Diseases, Devices and Delusions

We learned recently that the Food and Drug Administration approved a new high-tech device for weight loss. While this column isn’t really about the technological particulars, we should at least note that the device, which requires surgical implantation of electrodes something like a pacemaker, is designed to stimulate the vagus nerve with intermittent electrical pulses. Those pulses in turn are intended to activate the vagus nerve pathway, and provoke a feeling of satiety.

The FDA’s approval is based on successfully completed clinical trials, of course. But the success in those trials was rather modest. In fact, a group of experts asked about likely success with the product in the real world did quite a bit of hemming and hawing.

I wasn’t asked to opine on that occasion, but had I been, I would have hemmed and hawed along with them. As noted, the effectiveness of the product in the tightly managed construct of clinical trials was only fairly modest. But more importantly, we are richly endowed with redundant metabolic systems to prevent starvation, not obesity. For the most part, we have found that any given high-tech approach to obesity tends to wane in its effectiveness over time, as other pathways compensate. This is certainly true of drugs, and pertains to surgery. There is no reason to think a device like this would be exempt, and every reason to think otherwise.

We could go on about potential limitations of this particular device, but let’s move on, because we have bigger fish to fry. Let’s talk about the fundamental limitations of ourselves, and our culture, when it comes to managing obesity and the chronic diseases it portends.

Let’s acknowledge that FDA approval doesn’t guarantee coverage by insurers — but that it greases the skids for it. In general, insurers in the U.S. do wind up covering FDA-approved drugs and devices, just as they routinely cover surgery. In many such cases, the coverage comes before, rather than after, evidence of long-term effectiveness. In fact, in some cases, coverage comes — and evidence of long-term effectiveness never does. Sometimes, in fact, as is true of high-profile debacles in pharmacotherapy like the Vioxx saga, just the opposite happens: Insurers cover something we probably never should have been prescribing or taking at all.

Let’s contrast all this to the laudable efforts of my friend and colleague, Dr. Dean Ornish. Dr. Ornish, as I trust most readers here know, demonstrated — way back in 1998 — that a lifestyle intervention could actually cause regression (i.e., shrinkage) of atherosclerotic plaque in coronary arteries. In subsequent studies, he showed that the intervention cut rates of heart attack dramatically, too. In more recent studies, he and colleagues have shown that lifestyle interventions can favorably affect even gene expression; we can, in fact, nurture our very nature.

But while Dr. Ornish’s exemplary career is on the one hand a beacon of success for those of us in Lifestyle Medicine, it is, on the other hand, a precautionary tale.

Yes, the lifestyle intervention studied by Dr. Ornish in the ’90s is now reimbursed by Medicare and many private insurers as an alternative to coronary bypass surgery. But to make that happen took 17 years! It took 17 years of indefatigable effort by Dr. Ornish and others, even after the evidence was published. Does anyone think we will be still debating reimbursement of the vagal stimulator in 2032? If so, I have a bridge on sale I’d like to show you.

We live in a system that demonstrates almost no interest in wellness. The big drug and device companies exert a great influence on the big insurance companies, and the rest of us are spectators. So the default decision is to cover most new drugs, devices and procedures as soon as they come along — while more powerful, but less patentable, alternatives languish. They usually languish forever, but the best-case scenario appears to be: They languish for the better part of 20 years.

So while it’s almost certainly true that the right kind of schools can do for adolescent obesity what scalpels are doing ever more often, we fund the latter and the let former languish.

I have relatively little faith in the long-term efficacy of a vagal nerve stimulation device for the control of obesity. I have rather grave concerns about the attendant costs, the probable complications and the complete neglect with such an approach of other family or household members. But I suspect insurers will be covering the device quite soon, because that’s how we roll. Dollars are made available for drugs and devices. For the greater, safer, more universally-relevant effects of living well? Fuhgeddaboudit. Or, at best: Wait 20 years and check back.

My friends, it’s a delusion to think that drugs and devices can ever replace the salutary effects of good daily use of feet, and forks. It’s a delusion to think we can keep bankrolling the medicalization of socially-propagated morbidity and remain solvent. It’s a delusion in an age of rampant with childhood obesity to think that adults can just take a drug, try a fad diet, or have electrodes implanted — and somehow all will be well. It’s a delusion to think that anything at the cutting edge of biomedical advance can save us from ourselves, if we neglect our health at its origins in our culture.

It’s a delusion to think we can have the longevity and vitality we want, while embracing every labor-saving invention as a New Age necessity; while glorifying donuts as sustenance, bacon as a condiment and multicolored marshmallows as part of a complete breakfast.

It’s a delusion. How can I be sure? I have conferred quite closely with all the King’s horses, and all the King’s men. Standing amidst the fragmentary remains of a once glorious egg, they declare it so.