Reinvigorating the Concept of Benefit: The Failure of Drug Company-Sponsored Research on Human Subjects
61 Pages Posted: 19 Aug 2007 Last revised: 2 Jun 2013
Recent problems with drugs such as VIOXX and children's anti-depressants have revealed a wide-spread problem within the pharmaceutical industry about undisclosed risks and limited efficacy. The industry has exhibited a pattern of suppressing and manipulating data about drugs and medical devices in order to maximize profit. The data was largely generated through the use of volunteer human research subjects. This article argues that under the current regulatory structure that controls this type of research in the United States, much of this behavior by the industry is illegal.
A benefit to society must be anticipated from any study that is conducted on human research subjects for it to be considered an ethical study. This article examines when benefit to society is a legal, as well as ethical, requirement, binding on those who conduct or sponsor the studies. The article fleshes out what is meant by the concept of benefit, using, among other sources, the articles written by philosophers hired by the federal government in the 1970s to determine how research can be ethically conducted. Furthermore, shifts in the culture of medical research due to the legal and financial changes since the 1970s are also examined, to clarify why certain underlying assumptions about the role of benefit in research from that era are no longer accurate.
The suppression and manipulation of data by drug companies dilutes the possible benefit to society from a study to such a large degree as to render it unethical and, in certain critical aspects, illegal. The article calls for a reinvigorated concept of benefit, one that is examined critically in much the same way as informed consent has been.
Keywords: bioethics, pharmaceutical industry, research ethics, health law, Belmont Report, FDA
JEL Classification: I11, I18, I19, K23, K32
Suggested Citation: Suggested Citation