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    Court of Appeal CA040556

    J.C. WordAssist Ltd.Head Office Toll Free 1-888-811-9882Nanaimo Branch Office 250-754-7822

    COURT OF APPEAL

    ON APPEAL FROM THE SUPREME COURT OF BRITISH COLUMBIA,

    FROM THE ACQUITTAL OF THE HONOURABLE MR. JUSTICE JOHNSTON,PRONOUNCED ON THE 10TH DAY OF JANUARY 2013.

    REGINA

    APPELLANT

    v.

    OWEN EDWARD SMITH

    RESPONDENT

    TRANSCRIPTVolume 5 (Pages 717 - 795)

    Public Prosecution Service of Canada W. Paul Riley900 - 840 Howe Street

    Vancouver, B.C. V6Z 2S9 CounselPhone: (604) 775-7475Fax: (604) 666-1599

    Solicitors for the Appellant

    Kirk Tousaw Kirk I. Tousaw1135 Fisher RoadCobble Hill, B.C. V0R 1L4 CounselPhone: (604) 836-1420

    Solicitor for the Respondent

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    Document1

    J.C. WordAssist Ltd.Head Office Toll Free 1-888-811-9882

    Victoria Office 250-477-8080

    149345-2Victoria Registry

    In the Supreme Court of British Columbia(BEFORE THE HONOURABLE MR. JUSTICE JOHNSTON)

    Victoria, B.C.January 16, 17, 18, 19, 20, 23, 24, 25, 26, 2012

    February 1, 6, 7, 8, 27, 28, 29, 2012March 1, 2012April 13, 2012

    January 10, 2013

    REGINA

    v.

    OWEN EDWARD SMITH

    PROCEEDINGS AT TRIAL

    Crown Counsel: P. EcclesK. Guest

    Defence Counsel: K. Tousaw

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    INDEX

    VOLUME 1PROCEEDINGS AT TRIAL - JANUARY 16, 2012

    Proceedings .......................................................................................................... 1

    WITNESSES FOR THE CROWNCOLIN BREWSTER ................................................................................ 12EXAMINATION IN CHIEF ON VOIR DIRE BY MR. ECCLES: ................. 12CROSS-EXAMINATION ON VOIR DIRE BY MR. TOUSAW: .................. 35

    WITNESSES FOR THE ACCUSEDLEON EDWARD SMITH .......................................................................... 42EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............... 43

    PROCEEDINGS AT TRIAL - JANUARY 17, 2012

    Proceedings ........................................................................................................ 76

    WITNESSES FOR THE ACCUSEDLEON EDWARD SMITH .......................................................................... 80EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............... 80

    CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 140

    PROCEEDINGS AT TRIAL - JANUARY 18, 2012

    Proceedings ...................................................................................................... 156

    VOLUME 2PROCEEDINGS AT TRIAL - JANUARY 19, 2012

    Proceedings ...................................................................................................... 157

    WITNESSES FOR THE ACCUSEDLEON EDWARD SMITH ........................................................................ 158CROSS-EXAM ON VOIR DIRE BY MR. ECCLES, CONTINUING: ....... 158RE-EXAMINATION ON VOIR DIRE BY MR. TOUSAW: ........................ 212GAYLE QUIN ......................................................................................... 217EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 218

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    PROCEEDINGS AT TRIAL - JANUARY 20, 2012

    Proceedings ...................................................................................................... 233

    WITNESSES FOR THE ACCUSEDGAYLE QUIN ......................................................................................... 242EXAM IN CHIEF ON VOIR DIRE BY MR. TOUSAW, CONTINUING: ... 243CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 270

    PROCEEDINGS AT TRIAL - JANUARY 23, 2012

    Proceedings ...................................................................................................... 288

    WITNESSES FOR THE ACCUSEDDAVID PATE ......................................................................................... 288EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 291

    VOLUME 3PROCEEDINGS AT TRIAL - JANUARY 24, 2012

    Proceedings ...................................................................................................... 352

    WITNESSES FOR THE ACCUSED

    DAVID PATE ......................................................................................... 352EXAM IN CHIEF ON VOIR DIRE BY MR. TOUSAW, CONTINUING: ... 352CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 356RE-EXAMINATION ON VOIR DIRE BY MR. TOUSAW: ........................ 429

    PROCEEDINGS AT TRIAL - JANUARY 25, 2012

    Proceedings ...................................................................................................... 435

    WITNESSES FOR THE ACCUSEDSANDRA LARGE .................................................................................. 435

    EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 435CROSS-EXAMINATION ON VOIR DIRE BY MS. GUEST: ................... 459GIOCONDA HERMAN ........................................................................... 471EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 471

    PROCEEDINGS AT TRIAL - JANUARY 26, 2012

    Proceedings ...................................................................................................... 495

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    WITNESSES FOR THE ACCUSED

    GIOCONDA HERMAN ........................................................................... 495EXAM IN CHIEF ON VOIR DIRE BY MR. TOUSAW, CONTINUING: ... 495CROSS-EXAMINATION ON VOIR DIRE BY MR. ECCLES: ................. 499RUTH ARTHURS................................................................................... 511EXAMINATION IN CHIEF ON VOIR DIRE BY MR. TOUSAW: ............. 511CROSS-EXAMINATION ON VOIR DIRE BY MS. GUEST: ................... 524

    PROCEEDINGS AT TRIAL - FEBRUARY 1, 2012

    Proceedings ...................................................................................................... 532

    VOLUME 4PROCEEDINGS AT TRIAL - FEBRUARY 6, 2012

    Proceedings ...................................................................................................... 537

    WITNESSES FOR THE CROWNHANAN ABRAMOVICI .......................................................................... 539EXAMINATION IN CHIEF ON VOIR DIRE BY MR. ECCLES: ............... 539CROSS-EXAMINATION ON VOIR DIRE BY MR. TOUSAW: ................ 556

    PROCEEDINGS AT TRIAL - FEBRUARY 7, 2012

    Proceedings ...................................................................................................... 619

    WITNESSES FOR THE CROWNHANAN ABRAMOVICI .......................................................................... 619CROSS-EXAM BY MR. TOUSAW ON VOIR DIRE, CONTINUING: ...... 619

    VOLUME 5PROCEEDINGS AT TRIAL - FEBRUARY 8, 2012

    Proceedings ...................................................................................................... 717

    WITNESSES FOR THE CROWNHANAN ABRAMOVICI .......................................................................... 717CROSS-EXAM BY MR. TOUSAW ON VOIR DIRE, CONTINUING: ...... 717RE-EXAMINATION BY MR. ECCLES ON VOIR DIRE: ......................... 738

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    PROCEEDINGS AT TRIAL - FEBRUARY 27, 2012

    Proceedings ...................................................................................................... 783

    PROCEEDINGS AT TRIAL - FEBRUARY 28, 2012

    Proceedings ...................................................................................................... 784

    PROCEEDINGS AT TRIAL - FEBRUARY 29, 2012

    Proceedings ...................................................................................................... 785

    PROCEEDINGS AT TRIAL - MARCH 1, 2012

    Proceedings ...................................................................................................... 786

    PROCEEDINGS AT TRIAL - APRIL 13, 2012

    Proceedings ...................................................................................................... 787

    PROCEEDINGS AT TRIAL - JANUARY 10, 2013

    Proceedings ...................................................................................................... 791

    EXHIBITS

    EXHIBITS ON VOIR DIREEXHIBIT 1: Admissions filed January 16, 2012 ............................................. 3EXHIBIT 1-A: Amended Admissions filed January 17, 2012 ........................... 76EXHIBIT 2: Crown's Book of Photographs ................................................... 14EXHIBIT 3: Victoria Police Department Exhibit Flow Chart .......................... 17EXHIBIT 4.1: Original Analyst Report No. 09 14838 V ................................... 30EXHIBIT 4.2: Original Analyst Report No. 09 14835 V ................................... 30

    EXHIBIT 4.3: Original Analyst Report No. 09 14839 V ................................... 30EXHIBIT 4.4: Original Analyst Report No. 09 14803 V ................................... 30EXHIBIT 4.5: Original Analyst Report No. 09 14804 V ................................... 30EXHIBIT 4.6: Original Analyst Report No. 09 14805 V ................................... 30EXHIBIT 4.7: Original Analyst Report No. 09 14806 V ................................... 30EXHIBIT 4.8: Original Analyst Report No. 09 14807 V ................................... 30EXHIBIT 4.9: Original Analyst Report No. 09 14808 V ................................... 30EXHIBIT 4.10: Original Analyst Report No 09 14809 V .................................... 30

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    EXHIBIT 4.11: Original Analyst Report No. 09 14810 V ................................... 31

    EXHIBIT 4.12: Original Analyst Report No. 09 14811 V ................................... 31EXHIBIT 4.13: Original Analyst Report No. 09 14812 V ................................... 31EXHIBIT 4.14: Original Analyst Report No. 09 14813 V ................................... 31EXHIBIT 4.15: Original Analyst Report No. 09 14814 V ................................... 31EXHIBIT 4.16: Original Analyst Report No. 09 14815 V ................................... 31EXHIBIT 4.17: Original Analyst Report No. 09 14816 V ................................... 31EXHIBIT 4.18: Original Analyst Report No. 09 14817 V ................................... 31EXHIBIT 4.19: Original Analyst Report No. 09 14818 V ................................... 31EXHIBIT 4.20: Original Analyst Report No. 09 14819 V ................................... 31EXHIBIT 4.21: Original Analyst Report No. 09 14820 V ................................... 31EXHIBIT 4.22: Original Analyst Report No. 09 14821 V ................................... 31

    EXHIBIT 4.23: Original Analyst Report No. 09 14822 V ................................... 31EXHIBIT 4.24: Original Analyst Report No. 09 14823 V ................................... 31EXHIBIT 4.25: Original Analyst Report No. 09 14824 V ................................... 31EXHIBIT 4.26: Original Analyst Report No. 09 14825 V ................................... 31EXHIBIT 4.27: Original Analyst Report No. 09 14826 V ................................... 32EXHIBIT 4.28: Original Analyst Report No 09 14827 V .................................... 32EXHIBIT 4.29: Original Analyst Report No. 09 14828 V ................................... 32EXHIBIT 4.30: Original Analyst Report No. 09 14829 V ................................... 32EXHIBIT 4.31: Original Analyst Report No. 09 14830 V ................................... 32EXHIBIT 4.32: Original Analyst Report No. 09 14831 V ................................... 32EXHIBIT 4.33: Original Analyst Report No. 09 14832 V ................................... 32

    EXHIBIT 4.34: Original Analyst Report No. 09 14833 V ................................... 32EXHIBIT 4.35: Original Analyst Report No. 09 14834 V ................................... 32EXHIBIT 4.36: Original Analyst Report No. 09 14836 V ................................... 32EXHIBIT 4.37: Original Analyst Report No. 09 14837 V ................................... 32EXHIBIT 4.38: Original Analyst Report No. 09 14840 V ................................... 32EXHIBIT 4.39: Original Analyst Report No. 09 14841 V ................................... 32EXHIBIT 4.40: Original Analyst Report No. 09 14842 V ................................... 32EXHIBIT 4.41: Original Analyst Report No. 09 14843 V ................................... 32EXHIBIT 5: DVD containing scene video images......................................... 34EXHIBIT 6: City of Victoria Proclamation "International Medical Marijuana

    Day" ........................................................................................ 112

    EXHIBIT 7: Letter from Office of the Mayor of Victoria, B.C. to TonyClement dated March 20, 2006 ............................................... 116

    EXHIBIT 8: Letter to Leon Smith from Susan Fletcher, July 27, 2005 ....... 117EXHIBIT 9: Letter from Leon "Ted" Smith to Susan Fletcher dated

    January 4, 2006 ...................................................................... 119EXHIBIT 10: Letter to Ujjal Dosanjh from Leon "Ted" Smith dated

    February 3, 2005 ..................................................................... 121

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    EXHIBIT 11: Letter to Leon Smith from Beth Pieterson, dated

    February 24, 2006 ................................................................... 124EXHIBIT 12: Letter to Tony Clement from Leon "Ted" Smith dated

    August 1, 2006 ........................................................................ 128EXHIBIT 13: Letter to Leon Smith from Susan Russell dated

    September 26, 2006................................................................ 130EXHIBIT 14: Letter to Tony Clement from Leon "Ted" Smith dated

    January 3, 2007 ...................................................................... 133EXHIBIT 15: Letter to Leon "Ted" Smith from Ronald Denault dated

    2008-06-03 .............................................................................. 137EXHIBIT 16: Letter to Tony Clement on International Hempology 101

    Society letterhead dated December 4, 2007 (was Exhibit B

    for identification) ...................................................................... 139EXHIBIT 17: Cannabis Buyers' Club of Canada informational pamphlet ..... 176EXHIBIT 18: Cannabis Buyers' Club of Canada - Medicinal Cannabis

    Recipe Book ............................................................................ 258EXHIBIT 19: Breast imaging report - exam date 18-Apr-2011 ..................... 260EXHIBIT 20: Histopathology Report for Gayle Quin..................................... 261EXHIBIT 21: Prescription sheet from Dr. Roland Graham dated

    November 28, 1997................................................................. 261EXHIBIT 22: Urine Toxic Metals report of Dr. Peter Nunn dated

    August 12, 2002 ...................................................................... 262EXHIBIT 23: Letter from Dr. Kristen Bovee dated January 6, 2012 ............. 266

    EXHIBIT 24: Package of documents including original affidavit of Dr. Pate,curriculum vitae, list of publications and two studies ............... 290

    EXHIBIT 25: Colour photograph of close-up depicting female flower ofcannabis plant ......................................................................... 301

    EXHIBIT 26: Macro colour photograph of close-up of leaf surface .............. 302EXHIBIT 27: Macro photograph depicting isolated trichomes ...................... 319EXHIBIT 28: 1 page photocopy of prescriptions prescribed to Sandra

    Large ....................................................................................... 455EXHIBIT 29: 5-page document from St. Joseph's Health Care entitled,

    "Regional Evaluation Centre Multidisciplinary Health CareAssessment ............................................................................ 472

    EXHIBIT 30: Document from St. Joseph's Health Care, RegionalEvaluation Centre Multidisciplinary Health Care

    Assessment - Final.................................................................. 476EXHIBIT 31: Copy of report from St. Joseph's Health Care dated

    March 28, 2002 ....................................................................... 476EXHIBIT 32: 3-page letter dated May 7, 2004 addressed to Dr. Patricia

    Morley-Forster ......................................................................... 478

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    EXHIBIT 33: 1-page copy of document from London Health Services

    dated July 22, 2004 ................................................................. 484EXHIBIT 34: 1-page document from Vancouver Island Health Authority

    dated May 6, 2009 .................................................................. 485EXHIBIT 35: 3-page copy of fax dated May 11, 2005 from Dr. Laurence

    Jerome Re: Gina Herman ....................................................... 487EXHIBIT 36: 1-page document of Prescription Authorization Request

    printed on January 20, 2012 re Herman, Gioconda ................ 488EXHIBIT 37: 4-page copy of document entitled Form B1 ............................ 493EXHIBIT 38: Copy of letter from Dr. Grimwood to Mr. Brooks re Ruth Ann

    Arthurs dated April 15, 2010 ................................................... 515EXHIBIT 39: 1-page copy of assessment form for Life Mark

    Physiotherapy re Ruth Arthurs dated March 17, 2010 ............ 517EXHIBIT 40: Affidavit of Hanan Abramovici ................................................ 556EXHIBIT 41: "Multicenter, double-blind, randomized, placebo-controlled,

    parallel-group study of the efficacy, safety, and tolerability ofTHC:CBD extract and THC extract in patients with intractablecancer-related pain" ................................................................ 721

    EXHIBIT 42: "Adverse effects of medicinal cannabinoids: a systematicreview" .................................................................................... 726

    EXHIBIT 43: Large cerlox bound volume, affidavit of Eric Ormsby .............. 755EXHIBIT 44: Curriculum vitae of Eric Ormsby ............................................. 765

    EXHIBITS FOR IDENTIFICATION ON VOIR DIREEXHIBIT A: Cannabis Buyers' Club of Canada, Product Guide ................. 102EXHIBIT B: Letter to Tony Clement on International Hempology 101

    Society letterhead dated December 4, 2007 ........................... 136EXHIBIT C: Binder of Health Canada MMAR information .......................... 194EXHIBIT D: Affidavit of Dr. Harold Kalant sworn April 3, 2008 ................... 412

    RULINGS

    Plea ...................................................................................................................... 2Ruling re re Ban on Publication .......................................................................... 10Order re Exclusion of Witnesses ......................................................................... 11Ruling re admissibility of document .................................................................. 100Ruling re admissibility of document .................................................................. 115Ruling re admissibility of document .................................................................. 119Ruling re admissibility of question on re-examination ....................................... 214Ruling re Qualification of Witness re Pate ........................................................ 291

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    [RULING RE ADJOURNMENT APPLICATION] ............................................... 533

    Ruling re Qualification of Witness re Abramovici .............................................. 538Ruling on Voir Dire ............................................................................................ 787Ruling on Voir Dire ............................................................................................ 788Re-Election ....................................................................................................... 791Plea .................................................................................................................. 794Reasons for Judgment re Acquittal ................................................................... 795

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    717VOIR DIREProceedings

    Victoria, B.C.1February 8, 20122

    3THE CLERK: In the Supreme Court of British Columbia,4

    this Wednesday, the 8th day of February, 2012,5calling the matter of Her Majesty the Queen6against Owen Edward Smith.7

    8

    HANAN ABRAMOVICI9recalled, warned.10

    11

    THE CLERK: Witness, I remind you, having been12previously affirmed, you're still under13affirmation.14

    THE COURT: Be seated, Dr. Abramovici. Mr. Tousaw?15MR. TOUSAW: Thank you, My Lord.16

    17

    CROSS-EXAM BY MR. TOUSAW ON VOIR DIRE, CONTINUING:1819

    Q Doctor, I'm going to pass you a study titled20Volume 39, No. 2, February 2010, originally21published in the Journal of Pain and Symptom22Management, and the title of the study is23"Multicenter, double-blind, randomized, placebo-24controlled, parallel-group study of the efficacy,25safety, and tolerability of THC:CBD extract and26

    THC extract in patients with intractable cancer-27 related pain." Do you see that?28A I do.29Q And you've read that study before, haven't you?30A I believe so.31Q It's cited in the "Information for Health Care32

    Practitioners" article at 190?33A Yes.34Q And that is a study, just reading from the35

    abstract, that compared the efficacy of a THC:CBD36extract, essentially Sativex, with a THC extract37and with placebo in relief of patients38experiencing advanced cancer pain, correct?39

    A That's correct.40Q According to the abstract, 177 patients with41

    cancer pain who were not experiencing adequate42analgesia despite their use of chronic opioid43dosing entered the trial, and it was a two-week44trial, correct?45

    A Yes.46Q Sixty of those patients were given the THC:CBD47

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    718VOIR DIREHanan Abramovici (for Crown)cross-exam by Mr. Tousaw

    extract, 58 were given the THC extract, and 591were given placebo, correct?2

    A Yes.3Q The abstract says that:4

    5

    The primary analysis of change from baseline6in mean pain Numerical Rating Scale (NRS)7score was statistically significantly in8favor of THC:CBD compared with placebo . . .9

    10

    And then gives a ratio of improvement, correct?11A Yes.12Q And that's essentially concluding that the THC:CBD13

    extract worked in a manner that the placebo didn't14

    work in a way that's significant, statistically15significant?16

    A Yes.17Q Outside of the margin of error of these types of18

    tests, correct?19A Yes.20Q It goes on to read that:21

    22

    . . . the THC group showed a nonsignificant23change.24

    25

    Correct?26

    A Yes.27 Q The abstract continues that:2829

    Twice as many patients taking THC:CBD30showed a reduction of more than 30% from31baseline pain NRS score when compared with32placebo . . .33

    34

    Correct?35A Yes.36Q And this is a statistically significant ratio:37

    38

    . . . whereas the number of THC group39responders was similar to placebo.40

    41

    Correct?42A That's what it says, yes.43Q And that does not reach statistical significance,44

    correct?45A Yes.46Q This study provides some clinical evidence47

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    719VOIR DIREHanan Abramovici (for Crown)cross-exam by Mr. Tousaw

    supporting the hypothesis that, at least for some1patients, patients in this double-blind placebo-2

    controlled study, the THC:CBD combination was more3efficacious than both placebo and the THC alone4combination, correct?5

    A That's what this study reports.6Q Yes, and this study provides at least some level7

    of support for the hypothesis advanced by Dr. Pate8and Dr. Russo that there is potentially a9synergistic or enhancing effect between THC and10CBD that may not be experienced in people taking11THC alone, correct?12

    A Partially. I believe the article by Dr. Russo was13speaking about phytocannabinoid-terpenoid14

    synergy. This is cannabinoid to cannabinoid15interaction.16

    Q And you're aware that the Sativex, the THC:CBD17extract, the whole plant extract, it also contains18terpenes, correct?19

    A Yes, that's my understanding.20Q The conclusion of the study, however, is specific21

    to THC:CBD and with respect to that particular22interaction between THC:CBD this study provides23some clinical scientific evidence that the24hypothesis that CBD may have an enhancing effect25on THC's analgesic properties or vice-versa, that26

    has some support in the clinical evidence,27 according to this study, correct?28A I would be cautious about this study because it29

    says on the bottom left-hand side the study was30sponsored by GW Pharma, and sometimes that calls31into question the value of the scientific article32because it's supported by industry.33

    Q As we talked about, there may be some bias34depending on the source of information, correct?35

    A That's correct.36Q Now, this was published in the Journal of Pain and37

    Symptom Management, correct?38A That's what it says, yes.39Q Are you aware of any suggestion that the Journal40

    of Pain and Symptom Management is not a reputable41publication?42

    A I wouldn't off the top of my head, no.43Q And this appears to be a -- this would be a study44

    that's been peer-reviewed, correct?45A Presumably, yes.46Q Or it wouldn't be published in a journal of this47

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    720VOIR DIREHanan Abramovici (for Crown)cross-exam by Mr. Tousaw

    nature, correct?1A That's what I would assume, yes.2

    Q And, of course, the approval of Sativex with3conditions in Canada is largely based on studies4conducted by GW Pharmaceuticals, correct?5

    A Yes.6Q So this is part of the evidentiary backdrop, this7

    and studies like it would be part of the8evidentiary backdrop that Health Canada would9accept in approving a substance for marketing and10sale in Canada, correct?11

    A Potentially. I don't have familiarity with that12approval process, so I can't really comment13meaningfully on it.14

    Q Other than the caution, be careful of the source,15I am correct in suggesting that this provides some16clinical evidence supporting the hypothesis that17THC and CBD in combination at least for some18patients may be more efficacious in reducing19analgesia?20

    A Well, on the second page, on page 168 it actually21says that THC and CBD showed a worsening in nausea22and vomiting compared with placebo.23

    Q Yes, but I'm speaking of analgesia, correct?24A Well, for analgesia it may have had a beneficial25

    effect, but it had a worsening effect on nausea26

    and vomiting.27 Q Yes, but when I ask you about analgesia, I'm28speaking of analgesia. You understand that to be29not nausea and vomiting, correct?30

    A I understand.31Q Yes, and it's not that it may have, it did, it did32

    have a statistically significant increased33analgesic effect over both THC and placebo in this34gold standard double-blind randomized placebo-35controlled parallel group study, correct?36

    A According to this study, yes.37Q And you cited this study in your "Information for38

    Health Care Practitioners" document, correct?39A I did.40MR. TOUSAW: Rather than take you through the document41

    in great detail, I am going to ask that it be42marked as Exhibit 41 in these proceedings.43

    THE COURT: Exhibit 41.44THE CLERK: Exhibit 41, My Lord.45

    46

    47

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    721VOIR DIREHanan Abramovici (for Crown)cross-exam by Mr. Tousaw

    EXHIBIT 41 (on voir dire): "Multicenter,1double-blind, randomized, placebo-controlled,2

    parallel-group study of the efficacy, safety,3and tolerability of THC:CBD extract and THC4extract in patients with intractable cancer-5related pain"6

    7

    MR. TOUSAW:8Q Page 175 of Exhibit 41, Doctor, there --9THE COURT: He doesn't have it.10MR. TOUSAW: I apologize, My Lord.11A I'm sorry, what page?12Q Page 175.13A Yes.14

    Q There's a discussion of safety and tolerability,15correct?16

    A Yes.17Q And the first sentence is:18

    19

    The active compounds were generally well20tolerated, and no safety concerns were21identified during this study.22

    23

    Correct?24A And it goes on to discuss some of the treatment25

    related adverse effects being reported by about 6026

    percent of patients, that the common treatment27 related adverse effects were similar to those in28other THC:CBD trials; sleepiness, dizziness,29nausea, mostly mild to moderate severity, correct?30

    A That's what it says there, yes.31Q Some people died in the study group, but that was32

    considered to be because of the progression of33their disease, serious cancer, as opposed to the34actual treatment being administered, that's35correct, isn't it?36

    A That's what it says, yes.37THE COURT: Just before you go any further, there's38

    somewhere in this document that identifies AE as39adverse effect?40

    MR. TOUSAW: There is, My Lord. I apologize. I'm not41sure of the exact page.42

    Q But you understand AE to be adverse effect?43A I do.44Q And that's a common usage of the term in the45

    literature, correct?46A It is.47

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    722VOIR DIREHanan Abramovici (for Crown)cross-exam by Mr. Tousaw

    THE COURT: Thank you.1MR. TOUSAW: Thank you, My Lord. And I do see it's2

    defined, My Lord, at page 170, right-hand column,3first full paragraph.4

    Q Now, on page 170 there's a figure, Figure 1, study5design, that's essentially a flowchart?6

    A Yes.7Q And it explains the process of people moving8

    through the study, for lack of a better word,9correct?10

    A That's correct.11Q And they screened 192 people, they randomized, of12

    that screening they randomized out and accepted13into the study 177 people, split those into the14

    three groups of the numbers we've advised, and15then there's a completion number for the number of16people that completed the study, correct?17

    A That's correct.18Q And it appears that there were essentially 1219

    people that withdrew from the THC:CBD portion, 1320people that withdrew from the THC potion, and21eight that withdrew from the placebo portion, and22the explanation for those withdrawals or at least23general categories of the reasons for those24withdrawals are given in those boxes, correct?25

    A I believe so, yes.26

    Q And we know that because a number of patients27 passed away during the course of the study, that28was described that we just went over as an adverse29event, not a treatment related adverse event, but30that's going to explain a number of these31withdrawals?32

    A It could, yes.33Q Those are my questions on Exhibit 41. I'll put34

    another study in front of the witness. Doctor,35I've put before you a study titled "Adverse36effects of medical cannabinoids: a systematic37review". At the bottom of page 1 it appears that38this study appeared in the Canadian Medical39Association Journal June 17, 2008, Volume 178. Do40you see that?41

    A I do.42Q Have you seen this study before?43A It looks familiar.44Q And the Canadian Medical Association Journal is45

    commonly referred to as CMAJ, correct?46A That's correct.47

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    723VOIR DIREHanan Abramovici (for Crown)cross-exam by Mr. Tousaw

    Q And that's a publication put out by the Canadian1Medical Association, correct?2

    A It is.3Q And that's a publication that puts out peer-4

    reviewed research for the consumption by members5of the CMAJ and others, correct?6

    A I believe so, yes.7Q I'll direct your attention to the abstract of this8

    research paper, and this is on page 1, My Lord.9It gives the background which is essentially that10the therapeutic use of cannabis and cannabis-based11medicines raises safety concerns for a variety of12stakeholders and that most safety information13comes from studies of recreational use. That's a14

    fair assessment, isn't that correct?15A I would say so, yes.16Q And describes the methodology, and the methodology17

    of this study appears to be a systematic review of18safety studies published over the past 40 years,19correct?20

    A That's what it says, yes.21Q And that's the kind of systematic review of the22

    literature that we described earlier in your23testimony, similar to what you conducted in24putting together the "Information for Health Care25Professionals" document, correct?26

    A Correct.27 Q Under the "Results" category we see that they28found 321 articles eligible for evaluation. They29then excluded the ones that focused on30recreational use and included in the final31analysis 31 studies, 23 randomized controlled32trials and eight observational studies, correct?33

    A Mm-hmm, yes.34MR. ECCLES: I'm sorry, My Lord, that's not quite what35

    it says. What it says is:3637

    After excluding those that focused on38recreational cannabis use, we included . . .39

    40

    So of the 321 articles, 31 were non-recreational41use. That's not quite how my friend put it to the42witness.43

    MR. TOUSAW:44Q I think that's precisely what I said, but if45

    there's some confusion in my friend's mind about46that, there were 321 articles that were eligible47

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    and they excluded the recreational cannabis ones,1correct?2

    A That's what I understand.3Q That's what they're saying. And they included 314

    studies, presumably non-recreational cannabis use5studies, correct?6

    A That's my understanding, yes.7Q Twenty-three of those were randomized controlled8

    trials. They describe the median duration of the9exposure being two weeks, and the range being10eight hours to 12 months, correct?11

    A Yes.12Q And in the results they indicate that there were13

    4,779 adverse effects reported among participants14

    and that most, 4,615 or 96.6 percent were not15serious. Do you see that?16

    A That's what it says.17Q You don't have any reason sitting here today to18

    dispute that those were, in fact, the findings19made by the authors of this study, correct?20

    A No, but I would want to know what "not serious" is21defined as.22

    Q And that may well appear in the study, correct?23A Yes.24Q The abstract goes on to indicate that there were25

    of the 164 serious adverse events, most common26

    were relapse of multiple sclerosis, correct?27 A Yes.28Q Vomiting and urinary tract infections, correct?29A That's right.30Q And that the rate of nonserious adverse events was31

    higher among participants than among controls,32correct?33

    A That's what it says.34Q And then in terms of what they are describing at35

    least as nonserious adverse events, dizziness was36the most common such event?37

    A That's what it says, yes.38Q This provides at least some scientific basis for39

    interpreting some of the risks associated with40cannabinoid therapy, correct?41

    A Short-term risks.42Q And it's clear from the abstract that they're43

    talking about studies of relatively short44duration, correct?45

    A Yes, but it's important to look at the46interpretation that they provide there as well.47

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    Q Table 1 describes -- and that's on page 1672, My1Lord, numbered in the bottom left corner. Table 12

    describes essentially the different randomized3control trials that were reviewed. You see that,4correct?5

    A I do, yes.6Q And Table 2 which appears on page 1674 in the7

    bottom left corner describes at least what these8authors consider to be serious adverse effects,9correct?10

    A Yes.11Q And there were serious adverse effects reported12

    not just among people exposed to cannabinoids but13also amongst the control group, correct?14

    A That's right.15Q And so just by way of example, in terms of one of16

    the major headings, nervous system disorders, it's17about halfway down the table, 25 out of 16418persons exposed to cannabinoids or 15.2 percent19reported a serious adverse nervous system20disorder, and 18 out of 60 or 30 percent of the21controls reported a similar nervous system22disorder, correct?23

    A That's right.24Q And so what we don't have in this particular table25

    at least is a determination of whether or not the26

    serious adverse effects were necessarily caused by27 the cannabinoid exposure because, in fact, at28least for nervous system disorders it appears that29a greater percentage of persons in the control30group experienced those serious adverse effects?31Just for that particular heading. I don't propose32to take you through each category. I think the33document speaks for itself.34

    A I'm just a little confused because when I look at35cannabinoid exposure under nervous system36disorders, it reports 25 percent and under37controls 18 percent.38

    Q I think you're reading it perhaps incorrectly.39It's 25 is the number, 15 percent in parenthetical40and --41

    A Oh, I see, thank you.42Q Does that clear that up for you?43A Thank you, yes.44Q So at least with respect to that particular45

    category, a greater percentage of people in the46control group experienced a serious adverse47

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    nervous system disorder event than the people in1the cannabinoid group? That's a fair2

    interpretation of that particular category?3A For that particular category, yes.4Q And each category has varying numbers, and again I5

    don't propose to take you to each of them, but it6says what it says and you have no reason to7dispute this, falsified or not accurate in any8way?9

    A No.10Q Table 3 on page 1675 in the bottom right corner11

    again speaks to the nonserious adverse events and12same type of table, gives you the number of people13experiencing it out of the group and the14

    percentage in parentheticals afterwards, both for15the people exposed to cannabinoids and for the16control groups, correct?17

    A That's right.18MR. TOUSAW: My Lord, I'd ask that this be entered as19

    Exhibit 42 in these proceedings.20THE COURT: Exhibit 42.21

    22

    EXHIBIT 42 (on voir dire): "Adverse effects23of medicinal cannabinoids: a systematic24review"25

    26

    MR. TOUSAW:27 Q One of the studies that you cite in your affidavit28is a study called "Science of Marihuana" from the29year 2000, the author being Iversen, correct?30

    A That's right.31Q And that's a fairly lengthy document, some 30232

    pages, correct?33A Potentially. It's a book.34Q If I said to you -- yes, it's a book?35A It's a book.36Q One of the -- and I'm not going to put the book to37

    you, I don't propose to enter it as an exhibit, My38Lord, but one of the things that's reported in39Iversen is a quote from the Institute of Medicine40report from 1999, a report called "Marihuana and41medicine". Are you familiar with that report?42

    A I am.43Q And the quote from Iversen, I'm just going to give44

    you the quote, then I'm going to ask if you agree45with it. The quote from Iversen, including the46quote from the Institute of Medicine is [as read47

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    in]:12

    In all instances including the use of smoked3marihuana more properly controlled clinical4trials are needed and research in improved5means of delivering the drug is also a high6priority. The Institute of Medicine (1999)7in their report 'Marihuana and medicine'8summarized the safety issues succinctly:9

    10

    And here is the quote that I'm going to ask you11about:12

    13

    Marihuana is not a completely benign14

    substance. It is a powerful drug with a15variety of effects. However, except for the16harms associated with smoking, the adverse17effects of marihuana use are within the range18of effects tolerated for other medications.19

    20

    Do you have that quote?21A I remember -- I think I remember reading it or22

    seeing it, yes.23Q Do you agree with that quote from the Institute of24

    Medicine that:2526

    . . . except for the harms associated with27 smoking, the adverse effects of marihuana use28are within the range of effects tolerated for29other medications.30

    31

    A I would agree with it generally, but I think that32because we don't have enough -- we haven't carried33out enough clinical studies, it's hard to say. We34don't know.35

    Q Because clinical studies tend to be of relatively36short duration, correct?37

    A They can be. They can be a longer duration.38There's --39

    Q And at least as we -- excuse me. I didn't mean to40interrupt you.41

    A I'm sorry. I think it's also what was lacking42perhaps in 2000 were epidemiological studies43looking at population-wide effects of the use of44cannabis or specifically the medicinal uses of45cannabis and their adverse effects on patient46populations.47

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    Q In terms of the adverse effects that we know, even1sitting here today, about the effects of marihuana2

    use, cannabis use or cannabinoid use, those3adverse effects are within the range of effects4tolerated for other medications that are approved5for sale in Canada, aren't they?6

    A Some of them, yes, some of the effects.7Q And we've talked about many of the effects. I8

    don't propose to go over it again. Are you aware9of any studies analyzing the potential long-term10effects of chronic medicinal cannabis use?11

    A I don't think there are that many studies out12there. There's maybe one that I remember seeing13about -- I think it was a study looking at chronic14

    ingestion of cannabis by patients with MS and15their cognitive -- the effect on cognition, I16think, is probably the only study that comes to17mind.18

    Q In the course of your research in updating the19Health Canada "Information for Health Care20Professionals" document or in preparing to testify21today, did you happen to come across and review a22paper titled "Chronic cannabis use in the23compassionate investigational new drug program.24an examination of the benefits and adverse effects25of legal clinical cannabis", authored by Dr.26

    Russo, Mary Lynn Mathre, Al Byrne, Rob Velin,27 Paul Bach, Juan Sanchez-Ramos, and Kristin Kirlin?28Are you familiar with that?29

    A Nothing comes to mind.30Q And so if I said to you that that was essentially31

    a study that examined -- well, are you aware of32what the compassionate investigational new drug33program is?34

    A I'm not.35Q And if I indicated to you that the study that I'm36

    referencing was an investigation into persons that37had been receiving pre-rolled cannabis cigarettes38for greater than 20 years from the U.S. government39under the auspices of the National Institute for40Drug Abuse and the compassionate investigational41new drug program is the U.S. government's program42that provides marihuana to a very limited number43of patients and has done for a couple of decades,44are you aware of that generally, that program?45

    A Not really, no.46Q I will have no questions on that study. In terms47

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    of Exhibit 40 --1THE COURT: Does he have Exhibit 40?2

    THE CLERK: Yes, My Lord.3MR. TOUSAW:4Q I'm going to ask you to direct your attention to5

    paragraph 44 of that study, and in paragraph --6THE COURT: What part of Exhibit 40 are you --7MR. TOUSAW: Paragraph 44, it's in the conclusory8

    section, My Lord. It's the --9THE COURT: His affidavit.10MR. TOUSAW: The affidavit, yes, it's one of the11

    paragraphs written by Suzanne Desjardins.12THE COURT: Yes.13MR. TOUSAW:14

    Q In terms of paragraph 44, do you have that before15you?16

    A I do.17Q Your superior at Health Canada, Suzanne18

    Desjardins, wrote that [as read in]:1920

    Products made by persons who do not have the21capacity to perform laboratory, pre-clinical22and clinical studies such as those mentioned23above . . .24

    25

    -- and she mentions some above in the previous26

    paragraph --2728

    . . . are of unknown composition and quality29and hence may pose additional risks to users.30

    31

    Do you see that?32A I do.33Q That is a speculative statement, isn't it?34A I would agree with that statement.35Q But it's a speculative statement? She uses what36

    we described as careful language, that it may pose37additional risks. It's a speculative statement,38isn't it?39

    A Well, I think the reason that we carry out those40tests, people and companies carry out those tests41is to ensure that it's safe.42

    Q Or to at least ensure that it's within the safety43margins to the best of one's ability because44there's no guarantees of safety, of course?45

    A Well, I think there are certain rules and46regulations governing acceptable limits of certain47

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    contaminants or chemicals within certain products,1and it's based on many years of research and rules2

    and regulations and I think those -- you know,3when you bring a product to market, I think,4whether it's a toothpaste or something else, I5think it has to conform to certain standards.6That's my understanding at least.7

    Q And those are the rules and regulations that a few8moments ago you said you don't have any particular9expertise in, correct?10

    A I don't, but it's -- I think it's general11knowledge.12

    Q But with respect to the statement that I'm asking13about, that these products may pose additional14

    risks, that's a speculative statement, that's not15a definitive statement, is it?16

    A That's correct.17Q And you sitting here today don't have any evidence18

    that the products made and sold by the Cannabis19Buyers' Club of Canada have caused any harm to any20consumer, correct?21

    A I personally would not know.22Q And in your conversations with Ms. Desjardins she23

    didn't advise you that she had any personal24knowledge of any harm that's come to the consumers25of the baked goods and topical oils made by the26

    Cannabis Buyers' Club of Canada, correct?27 A That's correct.28Q At paragraph 45 of Exhibit 40, the affidavit,29

    again Suzanne Desjardins writes that essentially30there are good reasons for pharmaceuticals to31undergo lengthy and expensive processes that they32undergo before being authorized for sale and that33no cannabis-based products except for Sativex and34no cannabinoid products except for Marinol and35Cesamet have gone through those processes and36received notices of compliance. Similarly, the37cannabis being currently produced -- you see that38quote, yes?39

    A I do.40Q It's the case, isn't it, that the cannabis41

    currently produced by persons with licences to42produce cannabis issued by Health Canada, that43cannabis does not go through any extensive44analysis and is also not the subject of a notice45of compliance, correct?46

    A That's because from my understanding marihuana is47

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    not an approved therapeutic product in Canada.1Q Regardless of what your understanding is of why2

    that's not occurring, it is the case that the3cannabis that Health Canada authorizes people to4grow or to grow for others does not go through the5lengthy and expensive processes that are described6in the affidavit and has not been issued a notice7of compliance, correct?8

    A Yes.9Q And the cannabis being produced under contract for10

    the Government of Canada and being sold by Health11Canada to authorized persons, that too has not12received a notice of compliance, correct?13

    A It has not received a notice of compliance, no.14

    Q Paragraph 46, the final paragraph in the affidavit15Exhibit 40, Ms. Desjardins writes that:16

    17

    In the absence of any scientific evidence18that cannabis-based products such as oils,19ointments, baked goods, et cetera, bring any20additional therapeutic benefits over those of21marihuana (plant material) and in the22presence of significant safety risks23associated with the production of some of24these products as well as the additional25potential health risks associated to the26

    unknown composition, characterization and27 effects of these products, authorizing their28use in Canada would not be recommended.29

    30

    Do you see that quote?31A I do.32Q That's an overstated conclusion, isn't it?33A Not in my opinion.34Q There is scientific evidence, perhaps not clinical35

    evidence, but there is scientific evidence derived36from lab and animal studies that cannabis-based37products can, in fact, be more effective with a38lesser chance of negative side effects than smoked39cannabis, isn't there?40

    A Not exactly.41Q There's not clinical evidence of that, but there42

    is laboratory evidence, there is animal study43evidence that we've discussed over the last couple44of days that supports cannabis-based products45being more effective with a lesser chance of46negative side effects than smoking cannabis,47

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    correct?1A I wouldn't agree.2

    Q And just as you criticized Dr. Pate for you say3not fully setting out possible negatives in his4affidavit, paragraph 46 fails to note that there5are significant negatives associated with smoking6whole plant cannabis that do not exist when the7compounds are ingested topically or orally,8correct?9

    A There are different risks associated with smoking,10yes.11

    Q And that's not set out in paragraph 46, is it?12A No.13Q And moreover, putting aside any risks associated14

    with the quality control issues in the baking15process, the risks of the compound themselves, the16THC, the CBD, and the terpenes in a marihuana17cookie, for example, are not qualitatively18different for the cannabis cookies than for the19approved drugs, Marinol, Cesamet, and Sativex, are20they?21

    A I'm not sure I'm clear on your question.22Q Putting aside risks involved in baking a marihuana23

    cookie, contamination of food products, the fact24of the matter is the pharmacologically active25compounds in the marihuana cookie are the THC, the26

    CBD, and possibly the terpenes, correct?27 A That's correct.28Q And the risks of those compounds, whether they're29

    in the cookie or whether they're in Marinol,30Cesamet, and Sativex are the same. It's the same31compound and it carries the same risks, doesn't32it?33

    A Not necessarily. Depends how much you're taking.34Q Putting aside the dosing issue, it's the same35

    compound, it has the same risks, doesn't it?36A Again, I disagree because we're talking37

    about -- with pharmaceutical products we're38talking about, in the case of Marinol and Cesamet,39one compound or essentially one compound, with40Sativex several compounds. It's comparing a41little bit of apples and oranges.42

    Q The risk of THC in Marinol, hundred percent43synthetic THC in Marinol, there's no qualitative44difference for the risk of THC in Marinol as45compared to THC in a cannabis cookie, is there?46It's the same compound.47

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    A If you're comparing THC to THC then, yes.1Q Similarly, Sativex is a whole plant extract, THC:2

    CBD, and because it's a whole plant extract all3the other things that are in the whole plant,4correct? It's got the terpenes, it's got some of5the other cannabinoids, that's in Sativex, isn't6it?7

    A Yes, to my understanding.8Q And the risks of those compounds, just the9

    compounds, forget about dosing, forget about how10the things are made, the risks of the compound11themselves aren't any different for Sativex than12they are for the marihuana cookie being produced13at the CBC of C? It's the same compound, has the14

    same risks, doesn't it?15A If we know the exact composition of those products16

    and we're comparing them side by side, yes.17Q And the use of cannabis-infused olive oil on a18

    topical basis further reduces any potential risk19because topicals eliminate any risk associated20with the baking process and they eliminate any21risk associated with the smoking process, don't22they?23

    A They eliminate those particular risks, yes.24Q And that's not in paragraph 46, is it?25A Not those particular risks that you mentioned, no.26

    Q I'm going to suggest to you, Doctor, with the27 greatest of respect, that in coming to the facts28and opinions set out in your affidavit you've29overemphasized the potential risks and you've30downplayed the potential benefits of cannabis-31based medicines, haven't you?32

    A I've stated what I think.33Q In drafting your affidavit and in including the34

    sections written by Suzanne Desjardins, your use35of the term "no scientific evidence" from36critiquing Dr. Pate's opinions really means no37clinical studies, doesn't it?38

    A Well, I'd have to look at exactly which paragraph39and sentence you're talking about.40

    Q And the reason, sir, that you use the term "no41scientific evidence" when you really mean no42clinical studies is because you in responding to43Dr. Pate are prepared to discount anecdotal44evidence, you're prepared to discount animal and45laboratory research that supports Dr. Pate's46opinions, but you are -- because the hypotheses47

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    developed in those studies plus what we have1agreed are general pharmacological principles2

    provide some scientific support for Dr. Pate's3opinions, don't they?4

    A I think the scientific evidence is limited.5Q But you don't say limited when you say no6

    scientific evidence in your affidavit. You say no7scientific evidence in portions of your affidavit.8

    A Well, with regards to oils, ointments, or baked9goods, there isn't any scientific evidence.10

    Q You're discounting animal studies and you're11discounting laboratory research demonstrating12hypotheses and general pharmacological principles13of direct application to the site of pathology,14

    and you're focusing, aren't you, on clinical15studies, isn't that the case?16

    A With all due respect, Mr. Tousaw, it says17cannabis-based products such as oils, ointments,18and baked goods, and those have not been tested on19animals or on humans, clinical or pre-clinical20studies. What has been tested is single21compounds. That's different from oils, ointments,22and baked goods.23

    Q There are citations in your "Information for24Health Care Practitioners" document related to the25use of baked goods by humans for therapeutic26

    purposes, aren't there?27 A Yeah, but that's anecdotal evidence.28Q And that's evidence, isn't it?29A But it's anecdotal, it's not scientific.30Q And you're prepared to discount that evidence,31

    aren't you?32A I base it on the science.33Q By contrast, when you set out your view of the34

    risks and potential negatives of cannabis-based35medicines, you are prepared to rely on laboratory36research and animal studies, aren't you?37

    A I rely on the scientific evidence for therapeutic38and adverse effects.39

    Q You're even prepared to accept anecdotal evidence40in the form of case studies based on self-reports41when it comes to negatives which you're not42prepared to accept when it comes to positives,43aren't you?44

    A No, that's not necessarily the case.45Q But you do so, and with specific reference you do46

    so with self-reports of contact allergic47

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    reactions, you accept self-reports that the person1came into contact with an allergen and that's what2

    caused the rash, that's a self-report, isn't it?3That's anecdotal evidence, isn't it?4

    A Well, not necessarily anecdotal evidence. I also5include in the "Information for Health Care6Professionals" anecdotal evidence supporting and7discounting.8

    Q But not in your affidavit. In your affidavit9you're prepared to accept anecdotal evidence,10you're prepared to accept lab studies, you're11prepared to accept animal studies when you're12talking about risks, but you're not prepared to13accept those studies when you're talking about14

    benefits in your affidavit, isn't that the case?15A With regards to the topical administration it was16

    -- it was a report, anecdotal -- sorry, not an17anecdotal report but a case report, yes, but there18is no other evidence that suggests that it has an19effect, a therapeutic effect.20

    Q And the reason that you're prepared to accept lab21and animal studies, highlight negatives but not to22emphasize positives, is because you and your23superior at Health Canada have a vested interest24in defending the regulatory choices made by Health25Canada, your employer and her employer, don't you?26

    A Presenting the evidence, sir.27 Q It's much in the same manner that you say both28today and yesterday and the day before that Dr.29Russo's work can be called into question because30he has a vested interest in promoting the31positions adopted by his employer, GW32Pharmaceuticals? That's the case, isn't it?33

    A I don't know.34Q The fact of the matter is that Health Canada35

    through you and Ms. Desjardins, its employees, is36attempting to restrict as much as possible37Canadians' lawful access to cannabis and cannabis-38based medicines, and that is why your affidavit39consistently overemphasizes the potential and40actual risks and consistently underemphasizes the41potential and actual benefits that patients are42obtaining from the use of these products, isn't43it?44

    A I'm basing it on --45THE COURT: There were three questions there, weren't46

    there?47

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    MR. TOUSAW: I think there was just one, but I can1break it down.2

    Q Health Canada through its employees, you and Ms.3Desjardins, is attempting to restrict as much as4possible the lawful access by Canadians to5cannabis and cannabis-based medicines?6

    MR. ECCLES: I'll object if that's the first question,7My Lord. It's asking for a conclusion of law, and8it is well beyond the area of expertise of this9witness. Thats ultimately an issue for Your10

    Lordship at the end of the day. My friend is11asking --12

    THE COURT: Well, who issues permits?13MR. ECCLES: Health Canada does, My Lord, but this14

    witness --15THE COURT: So a question whether or not Health Canada16

    restricts access, doesn't that go right to whether17or not they are freely handing out permits or18restricting permits?19

    MR. ECCLES: It may well at the end of the day, My20Lord. The question becomes how does Dr.21Abramovici who is an expert in cannabis, its22pharmacology, absorption, and distribution in the23body, the pharmacological actions of cannabinoids24and cannabis, therapeutic and adverse effects that25can be consequence of its use, and the medicinal26

    aspects of cannabinoids, how does that question27 fall within the expertise of this witness.28THE COURT: As I said earlier, and that was a ruling,29

    the fact that this witness is tendered as an30expert does not mean his evidence is restricted to31areas within his expertise. If he is an employee32of Health Canada, he is fair game to be questioned33on Health Canada policy, to the extent that he34understands it or is familiar with it, or any35other part of the workings of Health Canada.36

    MR. ECCLES: Yes, My Lord, and if my friend wishes to37ask policy questions of the witness, he can do38so as policy questions, in my respectful39submission --40

    THE COURT: That's what he just did.41MR. ECCLES: In my respectful submission, no, he did42

    not, My Lord. He asked the witness his view of43the legal approach, the word "legal" was packed44into the question. That asked this witness to45give a legal opinion. That is an area no witness46can testify to, regardless of whether they're in47

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    direct or cross, unless they're called and1qualified as an expert in law on an issues alive2

    before the court. In my respectful submission,3this witness has not been qualified in these4areas. He can be asked as to whether that is the5policy of Health Canada to his knowledge, but that6is not what my friend is asking. My friend is7asking whether Health Canada has a legal interest,8is attempting to legally do things. That9incorporates into the question an element this10witness, in my respectful submission, cannot11answer because his answer cannot be relevant.12Generalized cross does not open up a witness who13is not qualified to give legal opinions to be14

    cross-examined on the law. That's my objection.15Policy, yes; law, no. And my friend phrased the16question as inviting a legal opinion, at least the17portion that I heard. Perhaps he was going to put18something at the end of it, but as soon as the19word "legal" appears with a witness who's not here20to give a legal opinion, the Crown will object.21

    THE COURT: All right. I don't need to hear from you,22Mr. Tousaw. The question, in my view, did not23invite this witness to voice a conclusion of law24or to give an opinion on a matter of law. I agree25that if he were asked he would not be permitted to26

    do so. The question, as I understood it or recall27 it, was whether or not Health Canada, as a matter28of policy perhaps, was deliberately restricting29access by the public to legal sources of30marihuana. That is an entirely different matter31than asking the witness for a conclusion of law.32I think the question as phrased was entirely33suitable.34

    MR. ECCLES: Thank you, My Lord.35MR. TOUSAW: Thank you, My Lord.36Q Do you remember the question?37A I do not.38Q The fact of the matter is that Health Canada39

    through you and Ms. Desjardins, its employees, and40in the affidavit you filed in these proceedings41and then testimony that you've given is attempting42to restrict as much as possible Canadians' lawful43access to cannabis and cannabis-based medicines,44and that reason is why your affidavit and the45conclusions of Ms. Desjardins consistently --46

    THE COURT: Now, Mr. Tousaw, that's two questions. Are47

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    they restricting deliberately is a question. If1the answer is no, the second question becomes2

    irrelevant. If the answer is yes, you can go into3why they're doing it. But that was my problem the4first time. If I get a yes, what is it, that5they're restricting?6

    MR. TOUSAW: Understood, My Lord.7Q The fact of the matter is that Health Canada8

    through you and Ms. Desjardins, its employees, the9filing of the affidavit in these proceedings is10attempting to restrict as much as possible11Canadians' lawful access to cannabis and cannabis-12based medicines, isn't it?13

    A I can't comment on that.14

    Q And that is why your affidavit consistently15overemphasizes potential and actual risks and16consistently underemphasizes potential and actual17benefits that patients are obtaining from the use18of these products, isn't it?19

    A The risks are better known than the benefits.20MR. TOUSAW: If I could have a moment, My Lord.21THE COURT: Yes.22MR. TOUSAW:23Q Doctor, we established two days ago that24

    paragraphs 43 to 46 of the affidavit that you25signed and filed in these proceedings were written26

    by Suzanne Desjardins before she wrote and you27 inserted those paragraphs. Did you have different28conclusions? Had you had something there that was29replaced by Ms. Desjardins' language?30

    A No.31MR. TOUSAW: Those are my questions for this witness,32

    My Lord.33THE COURT: Re-examination?34MR. ECCLES: Thank you, My Lord.35

    36

    RE-EXAMINATION BY MR. ECCLES ON VOIR DIRE:3738

    Q Dr. Abramovici, what if any impact will the39results of this case have on your employment or40your job duties?41

    A I have no idea. I don't know.42Q In your affidavit material you include at Tab G of43

    Exhibit 40 the "Information for Health Care44Professionals", the entire document, don't you?45

    A Yes.46Q And in that document you cite various studies at47

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    various points throughout the document, correct?1A That's right.2

    Q Why?3MR. TOUSAW: My Lord, doesn't arise or could've been4

    asked in direct. Doesn't arise out of cross.5MR. ECCLES: I'll refocus then.6Q The information for health --7THE COURT: It seems to me, Mr. Tousaw, that I may have8

    throttled Mr. Eccles down in terms of his9examination in chief when I presented him in10effect with the consideration whether he would11file the document or walk through examination in12chief using the document as the template perhaps,13but I'm not sure that it's a fair objection when I14

    invited him not to spend a great deal of time15going through each page of this document to say,16well, he could have. I think I must have given17Mr. Eccles the very clear impression that if he18had tried to do it in chief, I'd have been a bit19cranky.20

    MR. TOUSAW: My Lord, that may well have been the case,21but my recollection is that my friend did walk the22witness through substantial portions of the23affidavit in chief, whether that was a -- whether24his decision not to walk him through every25paragraph was one borne out of strategy or a26

    desire to conform with the implied statements that27 Your Lordship made, I don't know, but he certainly28did conduct direct examination on the affidavit.29In any event, I'll withdraw my objection to that30question.31

    MR. ECCLES: And I'll rephrase the question, My Lord,32and back it up. Perhaps before I turn to that,33could Dr. Abramovici please be shown Exhibit 4134which is the article entitled "Multicenter,35double-blind, randomized, placebo-controlled,36parallel-group study of the efficacy, safety, and37tolerability of THC:CBD extract and THC extract in38patients with intractable cancer-related pain."39

    Q My friend asked you some questions about this, Dr.40Abramovici. You have the Exhibit 41 in front of41you?42

    A I do.43Q The abstract states:44

    45

    This study compared the efficacy of a46tetrahydrocannabinol:cannabidiol (THC:CBD)47

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    extract . . .12

    From that study do you know whether that extract3was actually Sativex itself?4

    A I don't think the study says that it is Sativex5per se.6

    Q Now, does the study say whether the THC extract is7Marinol, the synthetic THC extract? Does it8identify what precise THC extract is being used in9this comparison study?10

    A Not that I know of, no.11Q Now, at the page 168 under the "Introduction", the12

    second full paragraph under "Cancer pain is a13common problem", there's a description of cannabis14

    containing 60 or more cannabinoids, correct?15A Yes.16Q Sixty or more -- my friend asked you a question in17

    relation to your report in which you indicated18there are more than 60 -- now more than 7019cannabinoids that are known, correct?20

    A Yes.21Q And the health care practitioners' guide refers to22

    more than 60, correct?23A I believe so.24Q Just before you refer you to that, the use of25

    "more than" indicates that 60 is the baseline and26

    there's at least 60 and possibly more, correct?27 A That would be my interpretation, yes.28Q Now, in this particular document at this paragraph29

    the main ones are identified and there's a cite304.5, and I take it if we look to the end of the31article we find a reference to correspond to that32footnote at the back of the article which is 425,33actually. It's the House of Lords Select34Committee on Science and Technology, London U.K.35House of Lords, 1988, and then a GW Pharmaceutical36and product monograph for Sativex. Those are the37two sources for that statement, correct?38

    A That's right.39Q And the product monograph for Sativex is40

    incorporated in your affidavit as an exhibit to41it?42

    A It is.43Q The report carries on:44

    45

    Sativex, an endocannabinoid system46modulator, is produced by GW Pharma Ltd,47

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    United Kingdom. It is derived from strains1of Cannabis sativa L. plants developed to2

    produce high and reproducible yields of3principal CBs . . .4

    5

    And that would be cannabinoids, correct?6A Yes.7

    8

    . . . (THC and CBD), with minor amounts of9other CBs and terpenes in a solution10containing ethanol, propylene glycol, and11peppermint oil flavoring. The named CBs12constitute at least 90% of the total CB13content of the extracts.14

    15And then a description of CBs. Does that assist16at all in determining what it is they're actually17giving to patients as part of this study, whether18it's Sativex or something else?19

    A No.20Q From your work in the area, your preparation of21

    the health care practitioners' guide and your22review of the literature, are the plant sources23that are used to create Sativex, are they a known24strain or are they just grabbing marihuana off the25street?26

    A These are known strains.27 Q Now, at page 170 of the report there's an28indication in this report under the study design29that 33 individuals dropped out, correct, for30various reasons that -- adverse event, consent31withdrawal, other. So that's under the column of32THC:CBD 12 withdrawn, THC extract 13 withdrawn,33adverse event 7, consent withdrawal 2, sponsor34decision 1, protocol violation 1, other 2. And35then under the placebo, withdrawn 8, adverse event363, consent withdrawal 2, other 3. Before we -- do37you know whether anywhere in the paper they define38what "other" is? Or would we just have to read39the paper and see for ourselves?40

    A I'd have to read -- I'd have to look through the41paper to see, yes.42

    Q Thirty-three dropping out out of a total of 192,4316, 17 percent dropout rate, isn't it?44

    A I would assume, yes.45Q From your review of the literature and from your46

    review of clinical trials generally, is that a47

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    normal dropout rate or is that a high dropout1rate?2

    A To be honest, I don't know.3Q Now, could Dr. Abramovici please be shown Exhibit4

    42, please, which is the "Adverse effects of5medical cannabinoids: a systematic review". Now,6my friend put to you the abstract heading, the7results. Under the heading "Interpretation":8

    9

    Short-term use of existing medical10cannabinoids appeared to increase the risk of11nonserious adverse events. The risks12associated with long-term use were poorly13characterized in published clinical trials14

    and observational studies. High-quality15trials of long-term exposure are required to16further characterize safety issues related to17the use of medical cannabinoids.18

    19

    Are you aware of the existence of high-quality20trials of long-term exposure of medical -- to21characterize safety issues for medical users?22

    A No, not generally.23Q And if we turn to, well, the first paragraph on24

    the first page:2526

    Cannabis is widely used as a recreational27

    drug, with an estimated worldwide annual28prevalence (defined as use at least once per29year) of 160 million.30

    31

    That's the definition they use for recreational32drug use. Do you know whether there is a33consistency in the scientific literature as to the34definition of recreational use, moderate use,35heavy use, and chronic use? Are these terms36defined within the literature? Is there an37accepted definition across the literature for what38constitutes chronic use?39

    A I don't think so, no.40Q And if we look to the interpretation section of41

    this article at page 1675, it states:4243

    In our review, we identified 8371 adverse44events related to medical cannabinoid use,454779 . . .46

    47

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    That's the first paragraph.12

    None of the reported adverse events was3unexpected, according to the International4Conference on Harmonisation criteria.5

    6

    And then it carries on:78

    Although the randomized controlled trial is a9powerful study design, several aspects of the10quality of reporting of adverse events in11published trials limited our results.12

    13

    And then it carries on to describe the14

    difficulties:1516

    First, not all published cannabinoid trials17provided safety information; we excluded 2818randomized controlled trials, including 219trials that examined cannabis smoked by20patients with HIV infection because they did21not quantify adverse events or they reported22events for only one intervention group.23

    24

    Is that a valid concern for a scientific -- for a25scientist who's reviewing another scientist's26

    work, these sorts of concerns?27 A Yes.28Q It carries on:29

    30

    The Jadad . . .3132

    What is Jadad?33A I believe that that's a way of measuring the34

    levels of evidence in scientific studies.3536

    Q And the authors of this study indicate:3738

    The Jadad score does not adequately reflect39the quality of safety reporting in randomized40controlled trials, which meant that rating by41the Jadad scale indicated good methodologic42quality for these studies, despite their poor43reporting of safety.44

    45

    Is that a legitimate concern for a scientist when46reviewing studies that have been done in the47

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    744VOIR DIREHanan Abramovici (for Crown)re-exam by Mr. Eccles

    field?1A Yes.2

    Q3Second, most of the trials selected did not4provide both the absolute number of adverse5events and the number of participants6reporting at least 1 event, as recommended by7the Consolidated Standards of Reporting8Trials (CONSORT) statement.9

    10

    Is that also a legitimate concern for a scientist11reviewing another scientist's work or study, pre-12clinical, clinical trials?13

    A Yes.14

    Q15This meant that we could focus only on the16incidence of adverse events, rather than17being able to analyze both the incidence18rates of events and the risks for19participants who had reported at least 120event. Third, because of the lack of data on21frequency of adverse events for each patient,22we had to assume that the occurrence of23adverse events was independent, which would24not be a valid assumption if a patient had25experienced more than 1 event. This26

    assumption would result in generation of27 artificially narrow CIs around the RR28estimates, which might have affected the29results of significance testing.30

    31

    What is artificially narrow CIs, what does that32mean?33

    A That refers to confidence intervals which is a34measure of data reliability.35

    Q And what's the RR estimates?36A I think they're risk ratios.37Q And are the concerns expressed by the authors of38

    this report in relation to the studies they've39reviewed, are those valid concerns for any40scientist to have regarding work in the field?41

    A Yes, very much so.42Q And as is often the case with research papers of43

    this sort, at the end of the paper there are44references numbered 1 through 60 corresponding to45the references within the article, correct?46

    A Yes.47

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    Q Now, my friend put to you there are different1risks associated with smoking as opposed to oral2

    ingestion and that information is not in the3affidavit. Is that information in Exhibit G,4"Information for Health Care Practitioners", the5varying risks between smoking versus other methods6of ingestion, smoking versus inhalation through7vapour, smoking versus oral ingestion, is that8dealt with in the info for health care9practitioners?10

    A I believe so, yes.11Q My friend put to you that you -- and that's part12

    of your affidavit as an exhibit thereto, correct?13A That's correct.14

    Q My friend put to you, you do not have any15knowledge of harms to consumers of products made16by the Cannabis Buyers' Club. If I was to suggest17to you that one individual purchased, on the18evidence of Mr. Smith, a hash oil product,19apparently waited a month and then consumed the20product, experienced a significant enough adverse21event that he had to be admitted to the hospital22for treatment of some kind of unidentified event23arising out of his use of the substance. Would24that be a harm to a consumer of a product made by25CBC, assuming everything I've told you in26

    hypothetical to be correct?27 A Yes.28Q You didn't receive a copy of the evidence of Mr.29

    Smith to review before you gave your evidence in30these proceedings?31

    A I did not, no.32Q Now, my friend put to you that we now know tobacco33

    is epidemiologically linked to cancer. You know34that to be so, correct?35

    A Yes.36Q Do you know how long it took to establish an37

    epidemiological link between tobacco and38consumption of cancer in smoked form?39

    A Probably three decades or so.40Q Now, my friend put to you various portions of Tab41

    G and certain sentences under the headings at page428, for example, of that particular document, and43it was in relation to the dosing, the smoking44section. He took you through, then he turned to45the sections dealing with the indications and use,46nausea and vomiting and wasting symptom, and you47

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    advised the information presented in the previous1and this section is a summary of the clinical and2

    pre-clinical studies. Now, when you prepared the3"Information for Health Care Practitioners", were4you intending it to be read as a -- for example,5the section on nausea and vomiting at the bottom6of page 9, it's one sentence at the heading 4.1,7and I believe my friend took you to one or two8sentences within that paragraph. Was that9paragraph intended for health care practitioners10to read in its total? Are they to read the whole11document or are they to just pluck a sentence out?12

    A No, it was for them to read in its entirety or as13a whole, yes.14

    Q And in each section under nausea and vomiting, for15example, there's the first sentence, at the end of16the first sentence, bracket 108, end bracket,17period. What's that a reference to?18

    MR. TOUSAW: My Lord, I rise to object. My friend19asked that question in direct. He took him to Tab20G. He asked him what the numbers meant. I think21we all know the answer is they're citations to22studies, but this testimony has already been23given.24

    MR. ECCLES: Then I'll move to the next question, My25Lord:26

    Q Why cite the studies?27 MR. TOUSAW: My Lord, again, that question was asked in28direct.29

    THE COURT: Are we covering the ground again, Mr.30Eccles, and, if so, is there a useful purpose in31doing so? I mean, I'm prepared to accept that32someone in Dr. Abramovici's position, when he33cites through a footnote the source of the34information, is doing that so that the reader will35be able, if the reader wishes, to look at the36cited material, or if the reader doesn't wish to37spend a great deal of time reading all of it will38have at least some comfort that there is some39authority for the statement footnoted. Do we need40to go any further?41

    MR. ECCLES: No, My Lord, I'll move on to a more42general question.43

    Q My friend put to you a number of times that -- the44concept of systemic delivery of THC or CBD orally45versus smoked. What exactly -- when you use the46phrase "systemic delivery" and the measurement of47

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    747VOIR DIREHanan Abramovici (for Crown)re-exam by Mr. Eccles

    nanograms per millilitre of blood or as an example1of an indication of systemic delivery, what do2

    you mean by systemic delivery?3A That it goes throughout the body.4Q In relation to the systemic uptake of oral5

    ingestion as set out in your answer to questions6to my friend and in your report, you describe7systemic uptake of oral ingestion as slow and8erratic, and my friend put to you and that's a9function of the first-pass effect, and your answer10was, in part. What else is it a function of when11one orally ingests and the systemic uptake tends12to be slow and erratic? Is it purely a first-pass13effect or is there something else playing in14

    there?15A There are many variables which govern oral16

    absorption of a drug. That can be differences in17digestion between people, what kind of food you've18eaten, when was the last time that you ate,19genetic differences in metabolism. There are a20whole host of factors.21

    Q My friend put to you if one reduces the amount of22cannabis ingested by smoking and if one can reduce23that amount by offering oral ingestion, that would24be a benefit to the health. Could Dr. Abramovici25be shown Exhibit 18 in these proceedings, please.26

    MR. TOUSAW: My Lord, while the clerk is finding27 Exhibit 18, I'm going to rise to object. This was28not put to the witness in direct. It could have29been. I did not put it to the witness in cross.30It does not arise out of cross.31

    THE COURT: What is Exhibit 18?32MR. ECCLES: Exhibit 18 is the Cannabis Buyers' Club of33

    Canada medicinal cannabis recipe book, My Lord. I34have an extra copy for Your Lordship.35

    THE COURT: I think I must have it somewhere.36MR. ECCLES: It may save Your Lordship a bit of time.37

    I'm quite certain that one has no marking on it.38My recollection was I actually did seek to put39this to the witness in direct, and my friend40objected on the basis that the witness was not41called as a medical expert and it was beyond the42scope of his expertise. Your Lordship upheld that43objection. My friend proceeded in his cross-44examination to ask the question that I've just put45to the witness regarding health, a benefit to46health through oral ingestion. What I propose to47

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    ask the witness is whether he is aware from his1review of the literature of any literature to2

    support any of the claims made at the second3paragraph of the first page of Exhibit 18.4

    MR. TOUSAW: My Lord, that doesn't arise out of cross-5examination. I didn't put this exhibit to the6witness. I didn't ask him about health claims.7He's not a medical doctor. My friend attempted to8do this in direct. He was prevented from doing so9by way of objection and Your Lordship's ruling.10He's now attempting to back-door it in again.11

    THE COURT: Well, but your friend says you did ask12about the respective health benefits of oral13ingestion versus smoking, and I do recall that was14

    asked more than once. If that were a relevant15line of inquiry in cross-examination, how does it16become irrelevant in re-examination?17

    MR. TOUSAW: That's not the line of examination my18friend proposes to embark upon. The paragraphs at19paragraph 18 that he's made reference to don't20speak to that particular issue, at least the21paragraphs at page 1 that he's referred to. It22talks about replacement of allopathic medicines.23That's a medical issue. It's not an issue of oral24versus smoking. It speaks to studies. It25indicates that the recipe book is a guide to26

    preparing and using cannabis.27 MR. ECCLES: My Lord, I wasn't going beyond the single28paragraph. My friend is going further into the29materials. If he wants me to, I'm happy to re-30examine in that area as well.31

    THE COURT: All right, well, Mr. Eccles, maybe you can32show me, now that I'm looking at the paragraph,33how that arises out of the witness's answer to a34question about oral ingestion versus smoking.35

    MR. ECCLES: And health benefits, My Lord, it's the --36MR. TOUSAW: My Lord, perhaps the witness could be37

    excused for this discussion.38THE COURT: I don't think Dr. Abramovici is going to be39

    polluted by this discussion. I suspect he's a bit40more resistant to suggestion than that.41

    MR. ECCLES: It's the second sentence, My Lord, that I42respectfully submit the Crown is entitled to ask43their expert about because my friend has opened44the doors to smoked versus oral ingestion having45health benefits. This is a specific reference of46extracts in the context of a cannabis recipe book47

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    that my friend entered as an exhibit as part of1his case that makes certain claims regarding the2

    health benefits of those products. I would like3to ask the expert whether he's aware of any4material anywhere to support the sorts of claims5advanced in that paragraph.6

    THE COURT: Does that presuppose that I should be7permitted to accept as true the claim in this8paragraph, in the sentence in the paragraph,9because I wasn't proposing to do so.10

    MR. ECCLES: I'm not suggesting it is true, My Lord.11This may well impact on the proposed s. 7 remedy12my friend seeks and the basis upon which he seeks13it based on the line of cross-examination he's14

    pursued with Dr. Abramovici.15THE COURT: All right. Mr. Tousaw, final word?16MR. TOUSAW: My Lord, that sentence has nothing to do17

    with health benefits of extracts versus smoking.18It doesn't even reference smoking in any way.19It's a paragraph that speaks to some medical claim20that this witness, frankly, hasn't been qualified21to respond to.22

    THE COURT: I think it's relevant, and I think it23arises out of the line of cross-examination, and I24couldn't cite particular questions, but the25general impression I have where this witness was26

    asked about the existence or his awareness of27 whether or not there have been studies that28demonstrate efficacy of cannabis products when29applied directly to the site of the pathology,30whether it's a skin lesion, a wound, or something31int


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