Yearwood_Aspirin

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					DFL Inquiry Activity #2                                               Burl Yearwood

Another inquiry activity I would like to put into practice is a role-play based activity by
my students. They would imagine themselves on a FDA approval panel. Their task would
be to decide (or debate) whether aspirin should be approved as a prescription drug.
Another group of students would have to decide (debate) whether aspirin should be
approved as an over the counter medicine. We would assume that aspirin is a relatively
new drug, and had not been around for hundred of years. The students would have to
research and learn about:
        - the FDA guidelines for approving and rejecting drugs
        - the need for clinical trials and the different stages of clinical trials
        - what is involved if the drug is meant to treat both adults and children

The students would have to provide examples (and explanations) of similar drugs that
have been (a) accepted, (b) rejected, and (c) recalled. The students could also be assigned
to decide whether aspirin could be marketed as a homeopathic remedy (since technically
it is derived from a natural source). Implicit in this inquiry is that students would have to
learn about the benefits and dangers of aspirin.

This role-play activity would be built upon a framework of guided questions meant to
help the students in their explorations of this topic. A great starting point would be the
FDA Center for Drug Evaluation and Research (CDER) web site:

CDER home page:
http://www.fda.gov/cder/regulatory/applications/default.htm#Introduction
CDER handbook: http://www.fda.gov/cder/handbook/
Benefits versus Risks: http://www.fda.gov/fdac/special/newdrug/benefits.html

Center for Public Integrity: http://www.publicintegrity. org/rx/report.aspx?aid=722

Benefits of Aspirin:
http://www.findarticles.com/p/articles/mi_m1041/is_n7_v76/ai_20806525


This web site provides information on the approval process and all the different stages.
Plus it provides very useful links to other sources of information.


This activity could be further expanded upon whereby students would have to include
public opinion in their deliberations. For this they could use the Library full text
databases for newspaper articles like Ebsco, Lexis-Nexis, or the Opposing Viewpoint
Resource Center
BACKGROUND: Acetylsalicylic Acid – Beneficial or Harmful?

A new drug (Acetylsalicylic acid) has been submitted to the FDA CDER (Food and Drug
Administration Center for Drug Evaluation and Research) drug approval panel for
consideration. The drug claims it will offer temporary relief of pain; reduce fevers from
colds and flu, and aid in the prevention of heart attacks.

Group 1: You are a health consumer advocacy group who is against the approval of this
drug, and the FDA approval process in general.
Group 2: You are the pharmaceutical company who is applying for approval of your
drug, and you support the FDA approval process.

We will assume that Acetylsalicylic acid (or aspirin) is a relatively new drug, and
has not been around for hundred of years. We will also assume that the
pharmaceutical company has already done the animal and human testing of the
drug, and the results are public information.

ACTIVITIES: (2 HOURS)

Part 1. Research (40 minutes)
Your first task is to find about the FDA approval process and aspirin.

a) Review the FDA CDER web sites on the next page to learn about the steps for a New
Drug Development and Review process (also look at the Accelerated Development /
Review description).

b) Review the web sites on the next page (and others you may find) to learn about the
benefits and dangers of aspirin.

Part 2. Analysis and evaluation of information (50 minutes)

Thoughts to consider:
- Why does the government regulate the availability of new drugs?
- What are the advantages and disadvantages of stringent, long-term studies of new
   drugs?
- Is it to the public’s advantage or disadvantage that the approval process has changed?
  Why?
- What are some prescription drugs that have been (i) accepted, (ii) rejected, and (iii)
   recalled by the FDA? What were the reasons for their actions?
- At what point in the process does the CDER seek additional (outside) opinions? Is it too
   early or late in the process?
- Is it possible for drug companies to have too great an influence on the approval process?
  Why or why not? Can you find articles on Ebsco Host or Lexis-Nexis to support your
   view?
- Is the FDA’s scope too limited or too expansive? How would you change it?
- Does the fact that you know about aspirin (and have probably used it before) influence
your approach (and views) to this activity? How?
- Do you think the scientists on the CDER panel are influenced by previous knowledge
they might have of a drug or a drug company?
-- What other information would you need in order to support your point of view and to
oppose the other side?


Part 3. Preparation for debate (30 minutes)
At this point, you should have some ideas and facts to support your point of view and to
oppose the other side.

1. Make a list of the major points that support your argument.

2. Provide evidence for each point.

3. Make a list of the major points that you think your opposition could use. Write down
how you would refute each expected argument from your opposition.

4. Produce a PowerPoint presentation that reflects your case.
Suggested Web sites:

As you look at these web sites, consider the source, in addition to the other points on the
evaluation of a web site by Marie Spina.

CDER home page:
http://www.fda.gov/cder/regulatory/applications/default.htm#Introduction
CDER handbook: http://www.fda.gov/cder/handbook/
Benefits versus Risks: http://www.fda.gov/fdac/special/newdrug/benefits.html

US Department of Health and Human Services:
http://www.hhs.gov/asl/testify/t040209.html

Center for Public Integrity: http://www.publicintegrity. org/rx/report.aspx?aid=722

New England Journal of Medicine: http://content.nejm.org/cgi/content/full/353/10/969

Benefits of Aspirin:
http://www.findarticles.com/p/articles/mi_m1041/is_n7_v76/ai_20806525

http://www.bayeraspirin.com/questions/a_fact_center.htm

http://www.aspirin.com/world_of_aspirin_en.html from Bayer Aspirin

http://www.aspirin.org/news/pr02.html

Dangers of Aspirin:

Look at the warning label on a bottle of aspirin.

http://www.doitnow.org/pages/138.html from the Do It Now Foundation

http://www.reyessyndrome.org/aspirin.htm from National Reyes Syndrome Foundation

http://www.acg.gi.org/patients/women/asprin.asp? from the American College of
Gastroenterology

http://www.orthop.washington.edu/uw/medications/tabID__3376/ItemID__72/PageID__
34/Articles/Default.aspx from University of Washington Sports Medicine Department
Web sites from the Workshop:

Test Tube to Patient:
http://www.fda.gov/fdac/special/testtubetopatient

* Click on CDER: The Consumer Watchdog for Safe and Effective Drugs

* Click on The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective

* Click on MedWatch: Managing Risks at the FDA

* Click on The Impact of Direct-to-Consumer Advertising

Lexis-Nexis:
1. HEADLINE: Fixing the FDA by George W. Conk, Miami Daily Business Review, October 3,
2005

2. FDA SEEKS PUBLIC INPUT ON RENEWAL PROCESS FOR PRESCRIPTION DRUG USER FEE
ACT, US Fed News, November 10, 2005

3. Aspartame's untold story, University Wire, November 15, 2005

				
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