By Kirell Lakhman

The American College of Clinical Pharmacology last week said direct-to-consumer ads marketing genetic tests should be regulated by the federal government, and cautioned that not doing so “soon” could slow advances in clinical pharmacogenomic testing.

In a position statement published in the Journal of Clinical Pharmacology last week, ACCP cautions that “response of consumers to such advertising can have both immediate and long-term effects on public health and the future adoption of pharmacogenetic/genomic testing.”

The statement concludes that the current “success” of clinical pharmacogenomic testing “may be short-lived … 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.”

Really, ACCP has nothing to fear from DTC genetic-testing ads for at least three reasons: First, many physicians support the use of the DTC pharmaceutical ads that ACCP implies threaten patient care when in fact those ads are running with a near-perfect record even before FDA has had a chance to review them.

Second, DTC genetic tests do not compete with the clinical pharmacogenomic tests performed by CLIA labs, and by extension would not threaten their advancement. Third, DTC genetic-testing shops currently mention the algorithmic limitations of their service — albeit some are not in the most obvious place.

In its statement, ACCP doesn’t describe how the federal government should become involved in DTC genetic-testing ads. Rather, it briefly mentions that FDA currently oversees DTC ads for pharmaceutical products — but omits the relevant point that oversight typically begins after the ads begin appearing — and says “a comparable oversight system is not currently in place for consumer-directed advertising of genetic testing.”

But creating similar oversight machinery for DTC genetic-testing ads would cost the federal government money it doesn’t have (the FDA arm responsible for DTC drug ads currently employs around 40 people) for a meager regulatory yield: Between 1999 and 2002 FDA reviewed nearly 1,600 broadcast ads. Since it began monitoring DTC drug ads in 1997, the agency has issued three warning letters regarding them.

This means that at least 99.875 percent of all broadcast ads that were aired met FDA’s regulatory standards without the purported benefit of having been prescreened by FDA. (According to FDA, “almost all companies send new proposed DTC broadcast concepts to [the agency] for comments in advance of use, although companies are under no obligation to follow [its] advice.”)

Superimposing this over DTC genetic-testing ads, I factor in results of a 2002 FDA survey that found “many physicians believe that DTC [pharma] advertising can play a positive role in their interactions with their patients;” “most agreed that because their patients saw a DTC ad, he or she asked more thoughtful questions;” “some physicians thought the ads made their patients more aware of possible treatments;” and “many physicians thought that DTC ads made their patients more involved in their health care.”

Another reason ACCP’s anxiety is misplaced: DTC genetic-testing vendors could not imperil the advancement of clinical pharmacogenomic tests because the former don’t play in the same league as the labs that perform the latter.

“At this stage I don’t see DTC shops to be serious competitors with hospital-based labs like ours since the target population is somewhat different,” KT Jerry Yeo, director of Clinical Chemistry Laboratories and the Clinical Pharmacogenomics Program at the University of Chicago, told me a few days before ACCP published its statement.

“DTC tends to target any consumer (mostly healthy) while hospitals deal with patients,” he said. “It is one thing for healthy consumers to order online a whole genome profile for whatever perceived health benefits they think it will provide, while it is a very different issue when a physician is ordering a targeted set of genomic panels based on the clinical presentation or a thorough workup of a patient.”