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
  

Two weeks after UC Berkeley backed away from its widely criticized “Bring Your Genes to Cal” program, commentary about the controversial experiment continues. Recent opinion pieces have been published in the Marin Independent Journal, Berkeley Daily Planet, and GenomeWeb.

 UC Berkeley announced a major shift in the program following public scrutiny and a warning from the California Department of Public Health that its plan to have students’ DNA samples analyzed at an uncertified lab would violate state law. Dean of Biological Sciences Dr. Mark Schlissel said that the university will therefore make only aggregate results available to the incoming students instead of providing individualized results. Several campus events about personal genomics will continue as scheduled.

The Center for Genetics and Society, the Council for Responsible Genetics and other public interest organizations applauded the decision to revamp the flawed project. Others expressing significant concerns included members of the California State Assembly Higher Education Committee, which held a public hearing on the program last month. Committee Chair Marty Block “welcomed news that the university will alter their program to comply with the state directive to ensure that laws assuring the accuracy and quality of medical testing are observed.”

National and state news outlets reported on the unraveling of events. Here is a sampling of the coverage:

San Francisco Chronicle:

[W]hat was meant to be a group educational exercise turned into an education for the university on the politics and policy of medical testing.

Jesse Reynolds, policy analyst at the Center for Genetics and Society in Berkeley, had opposed the university's program primarily over privacy concerns and what he considered the lack of research into the implications of such a mass experiment.

He said restricting students from receiving information about their personal genetics essentially cancels the "personalized medicine" aspect of the program. He said that although students signed consent forms to participate as part of submitting their DNA samples, he is concerned they have now signed consent forms for what is to be a different program.

Los Angeles Times:

Berkeley officials contend that the test results would not be medically significant. But the program was controversial with privacy advocates and ethicists complaining that it presented an unprecedented and disturbing use of genetic data by a university.
"It showed a lack of due diligence and consideration," said Jeremy Gruber, president of the Council for Responsible Genetics, based in Cambridge, Mass. He said he remained concerned about how the genetic samples would be used, despite UC's pledge to destroy the samples after collecting the results.

NPR Morning Edition blog:

The faculty who came up with the idea and some students are disappointed. But others say the change is prudent. Jesse Reynolds, policy analyst at the Center for Genetics and Society, says the state health department didn't dictate educational policy. Instead, [he] said, “[T]his is a medical test and you are conducting a medical test on thousands of young men and women without the involvement of a physician and without using an appropriately certified laboratory. These are not curriculum issues.”

Bloomberg News:

Personal gene testing has emerged as an increasingly controversial field. Medical ethicists criticized the Berkeley program, saying that students would feel pressured to submit saliva and wouldn’t know how to assess the results. Federal regulators, in a series of actions this year, have told makers of personalized gene test kits offered directly to consumers that the products must be approved before sale.

While educational experiences for students are a good thing, the main lesson here “was for the Berkeley administrators and for other universities thinking about doing something similar,” said Hank Greely, a Stanford University law professor focused on medical ethics. “Their goal was good but they hadn’t thought through sufficiently all the problems of implementing this in a safe and ethical way,” Greely said.

Sacramento Bee:

The plan was to test the saliva samples for three genes – those involved in breaking down lactose, metabolizing alcohol and absorbing folic acid. Genetics professor Jasper Rine testified that the goal was to engage students with an intellectual concept that had personal relevance.

Detractors said the plan was poorly thought out and rife with potential privacy violations and confusion for students. Hank Greely, director of the Center for Biomedical Ethics at Stanford, raised concerns that teenage students would misinterpret findings about themselves.

Jeremy Gruber, president of the Council for Responsible Genetics, said Berkeley freshmen could feel pressured to participate because of the way the test material was presented. The consent form that participating students had to sign listed the benefits of doing the genetic test, he said, but not the risks. "The consent form is pure marketing," Gruber said.

Berkeley Daily Planet:

“Schlissel and Rine have repeatedly described the orientation exercise as a scientific experiment. We asked what hypothesis the experiment was designed to test. 

Schlissel replied that the hypothesis being tested is whether or not programs such as “Bring Your Genes to Cal” are an effective way to engage students, particularly students not majoring in biology, in the complex issues that surround genetic testing. He added that the methodology would involve the taking of attitudinal surveys. 

In effect, what appears on the surface to be a biological experiment now turns out to be a sociological experiment designed primarily by biologists (in extensive consultation with colleagues of many disciplines).”

Previously on Biopolitical Times:

• UC Berkeley Proposes Genetic Testing of Freshman
• Growing Controversy Over UC Berkeley's Gene Testing Program
• The Big Game of Student Genetic Testing