Need money? Can’t afford medical supplies? Enroll in a Clinical Trial

I was reading through Bioedge newsletter (a great newsletter for bioethics news updates) , and came across an article on people enrolling in clinical trials for additional income. Several of the participants that were interviewed, said that they searched the internet for clinical trials, and responded to ones that they were interested in. Many of these people will participate in two to three clinical trials per year. Some of them have criteria for what kinds of trials they are willing to do, such as one participant who does not take drugs that may affect the brain, heart, or have severe side-effects. Several of the participants report that by doing these trials they were able to receive medical care or medical supplies that they would not have had otherwise. Also, many people who enroll in clinical trials end up having conditions such as cancer or hepatitis that would not have been detected had they not participated in a study. Personally, I knew a guy that enrolled in a ten-year heart study. He had to wear a pedometer and went in for tests and evaluations that would cost any other person thousands of dollars.  He thought it was a great deal and was glad to help with a study.

In many ways this seems like a great deal. I certainly sympathize with the scientist’s perspective of wanting volunteers to assist in clinical trials. Even though scientists can test and re-test and continue evaluating the effects of these drugs in animal trials, eventually it needs to be tested in human beings. By the time a drug has reached this point, though, it has been through extensive testing in animal studies. Also, these patients seemed to have had good experiences in participating in clinical trials.

However, financial compensation in medical procedures is always a cause for concern. I do think people should be compensated for their time and trouble. I also think that if insurance does not cover any harm that may occur in a clinical trial, the patient should be compensated by the company. But with compensation comes the risk of exploiting certain socio-economic groups or the vulnerable. These trials are voluntary, but, as with the case of a mother who had diabetes, the trials provided the medical supplies that she could not otherwise afford and it provided additional income that she needed. This doesn’t sound bad. In her case, it seemed to have worked out well, but there is still concern for people that are in medically or financially desperate situations. Some trials place a patient at a greater risk than others. As Arthur Caplan mentions in the ABC article, the amount of money the patient receives for participating is a good indicator of the potential risks. The compensation may entice financially strapped individuals into putting themselves at a greater risk than they would have done otherwise.

A second consideration is that clinical trials do not replace going to the doctor, or receiving medical treatment. This caution was touched upon in the ABC article, but merits some elaboration. Not all clinical trials are testing efficacy. This is an important point for people that have an illness that they are hoping will be alleviated or cured with these new trial drugs. Phase 1 clinical trials usually test for side effects, therefore some patients will not receive a strong dosage and some patients will likely receive a placebo. From what I understand, patients are told up front that they may receive a placebo and this part of the clinical trial is for toxicity or side effects, not for efficacy, but certainly with certain trials patients are hoping for something more.

Additionally, participating in a clinical trial is not the same thing as going to a doctor. The researchers are looking for specific things having to do with the drugs that they are testing. While they will often find other problems in the process of clinical trials, that does not mean they will catch everything. For example, my friend that is in the heart study gets very expensive tests for his heart and cardiovascular system, but the doctors may not catch a digestive disorder or a tumor in another system. It just depends on what they are testing and the extent to which they are examining the entire body. Generally, by the time a drug has hit clinical trials, researchers have a good idea of what systems will be targeted and what side effects will likely occur.

A third consideration, not covered in the ABC article but addressed in this Business Week article, is recruitment. Drug development is a very expensive endeavor and often the drug company loses money at the clinical trial level because it cannot find volunteers to fit the study’s criteria. Hospital medical records provide a way to filter patients who may be good potential candidates. This is a good idea, in theory, but raises privacy issues.

In sum, clinical trials have provided people with medical supplies, supplemental income, and in some cases, diagnoses that they would not have received otherwise due to various factors, including economic ones. However, compensation may entice some people to place themselves at a greater risk that they would have done otherwise, and clinical trials do not replace going to a doctor or receiving needed medical treatment for a condition. Finally, the drug company has an economic incentive to recruit people with particular qualifications to do trials, but in order to obtain this information, privacy issues must be considered.

Human trial is always a sticky subject and raises several questions about how we can best respect the rights of the human trial subject while still adequately testing a particular drug for treatment.

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