Earlier this week, the Financial Times – the go-to news source for entrepreneurs and global capitalists – published an opinion piece that rethinks privatization of intellectual property.
 
In “Who steals the gene from off the common,” Duke law professor James Boyle considers arrangements outside the current patent system that would create a “pre-competitive commons, a pool of information from which all can draw” and would benefit both science and commerce. Boyle has written extensively about the public domain, arguing that it has been seriously eroded by the current system of intellectual property laws.
 
With such a perspective being featured in the Financial Times, perhaps such ideas are becoming legitimate even in the eyes of science entrepreneurs and biotech venture capitalists. While, the pending appeal of ACLU v. Myriad Genetics gives these arguments renewed relevance, the seventeenth century protest poem that opens Boyle's piece demostrates their time-tested importance.

The law locks up the man or woman

Who steals the goose from off the common

But leaves the greater villain loose

Who steals the common from off the goose.

Previously on Biopolitical Times:

• Patent Happenings
• Historic Gene Patent Ruling Provokes Cheers and Jeers
• ACLU Lawsuit Says Gene Patents Are Unconstitutional

The recent investigation by the Government Accountability Office (GAO) - which revealed a significant number of problems in the direct-to-consumer (DTC) genetic testing industry - prompted a range of reactions, from applause to pushback.

Not surprisingly, those sympathetic to the personalized medicine industry led the pushback. Some lamented how the GAO report might impact the DTC industry, while others criticized the investigation's methods. The day of the report's release, Daniel MacArthur at Genomes Unzipped blogged:

On a personal note, today has been a difficult one for me… I don't know how much of this will survive the next few months; but if the regulators are allowed to have their way, [the personal genomics industry] will be dismantled piece by painful piece - and that makes me angrier than I've been in a long time.

23andMe focused on what it considered to be the unscientific nature of the GAO's findings:

We note that while such an exercise as conducted by GAO has the potential to raise questions, it does not provide the answers that a more rigorous scientific study would provide. This report raises questions, but leads to few conclusions because of its unscientific nature. The GAO itself recognizes this, writing, "It is important to emphasize that we did not conduct a rigorous scientific study."

Adding to this, deCODE Genetics founder Kári Stefánsson argued:

Among these companies there may be one or two that do this work at an extremely high quality but others that work at a lower quality, and to judge everyone on the basis of harmony of results is not a particularly good method.

Other observers, more cautious of the DTC industry, praised the GAO for bringing to light the many questions that DTC gene tests raise, including some troubling practices by even the more respectable DTC companies. Jeremy Gruber of the Council for Responsible Genetics, voiced the sentiments of many in support of the investigation:

The GAO report, for all its flaws, has at least shown that DTC genetics companies, by providing inaccurate information about risks, are not currently meeting that interpretive standard. Furthermore, some are following unethical practices (e.g. encouraging people to send in someone else's DNA without consent), which falls well short of the conduct expected from the medical profession. To us, at least, that's sufficient grounds for heavier regulation of these aspects of the industry. 

At this point, most in the industry actually share the view that regulation of some sort is necessary. 23andMe, Navigenics and deCODE seem to consider regulation of their industry a way to force less legitimate companies out of the market. The three have even begun discussions with the FDA to get a foot in the door on crafting regulatory rules.

 Rumblings in support of regulation can also be heard over at the Genomes Unzipped blog, whose writers are not industry players though they tend toward enthusiasm about personal genomics. Their "Regulatory Week" posts produced some invaluable discussion on DTC oversight, representing a spectrum of opinions- from support for regulation by the industry to an argument for public regulation and oversight. Arguing for a more hands-off approach, Caroline Wright says:

For years, academics and policy-makers have extolled the virtues of public education and participation in science, but with limited success. What if personal genomics offers a new way to involve and interest people? To deny individuals this chance to participate in one of the greatest scientific revolutions in human history, simply because of concerns over unproven harms and latent misunderstandings, would not only be paternalistic, but undemocratic, unscientific and unwarranted.

Fellow Genomes Unzipped bloggers Katherine Morley and Luke Jostins counter:

The trickier question (where disagreement arises) is how to regulate the interpretation of those results, whether by a private company or a medical practitioner. Whereas the technical accuracy side of DTC genetics is carefully monitored, at the moment, the interpretations provided by DTC companies are sold in what is effectively a free market. For other commodities we would generally allow the market to find the right balance between the companies acting in the interest of the customer (provide them with only validated, useful information) and in their own interest (increase profits by providing a sexy story about customers' genomes). Society doesn't, however, allow the practice of medicine to operate in an open market because we place a special value on it, and therefore impose regulations to ensure a minimum standard of care.

Ultimately, the GAO report in July - characterized as a "sting operation" - kicked up a storm. Now the dust has temporarily settled. But until the FDA makes its next move, the future of the DTC industry is very much up in the air.

In “Making a Killing” (Mother Jones, Sept./Oct. 2010), University of Minnesota bioethicist Carl Elliott provides a chilling account of what can happen when human research protections are compromised by market forces. The article details the circumstances surrounding Dan Markingson’s death – a young man who committed suicide while enrolled in a clinical trial funded and designed by AstraZeneca in coordination with researchers at the University of Minnesota. Elliott argues that this clinical trial death is striking since the research was not designed to produce objective scientific data, but rather to show that AstraZeneca’s antipsychotic drug worked better than its competitors.

Which raises a profound question regarding research subject protections: when is it ethical to enroll human subjects in what are essentially marketing campaigns? Or, as Elliott asks, “How much of a risk to human subjects is justified in a study whose aim is to ‘generate commercially attractive messages?’”

But research ethics at the University of Minnesota are also in the spotlight for other reasons. CGS’ Doug Pet raised an important issue about another project linked to the University named the Gopher Kids study, which is designed to understand the genetic underpinning of normal and healthy children by collecting hundreds of samples from kids and their parents.  The kicker? Research participants are being recruited at the state fair. As Pet pointed out:

The chaotic and otherwise jovial atmosphere of a state fair could not be further opposed from a clinic, lab, or other appropriately focused setting for gaining fully informed consent.

Jeremy Olson at the Star-Tribune recently published an interesting look into the first set of recruits for the Gopher Kids study. Olson’s interviews with research participants at least partially bear out Pet’s concern:

Consenting to the U's "Gopher Kids'' study wasn't part of the Poikonens' fair plan, but a recruiter quickly convinced the Mound, Minn., family to take part. "My son just wanted a sweatshirt," said Darren Poikonen, who watched as volunteers took his kids' blood pressure. "We didn't know about this until we were in here."

"I won't grow up." - P. Pan

The progressive news and opinion portal Alternet has always kept an eye on libertarians and their animus toward social justice and the public interest. Lately it's amped up its coverage of the libertarian transhumanists, a whacky fringe on the techno-utopian landscape.

An Alternet article posted last week focuses on Ray Kurzweil of singularity notoriety, and on the libertarian underpinnings of the ambition shared by Kurzweil and many other transhumanists to become "immortal cyborgs." Writer Brad Reed explains that this ilk sees "their future robot bodies as the best chance to escape statist control once and for all." As he says in the title of his piece, it's "The Ultimate Escape: The Bizarre Libertarian Plan of Uploading Brains into Robots to Escape Society."

Immortal cyborgs are just one of the bizarre libertarian plans hatched by transhumanists. Another (described by Reed in an earlier Alternet post) is "seasteading," a scheme to gather the libertarian elite on an ocean platform where they "can build new city-states to experiment with new institutions." The Seasteading Institute - yes, there's an organization devoted to this - is directed by the grandson of free-marketeer Milton Friedman, whose manifesto is published on Cato Unbound, the website of the libertarian Cato Institute.

With the recent revelations about the behind-the-curtain funders of the Tea Party in mind, just who is financing the libertarian transhumanists?

Both The Seasteading Institute and a number of groups whose missions include working toward immortality have been generously funded by one Peter Thiel, the co-founder and former CEO of PayPal who now runs a $2 billion hedge fund. According to a recent article in The Futurist, Thiel has "invested more than $4 million of his own money in groups working toward immortality" and "regularly speaks at trans-humanist gatherings." Thiel's anti-democracy rants can also be found at Cato Unbound.

Previously on Biopolitical Times:

• Capitalism 1, Transhumanism 0
  
• Libertarians Diss Democracy
  
• Marketing Transhumanism: A New Retail-friendly Face
  
• Transhumanists as Nihilists, Continued
  
• A Singular Kind of Eugenics