Allegations of commercialisation at Sanger

14 December 2019

Interview with 

Deepti Gurdasani; Segun Fatumo, MRC/UVRI & LSHTM Uganda Research Unit

PEN_PAPER_CONSENT

Pen lying next to a checkbox on a piece of paper with I Agree written beside it.

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After analysing an unprecedented dataset of African people's DNA, the obvious next step is to use that data and feed it back into research methods, with the aim of building capacity for science in Africa. Now that scientists know which genes are most interesting to study in African populations, they can tailor their research. For geneticist Deepti Gurdasani, that was the vision anyway - until a question of consent derailed the entire thing. She speaks to Phil Sansom...

Deepti - In order to study hundreds of thousands of Africans, we wanted to build an efficient and cost-effective tool.

Phil - What do you mean by tool?

Deepti - It's essentially a chip. It's a small chip with wells in it. So it's not able to build a full picture of somebody's DNA sequence, but it's able to provide a picture of between a hundred thousand to a million points across the genome that would best reflect the genetic diversity in Africa.

Phil - So did you develop the chip?

Deepti - So we essentially looked at the consents and the ethics, and noted that we would need to go back to the communities and the ethics committees. And the process was taken out of our hands. And senior managers at the Institute took this over and made the decision to go ahead and manufacture a product, and commercialise it.

Phil - When you say commercialise, are you talking like a 23andme DNA test?

Deepti - No, no. By commercialise I mean: the array was sold to the Wellcome Sanger Institute by Thermo Fisher. And there was essentially a purchase order placed by Sanger which made clear that the Sanger would receive certain fees in return.

Phil - I'm confused. You were developing the chip, you were at the Sanger. Why are suddenly the Sanger the ones buying stuff?

Deepti - We can't actually manufacture the chip. The chip has to be manufactured by a commercial organisation because we don't hold the technology. And this is a commercial arrangement because Thermo Fisher is profiting from sales to Sanger, if that makes sense.

Phil - Oh, the chip company is profiting.

Deepti - Exactly.

Phil - You give them the data...

Deepti - As scientists, we are only able to say, "oh, these are the genetic variance that we find in Africans. Like we found this alpha thalassemia variant, we want this to be on the chip," if that makes sense. It's like, for example, identifying a particular gene that a particular drug might work on, but the manufacture of the drug is done by a pharmaceutical company, you know?

Deepti - There were two parts to the commercialisation. So the first part to the commercialisation was that Sanger would buy the chip. Thermo Fisher would profit from it, they would buy the chip for research. The second phase of commercialisation was - which never took place because we intervened - was that the chip would be sold to third parties, other research institutions, other bodies across the world, and Sanger would receive a royalty share from that. Other partners were also supposed to receive a royalty share for that. But like I said, there was actually no consent or legal agreement to actually cover commercialisation. And in the end when we intervened, none of that took place.

Phil - Right. Ultimately commercialisation gives money to both Thermo Fisher and the Sanger.

Deepti - Exactly, yes.

Deepti - They wanted to buy the chip for African research, so essentially the chip was being developed to do a much larger study of about a hundred thousand individuals across Africa and this was very much a project that we wanted to lead on.

Phil - What was the permission issue?

Deepti - So there are different levels of permission issue. There was a permission issue with the actual consent from participants, because if you look at the consent for many of the data resources that were involved in developing this chip, they only had very restricted consent. So for example, some of them had only consented to the use of data for diabetes. Some of them had only consented to the use of data to study people's ancestry and history of their populations. So the consent from participants didn't actually allow the use of their data in this way. And definitely not for the development of a commercial product for many of these. But even for research use, broader research use would have required us going back to the ethics committees and potentially even to the communities to ask their permission before proceeding.

Phil - Even though the eventual chip was designed for research?

Deepti - Yes, because the organisation that makes the chip definitely profits from it. So it is a for-profit exercise, and that is something that needs to be clearly explained to the communities who have provided the samples and the data.

Phil - So how would you go about getting the extra permission?

Deepti - We and our African partners would have essentially gone back and spoken to communities, community leaders, and asked them how they felt about developing something like this, and told them that this would be really, really useful for science across Africa, but it would mean that companies would profit. It would also have involved going back to the ethics committees and asking them, would it be ethical to proceed balancing individual consent and harm?

Phil - How long does all that take?

Deepti - Probably around six months or so.

Phil - Hang on. With the Uganda data in particular that we were talking about earlier...

Deepti - Yep.

Phil - That was like a 10 year project. So six months isn't that bad...

Deepti - No, no it isn't that bad. And you know, it's something that we've done a lot. I mean, a lot of our studies involve field studies in different parts of the world. So we are used to going back, talking to communities, talking to research ethics committees and figuring out how to go about doing these things. So it definitely wasn't a long time.

Phil - So why did it get taken out of your hands?

Deepti - I'm not really sure.

Phil - Without passing judgement... I just don't understand. You already had a procedure in place and you had a plan to get the permissions.

Deepti - Yes.

Phil - What benefit is there in not?

Deepti - I'm speculating here, but had this been fully commercialised, it's a product that would have been used very, very widely across the research community. So it's something that potentially could have resulted in a lot of financial incentive back to the organisation. The second thing that I find quite striking is that the Sanger did discuss going ahead with the University of Cambridge, which was its partner within the UK, but didn't actually seek permission from the other African institutions. And potentially there is a thinking that African institutions may not be able to challenge, legally, something like this that happens, so they can be told about this later. I think there was also a fear that the price of the array would go up if there was a huge delay. I think that was a real fear. So I think, again, one of the motivations may have been to keep the price down, but I think we argued that getting the ethics right was much, much more important than keeping the price low.

Phil - These are Deepti’s own views on the Sanger commercialisation, of course - not her employers or anyone else’s. And to be clear - this episode of Naked Genetics is not about how the Ugandan Genome Resource. And she also wants to make it clear that the problems with the array are totally distinct from the Ugandan project, which a lot of people spent a decade working on. People like Segun Fatumo, who again was one of the key figures in the Uganda Genome Resource. His view on the consent issue is different - while Deepti previously mentioned that some groups in South Africa and Egypt only gave narrow consent, here Segun is talking about Uganda only...

Segun - So I would say that there are many categories of consent. As far as I understand we had a broad consent. What that means is that the research subjects, they allowed us to use their samples for this study and also for future studies,, both in Uganda, in the UK and also in the US and other countries. So what I cannot say specifically is if it allowed for commercialisation. But what I do know is that, supposing that it does not allow for commercialisation, there are all these ways about... we have an ethics committee in Uganda and other places in Africa, which normally you apply to them.

Phil - So if you're not sure, you go to the Ugandan ethics committee.

Segun - Yeah. If you're not clear about what the consent allows for the right thing to do is to go back to the ethics committee, in this case the Uganda ethics committee and other ethics committees in Africa, and ask for approval.

Phil - It’s important to note that the Sanger has been legally cleared of all wrongdoing - by both a barrister and independent intellectual property lawyers. And they completely refute allegations of misuse that came not just from Deepti, but from partner organisations in Africa. The Sanger certainly does have a reputation for good ethics - there were at the forefront of the legal battle to prevent people patenting genes for profit. Just like now they’re at the forefront of improving research and opportunities in Africa. The very reason behind developing a tool for making that research cheaper and more accessible. I really wish that they’d agreed to my request for specific comment, because at least when it comes to the consent issue, maybe they could explain themselves. But they didn’t.

Deepti - I think it's a huge ethical issue, even above being a legal issue, because there is a lot of helicopter science that happens with African samples. And by that I mean samples get taken out of Africa, data gets taken out of Africa, African researchers aren't involved, African institutes aren't involved. The communities who contributed data aren't involved. And there is a long history of this. In the context of that, we have to be very, very sensitive to what's happened in the past and ensure that African institutes and African researchers are empowered to lead their own research and to make decisions about what happens with their samples and data.

Phil - Did the chips get made?

Deepti - They did. The chips got made, but unfortunately there are about 75,000 chips that are lying in a warehouse, which will expire in December I believe.

Phil - That's a lot of money.

Deepti - Yes, it was a lot of money. And given how much more African research we need, if this had been done properly, that money would have gone towards creating a huge dataset and looking at genetic determinants of disease in African populations that potentially could have benefited African research hugely. But unfortunately, those chips are probably never going to be used and will just expire as they lie there.

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