ADHD

Rethinking an old diagnosis

Robert L Quillin MD FAAP

Disclosures

Speaker and consultant for VayaPharma makers of Vayarin

Previous research support provided by PernixTherapeutics

Will discuss off label use of medications medical foods and supplements

Presentation Outline

morbidity of the attention disorders

current diagnostic approach to attention

disorders

the neurobiochemistry of attention

approach to stimulant use in attention disorders

paradigm shift in the treatment of attention disorders

Faces not easy to forget

STATE OF THE UNION

ADHD Timeline

Impact of ADHD Approximately 11 of children 4-17 years of age (64 million) have been

diagnosed with ADHD as of 2011

The percentage of children with an ADHD diagnosis continues to

increase from 78 in 2003 to 95 in 2007 and to 110 in 2011

Rates of ADHD diagnosis increased an average of 3 per year from 1997

to 2006 and an average of approximately 5 per year from 2003 to 2011

Boys (132) were more likely than girls (56) to have ever been

diagnosed with ADHD

The average age of ADHD diagnosis was 7 years of age

Prevalence of ADHD diagnosis varied substantially by state from a low of

56 in Nevada to a high of 187 in Kentucky

httpwwwcdcgovncbdddadhddatahtmlus

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

Disclosures

Speaker and consultant for VayaPharma makers of Vayarin

Previous research support provided by PernixTherapeutics

Will discuss off label use of medications medical foods and supplements

Presentation Outline

morbidity of the attention disorders

current diagnostic approach to attention

disorders

the neurobiochemistry of attention

approach to stimulant use in attention disorders

paradigm shift in the treatment of attention disorders

Faces not easy to forget

STATE OF THE UNION

ADHD Timeline

Impact of ADHD Approximately 11 of children 4-17 years of age (64 million) have been

diagnosed with ADHD as of 2011

The percentage of children with an ADHD diagnosis continues to

increase from 78 in 2003 to 95 in 2007 and to 110 in 2011

Rates of ADHD diagnosis increased an average of 3 per year from 1997

to 2006 and an average of approximately 5 per year from 2003 to 2011

Boys (132) were more likely than girls (56) to have ever been

diagnosed with ADHD

The average age of ADHD diagnosis was 7 years of age

Prevalence of ADHD diagnosis varied substantially by state from a low of

56 in Nevada to a high of 187 in Kentucky

httpwwwcdcgovncbdddadhddatahtmlus

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

Presentation Outline

morbidity of the attention disorders

current diagnostic approach to attention

disorders

the neurobiochemistry of attention

approach to stimulant use in attention disorders

paradigm shift in the treatment of attention disorders

Faces not easy to forget

STATE OF THE UNION

ADHD Timeline

Impact of ADHD Approximately 11 of children 4-17 years of age (64 million) have been

diagnosed with ADHD as of 2011

The percentage of children with an ADHD diagnosis continues to

increase from 78 in 2003 to 95 in 2007 and to 110 in 2011

Rates of ADHD diagnosis increased an average of 3 per year from 1997

to 2006 and an average of approximately 5 per year from 2003 to 2011

Boys (132) were more likely than girls (56) to have ever been

diagnosed with ADHD

The average age of ADHD diagnosis was 7 years of age

Prevalence of ADHD diagnosis varied substantially by state from a low of

56 in Nevada to a high of 187 in Kentucky

httpwwwcdcgovncbdddadhddatahtmlus

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

Faces not easy to forget

STATE OF THE UNION

ADHD Timeline

Impact of ADHD Approximately 11 of children 4-17 years of age (64 million) have been

diagnosed with ADHD as of 2011

The percentage of children with an ADHD diagnosis continues to

increase from 78 in 2003 to 95 in 2007 and to 110 in 2011

Rates of ADHD diagnosis increased an average of 3 per year from 1997

to 2006 and an average of approximately 5 per year from 2003 to 2011

Boys (132) were more likely than girls (56) to have ever been

diagnosed with ADHD

The average age of ADHD diagnosis was 7 years of age

Prevalence of ADHD diagnosis varied substantially by state from a low of

56 in Nevada to a high of 187 in Kentucky

httpwwwcdcgovncbdddadhddatahtmlus

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

STATE OF THE UNION

ADHD Timeline

Impact of ADHD Approximately 11 of children 4-17 years of age (64 million) have been

diagnosed with ADHD as of 2011

The percentage of children with an ADHD diagnosis continues to

increase from 78 in 2003 to 95 in 2007 and to 110 in 2011

Rates of ADHD diagnosis increased an average of 3 per year from 1997

to 2006 and an average of approximately 5 per year from 2003 to 2011

Boys (132) were more likely than girls (56) to have ever been

diagnosed with ADHD

The average age of ADHD diagnosis was 7 years of age

Prevalence of ADHD diagnosis varied substantially by state from a low of

56 in Nevada to a high of 187 in Kentucky

httpwwwcdcgovncbdddadhddatahtmlus

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

ADHD Timeline

Impact of ADHD Approximately 11 of children 4-17 years of age (64 million) have been

diagnosed with ADHD as of 2011

The percentage of children with an ADHD diagnosis continues to

increase from 78 in 2003 to 95 in 2007 and to 110 in 2011

Rates of ADHD diagnosis increased an average of 3 per year from 1997

to 2006 and an average of approximately 5 per year from 2003 to 2011

Boys (132) were more likely than girls (56) to have ever been

diagnosed with ADHD

The average age of ADHD diagnosis was 7 years of age

Prevalence of ADHD diagnosis varied substantially by state from a low of

56 in Nevada to a high of 187 in Kentucky

httpwwwcdcgovncbdddadhddatahtmlus

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

Impact of ADHD Approximately 11 of children 4-17 years of age (64 million) have been

diagnosed with ADHD as of 2011

The percentage of children with an ADHD diagnosis continues to

increase from 78 in 2003 to 95 in 2007 and to 110 in 2011

Rates of ADHD diagnosis increased an average of 3 per year from 1997

to 2006 and an average of approximately 5 per year from 2003 to 2011

Boys (132) were more likely than girls (56) to have ever been

diagnosed with ADHD

The average age of ADHD diagnosis was 7 years of age

Prevalence of ADHD diagnosis varied substantially by state from a low of

56 in Nevada to a high of 187 in Kentucky

httpwwwcdcgovncbdddadhddatahtmlus

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

Financial Impact of ADHD

Using a prevalence rate of 5 the annual societal lsquolsquocost of illnessrsquorsquo for

ADHD is estimated to be between $36 and $52 billion in 2005 dollars It is

estimated to be between $12005 and $17458 annually per individual

There were an estimated 7 million ambulatory care visits for ADHD in

2006

The total excess cost of ADHD in the US in 2000 was $316 billion

The annual average direct cost for each per ADHD patient was $1574

compared to $541 among matched controls

ADHD creates a significant financial burden regarding the cost of medical

care and work loss for patients and family members

httpwwwcdcgovncbdddadhddatahtmlcost

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

ldquoI CAN CALCULATE THE MOTION

OF HEAVENLY BODIES BUT NOT

THE MADNESS OF PEOPLErdquo

Sir Isaac Newton

What exactly is ADHD

ADHD is one of the most common neurodevelopmental disorders of

childhood

Initial diagnosis in childhood and often lasts into adulthood

Children with ADHD may have

trouble paying attention

controlling impulsive behaviors (may act without thinking about what

the result will be)

or be overly active

The ADHD Molecular Genetics Network Report from the third international meeting ofthe attention-deficit hyperactivity disorder molecular genetics networkAmerican Journal of Medical Genetics 2002 114272-277

ADHD defined by DSM-5INATTENTION Six or more symptoms of inattention for children up to age 16 or

five or more for adolescents 17 and older and adults symptoms of inattention

have been present for at least 6 months and they are inappropriate for

developmental level

Often fails to give close attention to details or makes careless mistakes in

schoolwork at work or with other activities

Often has trouble holding attention on tasks or play activities

Often does not seem to listen when spoken to directly

Often does not follow through on instructions and fails to finish schoolwork chores

or duties in the workplace (eg loses focus side-tracked)

Often loses things necessary for tasks and activities (eg school materials pencils

books tools wallets keys paperwork eyeglasses mobile telephones)

Often avoids dislikes or is reluctant to do tasks that require mental effort over a

long period of time (such as schoolwork or homework)

Often has trouble organizing tasks and activities

Is often easily distracted

Is often forgetful in daily activities

ADHD defined by DSM-5HYPERACTIVITY AND IMPULSIVITY Six or more symptoms of hyperactivity-

impulsivity for children up to age 16 or five or more for adolescents 17 and

older and adults symptoms of hyperactivity-impulsivity have been present for

at least 6 months to an extent that is disruptive and inappropriate for the

personrsquos developmental level

Often fidgets with or taps hands or feet or squirms in seat

Often leaves seat in situations when remaining seated is expected

Often runs about or climbs in situations where it is not appropriate (adolescents or

adults may be limited to feeling restless)

Often unable to play or take part in leisure activities quietly

Often blurts out an answer before a question has been completed

Often has trouble waiting hisher turn

Often interrupts or intrudes on others (eg butts into conversations or games)

Is often on the go acting as if driven by a motorldquo

Often talks excessively

Basic types

1) ADHD predominantly inattentive type

2) ADHD predominantly hyperactive-impulsive type

3) ADHD combined type

Comorbidity the rule not the exception

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (female)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (male)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

httpstudentacademichelpblogspotcom200910

baseball-players-with-adhdhtmlixzz2bFzBnnv0

Tuesday October 6 2009

Baseball Players with ADHD

ADHD defined by DSM-5HYPERACTIVITY AND IMPULSIVITY Six or more symptoms of hyperactivity-

impulsivity for children up to age 16 or five or more for adolescents 17 and

older and adults symptoms of hyperactivity-impulsivity have been present for

at least 6 months to an extent that is disruptive and inappropriate for the

personrsquos developmental level

Often fidgets with or taps hands or feet or squirms in seat

Often leaves seat in situations when remaining seated is expected

Often runs about or climbs in situations where it is not appropriate (adolescents or

adults may be limited to feeling restless)

Often unable to play or take part in leisure activities quietly

Often blurts out an answer before a question has been completed

Often has trouble waiting hisher turn

Often interrupts or intrudes on others (eg butts into conversations or games)

Is often on the go acting as if driven by a motorldquo

Often talks excessively

Basic types

1) ADHD predominantly inattentive type

2) ADHD predominantly hyperactive-impulsive type

3) ADHD combined type

Comorbidity the rule not the exception

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (female)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (male)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

httpstudentacademichelpblogspotcom200910

baseball-players-with-adhdhtmlixzz2bFzBnnv0

Tuesday October 6 2009

Baseball Players with ADHD

Basic types

1) ADHD predominantly inattentive type

2) ADHD predominantly hyperactive-impulsive type

3) ADHD combined type

Comorbidity the rule not the exception

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (female)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (male)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

httpstudentacademichelpblogspotcom200910

baseball-players-with-adhdhtmlixzz2bFzBnnv0

Tuesday October 6 2009

Baseball Players with ADHD

Comorbidity the rule not the exception

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (female)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (male)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

httpstudentacademichelpblogspotcom200910

baseball-players-with-adhdhtmlixzz2bFzBnnv0

Tuesday October 6 2009

Baseball Players with ADHD

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (female)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (male)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

httpstudentacademichelpblogspotcom200910

baseball-players-with-adhdhtmlixzz2bFzBnnv0

Tuesday October 6 2009

Baseball Players with ADHD

From Comorbid Psychiatric Disorders in Youth in Juvenile Detention (male)

Arch Gen Psychiatry 200360(11)1097-1108 doi101001archpsyc60111097

httpstudentacademichelpblogspotcom200910

baseball-players-with-adhdhtmlixzz2bFzBnnv0

Tuesday October 6 2009

Baseball Players with ADHD

httpstudentacademichelpblogspotcom200910

baseball-players-with-adhdhtmlixzz2bFzBnnv0

Tuesday October 6 2009

Baseball Players with ADHD

Whatrsquos missing

Learning disorders

Dyslexia dysphasia dysgraphia

Autism spectrum disorders including PDD and

Aspergerrsquos syndrome

Tic disorders

Tourettersquos syndrome

Congenital genetic disorders ndash Down syndrome

DiGeorge syndrome and others

Cancers ndash leukemia brain tumors

Donrsquot forget your fundamentals

NEURO-developmental disorder

I History and Physical ndash with interview covering emotional and psychosocial concerns particularly early development

II Hearing and vision screen particularly hearing

III Labs

Complete blood count ndash anemia due to low iron low B12

Lead level ndash consider your patientrsquos exposures

Thyroid ndash too much or too little

IV EEG ndash is it a seizure

V Behavior Checklists

Tools of the trade

Behavior Rating Scales

subjective evaluations by teachers and parents self report

Vanderbilt Assessment Scale 6-12 years

Conners 3rd edition 6-18 years

More ADHD specific vs Conners CBRS

SNAP-IV R 6-18 years

The big players

Is that all to ADHD

Where they act

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Donrsquot forget your fundamentals

NEURO-developmental disorder

I History and Physical ndash with interview covering emotional and psychosocial concerns particularly early development

II Hearing and vision screen particularly hearing

III Labs

Complete blood count ndash anemia due to low iron low B12

Lead level ndash consider your patientrsquos exposures

Thyroid ndash too much or too little

IV EEG ndash is it a seizure

V Behavior Checklists

Tools of the trade

Behavior Rating Scales

subjective evaluations by teachers and parents self report

Vanderbilt Assessment Scale 6-12 years

Conners 3rd edition 6-18 years

More ADHD specific vs Conners CBRS

SNAP-IV R 6-18 years

The big players

Is that all to ADHD

Where they act

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

NEURO-developmental disorder

I History and Physical ndash with interview covering emotional and psychosocial concerns particularly early development

II Hearing and vision screen particularly hearing

III Labs

Complete blood count ndash anemia due to low iron low B12

Lead level ndash consider your patientrsquos exposures

Thyroid ndash too much or too little

IV EEG ndash is it a seizure

V Behavior Checklists

Tools of the trade

Behavior Rating Scales

subjective evaluations by teachers and parents self report

Vanderbilt Assessment Scale 6-12 years

Conners 3rd edition 6-18 years

More ADHD specific vs Conners CBRS

SNAP-IV R 6-18 years

The big players

Is that all to ADHD

Where they act

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Tools of the trade

Behavior Rating Scales

subjective evaluations by teachers and parents self report

Vanderbilt Assessment Scale 6-12 years

Conners 3rd edition 6-18 years

More ADHD specific vs Conners CBRS

SNAP-IV R 6-18 years

The big players

Is that all to ADHD

Where they act

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

The big players

Is that all to ADHD

Where they act

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Is that all to ADHD

Where they act

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Where they act

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Arenrsquot you glad thatrsquos over

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

To treat or not to treat

Gold standard ndash The stimulantRitalin Adderall Focalin

Daytrana Vyvanse Quillivant XR

Other choicesNonstimulants ndash Intuniv Kapvay Straterra

Medical foods ndash VayarinVitamins ndash Brsquos Drsquos Mg Zinc

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

COMPARE

4-5 years old lt50

pounds

Short acting better

Hyperactive

Family history

Side effects

Parental ambivalence

5 years old 50+

pounds

Long acting best

Inattentive

New diagnosis

Comorbidities

Parental Fear

CONTRAST

Where to start

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Prescription Medical Foods

Defined as

ldquoa food which is formulated to be consumed or administered enterallyunder the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluationrdquo

Section 5(b) of the Orphan Drug Act (21 USC 360ee (b) (3))

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

FDA Regulation of Prescription

Medical Foods

Foods

FDA GRAS for

Safety

Dietary Supplements

No Pre-Market FDA Approval for pre-1994 ingredients

-OR-

FDA review for new dietary ingredients

Prescription Medical Foods

FDA GRAS for Safety of Ingredients

FDA Required Clinical Evidence for Efficacy

Prescription Drugs

FDA Approval for Safety amp Efficacy

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Time is right for a change

Omega3 + Phosphatidylserine - Vayarin

B-vitamins folate B6 B12 choline ndashDeplin Cerefolin

Vitamin D

Magnesium

Zinc

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

PS-Omega-3 showed an endpoint that no

longer qualified as ADHD in the TOVA

Vaisman N et al Correlation between changes in blood fatty acid composition and visual sustained attention performance in children

with inattention effect of dietary n-3 fatty acids containing phospholipids Am J Clin Nutr 2008 87(5) p 1170-80

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

Folate

J Pediatr 2008 Jan152(1)101-5

Folate pathway genetic polymorphisms are related to attention

disorders in childhood leukemia survivors

Krull KR Brouwers P Jain N Zhang L Bomgaars L Dreyer Z Mahoney D

Bottomley S Okcu MF

Learning Support Center for Child Psychology Texas Childrens Hospital

Houston TX USA

CONCLUSION Preliminary data imply a strong relationship

between MTHFR polymorphisms and the inattentive symptoms of

ADHD in survivors of childhood ALL

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

MagnesiumVitamin B6Magnes Res 2006 Mar19(1)46-52

Improvement of neurobehavioral disorders in children

supplemented with magnesium-vitamin B6 I Attention deficit

hyperactivity disorders

Mousain-Bosc M1 Roche M Polge A Pradal-Prat D Rapin J Bali JP 1Explorations Fonctionnelles du Systegraveme Nerveux Centre Hospitalier

Universitaire Careacutemeau Nicircmes France

CONCLUSION In almost all cases of ADHD Mg-B6 regimen for at

least two months significantly modified the clinical symptoms of the

disease hyperemotivityaggressiveness were reduced school

attention was improved When the Mg-B6 treatment was stopped

clinical symptoms of the disease reappeared

ZincActa Med Croatica 2009 Oct63(4)307-13

[The role of zinc in the treatment of hyperactivity disorder in

children]

Dodig-Curković K1 Dovhanj J Curković M Dodig-Radić J Degmecić D1University Department of Child and Adolescent Psychiatry University

Department of Psychiatry Osijek University Hospital Osijek Croatia

kdodigyahoomail

CONCLUSION The dose of zinc sulfate used was 55 mgday which is

equivalent to 15 mg zinc The improvement achieved in ADHD children

with the use of zinc sulfate appears to confirm the role of zinc

deficiency in the etiopathogenesis of ADHD Additional studies are

needed to identify the real and efficient dose of zinc

Vitamin D

Pediatr Int 2014 Jan 13 doi 101111ped12286 [Epub ahead of print]

Vitamin D Status in Children with Attention Deficit Hyperactivity

Disorder

Goksugur SB1 Tufan AE Semiz M Gunes C Bekdas M Tosun M Demircioglu F1Department of Pediatrics Medical Faculty Abant Izzet Baysal University Bolu

Turkey

CONCLUSION 25-OH-vitamin D level in ADHD group and control

group was respectively 209plusmn194 ngmL and 349plusmn154 ngmL

(p=0001) Our results suggest that there is an association between

lower 25-OH-vitamin D concentrations and ADHD in childhood and

adolescence

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O

N

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I

O

N

THANK YOU TAPA

THANK YOU TAPA