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dtc genetic testing?

"Two things are infinite: the universe and human stupidity; and I'm not sure about the universe."

--Albert Einstein

In recent years, diagnostic genetic tests for well over 1,000 diseases have become clinically available. Results from such tests can lead to profound, life-changing decisions, such as whether to undergo prophylactic mastectomy, terminate a pregnancy or take a particular drug or dosage of a drug.

Predictably, as novel medical advancements emerge, there will always be a segment of our society rushing in to capitalize upon the profits that might be there for the taking. For review of a related phenomenon, refer to The DNA Ancestry Con Game - Consumer beware!

Over the past several years, Direct-to-consumer (DTC) genetic testing has been gaining tremendous momentum. In the article that I am presenting here today, I am asking my readers to sift through the mountain of information associated with this topic-including the many links provided below-and offer responses based on your knowledge of and/or experiences with these consumer-directed tests. Read on, …

In July 2007, the U.S. Government Accountability Office (GAO) released a scathing condemnation of the DTC genetic testing industry in an article entitled TESTS PURCHASED FROM FOUR WEB SITES MISLEADS CONSUMERS. The authors of this article revealed how elementary it can be to demonstrate the glaring lack of scientific reproducibility of the DTC genetic data.

Two months after the GAO article, a commentary was released by the American Society of Human Genetics (ASHG) entitled ASHG STATEMENT ON DIRECT-TO-CONSUMER GENETIC TESTING IN THE UNITED STATES. In this article, the authors report that the proponents of DTC testing were hard-selling the favorability of the changing environment, as it enhances consumer access to useful diagnostic tests and offers improved consumer autonomy and empowerment. Meanwhile, an elevated degree of privacy can be maintained over personal medical information. In contrast, the article established the following:

“Critics of DTC genetic testing have pointed to the risks that consumers will choose testing without adequate context or counseling, will receive tests from laboratories of dubious quality, and will be misled by unproven claims of benefit.”

The ASHG statement was released, in part, as a consequence of the intensifying firestorm of conflict between various state and federal government agencies (with the classic example being the GAO) and the rapidly growing legion of genetic testing companies-venturing into the DTC business market.

The FEDERAL TRADE COMMISSION (FTC) is our primary government agency-burdened with the responsibility of investigating questionable business practices-with the ultimate purpose of protecting American consumers. A July 2006 consumer alert—issued by the FTC—was entitled, AT-HOME GENETIC TESTS: A HEALTHY DOSE OF SKEPTICISM MAY BE THE BEST PRESCRIPTION.

In this article, the FTC asks consumers: “Could a simple medical test tell you if you are likely to get a particular disease? Could it evaluate your health risks and even suggest a specific treatment? Could you take this test in the privacy of your home, without a doctor’s prescription or guidance? Some companies say genetic testing can do all this and more. They claim that at-home genetic testing can screen for diseases and provide a basis for choosing a particular diet, dietary supplement, lifestyle change, or medication.”  

The article seems quite skeptical of these claims, as it points out:
“According to the Food and Drug Administration (FDA), which regulates the manufacturers of genetic tests; and the Centers for Disease Control and Prevention (CDC), which promotes health and quality of life, some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation. The FDA and CDC say that because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory, and the results should be interpreted by a doctor or trained counselor who understands the value of genetic testing for a particular situation.”

A recent, quite informative article was released by the INDIANA UNIVERSITY CENTER FOR BIOETHICS. This article includes useful background information relevant to the many ethical issues associated with DTC genetic testing. The article also focuses on various mechanisms by which state and federal government agencies are proceeding—or might proceed in the future—with regulatory measures.

Additional articles addressing the DTC genetic testing controversy include the following:

ASSUMING YOU WANT TO KNOW, GENETIC TESTS ARE NO CRYSTAL BALL. This April 2011 article provides an interesting, recent viewpoint on what is currently going on-relevant to the DTC genetic testing controversy and the ongoing skirmishes involving the GAO, the FTC, the FDA, and the CDC.

DIRECT-TO-CONSUMER GENETIC TESTING: RELIABLE OR RISKY? Clinical Chemistry, a leading international journal of clinical laboratory science, solicited opinions on DTC genetic testing from various renowned experts.

GENETIC TEST KITS: PREDICTIONS OF THE FUTURE OR PSEUDO-SCIENCE SCAM?. In this article, the authors point out that “....the General Accounting Office (GAO) thoroughly debunked the marketing of direct-to-consumer genetic test kits, charging that the biotech companies who peddle this high-tech snake-oil scam are guilty of providing misleading test results backed by deceptive marketing and other questionable practices.”

DIRECT TO CONSUMER GENETIC TESTING AND OPRAH.

Yes, even Oprah is joining in on the fun.

The next article is entitiled:

Wrongful Convictions: Society Loses Out, THREE TIMES OVER

Michael J. Spence, Ph.D.

January 27, 2012

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