The "other diseases" of the Millennium Development Goals: rhetoric and reality of free drug distribution to cure the poor's parasites

The sixth MDG aims 'to combat HIV/AIDS, TB, malaria and other diseases'. The residual category of 'other diseases' has become the focus of intense interest, partly because it has provided an opportunity to increase resources for the control of the mostly parasitic 'neglected tropical diseases' (NTDs). Intense lobbying has secured large amounts of funding from donors, as well as generous donations of medicines from the major drug companies. A massive programme is now underway to treat the parasites of the poor in Africa via integrated vertical interventions of mass drug administration in endemic areas. The approach has been hailed as remarkably effective, with claims that there is now a real prospect of complete control and, for some NTDs, even elimination. However, a closer look at evaluation and research data reveals that much less is known about what is being achieved than is suggested. Competition between implementing organisations is leading to potentially counterproductive exaggerations about treatment coverage. Detailed local-level research in Uganda and Tanzania shows that actual rates of drug take-up among target populations are often lower than is necessary to effectively control the diseases, and that methods of drug distribution may even lead to active resistance to treatment. If current trends are not corrected, declining rates of NTD infection will not be sustained. Much more rigorous and effective monitoring is essential.     

Fatality involving complications of bupivacaine toxicity and hypersensitivity reaction

This case represents unusual findings of elevated bupivacaine and tryptase concentrations following local anesthetic, bupivacaine, administered as a scalene nerve block for elective rotator cuff repair surgery. Following bupivacaine injection, the patient exhibited almost immediate seizure activity, bradycardia, and cardiac arrest. Resuscitative efforts including cardiopulmonary bypass restored a cardiac rhythm. However, the clinical medical status of the patient progressively declined and he died 7 h following administration of the local anesthetic. Autopsy revealed several abnormalities of the heart including cardiomegaly, myocardial bridging, and lipomatous hypertrophy of the intraatrial septum, which may have contributed to bradycardia and arrhythmia. Postmortem toxicology results revealed elevated bupivacaine and tryptase concentrations. Elevated postmortem bupivacaine concentrations 7 h following administration and abrupt onset of seizures indicate unintentional intravascular injection instead of nerve and tissue infiltration. An elevated postmortem tryptase concentration points to the possibility of a hypersensitivity reaction to bupivacaine.     

Accidental through and through penetrating injury to the neck

We present the case of a 24-year-old driver who died when a metal pole entered the front windshield, traveled through the victim's neck, and then exited via the back windshield. This case illustrated an unusual penetration injury and the importance of a thorough and complete death scene investigation.     

License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions

Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish patent protection for inventions deemed to have commercial potential and license them for product development. Such licenses help stimulate economic development and job creation, bring a stream of royalty revenue to the institution and, hopefully, advance the public good or public health by bringing new and useful products to market. In the course of applying for such licenses, a commercial development plan is usually put forth by the license applicant. This plan indicates the path the applicant expects to follow to bring the licensed invention to market. In the case of small molecule drug compounds, there exists a widely-recognized series of clinical development steps, dictated by regulatory requirements, that must be met to bring a new drug to market, such as completion of preclinical toxicology, Phase 1, 2 and 3 testing and product approvals. These steps often become the milestone/benchmark schedule incorporated into license agreements which technology transfer offices use to monitor the licensee's diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind.This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH's exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic benchmark schedule.     

Embracing the new professionalism: self-regulation, mandatory reporting and their discontents

In response to perceived failures in medical self-regulation in Australia, first in two States (for doctors) and now under the National Registration and Accreditation Scheme (for all health practitioners), mandatory reporting of peer status or practice that poses risks to patients has been introduced. Yet now, in response to the lobbying of State and federal health ministers by the medical profession, mainly in relation to the impairment provisions, this is to be reviewed. This column argues that claims concerning the negative consequences for practitioners of mandatory reporting are illogical and lack supporting evidence. There is, however, evidence that the medical profession does not consistently act in accordance with its professed positions in the area of physician impairment and departure from accepted clinical standards. The call for a review of mandatory reporting reflects an outdated model of regulation that does not align with increasing calls for a "new professionalism". In its own interests, but primarily in the interests of patients, the medical profession should embrace new attitudes and practices that will at first appear to threaten the privilege of self-regulation, but on proper scrutiny will be seen as necessary to retain it.     

Campaign allocations under probabilistic voting

We develop a probabilistic voting model where candidates compete by advertising in different media markets. Ads are viewed by everyone within a market and cannot be targeted to subgroups such as one candidate??s partisans. Candidates estimate the distribution of voter preference intensities in a market, and campaign ads then shift this distribution. Individuals with any intensity vote with some probability for each candidate. We derive comparative static implications of changes in a variety of factors on the advertising decisions of each candidate. Using campaign advertising data from 2002, we find these results to be consistent with actual campaign allocation behavior.     

In the Eye of the Beholder? Motivated Reasoning in Disputed Elections

This study uses an experimental design to simulate the ballot counting process during a hand-recount after a disputed election. Applying psychological theories of motivated reasoning to the political process, we find that ballot counters’ party identification conditionally influences their ballot counting decisions. Party identification’s effect on motivated reasoning is greater when ballot counters are given ambiguous, versus specific, instructions for determining voter intent. This study’s findings have major implications for ballot counting procedures throughout the United States and for the use of motivated reasoning in the political science literature.     

An economic view of food deserts in the united states

Considerable policy and academic attention has been focused on the topic of food deserts. We consider this topic from an economic perspective. First, we consider how the components of a standard economic analysis apply to the study of food deserts. Second, using this economic lens, we revisit the empirical literature on food deserts to assess the progress that has been made regarding whether food deserts are problematic in the U.S. Overall, despite several studies documenting the existence of food deserts in local areas, shortcomings in available data have not allowed researchers to convincingly document the presence or absence of food deserts on a national scale, and virtually no research has provided insight as to why food deserts might exist. © 2010 by the Association for Public Policy Analysis and Management.     

Cosmetic surgery in Australia: a risky business?

Cosmetic surgery is increasing in popularity in Australia and New Zealand, as it is across other Western countries. However, there is no systematic mechanism for gathering data about cosmetic surgery, nor about the outcomes of that surgery. This column argues that the business of cosmetic surgery in Australia has questionable marketing standards, is conducted with little scrutiny or accountability and offers patients imperfect knowledge about cosmetic procedures. It also argues that while medical practitioners debate among themselves over who should carry out cosmetic procedures, little attention has been paid to questionable advertising in the industry and even less to highlighting the real risks of undergoing cosmetic surgery. While consumers are led to believe that cosmetic surgery is accessible, affordable and safe, they are sheltered from the reality of invasive and risky surgery and from the ability to clearly discern that all cosmetic procedures carry risk. While doctors continue to undertake advertising and engage in a territorial war, they fail to address the really important issues in cosmetic surgery. These are: providing real evidence about what happens in the industry, developing stringent regulations under which the industry should operate and ensuring that all patients considering cosmetic surgery are fully informed as to the risks of that surgery.     

USING COUNTY-BASED MARKETS TO SUPPORT AND FEDERAL RESERVE MARKETS TO IMPLEMENT BANK MERGER POLICY

In this paper, we consider three issues raised by the apparentinconsistency between the current research practice of usingcounty-based markets (Metropolitan Statistical Areas (MSAs)and non-MSA counties) to investigate the validity of the theoreticalunderpinnings of bank merger policy and the current regulatorypractice of using Federal Reserve (FR) banking markets, whichoften do not follow county lines, to implement that policy.Using a national sample of bank and thrift branch deposit data,we find that county-based areas cannot simply substitute forFR markets in the implementation of bank merger policy. Forexample, numerous potential mergers would raise competitiveissues in county-based areas, but not in FR markets, and viceversa. We also conclude that, because of the relative difficultyof assembling demographic data for non-county-based areas, itis impractical to consistently use FR markets in bank mergerpolicy research. However, we do find that, despite the inconsistenciesbetween the two types of markets, analysis that uses county-basedareas is relevant for bank merger policy that is implementedwith FR markets. For example, we find that profitability regressionresults using variables based on FR markets are similar to thosefound using variables based on MSAs and non-MSA counties.