Earlier this week the Food and Drug Administration sent a warning letter to the direct-to-consumer gene testing company 23andMe ordering the company to stop marketing its $99 genotype screening test. The agency does, in fact, have broad authority to regulate any medical “device” ranging from bedpans to pacemakers that is used to treat or diagnose people. So if tongue depressors fall under the FDA’s jurisdiction, it’s pretty clear that 23andMe’s saliva collection kits do too. The letter gives the company 15 days in which to respond. If the agency doesn’t hear back or like what the company has to say, it advises that it might initiate regulatory actions that could “include, but are not limited to, seizure, injunction, and civil money penalties.”
23andMe has been selling its Personal Genome Service since 2006, so why did the FDA act now? It made its move, at least in part, because the company apparently has been ignoring the agency’s bureaucrats for too long. The warning letter notes that the FDA “has not received any communication from 23andMe since May.” Yet, the company rolled out a big new marketing campaign for its personal genome service this fall. Frankly, it is not very smart for a company to snub the regulators who have the power to shut it down at their whim. 23andMe’s belated response to the FDA acknowledges, “We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission.” The company diffidently adds, “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
So what are the FDA’s bureaucrats so worried about? Basically that purchasers of 23andMe’s personal genome services will do something dangerously stupid in reaction to the information that the tests provide. But will they? As an instance, the FDA letter puts forth a hypothetical in which 23andMe customers could be misled by the results of the company’s BRCA breast cancer gene tests. “If the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist,” argues the agency.
Researchers around the world use the same biochip, the Illumina OmniExpress Plus, that 23andMe uses and find that it provides highly accurate results. Nevertheless, all diagnostic tests produce false positives (false alarms) and false negatives (false all-clears). It bears noting that Myriad Genetics claims that the overall error rate for its more comprehensive BRCA test is less than one percent.
So let’s consider more deeply the likely reactions of 23andMe customers to the results of its BRCA test. First, 23andMe flatly states that it tests for only three of the more prevalent BRCA breast and ovarian cancer mutations found generally among Ashkenazi Jewish women. At the very top of its BRCA webpage the company emphasizes that there are hundreds mutations in the BRCA1 and BRCA2 genes for which it does not test that can cause cancer.
Now let’s assume that a 23andMe customer tests positive for one of the BRCA mutations, what are they likely to do next? On the strength of their letter, FDA bureaucrats seem to believe that women with a positive test will immediately go look for surgeons to remove their breasts; start gobbling down tamoxifen pills to ward off cancer; or get more mammograms. Of course, these scenarios are ridiculous. What a customer would do is consult with her physician and most likely get another more comprehensive genetic test. That is exactly what Huffington Post blogger Jill Steinberg did when her 23andMe results came back showing that she carried one of the BRCA mutations. Her subsequent test confirmed the 23andMe finding and she eventually decided to have a double mastectomy.
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