So here comes another flawed study – randomly-controlled and all, and published in The New England Journal of Medicine, no less – that purports to show that medications work better than lifestyle changes to reduce cardiovascular risk in diabetics.
The study was named Look AHEAD (Action for Health in Diabetics), but would more aptly be named Cover Your BEHIND for its defense of the medical status quo of over-medicating patients (see “Better Than Drugs“).
It comes, after all, on the heels of last week’s report that 7 in 10 Americans are on medications and over half are on multiple medication regimens (see “Medication Madness” for more on the risks of this dominant practice called “polypharmacy”).
The study was sponsored by the National Institutes of Health (NIH) and other federal agencies and 16 medical institutions, with some support from pharmaceutical and other corporate sponsors. There’s no separating the mainstream medical practices these institutions represent, however, and the insidious influences of pharmaceutical sponsorship of medical research I discuss in detail in Our Healthcare Sucks.
This would be less troubling if pharmaceutical companies didn’t dominate the list of companies forced to settle fraud claims with the federal government (see “The Biggest Crooks on Earth?” in Our Healthcare Sucks).
If you’re uncomfortable with our medical research being largely financed – and thereby controlled – by our most corrupt industry, well – you should be.
About Those Flaws
Where to begin?
How about the fact that the group in the study undergoing “intensive” lifestyle changes took fewer medications than those in the control group? This served to skew the results more than if both groups being compared were comparable in their medication regimens.
Or how about failing to require a high quality diet in the lifestyle group ? Simply losing weight – and the lifestyle group did lose substantially more weight than the control group – isn’t always healthy. There are both healthful and dangerous ways to lose weight – and some of the “meal replacements” allowed in this study tend to the latter.
Having few limits on the dietary composition of the lifestyle group essentially ignored the quality of nutrients consumed by the lifestyle group – a rather glaring omission. Requiring fewer simple (processed) carbohydrates and more healthful unsaturated fats found in Mediterranean diets would likely have had a much more significant impact on cardiovascular risk, not to mention a host of other life-threatening risks like stroke and Alzheimer’s Disease.
For more on the methodological and other flaws of this study, see the comments on the article in MedPage Today about this study.
Need more? The physical activity level of the lifestyle group was barely enough to move the needle on their aggregate metabolic equivalents, or METs (for more on relative METs of various physical activities, click here). If that’s “intensive”, this post is worthy of a Pulitzer.
It wasn’t, and this isn’t.
So What DID It Prove?
All this study really proved is that not all weight loss is healthful weight loss. I’m currently editing my book on that very point, so this comes as no surprise.
It would have been far more meaningful – and instructive – had it controlled for dietary quality and intensity of physical activity, as well as other crucial lifestyle factors like quality and quantity of sleep and stress reduction efforts. This synergistic package of healthful lifestyle behaviors would better mirror the polypharmacy regimen of the study’s control group and would undoubtedly have shown a much stronger impact on cardiovascular and other disease risk measures.
It’d also have helped if it measured the effects of both interventions on more than cardiovascular disease and deaths. There’s considerable evidence – of better quality than this – that insulin and other medications taken by the study’s control group create their own risks of harm, including twice the risk of premature death from cardiovascular and non-cardiovascular causes.
And What’s It Suggest?
An editorial accompanying the study in The New England Journal of Medicine outlined some additional concerns and considerations about this study. One of the effects of the study’s lifestyle interventions – under-powered as they were – that it notes is they “reduce the need for and cost of medications”.
Is it any wonder that pharmaceutical companies fund studies biased to discredit lifestyle interventions that reduce demand for their products? This may make their shareholders happy, but it’s no way to practice medicine. Or, perhaps more accurately, it’s no way to improve patients’ health.
The editorial concludes as follows:
“Even with no clear evidence of cardiovascular benefit, the Look AHEAD investigators have shown that attention to activity and diet can safely reduce the burden of diabetes and have reaffirmed the importance of lifestyle approaches as one of the fundamentals of modern diabetes care.”
Somehow I don’t see this as being the take-home message most doctors will glean from this study.
“Never Ask a Barber If You Need a Haircut”
Let me close with a question:
If you asked the association of barbers to study whether Americans need more or fewer haircuts, what do you suppose their study would conclude?