hellmans

1. Research Ethics

2. Hellman and Hellman
on the Problems of
Randomized Clinical Trials

3. Clinical Trials: Some Background
Clinical trials test the effectiveness of medical treatment. They aim to maximize objectivity, minimize bias,
and avoid errors.
 Gold standard for clinical trials: randomized controlled clinical trial
Randomized controlled clinical trial:
 Controlled: One group’s intervention is the standard of comparison, whereas the other group or groups receive
an experimental intervention.
 The standard of comparison may be a standard practice intervention, a placebo, or no intervention at all.
 Randomized: People are assigned by chance alone to one of the groups. This allows differences between the
groups to be attributed to the interventions being studied.
Blind clinical trial: the participants do not know which group they are in.
Double-blind clinical trial: neither the participants nor the researchers know which group participants are
in.

4. Hellman and Hellman Thesis
It is morally wrong for doctors to conduct
randomized clinical trials (except when they are
in a state of equipoise) because the
requirements of these studies conflict with the
doctor’s obligation to always act in the patient’s
best interests.

5. The Physician-Scientist
Randomized clinical trials require doctors to perform the dual role
of physician-scientist.
 As a physician, they are obligated to act in their patient’s best
interest.
 As a scientist, they are required to seek answers to questions about
treatments that will benefit society as a whole.
Hellman and Hellman point out that these roles often conflict!

6. Conflicting Roles
As physicians, doctors are obligated to act in their patients’ best
interests, which means that they should recommend to their patients
the treatment that they (the doctors) think is best.
But to conduct a successful randomized clinical trial, doctors must put
some patients in a group that they think is less good for those patients.

7. Moral Theory
Deontology/Kantianism/rights-based views: Claim that some rights and duties
hold independently of the overall consequences.
 Kant’s humanity principle: Treat persons as ends-in-themselves, never as
mere means to an end.
Utilitarianism: The consequentialist view that one ought to promote the
greatest good for the greatest number.
According to H&H, physicians must take a rights-based approach, and
scientists must take a utilitarian approach.

8. Because there is a conflict between the doctor’s role as physician
and the doctor’s role as scientist, which role should take priority?
H&H: The doctor’s role as physician takes priority.
• “… the ethical obligation created by the covenant between
doctor and patient requires the doctor to see the interests of
the individual patient as primary and compelling.” (p. 306)
• Thus the doctor should act in her patient’s best interests.
• It is therefore morally wrong for doctors to conduct
randomized clinical trials.

9. The Exception: Equipoise
State of Equipoise: When the physician has no preference
regarding the treatments in a clinical trial.
According to H&H, randomized clinical trials are only ethically
acceptable when the doctor is in a state of equipoise.
If the doctor is in a state of equipoise, she does not assign patients
to a group that she thinks is less good for them.

10. How Big is this Exception?
It seems uncommon for doctors to be in a state of equipoise regarding treatments.
 They will often have some reason to believe, even through anecdotal evidence,
that the standard treatment or experimental treatment is better.
Even when doctors are in a state of equipoise at the beginning of a study, they often form
opinions about which treatment is better during a study (especially when a double-blind
study is impossible).
 It will then be unethical for them to continue the study and subject some patients
to what they think is a less good therapy.
 The study may then be lost.

11. An Objection
Objection: It is morally permissible for doctors to conduct
randomized clinical trials because patients in those studies waive the
rights inherent in the doctor-patient relationship.
 H&H: No. Those rights are inalienable. Patients have the right to
the “physician’s best judgment and care…” (p. 307)
 Besides, illness complicates voluntary informed consent.
 Physician’s Oath of the World Medical Association: “Concern for
the interest of the subject must always prevail over the interests of
society.”

12. What’s the Alternative?
One possibility: non-randomized prospective studies in
which patients stay on the treatment recommended by
their individual doctors; third parties do the evaluations.

13. Tuskegee Syphilis Study

14. Syphilis is a STI that can (today) be easily treated with antibiotics
but that can have serious and even fatal health consequences if
left untreated.
The Tuskegee, Alabama syphilis study was conducted between
1932 and 1972. Its purpose was to study the natural progression
of untreated syphilis in rural Black men.
By 1947, penicillin was a standard (and effective) treatment for
syphilis.

15. Conducted by the US Public Health Service, later overseen by the
Centers for Disease Control.
Approximately 400 infected poor black men; 200 in the control group.
In 1972 a whistleblower broke the story, and the study was ended
soon thereafter.

16. Early 20th Century Racism in Science
 Scientists believed in the “mental, moral, and physical
deterioration” of freed Blacks.
 attributed to them “excessive sexual desire”
 assumed high rates of disease and lack of interest in
treatment

17. Assumptions vs. Truth
Assumption: Roughly 35% of the Macon County male population was
infected with syphilis.
Truth: 20% of those tested were infected.
Assumption: The men were not interested in treatment and would never
seek it.
Truth: The men would cooperate only if offered treatment.
“REMEMBER THIS IS YOUR LAST CHANCE FOR SPECIAL FREE TREATMENT.”
Truth: Researchers lied; treatment was neither given nor intended.

18. The HEW Final Report
 Department of Health, Education, and Welfare
 Focused on two questions:
 Was the study justified in 1932, and had the men given informed consent?
 Should penicillin have been provided when it became available?
 Brandt: The report obscures the biggest problems.
 There were (mildly) effective therapies pre-penicillin.
 The researchers lied; the men thought they were getting therapy, not
participating in an experiment.

19. Allan Brandt:
“There can be little doubt that the Tuskegee
researchers regarded their subjects as less than
human.”
“In retrospect the Tuskegee study revealed more
about the pathology of racism than the pathology
of syphilis.”