Industry leaders and some geneticists criticize a damning government report.
Last Thursday, the Government Accountability Office presented
Congress with a damning
report on the consumer genetic testing industry, concluding many tests are "misleading
and of little or no practical use." Company leaders and some geneticists,
responding via blog and twitter, have called the report one-sided and
unscientific, citing concern it will do irreparable harm to the nascent
industry. "There's no question that the sheer scale and ferocity of this
combined inquisition from the FDA and Congress will forever change the face of
the personal genomics landscape," writes
Daniel MacArthur, a geneticist and author of the Genetic Future blog.
The Spittoon, a blog published by 23andMe, one of the
companies named in the report, notes
that "The GAO refused to discuss its
concerns or its report with 23andMe, and now that the report is public and we
have had a chance to review it, we are troubled and find the report is deeply
flawed."
One of the main criticisms is that the GAO did not name the
companies in its report, thus lumping together the more reputable companies,
which have generally gone to great length to explain the limitations of their
testing, with the clearly charlatan ones, such as those selling supplements
tailored to an individual's DNA. "It conflates responsible companies offering
scientifically valid products with small-time con artists," writes MacArthur.
The report also largely failed to distinguish between useful
tests, such as those that predict whether someone will respond to a particular
drug, with those whose utility is still up in the air, including tests that
predict risk of complex diseases, such as diabetes or heart disease. Misha Angrist, an assistant professor at the Duke University Institute for Genome Sciences & Policy and a participant
in the Personal Genome Project (and who has written for
Technology Review), points out in
his GenomeBoy blog:
I found that learning my carrier status for a number of
diseases, risk for late-onset Alzheimer's, and genetic responses to a number of
drugs to be useful. I found the ancestry information to be interesting and
entertaining. Would I have paid $1000? No. $99? Yes. More than that? It depends
on what I'd be getting. That's why the GAO's failure to distinguish among the
companies, their pricing structures and their offerings is so unfortunate. The
net result does not allow for any nuance whatsoever. Rather, if one accepts the
GAO's conclusions, there seems to be room for only one response: "Off with
their heads." If that's the case, then consumer genomics will be driven
underground and/or overseas. In my view, that would be a shame.
A major criticism in the GAO report was that different
companies gave different predictions for disease risk based on the same DNA. The
targeted companies agreed this needs to be improved. 23andMe, for example, has
requested guidance from the FDA and NIH. Angrist suggests going a step further,
noting that these conclusions should trigger;
... a meeting of the
minds with a big tent full of experts to try to reach a consensus on
interpretation for things like prostate cancer and hypertension; 2) removal of
those conditions from their services in favor of, say, clearly useful and less
contested things like carrier screening and pharmacogenomics; or 3) a serious
downgrade of those results to "provisional" or "preliminary" status. The
companies have no one to blame but themselves for these discrepancies, which,
in my view, are the most damning aspect of the report and could have been
avoided. I would urge them to pursue at least one of the three aforementioned
options and get their ducks in a row.
Comments
- Misha
mhast8
07/26/2010
Posts:1