Shocking News on ICDs

One of the great shames of the U.S. health care system is that women and minorities routinely receive less care than white men. This is especially true for women and blacks suffering from heart disease. They're much less likely to be offered complicated procedures like stents, bypass surgery and implanted defibrillators.

Guess what? They may be the lucky ones, at least when it comes to implantable cardioverter-defibrillators (ICDs), for which Vice President Dick Cheney is probably the most famous patient.

A new study in the Journal of the American Medical Association shows that black men were only 73 percent as likely as white men with a comparable level of disease to get ICDs; white women were only 62 percent as likely, and black women were only 56 percent as likely to get the devices implanted.

The study used the first data in from the registry required by the Center for Medicare and Medicaid Services (CMS) when it expanded the use of ICDs, much to the chagrin of some of the advisers on the panel that evaluated the technology two years ago (see this GoozNews). The billion dollar question at the time (the devices cost about $40,000 per operation) was whether Medicare beneficiaries would have the same benefit as the patients who were enrolled in the original clinical trials, who were younger and (other than the fact they had heart disease) healthier.

This new study also looked at outcomes and, according to an accompanying editorial by Rita Redberg, a cardiologist at the University of California at San Francisco who served on the CMS advisory panel, the results "are troubling, but not for the expected reasons."

After controlling for comorbidities, the authors found that Medicare beneficiaries who received ICD implants for primary prevention had no benefit in terms of reduced all-cause mortality. In other words, the bad news may not be for women and minorities, but for white men who are undergoing a procedure that, for primary prevention, has not been shown to extend lives.

So much for the world of evidence. Now let's turn to news from the evidence-free zone, i.e., where medicine actually gets practiced. All last year, sales of ICDs were depressed because of safety concerns surrounding product recalls by Guidant, which is owned by Boston Scientific. But they're rebounding smartly, according to the financial press.

Medtronic, whose ICDs are its largest product line, said sales rose 8 percent from a year ago in the second quarter, according to its most recent report. St. Paul-based St. Jude Medical, the third largest maker, said that its sales of ICDs spiked 18 percent to $327 million in the second quarter. And Boston Scientific? Its ICD sales were down, but only slightly to $377 million from $383 million.

Do the math. About $1 billion a quarter in sales for the three makers. That's $4 billion a year just for the devices (this doesn't include the hospital and physicians payments, don't forget). Most of it probably comes from Medicare.

Let's give Dr. Redberg the last word:

Thus, the multibillion-dollar question is: Are too few ICDs for primary prevention being implanted in women (and minorities) or are to many ICDs being implanted in (white) men? The important clinical and policy question may be not why women and black Medicare beneficiaries are less likely to get an ICD, but which Medicare beneficiaries will benefit from ICD at all?

Posted by gooznews at October 3, 2007 08:13 AM