By Nicholson Price There’s a lot of talk and research about the drug industry, including its levels of innovation, its pricing patterns, transparency of clinical trials, industry changes over time, and how the industry is and should be regulated. But one thing that usually flies way under the radar is the question of actually making…
By Christopher Robertson I recently posted my new article “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment“. The article is forthcoming next year in Boston U. Law Review, but I have plenty of time to make revisions. So I would love to get the feedback from BillofHealth readers.…
By Scott Burris I am not disputing the value of properly trained health professionals acting as gate-keepers to potentially dangerous drugs. And I am not taking on here the question of which health care professionals should be allowed to prescribe which drugs, though that is an important question on which the states vary quite a…
By Nadia N. Sawicki A recent article in the New York Times (“Death Row Improvises, Lacking Lethal Mix”) described the challenges that correctional departments in death penalty states face in obtaining the drugs needed for lethal injection. The manufacturers of pancuronium bromide and pentobarbital, for example, have refused to supply drugs for execution purposes, and the…
By The Petrie-Flom Center The Edmond J. Safra Center for Ethics at Harvard University has organized a symposium on Institutional Corruption and Pharmaceutical Policy that will be published in the forthcoming issue of the Journal of Law, Medicine & Ethics, 2013: Vol. 14 (3). It will be published at the begining of September. The goals of…
By Nicholson Price In a unanimous opinion (pdf) in Cook v. FDA, the DC Circuit just held that FDA must prohibit the importation of misbranded or unapproved new drugs, including those made by unapproved manufacturers abroad. In this case, a set of prisoners on death row sued FDA to require it to prohibit the importation…
By Annette Rid Placebo controls usually get special treatment. Almost all ethical guidelines for research specify how to use placebo controls, in particular when an established or proven effective treatment exists. To list just a few: guidance issued by the World Medical Association, CIOMS and the Council of Europe all have provisions dedicated to the…
By Arthur Caplan An article in today’s New York Times explores allegations of improper research practices at GlaxoSmithKline’s research and development center in Shanghai, China. The article quotes Art Caplan in reference to evidence that researchers proceeded with drug trials in humans before animal studies were complete: “If that’s true, it’s a mortal sin in…
By Kevin Outterson In secret, during “trade” negotiations. Just one example: the 12 years of data exclusivity for biologics is currently US law, but that may get carved into stone in the new Trans-Atlantic Trade and Investment Partnership (TIIP). Once enshrined in a trade agreement, this rule and thousands more will be immune to change…
By Alex Stein Steven Brill’s TIME MAGAZINE blockbuster article, Bitter Pill: Why Medical Bills are Killing Us, uncovers the CHARGEMASTER: a publicly undisclosed pricelist accountable for what we see in hospital bills. What we see there doesn’t look good: it includes acetaminophen sold for $1.50 a tablet (you can buy 100 of those for the…
