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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.
How can placebos cause harm? Clinical        	  Trials! What is a clinical trial? ,[object Object],http://www.cartoonstock.com/lowres/rmo0169l.jpg
Clinical Trial: How to… Two groups are used in a clinical trial. These two groups are decided at random and are scientifically controlled.
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: ,[object Object],[object Object]
Ethical and Legal Protection ,[object Object]
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.,[object Object]
The Declaration of Geneva
Changes to the Declaration of Geneva 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. http://wiki.provisionslibrary.org/blog/wp-content/uploads/2008/12/human_rights_first.jpg 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 A placebo should not be used when an effective method is available. 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.
AZT TRIALS: AfricaThe Beginning…
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.sciencephoto.com/images/showEnlarged.html/M112336-AIDS_baby-SPL.jpg?id=771120336
AZT TRIALS: AFRICA             The Results  ,[object Object]
An additional 7% of the babies born in this trial could have been saved.,[object Object]
Is this ethical because they technically did receive the best method available to them?What about the women who received the placebo and no treatment at all? http://blog.americanhistory.si.edu/.a/6a00e553a80e1088340134872b7d11970c-800wi
AZT TRIALS: AfricaThe women who received the placebo
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- Internal Constraints External Constraints 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.

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Placebo pp

  • 1. Are Placebos Harming Us? The unknown dangers of placebo use. By: Melanie Jenkins
  • 2. 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.
  • 3.
  • 4. Clinical Trial: How to… Two groups are used in a clinical trial. These two groups are decided at random and are scientifically controlled.
  • 5. Processes of a Clinical Trial http://www.themesotheliomalibrary.com/clinical-trials-overview.jpg
  • 6.
  • 7.
  • 9. Developed in response to Nazi experimentation during WWII.
  • 11. Made to amend and clarify The Nuremberg Code.
  • 12.
  • 14. Changes to the Declaration of Geneva 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. http://wiki.provisionslibrary.org/blog/wp-content/uploads/2008/12/human_rights_first.jpg 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.
  • 15. ABUSE OF GUIDELINES A placebo should not be used when an effective method is available. 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.
  • 16. AZT TRIALS: AfricaThe Beginning…
  • 17. 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.
  • 18. 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.sciencephoto.com/images/showEnlarged.html/M112336-AIDS_baby-SPL.jpg?id=771120336
  • 19.
  • 20.
  • 21. Is this ethical because they technically did receive the best method available to them?What about the women who received the placebo and no treatment at all? http://blog.americanhistory.si.edu/.a/6a00e553a80e1088340134872b7d11970c-800wi
  • 22. AZT TRIALS: AfricaThe women who received the placebo
  • 23. 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.
  • 24. AZT TRIALS: Africa--Conclusion- Internal Constraints External Constraints 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.
  • 25. Update on African Women with AIDS or HIV. Having Problems viewing this video? Please visit: http://www.youtube.com/watch?v=7Pt7r-lHMbM
  • 26.
  • 28. Proves the mind-body connection.http://www.neurosciencemarketing.com/blog/wp-content/photos/thumb_placebo.jpg
  • 29. 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.
  • 30. Sources All 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.“ Bioethics17.2 (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.