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Independent research & practical ideas for global prosperity
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Independent research & practical ideas for global prosperity
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February 12, 2010FDA Goes Global: A New Approach to Food and Drug Import SafetyPosted by Tom Bollyky in Global Health, Global Health Architecture and Governance, Health Product Innovation and Access, Pharmaceuticals & Health Products
Last week, I participated in an event at the Center for Strategic and International Studies (CSIS) in which U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced a remarkable shift in the FDA’s thinking on food and drug import safety. If adequately supported by Congress and translated into concrete action, this change in strategy on food and drug safety could have significant benefits for U.S. and global health and development. Read More… 1 Comment »December 28, 2009A Public Health Time BombPosted by Rachel Nugent in Drug Resistance, Global Health, Health Product Innovation and Access, Pharmaceuticals & Health Products Tags: Drug ResistanceEmma Back and Alix Beith, consultants to the CGD Drug Resistance Working Group, contributed to this post. There’s a lot of attention being paid to the counterfeit drug trade at the moment. Former President of France, Jacques Chirac, recently chaired a meeting with West African leaders to discuss how to crack down on counterfeiting. Meanwhile, the Wellcome Trust and the American Pharmaceutical Group held an Opinion Formers’ conference on counterfeit medicines (presentations here); the International Federation of Pharmaceutical Manufacturers and Associations produced a brief on the issue; and Roger Bate has continued to draw attention to counterfeits and other drug quality issues in developing countries, including through his book Making a Killing. And this is all on top of the WHO-hosted IMPACT initiative on counterfeits, which started in 2006. 2 Comments »August 27, 2009Potential U.S. Supreme Court Case on Nigerian Drug Trial Presents Mixed Picture for Global HealthPosted by Tom Bollyky in Global Health, Global Health Architecture and Governance, Health Product Innovation and Access, Pharmaceuticals & Health ProductsA still from the movie “The Constant Gardener,” starring Rachel Weisz and based on the book by John le Carre, which was reportedly inspired by the Pfizer case. In 1996, Pfizer conducted a clinical trial of Trovan, a new antibiotic, on children during an outbreak of bacterial meningitis in Kano, Nigeria. Eleven children died and others were left badly injured, according to trial participants. In 2001, 30 Nigerian families sued in U.S. federal court, arguing that Pfizer deviated from its clinical trial protocol and failed to inform the children or their guardians of Trovan’s life-threatening side effects or that Médecins Sans Frontières was providing the conventional, proven treatment for bacterial meningitis for free at the same site. Pfizer has denied wrongdoing. Years of litigation followed over whether the case should be heard in U.S. courts. Earlier this year, a U.S. appeals court ruled that the Pfizer case could proceed. The U.S. Supreme Court is now deciding whether to hear the Pfizer case. If the Court hears the case, and there is a good chance it will, the Court will be asked to decide two important questions: (1) whether Pfizer acted in sufficiently close concert with the Nigerian government to be considered a “state actor” and, thus, possibly liable under the U.S. Alien Tort Statute (ATS) and (2) whether nonconsensual human medical experimentation violates customary international law. These questions sound pretty technical, but the Court’s answers could have significant practical implications for corporate responsibility, development, and global health. Read More… 11 Comments »August 24, 2009Reflections on NYT Magazine Special Issue on Gender: Three Questions to Guide the New CrusadePosted by Ruth Levine in Global Health Tags: Health Systems, Ruth Levine, UNAIDS, Women's HealthThis is a joint post with Molly Kinder and originally appeared on the Global Development: Views from the Center blog. This week The New York Times Magazine is dedicated to a single theme: women. The main attraction of this special issue is a stirring essay by journalists Nicholas Kristof and Sheryl WuDunn, who write passionately about the great moral, national security and economic development imperatives of investing in the world’s women and girls. The “women’s crusade” they call for seems already to have begun. A few pages beyond, an interview with Secretary Clinton heralds the start of a “new gender agenda” at the highest reaches of the U.S. foreign policy. Also noted is the growing philanthropic attention to the cause of women and girls – a trend that will be further evidenced next month, when the issue headlines at the annual (Bill) Clinton Global Initiative meetings in NYC. Read More… 4 Comments »August 12, 2009Terminology Matters: The Dispute between India and EU over Generic Drug TransshipmentsPosted by Tom Bollyky in 1, Global Health, Health Product Innovation and Access, Intellectual Property Rights, Pharmaceuticals & Health ProductsOver the last sixteen months, EU customs officials have impounded more than 20 shipments of pharmaceutical products manufactured by Indian companies. The EU maintains these seizures were intended to prevent trade in counterfeit medicines. India argues the EU is targeting developing country drug manufacturers and undermining access to lawful, safe, and low-cost generic drugs in developing country markets. Last week, India announced plans to seek settlement of the dispute at the World Trade Organization (WTO). The legal merits of the EU’s actions and India’s potential WTO claims are interesting questions. The more important issue for global health, however, is that disputes such as this one may be undermining international efforts to combat the trade in counterfeit medicines and the environment for legitimate generic products in developing countries. 3 Comments »July 24, 2009Keeping Up with U.S. Health Reform – Can We Do Better than China?Posted by Mead Over in Global Health Tags: Health Care ReformToday, as the Washington Post reports that Congress is suspending consideration of health reform for its August recess, it is a good time for those of us interested in following the issues to catch up with where the reform is going. Slate Magazine’s Online Guide to health reform is a great link to add to your favorites if you want to stay abreast of the discussion. An articleby Timothy Nash in today’s Slate magazine refers to Atul Gawande’s influential June 2009 New Yorker magazine article in support of increasing the share of health care delivered by multi-specialty group practices. If you found Gawande’s article persuasive, as I did, you will be depressed by Nash’s conclusion that the reform bill currently before the House of Representatives would do little to encourage or reward a shift of the mix of US health care provision in that direction. Read More… 6 Comments »July 13, 2009A C-Change in Presidential Rhetoric: Compassion to Conscience and Common InterestPosted by Ruth Levine in Global Health
In his speech on Saturday in Accra, Ghana, President Barack Obama described the motivation for U.S. support to AIDS, malaria and other health programs in Africa:
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