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Pfizer-owned Test in New VHA Guidelines Toolkit
Will Mark Gulf War Vets As Mentally Ill

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    One nine-item question on a Pfizer-owned test in the VHA/DoD's new Clinical Practice Guidelines can give a Gulf War vet a diagnosis of mental illness and a prescription for antidepressants. Pfizer's test diagnoses Major Depression on the basis of a few checkmarks, ignoring the extensive medical testing required under the American Psychiatric Association's diagnostic guidelines. For veterans with undiagnosed liver or kidney disease, antidepressants could cause serious harm.
     As part of their intake paperwork under new VHA/DoD Clinical Practice Guidelines, Gulf War vets with "Chronic Multi-Symptom Illness (CMI)" will be given a brief questionnaire developed and trademarked by Pfizer, Inc. On the basis of one nine-item question, vets with "CMI's" like Gulf War Syndrome, Chronic Fatigue Syndrome, Fibromyalgia, or Multiple Chemical Sensitivity will be diagnosed with Major Depression and will be made candidates for antidepressant therapy. (
www.pdhealth.mil)
    Under the recently-released "VHA/DoD Clinical Practice Guideline on the Management of Medically Unexplained Symptoms: Chronic Pain and Fatigue," clinicians are directed to "minimize excessive diagnostic testing" for veterans with "Chronic multi-Symptom Illness (CMI)." "CMI" is defined as a cluster of two or more symptoms such as pain, fatigue, or cognitive dysfunction - the hallmark symptoms of Gulf War Syndrome (GWS), Chronic Fatigue Syndrome (CFS), Fibromyalgia (FM), and Multiple Chemical Sensitivity (MCS).
    Clinicians are instructed by the VHA/DoD's new Clinical Practice Guidelines to give veterans with "CMI's" one of two questionnaires which are trademarked and copyrighted by Pfizer, Inc. Although the four-page version of the questionnaire assesses conditions like eating disorders and alcohol abuse, both the four-page and the two-page version contain a nine-item question which will earmark "CMI" Gulf War vets as mentally ill, suffering from major depression.
    Titled "Patient Health Questionnaire (PHQ)" and "Brief Patient Health Questionnaire (PHQ-Brief) in the VHA/DoD Guidelines, the questionnaires are mental health assessments based on diagnostic criteria from the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders: DSM-IV. 4th Ed., Washington, DC: American Psychiatric Association, 1994). Pfizer, Inc. funded the development of both tests to provide primary care clinicians with tools to diagnose depression in eight minutes or less - an average of one minute for the brief form. Through its websites (such as
www.zoloft.com), Pfizer is distributing the tests free to physicians under the names of PRIME-MD and PRIME-MD TODAY.
    Although the brief form of the test contains eight questions, the instructions for scoring the tests (in small print at the bottom of the page) make it plain that the diagnosis of Major (or other) Depressive Syndrome is based solely on the answers to one nine-item question. These nine items -- such as fatigue, sleep disorders and concentration problems - are all hallmark symptoms for "CMI's like Chronic Fatigue Syndrome. It is true that the same nine symptoms are considered as diagnostic criteria for Major Depressive Disorder in the DSM-IV -- but only in the absence of other underlying medical conditions, which must be ruled out by diagnostic testing.
    If a vet with "CMI" marks as few as one, and no more than sis, of the nine items as occurring more than half the days in the previous two weeks, a DSM-IV - based on diagnosis of depression will be entered in his or her VHA record. The VHA/DoD Guidelines direct clinicians to minimize diagnostic testing and to steer the patient into a regimen of aerobic exercise, cognitive behavioral therapy (CBT), and antidepressants.
    However, the DSM-IV specifically states that a diagnosis of Major Depression cannot be assigned until the clinician has performed diagnostic testing to rule out over forty medical conditions which can cause the same nine symptoms (see the DSM-IV at
www.psychologynet.org/major.html). Among the forty-plus conditions to be ruled out are immune disorders, endocrine disorders and porphyria. These disorders, and others in the DSM-IV's 'differential diagnosis' list, have already been established as important factors in CMI's such as GWS, CFS, MCS, and FM.
    Neglecting to perform the 'differential diagnosis' tests described in the DSM-IV ignores the current scientific understanding of CMI's and puts patients at risk of medication-induced harm. The major role of endocrine-immune disorders in Chronic Fatigue Syndrome has been acknowledged by the Centers for Disease Control (CDC), which has proposed renaming CFS as 'Chronic Neuron-Endocrine-Immune Disorder.' Patients with undiagnosed porphyria, or with other undiagnosed diseases affecting the liver or kidneys, can be harmed by commonly-prescribed antidepressants.
    Since porphyria is common among people with CMI's, it deserves a brief explanation. Porphyria is a disruption of the body's production of heme. Heme, the iron-containing part of red blood cells, is also in the P450 enzymes that metabolize many toxins and medications. In porphyria, the disruption of heme production releases small packets of protein, called amines, into the bloodstream. The mistakenly recognizes these amines as neurotransmitters and/or endocrine signals, and a cascade of chemical reactions floods the body. In some forms of porphyria, certain medications, including some antidepressants, make the body produce heme, causing the chemical cascade, resulting in an upsurge of neurological, gastrointestinal, and muscular symptoms, with the risk of kidney damage or even death from kidney failure.
    The Federal government has recently acknowledged a form of porphyria as the cause of Vietnam veterans' illnesses resulting from Agent Orange exposure. Although many factors probably come into play in these complicated 'CMI' diseases, porphyria alone is capable of producing all the symptoms of MCS and CFS. Many people with the Gulf War Syndrome or other CMI's also have a form of porphyria - over 90% of MCS patients tested have it, or other undiagnosed conditions, could be put at risk by antidepressant therapy.
    Yet the Gulf War vet who comes in for medical care, and who is assigned a diagnosis of depression based on the nine-item question in the Pfizer-owned tests, is not likely to receive the extensive medical testing dictated by the DSM-IV. Unless they read the small print at the bottom of the page, they probably not even know that the "Patient Health Questionnaire" is a psychological test.
    Not only are the Pfizer-owned tests included (as printable or downloadable forms) in the official VHA/DoD Guideline Toolkit at
www.pdhealth.mil, they have been incorporated into an online interactive Outcomes Management database under development at Walter Reed's website (www.wramc.amedd.army.mil). The home page of the Walter Reed site allows the visitor to access sample pages for the protocols for Cardiovascular Risk, COPD, Congestive Heart Failure, and other conditions. All of these pages contain information on the "Survey Tools" used in assessing and managing the conditions.
    According to the demonstration version of Walter Reed's Outcome Management protocols, patients with conditions other than 'CMI' are not given the Pfizer-owned "psychosocial assessment." Pfizer's nine-item depression-diagnosis test is apparently reserved for those Gulf War vets who suffer from Gulf War Syndrome and other "CMI's," such as Chronic Fatigue Syndrome, Fibromyalgia, and Multiple Chemical Sensitivity.

Internet Sources For Supporting Documents and Related Information:

    VHA/DoD Clinical Guidelines - www.pdhealth.mil - Official site for VHA/DoD's Post-Deployment Health Evaluation and Management program, in response to Public Law 107-103 (HR 1291). A wealth of information.

    www.pdhealth.mil/guidelines/appn/1BriefPHQ.pdf - the short form of the questionnaire (note the instructions for scoring at the bottom of page one).

    Both forms of the Pfizer-owned tests be accessed through the home page: select Post-Deployment Clinical Practice Guidelines' (on toolbar at left of screen); this takes you to the 'guideline toolkit' for "Post-Deployment Health Evaluation and Management" (PDHEM) (www.pdhealth.mil/PDHEM/Toolkit/frameset.htm) Scroll down to Heading 10, Unexplained Symptoms Guidelines, Section B. From the Toolkit screen, select the assessment tools for Unexplained Symptoms. (www.pdhealth.mil/PDHEM/guideline/content/appendices/appendices.html)

    (www.wramc.amedd.army.mil) - Walter Reed homepage, where the demonstration version of their Outcomes Management system can be found. Working from outside the site, an Internet search on the strings "PRIME FMPSSN IEN MD" - or some combination of the item - will bring up the four test-version computer screens for the CMI - 'Unexplained Symptoms' protocol.

INFORMATION ON THE TEST INSTRUMENTS

    http://nypisys.cpmc.columbia.edu/Report/Research/BiometricsResearch.htm -- development of the test instruments for use in primary care and OB/GYN settings.

    www.pfizer.com/pfizerinc/about/press/jamarelease.html - 1999 Pfizer press release to JAMA about questionnaires.

    www.conemaugh.org/jfmc/prime_md.cfm - 1998; patients assessed for mental disorder in one minute of physician's time.

    http://www.research.mednet.ucla.edu/Programs/sttp_abstract_public.cfm -- 2001; the test instruments in ER settings.

Gulf War Syndrome

    www.umdnj.edu.cfsweb/GW/njgwr_faqs.html - New Jersey NIH-backed Gulf War Research Center.

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