2019 submission - royal commission into victoria's mental ... · administration in the us has...

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2019 Submission - Royal Commission into Victoria's Mental Health System Organisation Name N/A Name Mr Tim Fraser What are your suggestions to improve the Victorian communitys understanding of mental illness and reduce stigma and discrimination? "A documentary series along the lines of Employable Me for mental health conditions, education throughout high schools on a diverse range of mental health conditions, more workplace initiatives that encourage open dialogue about mental health (something more in-depth and considered than RUOK day), and more discussion of alcohol & drug dependency that acknowledges that drug use is frequently non-harmful and potentially beneficial to mental health (to develop a more nuanced understanding of why problematic use develops i.e. self-medication for trauma, social/economic conditions, etc)." What is already working well and what can be done better to prevent mental illness and to support people to get early treatment and support? "Public dialogue has sufficiently shifted and it is much easier to talk about mental health. Workplaces need to be much more open however, as mental health significantly impacts on workplace performance and seeking help can be complicated by work requirements and culture." What is already working well and what can be done better to prevent suicide? Support lines and greater honesty about mental illness. What needs to improve is the provision of intensive support during acute periods of illness. What makes it hard for people to experience good mental health and what can be done to improve this? This may include how people find, access and experience mental health treatment and support and how services link with each other. "Stigma, lack of understanding from health professionals, lack of dedicated resources to support mental illness (e.g. adequate funding for treatment) and a lack of efficacious treatments. The public conversation around mental health needs to continue and deepen. Health professionals, particularly GPs, need further training and mentorship, as well as an understanding of the range of treatments available beyond prescription medicine. Greater funding for therapeutic options and workplace support (i.e. EAPs). A willingness to explore, fund and recommend alternative treatments (i.e. CBT/talk therapy not the default recommendation from GPs)." What are the drivers behind some communities in Victoria experiencing poorer mental health outcomes and what needs to be done to address this? Social justice issues that need to be acknowledged so that discussions of solutions broaden to a truly biopsychosocial model. What are the needs of family members and carers and what can be done better to support them?

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Page 1: 2019 Submission - Royal Commission into Victoria's Mental ... · Administration in the US has designated both psilocybin for anxiety+depression and MDMA for PTSD 'breakthrough therapy

2019 Submission - Royal Commission into Victoria's Mental Health System Organisation Name N/A

Name Mr Tim Fraser

What are your suggestions to improve the Victorian communitys understanding of mentalillness and reduce stigma and discrimination? "A documentary series along the lines of Employable Me for mental health conditions, educationthroughout high schools on a diverse range of mental health conditions, more workplace initiativesthat encourage open dialogue about mental health (something more in-depth and considered thanRUOK day), and more discussion of alcohol & drug dependency that acknowledges that drug useis frequently non-harmful and potentially beneficial to mental health (to develop a more nuancedunderstanding of why problematic use develops i.e. self-medication for trauma, social/economicconditions, etc)."

What is already working well and what can be done better to prevent mental illness and tosupport people to get early treatment and support? "Public dialogue has sufficiently shifted and it is much easier to talk about mental health.Workplaces need to be much more open however, as mental health significantly impacts onworkplace performance and seeking help can be complicated by work requirements and culture."

What is already working well and what can be done better to prevent suicide? Support lines and greater honesty about mental illness. What needs to improve is the provision ofintensive support during acute periods of illness.

What makes it hard for people to experience good mental health and what can be done toimprove this? This may include how people find, access and experience mental healthtreatment and support and how services link with each other. "Stigma, lack of understanding from health professionals, lack of dedicated resources to supportmental illness (e.g. adequate funding for treatment) and a lack of efficacious treatments. Thepublic conversation around mental health needs to continue and deepen. Health professionals,particularly GPs, need further training and mentorship, as well as an understanding of the range oftreatments available beyond prescription medicine. Greater funding for therapeutic options andworkplace support (i.e. EAPs). A willingness to explore, fund and recommend alternativetreatments (i.e. CBT/talk therapy not the default recommendation from GPs)."

What are the drivers behind some communities in Victoria experiencing poorer mentalhealth outcomes and what needs to be done to address this? Social justice issues that need to be acknowledged so that discussions of solutions broaden to atruly biopsychosocial model.

What are the needs of family members and carers and what can be done better to supportthem?

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N/A

What can be done to attract, retain and better support the mental health workforce,including peer support workers? "More places for psychology training at universities. Further financial support for postgraduatemental health (i.e. psychology, social work, etc) students."

What are the opportunities in the Victorian community for people living with mental illnessto improve their social and economic participation, and what needs to be done to realisethese opportunities? Supported employment through specialised social enterprises and not-for-profits. Communitygroups tailoring to their needs. Greater funding and organisational support for all of these.

Thinking about what Victorias mental health system should ideally look like, tell us whatareas and reform ideas you would like the Royal Commission to prioritise for change? "Funding research into alternative treatments, as current treatment models are insufficientlyeffective."

What can be done now to prepare for changes to Victorias mental health system andsupport improvements to last? Funding. It's always going to be helped by more funding.

Is there anything else you would like to share with the Royal Commission? "One way or another, I would very much like to see the Royal Commission recommend exploringalternative and promising emerging treatments, particularly the potential of using psychedelics totreat mental health conditions. Having spent years in the mental health care system and working,speaking and commiserating with many others who work or are a patient within it, I have come tothe conclusion that talk therapy and antidepressants are highly ineffective for a large plurality - ifnot a majority - of people who engage with the mental health care system. Research from studiesin the US, UK and elsewhere have indicated that psychedelics such as psilocybin, ayahuasca andMDMA may have immense potential in treating a range of mental health conditions, includingmood, anxiety, and dependence disorders. Research is now beginning in Australia, with the StVincent's trial of psilocybin for end of life anxiety+depression now underway and further researchsoon to be announced. The data from overseas trials is so promising that the Food and DrugAdministration in the US has designated both psilocybin for anxiety+depression and MDMA forPTSD 'breakthrough therapy' status and trials are only a couple of years away from changing theirscheduled status to legal medicines. Australia has some of the poorest mental health in the world,with 45% of Australians experiencing a mental illness in their lifetime. While I can understand theterms of reference for this inquiry may limit the commission's ability to recommend action in thisarea, I would implore that the commission considers the evidence included in my and others'submissions, as well as initiating its own research into the topic, so that it may best consider how itcan use the power of its recommendations to influence change in this area. As an ongoingpatient, a carer, a mental health support worker, and an advocate, I deeply hope you will considerthis request and thank you for your efforts in doing so."

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The Universe of FDA Drug Approval

On July 28,2017, MAPS

and the FDA reached 078 /oof all the drugs make it

agreement on the Special

Protocol Assessment for through Phase, mPhase 2Phase 3 clinical trials.

20%of all the drugs are

accepted for Phase 3

12%of all the drugs

are approved for

the market

The chart depicts all studies

that have entered the FDAdrug approval process as

represented by stars Studies

are placed according to how

much of the approval

process they completed. This

means that all stars In theouter layer represent studies

that dld not advance after thePhase 1 trials. Stars In theInner layer represent drugs

that have been approved by

the FDA for the market,

Source: Wong CH, Shaw K., L0 A. (201 B] Estlmatlnn 0f cllnlcal trlal success rates and related parameters. Biostatlstics (ptepublished). Numbers1mm 2000 to 2015. with oncology excluded.

BREAKTHROUGH THERAPY DESIGNATION (BTD)

On August 15, 2017, the FDA The BTD program was launched in 2012. The chart belowshows the percentage of novel drugs designated as

grafited Ereakthroth Therapy Breakthrough Therapies for each year.

Desngnatton to MDMA—aSSIsted

psychotherapy for PTSD. 10°80

60approximately 30%

of the requests for 40

BTD are granted by

the FDA ”mli%2013 2014 2015 2016 2017

Source: FDMW novel nmgs summaries for the years 2013-2017

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:2

V S

<me

because of it's uncanny ability to foster feelings of security and

well-being combined with acute focus creates an ideal state for exploring

traumatic events in the past. When the overarching feeling is 'safety',

the mind is comfortable to explore, repattern and heal trauma that may

be quarantined in the deep recesses of the brain.

Psilocybin diverts cognitive priority from fear and survival based

mechanisms to more conscious thought patterns, facilitating new ways

to look at problems and reprogram mental disease. It can be an incredibly

spiritual experience, often offering a different perspective on death

and the nature of life itself.

I IN 5 M000DISORDERSOne in five of us will

develop a mood disorder.

By 2020, depression will rank

second in morbidity among all

illnesses worldwide. Tragically,

suicide, often triggered by a

mood disorder, takes roughly

a million lives worldwide

every year.

40 MILLIONADDICTIONAddiction is America's

most neglected disease

According to a Columbia

University study, 40 million

Americans age 12 and over

meet the clinical criteria for

addiction involving nicotine

alcohol or other drugs."

That's more Americans than

those with heart disease,

diabetes or cancer.

PSILOCYBIN-ASSISTEDPSYCHOTHERAPY

1 SINGLE 003E CUREDFlexible dose of .3-1. mg per kg

80W

0F DEPRESSIUN AND ANXIETYIN THE PATIENTS STUDIED

,5HEB

PSILUCYBlN-FACILITATEDSMOK|N0 CESSATIUN

Flexible dose of .29mg-Jo3mg per kg

At six months, 30% oftheparticipants were still abstinent.

500.000VETERANSANDFmSTRESPONDERSwho served in Iraq

or Afg hanistan suffer

from PTSD

8 3 MILL|0NPSYCHOLOGICALDISTRESSAmerican adults 7

about 3.4 percent of

the U 5 population

suffer from serious

psychological distress,

an evaluation of federal

health data concluded.

70% 0F”.3. ADULTSTRAUMATIC EVENTat least once in their

lives. This equates to

approximately

223.4 MILLION PEOPLE MDMA-ASSISTEDPSYCHOTHERAPY

3 SESSIUNS BURED PTSDFlexible dose of 75-1875 mg

AND 00NTINUEO T0 REDUCE ITFOR YEARS LATER

@SUBVEYED 100 AUTISTID ADULTSWHO HAO EXPERIENCED MDMA

72% of MDMAexperienced individuals

reported being "more

comfortable in social

settings".

12% indicated that

these effects lasted for

TWO OR MORE YEARS EO0NOMICIMPAOT

Aéo‘s

t_AANXIETY DISORDERS ALONE HAVE AN ANNUAL COST OF

693% E? L?)$94141“ U Q»); @HLLH ® WI] PTSD IS THE MOST COSTLY

By enabling veterans to get off disability and return to work,

this treatmentcould reduce the need for VA services. improve

wait times, and reducereliance on Social Security.

THE SUBJECTIVEEFFECTS OF PSILOCYBINPsllocybin is a molecule that fits

into the serotonin receptors in the

brain, and diverts cognitive priority

to areas associated with higher

thought processes.

MDMA affects the brain by

increasing activity levels of three

different neurotransmitters: dopamine,

novepinephvine (noradrenaline),

and serotonin.

New perspective on 0 Increased empathy

emotional experiences and compassion

- Increased introspection 0 Enhanced communication

, Synaesthesia and introspection

(mixing sensory modalities) 0 Reduced feelings of fear

- Altered sense of time 0 Increased feelings of well-being

- Heightened feelings 0 Increased interpersonal trust

Of connectedness 0 Alert state of consciousness

SUPPORTING PSVCHEDELIC MEDICINEIS SUPPORTING FULL LECALlZATlONAll ofthe current clinical trials are testing psychedelic

medicine in controlled settings, with skilled practitioners

present Should psilocybin or MDMA become legal for

medicinal use it will remain under these controlled conditions

SHROOMS ARE PQlSONQUS

It's important to differentiate

mushroom poisoning from

nonvhallucinogenic species and

“intoxication" with hallucinogenic

species. 'Magic' mushrooms and

the active ingredient psilocybin is

not toxic and cause no known

major adverse effects.

Substances sold on the street under

these names may contain MDMA,

but frequently also contain unknown

and/or dangerous adulterants. These

adulterants and substitute chemicals can

be dangerous and as such, recreational

use of "MDMA" contains inherent risk.

SHROGMS MAKE ‘I’QU

GO ENSAN E

There is no conclusive evidence

suggesting that latent mental health

problems can be exacerbated by

psychedelic use in a controlled setting.

However people with mental health

problems should refrain from

recreational psychedelic use in the

absence ofa skilled medical practitioner.

There is no clinical evidence that

moderate use of MDMA can cause

damage to your brain. Frequent, high

dose use can cause heart problems

and memory problems. Early studies

to the contrary have subsequently been

retracted, as MDMA was accidentally

mislabeled as the amphetamine testedt

M. Thompson, Unlocking the secrets of PTSD," Time, val, 155, no. 12, pp. 1.073, Apr, 2015,

Natlmnal Center on Adtilctltm and Substance Abuse at leumbla umversrty, 'Addlctlon: A Preventable and Treatallle Dlsease,‘New van New Vork, USA, 2013,

3. Welssman, o, ssell, M,Jay,1. M, Beasley, o. Malasplna, and c Peg ‘Dlsparltles in Health Care Utlllmtlon and FuncunnaiUmltatlons Among Adults vwm Serlous Psycholaglcal Dlsuess, 200572014, sychlatv, sew, p. appv,ps.2oisaoz, 2017,

Staniord Mood Dlsnrders Center, 'Dloneerlng Sulutltms for Depression and Elpmlar Dlsorder,‘ 2m 7. [Onllne]. Avallable:http://med.stanford.edu/muoddlsavdershtml,

Wovltl Health Organlzatlon, 'Sulclde Data,‘ Am 7. [Onllne]. Avallable http://www,who.lnt/memalihealth/preventlon/sulclde/sulcldeprevent/en/

a. Buvge, ‘PRESS RELEASE: FDA Grams Breakthmugh Therapy Deslgnatlon luv MDMA“; ed Psychotherapy for PTSD,Agree "SpecialDmtocolAssessmentlmphaseSTvlals'Ma 2017. [Onllne]. Avallal ttp://www,map rg/news )erdlg/smepressrveleas largran breakthroughrtherapy eslgnatlnnrinrrmdmarasslste p.ycmmerapy ertsd,ragree‘ speclalrpmtucu ssessmentrfnrrphaseVSVtrlals.

A Daniunh nmage, Cmnnectlon,And Clar .Autism: Adu , Sofia University, 2013.

ML, drMethmds Callectlvercase Study of Mdma (Ecstasy) experiences of

n. u. Crlfl‘lths et a<.,-psnocybm produces substantlal anti sustalned tlecreas m depresslan and amtlety In patlents withllfeihreatenlng Cancer:A randomlzed dmublerbllnd trial, .Dsychopharmaco ,an 3 ,no. 12, pp. 1 1514 ‘7, Dec, 2015

.M. w. Johnson, A Gavclarnomeu, M, p, Coslmann, and a, Grlrflth Dllot study of the 57m ZA 9. agonlst psllocybln ln thetreatment of tobacco addlctlon,‘ 3. Psychopharmacok vol. 25, no] 1, pp. 534392, Nov. 2m 1.,

PTSD Unlted, ‘PTSD Statlstlcs,‘ 2m 3. [Onllne]. Available: http://www,ptsdunltednvg/ptsdrstatls

SUB.0002.0032.0042

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Depression

severity

(BDI

)50—

Sevele depression (230)

33-7 (7-1)

Mild or moderate

depression (>9 to >30)

2°- 15-2 ('11)9=2

10— ---------------------------------------- - - - - - -------------------------------

No depression (59) 42%0—! / IBaseline ‘ 1 week 3 months

High dose (Carhart—Harris et al, 2016, modified)

SUB.0002.0032.0037

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TREATING PTSDWITH MDMA-ASSISTED PSYCHOTHERAPY

Posttraumatlc Stress Dwsorder (PTSD) \S a wwdespread and devastamg wness for Whlch we urgermyneed more eflectwe Ireatments. Could non-profit research offer hope? The COHIIOI‘ed Use ofMDMA wn a psychotherapeutwc semng IS an Important step m the treatment 01 PTSD

What is PTSD?

Posllraumahc Shess stovder (PTSD) can PTSD Involves Changes m we Dram

be a CNOWC, devasmhng mness lhat severe‘y Palvenls have decreased aClMly m the

Impacts quamy 01 Me Sultevers onen stmgg‘e hippocampus and prelrontal cortexto mamlam healthy hves and Velailonsmps {aveas assocwated Wlm VWSVWOW and

\eammg) and Increased achv‘ly m the

amygdala (assocwaled w‘m tear).

t

. . 0 C 0 0 ° ' ' I in 7 u s semen membersII\ 1 ll‘ Ifl\ [mTT vatummg Worn \an and

Nghamslan suflms (mm PTSD.

PTSD can be caused by'

O . ’

wav sexua‘ assauu cmldnoud abuse \onure accidents omer stresslwevents

What is MDMA-Assisted Psychotherapy?A treatment that combines psychotherapy with the administration of MDMA, which

catalyzes the therapeutic process.

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How does MDMA-Assisted Psychotherapy work?MDMA can make it easier for people with chronic, treatment-resistant PTSD to

confront their traumatic memories.

Both FDA-approved PTSD treatments require patients to take drugs deny tor years or even the rest oftheir lives. But MDMA ‘5 only admlnlstered a vew Ilmes.

Even one sesslon can have prolound positive eflecls.

Current Results

In a study of the efficacy of MDMA-assisted psychotherapy for treating PTSD:

..

XXx

~ ~sublem Wye give“ durmg 2 amour sessxows‘ a‘ong thh weekly

mm, MDMA or placebo 3-5 weeks apart nonrdvug psychotherapysesswons

””mmem”Even more importantly, a long-term lallow-up conducted a mean cl 3.5 years later showedthat the benefits were (on average) maintained over time.

Fercent of Subjects Severity of PTSD Symptoms

Qualifying for PTSD Diagnosis (CAPS Score)

‘0095 m

70

60

50

25% 75% 40

30

EU

H)

50%

. Beiore treatment 0 Belore treatment

. Psychotherapy alone 0 2 months afler \reatmem

Q MDMArAsswsted Psychotherapy O 3 8 yeavs alter treannem

MT MTAH subjects reported at Study Vound no negatwe Many pamcxpants sand the\east some pevswsmg eflects 0n cognmve umcuon "eamem gave mg,“ abenefit {row the study assocwated vmh MDMA use new Sm 0,, mg

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Addmona‘ (:hmcal (He‘s 81C bomg manned Or conducted around "\C work}

For more information and to help make this treatment

available for people suffering from PTSD, visit:

MDMAPTSD.ORGThe Multxdlscxplmaw Assomamn tor Psychedehc Studwes (MAPS) \S a 501(c)(3) non»prollt research orgamzarhon wovkmg m develop MDMArAssusled Psychotherapy me an FDArapproved prescnphon trealmem

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