Do We Really Want (or Need) Big Electricity?

By Nathan Whitmore

For the last few weeks I’ve been followed around the internet by ads proclaiming that Thync, some sort of white triangle thing that can supposedly energize or relax you, is “how good feels”. Regardless of the validity of this statement it’s an indication that something interesting is happening–a class of devices and software that I refer to as “neuroapps” is rapidly becoming A Thing.

The key characteristics of neuroapp manufacturers–as opposed to the larger group of companies which develop electronic stimulators for research and other niche use–is their focus on developing devices to produce specific, targeted changes in the brain. Foc.us (likely the most popular of these companies) produces headsets which claim to enhance video game and atheltic performance, while Fisher-Wallace produces a device for treating a number of psychiatric conditions and the relatively new startup Thync has engineered protocols to electrically increae energy or promote relaxation.

In this way, neuroapp companies are not so much companies like Soterix that produce devices designed to stimulate the brain in arbitrary ways decided by the user as they are like pharmaceutical companies. Like pharmaceutical companies, the biggest questions they must deal with are biological ones: how does the brain work and how can we modify its function?

This similarity should give us reason to think about where neuroapps are going, and if it’s really where we want to go. A well-documented trend in the pharmaceutical industry, for instance, is that when companies are given responsibility for testing the efficacy and safety of their own products, the results are oddly likely to favor their commercial interests (far more so than when the research is conducted by a competitor or third party). Given the rise of use-specific, research-intensive neuroapps like Thync or Focus, now is an appropriate time to as: how to we ensure that the safety and effectiveness of these devices is based on solid science?

I’d like to believe that neuroapp companies will embrace good practices for conducting and disseminating research–but at present there’s very little reason for them to. The market leader, foc.us, has been successful selling two different headsets–without ever producing a scrap of evidence about what they actually do to the brain. The startup Thync, which has billed its “energy vibe” as based on intensive research, has yet to publish any data showing how–or if–it works. For neuroapps, where the effects on the brain are determined by a combination of intensity, waveform, duration and location, this is not unlike a pharmaceutical company selling a drug while refusing to disclose its chemical structure.

The remarkable willingness of regulatory agencies and users to accept this means that there is currently a strong disincentive for neuroapp companies to behave responsibly. Research is expensive, and publishing it can easily put a company at a competitive disadvantage–either by allowing others to create knock-off products without bearing the costs of doing the research, and because research may also show that the product is not effective for its intended use or has unintended side effects.

Part of this tolerance likely comes from the implicit assumption–among regulators , scientists, and consumers–that private and ultimately profit-driven initiatives are necessary to drive innovation and product development in the first place, and that some of the consequences of their operation (such as withholding information to protect intellectual property or studies biased towards commercial interests) are a “necessary evil” to provide the profit which enables the hugely expensive research in the first place and move the field as a whole forward.

This model has a deserved place in drug development, where the immense cost of developing a new drug means that there are few (if any) entities besides pharmaceutical companies with the resources to support such an effort (for perspective, the typical cost to develop a new drug can be more than a billion dollars , while the entire yearly budget for the National Institute of Mental Health is only 1.5 billion dollars) . But there are good reasons to think that the profitability of neuroapps is far less important than that of pharmaceuticals–and could become even less so with increased public funding that would be a remarkable good investment.

Neuroapps are fundamentally different from pharmaceuticals in several respects. First is that they do not require a distribution infrastructure. Once a brain stimulation protocol has been developed to accomplish something, an appropriate set of instructions or automated configuration file can be electronically distributed for a cost of essentially zero, and used with a wide array of existing stimulation equipment. This changes the game dramatically. Academic and government research groups–who have neither the resources nor the interest in running manufacturing and sales operations–can discover a brain stimulation protocol accomplishes something desireable and then distribute it widely while skipping the typical process of commercialization and technology transfer entirely.

Second, the cost to develop neuroapps is likely to be orders of magnitude lower than the cost to develop drugs for the same purposes, for several reasons. First, neuroapps interact with the body through a limited number of basic mechanisms (activating or deactivating nerves and brain regions, modulating synaptic plasticity, modulating ongoing brain rhythms) and are generally assumed to have negligible effects on systems not located in the head. Even extremely experimental neuroapps are usually considered safe enough to test on healthy humans. This means that, compared to an experimental drug which could interact with thousands of targets in the body through various means, pre-clinical and safety testing of neuroapps is very cheap. The very low regulatory burden imposed on neuroapps not designed for treating a specific disease also plays a role here, as they can largely sidestep the time-consuming FDA approval process for drugs and medical devices.

Both of these factors mean that, unlike drugs, it’s not so impractical to imagine neuroapps being created and tested with exclusively on public funding. In fact, such projects are going on currently at institutions such as the University of New Mexico which is developing a brain stimulation protocol that can accelerate learning , or the wide range of institutions currently conducting clinical trials of brain stimulation as a non-pharmacological treatment. The lack of a need for a distribution infrastructure, combined with greatly reduced barriers to sharing information when profit is not a factor, also means that public and nonprofit research efforts can benefit from collaboration and sharing of data and therefore achieve in aggregate the kind of large-scale evidence necessary to (tDCS as a depression treatment, for instance, was not developed exclusively by one particular center but rather from a group of studies conducted by different institutions that together have produced a large evidence base). Large, reliable studies, in other words, do not necessarily have to be the sole domain of privately funded research.

The takeaway here is this:academia, nonprofits, and funding agencies should not look to the private sector when it comes to brain stimulation, Rather, we should design mechanisms for funding and organizing large scale studies within the infrastructure of government, academic, and nonprofit agencies. It’s important to point out that simply changing where research conducted is not an instant fix for all issues of scientific integrity (academia has struggled with its own issues of replicability and fraud, for instance). But developing neuroapps explicitly for the public good, in environments where collaboration and scientific openness are not at odds with profitability, will strengthen research.

There are other reasons that we should look to public, rather than private, resources to develop brain stimulation. Drug companies rely heavily on their ability (protected by patents) to monopolize the market for a drug for a limited period of time; this often results in high (and sometimes exorbitant) prices while the drug is under patent. It is likely that neuroapp companies which invest heavily in research will behave the same way, out of a need to recoup their investment before others build cheap, knock-off devices.

This brings us perilously close to a situation that neuroethicists have worried about for years– the selective enhancement of the wealthy. Because neuroapps are likely to focus on enhancement over treating medical conditions, are unlikely be reimbursed by health insurance, and will probably be marketed in ways that can reach broader sections of the population than most drugs, the pressure for companies to recoup their investments has potential to drive up prices, in turn increase the problems posed by income inequality by allowing only those with enough money to afford to enhance their brain function. Publicly funded research and development initiatives are less vulnerable to this problem, because they typically expect a return on investment in terms of in scientific progress or a general social benefit–not just the return of a specific amount of cash. And make no mistake–developing technology that can safely modulate specific brain functions has the potential for enormous social benefits.

If research and development of brain stimulation protocols is handled principally by universities and government agencies, should there still be a role for private enterprise? Yes, there should, and it’s in producing the devices that will actually run the protocols, which are physical devices that require manufacturing, distribution, and marketing. A nascent market in these “flexible” brain stimulators in fact already exists, although there remains plenty of room for improvement in the user experience.

Designing these types of devices is something that industry does well; there’s not that much difference between building a phone that can run thousands of apps and building a brain stimulator that can run thousands of protocols. Importantly, these devices can be built to common standards and their quality can be easily assessed by third-party tests comparing their performance to the standard, a method that holds manufacturers accountable while protocol developers are held responsible for accuracy and integrity in their research by the scientific community.

Neuroapps are still a relatively young industry, and there’s a lot of uncertainty about how it should work. Because of that, there’s also a major opportunity to change how we conduct biomedical research for the better. We should leverage this early period and the possibilities that brain stimulation offers for low-cost and decentralized protocol development to build a socially responsible neuroapp ecosystem based on publically funded, high-quality research.