Ethical Issues in Clinical Trials in Developing Countries Article Discussion –

Other –

Ethical Issues in Clinical Trials in Developing Countries Article Discussion –

Please write a 3-4 page essay addressing all of the following. Submit to the Essay 4 Assignment Dropbox located in Module 11b by 11:30pm May 15

In the article “Ethical Issues in Clinical Trials in Developing Countries,” Brody discusses three criticisms of the clinical trials conducted in developing countries to evaluate the efficacy of a much lower dose of antiretroviral drugs administered for a shorter period of time in preventing maternal-fetal transmission of HIV. Many people have criticized these clinical trials as unethical. In your essay you must address all of the following:

  1. Explain and discuss the three criticisms of these clinical trials (these criticisms are listed on p. 285. But for this part of the essay, go beyond merely listing what these criticisms are and explain each)
  2. Brody argues that each of these criticisms are misguided and that the clinical trials were not unethical. Choosing one of the criticisms, explain and discuss Brody’s argument in response to the criticism (why he says the criticism is misguided and does not show that the clinical trials were unethical).
  3. Critically evaluate: which is the stronger position—the original criticism of the clinical trials or Brody’s response to the criticism? Assess the strengths/weaknesses of the competing arguments in light of one (or more) of the statements contained in Part C of the Declaration of Helsinki (on pp257-8 of our text).

For your information:

Here is a little background on clinical trials and the specifics of the clinical trial discussed in the Brody article…

First, a clinical trial a test to see whether new treatments/drugs/therapies work and what side effects they may have. Second, clinical trials often involve the use of a placebo, which is something that has no treatment value (for example, a “sugar pill”). Third, many clinical trials are randomized. Randomization occurs when two or more drugs or treatment alternatives are randomly assigned to subjects, and in this way, there is no bias, unfairness on the part of researchers in terms of which subjects receive which treatment.

The best proven therapeutic method for preventing maternal-fetal transmission of HIV infection is the “076 regimen,” so named because it was AIDS Clinical Trials Group protocol number 076 that demonstrated the effectiveness of AZT in reducing transmission…the 076 regimen is now accepted as the “standard of care” in the US and other developed countries. The clinical trials referred to in the Brody article were designed to evaluate the evaluate the efficacy of a much lower dose of AZT administered for a shorter term than the 076 regimen. It was thought essential to evaluate the lower-dose, shorter-term AZT regimen because large-scale use of the 076 regimen was not realistic in developing countries, due to its high cost and also because it was regarded as impractical since women in many developing countries usually do not come to clinics for prenatal care early enough to start the 076 regimen. The clinical trials used a placebo group…