New drugs developed by pharmaceutical drug companies must be tested in human subjects in order to eventually reach the open market. The Food and Drug Administration (FDA) currently has three main phases of testing for new drugs. In the first phase, the drug is administered to a small number of healthy volunteers in order to gauge the potential for serious side effects. In the second phase, the new drugs are given to sick volunteers in order to evaluate the drug’s effectiveness as well as to further document any side effects. Accompanying the second phase is the control group, which is given a placebo (an ineffective replica of the drug) to contrast the effects produced by the drug itself. When new drugs reach the third phase, they are given to a much larger population of sick individuals in order to get a more accurate reading on interactions with other drugs as well as to gather a profile for rarer side effects.
This process helps ensure new drugs that are ineffective or unsafe are not brought to market. Even with the most careful protocols in place, however, problems still arise. Take for example the extraordinarily difficult problem of the placebo: many people who believe they are actually receiving potentially lifesaving drugs for serious illnesses (cancer, AIDS, etc.) may in fact be receiving a placebo simply because current drug testing protocol established by the Food and Drug Administration requires it. The evidence-based scientific approach to current drug testing is in opposition to the end goal of medical professionals: to restore the health of the individual patient. Is there anything that can be done? Are there any other methods we might try?
Currently, the practice of informed consent makes up the bulk of patient protection law during human drug trials. Informed consent means that all participants in a drug study are aware of what they may be taking, as well as being made aware of the fact that they may be taking a placebo. This allows researchers to gather data from both the experimental and control groups while notifying everyone regarding the possibility of receiving a placebo.
It is this aspect of FDA-regulated drug testing that may need the most revision, given that lifesaving new drugs have the potential to restore patient quality of life despite terrible illnesses. It must also be noted that drug companies (and the individual developers of the new drugs) often feel pressure to administer their drugs to the patients most likely to benefit from treatment, which in turn enhances the probability that the drug will make the open market. We must expand access to these pharmaceutical drugs in order to ensure that patients have the greatest opportunity for survival.
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