4
Jun2013

by Maeve Luthin, JD, Project Coordinator

It’s been a busy two weeks in the research ethics world! Grab some iced coffee and take some time to catch up with current events.

Dirty Medicine: Earlier this month, generic drug manufacturer Ranbaxy pled guilty to federal criminal charges of selling adulterated drugs with the intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government. In this piece, Fortune investigates the company’s long-term fraud and misconduct, as well as subsequent steps taken by the Food and Drug Administration (FDA) in response to the company’s noncompliance with federal regulations.

Drug Shortages: Washingtonian explores the realities of drug shortages by profiling the practical effects of the current parenteral nutrition shortage. Parenteral nutrition, made up of some 20 nutrients, is a form of intravenous nutrition often given to premature infants. It is also one of more than 300 drugs, vitamins, and trace-elements in short supply in the US.

 

Avian Flu in Animal Models: Animal research on the H7N9 avian influenza strain shows that the virus is transmissible between ferrets. Learning about how the flu spreads among mammals allows researchers to predict the possibility of future human-to-human transmission of the virus.

SUPPORT Trial Debate: On the Bioethics Forum, the blog of the Hastings Center, John Lantos, MD, argues that the consent forms used in the controversial SUPPORT trial were adequate as they conveyed all reasonably foreseeable risks. In a response blog, Michael Carome, MD, and Sidney Wolfe, MD, reject Dr. Lantos’ conclusions, and outline inconsistencies between the consent form and the study protocol.

 

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