Law provisions are allowing for the funding of questionable clinical trials marketed towards US children in poor countries like India and Uganda. Many diseases in children are rare, so trials are often performed on adults instead. However, companies receive an extended six months of life for a patent with trial information from children, in accordance with the Pediatric Exclusivity Act. To conserve spending, these trials are often conducted in poor countries instead, where many families lack access to any other medical services; they greatly desire any kind of help. Many concerns are raised regarding informed consent. While the parents are the ones responsible for consent, language barriers have shown they do not often understand the details of the agreements. Very rarely do they even think to ask questions regarding side effects, effectiveness, policy, etc. After testing, it is also not mandated that these drugs will be available for use in the countries in which they were tested. Of all the trials that have been run, not even half of them end up published in medical journals.
Source: Joelving, Frederik. (2010, Aug 23). “Many drugs for U.S. Kids Tested in Poor Countries.” Reuters, http://www.reuters.com/article/idUSTRE67M1VO20100823?pageNumber=2
Student Researcher: Courtney McLamb
Expert Evaluator: Richard Moose, MD, SUNY Potsdam