The IOM is hosting a workshop *right now* on Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings. You can sign up via a quick online form, and they’ll immediately send you a link to the live webcast (agenda here), which will hopefully be archived. Our own Glenn Cohen is slated…
By Richard Epstein Bad News On December 14, 2012, the US Food and Drug Administration granted an accelerated approval to the drug Ponatinib, which is used to treat patients with serious and life threatening forms of leukemia. Unfortunately, the risks associated with the use of the drug have proved to be far greater than anticipated. …
By Ching-Fu Lin At the World Trade Organization (WTO) committee dealing with food safety and other issues under the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) held approximately three weeks ago, China raised several trade concerns about the Food Safety Modernization Act (FSMA). Other WTO members, such as Brazil, Belize, and Korea,…
By The Petrie-Flom Center [Ed. Note: This report stems from the “Issues in Clinical Data Sharing Conference” co-sponsored by MRCT and Petrie-Flom last May.] Press Release: A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that…
By Christopher Robertson The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science. There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they…
By Christopher Robertson Enjoying the fall foliage in Mt. Auburn Cemetery yesterday, I came across this marker for Benjamin Waterhouse. In the overwrought language that is appropriate on a grave marker: “In 1800 he introduced to the new world the blessing of vaccination. Overcame popular prejudice and distrust by testing it on his own children…
By Kuei-Jung Ni It has been over a week since the federal government shutdown started on October 1 and concerns over food safety due to the lack of essential food inspections have increased. The impasse on the budget constitutes a big challenge facing federal agencies responsible for monitoring food safety and protecting the public from…
By Ching-Fu Lin [See Part I here.] In response to the melamine-tainted milk scandal in 2008, China replaced its outdated Food Hygiene Act with the Food Safety Law, which came into effect in 2009. The 2009 Food Safety Law includes provisions on risk assessment methods, establishment of a food safety committee, mandatory product recall requirements,…
By Ching-Fu Lin Why should we be concerned about China’s food safety problem? A recent opinion by Adam Minter on Bloomberg offers yet another tough criticism on China’s food system: “For more than a decade, China has earned a reputation as one of the world’s worst food-safety offenders.” Melamine-tainted milk, rat meat sold as lamb, recycled “gutter oil” for…
By Nicholson Price This story is still developing, so this post will just be a quick pointer. You may have seen news stories about how FDA isn’t inspecting foods, and 90% of seafood isn’t getting inspected. And these are all worries about problems that we think might happen. Well, the problems have started. Salmonella-contaminated chicken…
