The title of the article is «Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs». This article has multiple authors, those are Jonathan J. Darrow, S.J.D., J.D., M.B.A., Ameet Sarpatwari, J.D., Ph.D., Jerry Avorn, M.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H. The article appeared in “The New England Journal of Medicine”. The article was published on the January 15. 2015.
The article discusses the expanded access system and use of investigational drugs in three spheres: practical, legislative and ethical. The first one describes the administrative process of obtaining the permit from the FDA to use the investigational drug and the burdens it holds. The second one touches upon the legal issues like 1) the patients’ constitutional rights to access the treatment at any stage of its investigation, 2) some patients have declared their contractual rights towards expanded access, and 3) the right-to-try laws in some States. The third ethical issue in the article observes that patients should have a right to lessen life-threatening situations and increase self-protection.
The article is of a mixed type. It provides its reader with an analyses of the expanded access system and use of investigational drugs via the practical, legal and ethical issues it faces. At the same time, the article has elements of the research paper in it as it has a lot of data in it. A prompt research on the FDA website has shown that the information in the article is valid and reliable.
Sure, there could be conflicting views to this article. Such topics as physician-assisted suicide, expanded access system, abortion always cause a lot of resistance in the legal and ethical spheres. No doubt that medical care is a very profitable industry, which requires big amounts of state and investor money. The information can be applied by the drug manufactures in the first place.
It is hard to agree or disagree with the authors views as the authors provides the reader with analyses, not personal opinion.
References
Jonathan J. Darrow, S.J.D., J.D., M.B.A., Ameet Sarpatwari, J.D., Ph.D., Jerry Avorn, M.D.,
Aaron S. Kesselheim, M.D., J.D., M.P.H. (January 15, 2015) Practical, Legal, and
Ethical Issues in Expanded Access to Investigational Drugs. The New England Journal of Medicine, 372:279-286.
