Chapter 7 1

Chapter 7

Data Ethics

Chapter 7 2

Thought Question 1

Many new treatments for rapidly lethal diseases offer very little or no benefit to patients. Thus, clinical trials to study the effectiveness of these treatments require large numbers of participants to determine if there is any benefit at all. Should patients volunteering for such trials (as a last resort, or to “advance science”) be told of their low chance of receiving benefits? What if the toxicity of the treatment may be harmful?

Chapter 7 3

Experiments:Ethical Requirements

Institutional review board– to protect subjects from possible harm

Informed consent

Confidentiality

Chapter 7 4

Confidentiality and Anonymity

Confidential answer– respondent is known, but the information is

a secret Anonymous answer

– the respondent is not known, or cannot be linked to his/her response

Chapter 7 5

Clinical Trials

Experiments that study the effectiveness of medical treatments on actual patients– Need comparative experiments to see true

effects of new treatments– Balance future benefits against present

risks– “Interests of the subject must always prevail

over the interests of science and society”

Chapter 7 6

Clinical TrialsControversies

Belief that the treatment is effective to justify exposing subjects to it; doubt that the treatment is effective to justify withholding it from other subjects

When is the treatment effective enough to stop the study and assign the treatment to the placebo or control groups also?

When is the treatment harmful enough to stop the study and discontinue use of the treatment?

Who can give consent?

Chapter 7 7

Case Study

Vioxx is a prescription anti-inflammatory drug that was approved by the FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, acute pain, menstrual symptoms, and rheumatoid arthritis

Ongoing long-term study of Vioxx was being conducted in patients at risk for developing recurrent colon polyps– study showed an increased risk of heart attack and stroke in patients on

Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months

Data Safety Monitoring Board recommended that the study be stopped early for safety reasons

Merck & Co. voluntarily withdrew Vioxx from U.S. market in Sept. 2004

Release from Food and Drug Administration, September 30, 2004

Drug Company Pulls Product

Chapter 7 8

Key Concepts

Basic data ethics

Confidential vs. Anonymous

Clinical trials