01.06.10
Treatment with folic acid plus vitamin B12 was associated with increased cancer outcomes and all-cause mortality in patients with ischemic heart disease in Norway, according to a controversial study published in the Journal of the American Medical Association (JAMA) in November. This study evaluated outcomes from two randomized, double-blind, placebo-controlled clinical trials (Norwegian Vitamin Trial and Western Norway B Vitamin Intervention Trial). A total of 6837 patients with ischemic heart disease were treated with B vitamins or placebo between 1998 and 2005, and were followed up through December 31, 2007. A total of 136 (4%) who received folic acid plus vitamin B12 compared with 100 (2.9%) who did not receive such treatment died from cancer. Results were mainly driven by increased lung cancer incidence.
Responding to the study’s release, Daniel Fabricant, PhD, vice president of scientific and regulatory affairs for the Natural Products Association (NPA), Washington, D.C., noted design flaws in both studies and questioned the overall conclusion. “This does not seem to be in the best interest of medical science or public health,” he said. In addition, most of the subjects in both trials were also being treated with beta-blockers and statins, and some were also being treated with ACE inhibitors and diuretics, “yet there are no numbers, no analysis on the effects these interventions may have on the incidence of cancer,” he added. Andrew Shao, PhD, vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN), Washington, D.C. said it is important to note that the results from this study “are inconsistent with the larger body of data and that this effect has not been observed previously. In fact, as the authors themselves point out, ‘Epidemiological studies have demonstrated no associations between intakes of folate or folic acid and lung cancer risk’.”
Responding to the study’s release, Daniel Fabricant, PhD, vice president of scientific and regulatory affairs for the Natural Products Association (NPA), Washington, D.C., noted design flaws in both studies and questioned the overall conclusion. “This does not seem to be in the best interest of medical science or public health,” he said. In addition, most of the subjects in both trials were also being treated with beta-blockers and statins, and some were also being treated with ACE inhibitors and diuretics, “yet there are no numbers, no analysis on the effects these interventions may have on the incidence of cancer,” he added. Andrew Shao, PhD, vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN), Washington, D.C. said it is important to note that the results from this study “are inconsistent with the larger body of data and that this effect has not been observed previously. In fact, as the authors themselves point out, ‘Epidemiological studies have demonstrated no associations between intakes of folate or folic acid and lung cancer risk’.”