FDA data underscores why patients need to ask tough questions about care

The epidemic of overtreatment is hardly new, and it often stems from physicians’ tendency to order excessive tests. But now Uncle Sam is getting ready to step in even more, prompted in part by disturbing data that detailed serious inaccuracies and flawed results with 20 case studies involving diagnostic tests for cancer, heart disease, autism, and Lyme disease.

As the New York Times described it, “one blood test to help detect ovarian cancer was never shown to be effective … but was used anyway. False-positive tests may have led to ‘unnecessary surgery to remove healthy ovaries.’ Pregnant women have considered or had abortions because other tests inaccurately indicated abnormalities in the fetus. Several tests now on the market detect a genetic variant that was once thought to increase the risk of heart disease, a link that has not been confirmed. Yet more than 150,000 people have been given these tests … and ‘many were likely over- or under-treated with statins,’ cholesterol-lowering drugs, at a cost estimated at more than $2.4 billion.”

More oversight of testing labs

To slash excess cost and to try to make health care more affordable, the Obama Administration, the Times reported, is seeking to step up regulation of diagnostic tests run out of a single laboratory. These tests have gotten complex and have not had as much oversight by the Food and Drug Administration, which, instead, traditionally has regulated testing run by multiple labs offering” commercial test kits.” Federal regulators required operators of the multiple lab tests to report recalls or incidences which their products contributed to patients’ harm or deaths.

Any moves to step up federal regulation of diagnostic testing, however, may run into a partisan divide, with the newspaper saying that Republicans, though split, will oppose it and Democrats will favor it.

Ask these four tough questions

So where does that leave patients? Perhaps, as I have stressed, with a big need for caveat emptor when the folks in white coats run at you, wanting to run the gamut of medical possibilities absent best practice and common sense.

The cardiology crowd, for example, has been struggling for a year or so with the results of research by Harvard, RAND, and USC, that found that the highest-risk cardiac patients had the best 30-day outcomes at some of the nation’s best hospitals when the top heart docs happened to be out of the house at medical conferences.

Ezekiel Emmanuel, an oncologist writing in the Times, not only runs down reasons why, including elite physicians’ reliance on aggressive testing and treatment regimens, he also offers four, tough, and likely uncomfortable questions that patients can insist their doctors answer about their care:

“First, what difference will it make? Will the test results change our approach to treatment? Second, how much improvement in terms of prolongation of life, reduction in risk of a heart attack or other problem is the treatment actually going to make? Third, how likely and severe are the side effects? And fourth, is the hospital a teaching hospital? [Studies have] found that mortality was higher overall at non-teaching hospitals.”

PSA test curbs working

When medical groups, physicians, and patients think through better care, by the way, the results can be significant: New research, for example, has found that a guidance is succeeding in getting MDs to curb excessive prostate cancer screening. After studying data about the protein specific antigen or PSA prostate cancer test, the U.S. Preventive Services Task Force, urged physicians, starting in 2011 and finalizing its recommendation in 2012, to reduce the wide, routine administration of the screening.

The testing rate declined 16% in 2012 versus the year before, the new American Cancer Society study finds.

Just to be clear: If men have a cancer history, individual or familial, or if they have other risk factors, the PSA test may be called for still. But the research has raised questions about the effectiveness of the PSA test and whether it detects cancers that will grow so slowly and not harm patients as much as aggressive treatments might.

The guidance remains controversial, with some specialists worrying that men, already reluctant patients, and now with their physicians’ support, may forego a test that could be valuable.

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