The March toward Marginal Medicine

Is there no room for discussion of cost-effective health care in the pages of our leading daily newspapers? Nearly 50 million people are uninsured in this country largely because health insurance is unaffordable. Medicare faces a financial crisis as the Baby Boom heads into its retirement years. Yet the New York Times today managed to splash across the top of its front page word of a new $300 prostate cancer screening test that purports to measure a man's risk decades beforehand. This is, don't forget, a disease already overdiagnosed and overtreated with horrendous side effects for thousands of late middle-aged men.

The story was sprinkled with a few comments questioning the need for this new test. But the last word -- usually reserved for a source who best sums up the attitude of the author (the ever enthusiastic Gina Kolata) -- was given to one of the test's co-inventors, William B. Isaacs, a urologist at Johns Hopkins University. As usual, Ms. Kolata failed to disclose that his university is a co-owner of the patent on the new test.

"We have worked with enough families that have a positive family history to know that people are anxious to know their risk of prostate cancer,” Isaacs said.

Why do I find myself cupping my hands over my privates as I read what these people have to say? Full disclosure: my father was diagnosed with prostate cancer around age 70, when he was already several years into his Alzheimer's decline. His urologist operated, leaving my mom with the added duties of cleaning up after an incontinent in addition to looking after her increasingly vacant husband.

The genetic variants measured by the new prostate cancer test are known as biomarkers. A biomarker is something you measure to indicate the presence of disease, but isn't a disease itself. The king of biomarkers (in a commercial sense) is cholesterol, whose measurement and resulting treatment has spawned a $40 billion-a-year industry. In the wake of a trial showing that Vytorin, a pill combining two cholesterol-lowering drugs, did not reduce heart disease, some doctors are now questioning the entire theory, according to this story buried in the business section.

Of course, a number of well-designed trials have shown that lowering "bad" cholesterol with statin drugs in patients seriously at risk of heart disease reduces heart attacks and strokes. And, as the story pointed out, "doctors generally believe that the amount by which cholesterol is lowered, not the method of lowering it, is what matters."

But there's always been an alternative theory percolating on the fringes of cardiology: that statins have anti-inflammatory effects -- sort of like aspirin -- and that may account for some of its cardio-protective properties. The Zetia component of Vytorin lowered cholesterol, but wasn't a statin. One possible explanation for the ENHANCE trial's failure is that the combination of the two drugs didn't have the same anti-inflammatory effects of a single large dose of a statin drug.

Hmmm. Has anybody ever conducted a comparative trial testing Lipitor versus aspirin for people at risk of heart disease? Just a thought.

Anyway, the story quotes Scott M. Grundy of Texas Southwestern Medical Center to defend the status quo. Grundy chaired the industry-influenced National Heart Lung and Blood Institute panel that issued controversial guidelines for cholesterol management in 2004. What the story failed to disclose is that Grundy has financial ties to virtually every statin manufacturer.

The final piece of depressing news this morning is a study in the New England Journal of Medicine reporting that a trials showing that anti-depressants are ineffective rarely appear in the medical literature. The Wall Street Journal has a good synopsis. The recently enacted Food and Drug Administration reform law now requires that the results of all clinical trials get posted in a government database, so this study, which only looked at trials prior to 2004, may be out of date. But the reality is that billions of dollars are being spent for drugs that are marginal or, in some cases, no effect on depression and other mental disorders.

That depressing.

Posted by gooznews at January 17, 2008 07:20 AM