Systematic review

• When other drugs would occasionally come up, I didn’t understand some of the slang terms they used for these drugs.
• Many people may have that feeling now when the topic of cannabis comes up – especially in its different and newer forms.
• A major change during my time in research is the legalization and explosion of cannabis availability across the U.S.

A shifting landscape

• It also serves as a catch-all term for any substance with chemical compounds from cannabis plants and addresses concerns that the word marijuana has some long-standing racist overtones.
• Cannabis now comes in a larger variety of forms than it used to.
• These include oils that can be vaporized by vape or dab pens, waxier substances and even powders.

How cannabis derivatives interact with the brain

• Each one interacts with the brain in different ways, producing different perceived effects.
• The differences between THC and CBD come from how they interact with cannabinoid receptors – the proteins onto which these drugs attach – in the brain and body.

The changing nature of cannabis products

• By increasing the amount of THC, concentrated products can increase blood levels of THC rapidly and more strongly than nonconcentrates such as traditional smoked cannabis.
• Cannabis concentrates also come in many different forms that range from waxy or creamy to hard and brittle.
• They are made in a variety of ways that may require dry ice, water or flammable solvents such as butane.
• The myriad names for cannabis concentrates can be confusing.

Cannabis use and adolescents

• A 2021 systematic review found that past-year cannabis vaping nearly doubled from 2017 to 2020 in adolescents - jumping from 7.2% to 13.2%.
• In addition, a 2020 study found that one-third of adolescents who vape do so with cannabis concentrates.
• Cannabis use by adolescents is scary because it can alter the way their brains develop.
• Adolescents who use cannabis are also more likely to experience symptoms of schizophrenia, struggle more in school and engage in other risky behaviors.
• This article is part of Legal cannabis turns 10, a series examining the impact of a decade of recreational cannabis use.

Ty Schepis receives funding from US Food and Drug Administration and the National Institute on Drug Abuse. His research is also supported by a faculty fellowship from the Texas State University Translational Health Research Center.

• If you were affected, you might want an explanation of why an AI system produced the decision it did.
• Yet AI systems are often so computationally complex that not even their designers fully know how the decisions were produced.
• Explainable AI systems help AI engineers to monitor and correct their models’ processing.
• We wanted to see to what extent researchers indicated awareness of cultural variations that were potentially relevant for designing satisfactory explainable AI.

Cultural differences in explanations

• The other is externalist, citing factors like social norms, rules, or other factors that are outside the person.
• However, such explanations are not obviously preferred over externalist explanations in “collectivist” societies, such as those commonly found across Africa or south Asia, where people often view themselves as interdependent.
• If people from different cultures prefer different kinds of explanations, this matters for designing inclusive systems of explainable AI.
• Our research, however, suggests that XAI developers are not sensitive to potential cultural differences in explanation preferences.

Overlooking cultural differences

• Moreover, when we checked the cultural background of the people tested in the studies, we found 48.1% of the studies did not report on cultural background at all.
• This suggests that researchers did not consider cultural background to be a factor that could influence the generalisability of results.
• Of those that did report on cultural background, 81.3% only sampled western, industrialised, educated, rich and democratic populations.
• Yet, out of the studies that reported on cultural background, 70.1% extended their conclusions beyond the study population – to users, people, humans in general – and most studies did not contain evidence of reflection on cultural similarity.

Why the results matter

• To address this cultural bias in XAI, developers and psychologists should collaborate to test for relevant cultural differences.
• As AI is being used worldwide to make important decisions, systems must provide explanations that people from different cultures find acceptable.
• As it stands, large populations who could benefit from the potential of explainable AI risk being overlooked in XAI research.

The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

• The completed comments form should be sent to
  [email protected]
  10
  11
  Keywords

  Committee on Herbal Medicinal Products; HMPC; European Union herbal
  monographs; European Union list of herbal substances, preparations and
  combinations thereof for use in traditional herbal medicinal products; herbal
  medicinal products; traditional herbal medicinal products; traditional use;
  well-established medicinal use; benefit-risk assessment; assessment report

  12

  1
  2

  Changes introduced in section 6 Overall conclusions.

• Peer-reviewer

  If not the same peer-reviewer
  since last version, all peerreviewers should be listed, and
  the version specified in
  brackets.

• 22

  23

  
  on
  .

• It is a working

  24

  document, not yet edited, and shall be further developed after the release for consultation of the

  25

  
  .

• The principle of the template is to make clear
  distinctions between presentation of data (methodology and results)
  and the assessment of the data (?assessor?s comment?).
• likely from an article but it seems it is concluded by
  the rapporteur; ?According to the author? to be added.
• Chapters with
  a heading including the word ?conclusion? should include a summary
  of all critical assessment of the assessor for that particular
  chapter.
• If an assessor?s comment is not needed, the Rapporteur
  should delete the box inserted in the template.
• ?
  The report should be sufficiently detailed to allow for secondary
  assessment of the available data by other HMPC experts.
• Overview of available pharmacokinetic data regarding the herbal substance(s), herbal
  preparation(s) and relevant constituents thereof ........................................................... 16

  97
  98

  3.3.

• Overall conclusions on clinical pharmacology and efficacy ........................................ 27

  Assessment report on
  EMA/HMPC/418902/2005

  Page 4/41

  119

  5.

• This sections is related to
  available quality standards and there is no need to repeat information
  on all preparations included in the monograph.
• Search and assessment methodology

  161

  The Rapporteur shall undertake a comprehensive search of relevant
  scientific literature and articles, Acts of law and regulations and
  other relevant sources.

• Cross-reference to the list of
  references in Annex, which should list separately the references
  supporting the assessment report.
• 143
  144
  145

  150
  151
  152
  153
  154

  162
  163
  164
  165
  166
  167
  168
  169
  170
  171
  172
  173
  174
  175

  Herbal substance(s)

  Herbal preparation(s)

  Relevant constituents for this assessment report

  Examples of scientific databases to be searched are Medline, PubMed,
  Cochrane Database of Systematic Reviews, EMBASE etc.

• Assessment report on
  EMA/HMPC/418902/2005

  Page 6/41

  176
  177
  178
  179
  180
  181
  182
  183
  184
  185
  186
  187
  188
  189
  190
  191
  192

  Additional relevant references could also be retrieved from the checked
  references.

• Examples of books are Hagers Handbuch, The Complete German
  Commission E Monographs, PDR for herbal medicines etc.
• In addition, information from non-EU regulatory
  authorities for examples Health Canada monographs or WHO monographs
  could be searched, if relevant to herbal substances and preparations in
  EU.
• 221

  225
  226
  227

  232

  When the assessment report is revised, the rapporteur should briefly
  summarise the main changes under this section.

• Data are collected using the template entitled ?Document
  for information exchange for the preparation of the assessment report
  for the development of European Union monographs and for inclusion of
  herbal substance(s), preparation(s) or combinations thereof in the
  list? (EMEA/HMPC/137093/2006).
• Assessment report on
  EMA/HMPC/418902/2005

  Page 8/41

  Herbal substance/

  Indication

  Posology and
  method of

  preparation

  administration

  Posology, age
  groups,
  pharmaceutical
  form, method of
  administration,
  duration of use
  As reported in
  the market
  overview

  As reported in
  the market
  overview

  As reported in
  the market
  overview.

• Assessment report on
  EMA/HMPC/418902/2005

  Page 10/41

  Herbal substance/

  Indication/Medicinal

  Posology and

  preparation

  use

  method of
  administration

  Posology, age
  groups,
  pharmaceutical
  form, method of
  administration,
  duration of use

  Regulatory Status

  Type of
  regulatory
  status where
  possible, date,
  Country

  287

  This overview is not exhaustive.

• Clinical Safety/Pharmacovigilance

  836
  837
  838
  839
  840
  841

  See ?Assessment of clinical safety and efficacy in the preparation of
  EU herbal monographs for well-established and traditional herbal
  medicinal products?(EMA/HMPC/104613/2005) for further details.

• Overall conclusions on clinical safety

  1067

  1068

  In terms of structure, the conclusion should follow the presentation of
  the results above.

• Overall conclusions

  1092

  1093

  1101

  Describe key aspects only briefly, these will already have been
  described in detail in the respective sections.

• This section should
  cover all recommended ?well-established use? and ?traditional use?
  indications and conclusions shall be provided for each therapeutic
  indication and each herbal preparation.
• 1102

  Well established use monograph

  1103
  1104

  The clinical studies supporting well-established use should be
  specified for each therapeutic indication and each herbal preparation.

• The choice for the wording of traditional use indications vis-?vis existing wordings in monographs in the same therapeutic area should
  be briefly discussed/justified.
• 1153

  List entry

  1154

  The conclusions should include a statement pointing to the
  possibility/non-possibility to support a European Union list entry.

• This was highlighted at an International Summit of Experts held at the Casa de las Encías in Madrid, Spain, the headquarters of the SEPA Foundation.
• "Periodontal diseases are prevalent worldwide, affecting hundreds of millions of people," says the meeting coordinator, Dr. Paula Matesanz, vice president of SEPA.
• As Dr. Iain Chapple summarizes, "It is time for a paradigm shift: we must control gingivitis and not wait until periodontitis develops."
• J Clin Periodontol 2022 Jun:49 Suppl 24:4-71 (version adapted by SEPA available at https://portal.guiasalud.es/gpc/tratamiento-periodontitis-estadio-iv )
  * Chapple I, Time to take gum disease seriously.