WASHINGTON -- House Speaker John Boehner invited James Plante, the CEO of Pathway Genomics, to attend President Obama's jobs speech Thursday as an example of a business leader whose efforts to create jobs have been stymied by "excessive regulations."
However, reports by the independent Government Accountability Office and the Food and Drug Administration indicate the product that Boehner, R-Ohio, claimed was unfairly maligned by federal regulators was unapproved and ineffective.
Pathway created home genetics tests for consumers to see whether they were at risk for 70 medical conditions. Pathway teamed with Walgreens to sell the kit in May 2010, but after the FDA wrote Pathway to say the agency had no record of its seeking approval for the device, Walgreens pulled out.
Boehner's press release presents the case differently: "Despite being in compliance with all available FDA regulations, the FDA attacked Pathway in the media following the announcement of the partnership. [Walgreens] consequently backed out, and Pathway was unable to create those 100 new high-paying jobs."
Reports from the FDA, GAO and the medical community show there's no proof the tests actually work.
Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, told a House committee in July 2010 that he had seen faulty data analysis, exaggerated clinical claims, fraudulent data and unacceptable clinical performance associated with the tests.
"These tests have not been proven safe, effective or accurate," Shuren said.
Michael Watson, director of the American College of Medical Genetics, agreed. "I think the general feeling was that we know too little about these tests to put them on the market," Watson told USA TODAY.
A July 2010 GAO report showed the tests are often unreliable. GAO investigators sent samples from the same people to four companies, the report said. In one case, the companies told the same donor he was at below-average, average and above-average risk for the same diseases.
San Diego-based Pathway Genomics, its website says, no longer sells tests directly to consumers over the Internet. It provides reports only to physicians.
House Republicans handled questions for Plante.
Dan Conston, a spokesman for Rep. Peter Roskam, R-Ill., said Pathway was chosen because it and the others "exemplify businesses and sectors hurt by excessive Washington-imposed barriers preventing them from innovating, growing and creating more jobs."