I read long and ridiculously legalistic oversight reports so that you don't have to, my friends. Seriously, can I get a raise? I know, the 91-bleeping-page "Analysis of Legal Issues Related to Structuring FDA Sentinel Initiative Activities" doesn't sound like something we'd care about here, where we have constant eyes are on the sweet spot at the intersection of technology and politics. But ooh boy, it is. Let me 'splain.
Back in May 2008, the Food and Drug Administration a handful of creative and forward-thinking sorts at the Food and Drug Administration launched a system called Sentinel. The problem that Sentinel is meant to solve is this: what public health officials know about how pharmaceutical drugs perform after they've gone to market ranks somewhere in between "abysmal" and "horrendous." At a recent meeting of the FDA Transparency Task Force, for example, a mother told the assembled officials that it was only after her teenage son died from complications from leukemia brought on by taking a drug to treat Crohn's Disease that she found out that the drug her son was taking tends to create blood cancers in young men.
What Sentinel would do, which would be groundbreaking, is to create a standard, a system, through which all that we know about drugs and medical devices that is locked inside electronic health records is extracted. With it, we might finally paint a picture of what drugs actually do out in the world. Think Google Trends for prescription drugs. The flip side, of course, is that unlocking the power of Sentinel also means unlocking some of the most personal information that a human being has -- information on their health. So the question that has been on the mind of Sentinel's advocates is, can we really build a system that respects patient privacy while unleashing the power of our collective electronic medical data?
In short, the answer is yes. At least, that's the finding of the above-mentioned report by outside legal counsel. You can stop reading here if your curiosity is satisfied with the short answer, or you can join me after the break for the nitty gritty...
Yesterday's first public meeting of the Food and Drug Administration's new Transparency Task Force was dedicated to brainstorming ways to make the FDA more accessible, knowable, and accountable, and thus the question came up: What can be done about the agency's notoriously glacial response to Freedom of Information Act requests on drug approvals, food recalls, and medical device oversight? One idea floated was that FDA documents, once published once through official channels, be posted on the FDA website for all the world to use and peruse. If the FDA decides to go that route, there's a new model coming out of a different world -- the news business -- that might help to flesh out what public document sharing might look like in the modern age.
It's called DocumentCloud, and it just received a two-year grant for a considerable $719,500 from the Knight Foundation's Knight News Challenge...
The somewhat beleaguered Food and Drug Administration, reports the New York Times' Gardiner Harris, is setting up a "Transparency Task Force" to examine how the FDA can more fully open up its operations to the public -- particularly when it comes to the testing and approval process for new drugs. Harris notes that open government poses a unique set of challenges for the FDA, which must wrestle with managing high-value information on drug approvals and powerful pharmaceutical industry interests. (Harris's piece supplies some wonderful industry context for the move, and is well worth a read.)
According to the FDA website, the creation of the transparency task force is in direct response to President Obama's call for federal agencies to embrace more open and transparent government -- despite the fact that the White House has yet to issue a formal set of directives on the topic to the executive branch.
If I might be so bold as to quote my own tweet from a minute ago, "Watching Rosa DeLauro evangelize against the fragmented food system on www.whitehouse.gov/live is exciting in at least two ways." At least two! The first is on political substance. For us food geeks, the antiquated and convoluted way the U.S. handles food safety is a constant source of agita. (I'm going bolding into the realm of self-promotion for the second time in a single post. About a year ago, I wrote on what's messed up about American food here.)
And the cause of that frustration bleeds into the second -- more tech-focused -- reason why the live web broadcast of the admittedly policy-light briefing happening right now is particularly compelling. (The policy stuff will be chewed over in off camera briefings. The White House is inviting comments via Twitter though the hashtag #WHsafefood, as well as through Facebook.) It's been 70 years or so since the last major overhaul of the American food safety system with FDR's creation of the FDA under the Food, Drug, and Cosmetic Act. Getting that done took a hundred people dying from consuming what turned out to be antifreeze. Since then, the scattered advocates for food reform in Washington have been outgunned and outmatched by industry interests who are fairly okay with the way things are now, and a USDA aligned with their interests.
But today, that balance of power seems to be tipping. Via a live web stream hosted by the White House, those in DC who are passionate about fixing the American way of food are stepping out into the light. They are showing their collective strength. And via the web, they are connecting with renewed public concern over what we stuff into our pie holes. The hope for those of us interested in creating a more sane food system is that, together, that will and energy will be enough to create change before more people have to get sick or die.
Tucked into a recent press account of how an emboldened FDA is going on the offense to address pistachio contamination is a little tech nugget that might seem exceedingly trivial, but is arguably a sign of real political change reflected in web practices.
The Food and Drug Administration, note the New York Times' Gardiner Harris and Andrew Martin recently posted a link from FDA.gov that points out to an industry-created list of pistachio products not covered by the voluntary recall, posted at PistachioRecall.org by the Western Pistachio Association and a coop of California pistachio growers. (For its part, the industry site links back to FDA.gov/pistachios.) Now, you're likely thinking, glory be, an actual hyperlink, as I live and breath! And sure, the link is coupled with that dumbest-invention-of-all-time known as the "you are leaving a government website" exit notice. But that humble link matters all out of proportion because, as Harris and Martin smartly note, "[it is] part of the agency's increased efforts to provide needed information directly to consumers." Even more than that, though, it's an acknowledgement that even the federal government of the United States of America is ensnared in a common web of humanity, interdependent with industry and individuals and interest groups and all the rest of us.
And that's a subtle but significant shift from the traditional bureaucratic view of the web world that spawned the evil exit notice.