Clark Nardinelli

Human capital and the rise of American cities, 1900–1990

Abstract We propose that cities that start out with proportionately more knowledgeable people grow faster in the long run because (a) knowledge spillovers are geographically limited to the city and (b) much knowledge is most productive in the city within which it is acquired. We found that city-aggregates and metropolitan areas with higher average levels of human capital grew faster over the 20th century. The estimated effects of human capital were large: a standard deviation increase in human capital in 1900 was associated with a 38% increase in average annual employment growth of city-aggregates over the period 1900–86. The estimated effects for metropolitan areas were smaller but still economically significant: a standard deviation increase in 1940 human capital was associated with an increase in average annual employment growth over the period 1940–90 of about 15%. Although the rise of the automobile appears to have overwhelmed the importance of human capital in cities dominated by manufacturing early on, human capital seems to have been economically more important in manufacturing cities than in non-manufacturing cities later on. Moreover, the estimated effects of human capital persisted for very long periods of time, suggesting either that adjusting to the steady state is very lengthy, or that shocks to growth are correlated with the presence of human capital.

Healthcare impact of personalized medicine using genetic testing: an exploratory analysis for warfarin

Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too high, the risk of serious bleeding increases; if the dose is too low, the risk of stroke increases. We estimate the potential health benefits and resulting changes in healthcare costs should it become feasible to base personalized warfarin dosing decisions on appropriate genetic testing. Using different assumptions regarding the costs and effectiveness of genetic testing, we estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 4500-22,000 serious bleeding events annually. Genetic-based therapy could also reduce the incidence of strokes among patients taking warfarin. We estimate that the additional cost per patient from integrating genetic testing into warfarin therapy could range from US

The Per Case and Total Annual Costs of Foodborne Illness in the United States.

300 in our pessimistic case, to substantial healthcare cost savings in the optimistic case.

Estimating the Benefits of Public Health Policies that Reduce Harmful Consumption

We present an economic welfare-based method to estimate the health costs associated with foodborne illness caused by known viruses, bacteria, parasites, allergens, two marine biotoxins, and unspecified agents. The method generates health costs measured in both quality-adjusted life years and in dollars. We calculate the reduction in quality-adjusted life days caused by the illness and add reductions in quality-adjusted life years from any secondary effects that are estimated to occur. For fatal cases, we calculate the life years lost due to premature death. We add direct medical expenses to the monetary costs as derived from estimates of willingness to pay to reduce health risks. In total, we estimate that foodborne illness represents an annual burden to society of approximately

Atomoxetine use during a period of FDA actions.

36 billion, with an average identified illness estimated to reduce quality-adjusted life days by 0.84, which is monetized and included in the average cost burden per illness of

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals

3,630.

Despite 2007 Law Requiring FDA Hotline To Be Included In Print Drug Ads, Reporting Of Adverse Events By Consumers Still Low

For products such as tobacco and junk food, where policy interventions are often designed to decrease consumption, affected consumers gain utility from improvements in lifetime health and longevity but also lose utility associated with the activity of consuming the product. In the case of anti-smoking policies, even though published estimates of gross health and longevity benefits are up to 900 times higher than the net consumer benefits suggested by a more direct willingness-to-pay estimation approach, there is little recognition in the cost-benefit and cost-effectiveness literature that gross estimates will overstate intrapersonal welfare improvements when utility losses are not netted out. This paper presents a general framework for analyzing policies that are designed to reduce inefficiently high consumption and provides a rule of thumb for the relationship between net and gross consumer welfare effects: where there exists a plausible estimate of the tax that would allow consumers to fully internalize health costs, the ratio of the tax to the per-unit long-term cost can provide an upper bound on the ratio of net to gross benefits.

The Talk of the Town: Human Capital, Information, and the Growth of English Cities, 1861 to 1961

Context:The Food and Drug Administration (FDA) issued a Public Health Advisory entitled “Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine)” on September 29, 2005. At FDA’s request, the manufacturer subsequently added a boxed warning to the drug’s labeling on November 8, 2005. Objective:To evaluate whether the boxed warning for suicidal thinking in atomoxetine’s labeling was associated with a change in the pattern of attention-deficit/hyperactivity disorder (ADHD) medication use. Methods:Patients who had an ADHD diagnosis and were prescribed either atomoxetine or stimulants between January 2004 and December 2007 were selected from IMS LifeLink Health Plan Claims database. In this ecologic analysis, the outcome measure is the incident atomoxetine use rate, defined as the proportion of atomoxetine incident users among all initial ADHD pharmacotherapy users. The impact of the boxed warning was evaluated using interrupted time series analysis. Results:A total of 16,311 patients met the definition of incident ADHD medication users. The incident atomoxetine use rate decreased from January 2004 to September 2005 among all age groups (range, −0.45% to −0.74%); and the rate among adult patients decreased by 11.89% (95% confidence interval, 3.05%–20.74%) from September 2005 to November 2005. No long-term impact was detected. Conclusions:Significant decline of the atomoxetine use rate was observed before the boxed warning in all age groups. No significant change was detected in the atomoxetine use rate among targeted children or adolescents after the FDA’s boxed warning concerning suicidal thinking.

An Improved Approach To Measuring Drug Innovation Finds Steady Rates Of First-In-Class Pharmaceuticals, 1987–2011

IntroductionAn important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions.MethodsWe study this question using an internal FDA database containing every new small molecule drug submitted to the FDA’s Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action.ResultsA total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing boxed warning.ConclusionAlthough drugs approved with a boxed warning or priority review are more likely to experience serious post-marketing safety events, other information provided during the FDA drug review that is easy to quantify is generally not associated with post-marketing safety events. It appears that these post-marketing events are not discernible during a pre-marketing review and therefore might not be avoidable using current review data.

Economic issues with follow-on protein products

In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agencys website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirements impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to