Digital Commons Network^™

Regulating Compounding Pharmacies After Necc, Kevin Outterson

Faculty Scholarship

Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.

A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson

Faculty Scholarship

The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.

Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson

Faculty Scholarship

In 2007, Vermont enacted the Prescription Confidentiality Law, prohibiting pharmacies from selling “prescriber-identifiable” prescription information to data-mining companies such as IMS Health and Verispan. These companies aggregate such data and sell them to many groups, including drug companies, so when drug sales representatives visit a physician, they can know exactly what prescriptions the physician has written.

Cancer And The Constitution: Choice At Life's End, George J. Annas

Faculty Scholarship

J. M. Coetzee's violent, anti-apartheid Age of Iron, a novel the Wall Street Journal termed “a fierce pageant of modern South Africa,” is written as a letter by a retired classics professor, Mrs. Curren, to her daughter, who lives in the United States. Mrs. Curren is dying of cancer, and her daughter advises her to come to the United States for treatment. She replies, “I can't afford to die in America. . . . No one can, except Americans.” Dying of cancer has been considered a “hard death” for at least a century, unproven and even quack remedies have been …

Counterfeit Drugs: The Good, The Bad, And The Ugly, Kevin Outterson

Faculty Scholarship

When I chose the title, Counterfeit Drugs: The Good, the Bad and the Ugly, some of my colleagues at this symposium blanched. They understood counterfeit drugs as Bad and Ugly, but resisted categorizing any counterfeit drug as Good. This article is intended to be provocative, challenging some of the conventional wisdom concerning counterfeit drugs.

We start with the fact that reports about the scope of pharmaceutical counterfeiting are remarkably anecdotal rather than empirical. As a professor once chided me, the plural of anecdote is not data. The FDA and the WHO must undertake comprehensive market surveillance to establish the true …

Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas

Faculty Scholarship

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …