Placebo pp
-
Upload
melaniee1988 -
Category
Education
-
view
152 -
download
0
Transcript of Placebo pp
What is a placebo?
• A pill that is made up of inert
ingredients manufactured for the act
of taking a pill.
• Often referred to as “sugar pills” or
“fake pills.”
• Designed so that a patient actively
takes a pill in place of one that
contains active medication.
Ho
w c
an
pla
ce
bo
s c
au
se
ha
rm?
• What is a clinical
trial?
A clinical trial is an
experiment that is
set up to test
subjects in a clinical
setting using various
types of treatments
or medication.
http://www.cartoonstock.com/lowres/rmo0169l.j
pg
Clinical Trial: How to…
Two groups are used in a clinical trial. These two groups are
decided at random and are scientifically controlled.
Control Group
This group receives the placebo.
No active medication is being given to any
person/being in this group
Experimental Group
This group is receiving the new type of medication or
treatment method that the experiment is
testing.
The members of this group will receive
medication with active ingredients.
But…How do clinical trials
cause harm?• In order to understand how a clinical
trial can cause harm… let’s look to a scenario:A eighteen year old male has just discovered
he has diabetes. He is approached to participate in a clinical trial that is testing a new, cheaper type of insulin to control blood glucose. He does not have a lot of money so consents to the trial. What if he is given the placebo and his blood “sugar” levels become unsafe? This could cause him serious and irreversible damage.
Ethical and Legal Protection
That scenario is very unlikely to happen but much worse examples happen in
real life.
Most people would assume that we are protected by rules and regulations set
forth by the government.
In fact, guidelines have been set to protect us...but the lines are easy to blur.
There are two important documents
to consider:
The Nuremberg Code
Developed in response to Nazi
experimentation during WWII.
The Declaration of Geneva
Made to amend and clarify The Nuremberg
Code.
Written by The World Health Organization.
Th
e N
ure
mberg
Code All participants must consent to be a part of
the research.
The experiment should prove to be beneficial.
The experiment should be "conducted to avoid all unnecessary physical and mental suffering" as well as injury.
No experiment should be conducted when death or injury is believed to be a result of the experiment.
A human should be able to stop their part in the experiment at any time.
The researcher must stop the experiment if any of the above guidelines are breached.
The D
ecla
ratio
n o
f G
eneva
The most important part to consider…
Article 39
This point declares that no placebo should be used
when an effective method exists.
http://wiki.provisionslibrary.org/blog/wp-
content/uploads/2008/12/human_rights_first.jpg
Since the first draft, one important revision
has been made…
Old Version: A placebo
should not be used
when an effective
method exists.
New Version: A placebo
should not be used
when an effective
method is available.
This opened the door for researchers to use placebos in clinical trials
when the effective method is not available due to money, location, or
scope.
ABUSE OF GUIDELINES
• The changing of the
word from “exists” to
“available” allows
experimenters to exploit
persons based on
where they live or their
socioeconomic status.
– One of the strongest
example of this is the
AZT trials in Africa.
A placebo
should not be
used when
an effective
method is
available.
AZT TRIALS: Africa
The Beginning…
New drug called zidovudine has
been developed to treat AIDS
Zidovudine or AZT shows promising results in AIDS
Patients
The cost of treatment is $800
per person
Available in the United States and
Europe
Developers would like to make this
cheaper to provide.
AZT Trials: Africa
The idea• The developers would like to make
AZT cheaper and more available, so
they developed a clinical trial.
– This clinical trial would offer less of the
drug to a patient to test if it would still
be effective in lower doses.
– The clinical trial would be placebo
controlled.
– The held clinical trials at 15 different
sites.
• Most of these sites were in Africa.
AZT TRIALS: Africa
The subjects• The subjects that they would test on were
pregnant women.
– Some of these women were extremely sick from
infection and sharing cots due to limited space
and funds.
– The tests were to see if lower amounts of
medication would reduce HIV transmission from
mother to child.
• AZT had been successful with the full course method
in the US and Europe.
http://www.scienc
ephoto.com/imag
es/showEnlarged.
html/M112336-
AIDS_baby-
SPL.jpg?id=77112
0336
AZT TRIALS: AFRICA
The Results 076 AZT Regimen (Long) Short Course Regimen
Medication
Doses
-Oral AZT at 100mg, 5 times
a day.
-Intravenous AZT at 2mg/kg
over an hour at beginning of
labor.
-Oral AZT syrup for the
newborn.
-Oral AZT at 300mg, 3
times a day.
-Oral AZT at 300mg at
beginning of labor.
Results HIV transmission reduced
from 25% to 8%
HIV transmission
reduced from 25% to
15%
Costs $800 per pregnancy $80 per pregnancy
Unfortunately, the transmission rates were not as effectively reduced
with the short course method.
An additional 7% of the babies born in this trial could have been
saved.
http://blog.americanhistory.si.edu/.a/6a00e55
3a80e1088340134872b7d11970c-800wi
• While they did offer some medication and reduced the
transmission of the virus slightly, the researchers did not
provide the effective method of treatment.
• Is this ethical because they technically did receive the
best method available to them?
AZT TRIALS: Africa
The women who received the placebo
Some women received a placebo instead of the best proven method of treatment.
Ethically and morally, these women were wronged.
If the researchers were able to provide some medication to some of the women, than all of the women should have received it.
AZT TRIALS: Africa
-Conclusion-• The use of
placebos in the
AZT trials were
wrong based on
permissible
medical acts.
– In addition, they
violated the
standards to
receive informed
consent.
• In order for
someone to give
consent they must
be acting
autonomously.
– To act
autonomously you
must not be
suffering from
internal or external
constraints.
AZT TRIALS: Africa
--Conclusion-
• The inability to
understand the
situation based on
mental capacity,
disorders, or
education.
– The pregnant African
women were under
internal constraints:
• Lack of education in
third world countries.
• Depression or
confusion due to
illness.
• The use of physical
force, physical
constraints, coercion,
or pressure.
– The women were most
likely under some
external constraints:
• Pressure to cure the
disease and save their
child.
• Coercion from the
researchers.
Update on African Women
with AIDS or HIV.
Having Problems viewing this video? Please
visit: http://www.youtube.com/watch?v=7Pt7r-
lHMbM
• In contrast, there are some positive
usages of placebos.
– They have shown to greatly reduce
pain in patients who believe that they
are receiving real and active
medication.
This eliminates the chance of side effects
from strong drugs.
Cheaper to provide.
Proves the mind-body connection.http://www.neuroscience
marketing.com/blog/wp-
content/photos/thumb_pl
acebo.jpg
To wrap things up…
• The use of placebos when there are
effective methods to treat, are
ethically and morally wrong.
– Every human should receive equal
treatment, regardless of place or birth,
economic status, or race.
– There are beneficial uses of placebos,
but there use is usually ill-conceived.
– The FDA still requires placebo-
controlled clinical trials to approve a
new pharmaceutical.
SourcesAll of the abovementioned information
is due in part to:• DeGrazia, David, Thomas Mappes, and Jeffrey Ballard. Biomedical Ethics. 7th ed. McGraw-Hill Social Sciences, 2010. Print.
• Ehni, Hans-Jorg, and Urban Wiesing. "International Ethical Regulations on Placebo-Use in Clinical Trials: A Comparative Analysis." Bioethics 22.1 (2008), 64-74.
• Hoffman, Ginger A., Anne Harrington, and Howard L. Fields. "Pain and the Placebo: What We Have Learned." Perspectives in Biology and Medicine 48.2 (2005), 248-265.
• Kottow, Miguel. "The improper use of research placebos." Journal of Evaluation in Clinical Practice 16.6 (2010), 1041-1044.
• Michels, Karen. "Are Placebos Obsolete?." American Journal of Hypertension 9.4 (1996), 183A.
• Michels, Karin B. and Kenneth J. Rothman. "Update on unethical use of placebos in randomized trials.“ Bioethics 17.2 (2003), 188-204.
• Wendland, Claire L. "Research, Therapy, and Bioethical Hegemony: The Controversy over Perinatal AZT Trials in Africa." African Studies Review 51.3 (2008), 1-23.