Med­i­cal Cannabis

AQ: Australian Quarterly - - FRONT PAGE - AR­TI­CLE BY: SUVI MAHONEN

On a cold April morn­ing, six years ago, Vic­tor Caprio stood at the sum­mit of Mount Warn­ing, north­ern NSW, throw­ing his fa­ther’s ashes over the rails. Ru­moured to be the first lo­ca­tion on main­land Aus­tralia to see the ear­li­est rays of sun­rise, Caprio had care­fully cho­sen this spot as his fa­ther’s fi­nal rest­ing place.

With shards of light spread­ing out over the dark green vista of trees be­low, Caprio reached into the urn and took out a hand­ful of ash. He leaned over and opened his fin­gers, eyes welling, as the ashes blew away in the strong west­erly wind.

“My dad was in ex­cru­ci­at­ing back pain and all he wanted was some re­lief,” Caprio, 34, told me. “But when he asked his doc­tors for some medic­i­nal cannabis to help with the pain, the doc­tors wouldn't pre­scribe it. The doc­tors were like, ‘Have some opi­oids in­stead'.”

Caprio's fa­ther was liv­ing in Canada when the fork­lift he was op­er­at­ing flipped over, caus­ing a back in­jury that pre­vented him from re­turn­ing to work.

“It was a down­ward spiral af­ter that,”

Caprio, who was only 13 at the time, said. “He suf­fered ter­ri­ble mood swings and had con­stant headaches and all he wanted to do was sit on the couch.”

See­ing how the in­creas­ingly large dosage of opi­oids that doc­tors were pre­scrib­ing was ad­versely af­fect­ing him, one of Caprio's fa­ther's friends gave him some mar­i­juana to try. “It re­ally helped,” Caprio said. "He liked the fact it was a nat­u­ral or­ganic plant and, more im­por­tantly, he didn't have to take as many painkillers.”

Caprio mi­grated from Canada to Aus­tralia nine years ago. When his fa­ther died sud­denly at the age of 50, from a mas­sive heart at­tack, Caprio had not seen him for over three years.

“There is no doubt in my mind that the opi­oids con­trib­uted to his death,” Caprio said. “My fa­ther was stressed out, de­pressed, and tak­ing too many pre­scrip­tion med­i­ca­tions.”

Cruel catch 22

Since 1989 it has tech­ni­cally been pos­si­ble in Aus­tralia to im­port and pre­scribe medic­i­nal cannabis for in­di­vid­ual pa­tients; how­ever, in prac­tice this has been ex­tremely rare, partly due to the Or­wellian twist that all forms of mar­i­juana were clas­si­fied as Sched­ule 9 (Pro­hib­ited Sub­stance) by the Ther­a­peu­tic Goods Ad­min­is­tra­tion ( TGA).

It wasn't un­til 2008 that the first ap­pli­ca­tion to pre­scribe medic­i­nal mar­i­juana was ap­proved in Aus­tralia, and over the pro­ceed­ing eight years only three ap­pli­ca­tions on av­er­age were ap­proved na­tion­wide per an­num.

Things changed in Fe­bru­ary 2016 when the Fed­eral Gov­ern­ment, with bi­par­ti­san sup­port, made amend­ments to the Nar­cotics Drug Act of 1967 – al­low­ing the Depart­ment of Health to reg­u­late the cul­ti­va­tion of cannabis for medic­i­nal and sci­en­tific use. The fol­low­ing month the Ther­a­peu­tic Goods Or­der No. 93 came into ef­fect – set­ting out the stan­dards for medic­i­nal mar­i­juana and, in Novem­ber 2016, the TGA down-sched­uled medic­i­nal cannabis prod­ucts from Sched­ule 9 to Sched­ule 8 (Con­trolled Drug).

These cu­mu­la­tive changes meant that, for the very first time, a le­galised medic­i­nal cannabis in­dus­try could be es­tab­lished in Aus­tralia.

By this stage, Caprio had built a suc­cess­ful ca­reer as a real es­tate agent in Surfers Par­adise, Queens­land. None­the­less, recog­nis­ing an op­por­tu­nity, he quit his job, pooled his sav­ings, and founded Phar­ma­cann, a biotech com­pany whose aim is to pro­duce and pro­vide nat­u­ral botan­i­cal cannabi­noids for pain re­lief.

De­spite his early op­ti­mism, months of hard work and large fi­nan­cial out­lay, Caprio's com­pany has only re­cently cleared all the bu­reau­cratic hur­dles nec­es­sary to im­port and dis­pense medic­i­nal cannabis, and his stor­age safe, which is housed in a se­cure ware­house un­der 24-hour sur­veil­lance, re­mains empty.

“It's been an ex­tremely frus­trat­ing ex­pe­ri­ence,” Caprio says.

His com­pany was not the only one be­ing es­tab­lished. Oth­ers tak­ing ad­van­tage of Aus­tralia's emerg­ing medic­i­nal cannabis in­dus­try in­clude Aus­cann, MGC Phar­ma­ceu­ti­cals, Creso Pharma and the Cann Group, which har­vested its first crop of medic­i­nal cannabis in Au­gust 2017.

“We be­lieve the ev­i­dence shows that medic­i­nal cannabis has a role to play in pain man­age­ment and we are pleased to be part of this ef­fort,” Cann Group CEO Peter Crock told me.

The pain bur­den

Ac­cord­ing to Pain Aus­tralia, pain is the num­ber one rea­son peo­ple seek med­i­cal help. There are three main

1 cat­e­gories of pain: acute pain, such as fol­low­ing surgery or an in­jury; can­cer pain; and chronic pain, which is de­fined as pain last­ing for longer than six months.

An es­ti­mated 29 per cent of Aus­tralians suf­fer from chronic pain2,

Since 1989 it has tech­ni­cally been pos­si­ble in Aus­tralia to im­port and pre­scribe medic­i­nal cannabis for in­di­vid­ual pa­tients; how­ever, in prac­tice this has been ex­tremely rare.

a con­di­tion that many doc­tors find par­tic­u­larly dif­fi­cult to man­age. A widely used main­stay of treat­ment in­volves the pre­scrip­tion of opi­oids, which act on the cen­tral ner­vous sys­tem to re­duce pain im­pulses reach­ing the brain; how­ever, these drugs can cause a num­ber of side-ef­fects in­clud­ing drowsi­ness, con­sti­pa­tion, nau­sea, re­s­pi­ra­tory de­pres­sion, mood changes and phys­i­cal de­pen­dence. Some­times these side-ef­fects can have deadly con­se­quences.

Fig­ures from the Aus­tralian Bureau of Sta­tis­tics show that opi­oids have been the leading cause of all drug-in­duced deaths in Aus­tralia, in­clud­ing those caused by al­co­hol, for the past 17 years.3

In 2016 nearly three-quar­ters of drug­in­duced deaths in­volved the us­age of opi­oids. And nearly three-quar­ters of these deaths in­volved pre­scrip­tion opi­oids such as En­done, Oxy­con­tin and Ms­con­tin.

“There's been a huge in­crease in the use of opi­oids in Aus­tralia over the last decade,” Pain Aus­tralia CEO Carol Bennett told me. “De­pen­dence and side-ef­fects can have a dev­as­tat­ing im­pact on peo­ple's lives. One of the rea­sons opi­oids are over­pre­scribed is that there aren't a lot of al­ter­na­tives in Aus­tralia.”

In recog­ni­tion of the dan­gers posed by opi­oids, the TGA re­cently made changes to the dis­pens­ing of all med­i­ca­tions that con­tain the opi­oid codeine. As of the 1st of Fe­bru­ary 2018 codeine-con­tain­ing med­i­ca­tions that were pre­vi­ously avail­able over the counter, such as Nuro­fen Plus and Panadeine, are now only avail­able by pre­scrip­tion in an at­tempt to re­duce opi­oid ad­dic­tion and over­dose.

In com­par­i­son, the num­ber of recorded peo­ple world­wide who have ever died of a mar­i­juana over­dose is zero.4

Un­der­stand­ing the ev­i­dence

A clin­i­cal re­view of medic­i­nal mar­i­juana pub­lished in the Jour­nal of the Amer­i­can Med­i­cal As­so­ci­a­tion found that ‘Use of mar­i­juana for chronic pain … is sup­ported by high qual­ity ev­i­dence' 5, and a re­cent re­port by the United States Na­tional Academies of Sciences, En­gi­neer­ing and Medicine stated that: ‘ There is con­clu­sive or sub­stan­tial ev­i­dence that cannabis or cannabi­noids are ef­fec­tive for the treat­ment of chronic pain in adults' 6. In ad­di­tion, re­search in the United States shows that the avail­abil­ity of medic­i­nal cannabis can po­ten­tially re­duce opi­oid over­dose mor­tal­ity rates.7

De­spite this, the use of medic­i­nal cannabis, es­pe­cially for chronic pain, re­mains a con­tentious is­sue within the med­i­cal com­mu­nity. “There are those that feel medic­i­nal cannabis is worse than the to­bacco in­dus­try 50 years ago, and those who be­lieve this is even­tually

Ac­cord­ing to Pain Aus­tralia, pain is the num­ber one rea­son peo­ple seek med­i­cal help.

go­ing to be a sci­ence-led ad­vance­ment of a mol­e­cule with clear phys­i­o­log­i­cal prop­er­ties,” says anaes­thetist and Di­rec­tor of Pain Ser­vices at Toronto Gen­eral Hospi­tal in Canada, As­sis­tant Pro­fes­sor Hance Clarke.

Clarke be­lieves medic­i­nal cannabis can help with a num­ber of con­di­tions, in­clud­ing epilepsy, chronic pain, post­trau­matic stress dis­or­der and anx­i­ety.

“For chronic in­flam­ma­tory dis­eases such as pso­ri­atic arthri­tis, medic­i­nal cannabis has been an ex­cel­lent choice over an opi­oid, with­out the de­pen­dence is­sues,” he says. “There is al­ready data sug­gest­ing that pa­tients are pre­fer­ring to sub­sti­tute pre­scrip­tion opi­oids with medic­i­nal cannabis”.

How­ever, even with the re­cent leg­isla­tive changes, the op­tion of sub­sti­tut­ing pre­scrip­tion opi­oids with medic­i­nal cannabis re­mains lim­ited in Aus­tralia, with only 546 ap­provals in to­tal to use medic­i­nal cannabis be­ing granted as of April 2018. The TGA'S Spe­cial Ac­cess Scheme Cat­e­gory B con­tin­ues to be the main point of ac­cess. To ob­tain ap­proval, the pre­scrib­ing doc­tor has to sub­mit a de­tailed re­port for each pa­tient out­lin­ing the con­di­tion be­ing treated, pre­vi­ous med­i­ca­tions used, why the prac­ti­tioner be­lieves the cur­rently avail­able med­i­ca­tions are in­ad­e­quate for the pa­tient, and the pro­posed dose, strength and route of ad­min­is­tra­tion of the medic­i­nal cannabis be­ing ap­plied for.

Al­ter­na­tively, some spe­cial­ists can ap­ply to be­come Au­tho­rised Pre­scribers of medic­i­nal cannabis for cer­tain groups of pa­tients. Ap­proval from an ap­pro­pri­ate Hu­man Re­search Ethics Com­mit­tee or Spe­cial­ist Col­lege must be ob­tained, and to date, of the 31 med­i­cal prac­ti­tion­ers that have been granted au­thor­ity to pre­scribe medic­i­nal cannabis, only one has been a pain spe­cial­ist.

And that is be­fore the in­di­vid­ual state and ter­ri­tory bar­ri­ers come into play, with each ju­ris­dic­tion hav­ing their own in­di­vid­ual re­quire­ments for ap­proval.

In Queens­land for ex­am­ple, an ap­pli­ca­tion for an in­di­vid­ual pa­tient must be made to Queens­land Health by a spe­cial­ist or, if by a GP, with a spe­cial­ist's writ­ten sup­port. The ap­ply­ing med­i­cal prac­ti­tioner must have par­tic­i­pated in for­mal ed­u­ca­tion on medic­i­nal mar­i­juana pre­scrib­ing; they must have coun­selled and ob­tained the pa­tient's writ­ten con­sent about the po­ten­tial risks and con­di­tions of us­ing medic­i­nal cannabis, in­clud­ing the in­abil­ity to drive or op­er­ate heavy ma­chin­ery; they must give de­tails on the con­di­tion be­ing treated, present ther­a­pies be­ing tried, and past ther­a­pies tried; they must give ev­i­dence for why they be­lieve medic­i­nal cannabis would be of ben­e­fit to the pa­tient, and plans for on­go­ing mon­i­tor­ing; they must also pro­vide de­tails on the pro­posed medic­i­nal cannabis to be pre­scribed in­clud­ing the THC con­cen­tra­tion, cannabi­noid con­cen­tra­tion, com­po­si­tion and route of ad­min­is­tra­tion. Ap­proval, if given, is valid for only 12 months and the doc­tor is ex­pected to re­view the pa­tient at least once ev­ery three months.

Many doc­tors who work with chronic pain pa­tients find these reg­u­la­tions cum­ber­some and ex­ces­sive. Gold Coast­based gen­eral prac­ti­tioner Dr Mark Jef­fery has many chronic pain pa­tients whom he is try­ing to wean off opi­oids and be­lieves that Aus­tralia has an overly de­mand­ing process for pre­scrib­ing.

“A lot of the gov­ern­ment reg­u­la­tions just make no sense,” Jef­fery told me when I vis­ited his prac­tice. “For ex­am­ple cannabid­iol oil, which has been shown to help with pain, nau­sea and anx­i­ety, con­tains no THC which means it has no psy­choac­tive ef­fects, and it has been proven

Of the 31 med­i­cal prac­ti­tion­ers that have been granted au­thor­ity to pre­scribe medic­i­nal cannabis, only one has been a pain spe­cial­ist.

to be safe even in very high dosages. This is why the TGA clas­si­fies it as a Sched­ule 4 drug, the same as any stan­dard pre­scrip­tion med­i­ca­tion such as an­tibi­otics.

“De­spite this I still have to fill out reams of pa­per­work to ob­tain both Spe­cial Ac­cess Scheme and Queens­land Health ap­proval in or­der to pre­scribe it.

“It's no won­der that most doc­tors will just pre­scribe Panadeine Forte or Lyrica in­stead, which only re­quire stan­dard or stream­lined au­thor­ity scripts, even though they are drugs that are both ad­dic­tive and more dan­ger­ous,” he said.

The eth­i­cal dilemma

Re­cently there has been a stream­lin­ing of the ap­pli­ca­tion process to pre­scribe medic­i­nal cannabis for doc­tors in NSW, a move that the Col­lege of Gen­eral Prac­ti­tion­ers has wel­comed.

“For too long there has been too much po­lit­i­cal in­ter­fer­ence in pa­tient ac­cess to medic­i­nal cannabis,” col­lege pres­i­dent Dr Bas­tian Sei­del told newsgp in March this year.8 “If I have a pa­tient who has tried all stan­dard treat­ment op­tions with­out suc­cess, I should be able to con­sider pre­scrib­ing medic­i­nal cannabis as a vi­able treat­ment op­tion with­out hav­ing to wait months.”

How­ever, not all doc­tors are sup­port­ive of medic­i­nal mar­i­juana.

“The tri­als that have been done sug­gest that any ben­e­fits in chronic pain would be very modest and likely to be out­weighed by the harms,” Aus­tralian chronic pain spe­cial­ist and Fac­ulty of Pain Medicine Dean, Dr Chris Hayes, said when I spoke to him fol­low­ing his at­ten­dance at a Depart­ment of Health meet­ing on the use of cannabis for chronic pain. “More of­ten, treat­ing chronic pain is about stop­ping med­i­ca­tions, not adding med­i­ca­tions.”

Hayes es­ti­mates that about 20 per cent of pa­tients in his own clinic are tak­ing il­licit cannabis for their pain, and his clin­i­cal im­pres­sion is that it works poorly.

“Peo­ple take it in the hope that it might im­prove their pain or calm their men­tal health, but that's off-set by the fact that, from a men­tal health per­spec­tive, it might make things worse.”

Other doc­tors have a prag­matic per­spec­tive. Emer­gency medicine spe­cial­ist and lec­turer at the Aus­tralian Na­tional Univer­sity's med­i­cal school, Dr David Caldicott, teaches a course for doc­tors on medic­i­nal cannabis. He says there is lit­tle point ar­gu­ing whether cannabis can help with chronic pain.

“The more im­por­tant point is that peo­ple are us­ing it for pain,” he said. “There's still an aw­ful lot for us to know, but in the in­terim, if what­ever is out

Cannabid­iol oil, which has been shown to help with pain, nau­sea and anx­i­ety, con­tains no THC which means it has no psy­choac­tive ef­fects, and it has been proven to be safe even in very high dosages.

there, is be­ing used to good ef­fect, with min­i­mal harm to the in­di­vid­ual, it's prob­a­bly un­eth­i­cal and im­moral of us to pre­vent it hap­pen­ing.”

For the fore­see­able fu­ture, medic­i­nal cannabis in Aus­tralia will not be added to the Phar­ma­ceu­ti­cal Ben­e­fits Scheme, which means many Aus­tralians, even if they can be pre­scribed medic­i­nal mar­i­juana, may not be able to af­ford it. With this in mind, Caprio has founded a char­i­ta­ble or­gan­i­sa­tion that will work to pro­vide vul­ner­a­ble pa­tients such as vet­er­ans and pen­sion­ers with af­ford­able medic­i­nal cannabis.

“I got into this in­dus­try to make a dif­fer­ence,” he said. “I be­lieve it is a hu­man right to have ac­cess to a medicine that can help re­lieve a con­di­tion and it means the world to me to be able to sup­port this cause.”

I asked Caprio if he thought his fa­ther would be proud of what he has done so far.

Caprio paused. Then smiled. Yes,” he said. “Yes he would.”

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