Lifestyle Trends Falsely Predicted and Diagnosed by Pseudo-DNA Tests

The "gene-diet/lifestyle connection" has been exploited by a number of companies and caught in a "sting" operation by the General Accounting Office.

The operation is ably reported by the Bioethics Web Log in article from Corresponding Editor Ricki Lewis entitled, The Nutrigenetics War - Science vs Semantics.

Lewis points out the perils of the targeted company practices, which supposedly took information from patients via simple cheek swabs, ran a genomic analysis, and then made lifestyle recommendations as well as predictions as to what kind of health conditions might ensure if left unaddressed:

Patients/consumers "were warned of familiar conditions. Another company used language so vague as to be meaningless. What do "faulty methylation patterns" mean to the average Joe or Jill? Is having methyls attached to your DNA a value judgment? What is "altered activity" in certain genes? "Brain aging"? Such pronouncements could be frightening or intimidating."

Lewis points out that the companies in defense argued that they were not misleading and harming patients. And the "response starkly reveals the source of the controversy - and it is semantics, not science."

Essentially, the companies, offered disclaimers, such as "[This is] not a genetic test for disease or predisposition to disease, nor does it determine a medical condition," followed by some variation of "if you're sick, see a doctor". Rather than diagnose, reads the rebuttal, the company "explains impacts on health parameters." Like the confusingly positive labels on food supplements, nutrigenetics tests purport to assess such "parameters" as bone health, heart health, inflammation, antioxidant/detoxification, and insulin sensitivity."

Such disclaimers and rebuttals are remarkably parallel to the attempted defense of holistic health and CAM professionals, especially back in the days before widespread licensing of chiropractors, massage therapists, and other complementary and alterantive medicine providers, that they were not practicing "medicine" because they were not "diagnosing and treating disease."

In at least one early case, People v. Amber, a court (in New York) rejected the defense and held that diagnosis constitutes any "sizing up" of a patient's condition, whether biomedical, conventional, orthodox, or not.

In Amber, an acupuncturist was indicted for practicing medicine without a license - in the days before acupuncture licensure. (See Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives for a discussion of Amber and other holistic healing cases).

The other line of cases involves dietary supplements, which are regulated as foods and not drugs. Somehow there appears to be this invisible dividing line between the two categories, as if supplements do not have drug-like properties. This is as much of a wave of the magic semantic wand as claiming that an energetic "assessment" by a healer is not a "diagnosis" under the broad meaning usually ascribed to medical licensing statutes. True, it is not a conventional medical diagnosis, but healers might tell patients something about their current medical condition, or suggest a treatment. In short, the lines between medicine and the holistic healing arts pretty much blur, as do even scope of practice distinctions between licensed professions.

One key to sorting it out may be the issue of whether or how consumers can be harmed by misleading information.

Lewis writes: "I'm not too worried about the danger of web-based nutrigenetics tests, though, because consumers are savvy." This is a long way from the more paternalistic position taken in Amber and similar cases. In the days when so much information is freely available on line, it may be that the more autonomy-centric approach exemplified in the above quote is more appropriate -- a bit of a return to caveat emptor, letting the precise contours of the companies' claims settle the matter, rather than insisting that anything on the blurry side of assessment is a medical diagnosis that should be regulated as such. We certainly do want to balance autonomy against paternalism when considering the ethics of regulating therapies, whether such therapies are considered "conventional" or "unconventional," "mainstream" or "complementary and alternative."