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 £50,000 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:
|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|
|8||ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT||CIMH||Germany|
|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|
|20||DEMCON ADVANCED MECHATRONICS BV||DEMCON||Netherlands|
|22||JOHANN WOLFGANG GOETHE- UNIVERSITATFRANKFURT AM MAIN||GU||Germany|
|23||UNIVERSITAIR MEDISCH CENTRUM||UMCU||Netherlands|
|25||UNIVERSITY OF NEWCASTLE UPON TYNE||UNEW||United Kingdom|
|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|
|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|
|47||UNIVERSITY OF BRISTOL||UNIVBRIS||United Kingdom|
|48||STARLAB BARCELONA SL||STARLAB||Spain|
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.