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

In a recent PFF paper I argued that “We Are Living in the Golden Age of Children’s Programming,” and showed how, despite incessant complaints by many policymakers:

the overall market for family and children’s programming options continues to expand quite rapidly. Thirty years ago, families had a limited number of children’s television programming options at their disposal on broadcast TV. Today, by contrast, there exists a broad and growing diversity of children’s television options from which families can choose.

I then documented there and in my book, Parental Controls & Online Child Protection:

• the many excellent family- or child-oriented networks available on cable, telco, and satellite television today;
• the growing universe of religious / spiritual television networks;
• the many family or educational programs that traditional TV broadcasters offer; or
• the massive market for interactive computer software or Internet websites for children.

And every time I turn around I find another great show, service, or site for families to choose from.  Earlier today I highlighted the excellent new online video search service, Clicker.com, which is essentially a “TV Guide for the Internet.”  It is absolutely awesome and I highly recommend you play with it. You’ll be instantly hooked if you are TV junkie.

Better yet, Clicker.com offers a wonderful compendium of kid- and family-oriented video programming options. Although the site is still fairly new, you can already find 660 shows and almost 5,000 unique episodes of kids programming there.  A lot of it is just good ‘ol fashion couch potato fare ranging from the old (The Jetsons, Fat Albert, The Flintstones, etc) to the new stuff that you’d find on various cable channels today.  But there’s also plenty of wonderful educational programming to be found on Clicker including shows like Arthur, Sesame Street (over 1,000 episodes), Martha Speaks, The Electric Company, Animal Exploration with Jarod Miller, Jonathan Bird’s Blue World, Postcards From Buster, Science on Brain Pop, Technology on Brain Pop, and more.

Although my kids aren’t really into TV, as they grow older, I bet they’ll be watching a lot more programming via services like Clicker.  Currently, my kids enjoy watching snippets of video via kid-oriented online search portals like KidZui and Glubble.  Such online walled gardens offer a safe place for parents to find terrific online content for their kids.   Bottom line: compared to the miserable state of affairs some of us faced growing up in the 1970s, kids and parents have never had it better in terms of the video programming options at their disposal.

Anyway, some of “kid-vid” issues — including potential expansion of the Children’s Television Act of 1990 — could be up for discussion in the FCC’s new proceeding, “Empowering Parents and Protecting Children in an Evolving Media Landscape” (MB Docket 09-194).  The FCC just tweeted about it here and I posted my thoughts on where the agency might be heading in this proceeding in this post last month.

In an earlier post, I mentioned an important new online child safety task force report that has just been released from the “Point Smart. Click Safe.” Blue Ribbon Working Group. It’s a great report and I encourage you to read the whole thing. It was my great pleasure to serve on this task force, and as we started finalizing our conclusions and recommendations, I started thinking about how much of what we were finding and recommending was consistent with what past online safety task forces had also concluded.

By way of background, over the past decade, five major online safety task forces or blue ribbon commissions have been convened to study online safety issues. Two of these task forces were convened in the United States and issued reports in 2000 (“COPA Commission”) and 2002 (“Thornburgh Commission“). Another was commissioned by the British government in 2007 and issued in a major report in March 2008 (“Byron Review“). Finally, two additional online safety task forces were formed in the U.S. in 2008 and concluded their work, respectively, in January (“Internet Safety Technical Task Force“) and July (“Point Smart. Click Safe.“) of 2009. [And yet another task force — the Online Safety Technology Working Group — was recently formed and has now gotten underway.]

In a new PFF white paper, ” Five Online Safety Task Forces Agree: Education, Empowerment & Self-Regulation Are the Answer,” I walk through a chronological summary of each of these past task forces [click on covers of each report below to read them in their entirety] and highlight some of the similar themes and recommendations from them.

Altogether, these five task forces heard from hundreds of experts and produced thousands of pages of testimony and reports on a wide variety of issues related to online child safety. While each of these task forces had different origins and unique membership, what is striking about them is the general unanimity of their conclusions. Among the common themes or recommendations of these five task forces:

• Education is the primary solution to most online child safety concerns. These task forces consistently stressed the importance of media literacy, awareness-building efforts, public service announcements, targeted intervention techniques, and better mentoring and parenting strategies.
• There is no single “silver-bullet” solution or technological “quick-fix” to child safety concerns. That is especially the case in light of the rapid pace of change in the digital world.
• Empowering parents and guardians with a diverse array of tools, however, can help families, caretakers, and schools to exercise more control over online content and communications.
• Technological tools and parental controls are most effective as part of a “layered” approach to child safety that views them as one of many strategies or solutions.
• The best technical control measures are those that work in tandem with educational strategies and approaches to better guide and mentor children to make wise choices. Thus, technical solutions can supplement, but can never supplant, the educational and mentoring role.
• Industry should formulate best practices and self-regulatory systems to empower users with more information and tools so they can make appropriate decisions for themselves and their families. And those best practices, which often take the form of an industry code of conduct or default control settings, should constantly be refined to take into account new social concerns, cultural norms, and technological developments.
• Government should avoid inflexible, top-down technological mandates. Instead, policymakers should focus on encouraging collaborative, multifaceted, multi-stakeholder initiatives and approaches to enhance online safety. Additional resources for education and awareness-building efforts are also crucial. Finally, governments should ensure appropriate penalties are in place to punish serious crimes against children and also make sure law enforcement agencies have adequate resources to police crimes and punish wrong-doers.

The consistency of these findings from those five previous task forces is important and it should guide future discussions among policymakers, the press, and the general public regarding online child safety.  As I note in the paper, the findings are particularly relevant today since Congress and the Obama Administration — including 3 federal agencies (NTIA, FCC, & FTC) are actively studying these issues. So, in light of all that, I hope this short paper can shed some light on the collective wisdom of the past task forces. While more study of online child safety issues is always welcome — including additional task forces or working groups if policymakers deem them necessary — thanks to the work of these five task forces, we now have better vision of what is needed to address online safety concerns.

Five Online Safety Task Forces Agree [PFF – Adam Thierer] http://d.scribd.com/ScribdViewer.swf?document_id=17181137&access_key=key-z6cxfgrjkqaqtxbix&page=1&version=1&viewMode=

I’ve got a new PFF paper out today entitled, “Who Needs Parental Controls? Assessing the Relevant Market for Parental Control Technologies.” In this piece, I address the argument made by some media and Internet critics who say that government intervention (perhaps even censorship) may be necessary because parental control technologies are not widely utilized by most Americans. But, as I note in the paper, the question that these critics always fail to ask is: How many homes really need parental control technologies? The answer: Far fewer than you think. Indeed, the relevant universe of potential parental control users is actually quite limited.

I find that the percentage of homes that might need parental control technologies is certainly no greater than the 32% of U.S. households with children in them. Moreover, the relevant universe of potential parental control users is likely much less than that because households with very young children or older teens often have little need for parental control technologies. Finally, some households do not utilize parental control technologies because they rely on alternative methods of controlling media content and access in the home, such as household media rules. Consequently, policymakers should not premise regulatory proposals upon the limited overall “take-up” rate for parental control tools since only a small percentage of homes might actually need or want them.

If you don’t care to read the whole nerdy thing, I’ve created this short video summarizing the major findings of the paper.

And the document is embedded below the fold in a Scribd reader. Who Needs Parental Controls PFF http://d.scribd.com/ScribdViewer.swf?document_id=12864194&access_key=key-4p1wl0cam0e5z4oxyfm&page=1&version=1&viewMode=list

Today’s USA Today features a debate between the editors and me on the question of the impact media has on children and what should be done about it. Their editorial argues that “Today’s mass media penetrate deeply and quietly, inflicting real damage on young children, an increasing body of research shows.” Specifically, they are referring to a new study commissioned by Common Sense Media (CSM), which claims that a review of 173 studies shows “that a strong correlation exists between greater exposure and adverse health outcomes.”

In my response entitled “Don’t Scapegoat Media,” which appears in its entirety down below the fold, I argue that “Media have long been a convenient scapegoat for the woes of the world,” and that we must be careful not to assume correlation equals causation when surveying the impact of media on kids. After all, I argue, “how do [those studies] account for the other variables that influence youth development, including broken homes, bad parents, socioeconomic status, troubled peer relations, poor schools and so on? And how is media exposure weighted relative to these other influences? Is a beer ad really as much of a negative influence as an alcoholic parent?” Again, read my entire response below. [Of course, even if one assumes some media has an impact on some kids, there are plenty of ways for parents and guardians to take control over the media in their lives, as I have shown in my big book on the subject.]

I was also quoted in this Washington Post article about the new CSM study on Tuesday.

Don’t Scapegoat Media by Adam Thierer 12/4/08

USA Today

Media have long been a convenient scapegoat for the woes of the world. In particular, fears about the influence media might have on our children have often prompted calls for “crackdowns” on speech and expression.

Typically, these fears fade as one generation’s media boogeyman becomes another’s treasured art form. That’s not to say media don’t have an impact on some children. Clearly, media are among many factors that influence culture and behavior.

But what about those other influences? Some studies summarized in the new Common Sense Media (CSM) report suggest a potential link between media exposure and certain social pathologies. But how do they account for the other variables that influence youth development, including broken homes, bad parents, socioeconomic status, troubled peer relations, poor schools and so on? And how is media exposure weighted relative to these other influences? Is a beer ad really as much of a negative influence as an alcoholic parent?

That’s why it’s important to recall a fundamental tenet of all social sciences: Correlation does not necessarily equal causation. Human behavior is complicated and quite difficult to measure “scientifically.” Just defining “media exposure” and “negative health outcomes” is tricky enough; identifying root causes is even more challenging.

The sky hasn’t fallen the way some media critics feared. While childhood obesity is a growing problem, it’s important not to lose sight of the impressive gains we’ve made in other areas, such as falling juvenile violence, teen pregnancy, and youth drug and alcohol abuse. Moreover, even if some media negatively influence some children, that must be balanced against the many ways media inspire and empower.

The authors of the CSM survey are to be commended, however, for avoiding regulatory recommendations and instead focusing on the sensible steps parents, schools, industry and government can take to educate kids and empower families to take control over the media in their lives. More information, increased media options and better mentoring of our children are the prudent approaches.