When Women and African-Americans Receive Better Care Than White Men

Last week a new study in the Journal of the American Medical Association documented yet another case of discrimination in American medicine. It turns out that blacks and women suffering from heart disease are much less likely than white men suffering from a comparable level of disease to have a defibrillator (a cutting-edge device that uses a jolt of electricity to shock an erratically beating heart back to a normal rhythm) implanted in their hearts.

But as Merrill Goozner points out at GoozNews:  "Guess what? They may be the lucky ones, at least when it comes to implantable cardioverter-defibrillators (ICDS) . . ."

The study showed no benefit for the white men who received the implant. Below, Merrill's analysis, plus his comment (from a separate post) on the need for more and better research into the effectiveness of new drugs and devices:

"The study, [which showed that black men were only 73 percent as likely as white men  to get ICDs; white women were only 62 percent as likely, and black women only 56 percent as likely] 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. [my emphasis-MM]

"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 [the fact that some patients suffered from more than one diseases] , 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.'"

In a separate, but related post the next day,    Merill reflected on the need for electronic medical records to create a database that would allow Medicare  to compare just how effective new devices and drugs actually are after they come to market—when they are used in the real world:

“I was intrigued this morning by comments made by Eli Lilly CEO Sidney Taurel at the Cleveland Clinic earlier this week (reported by FDA Webview, subscription required). He called on government and industry to collaborate on a health information technology system "to provide more rapid and useful insights on drug effectiveness and improve drug safety."

A well-functioning health IT system could not only frame hypotheses for post-marketing Phase 4 research studies but also be the practical equivalent of massive real-world trials. Such a system, he said, would collect detailed data from day-to-day medical practices and feed insights quickly, seamlessly, and at a lower cost to doctors, regulators, and drug manufacturers. . . “Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly,” he said.

But, as can be seen from the Medicare registry of implantable cardioverter-defibrillators (see yesterday's GoozNews post), such data will also give patients and their insurers a tool for studying how well those drugs and devices are performing in the real world. One of the great promises of universal electronic recordkeeping is that it will enable researchers to study how much benefit new technologies actually provide the general population that visits physician offices, clinics and hospitals, where economic incentives often trump medical science.

As we've seen time and time again, real world prescribers do not behave like the prescribers who participated in the limited clinical trials that led to a drug or device's approval. Their patients are usually younger or older, sicker or healthier, or women and minorities who are underrepresented in clinical trials. The efficacy seen in a clinical trial often disappears in the world of actual medical practice. Those interventions all too often are, in short, waste.

Universal registries enabled by a comprehensive health information technology system could become a powerful tool for rolling back the hundreds of billions of dollars of waste that is dragging down our health care system and making health insurance -- whether provided by the government or private companies -- unaffordable.”

Comments

[HowardCBerkowitz]

Structuring Phase IV surveillance is an excellent idea, as long as the data are available. Unfortunately, not all physicians do report adverse effects to the FDA; I've been wondering if they might take one directly from me.

Something rarely mentioned is that while surgical procedures may indeed go through randomized controlled trials, there is no approval requirement for surgical techniques as there are for drugs and medical devices. While the lack of efficacy of various cardiac angioplasty procedures has gotten much press attention, it's less obvious that bypass surgery has gone through what I might call generations. Contrast the efficacy of saphenous vein grafts to left internal mammary artery grafts.

Ironically, when I had my bypass, the excellent surgeon carefully explained his reasoning. Saphenous vein grafts tended to reocclude within 10 years or so, and I was young enough that he wanted to reserve the artery for what he expected would be a later operation. While I'm simplifying a bit, today's data shows that if he had used the artery in the first place, it would have been unlikely to reocclude.

He worked from the best knowledge of the time, but, when we think of evidence-based medicine, don't forget surgical ideas that...umm...seemed good at the time. Anyone remember internal mammary artery ligation?