© Virginia Caldwell Oct 21, 2005
|In 1994, clinical trials were conducted in the United States testing a treatment for HIV positive pregnant women. These randomized trials were held to find a treatment to aid in preventing transmission of the disease from the mother to her baby. The trials resulted in the treatment regimen of the drug zidovudine (Regimen 076) dramatically decreasing the chance of the transmission; therefore, it became the standard of care for this problem in the U.S. In 1995 the National Institutes of Health and the Centers for Disease Control and Prevention conducted trials in underdeveloped countries in order to find a drug basically as effective, but less expensive. In many of the trials conducted, a placebo control group was used even though there was already an existing standard of care (Munson, 32). If there is an existing standard of care, unnecessary placebo-controlled groups should not be used. In the United States, a doctor would be considered unethical if he were to administer less than the standard of care. Why should it be any different in a U.S. sponsored trial merely held in a different country?|
|The reason for holding the trials should first be to help the countries where the trials are being held. Their governments are unable to offer the best treatment due to lack of funds; finding a cheaper more obtainable treatment is very important. The trials are absolutely necessary in helping the countries, but using placebo-controlled groups is not. There is already an effective, existing treatment available which means there is no equipoise among the trial holders. Consequently, making their decision to allow the use of placebo-controlled groups is unjustifiable (Lurie, 4). Furthermore, the doctors have a duty to give the best treatment available. Giving placebos is not giving treatment at all, much less the best treatment. Ultimately, administering placebos in this case is unethical.||Withholding treatment is also unethical in this way; it interferes with a person’s right to life. “All humans have dignity and rights,” an agreement between all countries of the world since the Universal Declaration of Human Rights by the United National General Assembly in 1948 (Annas and Grodin, 201). All humans have dignity and rights; thus meaning every human has the right to treatment if it is available. In the test regimens where the treatment was replaced by placebos, it was estimated that more than one thousand babies who might have escaped infection if treated, would become infected (Munson, 33). HIV is a terminal illness, so, many people will die even though the trials had the potential to increase their chance of life. If doctors do not save lives when they have full access and capability of doing so, they are infringing on those person’s rights to life.|
Objectors to these views might say, “Giving placebos would leave these women no worse off and causes no harm because otherwise, they would be receiving no treatment at all.” The objectors may try to justify this in saying that even the women receiving the placebos would be provided with healthcare benefits they would not normally receive. They also think using placebos make the trials more accurate because the drug being tested is compared to something more realistic for the particular country. This leads to the argument that they are simply using the standard of care available in the country where the trial is being held (Munson, 33).
In reply, it does not matter what the countries standard of care is where the trial is being ran. Guidelines have already been set stating that, “The ethical standards applied should be no less exacting than they would be in the case of research carried out in the sponsoring country.” Plus, U.S. regulations state that studies performed with federal funds, no matter where they are held, must “not unnecessarily expose subjects to risk.” Holding someone’s life in the balance is a pretty large risk! For that matter, it is not only one person’s life, but there are 17,000 women and their unborn babies involved in these trials (Lurie, 2).
In reply, if there was not already a rule against such things, there is no standard of care in these underdeveloped countries. This is not because there is not one known, but simply because the government does not have the financial means to back it. The entire point of the trial is to find a cheaper but effective treatment which would in result, become that countries standard of care for the HIV transmission patients. The 076 regimen already proved that zidovudine is more effective than a placebo. So wouldn’t it be logical to compare the cheaper form of zidovudine to a form of it that is already proven to work? The same results will prevail whether or not the placebo control groups are used. Dr. Harold Varmus, the NIH director, even said that placebo-controlled studies are “not the only way to achieve results” (Lurie, 3). It is by far better to choose the approach that reduces loss of life.
|To add to these arguments, which in themselves could stand alone, treating a person as a mere means is morally and ethically wrong. In these trials, using placebos would be treating the volunteers as a mere means to get the desired new drug (Annas and Grodin, 202). The volunteer would basically receive no help at all when the treatment is more than available to the people sponsoring the trial. The manufacturers generally will donate the drug for trials such as these. Yes, it is good that women receiving placebos will be given health benefits, but ultimately their babies will not have life to make use of it. It would be more beneficial to the patient and the patient’s unborn child for them to receive both the treatment and the health care benefits. The trials should be run not only to profit those who run it, but it should also be to benefit the volunteers who subject themselves to being involved. Some zidovudine is more beneficial than no treatment at all. Because placebo-controlled groups are unnecessary, unbeneficial and treat people as a mere means, the groups are morally and ethically wrong.|
|All in all, offering placebos in trials to find a cheaper form of zidovudine is wrong. There is an alternative choice that has the same results, except it offers treatment and promotes the life of the unborn babies. Not only is it morally and ethically wrong to give placebos, but the rules and guidelines are even against it.|