In an amazing new MIT Technology Review piece, Antonio Regalado discusses how, “Some scientists are taking a DIY coronavirus vaccine, and nobody knows if it’s legal or if it works.” It is another powerful example of how “citizen-science” and medical self-experimentation (or “biohacking”) is increasingly being used to improve health outcomes, enhance human capabilities, or fight against deadly diseases like COVID. Regalado reports that:

Nearly 200 covid-19 vaccines are in development and some three dozen are at various stages of human testing. But in what appears to be the first “citizen science” vaccine initiative, Estep and at least 20 other researchers, technologists, or science enthusiasts, many connected to Harvard University and MIT, have volunteered as lab rats for a do-it-yourself inoculation against the coronavirus. They say it’s their only chance to become immune without waiting a year or more for a vaccine to be formally approved. Among those who’ve taken the DIY vaccine is George Church, the celebrity geneticist at Harvard University, who took two doses a week apart earlier this month. The doses were dropped in his mailbox and he mixed the ingredients himself.

Regalado notes that this is all happening despite legal and ethical questions:

By distributing directions and even supplies for a vaccine, though, the Radvac group is operating in a legal gray area. The US Food and Drug Administration (FDA) requires authorization to test novel drugs in the form of an investigational new drug approval. But the Radvac group did not ask the agency’s permission, nor did it get any ethics board to sign off on the plan.

Chapter 2 of my latest book (Evasive Entrepreneurs and the Future of Governance) features a discussion of DIY health efforts, citizen-science and biohacking. Average citizens are using new technological capabilities to address health needs, often beyond the confines of the law. Here’s the beginning of that discussion, which starts on p. 79 of the manuscript:

DIY health services and medical devices are on the rise thanks to the combined power of open-source software, 3D printers, cloud computing, and digital platforms that allow information sharing between individuals with specific health needs. Average citizens are using these new technologies to modify their bodies and abilities, often beyond the confines of the law. Welcome to the occasionally scary but oftentimes awe-inspiring world of biohacking. Biohackers are essentially “prosumers,” the term many used a decade ago to describe the way average citizens were taking advantage of new communications and computing technologies to become both producers and consumers of news, information, and entertainment. Pro-sumers evaded traditional industry norms and government regulations that had previously made it difficult for citizens to communicate freely. The same phenomenon is now shaking up the world of health and medicine as pro-sumers use new technological capabilities to take their health into their own hands and likely evade many traditional norms and regulations when doing so.

In other words, we can’t just put the genie back in the bottle with sweeping, repressive regulatory controls. Here’s an essay that Jordan Reimschisel and I wrote last year on “Biohacking, Democratized Medicine, and Health Policy” highlighting the many thorny policy issues in play here, as well as possible governance responses.

In another essay, Jordan and I argued that one of the most important and constructive policy responses would be stepped-up risk education and health literacy initiatives. We need constructive approaches to citizen-science and biohacking to make sure we address serious risks but simultaneously avoid blocking beneficial forms of health and medical innovation that our country desperately needs, especially at this time.

Margaret Talbot has written an excellent New Yorker essay entitled, “The Rogue Experimenters,” which documents the growth of the D.I.Y.-bio movement. This refers to the organic, bottom-up, citizen science movement, or “leaderless do-ocracy” of tinkerers, as she notes. I highly recommend you check it out.

As I noted in my new book on Evasive Entrepreneurs and the Future of Governance, “DIY health services and medical devices are on the rise thanks to the combined power of open-source software, 3D printers, cloud computing, and digital platforms that allow information sharing between individuals with specific health needs. Average citizens are using these new technologies to modify their bodies and abilities, often beyond the confines of the law.”

Talbot discusses many of the same examples I discuss in my book, including:

• the Four Thieves Vinegar collective, which devised instructions for building its own version of the EpiPen;
• e-nable, an international collective of thirty thousand volunteers, designs and 3-D-prints prosthetic hands and arms (and which has, more recently, distributed more than fifty thousand face shields in more than twenty-five countries.);
• GenSpace and other community biohacking labs; and
• Open Insulin and Open Artificial Pancreas System.

I like the way Talbot compares these movements to the hacker and start-up culture of the Digital Revolution:

The D.I.Y.-bio movement, which emerged in the early two-thousands, seems almost evolutionarily adapted to its historical moment,” she argues. “It echoes aspects of startup culture, especially the early days of personal computing, with its garage-based origin stories. First came the hardware, then the software; now even the wetware of life can be created in people’s homes. D.I.Y. bio reflects popular skepticism about professional authority and gatekeeping, but it is not skeptical about learning or expertise.

She also quotes others on this point, like John Wilbanks, a health technologist at the research nonprofit Sage Bionetworks:

when new biotech companies fail, they tend to sell off their equipment for a discount, and community labs and biohackers scoop it up. Wilbanks told me, “D.I.Y. bio is very similar to the home-brew, hacker-club culture of the late seventies in Silicon Valley. If you’ve not gone on eBay to shop for a DNA sequencer that they can ship to you in twenty-four hours, check it out—there’s a massive secondary market.”

Perhaps the most interesting thing about this bottom-up citizen-science movement is that it run the political gamut. It includes “anarcho-libertarians” to those “steeped in social-justice activism,” Talbot says. But they are all generally unified by a commitment to the widespread dissemination of scientific knowledge and transparency in health-related matters. “D.I.Y. biologists often have a greater commitment than their professional counterparts do to making their work open to scrutiny—and available for free on the Internet,” Talbot notes.

“The D.I.Y.-bio ecosystem includes a lot of do-gooders, and many of them have been galvanized by the covid-19 crisis,” she also observes. Quite right. I discussed that fact in the launch essay for my book, “Evasive Entrepreneurialism and Technological Civil Disobedience in the Midst of a Pandemic.” I documented dozens of examples of various individuals and organizations rising up to meet the challenges posed by the pandemic. “Eventually, people take notice of how regulators and their rules encumber entrepreneurial activities, and they act to evade them when public welfare is undermined,” I argued. “Working around the system becomes inevitable when the permission society becomes so completely dysfunctional and counterproductive.” DIY health innovation has gone mainstream out of necessity.

Importantly, Talbot notes that when it comes to what counts as success for DIY health and biohacking, sometimes good enough is, well, good enough. On this point, she quotes Jon Schull, an e-nable (non-commercial 3D-printed prosthetics) co-founder, who says, “it doesn’t matter that e-nable hands aren’t state-of-the-art. The job of professional prostheses-makers, he said, is “to produce something really good, and if it’s merely better than nothing it’s not good enough”—but, in some circumstances, something is better than nothing.”

That is a crucial point understanding why this movement is so important: Working together in a spontaneous, bottom-up fashion, citizen scientists and tinkerers can act quickly to fill pressing public health needs. Of course, that is exactly what makes these same innovations potentially risky and has some people wondering about the wisdom of such efforts—and the potential need for more regulation.

I wish Talbott would have spent a bit more time diving into these ethical and legal questions. I really struggled with them when writing about all this stuff in my new book on evasive entrepreneurialism and technological civil disobedience. She does briefly discuss how some FDA regs might affect DIY bio movement, including efforts like Open Insulin.  “Even if Open Insulin begins producing a consistent product, it will have to overcome all kinds of regulatory obstacles to demonstrate safety and purity before taking it to market,” she notes. “Manufacturers of pharmacy-grade medications must provide the F.D.A. with reams of evidence that they can produce the substances with complete consistency, in sterile environments. Proving this level of proficiency can cost millions of dollars.” But Talbot does not spend much more time exploring what might happen next on this front if DIY efforts continue to expand.

“But what should the law say about people… who are creating their own specialized medical devices in an open-source, noncommercial fashion?” I ask in my new book.

I outlined three potential future scenarios for the movement:

1. DIY technologies go mainstream and become more commercialized.
2. biohacking remains decentralized but becomes more mainstream and professional without becoming fully commercial.
3. biohacking turn even more rogue or underground in nature as a form of guerrilla innovation that sometimes borders on neo-anarchism.

Regardless of the outcome, the ethical and regulatory issues will persist and grow as technological capabilities continue to grow more sophisticated, decentralized, and inexpensive. I argue in the book that it would be foolish for policymakers to think they can (or should) bottle up this movement altogether:

biohacking and decentralized medicine will expand for a simple reason: People care deeply about improving their health and abilities. They will take advantage of new technological capabilities that let them do so—especially when those capabilities are significantly cheaper than other options. To reiterate, that does not make these technologies safe or smart, but it does mean we will need a new approach to governance as evasive entrepreneurialism expands in this arena.

And then I continue on to note how improved risk education and awareness efforts might be one solution to the growing DIY bio movement.

Anyway, for more discussion on this, see pages 79-87 of my new book. I’ve also listed a few other essays down below that you might find interesting, including several penned by my former colleague Jordan Reimschisel.

Additional Reading:

• Andrea O’Sullivan & Adam Thierer, “3D Printers, Evasive Entrepreneurs and the Future of Tech Regulation,” The Bridge, August 1, 2018, https://www.mercatus.org/bridge/commentary/3d-printers-evasive-entrepreneurs-and-future-tech-regulation
• Jordan Reimschisel, “Biohackerspaces,” Medium, June 29, 2017, https://medium.com/@jordanreimschisel/biohackerspaces-b0cbde63c492
• Jordan Reimschisel, “Technology Could Enable Personal Medicine Whether We Like It Or Not,” Medium, August 10, 2017, https://medium.com/@jordanreimschisel/technology-could-enable-personal-medicine-whether-we-like-it-or-not-ce6e19b826fe
• Jordan Reimschisel, “Evolving Oversight of Digital Health,” Medium, June 21, 2018, https://medium.com/@jordanreimschisel/evolving-oversight-of-digital-health-d65199913503
• Adam D. Thierer and Adam Marcus, “Guns, Limbs, and Toys: What Future for 3D Printing?” Minnesota Journal of Law, Science & Technology, Vol. 17, No. 2, (2016), p. 805-854, http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2795562

In a new essay in The Dallas Morning News (“Licensing restrictions for health care workers need to be flexible to fight coronavirus“),  Trace Mitchell and I discuss recent efforts to reform occupational licensing restrictions for health care workers to help fight the coronavirus.  Trace and I have written extensively about the need for licensing flexibility over the past couple of years, but it is needed now more than ever. Luckily, some positive reforms are now underway.

We highlight efforts in states like Massachusetts and Texas to reform their occupational licensing rules in response to the crisis, as well as federal reforms aimed at allowing reciprocity across state lines. We conclude by noting that:

It should not take a crisis of this magnitude for policymakers to reconsider the way we prevent fully qualified medical professionals from going where they are most needed. But that moment is now upon us. More leaders would be wise to conduct a comprehensive review of regulatory burdens that hinder sensible, speedy responses to the coronavirus crisis.

Few people are doing better reporting on the intersection of advanced technology and medicine — as well as the effects of regulation on those fields — than my Mercatus Center colleague Jordan Reimschisel. In a very short period of time, Jordan has completely immersed himself in these complex, cutting-edge topics and produced a remarkable body of work discussing how, in his words, “technology can merge with medicine to democratize medical decision making, empower patients to participate in the treatment process, and promote better health outcomes for more patients at lower and lower costs.” He gets deep into the weeds of the various technologies he writes about as well as the legal, ethical, and economic issues surrounding each topic.

I encouraged him to start an ongoing compendium of his work on these topics so that we could continue to highlight his research, some of which I have been honored to co-author with him. I have listed his current catalog down below, but jump over to this Medium page he set up and bookmark it for future reference. This is some truly outstanding work and I am excited to see where he goes next with topics as wide-ranging as “biohackerspaces,” democratized or “personalized” medicine, advanced genetic testing and editing techniques, and the future of the FDA in an age of rapid change.

Give Jordan a follow on Twitter (@jtreimschisel) and make sure to follow his Medium page for his dispatches from the front lines of the debate over advanced medical innovation and its regulation.

Artificial Intelligence

“Artificial Intelligence Advances”

“That AI You Hate, You Really Love” Co-written with Adam Thierer

“That Robot Saved My Life”

Biohackerspaces

“Biohackerspaces”

“Safe Enough”

Food and Drug Administration

“FDA Needs a Fresh Approach, and Fast” Co-written with Adam Thierer

“Insurance costs just the tip of the iceberg. Time to reform the FDA.” Co-written with Dr. Robert Graboyes

“Opening the Door for Medical Innovation” Co-written with Dr. Robert Graboyes

“The True Goal of the FDA Should Be Drug Innovation”

“Toward Patient-Centered Policy”

“When it comes to tobacco and cigarettes, people are smarter than you think”

Genetics

“Will Genetic Editing Advance Faster Than Our Ability to Regulate It?” Co-written with Adam Thierer

Personalized Medicine

“The Creative Destruction of Medicine: A Book Review”

“Technology Could Enable Personal Medicine Whether We Like It Or Not”

In theory, the Food & Drug Administration (FDA) exists to save lives and improve health outcomes. All too often, however, that goal is hindered by the agency’s highly bureaucratic, top-down, command-and-control orientation toward drug and medical device approval.

Today’s case in point involves families of children with diabetes, many of whom are increasingly frustrated with the FDA’s foot-dragging when it comes to approval of medical devices that could help their kids. Writing today in The Wall Street Journal, Kate Linebaugh discusses how “Tech-Savvy Families Use Home-Built Diabetes Device” to help their kids when FDA regulations limit the availability of commercial options. She documents how families of diabetic children are taking matters into their own hands and creating their own home-crafted insulin pumps, which can automatically dose the proper amount of proper amount of the hormone in response to their child’s blood-sugar levels. Families are building, calibrating, and troubleshooting these devices on their own. And the movement is growing. Linebaugh reports that:

More than 50 people have soldered, tinkered and written software to make such devices for themselves or their children. The systems—known in the industry as artificial pancreases or closed loop systems—have been studied for decades, but improvements to sensor technology for real-time glucose monitoring have made them possible. The Food and Drug Administration has made approving such devices a priority and several companies are working on them. But the yearslong process of commercial development and regulatory approval is longer than many patients want, and some are technologically savvy enough to do it on their own.

Linebaugh notes that this particular home-built medical project (known as OpenAPS), was created by Dana Lewis, a 27-year-old with Type 1 diabetes in Seattle. Linebaugh says that:

Ms. Lewis began using the system in December 2014 as a sort of self-experiment. After months of tweeting about it, she attracted others who wanted what she had. The only restriction of the project is users have to put the system together on their own. Ms. Lewis and other users offer advice, but it is each one’s responsibility to know how to troubleshoot. A Bay Area cardiologist is teaching himself software programming to build one for his 1-year-old daughter who was diagnosed in March.

In essence, these individuals and families are engaging in a variant of the sort of decentralized “biohacking” that is becoming increasingly prevalent in society today. As I discussed in a recent law review article, biohacking refers to the efforts of average citizens (often working together in a decentralized fashion) to enhance various human capabilities. This can include implanting things inside one’s body or using external devices to supplement one’s abilities or to address health-related issues.

I documented other examples of this trend in my essays on average citizens making 3D-printed prosthetics (The Right to Try, 3D Printing, the Costs of Technological Control & the Future of the FDA) as well as retainers (“In a World Where Kids Can 3D-Print Their Own Retainers, What Should Regulators Do?”) As “software eats the world” and allows for this sort of democratized medical self-experimentation, more and more citizens are likely going to be engaging in biohacking. In the process, they will often be doing an end-around the FDA and its complex maze of regulatory restrictions on health innovation.

Stated more provocatively, thanks to new technological capabilities and networking platforms, the public may increasingly enjoy a de facto “right to try” for many new medical devices and treatments. Technological innovation will decentralize and democratize medical decisions even when the legal status of such actions is unclear or even flatly illegal.

But is a world of increasingly decentralized, democratized, and such highly personalized medicine actually safe? Well, all risk is relative and as I discussed extensively in my recent book and other work on innovation policy, sometimes the greatest risk of all is the refusal to take any risk to begin with. If you disallow or limit efforts to engage in certain risky endeavours, ultimately, you could end up doing more harm because there can be no reward without a corresponding amount of risk-taking. It is only through constant trial and error experimentation that we find new and better ways of doing things. That is particularly true as it pertains to life-enriching or even life-saving medical treatments. While the FDA likes to think that its hyper-cautious approach to medical drug and device approval ultimately saves lives, in the aggregate, we have no idea how many lives are actually being lost (or how much pain and suffering is occurring) due to FDA prohibitions on our freedom to experiment with new products and services.

One of the parents Linebaugh interviewed for her story made the following remark: “Diabetes is dangerous anyway. Insulin is dangerous. I think what we are doing is actually improving that and lowering the risk.” That is exactly right. This father understands the reality of risk trade-offs. There are certainly risks associated with what these families are doing for their children. But these families also have a very palpable sense of the opposite problem: There is a profound and immediate risk of doing nothing and waiting for the FDA to finally get around to approving the devices that their children need  right now.

All this raises another interesting policy question: Why is it legal for these parents to engage in this sort of medical self-experimentation–experimentation on their children, no less!–while it remains flatly illegal for any commercial operator to offer similar products that could help these families? Many modern regulatory regimes accord differential treatment to commercial activities. Non-commercial versions of some activities are left alone, but as soon as commercial opportunities arise, policymakers seek to apply regulation.

Does this sort of commercial vs. non-commercial regulatory asymmetry make any sense? As far as I can tell, this regulatory distinction is mostly rooted in the fact that deep-pocked commercial operators make easier targets for regulators to go after when compared to harassing average citizens.  Going after average citizens would be bad PR and a serious legal hassle as well because issues pertaining to personal autonomy or parental rights would likely be raised both in the court of public opinion and courts of law.

Regardless, let’s not kid ourselves into thinking that this regulatory distinction is rooted in safety considerations. After all, it is almost certainly the case that those commercial medical innovators are likely building safer products, made by medical professionals with years of experience. Moreover, commercial operators are more likely to carry insurance to address any problems that may develop, and they possess strong reputational incentives to be good market actors. Commercial operators have to maintain brand loyalty to earn new or repeat business, or perhaps just to avoid stiff legal liability that non-commercial operators might not face. 

In any event, one thing should be abundantly clear: If the FDA doesn’t change its ways, we can expect an increasing number of citizens to begin pursuing medical treatments outside the boundaries of the law (and potentially outside the realm of common sense). Many people want a right to try new devices and therapies, and in our modern networked world, they are increasingly going to get it whether regulators like it or not.

Lawmakers in Congress need to exercise better oversight of rogue agencies like the FDA, which face no serious penalties for the sort of endless regulatory foot-dragging that threatens public welfare. If the agency was required by Congress to improve its drug and device approval process, then perhaps fewer Americans would be forced to take matters into their own hands to begin with. Down below, I’ve included a few reports suggesting how we might get this much-needed reform process started.

Additional reading from Mercatus Center scholars:

• white paper: “US Medical Devices: Choices and Consequences,” by Richard Williams, Robert Graboyes & Adam Thierer
• white paper: “The Proper Role of the FDA for the 21st Century,” by Joseph V. Gulfo, Jason Briggeman, Ethan Roberts
• white paper: “How Productive Is the FDA’s Devices Program?” by Richard Williams, Jason Briggeman, Ethan Roberts
• special report: “From Fortress to Frontier: How Innovation Can Save Health Care,” by Robert Graboyes
• blog post: “The Right to Try, 3D Printing, the Costs of Technological Control & the Future of the FDA,” by Adam Thierer
• blog post: “In a World Where Kids Can 3D-Print Their Own Retainers, What Should Regulators Do?” by Adam Thierer

Consider this recent  Washington Post headline: “A College Kid Spends $60 to Straighten His Own Teeth. What Could Possibly Go Wrong?” Matt McFarland of the Post reports that, “A college student has received a wealth of interest in his dental work after publishing an account of straightening his own teeth for $60.” The student at the New Jersey Institute of Technology, “had no dentistry experience when he decided to create plastic aligners to improve his smile,” but was able to use a 3D printer and laser scanner on campus to accomplish the job. “After publishing before-and-after pictures of his teeth this month, [the student] has received hundreds of requests from strangers, asking him to straighten their teeth.”

McFarland cites many medical professionals who are horrified at the prospect of patients taking their health decisions into own hands and engaging in practices that could be dangerous to themselves and others. Some of the licensed practitioners cited in the story come across as just being bitter losers as they face the potential for the widespread disintermediation of their profession. After all, they currently charge thousands of dollars for various dental procedures and equipment. Thanks to technological innovations, however, those costs could soon plummet, which could significantly undercut their healthy margins on dental services and equipment. On the other hand, these professionals have a fair point about untrained citizens doing their own dental work or giving others the ability to do so. Things certainly could go horribly wrong.

This is another interesting case study related to the subject of a forthcoming Mercatus paper as well as an upcoming law review article on 3D printing of mine, both of which pose the following question: What happens when radically decentralized technological innovation (such as 3D printing) gives people a de facto “right to try” new medicines and medical devices? In one sense, decentralized, democratized innovation of this sort presents us with an exciting new world of possibilities. On the other hand, we know that when average citizens take their health into their own hands, the results could be disastrous. The question is, what do want policymakers to do about it? Ban 3D printers? Restrict the distribution of 3D printed blueprints freely shared online? Try to license average users? Or regulate the materials used to make these medical devices?

For the reasons I suggest in my forthcoming paper, none of these options are likely to work very well in practice. It will  prove too complex and costly to employ top-down, command-and-control regulation in a world of such decentralized innovation. Moreover, many people will also find it highly offensive if the government takes steps to limit their personal autonomy and ability to self-treat themselves at a much lower cost than our currently health care system typically demands for similar treatments. The example in McFarland’s story is quite powerful in that regard because, as it makes clear, even young kids could be engaging in this sort of innovation and self-experimentation, at greatly reduced cost to themselves or their families. Again, this is both wonderful and a little bit scary.

The best hope, I argue in my forthcoming papers, lies in improved risk education. The goal should be to help create a more fully-informed citizenry that is empowered with more and better information about relative risk trade-offs. The Food & Drug Administration already engages in various product labeling efforts as well as public education campaigns and strategies. But this has always been a secondary mission for the agency, which has instead focused on trying to preemptively guarantee the safety and efficacy of drugs and devices. And much of the “education” the FDA does is basically explaining to companies and the public how to comply with its voluminous body of regulation.

This is going to have to change, and change quickly. Going forward, the FDA will likely have to reorient its focus in this way to cope with the rapidly evolving universe of not just mobile medical apps and 3D-printed technologies, but also all the wearable technologies that are part of the larger Internet of Things. For example, the FDA recently released a guidance document for “Management of Cybersecurity in Medical Devices,” encouraging innovators and other stakeholders to address security vulnerability in a collaborative, flexible fashion.  This same model could be applied to 3D printing and many other new technologies. As I continue on to note in my forthcoming paper:

Guidance documents should be crafted that suggest various best practices for developers as well as risk education and communication messaging for the general public. The downside of such guidance documents, however, is that they leave unanswered the question of exactly what regulatory authority the agency might bring to bear against companies who are found to violate the “voluntary” principles or best practices in the documents. On the other hand, those guidance documents are usually superior to the alternative path of overly-rigid, top-down, preemptive controls on innovation. Congress should monitor the FDA’s use of such guidance documents closely to ensure that the agency does not abuse its broad regulatory discretion through arbitrary guidance actions.

My forthcoming papers also suggests that other non-governmental bodies will need to play a more active role in this risk education process and help explain safe and sensible uses of new technologies to the public, especially kids. And product developers will need to step-up their “safety-by-design” efforts to try to make sure that the products they release into the wild are as safe as possible. Of course, as with other general purpose technologies (like computers and smartphones), there is only so much that can be done preemptively to make sure devices like 3D printers are “safe and secure” out of the box. The reality is that, the more open and generative a new technology or platform, the harder it is to preemptively design it in such a way to foresee and limit all its uses–for better or for worse.

We live in exciting times, but serious risks exist when radical technological decentralization places tools and capabilities in the hands of average citizens. The goal of public policy should  not be to retard the development or distribution of all these wonderful new tools, but instead to redouble efforts to education citizens about proper and improper uses of them.

I’ve been thinking about the “right to try” movement a lot lately. It refers to the growing movement (especially at the state level here in the U.S.) to allow individuals to experiment with alternative medical treatments, therapies, and devices that are restricted or prohibited in some fashion (typically by the Food and Drug Administration). I think there are compelling ethical reasons for allowing citizens to determine their own course of treatment in terms of what they ingest into their bodies or what medical devices they use, especially when they are facing the possibility of death and have exhausted all other options.

But I also favor a more general “right to try” that allows citizens to make their own health decisions in other circumstances. Such a general freedom entails some risks, of course, but the better way to deal with those potential downsides is to educate citizens about the trade-offs associated with various treatments and devices, not to forbid them from seeking them out at all.

The Costs of Control

But this debate isn’t just about ethics. There’s also the question of the costs associated with regulatory control. Practically speaking, with each passing day it becomes harder and harder for governments to control unapproved medical devices, drugs, therapies, etc.  Correspondingly, that significantly raises the costs of enforcement and makes one wonder exactly how far the FDA or other regulators will go to stop or slow the advent of new technologies.

I have written about this “cost of control” problem in various law review articles as well as my little Permissionless Innovation book and pointed out that, when enforcement challenges and costs reach a certain threshold, the case for preemptive control grows far weaker simply because of (1) the massive resources that regulators would have to pour into the task on crafting a workable enforcement regime; and/or (2) the massive loss of liberty it would entail for society more generally to devise such solutions. With the rise of the Internet of Things, wearable devices, mobile medical apps, and other networked health and fitness technologies, these issues are going to become increasingly ripe for academic and policy consideration.

A Hypothetical Regulatory Scenario

Here’s an interesting case study to consider in this regard:  Can  3D printing  of prosthetics be controlled? Clearly prosthetics are medical devices in the traditional regulatory sense, but few people are going to the FDA and asking for permission or a “right to try” new 3D-printed limbs. They’re just doing it. And the results have been incredibly exciting, as my Mercatus Center colleague Robert Graboyes has noted.

But let’s imagine what the regulators might do if they really wanted to impose their will and limit the right to try in this context:

• Could government officials ban 3D printers outright? I don’t see how. The technology is already too diffuse and is utilized for so many alternative (and uncontroversial) uses that it doesn’t seem likely such a control regime would work or be acceptable. And if any government did take this extreme step, “global innovation arbitrage” would kick in. That is, innovators would just move offshore.
• Could government officials ban the inputs used by 3D printers? Again, I don’t see how. After all, we are primarily talking about plastics and glue here!
• Could government officials ban 3D printer blueprints? Two problems with that. First, such blueprints are a form of free speech and government efforts to censor them would represent a form of prior restraint that would violate the First Amendment of the U.S. Constitution. Second, even ignoring the First Amendment issues, information control is just damned hard and I don’t see how you could suppress such blueprints effectively when are they are freely available across the Internet. Or, people would just “torrent” them, as they do (illegally) with copyrighted files today.
• Could government officials ban and/or fine specific companies (especially those with deep pockets)? Perhaps, but that is likely a losing strategy since 3D printing is already so highly decentralized and is done by average citizens in the comfort of their own home (and often for no monetary gain). So, attempting to go after a handful of corporate players and “make an example out of them” to deter others from experimenting isn’t likely to work. And, again, it’ll just lead to more offshoring and undergrounding of these devices and innovative activities.
• Could government officials ban the sale of certain 3D printing applications? They could try, but enterprising minds would likely start using alternative payment methods (like Bitcoin) to conduct their deals. But the question of payments is largely irrelevant in many fields because much of this activity is non-commercial and open-source in character. People are freely distributing blueprints for 3D-printed prosthetics, for example, and they are even giving away the actual 3D-printed prosthetic devices to those who need them.
• Could government officials just create a licensing / approval regime for narrowly-targeted 3D printed medical devices? Of course, but for all the reasons outlined above, it would likely be pretty easy to evade such a regime. Moreover, the very effort to enforce such a licensing regime would likely deter many beneficial innovations in the process, while also leading to the old cronyist problems associated with firms engaging in rent-seeking and courting favor with regulators in order to survive or prosper.

Anyway, you get the point: The practicality of control makes a difference and at some point the enormous costs associated with enforcement become an ethical matter in its own right. Stated differently, it’s not just that citizens should generally be at liberty to determine their own treatments and decide what drugs they ingest and what medical devices they use, it’s also the case that regulatory efforts aimed at limiting that right have so many corresponding enforcement costs that can spillover on to society more generally. And that’s an ethical matter of a different sort when you get right down to it. But, at a minimum, it’s an increasingly costly strategy and the costs associated with such technological control regimes should be considered closely and quantified where possible.

The Need for a Shift toward Risk Education

Let’s return to the question I raised above regarding the educational role that the FDA, or governments more generally, could play in the future. As I noted, a world in which citizens are granted the liberty to make more of their own health decisions is a world in which they could, at times, be rolling the dice with their health and lives. The highly paternalistic approach of modern food and drug regulation is rooted in the belief that citizens simply cannot be trusted to make such decisions on their own because they will never be able to appreciate the relative risks. You might be surprised to hear that I am somewhat sympathetic to that argument. People can and do make rash and unwise decisions about their health based on misinformation or a general lack of quality information presented in an easy-to-understand fashion. As a result, policymakers have taken the right to make these decisions away from us in many circumstances.

Although motivated by the best of intentions, paternalistic controls are not the optimal way to address these concerns. The better approach is rooted in risk education. To reiterate, the wise way to deal with the potential downsides associated with freedom of choice is to educate citizens about the relative risks associated with various medical treatments and devices, not to forbid them from seeking them out at all.

What does that mean for the future of the FDA? If the agency was smart, it would recognize that traditional command-and-control regulation is no longer a sensible strategy; it’s increasingly unworkable and imposes too many other costs on innovators and personal liberty. Thus, the agency needs to reorient its focus toward becoming a risk educator. Their goal should be to help create a more fully-informed citizenry that is empowered with more and better information about relative risk trade-offs.

Overcoming the Opposition & Getting Consent Mechanisms Right

Such an approach (i.e., shifting the FDA’s mission from being primarily a risk regulator to becoming a risk educator) will encounter opposition from strident defenders and opponents of the FDA alike.

The defenders of the FDA and its traditional approach will continue to insist that people can  never be trusted to make such decisions on their own, regardless of how much information they have at their disposal or how many warnings we might give them. The problem with that position is that it treats citizens like ignorant sheep and denies them the most basic of all human rights: The right to live a life of your own choosing and to make the ultimate determinations about your own health and welfare. And, again, blindly defending the old system isn’t wise because traditional command-and-control regulatory methods are increasingly impractical and incredibly costly to enforce.

Opponents of the FDA, by contrast, will insist that the agency can’t even be trusted to provide us with good information for us to make these decisions on our own. Additionally, critics will likely argue that the agency might give us the wrong information or try to “nudge” us in certain directions. I share some of those concerns, but I am willing to live with that possibility so long as we are moving toward a world in which that is the only real power that the FDA possess over me and my fellow citizens. Because if all the agency is doing is providing us with information about risk trade-offs, then at least we still remain free to seek out alternative information from other experts and then choose our own courses of action.

The tricky issue here is getting consent mechanisms right. In fact, it’s the lynchpin of the new regime I am suggesting. In other words, even if we could agree that a more fully-informed citizenry should be left free to make these decisions on their own, we need to make sure that those individuals have provided clear and informed consent to the parties they might need to contract with when seeking alternative treatments. That’s particularly essential in a litigious society like America, where the threat of liability always looms large over doctors, nurses, hospital, insurers, and medical innovators. Those parties will only be willing to go along with an expanded “right to try” regime if they can be assured they won’t be held to blame when citizens make controversial choices that they advised them against, or at least clearly laid out all the potential risks and other alternatives at their disposal. This will require not only an evolution of statutory law and regulatory standards, but also of the common law and insurance norms.

Once we get all that figured out—and it will, no doubt, take some time—we’ll be on our way to a better world where the idea of having a “right to try” is the norm instead of the exception.

(My thanks to Adam Marcus for commenting on a draft of this essay. For more general background on 3D printing, see his excellent 2011 primer here, “3D Printing: The Future is Here.”)

Earlier this week I posted an essay entitled, “Global Innovation Arbitrage: Commercial Drones & Sharing Economy Edition,” in which I noted how:

Capital moves like quicksilver around the globe today as investors and entrepreneurs look for more hospitable tax and regulatory environments. The same is increasingly true for innovation. Innovators can, and increasingly will, move to those countries and continents that provide a legal and regulatory environment more hospitable to entrepreneurial activity.

That essay focused on how actions by U.S. policymakers and regulatory agencies threatened to disincentivize homegrown innovation in the commercial drone and sharing economy sectors. But there are many other troubling examples of how America risks losing its competitive advantage in sectors where we should be global leaders as innovators looks offshore. We can think of this as “global innovation arbitrage,” as venture capitalist Marc Andreessen has aptly explained:

Think of it as a sort of “global arbitrage” around permissionless innovation — the freedom to create new technologies without having to ask the powers that be for their blessing. Entrepreneurs can take advantage of the difference between opportunities in different regions, where innovation in a particular domain of interest may be restricted in one region, allowed and encouraged in another, or completely legal in still another.

One of the more vivid recent examples of global innovation arbitrage involves the well-known example of 23andMe, which sells mail-order DNA-testing kits to allow people to learn more about their genetic history and predisposition to various diseases. Unfortunately, the Food and Drug Administration (FDA) is actively thwarting innovation on this front, as SF Gate reporter Stephanie Lee notes in her recent article, “23andMe’s health DNA kits now for sale in U.K., still blocked in U.S.“:

A little more than a year ago, 23andMe, the Google-backed startup that sells mail-order DNA-testing kits, was ordered by U.S. regulators to stop telling consumers about their genetic health risks. The Mountain View company has since tried to regain favor with the Food and Drug Administration, but it’s also started to expand outside the country. As of Tuesday, United Kingdom consumers can buy 23andMe’s saliva kits and learn about their inherited risks of diseases and responses to drugs.

While the FDA drags its feet on this front, however, other countries are ready to open their doors to innovators and their life-enriching products and services:

A spokesperson for the United Kingdom’s Medicines and Healthcare Products Regulatory Agency said the [23andMe] test can be used with caution. […]  “The U.K. is a world leader in genomics and we are very excited to offer a product specifically for U.K. customers,” Anne Wojcicki, 23andMe’s co-founder and CEO, told the BBC. Mark Thomas, a professor of evolutionary genetics at University College London, said in a statement, ”For better or worse, direct-to-the-consumer genetic testing companies are here to stay. One could argue the rights and wrongs of such companies existing, but I suspect that ship has sailed.”

That’s absolutely right, even if the FDA wants to bury it’s head in the sand and pretend it can turn back the clock. The problem is that the longer the FDA pretends it can play by the old command-and-control playbook, the more likely it is that American innovators like 23andMe will look to move offshore and find more hospitable homes or their innovative endevours.

This is a central lesson that my Mercatus Center colleague Dr. Robert Graboyes stressed in his recent study, Fortress and Frontier in American Health Care. Graboyes noted that if America failed to embrace the “frontier” spirit of innovation — i.e., a policy disposition that embraces creative destruction and disruptive, “permissionless” innovation — then our global competitive advantage in this space is at risk:

Moving health care from the Fortress to the Frontier may be more a matter of necessity than of choice. We are entering a period of rapid technological advances that will radically alter health care. Many of these advances require only modest capital and labor inputs that governments cannot easily control or prohibit. If US law obstructs these technologies here, it will be feasible for Americans to obtain them by Internet, by mail, or by travel. (p. 41-2)

Graboyes highlighted several areas in which this issue will play out going forward beyond genomic information, including: personalized medicine, 3-D printing, artificial intelligence, information sharing via social media, wearable technology, and telemedicine.

As Larry Downes and Paul Nunes noted in a recent  Wired editorial, “Regulating 23andMe Won’t Stop the New Age of Genetic Testing“:

The information flood is coming. If not this Christmas season, then one in the near future. Before long, $100 will get you sequencing of not just the million genes 23andMe currently examines, but all of them. Regulators and medical practitioners must focus their attention not on raising temporary obstacles, but on figuring out how they can make the best use of this inevitable tidal wave of information.

American policymakers must accept that reality and adjust their attitudes and policies accordingly or else we can expect to see even more global innovation arbitrage — and a correspondingly loss of national competitiveness — in coming years.

[ Note: Our friends over at TechFreedom launched a Change.org petition awhile back to call for a reversal of the FDA’s actions.]

Additional Reading:

• Robert Graboyes on What the Internet Can Teach Us about Health Care Innovation (11/10/14)
• Thinking about Innovation Policy Debates: 4 Related Paradigms (11/11/14)
• New Paper on Privacy & Security Implications of the Internet of Things & Wearable Technology (11/21/14)
• Europe’s Choice on Innovation (12/2/14)
• Permissionless Innovation: The Continuing Case for Comprehensive Technological Freedom (2014)
• [Video] Cap Hill Briefing on Emerging Tech Policy Issues (June 2014)
• Why Permissionless Innovation Matters (4/24/14)
• How We Learn to Cope with Technological Change (6/30/14)
• Problems with Precautionary Principle-Minded Tech Regulation & a Federal Robotics Commission (9/22/14)