Is desire clouding our objectivity or is there an emerging recognition that politically-correct medical science is imposing huge costs on our healthcare system? Junkfood Science led off this week with further coverage of the ethically-compromised ENHANCE trial, asking: "How much more are we spending for medications due to excessive mark-ups, but also for medications that may not provide the clinical benefits they purport?"
Blogger Sandy Szwarc revisits earlier posts (covered by our blog ), pointing out that reliance on a flawed process. We agree. Ignoring evidence-based results as has the U.S. Dietary Guidelines, produces scientifically-flawed recommendations. Just a glimpse of her perspective (which we heartily share):
Amidst all of the congressional hearings and media notice, and amidst the recent infestation of shark lawyers filing class-action lawsuits across the country over alleged cover-ups of the ENHANCE trial results, we mustn't lose sight of the far greater issue in all of this:
"The integrity of the scientific process ... in how drugs are researched and approved, and clinical guidelines are developed." JFS began covering the ENHANCE clinical trial issue last November . This trial provided an opportunity to examine the importance of randomized controlled clinical trials, the gold standards of evidence-based medicine. Sound trial designs that are fair tests include randomization; double-blinding; a placebo control group; control of study data and analysis of study data by bodies independent from drug company sponsors; and primary endpoints that are actual clinical outcomes, such as reduced premature deaths, versus false surrogate endpoints.
On January 17th, "How'd we get here ?" described the foundations of clinical trial evidence for drugs approved by the FDA that have been abandoned, and called into question the use of surrogate measures, like cholesterol, as proxies for actual clinical benefits to lives. When surrogate endpoints are used in order to expedite R & D for new drugs, post-market clinical trials are supposed to follow to provide the FDA evidence that these markers are valid and that the drugs actually save lives. But those studies never seem to come.
… Perhaps this hubbub will lead everyone to question their own assumptions and fears about health risk factors and to look closely at the evidence on cholesterol lowering for prevention of heart disease and whether it extends lives. Perhaps this hubbub will lead everyone to question their own assumptions and fears about health risk factors and to look closely at the evidence on cholesterol lowering for prevention of heart disease and whether it extends lives.
Our issue, of course, isn't cholesterol, but the same dynamic is playing out in the great salt debate. Let's keep the focus on the real issue: will reducing dietary salt improve health? Perhaps we can then realize the health improvements we deserve for the enormous investment society makes in our healthcare system.
Although the headline of today's Wall Street Journal misleads readers into thinking it focuses on blood pressure, WSJ blogger Shirley S. Wang makes it clear that her focus is on whether new medications "prevent heart attacks and death any better than an old-fashioned diuretic." Referencing a new report about the ALLHAT study in the Archives of Internal Medicine , she calls for a focus on the health outcomes of various interventions.
I responded for the salt industry:
ALLHAT was an important step for another reason not yet discussed in this thread: rather than focus on the "risk factor" of blood pressure, it addressed the truly important question of whether the intervention (in this case anti-hypertensive drugs) achieved the expected health outcomes benefit. Too often we've confused "risk factors" with absolute risk. It is the event -- the heart attack the stroke, i.e. cardiovascular health and mortality -- that should concern us individually and be the focus of our public health policy.
I am president of the Salt Institute, the industry association of salt producers. We monitor the medical literature and participate in the public health debate. ALLHAT provides important information to physicians who make recommendations to their patients. Likewise, as an exercise in focusing on the health outcomes of a recommended intervention, ALLHAT is a proper model for our public health decision-making as well. Regarding salt, for example, the question should not be "will salt reduction improve blood pressure?" Blood pressure is the "risk factor" and there are other risk factors (e.g. insulin resistance, plasma renin activity, sympathetic nervous system activity, etc.) which are affected by reducing dietary salt. As in ALLHAT, we should be asking: will this intervention improve health outcomes? Will reducing dietary salt improve actual risks of heart attacks and strokes? Will cutting back salt improve cardiovascular (and all-cause) mortality?
If you think you know the answer, I'd suggest that answer isn't "politically correct" and invite you to review the issue on our website at http://www.saltinstitute.org/28.html or access a comprehensive list of the studies of this question at http://www.saltinstitute.org/healthrisk.html .
We have recommended to the Department of Health and Human Services that it conduct a controlled trial of the health outcomes of reduced-salt diets using the ALLHAT rationale and modeled on a recent study, the Trials of Hypertension Prevention, which demonstrate both the ethics and the study protocol appropriate to determine whether those who encourage general salt reduction are likely to improve public health.
