Nutrition Support Blog: YOU are the Nutrition Support “FDA”
August 29, 2012
Most nutrition support professionals that I know were not attracted to clinical nutrition because they had the illusion the field offered ready opportunities for vast wealth, power or fame. A desire to help sick patients is often a core motivation for those of us who stay in the clinical arena for any length of time. Naturally, when nutrition products become available that promise to improve patient outcomes, there is an undeniable desire to use the new products.
I distinctly remember my excitement some years ago when the first abstracts about “Immune enhancing” enteral feeding products were published. Notwithstanding my nutrition-geekiness about being excited about a new enteral feeding product, the initial claims of 40% reduction in infections and a 25% decrease in ICU length of stay were very compelling. Many facilities immediately put these products on their formularies, despite the fact that the initial studies were very small and not well controlled. Unfortunately, follow-up studies suggested that some patient populations may be harmed by the arginine supplemented “immuno-enhancing” products. Although these is reasonable evidence that immuno-enhancing formulas improves outcome in elective surgery of GI malignancy, to date, adequate data does not exist for anyone to know if all of the ingredients are necessary, what is the best ratio of these pharmaconutrients, or who exactly (outside of GI oncology surgery) may be helped or harmed if they are used. The reality is that it takes very large multicenter trials to investigate outcomes in critically ill patients, and no company is willing to spend millions on research if they cannot patent a product and realize a return on their investment.
It is frustrating beyond measure that there may be nutrient combinations that may be helpful for our critically ill patients, but we still do not know what they are and whether they may be helpful or harmful. Regrettably, it would an incalculable error to give pharmaconutrients under the assumption that, “it might help, won’t hurt”- especially in critically ill patients. The pages of ICU journals are filled with trials of promising new therapies that turned out to be harmful when properly studied1, and a number of seemingly benign nutrients such as vitamin E, B-carotene and even calcium have turned out to be harmful in supplemental doses2-4.
Unlike medications, there is no FDA approval process that requires large, carefully controlled safety and efficacy studies for enteral nutrition products. The only real control over how much research is required before a product is infused in sick humans is the willingness of clinicians to use a product. As long as clinicians continue to use products based on marginal data, there is no motivation to continue research until full information is available. It is the responsibility of nutrition clinicians that care for sick people to understand the limits of available data, be able to distinguish science from advertising, and absolutely refuse to use products that do not have adequate outcome studies supporting their use – especially when these products come at an increased cost compared to standard fare. We would all like nutrition products that have a capacity to help our sickest patients, but without adequate data, our desire to do good can have results that we did not intend.
“Understand that I would use this Ring from a desire to do good. But through me... it would wield a power too great and terrible to imagine.”
- J.R.R. Tolkien
1. Wenzel RP, Edmond MB. Septic Shock — Evaluating Another Failed Treatment N Engl J Med 2012; 366:2122-2124
2. The Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994;330:1029–1035.
3. Klein EA, Thompson IM Jr, Tangen CM, et al. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011;306(14):1549-56.
4. Bolland MJ, Avenell A, Baron JA, et al. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ 2010;341:c3691.