Scrutiny of the freewheeling direct-to-consumer gene test industry is building in the US: just in the past few months, Congress and the FDA have held hearings, the GAO conducted a "sting" investigation, the public health departments of several states have gotten into the act, and public interest groups including the Center for Genetics and Society and the Council for Responsible Genetics [PDF] are weighing in.

European conversations about public oversight of DTC gene test companies also appear to be gathering steam. Last month, the UK Human Genetics Commission released a set of voluntary guidelines for DTC gene tests, but they were blasted as "weak and meaningless" by the public interest group GeneWatch UK, and criticized as "insufficient" and "ephemeral" by an editorial in The Lancet.

Now the European Society of Human Genetics has released a much stronger statement [PDF] on DTC gene testing "for health-related purposes." It calls for implementation of a protocol on gene testing that was added in 2008 to the EU's Convention on Human Rights and Biomedicine, and for national laws, which already exist in some European countries, to require "a responsible medical person to be involved before a genetic test is provided."

The statement succinctly summarizes the range of concerns and recommendations about DTC gene tests that are increasingly being voiced both in the U.S. and Europe. Some excerpts:

• "Various companies hold out that DTC genetic testing enhances an individual's autonomy and control over his or her future. ESHG underlines that this can occur only when consumers are offered adequate pre-test information, including counselling and psychosocial support when appropriate, and when the tests offered are of good quality and medically relevant."

• "Aggressive marketing strategies and slogans for DTC genetic testing might overstate the potential for predictive information of such tests and overrate its future health implications. All this is likely done to increase test uptake and artificially create new demands, that is, to earn money."

• "The clinical utility of a genetic test should be an essential criterion for deciding to offer this test to a person or a group of persons….For many recently developed tests, evidence for clinical utility is not available."

• "[T]he ethical, legal and social implications of the tests provided should be considered extensively in all of its phases (research, development and transfer into clinical practice). In light of these criteria, the ESHG opposes the premature DTC commercialization of various genetic tests."

• "The ESHG is concerned with the inadequate consent process through which customers are enrolled in such research. If samples or data are to be used in any research, this should be clear to consumers, and a separate and unambiguous consent procedure should take place.

• The Tempest: Following the Storm of Reactions after the GAO Report
• "Weak and Meaningless" Guidelines for UK DTC Tests
  

Donna Dickenson, emeritus professor of medical ethics and humanities at the University of London, and author of Body Shopping: Converting Body Parts to Profit and Property in the Body: Feminist Perspectives, is now turning her attention to the "seismic shift toward genetic personalized medicine." She approaches it with some skepticism.

Writing in Canada's national newspaper The Globe and Mail, Dickenson points out that

[C]redit for the greatest advances in human health and longevity over the past two centuries should go to "we" medicine, not "me" medicine. Public health and sanitation programs, polio and smallpox vaccinations, and tuberculosis screening in schools and workplaces have contributed the most to improved health in the Western world and beyond.

That was then. What about now? Dickenson believes, along with many others, that personal genomics and other instances of "me" medicine remain "more hype than reality - and sometimes dangerous hype."

Dickenson welcomes some kinds of personalized medicine, including genetic techniques that promise to tailor drug choices and doses to each patient's genome. But she is troubled that the "growing popular tendency to define all conditions as genetically determined" is likely to cause "public health measures…to be neglected in favour of individual genetic scans or personalized genetic-testing services."

What Dickenson calls "me" medicine isn't limited to gene-based developments. She mentions private umbilical cord banks and "enhancement technologies such as deep-brain stimulation" as other examples of practices that

promote the idea that you have a duty to be the best "me" possible. In fact, modern biotechnology is increasingly about "me" medicine, the "brand" being individual patients' supposed distinctiveness….

[L]ike the drunk who looks for his lost keys only under the streetlight, biomedicine is in danger of concentrating only where the glare is brightest - not on the most effective health interventions but on the most personalized and profitable, which nowadays go hand in hand.

Previously on Biopolitical Times:

• So You Think You Own Your Body?
• Oversight Agencies Crash the Spit Party
• The Big Game of Student Genetic Testing
• Caveat Emptor, Caveat Spittor
• Whither Personal Genomics?

At Biopolitical Times, we have frequently ridiculed a "gene of the week" -- an instance where someone, occasionally a huckster or scientist but usually a headline writer, has overhyped or oversimplified some discovery related to genomics. So it's a pleasure to give credit where it's due, for this accurate Reuters headline:

Study finds first genetic link
to common migraine

The story was based on a study published in Nature Genetics [abstract] that analyzed genetic data from over 50,000 people. As with all such genome-wide association studies, a number of caveats apply, which are addressed in the paper, as they should be. More impressively, some of them are noted in the Reuters piece:

The scientists said further research would be needed into the DNA variant, and into its effect on the genes around it, to find out more about how migraines occur. Further work was also needed to search for other possible genetic links, they said.

The writer, Kate Kelland, also included details about the risk variant being "on chromosome 8 between two genes known as PGCP and MTDH/AEG-1" and appearing "to regulate levels of glutamate ... by altering the activity of MTDH/AEG-1 in cells, which regulates the activity of the EAAT2 gene." Which may be dull to the general public, but does suggest a level of engagement with the material that should be more common than it is.

Not everyone followed this subdued example ("Migraine Gene Sparks Cure Hope" — Daily Mirror, a British tabloid), but the exact Reuters headline drew 134,000 hits on Google three days after it first appeared, about ten times as many as "migraine gene" or "gene for migraine." Kudos to Reuters!

The search for ever-stranger "genes for ..." is not, however, a thing of the past. A team of scientists from North Carolina, Arizona and Singapore is publishing a paper in the wonderfully named Journal of Organizational Behavior, suggesting that there are "genetic underpinnings of survey response." Yes indeed, some people have evolved predispositions to ... hang up the wretched phone when a pollster calls during dinner. Sigh.

Previously on Biopolitical Times:

• Genes of the Week: Inborn Talent Genetic Test
• Gene of the Week: Debt
• Gene of the Week: DIY
• Gene of the Week: Being a Gangsta
  

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