Environmental↗
PubMed2006

Description of a research-based health activism curriculum for medical students.

INTRODUCTION: Few curricula train medical students to engage in health system reform. AIM: To develop physician activists by teaching medical students the skills necessary to advocate for socially equitable health policies in the U.S. health system. SETTING: Montefiore Medical Center, the University Hospital of the Albert Einstein College of Medicine, Bronx, NY. PROGRAM DESCRIPTION: We designed a 1-month curriculum in research-based health activism to develop physician activists. The annual curriculum includes a student project and 4 course sections;health policy, research methods, advocacy, and physician activists as role models; taught by core faculty and volunteers from academic institutions, government, and nongovernmental organizations. PROGRAM EVALUATION: From 2002 to 2005, 47 students from across the country have participated. Students reported improved capabilities to generate a research question, design a research proposal,and create an advocacy plan. DISCUSSION: Our curriculum demonstrates a model for training physician activists to engage in health systems reform.

Curriculum↗
PubMed2005

Violations of exhibiting and FDA rules at an American Psychiatric Association annual meeting.

We conducted a cross-sectional study of all exhibit booths for the 24 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 "noneducational 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.

Congresses as Topic↗
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↗