turf wars

In my previous post I quoted from Mary Carmichael's excellent interview with two officials from the FDA, Alberto Gutierrez and Elizabeth Mansfield (part of her fantastic week-long DNA dilemma series, which you should read in full if you haven't already). There are numerous nuggets of gold tucked away in this interview that warrant further analysis, and I wanted to highlight a few in more detail. For a more complete dissection I'd recommend Keith Grimaldi's post commenting on the whole interview. I wanted to focus on two crucial tidbits unearthed by Carmichael: the attitude of the FDA towards…
The brief Golden Age of direct-to-consumer genetic testing - in which people could freely gain access to their own genetic information without a doctor's permission - may be about to draw to a close. In a dramatic week, announcements of investigations into direct-to-consumer genetic testing companies by both the FDA and the US Congress have sent the personal genomics industry into a spin, and it is still impossible to say exactly which way it will be pointing once the confusion passes. I've been frustratingly unable to find the time to cover the developments as they happened due to other…
Mark Henderson's interview with Anne Wojcicki, co-founder of personal genomics company 23andMe, is well worth a read. The big story is this: Wojcicki has floated the possibility of offering discounted genome scans to clinicians "to teach them to interpret genomic information that is now readily available to their patients". Wojcicki explains: "Clearly we need to engage with physicians to help them to understand this information," she said. "One of the things we've talked about is we'd love to get physicians comfortable with their own genomes first, have them understand what does it mean,…
The NY Times has an article entitled "Buyer beware of home DNA tests" that adopts the paternalistic party line of the medical establishment: taking DNA tests without a doctor's advice is hazardous to your health. Remarkably, the article acknowledges that qualified genetic counsellors are few and far between and that "most practicing physicians lack the knowledge and training in genetics to interpret [DNA tests] properly", and yet still suggests that customers should "take the findings to a qualified expert". Begging the question: which qualified expert should customers be taking their test…
OK, so this GenomeWeb Daily News article is approximately four centuries old in internet time (i.e. around a week), but it's worth going back and reading. I've previously argued at length that although personal genomics currently offers little in the way of useful, predictive health information, that lack of information in itself represents an important opportunity to educate consumers about the fuzzy nature of common disease genetics. So long as personal genomics companies represent the data accurately (which the major reputable companies currently do quite well, by and large), their…