CRN: RCT results don’t necessarily debunk benefits of dietary supplements
WASHINGTON Results of randomized, controlled trials that don’t vet the benefits of dietary supplements as noted in prior observational trials don’t necessarily debunk those benefits, the Council for Responsible Nutrition stated in a release last week.
“Over the past several decades, a series of observational trials resulted in exciting prospects for the benefits of antioxidant vitamins and chronic disease,” stated Andrew Shao, vice president, scientific and regulatory affairs, CRN. “These encouraging results led the scientific community to conduct the recently released randomized, controlled trials, which seemed to be the next logical step. While everyone—researchers, industry and consumers—would have been thrilled to see the positive findings from observational studies confirmed, this has not been the case. This leads to more intrigue for the scientific community—to try to determine why the results from these recent RCTs are in apparent conflict with the existing body of data,” he said.
“One explanation is that … RCTs may be inherently limited in their capacity to address the unique challenges presented by nutrients and dietary interventions. Nutrients appear to work best in combination with other nutrients, yet RCTs tend to examine effects of unique chemical molecules in isolation—which is how pharmaceuticals work. Further, in using RCTs to study nutrition questions, there is the challenge of being able to create a true control or placebo group,” Shao noted. “In contrast to pharmaceuticals, it is both impossible and unethical to ensure participants in the control group are not exposed at any level to vitamins and minerals.”
Vitamins play a vital role in promoting overall general health and filling specific nutrition gaps, Shao added. And despite the results from recent studies, there is additional research that suggests antioxidant vitamins may play a role in helping to lower the risk of chronic diseases. “However, vitamin supplements are just one piece of the puzzle, which may be why we didn’t see the results we anticipated from the recent clinical trials,” he said. The other pieces of the puzzle may include pursuing an active lifestyle and practicing good nutrition.
“Perhaps we need to revise our expectations that one single healthy habit will serve as a ‘magic bullet’ and allow us to live disease-free—after all, one piece does not complete the whole puzzle, but we certainly don’t discard the piece just because it doesn’t fit in a particular spot.”
ScriptPro wins FDA database contract
MISSION, Kansas The U.S. Food and Drug Administration has awarded a contract to ScriptPro USA Inc. to provide a searchable drug database for the agency’s internal use.
The data will be based on the drug information resource provided by ScriptPro to support its pharmacy automation systems, and will include all prescription and over-the-counter drug products available for human use in the United States.
Behind the FDA’s decision: ScriptPro’s deep and wide-ranging information capabilities. The pharmacy technology and robotics firm says it develops and maintains the largest and most complete electronic image database of drug and over-the-counter products.
Among the features the FDA is looking for: on-screen images of drugs and drug packaging for verification; data on all versions of each drug released in the market, including images, markings and other descriptive elements; auxiliary warning labels applicable to the products; and drug-specific alerts including FDA black box warning labels.
ScriptPro said it will work “closely with pharmaceutical and OTC manufacturers to incorporate new products and changes into the database,” and will monitor the agency’s internal records and provide information to keep FDA data current.
Fashion Sanctuary recalls weight loss capsules after FDA alert of undeclared additive
SAN DIEGO Fashion Sanctuary on Sunday recalled all lot codes of Zhen De Shou Fat Loss Capsules sold in 10 count blister cards. The recall was initiated after notification by the Food and Drug Administration that lab analysis of Zhen De Shou samples found the product to contain undeclared sibutramine, making it an unapproved drug, the company said.
Sibutramine is a prescription drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The product was primarily distributed in the United States and sold via Internet. It is sold in a box with an inner foil pouch. Inside the pouch is a blister pack containing light and dark green capsules. This recall affects all lot codes and use by dates. No illnesses or injuries have been reported to date in connection with this product, Fashion Sanctuary reported.