Decision Analysis and FDA Drug Review: A Proposal for Shadow Advisory Committees

The FDA seems to acknowledge that sometimes different standards of proof for assessing drug efficacy should be used. Dr. Mendeloff thus proposes a methodology that might illuminate the FDA\u27s decision-making and help better to assess its decisions

The Declining Effects of OSHA Inspections on Manufacturing Injuries: 1979 to 1998

This study compares the impact of OSHA inspections on manufacturing industries using data from three time periods: 1979-85, 1987-91, and 1992-98. We find substantial declines in the impact of OSHA inspections since 1979-85. In the earliest period we estimate that having an OSHA inspection that imposed a penalty reduces injuries by about 15%; in the later periods it falls to 8% in 1987-91 and to 1% (and statistically insignificant) in 1992-98. Testing for different effects by inspection type, employment size, and industry, we find differences across size classes, but these cannot explain the overall decline. In fact, we find reductions in OSHA's impact over time for nearly all subgroups we examine, so shifts across subgroups cannot explain the whole decline. We examine various other hypotheses concerning the declining impact, but in the end we are not able to provide a clear explanation for the decline.

Pediatric And Adult Lung Transplantation For Cystic Fibrosis

AbstractObjective: This paper was undertaken to review the experience at our institution with bilateral sequential lung transplantation for cystic fibrosis.Methods: Since 1989, 103 bilateral sequential lung transplants for cystic fibrosis have been performed (46 pediatric, 48 adult, 9 redo); the mean age was 21 ± 10 years. Cardiopulmonary bypass was used in all but one pediatric (age <18) transplant, and in 15% of adults.Results: Hospital mortality was 4.9%, with 80% of early deaths related to infection. Bronchial anastomotic complications occurred with equal frequency in the pediatric and the adult populations (7.3%). One- and 3-year actuarial survival are 84% and 61%, respectively (no significant difference between pediatric and adult age groups; average follow-up 2.1 ± 1.6 years). Mean forced expiratory volume in 1 second increased from 25% ± 9% before transplantation to 79% ± 35% 1 year after transplantation. Acute rejection occurred 1.7 times per patient-year, with most episodes taking place within the first 6 months after transplantation. The need for treatment of lower respiratory tract infections occurred 1.2 times per patient in the first year after transplantation. Actuarial freedom from bronchiolitis obliterans was 63% at 2 years and 43% at 3 years. Redo transplantation was performed only in the pediatric population and was associated with an early mortality of 33%. Eight living donor transplants (four primary transplants, four redo transplants) were performed with an early survival of 87.5%.Conclusion: Patients with end-stage cystic fibrosis can undergo bilateral lung transplantation with morbidity and mortality comparable to that seen in pulmonary transplantation for other disease entities. (J Thorac Cardiovasc Surg 1998;115:404-14

The social value of a QALY : raising the bar or barring the raise?

Background: Since the inception of the National Institute for Health and Clinical Excellence (NICE) in England, there have been questions about the empirical basis for the cost-per-QALY threshold used by NICE and whether QALYs gained by different beneficiaries of health care should be weighted equally. The Social Value of a QALY (SVQ) project, reported in this paper, was commissioned to address these two questions. The results of SVQ were released during a time of considerable debate about the NICE threshold, and authors with differing perspectives have drawn on the SVQ results to support their cases. As these discussions continue, and given the selective use of results by those involved, it is important, therefore, not only to present a summary overview of SVQ, but also for those who conducted the research to contribute to the debate as to its implications for NICE. Discussion: The issue of the threshold was addressed in two ways: first, by combining, via a set of models, the current UK Value of a Prevented Fatality (used in transport policy) with data on fatality age, life expectancy and age-related quality of life; and, second, via a survey designed to test the feasibility of combining respondents’ answers to willingness to pay and health state utility questions to arrive at values of a QALY. Modelling resulted in values of £10,000-£70,000 per QALY. Via survey research, most methods of aggregating the data resulted in values of a QALY of £18,000-£40,000, although others resulted in implausibly high values. An additional survey, addressing the issue of weighting QALYs, used two methods, one indicating that QALYs should not be weighted and the other that greater weight could be given to QALYs gained by some groups. Summary: Although we conducted only a feasibility study and a modelling exercise, neither present compelling evidence for moving the NICE threshold up or down. Some preliminary evidence would indicate it could be moved up for some types of QALY and down for others. While many members of the public appear to be open to the possibility of using somewhat different QALY weights for different groups of beneficiaries, we do not yet have any secure evidence base for introducing such a system

Individualized Cost-Effectiveness Analysis

John Ioannidis and Alan Garber discuss how to use incremental cost-effectiveness ratios (ICER) and related metrics so they can be useful for decision-making at the individual level, whether used by clinicians or individual patients

OSHA’s Role in Combating the COVID-19 Pandemic

Workplaces are a significant source of infection for COVID-19, as shown not only by the illnesses of health care workers, but also by the tens of thousands of positive cases and roughly 200 deaths at meatpacking plants. The Occupational Safety and Health Administration (OSHA) has responsibilities for keeping employees safe at work, but it has played a fairly limited role in addressing COVID-19. Some critics have called for a more aggressive enforcement role from OSHA. I agree that some increase in enforcement, including a new standard for infectious diseases, would be beneficial. But in addition, it is important to improve our ability to identify cases of infection where the workplace is a likely place of transmission. The objective should be to facilitate employers’ and employees’ efforts in identifying infected individuals. In addition to aiding in identifying cases, employers can and should aid in preventing transmission. Before discussing what role OSHA should play, it bears noting what its role has been to date during the pandemic. The most critical task in this pandemic is identifying ill people at an early disease stage, both for their own well-being and for reducing their role in spreading the disease. Although few evaluations of contact tracing for COVID-19 have been published, it appears that these efforts are often frustrated by lack of cooperation from the public. In many cases, employers should be a more reliable source of contact-tracing information. Employers also have their own incentive to prevent employees from spreading disease to fellow workers. An example of state initiatives that focus on employer reporting is a law enacted in California this summer, which requires employers to notify employees when a worker they interact with has a “potential exposure” to COVID-19. The notification requirement extends to contractors the employer is using and to unions representing the employees. The law also requires the employer to notify the local health department within 48 hours following an outbreak, as defined by the California Department of Public Health. The notification to a local health department in California must include the names of the individuals who the employer knows have either had positive tests or diagnoses, been told to isolate by a public health official, or died due to COVID-19. The law also requires the state’s public health department to post information about all worksites with positive test results and the number of cases reported. All of these measures appear consistent with Equal Employment Opportunity Commission stipulations. In California, the state’s Division of Occupational Safety and Health enforces these reporting requirements. All states could adopt similar rules except for the enforcement step. In states with federal occupational safety and health enforcement, states probably cannot assign power to a federal agency to enforce these state rules. Nonetheless, publication of the number of cases reported at each worksite would be valuable for helping federal OSHA target its limited resources, presumably at larger workplaces with more potential to spread infection. Two or three infections at a workplace with 500 workers, however, may indicate much better control efforts than two or three infections at a 20-employee workplace. Several other steps could be taken. First, OSHA could share information with state and local health departments about the workplaces where employees had filed complaints. Their additional capacity to investigate could be useful supplements to OSHA’s efforts. Second, OSHA should change its reporting rules to require employers to report positive employee COVID-19 tests to OSHA within 24 hours. OSHA already requires even quicker employer reporting of deaths, hospitalizations, and amputations. At least at first, we may find significant noncompliance with such a reporting requirement, but it would be one more way to increase the flow of information to identify cases. Finally, local health departments should be required by state law to report to employers that an employee tested positive for COVID-19. This reporting should occur naturally in the process of contact tracing. To ensure the transfer of information, however, this should be mandated by law. Health Insurance Portability and Accountability Act rules prevent the health department from providing the name of the employee, but employers may require employees to report positive tests. In the early days of the pandemic, an argument existed for OSHA to use penalties sparingly because of the uncertain information that employers received. Over time, that argument has lost force. U.S. Secretary of Labor Eugene Scalia reportedly observed in April that, “while coronavirus is a hazard in the workplace, it is not caused by work tasks themselves and cannot be viewed in the same regard as other workplace hazards.” It is true that the hazard did not arise from the regular production process. Close contacts at work and other settings, however, can help spread the disease. From a public health perspective, the difference is not germane. The argument about whether a more punitive approach would be more effective in preventing the spread of disease is more complicated. OSHA currently adheres to a long-standing principle that penalties should accompany the “first instance” of a violation and not be reserved only for employers who fail to come into compliance after being cited. This current practice probably serves a deterrent function, although the size of that precise effect has been difficult to determine. Nevertheless, OSHA’s current experience with the handful of violations it has cited in COVID-19 inspections suggests that enforcement actions may impose major burdens on the agency itself. Both of the general duty violations it issued against large meatpacking firms have been challenged and will probably take many months to resolve. OSHA probably faces a major hurdle demonstrating what steps firms can feasibly take to reconfigure workplaces to allow distancing between employees. In contrast, requirements for mask wearing should be easier to enforce. In the long term, it would be useful for OSHA to have a standard that makes it easier to enforce protections against infectious diseases. In the short term, however, it makes sense to focus on spreading information as widely as possible about where infections are occurring. Policymakers should also not forget other policies that offer protection to employees. These include allowing high-risk, unemployed workers to turn down jobs at workplaces that they do not view as safe but still maintain their benefits. Policies providing coverage under workers’ compensation for COVID-19 cases for diseases likely to be contracted at work could also provide incentives to employers and help for employees, especially those with poor benefits from their employers

OSHA’s Role in Combating the COVID-19 Pandemic

Workplaces are a significant source of infection for COVID-19, as shown not only by the illnesses of health care workers, but also by the tens of thousands of positive cases and roughly 200 deaths at meatpacking plants. The Occupational Safety and Health Administration (OSHA) has responsibilities for keeping employees safe at work, but it has played a fairly limited role in addressing COVID-19. Some critics have called for a more aggressive enforcement role from OSHA. I agree that some increase in enforcement, including a new standard for infectious diseases, would be beneficial. But in addition, it is important to improve our ability to identify cases of infection where the workplace is a likely place of transmission. The objective should be to facilitate employers’ and employees’ efforts in identifying infected individuals. In addition to aiding in identifying cases, employers can and should aid in preventing transmission. Before discussing what role OSHA should play, it bears noting what its role has been to date during the pandemic. The most critical task in this pandemic is identifying ill people at an early disease stage, both for their own well-being and for reducing their role in spreading the disease. Although few evaluations of contact tracing for COVID-19 have been published, it appears that these efforts are often frustrated by lack of cooperation from the public. In many cases, employers should be a more reliable source of contact-tracing information. Employers also have their own incentive to prevent employees from spreading disease to fellow workers. An example of state initiatives that focus on employer reporting is a law enacted in California this summer, which requires employers to notify employees when a worker they interact with has a “potential exposure” to COVID-19. The notification requirement extends to contractors the employer is using and to unions representing the employees. The law also requires the employer to notify the local health department within 48 hours following an outbreak, as defined by the California Department of Public Health. The notification to a local health department in California must include the names of the individuals who the employer knows have either had positive tests or diagnoses, been told to isolate by a public health official, or died due to COVID-19. The law also requires the state’s public health department to post information about all worksites with positive test results and the number of cases reported. All of these measures appear consistent with Equal Employment Opportunity Commission stipulations. In California, the state’s Division of Occupational Safety and Health enforces these reporting requirements. All states could adopt similar rules except for the enforcement step. In states with federal occupational safety and health enforcement, states probably cannot assign power to a federal agency to enforce these state rules. Nonetheless, publication of the number of cases reported at each worksite would be valuable for helping federal OSHA target its limited resources, presumably at larger workplaces with more potential to spread infection. Two or three infections at a workplace with 500 workers, however, may indicate much better control efforts than two or three infections at a 20-employee workplace. Several other steps could be taken. First, OSHA could share information with state and local health departments about the workplaces where employees had filed complaints. Their additional capacity to investigate could be useful supplements to OSHA’s efforts. Second, OSHA should change its reporting rules to require employers to report positive employee COVID-19 tests to OSHA within 24 hours. OSHA already requires even quicker employer reporting of deaths, hospitalizations, and amputations. At least at first, we may find significant noncompliance with such a reporting requirement, but it would be one more way to increase the flow of information to identify cases. Finally, local health departments should be required by state law to report to employers that an employee tested positive for COVID-19. This reporting should occur naturally in the process of contact tracing. To ensure the transfer of information, however, this should be mandated by law. Health Insurance Portability and Accountability Act rules prevent the health department from providing the name of the employee, but employers may require employees to report positive tests. In the early days of the pandemic, an argument existed for OSHA to use penalties sparingly because of the uncertain information that employers received. Over time, that argument has lost force. U.S. Secretary of Labor Eugene Scalia reportedly observed in April that, “while coronavirus is a hazard in the workplace, it is not caused by work tasks themselves and cannot be viewed in the same regard as other workplace hazards.” It is true that the hazard did not arise from the regular production process. Close contacts at work and other settings, however, can help spread the disease. From a public health perspective, the difference is not germane. The argument about whether a more punitive approach would be more effective in preventing the spread of disease is more complicated. OSHA currently adheres to a long-standing principle that penalties should accompany the “first instance” of a violation and not be reserved only for employers who fail to come into compliance after being cited. This current practice probably serves a deterrent function, although the size of that precise effect has been difficult to determine. Nevertheless, OSHA’s current experience with the handful of violations it has cited in COVID-19 inspections suggests that enforcement actions may impose major burdens on the agency itself. Both of the general duty violations it issued against large meatpacking firms have been challenged and will probably take many months to resolve. OSHA probably faces a major hurdle demonstrating what steps firms can feasibly take to reconfigure workplaces to allow distancing between employees. In contrast, requirements for mask wearing should be easier to enforce. In the long term, it would be useful for OSHA to have a standard that makes it easier to enforce protections against infectious diseases. In the short term, however, it makes sense to focus on spreading information as widely as possible about where infections are occurring. Policymakers should also not forget other policies that offer protection to employees. These include allowing high-risk, unemployed workers to turn down jobs at workplaces that they do not view as safe but still maintain their benefits. Policies providing coverage under workers’ compensation for COVID-19 cases for diseases likely to be contracted at work could also provide incentives to employers and help for employees, especially those with poor benefits from their employers