2. Benjamin Freedman:
“A Response to a Purported
Ethical Difficulty with
Randomized Clinical Trials
Involving Cancer Patients”
3. Freedman Thesis
It is morally permissible for doctors to conduct a
randomized clinical trial when there is clinical
equipoise – i.e., when there is honest disagreement
within the medical community about which of the
treatments in the trial is better. Most randomized
clinical trials meet this condition and thus are
morally permissible.
4. The Physician-Scientist
Randomized clinical trials require doctors to perform the dual role of physician-
scientist.
Hellman and Hellman claim that these roles typically conflict.
As a physician, doctors are obligated to act in their patient’s best interest.
In this role, they should recommend the treatment that they think is best, either the
control treatment or the experimental treatment.
They violate the patient’s right to treatment otherwise.
As a scientist, doctors are required to seek answers to questions about treatments
that will benefit society as a whole.
They need to put some people in a group that they think is less good for them,
sacrificing what they think is best for those people for the benefit of society.
5. According to H&H, the role of physician takes precedence, and so randomized
clinical trials are almost always morally wrong.
• A patient’s right to treatment takes precedence over the benefit to society.
Freedman Response:
• There is no conflict between a patient’s right to treatment and the benefit
to society in randomized clinical trials!
• H&H see a conflict because they are misunderstanding equipoise.
• When we understand equipoise correctly, we will see that randomized
clinical trials do not usually violate a patient’s right to treatment.
6. RECALL: For H&H, randomized clinical trials are morally permissible when the
doctor is in a state of equipoise.
Freedman AGREES with H&H that randomized clinical trials are morally
permissible (and only morally permissible) when there is equipoise.
The disagreement between Freedman and H&H is about HOW TO UNDERSTAND
EQUIPOISE!
• H&H understand equipoise in a way that makes it rare.
• Freedman understands equipoise in a way that makes it is common.
So how do they understand equipoise, and who is right?
7. How Should We Understand Equipoise?
Recall Hellman and Hellman:
State of Equipoise: When the physician has no preference regarding the treatments
in a clinical trial.
As H&H say, a physician will rarely be in this state, since they usually have some hunch or
belief about which treatment in a trial is better.
Freedman:
Clinical Equipoise: When the medical community is in genuine disagreement
regarding the treatments in a clinical trial.
When a trial “begins in a state of clinical equipoise… nobody enrolling in the trial is denied
his or her right to medical treatment, for no medical consensus for or against the
treatment assignment exists.” (p. 311)
Most trials begin in this state, and so most trials are morally permissible.
8. Freedman: Two Common Errors
about Equipoise
1. Not just about efficacy but also about other factors (toxicity,
ease of use, likelihood of compliance, etc.)
2. Not just about the individual doctor’s judgment (as H&H
think) but about the expert community’s judgment.
9. So the disagreement between Freedman and H&H comes down to
how we should under equipoise.
Who is right?
Freedman says that “an individual physician is not the arbiter of
appropriate or acceptable medical practice,” (p. 312), the medical
community is.
• And thus what the medical community thinks determines
equipoise.
10. Role of the Individual Physician
If the physician is convinced that a randomized clinical trial puts some
patients at a medical disadvantage or is too risky, then the physician
should:
1) Refuse to participate in that randomized clinical trial.
2) Inform the patient of their conviction and why they hold it. Possibly,
recommend that the patient not participate.
But mere preference or hunch is not enough. A physician can ethically “…
[set] aside private misgivings based upon anecdote as overbalanced by
the medical literature” (p. 313).
11. Question: Should a doctor always tell a patient their best judgment
about potential treatments?
• H&H: Yes.
• Freedman: No. A doctor should give the medical community’s
judgment unless they are convinced otherwise.
Question for Freedman: What happens if a doctor or the medical
community becomes convinced that a particular treatment is better
during the trial? Should the doctor tell this to the patient or stop
participating in the trial?
