NIH-funded clinical trials misguided for supplements

By Clarisse Douaud in Anaheim

- Last updated on GMT

Related tags: Clinical trials, Research

The traditional scientific model does not always apply to dietary
supplements, nor does the objective of government-funded clinical
trials in testing them necessarily suit their common applications,
according to NutraCon panelists.

As part of "The State of Governmental Science"​ panel, Joseph Betz, Luke Bucci and Dr. Mary Hardy discussed the relevance and challenges specifically facing large scale National Institutes of Health (NIH) funded clinical trials using dietary supplements. Despite government investment in such studies, according to panelists, outcomes have not often been favorable because the objectives did not fit the products. Not only does this reflect a bias on the part of researchers, they said, but it leads to misinformation in the media. Hardy, medical director at UCLA's Simms/Mann Integrative Oncology Program, cited the results of a Stanford University Medical School clinical trial on garlic released last week stating that garlic does not lower LDL cholesterol. This trial should never have been conducted, said Hardy, and a supplement scientist would have known this. But Hardy did not specifically blame the researchers involved. "I think these are sins of omission, not co-mission,"​ she said. The problem with supplement trials is that they often set the objective too high for products that are not meant to be therapeutic, or they use incorrect dosages, suggested panelists. "What kind of instruments can you use to test general wellness?"​ asked Hardy. Betz, a director at NIH's Office of Dietary Supplements, said that in his opinion, unlike many clinical trials involving dietary supplements, the Stanford garlic trial did not overreach in its conclusions. He added that NIH has learnt from its mistakes. "There are studies in the pipeline that will be less unflattering to this industry,"​ said Betz. He suggested that interdisciplinary research teams are a way to prevent against misdirected trials. Bucci, vice president of research with Schiff Nutrition International, commented that while industry wants to collaborate with NIH-funded clinical trials, it is not always motivated to because the risks involved. "The speed is not fast enough,"​ said Bucci. "And if it doesn't work you've lost the commercial viability."​ Bucci used the NIH GAIT clinical trial as an example of how NIH does not keep pace with industry's scientific research needs. The GAIT began in 1998, and tested the effects of glucosamine and chondroitin for supporting the symptoms of knee osteoarthritis. "By the time the study results were released in 2005, the industry had moved on to add other ingredients as well,"​ said Bucci. "So there was limited relevance anyway."​ Finally, Bucci pinpointed what he said is an anti-supplement bias in scientific research institutions. "There is a real mindset problem here,"​ said Bucci.

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