NPA Challenges Folic Acid, Cancer Study

WASHINGTONThe Natural Products Association released a statement challenging the  Journal of the American Medical Association (JAMA) study that indicated an associated increased risk of cancer and death from any cause if the study subjects received treatment with folic acid and vitamin B12 (2009 Nov 18;302(19):2119-2126).

In response to the findings, Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs for the Natural Products Association said the two studies analyzed in the reviewthe NORVIT (the Norwegian vitamin trial, a 2005 randomized trial of homocysteine-lowering with B-vitamins for secondary prevention of cardiovascular disease (CVD) after acute myocardial infarction) and WENBIT (Western Norway B-vitamin intervention trial presented at the European Society of Cardiology Congress 2007)were not conducted in a way to determine scientific results. He said:  Despite the authors justification for the analysis, previous review has indicated the NORVIT might not have been adequately powered and the factorial design might have been too complex, thus rendering the trial incapable of isolating the effect of folate per se. Being combined with the WENBIT, which was terminated early, and which wasnt without its design flaws, either, creates a scenario in which two flawed studies are combined to yield one larger flawed study. This does not seem to be in the best interest of medical science or public health.

Fabricant also states that 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. There is no adjustment of the baseline effect for these interventions, yet the authors adjusted the baseline for smoking, age and sex, which are all factors in the development of cancer. We have no way of determining these factors impact on this study as they just decided to leave that out, like ordering off of an a la carte menu," Fabricant said.