DTC Genetic Testing Industry and its Supporters Fail to Discredit Damning GAO Report

by jeeg 17. March 2011 18:24

Former FDA official Mary Pendergast, who now works as an adviser to some companies that seek to market genetic tests, raised eyebrows at an FDA hearing on regulation of direct-to-consumer genetic testing when she made some startling claims about the veracity of a damning GAO report which revealed that home genetic tests often provide incomplete or misleading information to consumers.

During the course of a heated condemnation of the Panel for "paternalism", Ms. Pendergrast claimed that the lead investigator of the GAO report, Greg Kutz, had been fired by the agency for errors in the report.  She provided no additional evidence during her testimony nor since.

Yesterday, PGx reporter Turna Ray discovered that not only had Mr. Kutz not been fired (he was reassigned) but that his reassignment stemmed from mistakes in a completely different report on for-profit colleges.

"We have not identified any problems with our genetic testing work and rumors that people were fired over the work or that we will be issuing changes to the work are completely false," Chuck Young, GAO's managing director of public affairs, told PGx Reporter.

Unsubstantiated claims are nothing new in the industry blogosphere, but it rises to a whole new level of chutzpah to make such claims during an agency hearing.  Particularly when the individual making the claim has clear industry ties.

Certainly attempts to discredit the GAO report have been numerous among industry and its sycophants, but at least most of those charges were aimed at the merits of specific areas of the report.  Perhaps Ms. Pendergrast has already achieved her goal by pushing numerous publications to echo her claims and dredge up the weak criticisms that preceded it. 

The supporters of the report have been drowned out by such chatter but it s important to remember their points as well.  As Dr. James Evans, chief consultant to the General Accounting Office in its investigation and editor in chief of Genetics in Medicine, told CRG:

they (the GAO) actually did an elegant experiment; it was entirely scientific. They had, really, the ultimate control. They took the same sample to different companies and simply presented the results: for the same  exact sample, one company says the individual has an increased risk of prostate cancer, one says he has an average risk, and one says he has a low risk. One of them is right, but it's a little like the broken clock which is right twice a day.  We have no idea, as that experiment readily demonstrated, how to interpret some of this genetic information. So the idea that the report was not scientific is, I think, a rather silly accusation. They did an experiment, and the results speak for themselves.

Yes they do.


Jeremy Gruber


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