Undercover Investigation Hits DTC Testing Companies Hard

by jeeg 22. July 2010 23:21

An undercover investigation of some firms that sell genetic test kits to consumers found misleading test results and “egregious examples of deceptive marketing,” according to a report published today by the Government Accountability Office.



Federal investigators bought 10 kits each from four companies that sell such tests, selected real donors to send in their samples for testing, and then, posing as fictitious customers seeking health advice about the results, made calls to the companies.

The report said the companies had sent the donors different results for the same sample, told donors they were at lower risk for getting diseases they already had, and suggested that a customer’s DNA could be used to create personalized supplements to cure diseases.

One company representative told a consumer that she was at high risk for breast cancer, even though the company did not test for the breast cancer mutations BRCA1 and BRCA2, according to the report.

Here’s an excerpt, provided by the G.A.O., from that telephone conversation:

Fictitious consumer: “So if I’m high risk, does that mean I’ll definitely get breast cancer?”

Company Representative: “You … you’d be in the high risk of, you know, pretty much getting it.”

In another example, a customer who had a pacemaker implanted 13 years ago to treat an irregular heartbeat was told that he was at decreased risk for developing that condition, the report said.

The report comes as both Congress and the Food and Drug Administration are investigating the genetic testing market for consumers. A subcommittee of the House Committee on Energy and Commerce held a hearing today into some companies that offer the tests.

Some officials have said they were concerned that the quality of the tests and the genetic markers they look for have not been verified, that the analyses of the samples may vary from company to company, and that people might make medical decisions based on the results without consulting the appropriate medical professionals.

On Monday, the F.D.A. sent letters to 14 companies that offer such services, saying that their diagnostic tests should not be sold without agency approval. Last month, the agency had sent similar letters to five other companies that offer such services.

The agency held a public meeting earlier this week to discuss greater oversight of these kinds of lab tests.


Natasha Singer (Abbreviated from NY Times Prescription Blog)

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