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

“Liberty upsets patterns.” That was one of the many lessons that the late Harvard philosopher Robert Nozick taught us in his 1974 masterpiece “Anarchy, State, and Utopia.” What Nozick meant was that there is a fundamental tension between liberty and egalitarianism such that when people are left to their own devices, some forms of inequality would be inevitable and persistent throughout society. (Correspondingly, any attempt to force patterns, or outcomes, upon society requires a surrender of liberty.)

No duh, right? Most people understand this today–even if some of them are all too happy to hand their rights over to the government in exchange for momentary security or some other promise.  In the world of media policy, however, many people still labor under the illusion that liberty and patterned equality are somehow reconcilable. That is, some media policy utopians and Internet pollyannas would like us to believe that if you give every man, woman, and child a platform on which to speak, everyone will be equally heard.  Moreover, in pursuit of that goal, some of them argue government should act to “upset patterns” and push to achieve more “balanced” media outcomes. That is the philosophy that has guided the “media access” movement for decades and it what fuels the “media reformista” movement that is led by groups like the (inappropriately named) Free Press, which was founded by neo-Marxist media theorist Robert McChesney.

Alas, perfect media equality remains an illusive pipe dream. As I have pointed out here before, there has never been anything close to “equal outcomes” when it comes to the distribution or relative success of books, magazines, music, movies, book sales, theater tickets, etc.  A small handful of titles have always dominated, usually according to a classic “power law” or “80-20” distribution, with roughly 20% of the titles getting 80% of the traffic / revenue.  And this trend is increasing, not decreasing, for newer and more “democratic” online media.

For example, recent research has revealed that “the top 10% of prolific Twitter users accounted for over 90% of tweets” and  “the top 15% of the most prolific [Wkipedia] editors account for 90% of Wikipedia’s edits.” As Clay Shirky taught us back in 2003 in this classic essay, the same has long held true for blogging, where outcomes are radically inegalitarian, with a tiny number of blogs getting the overwhelming volume of blogosphere attention.  The reason, Shirky pointed out, is that:

In systems where many people are free to choose between many options, a small subset of the whole will get a disproportionate amount of traffic (or attention, or income), even if no members of the system actively work towards such an outcome. This has nothing to do with moral weakness, selling out, or any other psychological explanation. The very act of choosing, spread widely enough and freely enough, creates a power law distribution.

The latest proof of the persistence of power laws in the media world comes from Slate’s Chris Wilson, who recently analyzed traffic distribution over on YouTube to answer the question: “Will My Video Get 1 Million Views on YouTube?” Alas, YouTube proves every bit as anti-egalitarian as every other media platform throughout history:

This is the great promise of YouTube: Your video can soar in popularity through sheer word-of mouth—or rather, click-of-mouth—until eventually people are making T-shirts about it. No one ever said this was going to happen for everyone. So, what are your chances of achieving YouTube stardom? I crunched the numbers to find out what percentage of YouTube videos hit it big, cracking even 10,000 or 100,000 views. The results: You might have better odds playing the lottery than of becoming a viral video sensation.

And after he runs the numbers to show how such a small percentage of videos dominate YouTube, Wilson goes on to note:

These figures certainly don’t ratify the grand promise of social media. Not everyone uses YouTube to launch their showbiz or political career, but the potential to do so is central to the Web 2.0 narrative that figures in so many newsmagazine panegyrics. When the odds of even 1,000 people viewing your video in a month’s time are only 3 percent, however, it’s tough to argue that hitting it big on YouTube is anything more than dumb luck. You could argue that this is the way it’s always been in show biz, and you’d be right. But wasn’t the Web supposed to change all that?

Indeed, why is that?  After all, as Wilson suggests, the Internet, blogs, social networks, Twitter, YouTube, and so on, were the revolutionary platforms that were supposed to democratize all media and give everyone a fighting chance to be heard.  Instead, power laws and media inequality have proven relentlessly persistent.  Here’s how I explained why this is the case in an earlier essay:

There are several reasons that power laws always exist in all media contexts. We used to think it was because the economics of media are quite different than most other industries. Namely, media industries typically exhibit “public good” qualities; high fixed (production costs), but lower distribution costs.  But the primary reason why power laws are probably more prevent in media industries than other sectors of the economy is because the creation and consumption of news and popular culture is a truly social phenomenon. Think of it as the economics of popular choice and the sociology of fashion and fads. People (and consumers) react to what others are reading or watching. Word-of-mouth counts. Bandwagon effects exist. First-mover advantages are significant. And so on.  The end result is a hopeless imbalance of outcomes or outputs.  Media egalitarianism is simply an impossibility.

OK, so now that I’ve said all this and rained on the New-Media-Will-Produce-Perfect-Outcomes-Parade, let me explain why NONE OF THIS MAKES A DAMN BIT OF DIFFERENCE.   What is really important is equality of media opportunity, not equality of media outcomes.  A focus on the latter is both foolish and destructive. It is foolish because media equality is an impossibility absent extreme measures, which in turn explains why it is destructive. We would need totalitarian government controls on media outputs and consumption in order to achieve anything remotely close to “balance” or “equality” in terms of media results.

Again, all that really counts is that people have a chance to be heard, not whether millions are listening.  New media platforms really do change some things for the better because at least we now all have an equal chance to make a go at it and grab a bit of that audience. That’s certainly more than could be said back in the old analog media world, in which we suffered from outlet scarcity and information poverty. Today, by contrast, will live in a wonderful world of media abundance, where every man, woman, and child really does have a soapbox on which to stand and speak to the world.

Of course, no one may be listening.  And there will always be someone else who will nab greater audience share than you.

Get used to it. It is the way the media world has always worked, and it is the way every media platform will work until the end of time.  So long as citizens are free to choose, media inequality is inevitable.