There are a lot of people who make money by doing drugs. Not the way you think though. They take on the role of human guinea pigs to test prospective medicinal drugs. Their role is mired in controversy, but it is hard to imagine the drug approval process without their contribution. We expect any drug that is prescribed to have been proven to be safe and effective. But that is easier to say than to do. No amount of testing on animals or even on humans can ever guarantee that a drug will work in everyone and be safe in every one. Indeed history tells us that this is an impossible expectation. First of all, people may be just as individual in their biochemistry as in their personalities. We know that you can blow the cold virus up the nose of volunteers and they will not all catch a cold. They have differently functioning immune systems, possibly due to genetic variations, previous exposure to microbes or even due to nutritional status. Similarly, we cannot expect drugs to work the same way in everyone, or to produce the same side effects. It is well known that the same pain killer may produce excellent results in one person and be totally ineffective in another. But of course we want to know that a drug has a good safety and efficacy profile, while understanding that there are no guarantees. And the safety and efficacy profile has to be determined by testing. The initial tests are carried out on mice or rats, but such studies can only tell us whether the drug is worth testing in humans. Obviously, if there are serious toxic reactions in rodents, it all stops right there. But if the rodents pass the safety test, then it is time to go to human trials.
The initial human trial is referred to as a Phase I trial and is designed only to determine if a drug is safe. Phase I trials do not address the effectiveness of the drug for any condition. As a general rule these trials do not involve more than a few dozen volunteers. Although they are referred to as volunteers, they are actually not that. People do not volunteer to be guinea pigs unless they are compensated somehow. At one time prisoners were used with the compensation being better prison conditions or earlier parole. Today, volunteers are paid, sometimes handsomely. A trial that involves no more than a couple of weeks can pay several thousand dollars. Sometimes the subjects stay in a research facility, sometimes not. Their body functions are monitored, their blood is drawn and they are asked to record and report any side effects. The volunteers are often people down on their luck who need some cash and cannot always be relied upon to document side effects. They may worry that if they report any illness they may be kicked out of the study. Some make a career of volunteering and don鈥檛 always abide by the rules. A significant rule is that there must be at least thirty days between volunteering for studies. This is to ensure that any previous drugs tested are out of the system. To make more money, some volunteers lie about this. Of course this can compromise a study because previously taken medications can skew the results. Sometimes subjects may also lie about medications they may be taking, fearing this would exclude them from a study. It is not a perfect system but it is difficult to think of an alternative. And of course problems that may affect a small percentage of patients taking a drug are not going to be picked up by testing on a couple of dozen volunteers. As with virtually everything else in life, taking medications comes down to an evaluation of risk versus benefit.
