The world’s first official trial for spinal cord injuries with embryonic stem cell-based products has been halted. Geron, the investigator company who received FDA approval for this study in 2009 and enrolled its first patient in 2010, announced on November 15 2011 that this trial would be discontinued with “immediate effect”.
Geron justified its decision on grounds of “capital scarcity and uncertain economic conditions” in its official press release. These concerns were reiterated in their webcast, which explained their steps along the lines of stakeholders’ interests: Geron had to keep the highest return for stakeholders in mind. The company suggested that the resources would now be used for advancing its in-house cancer trials (phase II).
Patient advocates were disappointed with the decision, particularly in relation to the motivations for the decision. Daniel Heumann was quoted by the Washington post as saying: “”I’m disgusted. It makes me sick. To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.””
Geron seemed to be less concerned about the patient population or the participants. In their webcast, they argued that first and foremost, the trial was a safety trial. The four patients, who had been enrolled and ‘treated’, had provided consistent data that no safety issues arose. Enrolling four more patients and finishing the trial, one of the Geron representatives suggested, would perhaps not even lead to incremental data. Second, the initial four patients had ended their treatment, as treatment in the Geron trial consisted of a single injection with a stem cell-based product. Monitoring of these four patients would continue, even upon termination of the trial. Finally, the company proposed that the individuals, who had consented to partake in the trial before the halt was announced, could still get their injection if they so desired. Geron emphasized that no one would be cut off from treatment. Interestingly, in response to being asked what the company would say to patients, its representatives answered that Geron had no direct contact with the patients; the announcement would have to be done by the clinics in which the trials would take place.
Geron also emphasized that it hoped to find a partner so that the trials could be continued under a future sponsor. The company is quoted here as saying “hoping not to let anyone down”, “hoped the program to have a future” hoped that “the field would continue to move forward” and finally Geron suggested that any hope would be welcome.
Whether the comment about patients being lab rats is fair, still remains a question for answering. Some scientists said that the halt was not surprising since the underlying science was perhaps not completely worked out. Robert Lanza, in the New Scientists, suggested for example: “It was a very difficult choice to go in and treat spinal cord injury…There was considerable concern in the scientific community that that might not have been the ideal first indication.” Similarly, John Martin, in the BBC news said: “The Geron trial had no real chance of success because of the design and the disease targeted. It was an intrinsically flawed study. And for that reasons we should not be describing this as a set back.” If these scientists are right, the comment about lab rats seems to gain some support, even when it is argued that the generated science is not necessarily lost. Furthermore, some support for this point of view could be drawn from the ethics literature. Here arguments have been put forward that the chosen patient population would perhaps not be the most ethically sound participants; whether the sub-acute patients could provide informed consent would be ethically contentious. Could the participants therefore be framed as lab rats under an ethical framework?
I’d like to identify here a further concern about participants as lab rats, from an ethical point of view. My concern is Geron’s offer to provide an injection to those who had already consented to participate in the trial (let’s call them ‘consentees’). Geron seemed, at least indirectly, to admit that their participation would not lead to incremental data. This makes the consentees’ efforts, arguably, futile. Consentees would not generate valuable data, while being exposed to risks (of an injection generally, unobserved long term effects etc.) The offer for ‘treatment’, as Geron euphemistically phrases the research participation, thus makes me raise my eyebrows; would it be ethically sound to inject these patients purely based on their consent? “Yes, I want this injection”. But on what basis can Geron justify this injection; it does not seem to be research, nor is it treatment either. The stem cell doses would was deliberately so low to generate as little effects as possible. Basing the injection on a principle of compassionate use seems also to be out of order in this experiment. Would it therefore be an injection of hope? And if so, what does this show us about participant’s therapeutic misconceptions? Perhaps an injection would reduce a consentee to the lowest status for lab rats: the leftover lab rat. To paraphrase what the injection would mean; ‘We can give you the injection, but it is only because you asked me to… It will not benefit anyone; neither you, nor science overall’. Indeed, arguably, this would certainly go towards treating the SCI injured individuals as lab rats.