Drugs become accepted by physicians and the FDA on the basis of scientific proof of their effectiveness and safety. Scientific proof is obtained through a series of tests called a clinical trial. A clinical trial involves the combined efforts of the pharmaceutical company that makes the drug; the independent investigators who test the drug; and the FDA, which licenses the drug. Testing drugs through clinical trials has been standard for over four decades and has provided the foundation for most of the recommended treatments in traditional medicine. While a drug is being tested in a clinical trial, it is considered experimental. If the drug proves effective and is not too toxic, it is then licensed and available to the public. For people with HIV infection, participating in clinical trials has both advantages and disadvantages. Clinical trials are experiments with human lives, and special safeguards are necessary to guard both the people and the scientific procedure. These safeguards, plus the options and aspects of participation in a clinical trial, are spelled out to the participant in painstaking detail. Some trials can be seen as especially risky: they involve taking a drug with no established benefit in place of a standard drug with established merit. With other trials—for instance, the comparison of two drugs, both of which are known to work, to find out which works better—the risk is lower. The motivation to participate is an individual decision. For further discussion, see below, “Advantages of Participating in a Clinical Trial” and “Disadvantages of Participating in a Clinical Trial.” Anyone worried about the safety of a clinical trial can be reassured that the trials are conducted under the strict supervision of the FDA and a local board charged with reviewing the trial. Both the FDA and the local board periodically review the results of the trial. If the drug being tested proves significantly better or worse than the drugs in standard use, the trial is promptly discontinued. Moreover, a standing rule in all clinical trials is that participants may withdraw from the trial at any time.*183\191\2*
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Acupuncture is a tradition in Chinese medicine now available from licensed acupuncturists in the United States. According to acupuncturists, HIV infection is a condition caused by the blockage of the flow of the life force, called chi. In addition, HIV infection might also be interpreted as a deficiency in a masculine, active quality called yang, as well as a deficiency in a feminine, passive quality called yin. Treatment is the insertion of needles at any of the 365 points along twelve body lines, which is said to permit the flow of chi. The needles are left in place for twenty to thirty minutes; treatment may continue to several days to several months. Acupuncture is poorly understood according to the criteria of traditional medicine, although it clearly has profound biologic effects: it can, in fact, be used in place of general anesthesia for some major operations. The usefulness of acupuncture as a treatment for HIV infection has not been tested with a clinical trial, so the benefits are not established. There are essentially no risks.*192\191\2*