From: [email protected] To: [email protected] Subject: Condition Petition for Thomas Rosenberger Date: Tuesday, December 31, 2019 5:12:55 PM Attachments: Question 2 GAD (3).pdf Question 5 GAD (2).pdf This message was sent from the Condition page on medicalmarijuana.ohio.gov. Box was check regarding file size being too large to upload. Action needed! Name: Thomas Rosenberger Address: 815 Grandview Ave Suite 400, Columbus, OH, 43215 Phone: (614) 706-3782 Email: [email protected] Specific Disease or Condition: Generalized Anxiety Disorder (GAD) Information from experts who specialize in the disease or condition. File larger than 3MB Relevant medical or scientific evidence pertaining to the disease or condition. See Attached Question 2 GAD (3).pdf Consideration of whether conventional medical therapies are insufficient to treat or alleviate the disease or condition. File larger than 3MB Evidence supporting the use of medical marijuana to treat or alleviate the disease or condition, including journal articles, peer-reviewed studies, and other types of medical or scientific documentation. File larger than 3MB Letters of support provided by physicians with knowledge of the disease or condition. This may include a letter provided by the physician treating the petitioner, if applicable. See attached file Question 5 GAD (2).pdf Question 1 Information from experts who specialize in the disease or condition Contents Overview – 3 Generalized Anxiety Disorder: Prevalance, Burden, and Cost to Society - 4 Final Agency Decision: Petitions to Establish Additional Debilitating Medical Conditions Under the New Jersey Medicinal Marijuana Program – New Jersey Department of Health - 17 Overview General Anxiety Disorder (GAD) is a debilitating condition that has proven difficult to treat. The burden created by GAD has been compared to that of major depression. As recently as March of 2018, the New Jersey Department of Health determined that GAD and anxiety as a broader set of conditions are so debilitating, and evidence of medical marijuana’s effectiveness so persuasive, that they add anxiety to the state’s qualifying conditions list. GAD has also been shown to have a significant impact on society at large. The social routines of patients suffering from GAD and those around them can be severely interrupted. Additionally, work productivity has been shown to decrease in those with GAD creating an economic consequence for society when treatment isn’t adequate. The attached documents seek to explain New Jersey’s reasoning for adding anxiety as a qualifying condition and explain the burden of GAD. DEPRESSION AND ANXIETY 16:162–171 (2002) Research Article GENERALIZED ANXIETY DISORDER: PREVALENCE, BURDEN, AND COST TO SOCIETY Hans-Ulrich Wittchen, Ph.D.n Generalized anxiety disorder (GAD) is a prevalent and disabling disorder characterized by persistent worrying, anxiety symptoms, and tension. It is the most frequent anxiety disorder in primary care, being present in 22% of primary care patients who complain of anxiety problems. The high prevalence rate of GAD in primary care (8%) compared to that reported in the general population (12-month prevalence 1.9–5.1%) suggests that GAD patients are high users of primary care resources. GAD affects women more frequently than men and prevalence rates are high in midlife (prevalence in females over age 35: 10%) and older subjects but relatively low in adolescents. The natural course of GAD can be characterized as chronic with few complete remissions, a waxing and waning course of GAD symptoms, and the occurrence of substantial comorbidity particularly with depression. Patients with GAD demonstrate a considerable degree of impairment and disability, even in its pure form, uncomplicated by depression or other mental disorders. The degree of impairment is similar to that of cases with major depression. GAD comorbid with depression usually reveals considerably higher numbers of disability days in the past month than either condition in its pure form. As a result, GAD is associated with a significant economic burden owing to decreased work productivity and increased use of health care services, particularly primary health care. The appropriate use of psychological treatments and antidepressants may improve both anxiety and depression symptoms and may also play a role in preventing comorbid major depression in GAD thus reducing the burden on both the individual and society. Depression and Anxiety 16:162–171, 2002. & 2002 Wiley-Liss, Inc. Key words: generalized anxiety disorder; prevalence; health care utilization; comorbidity INTRODUCTION mental health specialist settings and have been associated with over-utilization of general health care Generalized anxiety disorder (GAD) is a persistent resources [Maier et al., 2000; Roy-Byrne and Katon, and often severe mental disorder of the anxiety 1997; Wittchen et al., 2000; Wittchen et al., 2002]. spectrum, characterized by persistent (6 months or Further primary care studies conducted in the early more), excessive worrying, anxiety, tension associated with symptoms of hypervigilance, and other somatic Institute of Clinical Psychology and Psychotherapy, Technical symptoms of anxiety. The symptomology is associated University of Dresden, Germany and Max Planck Institute of with substantial and enduring subjective suffering, and Psychiatry, Munich, Germany the feeling of loss of control over the worrying and n symptoms as another criterion. Clinical reports suggest Correspondence to: Professor Dr. Hans-Ulrich Wittchen, Max Planck Institute of Psychiatry, Clinical Psychology and Epidemiol- that fewer than 20% of sufferers experience complete ogy Unit, Kraepelinstrasse 2, Munich D-80804, Germany. remission of their symptoms, and typically patients will E-mail: [email protected] have had their symptoms for between 5 and 10 years before they are diagnosed and effectively treated Received for publication 1 October 2001; Accepted 24 February [Ballenger et al., 2001; Kessler et al., 2001a; Rogers 2002 et al., 1999]. Patients with GAD have been found to be Published online in Wiley InterScience (www.interscience.wiley. frequent utilizers of primary care resources rather than com). DOI 10.1002/da.10065 && 2002 WILEY-LISS, INC. Research Article: Economic Burden of GAD 163 1990s have suggested that GAD is rarely recognized TABLE 1. Twelve-month and lifetime prevalence in the and diagnosed, and if it is diagnosed it is usually not, or NCS of GAD in males and females by age group only inappropriately, treated [U¨ stu¨n and Sartorius, [Wittchen et al., 1994] 1995]. This is particularly significant as GAD is Age (yr) Male (%) Female (%) Total (%) associated with a substantial degree of social disability [Wittchen et al., 2000]. 12-month prevalence Yet, there has been some debate concerning the 15–24 1.3 1.5 1.4 nosological status of GAD because of past reports of its 25–34 3.2 5.0 4.1 low diagnostic reliability using standard criteria [Di- 35–44 2.3 4.5 3.4 Z45 0.9 6.3 3.5 Nardo et al., 1993] and the fact that clinical studies Total 2.0 4.3 3.1 have found that GAD is usually seen in comorbid Lifetime prevalence presentations with major depression. Furthermore, 15–24 1.5 2.5 2.0 there have been reports that pure GAD is both an 25–34 4.7 7.1 6.0 extremely rare phenomenon with few indications of 35–44 4.6 7.2 5.9 disorder-specific impairments (for examples, see dis- Z45 3.6 10.3 6.9 cussions in Kessler et al., 2001a; Noyes et al., 2001]. Total 3.6 6.6 5.1 However, one needs to take into account that these reservations against GAD, being an independent clinical disorder of critical significance, are based on 69,400 patients. The 12-month and lifetime prevalence studies that have mostly used older diagnostic criteria rates of GAD (DSM-III-R) in the NCS were estimated for GAD and/or stem from highly selective clinical to be 3.1% and 5.1%, respectively. The lowest lifetime samples that might suffer considerable selection bias. prevalence rate was found in the 15–24 year age group Since the current diagnostic definition of GAD is a (2.0%), while the highest rate was reported for the 45– relatively recent addition to diagnostic classification 55 year age group (6.9%) [Table 1; Wittchen et al., systems, few studies have up to now reconsidered the 1994]. This survey also demonstrated that women were nature and true burden of GAD, as defined by the twice as likely to have GAD than their male counter- current DSM-IV criteria, on the individual and society. parts, with total lifetime prevalence rates of 6.6% and This paper aims to address the question ‘‘what is the 3.6%, respectively [Wittchen et al., 1994]. The prevalence, level of disability and burden to society prevalence rate increased to 10.3% for women aged associated with GAD, as defined by DSM-IV criteria?’’ Z45 years, but was unchanged for men aged Z45 years (3.6%). PREVALENCE These findings are relatively consistent with findings from a previous GAD community survey that used The concept and diagnostic criteria of GAD have earlier diagnostic criteria and different instruments [see changed significantly since it was first codified in the review by Carter et al., 2001]. The most recent Diagnostic and Statistical Manual of Mental Disorders epidemiological study using DSM-IV criteria [GHS; [American Psychiatric Association, 1994] in 1980 and Carter et al., 2001] has reported slightly lower 12- to date there are still small differences in the criteria month prevalence rates for GAD than the NCS (12- used in the USA and Europe. In the USA and in month prevalence 1.5% vs. 3.1%). However, this research, the DSM-III-R/DSM-IV criteria prevail, finding was found to be entirely due to methodology whereas in Europe the use of the 10th International because the inclusion of subjects with lifetime GAD Classification of Diseases [ICD-10; World Health and partially remitted subthreshold GAD accounts for Organization (WHO) 1992], which has broader this difference.