The Biotechnology Project: Thalidomide

CLASSROOM ACTIVITY: Should thalidomide be used for treating disease?

This is a role play that highlights some of the difficult societal issues relating to drug regulations

Purpose:

The purpose of this activity is to explore some of the complex societal and ethical issues relating to drug regulations. In this activity your class will explore the issues relating to the use of thalidomide for treating various diseases including cancer, leprosy, and AIDS.

Activities:

Prepare for this role play by discussing the Frances Kelsey case study (Link).
Divide the class into four groups:
- Medical Research Coalition. This group consists of dedicated medical researchers who want to investigate and use thalidomide because they believe it has important medical benefits.
- Scientific Advisory Panel. This group is responsible for providing a balanced, unbiased introduction to the science of thalidomide and its effects in humans.
- FDA. This group will listen to presentations by the other groups and will decide whether to approve thalidomide for treatment of certain serious diseases.
- Thalidomide Survivors and Families. This group represents people whose lives have been disrupted by the debilitating effects of thalidomide. They oppose its manufacture and use for any reason.
Each group reads the on-line information referenced below, prepares, and presents a short report to the class. The FDA panel can ask questions of the groups.
The FDA group moves to another room to consider its decision and determines whether thalidomide will be approved for research use or not.

Information Sheets for Each Group:

Medical Researcher Coalition

You are strong advocates of the use of thalidomide in special circumstances: in medical research for cancer and other life-threatening illnesses, and for treating leprosy. Because of the risk of thalidomide to a fetus, you advocate stringent control of thalidomide. This might include limiting the distribution of thalidomide to certain certified pharmacists, requiring a photo identification card when patients pick up prescriptions, and other such controls.

To learn more about thalidomide and its potential uses, read the article “Giving Thalidomide a Second Chance”, www.fda.gov/fdac/features/1997/697_thal.html

You may also find this site helpful:
www.fda.gov/cder/news/thalinfo

Scientific Consultants

You are hired to help the FDA decide what to do. You provide information and a balanced discussion of the pros and cons of approving the drug. You should not advocate a particular position. Try to keep your discussion as balanced as possible. Try to answer questions the FDA team might ask. To learn more about thalidomide, go to:
www.fda.gov/fdac/features/1997/697_thal.html
www.fda.gov/cder/news/thalinfo

The Food And Drug Administration

You decide! You have the major responsibility of deciding whether or not to approve the use of thalidomide for research purposes and for treatment of leprosy. Without your approval, the drug cannot be manufactured and used. You represent the public and must make the best decision for the public as a whole. Consider very carefully the arguments of everyone who provides testimony. Make certain that your decision is well-thought out – it may affect many people.

To learn more about your role, go to the FDA website at www.fda.gov. You can click on “About the Food and Drug Administration”. Begin here to learn about what this organization does.

Thalidomide Support Group

You represent victims of thalidomide and their families and supporters. You totally oppose the manufacture and distribution of thalidomide for any purpose whatsoever. You know first-hand the devastation caused by the drug. You believe that if the drug is manufactured that it will eventually be used by people for whom it was not intended and to whom it was not prescribed. Drugs have a way of moving from one person to another, even prescription drugs. The drug is very helpful in preventing morning sickness and is a very good aid for sleeping that does not make people feel drowsy during the day. Therefore, it will be attractive to women who may obtain it from well-meaning friends, or even a “black market”. Perhaps a woman will not know that she is pregnant and will take the drug as a sleeping pill.

To learn more about your organization, go to www.thalidomide.ca
If you have time, you can also go to these sites:
www.fda.gov/fdac/features/1997/697_thal.html
www.fda.gov/cder/news/thalinfo

The printable version of this document.