Informed Consent: An Understanding

Ethics in Clinical Research - Ethical Issues in Human Subjects ... from Medresearch

In September of 1999 the American Journal of Psychiatry had an Op-ed about Informed Consent in clinical research written by Dr. Carpenter, of The Maryland Psychiatric Research Center: Dr. Carpenter wrote the editorial because he said, "I am concerned that more harm to the future of individuals with mental illness is being caused by the rush to allegation and redress than is justified by anticipated benefit." To document Informed Consent he suggests the following:

1. Have patients or their advocates comment on proposed research and consent forms.

2. Ensure that informed consent is an educational procedure taking place in a time frame that enables the prospective subject to understand, appreciate, reason, and freely exercise choice.

3. Include clinicians other than key investigators in the informed consent process and assessment of decision-making capacity, but do not exclude the investigator from personal responsibility and participation.

4. Include significant others as the patient considers participation, but do not compromise the patient’s autonomy and dignity rights if decision-making capacity is adequate.

5. Provide material to all concerned clarifying that clinical care involving research is importantly different from ordinary clinical care. Work with patient subjects to minimize the therapeutic misconception that is commonplace in biomedical research (17).

6. Ensure that patient subjects have contact with a noninvestigator who can help resolve issues relating to research participation.

7. When accepting a consent form, document understanding of basic facts relating to the protocol (the Maryland Psychiatric Research Center administers an ­evaluation-of-signed-consent test [18]).

8. Provide educational and sensitivity-raising sessions in ethics for investigators and staff. Include an appreciation of the fundamental role in subject protection incorporated in institutional-review-board-related procedures.


My son was used in drug trials; on or off the books--it is the only explanation for the number of neuroleptic drugs a federally funded researcher pumped into my precious son after he was 13. Jon McClellan, like most psychiatrists and other mental health treatment professionals in Washington State, claim that parental consent is not necessary if the patient is 13 years old. This federally funded researcher claimed he did not need my Informed Consent consent for my  minor son's "medical" treatment because my son was 13; he then claimed since my son was a Ward of the State, my Informed Consent wasn't needed.

McClellan, intentionally or not, ensured that my son would have a psychotic break by withdrawing him off of Risperdal too rapidly. Risperdal is a neuroleptic drug my son had been on for YEARS, (I was oblivious back then to the corruption and fraud; I still trusted doctors, etc.) The Risperdal wad prescribed off-label, and fraudulently billed to Medicaid; my son is a victim of Johnson and Johnson's illegal marketing of Risperdal. To treat my son's horrific withdrawal psychosis, Jon McClellan pumped massive amounts of neuroleptic drugs with terrible adverse effects into my son; sometimes 2 and 3 neuroleptic drugs concomitantly, along with other psychotropic drugs. It's many miracles my son survived at all. I remember being utterly devastated--I thought my son was going to die.  I know he felt tortured.  I know he was begging me to rescue him.  I know will never forgive myself for not doing more to stop what (what the fuck do you call it/him?!) was doing to my son.  I know I was ridiculed for standing up for my son's Human Rights. I know I was denied my parental rights; specifically my right to make medical decisions and give Informed Consent for my by then floridly psychotic son. By law, I retained my parental rights to make mental health treatment decisions on Isaac's behalf; nonetheless, my rights were effectively denied by the Medical Director of Child Study and Treatment Center, Jon McClellan. He initially claimed he didn't need my consent because Isaac was over the age of thirteen. When I pointed out that Isaac lacked the capacity to give consent, he claimed he didn't need my Informed Consent because Isaac was a ward of the state. I was reassured prior to signing the agreed order for a Consent to Place, that  by law, I retained my parental rights to give consent for Isaac's mental health treatment.  I had to be coerced to sign the agreement-- The order effectively made my son a foster child, e.g. qualified for federal Child Welfare benefits. The Agreed Order was NOT necessary to ensure that Isaac's medical care would continue to be paid for through Medicaid, as I'd been told. Isaac was on SSI & Medicaid as a handicapped child, there was no risk he would lose his medical coverage...

The fact that my son was in fact a ward of the state was somehow perceived as proof I was a bad parent, undeserving of respect.
Dr. Carpenter's Op-Ed in it's entirety: 
The Challenge to Psychiatry as Society’s Agent for Mental Illness Treatment and Research

Society has a moral responsibility for its sick and disabled citizens. Psychiatry assumes this responsibility when clinicians provide care and treatment to mentally ill patients. But these very patients often lack insight into the nature of their afflictions, their causes, and their need for treatment. Experiencing altered perceptions, affects, and beliefs is very different from experiencing other somatic dysfunctions. Both patients and society view the latter as illness requiring medical intervention, whereas the former all too often are viewed as personal attributes rather than disease. Society is uncertain how to assert responsibility, looking simultaneously to law enforcement, religion, psychiatry, the family, and social planning. Given complex and competing themes, psychiatry’s capacity to assert and validate illness models and therapeutic interventions is invaluable. A major advance over the past 40 years has been establishing society’s confidence that psychiatry can identify individuals who suffer from mental disorders and intervene with effective therapeutics. At the same time, society has also advanced the cause of civil liberties for the mentally ill. Here, too, much good has been accomplished, but disquieting problems remain, problems that stir passions as the ethics and politics of personal autonomy and free will clash with the consequences of honoring these virtues.

Gardner and colleagues tackle a vexing paradox in this issue of the Journal. Psychiatry accepts a clinical responsibility for determining which individuals, on the basis of mental disease and law, shall be deprived of autonomy rights and dignity by involuntary commitment to receive protection and (perhaps) treatment through clinical services. This burden of judgment and responsibility weighs heavily on the physician-patient relationship and on the professional identity of the physician. Psychiatrists experience their discipline at risk when their assertion of this authority is criticized by society and by the patient whose autonomy rights are compromised. Nothing is quite as reassuring in the exercise of this responsibility as a grateful patient who has come to appreciate the physician’s action. Stone’s "thank you" theory (1) captured this important dynamic and has been used in support of psychiatry’s wise exercise of this authority.

Gardner and colleagues tested the theory’s validity with empirical data. They found that many patients who did not believe that hospital admission was needed entered as voluntary patients anyway. There is room for negotiation when physician and patient have discordant views. Patients who did not believe that they needed hospitalization but who believed they had a mental illness and accepted voluntary admission were most likely to change their view and agree that a need for hospitalization existed. However, patients who denied that they had a mental illness, felt coerced, and entered as involuntary patients most often sustained their view that hospital care was not needed. The "thank you" from these patients remained theoretical. Most of the patients in this study were given affective or "other" diagnoses, and substance abuse was common. It is uncertain how these results generalize to more specific populations where insight is commonly impaired (e.g., patients with schizophrenia or mania), but results are not likely to be more gratifying.

Psychiatrists most often must accept the responsibility of denying autonomy and dignity rights without the appreciative endorsement of their patients. Clear role definition regarding clinical and social responsibility, valid concepts and assessment procedures to meet legal and clinical standards, and an acceptable degree of predictive validity regarding safety and therapeutic advantage are essential. Most important is that society sanction this role assigned to the psychiatrist in addressing the moral obligation of protection and treatment for the very ill citizen. However, the tension will remain as long as the patients we serve fail to understand their illness and the physician’s purpose. Change in this regard is importantly dependent on new therapeutic advances through scientific research.

The role of the psychiatric investigator in meeting society’s obligation to develop new knowledge to benefit ill citizens is also a vexing paradox: society simultaneously expresses "best hope" and "worst fear" images. No responsible commentator doubts that new knowledge through science is critical to advancing treatment and prevention of mental illness, but current attention in the popular media involves harsh criticism of psychiatric investigations (2–11). Clinical research is not a perfect endeavor, and errors in subject protection procedures and occasional fraudulent investigators have been noted. Much of the criticism, however, is based on misunderstanding of science, misrepresentation of facts, and unsubstantiated allegations. Nonetheless, there is a common ground of concern on the issue of the capacity to make decisions in providing informed consent to research participation.

Subjects in mental illness research are usually presumed to be competent. This may be viewed as respect for the autonomy and dignity rights of persons with mental illness, but the question has also been raised that the presumption of competence permits too many patients with impaired decision-making capacity to sign consent forms they do not understand. Those who believe that valid informed consent can be (and usually is) obtained believe that optimal procedures require continual evolution and that better documentation is needed to enable society to judge the adequacy of the informed consent process. Those who believe that mental illness research is substantially conducted without valid informed consent doubt that investigators and institutional review procedures can ever ensure that this lynchpin of ethical research will be routinely secured. All agree on the urgent need for data that address decision-making capacity for providing consent among prospective subjects for mental illness research. It is here that Appelbaum and colleagues make an important contribution of empirical data in this issue of the Journal.

Using an experimental, but carefully constructed, assessment of decision-making capacity, Appelbaum and colleagues found that depressed patients in a clinical trial had largely unimpaired decisional capacity and, therefore, were likely to be able to exercise their right to self-determination regarding research participation. Moreover, the patients maintained this capacity over time, suggesting that they remained able to exercise important elements of informed consent such as a sustained understanding of the purpose of the research and the right to withdraw. Appelbaum et al. report that decision-making capacity was not significantly related to severity of depression, a finding compatible with the commonplace observation that many psychiatric patients maintain competence for most aspects of everyday life despite severe symptoms. This study involved moderately depressed outpatients. It is not certain how these results apply to more severely depressed or psychotic patients.

Adequacy of informed consent in psychiatric research was the leading issue when the National Bioethics Advisory Commission addressed subject protections in mental illness research (12). The commission’s focus on the mentally ill was not based on evidence of informed consent deficiencies or other abuse of subject protections that distinguished psychiatric research. Nonetheless, the commission made its report and recommendations on mental illness rather than a broader consideration of brain dysfunction, which increases risk for cognitive impairment, or a narrow consideration of individuals who actually lack decisional capacity for the purpose of informed consent. The commission made recommendations for regulatory redress in psychiatric research alone. In testimony to the commission, Dr. Appelbaum presented data from the depression study reported in this issue of the Journal and similarly reassuring data that most subjects with schizophrenia at the Maryland Psychiatric Research Center were able to achieve decision-making capacity similar to that of normal control subjects when participating in an educational informed consent process. Dr. Appelbaum’s view that problems that could be documented should be addressed with solutions that had been tested and subjected to a cost-benefit analysis was not apparent in the recommendations of the National Bioethics Advisory Commission. The result, at least in part, is another expression of society stigmatizing the mentally ill and those who serve them.

I am concerned that more harm to the future of individuals with mental illness is being caused by the rush to allegation and redress than is justified by anticipated benefit. Optimal and ever-evolving procedures for the protection of research subjects, including the mentally ill, are of fundamental importance. Stigmatizing those citizens who receive a psychiatric diagnosis, however, and creating a veil of mistrust between society and psychiatric investigator can be rationally justified only if research procedures in psychiatry are both unique and flawed. Commissions in New York (13) and Maryland (14) recently addressed issues of subject protection in medical research with populations at risk for impaired decision-making capacity. Michels (15)called attention to the substantial difference in tone and content of the New York and Maryland commissions compared with the National Bioethics Advisory Commission report, and the interested reader will see this contrast extended when reading the companion articles by Michels (15) and by Capron (16), a member of the national commission. Michels suggested that the failure of the national commission to include any member with experience and expertise in psychiatric research may explain the difference. In this regard, the two state commissions focused on the decision-making capacity of individuals rather than diagnostic groups, on investigator and review procedures that would enhance capacity assessment and ensure adequacy of consent, on how to design protections in a more realistic relationship to risk, and on how to avoid costly new procedures that would interfere with acquisition of knowledge unless evidence for need and effectiveness was presented. Involvement of psychiatric investigators in these two commissions also reflects the field’s commitment to examining problems and evolving optimal procedures.

The psychiatric investigator lives in interesting times. Although I believe much of the present public attention is ill-informed and unfair, the field has received a wake-up call. Adequate decision-making capacity for providing informed consent to research participation can be assessed and documented. But how well is this being done in all the various settings where research is conducted? What constitutes adequate capacity, and how is this to be determined and documented? Who should participate in informed consent, and how should research be conducted if the person is judged to be too impaired for competent consent? How should these procedures be reviewed, and which stakeholders should participate in the review? These and many other questions are on the table. As they are addressed in new federal procedures and regulations, there is already much to do at the local level to address subject protections. The following suggestions seem reasonable, helpful, not too demanding, and protective of both patient subjects and investigators. Not intended as comprehensive guidelines, these suggestions illustrate actions that can be initiated by clinical investigators and their institutions and have worked well at the Maryland Psychiatric Research Center.


1. Have patients or their advocates comment on proposed research and consent forms.

2. Ensure that informed consent is an educational procedure taking place in a time frame that enables the prospective subject to understand, appreciate, reason, and freely exercise choice.

3. Include clinicians other than key investigators in the informed consent process and assessment of decision-making capacity, but do not exclude the investigator from personal responsibility and participation.

4. Include significant others as the patient considers participation, but do not compromise the patient’s autonomy and dignity rights if decision-making capacity is adequate.

5. Provide material to all concerned clarifying that clinical care involving research is importantly different from ordinary clinical care. Work with patient subjects to minimize the therapeutic misconception that is commonplace in biomedical research (17).

6. Ensure that patient subjects have contact with a noninvestigator who can help resolve issues relating to research participation.

7. When accepting a consent form, document understanding of basic facts relating to the protocol (the Maryland Psychiatric Research Center administers an ­evaluation-of-signed-consent test [18]).

8. Provide educational and sensitivity-raising sessions in ethics for investigators and staff. Include an appreciation of the fundamental role in subject protection incorporated in institutional-review-board-related procedures.

This last point merits brief comment. The media and a handful of severe critics have taken findings of procedural errors and reported them as unethical research and implied that unethical scientists are harming patients (2–11). This I condemn, but clinical investigators have also sometimes regarded such findings as merely procedural. We need to inculcate a deep appreciation of the regulations for review and approval and the monitoring of research as fundamental to the protection of human subjects. These procedures must be conducted with care, and shortcomings must be addressed as a first priority in the ethical conduct of human research.



Address reprint requests to Dr. Carpenter, Director, Maryland Psychiatric Research Center, P.O. Box 21247, Baltimore, MD 21228.



References



1
Stone AA: Mental Health and Law: A System in Transition. Rockville, Md, NIMH Center for Studies of Crime and Delinquency, 1975

2
Hilts PJ: Agency faults a UCLA study for suffering of mental patients. New York Times, March 10, 1994, p A1

3
Hilts PJ: Medical experts testify on tests done without consent. New York Times, May 24, 1994, p A13

4
Hilts PJ: Consensus on ethics in research is elusive. New York Times, Jan 15, 1995, p 24

5
Hilts PJ: Psychiatric researchers under fire for experiments inducing relapse. New York Times, May 19, 1998, p C1

6
Hilts PJ: Psychiatric unit’s faulted. New York Times, May 28, 1998, p A26

7
Wilwerth J: Tinkering with madness. Time, Aug 10, 1993, pp 40–42

8
Whitaker R, Kong D: Testing takes human toll. Boston Globe, Nov 15, 1998, p AO1

9
Kong D: Debatable forms of consent. Boston Globe, Nov 16, 1998, p AO1

10
Whitaker R: Lure of riches fuels testing. Boston Globe, Nov 17, 1998, p AO1

11
Kong D: Still no solution in the struggle on safeguards. Boston Globe, Nov 18, 1998, p AO1

12
Research Involving Persons With Mental Disorders That May Affect Decisionmaking Capacity, vol I: Report and Recommendations of the National Bioethics Advisory Commission. Rockville, Md, NBAC, Dec 1998

13
New York State Department of Health Advisory Work Group on Human Subject Research Involving the Protected Classes: Recommendations on the Oversight of Human Subject Research Involving the Protected Classes. Albany, New York State Department of Health, 1998

14
Final Report of the Attorney General’s Working Group on Research Involving Decisionally Incapacitated Subjects. Baltimore, Office of the Maryland Attorney General, 1998

15
Michels R: Are research ethics bad for our mental health? N Engl J Med 1999; 340:1427– 1430

16
Capron AM: Ethical and human-rights issues in research on mental disorders that may affect decision-making capacity. N Engl J Med 1999; 340:1430– 1434

17
Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W: False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 1987; 17:20–24

18
DeRenzo EG, Conley RR, Love R: Assessment of capacity to give consent for research: state of the art and beyond. J Health Care Law and Policy 1998; 1:66–87

It is not something one can forget or forgive in the absence of Justice.

"If we should perish, the ruthlessness of the foe would be only the secondary cause of the disaster. The primary cause would be that the strength of a giant nation was directed by eyes too blind to see all the hazards of the struggle; and the blindness would be induced not by some accident of nature or history but by hatred and vainglory."  Reinhold Nieghbuhr in The Irony of American History  

I'm a MadMother.  

I was stripped of my inalienable rights without Due Process of Law. 

I was prevented from performing a sacred duty: 

to protect my own precious child from harm.

It is not something one can forget or forgive in the absence of Justice.

June 30, 2011, Robert Whitaker posted an article in Psychology Today titled, "Now Antidepressant-Induced Chronic Depression Has a Name: Tardive Dysphoria" six months later, he left this  comment:

"This is a very important issue, and it goes to how our society (and researchers) are willing to think of illegal drugs as harmful, but avoid such thoughts when the drugs are prescription drugs. There is evidence of cognitive impairment in many long-term users of SSRIs (researchers called this impairment "quite common"). And Grace Jackson, a psychiatrist, has written a book on this risk, called "Drug-Induced Dementia."

a couple of excerpts from the article:

"El-Mallakh detailed how tardive dysphoria may develop in patients who initially respond to an antidepressant and then stay on antidepressants long term. But what if patients respond well to an antidepressant and then stop taking the drug?  Their brains have been modified by exposure to the antidepressant (i.e. oppositional tolerance has developed), and thus, upon withdrawal of the drug, are they more likely to relapse than if they hadn’t been exposed to an antidepressant in the first place?"

"This same basic mechanism—oppositional tolerance to a psychiatric drug—has been proposed to be a cause of tardive dyskinesia (TD), which develops with some frequency in long-term users of antipsychotic medications. TD is characterized by repetitive, purposeless movements, such as a constant licking of the lips, which is evidence that the basal ganglia has been damaged by the drugs."

"But now here we are 40 years later, with perhaps ten percent of American adults taking an antidepressant, and researchers are writing about “oppositional tolerance,” and drug-induced “tardive dysphoria.” That is surely a health outcomes story that needs to investigated, and if we want to put this into an even sharper moral context, we need only consider this: Many teenagers are now being prescribed an antidepressant, and when they take the drug, their brains will develop “oppositional tolerance” to it. What percentage of these youth will end up with drug-induced tardive dysphoria, and thus suffer a lifetime of chronic depression?" read here.

Robert Whitaker makes a very important point in the last paragraph questioning the morality of the bio-medical paradigm of psychiatric treatment.  In all reality the abuse of power which underlies standard practice for treating symptoms associated with psychological distress whether the care is provided by a psychiatrist, by a pediatrician, a general practitioner or other medical professional: the prescription is invariably accompanied by a claim that the drug prescribed will treat an underlying condition in the brain which is causing the symptoms.  The cruel reality is the drugs used actually  alter brain function, causing normally functioning neurological processes to become dysfunctional.  The end result is cognitive impairment, which can be permanent.  

It is realistic and logical to think illegal drugs are harmful--the evidence is abundant and definitive. The same is also true for FDA approved mind and mood altering drugs used to treat psychiatric symptoms.  The evidence is being obscured by the direct-to-consumer marketing of the drugs; the "patient advocacy" groups with their campaigns to decrease the stigma of mental illness; the regulatory failure of the FDA; and the blind devotion to the idea that a revolutionary neuro-biological translational discovery is "right around the corner" of Thomas Insel, Director of the NIMH.  What is abundantly clear is that Conflicts of Interest have apparently prevented each of these "stake holders" from serving the best interests of the people given a psychiatric diagnosis ethically or altruistically. 

Each of these entitites has betrayed the trust of the American people.  I don't believe it's a conspiracy, nor do I think it's necessarily done with ill intent---with the exception of the drug industry and the research psychiatrists who ignored medical ethics and the harmful consequences of illegally marketing dangerous drugs as a panacea to "treat" emotional and behavioral problems caused by societal and environmental deficits. The drug industry has in all reality, been aided and abetted in a criminal enterprise, reliant on fraudulent claims about the diagnoses treated and the drugs used due to a successful albeit illegal marketing strategy. Federal authorities and "patient" advocacy groups remain silent about the pervasive fraud and corruption ans continue to benefit from the largess of their Big Pharma benefactors. Silence in effect is complicity in an ongoing criminal enterprise; the FDA and "patient advocacy" groups financially benefit by remaining silently complicit...

Each has colluded with the drug makers in perpetrating fraud.  These drug manufacturers have been found guilty several times of criminally marketing psychotropic drugs; the NIMH, the FDA and the patient advocacy groups have not warned the American people about the fraudulent claims used by the manufacturers to gain expedited FDA approval of the drugs; or about pHARMa's illegal marketing schemes. Drug Makers fail to perform the after market testing supposedly "required" by the FDA, while the FDA turns a blind eye to the failure.  In the illegally marketing phase of this criminal enterprise, it is clear that government regulatory authorities are utterly and completely worthless; it is also abundantly clear that advocacy groups have been willing participants. It is in this phase that the collusion comes clearly into focus:  each and every regulatory authority and patient advocacy group who receives funds from the drug industry has either actively participated and/or passively allowed this ongoing fraud, remaining silent and denying the horrific impact on the people with a psychiatric diagnosis who are disabled or killed the drugs. It is an egregious breach of the American people's trust that belies the self-proclaimed altruistic intent to advocate for the best interests of patients. It is made worse by the fact this collaboration relies on defrauding the American people whose tax dollars fund "patient" advocacy groups and the FDA, who approves the drugs and theoretically provides after-market regulatory enforcement on behalf of the American people. Relying on assurances of the safety and effectiveness of pharmaceutical drugs, without reliable evidence, could be hazardous to your health; it may even be fatal.     

Each government entity whose primary purpose is to serve the interests of the American people has utterly failed to do so; the failure has put our most vulnerable loved ones at risk.  Each has purposely lied about and/or concealed the results of federally funded research.  Each has lied to the American people about the safety and efficacy of psychotropic drugs, as well as the subjective nature of the diagnoses themselves.  Each has purposely misinformed the general public, the people diagnosed, and their families members with a fraudulent claim that was developed in an effort to lessen the stigma of a psychiatric diagnosis; but which has no basis in fact.  The claim that psychiatric diagnoses are caused by a genetic, neuro-biological, chemical imbalances or brain defects, is an idea that some had hoped would encourage the general public to be nicer to people with "mental illness;" that it would increase psychiatric patients inclusion into mainstream society.  

Ten years after this massive media campaign to inform Americans about how to help people with a psychiatric diagnosis, using this ill-conceived strategy, essentially, propaganda; it is discovered this "anti-stigma" campaign had the opposite effect. Now that the general public believe that mental illnesses are caused by brain diseases, people with psychiatric diagnoses are shunned and excluded even more by the general public than they were before this "anti-stigma" campaign.  Despite this failure, and in spite of the claim being a ploy with no scientific validity, it is still stated as if it is a fact by mental health professionals---including NIMH Director, Thomas Insel.   

The vast majority of NIMH research funding is directed towards searching for evidence to substantiate the disease hypothesis; the vast majority of public funds are expended for pharmaceutical drugs as if the disease hypothesis has been validated and is a medical certainty.

We have a publicly funded treatment system which is based on medically treating people with a psychiatric diagnosis as if psychiatric diagnoses are evidence of a biological defect in the absence of definitive evidence.  We pay for the prescription drugs prescribed to psychiatric patients and treat them under color of law by force if they are not cooperative.   A psychiatric diagnosis is now adjudicated in Courts of Law; a psychiatric diagnosis is a legal determination of one's social, political and legal status. The scientific evidence is insufficient, so a legal determination is substituted. It's not constitutional, nonetheless, it is legal in most states.  The laws passed do not require that evidence offered need not comply with the Rules of Evidence applicable in any and every other criminal and civil Court proceeding, nor do Standard court Procedures need to be followed---this is a separate, not equal, lower standard for the "mentally ill."

Under the guise of public service and benevolent assistance and advocacy, mental health practitioners and volunteer "advocates for the mentally ill" have, with the drug industry's help, misinformed millions of patients and families and have violated many individuals Substantive and Procedural Due Process Rights, to force "treatment" that violates a patient's Human Rights. These people are the primary victims, their families are also primary victims---the secondary  victims, are the taxpayers who pay for the Court Proceedings, and pay for the drugs, pay the subsistence disability payments made to those who are iatrogenically disabled.   The secondary victims are also passive perpetrators. This may harsh, but there are injustices that once one knows about them a failure to protest them and the refusal to act in defense of the victims becomes complicity. Human Rights crimes carried out under the Color of Law, would definitely qualify as a circumstance in which one's failure to act would make one complicit.

Every Federal Authority and patient advocacy group that has failed to inform, and has denied the deleterious negative effects of psychotropic drugs while simultaneously reassuring people in crisis and their family members, of the the safety and efficacy of the drugs; is guilty of fraud. They are using the same tainted inaccurate misinformation used to illegally market the drugs, and in effect, are aiding and abetting in an ongoing criminal enterprise.   People relied on this information have been disabled and have died, yet we are supposed to believe this is for their "benefit" and it is in their , "best interest."  Others have been forced to take drugs after being stripped of their dignity, deprived of their Human Rights and devoiced. Some can no longer speak up in their own defense, because they are traumatized and afraid, or the "necessary medical treatment" disabled and killed them.  

This is the worst Human Rights disaster in Human History. Who cares? Society has been trained not to care for or about "the mentally ill" by psychiatrists who are proponents of  biological reductive explanations for symptoms of distress, and it is propounded by unethical  government authorities and "patient" advocates. All are recipients of public funding from We the People, but also from pHARMa. It's apparent that pHARMA, the primary beneficiary of this ongoing fraud, is getting an excellent return on it's investment--and We the People are being royally screwed...Psychiatrists and "patient" advocates will tell you that the victims lack insight and have a disease that is genetic.  I fail to see how believing psychiatric symptoms are caused by a disease or defect would justify inhumane treatment. The fact is psychiatrists and self-appointed advocates who are devoted to the disease hypothesis, are advocating a perspective and a treatment agenda; this is NOT the same thing as advocating for an individual or an entire class of people.

Criminal mistreatment of the "mentally ill" is widely accepted and standard practice. I am haunted by memories and living an ongoing nightmare. We were traumatized by the inhumane manner both of us were treated by "professionals." It is the deleterious, traumatic impact the drugs have had on my brilliant, precious son that make it difficult to stand;   and  almost impossible to breathe because being forced to choke back my outrage and denied the right to defend my own child against those who tortured him, have made me a different person.  My spirit is altered in profound ways by the trauma of witnessing the torture that was  inflicted upon my child, and knowing that the harm is not yet, finished. Grieving parents can be ignored---after all, just like their "mentally ill" children just don't know what's "good for them," the parents can't possibly be right to protest the manner in which their children are mistreated and harmed by "professionals." (the obvious, but unspoken implication is that family members who object or protest about how a loved one is treated, mistreated or flat out tortured can be ignored. After all, the parents are probably genetically inferior don't you know...they probably just don't know...they have a lack of insight!) I was told by one psychiatrist, "in psychiatry, curing symptoms reigns suppreme(sic) over a collaborative approach. Parents who objected to medical treatment they would see as at best ill informed and at worst impaired themselves."

People in distress are getting "medical treatment" that is in fact not based on Ethical Medical principles, nor is it developed from ethically conducted or honestly reported research. This means it is treatment that is neither therapeutic or medical in nature; it is political in nature with psychiatry functioning as a social control authority. This fraud is still used in Standard Clinical Practice. Doctors are not supposed to lie to patients, and nobody is supposed to lie to the Police or in testimony offered in a Court of Law. Nonetheless, in Courts of Law around the Country, psychiatric diagnoses are adjudicated and become in effect, a legal sentence requiring psychiatric treatment compliance without needing to be supported on an evidentiary basis. How to "legally" justify forced psychiatric treatment: Abrogate the Rules of Evidence, Standard Court Procedures and Individual Rights under the Constitution.  

Gee, I think I know what the source of the stigma is!  The psychiatric diagnostic label itself is the stigma, always has been.  The very way that some advocacy is carried out is perpetuating stigma, yet claiming it's done to, "bust the stigma."  Worse than this, it is used as a justification for the grossly unethical treatment provided by “professionals” both in clinical research and clinical practice.

Driven by a small number of "psychiatric researchers" who are Key Opinion Leaders who minimize or dismiss the relevance of subjective experiences and minimize and dismiss the impact of political, environmental and societal causal factors, these psychiatrists are hell bent on finding the evidence to validate the disease hypothesis; dismissing as irrelevant any information which does not support the hypothesis.

Clinical trials are structured in a way that is biased, in a deliberate attempt to gather the data which will validate what is and has been Standard Practice in the provision of psychiatric treatment----This is BACKWARDS; the effort has been unsuccessful, yet it persists.  Psychiatrists are seeking definitive evidence for a hypothesis that they have been using to gain treatment compliance by telling patients and family members that it is brain disease that is the cause of mental illness, as if it is an objective fact, not merely a hypothesis. A hypothesis, that is not even validated isn't even a theory, let alone a medical certainty!    Psychiatric researchers have been saying that the discovery of the elusive definitive proof is right around the corner for decades now. People who hope it's true state the claim as if it is a fact, those who are advocates for the mentally ill, spread this misinformation and the safety and efficacy of the drugs.

It is a cruel deception, and it is fraud.  How could it be seen as anything else?  Medical professionals are telling people that they have a disease when they have not found one.  Why is psychiatry even considered a Medical Specialty?  Doctors who lie and say there is a disease, then treat this mythical disease with drugs that cause actual diseases; many frequently do not warn patients of the risks.  Many will deny the reported negative effects for what they are--early warning signs for neurological damage, frequently will be dismissed as "tolerable side effects."  This is abuse, and it is medical neglect of their patients who end up permanently impaired.  This is what is and has been happening to children in foster care, and at home with their parents---for decades.

Psychiatrists refuse to treat the iatrogenic diseases they cause; it is criminal medical neglect. The bio-medical model of psychiatry depends on deception, coercion and corruption of the scientific method, and necessitates ignoring the Ethical Guidelines of Informed Consent.  It also relies on the blind trust of a deceived populace: the public is informed that the people do not want  "help" and refuse this “medical care” ONLY due a lack of insight which they claim is another symptom. Psychiatrists and other medical professionals have been given the police powers, the Courts and the Police are psychiatry’s agents, Under Color of Law.

Psychiatry practiced in this way, is not therapeutic, and is not medicine.  Psychiatry has encouraged parents of minor and adult children to emotionally abandon them; stating that their child's pleas for help, protection and rescue are symptoms of their "disease."  It is one of the many things that I find utterly and completely despicable.  These "doctors" have managed to convince some parents to emotionally and physically abandon their own flesh and blood; denying them unconditional love and emotional support needed for them to recover.  Psychiatrists encourage parents to deny their victimized children protection "for their own good;" how is this not seen for the evil that it is?

It is immoral.  It is inhumane.  It is also clear that there is no intent to ameliorate the damage done to primary victims who are still living.  The Justice Department's Office of Civil Rights, Criminal Division has denied it has a duty to investigate Federal Crimes committed against my son---claiming it is not their "department" that deals with Civil Rights complaints when a mentally ill person's Civil Rights are violated Under Color of Law, even if the felony crimes were committed by Mental Health Professionals, acting under State Authority, paid with Federal funds.  I was informed that it is NOT their job...

The DOJ's Office of Civil Rights Criminal Division expects me to believe that the criminal complaint I filed on my son’s behalf remained for over a year in it's office, is in the wrong place. (12-2011)  I sent the complaint where I was told to send it by overnight mail, return receipt requested.  When it was received, I was assured it was in the right place, and told to call if I had additional information.  I wanted to inform them that Jon McClellan, who testified in a Senate Hearing, is the psychiatrist who disabled my son when he used him in Drug Trials without Informed Consent, and inspite of my vehement protests. The clerk asked me what was my new information, THEN told me The Depratment of Justice Office of Civil Rights Criminal Division doesn’t investigate crimes committed under color of law which violate the civil rights of people diagnosed mentally ill.

I may not have perfect insight--who the hell does?!  From the top of my head to soles of my feet, to the tips of my fingers and with every fiber of my being I know this: My right to perform my duty as a mother was denied by a federally funded psychiatric researcher who tortured and disabled my son.  

photo credit

Portions of this post first published December 21,2011 "Not Something One Can Forget or Forgive in the Absence of Justice"

Priceless...

A thirty day supply of the 4 teratogenic psychiatric drugs my son takes: $1,124.17

Number prescribed for Tardive Dyskinesia?: 1

Number of prescriptions taken daily known to cause iatrogenic injuries and cognitive impairment: 4

Number of drugs that were FDA-approved for pediatric: Zero.

Number of prescription drugs my son takes that the FDA has since approved for use in children 13 and older?: 0

My son was further victimized, traumatized and ultimately disabled by a doctor who acted with impunity; he abused my son, abused his medical authority, and disregarded medical ethics altogether.   More than a million dollars was stolen from the American people by the Children's Administration employees of Washington State that intentionally defrauded Federal programs by making my son a Ward of the State. In effect, public servants robbed my friends, my neighbors and my family to pay for what was done to my son. Knowing that I was deprived of my Constitutional Rights as a parent, and was not allowed to protect my own son is something I cannot forget. Knowing I was deprived of my parental rights to act in my son's best interest and make medical decisions on his behalf without Procedural or Substantive Due Process of Law by Jon McClellan. Aresearch psychiatrist and the medical director of CSTC said he didn't need my Informed Consent. A coerced assent from my traumatized child? Absolutely priceless!

This is a MadMother MasterCard moment...

I was told if I didn't sign A Consent to Place agreement, I would be portrayed by the State as being unwilling to ACT IN MY SON'S "Best Interests." There was a Team Child Attorney who had been involved for years--whose Federal mandate is to preserve and defend my son's Constitutional Rights as a disabled child; another Officer of the Court who failed their duty to my son...When I asked why can't the real reason for the Consent to Place Agreement (to provide for my son's medical care due to being beat up and put in a closet and never receiving the recommended treatment for his traumatic injuries) be stated on the petition; I was told that was not allowed!  They ALL knew what was being done was ILLEGAL and advised me to go along with it, or "it would make me look bad." Years later, I learned that day, at that hearing was the ONLY opportunity the Law allowed for me to state for the record the facts which the "professionals" said couldn't be used...My Attorney failed to advise me of my right to do so; in fact he advised I just go along or the State would make me look bad...I was assured that I retained my parental rights to provide Consent to all Medical Treatment for my son...Those parental rights are now, and were then, preserved according to State and Federal Law.  

I'm not the one who looks bad. I'm not an Officer of the Court. I have never perjured myself in a Court of Law. I learned what my rights are; I researched dependency and mental health law; and learned what Court Procedures needed to be followed and suuccessfully sought my son's release from a locked psychiatric facility. By the Grace of God, I finally brought my son home January 5, 2005. 

All I had was the Law, the truth, and a naive belief that in a Court of Law, the law and the truth are all that is required...

original June 2011 updated for accuracy

Thank You For The Ominous Long-Term Health Risks

Quack Master Jack McClellan

"Whenever a doctor cannot do good, he must be kept from doing harm."  Hippocrates

Jon McClellan, the lead researcher for childhood schizophrenia in Washington State, is a doctor who should be stopped.  He is the psychiatrist who gave my son neuroleptic and other  psychotropic drugs without consent. He repeatedly told me I had no say in treatment decisions; no say about what drugs he gave my son.  He drugged my son without consent, much less, Informed Consent; while trialing neuroleptic drugs for FDA approval; so the drugs he used were not approved for use on children.  Drugged my son over my objections, into a state of profound disability. He told me I had no say in what drugs were given to my boy, who had an IQ of 146.  It is frightening that this man is still the Medical Director of the State-run psychiatric facility for children.

Schizophrenia is a diagnosis of exclusion.  What that means is that any and all other explanations for the symptoms must be excluded.  Until this researcher got a hold of him, my son was diagnosed with Temporal Lobe Epilepsy and PTSD, the latter due to having been severely traumatized, in foster care.  Both of these can cause the symptoms which Dr. McClellan concluded were symptoms of schizophrenia.  When I asked him if he was going to do an EEG to rule out the Temporal Lobe Epilepsy; he said it was not necessary.  My protests were labeled denial, my input was dismissed; I was told I had no say.

Ultimately, McClellan put my son on Clozapine which between 1998 and 2005 was linked to 3,277 deaths in the U.S. and over 4,300 events that resulted in disability or required medical intervention, according to the data in the FDA Medwatch adverse events reporting system.  Dr. McClellan lied to me and said that since the drugs was  put back on market in the US, with mandatory blood draws, no one had died from it's use. He also told me that it was only over in Europe that anyone died at all.  This conversation happened only after he had put my son on the drug, as did all the conversations about what drugs he was using to treat my son. Like all of the drugs used by Jon McClellan, on my son, it was not approved for pediatric use for the reason McClellan prescribed them.

The reality is, no matter the diagnosis or the symptoms; this doctor had no right to use my son as a guinea pig---and he had no legal authority to drug him without my consent.  He did not have my son's consent---or his mother's permission; he did not comply with the Hippocratic oath, the ethics guidelines of the medical profession, the laws of the State of Washington, Federal Medicaid guidelines, the U.S. Constitution, or the Nuremberg Code.  There is no way in hell I would have given consent, had I been given the opportunity and actually been informed, which he did not think was necessary. Quack Master Jack, Jon McClellan, a "lead researcher" funded by NIMH, played God.

What is known and has been know about this class of drugs for decades, is that they cause iatrogenic, i.e. physician caused; diseases, neurological impairments, disability, and sudden, and early death.  These are know risks, and as such, should be information discussed prior to administration.  I found these facts out on my own, not in any conversation I had with "Dr. Jack," as he told the kids to call him.  My son, who still takes Clozapine, is unaware of these risks; no psychiatrist has discussed them with him.  McClellan used many anti-psychotics, on my son without adhering to any ethical, moral, or legal standard; knowing this, I am disgusted that this man never loses an opportunity to decry their over-use.  He had no problem using them to drug my son; without warning either my son or myself about the "Ominous Long-Term Health Risks."

It didn't matter to Quack Master Jack that he didn't have 
Informed Consent from the patient or his MadMother.

I was never asked if I wanted to sacrifice my son on the altar of corporate greed and have my son used in Drug Trials. Had I been asked, there's no way in hell I would have given consent. The TEOSS Drug Trial was a "seeding trial," the purpose of a "seeding trial" is gain FDA approval for a drug to treat a new condition, or a different population; to expand the drug market and ensure that BigPharma continues to make a killing

figuratively and literally...

It matters to this MadMother.

Does it matter to you?

Link to The Belmont Report and Nuremberg Code:


Originally published on December 17, 2010

mental illness is like any other illness? not in my family's American experience

I have wondered for years, why are reports and data from research paid for with Government Grants, is not readily accessible to the American people,  Is it because it is more difficult to defraud people when you put the actual information in front of them; not just the biased press releases and public service announcements developed by marketing departments?  Journalists, at one time used to independently verify information before "going with the story;" reporting the news.  There are studies conducted paid for by NIMH, and not published in this country.  How often is this happening?  It is not unusual, I have found.  In effect, the American people pay for research, and do not have ready access to the results.

Most of the research that is published here in the US is published in 'peer-reviewed' professional journals that restrict access.  Yet, we are expected to accept that the research was done correctly and ethically, our acceptance is to be based solely on a report, not the data itself. (reports can be biased and offered by someone with a Conflict of Interest)   Propaganda passes for news and press releases from marketing departments for 'news in the public interest.'  Major media news outlets use these press releases as 'news.' News can be reported along with a heavy dose of direct-to-consumer advertising for a product that is in the news. Biased reporting of medical studies being presented alongside copious direct to consumer marketing results in a seriously misinformed populace. Seems to me, it would increase the risk for harm.

It is a free country and any one who chooses to take the willfully blind and/or ignorant route is free to do so.  I am not one of them, and I am so totally outraged by how my family has been treated by people who are public servants and public employees, theoretically, working for us, but acting against us illegally at times, actually committing Federal Crimes, violating our civil rights.  Some public servants have committed perjury in Courts of Law, and retired with pensions.  These crimes were reported; and covered up,instead of being investigated or prosecuted.   I have been slandered and maligned by some of these people; so has my son.  In vain, I have desperately sought Justice for my youngest son; fought for my Constitutional Rights as a parent, and for my son's Human Rights as a trauma victim since 1993.  I have been treated with disrespect by public servants who have abused their authority and power people who have committed the felony crimes of perjury, forgery, Medicaid fraud. The worst of all, were those who medically neglected, tortured and physically abused my traumatized son, with impunity.  These events traumatized all of us--and disabled my brilliant son.

Jon McClellan, psychiatrist, "Quack Master Jack,"  i.e. the thug in a white coat who drugged my kid into a state of disability without Consent (Informed or otherwise).  He repeatedly told me I had NO SAY.  Quack Master Jack gets 1.8 million dollars bi-annually from the State of Washington.  I asked my State Senator and both State Representatives, to help me.  I have been given the silent treatment.  Good ol' boys, that I actually voted for.  I asked them to look into this knowing it is germane, I know that my concerns are valid.  The State of Washington's foster children, kids in treatment, in group homes and correctional facilities are not protected from the risks of the kind of iatrogenic harm that disabled my son.

Is it not a priority to protect children who are in the State's custody?

One of them the two representatives actually asked what I wanted him to do?!  I suggested he represent his constituents, namely my son, and myself.  I then suggested perhaps maybe the kids in state custody, even though they don't vote yet; are in need of his representation.  There are 47 children in Child Study and Treatment Center, consistently, at least 50 %, if not more are in fact Wards of the Court. Kids who do not have families involved to offer support, or Informed Consent.

My son spent more than 5 out of 10 years of his childhood in this facility.    He was "traumatized over and over and over;" it was none too easy on his brother and myself, I assure you.  He asked me in agony, "how could they take so much from me mom?"  I have no answer.  I know I will remember the sound of my child's terror-filled pleas echo in my memory for the rest of my life.  I know I tried to stop that prick.  I know I can not do anything to change what happened.  I know I have a duty to do whatever is in my power to stop it from happening to anybody else.

Kids who don't yet know that they have Constitutional Rights and that if these Rights are not defended, there is no equal protection under the law.  I bet a lot of those kids know they are not "protected."  I can't forget.

In Washington State, adolescents at the age of thirteen have the legal right to give consent for mental health services and substance abuse treatment.  Parental permission or consent is not required.  This law was passed to enable kids who have a desire to get help, who do not have their parent's support to get the help they need.  This law is in fact being used to exclude parents---in effect, denying parental rights to make medical decisions,  for their children.  This is happening in families who are not involved in "the system."   Reading the law it is clear to me that while it gives minors the right to consent to treatment--it does not diminish, or imply that a parent's Constitutional Rights are as a result diminished.

What is happening in real life is professionals are telling kids, "your parents do not need to be involved at all--we don't need them here.  You are old enough to make these choices for yourself."  In reality, an intelligent mature adult would have difficulty; since in order to provide Informed Consent, one needs to be given accurate unbiased information, and make a decision without being coerced.  Unless it is an emergency, a person is to have an opportunity to consult with others before receiving the prescribed "treatment" (drug or drugs)  Much of what is known about the drugs used for emotional and behavioral symptoms is based on a tainted and biased evidence base.  Rampant fraud and corruption in the FDA approval process and in the marketing of psychiatric drugs, puts everyone at risk.  It is obvious this law places children at risk. How many thirteen to eighteen year olds would know what kind of questions to ask about possible risks, potential benefits, and ask if there is anything besides drugs to help them? (that won't possibly cause dangerous negative effects, possibly disable them and/or cause their untimely death?) 


In the FDA AERs database, #574579 is Rebecca Riley, there is another 4 year old's death listed in 2007 from Seroquel--no gender is  listed and that is more that a little sad. A child who is reduced to a nameless, faceless statistic...I wonder did anyone cry over that child's death besides me?

How many kids (or parents) are actually told of the risk of fatality or heart damage from the drugs used to "treat" ADHD?  Are they told the drugs are in fact addictive, and that some have the same effect on the brain as illicit drugs?  Antipsychotics are being used for behavior control, for "bipolar" the most recent diagnosis de jour.  They are addictive, potentially disabling, and/or fatal; used as directed---even when the drugs appear to be 'helping' and are perceived as beneficial by the person taking them, used long term can cause serious iatrogenic diseases and brain damage.  I know this NOT because any psychiatrist or other mental health professional ever told me, but, because I made it my business to start researching when Quack Master Jack's behavior caused me to mistrust him.

Deceptive practices allow psychiatry and pharma to continue to do a smoke and mirrors snake oil medicine show with our psyches, our tax dollars, our Police, our Courts, AND our fundamental freedoms; our Human Rights.  Fraud, corruption and Human Rights crimes committed against individuals who are given a diagnosis. When diagnoses are adjudicated in Courts of Law, court procedures do not adhere to the same standards appplicable in any other court proceeding.  Civil Commitment laws virtually eviscerate the Rules of Evidence standard. The reason this is done is because diagnostic criteria and treatment standards rely on subjective opinions and are Standardized for clinical use by a quasi-democratic process. It is impossible to submit evidence in compliance with the Rules of Evidence that any psychiatric diagnosis is caused by a disease---such an attestation could not be supported with scientific evidence in compliance with the Rules of Evidence.

The treatment can be disabling or lethal...no biggie...at all.

NAMI says 'mental illness is like any other illness' 

A teacher in grade-school taught me about the Constitution of the United States of America. This document is gospel.  It is The American Gospel; it is why people seek refuge, and their own American dream here more than two hundred years after The Constitution was written.  I wonder... when I am once again struck by the injustice, the utter disregard for the law, and the manner in which our individual rights were neither preserved, nor defended; I (still) wonder, if I am naive?

I do not believe so.  I am grievously disappointed in my fellow man, and in My Country.  My sons and I are not victims; we are survivors.  The Constitution of the United States of America is Our American Gospel.  We know there just aren't enough people who understand exactly what is at stake.  We have elected representatives, and paid public servants who swear solemn oaths, yet fail to fufill their sworn duties.

It is a failure that has altered the course of my family's American experience.

"Whenever a doctor cannot do good, he must be kept from doing harm." 
Hippocrates


“Justice without force is powerless; force without justice is tyrannical.”  

Blaise Pascal

"Watch out for people who begin with another's concern to end with their own." 

Balthasar Gracian

"God grant me the courage not to give up what I think is right 
even though I think it is hopeless."

Chester W. Nimitz

The bible verse associated with my name

My Dad's Army Air Corps Unit's Motto

"Sustineo Alas" translation: "I sustain the wings"  

portions of this were first posted February 2011

AACAP Practice Parameters recommend using neuroleptic and other psychotropic drugs 'off-label'

Jon McClellan

It is Standard Practice to prescribe neuroleptic, called "antipsychotic," and other psychiatric drugs which have not been approved for pediatric use, that is, not tested for safety and/or efficacy in children and adolescents. The reason it is a standard practice is because Treatment Protocols and Practice Parameters and treatment algorithms written by Jon McClellan and other child and adolescent psychiatrists recommend prescribing the teratogenic drugs for children's behavioral problems, and for virtually every psychiatric diagnosis given to children and teens---there have even been reports the drugs are prescribed absent any psychiatric diagnosis...


What really gets me about this 'doctor' is considered a lead researcher, 'an authority' who actually wrote the book, so to speak, on prescribing teratogenic drugs to kids, yet he claimed in a Senate Hearing under oath that he had no insight into why it has become a "Standard Practice!"  Jon McClellan's failure to comply with or conform to Ethical Guidelines and Legal Standards when he 'treated' my son, should have cost him his license to practice medicine.  This 'doctor,' as an agent working for the State of Washington, violated every single Ethical and Legal parameter applicable to the practice of medicine and bio-medical research involving human subjects, he used my son like a lab animal without regard to his human dignity; without obtaining the proper consent, and over my vehement protests.  This 'doctor' claimed in a Senate Hearing to have no insight into how the teratogenic drugs he recommends in his professional writing and that he advises other professionals how to prescribe off-label, came to be widely prescribed to children and adolescents without the empirical data necessary to or support prescribing the drugs as a medical treatment at all, 


Jon McClellan's callous disregard for the deleterious effects of the drugs on my son was horrifying for a mother to witness; his utter lack empathy and compassion were devastating, as was the lack of accountability or responsibility for further traumatizing and ultimately disabling my once brilliant son.

Jon McClellan has ample experience prescribing psychotropic drugs off-label over the last couple of decades.  He has taught students at the University of Washington, and advises other medical professionals in phone consultations in a program that Washington State implemented.  In spite of these facts, and a professional career over 2 + decades, he claims to have no insight whatsoever into the prescribing practices he uses and recommends to others.  Prescribing practices which have defrauded taxpayers through the Medicaid program.  Worse than the decimated budgets and robbing of the American taxpayers, is the plight of the primary victims of this psychiatric practice: the children whose lives have been forever altered, like my son's has been; and the children whose lives have been lost: like Rebecca Riley and Gabriel Meyers.  


Does anyone really believe Jon McClellan has absolutely no insight into the reason this investigation is needed? Does anybody wonder what happens to doctors who prescribe drugs off-label, and ultimately cause a child's death? The doctor that "treated" Gabriel Meyer to death, got a "warning letter" and still has a medical license to practice medicine.  The doctor that "treated" Rebecca Riley to death was granted immunity for testifying against her mother at trial. As usual, Jon McClellan was quoted in the press when these events occurred:  This expert who claims he has NO IDEA why these drugs are being used so widely, with such ill effects, without being first tested or approved as safe and/or effective for pediatric use, always has something to say when the off label use of teratogenic drugs result in a child's death. He testified in a Senate hearing that he has NO IDEA why the drugs he himself recommends using off label and concomitantly in treatment guidelines and practice parameters, are being used in off label and concomitantly...

More importantly, what are the recommendations based on?  

via ACCAP:

PRACTICE PARAMETER FOR THE ASSESSMENT AND TREATMENT OF 

CHILDREN AND ADOLESCENTS WITH SCHIZOPHRENIA

This parameter was developed by Jon McClellan, M.D., and John Werry, M.D. here and here

PRACTICE PARAMETER FOR THE USE OF ATYPICAL ANTIPSYCHOTIC 

MEDICATIONS IN CHILDREN AND ADOLESCENTS

This parameter was reviewed at the Member Forum at the AACAP Annual Meeting in 

October 2006.

From January 2008 to October 2008 and from November 2010 to June 2011, this 

parameter was reviewed by a Consensus Group convened by the CQI. Consensus Group 

members and their constituent groups were as follows: CQI (Oscar Bukstein, M.D., chair and 

shepherd; Allan Chrisman, M.D., John Hamilton, M.D., and Matthew Siegel, M.D., members); 

Topic Experts (Jon McClellan, M.D. and Christopher McDougle, M.D.); AACAP Assembly of 

Regional Organizations (Sherry Barron-Seabrook, M.D. and Gail Edelsohn, M.D.); and AACAP 

Council (David R. DeMaso, M.D. and Melvin Oatis, M.D.).   

This practice parameter was approved by the AACAP Council on August 2, 2011 here

Practice Parameter for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder

Accepted August 15, 2006.

This parameter was developed by Jon McClellan, M.D., Robert Kowatch, M.D.,

Robert L. Findling, M.D., 

This parameter was reviewed at the member forum in October 2004 at the

annual meeting of the American Academy of Child and Adolescent Psychiatry.

During August 2005, a consensus group reviewed and finalized the content of

this practice parameter. The consensus group consisted of representatives of relevant

AACAP components as well as independent experts: Oscar Bukstein, M.D., Work

Group Co-Chair; Jon McClellan, M.D., author here

Summary of the Practice Parameters for the Assessment and Treatment of Children and Adolescents with Depressive Disorders

Principal Authors: Boris Birmaher, M.D., David A. Brent, M.D., and R. Scott Benson, M.D. This Summary was developed by the Work Group on Quality Issues: William Bernet, M.D., Chair, and John E. Dunne, M.D., former Chair, Maureen Adair, M.D., Valerie Arnold, M.D., R. Scott Benson, M.D., Oscar Bukstein, M.D., Joan Kinlan, M.D., Jon McClellan, M.D., and David Rue, M.D. here

Conduct Disorder

Practice Parameter for the Use of Stimulant Medications in the Treatment of Children, Adolescents, and Adults

via Alliance for Human Research Protection

Evidence of Neuroleptic Drug-Induced Brain Damage in Patients:
A partial, Annotated Bibliography
by Vera Hassner Sharav

For distribution: January, 2000

(links disabled)

Although patients, families and the public were not informed - some would argue they were deceived - clinical psychiatrists and researchers have long known about severe adverse drug reactions (ADR) and disabling changes in the central nervous system in a high percentage of patients taking standard neuroleptic drugs. Foremost among these is "tardive dyskinesia" (TD), an often irreversible, disfiguring disorder of the central nervous system resulting in a variety of involuntary movements, particularly of the tongue, lips, and jaw. muscle movements which affects 40% to 60% of patients taking neuroleptics. Recent research findings corroborate earlier reports (since 1970) linking TD to a deterioration of cognitive functions (see below).

Other severe ADRs include: "extrapyramidal symptoms" (EPS), Parkinson-like, impaired motor coordination; sedation; extreme restlessness ("akathesia"); reduced cognitive function;as well as cardiovascular effects, orthostatic hypotension, abnormal liver changes, anticholinergic side effects, sexual dysfunction, and weight gain. Psychotic relapse has been linked to long-term neuroleptic treatment --referred to as, "supersensitivity psychosis." Additionally, there is a one percent risk of "neuroleptic malignant syndrome" (NMS), a potentially fatal side effect. These, and a host of other adverse side effects, cause most schizophrenia patients to stop taking these drugs.

In an article written in 1986, Tardive Dyskinesia: Barriers to the Professional Recognition of Iatrogenic Disease, [Journal of Health and Social Behavior,1986, 27: 116-132], Brown and Funk stated: "tardive dyskinesia (TD), once regarded by psychiatrists as a rare syndrome, is currently recognized as the second most pervasive side effect following sedation of antipsychotic drugs." Although evidence linking TD to neuroleptic drugs had been shown since 1957, Brown and Funk point out that the recognition of TD as a side effect had been "a slow and uneven process, involving psychiatric resistance....Even when physicians believe that patients should be informed about the risks of TD, usually only incomplete information is given, not all patients at risk are informed...." And, they noted, "psychiatrists who are critical of the profession's lax treatment of the problem argue that if doctors were really concerned, they would reduce their use of neuroleptics and reduce dosages when drugs are employed..." and they would fully disclose the risks of TD to their patients.

But a review of the history of TD demonstrates clearly that despite the evidence physicians' disclosure and practice with respect to neuroleptic drugs has remained unchanged, and TD afflicts ever more patients, especially after long-term exposure-estimates range between 40% to 60%. The APA has opposed written informed consent from patients.

Van Putten T, Marder SR (1987) Behavioral toxicity of antipsychotic drugs. J Clin Psychiatry 1987 Sep;48 Suppl:13-9

Extrapyramidal symptoms cause much misery, often go undiagnosed, and can interfere with treatment and rehabilitation. Akinesia is a behavioral state of diminished motoric and psychic spontaneity that is difficult to distinguish from the negative symptoms of schizophrenia. The most useful clinical correlates of akinesia are a subjective sense of sedation and excessive sleeping. Akinesia interferes with social adjustment and may manifest as "postpsychotic depression." The subjective restlessness of akathisia is usually accompanied by telltale foot movements: rocking from foot to foot while standing or walking on the spot. Akathisia is strongly associated with depression and dysphoric responses to neuroleptics and has even been linked to suicidal and homicidal behavior in extreme cases.

Recent Findings Corroborate high incidence of drug-induced movement disorders:

Miller LG, Jankovic J (1990) Neurologic approach to drug-induced movement disorders: a study of 125 patients.South Med J 1990 May;83(5):525-32. Department of Family Medicine, Baylor College of Medicine, Houston, Tex.

Of 125 patients with neuroleptic (dopamine blocking) drug-induced movement disorders who had been referred to a specialized clinic to differentiate the predominant movement disorder, 63% had tardive dyskinesia, 30% had parkinsonism, 24% had dystonia, 7% had akathisia, and 2% had isolated tremor. Two or more movement disorders coexisted in 31 patients (25%).

Functional disability was more severe in patients with akathisia than in other patients. Women outnumbered men at a ratio of 4:1, except for tardive dystonia which affected both sexes equally. The average at onset was 56 years (range, 13 to 87); 69 patients (55%) had onset of movement disorder in the sixth decade. While tardive dystonia was distributed relatively evenly in all age groups, almost a third of patients with parkinsonism had it in the eighth decade. Haloperidol was implicated in 47 patients (37%), followed by amitriptyline/perphenazine in 30%, thioridazine in 27%, and chlorpromazine in 20%. Metoclopramide-induced movement disorders were found in 10 (8%). Most patients (101 or 81%) had history of psychiatric illnesses, but of these only 44 had psychosis.

Neuroleptic drugs had been prescribed for 33 patients (26%) who had gastrointestinal problems. It is important to recognize and differentiate various drug-induced movement disorders because such differentiation has pathophysiologic and therapeutic implications. Many patients could have been treated with less potent drugs.

Muscettola G, Barbato G, Pampallona S, Casiello M, Bollini P (1999) Extrapyramidal syndromes in neuroleptic-treated patients: prevalence, risk factors, and association with tardive dyskinesia. J Clin Psychopharmacol 1999 Jun;19(3):203-8

ABSTRACT: Prevalence and risk factors for extrapyramidal syndromes (EPS) were investigated in a sample of 1,559 patients. The overall prevalence of EPS was 29.4% (N = 458). Among the EPS-diagnosed patients, Parkinsonism as assessed by the presence of core Parkinsonian symptoms (rigidity, tremor, bradykinesia) was present in 65.9% of patients (N = 302), akathisia in 31.8% (N = 145), and acute dystonia in 2.1% (N = 10).

EPS was diagnosed in 50.2% of 285 patients with persistent tardive dyskinesia (TD). Distribution of EPS in patients with TD showed that tremor and akathisia were more frequent in peripheral TD cases than in orofacial TD cases. Furthermore, there was a stronger association of NL-induced parkinsonism with peripheral TD than with orofacial TD. This study suggests that the association between EPS and TD may be limited to specific subtypes of TD. Peripheral TD showed a higher association with parkinsonism and with akathisia, suggesting that these symptoms may share a common pathophysiology.

Bristow MF, Hirsch SR (1993) Pitfalls and problems of the long term use of neuroleptic drugs in schizophrenia. Drug Safety 1993 Feb;8(2):136-48. Academic Department of Psychiatry, Charing Cross and Westminster Medical School, London, England.

ABSTRACT: Although acute and immediate extrapyramidal syndromes are common and, in the case of neuroleptic malignant syndrome, may have serious sequelae, the most important problem with psychotropic medication in schizophrenia remains the tardive movement disorders. These are increasingly recognised as being aetiologically as well as symptomatically heterogeneous. Although risk factors are being identified with greater clarity, there is little in the way of effective treatment. This suggests that clinicians must embark on long term neuroleptic treatment with vigilance. Clozapine alone has few extrapyramidal effects, and has been described in isolated instances as improving established movement disorders. However, haematological idiosyncrasies will preclude its use in all where compliance is uncertain. Its superior efficacy will hopefully give impetus to research into safer analogues.

Hansen TE, Brown WL, Weigel RM, Casey DE (1992) Underrecognition of tardive dyskinesia and drug-induced parkinsonism by psychiatric residents. Gen Hosp Psychiatry 1992 Sept; 14(5):340-4. Portland Veterans Affairs Medical Center, Oregon Health Sciences University 97207.

Recognition of tardive dyskinesia (TD) and other neuroleptic, drug-induced, extrapyramidal side effects presents a major challenge in modern clinical psychopharmacology. Failure to recognize these disorders can lead to poor patient care and may contribute to societal pressure for external control of psychiatric practice. This study reports the occurrence of tardive dyskinesia and drug-induced parkinsonism (DIP) in 101 inpatients, and documents under recognition of both disorders by resident physicians.

Researchers noted TD in 28% of cases and residents only described TD (or symptoms ofTD) in 12%. The researcher determined DIP prevalence rate of 26% contrasted with an 11% rate found by residents. Patients with psychotic disorders were more likely than other patients to have researcher-identified TD, whereas DIP (researcher cases) occurred more often in patients with affective diagnoses. Residents tended to miss milder cases of TD, and to miss DIP in younger patients and in patients with affective disorders. Improved teaching and clinical exams are recommended to improve recognition.

Neuroleptic drug induced psychotic relapse ("supersensitivity psychosis")

Chouinard G. Severe cases of neuroleptic-induced supersensitivity psychosis. Diagnostic criteria for the disorder and its treatment. Schizophr Res 1991 Jul-Aug;5(1):21-33 Psychiatric Research Center, Louis-H. Lafontaine Hospital, University of Montreal, Quebec, Canada.

ABSTRACT: Tardive dyskinesia is thought to result from neostriatal dopaminergic receptor supersensitivity induced by chronic treatment with neuroleptics. Similarly, receptor supersensitivity occurring in other dopaminergic regions of the brain could result in the development of supersensitivity psychosis. As with tardive dyskinesia, severe forms of the disorder are rare. Ten such cases are described whose main characteristic is that psychotic symptoms can no longer be masked by increased dosages of neuroleptics. Diagnostic criteria for the disorder are proposed, and treatment with antiepileptic medication is described.

Kirkpatrick B, Alphs L, Buchanan RW (1992) The concept of supersensitivity psychosis. J Nerv Ment Dis 1992 Apr;180(4):265-70. Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine, Baltimore 21228.

ABSTRACT: The hypothesis that chronic neuroleptic treatment may induce relapse in some schizophrenic patients has received considerable attention. This effect, usually called supersensitivity psychosis, has been attributed to neuroleptic-induced changes in mesolimbic or mesocortical dopaminergic receptors. However, research has not established that neuroleptics cause the proposed effect, and considerations of mechanism have not been separated from those of causation. The focus of research in this area should be the establishment or refutation of a causal relationship between chronic neuroleptic use and psychotic relapse.

Chouinard G, Sultan S. Treatment of supersensitivity psychosis withantiepileptic drugs: report of a series of 43 cases. Psychopharmacol Bull 1990;26(3):337-41. Allan Memorial Institute, Montreal, Quebec, Canada.

Supersensitivity psychosis has emerged as a potential side effect of long-term neuroleptic therapy that may be similar to tardive dyskinesia. Schizophrenic patients with supersensitivity psychosis and considered to be drug-resistant were treated with anti-epileptic medication. Forty-three separate trials were conducted on a total of 35 patients. Over half improved on clinical global impression, some of them considerably. We propose that antiepileptic drugs ameliorate supersensitivity psychosis and so-called "drug-resistant" schizophrenic patients by correcting a pharmacological kindling effect in the limbic system which results from chronic neuroleptic therapy. Publication Types: Clinical trial

Kahne GJ. Rebound psychoses following the discontinuation of a high potency neuroleptic. Can J Psychiatry 1989 Apr;34(3):227-9

Increased familiarity with the effects of psychotropic medications has led to modifications in both prescribing habits and length of treatment. The case of a 34 year old woman is presented, in whom the return of psychotic symptoms following the discontinuation of neuroleptic medications is attributed to a rebound phenomena as opposed to a relapse of an underlying chronic illness

The author cites parallel situations previously described in the medical literature and outlines a conceptual framework for the understanding of this phenomenon.

Bowers MB Jr, Swigar ME. Psychotic patients who become worse on neuroleptics. J Clin Psychopharmacol 1988 Dec;8(6):417-21. Yale University School of Medicine, Department of Psychiatry, New Haven, Connecticut

ABSTRACT: We describe a group of psychotic patients who became worse early in the course of neuroleptic treatment. Characteristics of this group were: predominantly female sex, relatively brief onset, family history of affective disorder, hypomotoric presentation, and severe neuroleptic side effects. We propose that some patients with affective psychoses are uniquely susceptible to profound blockade of the nigrostriatal dopaminergic system by neuroleptics.

During the 1990s, the "Decade of the Brain:"

Newer "atypical" neuroleptics have been developed-clozapine, risperdone, olanzapine and quitepane-these drugs have a lower risk of EPS and TD, but are associated in varying degrees with sedation, cardiovascular and liver enzyme abnormalities, anticholinergic effects, extreme weight gain (30lbs to 50lbs) which significantly increases the risk for diabetes, sexual dysfunction, NMS, seizures, mania, and (in the case of clozapine) agranulocytosis.

Additionally, mounting clinical evidence and findings -from non-industry sponsored research-point to additional, severe, adverse neurological changes in response to long-term exposure to neuroleptics. These drugs' actions suppress certain brain receptors (e.g., dopamine, glutamate), and when such drugs are withdrawn (or a patient stops taking them) the drug-induced receptor changes are unmasked, causing an acute "discontinuation syndrome" (i.e., "rebound psychosis" ) that is often more severe than the original symptoms of the illness. Psychotic relapse can cause months of mental and emotional anguish and loss of functioning-rebound psychosis can cause violent and suicidal behavior in patients not previously violent. [Often, these drug-induced reactions are used to justify forcing the person back on the drugs.]

Collaborative Working Group on Clinical Trial Evaluations. Adverse effects of the atypical antipsychotics. J Clin Psychiatry 1998; 59 Suppl 12:17-22

ABSTRACT: Adverse effects of antipsychotics often lead to noncompliance. Thus, clinicians should address patients' concerns about adverse effects and attempt to choose medications that will improve their patients' quality of life as well as overall health. The side effect profiles of the atypical antipsychotics are more advantageous than those of the conventional neuroleptics. Conventional agents are associated with unwanted central nervous system effects, including extrapyramidal symptoms (EPS), tardive dyskinesia, sedation, and possible impairment of some cognitive measures, as well as cardiac effects, orthostatic hypotension, hepatic changes, anticholinergic side effects, sexual dysfunction, and weight gain.

The newer atypical agents have a lower risk of EPS, but are associated in varying degrees with sedation, cardiovascular effects, anticholinergic effects, weight gain, sexual dysfunction, hepatic effects, lowered seizure threshold (primarily clozapine), and agranulocytosis (clozapine only). Since the incidence and severity of specific adverse effects differ among the various atypicals, the clinician should carefully consider which side effects are most likely to lead to the individual's dissatisfaction and noncompliance before choosing an antipsychotic for a particular patient.

Wyderski RJ, Starrett WG, Abou-Saif A. Fatal status epilepticus associated with olanzapine therapy. Ann Pharmacother 1999 Jul-Aug;33(7-8):787-9. Department of Internal Medicine, School of Medicine, Wright State University, Dayton, OH 45409, USA. rjwyderski@mvh.org

OBJECTIVE: To report a case of fatal status epilepticus in a patient using olanzapine with no known underlying cause or predisposing factor for seizure. CASE SUMMARY: A 41-year-old white woman developed witnessed seizures at home that progressed to status epilepticus. She subsequently died from secondary rhabdomyolysis and disseminated intravascular coagulation.She had been taking olanzapine for five months prior to the event. No other toxic, metabolic, or anatomic abnormalities were identified pre- or postmortem to explain the seizures. Her seizures were a probable adverse drug reaction based on the Naranjo scale.

DISCUSSION: This is the first case of fatal status epilepticus described that has been associated with the use of olanzapine. The pharmacodynamics of olanzapine are similar to those of clozapine, which has been described to induce seizures in 1-4% of patients. It is possible that this patient may have suffered seizures due to a similar effect. Alternate explanations include neuroleptic malignant syndrome and alcohol or benzodiazepine withdrawal seizures, although her clinical history does not suggest these etiologies.

CONCLUSIONS: Although olanzapine has infrequently been associated with seizures in premarketing studies, its potential to induce them exists. Postmarketing surveillance should continue to determine how significant this effect may be.

Drug induced "rebound psychosis" & Mania

Shore D. Clinical implications of clozapine discontinuation: report of an NIMH workshop. Schizophr Bull 1995;21(2):333-8. Division of Clinical and Treatment Research, NIMH, Rockville, MD 20857, USA.

ABSTRACT: In September 1994, the National Institute of Mental Health convened a group of scientists to discuss the clinical effects of rapid clozapine discontinuation, especially in light of the introduction of risperidone for the treatment of schizophrenia. Despite concern over recent reports of clinical deterioration (psychotic exacerbations, somatic withdrawal symptoms, and extrapyramidal side effects) in a few patients abruptly discontinued from clozapine, there is currently insufficient information to determine the magnitude of the problems associated with clozapine withdrawal.

However, clinicians are reminded that the withdrawal schedule for clozapine indicates a gradual tapering schedule (unless the patient is experiencing severe side effects); that switching patients from clozapine to risperidone does not mean that such tapering is unnecessary; and that the use of risperidone may not produce all of the same effects as clozapine in some treatment-refractory patients. PMID: 7543218, UI: 95357664

Stanilla JK, de Leon J, Simpson GM. Clozapine withdrawal resulting in delirium with psychosis: a report of three cases. J Clin Psychiatry 1997 Jun;58(6):252-5. Department of Psychiatry, Allegheny University, Norristown State Hospital, Pa. 19401, USA.

BACKGROUND: Withdrawal symptoms for typical antipsychotics are generally mild, self-limited and do not include development of psychotic symptoms. In contrast, withdrawal symptoms for clozapine can be severe with rapid onset of agitation, abnormal movements, and psychotic symptoms. Different pathophysiologic etiologies have been suggested for these severe symptoms, including dopaminergic supersensitivity and rebound. METHOD: Three case reports of clozapine withdrawal symptoms are presented. A review of previous case reports and discussion of the etiology of withdrawal symptoms of typical antipsychotics and clozapine are provided.

RESULTS: These three patients developed delirium with psychotic symptoms that resolved rapidly and completely upon resumption of low doses of clozapine.

CONCLUSION: The severe agitation and psychotic symptoms after clozapine withdrawal in these three patients were due to delirium, perhaps the result of central cholinergic rebound. The withdrawal symptoms and delirium resolved rapidly with resumption of low doses of clozapine. Severe withdrawal symptoms can probably be avoided by slowly tapering clozapine and/or simultaneously substituting another psychotropic with high anticholinergic activity, such as thioridazine.

Durst R, Teitelbaum A, Katz G, Knobler HY (1999) Withdrawal from clozapine: the "rebound phenomenon". Isr J Psychiatry Relat Sci 1999;36(2):122-8. Jerusalem Mental Health Center, Kfar Shaul Hospital, Israel.

Clozapine is an "atypical" antipsychotic agent for treating previously resistant schizophrenic patients. Its main advantages over "typical" neuroleptics are low incidence of extrapyramidal side effects and its capacity to induce therapeutic response in previously treated refractory patients. However, withdrawal from clozapine has been observed to lead to "atypical" clinical characteristics or a "rebound phenomenon," manifested in two interwoven clinical forms: (1) psychotic exacerbation, and (2) cholinergic rebound. The underlying pathophysiological mechanism of this phenomenon is postulated to be a result of cholinergic supersensitivity. In this paper, the "rebound phenomenon" will be discussed and exemplified by three case histories in which abrupt cessation of clozapine led to serious deterioration and psychotic exacerbation, and one case in which gradual titration from the drug was employed in order to preempt this hazardous occurrence. PMID: 10472746, UI: 99401971

Still DJ, Dorson PG, Crismon ML, Pousson C Effects of switching inpatients with treatment-resistant schizophrenia from clozapine to risperidone. Psychiatr Serv 1996 Dec;47(12):1382-4. Department of Psychiatry, Community Hospitals Indianapolis, IN 46219, USA.

A prospective, open-label study in a 400-bed state psychiatric hospital evaluated change in therapeutic response among ten patients with treatment-resistant schizophrenia who were switched from clozapine to risperidone. Drug effects were examined before discontinuation of clozapine and at three, six, nine, and 12 weeks of risperidone treatment. No patients improved, and five discontinued treatment due to exacerbation of psychosis or adverse effects. Changes in scores on the Positive and Negative Syndrome Scale, the Brief Psychiatric Rating Scale, and the Barnes Akathisia Scale indicated clinically significant worsening of symptoms. The findings do not support replacing clozapine with risperidone for patients with treatment-resistant schizophrenia.

Delassus-Guenault N, Jegouzo A, Odou P, Seguret T, Zangerlin H, Vignole E, Robert H. Clozapine-olanzapine: a potentially dangerous switch. A report of two cases. J Clin Pharm Ther 1999 Jun;24(3):191-5. Department of Pharmacy, EPSM Lille-Metropole, Armentieres, France.

BACKGROUND: Withdrawal symptoms associated with switch between two typical antipsychotics are generally rare and mild. In contrast, switching from clozapine to risperidone can be lead to severe withdrawal symptoms. Different pathophysiologic aetiologies have been suggested for explaining these severe symptoms, including cholinergic supersensitivity and rebound. Theoretically, the switch from clozapine to olanzapine should not lead to any problems because those two agents have the same affinity in vitro for muscarinic receptors. OBJECTIVE: This study reports two cases of switches from clozapine to olanzapine, in refractory schizophrenic patients, which were associated with severe withdrawal symptoms.

RESULTS: After the switch, the two patients developed diaphoresis, hypersialorrhea, bronchial obstruction, agitation, anxiety and enuresis. The symptoms were treated with anticholinergic medication and by an increase in dose of olanzapine to 20 mg/day. For one of the patients this treatment led to normalization of secretion. For the other patient, a superinfection leading to a bilateral pneumopathy which required emergency hospitalization in a general hospital was observed.

CONCLUSION: The symptomatology and the response to treatment lead to the hypothesis of a muscarinic from abrupt weaning. The withdrawal symptoms disappeared rapidly with an increase in olanzapine dosage and with anticholinergic started at the beginning of the switch. We recommend slow clozapine weaning over 3 weeks or more with concurrent anticholinergic treatment.

Ekblom B, Eriksson K, Lindstrom LH. Supersensitivity psychosis in schizophrenic patients after sudden clozapine withdrawal. Psychopharmacology (Berl) 1984;83(3):293-4.

In two patients with chronic schizophrenia, who were on clozapine medication for more than 6 months, a sudden withdrawal of the drug resulted in a very pronounced deterioration of the psychosis within 24-48 h. The most prominent symptoms were auditory hallucinations and persecutory ideas and one patient tried to commit suicide. These observations are interpreted as supersensitivity psychoses induced by the very effective clozapine treatment.

Jauss M, Schroder J, Pantel J, Bachmann S, Gerdsen I, Mundt C. Severe akathisia during olanzapine treatment of acute schizophrenia. Pharmacopsychiatry 1998 Jul;31(4):146-8. Department of Psychiatry, University of Heidelberg, Germany. Jauss@USA.net

Olanzapine is a newly developed atypical neuroleptic with a marked affinity to the 5-HT2, D2 and D4 dopamine receptors. Like other atypical neuroleptics olanzapine is considered to show a reduced prevalence of extrapyramidal side effects when compared to classical neuroleptic drugs.

We report on three patients with acute schizophrenia, who developed severe akathisia during treatment with olanzapine (20-25 mg/d). In two of these cases akathisia resolved after withdrawal of olanzapine and substitution by a classical or an atypical neuroleptic agent, respectively. In one of these patients olanzapine was well tolerated when reintroduced in combination with lorazepam after complete remission of akathisia.

In the third patient akathisia as sufficiently controlled by dose reduction. Akathisia is generally considered to result from D2 dopamine receptor antagonism. In the case of atypical neuroleptics such as olanzapine a low but still considerable D2 dopamine receptor occupancy may be compensated by the 5-HT2 antagonism. However, this mechanism may fail under certain circumstances, in particular if D2 dopamine antagonism exceeds a certain threshold. One should therefore be aware of possible extrapyramidal side effects with olanzapine that are reduced compared to classical neuroleptic drugs but not completely eliminated.

Molho ES, Factor SA (1999). Worsening of motor features of parkinsonism with olanzapine. Mov Disord 1999 Nov;14(6):1014-6. Department of Neurology, Albany Medical College, New York, USA.

Clozapine is the current treatment of choice for drug-induced psychosis (DIP) occurring in Parkinson's disease. However, alternative medications have been sought because of the small but significant risk of agranulocytosis and the need for frequent blood testing. The new "atypical" antipsychotic olanzapine (OLZ) has recently been proposed as a safe and effective option for treating psychosis in this setting. To investigate this, we retrospectively evaluated all 12 of our patients treated with OLZ for DIP. Symptoms of psychosis were improved in nine of 12 patients, but nine of 12 patients also experienced worsening of motor functioning while on OLZ. The worsening was considered dramatic in six of these patients. Overall, there was no significant increase in levodopa doses on OLZ. Only one patient remained on OLZ at the time of the analysis. Nine patients were switched to alternative treatment for DIP.

"We conclude that although Olanzapine may improve symptoms of psychosis in parkinsonian patients, it can also worsen motor functioning. In some patients, the degree of motor worsening may be intolerable." read the rest here