Peter Huber's new book, The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine is both provocative and inspiring. Once again, the Manhattan Institute scholar shows his extraordinary grasp of both technological and legal issues.
Huber is certainly correct in arguing that a) laws concerning intellectual property and b) the regulatory procedures of the FDA and the federal government in general are inhibiting medical progress--at least within the current parameters of how medical progress is achieved. More specifically, the status quo is impeding medical cures--and it's great to see Huber using the word "cure" in the title.
Why? Because only the idea of cures fully animates political activity. In politics, goals drive process. By contrast, process by itself is kind of a snooze to politicians, and to the public. In 1962, John F. Kennedy didn't say that he wanted to increase NASA's budget by 84 percent--he said he wanted the US to go to the moon by the end of the decade.
It was that galvanic message that punched through. It was that goal that drove not only NASA's budget, but also, of course, America's success in putting a man on the moon.
Indeed, it's a good thing that Huber sets forth the goal of cures, because only that big and worthy goal will overcome the inertial, even hostile, forces that block progress.
In particular, Huber identifies two recent US Supreme Court cases, Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories, which have--incorrectly in Huber's view--dramatically limited the right of private companies to create and defend IP claims. If companies can't create monetizable IP, Huber reasons, they won't go to the expense of creating it at all.
As he puts it, "Well-crafted property rights promote the broad and economically efficient distribution of know-how."
It's a strong argument, but there's also a strong counter-argument.
In fact, there's a huge constituency in favor of "open source" medical research, as part of the larger open-source movement. These open-sourcers argue just the opposite of Huber--they argue that the public benefits of open exchange of information far outweigh the benefits of privatizing medical discoveries. Indeed, they would further dispute the very idea that a naturally occurring entity ought to be patented at all.
We might recall that the open-sourcers seem able to count a majority of the Supreme Court. In other words, those who vehemently disagree with Huber seem to have the upper hand right now.
In addition to arguing for a more "robust" IP regime, Huber argues that researchers and companies will need to be able to create data consortia, so that the benefits of Big Data can be fully felt in the medical field. As Huber puts it, "For well over a century, competing companies have been pooling their patents and interconnecting their telegraph, phone, and data networks, online reservation systems, and countless other information conduits and repositories."
Huber is right, of course, but every one of these arrangements was controversial. That's why politicians and regulators had to step in to make the system work; back in 1913, for example, the Kingsbury Commitment, for example, encouraged AT&T to create a near-monopoly over US telephone service, and as that monopoly became increasingly controversial, in 1984 it was reversed by the AT&T breakup.
So, three decades later, is this the time to bring in new kinds of data consortia? Is this the time to overcome various rules--most obviously, HIPAA--that inhibit, even prohibit, massive data sharing? Perhaps the correct answer is "yes," but if so, it will take a lot of political and legal muscle to overcome the opposition.
In fact, it will probably require some updated framework for medical research, one that takes into account a) the imperative of scientific progress, b) the imperative of making sure that the benefits are fairly shared across society, and c) the need to protect privacy. No doubt there's a way to achieve all three criteria, but the political coalition that's needed does not yet exist.
And as noted in my earlier post on M.D. Anderson's "moon shot" cancer initiative, the key to developing political energy to move forward is found in the establishing of big and worthy goals--goals such as curing cancer.
If those goals are established, and supported by the public, then just about anything is possible.
But if the goals are fuzzy, then the status quo survives.