Explore the vast range of titles available.

The Constitution of the World Health Organization (WHO) affirms that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.” The Universal Declaration of Human Rights lays the foundations for the international framework for the right to health. This human right is now codified in numerous national constitutions, as well as legally binding international human rights treaties, such as the International Covenant on Economic, Social and Cultural Rights.Although medical care and access to medicines are vital features of the right to health, almost two billion people lack access to essential medicines, leading to immense avoidable suffering. Improving access to essential medicines could save 10 million lives each year, four million of them in Africa and South-East Asia alone. Gross inequity is a shocking feature of the world pharmaceutical situation.

As a result of the growth of evidence-based practices across the world, health-care providers and policymakers in the United States, United Kingdom, and Europe have established institutes such as the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) to produce clinical guidelines that physicians are asked to use in their daily practice. This article discusses how the withholding of clinical trial information by pharmaceutical companies and academic researchers affects the reliability of clinical guidelines. It first offers a case study analysis of the U.K. drug regulator’s failure to prosecute GlaxoSmithKline, manufacturer of the bestselling antidepressant Seroxat (manufactured as Paxil in North America), for withholding information on the safety of Seroxat from regulators. It next examines the idea of a “Sarbanes- Oxley for Science,” a recent proposal that seeks to introduce legislation forcing companies to disclose clinical trials that have indeterminate or negative results. Legislation such as Sarbanes-Oxley for Science would solve some problems with the withholding of data, but not all. Until practitioners and policymakers address the political and legal barriers preventing full access to clinical trial data for all medical treatments, the ideals of evidence-based practice will remain elusive.

In 1996, Glaxo Wellcome offered to donate up to a million treatment courses annually of Malarone, a new antimalarial, with a view to reducing the global burden of malaria. The Malarone Donation Programme (MDP) was established the following year. Eight pilot sites were selected in Kenya and Uganda to develop and evaluate an effective, locally sustainable donation strategy that ensured controlled and appropriate use of Malarone. The pilot programme targeted individuals who had acute uncomplicated Plasmodium falciparum malaria that had not responded to first-line treatments with chloroquine or sulfadoxine-pyrimethamine. Of the 161 079 patients clinically diagnosed at the pilot sites as having malaria, 1101 (0.68%) met all the conditions for participation and received directly observed treatment with Malarone. MDP had a positive effect at the pilot sites by improving the diagnosis and management of malaria. However, the provision of Malarone as a second-line drug at the district hospital level was not an efficient and effective use of resources. The number of deaths among children and adults ineligible for MDP at the pilot sites suggested that high priority should be given to meeting the challenges of malaria treatment at the community level.

Like many organizations, GlaxoSmithKline (GSK) implemented e-sourcing tools only to find that the realized savings fell below predicted levels due to an abundance of noncompliant purchases (purchases made outside contractual arrangements). GSK estimates that it loses between $80 and $120 million dollars of procurement savings because of noncompliance. GSK changed its information and compliance systems and obtained various benefits. Its implementation of compliance techniques improved purchase compliance by 50 percent in some areas of GSK. Companies can use a three-phase process for solving problems of noncompliance: (1) gathering data, (2) identifying causes of noncompliance, and (3) designing conformance mechanisms. Organizational control mechanisms misaligned with supply chain strategy caused friction.

If anything, the episode makes the case for a bill that Sens. Edward M. Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) recently shepherded through the Senate. The most potent criticism of the FDA's behavior in the Avandia case is that it hasn't moved fast enough to quantify the drug's dangers. The legislation would give the FDA clear authority to order post-approval studies if the regulator got a whiff of undocumented risks. The bill would also promote the pooling of public and private data on prescription drugs so that possible side effects can be discovered earlier and appropriate studies commissioned more rapidly. The House should embrace the Senate's approach.

Mr. [Eliot Spitzer] is going after British-based Glaxo for \"concealing\" information about its popular antidepressant medicine, Paxil. According to America's new self-anointed drug czar, Glaxo's crime is that it publicized one study showing Paxil had positive results in adolescents, but didn't advertise four studies that showed inconclusive results or suggested Paxil may increase the risk of suicidal thoughts. Mr. Spitzer alleges these \"selective disclosures\" robbed doctors of relevant information and constituted \"fraud\" under New York law. Mr. Spitzer also had the embarrassing luck to pick on a class of drugs that the FDA has made a top priority. The agency has been minutely examining studies for depression drugs, and that includes those for Paxil. Not only has the FDA scrutinized the studies Mr. Spitzer claims were \"concealed,\" the agency has asked manufacturers to strengthen suicide warning labels and has provided a steady stream of guidance to doctors. The process is working exactly as it should. Mr. Spitzer's second-guessing could do genuine public-health damage, as evident from a recent California case. A plaintiff sued to require manufacturers of nicotine replacement therapies to put stronger warnings for pregnant women on their California products than is federally required. The FDA made the case that such a move would dilute the FDA's message that smoking is still more harmful to pregnant women than nicotine. The court ultimately agreed with the FDA that California women deserve to know that just like everyone else.