CURRICULUM VITAE

 

PART I:                       General Information

 

Date Prepared:         August 8, 2008

 

Name:                         Paul Millard Hardy

 

Office Address:         Hardy Healthcare Associates, P.C.

                                    62 Derby Street, Suite 11, Hingham, Massachusetts  02043-3718

 

PHONE:                      781-740-8300              FAX:    781-740-8242

 

WEBSITE:                  www.hardyhealthcare.com                

 

E-MAIL:                       drhardy@hardyhealthcare.com

 

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

            1972-73           Intern, Internal Medicine                                 

                                    Baylor Affiliated Hospital Program, Houston, TX                   

            1973-76           Assistant Resident, Associate Resident, Chief Resident, Neurology

Strong Memorial Hospital and the University of Rochester, Rochester NY

            1976-77           Joseph P. Kennedy, Jr., Fellow in Medical Ethics

                                    Kennedy Interfaculty Program in Medical Ethics, Harvard University, Cambridge, MA        

            1977-79           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     

            1973-76           Instructor in Neurology, University of Rochester School of Medicine

1978-80           Interfaculty Member, Kennedy Interfaculty Program for Medical Ethics, Harvard University, Cambridge, MA

1979-82           Clinical Instructor in Neurology, Harvard Medical School, Boston, MA

1980-95           Assistant Professor of Neurology, Tufts University School of Medicine, Boston, MA

1981-95           Assistant Professor of Psychiatry, Tufts University School of Medicine, Boston, MA

           

Hospital or Affiliated Institution Appointments

            1973-76           Resident in Neurology, Strong Memorial Hospital

1978-84           Attending Physician and Neurologist,

Paul A. Dever State School, Taunton, MA

1980-92           Attending Neurologist, Tufts New England Medical Center, Boston, MA

            1984-86           Attending Physician and Neurologist,

Walter E. Fernald State School, Waltham, MA

1984-86           Director of Clinical Medicine, Eunice Kennedy Shriver Center, Waltham, MA

           

Other Professional Positions and Major Visiting Appointments

            1987-92           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

1992-93           Neuropsychiatry Consultant, Monson Developmental Center, Monson, MA

 

Major Administrative Responsibilities

1980-83           Director of Behavioral Medicine Service, Paul A. Dever State School, Taunton, MA

            1982-84           Medical Director, Paul A. Dever State School, Taunton, MA

            1984-86           Medical Director, Walter E. Fernald State School, Waltham, MA

1984-86           Director of Clinical Medicine, Eunice Kennedy Shriver Center, Waltham, MA

1986-87           Co-Founder and Project Director, Boston Higashi School, Inc., Lexington, MA

1987-91           Chairman of the Board, Boston Higashi School, Lexington, MA

1990-91           Executive Director, Boston Higashi School, Lexington, MA

1991-92           Chief Executive Officer, Davicon Corporation, Burlington, MA

1992-               President, Hardy Healthcare Associates, P.C., Hingham, MA

 

Major Committee Assignments

1974-76           Admissions Committee, University of Rochester School of Medicine and Dentistry, Rochester, NY

1976-77           Member of the Work Group on Behavioral Changes and Treatment, Commission for the Control of Huntington’s Disease and Its Consequences, NIH, Bethesda, MD

1976-77           Member of the Medico-Legal-Ethical Work Group, Commission for the Control of Huntington’s Disease and Its Consequences, NIH, Bethesda, MD

1977-80           Committee Member, Ethics Committee, American Academy of Neurology

1980-82           Chairperson, Ethics Advisory Committee, Massachusetts Huntington’s Disease Center Without Walls, Boston, MA

1983-86           Chairperson, Committee for the Rational Use of Psychotropic Medication, Department of Mental Health, Commonwealth of Massachusetts

1984-86           Committee Member, Massachusetts Advisory Committee on Autism, Department of Mental Health, Commonwealth of Massachusetts

1984-86           Committee Member, Task Force on Neuroleptics, Department of Mental Health, Commonwealth of Massachusetts

                       

Professional Societies

            1975-92           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

1980-92           Medical Advisor and Board Member, Autism Society of America, MA Chapter

 

Editorial Boards, Journal Activities

            1987-90           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

            1976-77           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

1978-80           Preceptor to HMS fourth year students in Neurology at MGH and Eunice Kennedy Shriver Center, Waltham, MA.

 

b. Graduate Medical Courses

1978-80           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

1980-92           Preceptor to 4^th year medical students taking and elective neurology.

 

            b. Graduate Medical Courses

1980-92           Behavioral Neurology, Residency Programs in Neurology and Psychiatry

 

            c. Invited Teaching Presentations

1980-92           Grand Rounds in Neurology or Psychiatry, approximately one per year      

 

d. Continuing Medical Education Courses

1983-88           “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.

 

1885    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