Simulated Side Effects: FDA Uses Novel Computer Model to Guide Kratom Policy

FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug policy is a new development with implications that extend beyond the regulation of kratom. We currently live in the Digital Age, a period in which most information is in digital form. However, the Digital Age is rapidly evolving into an Age of Algorithms in which computer software increasingly assumes the roles of human decision makers. The FDA’s use of computer simulations to evaluate drugs is a bold first step into this new era. This essay discusses the potential risks of basing federal drug policies on computer models that have not been thoroughly explained or validated (using the kratom debate as a case study).

Kratom grows naturally in Southeast Asian countries such as Thailand and Malaysia where it has been used for centuries as a stimulant and pain reliever. In recent years, the plant has gained popularity in the United States as an alternative to illicit and prescription narcotics. Kratom advocates claim it is harmless and useful for treating pain and easing symptoms of opioid withdrawal. However, the FDA contends it has no medical use and causes serious or fatal complications. As a result, the US Drug Enforcement Agency (DEA) may categorize kratom in Schedule I, its most heavily restricted category.

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The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium

The Conduct of Clinical Trials of Treatments during Public Health Emergencies: A Health Policy and Bioethics Consortium
February 9, 2018, 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In the past several years, the United States has struggled to respond to viral outbreaks, such as Ebola and Zika.  There is now an awareness of the need to rapidly develop vaccines and treatments for epidemics that can quickly spread from country to country. But questions remain as how to best conduct clinical trials and development of vaccines in the context of an epidemic or outbreak.

Join two health policy experts in examining the appropriate conduct of clinical trials during public health emergencies.

Panelists

  • Susan Ellenberg, Professor Of Biostatistics, Biostatistics And Epidemiology, the Hospital of the University Of Pennsylvania and Director, Biostatistics And Data Management Core, Penn Center For AIDS Research
  • Jason Schwartz, Assistant Professor of Public Health (Health Policy), Yale School of Public Health and Assistant Professor, Program in the History of Science and Medicine, Yale University
  • Moderator: Carmel Shachar, Executive Director, the Petrie-Flom Center, and Lecturer on Law, Harvard Law School

Lunch will be provided. This event is free and open to the public.

Learn more about the Health Policy and Bioethics Consortia.

The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations. They are organized by the Center for Bioethics at Harvard Medical School and the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.