Reinvigorating the concept of benefit: the failure of drug company-sponsored research on human subjects (original) (raw)

2008, Seton Hall law review

In the early 1970s, Congress directed the Secretary of Health, Education and Welfare to create a commission for the purpose of ascertaining the important principles that should guide biomedical research that uses human research subjects. The report of this commission was to be published by the Secretary in the Federal Register and, unless the Secretary made any other proposals, it was to become law, a statement of what the United States government required. This report became known as the Belmont Report, and its contents are widely known, 1 though its legal status is not as well-known or appreciated. The world of research and science has changed dramatically since the Belmont Report was written. This Article is not making a new claim when it says that pharmaceutical companies manipulate and suppress data that is generated on human research subjects in order to protect and expand on the industry's profitability. However, the interplay between this use of data and the requirements of the Belmont Report have, until now, gone unexamined. Last year literally millions of Americans were participants in medical research, with estimates ranging from 2.3 million to upwards