Sat, 11 Aug 2018

Attempting to lift the veil of secrecy over AIMS-2

This post appeared first on the Participatory Autism Research Collective (PARC) blog.

Written by: Panda Mery, Dinah Murray & Kabie Brook

The Autism Innovative Medicine Studies-2-Trials (AIMS-2-Trials) was launched as the largest ever grant given to autism research on June 18th. Two weeks ago, we wrote some questions about this project and the autistic representation and monitoring, if any. Dr James Cusack, Director of Science, Autistica wrote a response that answered only some of our questions. Some people commented on both these posts (below each).

A key issue that appears pervasive with this project is the secrecy surrounding it. For any monitoring of AIMS-2 to be effective, a monitoring panel would need to a) have access to internal documents and staff of AIMS-2 projects, and b) be able to discuss them publicly. Otherwise either those doing the monitoring will not be able to understand what is happening or they will only be able to express that they have concerns or none, without being able to say about what!

Autistica will contribute £50,00 in-kind (equivalent to €56,274 at the exchange rate on the day I converted it). In-kind contributions from autism charities (the Simons Foundation, Autism Speaks and Autistica) combined will be €55.5 million. And the AIMS-2 grant is €115 million. That means that Autistica’s contribution is about 0.1% of the in-kind contributions from autism charities and less than 0.05% of the total grant; clearly any power that Autistica wields in that consortium is not financial. This makes the release of their agreement with AIMS-2 all the more important and it would help restore some of the lost trust.

The secrecy runs deep. Something as simple and essential as finding out the list of participants is fraught with difficulties. At launch, the AIMS-2 press release (pdf capture on 2018-07-31) stated there were 48 partners… and included 38 logos. We used the Innovative Medicine Initiative’s (IMI2) Access to document scheme to request the full list of participants as well as a copy of the AIMS-2 grant agreement, including its appendices (which should include details of any ethical processes). Requests are handled within 15 working days, unless IMI2 extends this limit, and our request for the agreement is still under consideration. However IMI2 did send us the list of participants. Not to make things too easy, the list was provided in a Word document with two low-resolution scan images (too low for OCR to work) of the print out of the table over two pages! So after a painstaking retyping here’s in exclusivity (the IMI2 JU Access to Documents Team did write that ‘the relevant information will be shortly published’ - we’re already more than a month and half since launch) the ‘List of beneficiaries’ of AIMS-2:

No

Name

Short name

Country

1

KING’S COLLEGE LONDON

KCL

United Kingdom

2

F. HOFFMANN-LA ROCHE AG

ROCHE

Switzerland

3

THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE

UCAM

United Kingdom

4

STICHTING KATHOLIEKE UNIVERSITEIT

RUMC

Netherlands

5

SERVICIO MADRILENO DE SALUD

SERMAS

Spain

6

INSTITUT PASTEUR

IP

France

7

UNIVERSITAT BASEL

UNIBAS

Switzerland

8

ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT

CIMH

Germany

9

BIOSCI CONSULTING

BIOSCI

Belgium

10

RIJKSUNIVERSITEIR GRONINGEN

RG

Netherlands

11

THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

UOXG

United Kingdom

12

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

INSERM

France

13

THE UNIVERSITY OF EDINBURGH

UEDIN

United Kingdom

14

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

APHP

France

15

THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN

TCD

Ireland

16

BIRKBECK COLLEGE - UNIVERSITY OF LONDON

BC

United Kingdom

17

STICHTING BURO ECNP

ECNP

Netherlands

18

NOLDUS INFORMATION TECHNOLOGY BV

NOLDUS

Netherlands

19

ARTTIC

ARTTIC

France

20

DEMCON ADVANCED MECHATRONICS BV

DEMCON

Netherlands

21

KAROLINSKA INSTITUTET

KI

Sweden

22

JOHANN WOLFGANG GOETHE- UNIVERSITATFRANKFURT AM MAIN

GU

Germany

23

UNIVERSITAIR MEDISCH CENTRUM

UMCU

Netherlands

24

UNIVERSITEIT GENT

UGent

Belgium

25

UNIVERSITY OF NEWCASTLE UPON TYNE

UNEW

United Kingdom

26

UNIVERSITAET ULM

UULM

Germany

27

CENTRE HOSPITALIER REGIONAL UNIVERSITAIRE DE TOURS

CHUT

France

28

KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN

TUM-MED

Germany

29

Fondazione Stella Maris

FSM

Italy

30

UNIVERSIDAD DE SALAMANCA

USAL

Spain

31

UNIVERSITY OF GLASGOW

UGLA

United Kingdom

32

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

CEA

France

33

UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG- AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS

UNG-GOE

Germany

34

STELLENBOSCH UNIVERSITY

SU

South Africa

35

UPPSALA UNIVERSITET

UU

Sweden

36

UNIVERSIDADE DE COIMBRA

UC

Portugal

37

FUNDAZIOA POLICLINICA GIPUZKOA FUNDACION

FPGF

Spain

38

FUNDACIO CLINIC PER LA RECERCA BIOMEDICA

FCRB

Spain

39

JANSSEN PHARMACEUTICA NV

JANSSEN

Belgium

40

NOVARTIS PHARMA AG

NOVARTIS

Switzerland

41

UCB BIOPHARMA SPRL.

UCB

Belgium

42

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Teva

Israel

43

AUTISM SPEAKS INC. NON PROFIT CORPORATION

AUTISM SPEAKS

United States

44

THE SIMONS FOUNDATION, INC

SFARI

United States

45

AUTISTICA

Autistica

United Kingdom

46

AUTISME-EUROPE AISBL

AE

Belgium

47

UNIVERSITY OF BRISTOL

UNIVBRIS

United Kingdom

48

STARLAB BARCELONA SL

STARLAB

Spain

(Here’s also the information as a spreadsheet in case you want to explore it further and the original Word document for reference.)

A few days after we received this list, in what must be a coincidence, the press release was updated and now features 48 logos (pdf capture on 2018-08-02 in case it has been changed again). The original 38 logos are a subset of the 48 ones. However if you compare attentively the logos and the list, you will notice that they don’t all match. When I queried this I didn’t get any explanation about the discrepancies, just that ‘we can confirm that the list of beneficiaries sent to you on Monday 30 July is authoritative and does describe all beneficiaries to the project.’

Some of the discrepancies have likely explanations. For instance the logos for 'KIND Center of neurodevelopmental disorders at Karolinska Institutet’ and for 'Karolinska Institutet’ likely are both for the same organisation (entry 21 of the table). For some it is possible that a logo, e.g., for the 'Nuffield Department of Clinical Neurosciences’ may correspond to that of a participant appearing under a different name (entry 11). However these are just guesses and do not explain all these discrepancies. For instance the 'NHS Greater Glasgow and Clyde’ whose logo features on the press release does not seem to fit with any of the participants on the allegedly authoritative list. Same goes for the logos of the Donders Institute and the Radboud University.

Could there be such a gross error in the press release? Or could there be more than 48 participants? We cannot say with the information currently available. And all that confusion is just about the basic information that is the list of participating organisations in the AIMS-2 consortium. If it is so difficult to get such basic information out of AIMS-2, getting access to what is needed for effective monitoring will require an enormous effort at best.

Dr Will Spooren, the EU-AIMS project coordinator (also Group Leader Behavioral Pharmacology at Hoffmann-La Roche) wrote a presentation, titled Precision Medicine Approaches in Autism Spectrum Disorders, giving a bit more details on AIMS-2. This does not mention ethics or autistic participation. Dr Spooren is also a co-author with Professor Dr Declan Murphy, EU-AIMS academic lead, and lead author Dr. Eva Loth, EU-AIMS project coordination, of a related paper titled Defining Precision Medicine Approaches to Autism Spectrum Disorders: Concepts and Challenges. This mentions ethics once: ‘A treatment that is likely only effective in early development would raise important ethical implications for clinical trial designs that usually first test safety, efficacy and side-effects in adults.’ According to these two documents, their only ethical concern is testing drugs on babies, and that would only raise ethical implications so would still be considered. And no mention of autistic involvement either.

So the situation a month and half after launch is we’ve managed to get a list of participants, but found discrepancies with the press release that remain unexplained. We found some further documents that demonstrate little attention to ethical concerns and no interest in autistic participation, other than as test subjects. There is no information at all on the agreement between participants. Autistica is talking about convening a committee to select a panel, but with a lack of clarity on its composition (it could be made of a minority of autistics from what is currently known) and no information on how any monitoring panel can be effective: this does not bode well.

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