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CURRICULUM VITAE
PART I: General Information
Date Prepared:
July 25, 2005
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:
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
1972-73 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
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.
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 4th 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.
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.
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.
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, 2005 (in
preparation).
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