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Autophagy

Michael Kinch

in Prescription for Change: The Looming Crisis in Drug Development

The title of the chapter is a Greek term that literally translates into “eating oneself” and is representative of a trend of mergers and acquisitions that has subsumed the drug development enterprise ... More

The title of the chapter is a Greek term that literally translates into “eating oneself” and is representative of a trend of mergers and acquisitions that has subsumed the drug development enterprise over the past three decades and now fundamentally threatens our ability to develop new medicines. We begin with two examples of acquisitions by Eli Lilly & Company. One product resulted from an unexpected discovery by Pfizer scientists of a drug meant to treat angina that had the unexpected but not undesired effect of treating erectile dysfunction. The second acquisition, of New York-based Imclone, was the final step in a high profile controversy that led the jailing of its CEO and the celebrity Martha Stewart for insider trading. Despite these two acquisitions, Eli Lilly largely did not participate in the merger mania of the past few decades and we relate how this most innovative company fell through the rankings to become a middling contender. This waning resulted from the meteoric rise of Pfizer as one of the most aggressive purveyors of pharmaceutical industry consolidation and the unlikely rise of Valeant Pharmaceuticals, a company with a checkered history and ongoing woes.Less

Offshoring Experiments, Outsourcing Public Health: Corporate Accountability and State Responsibility for Violating the International Prohibition on Nonconsensual Human Experimentation

Bethany Spielman

in The Globalization of Health Care: Legal and Ethical Issues

This chapter uses the Kano, Nigeria, pediatric trials of the oral antibiotic Trovan and the litigation it produced to explore the remedies available to individuals suing U.S.-based multinational ... More

This chapter uses the Kano, Nigeria, pediatric trials of the oral antibiotic Trovan and the litigation it produced to explore the remedies available to individuals suing U.S.-based multinational corporations and the foreign states that host their clinical drug trials. It concentrates on litigation under the Alien Tort Statute (ATS). In 2001 families of children with bacterial meningitis filed lawsuits against Pfizer in the United States under ATS for violating a norm of customary international law prohibiting nonconsensual medical experimentation. The allegation of nonconsensual medical experimentation on human subjects had stated a claim under the ATS for a violation of the law of nations. Litigation under the ATS may continue to be the only path through which pharmaceutical corporations will be held accountable for nonconsensual experimentation. It is noted that these corporations will continue outsourcing some experiments from the United States to relatively poor nations.Less

CCR5 and HIV/AIDS Diagnostics and Therapeutics

Myles W. Jackson

in The Genealogy of a Gene: Patents, HIV/AIDS, and Race

In the last years of the 20th century, the CCR5 gene and its protein product became the objects of state-of-the-art work on diagnostics and drug treatment. The CCR5 patent’s lineage is now the ... More

In the last years of the 20th century, the CCR5 gene and its protein product became the objects of state-of-the-art work on diagnostics and drug treatment. The CCR5 patent’s lineage is now the subject of biomedical research on chemokine receptors and is entangled in the complex political, social, and biomedical lineages of HIV/AIDS with Big Pharma playing the lead role. The gene’s genealogy has been humanized and inextricably linked to the lives of the tens of millions infected worldwide. Once again, intellectual property issues resurface. HIV/AIDS diagnostic tests and medications have been patented by Big and Small Pharma alike, and the ramifications of those patents have been felt worldwide, including India, where attempts are underway to create generic drugs, which bind to the HIV-co-receptor.Less

In Defense of the Pfizer Factors 1 , 2 , 3

J. Howard Beales, Timothy J. Muris, and Robert Pitofsky

in The Regulatory Revolution at the FTC: A Thirty-Year Perspective on Competition and Consumer Protection

This chapter examines one particular aspect of consumer protection law—advertising substantiation—highlighting its merits and defending it against recent transgressions. It analyzes the FTC's 1972 ... More

This chapter examines one particular aspect of consumer protection law—advertising substantiation—highlighting its merits and defending it against recent transgressions. It analyzes the FTC's 1972 Pfizer decision, which established the principle that an advertiser must possess and rely upon a “reasonable basis” to substantiate its advertising claims. This doctrine has allowed the Commission to determine on a case-by-case basis whether an advertiser's evidence is sufficient to support its claim without being constrained by overly rigorous or formalistic tests. The chapter explains why “competent and reliable scientific evidence” is the appropriate standard for health-related claims about foods, and discusses the application of the standard to dietary supplements. It explains why repudiation of the Pfizer factors cannot be justified as fencing in relief.Less

Viagra: Hard Science or Hard Sell?

in Impotence: A Cultural History

On March 27, 1998, Viagra became the first oral medication to be approved by the U.S. Food and Drug Administration to treat erectile dysfunction. A flood of books and articles, which shows no sign of ... More

On March 27, 1998, Viagra became the first oral medication to be approved by the U.S. Food and Drug Administration to treat erectile dysfunction. A flood of books and articles, which shows no sign of abating, has subsequently been devoted to analyzing the pill's impact. Among the more insightful is Meika Loe's The Rise of Viagra: How the Little Blue Pill Changed Sex in America (2004). But what does it mean to say sex is changed? Is Viagra a wonder drug? A magic bullet? The rejuvenating potion doctors sought for centuries? Supporters of the medicalization of sexuality certainly claim as much. Previous surveys suggested that when strictly defined as the inability to get an erection perhaps ten percent of men suffered at times from impotence. To appreciate the Viagra phenomenon we need to trace the emergence of the new pharmacological agents that arose in the 1990s but then situate them in the context of changing cultural attitudes toward masculinity, medicine, and the enhancement technologies.Less

Article 43 TFEU

André Bouquet, Friedrich Erlbacher, and Alexandre-Xavier-Pierre Lewis

in The EU Treaties and the Charter of Fundamental Rights: A Commentary

Article 37 EC The Commission shall submit proposals for working out and implementing the common agricultural policy, including the replacement of the national organisations by one of the forms of ... More

Article 37 EC The Commission shall submit proposals for working out and implementing the common agricultural policy, including the replacement of the national organisations by one of the forms of common organisation provided for in Article 40(1), and for implementing the measures specified in this Title. Less