Supplements are making headlines for the second time in a week. This time, vitamin E has been found to potentially increase risks for prostate cancer, according to a new study reviewing the effects of antioxidants on male health.
The announcement followed another announcement that some popular daily supplements such as multivitamins, iron, magnesium, and B6 are linked to increased death risks in women.
The SELECT trial, which involved the vitamin E study, was initiated in 2001, and utilized the well-respected double-blind, placebo controlled trial, considered, said MSNBC, to be the highest scientific evidence standard. The studyâ€™s goal was to prove that vitamin E and selenium reduced prostate cancer risks, a suggestion seen in prior, small studies, noted MSNBC. The study on women and vitamins was an observational study and calls for additional research.
The SELECT trial, which was funded by the National Cancer Institute, involved 35,000 men and tested one or both supplements, or a placebo. By 2008, the study was halted when no benefit was seen, explained MSNBC. Regardless, the team continued to monitor the participants and found that after four years of follow-up, that vitamin E increased prostate cancer risks by 17 percent in men taking a daily dose of 400 IUs, according to the report’s conclusion, said MSNBC. The report is published in the Journal of the American Medical Association. The researchers believe selenium might also reveal negative reactions. The team continues to follow the participants.
“I was surprised by the results of this trial,” said Dr. Eric Klein, a urologist and the team lead from the Cleveland Clinic in Ohio. “There was a substantial amount of evidence going into SELECT when it was designed in the early 2000s to suggest that vitamin E or selenium might prevent prostate cancer and that’s why we did the trial,” Dr. Klein added, wrote MSNBC. “Consumers should be skeptical about claims that are made on bottles and elsewhere unless there is solid scientific evidence,” Klein noted.
As weâ€™ve mentioned, about two-thirds of all Americans take at least one daily supplement and Americans spent about $11.8 billion on vitamins and minerals in 2010.
While medications undergo safety and efficacy testing in order to receive approval by the FDA for release to market, dietary supplements do not. In the case of supplements, manufacturers must ensure safety, efficacy, and proper labeling. Also, as weâ€™ve previously noted, supplements made from products available on the U.S. market prior to 1994 can be sold with no agency review, including a wide variety currently available. Sellers of products containing substances unavailable prior to 1994, need only advise the FDA and do not require approval to be sold.
Earlier this year, the FDA announced it is seeking clarification on safety rules in effect for dietary supplements, and was issuing draft guidelines meant to assist with firmsâ€™ compliance with the 1994 regulation, mandating makers file a safety notification with the agency prior to advertising any dietary ingredient not on the market in 1994. Since the lawâ€™s passage, the agency said it only received about 700 such notifications, but believes over 55,000 dietary supplement products are being sold and marketed today.
To date, the FDA has only ever banned one supplement ingredient: ephedrine alkaloids.