Estimating the benefits of public health policies that reduce harmful consumption.

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

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 $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 $3,630.

Atomoxetine use during a period of FDA actions.

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.

Economic issues with follow-on protein products.

The economic effects of the possible introduction of 'follow-on' protein products have been the subject of recent debate. Here, we aim to explore the economic issues surrounding this debate using three measures: total sales, product complexity and patent expiry. Our analysis shows that the sales of therapeutic protein products are concentrated in a relatively small number of branded products, which may be the most attractive targets for follow-on development. For the years 2013-2015, we estimate that products representing US$20 billion in annual sales--approximately half of all sales in 2006--can be expected to lose patent protection.

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

INTRODUCTION: An 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. METHODS: We 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. RESULTS: A 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. CONCLUSION: Although 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.

An improved approach to measuring drug innovation finds steady rates of first-in-class pharmaceuticals, 1987-2011.

For more than a decade, industry analysts and policy makers have raised concerns about declining pharmaceutical innovation, citing declining numbers of new molecular entities (NMEs) approved in the United States each year. Yet there is little consensus on whether this is the best measure of "innovation." We examined NME approvals during 1987-2011 and propose the three distinct subcategories of NMEs--first-in-class, advance-in-class, and addition-to-class--to provide more nuanced and informative insights into underlying trends. We found that trends in NME approvals were largely driven by addition-to-class, or "me too," drug approvals, while first-in-class approvals remained fairly steady over the study period. Moreover, the higher proportion of first-in-class drug approvals over the most recent decade is an encouraging sign of the health of the industry as a whole.

Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

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 agency's 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 requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.

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