This post appeared first on the Participatory Autism Research Collective (PARC) blog.
Written by: Panda Mery, Dinah Murray & Kabie Brook
Last month, the Autism Innovative Medicine Studies-2-Trials (AIMS-2-Trials) was launched as the largest ever grant given to autism research – €115 million, with money coming from the EU, pharmaceutical companies and charities.
A month has passed and little has been clarified about what exactly this project is and what autistic involvement there will be.
The Annual Activity Report 2017 of the Innovative Medicines Initiative describes AIMS-2, under its IMI2 Call 10’ as ‘Personalised medicine approaches in autism spectrum disorders’.
It is no wonder that a project on personalised medicine attracts big pharma. If you take a world-wide prevalence rate of autism of 3%, admittedly a slightly high one but it makes calculations easier, then if a participating lab is trying to develop a drug targeting a third of autistics, that drug could be sold to 1% of the world population.
Confusingly, autism is not listed in the strategic research agenda (SRA) for IMI2. The four major axes of research are listed as:
- Target validation and biomarker research (efficacy and safety)
- Adoption of innovative clinical trial paradigms
- Innovative medicines
- Patient-tailored adherence programmes.
New genomic drugs do fit several of the strategic research agenda items though: biomarkers to identify autistics, trials of innovative drugs… and compliance with treatment.
Autistica stated that it is getting involved to ‘ensure that AIMS-2-TRIALS focuses on community priorities and involves autistic people and families at every stage.’ It is ‘contributing £50,000 in staff time and resources’.
Autistica surveyed the autistic community and published a set of 10 community priorities:
- Which interventions improve mental health or reduce mental health problems in autistic people? How should mental health interventions be adapted for the needs of autistic people?
- Which interventions are effective in the development of communication/language skills in autism?
- What are the most effective ways to support/provide social care for autistic adults?
- Which interventions reduce anxiety in autistic people?
- Which environments/supports are most appropriate in terms of achieving the best education/life/social skills outcomes in autistic people?
- How can parents and family members be supported/ educated to care for and better understand an autistic relative?
- How can autism diagnostic criteria be made more relevant for the adult population? And how do we ensure that autistic adults are appropriately diagnosed?
- How can we encourage employers to apply person-centred interventions and support to help autistic people maximise their potential and performance in the workplace?
- How can sensory processing in autism be better understood?
- How should service delivery for autistic people be improved and adapted in order to meet their needs?
Personalised medicine approaches don’t seem to fit with these community priorities. How will this be reconciled?
Nothing was communicated before the launch, and very little in the last month. Even the initial grant agreement of AIMS-2 is confidential – or at least has not been published so will Autistica be able to hold anyone to account ‘publicly’? Publishing the confidentiality agreement binding them would help instil some confidence in such a statement. In the meantime Autistica shared some explanations:
We had two options – neither of which was ideal: refuse to take part and the bid would have gone ahead but with less autistic involvement and less focus on community priorities; or be involved and make the bid more inclusive, respectful and focused on what matters to autistic people and their families. Making that decision was extremely difficult. We would have been criticised either way, but I ultimately believe that it is better to be in the room than not. [...]
We are creating a Europe-wide representative panel which can hopefully act as an independent voice on the project, make suggestions and consider approach in terms of policy. It’s not ideal as a mechanism for involvement, but it is better than what would have been there if we were not involved.
The ‘we’ is Autistica aspiring to represent autistic people in the context of this vast project. Even though they employ an autistic Director of Science, James Cusack, and even though they have been drawing on more and more autistic support over the last few years, can they possibly get this right? At the moment many of those autistic people –who had for example reviewed research proposals, contributed to discussions, given their time towards projects, suggested lines of research, benefitted from grants, joined Autistica’s Discover network; and felt valued– are suffering a sense of betrayal. Yet in the bigger picture of the AIMS-2, Autistica is positioning itself as delivering our voice to the project.
James Cusack added: ‘I am particularly interested in how we can leverage [that] activity for greater impact.’
This remains very vague. What will be the process to select autistics, what will be their access to AIMS-2 documents and people, what will be their power, what confidentiality agreement will they have to sign, etc. Nothing yet concrete that indicates autistics will have a meaningful voice.
At this point, we need to give Autistica the benefit of the doubt and encourage them to extract the best possible outcome, i.e. to aim as high as possible to get more effective autistic representation and scrutiny on the project.
The panel Autistica mentioned should have access to AIMS-2 information and have a meaningful voice in the project. For instance it should:
On Twitter, Autistica also mentioned:
We’re working with @AutismEurope to ensure that the priorities of autistic people are heard and to catalyse an approach that works for autistic people across Europe.’
This is a concern as Autism Europe is not led by autistics and Autistica should be working with autistic-led organisations in all European countries.
The press release for the launch of the initiative included many statements as to what AIMS-2 is, not all of them consistent, and not all fitting neatly under the personalised medicines approach either. AIMS-2 will:
That press release also hints at autistic involvement:
AIMS-2-Trials brings together autistic people and their families, academic institutions, charities and pharmaceutical companies to study autism and provide an infrastructure for developing and testing new therapies.
The embryonic websites lists some of the partners but not who are these ‘autistic people and their families’. This may come later!
A common statement among autistics is ‘once you’ve met an autistic, you’ve met one autistic’. This is meant to make the point that there’s a strong diversity among autistics. AIMS-2 turns that on its head to raise the prospect of lucrative targeted genomic drugs:
All autistic people are different which makes identifying and testing new therapies challenging. AIMS-2-Trials will take a precision medicine approach aimed at tailoring therapies to a person’s biological profiles. Achieving this will require developing tests that can predict how a person’s autism may progress throughout development and their likelihood of developing additional mental health problems.
Another concern is who are the partners. The press release states that there are 48 partners… and lists the logos of 38. Ten partners are missing. Who are they?
Update 2018-08-02: See the Response from Dr. James Cusack to concerns regarding Autistica’s involvement in AIMS-2 on the PARC blog.