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

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.