In the early 1900s, when scientific research truly began being a systematic study, the American Medical Association (AMA) set up a list of regulations to follow when dealing with animal experimentation. It made it clear that the animals should not suffer. However, ethical codes were not truly followed until the 1940s when the AMA required consent of the subject and animal testing before human subjects were tested on. The opening of the Rockefeller Institute started of the era of animal testing. Anti-vivisection groups formed to prevent the testing on animals. They stressed that researchers were insensitive when it came to testing on children, when the Tuberculin experiment was being carried out. The Rockefeller Institute was criticized because its founder, John D. Rockefeller, was deemed a robber barron who only started the organization to prolong his own life. This short history shows how researchers put their own agendas before ethics. As with public health, researchers sometimes put the needs of the many before those of the few. Politics and economics comes into play because sometimes, good intentions may be tarnished by the man in question’s past, namely John D. Rockefeller. Pharmaceutical companies still come under fire for tainting medical data and making a drug look like it works better than it really does, just because a successful drug can make billions of dollars in profits, making the lengthy, expensive trials worth it.
What we learned from the Tuskegee Syphilis Experiment had to be how not to conduct clinical trials. Even though ethical guidelines were already in place, there were so many things wrong with how the experiment was conducted, perhaps the biggest being that there was already an effective treatment against Syphilis at the time the experiment began, meaning that the results would just show what would happen if the disease was not stopped. The sample of individuals was not diverse; it targeted poor, black males, who were said to have “strong sexual appetites” (Brandt, 3). The sample was chosen based on stereotypes and not on a scientific basis at all. The participants were not informed properly. They believed they were receiving free treatment but they clearly were not. The physicians also found the subjects more interesting post mortem, waiting for the autopsies more than result while the subjects were alive. Fearing that the hospitals would lose its black patient population if this fact got out, the researchers kept this step in the procedure a secret. It is not clear if even the blacks helping the physicians were aware of this. In the conclusions, the doctors admitted that they had contributed to an early death of the patients. Even after a CDC panel met to discuss the trials, they recommended continuation. All in all, the Tuskegee Syphilis Experiment showed more about race relations at that time than about the disease itself.
In America, the ACTG 076 is “the standard of care for HIV positive women” (Lurie & Wolfe, 853). It reduced the incidence of HIV infection of one in every seven infants born to HIV positive mothers. However, this treatment is too expensive in places like Sub-Saharan Africa. There have been debates about how to best go about researching for a less expensive alternative to reduce perinatal transmission of the virus. In 1994, World Health Organization came up with the statement that placebo controlled trials are the best at determining whether the potential treatment is effective. But the use of a control group in this manner is unethical when a potential treatment method is being proposed. In trying to find a less expensive or less toxic regimen, how can researchers find solutions without compromising their ethical values? The answer may lie in the way the researchers plan their experiment. Instead of using a placebo group as a control, they can compare the standard, administering ACTG 076, with the new trial. This way, transmission can still be prevented and effective data can be compared. Some researchers are defending the use of placebos by saying that the unproven regimens or no treatment is the standard of care in place in that country so administering the placebo is the same as if they received the standard of care. The problem is that this is not based on scientific information but on economics. The government cannot afford to give expensive drugs to their people. The double standard is exposed when the “acceptance of a standard care that does not conform to the standard in the sponsoring country” (Lurie & Wolfe, 855). This means that some researchers get away with placebo driven trials because they are conducting it in another country where treatments are not the standard but they are ethically bound to ensure this does not happen. Those in poor nations are being manipulated into participating in research trials and setting an international standard of ethical research will ensure that this practice will not continue.
The selections covered in this week’s reading raise several questions. Are researchers justified in hiding information from test subjects if their research produces results that may save lives? Should research being conducted in third world countries be held to the same standards of studies being conducted in the US, even though they may have fewer resources than we do?