USES AND ABUSES Statistics in the Real World 28 CHAPTER 1 Introduction to Statistics Uses An experiment studied 321 women with advanced breast cancer. All of the women had been previously treated with other drugs, but the cancer had stopped responding to the medications. The women were then given the opportunity to take a new drug combined with a chemotherapy drug. The subjects were divided into two groups, one that took the new drug combined with a chemotherapy drug, and one that took only the chemotherapy drug. After three years, results showed that the new drug in combination with the chemotherapy drug delayed the progression of cancer in the subjects. The results were so significant that the study was stopped, and the new drug was offered to all women in the study. The Food and Drug Administration has since approved use of the new drug in conjunction with a chemotherapy drug. Abuses For four years, 180,000 teenagers in Norway were used as subjects to test a new vaccine against the deadly bacterium meningococcus b. A brochure describing the possible effects of the vaccine stated, “it is unlikely to expect serious complications,” while information provided to the Norwegian Parliament stated, “serious side effects can not be excluded.” The vaccine trial had some disastrous results: More than 500 side effects were reported, with some considered serious, and several of the subjects developed serious neurological diseases. The results showed that the vaccine was providing immunity in only 57% of the cases. This result was not sufficient for the vaccine to be added to Norway’s vaccination program. Compensations have since been paid to the vaccine victims. Ethics Experiments help us further understand the world that surrounds us. But, in some cases, they can do more harm than good. In the vaccine experiment in Norway, several ethical questions arise. Was the experiment unethical if the best interests of the subjects were neglected? When should the experiment have been stopped? Should it have been conducted at all? When serious side effects are not reported and are withheld from subjects, there is no ethical question—it is just wrong. On the other hand, the breast cancer researchers would not want to deny the new drug to a group of patients with a life-threatening disease. But again, questions arise. How long must a researcher continue an experiment that shows better-than-expected results? How soon can a researcher conclude a drug is safe for the subjects involved? EXERCISES 1. Find an example of a real-life experiment other than the one described above that may be considered an “abuse.” What could have been done to avoid the outcome of the experiment? 2. Stopping an Experiment In your opinion, what are some problems that may arise when clinical trials of a new experimental drug or vaccine are stopped early and then the drug or vaccine is distributed to other subjects or patients?
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