Clinical Practice Should be Based on Valid Clinical Trial Results

Optimizing Phamacologic Treatment of Psychotic Disorders is from a company called ESG or Expert Consensus Guidelines.  


 Kane JM, Leucht S, Carpenter D, Docherty JP. The Expert Consensus Guidelines®: Optimizing Pharmacologic Treatment of Psychotic Disorders. Journal of Clinical Psychiatry 2003;64(suppl 12):1-100

A growing number of atypical antipsychotics are available for clinicians to choose from in the treatment of psychotic disorders. However, a number of important questions concerning medication selection, dosing and dose equivalence, and the management of inadequate response, compliance problems, and relapse have not been adequately addressed by clinical trials. There is also a need for information to guide clinicians in the use of long-acting atypical antipsychotics, which are expected to be available in the near future. To aid clinical decision-making, a consensus survey of expert opinion on the pharmacologic treatment of psychotic disorders was undertaken to address questions not definitively answered by the research literature.

A written survey with 60 questions and 994 options was sent to 50 national experts, 47 (94%) of whom completed it. The results of this survey were used to develop a set of user-friendly guidelines that cover 1) medication selection, dosing, and dose equivalence, 2) compliance issues, 3) use of long-acting atypical antipsychotics, and 4) how to definite remission and recovery in psychotic disorders.

Clinical research, neuroleptic drugs trials, specifically the NIMH CATIE trials, did not produce the results that were expected.   Which has caused psychiatry to rethink the newer neuroleptic drugs, which are called "antipsychotics,"   Neuroleptics are now used for many psychiatric diagnoses: used "off-label" and given to children and the elderly, prescribed for conditions they are not approved for.  Neuroleptic drugs are prescribed for conditions that there is no research, therefore, no EVIDENCE to recommend or validate using them for the symptoms they are prescribed to "treat."  CATIE did not validate the clinical prescribing practices for neuroleptics in the public mental health system, which has favored the newer drugs; believing they were "safer" and "more effective" than the older drugs.  CATIE demonstrated that the newer neuroleptics were neither safer or more effective, the belief they were was apparently based on marketing and hype.  Their widespread use has caused the Medicaid and Medicare programs to become unstable, while causing an increase in iatrogenic illnesses that further burden these systems.  

Excerpts from "Impact of the CATIE Findings on State Mental  Health Policy": 

"Before publication of the CATIE results, the preponderance of information indicated substantial and broad-ranging advantages of second-generation antipsychotics over first-generation agents. State mental health authorities focused on improving access to and increasing utilization of the newer agents. In many states, expenditures for these agents accounted for 10% of the total pharmacy budget of the Medicaid program. After CATIE, state policy makers have had to take a more critical look at the data and formulate more nuanced approaches. The authors summarize policy recommendations of the NASMHPD Medical Directors' Council, which reviewed efficacy studies of antipsychotics and formulated a position statement. The recommendations cover three broad areas of policy. First, neither complete open access for all patients at all times nor a uniform fail-first trial of a first-generation antipsychotic is an optimal approach. A more nuanced middleground is necessary. Second, excessive emphasis on the cost of second-generation antipsychotics has led to a lack of focus on optimizing use of all antipsychotic medication in usual practice. More research and management attention must be focused on improving how these medications are prescribed for individual patients. Third, more resources should be invested in clinical trials that more clearly and accurately reflect current practice." emphasis mine read it here.

I did not go to Medical School but aren't clinical drug trials supposed to lead to valid Evidence-Based prescribing practices?  The authors of the second article are recommending that research to validate current clinical prescribing practices, be conducted.  It seems backward, shouldn't clinical research be what informs and validates standard clinical practice?  When it does not, how can the "treatment" be truthfully declared to be "safe and effective?"  Exactly what are the claims be based on?  Worse, how can the treatment be declared to be life saving and necessary; whether it is effective or not, or causes debilitating illnesses or not?  What I would really like to know is why the drug industry and psychiatry do not have to comply with consumer protection or truth in advertising laws?  Drugs prescribed "off-label" are, by definition, according to the FDA, being used experimentally.  Given the risks to those who take neuroleptics, what is the belief that neuroleptics should be given to everyone experiencing  symptoms of psychosis?  Many psychiatrists and "advocates" declare people must be forced by court order to be "treated" with neuroleptics, for symptoms of psychosis, if unwilling.  The CATIE trials were not that definitive; did not demonstrate the safety and efficacy that would validate this belief--in absence of valid science--it is only belief.  To be considered science based medicine, it must actually be based on science; not hoped for results, actual results.

hat tip: Hooked: Ethics, Medicine, and Pharma