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.”