Public

How corporate involvement in psychedelic research could threaten public safety

Retrieved on: 
Tuesday, April 23, 2024

With an increasing cultural spotlight, there has been substantial economic growth of the psychedelic drugs market.

Key Points: 
  • With an increasing cultural spotlight, there has been substantial economic growth of the psychedelic drugs market.
  • Legislative restrictions have made it difficult to obtain government funding for psychedelic research, but now corporations are stepping up to fund clinical trials.

How conflicts of interest impact psychedelic research


Corporations work to pursue profit for shareholders, a motivational bias that differs from the goal of science which is to report findings as accurately as possible. At the same time, industry benefits the field by introducing new potential therapies. Nonetheless, there are numerous ways in which conflicts of interest may challenge scientific integrity in psychedelic trials:
Research topic selection: Corporations tend to prioritize research fields related to products that can be best commercialized.
Investigator psychology: Researchers may receive “gifts” from corporations, introducing a social and professional pressure to conform with their expectations and wishes.
Substance selection: Corporate interests are likely to favour substances that can be patented.
Population selection: Corporate interests may advocate for strict screening when recruiting volunteers to increase the chance of positive outcomes. This may result in the study cohort being easier to treat, which limits the generalizability of the results to real-world populations.
Study design: Corporate interests may favour study designs that are more likely to indicate statistically significant effectiveness, and less likely to identify adverse events.
Cost minimization: Corporate interests may favour less frequent sessions or follow-ups, reduced monitoring and fewer open interviews with participants in an effort to reduce costs. These changes make it more difficult to identify adverse events and might allow them to go unreported.
Reporting: Publication bias may occur in which scientific journals are more likely to publish positive findings, and negative findings remain unpublished.
Media engagement: Corporate interests may favour sensationalist media narratives that are not balanced. An emphasis on positive results can skew the public perception of psychedelics.
Participant psychology: Selective reporting in the media may contribute to “excessive enthusiasm” and expectancy bias in participants and researchers. This happens when individuals with positive views about psychedelics are more likely to volunteer for studies and expect positive outcomes.

Consequences for public health

  • The influence of conflicts of interest on psychedelic studies can contribute to an overly optimistic opinion by researchers, the public and policymakers.
  • This may pose safety risks to the public if legislative changes that increase access are made prematurely, as witnessed with tobacco and opioid industries in the past.

What we can do about it


There are a few ways to address these challenges:
Promote alternate funding sources: Government funding opportunities will allow psychedelic clinical trials to occur without or with partial corporate involvement.
Transparent reporting of corporate involvement: Disclosure of conflicts of interest is key in fuelling trust and allowing critical interpretation of findings.
Responsible reporting in the media: Sensationalist media coverage promotes inaccurate narratives, such as the ability of psychedelics to “cure” mental illness with one dose. Standards of reporting can be developed to ensure that media reports are as accurate as possible.
Research regulations and standards: Clinical trial protocols should be registered before the research acquires any corporate funding, with safety data as a main result. The inclusion of independent arbiters could help determine if any adverse events are related to the treatment.
Public education: Media literacy and public education programs, and ethical science communication, could help the public better understand psychedelic research results as well as promote informed policy changes and safe use.
Funding real-world evidence: Research funding agencies should support real-world cohort studies measuring long-term effects and health outcomes of psychedelic use.
Considering how to reduce the impact of conflicts of interest on psychedelic studies could help avoid public health risks and further setbacks on research efforts for these potentially life-saving therapies. While market-driven solutions have contributed to the development of life-changing therapies, more awareness is needed for how corporate interests may threaten research integrity and pose public safety risks in the pursuit of profit.

  • Elisa Brietzke receives funding from PSI Foundation (unrelated to this article) and Queen's University School of Medicine.
  • Marco Solmi receives funding from CIHR, and has received honoraria/has been a consultant for AbbVie, Angelini, Lundbeck, Otsuka.

China’s Interim Measures for the Management of Generative AI Services: A Comparison Between the Final and Draft Versions of the Text

Retrieved on: 
Tuesday, April 23, 2024

Authors: Yirong Sun and Jingxian Zeng Edited by Josh Lee Kok Thong (FPF) and Sakshi Shivhare (FPF) The following is a guest post to the FPF blog by Yirong Sun, research fellow at the New York University School of Law Guarini Institute for Global Legal Studies at NYU School of Law: Global Law & Tech [?]

Key Points: 


Authors: Yirong Sun and Jingxian Zeng Edited by Josh Lee Kok Thong (FPF) and Sakshi Shivhare (FPF) The following is a guest post to the FPF blog by Yirong Sun, research fellow at the New York University School of Law Guarini Institute for Global Legal Studies at NYU School of Law: Global Law & Tech [?]

Press release - Carbon removals: MEPs adopt a new EU certification scheme

Retrieved on: 
Thursday, April 18, 2024

- Certification framework to boost high-quality carbon removals and counter greenwashing

Key Points: 
  • - Certification framework to boost high-quality carbon removals and counter greenwashing
    - New rules will enable farmers to get paid to remove carbon
    - Public EU registry to ensure transparency
    The law will set up an EU certification framework for carbon removals to boost their uptake and help achieve EU climate neutrality by 2050.
  • Parliament on Wednesday adopted the provisional political agreement with EU countries on a new voluntary certification framework for carbon removals, with 441 votes in favour, 139 against and 41 abstentions.
  • The legislation covers different types of carbon removals, namely permanent carbon storage through industrial technologies, carbon storage in long-lasting products and carbon farming.
  • You can read more about the new rules in the press release after the deal with EU countries.

Press release - New EU rules to improve urban wastewater treatment and reuse

Retrieved on: 
Thursday, April 18, 2024

- Better monitoring of chemical pollutants, pathogens and antimicrobial resistance

Key Points: 
  • - Better monitoring of chemical pollutants, pathogens and antimicrobial resistance
    - Producers of pharmaceuticals and cosmetics and member states will have to finance costs of additional treatment for micro-pollutants
    - Wider reuse of treated urban wastewater to prevent water scarcity
    On Wednesday, MEPs approved new EU rules for the collection, treatment and discharge of urban wastewater.
  • the removal of nitrogen and phosphorus) will be applied in all wastewater treatment plants covering 150,000 p.e.
  • An additional treatment removing a broad spectrum of micro-pollutants ('quaternary treatment') will be mandatory for all plants over 150,000 p.e.
  • EU countries will be required to promote the reuse of treated wastewater from all urban wastewater treatment plants where appropriate, especially in water-stressed areas.

Press release - Geopolitical situation makes voting in European elections even more important

Retrieved on: 
Thursday, April 18, 2024

The European Parliament’s last Eurobarometer survey before the elections in June reveals awareness among citizens and concern for the current geopolitical context. Source : © European Union, 2024 - EP

Key Points: 


The European Parliament’s last Eurobarometer survey before the elections in June reveals awareness among citizens and concern for the current geopolitical context. Source : © European Union, 2024 - EP

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

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      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

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      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

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      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Focus group on veterinary pharmacovigilance reporting in aquaculture, European Medicines Agency, Amsterdam, the Netherlands, from 22 November 2023, 10:00 (CET) to 22 November 2023, 17:00 (CET)

Retrieved on: 
Thursday, April 18, 2024

Date

Key Points: 
  • Date
    - Wednesday, 22 November 2023, 10:00 (CET) - 17:00 (CET)
    Location
    - European Medicines Agency, Amsterdam, the Netherlands
    Event summary
    The European Medicines Agency has a coordinating role in the EU pharmacovigilance system and operates services and processes to support veterinary pharmacovigilance activities.
  • This entails surveillance of adverse events, including lack of expected efficacy reported after veterinary medicinal products are used in practice, to safeguard animal and public health and the environment.
  • The Agency is hosting a Focus group meeting for veterinarians or other healthcare professionals on facilitating pharmacovigilance reporting of medicinal products used in aquaculture.
  • Registration
    Attendance is by invitation only.

EMA/FVE info session on restrictions for the use of certain antimicrobials in animals, Online, European Medicines Agency, Amsterdam, the Netherlands, from 23 May 2024, 15:00 (CEST) to 23 May 2024, 16:00 (CEST)

Retrieved on: 
Thursday, April 18, 2024

During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.

Key Points: 
  • During this session, participants will have the opportunity to engage with experts who contributed to the development of the available guidance.
  • Registration
    Please register for the webinar using the below online form:
    EMA/FVE info session on restrictions for the use of certain antimicrobials in animals
    Please note this event will be recorded and published on the EMA website.
  • By registering for this event, you are consenting to EMA to process your personal data in accordance with Regulation (EU) 2018/1725.
  • EMA's data protection notice below explains how personal data is processed by the Agency and via the tool Webex:

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Thursday, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 6/14

      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Using research to solve societal problems starts with building connections and making space for young people

Retrieved on: 
Wednesday, April 10, 2024

Often, when scientists do research around a specific societal challenge, they hope their work will help solve that larger problem.

Key Points: 
  • Often, when scientists do research around a specific societal challenge, they hope their work will help solve that larger problem.
  • Yet translating findings into long-lasting, community-driven solutions is much harder than most expect.
  • Issues like climate change, renewable energy, public health and migration are complex, making direct solutions challenging to develop and implement.

Defining use-inspired research

  • A framework called use-inspired research and engagement, or UIRE, acknowledges this fact.
  • In use-inspired research, the potential applications of findings for society shape the directions of exploration.
  • Use-inspired research expands on translational research, prioritizing building connections between practitioners and communities.
  • In the U.S., the passage of the CHIPS and Science Act in 2022 further codified use-inspired research.

Producing science in partnership

  • Together, these teams apply the results and develop products, implement behavior changes, or further inform community decision-making.
  • For example, a large hospital, an academic organization and several nonprofits may partner together to explore issues affecting health care accessibility in the region.
  • These groups can then collaborate further to develop specific programs, such as educational initiatives and enhanced health care services.
  • They can tailor these to the needs of the community they serve.
  • Use-inspired research matters because it looks at all the different issues facing a community holistically and keeps them in mind when investigating potential solutions.
  • UIRE is not a substitute for basic, foundational research, which explores new questions to fundamentally understand a topic.

Harnessing early-career engagement

  • They also focus on making the findings accessible to those outside academia.
  • To craft necessary solutions for complex societal problems, institutions will need to continue backing traditional scholars who excel at pure basic research.
  • Creating opportunities for the ongoing involvement of young people will seed a vibrant future for use-inspired research and engagement.


Zoey England is currently completing a Use-Inspired Research Science Communications fellowship, funded through a grant from the National Science Foundation. She has also received funding from CTNext. Jennifer Forbey receives funding from the National Science Foundation. Michael Muszynski receives funding from the National Science Foundation. He is affiliated with the Maize Genetics Cooperation.