Friday, December 11, 2015

Should the Government Regulate Lab Testing ?

This morning the Wall Street Journal ran a 1750 word front page article entitled “The ‘Wild West” of Medicine,” with a subtitle of “Largely unregulated industry of lab testing comes under scrutiny.”

The article described the Mayo Clinic’s role in lab testing. It says Mayo receives 30,000 blood and cell samples each day and analyzes lab-developed tests for roughly $300 million each year. Mayo medical laboratories have annual revenues of over $600 million, and half of the comes from special tests outside the realm of routine lab tests. Overall, these special tests, developed by laboratories across the U.S. generate $10 billion in revenues.

The Federal Drug Administration is concerned some of these tests may be inaccurate, unneeded, and leag to unnecessary treatment, such as bilateral mastectomies because of a defective gene test. The FDA warns it may conduct unannounced inspections of labs doing these tests to fix problems associated with lab-developed tests with insufficient proof of their effectiveness.

I have a particular interest in this article because about 40 years ago I was interviewed as a possible candidate to direct Mayo’s Medical Laboratories outside its initial laboratory walls and to oversee development and marketing of new tests. I visited Mayo and was impressed by the thoroughness and accuracy in lab testing, but politely declined interest in the position. Dr. Michael O’Sullivan, created Mayo Medical Laboratories to test samples outside its original laboratory system, and it grew large enough to support a fleet of fans and a sales force and now has over 100 employees.

The FDA says it has found problems with certain tests, not necessarily at Mayo but across the nation, with certain tests for heart disease, ovarian cancer, Lyme disease, whooping cough, and autism. Defenders of lab-developed tests say these tests often prolong life and are used at guides for treatment.

The FDA fears too many tests lead to false and misleading information. Tests, the FDA maintains, should not be adopted without sufficient evidence of their accuracy or effectiveness before putting them on the market.

Fair enough. But there’s another side to this. Labs fear the cost of bureaucratic intervention may artificially raise the cost of tests and deprive patients of necessary tests. Supports of regulation says they worry more about the adverse consequences of ineffective tests.

Based on my experience with Mayo and as a clinical laboratory director, I do not regard lab-developed tests as the “Wild West.” And I am leery of the federal intervention and the underlying philosophy, namely, if it moves and grows and has any element of doubt, regulate it.

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