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Hardy Healthcare, PLLC
One Phoenix Mill Lane, Suite 101
Peterborough, NH 03458
Telephone: 603-784-5266
26x26 Curriculum Vitae 26x26
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PART I: GENERAL INFORMATION
   
DATE PREPARED December 1, 2011
   
NAME Paul Millard Hardy
   
OFFICE ADDRESS Hardy Healthcare, PLLC
One Phoenix Mill Lane, Suite 101, Peterborough, NH 03458
   
TELEPHONE (603) 784-5266
   
FAX (603) 784-5295
   
WEBSITE www.hardyhealthcare.com
   
EMAIL Click Here
   
PLACE OF BIRTH Attleboro, MA
   
EDUCATION
   
1968 B.S. Bates College (High Honors in Biology), Lewiston, ME
   
1972 M.D. University of Rochester School of Medicine and Dentistry, Rochester, NY
   
POSTDOCTORAL TRAINING
   
1972-1973 Intern, Internal Medicine
Baylor Affiliated Hospital Program, Houston, TX
   
1973-1976 Assistant Resident, Associate Resident, Chief Resident, Neurology
Strong Memorial Hospital and the University of Rochester, Rochester, NY
   
1976-1977 Joseph P. Kennedy, Jr., Fellow in Medical Ethics
Kennedy Interfaculty Program in Medical Ethics, Harvard University, Cambridge, MA
   
1977-1979 Research Fellow in Behavioral Neurology,
Aphasia/Neurobehavior Research Unit,
Boston Veterans Administration Hospital
and Boston University School of Medicine, Boston, MA
   
LICENSURE AND CERTIFICATION
   
1973 Diplomate, American Board of Medical Examiners
   
1977 Massachusetts (Medical License)
   
1977 DEA Registration (Federal and State)
   
1983 Diplomate, American Board of Psychiatry and Neurology
   
1985 Harvard School of Public Health, Program for Health Systems Management
   
1990 Program for Research Training.  Tufts University School of Medicine, Boston, MA
   
ACADEMIC APPOINTMENTS
   
1973-1976 Instructor in Neurology, University of Rochester School of Medicine
   
1978-1980 Interfaculty Member, Kennedy Interfaculty Program for Medical Ethics, Harvard University, Cambridge, MA
   
1979-1982 Clinical Instructor in Neurology, Harvard Medical School, Boston, MA
   
1980-1995 Assistant Professor of Neurology, Tufts University School of Medicine, Boston, MA
   
1981-1995 Assistant Professor of Psychiatry, Tufts University School of Medicine, Boston, MA
   
HOSPITAL OR AFFILIATED INSTITUTION APPOINTMENTS
   
1973-1976 Resident in Neurology, Strong Memorial Hospital
   
1978-1984 Attending Physician and Neurologist, Paul A. Dever State School, Taunton, MA
   
1980-1992 Attending Neurologist, Tufts New England Medical Center, Boston, MA
   
1984-1986 Attending Physician and Neurologist, Walter E. Fernald State School, Waltham, MA
   
1984-1986 Director of Clinical Medicine, Eunice Kennedy Shriver Center, Waltham, MA
   
OTHER PROFESSIONAL POSITIONS AND MAJOR VISITING APPOINTMENTS
   
1987-1992 Medical Director, Boston Higashi School, Lexington, MA
   
1997- Member, Defeat Autism Now! (DAN!) Clinical Research Committee, San Diego, CA
   
HOSPITAL AND HEALTH CARE ORGANIZATION SERVICE RESPONSIBILITIES
   
1992-1993 Neuropsychiatry Consultant, Monson Developmental Center, Monson, MA
   
MAJOR ADMINISTRATIVE RESPONSIBILITES
   
1980-1983 Director of Behavioral Medicine Service, Paul A. Dever State School, Taunton, MA
   
1982-1984 Medical Director, Paul A. Dever State School, Taunton, MA
   
1984-1986 Medical Director, Walter E. Fernald State School, Waltham, MA
   
1984-1986 Director of Clinical Medicine, Eunice Kennedy Shriver Center, Waltham, MA
   
1986-1987 Co-Founder and Project Director, Boston Higashi School, Inc., Lexington, MA
   
1987-1991 Chairman of the Board, Boston Higashi School, Lexington, MA
   
1990-1991 Executive Director, Boston Higashi School, Lexington, MA
   
1991-1992 Chief Executive Officer, Davicon Corporation, Burlington, MA
   
1992- President, Hardy Healthcare Associates, P.C., Hingham, MA
   
MAJOR COMMITTEE ASSIGNMENTS
   
1974-1976 Admissions Committee, University of Rochester School of Medicine and Dentistry, Rochester, NY
   
1976-1977 Member of the Work Group on Behavioral Changes and Treatment, Commission for the Control of Huntington’s Disease and Its Consequences, NIH, Bethesda, MD
   
1976-1977 Member of the Medico-Legal-Ethical Work Group, Commission for the Control of Huntington’s Disease and Its Consequences, NIH, Bethesda, MD
   
1977-1980 Committee Member, Ethics Committee, American Academy of Neurology
   
1980-1982 Chairperson, Ethics Advisory Committee,
Massachusetts Huntington’s Disease Center Without Walls, Boston, MA
   
1983-1986 Chairperson, Committee for the Rational Use of Psychotropic Medication,
Department of Mental Health, Commonwealth of Massachusetts
   
1984-1986 Committee Member, Massachusetts Advisory Committee on Autism,
Department of Mental Health, Commonwealth of Massachusetts
   
1984-1986 Committee Member, Task Force on Neuroleptics, Department of Mental Health, Commonwealth of Massachusetts
   
PROFESSIONAL SOCIETIES
   
1975-1992 American Academy of Neurology
   
1985- Professional Advisory Board, Autism Society of America
   
1997- American Medical Association
   
1999- Massachusetts Medical Society
   
COMMUNITY SERVICE RELATED TO PROFESSIONAL WORK
   
1980-1992 Medical Advisor and Board Member, Autism Society of America, MA Chapter
   
EDITORIAL BOARDS, JOURNAL ACTIVITIES
   
1987-1990 Reviewer, Journal of Clinical Psychopharmacology
   
ADVISORY BOARDS AND SPECIAL ASSIGNMENTS
   
1985- Panel of Professional Advisors, Autism Society of America
   
2007- Professional Advisory Board, European Defeat Autism Now!
   
AWARDS AND HONORS
   
1976-1977 Joseph P. Kennedy, Jr., Fellow in Medical Ethics
Kennedy Interfaculty Program in Medical Ethics, Harvard University, Cambridge, MA
   
1998 Humanitarian Award, Massachusetts Coalition of Families and Advocates for the Retarded
   
2003 Dale Alexander Prize for Research on Omega-3 Essential Fatty Acids,
Autism Research Institute, San Diego, CA
   
2005 Honorable Mention: Book Proposal Contest, Harvard Medical School Department of Continuing Education, Publishing Books, Memoirs, and Other Creative Non-Fiction Course
   
PART II: RESEARCH, TEACHING AND CLINICAL CONTRIBUTIONS
   
A. NARRATIVE REPORT Prior to 1997, my major research interest was the neuropsychopharmacology of the developmental disabilities, particularly autism. In the early 1980s, while working with the Eunice Kennedy Shriver Center, I began to use a variety of neuropsychopharmacologic agents such as lithium, beta blockers, antidepressants, and anti-epileptic drugs to treat a wide variety of severe behavioral problems in mentally retarded individuals: severe aggression, self injury, and destruction of property. By carefully observing the patients and their responses to different classes of medication, I realized that a wide variety of DSM-III/IV conditions were comorbid with the mental retardation. By diagnosing these comorbid conditions, the neuropsychopharmacologic treatment of the developmentally disabled fell into place. In 1997 at the urging of parents of children with autism, I became increasingly interested in the role of environmental factors that influence neuropsychiatric functioning. I began to look at the role of diet and nutritional factors in influencing the cognitive and affective disturbances in autistic children, adolescents, and adults. It was at this time that I became familiar with the work of Dr. Andrew Stoll. I began to formally evaluate essential fatty acid levels in persons with autism and found the omega-3 fatty acids to be severely deficient. This led me to begin treating young autistic children with omega-3 fatty acids which resulted in significant improvements in language and behavior. Dr. Stoll and I began to lecture together at several major conventions on autism. As a result of our effort, the use of omega-3 fatty acids has become a cornerstone of treatment for young children with autism across the country. What is now urgently needed is a formal double-blind placebo-controlled study.

During the last three years, I have been a principal investigator or co-investigator for three research studies. The first was a multi-center Phase III trial of Secretin in Autism. The second was a Phase IV open label trial of aripiprazole in Autism Spectrum Disorders. The third study currently underway in the use of Oral Human Immunoglobulin, Oralgam™, in Autism: A randomized phase II trial to evaluate the safety and efficacy of oral human immunoglobulin in the treatment of gastrointestinal dysfunction associated with autistic disorder in pediatric patients from two to eighteen years of age. During this three year period I have devoted the equivalent of a full day per week to research.

As a medical student I had the opportunity to experience great teaching of medicine. George Engel, M.D., the author of The Biopsychosocial Model, was a significant mentor. During my residency in Rochester, I began to teach medical students in a course entitled, “Clinical Reasoning”. The opportunity to experience great teaching continued during my fellowship in Behavioral Neurology under the late Norman Geschwind, M.D. During my early days at the Eunice Kennedy Shriver Center, I had the opportunity to begin teaching neurology residents under Raymond Adams, M.D. During my tenure at Tufts University School of Medicine, I enjoyed teaching medical students as well as residents in neurology and psychiatry. For the neurology residents I would emphasize the psychiatric aspects of the patient’s condition, and for the psychiatry residents I would teach the neurological exam, and how to reason regarding neurological differential diagnosis. Since 1992 when I left Tufts, my teaching has been primarily confined to numerous speaking engagements. I have missed the direct contact with students and residents. On several occasions I’ve had medical students spend several weeks to a month in my practice and this has been a rewarding experience.
   
B. RESEARCH FUNDING INFORMATION
   
PAST FUNDING  
   
2003-2004 Co-Investigator: Repligen Corp., Double-blind, Placebo-controlled, Phase Three Trial of Intravenous Secretin in Autism
   
2004-2005 PI: Bristol-Myers Squibb Pharmaceuticals, A Phase 4 Open Label Trial of aripiprazole (Abilify) in Autism.
   
CURRENT FUNDING  
   
2005- Co-Investigator: PediaMed Pharmaceuticals, Inc., Protocol 004: Oral Human Immunoglobulin, Oralgam™, in Autism: A randomized phase II trial to evaluate the safety and efficacy of oral human immunoglobulin in the treatment of gastrointestinal dysfunction associated with autistic disorder in pediatric patients from 2 to 18 years of age.
   
C. REPORT OF CURRENT RESEARCH ACTIVITIES
  Oralgam™ in Autism (Co-Investigator)
  Aripiprazole in Autism Spectrum Disorders (PI)
  Omega-3 Essential Fatty Acids in Autism Spectrum Disorders (PI)
   
D. REPORT OF TEACHING
1. LOCAL CONTRIBUTIONS  
   
HARVARD MEDICAL SCHOOL  
a. Medical Student Teaching
1978-1980 Preceptor to HMS fourth year students in Neurology at MGH and Eunice Kennedy Shriver Center, Waltham, MA.
   
b. Graduate Medical Courses
1978-1980 Preceptor to MGH Neurology Residents rotating at the Eunice Kennedy Shriver Center, Waltham, MA.
   
c. Invited Teaching Presentations  
1980 McLean Hospital, Mailman Research Seminar, Invited to speak on “The Neuropsychiatric Disorders in Mental Retardation”.
   
1981 Massachusetts Mental Health Center, Friday Psychopharmacology Conference, Invited to speak on “The Neuropsychopharmacology of Mental Retardation and Autism.
   
2001- Boston University School of Medicine, Forensic Neuropsychology,
Invited to lead one seminar annually on neuropsychiatric disorders and legal issues.
   
2005 Harvard Longwood Psychiatry Grand Rounds, Invited to speak on “The Neurobiology of Autism: New Developments in Biologic Therapies”.
   
d. Continuing Medical Education Courses
2005 HMS Department of Continuing Education and Cambridge Health Alliance course “Autism Spectrum Disorders: From Childhood to Adulthood”, Invited to speak on “The Biopsychosocial Model for Treating Autism Spectrum Disorders”.
   
TUFTS UNIVERSITY SCHOOL OF MEDICINE
a. Medical Student Teaching  
1980-1992 Preceptor to 4th year medical students taking and elective neurology
   
b. Graduate Medical Courses  
1980-1992 Behavioral Neurology, Residency Programs in Neurology and Psychiatry
   
c. Invited Teaching Presentations  
1980-1992 Grand Rounds in Neurology or Psychiatry, approximately one per year
   
d. Continuing Medical Education Courses
1983-1988 “Psychopharmacology of Mental Retardation and Autism”, Annual Psychopharmacology Update CME course, Department of Psychiatry, R. Shader and D. Greenblatt, Directors.
   
2. REGIONAL, NATIONAL OR INTERNATIONAL CONTRIBUTIONS
   
1981 Richmond, TX. A Biomedical Basis for Self-Injury. Richmond State School.
   
1985 Los Angeles, CA. Comorbid Anxiety Disorder in Autism. Autism Society of America Annual Meeting.
   
1987 New Orleans, LA. Tourette Disorder in Autism. Autism Society of America Annual Meeting.
   
1990 Atlanta, GA. Keynote Speaker. Sixth Annual Autism Conference, Georgia Chapter, Autism Society of America.
   
1997 Orlando, FL. Comorbid Neuropsychiatric Disorders in Autism. Autism Society of America Annual Meeting.
   
1997 Newton, MA.  Neuropsychiatric Disorders that Affect Children and Adolescents. A day- long workshop for teachers, psychologists, and nurses.
   
1997 Norwell, MA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
1997 Middleboro, MA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day- long workshop for teachers, psychologists, and nurses.
   
1998 Lexington, MA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
1998 Hyannis, MA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
1998 Sitka, AK. Neuropsychiatric Aspects of Autism. A day-long workshop for teachers, psychologist, and nurses.
   
1998 Philadelphia, PA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
1998 Portland, ME. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses. 
   
1998 Topsfield, ME. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
1999 Albuquerque, NM. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
1999 Chelmsford, MA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
1999 Kansas City, MO. Emerging Practices: Use of Secretin as a Treatment for Autism. Annual Meeting of the Autism Society of America.
   
1999 Montpelier, VT. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses. 
   
2000 Beverly, MA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses. 
   
2000 Orlando, FL. Physicians Implementing Biological Therapies, A Panel Discussion. New Biological Directions in Autism. Autism Recovery Network of Florida.
   
2000 New York, NY. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses. 
   
2001 Glasgow, Scotland. Comorbid Neuropsychiatric Disorders in Autism. Third World Congress on Autism.
   
2001 Tom’s River, NJ. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
2001 Los Angeles, CA. DAN! Protocol, A Panel Discussion. Annual Meeting of the Autism Society of America.
   
2001 Plattsburg, N.Y. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
2001 Heidelberg, Germany. Omega-3 Fatty Acids in the Pathophysiology and Treatment of Autism and Related Disorders. Heidelberg Autism Society Annual Meeting.
   
2001 Atlanta, GA. Omega-3 Fatty Acids in the Pathophysiology and Treatment of Autism and Related Disorders. Defeat Autism Now! Conference.
   
2001 San Diego, CA. Omega-3 Fatty Acids in the Pathophysiology and Treatment of Autism and Related Disorders. Given jointly with Andrew Stoll, M.D. Defeat Autism Now! Conference.
   
2002 Boston, MA. Omega-3 Autism Connection. Given jointly with Andrew Stoll, M.D. Defeat Autism Now! Conference.
   
2002 Indianapolis, IN. DAN! Protocol, A Panel Discussion. Annual Meeting of the Autism Society of America.
   
2002 San Diego, CA. Omega-3 Autism Connection. Given jointly with Andrew Stoll, M.D. Defeat Autism Now! Conference.
   
2002 San Diego, CA. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
2003 San Antonio, TX. Omega-3 Fatty Acids in the Pathophysiology and Treatment of Autism and Related Disorders. Texas Chapter Annual Meeting, Autism Society of America.
   
2003 Philadelphia, PA. Omega-3 Fatty Acids in the Pathophysiology and Treatment of Autism. Defeat Autism Now! Conference.
   
2003 Portland, OR. Essential Fatty Acids, Membrane Fluidity and Prostanoids. Defeat Autism Now! Conference.
   
2003 Salt Lake City, UT. Neuropsychiatric Disorders that Affect Children and Adolescents. A day-long workshop for teachers, psychologists, and nurses.
   
2003 Port Gerardo, MO. Biological Therapies for Autism. Annual Meeting, Missouri Chapter, Autism Society of America.
   
2004 Pittsburgh, PA. Omega-3 Essential Fatty Acids in Autism, Conference entitled: Treating the Biology of Autism, Pittsburgh Chapter, Autism Society of America.
   
2004 Pontiac, MI. Omega-3 Essential Fatty Acids in Autism, Conference entitled: Treating the Biology of Autism, Oakland County Chapter, Autism Society of America.
   
2004 Washington, D.C. Omega-3 Essential Fatty Acids in Autism, Defeat Autism Now! Conference.
   
2004 Washington, D.C. Behavioral Disorders in Autism, Defeat Autism Now! Conference.
   
2004 Los Angeles, CA. The Nutraceutical Basis for Pharmaceutical Therapy, Defeat Autism Now! Conference.
   
2005 Boston, MA. The Nutraceutical Basis for Pharmaceutical Therapy, Defeat   Autism Now! Conference.
   
2006 Invited Poster Presentation, American Academy of Child and Adolescent Psychiatry annual meeting, Toronto, Canada
   
E. REPORT OF CLINICAL ACTIVITIES
1. Description of clinical practice Since 1992 Hardy Healthcare Associates, PC has been the home of my private practice in Behavioral Neurology/Neuropsychiatry. I have placed a premium on quality of care and service that my patients and their families value; many patients have severe, or refractory conditions which have not been diagnosed or treated well in other health care settings. Because of the expertise which I have developed in treating severe behavioral disorders of children, I see children as young as two years of age. I also evaluate and treat elderly individuals with various forms of dementia. Some patients have sought my care for advice around nutritional management of chronic illness. Currently, 20% of my time is devoted to conducting research. My practice includes an advanced psychiatric clinical nurse specialist, and a nurse who is also an LICSW. 
   
2. Patient load Approximately 60% of my practice involves treating children, adolescents, and adults with various developmental disabilities, especially autism. The remaining 40% involves the evaluation and treatment of adolescents and adults with various types of neuropsychiatric conditions: epilepsy with comorbid depression or anxiety, learning disorders with comorbid bipolar disorder, and cognitive or behavioral impairment in the elderly. The practice also includes children, adolescents, and adults requiring traditional biological psychiatry approaches to affective disorders, anxiety disorders, and attentional disorders. Some of my patients have rare disorders such as Batten’s disease, and Smith-Lemli-Opitz syndrome.
   
3. Clinical contributions Since 1978 I would say that my most significant clinical contribution has been in the neuropsychopharmacologic management of the developmental disabilities. As new medications entered the pharmacopoeia I would explore their use for the developmentally disabled. I have been one of the first clinicians to evaluate the efficacy of aripiprazole in autism. An associated contribution has been the identification of comorbid disorders embedded in the developmental disabilities. By learning to recognize anxiety, depression, mania, intermittent explosive disorder, and subtle complex partial seizures, a more broad-based neuropsychopharmacology emerged. In the late 1990’s I began to collaborate with Andrew Stoll, M.D. on the use of omega-3 fatty acids in autism. As a result of this collaboration, omega-3 fatty acids are now being widely used as one of the first biologic therapies by the parents of young children with autism.
   
BIBLIOGRAPHY  
Original Articles 1. Feibel JH, Goldstein MN, Hardy PM, et al. Catacholamine and cortisol reponse tO stroke and subarachnoid hemorrhage: prognostic implications. Circulation Supplement II-80, Vol 51, 1975.
   
  2. FeibelJH, Hardy PM, Campbell RC, et al. Prognostic value of the stress response following stroke. JAMA, Vol 238, pp 1374-1376, 1977.
   
  3. Hardy PM, Ethical issues in Huntington’s disease. Appendix to the Report to Congress and the President, Commission for the Control of Huntington’s Disease and Its Consequences.1977.
   
  4. Hardy PM, Sandson J, Albert ML. Competency in senile dementia – the right to refuse treatment. Archives of the Foundation of Thanatology. Vol VII, 2, p 75, 1978.
   
  5. Cransford RE, Beresford R, Coronna JP, Hardy PM. Uniform brain death act. Neurology Vol 29, pp 417-418, 1979.
   
  6. Hardy PM. The issue of Competency in life-prolonging Treatment. In Teichler-Zallenm D, Clements CD (eds), Science and Morality, Lexingnton, MA 1982. 
   
  7. Hardy PM, Waters JM, Cohen MN. A biomedical basis for self-injury in the developmentally disabled. In Griffin JC, Stark MT, Williams DE, et al (eds), Advances in theTreatment of Self-Injurious Behavior. Austin, TX: Department of Health and Human Services, Texas Planning Council for Developmental Disabilities, 1984.
   
  8. Waters JM, Hardy PM, Cohen MS. Interactions of medication and programming in mental retardation: a clinical approach. In Mulich J, Mallory (eds), Transitions in Mental Retardation Vol II, 1984.
   
  9. Cole JO, Hardy PM, Marcel MA, et al. Organic states. In Schatzberg AE (ed) Common Treatment Problems in Depression, American Psychiatric Press, Inc, Washington DC, 1985.
   
Peer-Reviewed Letters to the Editor 1. Ehrenberg BL, Hardy PM, Zifkin BG. Psychomotor Epilepsy and Violence. American Journal of Psychiatry   140:5, pp 646-647, 1983.  
   
Abstracts 1. Spiers, PA, Hardy, PM, Hochanadel, GS. The Psychophysiological Amobarbitol Interview: an improved technique for uncovering deception. (Poster Presentation). Journal of Neuropsychiatry & Clinical Neurosciences 9:1, 147, 1997.
   
  2. Hardy, PM, Chapman, P, Hardy, SM. Aripiprazole in Autism Spectrum Disorders: An Open Label Trial. American Academy of Child and Adolescent Psychiatry Annual Meeting, October, 2005.
   
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