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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.

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[Updated: March 2022]

I was speaking at a conference recently and discussing my life’s work, which for 30 years has been focused on the importance of innovation and intellectual battles over what we mean progress. I put together up a short list of some things I have written over the last few years on this topic and thought I would just re-post them here. I will try to keep this regularly updated, at least for a few years.

UNDERSTANDING THE CHALLENGE WE FACE:

HOW WE MUST RESPOND = “Rational Optimism” / Right to Earn a Living / Permissionless Innovation

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Teacher pay raise funding passes House | Local | idahostatejournal.comWhy can’t governments ever clean up their messes? Occasional spring cleanings are essential not only for keeping our own homes tidy and in good working order, but also for keeping our government systems functioning effectively. What can be done? In a new essay with my Mercatus Center colleagues Patrick McLaughlin and Matthew Mitchell, we note that Idaho Governor Brad Little has just issued a smart Executive Order that aims to clean house by bringing state rules in line with common sense. Specifically, the governor’s order addresses what to do with the 150-plus regulations that Idaho state agencies waived in response to the COVID-19 outbreak. This is a great model for other states, and it tracks a proposal that Patrick, Matt, and I floated in a white paper just a few months ago. The entire essay, which originally ran on The Bridge, is reprinted below.


Idaho “Spring Cleaning” Order a Model for Other States

by Patrick McLaughlin, Matthew D. Mitchell & Adam Thierer

Regulations tend to accumulate endlessly. Today there are over 1 million restrictive words (think “shall” or “must”) in the Code of Federal Regulations. Some states, like California and New York, layer on hundreds of thousands of additional regulatory restrictions. Fewer than 1 percent of these rules have been subjected to rigorous cost-benefit analyses. And once regulations are on the books, it is fairly rare to see them subjected to any sort of retrospective review to see how they have performed. Continue reading →

Here’s a webinar video of a discussion I had recently with Kevin Gomez and his colleague at the Institute for Economic Inquiry at Creighton University’s School of Business.  We discussed my new book, Evasive Entrepreneurs and the Future of Governance: How Innovation Improves Economies and Governments and the future of “permissionless innovation” more generally. My thanks to Kevin and his team at Creighton for inviting me to join them for a fun discussion. Topics include:

  • why evasive entrepreneurialism is expanding
  • the growth of innovation arbitrage
  • the difference between technologies that are “born free” versus “born in captivity”
  • the nature of “the pacing problem” and what it means for policy
  • the problem with “set-it-and-forget-it” & “build-and-freeze” regulations
  • technological risk and the potential for “soft law” governance
  • sensible legislative reforms to advance permissionless innovation (such as “the innovator’s presumption” and “the sunsetting imperative”)
  • how the COVID crisis potentially opens the Overton Window to much-needed policy change

DIY medicineMargaret 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: Continue reading →

I’m making the opening chapter of my new book, Evasive Entrepreneurs and the Future of Governance: How Innovation Improves Economies and Governments, available here. Also here’s the launch essay and the event launch video, which discuss how the themes discussed throughout the book have become even more visible during the coronavirus crisis.

Also, here are some lists of 10 major themes from the book13 key terms found in the book, and 5 innovation policy scholars who inspired my thinking. Reminder: this book is a sequel to my previous book, Permissionless Innovation: The Continuing Case for Comprehensive Technological Freedom.

I hope you will consider buying Evasive Entrepreneurs after reading this opening chapter.

[Originally published on the Cato Institute blog.]

A pandemic is no time for bad governance. As the COVID-19 crisis intensified, bureaucrats and elected officials slumbered. Government regulations prevented many in the private sector from helping with response efforts. The result was a sudden surge of evasive entrepreneurialism and technological civil disobedience. With institutions and policies collapsing around them, many people took advantage of cutting‐​edge technological capabilities to evade public policies that were preventing practical solutions from emerging.

Examples were everywhere. Distilleries started producing hand sanitizers to address shortages while average folks began sharing do‐​it‐​yourself sanitizer recipes online. The Food and Drug Administration (FDA) looked to modify hand sanitizer guidelines quickly to allow for it, but few really cared because those rules weren’t going to stop them. Gray markets in face masks, medical face shields, and respirators developed. Some people and organizations worked together to make medical devices using off‐​the‐​shelf hardware and open source software. More simply, others just fired up sewing machines to make masks—and then, faced with an emerging public health consensus, the guidance from the federal government shifted dramatically: where formerly ordinary people were instructed not to buy or use masks, within a matter of days, the policy reversed, and all were encouraged to make and use cloth protective masks. Continue reading →

[First published by AIER on April 20, 2020 as “Innovation and the Trouble with the Precautionary Principle.”]

In a much-circulated new essay (“It’s Time to Build”), Marc Andreessen has penned a powerful paean to the importance of building. He says the COVID crisis has awakened us to the reality that America is no longer the bastion of entrepreneurial creativity it once was. “Part of the problem is clearlyforesight, a failure of imagination,” he argues. “But the other part of the problem is what we didn’t do in advance, and what we’re failing to do now. And that is a failure of action, and specifically our widespread inability to build.”The Mind of Marc Andreessen | The New Yorker

Andreessen suggests that, somewhere along the line, something changed in the DNA of the American people and they essentially stopped having the desire to build as they once did. “You don’t just see this smug complacency, this satisfaction with the status quo and the unwillingness to build, in the pandemic, or in healthcare generally,” he says. “You see it throughout Western life, and specifically throughout American life.” He continues:

“The problem is desire. We need to want these things. The problem is inertia. We need to want these things more than we want to prevent these things. The problem is regulatory capture. We need to want new companies to build these things, even if incumbents don’t like it, even if only to force the incumbents to build these things.”

Accordingly, Andreessen continues on to make the case to both the political right and left to change their thinking about building more generally. “It’s time for full-throated, unapologetic, uncompromised political support from the right for aggressive investment in new products, in new industries, in new factories, in new science, in big leaps forward.”

What’s missing in Andreessen’s manifesto is a concrete connection between America’s apparent dwindling desire to build these things and the political realities on the ground that contribute to that problem. Put simply, policy influences attitudes. More specifically, policies that frown upon entrepreneurial risk-taking actively disincentivize the building of new and better things. Thus, to correct the problem Andreessen identifies, it is essential that we must first remove political barriers to productive entrepreneurialism or else we will never get back to being the builders we once were.     Continue reading →

The Mercatus Center at George Mason University has just released a new paper by Patrick A. McLaughlin, Matthew D. Mitchell, and me entitled, “A Fresh Start: How to Address Regulations Suspended during the Coronavirus Crisis.” Here’s a quick summary.

As the COVID-19 crisis intensified, policymakers at the federal, state, and local levels started suspending or rescinding laws and regulations that hindered sensible, speedy responses to the pandemic. These “rule departures” raised many questions. Were the paused rules undermining public health and welfare even before the crisis? Even if the rules were well intentioned or once possibly served a compelling interest, had they grown unnecessary or counterproductive? If so, why did they persist? How will the suspended rules be dealt with after the crisis? Are there other rules on the books that might transform from merely unnecessary to actively harmful in future crises?

Once the COVID-19 crisis subsides, there is likely to be considerable momentum to review the rules that have slowed down the response. If policymakers felt the need to abandon these rules during the current crisis, those same rules should probably be permanently repealed or at least comprehensively reformed to allow for more flexible responses in the future.

Accordingly, when the pandemic subsides, policymakers at the federal and state levels should create “Fresh Start Initiatives” that would comprehensively review all suspended rules and then outline sunsetting or reform options for them. To this end, we propose an approach based on the successful experience of the Base Realignment and Closure (BRAC) Commission.

Read the entire paper here to see how it would work. This is our chance to finally do some much-needed spring cleaning for the regulatory state.

Building broadband takes time. There’s permitting, environmental reviews, engineering, negotiations with city officials and pole owners, and other considerations.

That said, temporary wireless broadband systems can be set up quickly, sometimes in days and weeks, not months or years like wireline networks. Setting up outdoor WiFi, as some schools have done (HT Billy Easley II), is a good step but WiFi has its limits and more can be done.

The FCC has done a great job freeing up more spectrum on a temporary basis for the COVID-19 crisis, like allowing carriers to use Dish’s unused cellular spectrum. Wireless systems need more than spectrum, however. Operators need real estate, electricity, backhaul, and permission. This is where cities, counties, and states can help.

Waive or simplify permitting

States, counties, and cities should consider waiving or simplifying their permitting for temporary wireless systems, particularly in rural or low-income areas where adoption lags.

Cellular providers set up Distributed Antenna Systems (DAS) and Cells on Wheels (COWs) for events like football games, parades, festivals, and emergency response after hurricanes. These provide good coverage and capacity in a pinch.

There are other ad hoc wireless systems that can be set up quickly in local areas, like WISP transmitters, cellular or WISP backhaul, outdoor WiFi, and mesh networks.

Broadband to-go.

Allow rent-free access to municipal property

Public agencies own real estate and buildings that would lend themselves to temporary wireless facilities. Not only do they have power, taller public buildings and water towers allow wireless systems to have greater coverage. Cities should consider leasing out temporary space rent free for the duration of the crisis.

Many cities and counties also have a dark fiber and lit fiber networks that serve public facilities like police, fire, and hospitals. If there’s available capacity, state and local public agencies should consider providing cheap or free access to the municipal fiber network.

Now, these temporary measures won’t work miracles. Operators are looking at months of cash constraints and probably don’t have many field technicians available. But the temporary waiver of permitting and the easy access to public property could provide quick, needed broadband capacity in rural and hard-to-reach areas.