BB&T

American patients. American guinea pigs?

No, not pleasant to think of oneself as a laboratory animal, but that is pretty much what the American patient is these days while continually told that medical technology is a game of high-stakes dice, but media-driven to the belief that he or she will most always end up on the "benefit" side of the risk/benefit ratio.

An American as healthcare guinea pig is counter-intuitive, of course.

It is usually thought that Europe and European patients bear the major brunt of U.S. med-tech experimentation since the CE mark is the primary staging area for new technologies. But at least in Europe the adverse events of bad products may become obvious early, so that the damage to patients from bad technologies, or bad uses of them, can be somewhat limited.

In contrast, the damage done by approved but highly equivocal technologies might be much more widespread, subtle and continuous in America. The reasons for this, of course, are embedded in this country's robust healthcare economics.

Most commentators on these economics have formed a chorus which claims that the main reason for sharply rising U.S. healthcare costs is a proliferation of new medical technologies. But the blanket blame put on med-tech is simply a flimsy shorthand, with the real reason being a complicated and intertwined series of circumstances permeating the culture of U.S. med-tech.

Any new technology, healthcare or otherwise, usually is more costly. And if a new med-tech system can be shown in enough studies to be effective (studies often de facto-rigged in favor of effectiveness), it attracts dollars from two sources: from those willing to pay out of pocket and from insurers, private and public. Those dollars are divvied up by manufacturers and providers, and together manufacturers and providers collude in a variety of ways to attract the most possible, by tending to favor the technologies that bring them the most dollars (always of course adding to this dollar-heavy cake tasty claims for superior outcomes for patients).

Providers thus line their pockets, and the best in the med-tech manufacturing put hefty dollars back into research to keep pushing the cycle (all of these interconnected factors working piston-like to drive the engine of innovation and more technology).

This is well case-study-demonstrated by the recent curious case of the drug-eluting stent, curious because DES problems appeared to have escaped the notice of the FDA until four years post-approval.

The recent information concerning DES technology is clearly tending to indicate that DES is no better than its basic first-generation bare-metal stent progenitors, when looked at in large populations and longer terms of follow-on evidence.

Even more broadly, there seems to be a building tide of evidence suggesting that the angioplasty/stenting strategy isn't all that superior to bypass surgery or even well-directed drug therapy. In particular, angioplasty/stenting has been revealed by new studies as not being particularly effective in the treatment of heart attack patients if not used rather quickly — the effective window only about three weeks wide after the MI.

And the play-in of health insurance as a driver to the more sophisticated DES over BMS is pretty clear as well. For instance, a study presented at the recent American Heart Association conference demonstrated rather cogently that the heart disease patient on the ramp for angioplas-ty/stenting is more likely to get the DES device if he or she has health insurance. The particular economics here are twofold: the uninsured patient is less able to pay for the DES and less likely to afford the necessary follow-on regimen of expensive anti-platelet therapy.

All of this is a fairly complex syllogism that leads to the conclusion that a firm and rather powerful decider of therapeutic decision-making is, one, the ability to pay, and, two, the ability to attract health reimbursement.

Yes, medical technology has done wonderful things. This writer has experienced its benefits, as probably have most readers of Biomedical Business & Technology. But many of us, or people we know, have probably experienced its down sides. And the umbrella fact is that the U.S., while having the best, most expensive healthcare technology in the world does not have the best healthcare — or health. And despite all of the many, many benefits of med-tech, those benefits may be part of a system that puts too many Americans too often on the risky side of the risk/benefit ratio.