Anup Malani

Clinical and Economic Outcomes Attributable to Health Care-Associated Sepsis and Pneumonia

BACKGROUND Health care-associated infections affect 1.7 million hospitalizations each year, but the clinical and economic costs attributable to these infections are poorly understood. Reliable estimates of these costs are needed to efficiently target limited resources for the greatest public health benefit. METHODS Hospital discharge records from the Nationwide Inpatient Sample database were used to identify sepsis and pneumonia cases among 69 million discharges from hospitals in 40 US states between 1998 and 2006. Community-acquired infections were excluded using criteria adapted from previous studies. Because these criteria may not exclude all community-acquired infections, outcomes were examined separately for cases associated with invasive procedures, which were unlikely to result from preexisting infections. Attributable hospital length of stay, hospital costs, and crude in-hospital mortality were estimated from discharge records using a multivariate matching analysis and a supplementary regression analysis. These models controlled for patient diagnoses, procedures, comorbidities, demographics, and length of stay before infection. RESULTS In cases associated with invasive surgery, attributable mean length of stay was 10.9 days, costs were

Identifying Placebo Effects with Data from Clinical Trials

32 900, and mortality was 19.5% for sepsis; corresponding values for pneumonia were 14.0 days,

Improving the FDA Approval Process

46 400, and 11.4%, respectively (P < .001). In cases not associated with invasive surgery, attributable mean length of stay, costs, and mortality were estimated to be 1.9 to 6.0 days,

Valuing Laws as Local Amenities

5800 to

Advertisements impact the physiological efficacy of a branded drug

12 700, and 11.7% to 16.0% for sepsis and 3.7 to 9.7 days,

Economic epidemiology of avian influenza on smallholder poultry farms

11 100 to

Does Nonprofit Status Signal Quality

22 300, and 4.6% to 10.3% for pneumonia (P < .001). CONCLUSION Health care-associated sepsis and pneumonia impose substantial clinical and economic costs.

Measurement errors: A principal investigator-agent approach

A medical treatment is said to have placebo effects if patients who are optimistic about the treatment respond better to the treatment. This paper proposes a simple test for placebo effects. Instead of comparing the treatment and control arms of a single trial, one should compare the treatment arms of two trials with different probabilities of assignment to treatment. If there are placebo effects, patients in the higher‐probability trial will experience better outcomes simply because they believe that there is a greater chance of receiving treatment. This paper finds evidence of placebo effects in trials of antiulcer and cholesterol‐lowering drugs.

Incentives for Reporting Disease Outbreaks

The FDA employs an average-patient standard when reviewing drugs: it approves a drug only if is safe and effective for the average patient in a clinical trial. It is common, however, for patients to respond differently to a drug. Therefore, the average-patient standard can reject a drug that benefits certain patient subgroups (false negative) and even approval a drug that harms other patient subgroups (false positives). These errors increase the cost of drug development – and thus health care – by wasting research on unproductive or unapproved drugs. The reason why the FDA sticks with an average patient standard is concern about opportunism by drug companies. With enough data dredging, a drug company can always find some subgroup of patients that appears to benefit from its drug, even if it truly does not. In this paper we offer alternatives to the average patient standard that reduce the risk of false negative without increasing false positives from drug company opportunism. These proposals combine changes to institutional design – evaluation of trial data by an independent auditor – with statistical tools to reinforce the new institutional design – specifically, to ensure the auditor is truly independent of drug companies. We illustrate our proposals by applying them to the results of a recent clinical trial of a cancer drug (motexafin gadolinium). Our analysis suggests that the FDA may have made a mistake in rejecting that drug.

Incentives for Reporting Infectious Disease Outbreaks.

The conventional approach to evaluating a law is to examine its effect on proximate behavior. To evaluate a new criminal law, for example, the conventional approach would look to changes in the crime rate. This paper argues instead that laws should be judged by the extent to which they raise housing prices and lower wages. The logic is that the value of a law, much like the value of a lake or a public school, is capitalized into local housing and labor markets. Desirable laws increase housing prices and decrease wages because more people want to live in the relevant jurisdiction; undesirable laws have the opposite effects. Evaluating laws in the manner has several advantages over the conventional approach. First, it employs a more direct proxy for utility. Second, it accounts for all the effects of a law, including hard-to-measure outcomes, unintended consequences, and enforcement costs. Third, it permits direct comparison of different types of laws, which is important in instances where law-makers have limited resources to invest in law-making. Lastly, it sheds light on the distributional consequences of a law. In particular, it makes clear that a significant portion of every laws benefits are reallocated through housing and labor markets to property owners.