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GAO Stands By Its 2010 Report on DTC Genomics Firms; Lead Investigator Assigned to New Position

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By Turna Ray

This article was originally posted March 10.

The Government Accountability Office has denied a rumor that has been circulating regarding the firing of an investigator responsible for a report on the practices of for-profit colleges and is standing by the merits of a report led by the same investigator on direct-to-consumer genomics firms that it released last July.

At a US Food and Drug Administration advisory committee meeting on direct-to-consumer marketing of genetic tests last week, Mary Pendergast, a lawyer and director of ARCA Biopharma, said that the lead investigator of the GAO's report on DTC genomics, Greg Kutz, was fired due to errors in a 2010 GAO report that identified fraudulent practices by for-profit colleges. Pendergast went on to suggest that the dismissal signals that the GAO also employed questionable methods when conducting its investigation on DTC genomics firms.

"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.

The agency is, however, undergoing a restructuring in the wake of its report on for-profit colleges, which did contain flaws that the agency later clarified.

Kutz, formerly managing director of GAO's Forensic Audits and Special Investigations Unit who headed up the agency's investigation on DTC genomic firms, has not been fired, but assigned to a different position within the GAO.

According to a March 1 memo from GAO comptroller General Gene Dodaro, Rick Hillman, current managing director of the Financial Markets and Community Investments team, will assume Kutz's post and the group has been renamed the Forensic Audits and Investigative Service team. The new team will be subject to internal inspections, external peer reviews, and work with other teams in the agency.

"The inspection report on the for-profit school work identified areas to improve quality control," Dodaro wrote in the memo.

Kutz will continue to serve in the GAO as the director of audit services. GAO is currently searching for another executive to serve as the director of investigative services. The changes to the investigations team "will allow us to take better advantage of … Kutz's wealth of experience in forensic and other audit services," Dodaro wrote in the memo.

A Tale of Two Profiles

When the GAO released its report, "Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices," representatives of the genomics industry charged that the study was fraudulent and misleading due to its unscientific nature (PGx Reporter 07/28/10). The GAO presented its findings to the House Committee on Energy and Commerce last year.

The GAO's investigation from June 2009 to June 2010 was conducted at the request of the House Committee on Energy and Commerce. To examine the practices of DTC genomics firms, the GAO deployed five fictitious customers to look into the marketing practices of 15 firms selling tests to consumers online. These customers also purchased gene scans from four DTC firms â€" 23andMe, Navigenics, Decode Genetics, and Pathway Genomics â€" to compare how closely the disease predisposition results agreed between companies and to assess whether company representatives were providing accurate information to customers.

In a review of the donors' test results across all four companies, the GAO found contradictory risk predictions for at least nine diseases for each donor. The agency also concluded that follow-up consultations "provided only general information and not the expert advice the companies promised to provide."

At the congressional hearing, Kutz revealed that he was one of the five fictitious consumers and said he received conflicting risk predictions for prostate cancer. Kutz learned from 23andMe and Decode that he had average risk for prostate cancer. Meanwhile, Pathway told him he had below average risk and Navigenics determined that Kutz had above average risk for the disease.

Pendergast asserted at the advisory committee meeting this week that the GAO essentially set up DTC genomics firms for failure because investigators submitted a real profile and a fake profile for the same saliva sample.

As part of the investigation, the GAO sent in two profiles for each customer who submitted a sample to the companies for analysis. One profile gave the factual data about the donor's age, race, and ethnicity, while the other profile was made up. The GAO did this to "determine whether altering the donors’ backgrounds had any effect on the companies’ DNA analysis."

However, the GAO only compared the disease risk scores between each donor's factual profiles to determine how similar the results were across the companies, and whether the risk predictions agreed with donor's actual illness and family histories. The fictitious profiles were used to examine whether genomics firms were able to provide complete risk reports to customers of Asian and African American ancestry, since most gene-disease risk associations are validated only in European populations.

The GAO took issue with the fact that these firms did not make these testing limitations known to customers before they paid for these services. The agency was able to get a refund from two of the four DTC genomics firms.

All four genomics firms criticized the GAO report when it was released last summer. Kari Stefansson, president of research at Decode, said that the GAO's unscientific approach was "making a game out of the numbers for the purpose of arriving at a self-fulfilling conclusion."

The GAO emphasized in the report that it did not pursue a scientific investigation, "but instead documented observations that could be made by any consumer."

A 23andMe spokesperson this week reiterated that the company had "serious concerns about the methodology of the investigation and the validity of the conclusions the GAO drew from it."

The spokesperson added that 23andMe "is pleased to see the GAO is taking steps to ensure that future investigations and reports are objective, accurate, and valid."


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