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Discussion is accelerating in the United States and European Union to regulate private genomic testing that provides consumers medical information, according to Science magazine and the European Journal of Human Genetics. No mention is made in the reams of white papers about ancestry testing, but some of the pitfalls and bureaucratic morasses in the thinking about true genetic/medical testing are fairly ominous, if not silly.

"Although there has been speculation about the potential psychosocial harms of testing [that is, genomic medical testing], such as an increase in anxiety or encouragement of fatalistic behavior, there are, to date, few studies addressing these concerns," writes the reporters for Policy Forum in the Oct. 8 issue of Science. "The limited evidence tends to be reassuring, even for risk information associated with relatively serious ailments...however, the scope for potential harm from unnecessary or unproven treatment after genetic risk assessment is an important unstudied question" (pp. 181f.).

We commend scientists and physicians for finding a new field of study divorced from reality but have to wonder what they will do about ancestry testing once they have conquered and tamed Frankenstein's elder monster. We suggest the following guidelines:

• Labeling on Internet sites and Zen Shopping Carts that explicitly states, "The claims for this ancestry product have not been evaluated by the U.S. Government Accountability Office (GAO), U.S. Federal Trade Commission (FTC), House Energy and Commerce Committee, Food and Drug Administration, National Institutes for Health or Department of Bioethics and Humanities, University of Washington School of Medicine, Seattle, WA 98195 USA."
• Predictive ancestry information may be hazardous to your progeny.
• No animal has been harmed in the production or clinical evaluation of this ancestry test.
• If you discover you have ancestry you did not expect, take a deep breath. Then take a healthy dose of skepticism, followed by two aspirins and a glass of water.

In an article titled "Indian Tribe Wins Fight to Limit Research of Its DNA," Amy Harmon reports that Arizona State University has agreed to pay the Havasupai Indians of the Grand Canyon $700,000 and return blood samples collected from them for diabetes studies in the 1990s. The university's Board of Regents apologized to the tribe for...well, that part of the story is not clear. Not informing them that the samples might be used for "wider-ranging genetics"? Not informing the subjects that they reached negative conclusions and found no "diabetes gene" as they believed they had in a Pima Indian study? Not getting permission (no, that was done with simple-to-understand, signed consent forms, as was proper)? Coming to different conclusions about the Havasupai's origins than their myths and legends? Allowing people to "get degrees and grants" using "our blood"? Implying that the Havasupai are inbred? One Havasupai woman found that offensive.

Many tribal members were disgruntled because they were still suffering from diabetes after the university "took their blood."

Sorry, Havasupai Indians, a project participation consent form is not a treaty. But if you signed it, you should honor your word. You cannot go back now and require the researchers who use your samples to come to research conclusions that suit you and be silent about those that do not. Science (and society) doesn't work like that.

The tribe's dictates to the University were mercenary and the University's decision to pay the tribe off, wrong. The case sets a bad precedent and places another barrier between Indian peoples in remote areas and the real world. 

In the last blog post, we responded to the call of Nature (the journal, that is) in “Genetics without Borders.” In this, we examine the second of three editorials in this week’s issue concerning regulation of DNA testing companies:  “Putting DNA to the Test.” 

It should be pointed out at the beginning that the wrath of the editors descends in unequal fury on commercial enterprises. They are not as irate at ancestry companies as “personal genomics providers.” They seem to have in mind mostly concerns like 23andme, which promises for $399.00 to sequence your personal genome and give you “access to all health, disease, and trait reports” maintained by its staff, together with “ all ancestry features and raw data download.” To the editors of Nature, this is akin to practicing medicine and genetic counseling on the Internet. Spit into a cup, discover your personal DNA sequences and get an email when a medical article mentions your nucleotide position.

The presumptuous and condescending attitude of the editors is evident in their first paragraph (italics added):  “The availability of affordable, direct-to-consumer genetic tests has mushroomed, leaving regulation lagging behind. Dozens of companies now offer inexpensive (elsewhere: cheap) home kits that allow people to spit into tubes, send the samples for DNA analysis and receive a report that allegedly details their ancestry or their possible susceptibility to a long list of disorders that have been linked — often tenuously — to particular genes. But the value of these tests remains debatable, which is why (bad predication in our grammar book) the industry needs a strong set of quality standards and codes of conduct to protect both its consumers and its own credibility.”

Aside from poor writing (which seems to be a requirement for an advanced degree in the natural sciences), there are numerous examples of logical fallacies in this and the rest of the article. Perhaps Wittgenstein was right. What cannot be put into words cannot be thought. What can only be poorly expressed is poorly thought.

It is unclear whether the regulators would extend the same benevolent protection to the academic researchers who also consume genomics laboratory services. A case can be made that even their understanding is not always perfect and up-to-date. Elsewhere in the same issue of Nature are warnings to fellow scientists who make exaggerated claims about their research. The editors also reprove wayward brethren who seek to dip more than once in the immortalizing waters of the Pierian springs, by submitting their work to multiple journals, often under different guises or false pretenses.

The world of science has so much dirty underwear of its own, it is surprising it wishes to examine that of others. Credibility seems to be in short supply everywhere.

Without dissecting what is a mess of snips to start with, let us draw attention to one scenario the would-be regulators raise. “Customers,” they predict, “will frequently receive results telling them only that they face the ambiguous possibility of a somewhat elevated risk of a little-understood disorder.... If the ambiguous, slightly elevated risk relates to a frightening condition such as breast cancer, some individuals might feel compelled to undertake drastic and perhaps needless measures, such as prophylactic mastectomy [surgical removal of a breast to avoid cancer].”

I read this horrific statement to a friend of mine over the phone, who said she had been in that exact situation. Doctors found a lump in her breast. Knowing that ancestry testing had placed her in a category of predisposition to developing breast cancer, she underwent, after due deliberation, “prophylactic mastectomy." “I was thankful I took the DNA test,” she said, “because it gave me information that helped me evaluate my risks.” She says she is sure that if she had not taken the step she did, she would have breast cancer today.

It is arrogant of scientists to think they must protect people from information. This is the stance of a totalitarian state that controls and censures the information consumed by the populace, or of a state religion such as that which ruled supreme during the Middle Ages. It was attempted with disastrous results in so-called “activist era” of the Federal Trade Commission during the 1960’s and 1970’s under Commissioner Mary Gardiner Jones. An institutional ideology of this sort assumes that consumers require protection from scientific information that they may misinterpret and that may lead to personal or social distress. For example, misplaced information like this might lead historically disadvantaged communities to increase their distrust of the scientific establishment . . . . as though the scientific establishment didn’t do enough in that direction!

Another of the editors’ arguments against releasing genetic information to the populace is that genetic information is always evolving and may not be complete. Quoadusque? we may ask with Cicero. When will it be complete? Or complete enough? And who is to make that judgement?

Instead of mad, speculative and needless worry about consumers who are supposedly ignorant and defenseless, why don’t we let reason and the unimpeded flow of information take their course? Those two forces educated, up to a point, the scientists who are now trying to second guess the public. While it may have taught them a lot of facts, it did little apparently to sharpen their powers of philosophical reflection.