Are Placebos Harming Us?

The unknown dangers of placebo use.

By: Melanie Jenkins

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.

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bo

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se

ha

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• 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.

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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.

Processes of a Clinical Trial

http://www.themesotheliomalibrary.com/clinical-trials-overview.jpg

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.

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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

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AIDS_baby-

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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.