Still Taxed to Death: An Analysis of Taxes and Tariffs on Medicines, Vaccines and Medical Devices

This paper examines the role that tariffs, domestic taxes, and regulatory requirements pose on access to essential drugs, vaccines and devices for the diseases that afflict the developing world. While aid has increased in recent years and the price of many drugs has fallen, access to medicines, vaccines and devices has not increased greatly. There are numerous reasons for this, notably the paucity of medical professionals in the poorest countries. The major one discussed in this paper is the barrier imposed by recipient countries themselves. For example the combined domestic tax and import tariff barrier in India until recently was over 60% and in Morocco it currently stands at 38%. Only just over a third of Indians have access to essential drugs and it is likely that a reduction of these financial impediments would increase access. Removal of these barriers would therefore likely save thousands of lives across the developing world. Southern African countries generally have fewer tariff barriers. But if South Africa removed its 14% sales tax, HIV patients could afford more food, and many are currently malnourished. Furthermore, many Southern African countries, such as Namibia, impose regulatory constraints (expensive and time consuming registration of products already approved in US/EU), which reduce access to essential medicines.Health and Safety, Regulatory Reform

Distinguishing skills from luck in trading and investment

This thesis develops a series of statistical frameworks to control type I errors in picking out-performers. It consists of three independent essays which assess performance of U.S. equity mutual funds, currency trading strategies and hedge funds. The first essay introduces a novel multiple hypothesis testing method named the functional False Discovery Rate“plus” (fFDR+). The method incorporates informative covariates in estimating the False Discovery Rate (FDR)of predictive models’ “conditional” performance. In simulations, the fFDR + control swell the FDR and gains considerable power over prior methods that do not account for extra information. In empirical analyses, we construct portfolios based on several covariates and show that they enhance the performance of mutual fund portfolios, highlighting the value of extra information in the multiple hypothesis testing framework. The second essay develops the multivariate functional false discovery rate (mfFDR) method that accounts for multiple informative covariates to examine the conditional performance of predictive models and gain a considerably higher power than prior methods including the one in the first essay. The proposed method is then applied to control luck in detecting profitable technical trading rules using 30 developed and emerging market currencies. It selects more profitable rules than prior methods; more importantly, these rules offer better out-of-sample performance. The third essay introduces a new procedure to control for family error rate (FWER) in picking out-performers. The method utilizes multiple side information to more precisely estimate the FWER and gains much higher power in detecting out-performers compared to existing ones. In empirical analyses, the method allows investors picking out-performing hedge funds with very low FWER. The portfolios of hedge funds selected by the method beat passive benchmarks in various settings. Further analyses show that the new method detects truly out-performing hedge fund managers who can repeat their past performance over a long horizon

Fundamental study of the development and evaluation of biodegradable Mg-Y-Ca-Zr based alloys as novel implant materials

Degradable metals hold considerable promise as materials which exhibit higher mechanical properties than degradable polymers while corroding over time to alleviate complications such as stress-shielding and infection that is inherent to permanent, bioinert metallic biomaterials. Specifically, degradable magnesium (Mg) alloys have emerged as a promising alternative for orthopedic and craniofacial applications due to their positive bone remodeling behavior, good biocompatibility, and relatively high strength compared to polymers while exhibiting similar stiffness to natural bone. Increasing the strength to maintain device integrity during degradation while simultaneously controlling the rapid corrosion of Mg to reduce the risk of hydrogen gas accumulation and toxicity are ongoing paramount goals for optimizing Mg alloys for musculoskeletal applications. In order to address these goals, novel Mg-Y-Ca-Zr based alloys were developed with alloying elements judiciously selected to impart favorable properties. Processing techniques including solution heat treatment combined with hot extrusion were employed to further enhance the desired properties of the material namely, controlled corrosion, high strength and ductility, and minimal toxic response. Increasing the Y content contributed to improved corrosion resistance yielding corrosion rates similar to commercial Mg alloys. Hot extrusion was employed to reduce the grain size, thereby improving mechanical properties through the Hall-Petch relation. Extrusion yielded extremely high strength relative to other Mg alloys, values approaching that of iron-based alloys, due to the presence of Mg12YZn, a long period stacking order phase that served to impede dislocation propagation. Both as-cast and extruded Mg-Y-Ca-Zr alloys demonstrated excellent in vitro cytocompatibility eliciting high viability and proliferation of MC3T3 pre-osteoblast cells and human mesenchymal stem cells. Alloying elements Y and Zr were specifically shown to improve cell proliferation. Finally, implantation of Mg-Y-Ca-Zr based alloys into the mouse subcutaneous tissue and intramedullary cavities of fractured rat femurs resulted in a normal host response and fracture healing, without eliciting any local or systemic toxicity. Thus, the alloys investigated in this work demonstrated great potential for applications as orthopedic and craniofacial implant biomaterials, warranting additional pre-clinical safety and efficacy trials that will be conducted in the near future

Pilot Study of Essential Drug Quality in Two Major Cities in India

BACKGROUND: India is an increasingly influential player in the global pharmaceutical market. Key parts of the drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit drugs available in the market and to discuss how the Indian state and federal governments could improve drug regulation and more importantly regulatory enforcement to combat these drugs. METHODOLOGY/PRINCIPAL FINDINGS: Random samples of antimalarial, antibiotic, and antimycobacterial drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard drugs (30% and 0% respectively), as was product heterogeneity, with some drugs being more or less frequently substandard (12% and 7% respectively). CONCLUSIONS/SIGNIFICANCE: In a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, important spatial and product heterogeneity exists, which suggests that India's substandard drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the drug regulatory system in India needs to be improved for domestic consumption, and because India is an increasingly important exporter of drugs for both developed and developing countries. Some poor countries with high burdens of disease have weak drug regulatory systems and import many HIV/AIDS, tuberculosis and malaria drugs from India

Mutual Funds' Conditional Performance Free of Data Snooping Bias

We introduce a test to assess mutual funds' "conditional" performance that is based on updated information and corrects data snooping bias. Our method, named the functional False Discovery Rate "plus" (f F DR +), incorporates fund characteristics in estimating fund performance free of data snooping bias. Simulations suggest that the f F DR + controls well the ratio of false discoveries and gains considerable power over prior methods that do not account for extra information. Portfolios of funds selected by the f F DR + outperform other tests not accounting for information updating, highlighting the importance of evaluating mutual funds from a conditional perspective

DDT and Malaria Prevention: Addressing the Paradox

Background: The debate regarding dichlorodiphenyltrichloroethane (DDT) in malaria prevention and human health is polarized and can be classified into three positions: anti-DDT, centrist-DDT, pro-DDT. Objective: We attempted to arrive at a synthesis by matching a series of questions on the use of DDT for indoor residual spraying (IRS) with literature and insights, and to identify options and opportunities. Discussion: Overall, community health is significantly improved through all available malaria control measures, which include IRS with DDT. Is DDT “good”? Yes, because it has saved many lives. Is DDT safe as used in IRS? Recent publications have increasingly raised concerns about the health implications of DDT. Therefore, an unqualified statement that DDT used in IRS is safe is untenable. Are inhabitants and applicators exposed? Yes, and to high levels. Should DDT be used? The fact that DDT is “good” because it saves lives, and “not safe” because it has health and environmental consequences, raises ethical issues. The evidence of adverse human health effects due to DDT is mounting. However, under certain circumstances, malaria control using DDT cannot yet be halted. Therefore, the continued use of DDT poses a paradox recognized by a centrist-DDT position. At the very least, it is now time to invoke precaution. Precautionary actions could include use and exposure reduction. Conclusions: There are situations where DDT will provide the best achievable health benefit, but maintaining that DDT is safe ignores the cumulative indications of many studies. In such situations, addressing the paradox from a centrist-DDT position and invoking precaution will help design choices for healthier lives

Drug procurement, the Global Fund and misguided competition policies

In an effort to increase competition and decrease price, the Global Fund to Fight AIDS, Tuberculosis and Malaria recently began asking some grant recipients to use international competitive bidding processes for certain drug purchases. Unfortunately, for countries like Kenya, this request has caused more harm than good. After awarding the tender for its annual supply of the anti-malarial artemether-lumefantrine to the lowest bidder, Ajanta Pharma, Kenya experienced wide stock-outs in part due to the company's inability to supply the order in full and on time. Similar problems could arise in Uganda. Despite Kenya's experience, Uganda has awarded its next tender for artemether-lumefantrine to Ajanta Pharma. Uganda is already facing wide stock-outs and risks exacerbating an already dire situation the longer it takes to fulfil the procurement contract. A tender process based primarily on price cannot account for a company's ability to consistently supply sufficient product in time