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The Ethics of Research Trials

© Ian Chovil

Articles on ethics are generally the ones I throw out first. Ethics to me is one of those obscure quasireligious pursuits of true academics. Real life ethics is simply the bottom line, twisted by ethnic and/or religious conviction. When push comes to shove the bottom line wins every time. Maybe that's the ten years of abject poverty I survived without medical attention talking. Is it ethical to walk by someone who is homeless, hungry, and not even sure what planet they are on because they are psychotic from untreated schizophrenia? Apparently. So why am I writing on ethics?

All testing of new antipsychotics on people must be approved by ethics review committees. The research trials are the documentation needed to get government approval to sell the new drug. A researcher at a hospital will typically have to get all research with human subjects approved by an Ethics Review Committee. Federal governments set minmum standards of their own for experiments with humans. The United Nations has come out with at least one multinational accord on the standards by which experiments are carried out on humans, which includes the research trials for new medications.

What I want to discuss are double blind placebo controlled studies. A double blind study is about the only type of research that psychiatrists listen to. In it people are subjected to different treatments and no one is sure which person is getting which treatment. To test a new drug for schizophrenia the pharmaceutical company will hire psychiatrists to conduct double blind studies supplying them with identical unmarked medication. For example they may want to give one half of the subjects Haldol and one half Olanzapine and measure the differences with various tests (called instruments) over time. These are the arms of the study. There are many variations. You could have three populations with three different fixed doses of Olanzapine to see what dose works best with the most people. No one would know what dose they were taking. Breaking the blind is a last resort. If someone had an adverse event that might be related to the medication, like a seizure, the researcher could break the blind to find out what the person was taking.

The ethics of human trials are an attempt to circumvent the unavoidable risk of any new medication. People have to try it, to be sure it works and to to be sure it is safe. Safety is usually resolved in the animal studies, but not completely. Efficacy, that is how effective the medication is, is an educated guess. It costs at least $400 million to bring a new medication to market. One pharmaceutical representative told me it is a kind of horse race. One new medication will earn a lot of money, two will break even, and one will lose money. New medications are not always better, but you hope that they will at least have fewer side effects.

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