PRO & CON

DAVID ORENTLICHER, M.D., J.D., IS CODIRECTOR OF THE CENTER FOR LAW AND HEALTH AT INDIANA UNIVERSITY SCHOOL OF LAW, INDIANAPOLIS.

Yes | No

Yes - Although some studies raise the concern of whether patients are put at too much risk, we must also ask if research safeguards are sometimes overly protective of people who might enter clinical trials. As I wrote in the September-October Hastings Center Report, there are many medical problems for which physicians can choose among multiple therapeutic options, and the decision is typically based more on hunch than on data. Patients would benefit greatly from studies that clarify the benefits and risks of different options for their illnesses.

However, these studies are delayed--and medical progress impeded--by difficulties in securing the participation of enough individuals. For instance, in one study comparing the two leading therapies for chronic atrial fibrillation, only 55% of patients invited to enroll in the study agreed to do so.

Given the difficulties in enrolling patients, physicians should be able to make access to treatment they provide contingent on the patient's willingness to enter a clinical trial, when the trial compares two or more accepted therapies to determine if one is superior. Patients would not be subjected to any risk by their participation--they would be receiving treatment that, under current knowledge, is as good as the alternatives--and they would be free to decline participation and receive care from another physician. Of course, patients should not be required to take part in trials of experimental therapies; such a requirement would be unethical.

Some worry that making treatment dependent on clinical trial participation would undermine the patient's trust in the physician. Although this concern is important, it should not lead us to reject the idea entirely. Past abuses of clinical trials have involved either lack of informed consent or an unacceptable risk to patient health, neither of which we are talking about here. Conducting clinical trials might actually bolster patients' trust in their physicians by assuring them that their doctors are trying to find out which treatments work best.

Some people may also worry that patients will feel pressured to enroll in the study. But if they agree to participate, they will not be placed at any greater risk than if they decline. And importantly, they can always decline participation and receive their preferred care from another physician. Moreover, the purpose of the pressure is to encourage patients to help doctors understand and treat disease.

No - As a physician who has conducted clinical trials, I've found that the most important thing is being able to offer the patient a choice.

When there is a trial involving two therapeutic regimens, the patient should give fully informed consent and should be given latitude not to participate without sacrificing the physician-patient relationship.

Although it can be challenging to enroll patients in a study, we should respect the fact that patients are masters of their own destinies. That may be looked on as stonewalling the progress of medical science, but we serve our patients one on one and build relationships on trust.

If the patient is given a choice of Plan A or "I'll no longer be your physician," it would further the science of medicine, but it also would detract from the healing process. An integral part of healing is not only the medicine we give, but also the trust patients afford us and the relationship patients have with their physicians.

The way I look at it is, how would I want my family--or even myself--to be approached or treated?

I would want family members to have the ability to make a decision. Although the research and data express a sense of urgency about being able to further medical science, we can't lose the importance of patients whom we serve in the name of medical science.

My own experience as a researcher in a comparative study of two hypertension drugs has been that when patients are given proper informed consent, we can get a 90% or better participation rate.

If you have a study you think a patient might benefit from, you can say to him, "There are two arms of this study, Arm A and Arm B. And looking at your problem list, you seem to meet all the criteria for the study, and you might benefit from it--with free medical visits and free medication--and you'll also be helping people." When you present that to patients, few will be averse to it.

This is an anecdotal result, but I didn't think I needed at any time to strong-arm anyone into participating.

The patients got the advantage of the free office visits and free medicine, and no one gave them an ultimatum. As long as patients are educated and well-informed, they recognize the benefits of participating in studies.