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State Laboratory Response to „Legal Highs‟ and Gulf Oil Jeffery H. Moran, Ph.D. Arkansas Department of Health Public Health Laboratory

State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

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Page 1: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

State Laboratory Response to

„Legal Highs‟ and Gulf Oil

Jeffery H. Moran, Ph.D.

Arkansas Department of Health –

Public Health Laboratory

Page 2: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Two Faces of K2

Page 3: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Designer Drugs & “Legal Highs”

“Where does a

parent go to get

answers?”

“We talk to our kids

about sex.

We talk to our kids

about drugs, and we

talk to our kids

about drinking and

being responsible.

But how can you

talk to your kids

about something you

don’t even know

about?”

Page 4: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Synthetic Marijuana/THC Based Drugs

• Decreased intraocular pressure

• Anti-emetic*

• AIDs wasting*

• Anti-convulsant

• Muscle spasm

*FDA approved indication for dronabinol

Page 5: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Many Synthetic

Derivatives Fail

Human Trials

NO

JWH-018 JWH-073

NO

H

H

O

OH

Delta-9-THC

Page 6: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Reasons for K2 Popularity

• Pharmacologically active

• Legal

• Easily produced and distributed

• Easily modified to stay in front of regulations

• Not detectable on a clinical drug screen!

…Get your weekend high and show up to work on Monday with no worries.

Page 7: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Public Health Problems

• Product Specific:

– Potency differences (less than, no difference, and 5 to 10X)

– Complex Mixtures

– Overdosing

• Memory and learning problems

• Anxiety, panic attacks, extreme agitation, hallucinations,

seizures

• Loss of judgment

• Driving impairment

• Increased CB2 Effects – Immunosuppression

“their [JWH Compounds] effects in humans have not

been studied and they could very well have toxic effects.”

– John W. Huffman, NY Times 2010

Page 8: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Arkansas K2 Research Consortium

• Statewide Surveillance

• K2 Product Testing

• Testing of Human Specimens

• State Regulations

• Basic Research

• Poison Control Center

Tra

nsla

tion

al S

cie

nc

e

• Compiling Clinical Data

& Samples

Page 9: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Product Material & Packaging

Page 10: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

124 Different Products Submitted

• Armageddon

• Astral Blast

• Blue Fire

• Cloud 10

• Coma

• Demon Ritual Botanical

• Funky Green Stuff

• Head Trip

• Herbal Incense

• K2

• K2 Blonde

• K2 Blue

• K2 Blueberry

• K2 Cloud 9

• K2 Melon

• K2 Pink

• K2 Summit

• K2 Watermelon

• K3

• K3 Ultimate

• Kush

• Legal Eagle

• Super Kush

• Texas Kush

• Utopia

• Voodoo Spice

• Zombie Twilight

Page 11: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Forensic Surveillance-

GC/MS Analysis of K2 Case Submissions

• 566 samples

(206 cases)

since March

2010

Page 12: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

46 Different Combinations of Compounds

JWH-018,

JWH-073

(13%)

AM2201

(10%)

• Compounds detected in products collected in Arkansas:

-- JWH-018, JWH-019, JWH-073, JWH-081, JWH-122,

JWH-203, JWH-210, JWH-250

-- AM-694, AM-2201

-- RCS-4, RCS-8

JWH-203,

JWH-250

(3%)

JWH-122,

JWH-210

(4%)

JWH-250

(3%)

RCS-4

(3%)

AM2201,

JWH-122,

JWH-210

(3%)

AM2201,

JWH-210

(5%)

• Each color on chart represents a unique drug combination

Page 13: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Clinical/Toxicology Testing Capabilities

“Phase I”

Liver P450

Hydroxylation

(Sobolevsky et. al.

2010)

Parent Drug:

JWH-018

“Phase II”

Liver UGT

Conjugation

(Sobolevsky et. al.

2010)

Purpose: Increase Water Solubility

Metabolic Excretion

Page 14: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Regulatory Process

• Several states have banned these substances by scheduling.

• The US Armed forces have banned both use and distribution.

• Several counties and municipalities in Arkansas banned it by local ordinance.

• Arkansas became the first state to ban it by rule on July 2, 2010.

• Arkansas Acts 587 and 751 in March 2011

• Federal regulations began March 1, 2011.

Page 15: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Summary

– Deceptive labeling

– Compounds vary from product to product

– Concentrations of the compounds vary within the package – “Hot Spots”

– Concentrations of the compounds vary between different lots of the same products

• New compounds emerging that skirt the existing regulations

• No Quality Assurance/Control for K2 products:

• Human testing now available for some derivatives

Page 16: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Conclusions: Effective Public Health Response

HUMAN

TESTING

BASIC

RESEARCH

REGULATION

K2 PRODUCT

TESTING TRANSLATIONAL

SCIENCE

Educational and

Community Outreach

Page 17: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

http://www.ncsl.org/?TabId=21398

Educational Resources for K2

Page 18: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

State LRN Response to Gulf Oil

Page 19: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Meets FDA Requirements and Analytical Demands

Page 20: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Summary

• Diverse examples showing how the AR PHL

constantly protects public health

• Everyday lives touched by the AR PHL

• Understand how the AR PHL responds to new

threats & why part of our mission involves

non-routine testing

Page 21: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

Acknowledgements

Cindy Moran, Felesia Lackey, Amy Patton

Forensic Chemistry Section

Krishna Chimalakonda, Vi-Huyen Le, Katie Seely,

John Blevins, Kevin Stewart. Morgan Donaldson,

Suzanne Owen

Laura James, Beth Storm, Leah Dawson, Michelle Frost,

Lisa Bates-Dubrow, Jessica Enderlin

Anna Radominska-Pandya, Stacie Bratton, Paul Prather,

Lisa Brents, Bill Fantegrossi

Arkansas K2 Translational Research Group

Page 22: State Laboratory Response to · Reasons for K2 Popularity •Pharmacologically active •Legal •Easily produced and distributed •Easily modified to stay in front of regulations

• APHL – Innovations Contract Award

(U60/CD303019)

• UAMS Center for Clinical and

Translational Research, (1UL1RR029884)

• UAMS - Center for Translational

Neuroscience (RR020146)

• NIH - GM075893 and R01-GM075893

Acknowledgements Grants and Contracts