John R. Hoffman is a Professor of Biology, public speaker and a scientist examining the recovery of the nervous system after injury. Since 2006 he has written several unpublished manuscripts and he is currently working on the first Nathaniel Smythe novel and short story collection. He spends his spare time with his family and running.

26 Stem Cell Policies

Objectives

By the end of this lecture, the student will be able to:

  1. Describe the basic process of determining if a medical procedure is covered by insurance.
  2. Describe the laws, regulations, and guidelines for the development and research of embryonic stem cells.
  3. Describe the regulatory mechanisms involved with the use of human stem cells.

Part 1. Stem Cell Policies: Health Care Coverage

This mini-lecture examines how insurance companies and medicare approve and reimburse for medical treatments such as stem cell therapy.The handout for this presentation can be downloaded and printed.

Part 2. Stem Cell Policies: Legal Rules

This mini-lecture examines the legal rules associated with stem cell research and use in the United States. The handout for this presentation can be downloaded and printed.

Readings:

Halme, D.G., Kessler, D.A. (2006) FDA Regulation of Stem-Cell-Based Therapies. New England Journal of Medicine, 354:1740-1735.

Koleva, G. (2012) Stem Cells and the Lawsuit that May shape our Medical Future. Forbes.

Koleva, G. (2012) Stem Cells, FDA, and the Edge of Science: Three Expert Viewpoints. Forbes.

Assignment: FDA – Watch dog or Pitbull

The Food and Drug Administrations primary role in monitoring and regulating drugs is to protect the public health from unsafe and/or unproven treatments. The FDA is in a precarious position between the developers of innovative treatments and physicians and patients seeking the most effective cures. The FDA is viewed as to lax when safety concerns develop with a previously approved medication, but too stringent when the need for additional safety and effectiveness data  that is being slowly collected in clinical studies results in the delay in approval of a new drug. The knowledge of stem cell science and claims of miraculous stem cell cures race ahead of data from clinical trials, leaving the FDA to navigate through conflicting interests.

In your discussion group: Review the articles on the court challenge between Regenexx and the FDA and then discuss with your small group, what criteria should the FDA use in determining whether or not to approve stem cell therapies.

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