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Clinical Pharmacologists Warn of DTC Genomics Backlash on PGx

NEW YORK (GenomeWeb News) – The American College of Clinical Pharmacy has called for federal oversight of direct-to-consumer genetic testing companies, which it believes could inadvertently hold back advances in clinical pharmacogenetic and pharmacogenomic testing.

In a position statement published in the Journal of Clinical Pharmacology, ACCP argued that consumer response to genetic testing advertising could have "both immediate and long-term effects on public health and the future adoption of pharmacogenetic/genomic testing."

The paper explains that consumers could be let down or confused by the performance of DTC genetic tests, which could have a negative impact on other genetic testing firms that do not market directly to consumers.

The ACCP likened consumer ads for genetic tests to those for prescription drugs, which are regulated by the US Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications. The group noted that a similar oversight system is not yet in place for the young genetic testing field.

"Given the rate of development of genetic testing and its widespread availability and accessibility by the public, the establishment of effective governmental oversight needs to be undertaken soon," ACCP stated.

The harm that DTC genetic test marketing "is particularly likely when the consumer does not work closely with his or her clinician" or a qualified genetic counselor, ACCP noted.

Although ACCP said that pharmacogenetics has had some successes, such as warfarin sensitivity tests, these successes "may be short-lived, however, if poor consumer experience stigmatizes the genetic testing field or if an inequitable regulatory policy regarding laboratory-developed tests stifles innovation in the creation of validated genetic tests."

Because there currently is "limited ability" to predict disease risk using genetic profiles or genomic expression patterns, ACCP suggested, consumers must realize that the "scientific quality" of such tests "is not uniformly there yet."

The collective experiences of consumers who are not prepared for the uncertainty of genetic testing could lead to a "negative branding" and consumer distrust of genetic tests in general.

"This outcome could deter the future utilization of pharmacogenetic testing to inform choices about medication use, which is a long-awaited scientific advance in our discipline," the group argued.

Clinical pharmacologists may take some steps to help prepare consumers by offering them several pieces of "cautionary advice," ACCP said.

Namely, pharmacologists should advise consumers to consult with knowledgeable and trusted professionals about specifics concerning population risk and about the strength of a genetic correlation to disease expression.

The ACCP also said that consumers should make sure that they are being advised by someone trained in genetics, they should recognize the limitations of the tests, and they should understand that many companies that offer genetic testing services do not provide interpretation of test results.

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