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Sci Tech    H2'ed 9/13/14

How Pharmaceutical Products Differ From Tennis Balls

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Stephen Unger
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The existence of this wealthy, aggressive industry, constantly seeking ever-more profitable drugs, exerts an influence on medical research in general. Since they are an important source of employment for scientists, and a source of research funds, they surely are part of the reason why so little research is done on simple factors that can promote good health and reduce the likelihood of various diseases [19].

Testing pharmaceutical products

Before a medication can be marketed, the FDA must approve it as being safe and efficacious. But, because the FDA is not adequately funded, it is incapable of testing products in the laboratory, or of carrying out large scale tests on animals and humans, or of carrying out epidemiological surveys. So pharmaceutical companies are required to have this done privately, and to submit the results to the FDA.

This is done by contracting out the work to private testing companies, who report back to the pharmaceutical companies. If the results of a test are not satisfactory, they are kept confidential, and additional tests are ordered. This can be repeated, as necessary, until positive results are found in two surveys.

Companies are strongly motivated to get new products approved, and on the market, as soon as possible, so that they can start start bringing in money. The companies argue that minimal testing is adequate to demonstrate efficacy and safety. Now suppose that, after a new product has been used for a few years, reports begin appearing that the medication is causing a disturbing number of people to suffer significant harmful side effects, perhaps even including death. The company's view on the topic of how much experimental data is needed to draw conclusions about the properties of a medication suddenly changes drastically. Before agreeing to suspend sales, it will insist that there be extensive studies made--studies that will take years. Every effort is made to delay suspension of sales.

When a new medication is tested for its ability to alleviate the effects of a particular disease, the standard practice is to compare it with placebos, substances that look to the patient just like the medication, but which are actually inert, and have no biological effect. In such double-blind drug tests, usually half the subjects are given placebos. Neither the subjects, nor the experimenters know which people are getting the placebos--this information is encoded, and revealed only at the end, after the condition of each subject has been evaluated.

An important point is that, if the recipients believe that it is the real medication, even a placebo can have a positive effect. This is called "the placebo effect". If the medication is useless, then its curative effect will be no different from that of the placebo, i.e., entirely due to the placebo effect. Consider now what happens if the subject realizes that he or she has received a placebo. Then that subject will not benefit from the placebo effect, and the medication, even if actually useless, will benefit from the placebo effect.

So, we have the strange situation that a medication under test might look better than a placebo because of the placebo effect! This can happen if the placebo is not designed to have side effects recognized by subjects as resembling those they were told are those of the real medication. It is one of the explanations for why some almost useless medications are on the market. Tests in which the placebo does not produce obvious symptoms similar to those of the product being tested, should not be taken seriously.

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I am an engineer. My degrees are in electrical engineering and my work has been in the digital systems area, mainly digital logic, but also computer organization, software and theory. I am a Professor, Emeritus, Computer Science and Electrical (more...)
 

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