Equivalence studies (which compare old and new drugs) require more patients and consequently more time and money. It is easier to show that a drug is better than placebo than existing therapies. There are generally two advantages for the pharmaceutical company for doing a trial in which their drug is compared to placebo and not to existing effective drugs. Public Citizen has also criticized a Latin American trial of surfactant in preterm babies with respiratory distress syndrome which included a placebo arm. This meant that some women gave birth to children with HIV infection whose disease might have been prevented by the investigators. ![]() In these trials some pregnant women were given placebo treatment at a time when the benefits of AZT for preventing maternal to child transmission had been demonstrated. In 1997 Peter Lurie and Sidney Wolfe published an article in the New England Journal of Medicine criticizing trials of maternal to child HIV transmission prevention in several countries around the world. Why is there concern over the use of placebos in international trials? The Declaration does, however, allows for the use of placebos in certain circumstances. This assures that participants in a clinical trial are not denied the benefits of proven treatments. In other words new treatments should be tested against old treatments instead of placebos. In general the Declaration takes the position that “ extreme care must be taken in making use of a placebo-controlled trial” when there is an existing proven therapy. The Declaration of Helsinki was adopted by the World Medical Association in 1964 as “ as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.” It has been amended five times, the most recent version being in 2000. Doing research in poorer countries offers several benefits for CRO’s including lower costs and – now- the possibility to use placebos in control groups. The change will have important practical implications as more and more medical research is being done overseas by for-profit Clinical Research Organizations (CRO’s). ![]() those who are not getting the experimental drug) can be treated with placebos instead of the best standard medical care. In effect the FDA will now allow the pharmaceutical industry to run international clinical trials in which patients in the control group (i.e. Integrity in Science has written a critique of this decision in which Peter Lurie of Public Citizen’s Health Research Group is quoted as saying that it is “in line with other U.S. The FDA’s decision had been in the making for several years and is a major victory of corporate interests which have sought to loosen the ethical standards for international clinical trials. At the end of April the US Food and Drug Administration (FDA) published a regulatory change ending the need for clinical trials conducted outside of the US to comply with the Declaration of Helsinki.
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