---

Pharmaceutical Testing in the Incompetent Patient

---

Pharmaceutical companies must test new drugs for the treatment of mental illness on patients with the illnesses for which the drugs were developed to treat. This seems a very clear statement. The ethical concern is how can these patients who may have lost the capacity to understand the purpose, nature, risks, benefits and alternatives (including nonparticipation) of the research, to make a decision about participation? Should a family member or other surrogate make the decision for such a patient? Ordinarily, surrogate medical decisions deal with therapeutic issues. In the case of drug testing, the testing itself may not prove to be therapeutic, may be painful or even harmful for the patient. Should surrogates be given the power to allow the patient to be subjected to medications which have not been proven therapeutic but may be harmful? If there is no surrogate, who should make the decision or should the patient be eliminated as a candidate for the study?

Here are the questions:

How can the patient's rights be protected and still provide for necessary testing of drugs in the mentally ill? Who, if anyone, should make the decision for an incompetent patient regarding participation in a drug testing experiment?

Please do not employ the term, "the" mentally ill. No group is generic.How to obtain informed consent when a person is not capable of giving it? Stop.If I know someone is not competent, proceeding is unethical. Only greed motivates past knowing the person cannot consent. The greed for an answer or for a recognition.More the latter than the former. Harold A. Maio

How can the patient's rights be protected and still provide for necessary testing of drugs in the mentally ill? Who, if anyone, should make the decision for an incompetent patient regarding participation in a drug testing experiment?

There is no generic "the" mentally ill. There is however a commodity, "the" mentally ill, which is widely exploited. There have been many such "commodities" in history. Once one has retreated to an abstract "the", societies seem to offer that group to be expolited. Generally the exploited group has no political power, ergo the Tuskegee "study". Even the Salk vaccine was tested on people unable to consent.

If one is a "patient" are there not already ethics in place, or is the term just a convenient empty metaphor?

Should a person unable to consent be forced to participate? No. Whatever term someone wishes to employ, it amounts to force since consent cannot be obtained. Florida law accepts that infomed consent has been obtained when "sufficient" explanation has been given. "Sufficient" is a metaphor of force, since it will be defined by the person intent on forcing, not by the person forced.

Harold A. Maio,Consulting Editor Psychiatric Rehabilitation Journal Boston University

I believe that it is wrong to conduct experimental testing for unapproved drugs on the mentally ill without express consent from a legal guardian, power of attorney, or judgment of the state. As a nursing student we have been taught that our highest priority is to protect the rights of our patients. Through education we can help the families and guardians come to a better understanding of how pharmaceutical companies work to improve and or create new drugs that could better serve the people. With this education now comes the power of the families and guardians to decide what is in the best interest of the patient. We cannot arbitrarily stand by while others decide our fate. We have to stand up for the rights of those who cannot stand up for themselves. If we don't who will stand up for us if the time comes?

Becki Price

Not all mentally ill people are incompetent. I think that has to be determined before you can make a blanket statement as to who can make the decision for their participation in a drug trial. Many mentally ill patients would welcome the chance even during stable periods, if it meant decreasing the effects that their illness has on their lives. Look at the Clozaril trials for instance...while there are great risks associated with this medication the benefits for the majority of the patients outweighed the risk. I believe we allow the patient to make the choice unless the court has declared them incompetent and if that is the case, give the information to the legal guardian and assist them in make the appropriate decision as needed.

Using experimental drugs on persons who are mentally incompetent because of illness is not a clear cut issue. However, if the drugs are being designed to specifically treat their disease or disorder, and this disease or disorder often or always leads to mental incompetence, the treating physicians are really left with no choice but to test the drugs on these people. Certainly the drugs cannot be used on healthy people. I think the decision of whether or not these patients should be used in experimental drug testing should be left up to their relatives, who will hopefully act in the best interest of the patient.

Pharmaceutical testing in the incompetent patients? This is a really tough issue. It's like a gamble, you test the drug on a person like a guinea pig, if it lives and does its purpose it works, but if the patient gets worse or dies it's a failure and you loose. I say let a family member make the decision for him or her. Discuss the drugs purpose and whats expected to happen, Also explain it's risk and possible side effects. Also explain what the patient may feel physically and mentally.

Mentally ill patients are not by definition incompetent to consent to drug testing. Many mentally ill patients do not lack the capacity to understand the purpose, nature, risks, benefits, and alternatives of the research. As a matter of fact, I have many patients (I am a Psychiatrist) who are more altruistic than their non-mentally ill designated counterparts. If a drug can be tested on willing and factually competent individuals, it should. Only if it can be proved that an illness renders all people who contract it incompetent to consent then legislation could be enacted to appoint a committee to decide based on the individual's premorbid preferences if possible whether or not to allow the person into the study. The principle of autonomy should rule whenever possible.

The problem of consent to diagnostic and therapeutic procedures of incompetent individuals has not yet been solved adequately and you already ask about the consent relative to experimental therapy ?! It seems evident that caring for, let's say, a demented Alzheimer patient is quite easy when benefits prevail over risks by far :e.g.in case of arterial hypertension or acute appendicitis. If, on the contrary, performing diagnostic and therapeutic procedure entails a certain morbidity (annoying side effects) or mortality e.g. coronary disease, then every person deciding for the incompetent patient will be criticized , and perhaps also legally sued by relatives with conflicting interests , if things don't go straight. Deciding about new diagnostic or therapeutical procedures (namely drugs) to be applied in incompetent patients should start from the same point: the benefits either real or awaited (on serious scientific grounds)should prevail by far over risks. It must brought in mind however that only at the beginning of the dementing process, such as Alzheimer or Multiinfarctual dementia, a real benefit may be awaited from a therapy and it will be, when it will be, a stop to mental deterioration. It seems actually unbelievable to restore mental abilities that have been lost because the corresponding neuronal centers are atrophic and millions of neural cells and their fibers are absent. This stimulates drug researchers to focalize their efforts on the beginning of the dementia when the best resuls are perhaps attainable and, if attained, best measurable. But it is just the moment when patients usually are still competent and may be asked their consent about new drug treatments. I think morevover that in this period of initial restriction of mental capacity which does not intefere yet with the ability of caring about theirselves patients may be asked advanced directives about the future behaviors of the caregivers (deciding substitute) and the medical staff.

Society provides a surrogate decision maker for its immature and mentally incompetent members. To an extent, the rights of this unfortunate class are transferred to those close enough to them to act in a manner as similar as possible to the incompetent person. Usually, this is a family member, but it might be a friend, or even the state when that's the best society can come up with. It's not a perfect system, but more often than not, the designated decision maker acts in the incompetent individual's best interest and in a way that is reasonably similar to the way that individual would act if he or she were competent.

I think the testing of psychotropic drugs is so important that the risk of unnecessarily violating a person's right to make an informed decision is significantly outweighed by the benefit of making appropriately tested and effective drugs available to those who need them. (Not only does the mentally ill patient benefit from the drug, but society benefits from him or her taking the drug.)

I say, let the party designated to make any important healthcare decision on behalf ot the incompetent individual make the decision regarding participation in a drug study. The only exception I would make to this rule would be when the incompetent individual's guardian is the state because the state is least likely to know how the incompetent individual would act if he or she were competent.