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Elon Musk’s medical-device startup Neuralink, whose brain-computer interface for patients with paralysis was recently touted as being on the verge of beginning human trials, has come under federal scrutiny for alleged animal-welfare violations.

The probe, opened by the Department of Agriculture at the behest of a federal prosecutor, came amid a staff outcry that the company’s testing is being done hastily, causing extraneous pain and death to animals, per a recent Reuters exposé on both the investigation and internal complaints.

Over the four years Neuralink has been testing its brain implant, according to the report, some 1,500 animals have died. 

In and of itself, the count isn’t necessarily indicative of a violation of standard research practice or of the Animal Welfare Act, which sets the parameters for how researchers need to treat and test animals. 

Yet, employees have raised red flags about their work culture, namely that Musk has set unrealistic demands for speed. Those demands, they claim, have caused them to sweat deadlines and make last-minute changes to surgeries, resulting in slip-ups in scientific procedures that then need to be repeated, compounding the loss of life.

In one instance, Reuters noted based on interviews with 20 current and former Neuralink staffers in addition to the wire service’s review of internal documents, 25 out of 60 pigs had the wrong-sized device implanted in their heads. Another involved botched surgeries that left one employee warning of the need to prevent further “hack jobs.”

Musk defenders tend to have a field day with anything related to the world’s richest man, new Twitter owner and Tesla/SpaceX CEO. Thus, the optics around its high-profile CEO/co-founder have no doubt intensified the spotlight on Neuralink.

However, the revelations portray a leader hell-bent on making faster progress. Rival startup, Synchron which, like Neuralink was also founded in 2016 to develop a brain-computer interface, has beaten it to the clinical trials stage, while notching a comparatively low 80 animal deaths, Reuters pointed out. 

This also isn’t the first time questions have been raised around Neuralink’s use of research animals taking place at the California National Primate Research Center. Mostly, those questions have come from the group Physicians Committee for Responsible Medicine (PCRM), which has brought to light the often gory details of Neuralink’s cranial experiments.

What’s not clear at this point is the full scope of the federal probe, how it overlaps with the staff accusations, and the extent to which ethical or legal lines may have been crossed. 

To that end, Paul Root Wolpe, PhD, who is the Raymond Schinazi professor of bioethics and director, Center for Ethics at Emory University, spoke with MM+M about the case. 

Earlier in his career, Wolpe took part in discussions both at the University of Pennsylvania and NASA about animal welfare. As part of his role at Emory, he currently consults on ethical issues, including those involving animal research.

The following interview has been edited and condensed.

Marc Iskowitz, MM+M: Do you have an overall comment before we get into the details of the Neuralink case? 

Paul Root Wolpe, Emory University: There are a couple of different factors at play here. First of all, animals in research are always a means to an end. Because of that, there’s always the potential for violating their welfare, whether in businesses, laboratories or universities. There’s always pressure to try to get the result, and that’s why we put the Animal Welfare Act and public health policies in place to try to prevent that, to the degree possible. 

Part of the problem is there’s more oversight in universities and other institutions who get federal grants. But there’s another layer of protection when you have a grant — from the National Institutes of Health or some other institution — that isn’t there when you don’t, and especially isn’t there in business. We have to be especially vigilant when it comes to private businesses and these animals. 

The other important thing to say is that the Animal Welfare Act specifically excludes rats, mice and birds from its oversight. When it comes to how research facilities treat those types of animals, there’s even less protection and much more opportunity for abuse. 

MM+M: Neuralink has tested sheep, pigs and monkeys. Are they all covered by the Act? 

Wolpe: Monkeys are; mice, rats and birds are not. 

MM+M: So, U.S. regulations exclude those types of animals. They also don’t specify how many animals companies can use for research. They seem to give significant leeway to scientists to determine when and how to use animals and experiments. I should note that regulatory filings show Neuralink’s facilities have passed all of their USDA inspections. 

Whether killing animals in the pursuit of science is necessary is a separate issue. But are these 1,500 deaths something that we should just chalk up to science or is there a point where one faults the researcher for causing needless harm? 

Wolpe: Right, so there’s no way to evaluate whether 1,500 animals is too many or not. Everything depends on how long it’s been going on, how many different research projects are involved, etc. What’s more important is to ask the question, “Given the goals of the project, is the organization doing everything possible to – first of all – minimize the number of animals used? And second of all, to be stewards of their welfare?” We don’t know the answer with Neuralink.

However, there seems to be enough smoke to believe that there’s fire. There are employees who have resigned over the treatment of animals, who have complained about [the company]. What makes the case a little more complicated is that so much of the research is being done at UC Davis Primate Center, and that center should come squarely under the increased protections provided by the public health service. 

Any institution that takes any federal money has to follow those rules in all of its animal research, even in its animal research not covered by the federal money. That’s the deal you make with the federal government when you accept a federal grant. The UC Davis Primate Center should be covered by these higher-level protections. 

Now, I don’t know if Neuralink does research anywhere else, but there were also complaints about pigs and other animals. I don’t know where they do that research, so I don’t know whether those other animals are also covered by these federal guidelines that are on top of the Animal Welfare Act or not. 

MM+M: UC Davis is where the first complaints about the company’s testing arose, after PCRM filed a complaint with the USDA accusing Neuralink of botching surgeries that killed monkeys and aired the findings publically. 

To your earlier comment, this is taking place within an academic institution. One would think the project would thus come under more oversight to prevent these kinds of violations. 

Wolpe: UC Davis should have an Institutional Animal Care and Use Committee (IACUC), which is responsible for overseeing any animal use. 

All of the primate research should have been reviewed by the institution’s IACUC. It’s their responsibility to both screen the studies – making sure that they’re reasonable to begin with, that they’re not just frivolous or aren’t using animals for no purpose – and then to look at the animal protections that are being put into place. 

They need to make sure the animals aren’t experiencing pain, that their environments are correct, their food is adequate, they’re getting groomed and cared for by the animal techs. The IACUC should have reviewed anything that happened at UC Davis, and then should oversee it in the sense that they should get reports back, such as if adverse events happen that weren’t part of the protocol. 

I’m not privy to which studies the IACUC approved. The committee often says, “You can do this under the following conditions,” and changes the protocol in some way if they find something inadequate. I have no idea if the IACUC altered any of Neuralink studies to increase animal protection or how much it has reviewed what has been going on. But they’re the real institutional barrier to animal abuse. They’re the structure that we put in place in universities to oversee animal health, not the only one but the primary one. They’re at every university that does any animal research. 

The IACUC is supposed to protect mice and rats as much as it’s supposed to protect monkeys. It’s not subject to the Animal Welfare Act. It is supposed to protect any research done at an institution, especially one that gets any federal money. 

MM+M: What does Neuralink need to suss out that it’s exposing so many animals to this deadly harm? 

Wolpe: The important thing here is that the reports we’re getting are that there’s such enormous pressure to move quickly, that the animals are the ones being sacrificed and are suffering. 

Also, as someone who’s worked in science my whole life, it would give any scientist pause to hear that they’re pushing the research so fast that they’re having to redo experiments with animals because the pressure has fouled those experiments. The reason that’s worrisome is that in a situation where you have a lot of pressure to get things done quickly and you are seeing mistakes being made in science, the suffering of the animals is a secondary effect of bad science. 

It’s bad science that is also worrisome here, that the pressure to get these products to market is so great that the science is being sacrificed and the animal suffering is a byproduct of bad science. What we seem to be reading is that they had to redo experiments and sacrifice more animals because of the science not being done carefully and methodically. There is a tension between the desire to get a product to market and the need to make sure that it’s safe. This is true in all medical instrumentation and development, whether it’s a heart stent or some other new medical device.

There’s always pressure to get to market and always the important steps of scientific validation because it’s going into the human body. When you’re dealing with brain prosthetics or brain devices, it’s that much more important. Mechanisms that go awry in the brain have a profound impact on human beings. Equally worrisome to the animal suffering is the question of how good science is.

One article I read said that Musk wants to start human experimentation in six months. Well, that’s going to have to go through human subject protection committees. If I was on that committee, I would be very, very wary of the animal experimentation flaws. 

MM+M: If the researchers are killing that many animals, what does that say about the safety of the underlying technology? Are you commenting on that or are you saying it’s just not being carried out properly? 

Wolpe: Something subtler than that. Yes, it makes you worry about the underlying technology, but not because the technology is problematic but because the science seems to be problematic. They have to repeat experiments because they did such bad science. 

Then you have to ask, “Well, if your science is so flawed that you’re ruining experiments and having to repeat them, then how much trust can I have in the scientific results you’re reporting to me?” 

The most important thing in these kinds of cases is trust in what the company is reporting to the federal agency. 

Pharmaceutical companies are careful about that. They deliver reams of paper trying to show what the scientific results were of their studies, to show that their drugs are safe. As soon as the federal agency begins to worry about whether the science itself is valid, then you’ve got a real problem. 

If I were reviewing Neuralink’s move to human experimentation, I would be scrupulous at examining that science, looking for flaws and looking for reports that seem to be cast in a positive light when the actual data shows more problems. They have set up a situation where there’s reason to mistrust science.

MM+M: So the animal deaths may just be a side effect of that breakdown in the scientific process, aside from the underlying technology which the experiments are trying to suss out?

Wolpe: Right. Remember that a lot of these animals get killed intentionally. That is, you do an experiment and then you intentionally — they call it “sacrificing” because they don’t want to say “killing” to the public — to do a postmortem, take out its brain and see if your device caused any problems in the brain. The deaths themselves are not the issue because almost all of these animals are going to end up dead at the end. 

What’s problematic is the reports that we’re getting, that research had to be repeated; because after the research was over and all these animals were sacrificed, it turned out that the research was flawed so that the deaths of these animals was not useful. It meant nothing. You couldn’t use that data because the research was bad. That’s what concerns me. Yes, the research itself seems to be less than careful, and having to repeat research more than once, which is what the reports are saying, is a big red flag. 

MM+M: To your earlier point, should moving to human trials give us pause?

Wolpe: I would say “yes,” until the questions that these complaints have raised have been fully investigated and resolved. The applications for human subject trials should be looked at very, very carefully. There are many people who think that animal trials shouldn’t be conducted at all. But making the same mistakes in human trials is uncontroversially a threat. So you need to make sure that when human trials start, they are at the highest level of science.

MM+M: Finally, how atypical is it for the USDA inspector general to be asked to investigate an animal research facility?

Wolpe: It happens. I don’t know the actual frequency, but there’s also politics here. Elon Musk these days is about as high-profile a human being out there. It would be different if this were some obscure tech startup with exactly the same problems. Because it’s Neuralink, it gets far more media and public scrutiny — the Musk-a-phobes are all on top of this. There’s an optics issue here as well and that’s part of the reason why it went all the way up to the top.