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1 NEIL A. CAPRETTO, D.O., F.A.S.A.M. PROFESSIONAL EXPERIENCE Gateway Rehabilitation Center, Aliquippa, PA Medical Director. January 1998 to Present. Director of Treatment. October 1989 to December Duties include: Supervision of the Therapy Staff and providing psychiatric evaluation and treatment to select patients. The Medical Center, Beaver, PA. Psychiatric Consultant. October 1989 to Present. The Medical Center of Beaver, Beaver, PA. Medical Director, Senior Psychiatric Unit. April October 1989 Psychiatric Associates of Beaver Valley, Rochester, PA. President. January 1988 October This professional corporation included five full-time and three part-time psychiatrists. Community Mental Health of Beaver County, Rochester, PA. Medical Director. October 1986 October Staff Psychiatrist. July October 1989 Duties included the clinical supervision of approximately 70 staff members as well as work on active inpatient and outpatient units. Consultation-Liaison work with 500 bed Medical Center of Beaver and coverage for emergency services and adolescent inpatients are included in these duties. Other responsibilities included coverage for eating disorder unit and consultation work with Gateway Rehabilitation Center. Dixmont and Mayview State Hospitals, Pittsburgh, PA. Psychiatric Physician In-Charge, Deaf Unit. January 1983 June LICENSURE State of Pennsylvania #OS L Certified by the American Board of Psychiatry and Neurology, November 1986 Certified by the American Board of Psychiatry and Neurology with added qualification in Addiction Psychiatry, March Recertification March 2003 Certified by the American Society of Addiction Medicine, December Recertification November 2002

2 LICENSURE (cont d) Certified by the American Society of Addiction Medicine as a Medical Review Officer, November 2003 Fellow American Society of Addiction Medicine, January 1997 Certified by the American Board of Addiction Medicine, 2010 EDUCATION St. Francis General Hospital, Pittsburgh, PA. July June Chief Resident during fourth year of training in psychiatry. Philadelphia College of Osteopathic Medicine, Philadelphia, PA. Class of Allegheny College, Meadville, PA. Class of Bachelor of Science - Major in Biology and English; Minor in Writing. Kiski Area High School, Vandergrift, PA. Class of 1973 ACTIVITIES AND AWARDS Professional: Advisory Board of the Pennsylvania Medical Society's Physicians Health Program Board of Directors of the Pennsylvania Medical Society's Physicians Health Program , Secretary of the Pennsylvania Society of Addiction Medicine Board of Directors of Pennsylvania Society of Addiction Medicine Present. Vice President, Pennsylvania Society of Addiction Medicine, 2002 Present. Board of Directors, Beaver County Mental Health/Mental Retardation Vice President of the Board of Directors , President of the Board of Directors , Re-appointed to the Board Member, American Society of Addiction Medicine. Member of A.S.A.M.'s Task Force on Addiction Medicine in the 21st Century. Member of the American Academy of Psychiatrists in Alcoholism and Addiction. Past Vice-President, Residents' Association, St. Francis General Hospital, Member, Outreach to Professional Advisory Committee, Al-Anon World Service Headquarters, 2006 Present. Medical School: Scholarship Recipient , Addison Gibson Foundation, Pittsburgh, PA. Scholarship Recipient , Citizens General Hospital, New Kensington, PA. College: Alden Scholar Award for High Academic Achievement Elected member of the Student/Faculty Pre-Health Advisory Committee Four-year letterman in track; three-year letterman in football Reporter for "Campus," the college newspaper Vice President, Inter-fraternity Council (member, Phi Delta Theta Fraternity) High School: National Honor Society President, Student Council Varsity Club with four years of track and football.

3 Neil A. Capretto D.O., F.A.S.A.M. 1. Medical Director at Gateway Rehabilitation Center since 1998 and full time Psychiatrist with Gateway since Served on the Board of Directors of the Pennsylvania Medical Society s Physicians Health Program from and Past Chief of Medical Staff of the Beaver County Community Mental Health Center and the first Medical Director of Psychiatry at the Medical Center, Beaver, PA. 4. He has also been used on numerous occasions as a consultant for local media, The National Football League, has served as a consultant for ABC and NBC national broadcast news, New York Times and People Magazine, Lifetime TV Network. 5. Member, Outreach to Professional Advisory Committee, Al-Anon World Service Headquarters, 2006 Present. 6. Serve on the Board of Directors of the Pennsylvania Society of Addiction Medicine, 1992 Present. 7. Serve on the Allegheny County Overdose Prevention Coalition Executive Committee, 2009 Present.

4 NEIL A. CAPRETTO, D.O., F.A.S.A.M. MEDICAL DIRECTOR GATEWAY REHABILITATION CENTER 1. Is smoke a healthy, scientific route of administration? 2. Is it in the public interest to approve a drug, especially a widely abused drug, by ballot initiative or legislative action? How anyone particularly any physician could answer yes to either question is baffling 1

5 It is important to distinguish between cannabinoids and crude marijuana: A medicine that is a purified chemical (sometimes from a plant or a synthetic analogue) in controlled doses A plant itself If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives. Isolated cannabinoids will provide more reliable effects than crude plant mixtures. Therefore, the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug but rather to serve as a first step toward the development of nonsmoked rapidonset cannabinoid delivery systems. In summary, there are many reasons to worry that for people who might choose to use marijuana as medicine and especially those who smoke it the drug could actually add to their health problems. Proof that habitual marijuana smoking does or does not lead to respiratory cancer awaits the results of extensive, carefully designed epidemiological studies. In the meantime it appears that, for people with chronic medical disorders or those with compromised respiratory or immune systems, smoking marijuana is likely to do at risk of cardiovascular disease, pregnant women, and couples trying to conceive, the marijuana appear to exceed the potential medical benefits. 2

6 Cannabis contains more than 400 chemicals, including ~66 cannabinoids Delta 9 tetrahydrocannabinol (THC) is the major psychoactive component, first isolated in 1964 (Hirst et al., 1998) Marijuana generally refers to the dried flowers, leaves, and stems of the female cannabis plant contains 3% to 22% THC Hash oil is a mix of essential oils from seeds and resins extracted from cannabis high proportion of cannabinoids (ranging from 40 to 90% THC) used in a variety of cannabis foods 3

7 Hashish or Hash is a concentrated resin (hydrocarbon secretion) produced from the flowers of the female cannabis plant can contain up to 70% THC Inhaled THC: peak plasma levels achieved within 10 minutes Intoxication effects last approximately 2 4 hours. Oral THC: 2 3 x the time duration to achieve peak plasma levels (0.5 2 hours) About 1/4 to 1/3 as potent as compared with inhalation Effects can last 5 6 hours because of continued GI absorption Metabolized by the hepatic p450 system, with 1/3 of THC is eliminated through urination and 2/3 eliminated through fecal excretion. High lipid solubility accumulates in fatty tissues, such as adipose, brain, pulmonary surfactant, and breast milk UDS can be positive for up to 10 days Body Tissue samples can be positive for up to 30 days 4

8 CB 1 receptors: Located on presynaptic glutamatergic and GABAergic neurons in the Ventral Tegmental Area, and act to influence dopamine, which is believed to activate the reward pathway (Maldonado et al., 2006). Very few cannabinoid receptors are located in the brain stem, which may explain the lack of association respiratory depression (Tsou et al., 1998). Highly expressed in the areas involved in pain modulation, including the periaqueductal gray matter, and the dorsal horn of the spinal cord. (Tsou et al., 1997; Farquhar Smith et al., 2000) Also discovered in peripheral tissues including the cardiac, liver, respiratory, and GI system, and have been found to be involved in regulation of appetite stimulation, fat accumulation, and lipid and glucose metabolism (Osei Hyiama et al., 2005) CB 2 receptors: Closely linked with cells of the immune system, predominantly the spleen and macrophages (Kumar RN, et al., 2008) Commonly associated with: altered conscious perception euphoria, feelings of well being relaxation or stress reduction increased appreciation of humor, music, and the arts metacognition, introspection increased sensuality and libido paranoia, anxiety, panic attacks increased appetite At higher doses: Altered body image Auditory and visual hallucinations, illusions Ataxia, incoordination Dysarthria Short term memory, attention deficits Impaired motor skills, decreased reaction time 5

9 Eye Decreased intraocular pressure Cardiovascular System Heart rate: tachycardia with acute use, bradycardia with chronic use Peripheral circulation: vasodilatation, conjunctival redness, postural hypotension Cardiac Output: increased output and myocardial oxygen demand Cerebral blood flow: increases with acute use, decreased with chronic use Pulmonary System Ventilation: stimulated by small doses, depressed by larger doses Bronchodilation: irritant, coughing Airway Obstruction: seen with chronic smoking Immune System Impaired bactericidal activity of macrophages in lung and spleen Reproductive System Decreased sperm count, sperm motility; supression of ovulation Marijuana has NOT been approved by the US FDA Currently, there are 2 FDA approved cannabinoid pharmaceuticals available by prescription: 1. Dronabinol (Marinol) Schedule III drug, indicated for the nausea and vomiting associated with cancer chemotherapy 2. Nabilone (Casemet) Schedule II drug, indicated for anorexia and weight loss in HIV/AIDS patients and Nausea and vomiting associated with cancer chemotherapy Outside of the USA, Sativex (a Cannabis extract) has been approved for use in Multiple Sclerosis Machado et al., 2008, European Journal of Cancer Care Systematic Review of 30 studies involving patients undergoing chemotherapy for various cancers Dronabinol vs. Neuroleptics ( 5 studies) = The cannabinoid dronabinol had an anti emetic efficacy superior to neuroleptics for cancer patients receiving chemotherapy. Nabilone vs. Neuroleptics (6 studies) & Lenonvantradol vs. Neuroletpics (2 studies) = No statistically significant difference, a clinically significant difference in favor of nabilone or Levonantradol was observed. Patient preference for Cannabinoid vs. Other drug (18 studies) = Patients showed clear preference for cannabinoids as anti emetic medication Regarding medical safety: 5% of patients reported paranoid delusions, 6% reported AVH, 13% reported dysphoria as adverse SE. euphoria and sedation viewed as beneficial, not recorded as adverse SE 6

10 Campbell et al, 2001, BMJ 9 total trials examining cancer pain, chronic non malignant pain and post op pain Compared cannabinoid treatment with codeine Conclusions: Cannabinoids were not efficacious in post op pain Cannabinoid treatment no more effective than codeine in pain control CNS side effects limited cannabinoid treatment Martin Sanchez et al, 2009, Pain Medicine Systematic Review and meta analysis of 18 trials patients with chronic pain (of various etiologies), Received cannabinioid treatment or placebo Conclusion: There is reported efficacy in chronic pain treatment High number of serious adverse SE in the short term use Risks out weight Benefits Few controlled studies were found with objective data on the use of cannabinoids or marijuana for appetite stimulation. Strasser et al., 2006, Journal of Clinical Oncology Cannabis vs placebo in 164 patients with Cancer Related Anorexia Cachexia Syndrome Conclusion: No difference in appetite or weight gain among the patient groups Haney et al. (2005, 2007) demonstrate that both smoked cannabis (up to 3.9% THC) and oral Dronabinol (up to 10 mg daily) stimulate appetite and weight gain in patients with HIV wasting syndrome Several anecdotal reports, few published case controlled studies Merrit et al., 1980, trial of 18 glaucoma patients smoked a marijuana cigarette (~ 2% THC). significant reduction in IOP Adverse SE including various sensory alterations (100% of the cases), tachycardia and palpitations (44% of the cases) and postural hypotension (28%). Merrit et al., 1982, clinical trial with 8 patients using eye drops containing 0.01%, 0.05%, or 0.1% THC significant reduction in IOP with 0.05 and 0.1% topical solutions of THC 0.1% topical solution of THC induced a mild hypotension no psychotropic effects were observed The Institute of Medicine deemed the use of cannabis in glaucoma as unsatisfactory with limited beneficial effects: short term action (a few hours) high incidence of undesirable central and peripheral reactions, especially in the elderly Can use other more effective and less toxic drugs 7

11 Conclusions: Cannabinoids have not been shown to improve objective findings in MS Cannabinoids are associated with subjective improvement in MS symptoms Intoxication increases risks of MVA (Hall et al. 2009) Reduced hippocampal and amygdala volumes in chronic heavy users (Yucel et al., 2008) Subtle cognitive impairment with frequent and longterm cannabis use (Solowij et al., 2002) - Deficits in verbal learning, memory, attention - Unclear if function recovers after cessation of Cannabis 8

12 Risk for MI is 4.8 times increased in the hour after cannabis use (Mittleman et al., 2001) Smoking cannabis provokes angina (Gottschalk et al. 1977) Patients with COPD report more symptoms (Tetrault et al., 2007) Dose response relation between frequency smoked cannabis and lung cancer risk (Aldington et al, 2008) Increased respiratory infections in cannabis smokers (Tashkin et al., 2002) Reduced Birth weight (Fergusson et al., 2002) Mild developmental abnormalities (Fried et al., 2001) Postnatal Behavioral Effects (Huizink et al., 2006) _ Poorer performance on memory and verbal skills at 3 years old _ Increased delinquency by 10 years old _ Cannot control for confounding factors A typical joint contains <10 mg of THC, and >1000 would need to be smoked to reach toxic levels (from Merck Index LD 50 of THC) No clearly documented case of death caused by cannabis intoxication alone. 9

13 (Kandel, 2002) Cannabis users are more likely to later use Rx opiates, heroin, and cocaine The earlier the age at which a young person uses cannabis, the more likely they are to use Rx opiates, heroin, and cocaine Several studies suggest that cannabis is an independent risk factor for the development of chronic psychotic disorders - 13% of schizophrenia cases could be averted if cannabis use was prevented (Zammit et al., 2002) Increased rates of depression and anxiety? Increased risk of suicide attempts in adolescents if Cannabis use disorder present (Beautrais et al., 1999) In Australian National Survey of Mental Health and Well Being, 2001 Major dep 6% among nonusers of cannabis v. 14% among those who met cannabis dep. Rey et al in Australian teens Those ever used cannabis were 3 times depression v. never used Fergusson et al 1997, N=1265 prospective from birth in New Zealand, unpublished 15 16yo used none v 1 9 times v 10+ times 11% v 18% v 36% met mood disorder criteria 20 21yo, used at least weekly 30% dep v 15% not using 10

14 Teens who use marijuana have 8 times higher rate of suicidal ideation than nonmarijuana users and a 16% times higher rate of suicide attempts. Loss of interest in things in general: apathy and passivity Loss of desire to work, loss of work performance concern resulting in lost productivity Loss of energy and fatigability Moodiness and irritability Impaired concentration Lack of concern for personal appearance and hygiene Lifestyle that prioritizes getting and using it For dependent people, more immediate psychotic symptoms twice the non users Possible high vulnerability population can precipitate psychosis more with heavy use of cannabis More positive symptoms with cannabis Fewer negative symptoms with cannabis in some studies Most case reports remitted quickly when psychotic sx 11

15 General population: 1.0% Use of marijuana 10 times: 2.1% Use of marijuana 80 times: 2.9% PHARMACOLOGY marijuana is fat soluble effects may persist or reoccur for hours the ability to drive a car or a plane, other motor performance tasks, alertness and the ability to concentrate may be affected for hours to days Marijuana and Driving 65% of heavy drinkers also smoke marijuana marijuana appears in urine and blood 3 5 times more frequently in fatal driving accidents than in the general population. (SAMSHA, 1999) marijuana, drive slower; alcohol, drive faster; low dose marijuana + low dose alcohol (.04 BAC) =.09 BAC moderate marijuana + low dose alcohol = >.12 BAC high marijuana + low dose alcohol = inability to stand impairment lasted 3 hours Source: James O Hanlon, Ph.D. Institute of Human Psychopharmacology/The Netherlands (2000). 12

16 MARIJUANA AND DRIVING impairment dose related 60% failed field sobriety test 2 1/2 hours after moderate smoking impairment documented 3 8 hours later (Hollister, 1986) low amounts, diminished ability to perceive and respond to changes on the road did not make appropriate speed adjustments induces drowsiness and impairs judgment (Mathias, 1996) with alcohol, performance worse (SAMHSA/NHTSA) Marijuana use among teens rose in 2011 for the fourth straight year Daily marijuana use is now at 30 year peak high among high school seniors Synthetic marijuana, K2, Spice, used by 11.4% of high school seniors in prior 12 months One possible explanation for the resurgence in marijuana use is that in recent years fewer teens repeat seeing much danger associated with its use, even with regular use. Perceived risk of marijuana by teens has been falling rather sharply over the past five years Teens disapproval of marijuana use also has fallen over the past three to four years, suggesting a lowering of peer norms against use Monitoring The Future 13

17 4.9% If parents strongly disapprove of marijuana 26.9% If parents do not strongly disapprove Studying the biology of cannabinoids may produce future medications and therapies FDA approved Marinol, synthetic THC, available since 1985 FDA approved Cesamet, available since 2006 We may soon have Sativex 1:1 ratio of THC and Cannabidiol (CBD) Approved in the UK and Spain CBD is often bred out of modern herbal cannabis because it interferes with the high Investigational New Drug Application (IND) Preclinical animal trial showing drug is reasonably safe Clinical Trials Phase I: Determine most frequent side effects, metabolism and excretion Healthy volunteers Phase II: Effectiveness and safety and short term side effects Phase III: Large scale studies gather more information about safety and effectiveness and study different populations and dosages and use with other drugs New Drug Application (NDA) Evaluation of all animal and human data and manufacturing process 14

18 Cannabis, cannabis based products, and cannabis delivery devices should be subject to the same standards that are applicable to other prescription medications and medical devices Medical products should not be distributed or used unless and until they have received marketing approval by the Food and Drug Administration (FDA) Rejects smoking as a means of drug delivery because it is not safe Recognizes the supremacy of federal regulatory standards for drug approval and distribution States should not enact more permissive regulatory standards Objects to state violation of the federal medication approval process Rejects approval of medicines through states and local ballot initiatives Recommends its members and other physician organizations reject responsibility for providing access to cannabis and cannabisbased products unless they receive FDA approval 15

19 The practice of medicine is increasingly evidencebased; yet some physicians are willing to consider recommending cannabis to their patient, despite the fact that they lack even the most rudimentary information about the material currently being consumed by patients including: composition, quality and dose and no controlled studies provide information on its benefit and safety of it s use in chronic medical conditions All cannabis based and cannabinoid medications should be subjected to the rigorous scrutiny of the FDA regulator process that provides important protections for patients, making medications available only when they: 1. Are standardized by identity, purity, potency and quality 2. Are accompanied by adequate directions for use in the approved medical indication 3. Have risk/benefit profiles that have been defined in well controlled clinical trials (ASAM, Sept 2010) Cannabis based medications must meet the exacting standards that we apply to other prescriptions medications Any use of a controlled substance must meet high standards to protect the patient and the public; the approval of medical marijuana does not meet this standard 16