The Journal of the California Alliance for the Mentally Ill
Spring 1994; Vol. 5, No. 1, pp. 42-44
PSYCHIATRIC RESEARCH: REALITY CHECK;
An Open Letter To Persons With Mental Illness And To Their Families
By Dianne N. Irving, M.A., Ph.D.
" ... there has emerged a phenomenon unknown to antiquity that permeates our modern society so completely that its ubiquity scarcely leaves us any room to see it at all: the prohibition of questioning ... We are confronted here with persons who know that, and why, their opinions cannot stand up under critical analysis and who therefore make the prohibition of the examination of their premises part of their dogma ... The questions of the "individual man" are cut off by the ukase of the speculator who will not permit his construct to be disturbed."
My nickname as I was growing up was "brat"! I asked too many questions. But, I figured, no questions, no information. No information, no way to sort out what is true or false, relevant or irrelevant -- right or wrong. Relentless questioning became my personal tool for "reality checking."
Needless to say, I've gotten into some tight fixes since then with my questioning. Not everyone is delighted with the probes, or concerned with truthful answers. And then there are those who are afraid to even ask the questions. Pity, because silence breeds arrogance; and fear breeds cowardice. Nowhere should this be of more concern than in psychiatric research.
Families with mentally ill members have hopes and dreams -- hopes that psychiatric research will end the suffering; dreams that their personal nightmares will end and their loved ones will be cured -- or at least gain some greater degree of dignity and useful functioning. If some aspects of this enterprise are questioned -- are those hopes and dreams at stake? Of course not. More harm will come if questions are not asked -- and reality is not checked.
Everyone agrees that psychiatric research is important and ought to be done. But not "at all costs" and not "no matter what". This is sheer brute arrogance and a disaster waiting to happen. Unethical research should not be done -- for any reason; ethical research should. Because the very nature of psychiatric research requires the direct use of human subjects, ethics more immediately enters the picture. If ethics is not important for psychiatric research, your family members with mental illness could be seriously harmed. We don't live in a perfect world. We are all subject to pressures, greed and confusion -- and "we" includes the best physicians and brightest researchers. With valid ethical constraints, patients with mental illness who take part in research will be respected for their inherent dignity as human persons, their health and rights will be protected, and considerable good for them can be realized.
Yet, even with certain ethical constraints in place, because persons with mental illness are obviously vulnerable and sometimes questionably able to give informed consent -- should they participate in research only when it benefits them directly? Most people recognize the common sense reasoning for this. But sometimes even common logic can get a little off the mark. For example, some agree that the good of the individual patient should come first. But they also say that some human individuals may be human beings -- but they are not human persons when they cannot exercise "rational attributes" (i.e., rational autonomy and competence, self-consciousness, the ability to relate to the world around them, etc.) If this "logic" is pushed, then the mentally ill (including those with schizophrenia), Alzheimer's and Parkinson's patients, drug addicts, alcoholics, etc., could easily be rendered "non-persons" too (which in fact did happen in Nazi Germany), losing their ethical and legal rights and protections. Thus your family members with mental illness could be subjected to serious harms and indignity.
Others say you should put society first, not the individual -- but I would disagree. There is something fundamentally wrong with the formulation of the "social good" when that "good" is harmful to and destructive of the very individuals who comprise that society. Likewise, patients should not be pressured to participate for the "greater good of society" -- read, "for the benefit of future mentally ill patients." If psychiatric research is to be done, it should be therapeutic research only -- done only for the direct benefit of that patient. If information arises that may help future patients, that is an added bonus. But no person should feel pressured into taking part in an experimental research protocol for someone else's good. Sometimes research protocols are explained to patients in terms of risk/benefit ratios, as if in order to "get a little" you have to "give a little". Nonsense. No person with mental illness should be pressured into believing that he or she has to take part in any experiment -- regardless of any benefits.
Other research, performed "for the sake of scientific knowledge itself", might also be unethical. Recent examples include induced relapses and sham surgeries. A 1987 study in the American Journal of Psychiatry describes a research protocol which was purposely designed "for the sake of scientific knowledge," i.e., as a "clinical tool" "to predict the time to relapse." It was not designed for the direct benefit of the patients used. Perhaps the researchers gained knowledge which may have been great to get -- but it was come by unethically and at the painful expense of many of these patients. A "wash out" period was required before the administration of L-dopa, during which patients were taken off of their regular medications for a period of time in order to "cleanse" their systems of their usual drugs. Even amphetamines -- that act as a sort of pseudo-psychiatric "kick" (which are obviously harmful in themselves) were administered to some of these patients in order to give the researchers a better "understanding" of "time to relapse". After the L-dopa or amphetamine challenges, these patients were then "discharged into the community ... and rated at weekly intervals for 52 weeks or until they relapsed." Many patients suffered "emotional withdrawal, blunted affect and motor retardation" because of the relapses purposefully induced by the researchers "for the sake of scientific knowledge".
Of course, "informed consent" was obtained from these psychiatric patients -- but did the researchers really explain the true purpose of the experiment -- that the protocol itself was designed specifically to induce relapse? Often not. Especially given the fact that relapses were most likely expected, why would these patients be discharged out into the community? Relapsing is an anguishing, painful ordeal -- sometimes causing further permanent brain damage, worsening an already bad situation. Because relapses render these patients so dysfunction, they can result in loss of work, homelessness, degradation and abuse of persons in very vulnerable situations by others "in the community" -- depression, loss of self-respect, and sometimes even suicide. It is an extremely harmful, painful nightmare for these patients and family members alike -- and should be avoided at all costs. It is unconscionable and outrageous that any researcher could so coldly and methodically design a protocol to intentionally cause relapse -- for any reason. It is an example of how the goals of the "researcher" (good accurate data) can be quite different from the goals of the "physician" (medical care for the benefit of his or her patient).
How could monitoring at "weekly intervals" be either psychiatrically sound or scientifically significant? Did the researchers assume that the one time during the week that the patient was observed would in any way indicate with any statistical meaning what the real conditions and reactions of these patients truly were? There seems to be no real concern, either, for the devastating relapses which did occur while the patients were out in the community -- other than that they happened, as planned. Was there any follow-up medical care or monitoring, especially for those who did suffer negative symptoms -- or might suffer them later, somewhere out of the clinician's view? Or were they simply thanked for their cooperation and shown the door? Were any of these patients compensated for any harm which they had suffered? Or for their time?
Another example of unethical research performed "for the sake of scientific knowledge itself" is a an experiment just recently reported in Science having to do with research in Parkinson's disease. Although this experiment was designed to test the possible beneficial effects of implanting fetal tissue into the brains of 20 Parkinson's patients, it was also designed to include boring holes in the skulls of 20 Parkinson's patients without further insertion of fetal brain tissue, as a control, to eliminate any placebo effect due to the surgery itself. Many good researchers complained. One stated, "I think that's the most outrageous protocol I've heard of in my life!" Another remarked that his country's " ... ethics review boards have expressly forbidden sham surgeries". Interestingly, this experiment was approved by three IRBs and NINDS's advisory council -- necessarily leading one to question just how effective IRBs and advisory councils really are in protecting even non-vulnerable, much less vulnerable, human research subjects. The researcher's innocuous response was that the risk of the sham is "vanishingly small." From whose perspective?
One of the most neglected ethical issues is that of informed consent. How and under what circumstances can psychiatric patients give real informed consent? Sometimes there seems to be a little tweaking of the psychiatric and even legal facts in order to enlist non-competent human subjects in a protocol -- especially if they do not happen to have loving family members to protect them. For example, policies are presently in place which allow surrogates to be chosen by cognitively impaired patients, persons whom they designate to give "their" informed consent. These surrogates will then decide if these patients can take part in medical research. One such existing policy at NIH is actually improperly based on a Maryland durable power of attorney law. But this Maryland law only allows competent citizens to give informed consent to choose surrogates who can later make health care decisions for them if they themselves should later become incompetent. It cannot be used legally for an incompetent patient to give "informed consent" by choosing a surrogate who will then decide if the patient can participate in medical research. This NIH policy also states that seriously impaired patients may have a surrogate chosen for them by the physician-researcher, in consult with the bioethicist or others approved by the Director of the Clinical Center! This is an example of how some of the legitimate enthusiasm for the rights' of the mentally ill can be a source of potential harm for them instead.
What about the researchers? Are their credentials really credible? A wall full of diplomas does not necessarily a competent expert make. The most basic ethical criteria of a research protocol is that the science is sound. If a researcher's competence in the basic facts of his or her own scientific field is questionable, then so is his or her competence to design a scientifically sound protocol. If the protocol is not scientifically sound, it could result in serious harm to some unsuspecting ill persons. Also, stellar academic scientific credentials do not guarantee that a researcher will not fake his data. Although scientific fraud is on the rise, we keep waiting for the scientists to" monitor themselves", as they organizationally promise to do with each succeeding scandal.
As old Aristotle once so aptly put it, a small error in the beginning leads to a multitude of errors in the end. Any experiment in which the experimental design is flawed or in which the data is fraudulent is automatically unethical, and more than likely has not only already harmed the psychiatric human subject immediately involved -- but will harm all of the other patients to whom such data will be later applied.
Are there many conflicts of interests? Are researchers being financially pressured by their pharmaceutical funders to make their drugs look better than the competition's? Are researchers profiting financially in a drug company's successes? What do the pharmaceutical companies get out of psychiatric research? And isn't there a possible conflict of interest when they are funding research on their own drugs? What oversight is provided to ensure the public that there are no conflicts of interests? Although the government now requires quality assurance auditors to audit the research data of the drug company, who audits the auditors? Isn't there a possible conflict of interests when the QA unit is housed in and their salaries paid by the very drug companies that they are auditing? And who is monitoring the monitors employed during the actual performance of these research protocols -- if any one is monitoring at all?
Who is enforcing this oversight, and what are their possible (political) conflicts of interests? Just as political appointees, judges, etc., must file conflict of interest statements, shouldn't researchers and others involved who might profit financially or politically be required to file an affidavit concerning any financial or political ties they might have with any funders, such as ownership in pharmaceutical or bioetech stocks, potential interest in patents, the marketing and sale of devices and drugs, etc.? Up to this point, no one seems to be really accountable to anyone for anything.
Ultimately only the families of persons with mental illness can effectively insist on some straight answers to these very complex questions. When researchers react with irritation, or derogatory remarks, or intimidating suggestions because serious and legitimate questions are being raised -- I suggest that families and their ill loved ones walk out the door and find a good, competent and ethical researcher who will be more than happy to answer your questions ... truthfully.
Finally is it possible that some of the rush to research might be blown a little bit out of proportion? What about all the other aspects concerning persons with serious and persistent mental illnesses, aspects which also need so much effort and attention? Have we been orchestrated into a "finding a cure at all costs -- no matter what" mentality? Some serious agenda restructuring seems to be in order. Perhaps there is really more at stake and more involved here than just the challenge to find a "cure". Time for a reality check.